Articles Posted in Diet Supplement, OTC, Pharmaceutical Claims

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.

The FDA has recalled 14 Hydroxycut weight loss supplements after receiving reports of severe liver damage that led to the death of a 19-year-old man, and a liver transplant in another supplement user, as well as reports of jaundice and liver enzyme elevation. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. Other adverse events include seizures, cardiovascular disorders, and rhabdomyolysis, a serious type of muscle damage. The supplement manufacturers, Iovate Health Sciences USA of Blasdell, N.Y., and Iovate Health Sciences of Oakville, Ontario, in Canada, have agreed to voluntarily cooperate with the FDA.

The death occurred in 2007, but the FDA did not learn of it until March, 2009, a delay that is not unusual given that supplement manufacturers are subject only to voluntary, not mandatory, reporting of adverse events. And, unlike drug manufacturers who must follow strict disclosure regulations regarding active ingredients, supplement manufacturers are not required to disclose precise ingredients to the FDA, but can hide behind the “proprietary blend” rubric. This makes it especially difficult for the agency to identify the toxic substances causing the adverse events. The FDA was unable to identify the precise substance believed to be at work here, but the pattern of injury suggests that adverse events may occur regardless of dosage or the length of use of the product.

The surprise here is not that untested diet supplements can cause hepatotoxicity, even at recommended doses, or that there is no free lunch in the world of weight loss supplements. The surprise is that Hydroxycut is still in business. Remember its tattered history of using ephedra in its products, using deceptive before and after photographs, and falsely claiming that it had scientific data of its product’s effectiveness (when, in fact, study participants were dropping out due to adverse events and the company replaced them with new study participants). The surprise is that our current regulatory scheme has allowed the company to remain in business at all.

The FDA has again issued a nationwide alert to consumers about weight loss products that have been “spiked” with undeclared drugs. The FDA identified Herbal Zenicol, Slimbionic, and Xsvelten, bringing its list of adulterated weight loss products to a total of 72 products. The products were spiked with fenproporex (a controlled substance not approved for marketing in the United States), fluoxetine (an antidepressant available by prescription only), furosemide (a potent diuretic available by prescription only), and cetilistat (an experimental obesity drug not approved for marketing in the United States). In the supplements the FDA previously found to be spiked, the supplements contained sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent).

The FDA has warned that some of the supplements contained drugs far in excess of the maximum recommended dosage of the drug. The risks posed by these products include high blood pressure, seizures, tachycardia, palpitations, heart attack, or stroke.

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The Bush Administration’s attempt to provide complete immunity to the drug industry ended today with a 6-3 vote of the United States Supreme Court. (We previously explored the Bush Administration’s attempt to use the preemption doctrine improperly here and here.) The Court has now issued its decision in Wyeth v. Levine, ruling that patients injured by a drug can sue the drug’s manufacturer for damages, even if the FDA had approved the drug to be marketed. The decision upholds a $6.7m verdict in favor of a Vermont musician who had her arm amputated when Wyeth’s Phenergan, an anti-nausea drug, entered an artery and caused gangrene. The manufacturer claimed that it was entitled to complete immunity from suit based on the FDA’s approval, and that any state claims should be preempted.

This opinion completes a trio of Court decisions on the preemption doctrine. The first, Riegel v. Medtronic, Inc. v. Good, established that state products liability suits were preempted by federal medical device regulations unless there were other FDA violations. The second, Altria Group, Inc. v. Good, established that state claims based on unfair trade practices could be asserted against cigarette manufacturers even though cigarette labeling is regulated by the FTC.

Today’s decision in Wyeth v. Levine is an essential one because the FDA is not able to ascertain before marketing all the risks of a drug or errors in labeling. When there is negligence by the manufacturers, the safeguard of the courts is needed to protect consumers fully. If the FDA were the only safeguard in the system, and there were no checks-and-balances provided by the courts, consumers would unquestionably be at greater risk. There is no doubt that the Court’s decision today was the correct one.

The GAO released a 77-page audit report today critical of the FDA’s efforts to protect consumers from dangerous diet supplements. Since manufacturers became required to report adverse events, well-known to be underreported even in the best of circumstances, the FDA has seen a three-fold increase in the number of adverse events reported. Over 948 adverse event reports were received, and 596 of them were mandatory reports submitted by industry. Those included 9 deaths, 64 life-threatening illnesses, and 234 hospitalizations. Once underreporting is accounted for, the FDA estimates that the true number of adverse events exceeds 50,000 adverse events. The audit was conducted at the request of Congressman Henry Waxman, and several other members of Congress.

The GAO ticked off the items we know already: that the FDA should request more power from Congress to regulate the diet supplement industry, that the FDA can’t require that a company remove tainted supplements from the marketplace, that the public does not know there has been no testing of the products for safety and efficacy, and that manufacturers should register with the FDA and disclose the specific supplements and ingredients to the agency. We certainly know that “consumers remain vulnerable to risks posed by potentially unsafe products.”

Key Events in the Regulation of Dietary Supplements