Pharmaceutical profit, big government and bias

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The FDA has a worrisome, consistent record of approval of dangerous drugs, subsequently withdrawn from the marketplace due to safety concerns. Some examples of drugs the FDA approved and then were subsequently withdrawn from the marketplace include: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.