Monday, October 13, 2008

The Nemeroff Case vs the Anechoic Effect

The saga of Dr Charles Nemeroff was most recently discussed on Health Care Renewal here and here. We had first posted about his failure to disclose relevant conflicts of interest relating an article he wrote for a journal he also edited here. Other posts about Nemeroff's questionable behavior are here, here. Nemeroff has also starred in numerous posts on the Clinical Psychology and Psychiatry Blog, amongst others.

Now the tale of how Nemeroff raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while he ran a US government funded project meant to evaluate some of the products of his commercial sponsors, has splashed across major newspapers. There has been a lot of good discussion about the case in the blogsphere. (We await, of course, discussion in scholarly medical and health care journals, if it ever appears.)

I am a bit surprised that, in defiance of the anechoic effect, this case has now inspired some pithy commentary in the editorial pages of major media outlets. Particularly vigorous was Judith Warner writing admittedly for her blog, but a blog sponsored by the New York Times.

Yet the story of Nemeroff, who earned $2.8 million in fees from 2000 to 2007, and had at one point consulted for 21 drug and device companies simultaneously, wasn’t really a departure from the news of the week – or of this whole benighted era – at all.
It was, rather, yet another iteration of the ever-unfolding saga of greed and how the deregulation of absolutely everything has brought our country to this painful season of reckoning. Because Nemeroff’s story – which is hardly unique – belongs uniquely to this time in our nation’s history.

It is a product of legislative and cultural changes that have altered the practice of medicine, the work of research universities and the relationship between those universities and industry. And it is marked, like so much of what’s gone off the rails in our era, by the failure of our government to step in to protect citizens.

Nemeroff didn’t bring down any banks, didn’t freeze the American credit markets, hasn’t plunged the world economy into recession. But his extensive, excessive and untransparent ties to the pharmaceutical industry are all too common, unfortunately, among his cohort of 'thought leaders' in psychiatry and other medical specialties. And these relationships have led to a dangerous crisis of confidence in the basic integrity and validity of America’s medical research.

Her discussion of the history behind the Nemeroff case is of interest,

How did all this happen?

It’s a familiar story: About three decades ago, it became possible to make serious money as a university researcher. Not that the money was so bad before, of course. It was respectable. But it wasn’t Wall Street-type money.

That changed in the early 1980s with the passage of legislation that allowed universities to patent their publicly funded research results and then grant exclusive licenses to pharmaceutical companies. The public-private wall came down. The universities received royalties on the drugs, and the royalties were split between the researchers and the departments. Start-up companies were spun off and sold. University researchers became, essentially, partners to industry.

The change wasn’t just structural, however. There was a cultural shift, a kind of boundary melt.

'Greed became respectable,' Angell, a professor of global health and social medicine at Harvard Medical School and the former editor in chief of The New England Journal of Medicine, recalled. 'There used to be a sort of tension between doing well and doing good for medical researchers. If they wanted to make a lot of money in a high-risk sort of job they could work for industry. If they wanted to do important, exciting research they stayed in academia and they had a comfortable life but not great wealth.'

'Before 1980, they were aware of this tension,' she said. 'Before 1980, those who went into industry were held in some disdain. With Reagan, all this changed. There was a strong feeling that the world divided into winners and losers. In medical research this just has had enormous implications.'

It’s had enormous implications for our world generally. On Wall Street, change had to come via catastrophe. Let’s hope it won’t take a disaster to bring sense back to medicine.

We have said similar things on Health Care Renewal.

I must add, however, that I think the cultural change went beyond just making greed respectable. It also somehow made deception respectable, even in the context of academic institutions that are supposed to be about discovering and disseminating the truth. So it not only became acceptable for top academics to earn hundreds of thousands in consulting fees and honoraria for talks. It became acceptable for those academics to give their talks and write articles while cloaked in their academic respectability, and without revealing that they were being paid extremely generously by drug marketers to help them hawk drugs. It became acceptable for these academics to let drug, biotechnology and device companies tell them how their clinical research would be designed, implemented and reported, but the academics still took credit for being pretend "principal investigators," and "first authors." It even became acceptable for academics to let these companies make the slides for their talks, and provide ghost-writers for their articles, but the academics still acted like they were speaking their own words of wisdom, rather than signing off on pitches authored by marketers.

Also, an unsigned editorial in the New York Times declared,

We’ve long feared that the integrity of medical research is being eroded by conflicts of interest and manipulation of scientific data. Still, it was disheartening to learn that one of the nation’s most prominent psychiatrists has taken large, undisclosed payments from a drug company whose products he evaluated and that another company manipulated studies to make a drug look far more beneficial than it actually is.

It also linked the Nemeroff case to the allegations that Pfizer marketers manipulated the reporting of clinical research to make it appear more favorable to their drug, Neurontin, as we discussed in this post.

In addition, an editorial in the Atlanta Journal-Constitution began to suggest solutions,

It now seems pretty clear that researchers at major universities — including the head of psychiatry at Emory University — failed to properly disclose their financial ties to drug companies. And evidence of that failure suggests academic medical centers are not capable of policing their faculty’s potential conflicts of interest.

These recent disclosures are more evidence that the requirements for reporting payments from the drug industry — in essence an honor system that relies on the researchers to tell their universities what they are earning — are simply inadequate. At a minimum, Congress should approve Grassley’s proposal requiring annual disclosures by companies of payments of $500 or more to researchers, a suggestion several pharmaceutical manufacturers have voluntarily adopted.

But much more needs to be done. The culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing. Disinfecting it may result in a temporary reduction in the amount of money going into research and continuing physician education. But in the long run, the nation’s medical schools will want to enhance the reputation of faculty members who are doing quality, independent research unencumbered by questions about whether they are protecting the lives of patients or protecting their own wealth.

This was echoed by an op-ed in the same newspaper by Peter Lurie and Jonas Hines from Public Citizen,

The problem is the notion that disclosure alone is a panacea for conflict of interest. Disclosure amounts to an evasion of responsibility because the consumer of the disclosed information then becomes responsible for interpreting it. Is a talk by a presenter who has received $30,000 from a sponsor twice as tainted as one by a presenter who has accepted $15,000?

Certain relationships are so egregious that no amount of disclosure will suffice. For instance, investigators in clinical trials should have no direct financial interest in the products they are investigating.

There should also be a low ceiling on total external payments to academics. What assurance did Emory have that Nemeroff was fulfilling his responsibilities as department chair if he was continually jetting off to extol Paxil’s virtues?

Congress is considering bills that would create a database of drug and device companies’ payments to physicians. But the legislation has been watered down to garner support from drug companies and organized medicine. Meanwhile, some leading medical schools, such as the universities of Pennsylvania and Massachusetts, are taking the initiative, implementing stringent policies that restrict the relationships between physicians and industry.

But these efforts remain voluntary and compliance is likely to be spotty. To restore public trust, doctors will have to “just say no” to drug company trinkets, medical schools should keep companies out of clinics and insulate company-funded research from meddling, and government must develop policies that stamp out the worst excesses. Mere disclosure will not suffice.

On the other hand, the President of Emory University wrote,

The federal government has ... long understood the importance of well-managed collaboration between private industry and the academy. From such collaborations have come many of the biomedical discoveries that have improved human life and alleviated suffering in the past 20 years.

It is also essential, however, to manage properly any conflicts of interest that might jeopardize the scientific validity of the results of these collaborations.

As we have said before, requiring full and detailed disclosure of conflicts of interest affecting physicians, medical academics, and health care decision makers would begin to make the public and the medical profession aware of the magnitude of the conflicts of interest problem. What should be disclosed is not merely the existence of a relationship, but the size of payments and the nature of the activities that were done to earn that payment. Even for a simple talk, it is very different for someone to say, for example, "This talk was supported by GSK," than to say, "I was paid $3500 plus all expenses by the marketing department of GSK for this talk meant to help market Paxil." Given the fragmentary nature of the disclosure now usually made, it is particularly outrageous when influential figures in health care fail to provide even limited information.

That being said, I fully agree (and have said before) that even full disclosure is not a way to adequately "manage" many conflicts of interest. Disclosure does not remove the subconscious influence and confusion that conflicts may create, especially conflicts involving substantial sums of money. In fact, there is evidence that disclosure may give some of the conflicted a license to slant their speech and writing even more heavily (see this post). There is also evidence that people who receive disclosures do not know how to interpret them, and may fail to allow for the degree of influence the disclosed conflict may have on the conflicted.

So I agree that we ought to put an end to most of the financial relationships between health care academics whose teaching could sway audiences to use specific products and services, and who do research evaluating specific products and services, and the companies who supply those services and manufacture those products. Although it is true that collaboration between academics and industry can yield innovation, one can collaborate without being paid off by one's collaborators. As long as academics are paid on the side for nebulous consulting work and to give talks for "education" arranged by marketers, trust in them as finders and disseminators of truth will continue to erode. That is bad for academics, bad for health care, and very bad for patients.