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Drug Research Contracts: Keeping Pharmaceutical companies out of reach from procsecution?

An article published in the NYT in November 29, 2004

“Of the 12 studies for (the church of Pfizer), all 5 of the reports claiming positive results, meaning the drug worked without worrisome side effects, that were submitted for possible regulatory approval were published.

The 7 other studies were inconclusive or negative, which can mean that the drug failed to work or that the test failed because of its design.

(Two of the studies were never submitted to the Food and Drug Administration to support an application for the drug’s approval.)”

“In her Zoloft study, Dr. Wagner acknowledged that she had received “research support” over the years from several drug manufacturers including Pfizer, which paid $80,000 to the Galveston center in connection with the Zoloft test.

But she did not state that she also received sizable payments from the company for work she did related to the study.”

Dr. Karen Dineen Wagner of the University of Texas Medical Branch at Galveston Published in November 29, 2004 under “Contracts Keep Drug Research Out of Reach”

(Page 3 of 5)

Dr. Wagner, vice chairwoman of the department of psychiatry and behavioral sciences at the Galveston center, declined to be interviewed for this article but did reply to some questions in writing. Officials of the Galveston center insisted that the industry money she received did not affect her work.

A Researcher’s Role

It was hardly surprising that many manufacturers of popular antidepressants already approved for use in adults would turn to an established researcher like Dr. Wagner to test them in young patients.

In the late 1990’s, she was one of a small number of researchers with experience in testing drugs intended to treat children with problems like attention deficit disorder and bipolar disorder.

Over the last decade, Dr. Wagner has led or worked on some 20 studies published in medical journals, and the government has financed some of her work.

She has also attracted a large number of including those aimed at testing whether antidepressants approved for use in adults were safe and effective in children and adolescents.

Dr. Wagner’s role varied in 12 industry-sponsored trials in which antidepressants were tested against placebos for depression or other problems. On three of them, including a Zoloft trial, she was a lead investigator, working with company researchers to plan, analyze and write results up for publication.

On the others, her duties were limited to overseeing test patients at her clinic.

Of the 12 studies, all five of the reports claiming positive results, meaning the drug worked without worrisome side effects, that were submitted for possible regulatory approval were published. The seven other studies were inconclusive or negative, which can mean that the drug failed to work or that the test failed because of its design. (Two of them were never submitted to the Food and Drug Administration to support an application for the drug’s approval.)

Because many of the antidepressant studies were unpublished, many doctors never heard about the results.

Their findings were typically disclosed in limited settings, like talks at meetings of medical specialists or on a poster displayed in a room with dozens of other posters, which is a typical way of disseminating research results at professional conferences.

Several researchers who worked on the pediatric antidepressant trials said that in many cases they had little incentive to submit ambiguous or failed trials to medical journals because they thought the papers would be rejected by journal editors.

One of those researchers, Dr. Neal Ryan, a professor of psychiatry at the University of Pittsburgh, said there has typically been little publishing interest in studies with inconclusive findings or those that failed to work because of study design, a type sometimes referred to as a negative study.

“No one gets famous from publishing negative studies,” Dr. Ryan said.

In response to a question, Dr. Wagner wrote that in all the cases where she was the lead investigator, test results had been or would soon be published or presented at medical meetings.

It was her study of Zoloft for childhood depression, financed by Pfizer, that attracted the most attention and criticism. Results were published last summer in The Journal of the American Medical Association as the debate on pediatric antidepressant use was rising; the study concluded that the drug effectively treated depression.

The finding received widespread publicity in newspapers, including The New York Times.

“This study is both clinically and statistically significant,” Dr. Wagner said last year. “The medication was effective.”

But some academic researchers said that the difference in improvement that the study found between young depressed patients taking Zoloft and similar patients who received a placebo – 10 percentage points – was not substantial.

Asked about complaints about the trial, Dr. Wagner referred to a statement in The Journal of the American Medical Association in which she responded last year to critical letters.

In that statement, Dr. Wagner said she believed that the 10 percentage point difference was “clinically meaningful.”

A Possible Conflict (of interest?)

In her Zoloft study, Dr. Wagner acknowledged that she had received “research support” over the years from several drug manufacturers including Pfizer, which paid $80,000 to the Galveston center in connection with the Zoloft test. But she did not state that she also received sizable payments from the company for work she did related to the study.

Note: Dr. Karen Dineen Wagner participated in more than a dozen industry-financed pediatric trials of antidepressants and other types of drugs from 1998 to 2001.

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