BROOKLINE — The dietary supplements had ominous names, like Black Widow and Yellow Scorpion. They contained an illegal and potentially dangerous molecule, similar in structure to amphetamines.
But when a Harvard researcher dared to point that out, in a scientific, peer-reviewed study and in news media interviews, the supplement maker sued him for libel and slander.
The jury trial that followed, detailed for the first time by STAT, had momentous implications for the future of research into the safety of weight-loss and muscle-building pills; for the freedom of academics to speak out about matters of public health; and for our ability to learn what’s in the supplements on our kitchen counters.
In case things weren’t interesting enough, a bizarre back story involved the wealthy founder of the supplement company, who dreamed up the business while in prison on a charge stemming from selling ecstasy.
The Harvard researcher, Dr. Pieter Cohen, won the defamation trial in federal court in Massachusetts in November.
But the man who sued him, Jared Wheat, owner and CEO of Hi-Tech Pharmaceuticals, doesn’t see the verdict as a loss: He’s hopeful the long, costly legal battle will scare away other academics from investigating the supplement industry.
If that doesn’t work, he’s counting on President-elect Donald Trump to follow through on vows to “open up’’ the libel laws to make it easier for parties who feel they have been defamed to win lawsuits. Trump has discussed this goal in the context of his grievances against the news media. But it could also have ramifications for published research.
Meanwhile, the six adulterated supplement brands from Hi-Tech are still on the market, despite alarms raised not just by Cohen, but by the Food and Drug Administration. It has ordered Hi-Tech to recall several products. Wheat has refused, though he said the company has voluntarily made minor tweaks to the formulas for some of them to satisfy distributors.
The entire episode opens a window into the Wild West world of supplements. Unlike drug companies, supplement manufacturers don’t have to show that their formulations are safe and effective before putting a product on the market. They don’t have to run clinical trials. They don’t have to consult federal regulators.
With little oversight, they can jump right into a highly lucrative industry: Wheat, a convicted felon, said his company brings in more than $100 million a year in revenue.
And Wheat has no regrets about spending what he estimated as between $300,000 and $400,000 in corporate funds on the lawsuit.
“I spent a lot of money, but hopefully it will deter others from going out there and making baseless allegations,’’ Wheat said in a phone interview from his company’s headquarters in Georgia. He advises other academics pondering similar research to “think twice.’’
Weight-loss pills and BMPEA
Pieter Cohen launched the study that would lead to the libel suit with the goal of prodding the FDA crackdown on supplements illegally containing a compound that’s known as BMPEA. Chemically similar to amphetamines, BMPEA has been shown to send blood pressure and heart rates soaring in dogs and cats. It’s been linked to a stroke in a Swedish woman. Such evidence prompted Canadian health officials to call it a “serious health risk.’’
Supplement makers often claim that BMPEA is a natural botanical product from a Southwestern shrub, Acacia rigidula. But it hasn’t been shown to come from the shrub. And the shrub itself is illegal to include in supplements because no manufacturer has gone through the necessary steps to prove it’s safe to ingest.
Cohen’s team chemically analyzed 21 popular supplements, made by a handful of manufacturers and labeled as containing Acacia rigidula. Eleven contained BMPEA — including six of the 10 Hi-Tech weight loss products in the study.
Hi-Tech’s “Fastin-XR’’ pills, for example, contained 82 milligrams of BMPEA in the maximum daily dose recommended on the label. The maximum recommended dosage of “Yellow Scorpion’’ pills had 69 milligrams. Because BMPEA has not been studied in humans, it’s hard to compare the strength of these pills to, say, ADHD medication, but it was clear this was more than a trace.
Such pieces of evidence “strongly suggest’’ that BMPEA is synthetically produced and used to spike the products, Cohen’s paper concluded.
The study immediately made waves: Cohen went on “CBS This Morning.’’ Two senators issued a stern statement urging the FDA to keep such products off the shelves. And within two weeks, the FDA had issued warning letters to Hi-Tech and four other companies, ordering them to recall products containing BMPEA.
Cohen did not mention Hi-Tech in any of his interviews, and the company’s name appeared only in a table in his paper. Still, Hi-Tech’s customers were getting cold feet. So Wheat sued. Wheat said he got “hundreds’’ of supportive calls and e-mails from people in the industry “hoping that we were able to silence this guy.’’
Watchdog becomes target
Cohen, 46, got interested in studying supplements after seeing Brazilian immigrant patients with alarming symptoms, such as palpitations, panic attacks, and even kidney failure. It turned out they had been taking a Brazilian weight-loss supplement spiked with amphetamines, antidepressants, and benzodiazepines.
With hardly any research funding, Cohen has turned out study after high-impact study identifying hidden synthetic stimulants in popular weight-loss products.
Even some who disagree with him regard him well. Steve Mister, president of a trade group for dietary supplement makers, praised Cohen for performing an “important watchdog function.’’
Cohen, an assistant professor at Harvard Medical School and an internist at Cambridge Health Alliance, was lucky to have Harvard in his corner for the lawsuit. Still, it was grueling. He had to put aside all his research projects. He was deposed for an intense 6½hours. And he worried about the financial hit should the jury decide against him. (Eventually, Harvard’s insurer agreed to cover damages up to $5 million.)
Worst of all, Cohen was required to turn over hundreds of pages of his notes, peer-review feedback, and correspondence with coauthors and journalists.
A checkered past
The seven-day trial, which started in October, wasn’t about whether Hi-Tech’s supplements contained BMPEA. Hi-Tech admitted they did in the initial lawsuit — a few of the products in question actually listed it on their labels — but claimed, without evidence, that it had naturally extracted the substance from Acacia rigidula.
Instead, the case hinged on what Cohen had said about BMPEA: Had it really never been tested for safety or efficacy in humans? Was it really potentially dangerous? Was it really synthetic, not derived from Acadia rigidula?
These are not controversial questions in the scientific community. (The answers are yes, yes, and yes.) But they are scientifically complex questions, and it was far from certain how the jury would assess the evidence.
Hi-Tech’s lawyers and witnesses claimed, without evidence, that BMPEA had been evaluated in proprietary studies that have never been published.
Cohen’s lawyer, Brian Sullivan, focused on the high stakes for public health, urging the jury to consider the evidence “in the context of Dr. Cohen’s ability and his right to speak the truth to powerful interests.’’
The trial and depositions also aired unsavory details about Hi-Tech.
Convicted for selling ecstasy while a teenager, Wheat went on to violate the terms of his release and spent several years in prison, where he conceived of Hi-Tech.
The business was rolling by 1998, but Wheat didn’t stay out of trouble for long. In 2003, the FDA forced his company to destroy supplements spiked with an unapproved erectile dysfunction drug. In 2006, the agency seized $3 million worth of products containing ephedra, a banned and potentially dangerous stimulant. Later that year, Wheat and several Hi-Tech associates were arrested for running an illegal online pharmacy based out of Belize. He pleaded guilty and was sentenced to four years in prison.
Asked about the conviction, Wheat said, “it would take hours to explain, and I just don’t have time to deal with it.’’
The trial was tough on Cohen. At one point, he had to rush to the emergency room when the lymphatic system in his leg got infected, stemming from a hiking injury. And he knew that his own research career — and the whole field of independent research into the safety of supplements — hung in the balance. After all, if Hi-Tech could successfully sue over research it didn’t like, what would stop other companies from trying the same?
Two and a half hours after they left to deliberate, the jurors returned a verdict in Cohen’s favor.
Cohen was still too wound up to feel anything. It wasn’t until a few days later, when it dawned on him the trial was finally over, that he felt relief.
Then he got back to work.
More research on the way
After the verdict, Wheat said “a few dozen’’ people in the industry called to say they hoped his lawsuit had at least “deterred’’ Cohen from actively publicizing his critical research.
They might be unwise to count on it. Cohen submitted a new study for publication days after he won, and has three new projects in motion now.
“My experience,’’ Cohen said, “has really reinforced to me why it is so important to not only continue the research we’re doing but to be very aggressive about speaking out about it.’’
He also hopes to spur discussion about legal protections for researchers. “How many people can continue in the field if this is what it takes?’’ he said. “If one paper leads to this?’’
Rebecca Robbins can be reached at rebecca.robbins @statnews.com.
