Free Academic Drug Tests – NYT Editorial Delivers Fatal Blow to Leaders of Psychiatry
Tue, 30 Nov 2004
Today’s editorial in The New York Times is a follow-up to yesterday’s solid report by Barry Meier, that focused on the culpability of academic researchers and their prestigious medical institutions in undermining the integrity of published medical research reports.
The editorial notes that academic medical centers "will have to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs."
Ironically, the Times editorial issued a decisive blow to the reputation of the most prominent opinion leaders of American psychiatry!
The Times refers to the American College of Neuropsychopharmacologists (ACNP) task force on SSRIs and suicide as a group of "data deprived academic researchers" who "[e]ven so issued a report disputing evidence that [sic antidepressants] increased suicidal tendencies, only to have the Food and Drug Administration, which had access to all the relevant data, find that the risk was real for some depressed youngsters."
The members of the ACNP task force included: Graham Emslie, M.D., Co-Chair of the ACNP Task Force and Chief, Division of Child and Adolescent Psychiatry and Professor of Psychiatry, The University of Texas Southwestern Medical Center at Dallas; J. John Mann, M.D., Co-Chair of the ACNP Task Force and Professor of Psychiatry at Columbia University College of Physicians and Surgeons, and Chief, Department of Neuroscience, New York State Psychiatric Institute; William Beardslee, M.D., Psychiatrist-in-Chief and Chair, Children’s Hospital Department of Psychiatry, Professor of Child Psychiatry, Harvard Medical School; Jan Fawcett, M.D., Professor of Psychiatry, University of New Mexico, ACNP member; Andrew Leon, Ph.D., Professor of Biostatistics in Psychiatry and Professor of Public Health Weill Medical College of Cornell University; Herbert Meltzer, M.D., Professor of Psychiatry & Pharmacology, Director Division of Psychopharmacology, President, Collegium Internationale Neuropsychop! harmacologicum, Vanderbilt University Medical Center, ACNP member; Fredrick Goodwin, M.D., Research Professor of Psychiatry and Director, Psychopharmacology Research Center, George Washington University, ACNP member; David Shaffer, M.D., Professor of Child Psychiatry, and Professor of Psychiatry and Pediatrics, Columbia University College of Physicians and Surgeons, Director, Division of Child Psychiatry, New York State Psychiatric Institute; Karen Wagner M.D., Ph.D., Director, Division of Child and Adolescent Psychiatry, Professor and Vice Chair, Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch, Galveston, ACNP member; and Neal Ryan, M.D., Professor of Psychiatry, Western Psychiatric Institute & Clinic, University of Pittsburgh, ACNP member.
THE NEW YORK TIMES
November 30, 2004
EDITORIAL
Free the Academic Drug Tests
Academic medical centers represent the top rung of medical research in this country and are widely thought to be impartial and independent. So it is disheartening to find them signing restrictive contracts with pharmaceutical companies that allow the companies to dictate what drug testing data can be openly discussed and published. The manufacturers of drugs and medical devices are already under increasing pressure to list all of their clinical trials and results in public databases. Now academic medical centers will need to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs.
The collaboration of academic institutions in industry practices that distort perceptions of important drugs was spelled out by Barry Meier in yesterday’s Times (“Contracts Keep Drug Research Out of Reach“). The drug and device industries annually funnel millions of dollars into many medical institutions to pay for clinical trials of their products. The hitch is that contract clauses typically give the company that finances the trials enormous sway over when, how or even if trial results are made public.
In an egregious example cited by Mr. Meier, medical school researchers who had conducted studies for the industry on the effects of antidepressants on children and adolescents urgently sought access to unpublished data to look for evidence that the drugs might increase the risk of suicide. Some drug companies refused to turn over data to the group or told researchers they could not discuss the findings of their part of a study with scientists who had not participated in that part.
By adroit use of contracts that Balkanized the testing process among multiple institutions, the drug companies ensured that only they had a clear view of the total body of evidence. Even so, the data-deprived academic researchers issued a report disputing evidence that the drugs increased suicidal tendencies, only to have the Food and Drug Administration, which had access to all of the relevant data, find that the risk was real for some depressed youngsters.
A few of the most prestigious medical centers have managed to negotiate contracts that give them the final say on publishing the results of multisite clinical trials, but a much broader approach is needed. With the industry on the run for its secretive practices, the time seems ripe to revive the notion of a standardized contract for all institutions that would ensure researchers’ access to data and prompt publication of results.
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