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.
The pharmaceutical industry supplies approximately 50% of the annual operating budget of the FDA, a synergistic relationship. The pharmaceutical lobby needs legislators to continue to provide tax relief and enact government regulation to protect drug revenue aggressively at a time when patented drugs are rapidly expiring. The FDA sees an opportunity to expand and acquire a greater slice of the budget pie as well as divert attention away from a long list of regulatory failures.
The FDA has a worrisome, consistent record of approval of dangerous drugs, subsequently withdrawn from the marketplace due to safety concerns. Some examples of drugs the FDA approved and then were subsequently withdrawn from the marketplace include:
- Baycol® (a cholesterol-lowering statin drug linked to 31 cases of deaths associated with rhabdomyolysis prior to market withdrawal in 2001);
- Rezulin® (an anti-diabetes drug pulled from the market in 2000 after multiple cases of severe liver damage and liver failure were reported);
- Permax® (a dopaminergic drug used to treat Parkinson’s symptoms, removed in 2007 due to cardiac fibrosis in heart valves).
- Cylert® (a drug used to treat Attention Deficit Hyperactivity Disorder linked to 13 cases of liver failure prior to withdrawal);
- Seldane® (an antihistamine drug used to treat allergy symptoms removed from the market in 1998 due to reports of dangerous cardiac arrhythmias);
- Vioxx® (an anti-inflammatory pain relieving drug removed in 2004 after data analysis revealed strikingly higher heart attack and stroke risk in prescribed patients);
- Palladone® (a narcotic pain reliever removed in 2005 after reports of severe side effects including depression and coma).
In the United States, there are more than 106,000 deaths every year attributed to prescribed pharmaceutical drugs. Consider the 2008 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS). Of interest, the drug acetaminophen, the ubiquitous over-the-counter pain reliever and fever-reducer, was reported in more poisoning deaths than all complementary and alternative strategies combined. Forty-three acetaminophen-related deaths were reported, none for alternative medicine.
Furthermore, congressional testimony on May 26, 2010 by a representative of the Government Accountability Office (report – GAO-10-662T) included information that aspirin and concomitant administration of Ginkgo biloba) dramatically increase bleeding risk.[i] However, the GAO report failed to describe prospective, randomized, placebo-controlled clinical studies that do not show an increase in bleeding risk with 300 mg of standardized Ginkgo biloba extract used in combination with 325 mg aspirin daily, nor with 240 mg. of Ginkgo biloba extract used with 500 mg. of aspirin daily in high risk elderly patient populations.
Against a background of regulatory missteps on pharmaceutical approvals, rather than focus upon strategies designed to speed the approval process for promising, lifesaving drugs and tighten the safety assessment around dangerous drugs to protect patients, the Dietary Supplement Safety Act (S. 3002) was introduced in 2010. This new bill sought to overturn key aspects of DSHEA and provide dramatic expansion of FDA power to regulate dietary supplements as new drugs.
Despite coordinated attempts by career bureaucrats and the pharmaceutical lobby to push the bill forward, a citizen backlash erupted over the Dietary Supplement Act of 2010. Health conscious citizens correctly saw the bill as an attempt to expand FDA power and protect pharmaceutical profit. The efforts of informed citizens helped sideline the Dietary Supplement Act of 2010.
However, subsequent to the sidelined Dietary Supplement Safety Act, new language was quietly incorporated into the Wall Street Reform Bill (H.R. 4173), a bill aimed at curbing some of the wild Wall Street practices responsible for the current economic crisis. The fact that new language on dietary supplements was added to a bill designed to curb abusive Wall Street behavior is a sad testament to the use of misdirection on the part of some career bureaucrats to push an agenda.
The new language serves to expand bureaucratic authority on the part of the Federal Trade Commission (FTC) to regulate health claims on dietary supplements in such a way as to greatly increase cost. By mandating the conduct of trials similar to the type of registrational studies used by pharmaceutical companies to obtain FDA drug approval, the new language added to the Wall Street Reform Bill will demand that dietary supplements adhere to pharmaceutical standards of scale for cost.
Since the estimated cost of approval for a new pharmaceutical drug is about $1 billion dollars (US), the new language effectively seeks to ban dietary supplements from the marketplace. Dietary supplement companies do not have the resources to spend this amount of money on natural ingredients that are not patentable, and the dietary supplement industry will not be able to fulfill the proposed FTC requirements in the bill.
Rather than dramatically expand bureaucratic power and protect pharmaceutical profit at a time in our history when our elected officials seem focused on extravagant spending on health care, the type of flawed legislation embodied by S. 3002 and H.R. 4173 serves as a stark warning.
Without engaged and informed citizens, we run the risk of career bureaucrats, elected by us, accountable to us, promoting an agenda that will serve to limit or restrict access to dietary supplements for health conscious citizens.
Steven Joyal, M.D., is vice president of Science and Medical Affairs of the Life Extension Foundation.