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Posted on Wed, Jun. 09, 2004

Getting the bad news with the good news about a drug

The AMA may ask Health and Human Services to create a registry of all clinical trials and their results.

Inquirer Staff Writers

A doctor is thinking of trying a new drug on a 67-year-old patient because a study shows it works well in men only slightly younger. But the doctor doesn't know about a clinical trial that found serious side effects in older patients. Those results were never published.

John Schneider, a doctor of internal medicine and a member of the American Medical Association's Council on Scientific Affairs, fears that that scenario happens all too often.

Because drug companies often do not reveal the contents of studies that make their drugs look bad, he said, many doctors are frustrated because they sometimes prescribe medications without knowing all the information about them and possible side effects.

Now, the AMA is considering asking the federal government to open up this secretive world. The group's House of Delegates will vote during a meeting that starts Saturday on a resolution urging the U.S. Department of Health and Human Services to create a registry of all clinical trials and their results.

"No comprehensive system for tracking, organizing and disseminating information about ongoing clinical trials currently exists," the Council on Scientific Affairs wrote in a report supporting the registry resolution.

Last week, New York state's attorney general, Eliot Spitzer, took another approach when he filed a civil lawsuit accusing GlaxoSmithKline P.L.C., which has a U.S. headquarters in Philadelphia, of consumer fraud in its promotion of the antidepressant Paxil. The suit alleges that, beginning in 1998, Glaxo failed to disclose negative information from clinical trials of Paxil in children, and even misinformed its sales staff about the drug's effectiveness.

Glaxo spokeswoman Mary Anne Rhyne said that the company conducted eight pediatric clinical trials and that the data from all of them were communicated in more than 25 presentations at major medical meetings. Glaxo has never sought regulatory approval to market Paxil for children, and "the company's policy is not to promote off-label uses," Rhyne said.

Peter J. Pitts, associate FDA commissioner for external affairs, said that, under FDA rules, a company seeking approval to sell a new drug must submit the results of all clinical trials, but the agency considers that information proprietary. If the drug is the subject of public FDA hearings, some of the data often become public then and in labeling information.

When companies are testing a drug for a new use, they must report any safety problems to the FDA, but they do not have to turn over all their data until they file for approval.

Eighty percent of the $5.6 billion spent on clinical trials involving people in 2002 came from pharmaceutical companies or manufacturers of medical devices, prompting concerns about their role in designing studies and providing the public with information about the research, according to the AMA.

"One of the problems with the whole system of reporting is that the people who design and report the trials are not dispassionate," said Dr. Jeffrey Drazen, editor in chief of the New England Journal of Medicine. "They have a fiduciary interest in it."

When pharmaceutical companies sponsor reseach, they do not have to seek publication of studies that make their drugs look bad. And there is evidence that medical journals are more likely to publish "positive" studies - those that show a drug works - than negative or inconclusive studies.

Drug industry officials will watch the AMA's debate closely. "We are examining whether we need to take any new position," said Alan Goldhammer, associate vice president for regulatory affairs of the Pharmaceutical Research and Manufacturers of America, the industry trade group. He said they had not taken up the issue in the past.

In 1998, Glaxo Wellcome - which merged with SmithKline Beecham in 2000 - provided public summaries of all clinical trial protocols, Rhyne said. GlaxoSmithKline is working on an expanded version of the registry that would summarize trial protocols as well as results of company-sponsored clinical trials, both negative and positive, she said. The online registry would not provide the underlying data, only a summary.

The AMA's resolution grew from lobbying by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.

"There has been a concern in the psychiatric community about the accuracy, validity and reliability of the studies in our literature," said David Fassler, a child and adolescent psychiatrist in Vermont who is a proponent of a clinical trial registry. While the possibility that some antidepressants may cause suicidal thoughts in children has made them the focus of media attention recently, Fassler said the issue of unpublished drug information affects all medical specialties.

Prestigious medical journals, such as the Journal of the American Medical Association and the New England Journal of Medicine, publish less than 10 percent of the scientific papers submitted to them, their editors said. In recent years, they have tried to publish more negative studies, but there are factors that work against that, Drazen said.

Because of the way statistics work, he said, it often takes fewer people to prove that a drug does work than to prove it does not.

Several people who support the idea of a registry said it would be especially helpful for researchers who evaluate all the studies on a topic. Many doctors use such reports.

"My sense is that it would be extraordinarily useful," said Brian Strom, an expert on adverse drug reactions at the University of Pennsylvania Health System.

Contact staff writer Stacey Burling at 215-854-4944 or

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