Given the dismal track record of the U.S. Senate in the 111th Congress in producing important legislation to improve the lives of Americans, it appears that some of that body's members are looking for new things to do. In the case of Senator Max Baucus and Senator Chuck Grassley, that would be evaluating the safety of drugs, or at least for this week, one drug. And their action set off a great deal of reaction.
With an unusual Saturday press release, the Senate Finance Committee carried news of the release of a committee staff report on a two-year committee inquiry on the GlaxoSmithKline's drug Avandia. The inquiry was begun after a 2007 publication in The New England Journal of Medicine authored by Dr. Steven Nissen, who was widely discussed as a possibility for FDA Commissioner in 2008. The publication in 2007 resulted in a Congressional hearing on the House side and, as I wrote at the time, where some members of Congress on the Committee were questioning whether the publication and the hearing were designed to protect public safety or to provoke a political reaction. After the hearing, the FDA held a meeting of the Endocrinologic Drugs Advisory Committee about the subject. That all happened in 2007.
Back to 2010 – the Senate Finance Committee chairs have sent the report to the Food and Drug Administration with a cover letter that outlined concerns regarding the drug in question and asking how FDA would handle the findings from the report.
That caused several reports in the media accompanied by some sensational headlines – some of which suggested Avandia is dangerous, while others reassured patients to stay on Avandia if they are currently taking it. Nice public health outcome there – thanks Congress. This, by the way, is a repeat of the news and types of headlines from 2007.
Back to 2010 again, after the release by Senate Finance, the manufacturer, GlaxoSmithKline put out not one, but two press releases. One entitled "GSK Rejects Conclusions of Senate Finance Staff Report on Avandia" and one entitled "GSK Rejects Conclusions Reported in New York Times Story on Avandia". Further regarding the matter, the company used the message platform of its blog, More Than Medicine, to issue a rebuttal to the media on several counts.
Then the FDA finally spoke. The agency put up an updated safety announcement about Avandia on its Web site and announced that there would be a meeting of the Endocrinologic Drugs Advisory Committee in July 2010. The agency also provided an update using MedWatch. The entire pattern of events evokes 2007.
But think about it. It is an unusual turn of events. One would normally think of the communication about safety research on a drug coming first from the agency that regulates it, then from the company, and then perhaps from some key stakeholders, such as policymakers. This one unfolded in the opposite manner. Why?
There is no question that there is a role for Congress to have oversight over federal agencies as attested to by the vast number of reports that are issued each year by the Congressional Research Service and by the General Accounting Office. But these reports examine systems – how well they function and how they might be improved. They don't tend to examine the handling of individual matters. It would have been more seemly that, rather than focus on the FDA's handling of an individual drug though reports and hearings, Congress examine the entire post-marketing structure and how the agency makes decisions to continually examine the safety of drugs once they are approved. That would have resulted in a systemic evaluation where the issues and options could be rationally discussed and reform suggested. It would have been a prudent approach.
Here, however, that is the case here. In this case, Congress has focused on a single compound and how the agency has handled it. It is not the first time, as this appears to be a near repeat of 2007 – it is deja vu all over again.
But the focus on a single compound is perhaps unseemly given the outcome – headlines offering a range of conflicting conclusions so that a patient – a diabetic patient – might have reason to be both frightened and confused. Beyond all the substantive issues raised by the investigation, one has to wonder whether in driving this investigation in this manner, members of Congress have indeed acted in the best interests of public health.
And when one is forced to raise such a question, the investigation itself becomes the subject of an investigation.
Given the FDA’s poor track record on informing and protecting Americans, they need to be sidestepped in safety reports as proof of their ineptitude. FDA retaliated against Dr. David Graham when he blew the whistle on FDA’s downplaying and concealment of Vioxx side effects (they may do likewise regarding his Avandia stance), yet the agency persists in the same pattern.
Part of being adult is making informed decisions. It is worth knowing the dangers of a drug (without vilifying or demonizing it entirely, since almost all drugs have medicinal value) in order to determine the wisdom of using it. If FDA would do its job in promoting safety (including the enforcement of post-marketing requirements and assessment) in the first place, Congress wouldn’t need to substitute as the reporter of safety info.
The FDA doesn’t simply bungle toward the end of the approval process- it has a history of failing to protect Americans from the beginning of the drug approval process. FDA knowingly accepted a fraudulent safety study when it approved Ketek, resulting in several patients experiencing liver failure.
Hopefully, this individual investigation will prompt reform of the FDA, including its post-marketing structure.
This is unbelievable – what else does Congress want to control??
Stephanie
I see serious similarities in this and in the more recent Congressional reaction to Toyota miscues (I’m not downplaying the Toyota quality mistakes, just Congress’s reaction); it’s a lot easier for members of Congress to grandstand and point fingers than it is for these same members to actually work together to solve problems.
Given that we have an election coming up in November, grandstanding seems to have more appeal and PR associated with it than rolling up the sleeves and hammering out compromises and dry as dust details.
That said, Mark’s raised a good question – why was the information on the drug taken by Nissen to the Hill?
One possible reason is based on the self-interests of those involved.
First, it is easier for someone with a potentially dramatic story to tell to get Congress interested (see grandstanding above) than to get FDA interested. Any review of these types of serious safety considerations inevitably cast aspersions on the FDA personnel involved in the original approval of the drug. Thus, listening to these types of complaints is – ironically – not in the interest of some folks within the agency.
Conversely, giving the issue publicity and pointing fingers is in the interest of Congress; that’s less real work with the potential for accountability that the members will actually have to do.
Thus, listening requires more real work and accountability from FDA, listening requires less real work and accountability from Congress. And so I think Nissen found a far more favorable, albeit unaccountable, audience in Congress.