Making data from clinical trials fully and easily accessible for professional review would help doctors and patients Tuesday, June 19, 2007

The United States needs a better way of judging the safety of pharmaceuticals and medical devices. The Food and Drug Administration, which is responsible for certifying the safety of products meant to cure people or make them healthier, is struggling to keep up with an ever-increasing burden.

Help for the FDA and the American consumer is out there, but it's informal, and too much detective work often has to take place before the most important detective work - on drugs' effects on patients - can begin. In recent years, much of that help has come from doctors at the Cleveland Clinic who have taken it upon themselves to revisit data from clinical trials of medicines and compare them with real-world outcomes for patients once the drugs have been approved for general use.

The latest case is Dr. Steven Nissen's assertion that Avandia, a diabetes drug made by GlaxoSmithKline and approved for prescription in 1999, significantly elevates a patient's chances of suffering a heart attack. The drug already was the subject of FDA concern about heightened risk of congestive heart failure.

Nissen, chairman of the Clinic's Department of Cardiovascular Medicine, published his findings on Avandia in this month's New England Journal of Medicine.

Nissen has a history of rolling out drug data analysis that stirs up safety concerns about side effects of medications in widespread use. Some in Congress, notably California Republican Rep. Darrell Issa, are trying to dismiss Nissen as a self-promoter. Others, fortunately, are more willing to address the pressing issue of how public safety is affected by the current inefficient and overburdened system of FDA oversight.

Nissen, and clinicians like him around the country, aren't sifting drug performance data so they can add to their scrapbooks of news clippings. They're doing it so they can add to the store of knowledge in the medical community, which can then improve care for patients.

What has happened with Avandia, and a score of other drugs whose potential for dangerous side effects has come to light only after FDA approval, highlights the need for more widely accessible data from clinical trials.

Drug companies should not be able to promote data favorable to their products, while bottling up data that point to risks. That's nothing more than advertising.

Rather than exploring Nissen's motivation for doing the right thing, Congress ought to do what some states already have done: pass a law requiring pharmaceutical firms to make all data from clinical trials available for medical professionals to review. Aiming the presentation at laymen would almost certainly be time-consuming and counterproductive, but putting it online for clinicians to analyze would make all the sense in the world.

As it now stands, public-spirited doctors like Nissen, who are trying to save patients grief, can be accused of poking their noses where they don't belong. That's ludicrous.

Lay out all of the information and let the best minds in the medical field dissect it.

• Avandia
• Acetaminophen
• Accutane
• Ambien
• Aredia
• Baycol
• Bextra
• Celebrex
• Celexa
• Cialis
• Crestor
• Darvon (Darvocet)
• Depo-Provera
• Diclofenac
• Effexor
• Ephedra
• Evista
• Fluvoxamine
• Fosamax
• Gleevec
• Ketek
• Levitra
• Lexapro
• Meridia
• Mirapex
• Neurontin
• Paxil
• Pergolide (Permax)
• Prempro
• Promethazine HC1
• Prozac
• Risperdal
• Seroquel
• Serzone
• Symbyax
• Tamiflu
• Tequin
• Viagra
• Vioxx
• Zelnorm
• Zoloft
• Zometa
• Zyprexa
• Ortho Evra Patch
• Adderall
• Aleve

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• Defective Drugs

• Dangerous Drug - Center for Drug Evaluation and Research
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