Glaxo: ‘They’re Beating Us With A Club!’
9 CommentsBy Ed Silverman // June 15th, 2007 // 4:47 pm
Chris Viehbacher would like everyone to believe that Glaxo is an unfortunate pawn in a political battle between Democrats and Republicans. The head of Glaxo’s pharma biz tells The Wall Street Journal (subscription required) that the overtone in last week’s congressional hearing about Avandia safety was just sooo obvious.
“You’ve clearly got a major political battle in the middle of this, with Congress trying to paint the Bush administration yet again as having in some way failed, and Avandia is kind of the latest club to beat the administration with,” he observes. “It’s pretty much Democrats beating up on us.” And in the process, they’re undermining the FDA, he adds.
Chris is more optimistic about the July 30 FDA advisory panel meeting to review Avandia, because he expects a more scientific discussion. “In the end,” he offers, “science will win.”
Maybe. But science can only win if the science is accessible. Remember, Glaxo performed some small trials, but only placed them on a company web site after being forced to do so by a New York attorney general. And even then there was no effort to publicize the site.
Steve Nissen’s meta-analysis may be imperfect. And of course, congressional hearings are political. But if Chris finds such gatherings tasteful, he should instruct his company to be more diligent about pursuing and disclosing the science in which he places so much stock.
Nancy Pekarek, GSK
Just to clarify, GSK scientists did conduct meta-analyses of safety data from multiple clinical trials, knowing the approach could not yield conclusive information, but only generate hypotheses. More importantly, the company has conducted rigorous, long-term prospective clinical trials to yield more definitive conclusions about both the safety and benefits of Avandia. In fact, Avandia is the most widely studied oral anti-diabetic medicine for the treatment of type 2 diabetes, with experience in over 52,000 patients.
That data is accessible. Any fair examination of the company’s record will show that GSK has been transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways. We report new data to the FDA and other regulatory authorities. We have revised our label over time so that physicians have appropriate information on which to base their treatment decisions for individual patients in a timely and transparent way. We have presented data at scientific symposiums and in scientific publications. Data is also posted publicly on the company’s Clinical Trial Register, which can be accessed by anyone at gsk.com.
Ed Silverman
Hi Nancy,
Thanks for stopping by. And for providing the statement. The question revolves not only around what studies were pursued, but also the extent to which results were accessible and the timing involved.
With that said, I appreciate your remarks.
Regards
ed
Laurie
If GSK was a forthcoming as their representative would like us to believe, there wouldn’t be Congressional hearings going on. I believe that general public has recognized, with all the recent problems, that clinical trials can show whatever the “sponsor” of that trial chooses. I know that I have had an education in the last few years of reading them!
Nick
Laurie,
I agree. To that point, Dr. Nissen can tailor a study to meet his goal. The best way to do that is a Meta. It’s all a mess and Dr. Nissen is just to blame as others. I have seen the numbers (I am not associated with Avandia) and Dr. Nissen has probably put more people in harm than he “thinks” he has saved. All of us know in the medical field that patients are not compliant. Once they heard this news they stopped taking the meds. They didn’t call the Doctors…the media “told them to stop taking it”.
One should look into Dr. Nissen’s motives and background with the industry.
Dr. Remulac
What needs to be immediately questioned by the feds, the medical profession, the pharma industry, the press, and patient advocacy groups is who has benefitted from all of this Avandia business. Avandia sales have plummeted in the aftermath of this, but sales of Lilly/Takeda’s Actos have SKYROCKETED, presumably due to switching from Avandia. I pose to you all as a scientist and as a clinician that there is absolutely NO conclusive evidence that Actos is any safer from a CV outcomes perspective than Avandia. In fact, both agents have well-known risks of CHF, and both will be getting a black box warning for the same. As for endpoints like MI and CV death, there is one trial for Actos designed around CV endpoints (called PROactive) which DID NOT show any difference versus placebo. Takeda has promoted this trial around cherry-picked secondary endpoints in their favor. Lilly/Takeda has never released any info on pooled-analysis of data from their clinical trial program as GSK has done. However, they can no longer hide as the FDA has specifically asked them for this information in advance of the review panel meeting at the end of July. Mark my words: this analysis WILL show that Actos carries the same risk as Avandia on meta-analysis. I know personally that Takeda reps have been making sure that the docs they call on are aware of the “dangers” of Avandia, but have little beyond this one trial (PROactive) to share with them regarding the CV safety of Actos. They have not investigated the CV safety of their drug as thoroughly as GSK and others have Avandia, but they are very happy to create the illusion of better safety in order to gain business. GSK made their data available to anyone, friend and foe alike, but what has Lilly/Takeda done? Their day is coming soon. Stay tuned.
Lisa Van Syckel
Nancy,
Where was GSK’s transparency of the safety and efficacy relating to the Antidepressant Paxil’s use in children.
1998 Memo ring a bell…..
Better yet how about the Money Bag and Your Business Plan Guide…..
What about the Lyme Vaccine!!!…..
We just want rhe truth1,Not Pharma Spin
GC
my mom took pioglitazone (actos generic here in india) for year and half. she had CHF this april 2007. and she had no history of heart disease before that. left ishemic to be specific the doc quietly took it off her prescription list.
she was on combined therapy with metformin and glimiperide for type 2 diabetes. i wish i had known at that time when the doc introduced pioglitazone into the mix…she didnt need to have it but maybe he was convinced by the local rep. she hads quite few of the symptoms…fluid retention, weight gain…as well.
the FDA in india is more useless than the FDA there and both the glitazones are still sold separately and in combined form with metformins or glimiperide. and millions are here taking it without any warning..black, white or grey box…yes..nothing.
GSK and Takeda should move their research to India to get the accuracy and precision to their admitted 31.XX% CHF rates..
what a rotten system…no integrity! and just spin. GSK..why dont you also reintroduce troglitazone or get rights to muraglitazar eh?
jason
Actually I take that as a ringing endorsement for our FDA. It is obviously not great, but not horrible either.
Look at the new prostate cancer vaccine from Dendrion. It was rejected d/t efficacy concerns (it actually appeared to clear the safety bar). But now you have pts gathering to protest to get access to what they consider a life saving medication. This is a see-saw and you have to carefully consider both sides. Pts. by and large are on too many meds period. There is no completely safe medication. Maybe once that happens people will understand and take responsibility for their own health. Until then this is the result.
Lisa Van Syckel
Jason,
“Our FDA” Thought you were English!
It is good to see that spell check works for you..
Have a nice day….