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Posts Tagged Food and Drug Administration

The consumer lab rat: More questions about supplement safety

Laboratory Rats
Do you take a vitamin or dietary supplement? Over half of all American adults do, making this a $30 billion dollar business. Many of us even take supplements in the absence of any clear medical or health need. I’m often told it’s a form of nutritional “insurance” or it’s being taken for some presumed beneficial effect – like Steven Novella outlined in yesterday’s post on antioxidants. We love the idea of a risk-free magic bullet that improves our health and wellness. Especially one that avoids what are presumed to be toxic, unnatural drugs. Supplements are marketed as safe, natural and effective, and there is no question that messaging has been effective.

I used to take supplements. For me it was multivitamins. But as I’ve taken a closer look at the evidence for supplementation, my personal behaviors changed. The primary reason is a lack of evidence. There is no evidence to suggest that vitamins offer any health benefits in the absence of deficiency. The balance of evidence suggests that routine multivitamins are unnecessary for most people. Vitamins should come from your food, not from supplements. More generally, looking at the broader category of supplements that range from probiotics to herbal remedies, there is little evidence to support most of them. With a few exceptions, the research done on dietary supplements is unconvincing and largely negative. If you don’t supplement, you don’t seem to be missing out on any tremendous health benefits.

Going beyond the lack of evidence, there’s an even more compelling need for consumers to be wary of them. The safety of supplements is increasingly being called into question. Evidence has emerged demonstrating that quality standards for supplements sold in many countries are erratic and unpredictable. The root cause seems to be regulatory systems that prioritize manufacturer interests ahead of consumer protection. With supplements, products are effectively being tested for safety after they are marketed, and the consumer is the unwitting research subject. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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Continued Battle over Homeopathy

Homeopathy - not medicine
The battle to rid modern scientific societies from the blatant and harmful pseudoscience of homeopathy continues. This past year has been overall a good one – in the US both the FDA and FTC decided to review their regulation of homeopathy. They have gathered their testimony and are now apparently reviewing everything. Their decisions on this topic are eagerly anticipated and could decide the fate of homeopathy for the next one or more generations.

Some success

In the UK the situation is also very positive. Their national health service is considering blacklisting homeopathy so that general practitioners cannot prescribe homeopathic products.

Success in the UK is largely due to The Good Thinking Society, founded by Simon Singh. They have been tirelessly campaigning against NHS coverage of homeopathy and are making steady progress. They are demonstrating that skeptical activism can be effective.

Likewise, SBM and the Society for SBM are having an impact in the US, mainly through persistent persuasive writing and being available as a resource to politicians, the press, and regulators. Members have personally consulted with the FDA, FTC, and staff of senators interested in the issue.

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Posted in: Homeopathy

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Worshiping at the altar of the Cult of the Brave Maverick Doctor

Death of Cancer

One of my favorite television shows right now is The Knick, as I described before in a post about medical history. To give you an idea of how much I’m into The Knick, I’ll tell you that I signed up for Cinemax for three months just for that one show. (After its second season finale airs next Friday, I’ll drop Cinemax until next fall.) The reason why I’m bringing up The Knick (besides I love the show and need to bring it up at least once a year) is because an article by Malcolm Gladwell in The New Yorker entitled “Tough Medicine“, which is a commentary based on a new book on cancer by a veritable god of cancer research, Vincent T. DeVita, Jr., immediately resonated with a storyline in this season of The Knick. I haven’t yet read The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable–and How We Can Get There by Vincent T. DeVita and Elizabeth DeVita-Raeburn, but I want to. I can tell, though, that there will be parts of the book I find annoying just from Gladwell’s take on it, which approvingly describes DeVita as railing against the cautiousness and incremental nature of today’s cancer research. To give you an idea of where Gladwell’s coming from, I note that his article shows up in the title bar of my web browser not as “Tough Medicine” but rather “How To Cure Cancer”, even as the title on the web page itself remains “Tough Medicine”. On the other hand, the article does conclude with Gladwell demonstrating a better understanding of the disadvantages of what DeVita is proposing than it seems that he will in the beginning. In fact, it is Gladwell who is more reasonable than his subject, although he does appear share DeVita’s apparent assumption that potentially all cancer patients are savable if only we try hard enough. (more…)

Posted in: Cancer, Clinical Trials, History, Medical Ethics

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US Department of Justice Goes After Supplements

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice

It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.

Now the US Department of Justice (DOJ) is getting in on the fun:

USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.

This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.

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Posted in: Herbs & Supplements, Legal

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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“Female Viagra?” Misleading Headlines and Regulatory Dilemmas

addyiThe FDA recently approved flibanserin (brand name Addyi) for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The story of flibanserin illustrates several of the issues we have confronted on this blog:

  • It was hyped in the media.
  • Misleading headlines called it the female Viagra.
  • It was initially rejected by the FDA and was approved only after extensive lobbying efforts.
  • The drug is only minimally effective and has a lot of drawbacks.
  • Two of the three supporting scientific studies claimed effectiveness based a surrogate measure but failed to show any measurable improvement in sexual desire.
  • A campaign to support “women’s sexual health equity” pushed for approval, framing it as a step towards correcting what they perceived as gender bias (they claimed the FDA was biased because it had provided Viagra to help men have sex but hadn’t done anything to help women have sex).
  • And the validity of the diagnosis of HSDD itself has been questioned.

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Posted in: Pharmaceuticals, Politics and Regulation

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The Federal Trade Commission takes on homeopathy—maybe

FTC vs. homeopathy: Cage match?

FTC vs. homeopathy: Cage match?

Well, I’m back.

OK, returning from London isn’t nearly as epic as Sam Gamgee’s final words in The Lord of the Rings returning to his wife and daughter after having accompanied Frodo, Gandalf, Bilbo, and key elves of Middle-Earth to the Grey Havens, there to say goodbye to them as they boarded a ship to the undying lands. I just love the quote. It says something to me returning home after a long journey, even if it was just a vacation to J.R.R. Tolkien’s native land. It also suggests a bit of the exhaustion after a long day of traveling, complete with a long-delayed flight, a late arrival, and a state of utter exhaustion that accompanied it, plus an unfortunate lower gastrointestinal issue.

All of this is a way of saying that this post might actually be relatively brief for a post by me…no epics this week. [Addendum: Nope. Even lower GI annoyances and exhaustion couldn’t keep me from going over 2,000 words. At least I didn’t hit 3,000.] In its nearly eight year history, I’ve never missed more than one week at SBM, and I don’t intend to start now. Specifically, with the FTC workshop on homeopathy rapidly approaching, one week from today, I couldn’t resist adding my 2 pence to the mix, now that the agenda and list of participants have been announced.
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Posted in: Homeopathy, Politics and Regulation

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Battle of the feds: FTC tells FDA to do its job regulating homeopathy

Two institutions duke it out: FTC vs FDA.

Two institutions duke it out: FTC versus FDA.

Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). Lax regulation has resulted in consumer confusion: consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, and the lack of scientific evidence underlying claims made by homeopathic drug companies.

As it turns out, we were in excellent company. The Federal Trade Commission (FTC), the agency charged with preventing fraudulent and deceptive business practices, submitted its own comment to the FDA, making these same points. (The FTC is holding its own workshop on advertising homeopathic drugs later this month. We’ll get to that shortly.)

The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation. (more…)

Posted in: Clinical Trials, Health Fraud, Homeopathy, Legal, Politics and Regulation

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The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly

The 21st Century Cures Act: Unnecessary and misguided.

The 21st Century Cures Act: Unnecessary and misguided.

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It’s also a powerful force potentially for ill, as I’ve documented in my posts about the understandable but misguided “right-to-try” movement. After all, what politician can say no to a constituency representing desperately ill people who only want a shot at survival? It’s not all desperate patients, however. Also wanting more rapid drug approval are powerful business interests in the form of the pharmaceutical and medical device industries, for whom the time and expense of prolonged clinical trials eat into profits and make some drugs not worth developing from a business standpoint.

In 1962, after Frances O. Kelsey, MD, PhD (who died on Friday at the age of 101) successfully prevented the approval of the drug thalidomide in the US, a drug found to cause serious birth defects, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety before their drugs could be FDA-approved, as had been the case prior to the amendments, but also to provide substantial evidence of effectiveness for the product’s intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force in the United States today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications

Medicine is a lot more complex now than it was in the 1960s however, and there has been a growing sentiment that the system is, if not broken, at least functioning in a way that is behind the times, a manner that was acceptable and appropriate 40 years ago but is no longer so in this era of genomics, precision medicine (formerly known as “personalized medicine”), and targeted therapies. The new drug approval process, which can take up to a decade and cost a billion dollars, it is argued, is too rigid, cumbersome, and slow for the 21st century. (Why it wasn’t too rigid, cumbersome, and slow in the 20th century, no one seems to say. I guess that “21st century” sounds way cooler.)

Into this ongoing controversy have marched Rep. Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), who have sponsored a bill passed by the House of Representatives in a rare display of bipartisanship in July. The bill, H.R.6, is entitled the “21st Century Cures Act“. Given how it passed the House by a vote of 344-77, one would think that it should glide through the Senate easily. Certainly, its sponsors and supporters have mounted a mighty PR effort. That might not be the case, given that in the Senate a single senator can hold up or even kill a bill through a filibuster, and to shut down a filibuster or prevent a threatened filibuster requires 60 votes. Be that as it may, I’m not so much interested in the politics of this bill, which, if it survives the Senate, will almost certainly be significantly amended, but rather what the bill does.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation

Sisyphus

Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.

Society for Science-Based Medicine

Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century

All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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