Using transparency as the means to restore patient trust
In response to the current concerns, I suggest that Glaxo and the FDA work together, using transparency as the means to restore patient trust and to support the effort to make the right decisions.
By on Jul 6, 2010In response to the current concerns, I suggest that Glaxo and the FDA work together, using transparency as the means to restore patient trust and to support the effort to make the right decisions. The relevant trial data about Avandia should be placed in the public domain - all of it. This is a quote from a physician in a Forbes article and makes a lot of sense.
The author, Dr Harlan Krumholz is the Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University. He further states:
"Glaxo should demonstrate its willingness to learn the truth about its blockbuster drug, whatever the data demonstrate that truth to be. Importantly Glaxo should make available the unaltered raw data files. With these data, academics can review all key decisions about determining and assigning outcomes, and conduct appropriate analyses. At this point, I am not aware of any independent investigators that have been able to do so. The limited data that are in the public domain prohibit investigators from using optimal methods to reach a conclusion from the available evidence".
This, at least to me, is common sense and it no longer an option for the drug industry. Even the American Heart Association has weighed in on Avandia;
In other words, if you ask the cardiologists and ask the endocrinologists, they will tell you that Avandia doesn't look as bad as the press is making it out to be. The JAMA article was a negative study. In other words, Graham, concerned about heart attacks, did a retrospective analysis comparing Actos to Avandia and found NO DIFFERENCE. However, he did find a difference in terms of heart failure (a side effect of both drugs) and stroke. Previously,no one had ever suggested that Avandia has more heart failure than Actos (and studies seem to confirm this). As far as stroke, if anything Avandia may prevent stroke. (If you look at the confidence intervals in the FDA meta-analysis and RECORD, they come close to showing that Avandia prevents stroke). Yet, the media is relaying this as "one more nail in the coffin" for Avandia. Also, the cardiologist discuss the BARI 2D analysis showing Avandia likely PREVENTS heart attacks! Why isn't the media reporting about this study, which was an NIH sponsored (no axe to grind), randomized clinical trial (much better than meta-analysis or retrospective claims analysis)?
The bottom line is that in an age of transparency and open availability of information being honest and "opening the books" on your data is a must before some irresponsible bloggers spread unpublished and non-peer reviewed studies that could do harm to patients.
Disclosure: Matthew Mintz, M.D, Associate Professor of Medicine, Director, Primary Care Clerkship George Washington University School of Medicine, contributed thoughts to this piece.