FDA Requires Added Warnings on ADHD drugs_Sweden’s “Gillberg Affair”

Ten months after the FDA directed ADHD Drug Manufacturers to revise 15 product labeling for doctors to reflect concerns about serious adverse cardiovascular and psychiatric events (May 2006), the agency finally got around today to issue a directive to these manufacturers to notify patients and families about these serious, for some, life-threatening events. See: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01568.html

As Ed Silverman notes on Pharmlot.com, "In a bit of understatement, Steve Galson, who heads the FDA's Center for Drug Evaluation and Research, said: “Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well.” http://pharmalot.com/2007/02/adhd_drugs_get_heart_psychiatr.php

The label warnings and the creation of a Patient Medication Guide for each individual product were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee after learning of FDA safety officers' review of numerous reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products.

One review included reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA safety review of ADHD medicines revealed a increased risk for children (about 1 per 1,000) for drug-related psychiatric adverse events. These included drug-induced psychosis–hearing voices, becoming paranoid for no reason, hallucinating, or becoming manic–even in patients who did not have previous psychiatric problems.
 
FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

A Swedish ADHD "Gillberg affair":
The most prominent child psychiatrist who coined his own term for ADHD–“DAMP” (Deficits in Attention, Motor control, and Perception),  Dr. Christopher Gillberg, a professor of Child and Adolescent Psychiatry at Gothenburg University, in Sweden, is at the center of a major research scandal, known locally as the “Gillberg affair.”

Douglas J. Keenan reviews this sordid "affair" in English with links to documents. http://www.informath.org/apprise/a6400.htm

Dr. Gillberg has an international reputation and has been a professor or visiting professor at the universities in Europe and the U.S. (Bergen, London, New York, Odense, San Francisco, and Strathclyde). He is the author or editor of several scientific books, and he has authored or co-authored more than 300 research articles.  However his concept of DAMP has been largely ignored or strongly criticized by other researchers.

The "affair" which has dragged on for several years, centers on Dr. Gillberg's refusal to disclose his data to two prominent researchers who are skeptical about his claim that 10% of Swedish children are afflicted with DAMP–for which the treatment is invariably ADHD drugs.

This "affair" has been the topic of much discussion in the Swedish media. It reads like a detective story:
In the "Gillberg camp" are academics who have defied, all told, four court orders to allow independent researchers access to the data that Dr. Gillberg claims supports his contention. His allies in academia deliberately stirred fear among the patient-subjects by misinforming them that their medical records will be made public. When all else failed, these academics committed the ultimate research crime–they destroyed  the research records.

"In June 2005, Gillberg and the rector of Gothenburg University, Svedberg, were convicted (by a criminal court) for not making the data available to Kärfve and Elinder. Gillberg received a suspended sentence and a fine; Svedberg received a fine. Gillberg appealed his conviction up to the Supreme Court, and had his last appeal rejected in April 2006. Separately, the three coworkers were convicted for destroying the data. Each of the three received a suspended sentence and a fine. The rector resigned his position at the university."

"The Swedish Parliamentary Ombudsman published its English Summary for the fiscal year ending June 2006. The Summary is 22 pages long; 15 pages are about the Gillberg case. It is very critical of both Gillberg and Gothenburg University."

"The Swedish government decreed a new regulation for the handling of research misconduct allegations. The decree states, “A university that, by a petition from someone or in any other way, receives information about possible scientific misconduct in research, artistic research, or any other research at the university, will investigate the allegations”.

Nevertheless, Gillberg and his colleagues continue with their work at the university, and in November 2006, the Swedish Research Council awarded Gillberg a substantial research grant.  This might explain the reason the university shields Gillberg–it is likely that he brings in large sums of money from industry.

 To date, there has been little media coverage outside Sweden, with the exception of Norway where a series of news stories resulted in a loss of confidence in Gillberg, who was head advisor of the Children in Bergen project (a project involving close to 10 000 children).

That Sweden, the nation that hands out the Noble prize, would tolerate the scientific shenanagans evident in the “Gillberg affair” is truly astonishing. 
What powerful motives might have propelled scientists to violate research standards, to break the law, and to destroy medical research records?
What does the "Gillberg affair" suggest about the integrity of the data underlying the DAMP hypothesis?
What does the "affair” suggest about the the scientific integrity of research conducted by Gothenburg University faculty?
Who are the powerful vested interests that have shielded Dr. Gillberg and his close allies from the blatant contempt for Swedish Court?
What role do those vested interests play in the Swedish Research Council?

See also: BMJ  2005;331:180 (23 July), doi:10.1136/bmj.331.7510.180-f

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
 
 
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