FDA drug rush is ill-advised


fdaWith a lot of fanfare, the Food and Drug Administration last week announced a first — its approval of a diet pill that can be bought without a prescription.

A lower-dosage version of the prescription drug Xenical, the over-the-counter medication will be marketed by GlaxoSmithKline and goes on sale this summer. Since nearly 130 million Americans are considered overweight, the drug is expected to be popular. Conservative estimates are that 5 million-6 million Americans will use the drug in its first year.

Since obesity has been identified as a worsening problem in the United States, this news could be greeted with optimism, except for the many "ifs" and "buts."

The drug, which will be named Alli, blocks absorption of some fat consumed. This produced gastrointestinal side effects in half of patients during clinical trials. Because those side effects include diarrhea, officials suggest those who take the drug also take vitamin supplements.

In addition, the drug is ineffective unless it is used in combination with a diet and exercise program.

Then, Alli carries the usual risk of drug interactions for people who have had organ transplants, who take blood-thinning medicines, or are being treated for diabetes or thyroid disease.

And there is another problem: The watchdog group Public Citizen reports the drug can cause precancerous lesions of the colon.

GlaxoSmithKline denies that is the case, and points to its clinical trials of 30,000 patients as proof of the drug's safety. But Dr. Sidney Wolfe, Public Citizen's director of health research, called the FDA approval "a dangerous mistake in light of its marginal benefits, frequent coexistence of other diseases, common, bothersome adverse reactions, and significant inhibition of absorption of fat-soluble vitamins."

There was a time when the FDA was the watchdog for American consumers; now, it seems, it requires constant watching. In the past few years, the FDA's oversight has been questioned after studies linked antidepressants to suicide risk for children, and painkillers including Vioxx to elevated chances of heart attacks.

A blue-ribbon panel of medical and legal experts concluded last year that the FDA's priorities were skewed to approving new drugs without enough follow-up study. The agency appeared to accept most of the panel's findings last month, when it announced a new set of measures to improve drug safety.

That is why last week's approval of Alli is particularly alarming. Could the new measures just be lip service to the FDA's critics? As more and more popular drugs are going generic, drug makers are pushing the government to allow delivery of new drugs. And under politically appointed acting director Dr. Andrew von Eschenbach, the FDA has streamlined its drug-approval process.

One of the findings of the blue-ribbon panel was that FDA managers often dismissed warnings of their own experts. Some of those experts have begun to speak out, and are now working with members of Congress on proposals to revamp the FDA. The most significant change, if approved, would be to create an independent office of drug safety. Currently, that office operates within the same division as the more powerful office that decides whether or not to approve a new drug.

Pharmaceutical companies have opposed all such changes, insisting that the current system allows for thorough testing and review of drugs to ensure safety.

But when it comes to the food we eat, the medicines we take, and the guarantees on the label, the government should adopt an adversarial relationship with private industry. If that requires a splitting of the FDA into two agencies, so be it.

Americans' safety demands it.

source RC Times