Weer
een medicijn met problemen.*
Volgens een studie in The New England Journal of Medicine lijkt het dat het medicijn Avandia, dat gebruikt wordt bij diabetes de kans op hart- en vaatziektes wel tot 43% kan verhogen en het risico op sterven hieraan wel met 64%. Dit blijkt ook al langer bekend te zijn bij de fabrikant en de Amerikaanse FDA want al zeven jaar gelden werd voor het eerst door een bekend staand dokter al melding gemaakt van opvallend meer doden als gevolg hartproblemen. Doch tot op heden werd nog weinig actie ondernomen waardoor nu door de cardioloog Steven Nissen, die ook al het Vioxx-schandaal aanzwengelde, dit onderzoek uitgevoerd werd.
Ignoring
the Warnings, Again?
The
latest findings on Avandia, a top-selling diabetes drug, raise concerns both
about its safety and about the way the manufacturer and the Food and Drug
Administration have responded to signs of danger. It would be rash to make
definitive judgments until the F.D.A. completes a detailed analysis. But the
handling of this case bears disturbing resemblances to the Vioxx debacle, in
which early warning signs were ignored by its manufacturer until the evidence of
serious harm became inescapable and the drug was pulled from the market.
Avandia
was approved for sale in 1999 based on studies showing that it could lower blood
glucose levels in patients suffering from Type 2 diabetes, also known as
adult-onset diabetes. The assumption was that the drug could alleviate some of
the most damaging effects of the disease, such as heart attacks and other
cardiovascular ailments. But a paper just published in The New England Journal
of Medicine suggests that Avandia may instead increase the risk of a heart
attack by 43 percent and perhaps the risk of cardiovascular deaths as well.
The
study — an analysis of the combined results of 42 previous studies that
compared people who took the drug with people who did not — is not definitive,
and the absolute risk to any given patient is small. But the study points to a
risk that could potentially harm thousands of patients a year. Its lead author
was Steven Nissen, a cardiologist at the Cleveland Clinic, who blew the whistle
on the cardiovascular risks of Vioxx, which adds to the sense of déjà vu.
What’s
most troubling is the possibility that early warning signs were not adequately
heeded.
Seven
years ago a leading diabetes doctor warned the F.D.A. of “a worrisome trend in
cardiovascular deaths,” two years later a safety monitoring group within the
agency expressed concern over cases of heart failure in patients taking the
drug. In late 2005 and again in August 2006 the drug’s manufacturer —
GlaxoSmithKline — informed the F.D.A. that its own combined analysis of
various studies showed a 31 percent increase in adverse cardiovascular events.
But the company also cited studies that it said showed no evidence of harm, and
the F.D.A. concluded the findings were too mixed to take immediate regulatory
action.
Now,
prodded by Dr. Nissen’s article, the agency has issued a safety alert, is
completing its own safety analysis and will convene a panel of experts to review
the data. The best hope for a definitive answer may lie in a clinical trial that
won’t finish monitoring all enrolled patients until late next year.
If
the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot to
explain. Congress will need to probe hard to determine what risks the agency and
the manufacturer were aware of and what they did — or didn’t do — to
mitigate them.
(New York Times May 25, 2007) (Mei 2007) (Opm Wellicht toch verstandiger met gezonde voeding trachten zoveel mogelijk de problemen te verhelpen. Voor zij die denken dat dit alleen een Amerikaans probleem is kijken hier.)