Former FDA Reviewer Says Glaxo Withheld Study
6 CommentsBy Ed Silverman // July 12th, 2010 // 11:23 am
Three years after FDA medical reviewer Rosemary Johann-Liang left the agency amid controversy over her work on GlaxoSmithKline’s Avandia diabetes pill, she’s back in the news. Now, Johann-Liang is telling laywers, who are suing the drugmaker, how a study was withheld from the FDA showing a link to heart attacks, Bloomberg News writes.
The 2001 study, according to a deposition cited by the news service, found Avandia posed a greater risk than other diabetes meds. What’s more, she claims Glaxo also failed to provide the FDAS with an e-mail from researchers who found Avandia “strengthens the signals” for heart problems while, at the same time, FDA officials gave Glaxo details of internal agency discussions about enhancing Avandia warnings, which she told the lawyers violated agency policy. Glaxo disputes her claims, according to Bloomberg.
Whether she will play a role in the two-day advisory committee starting tomorrow remains to be seen, but Johann-Liang caused a stir three summers ago, claiming she was harassed from the FDA for raising red flags about Avandia. Some FDA officials were upset with the recommendation for a Black Box warning and waited 17 months to implement it, but meanwhile, she was no longer allowed to make such recommendations and excluded her from safety review meetings, prompting a probe by the US Senate Finance Committee (background here, here and here).
Glaxo faces about 13,000 Avandia lawsuits and is holding talks to settle about, according to Bloomberg. Two months ago, the drugmaker agreed to pay about $60 million to settle 700 lawsuits (back story).
Justice in MI
What are the odds of FDA/DOJ bringing fraud charges against GSK?
pharmavet
JiM, this explains why GSK and others were so reluctant to endorse a public database of clinical trial results. This is also consistent with why certain companies have “accidentally” forgotten to include some studies in their required IND Annual Report.
If I were an FDA auditor, to get at the truth, I would show up unannouced and park myself in the company’s Central File Room, where all documents MUST be kept, unless the company is deliberately committing fraud by ommission. I would go chronologically from even BEFORE the filing of the IND, through the IND, each periodic update, annual report, clinical study report, and finally the NDA to make sure I had everything. I would also audit sight unseen the backup data storage facility and look at evey byte and keystroke that had ever been entered for that compound. I would also impound all CRA travel records and study site reports to make sure that I was capturing all monitored studies.
Separately I would go unnanounced to the CRO and repeat the process. It is unlikely that a “missing’ study could escape detection at both the sponsor’s HQ and that of the CRO.
To me, that is the only was to effectively capture every scrap of data.
Dr. Talluri
For the sake of argument, even if one study results were omitted as claimed, logically shouldn’t there be evidence of the risk (at least some)in all the other studies that were part of the NDA submission.
There seems to be a lot more there than meets the eye with AVANDIA.
Justice in MI
Vet–I think your scenario explains why, in the end, we have to rely on companies’ self-regulating the vast majority of the time.
We’d need a Stalinist-sized FDA to enforce externally, and even that wouldn’t be enough. Nobody wants that (except when they get really pissed off!).
On the other hand, a few “good examples” could help.
re: Dr. T’s comment–my understanding is that there was good evidence of risk in a number of the studies published or otherwise available. I think the stuff allegedly cooked or withheld made the risk look riskier.
Former Big Pharma
Sadly, nothing will ever change until the executives that make these decisions are held accountable and pay for their misdeeds. Until then, there is no reason for them to be moral, truthful, decent and ethical. I’ve worked in pharma and there are more crooks than good guys in the commercial organizations. It’s all about the money, money, money!
clarkkent
Tachi and Moncef should be put in jail.