Being emotional and worrisome about tidbits in your life is natural.
But if you are suffering from anxiety, can’t optimize mood swings or unable to clarify the cloud of mental stress, then this could lead to a major reason for depression.
Above all these emotional outbreaks turn into a dysfunction and other serious psychological illnesses.
According to numerous researchers based on distress, mental health problems cost you financially, socially and emotionally.
But surprisingly, there are more organic ways to minimize the psychological stress from your life than to walk into a psychiatrist’s clinic.
We often opt for quick remedies like painkillers, antidepressants or anti-insomnia medicine to suppress the agony we feel.
But little do we know that our daily diet, physical activity, sugar intake, alcohol consumption and numerous other factors play a vital role in maintaining the mental balance and throwing the outburst of negative emotions.
Adding greens to your diet, properly hydrating yourself, cutting down on sugar, smoking, and alcohol and incorporating moderate exercise regime can benefit you immensely to overcome the stresses.
Above, we have discussed the natural ways to optimize our lifestyle.
Thankfully, a wide variety of God gifted herbs are also present to save us from insomnia, herbs for mood swings, nervousness, anxiety or pain.
These herbs can do wonders by calming the nervous system and stimulating neurons in the brain to feel happy, relaxed and loosen up the mental stress.
The wonder plant all the way from South Pacific Islands have numerous benefits.
It has been used in ceremonies and as medicine for centuries.
Kava plant shows visible calming effects such as its deals with restlessness, anxiety, sleeplessness, and pain.
It also aids in relieving stress-related symptoms like muscle tension and spasm.
For insomnia patients, it often shows a great result in stimulating deep sleep without disturbing restful REM sleep.
Usage: Traditionally kava is used as a tea, kava root is often available in dietary supplements as powder and tincture.
Kava should not be used with psychotropic medicine (a medicine used to treat psychiatric disorders)
Long-term use of kava can lead to liver damage
Alcohol aggravates the kava’s sedating effects. It is advised not to drive or use heavy machinery while the effect is ongoing.
St. John’s Wort (Hypericum perforatum)
For centuries, this flowering plant, St. John’s Wort has been used in Europe to treat depression and mood disorders.
This herbal medicine is best for treating numerous kind of disorders such as anxiety disorder, obsessive-compulsive disorder (OCD), severe depression and seasonal affective disorder.
Therefore it is one of the most widely used herbs for mood and emotional distresses.
Usage: The standard dose for adults suffering from depression is 300mg of St. John’s wort (of 0.3% hypericin extract) three times a day.
John’s wort should not be used with antidepressants, birth control pills, the blood thinner, HIV and cancer medications.
Uncommon side effects are dizziness, headache, anxiety, stomach upset, sexual problems and fatigue.
Lemon Balm (Melissa Officinalis)
The everlasting calming herb belonging from the mint family is a highly used lemon balm.
Many people have benefitted and stated for its high calming effects such as it is used to relieve anxiety, restlessness and sleep problems.
Lemon balm is also beneficial in treating digestive problems, upset stomach, menstrual cramps, vomiting and psychological disorders including, hysteria, melancholia, and ADHD (attention deficit hyperactivity disorder).
Due to its visible effects, many doctors suggest its usage for Alzheimer’s disease and autoimmune disorder involving the thyroid (Graves’ disease), high blood pressure, sores and insect bites.
Usage: Lemon balm leaves are often dried to make tea. It can be applied on the skin to treat cold sores and It is also used as aromatherapy for Alzheimer’s patients.
There are no visible side effects associated with lemon balm, however, when taken raw it showed minor side effects like nausea and vomiting in some of its users.
It is suggested for pregnant and breastfeeding women to avoid taking lemon balm although there are no evident side effects.
Similar to rose, the wild shrub naturally grows in Mexico and Central America.
Damiana has natural chemicals which help in maintaining mental balance and calming the nerves.
Traditionally the leaf and stem of damiana are used to make medicine to treat a headache, depression, bedwetting, boosting mental and physical stamina.
Usage: The appropriate dose of damiana is based on different factors such as user’s health, age, and several other conditions.
It is required to consult physician or herbalist for proper guidance and Damianausage.
Damiana is likely safe when taken in an appropriate amount.
It often shows side effects in patients suffering from diabetes.
As it affects the glucose level in the blood (hypoglycemia), therefore it is advised to monitor diabetes if you are an active user of damiana.
Passiflora is a plant consist of chemicals which have sleep-inducing, muscle relaxing, calming and relieving effects.
The above ground part of the plant is used to make medicine to treat sleep problems (insomnia), general anxiety disorder and nervousness.
Passionflower is often used in combination with other herbal products to induce sedation to promote calmness and relaxation.
Other usages of passionflower are for the treatment of seizures, hysteria, excitability, high blood pressure, asthma and pain relief.
Some people often use passion flower as topical medicine to treat inflammation, hemorrhoids, skin burns and pain.
Usage: According to scientific research for the usage of generalized anxiety disorder, 40 drops of passion flower liquid extract daily is beneficial. Passionflower is also available in the form of tablets or tea.
Passion flower doesn’t show any side effect when taken in right amount as of normally found in food.
If taken in large amount it could show negative effects like high blood pressure, confusion, dizziness, irregular muscle action, altered consciousness, nausea, and vomiting.
Golden Root (Rhodiola Rosea)
Golden root is also known as Aaron’s rod is a flowering plant, commonly found in cold regions.
For centuries, golden root has been used by people to deal problems with extreme cold.
It is an adaptogen plant which has natural chemicals to reduce stress and optimize the power of the mind.
Golden root is also an endurance level controller due to which it has high regards among bodybuilders.
It has various other benefits like optimizing physical performance, stimulating happiness and hopefulness in mind.
Usage: Rhodiola tea is mainly used as it is also said: “people who drink Rhodiola tea lives for more than 100 years”.
Golden root extracts are also available in powdered supplement form. It is advised to take not more than 180 to 600mg per day.
There are no visible adverse effects related to goldenrod however, it is advised not to exceed the given dosage.
Should not be used on people suffering from fluid retention (heart or kidney diseases).
Oatstraw (Avena sativa)
From calcium to several other mineral deficiencies, Oatstraw is used to combat insufficiencies in a human body.
Avena sativa is a favorite cereal grain used as breakfast in western parts of the world for centuries.
Oatstraw is beneficial nervine, sedative and nutritive.
It boosts the quality of mental health and enhances psychoactive effects for treating nervousness, anxiety, mood, and behavior.
It is also considered in treating migraines, shingles, and fatigue and skin inflammation.
It helps in relaxing spasmodic muscles and often recommended to pregnant women to combat nervous exhaustion.
Usage: Is adopted by people such as young milky oats as a fresh tincture. Dried Oatstraw as tea and bath. Oat grains in cereals there are several forms of Oatstraw which for breakfast.
There is no evidence of adverse effects related to usage of Oatstraw. However, it can cause gastrointestinal discomfort, gas and bloating.
If you have a problem while swallowing (for example in stroke patients) or trouble chewing, it is advised to avoid eating oats as it can cause blockage of the intestine.
Binomial name for kratom is MitragynaspeciosaKorth which natively grows in the region of Southeast Asia.
This tropical evergreen plant belongs to a coffee family.
It has a number of visible effects in the human brain, such as it causes alertness, relief from depression, controls mental balance, boost energy levels, relief fatigue, improve concentration, focus and mental acuity.
A large dose can also cause sedation as well analgesic effects.
Other advantages associated with kratom include lowering blood sugar levels, control hypertension, antidiarrheal effects, also relief from cold and allergy symptoms.
Usage: Dosage prescribed is usually based on person’s age, body mass, and general tolerance, so it is required to start with low to moderate dose.
Kratom generally comes in powdered form which can be mixed with coffee, juice or milk. The moderate dose of kratom usually lasts for up to 4 hours.
Muscle jerking, irritability, and runny nose are possible adverse effects seen after large doses of kratom.
It is advised to use kratom after proper guidance from healthcare professionals as it can cause over-sedation.
Ashwagandha (Indian ginseng)
Ashwagandha is also known as winter cherry. It is one of the well-known Ayurvedic and Unani medicines.
Benefits related to ashwagandha are called adaptogenic as it is used as a general tonic to treat daily stresses.
Some of the other optimistic effects are anxiety reliever, deals with insomnia, backache, high blood pressure and menstrual problems.
The famous Dr. Frank Lipman has called ashwagandha the “nature’s miracle anti-stress and fatigue fighter” because it promotes longevity, vitality, energy boost, endurance, stamina and combats the mental and physical exhaustion.
Usage: Specific dose is based on person’s health, age, and body mass. Although doctors prescribe doses of dried root range from 3-6 grams per day.
Long-term use of ashwagandha might cause nausea, stomach upset and vomiting.
For diabetic patients, it is recommended to avoid Ashwagandha with any other diabetic medication as it lowers blood sugar level.
Naturally grown plants and herbs are god gifted organic medicine to treat a number of disorders.
However, it is advised to consult herbalist or healthcare professionals before using such herbs for mood as every human body reacts differently, and an incorrect amount of dose could lead to possible dangers.
It is often advised especially for patients suffering from other major diseases as well as pregnant and breastfeeding women to consult their physician for proper guidance.
June 21, 2018
The Honorable Mitch McConnell
United States Senate
Washington, D.C. 20510The Honorable Charles Schumer
United States Senate
Washington, D.C. 20510
The Honorable Paul Ryan
United States House of Representatives
Washington, D.C. 20515
The Honorable Nancy Pelosi
United States House of Representatives
Washington, D.C. 20515
Dear Leader McConnell, Leader Schumer, Speaker Ryan, and Leader Pelosi:
We write today to address the U.S. Food and Drug Administration’s (FDA) recommendation
to the Drug Enforcement Administration (DEA) to schedule the kratom plant and its two
biologically active alkaloids, mitragynine and 7-hydroxymitragynine, under Schedule I of the
Controlled Substances Act (CSA). Based on the substantial science and safety signal data, we
conclude that kratom does not meet the statutorily mandated criteria for Schedule I
substances based on their potential for abuse, safety, dependence liability, and medical use
Therefore, we strongly recommend that the DEA return the scheduling recommendation to
the FDA for additional review and research and encourage the FDA’s Office of Dietary
Supplements to appropriately regulate kratom products. This matter is urgent because there
is a foreseeable negative public health consequence if legal kratom is banned: thousands of
former opioid users will be at risk of returning to high-risk opioid use and may add to our
nation’s opioid overdose epidemic.
We urge you to do all you can to convince the DEA and FDA to take these needed actions.
We need the FDA taking every reasonable step to reduce opioid overdose deaths, which
includes not risking feeding the epidemic by banning kratom.
Contrary to the FDA’s public statements, four internet surveys of more than 20,000 kratom
users and 20,236 comments on the DEA’s docket in the federal register suggest that most
kratom consumers are not opioid abusers, are not using kratom to get high, and no federal
survey has detected kratom abuse as a public health problem. In fact, people with opioid
experience generally report kratom as a poor alternative to opioids for getting high and are
not motivated, as they are with classical opioids, to intensify the experience by injecting,
smoking, or snorting the substance. Most people use it in food or beverage form for health
and well-being. Major reasons for use include increased general alertness and focus (similar
to caffeinated products), use to relieve depression and anxiety, use to relax and as a sleeping Congressional aid, and use to relieve pain in place of over-the-counter and prescription pain relievers,
including opioids. The nearly 14,000 respondents to the three internet surveys that collected
demographic information found that U.S. kratom users largely represent a cross-section of
the middle-aged adult population having at least some college education, who are employed
and have health care coverage.
An additional motivation for kratom use that warrants particular attention in the midst of our
nation’s opioid emergency is the use of kratom in place of classical opioids for pain and/or
addiction. This is a major reported reason for use among the more than 43,000 survey
respondents and comments to the FDA. At a time that our nation is experiencing more than
115 opioid overdose deaths each day, or more than 42,000 per year, we would expect the
FDA and the Centers for Disease Control (CDC) to welcome this potential safer alternative to
classical opioids. Indeed, the FDA’s dockets, including its April to June Opioid Use Disorder
treatment development docket, include testimonials from kratom users who are “terrified”
that obstacles to kratom access will lead to a relapse of opioid use disorder.
It is with these people in mind that we write to you. This is a truly urgent matter.
Let us tell you more about the science related to how kratom works, what it does, its relative
safety, and public health implications to help you understand why we assert that FDA is
wrong on the science, and wrong in its efforts to ban legal kratom by placement in Schedule I
of the Controlled Substances Act.
There is a long history of kratom use; it has been used safely for centuries in the Southeast
Asia (SEA) region, where it grows in the wild, and for at least a decade in the United States.
Importantly, SEA authorities have not reported any kratom overdose deaths. The reasons for
kratom use in this region largely mirror those in the U.S., including use as a mild stimulant by
agricultural workers and as an alternative to opioids for pain relief and addiction treatment.
Such traditional use is reported to benefit quality of life, and improve social and occupational
behavior, with little evidence of serious personal or social harm.
A review of the available medical records for each of the 44 total deaths the FDA claims are
“attributable to kratom” shows that none of those deaths have been clearly established as a
kratom-caused overdose poisoning. Importantly, what is missing from the FDA data is a
pattern of deaths that look opioid-like (i.e., acute respiratory depression); or alcohol or
sedative-like (acute sedation and respiratory depression); or cocaine and methamphetaminelike
(i.e., cardiovascular types of deaths); which would typically be included in data submitted
to the DEA supporting a scheduling recommendation. Rather, the data are comprised of an
unusual mix of alleged “kratom-associated” deaths including various unrelated causes, such
as, (1) polydrug use of toxic doses of illegal and/or prescription drugs; (2) an underlying
medical condition that contributed to the death (e.g., leg thrombosis in an obese person); (3)
the use of an adulterated or contaminated kratom product; or (4) non-drug related
circumstances (e.g. suicide and homicide). For example, the FDA consistently points to 9
deaths that occurred over a 12-month period in 2009 in Sweden resulting from the use of an
internet drug known as “Krypton.” Krypton is a concoction that contains powdered kratom
leaves adulterated with O-desmethyltramadol (a potent opioid analgesic). Researchers
concluded that this O-desmethyltramadol adulterant was the cause of death in each of these
9 cases. In the case of the reported homicide, the decedent was shot in the chest resulting in
his death, and he happened to be a kratom user at the time of his death. The science does
not support the conclusion that kratom causes deaths on its own. Even if the FDA were
correct in its estimate of 44 kratom-caused deaths world-wide over a decade of use by many
millions of people, that would indicate a very low risk compared to many OTC drugs, dietary
supplements, and even household cleaning products.
Further, the recently publicized health risks associated with bacterial contamination of
kratom products are not unique. In fact, romaine lettuce, cantaloupes, chicken, and many
common food products have been recently identified as contaminated with salmonella, E.
coli, or other pathogens. In each case, the FDA and CDC have the statutory authority and
regulatory tools to identify the source, remove contaminated products from the
marketplace, and take appropriate steps to protect the public safety. FDA regulation of
kratom as a dietary supplement could greatly reduce such risks in the future.
Accordingly, there are no safety data to support the conclusion that kratom poses an
imminent public health risk to consumers that would justify its scheduling
Available scientific data also fail to support placement of kratom in Schedule I of the CSA. The
CSA scheduling authority is premised on the pharmacology of the substance and it is
incumbent on the FDA to submit valid scientific data supporting its scheduling
recommendation to the DEA. The pharmacology of the alkaloids isolated from kratom has
been studied enough to undermine the FDA’s claims that kratom has a high potential for
abuse, as statutorily required for Schedule I placement.
The seemingly mild to moderate effects of the raw kratom plant in humans may be explained
by the observation that mitragynine, while representing the most abundant active
compound in the plant, is typically found in concentrations of only ~1-2% by weight of the
dried leaf. Further, mitragynine is a low potency partial agonist of the mu-opioid receptor. In
contrast, the more potent 7-hydroxymitragynine occurs in only trace quantities in kratom,
suggesting that this compound does not play a major direct role in the pharmacological
activity of raw kratom or its extracts. Relatedly, the low concentrations of the relevant
compounds in the kratom plant are expected to limit the risk of adverse medical outcomes
from its consumption. Likewise, there is no evidence that the compounds mitragynine and 7-
hydroxymitragynine are available in a pure form to consumers, even via the black market,
and thus, any potential dangers of such pure compounds are not relevant to any scheduling
review of kratom itself.
Importantly, even in their pure form, the active compounds of kratom have been found to be
safer than classical opioids. Studies in multiple animal species have shown that mitragynine
does not depress the respiratory system as strongly as classic opioids, which is the main
cause of death from opioid overdose. These findings are consistent with the lack of acute
overdose deaths induced by kratom in humans. Kratom also does not provide “addictive
reward” in animal studies as compared to addictive opioids (e.g., morphine). In fact, two
intravenous drug self-administration studies in animals have shown that mitragynine acts
more like saline placebo control than morphine or heroin. Therefore, available data clearly
does not demonstrate a high potential for abuse, as required for placement of a substance in
Schedule I of the CSA. In sum, this work, reported at recent scientific meetings and
conducted in part by scientists at the National Institute on Drug Abuse (NIDA), shows a
radically different profile in terms of abuse potential and side effects from that of “narcoticlike”
opioids to which the FDA compared kratom in their public pronouncements in
In February 2018, the FDA, using a poorly documented computational model, made the claim
that kratom alkaloids are opioid analogues and concluded it was “confident in calling
compounds found in kratom, opioids”, thereby implying that such compounds are inevitably
associated with all the same negative consequences of classical opioids (e.g., respiratory
depression and addictive liability). This simplistic analysis ignores the fact that substances
binding to mu-opioid receptors vary widely in their effects and safety. For example, the lifesaving
drug naloxone, the OTC antidiarrheal loperamide (Imodium®), and the addiction
treatment buprenorphine, all bind to mu-opioid receptors. Although kratom’s compounds do
in fact bind to mu-opioid receptors, real experimental data show that these compounds have
unique signaling properties at mu-opioid receptors and do not induce the same degree of
respiratory depression or present the same risk of abuse as classical opioids.
A 2017 panel at the prestigious American College of Neuropsychopharmacology meeting
addressed analogues of mitragynine and like substances as potentially safer, minimally
addictive pain relievers of the future. The panelists pointed to the substantial body of
scientific studies both in the U.S. and globally that show that such “G protein-biased”
substances are very different from narcotic-like opioids with respect to addiction profile and
potential lethality, and that analogues of these substances might be among the next
generation of safer medications. Much of the current research in this area will come to a halt
if kratom is placed in Schedule I; another serious adverse consequence of scheduling.
We strongly recommend an inquiry to NIDA to determine if kratom is appropriately
designated a “narcotic-like” opioid with respect to risk of addiction and death. Addressing
the broader public health issue, NIDA could be asked to evaluate reports of using kratom as a
replacement for opioids. NIDA should also be asked to conduct a nationally projectable
survey determining whether a ban on legal kratom increases the risks of exposure to black
market kratom or opioid overdose for some fraction of kratom users and if so, how many.
The preceding discussion should not be construed to suggest that consumption of kratom
itself is risk free. It is true that nothing, not candy, vitamins, probiotics, or caffeine are free
from risk; but those risks should not be exaggerated to advance public health policy
initiatives which, although well intentioned, are likely to have unintended negative
While we do not believe there is a legitimate basis for Schedule I placement of kratom under
the criteria of the CSA, we do believe there is an appropriate role for FDA regulatory
regimens in each of the kratom categories of use that reflect current consumer use.
Kratom Leaf as a Food: There is an extensive history of use of kratom leaves as
conventional foods in SEA and under the Federal Food, Drug, and Cosmetic Act
(FFDCA) Section 413(a)(1), traditional kratom leaf preparations are exempt from the
premarket notification requirements as they were present “in the food supply in a
form that has not been chemically altered.” Importantly the plain language of the
FFDCA recognizes history of use “could be from the United States or another country,
as long as the substance was consumed as a food, dietary supplement, or, in the case
of foreign history of use, category of product comparable to a dietary supplement in
the U.S.” As such, consumers have a right to unfettered access to traditional kratom
leaf products that meet food standards. FDA can and should apply all applicable food
regulations to kratom leaf products prepared as per traditional use (ground leaf
either directly ingested or prepared as a tea, which accounts for the majority of
current use in the US).
Manufactured Kratom Products as Dietary Supplements: Extracts prepared from
Kratom leaves that demonstrate the constituents in the dietary ingredient have not
been chemically altered, should be considered as a Dietary Supplement under the
Dietary Supplement Health and Education Act of 1994 (DSHEA). Ensuring Kratom
products in the market place meet all requirements under DSHEA for Current Good
Manufacturing Practices (CGMP), including specifications for identity and purity, and
maximum allowable levels of alkaloids, is essential for ensuring the public has access
to products that are of high quality and not contaminated or otherwise adulterated.
Adulterated Kratom Products: Any kratom product that is adulterated with
undeclared substances or deleterious agents, fails to meet Dietary Supplement
CGMP, or where a manufacturer asserts impermissible health claims for a kratom
product, each should be appropriately addressed by FDA through its statutory
authorities. The FDA and DEA currently have sufficient authority and regulatory tools
to interdict and remove such illegally marketed and dangerous products. This means
that under FDA regulation, consumers would have some assurance that their
products are not adulterated and if they are, that they will be recalled. Without FDA
regulation there is no such consumer protection, and this is appropriately terrifying to
kratom users who feel they benefit from kratom and fear an unregulated black
market as their only kratom source.
We strongly urge the Congress to protect the freedom of American consumers to make
informed decisions on products they safely use for their general health and well-being and
allow for use of a safer alternative pain management product for those suffering from acute
or chronic pain. The natural kratom plant does not kill consumers when used responsibly.
The FDA and DEA should focus their regulatory efforts in dealing with dangerous adulterated
products that pose a real threat to public safety.
The FDA has a range of regulatory tools that can be used to reduce risks of dietary products.
This includes setting standards for maximum allowable levels of active constituents,
screening for potential toxicants, packaging, labeling, and consumer information. The FDA
can track and trace regulated marketers and it can withdraw from the market products that
are not made or marketed to agreed upon standards.
With FDA regulation, purchasers of lawfully marketed products have the same reassurance
that they do for other FDA-regulated dietary supplements and foods. Our nation’s kratom
consumers deserve an FDA-regulated market. The increasing use of kratom as a path away
from opioids is an especially important one, which we hope you will help to address by asking
the FDA, DEA, and NIDA to work together to preserve kratom product access while
accelerating research, surveillance, and balanced regulation.
Jack E. Henningfield, Ph.D.
Vice-President, Research, Health Policy, and
Pinney Associates, Bethesda, Maryland, and
The Johns Hopkins University School of
Marc T. Swogger, Ph.D.
Department of Psychiatry
University of Rochester Medical Center
Bentuangie is an unfamiliar word which is a rare type of Kratom. It is a powerful plant which is recognizable for the visible red veins in leaves. This strain is from the dense forests of Indonesia which are native to many Kratom species.
Among all other strains of Kratom, Bentuangie Kratom is a mild, soothing and relaxing fix for a hectic day. As it is among red vein species and most of the red strains are highly efficient pain killers, it also acts the same. It has this potential, but the effect is comparatively low than the rest.
What to know about Bentuangie Kratom?
The Bentuangie Kratom name is not so common and little information available online. It is also known as the superior Bentuangie or the tropical Kratom blend. The world is thankful to the botanists who could locate and discover it from Indonesian forests.
The red veins of Bentuangie leaves are highly prominent. Like Red Indo or Red Bali, the properties of red Bentuangie are also the same. The perfect balance of benefits makes it distinct from the other strains.
Usually, a red vein Kratom doesn’t offer much. It’s only one or two strong effects which it produces. In the case of Bentuangie Kratom, the red vein leaves provide a lot more than just one or two effects.
It has the high quantity of 7-hydroxymitragynine alkaloid in it. There is no scientific research yet to prove the exact quantity of this alkaloid. But this assumption is as per user reviews. These reviews are same for all. Almost all the users elaborate Bentuangie as a relaxing and medicinal strain which is so versatile by nature.
Bentuangie strain of Kratom is useful for a state of well-being. The combination of effects which it offers to a user is mild yet diverse. Order Kratom
What to expect by using Bentuangie Kratom?
The name “Bentuangie” signifies benefits. It now has so many followers worldwide. As being an Indonesian product, it was only limited to the native area. It has only been a few years that Bentuangie is in most demand among all other countries.
Here are a few effects which a user can expect from Bentuangie Kratom. In most of the cases, these effects were common among all users.
A relaxation state
The calming and soothing effect of Bentuangie Kratom makes it a highly desirable product among users. In a time where everyone is a victim of stress, it is a dire need to try something which is effective and safe.
Bentuangie Kratom is a quick fix to all such problems. There is only one thing which can be a concern. It is that Bentuangie strain is a red vein strain and most of the red vein strain need high amount to show effects.
It suggests using a higher dose of Bentuangie powder for mental relaxation.
The perfect mood
There are many things which can annoy a person. It doesn’t necessarily need to be a professional thing. Sometimes even the smallest things wash the good mood away.
It helps to control the nerves, makes a person calm and in the meantime, it induces a positivity. It is not an anti-depressant or anxiety solution.
It just makes a good feeling surrounding the body which initiates positive vibes. No one should confuse it for a stress relief medicine or help to remove anxiety.
Regulation of sleep cycle
What is worse than body working all day and yet finding no time to sleep?
Everybody needs rest, and so the case with the human body. The stress, burden, workload and mechanical lifestyle doesn’t let a person sleep.
The restlessness sometimes turns into insomnia, and the problem is even worse. It is necessary to regulate the sleep cycle so the risk of insomnia and sleeping disorders can be lower.
The analgesic property
Analgesia means related to pain control. Bentuangie leaves work best as a pain control agent. Many users endorse this property by the safe alternative to synthetic drugs. Whatever the reason for pain is, Bentuangie works best for every type.
Be it a chronic joint pain or a daily life headache or a migraine, like other red vein Kratom the Bentuangie strain comforts it well. It is readily available without a prescription and safe for everyone.
Directions for Bentuangie
Just like all other strains, Bentuangie Kratom is also available in powder form. There are only a few authentic vendors who deal with the original strain. Once Bentuangie powder is available, it is used in direct oral consumption with water, tea or a mixture of food.
For this reason, it is ideal to use Bentuangie Kratom with a food recipe. Most of the people won’t support the idea of direct oral consumption.
Also, making Kratom tea is also not a common for all way. In this situation, adding Bentuangie Kratom in custom recipes is an idea.
For example, Bentuangie Kratom makes a good combination with fruit juice i.e. orange juice, banana juice, apple juice, etc.
For one glass 3-5 grams of Bentuangie Kratom powder is the average quantity. After vigorous shaking, the solution takes a color of brown, green shade. It tastes better with fruit juice.
For most of the effects, 6-7 grams is a perfect quantity to add. The effects such as pain-killing only come when high quantity is available.
Some users prefer extreme effects, for which combining two Kratom types is a new trend.
Bentuangie Kratom is helpful in combination with Maeng Da. Three parts of Bentuangie Kratom in two parts Maeng Da makes the best recipe for instant pain relief of
The duration of benefits
Among all Kratom strains, there are only a few which gives long lasting effects. Fortunately, Bentuangie strain is one of them.
The duration of Bentuangie Kratom is comparable with any other Kratom strain. The general range is between 5-10 hours. It shows longer effects on inexperienced users.
The accuracy of dosage
Accuracy is crucial for all Kratom strains. A general dosage is between 2-3 grams which are a starter dose. Most of the effects of this strain are achievable on the higher dosage which is generally above 5 grams.
One should always start with the low dose and then gradually increase it with time and experience.
How expensive is it?
Bentuangie Kratom is not an expensive product. It is a tender and moderate strain of Kratom which has an equally reasonable price. It is mostly available in $ 12-15 USD per 250 grams. The rates may fluctuate with time, so it’s better to compare rates among top vendors before making the order.
Final thoughts on Bentuangie Kratom
Bentuangie is a relatively new strain of Kratom which is gentle by nature. The effects are so easy going and subtle that even a non-regular user can enjoy the full spectrum of effects in first use.
It is most famous for pain control, relaxation and social confidence boosting product. It is entirely safe for use.
Every dose needs careful administration by a quantity which determines its fate.
Bentuangie Kratom is highly valued for the promising effects, benefits and the ease of usage.
I often have people coming into my store talking about the recovery groups that they are involved in such as AA. Just as the author is not busting on I AA, neither am I. It works for some people. What it neglects to do is lift people up. For 70 years we have been teaching society that we have to punish ourselves to get past addiction. What really need to happen is that we need to treat the immediate effects of the withdrawal from addiction rather than the mind for the future. The mind cannot be treated until the body achieves homeostasis. Bill Wilson almost died with a drink in his hand.
Little Known Facts About Bill W.
It’s crucial that we take a look at the life of Bill Wilson, aka Bill W., the founder of Alcoholics Anonymous, because he is responsible for creating a phenomenon that has been adopted by our society as the main treatment method for not only alcoholism, but addiction in general.
A program that is falsely believed to be successful and based on sound principles, when what we really have is an entire medical society and justice system demanding attendance in a program that emerged from the mind of a man that was consumed with sexual obsession and crippling depression and heavily influenced by the brainwashing of a religious cult.
I point this out not to discredit Bill Wilson, he was doing the best he could with what he had to work with at the time. Unfortunately he didn’t have at his disposal the knowledge we have today about genetics and addictive biochemistry. I believe he had a true desire to help people and was a man in search of the truth, however he did not have all the pieces of the puzzle.
Bill Wilson’s Background
Before getting sober, Bill Wilson was repeatedly admitted to a hospital that was famous for treating alcoholics, called Town’s Hospital, where he met a wise doctor named Dr. Silkworth. Dr. Silkworth believed that alcoholism was caused by an allergy to alcohol, not a lack of willpower, and it was the allergy that created the cravings for alcohol. He shared this belief with Bill W. and told him that once you have the allergy, you can never drink again because it results in the inability to control your drinking. This theory made great sense to Bill Wilson. and he embraced it thoroughly; and this is where the whole “alcoholism is a disease” concept originated.
Bill W. tried over and over and over again not to drink, but couldn’t succeed. Unfortunately, during this time he had another alcoholic friend who had joined the Oxford Group, an evangelical Christian cult, and he tried to convince Bill that this was the path to sobriety. Initially Bill was resistant, but as his drinking grew more and more out of control and he was facing the possibility of being committed to an insane asylum, he grew increasingly desperate and started to be influenced by the teachings of the Oxford Group, which included admitting defeat, taking personal inventory of sins, confession, making restitution, helping others, prayer and passing the message on.
During one of his many hospitalizations for alcoholism, after a visit from his friend from the Oxford Group, while he was experiencing severe delirium tremors and highly sedated with a mixture of morphine, psychoactive drugs and belladonna (a hallucinogen), Bill experienced what he described as an intense religious experience where he came to believe that God was now his higher power as he had been taught by the Oxford Group. When in reality, what Bill was probably experiencing were hallucinations.
The primary concept of the Oxford Group was called “God Control.” They believed that human beings were powerless and that the only way to solve our problems was to submit our will completely to God. They also believed that all human problems were a result of sin, so Bill Wilson had adopted this concept as well. Frank Buchman, the leader of the group, had an obsession with sexual matters — he liked to focus on and pry sexual information out of his followers. He had a particular fondness for spending time with young men and talking about sexual matters. Buchman was asked to leave and even banned from more than one institution for inappropriate behaviors of a sexual nature with young students that sounded an awful lot like sexual abuse; and if we really had all the facts, we would probably learn it actually was.
Buchman was a very unreliable person who didn’t show up for appointments and would simply state that God had guided him to miss the appointment. He encouraged others to engage in irresponsible behavior and just trust that God would provide. At one point, he actually “publicly thanked God for the existence of Adolph Hitler and said he thought Hitler would make a great key person for the Oxford Group.” So this tells you just a little bit about where their head was at.
Bill Wilson introduced Dr. Bob (co-founder of AA) to the Oxford Group and convinced him that this was the path to sobriety, and the two of them began to carry the message to other alcoholics. The Oxford Group held meetings around town in hotels or members homes and targeted the educated and elite. It used elder members of the group to teach the newer members. The very first AA meeting was a group of alcoholics who were members of the Oxford Group that Bill pulled together. Eventually, the Oxford Group grew intolerant of the untidy drunks because they didn’t fit in with the wealthy bunch they catered to, so they stopped allowing them to attend their meetings. Bill W. and Dr. Bob left and formed their own Oxford Group, called Alcoholics Anonymous, where they brought all their teachings with them. The 12 Steps of Alcoholics Anonymous are taken directly from the teachings of the Oxford Group. In the Oxford Group, the steps were used to cure sin; but in AA, they are used to cure alcoholism. Bill Wilson tells us this directly on page 39 in his book, Alcoholics Anonymous Comes of Age.
“Early AA got its ideas of self-examination, acknowledgement of character defects, restitution for harm done, and working with others straight from the Oxford Group and directly from Sam Shoemaker, their former leader in America, and nowhere else.”
The tragedy in this story is that Dr. Silkworth was absolutely right. We now know that allergy is one of the most powerful roots in the cause of alcoholism and that alcoholism is most definitely a physical disease. However, although Dr. Silkworth knew the cause, he didn’t yet know what to do about it other than tell Bill not to drink ever again. Dr. Silkworth and Bill Wilson were on the right track, but because they didn’t yet have enough knowledge about what they had discovered, they weren’t able to find a solution and stop the cravings.
It is unfortunate that out of his desperation Bill Wilson. turned to the Oxford Group and ended up combining the whole “alcoholism is a disease” concept with the “religious sin” concept; thus, in the process, we really ended up losing the truth about alcoholism in the 12 Step Program. It is apparent when we look at the 12 Steps of Alcoholics Anonymous that although Bill believed in his mind that alcoholism is a physical disease, in his heart he felt it was a spiritual disease that emerged from sin, and he was not able to break free from the hold that the Oxford Group had instilled in him.
Bill W.’s Disturbing Behavior
Additionally, Bill Wilson struggled with depression throughout all his recovery that was so severe at times that he would hold his head in his hands and weep, he wasn’t able to respond to questions and he couldn’t get out of bed. Sometimes it was accompanied by heart palpitations, a stomachache and feeling sick all over. His wife, Lois, often referred to him as “almost a hypochondriac” and he sometimes experienced hysteria and breathing problems that he felt he couldn’t control.
Bill’s behavior indicated that he also had a very active sex addiction that completely ruled his life and often threatened to destroy everything he had worked for. Bill Wilson’s sex life is not well known or talked about because people of AA “shrouded it in secrecy.” It was intentionally kept out of official AA literature and archives because it would have a negative impact on the AA movement.
Bill Wilson was the original 13 stepper. It is where the term was coined. If you’re unfamiliar with what a 13 stepper is, it is an elder member in AA who takes advantage of the newer and vulnerable members by using them for sex. Although Bill was married, he engaged in numerous affairs over the years with AA members, particularly the newcomers, and is said to have had an eye for the younger ladies. The older he got, the younger he liked them. The sad truth of the matter is that Bill W. used his position as a leader in the AA community to use and sexually exploit young women who were new to the program.
His behavior was so out of control that it is rumored that certain members of AA were actually delegated the responsibility of following Bill Wilson and working as “watch dogs” to keep vulnerable young women out of his grip. Whenever they saw him zeroing in on his prey, one person would distract Bill while another person took the young woman under their wing for protection.
Later on he maintained a long-term mistress with a woman who was 22 years younger than he was, Helen Wynn, and even left her 10 percent of earnings from the Big Book in his will. He had wanted to leave her a much heftier amount, but the AA trustees wouldn’t allow it. At more than one point Bill contemplated leaving his wife for Helen, but never went through with it out of fear for the controversy it would cause in AA.
Bill Wilson’s sexual behavior with the women caused a great deal of controversy and concern throughout the AA community and even caused him loss of friendships. Tom Powers, a long time close friend, colleague and editor, actually left the fellowship and developed his own offshoot group as a result of his disappointment and disgust with Bill’s inability to control his sexual urges. He didn’t want to be publicly associated with Bill and is quoted as saying, “this sex thing ran through the whole business” and “Bill had to get this sex thing straightened out in program terms so he wasn’t lying about it all the time.”
A lot of people, including trustees, worked very hard to keep Bill Wilson’s big sexual secret hidden and actually devoted their life to protecting the image of Bill W. in order to prevent public embarrassment of AA. Even his wife, Lois, accepted his infidelities, kept quiet and participated in the cover up.
Friends who were close to Bill Wilson. would try and talk to him about the sex issue and he would acknowledge that they were right and try to mend his ways, but he just couldn’t do it. They report that it was a source of great inner conflict and agony for him. In Bill’s writings he often referred to the sex drive as a natural human trait that could at times rage out of control. His friends tell us he was tortured by his behavior that violated his own values and morals; however, he vacillated back and forth between attempting to change and then rationalizing and justifying his behavior when he fell backwards.
In a program that Bill Wilson himself designed to demand rigorous honesty and unselfishness, Bill was living a lie and a very poor example of a man who was supposed to be living an unselfish, spiritual life. He was constantly cheating, lying and sneaking around on his wife and exploiting vulnerable women in the program with no regard for the impact it had on their life. His friends say he was consumed with remorse, self-loathing, guilt, despair and shame as a result of his inability to live up to his own expectations as well as others, and often felt he wasn’t worthy of leading AA.
Sex was not the only addiction Bill Wilson was still struggling with. He was also a heavy chain smoker and caffeine consumer. It is reported that his wife, Lois, often complained of these behaviors and accused him of being addicted to them, but Bill brushed it off by referring to her as an overreacting nag.
Bill repeatedly struggled with a battle to give up cigarettes. He would give them up for a while and then drive other people crazy by begging for theirs. He was rarely seen without a cigarette in his hand. Papers on his desk were consistently covered with ashes and little burn holes, and the edges of tables and desks were scarred with long cigarette burns.
Bill Wilson was so addicted to nicotine that he continued to smoke even though he developed emphysema and became dependent upon an oxygen tank to get through the days. It was clear to Bill that smoking was the cause of his emphysema, but he couldn’t quit. Those close to him report that he often struggled with making a decision about what he needed or wanted more — cigarette or oxygen. More often than not the cigarette won out.
In 1969, as he got sicker and sicker, he pretended to quit smoking, but he kept cigarettes hidden in his car and would sneak out for a drive to have a secret smoke. Bill Wilson literally smoked himself to death. He died from emphysema and pneumonia.
Bill also continued to fight intense cravings for alcohol until the moment he died. As he lay on his deathbed, he wanted a drink so badly that he asked his assistants to bring him one on at least five different occasions; but knowing the disastrous impact it would have on AA, they refused. His cravings were so intense that on one of these occasions he became belligerent and threatened to punch a nurse.
A Legacy of Lies
These facts about Bill Wilson, although disturbing, are important, because all concepts, beliefs, values and methods in AA and the 12 Step Program are a reflection of what was going on in Bill’s mind and life. Bill Wilson did not discover a
“cure” or “great secret” for alcoholism or any other addiction. He was very clearly still a full blown addict and just switched his substance of choice and replaced his cravings for alcohol with women, sex, cigarettes, caffeine and cult-like religious fanaticism.
Bill Wilson was projecting his struggles, feelings of powerlessness, depression, inadequacy and shame over his inability to control his sexual compulsions and nicotine addiction and his religious beliefs into the principles and methods, which became the 12 Step Program of Alcoholics Anonymous. One only needs to look at the words in the 12 Steps, the Big Book and the Twelve Steps and Twelve Traditions to see that this is true.
In Twelve Steps and Twelve Traditions, many of the discussions revolve around sex and sexual needs. These are not the words of a man who was divinely guided by God, as he so often claimed, and people still believe to this day. These are the words of a man struggling with shame, self-loathing, guilt and remorse and trying to find a way to deal with them and explain his behaviors. Unfortunately, all he had to turn to at the time was the teachings he had learned from the religious cult, the Oxford Group. Like all religions, they attempted to control behavior through shame and guilt and this is the method that Bill W. adopted and passed along.
I do not sit in judgment of Bill Wilson. I have compassion and complete understanding for his plight. Like most addicts, I too have struggled with most of the same or similar issues. Unlike me, he did not have the good fortune available to him that we now know about the biochemistry of addiction. Bill was not aware that his addiction to cigarettes, caffeine and sex were all interconnected to his alcoholism or have the means to learn about it. He didn’t understand that when his mother and father abandoned him as a child, it too had a profound impact on his addictive biochemistry. If Bill W. were alive today and could take advantage of the knowledge we’ve gained, we would probably be telling a very different story.
However, the problem is that Bill Wilson had not yet conquered these problems and his mind was not physically, emotionally or spiritually healthy. Although he had good intentions, the message he was carrying was tainted with dysfunction and half-truths. Thus, we ended up with a treatment program for alcoholism and addictions that is based on Christian evangelical cult beliefs and uses shame and guilt to try and encourage sobriety instead of an effective medical treatment that addresses the true roots of addiction. This results in the high rate of failure to achieve and maintain long-term sobriety that we see in AA in mainstream treatment.
The even bigger tragedy in this story is the fact that the medical community embraced this irrational way of thinking. Unfortunately, that is probably due to the fact that Bill had buddied up with Dr. Bob, a medical doctor, which gave him a foot in the door to the medical society and added credibility to his approach. However, you would think that somewhere along the line someone would have questioned the methods or suggested we grow with the times instead of engaging in mass delusion for over 70 years.
It’s been almost 75 years since Alcoholics Anonymous was developed. The principles that Bill Wilson developed for this program were a sign of the times when very little was known about alcoholism and they didn’t have much to work with. We now have a much better and accurate understanding of the roots of alcoholism and addiction. Scientific research now tells us that the roots of alcoholism reside in neurotransmitters in the brain and balancing these neurotransmitters will lead to successful recovery. It is not the result of character flaws, personality disorders, lack of will power or a spiritual disease.
As a mental health professional and a fellow alcoholic with more than 25 years of uninterrupted craving-free sobriety, I can share with you that this is a recovery program that works. When you balance your neurotransmitters, then cravings for alcohol and drugs simply disappear and staying sober is no longer a struggle.
Cheever, Susan. My Name is Bill: Bill Wilson – His Life and the Creation of Alcoholics Anonymous. Simon & Schuster 2004
Hartigan, Francis. Bill W: A Biography of Alcoholics Anonymous Co-Founder Bill Wilson. St. Martins Griffin, 2001.
Alcoholics Anonymous Comes of Age: A Brief History of AA. Alcoholics Anonymous, World Services. 1957
We are happy to announce our new brand. Even better than before and here’s a new strain too. Enjoy. To order go to Get Kratom Here.com
June 21, 2016
New Yellow Vietnam Kratom Strain is one of the newest additions to the Kratom strains. This new strain has instantly grabbed the attenti
on of many Kratom users and has now gained a long list of enthusiastic followers. It may sound strange to call the Vietnam new strains since Southeast Asia is the country where a majority of Kratom strains are being sourced from.
Kratom plants were thriving in Southeast Asia way before the Vietnam strains were discovered over 5,000 years ago. As long as there are Asian cultures in the area, the Kratom plant has been used for a wide range of medicinal purposes. Until currently, Kratom leaves weren’t harvested from Vietnam and were not being available for the users in the Western World including the US. Today users from all over the world can give a try to this strain and benefit from it.
Where In Vietnam The Growing Kratom Can Be Attained?
Located in beautiful 200 miles long scenery of dense forest along the Mekong River, the large number of Kratom plants offers a never ending supply of health and beneficial Kratom leaves. The Giang province Capital Long Xuyen is an attractive location for exporting rice. It just recently turned into a place for exporting and harvesting the Kratom herb.
The weather conditions in this area are the main factors in making high-quality Kratom plant. These factors include appropriate elevation, humidity, river proximity, and mineral-rich local soil. Kratom plants that flourish in such surroundings are extensively practical to feature 20% more alkaloids than other Kratom plants from other areas.
Such alkaloids are what make this Kratom plant so powerful in offering elements that can elevate mood and have healing properties. For the first time, the New Yellow Vietnam Kratom Strain is making its way to the other parts of the world where it is being welcomed by the Kratom fans.
Known Effects Of The Yellow Vietnam Kratom
With the increasing number of Kratom enthusiasts they now get a chance to get their hands on the Yellow Vietnam Kratom Strain, the strain is receiving serious praise. The Vietnam Kratom is offering highly enjoyable and sophisticated effects for both the body and mind.
Kratom users have listed a complete sensation with the whole experience of the Yellow Vietnam Strain and included these effects:
A balance in terms of energy and calmness
The best mind clearing effect
Soothes the stomach
Elevates the mood
Heightens the visual perception
No bitter taste
Comparing Yellow Vietnam Kratom With Maeng Da
The other Kratom strain that has been the best and a hit on every Kratom users list is the Maeng Da for its popular effects like strength and intensity. But how does it compete with the Yellow Vietnam Kratom Strain? Both offer high alkaloid content. When both compared to each other Kratom users find them both calming and soothing varieties. Maeng Da is often considered to be a highly powerful, stimulating and energizing. Vietnam Kratom strains have been experimented to have pain relieve characteristic and a feeling of bliss. But definitely, the most important factor is person body chemistry mixed with the taste preferences and depends on the Kratom user.
Is Kratom Legal In Vietnam?
It’s very unfortunate but the ironic twist is that the Kratom plant grows in abundance is illegal to utilize in areas where it is grown for more than centuries. Information on whether the Kratom is legal in Vietnam is still tricky. Some reports state that taking Kratom in the form of powder in some countries is illegal. The other states that the ban is merely a law which has not been implemented yet.
Though considered to be very rare, leaves and powder Kratom from Vietnam are now widely available in international market. This outstanding strain mixed with its suitable environment and geography from where it originated, is a new experience and option for Kratom lovers in the Western world. You can take it in the form of a capsule which is available with some of the vendors online or you can take it in the powder form.
Thanks to all of you for your patience. We are now fully stocked with over twenty strains of Kratom that are lab-tested and cleansed after arriving in the U.S. for the safety of our customers. Some of you have tried our six new ones while waiting for our other regular strains to arrive.
Additionally, our new brand “Happy Dragon Kratom” is on the shelves. Hope to see you here at our shop. We look forward to serving you for years to come as your go to for the best natural remedies in the country.
According to authorities in Washington DC, Kratom is not listed, nor are any chemicals in Kratom listed, as controlled substances and they are also not scheduled at all. This from a customer today and verified with multiple sources from DC.
ON APRIL 23, 2015Sometimes, solutions to even the most entrenched public health crises are right in front of our eyes, growing naturally from Mother Earth.Richard Smith* struggled with an opiate painkiller addiction for four years before he found a way out through something called kratom.
“It works amazingly well,” Smith said. “I’m surprised it isn’t being prescribed as a treatment by doctors.”
Kratom comes from a tree, Mitragyna speciosa, that grows in Southeast Asia. The leaves have long been taken as medicine by people living in its native jungles, but the remedy is now growing in popularity around the world. Leaves can be chewed fresh, or dried and consumed in powder, tea or bar form. In small doses, it can have stimulative effects, but in larger quantities it acts as a sedative.
Kratom has been used as an aphrodisiac, painkiller, appetite suppressant and for diarrhea relief. Its most promising effect, however, is in weaning people off heroin and morphine addiction using chemicals that stimulate opiate receptors, reducing the brain’s cravings for the genuine article.
Smith got hooked on painkillers after undergoing surgery for an injury he suffered in the military.
“I was prescribed the medication by a doctor for three or four years,” he said. He tried quitting cold turkey, and by replacing the opiates with alcohol, but nothing worked.
That’s when he heard about kratom. The idea appealed to him more than checking into rehab to go onto methadone or suboxone, so he purchased some from a local natural products store and gave it a shot. He took the kratom for two or three months and was able to leave behind his addiction completely, without experiencing the crippling symptoms that usually accompany opiate withdrawal.
“I was able to go to work, take care of my family,” Smith said.
Awareness of the kratom’s therapeutic properties seems to be growing. “If you want to treat depression, if you want to treat opioid pain, if you want to treat sleepiness, this [compound] really puts it all together,” Edward Boyer, a professor of emergency medicine and director of medical toxicology at the University of Massachusetts Medical School, said to Scientific American.
Side effects are minimal, including nausea, itching, sweating, dry mouth and increased urination. Kratom can be addictive, according to reports, but a 2011 study by the International Drug Policy Consortium and Transnational Institute found that withdrawal symptoms were weak and nearly inconsequential compared to the suffering of people trying to quit opiates or amphetamines.
“I’ve heard there are withdrawal symptoms from kratom itself, but I didn’t experience that,” Smith said. “At least in comparison in trying to wean myself off narcotics for pain.”
The public profile of kratom is thriving, at least online. Reddit has over 5,000 members on its kratom forum that discuss its effects and how to acquire it.
Vocativ described it as the “sleeper-hit wonder drug that’s as schizophrenic as the Internet that spawned it” and called for 2015 to be “the year of kratom.” The site surveyed internet reviews and concluded that the substance could cause you to have the best or worst sex of your life, would make you feel amazing or terrible, gain superhuman strength or suffer crippling weakness, and might make you poop weird.
Another kratom enthusiast, Brandon Bird, who buys in bulk from Indonesia and resells it under the name Snake Oil Peddlers, spoke to Resetlast year about how kratom helps him manage his PTSD and allowed him to quit taking prescription painkillers.
It hasn’t gotten on the bad side of America’s drug warriors yet, so kratom remains unregulated and unlisted under the Controlled Substances Act, although the Drug Enforcement Agency has ominously and inaccurately claimed that it has “no legitimate medical use.”
However, its active chemicals, mitragynine and 7-hydroxymitragynine, were banned in Indiana in 2012, and Tennessee followed suit in 2013.
Restrictions in other states and localities are under consideration. Lawmakers in Arizona tried to ban kratom last year, but the bill failed to pass. And Palm Beach County in Florida mulled over forcing vendors to post signs warning of its addictive properties, but recently decided against moving forward with the measure.
Internationally, kratom is illegal in Thailand, Australia, Myanmar and Malaysia, although Thailand has reportedly been considering dropping the ban.
When governments think about banning a substance or smearing it as a drug, it’s important to consider the evidence and harm reduction potential. With opiate addiction a growing problem in the United States, kratom is one therapy that can help people get their lives back on track. “Painkillers are an addiction that a lot of people are dealing with,” Smith said. “I think it’s important that people are aware that this is an option. It worked for me.”
Per request, one or more names have been changed for this article to protect the source’s identity.
LEXINGTON, Ky. (WKYT) — The Federal Drug Administration is keeping a close eye on the herbal substance, kratom.
Most recently, The FDA issued a mandatory recall for all products containing kratom that were made by Triangle Phamanaturals, which carries more than twenty brands under it’s umbrella. The FDA claims Salmonella was found in several of its kratom products.
“This product has been used for decades,” Eduardo Brambila with the Kratom Trade Association told WKYT’s Miranda Combs. “It’s actually been used for centuries in other countries. We have a good track record showing the safety of this product.”
But why is the federal government showing increased scrutiny over it? Brambila could not provide a definitive answer.
“That’s exactly the kind of questions we are posing and we want to clarify, as well,” Brambila said.
At least 3 million people in America use kratom. They came out by the thousands a few years ago when the Drug Enforcement Agency tried to make kratom a Schedule I drug, putting in a category with drugs like heroin and morphine.
“Over 33,000 comments that they (DEA) received in a 30-day period,” Brambila explained.
The DEA reversed their decision, in an unprecedented move.
Branbila believes the DEA’s retreat eventually led to the beginning of the Food and Drug Administration’s increased scrutiny.
“The overreach that have been used for this particular product fro the FDA is definitely of concern,” Brambila says. “I definitely say there is a serious bias for this product right now. The FDA is coming up with a lot of information that may not represent the product as accurately as it could be presented.”
He and other kratom supporters argue kratom is literally a life-changing organic substance. WKYT spoke with Rebecca Patrick-Howard in February who said her life is worth living again because of kratom. She suffers from chronic pain because of a life-long disease. She mixes kratom powder into a tea several times a day.
“People don’t use kratom for the euphoria effect of it. It’s just not there,” she advocated.
The FDA disagrees and said in multiple press releases that there are reports of deaths associated with kratom. The federal government believes kratom affects the same opioid receptors in the brain as morphine, and it is just as addictive. Three men WKYT interviewed last month at the Isaiah House Recovery Center agree. One man said he was “heavily addicted to kratom” and spending $60 a day to have it.
WKYT told Brambila about the men in rehab, and he believes it’s important to look at their cases.
“If anyone’s having effects that are of concern we definitely want to know about this and figure out what the whole story is,” he replied.
Brambila believes the kratom debate shows why some regulation could provide benefits for both sides.
“When you have regulation, it means there’s been some testing done, it means there’s an understanding of how a product is best used. It also sets standards and quality assurance for the consumer which is the upmost importance.”
Kratom is an all-purpose herb that is gaining popularity across the whole world.
Derived from the species of Mitragyna speciosa, you can buy Kratom locally and appropriate some benefits.
It works in an amazing way and produces different effects at different doses. It can provide stimulation to the body to have a fresh day and energizes it to tackle the difficult tasks.
At the same time, Kratom can also help in producing sedation and inducing sleep.
While everyone wants to try these significant effects of Kratom, some might face difficulty in finding Kratom.
Kratom is a naturally transpiring herb that is an alternative to therapeutic medication and not sold over the counter in pharmacies.
Although many countries like the United States and those in Europe have hailed the current consumption of Kratom, short listing the best places that sell premium quality Kratom at the most convenient prices may involve some exertion.
Choosing the best places to obtain the Kratom powder, extracts or capsules depends on the requirements and desires of the customer.
Following are some of the ways how you can buy Kratom locally, of which some are best while others might not prove as reliable.
Smoke shops are an option to buy Maeng da Kratom on a local level.
However, these shops do not serve as a reliable source for this purpose.
Smoking shops are not bad; some of them might even have finest forms of Kratom in stock.
However, strains available from these kinds of shops do not have any guarantee of being real.
Therefore, always be careful while buying Kratom from smoking shops. Do not go for Kratom packed in the shiny package.
Also, make sure that you can scrutinize the product in visual terms. Prefer purchasing Kratom in the form of powders.
Avoid buying it in capsule form or Kratom extracts as they have a high risk of being expired or impure.
Shops at Gas Stations
If there is no smoking shop or a head shop in a particular locality, the chances are that the stores and mini-marts at gas stations are selling it.
Kratom is legal product now hence; its availability at the shops present in gas stations must not seem surprising. Take great care in using Kratom from these stores.
That is because there is a possibility of being fake or polluted as these kinds of shops do not have the best interests of consumers in their minds.
Special shops selling CBD and Kratom
Special shops selling cannabinoids are in almost every locality.
There is a high probability of finding Kratom products in these stores.
Just like Kratom, cannabinoids are the derivatives of a plant named cannabis.
Because it is a plant derivative just like Kratom, store retailers also have Kratom locally along with the cannabis products in their shops.
Using Google map to find Kratom shops locally
If there are no apparent shops in a state, the internet is a great way to sort them out.
Google Map is the latest technology that provides an overview of an area with all the essential details.
Just like we can find the places to eat and drink in a locality, it can also search for shops that were specifically selling Kratom and related products.
Both mobile phones and laptops support the app to find out more about the desired places. Install the app and type “Kratom shops near me” and search for the nearest store.
Always remember to switch from the “lite mode” in the app to find out about the Kratom shops unique to an area.
Using Yelp and Yellow Pages to locate local Kratom stores
Yelp is a most popular local directory to know all types of businesses surrounding a particular field.
It is a community that provides people with all kinds of activities including that of Kratom. Why using Yelp to locate stores selling Kratom locally is beneficial because it will filter the shops by rating, distance, price and hour of operation.
Moreover, it will also provide the reviews made by other customers about a Kratom shop.
That will help people choose the best shop for purchasing Kratom with the high levels of credibility and user ratings on Yelp.
Just like Yelp, the US residents can also make use of Yellow Pages to locate the best shops engaged in selling Kratom locally.
It not only provides the address of the nearest Kratom store but will also provide the contact number and customer rating in most of the cases. That will reduce the chances of getting adulterated Kratom.
Is kratom available at Walmart and GNC?
Both Walmart and GNC are large corporations, and Kratom is not usually available for sale in these stores.
The reason why big stores like Walmart and GNC do not keep Kratom in any form because the DEA has some concerns regarding the effects of Kratom on the body.
The sales and use of Kratom are still controversial even after it acquired a legal status. That’s why Kratom will not be present in these best-ranking chains of stores.
Which areas don’t sell Kratom locally?
Even though Kratom has a lot of benefits to offer, its consumption has always faced issues. Two schools of thoughts are present regarding the use of Kratom.
The first one suggests it to be a useful drug while the second one considers it a drug just like marijuana.
Currently, four out of 196 countries in the world have made it illegal to consume Kratom under any circumstances. Some of the countries have not entirely banned it, but have strict rules that govern its usage.
Most the countries consider the sales and purchase of Kratom legal at a local level.
Areas like Australia has not allowed Kratom sellers to sell it on a local level while the government of Myanmar and Lithuania have completely banned the sales and purchase of Kratom. In Denmark, Kratom is legal to use but it is a controlled substance, and its availability at a local level is quite difficult.
Other countries where Kratom is not available locally include New Zealand, Poland, Malaysia, South Korea, and Israel. Kratom is legal and locally available in many states except for Alabama, Arkansas, Indiana, Vermont, and Wisconsin.
Find the legality of Kratom here.
Are Kratom capsules available at local stores?
The shops selling Kratom online are quite a few. Most of these shops sell Kratom in the form of powders and extracts.
Kratom capsules are quite rare to find. That is because consumers prefer to buy Kratom locally in powdered or obtain forms because these forms are purest in most of the cases.
Capsules can be impure or expired, and a high risk involved in buying these. Hence, not many places exist on a local level where Kratom capsules are available, but it is not entirely impossible to find them.
Brewing up a cup of Kratom tea is one of the most preferred ways by many to consume the naturally grown herbal, Mitragyna Speciosa. If increased energy and enhanced mood is what you’re after then you’ll be able to reap full benefits from drinking Kratom tea. Easy to prepare, all you really need is Kratom in a coarsely ground or crushed form, weigh scale, a pot, strainer, cup, some water, and a stove to boil on. We’ll help you through the process and provide recipe guidelines along with variations, Kratomdosage information, and how to store your Kratom tea. Before we get into all that, I’m sure you’d like to know the characteristics of Kratom tea and what makes this method of consumption so great; let’s dive in!
What is Kratom Tea
Kratom tea is a herbal remedy that is consumed by many for its invigorating, energizing and stimulating effects on the body and mind. When Kratom leaves are brewed as a tea or kratom powder is added to hot water, the alkaloids in the kratom infuse into the water and through ingesting, the individual’s physiology is modulated. Drinking Kratom tea often results in increased desired physiological effects.
As a note: The amount of sediment that is found at the bottom of the Kratom powder tea, may be an indicator of the alkaloid constitution. The more sediments, the more alkaloids, the more effects.
Benefits of Drinking Kratom Tea
The way you consume your Kratom with yield specific side effects. Many people enjoy drinking Kratom tea because they claim there are minimal side effects. Individuals also say that drinking Kratom tea eliminates the possibility of the nasty wobbly side effect that is often associated with consuming the powder straight.
If you are looking for a method to consume your Kratom, that will offer greater stimulation effects, then drinking Kratom tea is the answer.
*It’s important to note that if maximum pain benefits are what you desire from drinking your Kratom tea, this method will not be the best for you; this is because the analgesic effects are masked slightly when Kratom is made into tea.
How long before the effects kick in?
Within 20-30 min the effects of Kratom tea can kick in, thus making it one of the most fast acting methods of consumption. What’s great about taking Kratom in a tea is that it’s an easy way to control your intake for the simple fact that it’s being consumed slowly. If you feel any small unwanted side effects coming on, you can simply stop drinking the tea. The relaxing and stimulating effects of drinking Kratom tea will typically last 2-3 h but could last longer depending on the strength of the batch. Strains such as Maeng Da often last longer.
For tips on how to increase the length of time you feel the effects,
check out #6 in our FAQ, found at the bottom of this article.
What are the main benefits of drinking Kratom tea?
First things first, the great thing about consuming Kratom in a tea is that drinking tea naturally helps release endorphins in the brain which activate your opiate receptors thus bringing about feelings of happiness. There are numerous benefits of consuming Kratom powder in tea, these are the most common:
Offers energy boosting effects
Helps lesson feelings of bloating and/or abdominal cramps
Improves skin complexion
Boasts healing properties by increasing circulation and blood flow
Kratom Tea Recipes – Basics to Brewing
There are a variety of procedures for brewing Kratom tea, some more simplified than others but they all share a similar method. If you’re looking for a simplified method to brew a cup of Kratom tea, head to the bottom of this section.
Take a look below for what you’ll need to make Kratom tea:
Kratom tea leaves or powder (depending on the recipe)
Heat source (stove or kettle)
Flavour enhancer (ex. Lemon)
Standard method for how to make Kratom tea – Maximum benefit method
The following recipe is for 8 doses of a semi strong Kratom tea. Remember that properly making the tea takes a bit of time which is why making more and storing for same day use or next day use will help you save on time.
For 8 doses you will require 2 oz of dried crushed or coarsely ground leaves. In a saucepan, combine the leaves as well as 1 litre of water.
* See the next section for how to properly measure your dosage
* If you have a blender or coffee grinder you can use either to grind your Kratom leaves
Bring the liquid to a simmer for 15 min
Pass the liquid through a colander or strainer into a container and reserve
Squeeze the leaves in the colander to extract the remaining water
Return the leaves to the saucepan, add another litre of water
Simmer again for another 15 min
Strain the liquid into the container where you put the liquid from step 3
Simmer both batches together & reduce
The longer you reduce the liquid, the more concentrated it will become. You can experiment at this stage to see how much reduction in the liquid provides you with your desired effect.
Throw the leaves out after you’ve simmered them a second time
Simplified method of a Kratom tea recipe
Take 1/2 cup of water & squeeze in the juice of 1/2 lemon.
Bring the water to a simmer while stirring in the Kratom powder or leaves (measured out based on your deserted dosage – see section to follow on dosage guidelines)
Simmer for 15 minutes
Take off the heat source & Strain
Reserve any undissolved powder or the leaves, for use later or throw away.
*Remember, when using the leftover kratom a second time, the tea will not be as potent.
Although you can simply mix in powder to a hot cup of water, you will not receive maximum benefits and that’s because simmering the tea will allow for maximum release and absorption of the alkaloid properties into the water.
For accurate dosages, always measure your Kratom with a scale rather than by volume for the simple reason that 1 tsp of finely ground kratom will weigh different then 1 tsp of crushed leaves. Measuring by volume will result in inaccuracies.
The information below on dosages serves only as a general guide for the average person. Everyone will react differently to a specific dosage which is why, it’s always good to listen to your body and take care when experimenting with a herbal remedy that is new to you. What may be strong or weak for one may not be for another.
As a general guide, for a finely ground powder:
1-3 grams will produce a mild effect
5 g – standard dose for an average user
10 g – strong dose
11 + – extremely strong dosage
Measuring your dosage
1 tsp of:
Coarsely ground = 0.8g
Finely ground = 2g
Very finely ground = 2.25g
Storing & Reheating Your Kratom Tea
For the best effects, it is advisable to drink your Kratom tea immediately following preparation. If you want to make a larger batch and store it for later consumption you’ll still be able to enjoy the benefits if you follow these steps for proper storage.
1) Cool your batch of tea before pouring it into a container, preferably a sealed glass container. Glass is best to ensure that no contaminants can leach through.
2) Place inside the fridge for storage up to 5 days.
3) If drinking the tea cold, make sure you stir the liquid so that the sediments can be mixed back in, these would have precipitated out while sitting in the fridge. We do advise heating the tea back up so these sediments can properly dissolve.
4) Re-heat on a simmer just until the tea is adequately warmed and the sediments have been dissolved.
5) Pour yourself a cup of tea and enjoy the effects.
*Take a look below at #4 in the FAQ to know how to add flavour to your Kratom tea; you’re going to want to!
What’s the best time of day to drink my Kratom tea?
First thing’s first, the time of day you drink your tea may change the type and intensity of the side affects you experience. These slight difference in the side effects is affected by the time of day of ingestion. The circadian biology of your system plays a huge factor in these side affects. For example, we will naturally feel drowsy closer to the evening therefor, if drinking Kratom tea at night then these feelings may be amplified more.
Should I drink my tea on a full or empty stomach?
This is an area that has not yet been scientifically observed very well. What is known though, is there is a possibility that when consuming Kratom tea on an empty stomach, individuals may potentially experience a mild irritability and anxiety; for others, no side effects will be noticed at all. Factors such as the time between meals & Kratom ingestion, as well as hydration, type of macronutrients & micronutrients ingested before or after Kratom may all effect the side effects you may experience. Research suggests that certain drugs reach their maximum plasma concentrations when ingested on an empty stomach. Studies also claim that eating before ingesting a drug will affect the production of hormones and neurotransmitters which determine how you respond to a particular substance.
What type of powder should I use to make my Kratom tea?
The answer to this question will depend on the desired effect you’re after although, the preferred strain is red-veined Bali. This variety is known to produce the most relaxing and powerful effects, leaving the individual with a feeling of comfort and ease. For a more stimulating effect and an enhanced energy booster, the Maeng Da variety as well as a white vein kratom will produce the best effect.
We advise you to experiment with different strains as each one will provide you will varied effects; what may work for one, may not be as effective for another. Experimenting with various strains will help you determine the best one for you.
What’s the flavour like?
You now have the knowledge to brew a cup of the best Kratom tea but before you make your first batch, we’d like to remind you of one very important thing. Kratom tea does not taste good, we’d like to say it’s an acquired taste but that would be an understatement. Kratom tea is extremely bitter and undesirable to drink which is why you’ll want to jazz it up a bit.
Here’s a few ways you can add flavour to your Kratom tea:
Squeeze in a little fresh lemon into your cup. Not only will the lemon improve the flavour, it will actually help to protect the alkaloids present in the Kratom.
For all those chocolate fans, you can add powdered chocolate to the mix for an energy boosted hot chocolate.
Some other examples of flavour enhancers are honey, raw sugar, and cinnamon.
Is Kratom stable at high temperatures?
Although Kratom is stable at high temperatures it doesn’t hurt to take precautions to protect the alkaloids which is why we recommend that rather than boiling Kratom tea it is best to only simmer it.
How can I make the effects of Kratom tea last longer?
If you want to lengthen the time you’ll feel the effects of your tea you can do a number of things such as: Using a more powerful strain, combining 2 strains, drinking the tea on an empty stomach, brewing the tea for longer, or by taking a more concentrated dosage.
With our guide on how to make Kratom tea, we’re sure you now have the knowledge to become a pro at brewing up the best cup of tea on the block with the maximum effectiveness you desire. Always remember to follow the procedure for your Kratom tea recipe and use the proper measurements to ensure you’re consuming a safe amount; if you do this, you’ll have nothing to worry about. Due to the fact that Kratom tea doesn’t have extreme risks associated with it, and drinking Kratom tea in Canada is legal, you can drink it with peace of mind and ease.
Disclaimer: Make sure that you are buying your Kratom from a reliable source, one that completes rigorous testing on their products to ensure there are no contaminants present.
So is the FDA helping or hurting. Botanicals like Kratom and even Marajuana don’t make them money, but addiction and misfortune do. The FDA continues to approve drugs that kill people and fights drugs that save people. Are they working in our best interest or their bottom line?
Last updated on: 1/30/2014 1:09:10 PM PST
35 FDA-Approved Prescription Drugs Later Pulled from the Market
Below are the 35 drugs we could find that have been recalled from the US market since the 1970s, some that had been in use since the 1930s. A sample of advertisements for only some of the drugs are included because there is a scarcity of ads for withdrawn drugs online due to manufacturers removing ads for withdrawn drugs as part of the agreement to no longer market the drugs.
According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.” The FDA also takes into account the number of people taking a drug being considered for removal so as to not harm those patients.
1. Accutane (Isotretinoin)
on the market for 27 YEARS
Use: Acne Manufacturer: Hoffman-La Roche
1982 to June 2009
Cause for recall:
increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendenciesOver 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.
Cause for recall:
rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid)
Cause for recall: serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleedingThe FDA determined that Bextra showed no advantage over other NSAID pain relievers on the market.
Bernadette Tansey, “Hard Sell: How Marketing Drives the Pharmaceutical Industry/The Side Effects of Drug Promotion/Aggressive Ads for Painkillers Left More Patients Exposed to Risk,” www.sfgate.com, Feb. 27, 2005
4. Cylert (Pemoline)
on the market for 30 YEARS
Use: Central nervous system stimulant to treat ADHD/ADD Manufacturer: Abbott Laboratories
1975 to Oct. 2010
Cause for recall:
liver toxicityThe FDA added a box warning to Cylert in 1999, alerting doctors and patients to the potential of liver damage.
Abbott Laboratories, “Cylert,” American Journal of Diseases of Children, www.bonkersinstitute.org, 1976
5. Darvon & Darvocet (Propoxyphene)
on the market for 55 YEARS
Use: Opioid pain reliever Manufacturer: Xanodyne
1955 to Nov. 19, 2010
Cause for recall: serious toxicity to the heart; between 1981 and 1999 there were over 2,110 deaths reportedThe UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen.
Christian Sinclair, “Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?,” www.pallimed.org, Nov. 30, 2010
6. DBI (Phenformin)
on the market for 19 YEARS
Use: antidiabetic Manufacturer: Ciba-Geigy
1959 to Nov. 1978
Cause for recall:
lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes
7. DES (Diethylstibestrol)
on the market for 31 YEARS
Use: synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications Manufacturer: Grant Chemical Co.
1940 to 1971
Cause for recall:
clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginningStudies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.
Barbara Hammes and Cynthia Laitman, “Pharmaceutical Company Advertisement for DES by the Grant Chemical Company, Brooklyn, NY, Printed in the American Journal of Obstetrics & Gynecology in 1957,” Journal of Midwifery and Women’s Health, www.medscape.com, 2003
Cause for recall: 4 deaths; 8 patients requiring liver transplants; 12 patients with severe liver damageDuract was labeled for maximum use of 10 days but patients often received/took more than 10 days worth of pills; all cases of death and liver damage involved patients taking pills for longer than 10 days.
9. Ergamisol (Levamisole)
on the market for 11 YEARS
Use: Worm infestation; colon and breast cancers; rheumatoid arthritis Manufacturer: Janssen Pharmaceutica
May 8, 1989 to 2000
Cause for recall:
neutropenia (a type of low white blood cell count), agranulocytosis (a type of low white blood cell count), and thrombotic vasculopathy (blood clots in blood vessels) which results in retiform purpura (a purple discoloration of the skin that can sometimes require reconstructive surgery)Levamisole is still used to treat animals with worm infestations in the US. It is also being found in street cocaine as an adulterant to increase euphoric qualities.
Cause for recall:
slowed potassium channels in the heart that could cause torsade de pointes (TdP; a heart condition marked by a rotation of the heart’s electrical axis) or long QT syndrome (LQTS; prolonged QT intervals)
11. Lotronex (Alosetron)
on the market for 0.8 YEAR
Use: Irritable bowel syndrome (IBS) in women Manufacturer: Prometheus Laboratories, Inc.
Feb. 9, 2000 to Nov. 28, 2000
Cause for recall:
49 cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine)Lotronex was reintroduced to the US market in 2002 with restricted indication.
Irritable Bowel Syndrome Self Help and Support Group, “Lotronex,” www.ibsgroups.org (accessed Jan. 6, 2014)
Cause for recall: increased cardiovascular and stroke riskFDA reviewer Dr. David Graham listed Meridia with Crestor, Accutane, Bextra, and Serevent as drugs whose sales should be limited or stopped because of their danger to consumers in Sep. 30, 2004 testimony before a Senate committee, calling the drugs “another Vioxx.”
13. Merital & Alival (Nomifensine)
on the market for 3 YEARS
Use: Antidepressant Manufacturer: Hoechst AG (now Sanofi-Aventis)
1982 to 1985
Cause for recall:
haemolytic anemia; some deaths due to immunohemolytic anemia
Cause for recall:
QT prolongation and potential for cardiotoxicity
15. Mylotarg (Gemtuzumab Ozogamicin)
on the market for 10 YEARS
Use: Acute myeloid leukemia (AML, a bone marrow cancer) Manufacturer: Wyeth
May 2000 to
June 21, 2010
Cause for recall:
increased risk of death and veno-occlusive disease (obstruction of veins)
16. Omniflox (Temafloxacin)
on the market for 0.3 YEAR
Use: Antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments. Manufacturer: Abbot Laboratories
Jan. 31, 1992 to June 5, 1992
Cause for recall: 3 deaths; severe low blood sugar; hemolytic anemia and other blood cell abnormalities; kidney disfunction (half of the cases required renal dialysis); allergic reactions including some causing life-threatening respiratory distress
Cause for recall: high levels of palladone could slow or stop breathing, or cause coma or death; combining the drug with alcohol use could lead to rapid release of hydromorphone, in turn leading to potentially fatally high levels of drugs in the system
18. Permax (Pergolide)
on the market for 19 YEARS
Use: Parkinson’s disease Manufacturer: Valeant
1988 to Mar. 29, 2007
Cause for recall:
valve regurgitation (a condition that causes the valves to not close tightly, which allows blood to flow backward over the valve) in the mitral, tricuspid, and aortic heart valves, which can result in shortness of breath, fatigue, and heart palpitationsPermax is still available in the U.S. for veterinary use, specifically for pituitary pars intermedia hyperplasia or equine Cushing’s Syndrome (ECS) in horses.
Cause for recall:
30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve diseasePondimin is better known as “Fen-Phen” when prescribed with Phentermine.
Cause for recall:
fatal interactions with at least 25 other drugs (ex: common antibiotics, antihistamines, and cancer drugs) including astemizole, cisapride, terfenadine, lovastatin, and simvastatinPosicor was found by the FDA to offer no significant benefit over other anti-hypertensive or antianginal drugs, which made the risks of drug interactions “unreasonable.” Patients immediately switching from Posicor to another calcium channel blocker were at increased risk of going into shock within 12 hours of the drug switch.
21. Propulsid (Cisapride)
on the market for 7 YEARS
Use: Severe nighttime heartburn associated with gastroesophageal reflux disease (GERD) Manufacturer: Janssen Pharmaceutica
1993 to July 14, 2000
Cause for recall:
more than 270 cases of serious cardiac arrythmias (including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation) reported between July 1993 and May 1999, with 70 being deaths.Propulsid is also banned in India (2011) and available for limited use in Europe. It is still available for use in animals in the US and
22. PTZ & Metrazol (Pentylenetetrazol)
on the market for 48 YEARS
Use: Convulsive therapy for schizophrenia and other psychiatric conditions Manufacturer: not known
1934 to 1982
Cause for recall:
uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients
Use: Sedative and hypnotic Manufacturer: William H. Rorer Inc. & Lemmon Company
1962 to 1985
Cause for recall: mania; seizures; vomiting; convulsions; deathMethaqualone was originally tested in India as a malaria treatment (it was ineffective). The drug is now a schedule 1 drug in the United States (like heroin, marijuana, and LSD).
Res Obscura, “From Quacks to Quaaludes: Three Centuries of Drug Advertising,” www.resobscura.blogspot.nl, June 11, 2012
24. Raplon (Rapacuronium)
on the market for 2 YEARS
Use: Non-polarizing neuromuscular blocker (used in anesthesia Manufacturer: Organon Inc.
1999 to Mar. 27, 2001
Cause for recall: bronchospasms and unexplained deaths
25. Raptiva (Efalizumab)
on the market for 6 YEARS
Use: Psoriasis Manufacturer: Genentech
Apr. 8, 2009
(completely withdrawn by
June 8, 2009)
Cause for recall:
progressive multifocal leukoencephalopathy (PML; a rare and usually fatal disease that causes inflammation or progressive damage of the white matter in multiple locations of the brain)
26. Raxar (Grepafloxacin)
on the market for 2 YEARS
Use: Antibiotic for bacterial infections Manufacturer: Glaxo Wellcome
Nov. 1, 1999
Cause for recall:
cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes)
Cause for recall: 30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve diseaseRedux is better known as “Fen-Phen” when prescribed with Phentermine.
28. Rezulin (Troglitazone)
on the market for 3.25 YEARS
Use: Antidiabetic and anti-inflammatory Manufacturer: Parke-Davis/Warner Lambert (now Pfizer)
Jan. 29, 1997 to Mar. 21, 2000
Cause for recall: at least 90 liver failures; at least 63 deathsAbout 35.000 personal injury claims were filed against the manufacturer (Pfizer).
29. Selacryn (Tienilic acid)
on the market for 3 YEARS
Use: blood pressure Manufacturer: SmithKline
May 2, 1979 to 1982
Cause for recall: hepatitis; 36 deaths; at least 500 cases of severe liver and kidney damageAnphar Labs (which developed the drug in France and sold rights to sell in US to SmithKline) sent a report to SmithKline in Apr. 1979 (translated in May 1979 to English from French) stating Selacryn damaged livers. On Dec. 13, 1984, SmithKline Beckman plead guilty to “14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage”
30. Seldane (Terfenadine)
on the market for 13 YEARS
Use: Antihistamine Manufacturer: Hoechst Marion Roussel (now Sanofi-Aventis)
Feb. 1, 1998
Cause for recall:
life-threatening heart problems when taken in combination with other drugs (specifically erthromycin (an antibiotic) and ketoconazole (an antifungal)Seldane was not considered an imminent threat. The FDA pulled Seldane from the market because Allegra and Allegra D were produced by the same company and were deemed safer by the FDA.
31. Trasylol (Aprotinin)
on the market for 15 (48) YEARS
Use: antifibrinolytic to reduce blood loss during surgery Manufacturer: Bayer
1993 (but used since the 1960s) to Nov. 5, 2007 (marketing suspension request to phase it out of the market);
May 14, 2008 (manufacturer announced complete removal from market)
Cause for recall:
increased chance of death, serious kidney damage, congestive heart failure, and strokesOn Feb. 8, 2006, the FDA issued a public heath advisory to surgeons who perform heart bypasses, alerting them of possible fatal side effects.
32. Vioxx (Rofecoxib)
on the market for 5.3 YEARS
Use: NSAID (pain relief) Manufacturer: Merck
May 20, 1999 to Sep. 30, 2004
Cause for recall:
increased risk of heart attack and stroke; linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003Ads for Vioxx features Olympic gold medalists Dorothy Hamill and Bruce Jenner. Vioxx was prescribed to more than 20 million people.
Use: Severe sepsis and septic shock Manufacturer: Eli Lilly & Company
Nov. 2001 to
Oct. 25, 2011
Cause for recall:
no survival benefit
34. Zelmid (Zimelidine)
on the market for 0 YEARS
Use: Anti-depressant Manufacturer: Astra AB (now AstraZeneca)
1982 to 1982 (withdrawn by the FDA before being released in the US market)
Cause for recall:
Guillain–Barré syndrome; higher risk of suicide
35. Zelnorm (Tegaserod maleate)
on the market for 4.6 YEARS
Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 Manufacturer: Novartis
July 24, 2002 to Mar. 30, 2007
Cause for recall:
higher chance of heart attack, stroke, and unstable angina (heart/chest pain)The FDA permitted restricted use of Zelnorm on an emergency basis (with prior case-by-case authorization from the FDA) on July 27, 2007.
FDA, “Zelnorm (tegaserod maleate) Information,” www.fda.gov, May 11, 2012
Jef Feeley, “Pfizer Ends Rezulin Cases with $205 Million to Spare (Update1),” www.bloomberg.com, Mar. 31, 2009
Barbara Forney, “Pergolide for Veterinary Use,” www.wedgewoodpetrx.com (accessed Jan. 6, 2014)
Curt D. Furgerg and Bertram Pitt, “Withdrawal of Cerivastatin from the World Market,” www.ncbi.nlm.nih.gov, Sep. 26, 2001
Raymond Goldberg, Drugs across the Spectrum, 6th edition, 2010
Barbara Hammes and Cynthia Laitman, “Pharmaceutical Company Advertisement for DES by the Grant Chemical Company, Brooklyn, NY, Printed in the American Journal of Obstetrics & Gynecology in 1957,” Journal of Midwifery and Women’s Health, www.medscape.com, 2003
David Healy, Let Them Eat Prozac: The Unhealthy Relationship between the Pharmaceutical Industry and Depression, 2004
Charles D. Helper and Richard Segal, Preventing Medication Errors and Improving Drug Therapy Outcomes: A Management Systems Approach, 2003
Irritable Bowel Syndrome Self Help and Support Group, “Lotronex,” www.ibsgroups.org (accessed Jan. 6, 2014)
Harvey Kirk, “Darvon and Darvocet Deaths Lead FDA Panel to Recommend Recall,” www.youhavealawyer.com, Feb. 2, 2009
Lilly, “Lilly Announces Withdrawal of Xigris R Following Recent Clinical Trial Results,” www.fda.gov, Oct. 25, 2011
National Cancer Institute, “Diethylstilbestrol (DES) and Cancer,” www.cancer.gov, Oct. 5, 2011
Steven Morris, “Abbott Gets FDA Approval for Omniflox Antibiotic,” www.chicagotribune.com, Feb. 1, 1992
MSNBC Staff, “Report: Vioxx Linked to Thousands of Deaths,” www.nbcnews.com, Oct. 6, 2004
Pink Sheet, “FDA Clears Treatment IND for Colon Cancer Drug Levamisole,” www.elsevierbi.com, May 15, 1989
Res Obscura, “From Quacks to Quaaludes: Three Centuries of Drug Advertising,” www.resobscura.blogspot.nl, June 11, 2012
Renato M.E. Sabbatini, “The History of Shock Therapy in Psychiatry,” www.crerbromente.org.br (accessed Dec. 19, 2013)
Christian Sinclair, “Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?,” www.pallimed.org, Nov. 30, 2010
Ruth SoRelle, “Withdrawal of Posicor from Market,” www.circ.ahajournals.org, 1998
Sheryl Gay Stolberg, “New Painkiller Is Withdrawn after 4 Deaths,” www.nytimes.com, June 23, 1998
Bernadette Tansey, “Hard Sell: How Marketing Drives the Pharmaceutical Industry/The Side Effects of Drug Promotion/Aggressive Ads for Painkillers Left More Patients Exposed to Risk,” www.sfgate.com, Feb. 27, 2005
How can we possibly trust the FDA to make decisions about our best interest when they approve everything except drugs proven to be safe and that are impossible to overdose and die from. Drugs that have been used safely for hundreds of years, leaving the people criminalized. They research forever and then approve dangerous drugs only to turn around in criminalize safe drugs that do the same thing without the safety issues (CBD, Kratom, etc).
May 9, 201712:29 PM ET
Kaiser Health News
The anti-inflammatory drug Bextra was taken off the market because it increased the risk of heart attack and stroke.
Tannen Maury/Bloomberg via Getty Images
The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross says. The Yale researchers’ previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.
It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.
Taking Shortcuts In Drug Testing Can Put Patients At Risk
SHOTS – HEALTH NEWS
Taking Shortcuts In Drug Testing Can Put Patients At Risk
Drugs ushered through the FDA’s accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.
“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross says. “In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”
President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven’t been adequately tested.
“I’m actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job,” says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University who did not work on the study. “The one place you don’t want to cut a corner is safety and efficacy prior to coming to market.”
The FDA’s system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.
FDA spokeswoman Angela Hoague said the agency is reviewing Ross’ findings.
“In general, the FDA does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” she said.
Surprisingly, drugs approved in under 200 days were less likely to have safety issues, which the authors speculate could be because “some approval packages provide clearer evidence of safety, allowing for more rapid regulatory approval.”
The study included market withdrawals of three drugs: the anti-inflammatory drug Bextra; Zelnorm, which was used to treat irritable bowel syndrome; and the psoriasis drug Raptiva. Bextra and Zelnorm were withdrawn because of cardiovascular risk, and Raptiva was withdrawn because of increased risk of a rare and fatal infection that causes brain damage.
Still, it’s important to keep in mind that the post-approval safety issues cover the spectrum from relatively minor to serious, says Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness who did not work on the study. Good next steps would be to dig into the most serious safety problems, determine whether the FDA could have flagged them sooner and examine how they might have been missed, he says.
Alexander commended the researchers, saying their study “underscores the importance of surveillance” after a drug has been launched. He says this helps researchers find new problems — and new benefits — associated with a drug.
“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” he says. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
The FDA has been in the pockets of big pharma forever as we all know. What most people don’t know about though is that they approve hundreds of drugs that are extremely dangerous. Even after significant study and warnings from the drug industry, doctors, patients, and their own studies, many of these dangerously addictive drugs, still made it to the market and as more are coming along they keep approving them. Bad decisions made by the FDA kill thousands every year and they have yet to be held accountable for their failure of their entire mission to protect the American people from dangerous and deadly drugs and food. Yet they have plenty of time to fight the two most natural substances that actually save lives and have been proven safe and have killed no one. The FDA is no longer viable and needs to be overhauled. Drug industries should not be advertising since their product should only be used as needed. It time for kickbacks and favors to end.
The Kratom market is constantly changing. With the FDA and DEA putting their noses where they don’t belong and Mastercard and Visa give vendors a hard time about how our customers can pay. It’s not just Kratom though, its CBD and other herbs that they have decided to attack, though they admittedly have no evidence. This volatility is causing vendors to find new ways of doing business and some are dropping out of the market.
Because of this I have found some other suppliers. I like to buy from suppliers in the states that get their product from the farmers. This way it is fresh and lab-tested. So, there will be different strains that are no longer available and new ones added. Keep this in mind when making orders as I phase out some strains from certain suppliers that are exiting the market.
Thanks so much for you past support. I will continue to provide the best quality Kratom I can find.
This articles backs my previous statement that the FDA is no longer a viable institutions as it is no longer serving the people at this point. They are also killing people daily with their policies and their unbelievable attempts to become the food and drug police. BD
DAVID WILLMAN, Times Staff Writer
For most of its history, the United States Food and Drug Administration approved new prescription medicines at a grudging pace, paying daily homage to the physician’s creed, “First, do no harm.”
Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as “partners, not adversaries.”
The FDA achieved its new goals, but now the human cost is becoming clear.
Seven drugs approved since 1993 have been withdrawn after reports of deaths and severe side effects. A two-year Los Angeles Times investigation has found that the FDA approved each of those drugs while disregarding danger signs or blunt warnings from its own specialists. Then, after receiving reports of significant harm to patients, the agency was slow to seek withdrawals.
According to “adverse-event” reports filed with the FDA, the seven drugs were cited as suspects in 1,002 deaths. Because the deaths are reported by doctors, hospitals and others on a voluntary basis, the true number of fatalities could be far higher, according to epidemiologists.
An adverse-event report does not prove that a drug caused a death; other factors, such as preexisting disease, could play a role. But the reports are regarded by public health officials as the most reliable early warnings of danger.
The FDA’s performance was tracked through an examination of thousands of pages of government documents, other data obtained under the Freedom of Information Act and interviews with more than 60 present and former agency officials.
The seven drugs were not needed to save lives. One was for heartburn. Another was a diet pill. A third was a painkiller. All told, six of the medicines were never proved to offer lifesaving benefits, and the seventh, an antibiotic, was ultimately judged unnecessary because other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for its speed than its caution. In 1988, only 4% of new drugs introduced into the world market were approved first by the FDA. In 1998, the FDA’s first-in-the-world approvals spiked to 66%. The drug companies’ batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80% of the industry’s applications for new products, compared with about 60% at the beginning of the decade.
And the companies have prospered: The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.
Once the world’s unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe.
“This track record is totally unacceptable,” said Dr. Curt D. Furberg, a professor of public health sciences at Wake Forest University. “The patients are the ones paying the price. They’re the ones developing all the side effects, fatal and non-fatal. Someone has to speak up for them.”
The FDA’s faster and more lenient approach helped supply pharmacy shelves with scores of new remedies. But it has also yielded these fatal missteps, according to the documents and interviews:
* Only 10 months ago, FDA administrators dismissed one of its medical officer’s emphatic warnings and approved Lotronex, a drug for treating irritable bowel syndrome. Lotronex has been linked to five deaths, the removal of a patient’s colon and other bowel surgeries. It was pulled off the market on Nov. 28.
* The diet pill Redux, approved in April 1996 despite an advisory committee’s vote against it, was withdrawn in September 1997 after heart-valve damage was detected in patients put on the drug. The FDA later received reports identifying Redux as a suspect in 123 deaths.
* The antibiotic Raxar was approved in November 1997 in the face of evidence that it may have caused several fatal heart-rhythm disruptions in clinical studies. FDA officials chose to exclude any mention of the deaths from the drug’s label. The maker of the pill withdrew it in October 1999. Raxar was cited as a suspect in the deaths of 13 patients.
* The blood pressure medication Posicor was approved in June 1997 despite findings by FDA specialists that it might fatally disrupt heart rhythm and interact with certain other drugs, posing potentially severe risk. Posicor was withdrawn one year later; reports cited it as a suspect in 100 deaths.
* The painkiller Duract was approved in July 1997 after FDA medical officers warned repeatedly of the drug’s liver toxicity. Senior officials sided with the manufacturer in softening the label’s warning of the liver threat. The drug was withdrawn 11 months later. By late 1998, the FDA had received voluntary reports citing Duract as a suspect in 68 deaths, including 17 that involved liver failure.
* The diabetes drug Rezulin was approved in January 1997 over a medical officer’s detailed opposition and was withdrawn this March after the agency had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect in 391 deaths.
* The nighttime heartburn drug Propulsid was approved in 1993 despite evidence that it caused heart-rhythm disorders. The officials who approved the drug failed to consult the agency’s own cardiac specialists about the signs of danger. The drug was taken out of pharmacies in July after scores of confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect in 302 deaths.
The FDA’s handling of Propulsid put children at risk.
The agency never warned doctors not to administer the drug to infants or other children even though eight youngsters given Propulsid in clinical studies had died. Pediatricians prescribed it widely for infants afflicted with gastric reflux, a common digestive disorder.
Parents and their doctors had no way of knowing that the FDA, in August 1996, had found Propulsid to be “not approvable” for children.
“We never knew that,” said Jeffrey A. Englebrick, a heavy-equipment welder in Shawnee, Kan., whose 3-month-old son, Scott, died on Oct. 28, 1997, after taking Propulsid. “To me, that means they took my kid as a guinea pig to see if it would work.”
By the time the drug was pulled, the FDA had received reports of 24 deaths of children under age 6 who were given Propulsid. By then the drug had generated U.S. sales of $2.5 billion for Johnson & Johnson Co.
Questions also surround the recent approvals of other compounds that remain on the market, including a new flu drug called Relenza. In February of 1999, an FDA advisory committee concluded that Relenza had not been proved safe and effective. The agency nevertheless approved it. Following the deaths of seven patients, the FDA in January issued a “public health advisory” to doctors.
A ‘Lost Compass’
A total of 10 drugs have been pulled from the market in just the past three years for safety reasons, including three pills that were approved before the shift that took hold in 1993. Never before has the FDA overseen the withdrawals of so many drugs in such a short time. More than 22 million Americans–about 10% of the nation’s adult population–took those drugs.
With many of the drugs, the FDA used tiny-print warnings or recommendations in package labeling as a way to justify approvals or stave off withdrawals. In other instances, the agency has withheld safety information from labels that physicians say would call into question the use of the product.
Present and former FDA specialists said the regulatory decisions of senior officials have clashed with the agency’s central obligation, under law, to “protect the public health by ensuring . . . that drugs are safe and effective.”
“They’ve lost their compass and they forget who it is that they are ultimately serving,” said Dr. Lemuel A. Moye, a University of Texas School of Public Health physician who served from 1995 to 1999 on an FDA advisory committee. “Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry.”
The FDA’s shift is felt directly in the private practice of medicine, said Dr. William L. Isley, a Kansas City, Mo., diabetes specialist. He implored the agency to reassess Rezulin three years ago after a patient he treated suffered liver failure taking the pill.
“FDA used to serve a purpose,” Isley said. “A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what’s been swept under the rug.”
FDA officials said that they have tried conscientiously to weigh benefits versus risks in deciding whether to approve new drugs. They noted that many doctors and patients complain when a drug is withdrawn.
“All drugs have risks; most of them have serious risks,” said Dr. Janet Woodcock, director of the FDA’s drug review center. She added that some of the withdrawn drugs were “very valuable, even if not lifesaving, and their removal from the market represents a loss, even if a necessary one.”
Once a drug is proved effective and safe, Woodcock said, the FDA depends on doctors “to take into account the risks, to read the label. . . . We have to rely on the practitioner community to be the learned intermediary. That’s why drugs are prescription drugs.”
In a May 12, 1999, article co-authored with FDA colleagues and published by the Journal of the American Medical Assn., Woodcock said, “The FDA and the community are willing to take greater safety risks due to the serious nature of the [illnesses] being treated.”
Compared to the volume of new drugs approved, they wrote, the number of recent withdrawals “is particularly reassuring.”
However, agency specialists point out that both approvals and withdrawals are controlled by Woodcock and her administrators. When they consider a withdrawal, they face the unpleasant prospect of repudiating their original decision to approve.
Woodcock, 52, received her medical degree at Northwestern University and is a board-certified internist. She alluded in a recent interview to the difficulty she feels in rejecting a proposed drug that might cost a company $150 million or more to develop. She also acknowledged the commercial pressures in a March 1997 article.
“Consumer protection advocates want to have drugs worked up well and thoroughly evaluated for safety and efficacy before getting on the market,” Woodcock wrote in the Food and Drug Law Journal. “On the other hand, there are economic pressures to get drugs on the market as soon as possible, and these are highly valid.”
But this summer–following the eighth and ninth drug withdrawals–Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve safety concerns.
“As medical practice has changed . . . it’s just much more difficult for [doctors] to manage” the expanded drug supply, Woodcock said in an interview. “They rely upon us much more to make sure the drugs are safe.”
Another FDA administrator, Dr. Florence Houn, voiced similar concern in remarks six months ago to industry officials: “I think the lessons learned from the drug withdrawals make us leery.”
Yet the imperative to move swiftly, cooperatively, remains.
“We are now making decisions more quickly and more predictably while maintaining the same high standards for product safety and efficacy,” FDA Commissioner Jane E. Henney said in a National Press Club speech on Dec. 12.
Motivated by AIDS
The impetus for change at the FDA emerged in 1988, when AIDS activists paralyzed operations for a day at the agency’s 18-story headquarters in Rockville, Md. They demanded immediate approval of experimental drugs that offered at least a ray of hope to those otherwise facing death.
The FDA often was taking more than two years to review new drug applications. The pharmaceutical industry saw a chance to loosen the regulatory brakes and expedite an array of new products to market. The companies and their Capitol Hill lobbyists pressed for advantage: If unshackled, they said, the companies could invent and develop more remedies faster.
The political pressure mounted, and the FDA began to bow. By 1991, agency officials told Congress they were making significant progress in speeding the approval process.
The emboldened companies pushed for more. They proposed that drugs intended for either life-threatening or “serious” disorders receive a quicker review.
“The pharmaceutical companies came back and lobbied the agency and the Hill for that word, ‘serious,’ ” recalled Jeffrey A. Nesbit, who in 1991 was chief of staff to FDA Commissioner David A. Kessler. “Their argument was, ‘Well, OK, there’s AIDS and cancer. But there are drugs [being developed] for Alzheimer’s. And that’s a serious illness.’ They started naming other diseases. They began to push that envelope.”
The wielding of this single, flexible adjective–“serious”–swung wide the regulatory door knocked ajar by the AIDS crisis.
New Order Takes Hold
In 1992, Kessler issued regulations giving the FDA discretion to “accelerate approval of certain new drugs” for serious or life-threatening conditions. That same year a Democrat-controlled Congress approved and President Bush signed the Prescription Drug User Fee Act. It established goals that call for the FDA to review drugs within six months or a year; the pharmaceutical companies pay a user fee to the FDA, now $309,647, with the filing of each new drug application.
The newly elected Clinton administration climbed aboard with its “reinventing government” project. Headed by Vice President Al Gore, the project called for the FDA, by January 2000, to reduce “by an average of one year the time required to bring important new drugs to the American public.” As Clinton put it in a speech on March 16, 1995, the objective was to “get rid of yesterday’s government.”
For the FDA’s medical reviewers–the physicians, pharmacologists, chemists and biostatisticians who scrutinize the safety and effectiveness of emerging drugs–a new order had taken hold.
The reviewers work out of public view in secure office buildings clustered along Maryland’s Route 355. At the jet-black headquarters building, the decor is institutional, the corridors and third-floor cafeteria without windows. The reviewers examine truckloads of scientific documents. They are well-educated; some are highly motivated to do their best for a nation of patients who unknowingly count on their expertise.
One of these reviewers was Michael Elashoff, a biostatistician who arrived at the FDA in 1995 after earning degrees from UC Berkeley and the Harvard School of Public Health.
“From the first drug I reviewed, I really got the sense that I was doing something worthwhile. I saw what a difference a single reviewer can make,” said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed by Glaxo Wellcome. He recommended against approval.
“The drug has no proven efficacy for the treatment of influenza in the U.S. population, no proven effect on reducing person-to-person transmissibility, and no proven impact on preventing influenza,” Elashoff wrote, adding that many patients would be exposed to risks “while deriving no benefit.”
An agency advisory committee agreed and on Feb. 24 voted 13 to 4 against approving Relenza.
After the vote, senior FDA officials upbraided Elashoff. They stripped him of his review of another flu drug. They told him he would no longer make presentations to the advisory committee. And they approved Relenza as a safe and effective flu drug.
Lost Faith in the System
Elashoff and other FDA reviewers discern a powerful message.
“People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it’s worth,” he said. “Before I came to the FDA I guess I always assumed things were done properly. I’ve lost a lot of faith in taking a prescription medicine.”
Elashoff left the FDA four months ago.
“Either you play games or you’re going to be put off limits . . . a pariah,” said Dr. John L. Gueriguian, a 19-year FDA medical officer who opposed the approval of Rezulin, the ill-fated diabetes drug. “The people in charge don’t say, ‘Should we approve this drug?’ They say, ‘Hey, how can we get this drug approved?'”
Said Dr. Rudolph M. Widmark, who retired in 1997 after 11 years as a medical officer: “If you raise concern about a drug, it triggers a whole internal process that is difficult and painful. You have to defend why you are holding up the drug to your bosses. . . . You cannot imagine how much pressure is put on the reviewers.”
The pressure is such that when a union representative negotiated a new employment contract for the reviewers last year, one of his top priorities was to defend what he called the “scientific integrity” of their work.
“People feel swamped. People are pressured to go along with what the agency wants,” said Dr. Robert S.K. Young, an FDA medical officer who in 1998 formed a union chapter to represent the reviewers. “You’re paying for these highly educated, trained people, and they’re not being allowed to do their job.”
Each new drug application is accompanied by voluminous medical data, enough at times to fill 1,000 or more phone books. The reviewers must master this material in less than six months or a year, while juggling other tasks.
“The devil is in the details, and detail is something we no longer have the time to go into,” said Gurston D. Turner, a veteran pharmacologist with the FDA’s scientific investigations division who retired this year. “If you know you must have your report done by a certain date, you get something done. That’s what they [top FDA officials] count, that’s all they count. And that is really, to me, a worrisome thing.”
The FDA did spur reviewers to move at record speed.
In 1994, the FDA’s goal was to finish 55% of its new drug reviews on time; the agency achieved 95%. In 1995, the goal was 70%; the FDA achieved 98%. In 1996, the goal was 80%; the FDA achieved 100%. In both 1997 and 1998, the goal was 90% and the FDA achieved 100%.
From 1993 to 1999 the agency approved 232 drugs regarded as “new molecular entities,” compared with 163 during the previous seven years, a 42% increase.
The time-limit goals quickly were treated as deadlines within the FDA–imposing relentless pressure on reviewers and their bosses to quickly conclude their work and approve the drugs.
“The goals were to be taken seriously. I don’t think anybody expected the agency to make them all,” said William B. Schultz, a deputy FDA commissioner from 1995 to 1999.
Schultz, who helped craft the 1992 user-fee act as a congressional staff lawyer, added: “You can meet the goal by either approving the drug or denying the approval. But there are some who argue that what Congress really wanted was not just decisions, but approvals. That is what really gets dangerous.”
Indeed, the FDA drug center’s 1999 annual report referred to the review goals as “the law’s deadlines.” And, Dr. Woodcock, the center director, elaborated in a subsequent agency newsletter:
“In exchange [for the user fees], FDA makes a commitment to meet certain goals for review times. [The agency] has exceeded almost all of the goals, and it expects to continue to exceed them. Basically, the number of new approved drugs has doubled, and the review times have been cut in half.”
The user fees have enabled the FDA to hire more medical reviewers. Last year, 236 medical officers examined new drugs compared with 162 officers on duty in 1992, the year before the user fees took effect.
Even so, Woodcock acknowledged in an FDA publication this fall that the workloads and tight performance goals “create a sweatshop environment that’s causing high staffing turnover.”
An FDA progress report in 1998, describing the work of agency chemists, said that “too many reviews are coming ‘down to the wire’ against the goal date. . . . This suggests a system in stress.”
Said Nesbit, the former aide to Commissioner Kessler: “The clock is always running, whereas before the clock was never running. And that changes people’s behavior.”
Dozens of officials interviewed by The Times made similar observations.
“The pressure to meet deadlines is enormous,” said Dr. Solomon Sobel, 65, director of the FDA’s metabolic and endocrine drugs division throughout the 1990s. And the pressure is not merely to complete the reviews, he said. “The basic message is to approve.”
Over the last seven years, “there has been a huge shift,” said Kathleen Holcombe, a former FDA legislative affairs staffer and congressional aide who now is a drug industry consultant. “FDA, historically, had an approach of, ‘Regulate, be tough, enforce the law [and] don’t let one thing go wrong,’ ” Holcombe said, adding that now, “the FDA sees itself much more in a cooperative role.”
The perception of coziness with drug makers is perpetuated by potential conflicts of interest within the FDA’s 18 advisory committees, the influential panels that recommend which drugs deserve approval or should remain on the market. The FDA allows some appointees to double as consultants or researchers for the same companies whose products they are evaluating on the public’s behalf. Such was the case during committee appraisals of several of the recently withdrawn drugs, including Lotronex and Posicor, The Times found.
Few doubt the $100-billion pharmaceutical industry’s clout. Over the last decade, the drug companies have steered $44 million in contributions to the major political parties and to candidates for the White House and both houses of Congress.
The FDA reviewers said they and their bosses fear that unless the new drugs are approved, companies will erupt and Congress will retaliate by refusing to renew the user fees. This would cripple FDA operations–and jeopardize jobs.
The companies’ money now covers about 50% of the FDA’s costs for reviewing proposed drugs–and agency officials say that persuading Congress to renew the user fees into 2007 is now a top priority.
Yet even if the user fees remain, the FDA is prohibited from spending the revenue for anything other than reviewing new drugs. So while the budget for pre-approval reviews has soared, the agency has gotten no similar increase of resources to evaluate the safety of the drugs after they are prescribed.
“It’s shocking,” said Dr. Brian L. Strom, chairman of epidemiology at the University of Pennsylvania. “How can you say, ‘Release drugs to the market sooner,’ and not know if they’re killing people? . . . It really is a dramatic statement of public priorities.”
More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported each year. And those “adverse-event” reports by doctors and others are only filed voluntarily. Experts, including Strom, believe the reports represent as few as 1% to 10% of all such events.
“There’s no incentive at all for a physician to report [an adverse drug reaction],” said Strom, who has documented the phenomenon. “The underreporting is vast.”
Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including preexisting disease or use of another medicine.
To be sure, a chain of events affects the safe use of a prescription drug: The companies’ conduct of clinical studies; the FDA’s regulatory actions; the doctor’s decision to prescribe; the pharmacist’s filling of a handwritten prescription; the patient’s ability to take the drug as directed. A lapse at any link could prove fatal.
And once a pill is approved by the FDA, the manufacturer often spends heavily on promotion to seize the largest possible market share. This can exacerbate the risk to public health, according to experts.
“Aggressive promotion increases exposure–and doesn’t give you the time to find the problem before patients get hurt,” said Dr. Raymond L. Woosley, pharmacology department chairman at Georgetown University and a former FDA advisory committee member.
When serious side effects emerge, the FDA officials have championed using package labeling as a way to, in their words, “manage” risks. Yet the agency typically has no way to know if the labeling precautions–dense, lengthy and in tiny print–are read or followed by doctors and their patients.
The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. But the research frequently is not performed–prompting the inspector general of the Department of Health and Human Services to say in 1996 that “FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence.”
Since that report was issued, the FDA has not withdrawn any drug due to a company’s failure to complete a post-approval safety study. Officials conceded this week that they still do not know how often the studies are performed.
One consequence is that greater risk is shifted to doctors and patients.
For example, Woodcock and her senior aides allowed Rezulin to remain on the U.S. market nearly 2½ years after it was withdrawn in Britain in December 1997. The FDA recommended frequent laboratory testing of patients using the drug but had no scientific assurance that the tests would prevent Rezulin-induced liver failure.
“They kept increasing the number of liver-function tests you should have,” noted Dr. Alastair J.J. Wood, a former FDA advisory committee member who is a professor of medicine at Vanderbilt University. “That was clearly designed to protect the FDA, to protect the manufacturer, and to dump the responsibility on the patient and the physician. If the patient developed liver disease and he hadn’t had his [tests] done, somebody was to blame and it wasn’t the manufacturer and it wasn’t the FDA.”
Leading industry officials say Americans have nothing to fear from the wave of drug approvals.
“Do unsafe drugs enter and remain in the marketplace? Absolutely not,” said Dr. Bert A. Spilker, senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, in remarks last year to industry and FDA scientists.
But during interviews over the last two years, current and former FDA specialists cited repeated instances when drugs were approved with less than compelling evidence of safety or effectiveness. They also said that important information has been excluded from the labels on some medications.
Elashoff, for instance, was surprised at the labeling for a drug called Prograf, approved in 1997 to prevent rejection of transplanted kidneys. The drug first had been approved in 1994 for use among liver-transplant patients.
The new label notes that Prograf was proved effective in a study of 412 U.S. kidney transplant patients. But no mention is made of the company’s 448-patient European study, in which 7% of the patients who took Prograf died–double the 3.5% death rate among those who received a different anti-rejection drug, documents show.
An auditor from the FDA’s scientific investigations unit, Antoine El-Hage, examined the European study results and concluded the “data are reliable.” Elashoff agreed in his review.
Yet the only way for doctors or patients to find that data is to search the medical literature or seek the FDA’s review documents.
Excluding the European study from the Prograf label, Elashoff said, “was just a total whitewash. . . . I think any rational person would reconsider taking this drug if they knew what happened in Europe.”
A spokesman for the manufacturer of Prograf said the company had no objection to including the European study results in the labeling. William E. Fitzsimmons, a vice president of drug development for Fujisawa Healthcare Inc., said the decision to exclude the results was entirely the FDA’s.
“We submitted that data,” he said. “It came down to what the FDA was comfortable putting in the label. . . . We certainly have no interest in trying to hide that information. We presented it at major meetings on transplantation. . . . We’re comfortable with that information being out in the public domain.”
But if the FDA had included the European results in the label, it would have impugned the agency’s basis for approving the new, expanded use for Prograf, according to Elashoff and others.
Asked why the agency excluded the information, Woodcock said the European results were “unreliable . . . and could be potentially misleading to doctors and patients in the U.S. if these were included in the label.”
“CBD Kratom” reads the large sign over Dafna Revah’s storefront on Central Expressway’s frontage road. Just south of trendy Knox Street, it sits beside a Marble Slab Creamery, two doors down from a Potbelly Sandwich Shop and around the corner from an Apple store and Kate Spade shop. “You can’t miss it,” Revah says. Unblemished glass walls, doors and windows communicate to passersby: We’ve nothing to hide here.
At least not for the moment.
St. Louis native Revah and husband David Palatnik co-own a few successful smoke shops — that’s a polite term for head shop — an endeavor that began with a store in St. Louis called Mr. Nice Guy. They added another in Chicago and partnered with a California dispensary that sells medical marijuana.
A shrewd, bold businesswoman, Revah remains sanguine despite having opened two dispensary-style boutiques in Dallas, both called CBD Kratom. Medical marijuana isn’t legal in Texas, so don’t expect to find kush at the shop on Knox Street or the second on Davis Street in Oak Cliff. Still, the name is ballsy considering the controversy surrounding kratom, a South Asian plant that many users hail as a potential life-saving herbal alternative to opioids.
While conventional head shops often camouflage controversial products, at CBD Kratom, these supplements stand tall. The small bags, jars and bottles of kratom are aesthetically packaged, benign looking, and customers rattle off praises for the plant. Unfortunately, kratom’s fans don’t include federal regulators. In February, the Food and Drug Administration threatened to stop kratom from entering the United States, and the Drug Enforcement Administration has threatened its legality.
Revah seems unfazed, but the government’s threats have stirred fear and lobbying efforts among some of the countless Americans who are treating themselves for chronic pain with kratom. Some are convinced they will die without it, killed by the addictive narcotics that kratom purportedly replaces.
Kratom has been used since the 1800s for a number of purposes, including reducing the pain of opium withdrawal, but the FDA’s letter declared the plant dangerous and addictive.
Revah disagrees. Thousands use kratom for wide-ranging reasons — insomnia, coughing, pain, Crohn’s disease. There is voluminous anecdotal evidence that the herb’s subtle narcotic effects have bettered the lives of chronic pain patients and people dependent on prescription opioids.
Right now, more than 2 million Americans are hooked on some variety of opioid. Overdoses from heroin and its more powerful synthetic cousin fentanyl claimed some 30,000 American lives last year. The Centers for Disease Control and Prevention estimate opioids will kill another 52,000 Americans this year and as many as half a million in the next decade.
Revah says she worries for the people in pain. “It’s sad,” she says. “They do not want to addict themselves to oxycodone, so they come buy kratom. Taking it away would be very bad.”
As feds require, CBD products in her shop — oils, creams, capsules, edibles and waxes — contain less than 0.3 percent tetrahydrocannabinol, the chemical that produces marijuana’s high. Regardless, consumers and sellers say CBD goods produced from hemp can relieve pain and inflammation and reduce anxiety and nausea.
At Revah’s shops, educated, friendly staffers won’t hover but usually are on hand to answer questions. The space resembles the sterile, practically clinical environment of legal marijuana dispensaries found throughout Colorado and other states.
CBD sales are carrying on with minimal fuss. The lesser-known kratom, however, is fighting for its legal life.
Customers browse kratom products at the CBD Kratom store in Knox Henderson.
Why stop kratom?
In 2012 and again in 2014, FDA import reports included mention of kratom, indicating the agency felt it had enough evidence to warrant stopping it at the border. Since 2014, federal law enforcement officials have seized at least $5.5 million worth of kratom, according to the FDA.
So kratom disappeared from shelves of American shops, and most of the industry moved online. A growing contingent of users bought from “trusted” online vendors. (Scammers promptly were called out on kratom forums.)
And merchants placed labels like “incense: not-for-human-consumption” on bags and boxes before shipping them overseas.
In spring 2016, the DEA announced plans to make kratom (more precisely, its two primary psychoactive compounds, mitragynine and 7-hydroxymitragynine) a Schedule 1 drug under the Controlled Substances Act. That’s the category reserved for the worst chemicals that are medicinally irrelevant and have the highest potential for abuse — heroin and ecstasy, for example. It would mean an all-out ban.
To the thousands of Americans who treat pain with kratom, the news ignited fear and indignation. Online vendors, who spent the previous few years booming in business, stood to lose thousands of dollars in sales and inventory or risk becoming criminals.
Protests, letters, videos, petitions — the outcry was more than the government expected, and Congress stalled “for an FDA analysis.”
Still, CBD Kratom opened its two Dallas stores earlier this year, and the herb is on gas station counters again.
Producing stimulant or depressant effects at varying doses, kratom is an unusual compound. Its voyage has been as peculiar.
In the 1800s, amid the humid thickets of Southeast Asia, laborers discovered kratom (Mitragyna speciosa) leaves growing — broad, glimmering green in tall tropical trees. The vegetation, when nibbled upon, eased pain and increased energy.
Around that time, it first was documented as a potential opium substitute. In Thailand, it became “part of the ritual worship of ancestors and gods,” Darshan Singh noted in “Traditional and non-traditional use of Mitragyna speciosa,” which surveyed and summarized dozens of published studies conducted in Thailand.
Extracts from the plant found use as a local anesthetic and a treatment for coughs and intestinal infections. The stuff reportedly staved off pain, depression, exhaustion, coughing and dysentery. Users described feeling happy, creative, energetic and even horny, according to “The pharmacology and toxicology of kratom,” published in the 1996 International Journal of Legal Medicine.
Enterprising sharecroppers figured its recreational, feel-good effects meant money, especially if peddled outside Asia, where the plant did not grow. In the late ’90s, kratom spread to America and was touted as a euphoric “legal high” on shelves in head shops.
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The brown plant extract came as dirt-flavored dust inside colorful containers. Bright, playful fonts read “Purple Sticky Stuff” or “Captain Kratom.” A dose or two went for $20 to $25.
Wayward marketing maybe cultivated its ill repute, as did its listing on the DEA’s “drugs of concern” resource guide, which made it tough for medical researchers to study its lifesaving or harm-reducing potential. The National Center for Complementary and Integrative Health denied a grant request to study kratom, explaining that the foundation does not fund the research of “hazardous materials.”
“Were it further regulated or banned, kratom would become even more difficult, virtually impossible, to analyze,” American Kratom Association President Susan Ash warns.
That’s one of the many catch-22s in America’s approach to drug regulation. Because plants such as kratom or marijuana lack acceptable studies demonstrating their value as medicine, the DEA can declare the drugs medically useless, making it virtually impossible for researchers to actually study them, according to University of Mississippi’s Chris McCurdy, a researcher studying drug withdrawal and kratom, in a 2016 Scientific American article. “Not many of us [researchers] have a Schedule I license,” he notes.
Dallas resident and Marine Anthony August Larson relies on kratom for relieving constant back pain.
Fighting pain and fighting back
Among those working to promote the plant’s goodness and educate users and vendors is Anthony August Larson, a Dallas resident, disabled Marine, a trained herbalist and one of America’s staunchest, most outspoken and organized advocates for kratom’s legitimacy and continued legality. He is hell-bent on changing that “legal high” perception.
Because of condition that caused constant back pain, Larson says he relied on morphine prescribed by doctors in order to function. He learned about kratom when traveling in Indonesia, after he ran out of pain pills and sought out a prescription. Instead of pharmaceuticals, the doctor gave him kratom. After kratom, he says, he dosed less morphine and quickly quit craving it.
In the early ’00s in Seattle, he worked at a Veteran Affairs hospital, where, he says, he learned some of the more traumatized soldiers were using kratom.
“They had heard of it — some of them — he says, but they were buying it at head shops at these insane markups, so I would give it to them,” he says.
Larson says he could see their demeanor, confidence level and general wellbeing transform with a combination of kratom, other doctor-recommended treatment and counseling.
In 2003, he launched a project called KratomDocumentary.com. It’s a website containing hundreds of interviews with all manner of people lauding the benefits of kratom.
He wanted to start this, he says, because he could see what was coming.
“I am a capitalist, not a conspiracy theorist,” Larson says. “But it doesn’t take a genius to see that if a cheap plant stands to diminish the need for billions of dollars in pharmaceutical sales, well, someone decided it was time to make it go away.”
Scientific research is preliminary at best, but anecdotal evidence related to kratom abounds. Larson has been collecting and documenting testimonials, and he says he constantly is surprised and impressed by what he hears.
Spencer Owens at 43 was preparing for a total hip replacement.
“It had been two years living uncomfortably since I was diagnosed with this hip problem,” he says. “They determined I had no cartilage left, a torn labrum. It couldn’t be fixed with arthroscopic surgery, so I was going to have this major operation.”
After a second opinion, Owens, an active, scarcely middle-aged man, rejected the invasive procedure and opted for physical therapy, weight loss and pain management using narcotics such as hydrocodone and oxycodone.
The latter option seemed considerably safer, at first.
As the American opioid crisis began dominating news headlines, Owens questioned his reliance on narcotics for relief. Even more disturbing, Owens’ body adapted to his prescribed doses. The pills worked wonders at first. Then his physiology changed, and his body grew accustomed to the medicine. The pain increased.
He lost weight and performed agonizing therapeutic exercises, but his hip did not improve, and every few weeks, his pain medication lost effectiveness. Like millions of legitimate chronic pain patients, he was at the mercy of doctors when it came to controlling his pain. Hospital visits became nerve-wracking ordeals.
As the opioid epidemic worsened, the DEA imposed limits on doctors prescribing or ordering controlled substances, so physicians fear prescribing enough medicine to adequately treat patients’ pain.
Within two years, Owens could hardly walk — physical therapy, jogging, outings with the dog all became unbearable without strong narcotic analgesics, which, to make everything worse, also made his head “fuzzy.” And he battled to bury this nascent apprehension that even if his hip magically healed, his body would demand the pills all the same.
Frightened about his steadily growing reliance on the drugs, fed up with feeling foggy all the time and worried antsy prescribers would cut him off, Owens began looking for an alternative.
People in pain can grow desperate for relief. Moms, teachers, lawyers, cops — anyone in physical agony is capable of things they never imagined.
A single mother of two leaving CBD Kratom in Oak Cliff (we will call her Cheryl; she only agreed to chat anonymously) works in an expensive, exclusive preschool by day and picks up occasional nighttime catering or bar-tending shifts.
A few years ago, she began experiencing severe pelvic pain. The petite, freckled strawberry blonde, 32, is resilient to the core, and she regularly runs herself ragged, forever fighting misery.
“It hurts physically, yeah,” she says, “but it makes me sad too, depressed even. I want to do things, like with the children, and … [gazes down at shaky hands, folded in her lap] I just can’t.”
When she was 30, doctors diagnosed interstitial cystitis, a painful bladder condition with no cure but some moderately effective treatment options. She tried nerve stimulation, physical therapy and anti-inflammatory drugs, antidepressants, and — finally, reluctantly — narcotics.
She spreads paperwork across a table, her documented diagnosis with instructions, prescriptions, insurance letters and specialists’ phone numbers — a cache kept in a bound, pocketed journal.
As with Owens, Cheryl’s opiate regimen worked — for a time. By winter 2017, she needed something stronger because her tolerance had increased. She had to work double shifts to cover bills and put presents under the tree. But her doctor refused to prescribe stronger meds. In fact, he told her he planned to wean her off the narcotics. He had few options.
When your body hurts all the time, “this plague, the crisis, outbreak everyone’s talking about — it means very little to you, personally. All you can think about is your own pain, sleeplessness and frustration,” she says, tears streaming.
Despairing, Cheryl first committed a crime of opportunity: she swiped an old, barely touched bottle of oxycodone from a relative’s medicine cabinet.
At a Christmas party she worked last year, a bartender at the end of a shift snorted a tiny bump of beige powder. Heroin. She was hurting so badly she could hardly think.
The bump of heroin up her nostril felt just like morphine, she recalls telling her pusher. “It’s basically the last thing I remember before waking up in a hospital bed, a tube down my throat, dried vomit in my hair.”
She would have died without a shot of naloxone, the drug that reverses opioid overdose, at the ER.
In the white room, Cheryl drew her knees to her atrophied, aching tummy. At midnight two days before Christmas, she brought her smartphone close to her blurry eyes and scoured the internet for alternatives to opiates. Anything, she wept. Trembling — exhausted to the bone but wired “like a speed freak” — she mussed the sheets, soaked them in sweat, snot and tears.
Her fumbling fingers after a few minutes took her to Reddit.com and the site’s kratom forum, where she read narratives she could have typed herself.
“I could not believe there were this many of us out there,” she says.
Some of the sub-Reddit’s 40,000 members said they took the herb for physical relief while others called it the antidote to anxiety and depressive disorders.
To her amazement, self-identified “junkies” — one after another — wrote of weaning themselves off all manner of pharmaceutical narcotics.
She read the reviews, inspected vendors and, in an attempt to save her life, or at least any semblance of its quality, ordered a bag of powdered plant. She relied not on physicians but anonymous mentors — Weezer2040, BisonPuncher, Drunkendolphin1, MichaelKeaton.
She felt different — hopeful, even — when that first teaspoon took effect 15 minutes after she ingested it (place powder on tongue, drink full glass of water or orange juice, do not puke) a few days after Christmas.
“It was gentler than oxycodone but eased all my tension in the most painful areas; the agony, oh my God, the agony, eased up,” she says.
She alternated oxy and kratom, but within a week or two, she says, she preferred kratom. Not only did it alleviate the pain, but also she found herself smiling, playing with the children. She did not feel foggy when driving to school, work, overtime gigs. She somehow felt safer, she says, and cleaner — although she was chugging a teaspoon of dirt every four to five hours.
When the pharmaceutical drugs ran out, she experienced withdrawal symptoms from oxycodone. But instead of the norm — shaking, freezing, sweating, pounding heart, panic, vomiting, feeling as if her skin was inside out, each nerve exposed — she says she dealt with irritability, runny nose, chills and a little trouble sleeping for about a week.
Owens, too, sought alternatives, but not in street drugs. Rather, he looked into homeopathic and herbal supplements.
His search, much like Cheryl’s, led the Dallas man to kratom.
Owens’ description of his kratom trial, also like Cheryl’s, seems too good to be possible. He feared his first dose was a dud, he says.
“But when I increased my intake just a little, it did wonders,” he says. “It relieved my pain without any intoxicating effects, and I thought, I have found something that works. And it curbed my cravings for narcotic pain medicines. In fact, it just pretty quickly cut out my use of them altogether.”
He conferred with his physician, he says, but the doctor had never heard of kratom. If some herbal supplement helped him, the doctor told him, go for it.
He has been self-medicating with kratom ever since, he says. “I kinda don’t know what I’d do without it,” Owens says. “I’ve done endless research on this by now — most controversy about kratom is due to lack of knowledge.”
Stirring the masses
The DEA drug scheduling announcement of 2016 brought kratom users out of hiding — protests in Washington, hometown rallies (a couple hundred people showing up at many, especially when Larson went with his camera) — to record more web testimonies:
“I work a full-time job now,” a 40-year-old woman says. “I raise two kids all by myself without feeling drugged out because of pain pills.”
“Tried everything from surgeries to acupuncture for 13 years, finally discovered that opiate pain meds work — 60 milligrams of oxycodone per day,” an older man says, “but now doctors bullied by the DEA don’t want to prescribe. Kratom has been an absolute lifesaver … but if they take it from us … what then?
DEA scheduling could prove devastating for the thousands of Americans self-treating pain and other ailments, those weaning themselves off opioids such as hydrocodone, oxycodone, morphine and fentanyl, and it would essentially put a stop to research on humans.
Even Trae Crowder, the comedian known as Liberal Redneck, spoke up: “This is deeply personal to me. My momma’s a recovering addict. Pills. Hillbilly heroin, Percocet … the DEA just did something that will make it even worse … an epidemic that no one is doing anything about, partly because it effects mostly poor people. and everyone knows poor people are super gross. … Pills are as bad as any drug out there. I’ve seen it. They have made a lot of dirty people a lot of dirty money.”
Larson says he was caught off guard when the stories of opiate withdrawal treatment began to emerge. People did not want to talk about that at first, but when they did, it was a floodgate, he says.
“What an opportunity during an opiate crisis in our country!” His enthusiasm, if possible, intensified.
But the FDA’s announcement, which released results from the promised further study of kratom, was a kick to the gut. FDA administrator Scott Gottlieb cited “44 reported deaths associated with the use of kratom [among other drugs, since 2011].” He continues, “There is no evidence to indicate kratom is safe or effective for any medical use.” And he stated that the supplement “isn’t just a plant — it’s an opioid.”
Ash, president of the AKA, says there’s more to the numbers.
“They are saying 44 people died from a range of causes and that they had kratom in their system. It’s like blaming fatalities on coffee because 44 people who drank coffee died today,” she says.
Larson puts it like this, acknowledging kratom can indeed make one sick, or, combined with other drugs, dead: “So say you order kratom from some rando off the internet and you get sick, throw up, dizzy,” Larson hypothesizes. “Some vendors just do not care. Others do not actually know about keeping their product pure and clean.”
Larson travels the country talking to sellers and, if they will have him, letting them know how to properly wash and prep their inventory. Some — especially the “hippie types on the West Coast” — truly care about their clients and kratom’s image, he says. The point: Kratom isn’t causing illness; it’s contamination or adulteration somewhere along the way.
“But when the ER doc asks you what you took, you say kratom, they call poison control and we have another ‘adverse incident’ on the books,” he says. There is not one record to date of a kratom-caused death, he insists. Not from kratom alone. Mixed with other drugs and conditions, yes, apparently 44.
Kratom-associated death, according to the FDA, can include something like this: A 43-year-old man suffering severe complications because of deep-vein thrombosis had a long list of medical problems, including chronic back and shoulder pain and a history of alcohol and prescription drug abuse. Toxicology tests returned positive for opioids, benzodiazepines, antidepressants, a medication used to treat Tourette’s syndrome and kratom. The FDA listed his death among “kratom-associated” fatalities.
Among deaths of people who are chronically ill, drug addicts, abusers of illicit substances, patients undergoing treatment for a variety of mental illnesses among them, 44 have involved kratom in some manner, backing evidence that it is potentially deadly, Gottlieb insists. But people do not die from kratom, Larson says. Not from just kratom. It does not depress breathing as other opiates do.
“No one, not a single person, has died by kratom use alone,” Larson says. “The kratom-related deaths they point to, in every case, involve other illicit or prescription drugs, alcohol or some major underlying condition.
“If I took way too much kratom, and I did take three times too much at first because the consistency was different from what I knew in Indonesia, I would feel nauseated, might vomit, might get a headache and go to bed,” Larson says. “In a few hours, I’d be fine. Do the same with oxy, fentanyl, heroin — not so. You are probably going to die.”
Even allowing for these 44 kratom-related deaths in America since 2011, that pales compared with the anticipated more than 50,000 deaths expected from opioid overdoses this year. This doesn’t mean kratom is always safe, either. Kratom bought online can be contaminated or adulterated with other substances, possibly to hook customers.
A smaller sub-Reddit focused on quitting kratom contains heart-tugging tales and conversations among kratom users who feel they have lost control and want to stop and others who say they have been physically addicted but tapered off. They experienced similar symptoms to those detoxifying from heroin — diarrhea, agitation, chills, sweats, insomnia and restless leg syndrome — but to a lesser degree, according to member I_Wise. One woman says all was fine until she purchased a so-called “enhanced” tincture.
“Then I was like a heroin addict,” she says. “There are products out there one must stay away from — do your research.”
About 4,000 members belong to the quitting kratom sub-Reddit. “We are a group of people dedicated to helping each other kick the kratom habit,” its administrator notes.
What better way to be able to hold your kratom vendor accountable than selling it from a storefront, Larson asks rhetorically, expressing excitement about Dallas’ new brick-and-mortar shops. “As long as they are honest with people, don’t gouge people, educate consumers, I think it is great. I mean, you are going to pay a little more for the overhead and security,” he says, adding that he wants to meet the owners.
Although kratom is not a magic cure and there are risks (dirty vendors, adulterated products, evidence of addiction potential, and more), its possibilities seem to shine most brightly in matters of harm reduction, an emerging movement in which the main goal is to not die. Stay alive, and there is always a chance — it’s a phrase often heard in 12-step meetings.
Alcoholics Anonymous and Narcotics Anonymous, the mainstays for addiction recovery, do not consider a person using any mood-altering substance clean or sober. It’s a problem because there is no instant cure, says one former NA member shopping for kratom. “If you want to fully recover, you must have spiritual, therapeutic support as well as medicinal treatments,” he adds.
A couple of university professors, whose research focuses on design, synthesis and development of drugs to treat pain and drug abuse, concentrate on opioids and have studied kratom as a replacement for methadone, a powerful opiate used for long-term weaning off heroin, morphine, oxy, fentanyl and the like. Kratom can touch the brain’s opiate receptors, creating a similar, if subtle, narcotic effect. However, unlike every other opioid, including maintenance drugs such as methadone and Buprenorphine (pharmaceutical, long-acting, expensive opiates the FDA champions as the only approved medicinal treatments for withdrawal syndrome) kratom does not cause any significant respiratory depression.
Dr. Edward W. Boyer, professor of emergency medicine and director of medical toxicology at the University of Massachusetts School of Medicine, collaborated on a study with Christopher R. McCurdy, then at the University of Mississippi. They discovered the plant’s most abundant alkaloid, mitragynine, and tested the pure compound on lab mice.
“Results indicate this compound’s activity is superior to methadone in treating withdrawal … and that carefully created chemical variations may provide an alternative to methadone in treating addictions to opiates,” McCurdy determined. “Mitragynine completely blocked all withdrawal symptoms and could provide a remarkable step-down-like treatment for people addicted to hardcore narcotics such as morphine, oxycodone or heroin. The compound has been known for years, but we’re working to come up with an improved synthetic analog or a better formulation of the tea for testing in humans.”
Opioid analgesics kill so many people because the medicines can lead to respiratory depression, Boyer says. “When you overdose on these drugs, your respiratory rate drops to zero. In our animal studies where rats were given mitragynine, those rats had no respiratory depression. This opens the possibility of someday developing a pain medication as effective as morphine but without the risk of accidentally overdosing and dying.”
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Revah says she wants anyone who needs kratom or CBD to have access. Some of the people who need or want to try kratom, for example, are older people who are not comfortable walking into a head shop and asking for a product the DEA called hazardous and almost banned.
“We are here to put our clients at ease,” she says. A customer or two have complained about prices steeper than they find online, but the stores are drawing curious newbies and thankful longtime users. Sometimes it’s just about relaxing with a little kratom tea after a long week, she says.
She understands the risks of building a business around a product that just a year ago was one step away from being outlawed. She is prepared for pushback. Although the couple’s multiple stores, including Mr. Nice Guy, generate more than $1 million annually under their M&G umbrella, they would not have opened a kratom store if they did not think it would remain legal, Revah says.
The FDA and DEA, she says, are lying. “They say they want to save people dying from opiates and unbearable pain — well, we feel they aren’t doing their job, and this war against kratom certainly is not going to help a thing.”
The use of the herb kratom in pets has been a subject of much interest, due to the amazing results pet owners have reported and credited to the botanical. Much of the research to determine the safety of kratom has been done on animals, generally on rats and mice, but occasionally on dogs and cats. The good news, though limited, is that — even at absurdly high doses of the pure principle alkaloid, Mitragynine or standardized extracts of the whole plant, all the animals survived. Only at the highest doses of pure Mitragynine was there found to be any damage to the animals’ kidneys and/or livers.
Anecdotal reports by those who care for pets have been very encouraging for dogs with hip dysplasia, other injuries, anxiety, and age-related low energy, etc., as you’ll see below.
The comments of several veterinarians and care-givers in pet rescue facilities have been supportive of giving kratom to dogs in small doses. For some unconfirmed reason, veterinarians are apparently universally opposed to giving kratom to cats. Nobody has been able to tell us why or to direct us to research that would confirm this.
We can only speculate on whether kratom supplementation in other pets, such as rabbits, donkeys, and reptiles would be healthy for them. By deductive reasoning, those that are able to digest plant matter should be fine. The owners of pets should keep in mind that kratom, even with all fiber removed, still has the effect of slowing digestive motility, so it’s important to keep doses to a minimum and watch for signs of constipation.
Having said this, let’s allow the pet owners tell what they have seen in their Pets:
Dominique: My 3 legged pit bull gets Kratom when he’s in pain. 1/8tsp does it and you can see the relief both in his expression and movement within 20 minutes.
Kristie: I wet the part of my finger they take your finger print from and then press it into my dogs kratom. Then rub it on their gums and whats left rub on their tongue. I use it on my beagle for her seizures. They have stopped since I started her on kratom. Then I give my pit kratom for pain. She has cancer. I only give them reds with just a tiny bit of yellow kapuas. With the pit I will add just a tad of white if she is having a good day and wants to go and do doggie things.
Katie: We had a dog named Red, he was an old boxer with terminal bowel cancer, in his last few days before he was to be put down I gave him a dose of Kratom, I figured that it helped me feel better, and his pain meds were doing nothing. Lo and behold, the old bastard got up from his somber sad corner of the world and started playing for the first time in months, and he ate for the first time in a couple of days, it was like he was a totally new dog. I only wish I would have given it to him much sooner maybe it would have slowed the whole process down or even stopped it. He was still put to sleep, because it was 2 little too late, but at least he was able to enjoy his last few days, I definitely would recommend kratom to literally anyone or any animal. I hope this story helps.
Bekkah: My Winston, he’s a little Jack Russell/Javanese mix and the biggest baby you’ve ever seen. We thought he had sprained a paw or something, he was limping around all afternoon so for dinner I took about an eighth of a teaspoon or a little less and sprinkled it on his food. Took a little coaxing but he ate it. About 45 minutes later I noticed him jumping on the couch without trouble.
Connie: I used it for my Jack Russell for several months before we let her rest. She was hurting a lot and 1/4 tsp on her good morning and night helped her get through the day with her tail wagging. I alternated red Sumatra at night and bentuangie in the mornings.
Stormy: I use it for my two chihuahas all the time. The past 3 weeks my female is in heat so my male has been running around house nuts whining 24 hours a day. I give him half gram Green Indo[a type of kratom] and he relaxes and is not in misery anymore.
Kerra: This past summer an old stray dog showed up here. In bad shape! Hungry, covered in fleas, ticks, and some sores. Missing teeth and arthritic, we took him in, bathed and pampered him. He got real bad at one point. Wouldn’t or couldn’t get up to go outside or eat. We sprinkled just under 1/4 teaspoon Red Bali [another type or “strain” of kratom] in his breakfast for three days. Day 3 he got up, running around like a young pup. Doing fine since then. Haven’t had to give more at this point.
Julie: I have been giving kratom to my senior dog for his arthritis for about 4 months now. He was at the point where he could hardly get up or walk. I hate the arthritis meds the vets give for dogs (really damaging to liver and expensive). I mix a 1/4 tsp Red Borneo or Bali in a tsp of coconut oil, morning and evening, and he laps it right up. I’ve even started to mix in a pinch of turmeric. (He’s about 50 lbs) Everybody has noticed the difference in him, in fact my husband was getting a little annoyed because now he’s up and begging in the kitchen again lol! If I am late for a dose he will come and find me to remind me, so I know even he knows it’s helping him. I don’t know anything about using kratom in younger dogs, but for these older dogs who aren’t going to be around much longer, it sure is nice to know there is something to help them feel comfortable in their senior years.
Jeannette: I used it for our little dog that is about 30 lbs and 2 yrs old. He had abdominal surgery for a blockage. The surgery went well but the vet tech put him on a heating pad while he was still out of it and he ended up with 3rd degree burns on about 1/2 of one side of his body. He was in so much pain and tramadol was not even touching it. He just laid there and cried. I gave him 1 (00 size) capsule and it seems to really help but he was still whimpering. I gave him another and he quieted right down so he was getting 2 capsules about every 4 hrs for about a month and a half. He would just eat them like a treat. When it began to wear off, he would cry and whine. After about 2 months he is about healed up and no longer needs the kratom but he still begs for it. His scars look great and hair is slowly beginning to grow back. I really think kratom probably saved this little guy’s life. If not that, it sure helped him with recovery.
Sue: I’ve been giving Kimmie, my twelve year old Border Collie Mix three capsules of red every day. She seems to feel so much better from her arthritis.
Amy: I have a 3 year old golden with severe hip dysplasia. I’ve tried all the supplements. NONE of them worked except this one! I also have a ton of friends in golden rescue who I’ve switched them over to it as well. Not a single complaint. Only positive stories.
Jill: I’m a foster mom for the local shelter and I use kratom for scared, anxious or hurt dogs. I also use it for my 18 yr old Collie and it helps my Terrier with her nervous behavior.
Ryan: So I gave Kratom to my chihuahua. His paw was hurting for some reason. He was barely walking around.. After he ate it though, he was running around the yard like it’d never even happened. It was strange cuz he hasnt been limping since.
Robert: We utilized kratom with our 14 year old black lab, ‘Bear’. He had severe joint/hip pain (and other issues), so severe, that he didn’t jump on ‘his couch’ for 3+ years. I mixed aprox. 2 grams of a green vein, in with his wet/dry dog food mix.
ONE hour later, he had jumped his big ass on ‘his couch’ again! It may seem insignificant, but this was HYUUUGE for him, at that stage in his life!
He left us a year & a half ago, but ever since that jump, he had his proprietary blend of kratom mixed in with his dog food every day.
Our ONLY regret was not trying this ‘experiment’ sooner.
Gina: I have a 10 year old male poodle who weighs 20 pounds. He was diagnosed with arthritis in both of his back legs about 6 months ago. The vet put him on 2 prescription drugs. It helped very little. I started him on kratom 7 days ago. 1 gram of a mixture green/red. Once again kratom worked its magic! He is back to walking normal and going up and down steps. He even wants to play ball again. My only regret is not putting him on kratom 6 months ago. He’s back to being my mischievous boy!
Adan: I have a 15 year old Maltese with cancer, I’ve been feeding her kratom, turmeric, cat’s claw and graviola, needless to say the doctors were shocked to see her tumors disappearing, she was diagnosed 3 years ago. Kratom helped most of all to get her up, motivated, active and helped with her appetite. I assume it’s because of its pain relieving properties that she’s so healthy and eating well despite having had cancer.
Here is the little that I’ve been able to find in the kratom published research concerning cats:
“…it had little effect on the blood pressure of dogs, was only hypotensive in cats at high doses, and was much less of a respiratory depressant than codeine.” Referring to testing with pure mitragynine on cats and dogs. It went on to say, “Large doses in cats had stimulating effects, qualitatively different than opiates.” From “Ethnopharmacology of Kratom and the Mitragyna Alkaloids” Journal of Ethnopharmacology, 231988115119, Elsevier Scientific Publishers Ltd. Ireland
The researchers’ idea of high doses was 18.4 — 46mg/Kg of PURE Mitragynine, without the moderating effects of the other alkaloids in the botanical — and no deaths or other negative side-effects were mentioned, which leads me (tentatively) to believe, pending further evidence of possible negative effects of other of the 27 alkaloids usually present in whole kratom, that kratom for cats is safe, at least for acute pain relief in the short term.
We heard one anecdotal report of a cat whose leg was broken when a car hit the cat during the winter in Maine. The cat was found by its owners with a chicken sitting on it, keeping it warm (and alive). It being the weekend and no veterinarian available, they gave the cat kratom to ease the pain, which caused the cat to stop crying and be able to eat, rest, and recouperate. When the cat began crying again, a few hours later, the kratom was given again as needed. When the cat was strong enough, the leg had to be amputated, but the cat is now healthy and no longer needs kratom.
It is my hope that pet owners can deduce for themselves a sense of the safety and efficacy that the use of kratom may provide their pets so they can enjoy life more, in spite of aging and injuries. There were many more owner accounts — all favorable — that I will use in a future article on the subject of pets and kratom.
Paul Kemp is fascinated with all the many uses people have found for the herb kratom. He has written about it frequently since 2012.
Here is a study that demonstrates that pure Mitragynine is relatively safe for rats (and we may assume other mammals) at lower sub-chronic doses.
For more information on how to provide the essential nutrients needed to prevent and reverse the common symptoms blamed on aging, contact the author of this blog.
When one of our institutions get to a point in which its mere existence is causing pain and suffering, then it is time to reconsider whether it is needed. Since its creation, the FDA has consistently tested and approved drugs and procedures that kill people on a regular basis and a massive scale.
The FDA approved opiods. The FDA encouraged the prescribing of opioids by allowing high pressure sales professionals to market right to the prescriber. Promising nice trips and kickbacks to doctors that are already squeezed by over-regulation. All this time the FDA has known that opioids are deadly. It wasn’t even until it began to get out of hand, that they even reacted, and when they reacted they caused the criminalization of Americans over and over again and still do to this day.
When the FDA and the DEA realized there was something getting in the way of their cash cow, they chose to try to make it illegal. Our government is screwing with the lives of millions who are just trying to take their lives back from the grips of addiction caused by the same people who are attempting to criminalize the only legal way to get past opioid addiction without creating another addiction or dying of an overdose as the FDA would have you do.
So if you are an addict, are in pain, have high anxiety, or use Kratom for anything to avoid using the death elixir the FDA would have you use and risk death or arrest. Folks, counseling works 18% of the time because most people are not originally addicted due to mental illness and prefer not to put their dirty laundry out to a bunch of strangers when all they really need is to get relief and over withdrawals to move on with their lives.
Ask yourself if the FDA is really an institution that is protecting YOU – or are they protecting their pockets.
Oct. 26, 2017 — Eric Mayhew Jr. wanted to break his more than decade-long addiction to opioids — one that started when his doctor prescribed them for knee pain.
But he didn’t want to do an in-house treatment and tried to detox on his own.
Nothing worked, until 2 years ago when he tried kratom.
“What kratom does is kills your brain’s desire when you are addicted to opiates and you want opiates,” says Mayhew, 37. “It dulls your painand you start to get your wits back again.”
Now he takes the recommended dose of two to four capsules a day. He says he has had no side effects but admits he still needs his willpower.
“You have to want things to work. Nothing works unless you understand that,” says Mayhew.
He says he hasn’t relapsed since.
When it comes to withdrawing from opioids, medical experts and addiction counselors agree that you will be far more successful with support than trying it alone. But traditional treatment can be expensive and time-consuming, if it’s even available. Many treatment centers have long waitlists.
One study from 2015 found that only 21.5% of people with opioid abuse disorders are getting treatment. At the same time, about 91 Americans die every day from reasons related to opioid dependence.
That’s why some people dependent on opioids are rejecting traditional, medical-based withdrawal and seeking a do-it-yourself path.
Experts say — and conversations online show — that one of the most talked about methods is using kratom, a little-known herb made from the leaves of a tree that grows on the other side of the world. A recent survey found that nearly 70% of people using kratom were doing so to cut back on or get off of opioids or heroin.
But there’s little research on the herb’s effects on people, and some experts say it also can be addictive.
The herb is illegal in six states and the District of Columbia, and the Drug Enforcement Administration is considering labeling it as a Schedule I drug — a category that includes heroin, ecstasy, marijuana, and LSD. For now, the agency calls it a “drug of concern.”
Christopher R. McCurdy, PhD, a professor of medicinal chemistry at University of Florida’s College of Pharmacy in Gainesville, studies kratom and says while he believes the raw substance holds great promise for opioid withdrawal, he has deep concerns about how it is bought and sold.
“I definitely believe there is legitimacy to using kratom to self-treat an opiate addiction. I believe it from the standpoint of the material we know is pure and unadulterated and good. I just don’t know if all products available are consistently pure and good,” McCurdy explains.
Kratom for DIY Withdrawal
Kratom is made from the leaves of a tropical tree in Southeast Asia (Mitragyna speciosa) that have been used for hundreds of years to relieve pain. The leaves can be eaten raw, but more often are crushed or ground and brewed as tea or turned into capsules or liquids. It is sold online, where prices vary depending on the strains, amount, and form you buy.
DEA spokeswoman Katherine Pfaff says the agency considers it “harmful and dangerous.”
The FDA has warned people not to use any products labeled as containing kratom out of concern for its toxicity and potential health impacts.
“As our nation struggles with epidemic levels of opioid abuse, we should be doing everything possible to ensure that those suffering with addiction have access to FDA-approved medicines and appropriate treatment options; not unregulated substances bought and sold over the internet,” Pfaff says.
In August 2016, the DEA announced its plans to temporarily classify the main psychoactive elements of kratom as Schedule I drugs, calling them an “imminent hazard to public safety.”
The DEA says it is aware of 15 kratom deaths, although other drugs were also reportedly found in those victims.
But after a public outcry, the agency agreed to allow time for public comments and an FDA investigation. The DEA says as of Oct. 12, 2016, it had received more than 23,000 comments from the public about kratom and is reviewing them as part of its decision on the fate of the herb, which for now is up in the air.
The FDA is preparing an analysis of kratom. A spokesperson says the agency has no time frame to complete this review.
A study published in July 2017 found kratom is used for self-treatment of pain, mood disorders, and withdrawal symptoms that come with prescription opioid use. It was found to have few negative effects, including nausea and constipation, but generally only at high doses or when taken frequently.
But there aren’t a lot of human studies of kratom. In 2008, Edward W. Boyer, MD, director of academic development in the Department of Emergency Medicine at Brigham and Women’s Hospital in Boston, published a study about a 43-year-old man who abruptly stopped abusing opioid pain medicine by taking kratom.
The man spent $15,000 a year on kratom he bought online, drinking it in tea four times a day to ease his opioid withdrawal. The man said the herb cut his pain a lot and didn’t make him drowsy or cause any real side effects.
“I think the cool thing about it is this guy went from injection drug use to nothing, and all he had was a runny nose,” Boyer says. “It’s similar to something like methadone or any other opioid, but what is different is withdrawal from those substances is far more involved.”
People who use kratom typically don’t have withdrawals, says McCurdy, the University of Florida professor.
“That it helps them stop their cravings for going back to opioids and helps them with their mood. They feel good. They mention that they aren’t lazy like when using opioid prescriptions or addicted to opioids. They feel more productive and are doing things they love again, returning to a normal lifestyle.”
McCurdy’s research on mice shows kratom has a clear potential to treat opioid withdrawal with few side effects.
“It is probably addictive, but its addictive equivalent is something like coffee, which isn’t surprising because the leaf is in the coffee family,” McCurdy says. “We firmly believe that it will be very good for treating opioid withdrawal and may be a possible solution to the opioid epidemic we are facing as a country.”
But he says that would require testing kratom in clinical trials and controlled studies. He’s hopeful that will happen in the next 5 to 10 years. For now, he warns buyers to beware.
“You don’t know what you are getting, and I think that is the scary thing about going into self-treatment. On the flip side, I can tell you I get at least one email a week from someone on prescription opioids or heroin that states they have gotten off those drugs by using kratom,” McCurdy says.
Boyer agrees, urging caution because he says it’s still not well understood. Kratom isn’t regulated, and there are no standards for what is sold in the U.S. McCurdy and Boyer were involved with a study published in 2016 that analyzed several commercial kratom products and found many had opioid levels that were “substantially higher” than those in kratom’s raw leaves.
“We know that people buy what they think is kratom. We don’t know that it actually is,” Boyer says. “Some people have found it useful, but nobody can vouch for its safety or efficacy. So to say that it is miraculous is clearly an overstatement.”
While kratom seems to be the most commonly used substance for self-detox from opioids, experts say other people try marijuana, Imodium, and over-the-counter pain relievers for body aches.
“It’s not surprising to me that people would try anything to alleviate the symptoms,” says Darren Ripley, a counselor with the Alliance for Addiction and Mental Health Services in Augusta, ME. “What I am hearing more of is marijuana.” He says people claim it helps with pain and anxiety.
Research out of Johns Hopkins Bloomberg School of Public Health finds the most common treatment option is self-help groups.
But the National Institute on Drug Abuse says successful treatment for drug addiction includes medical and mental health services.
FDA Commissioner Scott Gottlieb, MD, says people who use medication-assisted treatment (MAT) for opioid addiction cut their risk of death from all causes in half. Medication-assisted treatment is the use of medications like methadone and buprenorphine along with counseling and behavioral therapies.
What Can You Do?
Ripley is not just a counselor but also a recovering addict. More than 25 years ago, he says, he got clean with the help of a 28-day medication-based detox program. He thinks that to successfully detox, people also need a support system and peer-to-peer help like a recovery coach.
“There was nothing that was easy about it, and I have all the empathy in the world for someone just starting out and trying it,” he says.
When patients overdose on opioids, they often end up in emergency rooms, where they may have a chance to get professional help.
Bayshore Medical Center in Holmdel, NJ, started an intervention program in July to help addicts find treatment. Since then, 64% of those involved in 34 bedside interventions with recovery coaches have entered into treatment and recovery programs.
“When you have a coordinated support team, your success rates will be higher than going home and doing treatment out-patient or on your own,” says Rajiv Prasad, MD, medical director of the hospital’s Department of Emergency Medicine.
If you want to try to detox yourself, Boyer says it’s helpful to at least understand and expect that withdrawal is not going to be pleasant. “Opioid withdrawal is certainly uncomfortable but is not life-threatening. So the safest but most unpleasant approach is just to go cold turkey.”
But Mayhew says kratom was the answer for him. He works, is a proud uncle, takes things one day at a time, and says kratom has been a real lifesaver.
“I am just a guy from Kentucky, but I can tell you it gave me my self-respect, my word, my accountability back, and it gave me back what I felt like before I took opiates. It’s a long road. But you get your life given back. It is a really powerful thing.”
Choosing the right type of Kratom strain that fully meets your requirements is not an easy task. Buying a Kratom was not that challenging a decade ago as it has become today. The only popular Kratom strains that were known several years ago were Maeng Da and Bali.
But the ever-increasing variety of Kratom strains has made it really difficult for the consumers to choose the ideal Kratom strain that better meets their needs. To make it easier for Kratom users to shop this incredible herb, this article provides detailed information about the most potent Kratom strains that they can buy from the market.
Kratom is a popular medicinal plant that belongs to mitragyna speciosa family. Kratom is cultivated in the lush green rainforests of Thailand and Malaysia. It has been used for decades as a natural remedy for low energy levels, stress, and anxiety, as well as pain relief.
A long time ago people who used Kratom were only limited to Bali and Maeng Da Kratom. But today, there is a wide range of this herbal plant to choose from. While the locals prefer to directly chew on raw Kratom leaves to attain desired results, in other parts of the world this herb is majorly sold in the form of powder, extract, capsules and teas.
No matter which type of Kratom product you are using, if you have purchased premium quality Kratom supplement, you can easily get the dynamic benefits this plant can deliver.
Since there are many types of Kratom strains, we decided to categorize the strongest strains based on benefits that they deliver. For example, analgesic, nootropic, stimulation, etc.
The Strongest Kratom Strains
If you are seeking natural remedies to overcome fatigue, depression, pain, and insomnia instantly, then we suggest that you chose from the following strains of Kratom.
Powerful Analgesic Kratom Strains
Kratom contains particular chemical compounds known as 7-hydroxymitragynine and mitragynine. Both alkaloids that interact with the mu-opioid receptors in the body to alleviate pain and aches.
However, some Kratom strains, despite being natural painkillers, are mild in their action. They might not be able to relieve chronic pain and aches. Therefore, it is important to get powerful analgesic Kratom strains to get rid of pain and suffering.
The strongest analgesic Kratom strains that you can buy include:
Red Bali Kratom
Maeng Da and Indo Kratom are the very much credited for their pain-relieving potential. But, in case you want to get rid of a pain in the fastest possible way, then nothing can match the potency of Red Bali.
Red Bali has remarkable pain relieving capabilities that instantly alleviate pain and provide quick relief and relaxation to the users.
The 7-hydroxymitragynine content in Red Bali is comparatively higher as compared to that of other Kratom strains. This alkaloid makes it a potent painkiller and muscle relaxant. People who suffer from joint aches and cancer-related agonizing pain can definitely benefit by including Red Bali in their daily routine.
This is the latest addition to the Kratom variety. Bentuangie Kratom belongs to the Red Vein family and it has even more remarkable pain alleviating properties than Red Bali.
If you are looking for a fast-acting remedy, then Bentuangie Kratom might not help. It takes time before delivering its desired, but it is quite powerful in its effects. It not only eliminates even the most excruciating and unbearable pain but it also wipes out body’s perception of painful sensations.
When choosing between the two for pain relief, it must be kept in mind that Red Bali has the potential to induce sedation in users. So, if you don’t want to feel dizzy or hung-over throughout the day then picking Bentuangie Kratom would be a wise decision. (2)
Indo Kratom is very powerful, both in its action and effects. Because of its sedating properties, Indo Kratom is considered one of the most effective strains for relieving stress and anxiety.
It is also remarkable when it comes to dealing with insomnia. Indo Kratom helps users to fall and stay asleep by eliminating all sorts of thoughts and chatters in the mind. Individuals can relax and sleep peacefully. Eventually, they wake up fresh, active, and energetic the next day.
Strongest Stimulating Kratom Strains
Finding a stimulating Kratom strain is not tricky at all. It is the advantage of this incredible plant. Almost every variety and strain of Kratom possesses cognition-boosting properties. But for those who want to know the most active and potent nootropic Kratom, following are a few strains popular for enhancing cognition:
Green Malay Kratom
When talking about nootropics, Green Malay tops the list of cognition enhancing strains. Green Malay has a perfect blend of flavonoids as well as opioids that make it a highly effective nootropic supplement. People can get rid of brain fog, improve their mood and thoughts, feel motivated and combat anxiety by using Green Malay.
It is considered an excellent remedy to overcome stress and depression. It helps individuals to feel positive and motivated by producing positive thoughts and joyful feelings. It is also known for improving focus and concentration levels in individuals.
Borneo is subtle when it comes to action but considering its nootropic effects, it is one of the strongest Kratom strains that you can buy. Borneo is an incredible remedy for people who suffer from stress and anxiety. It produces comfort, relaxation and peace of mind to users. It is a powerful Kratom strain for combating anxiety and insomnia.
Since it does not induce sedation, many people prefer to buy Borneo over other powerful nootropic Kratom strains.
Strongest Energy Boosting Kratom Strains
Feeling sluggish and fatigued all the time? Does lethargy seem to have taken over you for the rest of your life? Well, there is no need to feel upset about your condition because we know some of the most powerful and effective Kratom strains that can boost your energy levels instantly.
Sourced from the mainland Thailand, Thai Kratom is the most robust strain of Kratom you can buy to overcome low energy levels. Thai Kratom is an instant energy booster and works better than caffeine. It is its high mitragynine content that makes this strain such a powerful energizing agent.
Just replace your daily dose of coffee with Thai Kratom, and we bet you would feel upbeat, active and alert throughout the day.
Vietnam Strains are prized a lot for their stimulating properties. Unlike Thai Kratom, the Vietnam variety doesn’t produce get-up-and-go effects, but it delivers a slow yet remarkable burst of energy that lasts for quite a long time.
White Vein Kratom
The white vein variety of Kratom is quite famous for its energizing effects. This type is very stimulating and enhances energy levels, significantly. People who suffer from lethargy and fatigue can stay active and alert throughout the day by using white vein Kratom.
White Vein Kratom is also credited for its potential to efficiently remedy depression related to low energy levels. (8)
The Most Potent Kratom Strains for Euphoria
Did you know that the 7-hydroxymitragynine which gives Kratom the quality to deliver astounding medical benefits can also produce euphoric effects?
The alkaloids present in Kratom leaves (mitragynine, and 7-hydroxymitragynine), are opioid agonists and can result in euphoria. They can interact with the opioid receptors in the brain to produce high effects.
Kratom users who want to use this herb for recreational purposes, to attain euphoric effects, can try one of the following Kratom strains.
Borneo is the most potent strain of Kratom when it comes to euphoric effects. Although Borneo is more famous for its immense energizing qualities, this powerful Kratom strain delivers intense feelings of euphoria, when taken in the right dose.
Borneo leaves its users in a relaxed state of mind, making them feel joyful and happy. It improves one’s moods and produces positive feelings and thoughts.
Green Malay Kratom
Green Malay Kratom is another strong Kratom that can cause euphoria. Green Malay is known for its high potency and maximum impact. It contains higher alkaloid levels, which interact with the mu opioid receptors in the brain. This results in feelings of relaxation and happiness.
Green Malay doesn’t act very fact, but once it kicks in, its euphoric effects last longer than Borneo and Maeng Da. People who are looking for get-up-and-go effects should pick Borneo instead of Green Malay as it doesn’t act instantly to produce a High.
Maeng Da Kratom
Despite the availability of other powerful Kratom known for their euphoric effects, Maeng Da is still the most popular strain of Kratom among all.
Maeng Da is prized for its perfect combination of analgesic and stimulating effects. It is still many people’s favorite euphoric Kratom.
What really adds to the popularity of Maeng Da is its mechanism of action. Maeng Da can deliver strong euphoria instantly, and its effects do not last longer than a couple of hours.
It might be too high for the beginners, and therefore, they must choose from a variety that produces delayed effects.
The Food and Drug Administration recently released another attack on kratom yet, and in its logic, continues to undermine their own claims. The latest release tallies the deaths attributed to kratom, scientific jargon, and includes an explanation of a 3-D modeling on how kratom attaches itself to the body’s opioid receptors like a addictive drug.
Because of this, according to the FDA, kratom should be considered dangerous and scheduled like heroin, hydrocodone, fentanyl, and methadone.
But after filtering through all mumbo jumbo, all that FDA’s Commissioner Scott Gottlieb is pushing is junk science.
Take for example the number of deaths the FDA claims were caused by kratom. In November, the agency claimed there were 36. Today, it’s up to 40 with nine being in Sweden. In their fake science news, the FDA also distributed selected portions of the medical examiners’ reports of those deaths attempting to confirm the danger of kratom. What those reports clearly show are people dying from anything other than kratom. For examples: one person was shot in the chest and it was ruled a homicide. Another person fell out of a second story window, broke bones, and then refused medical treatment. The following day he was found dead. An obese man with a history of drug abuse and alcoholism was taking medication for his high blood pressure, Xanax, other anti-depressants, marijuana and opioids died from a blood clot. The Swedes took a poisonous illicit synthetic drug. Others were addicts making their own concoction of illicit drugs, synthetics and alcohol. Only one person who ingested kratom by itself died. The results are still inconclusive because the FDA refuses to release the complete report.
This hodgepodge of anecdotal reporting does not bolster the agency’s credibility; rather it makes it suspect at best.
Kratom grows in Southeast Asia and yet, in the 200 years of Western knowledge, not one Asian death can be attributed to the plant. Even a Lexis-Nexis search of thousands of newspaper archives failed to find one story saying a Southeast Asian died from kratom.
According to a 2008 national survey in Thailand, more than a million people reported using kratom. In several southern districts in Thailand, up to 70 percent of the male population use kratom daily. And yet the FDA is not capable of pointing to what should be a staggering number of Asian deaths attributed to the plant. Are Americans and Swedes the only ones susceptible to the deadly plant?
The FDA website discreetly places a caveat of their findings, saying the medical cases don’t imply a “causal relationship” between a product and an event. It also notes the “(medical) reports do not always contain enough detail to properly evaluate an event.” So the FDA is pushing fake science.
The FDA’s smoke and mirror show continues with the claim they did computer modeling showing the compounds found in kratom attaches itself to the mu-receptors in the body. Mu-receptors attract opioids. The agency’s conclusion is “we feel confident in calling compounds found in kratom, opioids.”
Using the FDA’s logic, if a compound sticks to the receptors it must be an opioid. Well then, they are going to have to put coffee, chocolate and dairy products on the dangerous drugs list too, for they all latch onto to the receptors as shown by numerous National of Institute of Health studies.
But this is old science. Scientists have known this for years.
Andrew Kruegel, an associate research scientist at Columbia University, said the FDA’s computer modeling adds nothing new to the research.
“They said these compounds are predicted to turn on those opioid receptors; that’s already known,” Kruegel said. “I don’t understand what that’s contributing to the field. It’s almost like going back to an earlier stage of scientific discovery.”
Kruegel said the FDA’s claim was akin to “saying that all opioid agonists have the same effect, which is not true based on what we’ve learned about these compounds.”
The fallacy of computer modeling is, that it is done in a vacuum, and the rules are set by programmers. The modeling process doesn’t end when you complete it. You have to compare it to the real world, and that’s done with real-world testing which the FDA and other agencies willingly will not do.
“Molecular modeling is not infallible,” said Josh Bloom, senior director Chemical and Pharmaceutical Sciences at American Council on Science and Health. “When used in drug design it is not uncommon for the model to explain the activity of a molecule rather than predict it.”
Bloom adds, “The magnitude of the effect of any drug is dependent on its dose and binding affinity. Without knowing both, it is impossible to determine the pharmacological effect of a given drug.”
The risk of not having kratom available to those who need it, despite all its liabilities, may be greater than whatever harm the drug may cause, Bloom said.
One has to ask, with all the science that contradicts the FDA’s announcements, why are they so intent in wanting to schedule kratom? What is the real reason for wanting to ban the plant, and yet support pharmaceutical drugs that are more dangerous?
The FDA’s anti-science attacks against kratom fail to recognize that thousands of people using the plant are suffering from intolerable pain, some caused by the very drugs they have approved. By making kratom illegal, Gottlieb’s actions will make law-abiding American citizens criminals by forcing them to seek relief from street drugs. Those have a guaranteed consequence of long-term addiction and death. The FDA is better than that, and should allow real independent science to take place, instead of pushing fake science.
Once again, the failing FDA, CDC and DEA let us down. Now they try through the CDC to stop Kratom use by saying it is the cause of salmonella poisoning, however only 8 of 11 interviewed used Kratom. If Kratom is the cause it would make sense everyone would have to ingest it somehow to get the salmonella. Makes more sense that they got their Kratom at a specific shop. Just another shot from this corrupt government and big pharma that created the opiod crisis by approving the drugs in the first place. Oh yes and the 65000 that will die this year from overdoses according to the FDA should go ahead and die because Kratom as an alternative is too dangerous. I don’t see the comparison but I do see the failing FDA with their hands out to big pharma.
Also, look at the map in the next article which shows multiple states in which Kratom is illegal were effected by this outbreak. Very hard to believe this story at all especially when experienced in addiction, Kratom, and other herbs.
Kratom blamed for salmonella outbreak in 20 states.
CDC says stay away from kratom for now
by Maggie Fox /
Kratom may be linked to salmonella outbreaks, the CDC said.Joe Raedle / Getty Images file
The popular herb kratom is linked to an outbreak of salmonella that has made 28 people sick in 20 states, federal health officials said Tuesday.
Most of the people who have been made seriously ill in the outbreak remember having recently used some form of kratom, the Centers for Disease Control and Prevention said.
It said 11 people were sick enough to have been hospitalized.
“At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick,” the CDC says on its website.
The Drug Enforcement Administration is looking at a strong restriction on the sales of kratom, which is currently traded freely on the internet and in some stores.
“Kratom is a plant consumed for its stimulant effects and as an opioid substitute. Kratom is also known as Thang, Kakuam, Thom, Ketom, and Biak,” the CDC says.
Kratom enthusiasts say it’s enjoyable to use recreationally, but say it is also useful for treating withdrawal from opioid use and can be used to treat pain.
“Kratom is not a drug,” the American Kratom Association says on its website.
“Kratom is not an opiate. Kratom is not a synthetic substance. Naturally occurring Kratom is a safe herbal supplement that’s more akin to tea and coffee than any other substances.”
It says kratom is illegal in Indiana, Tennessee, Wisconsin, Vermont, Arkansas, Alabama and Rhode Island, as well as some local jurisdictions including Sarasota County in Florida, San Diego and Washington, D.C.
Salmonella is a very common bacteria that causes food poisoning. The CDC says it is not clear how it could have gotten into supplies of kratom. But genetic testing links the cases that have been reported.
“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73 percent) of 11 people interviewed reported consuming kratom in pills, powder, or tea,” the CDC said.
“No common brands or suppliers of kratom have been identified at this time.”