Monday, June 13, 2011

How the FDA Fails to Protect Us

Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America

The US Food and Drug Administration (FDA) is responsible for the safety of foods and medical treatments. The interest here is in its role as the regulator of prescription drugs. That function resides in the Center for Drug Evaluation and Research (CDER). Marcia Angell has provided an article in the New York Review of Books, FDA: This Agency Can Be Dangerous, that exposes some of the weaknesses and mistakes CDER makes in failing to protect the public from the drug companies.

Angell takes CDER to task for allowing drugs that are outright dangerous or of dubious value to reach the marketplace, and to stay there even after they have been proven to be harmful.

She also faults it for not policing the marketing of drugs that are approved for sale.

“CDER also does not fulfill its obligation to oversee the marketing of prescription drugs, thus permitting misleading drug ads and illegal practices such as drug companies inducing doctors to prescribe drugs for uses that have not been approved by the FDA. Although nearly every major drug company has paid enormous fines to settle charges of illegal marketing (Pfizer’s recent $2.3 billion fine—for illegally promoting its painkiller Bextra and three other drugs—is the current record), they evidently consider the fines the cost of doing business, since the same practices keep recurring with little interference from CDER.”

CDER shortcomings are both organizational and political. Angell lists a series of changes that could be made to correct many of these problems, but the systemic issue of defining the effective role of the organization is the most troubling. A president and Congress that is anti-regulation will instill in the CDER the notion that the main function is in assisting the drug industry in getting product to market in a timely fashion. This attitude, which currently reigns, is directly opposed to the role of protecting the consumer. The Prescription Drug User Fee Act (PDUFA) enshrines this notion of collaboration by requiring drug companies to provide funds to support CDER activities associated with drug approval. Angell says that fees paid by private companies now provide more than half the CDER budget. The net result is the creation of a sense that CDER is a service to the drug industry rather than to the public. It has also created an excessive focus on drug approval at the expense of other critical functions.

“As of the first of the year, the Office of New Drugs, which approves brand-name drugs, had 930 employees, while the Office of Surveillance and Epidemiology (OSE), which monitors the safety of drugs on the market, had only 206. The Office of Generic Drugs (OGD) had 268, the Division of Drug Marketing, Advertising, and Communication had fifty-one, and the Division of Manufacturing and Product Quality (DMPQ) had eighty-three.”

“This staffing is manifestly unbalanced. How, for example, can only fifty-one people ensure that tens of thousands of ads and promotional campaigns accurately convey the balance between risks and benefits of prescription drugs? Similarly, how can a staff of only eighty-three possibly ensure that the thousands of foreign manufacturing plants under its purview follow good manufacturing practices?”

One of Angell’s prime reforms would be to terminate this funding practice and make CDER fully beholden to the taxpayer.

Another of her reforms involves limiting conflicts of interest that occur. The drug industry buys the allegiance of—or at least provides financial incentives to—as many medical professionals as possible. It is quite difficult to assemble a panel of experts on any drug-related issue that does not involve “experts” who have a financial interest in the drug or the company. It is common practice to provide waivers so that compromised individuals can continue to participate.

“Conflicts of interest matter. Consider the case of Vioxx, the arthritis drug that was removed from the market in 2004 because it was associated with an increased risk of heart attacks and strokes. In 2005, a special FDA panel, consisting of two of the standing advisory committees, held public hearings to consider whether Vioxx and two other drugs in the same class, Bextra and Celebrex, were safe enough to stay on the market. After three days, the panel recommended that all three drugs be allowed on the market, perhaps with strong warnings on the labels and a moratorium on advertising directly to consumers.”

“About a week later, however, The New York Times revealed that ten of the thirty-two members of the panel had financial ties to the makers of the drugs. If their votes had been discounted, the panel would have recommended that only Celebrex stay on the market. In a departure from its usual practice, CDER, no doubt embarrassed, rejected the advice of the full panel and allowed only Celebrex to stay on the market. If not for the revelations in The New York Times, the decision would probably have gone the other way.”

Angell suggests a reform to existing practice whose effect would be monumental in protecting consumers.

“....approval of new drugs should be limited to three years, and during that time advertising aimed directly at consumers should be prohibited.”

Most drugs are approved after short-term clinical studies are completed. The accuracy of these studies aside, this is not sufficient time for long-term effects to become evident. Three years seems like a reasonable trial period. Without a few years of wide-spread use, the drug companies are in no position to claim they know anything about the safety of their product.

I am currently consumed by the story of the drugs being used to alleviate the symptoms of schizophrenia, depression, bipolar disorder, and ADHD. Robert Whitaker has written a book, Anatomy of an Epidemic, that provides evidence that these medications actually cause more harm than good. They cure nothing, they have serious side effects, they are near impossible to withdraw from, and they cause irreversible brain damage and cognitive impairment. The net effect is to worsen the health outcomes of the patients relative to those who receive no medication. He argues that the epidemic of mental health sufferers observed in the last few decades is directly related to the epidemic in prescriptions for these psychoactive drugs. The data he has accumulated suggests that the long-term harmful effects of the medications do not become obvious for about two years.

Whitaker’s findings also encourage the implementation of another of Angell’s recommendations. She wants CDER to be aggressive in forcing drug companies to carry out follow-up studies to ensure safety after widespread use by the public. Such a practice, applied vigorously and widely, would ensnare the psychoactive drugs in the regulatory net.

“Some drugs are now approved on the basis of only one or two short clinical trials, or trials that use “surrogate endpoints.” (A surrogate endpoint is an outcome, like cholesterol level, that is probably correlated with a clinical outcome, like heart attack, but isn’t itself a clinical outcome.) When drugs receive such fast-track approval, sponsors agree to conduct post-marketing studies to ensure that the drugs are safe and effective after they are in widespread use. However, drug companies regularly disregard this commitment. As of 2008, there was reportedly a backlog of more than 1,200 required post-marketing studies, of which 900 hadn’t even been started.”

“CDER often asserts that it does not have the legal authority to enforce the completion of these studies. But it does have the authority to withdraw drugs from the market, and that threat ought to persuade drug companies to honor their commitments.”

Angell provides nine recommendations in all. They make excellent sense and should be implemented.

This is serious business. Mental illness in children was so rare that not too long ago it was considered so unusual as to not be worth studying. Now mental illness is the primary cause of disability in children, exceeding physical causes such as Down syndrome or cerebral palsy. The change occurred when drug companies and their psychiatrist vendors began to provide dangerous drugs to defenseless children. Many are now doomed to lifetimes of drug dependency, mental and physical impairment, and early death. Something is terribly wrong here. If the FDA is not going to do its job and protect our citizens, then who is?

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