Healthy Skepticism Library item: 3846

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harris G.
New Drugs Hit the Market, but Promised Trials Go Undone
New York Times 2006 Mar 4
New Drugs Hit the Market, but Promised Trials Go Undone

Notes:

Ralph Faggotter’s Comments:

To us ordinary folk it seems incredible that the FDA would approve the marketing of new drugs on the promise of further studies to be done on safety and eficacy, when those making the promises have such a poor track record in fulfilling their previous promises!

It also seems incredible to us that drugs would be approved as being safe on the basis of promises to do studies to demonstrate that they are safe!!

No wonder the pharmaceutical companies are tempted to fudge the figures if and when the studies do finally get done.

Full text:

March 4, 2006
New Drugs Hit the Market, but Promised Trials Go Undone
By GARDINER HARRIS
WASHINGTON, March 3 – When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.

Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs’ approval.

Critics of the industry promptly seized on the new numbers, saying they demonstrated that the drug agency needed more power to compel drug makers to complete needed studies.

Representative Maurice D. Hinchey, Democrat of New York, said that while the agency insisted that it demanded that drug makers prove their medicines safe, those demands “continue to be blatantly ignored by the pharmaceutical industry.”

Mr. Hinchey has introduced legislation that would authorize the agency to require drug makers to follow through on their promised commitments.

But Dr. John Jenkins, director of the Office of New Drugs at the agency, said that many drug companies who promised to undertake trials “are taking that commitment very seriously.”

Dr. Jenkins emphasized that only 5 percent of the promised drug trials were officially considered “delayed.” In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for the tests.

As with many debates regarding the F.D.A., the controversy over promised but uncompleted trials revolves around what level of certainty drug reviewers should insist upon before approving medicines.

Conservatives and some patient-advocacy groups have long argued that the F.D.A. should approve medicines as rapidly as possible even when there are significant doubts about whether they work or are safe. Drug-safety advocates have argued that the agency needs to slow its approval process by demanding more thorough drug testing.

The agency often compromises by approving a drug quickly and then insisting that its maker prove after approval that the drug actually works. This strategy, as the numbers released Friday show, has been only marginally successful.

As of Sept. 30, of the 1,231 promised drug trials, 797, or 65 percent, had not begun or were “pending,” according to the F.D.A. Another 231 were considered “ongoing” and 28 were “delayed.” In the 2005 fiscal year, drug makers completed and submitted the results of 172 trials, the agency reported.

Dr. Scott Gottlieb, the deputy F.D.A. commissioner for medical and scientific affairs, said last month that the agency would ask an outside group to evaluate the problem, a process that could take a year.

Dr. Steven E. Nissen, chairman of the cardiology department at the Cleveland Clinic Foundation, said, “I think it’s very disappointing that we’re not seeing the studies that are promised being done.”

Companies complete trials rapidly when the F.D.A. demands the results as a condition for approval, Dr. Nissen said.

Alan Goldhammer, an associate vice president of the Pharmaceutical Research and Manufacturers of America, a trade group, said that “approving medicines for public use is a lengthy and difficult process.”

Although the controversy about these numbers has raged for years, the ratio of uncompleted trials has remained largely unchanged. In 2002, the first year that the F.D.A. began closely monitoring the issue, 820 of 1,339 promised trials, or 61 percent, were “pending.”

One problem is that the promised studies are often difficult to complete. For instance, few cancer patients would willingly risk enrolling in a study that might result in theirreceiving a placebo when the active drug was easily available at any oncologist’s office.

As a result, just one cancer medicine in five has ever proved that it extends patients’ lives – the usual endpoint demanded of postapproval cancer trials.

The trials are also expensive, and drug makers sometimes have few incentives to complete them. The F.D.A.‘s only recourse is to withdraw the drug, but because such a step might hurt patients it is considered so draconian that regulators have never taken it over a failure to complete a study.

Dr. Alastair Wood, associate dean of Vanderbilt medical school, said the F.D.A. needed to get tougher on drug makers. “Who would turn in their homework if they didn’t have to?” Dr. Wood asked.