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Drug Safety Dominates DIA


By Mark D. Uehling

Aug 15, 2005 | “We are all aware of the limitations of spontaneous reports” of adverse events, epidemiologist Charles Gerritz of Takeda Pharmaceuticals told the 2005 meeting of the Drug Information Association (DIA). “There is inconsistency of coding. Reporting databases are influenced by many factors, including media attention.”

Patients who may have a dim view of the industry, a Harris Poll demonstrated, are still willing to participate in its research all over the world. There were encouraging indications of a resurgence of clinical trials. Parexel International announced that there were a record 542 investigational new drug (IND) applications filed at the FDA in 2004, a 39-percent jump. A total of 4,227 INDs were ongoing and active at the end of last year, a 6-percent rise.

The FDA had its usual commanding number of presentations at DIA. Robert Temple, director of the office of drug evaluation at the Center for Drug Evaluation and Research (CDER), made a conference-best seven appearances.

Drug safety was a recurring theme, even in sessions devoted to other topics. In recalling his first years at the FDA, Temple described the agency as comfortable with debate. “What I found — and what I believe is still true — is that the place was and is devoted to getting the right answer. It is perfectly comfortable with internal disagreement,” said Temple.

Theresa Toigo, FDA assistant commissioner for special health issues, reviewed FDAMA 113, the law requiring that any trial evaluating treatments for serious or life-threatening diseases be listed in an online federal registry. Two FDA analyses of FDAMA 113 compliance have both been grim. Only a third of all appropriate trials are registered at ClinicalTrials.gov. The industry faces no legal penalties or enforcement, however.

 Marcia Angell
 ANGELL AND DEMONS: Marcia
Angell, former EIC of New
England Journal of Medicine
,
spoke at DIA.
Angell 1, Industry 0
At another session, there was a talk-show ambiance that was oddly enjoyable. The featured attraction was Harvard’s Marcia Angell, former editor-in-chief of the New England Journal of Medicine. Angell’s intellect and rhetorical skill appear to be so intimidating that no one from the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s lobbying arm, had the courage to join her panel and debate her in person.

Angell believes drug research is bedeviled with a conflict of interest in which industry scientists decide which experiments succeed, how success is defined, and what to tell physicians and regulators.

Another stirring presentation was from Lee Evans, director of clinical and regulatory information services at Merck. He rallied his listeners around the notion that data from pharmacogenetics and clinical trials must be integrated — soon. Said Evans: “The miraculous advancements in genomic medicine are threatened by inadequate systems for the acquisition, disposition, and evaluation of data. This is a true threat to the public health.”

Evans continued: “The challenge for industry lies not only in dealing with these two large mountains of data but more importantly in integrating those two data sets. We need to breach that data gap.”

WHO Safety Data
One of the most adroit uses of databases appears to be ongoing at the World Health Organization (WHO). Program leader Andrew Bate spoke about his work at the WHO’s Uppsala Monitoring Centre. Some 80 countries are now submitting data to Bate and his team; their repository holds 3.2 million suspected adverse-event reports.

“The idea of data mining is to find possible associations that you wouldn’t see if you looked at all the case reports,” said Bate. Briefly, the WHO is trying to use data mining to discover causal relationships between medicines and side effects. He acknowledged the limitations of such analyses but quickly plunged into an impressive demonstration of the power of neural networks and scoring algorithms to detect not only unsafe drugs but safe medicines, too.

One of his case histories concerned antidepressants. The quality of the WHO data is such that it shows that suicidal ideation — a plan to take one’s life — often predates the swallowing of any medication. “There seems to be strong indications that there are lots of thoughts of suicide events well before a selective serotonin reuptake inhibitor is prescribed,” Bate noted.

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