Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

The New York Buyers’ Club Co-Op’s Treatment Director advocates for more useful research on supplements from the federal government, and shares his long expertise and personal experience in managing liver health with supplements:

Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

The Food and Drug Administration (FDA) recently released a proposed new rule, which many believe could unnecessarily restrict consumer access to supplements introduced after 1994. (Access to supplements on the market before 1994 is generally protected by the Dietary Supplements Health and Education Act, passed that year.)

Perhaps the greatest concern is the form of vitamin B6 known as pyridoxal- 5′-phosphate or P5P. (Used for example, in the MAC-Pack, NYBC’s low-cost alternative to the K-PAX multivitamin/antioxidant combination for people with HIV.) There has been a concerted effort by pharmaceutical companies over the years to turn this vitamin into a drug, thus restricting access to it, and likely raising the price.

Overall, it is unclear what benefit the proposed new FDA rule would have for supplement users—if any. Certainly we believe there is much the FDA can do for consumers, including a robust program to test supplements for identity, potency and purity and broadcast the results quickly and widely. And, turning to the major health research agency of the federal government, we would welcome the National Institutes of Health (NIH) conducting more clinical trials to assess benefits and limitations of supplements. This type of research can answer important clinical questions and truly help consumers.

I am living with hepatitis C and without health insurance, and have relied on diet, lifestyle changes and supplements—identified through years of personal research–to normalize my liver enzymes, slow disease progression and keep my viral load fairly low while I try to enroll in a clinical trial. * Why can’t our federal agencies promote more research on supplement combinations like the ones I have used and circulate useful knowledge about the results, rather than wasting resources on restricting access to widely used supplements like the form of vitamin B6 mentioned above?

George Carter

*You can find a pocket guide to my recommendations for using supplements for liver health in NYBC’s Summer 2010 Supplement Special Issue, 50+ Ways to Love Your Liver.

You can also find a library of other useful guides to using supplements to maintainn and improve your health at NYBC’s SUPPLEMENT Archive Page:

http://newyorkbuyersclub.org/supplement/index.html

New England Journal of Medicine Editorial: Vytorin and Zetia may not work, and should only be prescribed as a last resort

Here’s the latest news on Vytorin and Zetia, two drugs that are widely prescribed as cholesterol-lowering agents.

We repeat some of the suggestions we made when the failings of these two drugs were first revealed: consider such alternatives as statins plus niacin*; or a supplement based on plant sterols and other components, Cardio Edge from Douglas Labs.

* See NYBC entries for Niacin 100mg (recommended as initial dose to minimize “flushing”) and Niacin Timed-Release / Niatab 500mg, the full-strength dose.
 —- 
Journal Issues Warning on Two Cholesterol Drugs
New YorK Times
By ALEX BERENSON
Published: March 30, 2008

CHICAGO — Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, The New England Journal of Medicine said in an editorial published on Sunday.

The journal’s conclusion came as doctors at a major cardiology conference in Chicago saw for the first time the full results of a two-year clinical trial that showed that the drugs failed to slow, and might have even sped up, the growth of fatty plaques in the arteries. Growth of those plaques is closely correlated with heart attacks and strokes.

We accessed the full story at http://www.nytimes.com on 3/30/2008.

New England Journal of Medicine article: Pharmaceutical companies don’t publish studies that show antidepressants less effective

The New York Times – January 17, 2008
Antidepressant Studies Unpublished
By BENEDICT CAREY
The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.
In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine.

….




Pharmaceutical companies mislead the public about the effectiveness of their prescription antidepressants.

That’s the bottom line of this New York Times story, which reports on an investigation published in the New England Journal of Medicine this week.
Well, not surprising. We knew that the FDA drug approval process, which ideally should represent a gold standard in evaluating the effectiveness and safety of medicines, has been seriously compromised by its dependence on pharmaceutical company-funded research.
And, we think we know why there’s comparatively little public attention given to some very substantial research showing that such dietary supplements as DHEA, SAM-e, St. Johns Wort may be useful for depression. These are supplements, not patentable drugs, so the pharmaceutical companies can’t establish exclusive rights to them and charge enormous sums for their distribution.
If you’d like to take a look at some of the evidence about dietary supplements for depression, look under the “Depression” category of this blog, or refer to the information sheet on depression from the New York Buyers’ Club.