FDA For Profit

The Food & Drug Administration has become the most effective lobbying arm of the pharmaceutical industry, at no cost to the drug makers. Through its regulating powers, FDA has been driven by a policy that sides heavily with those who manufacture and market drugs. Patients (often referred to as "consumers" by FDA officials, which is an industry term) and often doctors, are left to their own devices to judge the true efficacy of any given drug, weighing that against the known side effects and possible dangers.

In an atmosphere of swiftly rising prices for medications here in the US, patients began to purchase their drugs from Canada, an action technically in violation of US law, though no one on an individual basis has yet been prosecuted. FDA came out against re-importation from Canada, citing the potential dangers of counterfeit drugs and the harm they might cause. While it is true that buying Viagra off the Internet is dangerous, buying drugs from Canada is not. Those drugs are tightly regulated by the Canadian authorities. The State Of Minnesota sent a party of officials to visit several Canadian pharmacies and certify them as safe for Minnesotans.

Still the FDA insists re-imported drugs are unsafe. They have dropped Canada specifically from their repeated warnings, choosing to use the word "foreign" as a catch all. A matter of semantics, but it allows the FDA to better serve the pharmaceutical industry's quest to maintain artificially high drug prices here in the US.

All of this is a prelude to the latest anti-patient move by the FDA. In a newspaper article this morning, it is revealed that the FDA suppressed studies done by the drug industry itself and other research organizations that indicate the use of anti-depressant medications in children are not very effective, if at all. Further, and more ominous, the FDA urged the drug companies to suppress portions of those studies that clearly indicate the use of anti-depressants in children raises the probability of suicide. The British government reached this conclusion last year, issuing a warning to doctors to avoid prescribing such medications to children.

The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday.

Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer's decision to amend its drug label to say that the drug was associated in studies with increased hostility and suicidal thinking among children.

"Why would FDA require a company to remove stronger labeling?" demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a hearing of the House Energy and Commerce subcommittee on oversight and investigations. "FDA should want to encourage a company to do that kind of thing."

Janet Woodcock, FDA's deputy commissioner for operations, responded that regulators believe the jury is still out on the drugs. The negative trials, she said, did not mean the medications were ineffective.

Several representatives noted that the study results were obtained at tremendous cost to the American public because Congress granted companies profitable patent extensions as an incentive to conduct the trials.

Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said it was absurd to give companies profitable patent extensions on their drugs to encourage the trials and then limit dissemination of the results. He said his staff had estimated that a patent extension given to Pfizer Inc. was worth $1 billion dollars. Wyeth Pharmaceuticals, he said, made $500 million.

The hearing was prompted by widespread complaints that crucial information about the safety and effectiveness of antidepressant medications had not been communicated to physicians and the public. More than two-thirds of all studies of antidepressant use among depressed children have failed to show the drugs are effective.

Two problems immediately arise.

One, the pharmaceutical industry made use of the cover provided by the FDA, and did not disclose their in house studies.

Two, the FDA, a federal agency charged with regulating, among other things, the pharmaceutical industry and its products, actively instigated a cover up of information vital to the public interest. While citing safety concerns over less expensive re-imported drugs from Canada, the agency betrayed its mandate by suppressing those studies that illustrate the ineffectiveness of a class of medications in children that also raise the rate of suicide among those children.

For years FDA has acted to promote and protect the profit generating ability of the pharmaceutical companies over the well being of patients. Now, it has been caught advocating the use of a potentially dangerous medication for child patients who gain no medical advantage from it, and in fact, may sustain great harm form its use. This goes beyond despicable and straight into the criminal. Those FDA officials involved, including the head of the agency, ought to be vigorously prosecuted.