“In making this plea to keep Avandia on the market, I believe I am pleading for my life.” For people like himself, he said, pulling Avandia would be a “death sentence.” Chuck Keyserling telling the advisory panel he had taken Avandia for the past 10 years.
Then there is this line from today’s NY Times Editorial section:
The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly. The company must be watched like a hawk as additional trials that it sponsors go forward.
“I don’t have any patients currently taking Avandia,” said Dr. David Nathan, director of the diabetes center at Massachusetts General Hospital. He stopped prescribing the drug because “it just didn’t make sense,” considering there are alternatives that didn’t carry the potential risk, he said.
How would you like to be a GSK salesperson today ? I sure wouldn’t. Yet from a patient/consumer standpoint both the FDA and GSK have failed them again. They have failed because for most patients taking or considering Avandia you’re pretty much on your own trying to cut through all the information and determine if the risk is acceptable. Health care professional are left with either taking their patients off Avandia or trying to cut through all the conflicting studies and become statistical analysts.
The biggest failure is the lack of leadership and transparency at both the FDA and GSK to put patients first. People are asking “how can they trust the science when the science data is untrustworthy ?”
More importantly people maybe asking “what’s the real truth here ?” The New York Times in the past has quoted “selective” data from drug litigation that does not exactly shine the light of trust on pharma.
The lesson here is simple. The FDA needs to do a better job to reassure the public and HCP’s that drugs are evaluated on good clinical trial data not conjecture and innuendo. For most people however they are going to sort through the data themselves to determine if the risk is acceptable.





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