The Avandia Soap Opera Continues
Back in 1793 a noted English philosopher, William Godwin, wrote; “What ….can be more shameless than for society to make an example of those whom she has goaded to the breach of order, instead of amending her own institutions which, by straining order into tyranny, produced the mischief?”
Although not a perfect explanation between what’s going on between Steven Nissen, MD, the FDA, the US Senate Finance committee, GlaxoSmithKline (NYSE:GSK) and now the Journal of the American Medical Association (JAMA) it’s pretty close. In the current issue of JAMA released today there is an article by Dr. Nissen “Setting the RECORD Straight” and an accompanying editorial by Catherine DeAngelis, MD, MPH and Phil Fontanarosa, MD, MBA “Ensuring Integrity in Industry-Sponsored Research Primum Non Nocere, Revisited.”
In his article Dr. Nissen writes; “The documents released by the Senate include internal company e-mails that provide an extraordinary window into the conduct of industry-sponsored clinical trial. The implications of these e-mails and other documents released by the Senate have profound consequences for academic oversight of commercially sponsored clinical trials.” The article then goes onto to condemn GSK’s conduct and includes the following passage; “At this time, I was aware that the company had previously threatened and intimated an independent physician-scientist who criticized rosiglitazone, so I sought to protect myself by secretly taping the meeting, which is legal in Ohio.” (Highlighting added by Diabetic Investor.)
In their strongly worded editorial the authors write; “The Commentary in this issue of JAMA by Nissen describes a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial of rosiglitazone and reveals a situation in which concerns about preserving market share apparently trumped concerns about the potential for causing patient harm. Analyzing this situation and others involving misleading reporting and possible misrepresentation of industry-sponsored research has become only too common, and it appears that physicians functioning at several levels failed to put the well-being of patients first.”
Before we begin here a few very important points:
1. What GSK did here is indefensible.
2. It’s time to stop worrying about Avandia as the market has already spoken and use of the drug has declined dramatically already.
3. The only people happy about this whole situation are class-action attorneys.
4. The FDA is not blameless and should not be given a pass for the role they played in this controversy.
5. The use of meta-analysis should not be overlooked and is an equally important element of this controversy. As the old saying goes; “Liars figure and figures lie.”
What really disturbs Diabetic Investor is the belief somehow that Dr. Nissen is some type of hero for bringing this issue to light. Diabetic Investor has always found it interesting that the results of Dr. Nissen’s now famous meta-analysis were leaked to the media PRIOR to being published. While no one knows who actually leaked the story, this leak created a news feeding frenzy which ultimately hurt the millions of patients with diabetes and not just the ones taking Avandia. Keep in mind that Dr. Nissen in today’s article admits that he secretly taped meetings between himself and GSK officials as if this behavior is somehow ok because it just happens to be legal in Ohio. Wonder if Dr. Nissen bothered to find out why it is legal in Ohio and not in the other 49 states?
Diabetic Investor also finds the accompanying editorial slightly disingenuous and just as self-serving. In light of the recently passed healthcare reform legislation it’s pretty easy to blame the big bad pharmaceutical companies for every ill there is, including producing tainted research. Yet nowhere in the editorial or the article by Dr. Nissen is any mention made of the role the FDA played in this controversy. Nor did they make any recommendations as to how the FDA could avoid controversies like this in the first place.
What Diabetic Investor sees happening here is Dr. Nissen practicing the well practiced public relations strategy of shameless self-promotion, disguising himself as the champion of public safety protecting everyone from the big, bad pharmaceutical companies who only care about profits and not patients. JAMA has joined Dr. Nissen in this crusade pilling on the criticism. If this was a football game the referee would have thrown the flag and called the penalty already. But this isn’t a football game, this is the real world, and in the real world millions of patients were harmed and the physicians who treat them have been handcuffed.
Take a look at the result of the Dr. Nissen’s now famous meta-analysis, the FDA has added yet another series of requirements for new diabetes drugs. So not only does the drug have to control glucose levels, it must now pass another series of test to show that it does not increase adverse cardiovascular events. A noble goal, until you consider that patients with diabetes are already at greater risk of an adverse cardiovascular event just by the fact they have diabetes. It is also true, that it is difficult even when looking at the Nissen meta-analysis and resulting work performed since then to draw a straight line between Avandia usage and adverse cardiovascular events. What makes the FDA’s new requirements even worse is, companies are supposed to study their drugs in a high risk patient population where you are likely to find greater adverse events no matter what.
Will someone also explain to Diabetic Investor the continued assault on GSK? As Diabetic Investor already noted what GSK did was indefensible; however what possible purpose other than self promotion does it serve to continually dump on the company. Given the information that has become public a d the numerous class action suits already filed in the courts, GSK will pay a heavy financial price for their transgressions to go along with their already tainted reputation in the medical community.
Today patients face a world where it appears that no drug they take is safe which has lead to patients being more non-compliant with their therapy regimen. Based on how the FDA is proceeding it appears they are actively looking for reasons NOT to approve new drugs to fight diabetes. While even one death is tragic it appears we have lost all perspective and that all drugs no matter how long they are studied, no matter how many clinical trials are done do carry with them a degree of risk. They way things are going it seems as though if just one death or serious adverse event occurs a drug is condemned even though it could help millions of patients.
Diabetes is an epidemic that continues to place a huge burden on our economy and healthcare system. Along with diabetes comes a host of co-morbidities not just heart disease but blindness and kidney failure. It is a well known fact that a major factor as to why nearly two-thirds of all patients are not achieving control can be linked to therapy non-compliance. Simply put diabetes is the enemy and we need more, not fewer, options to fight this battle, a battle which by all measures we are losing.
Diabetic Investor believes it’s about time we move on from the Avandia controversy; stop playing the blame game and get on with the business at hand; finding more and better ways to combat this terrible disease. It’s pretty easy to kick someone while their down, it takes true leadership and wisdom to get beyond the blame game and work towards solutions to the real problem which is diabetes itself.