Dr. Mark Moyad (photo) is Director of Preventive and Alternative Medicine at the University of Michigan Medical Center in Ann Arbor. His thoughts about the FDA’s plan to establish good manufacturing regulations for dietary supplements are published in Urology Times.
He also looks to the next big issue that will confront the supplement industry.
Once you know the issues, you can play the role of the pharmaceutical executive and decide if your product “Best Prostate Health” should be withdrawn from the market.
The real dilemma with supplements, according to Dr. Moyad, is shifting to “how companies decide what ingredients they put into their products.” Formulas are protected under patent laws, which means manufacturers can’t use exactly what was successful in a specific clinical trial.
Furthermore, companies must be willing to make a medical/business decision when to keep or remove ingredients shown to be ineffective in clinical trials. “Why,” asks Dr. Moyad, “should a manufacturer charge a fortune for a pill containing a high dose of saw palmetto [for example] when the latest study of this supplement shows that it doesn’t work?”
He says that reputable manufacturers should acknowledge the failure of a supplement to impact disease in a definitive trial rather than invent excuses as to why the study was flawed. The bottom line is “they would simply remove the product, admit the failure, and move on.”
That sounds like good advice, and applicable to big as well as little pharma.
You be the pharmaceutical executive.
After years of data supporting the role of lycopene and saw palmetto for prostate health, contrary views are emerging. Your fictional product, “Best Prostate Health,” contains lycopene, saw palmetto, selenium, beta sitosterol, zinc, amino acids, stinging nettles, and vitamin B6. Based on a negative study of saw palmetto and these negative reports on lycopene here and here, what do you do?
Withdraw the product from the market.
Remove just the saw palmetto.
Remove just the lycopene.
Make no change until the FDA requires it.
One more factor to consider. The net profit from sales of Best Prostate Health is $60 million annually.
John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at www.Vicus.com, a complementary and alternative medicine website.