Supplements – lack of scientific rigor

Frequent readers know that I dislike the dietary supplement industry. The 1994 law which allowed this industry to grow was, in my opinion, a menace to public health. While I have multiple problems with the industry, the hot button issue these days is ephedra. One must view each supplement individually, however one can attack the entire industry. Studies of Dietary Supplements Come Under Growing Scrutiny

When a California judge handed down a $12.5 million false-advertising judgment against the maker of an ephedra-based weight-loss pill late last month, he also issued what amounted to a bill of reproach against the science of dietary supplements.

The company, Cytodyne Technologies, maker of Xenadrine RFA-1, the supplement implicated in the death of a Baltimore Orioles pitcher, had not just exaggerated the findings of clinical trials it commissioned, Superior Court Judge Ronald L. Styn said in ruling on a class-action suit, but had also cajoled some researchers into fudging results in published scientific articles.

The evidence, Judge Styn said, had left him no alternative but to conclude that the researchers had set out to create a study that “justified the money being spent” by Cytodyne and would ensure that they received further work from the company.

The Cytodyne case is part of a swelling tide of litigation that is raising serious questions about the way makers of ephedra and other dietary supplements use — and often misuse — the promise of scientific proof to market their products.

In the last eight months, three leading manufacturers of weight-loss pills have been hit with false-advertising verdicts in the millions of dollars. A fourth has been rebuked by a federal judge for hiding evidence. The Missouri attorney general and a group of district attorneys in California have also brought false-advertising suits against manufacturers, and Congress has demanded Cytodyne’s research records.

The dietary supplement industry can endanger the public. The lack of regulation spells danger.

Precisely because the industry is not regulated, though, its research is sometimes less than strictly scientific, experts say.

“There will be 250 to 300 clinical trials on nutraceuticals this year,” said Anthony Almada, a consultant and founder of EAS, the biggest sports nutrition company, who advocates scientific research on products but has become a critic of the way supplement makers conduct it. “The rigor applied in these studies on the average is somewhat notably less than that of a drug study.”

Often relying on as few as a dozen subjects, these studies are scaled-down versions of the double-blind, placebo-controlled clinical trials required before drugs can be approved. Some are published in abbreviated form at meetings of scientific organizations, or in obscure journals, providing a basis for marketing claims like “clinically proven.”

An industry spokesman, Steven Dentali, vice president for science and technical affairs at the American Herbal Products Association, acknowledged that “whenever there’s a desired outcome, you’ve got the potential for bias.” At the same time, he argued that supplement science is no worse than that done for pharmaceuticals.

Read the entire article. Stay away from unproven supplements. Do not get duped by fancy glossy ads. This industry needs regulation – for the public health.