Undisclosed conflict of interest in the FDA review process

A report from the WSJ this week detailed the fact that FDA reviewers had significant and undisclosed financial ties to industry. I found this discovery remarkable, especially the undisclosed part.

But perhaps more remarkable was the lack of reaction it created. The article has only 39 comments, paltry numbers of Tweets and FB shares and little buzz on social media. That seems weird. These are FDA reviewers. The FDA follows their advice in the majority of cases. These people have great influence; millions of patients depend on them.

The WSJ article said, “a third of 122 members had received compensation—such as money, research grants or travel and food—from medical-device companies.” But the FDA “disclosed roughly 1% of these corporate connections.”

There is a lot of talk these days about conflicts of interest in healthcare. In clinical medicine, pens with logos have been banned, and gifts of bagels and burritos must be disclosed. At medical meetings and in scientific journals, industry ties must be displayed prominently. In September of this year, the first release of data from the Sunshine Act showed doctors and hospitals received $3.5 billion from drug firms. It isn’t easy but you can find my conflicts.

The aim of these efforts is transparency. Gifts, however small, have an effect. I can, for instance, look at a patient’s medicine list and tell whether her doctor has been influenced by marketing and hype. The presence of brand-name drugs is the give away. But these are just single doctors taking care of single patients.

Think of the influence at the level of the FDA review committees.

One recent example comes to mind. It’s in Europe, but it also could happen here. The procedure called renal denervation, which is ablation (burning) of nerves in the kidney, was supposed to control high blood pressure. Early data showed it had striking effects. But the early data came from poorly controlled studies with small numbers of patients, among other problems. It was flawed data.

Yet the European equivalent of the FDA sanctioned the device and the procedure. Thousands of patients underwent the invasive procedure across Europe. Then, this spring, a large well-controlled, multi-national trial found that the procedure did not work. The reversal was a shocker to the medical community. Most of the discussion centered on the science itself. There was little talk about the thousands of patients who underwent unnecessary kidney burns.

I am not suggesting the European agency made this mistake because of industry influence, but you could see how it is possible. If pens with logos can influence a practicing doctor, surely big dollars can influence reviewers.

Dr. David Kandzari is a well-known leader in cardiology. He is involved with clinical research, and as such, has industry relationships. He also serves as an FDA reviewer. Here is his quote in the WSJ piece:

“I’ve never sat there on a panel and thought, ‘I wonder what my friends at companies X, Y and Z would say.’ I just don’t view it that way.”

How do you interpret this statement? To me, it sounds akin to the doctor who says pens and burritos don’t affect him. Maybe they don’t, but why else would there be pens with logos and free burritos?

I exchanged emails with a respected colleague about this issue. He doesn’t see much bias in the FDA review process. He made the point, a good one, that it’s hard to find qualified experts who haven’t had collaboration with industry. Then he sent me a huge file of one recent transcript of an FDA review. “Look at the transcript here and see if you can see any bias,” he said.

And that is the point, isn’t it?

You can’t see bias. It’s invisible; it’s in our human consciousness.

It seems reasonable, therefore, that if bias can’t be seen or eliminated, the potential conflicts that lead to bias (e.g. dollars) should be disclosed.

JMM