Feature: Revealing the hidden dangers of dietary supplements

16:59
Feature: Revealing the hidden dangers of dietary supplements -
Internist and amateur detective Pieter Cohen is outraged that some of the supplements on the market are unsafe.

internist and amateur detective Pieter Cohen is outraged that some of the supplements on the market are unsafe.

Dominick Reuter

P ieter Cohen brush with death came at a most inopportune time. as he was about to nail another ingredient lurking in a dietary supplement

hike last August in New Hampshire with his wife and three children, Cohen, an internist at Cambridge Health Alliance in Massachusetts, stumbled and fell. A rock pierced his left calf. "It was a small cut, but deep," recalls his wife, Lauren budding. The next day, the bacteria were coursing through the bloodstream of Cohen. The leg became red and swollen. His blood pressure dropped precipitously. Cohen was taken to a community hospital and soon after by ambulance to a trauma unit in Boston.

Doctors worked feverishly to stabilize and stop the spread of infection. In the coming days, the threat of death receded, while the risk that he would never walk normally stayed. Cohen, meanwhile, frets on the same issues he did in general consumers, including patients, which could be swallowed up food supplements enriched with medication. And confined to bed burning pain, he asked his computer. His wife refused.

"I'm like, 'I'm sorry, that person needs to sleep," she told the hospital staff. So Cohen had his mother smuggled into the laptop, and data sets hidden inside the Boston Globe . "I could work on the manuscript when Lauren was not looking," he reasoned.

Eleven days after the accident, and after the fourth of what would be five surgeries, Cohen and two colleagues presented their document Drug Testing and Analysis . The report was unnerving: At least a dozen supplements sold in the United States for weight loss, improved brain function, and improve athletic performance contained a synthetic stimulant. The compound, which Cohen and his co-authors cited DMBA, resembled its chemical structure called a stimulant dimethylamylamine or DMAA. It has never been tested in people, in two animal studies of the 1940s "Its efficacy and safety are entirely unknown," they wrote

Now installed in a bed hospital in his living room and waiting for skin grafts to heal, Cohen appealed to the review :. "I can not walk, I am totally available. Can you Crank guys agree?" The paper was published online a month later, last October. In April this year, the US Food and Drug Administration (FDA) has issued warning letters to 14 companies that sell products containing DMBA. "FDA believes that these food supplements adulterated," he wrote. And boom, Cohen was on his next project.

FDA

Since 05, when he found his patients were sickened by a Brazilian against supplement containing -Depressants weight loss and thyroid hormones, Cohen become something of a mix of Indiana Jones and Sherlock Holmes in the world supplement. Chemist with colleagues in the United States, Brazil and Europe, hunting for drugs illegally buried in supplements. Then it goes public. His unorthodox public relations strategy is to publish the Quick Search low profile, journals, reaching out to a network of journalists handpicked, and he hopes eventually inspire new regulations. It has virtually no funding, nor aspire to guarantee all. "I have total freedom," he said. . So far, he and his collaborators have identified three stimulant drugs hidden in supplements

Cohen discoveries point to a larger problem, he and others argue: a dys-functional system for maintenance of order food supplements. "It comes to this," said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, who published a book entitled Do you believe in magic? on alternative medicine. "Basically a citizen [is] take the test to make sure that what is on the label is in the bottle. ... It is absurd. "

But this citizen has an impact. Actions by the FDA cited the work of Cohen and monitoring its publications, like the warnings of DMBA did. He also drew the attention of supplement manufacturers, y included in a lawsuit filed against him in April looking for $ 0 million in damages. "Everything I write gets such a review" it creates enormous pressure, he said. "I want our science to be bulletproof."

THE AGE OF MODERN SUPPLEMENT started in 1994, when Congress passed the Education Act of health, or DSHEA and Dietary Supplement (pronounced duh-shay-uh). in the decades that preceded it, the supplement industry has been heavily concentrated on vitamins and minerals. much of the regulation based daily allowances . recommended products such as vitamin C, iron and calcium

DSHEA established the first general framework for the regulation of supplements It also gave supplements a legal definition. power as for substances "to supplement the diet," containing "food ingredients" such as herbs, plants, or vitamins

at the same time, the law greatly reduced the FDA .. companies are not required to notify the FDA provided food ingredient was a law before the use of history was adopted. For the first time, DSHEA has allowed them to make claims on supplement labels suggesting affect the structure or function of the body for example, by stimulating the immune system or the protection of the health of the prostate. DSHEA and codifies a loose arrangement: Under the law, as noted by the FDA on its website, "unlike pharmaceuticals that must be proven safe and effective for their intended use before marketing, there is no provisions in the law of the FDA to "approve" dietary supplements ... before they reach the consumer. "The agency can act only after a supplement is on the market and the evidence shows that it is dangerous.

Whereas consumers from industry and much celebrated DSHEA to expand access to supplements, the act was skewered by doctors, journalists and consumer protection groups. in an editorial shortly before DSHEA passed, the New York Times called the "snake oil protection law "suggesting that it was" the right unscrupulous companies and individuals to maximize profits by making fraudulent claims. "Meanwhile, the industry has grown exponentially: since 1994, the number of supplements food marketed in the United States has swelled from about 4,000 to more than 75,000. about $ 36 billion were sold last year.

the ink was barely dry on DSHEA when trouble began . Within 2 years, a Chinese herb called ma huang or ephedra, the companies promoted as a legal alternative to ecstasy, was under control. Although a natural product, the plant contains the chemical ephedrine, which stimulates the nervous system and constricts blood vessels. In early 1996, he had been linked to at least 15 deaths. Meanwhile, the FDA regularly published warnings on the liver, kidneys and other health risks associated with supplements.

"There are food authentic multivitamin-supplements, calcium, iron which supplement the diet" and can help many people, says rheumatologist and immuno-logist Donald Marcus Baylor College of Medicine in Houston, Texas, an early critic of the supplement industry. But other supplements, such as "St. John's wort, echinacea ... are used as drugs," he said. Partly because "botanicals are complex mixtures of chemicals," supplements in this category present "a serious and growing public health problem," Marcus and colleague, pharmacologist Arthur Grollman of the State University of New York at Stony Brook, wrote in the New England Journal of Medicine in 02 how great problem was unclear, however, because the FDA hears a tiny fraction of the effects adverse business, they noted.

Meanwhile, concerns about ephedra continued to rise. commissaries army stopped selling after he was involved in the death of soldiers; after 16 years of taking the supplement died in Illinois, the state halted sales of ephedra, too. FDA banned ephedra in 04 after a 23-year-old Major League baseball pitcher collapsed and died during practice and was found to be the grass.

CDC; Journal of the Academy of Nutrition and Dietetics; CDC; NIH

The initiation of supplementation Cohen came to work. After finishing at Yale School of Medicine, he started his residence and then work at Cambridge Health Alliance, a network of neighborhood clinics and community hospitals. Many of Cohen's patients were Brazilian immigrants who settled nearby.

Before long, patients of the clinic developed mysterious symptoms. A woman came "with palpitations, sweating, anxiety, but also feel very tired," recalls Daniel McCormick, primary care internist in the same practice, mentor Cohen residence and shares a small office with him. Another rolled up in the emergency room with kidney failure. A man has lost his job after his urine tested positive for amphetamines

Cohen made the connection :. patients were all weight loss pills taking called diet arc pills, imported in bulk from Brazil. He sent the capsules to a private laboratory for testing. the results shocked the doctors. the tests revealed amphetamines, thyroid hormones, diuretics, benzodiazepines and antidepressants such as fluoxetine. "It was a Pharmacopoeia in a pill," says McCormick. "It became clear to many of us that you could explain the symptoms diet pills."

McCormick, Cohen and three colleagues conducted a survey of 307 Brazilian patients in their clinic and two neighboring churches. They found that 18% in clinical and 9% in churches reported taking the pills, and two-thirds reported side effects. The paper was published online in 07 in the dark Journal of Immigrant and Minority Health .

"Less than 10 people will read that," Cohen admitted to himself, because the magazine is so specialized. "I knew that if I wanted more ... I had to do some outreach." He contacted a local journalist who had recently NPR ran a story on Latino bodegas selling antibiotics without prescription, thinking he might be interested. The journalist invited to an interview in the studio. Folha de S.Paulo , a major Brazilian newspaper, contacted Cohen and published an article on the front page. a few years later, diet pills rainbow were banned in Brazil, though Cohen does not know if his work had something to do with it.

Cohen thought the enriched supplements were limited anomaly Brazilian neighborhoods. But then he received a call an official of the division of drugs to the FDA. "what you found in these diet pills shipped from Brazil," the official said, "are actually found in supplements weight loss in the US and is a major problem. "

" wE WERE WORRIED on contaminated food supplements for ages, "said Amy Eichner Agency US Anti-doping in Colorado Springs, Colorado. In 03 and 08 two elite swimmers have lost the chance to compete in the Olympics after testing positive for performance-enhancing drugs they said they did not know were in their supplements. A similar fate two best cyclists. "This is our nightmare scenario," said Eichner.

Another concern is longtime Patricia Deuster at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, which estimates that between 15% and 20% of soldiers swallow supplements she and others worry about most.. the products marketed for bodybuilding, weight loss, and athletic performance another worrying category includes products for sexual enhancement

So in 2013, she and Eichner started the systematic analysis of additional ingredients. preliminary results, not yet published, show that of the 169 products tested at high risk so far, 107 "contained at least a banned substance in sport, "said Eichner, and often it did not clearly included on the label. In many cases, she said, the ingredients are "either Schedule III substances on the Controlled Substances Act, which is quite large and they have been specifically declared illegal by the FDA."

About this time Cohen had an electrifying telephone conversation. a scientific laboratory that tests supplements for the companies told Cohen he was deeply troubled by the prevalence of a substitute for ephedra, DMAA, which kept appearing in products despite increasing concerns about its safety. this conversation was "the catalyst that opened a new world to me," says Cohen.

with diet pills in the sky, he was focused on prescription drugs. Although DMAA had appeared in nasal sprays there decades before being removed from the market, it was now more like a "research chemical," Cohen said, some companies claimed came plants but Cohen and others challenged. It began to look dangerous additives in the supplements. FDA said the supplements containing DMAA illegal shortly after, in 2013, but as Cohen quickly learned there was no shortage of other targets.

"It is a situation Sherlock Holmes," he said with relish. "There is a crime scene, there are hints fight, people die after taking the supplements.? ... What really happens"

He found a ideal partner to more than 5000 kilometers, near Utrecht, the Netherlands: Bastiaan Venhuis, medicinal chemist who also analyzes the ingredients supplement. One of their first joint publications, in collaboration with NSF International, which tests foods, supplements, and other consumer products, appeared online in the fall of 2013 Drug Testing and Analysis . It considered a popular workout supplement called Craze. When Venhuis diluted powder and ran through his analyzer, revealing peaks indicated DEPEA, an analog of methamphetamine.

To collect advertising, Cohen has expanded the strategy he had followed with Brazilian supplements. He sought a final manuscript of the newspaper on a week in advance and sent personal emails to rise three dozen journalists, carefully selected for their coverage or the relationship he had fed them before.

boyfriend office McCormick Cohen acknowledges that these media awareness, which he made himself, can feel awkward. It is often considered "as self-promotion," says McCormick. "At first I felt this intense and it was very uncomfortable. ... But the number of hours that go into reflection on a research project, write, is simply wasted "if it stops there, especially when it could have an impact on health policy.

Cohen has attracted the attention not only of journalists but a myriad of the supplement industry, too. In late April, a company called Hi-Tech Pharmaceuticals has applied for $ 0 million in damages against Cohen and two colleagues, after researchers published a paper suggesting Hi-Tech supplements and other companies were marketing that contained a stimulant amphetaminelike, BMPEA they mislabeled as Acacia rigidula , a shrub that grows in Texas and south into Mexico.

company vigorously denies that BMPEA not part of the plant. "A true scientist concerned with objectivity would have taken steps to ensure they are not disparaging products before they did it to the public," said Edmund Novotny, a lawyer in Atlanta who represents Hi-Tech .

Cohen was not alone in singling BMPEA: His study was approximately 18 months after FDA scientists reported detecting BMPEA in supplements, also noting that nowhere could -they find evidence that BMPEA was a natural component of plants. Shortly after the publication of Cohen, the FDA sent warning letters to five companies that sell BMPEA-laced supplements, including Hi-Tech.

Like others, Cohen agrees that the FDA police extra powers are too limited. But this does not mean that the agency has no muscle. "There are so many things that could FDA they do not, "he said, for example, the removal of stores shelves supplements when companies do not fully pass FDA inspections. The agency, Cohen believes, is overwhelmed by the volume of supplements and discouraged by the political forces to act aggressively. When it comes to take an extra ingredient, the attitude of the FDA is "show us the bodies," he said.

Top swimmer Jessica Hardy tested positive for a banned substance she said she didn't know was in a supplement she was taking, "That's our nightmare scenario," says a U.S. antidoping official.

Top swimmer Jessica Hardy tested positive for a banned substance, she said she did not know she was in a supplement to take, "This is our nightmare scenario," said an official of the fight against US doping.

Mark Savage / Corbis

FDA officials would not put it that way, but they strongly disagree not. " Under current law, the FDA faces a strong charge before taking enforcement action on a food supplement, "wrote spokeswoman Lyndsay Meyer in an email. The agency has its own frustrations. "... The supply chain is highly fragmented," wrote Meyer. "Individuals and companies that sell these products can run on residential homes, and distribute via internet, small shops, and email ... We recognize that more can and should be done."

Near a year after his terrible ordeal while hiking, Cohen has resumed full function of his leg, but he still has a low black compression. Sitting in his office in June, surrounded by pictures of his three children and a pell -mêle bottles of patients supplements given to him for testing, Cohen shows little fatalism of those who fought against the supplements for years. the reform movement "certainly has the momentum," he said. "I think we'll look back 50 years from now and say" How could supplements were regulated like that? "

In anticipation of that day, Cohen now works for nail two other drugs that appear in supplements. He also studied yohimbine, a prescription drug that can be extracted from the bark of a tree species Evergreen West Africa and sometimes appears in bodybuilding capsules. Like ephedrine, yohimbine "comes from a plant, but is pharmaceutically active," he said, blurring the line between the drug and the supplement.

His dream is an informed population with businesses required to fork over revenues and risks of their products. "Whenever possible, we should have the freedom to be able to buy everything we want to put in our bodies," says Cohen. "People should be able to buy echinacea. It's just, when they buy echinacea, they must know what they are getting"

* Correction, September 3, 11:37 :. This article has been corrected to reflect that the DMBA structure resembles that of a stimulant called DMAA, not methamphetamine.

Previous
Next Post »
0 Komentar