Tagged FDA

Hidden Drugs And Danger Lurk In Over-The-Counter Supplements, Study Finds

Everyone has seen the ads or the products on the shelves.

A dietary supplement that promises to make consumers skinny, without dieting or exercise. Or the one that will bulk them up and turn them into the envy of other weightlifters at the gym. Not to mention the one to make them perform better in the bedroom.

Their labels say they are safe and all-natural. But are they?

Many of these products contain unapproved and unregulated pharmaceutically active ingredients, according to a study published Friday in JAMA Network Open. The authors wrote that the substances represent “a serious public health concern.”

Researchers from the California Department of Public Health found that, from 2007 to 2016, 776 products marketed as dietary supplements contained hidden active ingredients that are unsafe or unstudied. Among them, dapoxetine, an antidepressant that is not approved in the United States; and sibutramine, which was included in some weight-loss supplements but was banned from the U.S. market in 2010 because of cardiovascular risks.

“It’s mind-boggling to imagine what’s happening here,” said Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Massachusetts. Cohen wasn’t involved in the study but wrote a commentary published alongside the research.

The California researchers based their findings on an analysis of a Food and Drug Administration database that identifies “tainted” supplements. “The study lays a foundation for ongoing enforcement work in this area, by the FDA and other partner agencies, to curb the illegal manufacture, importation, distribution, and sales of adulterated dietary supplements,” CDPH spokesman Corey Egel said in an email.

Being tainted or adulterated means the product contains active ingredients not listed on the label that fly under the FDA’s radar.

Dietary supplements aren’t classified by the FDA as drugs. They are instead considered foods. They include vitamins, minerals and botanicals, among other things. They are not intended to treat or prevent disease and are not subject to premarket safety and efficacy testing that drugs undergo.

The FDA database tracked problems that emerged during “post-market surveillance” — for instance, adverse events reports and consumer complaints — when bottles were already in consumers’ medicine cabinets. These issues generally draw FDA warning letters and agency requests for voluntary recalls by the manufacturer.

With an estimated 50 percent of Americans consuming some type of supplement, researchers note that the $35 billion industry is a big business.

But Duffy MacKay, senior vice president for scientific and regulatory affairs at the supplement industry’s Council for Responsible Nutrition, noted that with between 50,000 and 80,000 supplement labels on the market, 776 tainted products is serious but not widespread.

Of the adulterated products, nearly 46 percent were for sexual performance, 41 percent were for weight loss and 12 percent were for building muscle. Ingredients like sildenafil, the active drug in Viagra, and ephedrine, a stimulant banned from diet pills since 2004, were found in supplements. Anabolic steroids, or ingredients like them, were in 73 of the muscle-building supplements.

Nearly a fifth of these supplements contained more than one unapproved ingredient.

“Adulterated dietary supplements have the potential to cause adverse health effects both on their own and also in combination with other medications an individual may be taking,” the authors wrote.

Cohen agreed, noting that a patient with heart disease might be told to steer clear of prescription erectile dysfunction meds because they could interact with other prescription medications and dangerously lower the consumer’s blood pressure.

Instead, that patient turns to over-the-counter supplements that are marketed as all-natural, thinking this product will not pose the risks he was warned about. “And that’s very worrisome,” said Cohen.

The study authors wrote that these adulterated dietary supplements “are consumed under the presumption of safety and have the potential to cause dangerous consequences in cases of misuse or overdose.”

Cohen suggested looking for supplements with a single ingredient, because they probably will have a lower likelihood of containing secret, harmful ingredients. And never trust a supplement that definitively says it can improve your health.

That advice was echoed by MacKay, from the supplement industry’s trade group, who said outrageous claims about weight loss or body building are red flags.

These products are sold online or by shady retailers and have ridiculous names like “Ball Refill” or “Weekend Prince,” he said.

“There is such a difference between legitimate products and these products,” he added, noting that these “very extreme products” are marketed to “a consumer base that may be OK with this kind of illegal stuff.” That could include, he said, consumers who are “gym rats” and people who want Viagra without a prescription.

But earlier research conducted by Cohen and cited in this study offered a different lens through which to consider the numbers. It pointed to shortcomings in the post-marketing surveillance system, especially the inability of physicians and consumers to identify an adulterated product as the cause of a health problem or to know that such things should be reported to the FDA.

“In fact,” the researchers wrote, “poison control centers received over 1,000 more reports of adverse events associated with dietary supplements use than the FDA did over a 3-year-period.”

There’s little the FDA can or will do once a bad actor is identified. Supplement recalls aren’t like food recalls, Cohen said. With supplements, the FDA can only notify a company that their products have unapproved ingredients. It’s up to the company to conduct a voluntary recall.

“The recall process itself has completely broken down as far as I can tell,” Cohen said.

Podcast: KHN’s ‘What The Health?’ Falling Premiums And Rising Political Tensions

The Trump administration announced that, for the first time, the average premium for a key plan sold on the federal health law’s insurance marketplaces will fall slightly next year. Federal officials said that changes they have made helped facilitate the reduction, but others argue that it was because more plans are moving back into those federal exchanges and making money.

The news is likely to further inflame the political debate on health care in the run-up to the midterm elections. Democrats and Republicans are battling over which party is more attuned to consumers’ needs on protections for people with preexisting conditions and affordable health care.

Meanwhile, President Donald Trump signed two bills this week that would ban efforts to keep pharmacists from telling customers that their prescriptions would be cheaper if they paid in cash, rather than using their insurance. And the Food and Drug Administration this week announced it will ease the process for drugmakers to bring some products to market.

This week’s panelists for KHN’s “What the Health?” are Mary Agnes Carey of Kaiser Health News, Rebecca Adams of CQ Roll Call, Anna Edney of Bloomberg News and Julie Appleby of Kaiser Health News.

Among the takeaways from this week’s podcast:

  • The drop in the average price for ACA plans follows a recent analysis that found insurers are regaining profitability in the individual market.
  • Democrats this week were unsuccessful in their effort to get the Senate to reverse a new policy that eased rules for short-term health plans. The administration argues that these plans help provide a more affordable option for many people, but Democrats complain that they are junk insurance because they don’t have many of the protections offered through the ACA.
  • Trump and members of Congress celebrated a rare moment of bipartisanship on health care when the president signed the two bills restricting gag orders on pharmacists. Despite the goodwill, the much-touted aim of the administration to constrain drug prices has not made much progress.
  • Health care has been a key issue in midterm campaigns, with Democrats hitting hard at their opponents to charge that the GOP would not guarantee ACA protections for people with preexisting conditions. But Republicans are fighting back with personal stories of their own health concerns — and an op-ed by the president on concerns about some Democrats’ plans to expand Medicare.
  • The new policy announced by the FDA this week will apply to complex drugs, which are drugs that are coupled with a device, such as patches or auto-injectors. The agency said it would be more flexible in reviewing materials for approving those devices.

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The Feds’ Termination Of A Tiny Contract Inflames Bitter Fight Over Fetal Tissue

Federal health officials announced late last month they had terminated their contract with a company that supplies human fetal tissue for medical research and were checking that similar contracts, as well as studies conducted with that tissue, comply with federal law.

The seemingly innocuous release about a tiny government contract, which came out as Americans focused on Judge Brett Kavanaugh’s nomination to the Supreme Court, belied the big stakes and contentious issue behind it. Government officials are considering pulling federal funding for a decades-old form of research that has yielded a number of medical advances, including the polio vaccine.

The Department of Health and Human Services has faced mounting pressure from conservative lawmakers and abortion opponents, who strongly supported President Donald Trump’s candidacy, to halt the use of tissue obtained from aborted fetuses.

“The federal government must find ethical alternatives as soon as possible, and should end all association with those who participate in any trafficking or procurement of aborted baby organs,” 45 leaders from groups, including Susan B. Anthony List and the Family Research Council, wrote in a recent letter to HHS.

But a letter to congressional leaders, signed by 64 medical and scientific institutions including the American Academy of Pediatrics and Johns Hopkins University, said interfering in fetal tissue research would be “devastating.” The letter cited its impact in understanding viruses like Zika and HIV, as well as ongoing clinical trials to find treatments for spinal cord injuries.

“Fetal tissue research has been critical for scientific and medical advances that have saved the lives of millions of people,” they wrote.

The supplier whose contract was terminated, a California-based company called Advanced Bioscience Resources, came under fire in 2015 when it was identified in videos that surreptitiously captured Planned Parenthood officials discussing how fetal tissue is provided to researchers.

The videos were part of a controversial sting operation by activists who alleged Planned Parenthood was unlawfully profiting from the sale of fetal tissue, including to Advanced Bioscience Resources. Planned Parenthood officials condemned the videos, which they said were deceptively edited. After its own investigation, a Texas grand jury declined to indict anyone from Planned Parenthood, instead indicting two of the activists responsible for the videos.

HHS vowed to look into the research “in light of the serious regulatory, moral, and ethical considerations.”

The announcement also comes weeks before Election Day, giving Republicans an opportunity to employ a potent talking point — their rigid opposition to Planned Parenthood — as they urge their supporters to vote.

Here’s what you need to know to understand the debate.

Where does fetal tissue come from, and how is it used in research?

Tissue from human fetuses is frequently used to make cell cultures, which allow researchers to examine biological processes in a laboratory setting.

The tissue comes from elective abortions, with the written consent of the woman donating the tissue. Health facilities where the abortion occurred may provide it directly to researchers or transfer it to a supplier, such as Advanced Bioscience Resources.

It is unclear how many suppliers there are. A 2015 report from the Congressional Research Service identified just a few known suppliers, citing a New York Times story that said many researchers go to just two companies: Advanced Bioscience Resources and another California-based company called StemExpress.

Researchers have used fetal tissue to study genetic diseases and development disorders like Down syndrome, as well as to test the toxicity of medications taken by pregnant women and the efficacy of vaccines. The measles vaccine, for example, was developed with the help of fetal tissue.

Fetal tissue also has been transplanted into patients in attempts to treat various disorders, injuries and illnesses, including Parkinson’s disease.

Why is HHS reviewing compliance with federal law? Isn’t this research legal?

It is legal to conduct research using fetal tissue, subject to laws and regulations addressing issues such as consent from the woman undergoing the abortion. Researchers in the United States have used fetal tissue since the 1930s, and the federal government has funded such research since the 1950s, according to the Congressional Research Service.

Things get thorny when it comes to acquiring the tissue. A 1993 law made it illegal “to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.” In other words, you can neither sell nor purchase fetal tissue in the United States.

But the ban comes with a caveat: Companies that supply researchers with fetal tissue can charge to cover their costs for things like storage, preservation and transportation.

Republican lawmakers and abortion opponents have accused Advanced Bioscience Resources, as well as StemExpress and another supplier that has since gone out of business, of inflating their costs to turn a profit.

After the release of the sting videos in 2015, House and Senate Republicans launched lengthy investigations into fetal tissue acquisition and research, culminating in a pair of reports that accused the suppliers, Planned Parenthood and a handful of its affiliates of illegal sales and purchases.

In late 2016, Republican lawmakers asked the Justice Department to investigate the matter, and several news outlets reported last December that it appeared to be doing so. (The Justice Department typically does not confirm the existence of ongoing investigations.)

So, why is HHS doing this now?

In August, the conservative news outlet CNSNews.com reported the Food and Drug Administration had signed a one-year, nearly $16,000 contract with Advanced Bioscience Resources to acquire fetal tissue for transplantation in mice in federal research labs.

It was not the government’s first contract with the supplier. Records show the FDA contracted with Advanced Bioscience Resources in 2015 and 2016.

In September, 85 House Republicans sent a letter to Scott Gottlieb, the head of the FDA, noting that lawmakers had found evidence the supplier may have violated federal law during their investigations.

“We urge you to cancel this contract immediately and utilize alternative, modern scientific techniques that do not contribute to the trafficking in baby body parts,” the lawmakers wrote. 

Has fetal tissue research been an issue in the past?

Yes. In 1988, in fact, HHS banned funding for research on fetal tissue transplantation while an advisory panel reviewed the issue. While divided in their views on abortion, most panel members supported the conclusion that, since abortion was legal and the research could yield significant medical discoveries, this research was “acceptable public policy.”

The George H.W. Bush administration rejected the panel’s conclusion, concerned the research would create incentives for women to have abortions, and the ban stood until President Bill Clinton eliminated it in 1993, shortly after being sworn in.

Democrats in Congress seized on the safeguards recommended by the panel and soon passed the 1993 law that, among other things, banned the sale and purchase of fetal tissue.

A similar fight over stem cells erupted in 2001, when President George W. Bush severely restricted research on embryonic stem cells, which are taken from human embryos donated by couples undergoing in vitro fertilization. President Barack Obama later lifted the restrictions.

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation.