Alaska Injury Law Blog

Today’s news is that gingko biloba, touted since the 1970’s by the diet supplement industry as an herb that would improve memory or forestall cognitive decline in aging or in dementia, has been found to be useless. As routine scientific scrutiny has been applied to the nostrums of the industry in recent years, we see these “ancient healing” claims fall one by one: chondroitin and glucosamine for osteoarthritis, vitamin E and selenium for prostate cancer, or vitamin E and C for prevention of cancer or heart disease. (Indeed, recent studies have shown that the use of vitamin therapies can sometimes increase the risk of disease, as in folic acid increasing the risk for precancerous polyps or higher lung cancer rates for those trusting to beta carotene supplements.) When asked for data in support of their claims of efficacy, the industry simply trots out the claim that the Chinese have used the product for 5,000 years or that sharks never get cancer. By doing so, they seek to avoid the hard work of any scientific endeavor, i.e., proving that their product works.

As for the safety of these products, the industry has repeatedly picked the pockets of consumers with this magical thinking: “it is all-natural, so it has no side-effects but it works better than drugs.” Of course, for a compound to work, it must have an effect, which means it is capable of affecting the body and causing side effects. It can’t be effective and affect the body positively but never affect the body negatively. If it can affect the body at all, it is capable of having side effects, period. It is as if they were saying, “yes you can have the money and never pay taxes on it.” Yet, we know that the IRS always gets its piece. And, herbals and diet supplements will always tax the body–there are always side effects.

We can’t blame the industry, because we let them get away with selling billions of dollars of useless or dangerous or tainted products. We let Congress take money from the industry’s lobbyists to pass DSHEA and dodge the effective regulation of the marketing and manufacturing of these products. We let the diet supplement industry tell consumers, “Ego exigo, proinde is est bonus,”….”I sell it, therefore it is good.” We do not demand that the marketeers prove their case that a product is safe or efficacious, the simple standard the drug and OTC industries must meet.

As consumers, we have been repeatedly told that generic drugs are exact copies of their brand-name counterparts. We have been forced by insurers to accept generics over brand-name drugs. This is done by the insurer imposing financial disincentives and refusing to honor our physicians’ prescriptions without getting the doctor’s office to confirm the prescription. Pharmacies substitute generics for brand-name drugs without asking us first or telling us when they have made the switch. All the while there is an unsettling and nagging question in the back of our brains about whether generics are truly equivalent.

The FDA has taken the position that generics are equivalent, but the public is not informed about the agency’s standard of review: a generic is deemed “bioequivalent” if it achieves 80 to 125% of what the brand-name drug provides. This is a huge variance, and one we don’t accept in many human endeavors, whether we are talking about a pilot landing a plane or sending in what we owe to the IRS.

Indeed, specialists acknowledge a growing concern that patient experiences on generics are problematic, especially for those patients who have conditions that present significant risk of injury if chronic conditions are not properly treated, as in epilepsy or atrial fibrillation. For example, The American Academy of Neurology has released a position paper on generics, stating that: “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”

The United States Court of Appeals for the Eighth Circuit, in Mensing v. Wyeth, Inc., has just ruled that generic drug manufacturers cannot use the doctrine of federal preemption as a shield to avoid liability in claims arising out of the manufacturers’ failure to warn consumers about their drugs’ dangers.

This decision follows on the heels of the United States Supreme Court’s ruling in Wyeth, Inc. v. Levine that the FDA’s approval of a drug’s label does not provide immunity from suit by federal preemption when name-brand drugs cause injury. The Eighth Circuit’s decision in Mensing was the first federal appellate decision since Levine to rule that federal preemption does not immunize generic drug manufacturers from liability.

Please see our earlier discussions about the importance of defeating this preemption doctrine.

The most recent issue of the New England Journal of Medicine has directly called upon Congress to give the FDA the requisite authority and resources to regulate diet supplements. The article is written by Dr. Pieter Cohen, of Cambridge Hospital, and emphasized some alarming statistics:

•More than half of the adult population, about 114 million people, consume dietary supplements.

•The majority of consumers mistakenly believe that dietary supplements are approved by a government agency –- two-thirds of them thought that the government requires that labels on supplements include warnings about their potential side effects or dangers.