Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs

Does Steve Nissen, an outspoken critic of inappropriate industry influence in medicine, have his own conflict of interest problem?

This week Nissen, the chief of cardiology at the Cleveland Clinic, was widely quoted in news reports about the FDA advisory panels evaluating two new highly promising cholesterol drugs from Amgen and Sanofi/Regeneron.

Nissen was broadly supportive of the drugs. Although he has been one of the leading voices against approving and using drugs based solely on their effect on surrogate outcomes, he was much more liberal about these drugs than some other experts and many of the panel members. According to CNBC:

“I am somebody who generally is opposed to approving drugs on the basis of surrogate endpoints without the outcome data,” Nissen said by telephone Wednesday, referring to lowering of LDL cholesterol already shown by the medicine. “However, in this case, I actually support approval and I actually think the concerns of the committee are not on target.”

On the NBC Nightly News program he was even more effusive:

These drugs are breakthrough drugs, they are blockbuster drugs that are very likely going to have a big impact.

But it wasn’t always clear in these and some other news reports that Nissen may not be an entirely objective observer. NPR reported that, “for the record, he is leading a study of one of the drugs and is on the steering committee for a Pfizer clinical trial. He takes no money from the companies.”

A New York Times report included a fascinating detail. Prior to the actual FDA panel Nissen, along with other leading cardiologists, participated in a mock panel hearing in Amgen’s offices. Nissen, writes Gina Kolata,

…said he felt a bit uncomfortable agreeing and refused compensation. But he said he wanted to push the company on the quality of its data on the drug.

“I asked the kind of hard questions that should be asked,” he said. He added that he and others pressed on the effects of a very low LDL level. “We tortured them over it,” he said. In the end, he said he was convinced that from what was known to date, there was no evidence yet of harm and reason to hope for benefit.

But it is not clear in the Times article that Nissen is the chairman of a multi-million dollar study of Amgen’s evolocumab (Repatha). Nissen doesn’t receive any money directly from Amgen but his work brings millions of dollars to the Cleveland Clinic.

I asked Nissen for his policy about disclosing these conflicts. Here’s his response.

I am always completely candid with reporters about these issues.

I have a simple rule. I just don’t accept income for consulting or any other reason from “for profit” companies.

All sites that do clinical trials, whether they are a coordinating center or an enrolling center are reimbursed for their direct expenses in conducting clinical trials. The Cleveland Clinic is a non-profit entity and is not allowed to engage in “for profit” activities. I am not involved in negotiating services between industry and the Cleveland Clinic for studies in which I participate. I do not even see the budgets. I address the science exclusively.

But I think this deserves closer examination. In addition to his position against surrogate endpoints Nissen is well known for calling attention to conflicts of interest in medicine. Over the years Nissen has repeatedly stated that he doesn’t take any money directly from industry and that when he does consult or perform other services for industry he directs the money to nonprofit organizations. I think it should be pointed out that in the academic medical world running clinical trials confers prestige, power, and, the ultimate academic currency, publications. I’ll leave it to finer minds than my own to determine how this weighs on the COI scale but it seems to me that at the very least this is a COI which should at least be fully disclosed to reporters and that reporters should include this information in their stories.

I don’t want to be misunderstood here. I don’t want to attack Nissen or suggest that he shouldn’t play a role in the public discussion about drugs. There’s a reason journalists turn to Nissen for quotes. He’s as smart as they come and he knows how to explain difficult scientific concepts in accessible language. I don’t think there’s any reason that journalists shouldn’t use him as a resource. But they should be aware that Nissen, like others, is not perfectly objective, and it is only fair for readers to be aware of the full context of his statements.

Source: Forbes