Sen. Charles Grassley (R-Ia.) has been on a tear lately, badgering the Food and Drug Administration about whether it’s doing enough to crack down on financial conflicts of interest among doctors who participate in clinical trials to test new medicines. Grassley suggests that the payment of consulting fees to doctors could create a “potential bias that may compromise the reliability of data” generated to support the approval of drugs and medical devices.
While collaborative arrangements between medical products manufacturers and academic researchers has in fact been a huge boon for medical progress during the past half century or so, and financial connections are not the only source of relevant bias, it’s not entirely unreasonable to be alert to possible conflicts of interest. What’s hypocritical about Grassley’s crusade is that he only seems to be concerned about financial conflicts of interest when they’re used to condemn products he doesn’t happen to like.
Take, for example, Grassley’s partnership with Cleveland Clinic cardiologist Steven Nissen and their joint campaign against the GSK diabetes drug Avandia. There’s been a fair amount of news over the past couple of years describing the controversy over Avandia (see here, here, and here for examples). The drug appears to work wonders for the treatment of Type II diabetes, but research conducted by Dr. Nissen indicates that it also leads to a significant elevated risk of cardiovascular events, such as heart attack and stroke. Nissen was a key source for a February 2010 Senate Finance Committee report condemning Avandia, which was instigated by Grassley, and both men think that Avandia should be pulled from the market. They would have gotten away with it too, except that lots of patients actually taking the drug have decided that the huge health benefits associated with controlling their diabetes far outweigh the higher cardiac risk. They demanded to have continued access to the drug. So, last month, FDA decided to keep Avandia on the market, but place heavy restrictions on its use. Nissen said that “more than 99 percent of Avandia use in the U.S. will disappear” because of the restrictions.
So, where’s the hypocricy? It turns out that Nissen just happens to be one of the investigators on a study purporting to show that Avandia’s closest competitor, Takeda Pharmaceutical’s drug Actos, is superior to Avandia because it doesn’t increase cardiac risk. And, as it turns out, Takeda provided $25,000 in funding to Nissen’s Cleveland Clinic team to conduct the Actos study. As my 5-year-old son, who is newly taken with episodes of the classic cartoon Scooby-Doo, might say … “Ruh-Roh!” The golden boy, upon whose research Grassley’s crusade against Avandia has been built, has taken funding from a GSK competitor to conduct research that boosts Actos over Avandia. Can you say “conflict of interest”, boys and girls?
Now, just to be clear, I want to explain that Steven Nissen is a highly regarded scientist, and there appears to be no good reason to believe his research on Avandia or Actos has actually been biased by the funding from Takeda. (Although the kind of meta-analysis Nissen used to study Avandia has inherent methodological weaknesses that make the findings suspect. But that’s an argument for another day.) So, it’s not entirely inappropriate for either the FDA or Charles Grassley to listen to what Nissen has to say. But, for someone like Chuck Grassley who’s been riding a hobby horse against financial conflicts of interest in the pharmaceutical industry, the arrangement ought to have come under a bit more scrutiny.