Pharmaceutical profit, big government and bias

Career bureaucrats and pharmaceutical industry insiders appear quite content to use an old trick to further their agenda against dietary supplements.

Sun Tzu said in The Art of War, “When your enemy has the superior position, use misdirection to throw them into disarray.”

The Dietary Supplement Health and Education Act (DSHEA) of 1994 established right of access to nutritional supplements for health conscious citizens, as well as guidelines for the FDA to regulate dietary supplements. Furthermore, the Food and Drug Administration (FDA) published comprehensive regulations for Current Good Manufacturing Practices (GMP) in 2007 to ensure the identity, purity, and quality of dietary supplements. Both DSHEA and GMP are enforceable by law.

Over the past decade, the pharmaceutical industry has experienced financial pain as blockbuster drug assets drifted off patent, paving the way for low-cost, effective generic substitutes. The result for the historically profitable pharmaceutical industry was an abrupt decline in billions of dollars of revenue generated by patented pharmaceutical ingredients. This loss of profit caused the industry to look very carefully at strategies designed to protect their revenue stream in a changing world, and during the frenzy of pharmaceutical mergers and acquisitions that characterized the past decade, the pharmaceutical industry focused on the threat posed by low-cost dietary supplements.

A critical source of scientific information is the peer-reviewed journal. Information contained within peer-reviewed journals is widely perceived to be free from undue commercial bias. However, the influence of pharmaceutical advertising upon objectivity in peer-reviewed journals related to dietary supplement studies is sobering. A 2008 study showed that the percentage of major articles concluding that dietary supplements were unsafe was 4% in journals with the fewest, and 67% among those with the most pharmaceutical advertisements, and the percentage of articles concluding that dietary supplements were ineffective was 50% higher among journals with more, than among those with fewer, pharmaceutical advertisements.

Dietary supplement safety is an important topic. In what may be a revelation to a variety of misinformed, though vocal, media pundits and Internet personalities, the FDA’s post-marketing responsibilities include monitoring safety (adverse event reporting, product labeling, claims, package inserts, and accompanying literature), and the Federal Trade Commission (FTC) regulates dietary supplement advertising.

The most recent peer-reviewed, published article on the topic of dietary supplement safety that achieved dramatic, widespread media attention appeared in 2008, a Cochrane Database meta-analysis, which was essentially an updated version of a review that originally appeared in the Journal of the American Medical Association in 2007.

While 67 clinical trials were included in the 2008 Cochrane Database meta-analysis of dietary supplement studies that suggested an increased mortality risk, most people were not aware that 748 trials were excluded from the analysis, including 405 studies with no reports of death in study subjects ingesting dietary supplements.

Of interest, a critical study co-author of the 2008 Cochrane Database meta-analysis has close financial and professional ties with the pharmaceutical industry as an Ambassador and Member of BioLogue’s Scientific Advisory Board, closely associated with the Danish Pharma Consortium, including pharmaceutical companies such as AstraZeneca Denmark. BioLogue’s Steering Committee members include representatives of the Danish Association of the Pharmaceutical Industry.