Banning a Promising Cure for Opioid Addiction Is a Bad Idea

March 4, 2015 - Clearwater, Florida, U.S. - JIM DAMASKE   |   Times.An opened capsule containing Kratom.  -  Following the recent crackdown on prescription and synthetic drugs across the state, authorities are now focusing on controlling an herbal supplement that is legal in Florida and believed to elicit the same effects of some narcotics. Made from the crushed leaves of a tree growing in southeast Asia, Kratom comes in pills as well as powder that can be added to tea, according to the Drug Enforcement Administration. It is legal in most states except Indiana and Tennessee. Florida might be next in outlawing Kratom: State Rep. Kristin Jacobs filed legislation in January that would make the supplement a controlled substance. (Credit Image: © Jim Damaske/Tampa Bay Times/ZUMA Wire)

March 4, 2015 – Clearwater, Florida, U.S. – JIM DAMASKE | Times.An opened capsule containing Kratom. – Following the recent crackdown on prescription and synthetic drugs across the state, authorities are now focusing on controlling an herbal supplement that is legal in Florida and believed to elicit the same effects of some narcotics. Made from the crushed leaves of a tree growing in southeast Asia, Kratom comes in pills as well as powder that can be added to tea, according to the Drug Enforcement Administration. It is legal in most states except Indiana and Tennessee. Florida might be next in outlawing Kratom: State Rep. Kristin Jacobs filed legislation in January that would make the supplement a controlled substance. (Credit Image: © Jim Damaske/Tampa Bay Times/ZUMA Wire)

Forty-five years after the drug war was declared by President Richard Nixon, the United States leads the world in both recreational drug usage and incarceration rates. Heroin abuse rates continue to soar. Drug-related violence in our nation’s cities and cartel wars in Latin America exact horrific tolls.

And then there is the ever-present bully on the block, prescription drug abuse. More than two million Americans have become hooked on the pharmaceuticals that doctors prescribe to ease their pain. Opioids—both legal and illicit—killed a mind-boggling 28,647 people in 2014.

But not to worry: The Drug Enforcement Administration is on the case. “To avoid an imminent hazard to public safety,” the agency said in a press release, it will be adding kratom, a medicinal herb that has been used safely in Southeast Asia for centuries, to its list of Schedule 1 substances, placing the popular botanical in a class with killers like heroin and cocaine at the end of September.

Why ban the mild-mannered tree leaf? Well, because the DEA claims it’s an opioid with “no currently accepted medical use.” Wrong on both counts.

Pharmacologists label kratom as an alkaloid, not an opioid. True, kratom stimulates certain opioid receptors in the brain. But then, so does drinking a glass of wine, or running a marathon.

Kratom is less habit-forming than classic opioids like heroin and the pharmaceutical oxycodone, and its impact on the brain is weaker and more selective. Nevertheless, the herb’s ability to bind loosely with certain opioid receptors makes it a godsend for addicts who want to kick their habits. Kratom is currently helping wean thousands of Americans off illegal drugs and prescription pain relievers, without creating any dangerous long term dependency.

The powdered leaves are readily available from scores of herb sellers on the Internet. Since the ban was announced in late August, websites and social media have exploded with accounts from people who credit the plant with saving them from lives of addiction and chronic pain.

Take, for example, Virginia native Susan Ash. She was using Suboxone to help cope with severe joint pain resulting from Lyme disease. “My life was ruled by the clock—all I could think was, ‘when do I take my next dose,’” Ash says. Then someone suggested she try kratom to help kick her addiction to the prescription pain killer. “In two weeks time, I went from being a bed-bound invalid to a productive member of society again.

She founded the American Kratom Society in 2014 to help keep this herbal lifeline legal. Ash says that tens of thousands of people use kratom not just to help with chronic pain, but also to alleviate depression and to provide relief from PTSD. She strongly disputes that users like herself are simply exchanging one addictive drug for another.

“I have never had a craving for kratom,” Ash says. “You can’t compare it to even the mildest opiate. It simply won’t get you high.”

What it might do, users say, is slightly tweak your mood. The leaves of the Mitragyna speciosa tree, a biological relative of coffee, have been chewed for centuries in Southeast Asia by farmers to increase their stamina. Kratom is gently euphoric and also relaxing—think coffee without the jitters and sleeplessness. It is hard to take toxic levels of the herb, since larger doses induce nausea and vomiting.

But does it provide medical benefits? Dr. Walter Prozialeck, chair of the Department of Pharmacology at Midwestern University in Downers Grove, Illinois, who conducted a survey of the scant medical literature on kratom, says the herb did indeed help to relieve pain in animal studies.

While no clinical trials have yet been done with humans, addicts in Thailand and Malaysia have used kratom for decades to detox from heroin and alcohol. It was so successful in getting people off opium that Thailand banned kratom in 1943 to stem the loss of the opium taxes that funded the government.

Nobody knows how many are using kratom here in the US. “There are so many testimonials out there [from kratom users] on the Internet that I personally found quite compelling,” Dr. Prozialeck says. “This merits further study.”

But study has proven difficult. Dr. Edward Boyer, director of toxicology at the University of Massachusetts Medical School, says that when he tried to conduct research on kratom, potential partners told him, “we don’t fund drugs of abuse.” Drug companies have shown sporadic interest in isolating the active constituents in kratom since the 1960s, he says, but no pharmaceuticals have yet been developed from them.

Given the current opioid crisis, Boyer hopes researchers will dive deeper into the plant’s pharmacology. “Wouldn’t it be great to have an analgesic that will relieve your pain and not kill you?” Boyer notes that kratom is free from the potentially deadly side effects like respiratory failure that have bedeviled prescription opioids.

However, drug companies have shown little interest in a plant remedy that cannot be patented. While some of kratom’s active ingredients have indeed been patented by researchers who hope one day to market them to pharmaceutical firms, Boyer said that these compounds have failed to exhibit as powerful pain-killing effects as the whole plant. “There is something in there that we don’t yet understand,” he added.

And if the DEA’s ban goes into effect, we may never understand kratom’s remarkable potential. That’s because the federal action would have a chilling effect on research, according to Boyer.

The DEA claims that kratom is addictive. Since you can get hooked on most anything— even coffee or chocolate, as Dr. Boyer pointed out, this claim is both relatively meaningless and also hard to dispute. Users report that withdrawal symptoms from kratom are comparable to giving up coffee—a few days of irritability, perhaps a headache.

In issuing its scheduling notice, the DEA said that the Centers for Disease Control received 660 complaints about kratom (including reports of constipation and vomiting) between 2010 to 2015, out of 3 million calls annually reporting adverse reactions to assorted other foods and drugs. To put this number in perspective, the National Poison Data System registers more than 3,700 calls about caffeine annually, every year leading to multiple overdoses that result in death.

“This hardly constitutes a public health emergency,” says Susan Ash. “They definitely get more calls about energy drinks.”

In banning kratom, the DEA dispensed with the usual public comment period. Advocates, however, refuse to be silenced. They plan to challenge the DEA’s action in court and are marching on the White House on September 13. A petition urging President Barack Obama to reverse the ban has surpassed the 100,000 signature mark which, by law, requires a personal response from the president.

“There is a cheap plant out there that’s helping people getting off opioids,” Ash says, “and now so many are going to be forced back into active addiction, or made a prey to black market drug dealers.”

What if, instead of turning tens of thousands of law-abiding Americans into either addicts or felons, the DEA listened to those who have used kratom successfully to kick their addictions and manage chronic pain? Instead of banning the herb, why not draft some sensible regulation to establish dosage and labelling requirements and to protect consumers from adulterated product?

And while they are at it, America’s drug agency should sponsor some long overdue scientific research into a substance that may be the best thing going to combat our runaway epidemic of opioid addiction.

Health Benefits of Hemp

Hemp has been called a plant of “major economic importance,” as it grows like a weed, yet can be used in the production of food, personal care products, textiles, paper, and even plastic and construction materials.1

Valued since ancient times as a fiber source for textiles, the hemp industry eventually made it to the US, where it flourished in the mid-1800s, through World War I and again briefly during World War II, when the war cut off supplies of fiber.2

In the US, the cultivation of hemp has been banned since the 1970s when the federal Controlled Substances Act took effect. The law doesn’t distinguish between marijuana, the drug, and hemp, the plant, despite major scientific differences.

Ironically, the US is the world’s largest consumer of hemp products, yet is the only industrialized country that also outlaws its production. As a result, all US hemp products – a more than $600-million market in the US – are imported.3 As noted in “Hemp: A New Crop with New Uses for North America:”4

“Cannabis sativa [hemp] is extremely unusual in the diversity of products for which it is or can be cultivated. Popular Mechanics magazine (1938) touted hemp as ‘the new billion dollar crop,’ stating that it ‘can be used to produce more than 25,000 products, ranging from dynamite to Cellophane.'”

What’s the Difference Between Hemp and Marijuana

Hemp and marijuana come from the same plant species, Cannabis sativa, but there are noted differences between the two plants. They both contain cannabidiol (CBD), which has medicinal properties. The amount of CBD however, differs greatly between the two.

Dosing, therefore, is dramatically different when you to try to use hemp in lieu of cannabis for medicinal purposes, as the latter, cannabis, is up to 100-fold more potent.

Another difference that appears to matter in terms of its usefulness as medicine relates to differing terpene profiles. Hemp contains very little of these valuable medicinal compounds.

Lastly, there’s the tetrahydrocannabinol (THC) content. THC is the psychoactive component of marijuana; it’s the molecule that makes you feel “stoned.” (While cannabidiol (CBD) also has certain psychoactive properties.

It does NOT produce a high.) By legal definition, hemp cannot have more than 0.3 percent tetrahydrocannabinol (THC) in it. So to summarize:

  • Hemp has less value for medicinal uses, as it only contains about 4 percent CBD and lacks many of the medicinal terpenes and flavonoids.It also contains less than 0.3 percent THC, which means it cannot produce a high or get you stoned. While hemp may not have the same medicinal uses as marijuana, it does have excellent nutritional value that may boost health.
  • Marijuana can act as a potent medicine courtesy of high amounts (about 10 to 20 percent) of CBD, critical levels of medicinal terpenes, and flavonoids, as well as THC in varying ratios for various diseases. The higher the THC, the more pronounced its psychoactive effects.
  • Genetic Difference Between Hemp and Marijuana Uncovered

    If there were still any question over whether or not hemp and marijuana are two different plants, it should be put to rest with the publication of a new study that shows the genetic difference between hemp and marijuana.5

    Researchers from the University of Minnesota’s (U of M) College of Biological Sciences and College of Food, Agricultural, and Natural Resource Sciences belong to one of the few groups of US scientists that have been granted federal clearance to study cannabis.

    After more than 12 years of research, the team found a single gene that is responsible for the genetic differences between hemp and marijuana. As noted by Medical Daily:6

“While hemp produces a non-euphoric cannabidiol (CBD) with approximately 0.3 to 1.5 percent tetrahydrocannabinol (THC) concentration, marijuana is packed with between five to 10 percent (or even higher) psychoactive THC concentration.”

The researchers believe they have “indisputable evidence” that hemp and marijuana should be regarded as separate plants.

Nearly half of US states now separate hemp from marijuana. George Weiblen, a professor with a joint appointment in the U of M’s College of Biological Sciences and College of Food, Agricultural and Natural Resource Sciences, said:7

“It’s a plant of major economic importance that is very poorly understood scientifically… With this study, we have indisputable evidence for a genetic basis of differences among cannabis varieties, further challenging the position that all cannabis should be regulated as a drug.”

  • Health Benefits of Hemp

    One of the under-appreciated benefits of hemp, at least in the US, is as a food source. Hemp seeds, which are technically a nut and are also known as “hemp hearts,” are rich in healthy fats, protein, and minerals.

    Hemp seeds are usually consumed after the hard outer shell is removed, leaving just the soft, creamy “heart” behind. The seeds have a slight nutty flavor, making them incredibly versatile for use in cooking, baking, or for adding to smoothies and salads. Some of their primary health benefits include:8

 

  • Excellent Source of Nutrition

Hemp seeds are composed of more than 30 percent healthy fats, including the essential fatty acids linoleic acid and alpha-linolenic acid (plant-based omega-3). According to research published in Nutrition & Metabalism

“Dietary hempseed is… particularly rich in the omega-6 fatty acid linoleic acid (LA) and also contains elevated concentrations of the omega-3 fatty acid α-linolenic acid (ALA). The LA:ALA ratio normally exists in hempseed at between 2:1 and 3:1 levels. This proportion has been proposed to be ideal for a healthy diet.”

Hemp seeds also contain gamma-linolenic acid, which supports the normal function and growth of cells, nerves, muscles, and organs throughout your body.

Hemps seeds are about 25 percent protein and also provide nutrients including vitamin E, phosphorus, potassium, magnesium, sulfur, calcium, iron, and zinc.

  • Heart Health

 

      Hemp seeds contain numerous heart-healthy compounds, including the amino acid arginine. L-arginine is a precursor to nitric oxidein your body. It has been shown to enhance blood flow and help you maintain optimal blood pressure. Nitric oxide signals the smooth muscle cells in your blood vessels to relax, so that your vessels dilate and your blood flows more freely.
      This helps your arteries stay free of plaque. When you have inadequate nitric oxide, your risk for coronary artery disease increases. The gamma-linolenic acid found in hemp seeds is anti-inflammatory, another bonus for heart health. Past research has also shown hemp seeds may help reduce blood pressure, decrease the risk of blood clots, and boost recovery after a heart attack.
  • Skin Health

 

      Fatty-acid deficiency can manifest in a variety of ways, but skin problems such as eczema, thick patches of skin, and cracked heels are common. Hemp seeds are a rich source of fatty acids in the optimal omega-6 to omega-3 ratio. Research suggests hempseed oil may improve symptoms of atopic dermatitis10 and potentially provide relief from eczema.
  • Plant-Based Protein

 

      Although I believe protein from high-quality animal sources is beneficial for most people, if you are following a plant-based diet, hemp makes a healthy source of protein. With all of the essential amino acids and an amount of protein similar to beef (by weight), hemp seeds are an excellent form of plant-based protein.
      Two to three tablespoons of hemp seeds provides about 11 grams of protein, complete with the amino acids lysine, methionine, and cysteine. Two main proteins in hemp seed protein, albumin and edestin, are rich in essential amino acids, with profiles comparable to soy and egg white. Hemp’s edestin content is among the highest of all plants. Hemp protein is also easy to digest because of its lack of oligosaccharides and trypsin inhibitors, which can affect protein absorption.
  • PMS and Menopause Symptoms

 

        The gamma-linolenic acid (GLA) in hemp seeds produces prostaglandin E1, which reduces the effects of the hormone prolactin. Prolactin is thought to play a role in the physical and emotional symptoms of premenstrual syndrome (PMS). GLA in hemp seeds may also help reduce the symptoms of menopause. 11
  • Digestion

 

        Whole hemp seeds contain both soluble and insoluble fiber, which may support digestive health and more. Soluble fiber dissolves into a gel-like texture, helping to slow down your digestion. This helps you to feel full longer and is one reason why fiber may help with weight control. Insoluble fiber does not dissolve at all and helps add bulk to your stool. This helps food to move through your digestive tract more quickly for healthy elimination.
      Fiber plays an essential role in your digestive, heart, and skin health, and may improve blood sugar control, weight management, and more. Please note that only whole hemp seeds contain high amounts of fiber; the de-shelled hemp seeds or “hearts” contain very little fiber.

Agricultural Hemp Returns to Kentucky

Kentucky was once home to a flourishing hemp industry, but once hemp was outlawed, tobacco became the go-to cash crop. That is now slowly changing once again, as farmers take advantage of the five-year pilot Industrial Hemp Research Program, which was established by James Comer, Kentucky’s commissioner of Agriculture.12 The program is one recently launched in a number of states, where permission has been granted for industrial hemp to be grown for research purposes. As reported by Newsweek:13

“Kentucky led the U.S. industrial hemp business until the end of the Civil War, when production of the crop declined and was generally replaced by tobacco. The Marihuana Tax Act of 1937 put the kibosh on all production and sales of cannabis, including industrial hemp, but the crop saw a rapid resurgence during World War II. Hemp fiber became essential to produce military necessities such as uniforms and parachutes.

The U.S. Department of Agriculture launched its national ‘Hemp for Victory’ program, which provided seeds and draft deferments to farmers. In 1942, farmers planted 36,000 acres of hemp seed. A USDA-funded informational film from that year noted that ‘hemp grows so luxuriantly in Kentucky that harvesting is sometimes difficult.'”

Comer reportedly wants to “single-handedly turn industrial hemp into Kentucky’s No. 1 cash crop” and “breathe new life into family farms that have lost millions of dollars with the fall of the tobacco industry.”14

Currently, most industrial hemp comes from China, but the plant could bring great economic growth to areas of the US. Among the many products provided by industrial hemp are:

  • Cannabidiol (CBD), the medicinal compound, which can be extracted from the leaves, blossoms, and stems
  • Cannabis oil, which comes from cold-pressing the seeds and can be used for cooking, cosmetics, and beauty products
  • Fiber, which can be used as a substitute for cotton, wood, and plastic, with potentially endless uses
  • Hemp seeds, which are poised to become a human superfood and could also be used in animal feed

Hemp Could Provide an Environmentally Friendly Alternative to Plastic Hemp plastic is a “material of the future” that could drastically cut down on the need for plastics and their devastating toll on the environment. In some cases, standard plastics may be reinforced with hemp, which may account for up to 80 percent of the plastic’s weight. Hemp can also be used to make 100 percent hemp plastic, which is recyclable and can be 100 percent biodegradable.

Currently, the most common type of hemp plastics are those infused with hemp fibers, which means less plastic is used and the resulting product is more durable (hemp plastic is said to be five times stiffer and 2.5 times stronger than polypropylene).15 According to Hempowered.com:16

“Using sustainable and renewable natural plant fibers (such as hemp, flax, jute, and kenaf) and through industrial production techniques that mix them into plastics, a new award winning (Biomaterial of the year 2010) granule has been made from a combination of hemp with polypropylene, thus reducing the use of petroleum products.

… Their recoverable component comes from these natural plants and can make up over half of their weight, up to 80 percent. All these features make them suitable for the production of durable products. Hemp Plastic granules offer many advantages like good insulation, dimensional stability at high temperatures, a high thermal deformation temperature, and impermeability… The granules are currently produced for a range of applications in automobiles, construction materials, packaging, toys, and electronic products and launched onto the market in 2010.”

Hemp Could Soon Be Reclassified As an Agricultural Crop

Currently, hemp can only be grown in select US states for research purposes. However, even then the US Drug Enforcement Administration makes it challenging for growers. According to Newsweek:17

The DEA’s cannabis eradication program provides funding to local law enforcement to form a SWAT team of ‘cowboys flying around in helicopters.’ They have been known to sweep through private farms to confiscate the plants, and have even been known to mistake okra for marijuana.”

A bill in Congress could change that as, if passed, it would reclassify hemp from a narcotic to an agricultural crop. Rep. Jared Polis (D-Colo.), a co-sponsor of the bill – the Industrial Hemp Farming Act of 2015 — told the Huffington Post:18

“The federal ban on hemp has been a waste of taxpayer dollars that ignores science, suppresses innovation, and subverts the will of states that have chosen to incorporate this versatile crop into their economies… I am hopeful that Congress will build on last year’s progress on hemp research and pilot programs by passing the Industrial Hemp Farming Act to allow this historical American crop to once again thrive on our farmlands.”

References

 

‘Elixir of youth’ found in sex hormone

youth

A team of US and Brazilian researchers have used a synthetic sex hormone to stimulate production of a naturally occurring enzyme called telomerase that is capable of reversing ageing and has been dubbed a possible “cellular elixir of youth.”

While in embryos, telomerase is expressed by practically every cell. It can then only be produced in cells that are constantly dividing, such as blood-forming stem cells, which can differentiate into various specialized cells, scientists say. Certain cells avoid aging by using telomerase to lengthen their telomeres, which are DNA-protecting structures at the ends of chromosomes. The length of telomeres is a laboratory measure of a cell’s age, as each time a cell divides, its telomeres get shorter.

“In a healthy adult, telomere length varies from 7,000 to 9,000 base pairs on average. A normal person’s telomeres lose 50 to 60 base pairs per year, but a patient with telomerase deficiency can lose between 100 and 300 base pairs per year,” said Professor Rodrigo Calado, one of the scientists behind the research, the results of which were published in the New England Journal of Medicine.

Telomerase deficiency may cause some blood-related diseases, such as aplastic anemia. In the recent study, scientists treated 27 patients having telomere diseases with a steroid called danazol, a synthetic male hormone, leading to telomere elongation.

“In the patients who received danazol, telomere length increased by 386 base pairs on average over two years,” Calado said.

The research was based on previous findings that showed that androgens, which are converted into estrogens in humans, bind to female hormone receptors in the telomerase gene promoter region, stimulating expression of the enzyme in cells. The latest study “was designed to find out whether the effect we’d observed in the lab also occurred in humans, and the results indicate that it does,” the professor said.

While finding that sex hormones may be used to reverse one of the biological drivers of aging, researchers are cautious, as the risks of using the treatment in healthy people are not yet clear.

SSRI Antidepressants Put Patients at Clear Risk of Suicide

gun_pills

By Dr. Mercola

It is now estimated that 1 in 8 Americans are on serotonin reuptake inhibitors (SSRI) antidepressants1 and a shocking 1 in 4 among women in their 40s and 50s.2 Yet the U.S. suicide rate of 38,000 a year has never been higher.3

Clearly the glut of SSRI prescriptions is not lowering the national suicide rate; rather there is compelling evidence that the popular pills are actually contributing to suicide.

SSRIs and Violence

The first suspicion that SSRIs can cause dangerous and unintended psychiatric effects was a Kentucky shooting in 19894 in which pressman Joseph T. Wesbecker entered his former workplace, Standard Gravure, killed eight people, injured 12 and committed suicide after being prescribed Prozac.

Families of the wounded and killed soon filed a lawsuit against Prozac maker Eli Lilly and Company, claiming the SSRI contributed to the violence. The case went to a jury that sided with Lilly.

Yet three days before the shooting, Wesbecker’s psychiatrist had written “Prozac?” in his patient notes as a possible explanation of his bizarre behavior.

Since the Standard Gravure killings, psychiatrists, drug safety advocates and bereaved families have consistently tried to expose links between SSRIs and suicides but are hampered by mainstream safety data that deny a suicide link.

Study Suggests ‘No Suicide Link’ Is Not to Be Trusted

However, a recent study suggests the “no suicide links” findings are not necessarily to be trusted, noting that: “Therapists should be aware of the lack of proof from RCTs (randomized control trials) that antidepressants prevent suicides and suicide attempts.”5

Dr. David Healy, professor of psychiatry at Bangor University and author of 20 books including “The Antidepressant Era,” “The Creation of Psychopharmacology,” “Let Them Eat Prozac,” “Mania,” and “Pharmageddon,” heartily agrees that the SSRI statistics given to the public is problematic.6

“People haven’t had access to the data. There have been no publications around it. This is one of the biggest problems on which there’s a huge amount of data, but to which we’ve got little or no access …

If we were getting our drug information from The New York Times instead of medical journals, we would all be a lot safer. When the Times reporter Jayson Blair was found to have fabricated stories, he was history.

But the editors and writers involved with journal fraud still have their jobs and the articles are not even retracted. In fact, Liz Wager, Ph.D., the chair of the Committee on Publication Ethics (COPE) is herself Pharma-linked.”

The COPE website said about Wager,7 its former chair, “Liz provides writing, editing, training and consultancy services for various pharmaceutical companies” (most recently AstraZeneca, Cephalon, Cordis Corporation, GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine, Novo Nordisk, Sanofi Pasteur and Vifor Pharma) at the time of the interview with Healy.

Healy estimates as many as 1,000 to 2,000 Americans on SSRIs kill themselves each year, when they otherwise would not have done so. Violent acts against others and birth defects are also linked to the pills, he says.

Suicides Linked to Antidepressants Number in the Thousands

Even as high level links between medical editors and the drug industry prevented accurate information from reaching the public, in 1997, drug safety activists launched a website called SSRIstories.com,8 which archived credible and published reports that cite the role of SSRIs and related antidepressants in suicides and other violent behavior.

There are now thousands of entries. “The kind of energy, rage and insanity seen in a lot of crimes today was not seen before SSRIs appeared,” said Rosie Meysenburg, a founder of the website in an interview shortly before her death.9

In addition to the thousands of suicides, “there are two cases of women on the SSRI Stories site who stab a man close to 200 times and a case of a man who stabs his wife over 100 times and then goes next door to the neighbor’s house and stabbed the neighbor’s furniture about 500 times.”

The SSRI stories archive includes people on SSRIs setting themselves on fire, violent elderly people (which is rare) and bizarre cases of kleptomania and female school teachers molesting their minor male students. The common denominator in all the recorded crimes is the drug.

Drug companies routinely blame suicides on the depression that was being treated, not the drugs — but the experiences of patients treated with the same drugs for non-mental indications like pain and the experiences of healthy volunteers cannot be written off as the “disease.”

The Dark Side of Cymbalta

In 2004, 19-year-old Traci Johnson who had no history of mental problems hung herself in the Eli Lilly Clinic in Indianapolis while testing the drug giant’s serotonin–norepinephrine reuptake inhibitor (SNRI) duloxetine, sold under the brand name Cymbalta, a type of antidepressant similar to SSRIs.10

The suicide did not delay the drug’s approval and wide use. In 2008, the Journal of Clinical Psychopharmacology describes a 37-year-old man with a stable marriage, stable employment and no history of mental problems trying to kill himself two months after being prescribed Cymbalta for back pain.

“The patient was unable to state exactly why he wanted to commit suicide,” wrote the four physician authors in the report, also noting that the man returned to normal when the drug was stopped.

The authors also report a 63-year-old man with no mental health history becoming suicidal two weeks after being put on Cymbalta for fatigue, insomnia and sadness, yet he too was “unable to explain why he was having thoughts of wanting to die.”

Other cases of healthy people committing suicide on Cymbalta have been reported11 and many still remember the suicide of Carol Gotbaum at Phoenix’s Sky Harbor International Airport who was on the drug. She was the stepdaughter-in-law of New York City’s public advocate at the time, Betsy Gotbaum.

Writing for Slate, reporter Jeanne Lenzer identified 13 suicides12 linked to Cymbalta besides Traci Johnson. Eli Lilly wanted to market the drug as a treatment for urinary incontinence too but withdrew its application and would not release the study data to Lenzer, she says. It may well have contained more evidence of suicide side effects.

The Drug Industry Still Fights Black Box Warnings Added in 2004

In 2004,13 in response to the outcry over antidepressant-linked suicides, the U.S. Food and Drug Administration (FDA) directed drug makers to add a “Black Box” warning to SRRIs and related psychiatric drugs, highlighting suicide risks and the need for close monitoring of children and adolescents for suicidal thoughts and behavior.

“Today’s actions represent FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them.

Our conclusions are based on the latest and best science. They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us,” said Dr. Lester M. Crawford, acting FDA commissioner at the time.

Unfortunately, then and now, drug industry funded doctors have tried to claim that the warnings scare doctors and patients away and heighten suicide. While it would be ridiculous to blame obesity on tighter restriction of obesity drugs, that is essentially what drug industry spokesmen have done with SSRI warnings and continue to do.

Even The New York Times was misled by such disinformation, reporting that SSRI warnings were causing a leap in suicides.

Journalist Alison Bass, however, revealed14 the paper on which the Times article was based was funded by a $30,000 Pfizer grant. The conclusions about higher suicides also turned out to be wrong because the researcher got his years mixed up.15

Contrary to drug industry claims about the warnings, the proportion of children and teens taking antidepressants actually rose in the U.S. after the Black Box was added from more than 1 percent to nearly 2 percent says Dr. Andrea Cipriani, associate professor in the department of psychiatry at the University of Oxford, in England.16

Still, both David Shern, Ph.D., president of Mental Health America, a group investigated by Congress for undisclosed industry funding17 and Dr. Charles Nemeroff, also investigated by Congress, blamed18 the Black Box warnings for rising suicides. Speaking to ABC News, Nemeroff said:19

“I have no doubt that there is such a relationship. The concerns about antidepressant use in children and adolescents have paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates.”

False Charges About Black Box Warnings Continue

Nemeroff left his post at Emory University in disgrace because of his drug industry links20 and a National Institutes of Health (NIH) grant he managed was suspended because of the conflicts of interest — a rare occurrence.21 Nor have the false charges about Black Boxes died down. Here is how a New York Times editorial read just last year.22

“Worse, antidepressants, which can be lifesaving, are probably being underused in young people. Their use fell significantly after the FDA issued its so-called black-box warning in 2004, stating that all antidepressants were associated with a risk of increased suicidal feeling, thinking and behavior in adolescents. That warning was later extended to young adults.

It’s not hard to understand why. The FDA’s well-intended warning was alarming to the public and most likely discouraged many patients from taking antidepressants. Physicians, too, were anxious about the admittedly small possible risks posed by antidepressants and were probably more reluctant to prescribe them.

This very small risk of suicidal behavior posed by antidepressant treatment has always been dwarfed by the deadly risk of untreated depression … Parents and teenagers, and their doctors, too, should not be afraid of antidepressants and should know that they can be very helpful. Indeed, with careful use and monitoring, they can be lifesaving. The only thing we should all fear is depression, a natural killer that we can effectively treat.”

Blaming underuse of drugs and falling sales on warnings that made patients or doctors “anxious” is not limited to antidepressants. Recently, industry-funded groups charged that warnings on the bone drugs called bisphosphonates about fractures and osteonecrosis of the jaw were scaring patients and doctors away and denying patients the drugs’ benefits.23

SSRIs Ignored in the Extremely High Rate of Suicide in the Military

During the wars in Iraq and Afghanistan, troop suicides were higher than combat fatalities themselves and the majority of the suicides were among troops who had never even deployed.24 But when a long awaited Army report came out, it largely blamed soldiers themselves for the deaths, especially highlighting illegal drug usage and barely mentioning the huge number of troops on prescription psychoactive drugs. In fact, the word “illicit” appears 150 times in the Army report and “psychiatrist” appears twice.25

At the time of the Army report, 73,103 prescriptions for Zoloft had been dispensed to troops, 38,199 for Prozac, 17,830 for Paxil and 12,047 for Cymbalta.26 In fact 4,994 troops at Fort Bragg alone were reported to be on antidepressants by the Fayetteville Observer.

Four years after the Army report, researchers addressed the military suicides in JAMA Psychiatry27 again not finding or considering the high prescribing of SSRIs within the military. The authors had financial links to Eli Lilly, GlaxoSmithKline, Ortho-McNeil Pharmaceutical, Janssen-Cilag, Pfizer, Sanofi-Aventis, Shire and Johnson & Johnson.

In a series during the Iraq and Afghanistan wars called “Medicating the Military,” when SSRI use was mushrooming, Military Times reported:28

“A Military Times investigation of electronic records obtained from the Defense Logistics Agency shows DLA spent $1.1 billion on common psychiatric and pain medications from 2001 to 2009. It also shows that use of psychiatric medications has increased dramatically — about 76 percent overall, with some drug types more than doubling — since the start of the current wars.

Troops and military health care providers also told Military Times that these medications are being prescribed, consumed, shared and traded in combat zones — despite some restrictions on the deployment of troops using those drugs. The investigation also shows that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

Such ‘off-label’ use — prescribing medications to treat conditions for which the drugs were not formally approved by the FDA — is legal and even common. But experts say the lack of proof that these treatments work for other purposes, without fully understanding side effects, raises serious concerns about whether the treatments are safe and effective.”

Many military administrators have unabashed drug company links, like Dr. Matthew Friedman, former executive director of the Veterans Affairs’ National Center for PTSD,29 who admitted receiving AstraZeneca money in a video on the Center’s site a few years ago (a video since taken down) and served as Pfizer Visiting Professor while helming a government organization.30

Recently, the Annals of Internal Medicine ran another study looking at military suicides without finding an antidepressant role. The study’s editors at the Annals had links31 to Eli Lilly, Pfizer and Johnson & Johnson. Considering all the risks associated with antidepressants, it would be wise to use them as a very last resort. To learn more about safer treatment options, please see my previous article, “Supplements Proven Beneficial for Your Mental Health.”

Source:  http://articles.mercola.com

Brazil opens probe as cases of Zika babies defy predicted patterns

© Daniel Ramalho for The Globe and Mail The bulk of the cases of congenital Zika syndrome, fetal brain defects that sometimes cause microcephaly, remain clustered in the northeast region of Brazil, leading experts to wonder if there are other contributing factors.

© Daniel Ramalho for The Globe and Mail
The bulk of the cases of congenital Zika syndrome, fetal brain defects that sometimes cause microcephaly, remain clustered in the northeast region of Brazil, leading experts to wonder if there are other contributing factors.

Brazil’s Ministry of Health has launched an investigation into the cluster of babies born with brain defects linked to the Zika virus, after an expected “explosion” of cases across the country did not occur.

The bulk of the cases of congenital Zika syndrome – fetal brain defects that sometimes cause microcephaly, or abnormally small skulls – remain clustered in the northeast region of the country where the phenomenon was first identified last October, the ministry says.

And that has epidemiologists and infectious disease experts asking what is going on: Is it Zika and another virus working together that damages the fetal brains? Is it Zika and an environmental factor? Or something about the women themselves whose fetuses are affected?

The research in Brazil won’t have conclusions for months, but will have implications across the Americas, where the Brazilian experience and the rapid spread of Zika has caused governments to take protective measures and even warn women to delay getting pregnant.

“We can see there is a kind of cluster in [part of] the northeast region with high prevalence and high severity, of miscarriage and congenital malformation that is really severe,” said Fatima Marinho, co-ordinator of epidemiological analysis and information at the ministry.

But we didn’t find this in other states – even the [adjacent] states didn’t see the same situation as in the epicentre…. We were preparing for an explosion and it didn’t come.

“So we started to think that in this central area maybe more than Zika is causing this intensity and severity.”

A central theory the ministry is now exploring is whether co-infection with other viruses, such as dengue or chikungunya, is the factor. For example, does a mother’s previous (or simultaneous) infection with dengue, which is also ubiquitous in Brazil, mean that the Zika virus affects a fetus differently? Or is it other viruses?

“This is an area that was under attack by viruses: Some parts even had measles,” during the period when the bulk of the congenital Zika babies were conceived, Dr. Marinho said.

The ministry is also looking at social determinants, she said, because initial analysis makes it clear the women with affected fetuses have a clear “profile.” Some 77 per cent of them are black or mixed-race (the national figure is 52 per cent), and the great majority are poor. That’s surprising, she said, given that dengue, for example, carried by the same mosquito, infects people across social classes. Most of the mothers are young (between 14 and 24) whereas typically birth defects affect older women.

The World Health Organization is supporting research into co-factors. “Even though a causal link between Zika virus and congenital malformations has been conclusively demonstrated as published in international peer-reviewed scientific publications, other factors that may aggravate these conditions also require investigation,” said Sylvain Aldighieri, incident manager for Zika with the Pan American branch of the WHO.

“I totally agree some co-factors are likely involved,” said Eduardo Marques, a professor of infectious disease and microbiology at the University of Pittsburgh and scientific director of a program called Cura Zika. But it isn’t the cluster that convinces him: “It’s because not every woman exposed during pregnancy has a baby with the congenital effects.”

But not all epidemiologists concur: “I think it’s too early to say there is a disparity in the rate of microcephaly,” said Laura Rodrigues, a professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, who has been working on Brazil’s Zika epidemic since it was first identified. The epidemic is nearly a year behind in its spread in some other countries and perhaps other parts of Brazil, she said. “So maybe haven’t got to the peak. But that’s not to say we shouldn’t think about co-factors.”

Because the virus produces no symptoms in up to 80 per cent of people who get it, and only mild symptoms in many others, few people confirm Zika infection with laboratory tests, and so statistics of Zika cases are always estimates. The virus currently infecting Brazilians is a new, Asian strain of Zika, which was identified more than 60 years ago but never associated with congenital problems, or known to be sexually transmissible, as this strain is.

After Brazil, the next country that was expected to see the wave of congenital Zika was Colombia, which has the second-largest number of reported Zika cases. But of more than 12,000 pregnant Colombian women with Zika, only 21 have had fetuses or babies with the brain defects.

Dr. Marinho, with the ministry, said this reinforces her suspicions about the role of co-infection or other factors in Brazil. Dr. Marques said Colombia is only seeing the babies of women who were infected late in their pregnancies so far (because the virus season is about six months behind, further to the north) and the evidence is that the likelihood of damage by Zika is higher earlier in gestation – so those babies may yet come.

But Dr. Rodrigues had another explanation. “Now we know that in places where Zika comes the rate of abortion shoots up,” she said. “The feminist groups that will send pills by post to women … as a way of making up for the unfairness of the restrictive abortion laws, report an enormous increase in requests from Brazil and Latin America. I wouldn’t be surprised if when we look at cohorts in other counties, pregnancies disappear, and we can’t say if it was spontaneous or medical abortion.”

Researchers reported in the New England Journal of Medicine on July 28 that in Latin American countries where the new strain of Zika is spreading and abortion is illegal, there has been a huge spike in the number of requests to Women on Web, a Dutch-based organization which proves women with online consultations and then mails the drugs to induce a medical abortion. The increase over the rate of requests last year ranges from 38 per cent to 108 per cent in Brazil. (Brazilian authorities are now intercepting all deliveries to Brazilian women, the group said.)

On July 15, Adriana Melo, a fetal medicine specialist in the state of Paraiba who was the first to find Zika in the brains of affected babies, released research in which she and her co-authors report finding proteins of bovine viral diarrhea virus (BVDV), a cattle disease, in the brains of three fetuses with microcephaly from Paraiba whose brains also tested positive for RNA from the Zika virus. BVDV is known to cause serious birth defects in cows, but not to infect people. The findings were posted on BioArchive, a U.S.-based website for scientists to quickly share research findings on urgent matters, before peer review and publication. Their hypothesis is that Zika infection may weaken physiological barriers, so the cow virus that would not normally affect a human fetus can cause damage.

However other researchers are expressing skepticism of this theory – and Dr. Melo and her colleagues acknowledged the possibility that the BVDV they found was the result of sample contamination, because the virus is often found in fetal bovine serum, which is a reagent (a substance used in chemical analysis) frequently used in laboratories.

Dr. Marinho is at pains to make clear that the health ministry does not doubt that Zika is the primary cause of the fetal brain damage. (Brazilian doctors were quick to persuade the ministry of the link last year, but had a much longer job to convince the World Health Organization, which declared an emergency over microcephaly only in February.) Then conspiracy theories tore through the public in Brazil and beyond – that microcephaly was actually caused by a pesticide, or vaccines, or genetically modified mosquitoes – and she does not want to revive that debate.

“We know here Zika caused neurological damage – we have no doubt – but the question is how can we explain this situation in the epicentre that was not reproduced in other areas – in Colombia, and in other states in Brazil. A lot of pregnant women were infected and there were few cases of microcephaly or congenital malformation – it must be more than Zika itself,” she said. “We could be wrong of course but it is the responsibility of the Ministry of Health to investigate all possibilities.”

Beneath all of these theories lies a fundamental problem with data. Until this crisis, Brazil had very weak reporting of microcephaly, with rates in some areas reported as 1,000 times lower than in Europe even though researchers have every reason to believe that it occurred at roughly the same rates.

With the emergency declared, health workers suddenly erred in the wrong direction, overreporting microcephaly. Almost none of the women with affected babies had a serologically confirmed Zika diagnosis. Beyond that, Dr. Melo and her colleagues realized many of the worst-affected babies had completely normal looking skulls, and it was not until they showed neurological problems that they were reported as Zika-affected. She told The Globe in February that it was impossible to know how many had slipped through the net and were as yet undiagnosed. In addition, an unknown number of affected pregnancies ended in miscarriage.

The current epidemiological info is very fragile, so how do we know, for example, that we didn’t have an explosion of cases in Rio in 2014 and we didn’t pick it up?” asked Dr. Marques.

The Asian strain of Zika hit French Polynesia in 2013 and researchers have gone back to retrospectively diagnose 17 cases of babies born with microcephaly in a total population of 275,000 people – but researchers hotly debate how useful that information is for indicating the likelihood of co-factors, since it’s retrospective and based on modelling. In addition, while Zika was not known to be related to fetal development problems at the time, abortion is legal in French Polynesia and women who were told their babies had brain defects could have terminated their pregnancies.

Brazil has 1,749 cases of confirmed congenital Zika syndrome so far, with 106 stillbirths and deaths. Dr. Marinho said it will be months before the ministry has solid data to confirm that the cases are clustered and there are co-factors involved, let alone what they are, and meanwhile congenital Zika remains a real threat: Paraiba is now seeing a second wave of cases. “But this could be good news, for other areas of Brazil, and other countries,” she said.

Zika Virus Mystery: New Utah Case Stumps Researchers

In a puzzling case, a person in Utah became infected with the Zika virus, but health officials can’t figure out how the person contracted it.

The infected person was a caregiver for an elderly man who had Zika. But the case is mysterious: As far as health officials can tell, the caregiver wasn’t exposed to Zika in a way that would transmit the virus, at least from what’s currently known about Zika. So far, the only way Zika was thought to spread from person to person is through sexual contact, and the caregiver did not have sexual contact with anyone who had Zika.

“Zika continues to surprise us,” and there’s still a lot we don’t know about the virus, Dr. Satish Pillai, incident manager for the Centers for Disease Control and Prevention’s Zika response, said at a news conference today (July 18). [Zika Virus News: Complete Coverage of the 2016 Outbreak]

Health officials are currently investigating how the caregiver could have caught the virus, including whether Zika could be passed from person to person in special situations, even if the situation does not involve sexual contact.

“We’re still doing a lot of investigation to determine whether Zika can be spread from person to person through contact with a sick person,” Pillai said.

But the health officials stressed that the primary way that Zika is spread is through bites from mosquitoes that carry the virus. Of the more than 1,300 cases of Zika in the United States, nearly all involve people who caught the virus while traveling in an area where Zika is spreading. Fourteen people in the United States have now caught the virus through sexual transmission, and one person caught Zika while working with the virus in the laboratory.

“We don’t have evidence right now that Zika can be passed from one person to another from sneezing or coughing,” or from other types of casual contact, such as touching or sharing utensils, Pillai said.

The caregiver in the Utah case had not traveled to an area where the Zika virus is spreading, and mosquitoes that spread Zika have not been found in Utah.

But the person did take care of an elderly man who caught Zika virus while traveling to another country. The elderly man later died, although it’s not clear if he died from Zika or another underlying condition, officials said.

There was an unusual aspect of the elderly man’s case: He had extremely high levels of the Zika virus in his blood before he died — more than 100,000 times higher than the levels seen in other people infected with the virus so far, officials said.

“This is a very unique situation,” with such high levels of the virus, Pillai said. But researchers still don’t know whether this high level of the virus played a role in how the man’s caregiver caught Zika.

Health officials are currently interviewing the newly infected person and the person’s family members to learn more about the types of contact the caregiver had with the elderly man, according to the Utah Department of Health.

The caregiver showed mild symptoms of Zika, and has since recovered from the infection, officials said

Source:  livescience.com