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Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

Thanks, Congress, for making bull testicles available as a dietary supplement!

On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:

Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.

S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.

Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.

First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)

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

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More Trouble for Antioxidants

Antioxidants are better acquired through food than pills.

Antioxidants are better-acquired through food than pills.

Antioxidants are now an iconic example of premature hype making its way into marketing and the public consciousness long before the science is adequately understood. There are multiple lessons to be learned in this story, and a new study just emphasizes those lessons further.

A brief history of antioxidants

One of the unavoidable consequences of metabolism (burning food for energy) is the creation of oxygen free radicals, or reactive oxygen species (ROS). These are molecules that are highly reactive. They essentially contain oxygen with an extra electron, which can react with another molecule, breaking bonds and causing damage.

As you might expect, the body has natural antioxidants which react with ROS to form benign molecules.

In the 1990s it became increasingly apparent that oxidative stress was playing an important role in cell damage, even sometimes triggering apoptosis, or programmed cell death. Many degenerative diseases, like Alzheimer’s disease, were shown to be driven in part by oxidative stress. In addition, it seemed that ROS play a role in aging.

(more…)

Posted in: Herbs & Supplements, Nutrition

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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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Should I Take a Multivitamin?

I’ll start with a confession. I used to do something irrational. I used to take a daily multivitamin, not because I thought there was good scientific evidence to support the practice, but for psychotherapy. I tried to eat a healthy diet and worried about it. By taking a pill, I could stop worrying.

Then I found out that higher intake of vitamin A was associated with an increased risk of hip fractures in postmenopausal women like me, and I stopped. (High doses of vitamin A also cause births defects and are contraindicated in pregnancy.) Now I only take supplemental calcium and vitamin D, not on general principles but because of personal risk factors.

We’re being bombarded by advice to take vitamins and various other supplements. Health gurus like Andrew Weil recommend that everyone take vitamins (which they just happen to sell). The orthomolecular followers of Linus Pauling want us to take megadoses of vitamins. Ray Kurzweil tells us we should take vitamins to make us live longer; he takes 250 vitamin and supplement pills a day and thinks he will live forever. (You can read about his ideas in his book Fantastic Voyage: Live Long Enough to Live Forever.) Who should we believe? (more…)

Posted in: Herbs & Supplements, Nutrition

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