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’m 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 completely everything has brought our country to this painful season of reckoning. Because Nemeroff’s story – which is hardly one-of-a-kind – 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 perilous 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 allow 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. Begin-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 stated. ‘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’ve stated 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 massive, 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 current disclosures are more evidence that the stipulations for reporting payments from the drug industry — in essence an honor system that relies on the researchers to tell their universities what they’re 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 recommendation 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 might result in a temporary reduction in the amount of money going into research and continuing doctor 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 prone to be spotty. To restore public trust, physicians 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’ve said before, requiring full and detailed disclosure of conflicts of interest affecting physicians, medical academics, and health care decision makers would start to make the public and the medical profession aware of the magnitude of the conflicts of interest problem. What should be disclosed isn’t 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 easy speak, it is very different for someone to state, for example, “This speak 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 might 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 don’t know how to interpret them, and might 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’s bad for academics, bad for health care, and very bad for patients.

[Source : Health Care Renewal]

The Wall Street Journal Health Blog recently reported about some New York City hospitals worried about the current financial/ economic crisis, but for interesting reasons:

To give you a sense of how the crisis on Wall Street is affecting New York hospitals, we need only provide the names of some financial execs who are on the board and donor list of of New York-Presbyterian Hospital.

The chairman of the board is John Mack, Chairman and CEO of Morgan Stanley — you know, that large investment bank that just scrapped its business model? Serving alongside him was Richard Fuld, CEO of Lehman Brothers, the one that’s now reorganizing under bankruptcy protection. Another board member is John Thain, CEO of Merrill Lynch, which is selling itself to Bank of America. The hospital’s chairman emeritus is Maurice “Hank” Greenberg, former chairman and CEO of AIG, the insurance titan effectively taken over by the government.

Hospital execs worry that now just might not be the time to call their friends on Wall Street to ask for donations.

I’ll make a bet that if one were to get lists of the top current and current former leaders of all the financial corporations that have just failed, one way or the other, in particular, Bear Stearns, Lehman Brothers, Merrill Lynch, Fannie Mae, Freddie Mac, and AIG, you would find quite a few who also have leadership positions (often as board members) of important health care organizations, both for-profit and not-for-profit. For example, we noted that the former CEO of Fannie Mae, James A Johnson, who was forced out after an accounting scandal that presaged the current plight of the company, was also a board member of UnitedHealth, and had approved the outlandish compensation given to now prematurely retired UnitedHealth CEO Dr William McGuire.

But the board members of a not-for-profit teaching hospital are not just supposed to be a group of the largest contributors. The board of directors or trustees of a not-for-profit institution provides the highest and final layer of oversight for the organization. Hospital executives are supposed to answer to, and are hired and fired by the board. The board has ethical, and in some states legal responsibilities to uphold the mission of the organization, and when making decisions for the organization, to put the mission and the interests of the organization ahead of personal interests.

So it seems reasonable that all the board members of not-for-profit hospitals should be devoted to the mission of the hospital, and the values that underlie it. Furthermore, it seems reasonable that all board members should at least either have substantial knowledge about the health care context, and/or have considerable intelligence and leadership capabilities.

However, the board of this one illustrious teaching hospital included four corporate executives who had no particular knowledge of health care. They’ve now been shown to have lead spectacularly failed corporations, corporations whose failures have contributed to what some people now call the biggest economic crisis since the great depression. This is not a great testament to the intelligence and leadership abilities of these former “masters of the universe,” although it is perhaps a testament to their capability to promote themselves.

So whoever is now responsible for leading the hospital, and beyond that, all those who are concerned about the reputation of the hospital and its ability to fulfill its mission should be wondering why in the world these people were on the board? Furthermore, they should be wondering what was and is wrong with the process that appointed such leaders to this level?

We’ve frequently discussed how leaders of health care organizations have often proved to be autocratic and “imperial,” ill-informed about health care, indifferent to the values of health care, isolated and insulated, self-interested, conflicted, or even corrupt. We have contended that such bad leadership is a major, but rarely discussed cause of what has gone wrong with health care.

That arrogant and over-paid CEOs of some of the most spectacularly failed financial corporations of this century were also leading one of the country’s (formerly?) great teaching hospitals states something major about what has gone wrong with the leadership of health care.

ADDENDUM (24 September, 2008) - the US Federal Bureau of Investigation (FBI) is now investigating four of the above firms, Fannie Mae, Freddie Mac, Lehman Brothers, and AIG, according to the New York Times.

[Source : Health Care Renewal]

Some of the issues most important to us at Health Care Renewal are how bad leadership and governance of health care organizations threaten physicians’ core values, and thus help fuel our continuous health care crisis of rising costs, decreasing access, stagnant quality, and demoralized health care professionals. These issues are not often discussed in the “main stream medical media,” but have been creeping in more often lately.

An important cri de coeur just appeared in the Cleveland Clinic Journal of Medicine, by Thomas F Lansdale III MD [Lansdale TF. A medical center is not a hospital. Cleveland Clinic J Med 2008; 75: 618-619. Link here.] Dr Lansdale dealt mainly with poor leadership of teaching hospitals that threatened the core clinical and academic mission.

The leadership was poor in that it was ill-informed about health care and its values, and perhaps incompetent:

Now the medical center, riddled with ‘centers of excellence’ instead of departments, answered only to administrators who cared nothing about medical education, except for the Medicare dollars they would lose if they cut the training programs. They spent enormous amounts of money marketing the centers of excellence, and they cut everything else to manipulate the bottom line.

Poor hospital leadership was abetted by poor leadership of accrediting agencies and insurance companies.

We struggled to keep up with the unending deluge of arcane demands from the accreditation organizations watchdogging our teaching efforts.

we capitulate to the for-profit insurance industry that informs us they won’t pay for day 4 of Mr. Jones’ hospitalization because he has failed to meet some arbitrary criteria in their manual.

The effects of the poor leadership were mediated through a stifling bureaucracy that ignored the health care and educational mission.

Nurses now cared for their patients by managing their own support staff, and spent much of their time entering useless information in the personal.

I couldn’t stand the management retreats in which we obsessed about ‘customer service’ while the waiting time in the emergency department ballooned to 12 hours because there were ‘no beds.’ There were plenty of beds, but no nurses to staff them.

Furthermore, as we’ve seen time and time again, managers were quick to suppress any criticism of their power.

I was marginalized when I protested the budget cycles bleeding out support of medical education in favor of the annual purchase of new scanners and surgical gizmos.

The results were:

Medical education slowly slipped from being a calling to folks like me, finally succumbing to bureaucratic lunacy. The pace of teaching and caring for acutely ill patients became intolerable.

The biggest casualty, of course, was the nursing staff. Underpaid, depleted of leadership and morale, they simply disappeared. They were replaced by agency nurses who worked their shifts and didn’t know the physicians or the patients.

We lurch toward doctor computer order entry, clinging to the false belief that software programs will prevent adverse drug reactions and delivery of the wrong perilous drug to the wrong patient. We understaff our pharmacies so that they can’t get the medications to the patients on time or alert us to our own prescribing errors. We burn out our nurses despite years of loyal service

So finally,

My real job is to do everything in my power to keep my patients out of the medical center. I walk the halls now and don’t recognize the institution I grew up in and came to love. Everywhere I look, I see not magic and promise, but dirt and danger.

I’m not a hospital guy anymore.

Read the whole thing, and weep.

So I get to say again: health care is reeling under poor leadership of increasingly large and dominant health care organizations, enabled by poor governance structures. We need to make health care governance more representative of its constituencies, accountable, transparent, and subject to ethical standards. We need health care leaders who are informed about health care and understand its values, are committed to the mission ahead of personal gain, and are unfailingly ethical and honest. Meanwhile, demoralized doctors and nurses succumb to foolish bureaucracy piled up by self-interested managers, and it is the patients finally who suffer the most.

[Source : Health Care Renewal]

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discussed an article in the British Medical Journal by Jeanne Lenzer about the increasing role that contract research organizations (CROs) are taking in clinical research. Particularly enlightening were the discussions of academic CROs, a species not previously much in the limelight. It seems that medical schools, academic medical centers, and even schools of public health, stung by the loss of industry sponsored research to for-profit CROs, have spawned their own line of extra industry friendly affiliates. It seems not-for-profit academic medicine is getting less and less distinguishable from their for-profit benefactors.

[Source : Health Care Renewal]

This week’s Journal of the American Medical Association (3 September, the paper version of which seems to arrive early at my house) is notable for having three commentaries on relationships among doctors, academic medicine, and industry. One, by David Rothman and Susan Chimonas, seemed rather optimistic, while two, by Dr Arnold Relman and by Dr Marcia Angell, were quite dark.

The latter [Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008; 300: 1069-1071. Link here when available] should be required reading for anyone who worries about the issues we raise on Health Care Renewal. Dr Angell provided an excellent summary of how commercial “sponsors” have come to dominate clinical research, and thus ensure that the resulting studies favor their vested interests. My only criticism of her summary of the data was that it may actually have been too optimistic. For example, Dr Angell focused nearly exclusively on pharmaceutical companies’ influence on research, while the problem is even more massive. Biotechnology companies, device manufacturers, and multiple miscellaneous commercial suppliers of health care goods and services also might influence research. Dr Angell’s admittedly extensive list of the kinds of relationships among researchers and industry (grant support, paid consulting, service on speakers’ bureaus and advisory panels, and stock ownership) was incomplete, leaving out, for example, the even more acute conflicts of interest generated by service on companies’ boards of directors and service as companies’ officers.

But those are quibbles. Most striking was Dr Angell’s summary:

Looking at this picture altogether, it would be naive to conclude that bias is only a matter of a few isolated instances. It permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information. This is the conclusion I reluctantly reached toward the end of my 2 decades as an editor of the New England Journal of Medicine, and it has been reinforced in subsequent years. Clinicians just don’t know anymore how safe and effective prescription drugs really are, but these products are probably nowhere near as good as the published literature indicates.

I’m afraid I must concur, and also agree with her summary of the effects of the substitution for valid clinical research of pseudo-evidence favoring the vested interests of “research” sponsors:

Physicians learn to practice a very drug-intensive style of medicine.

Doctors are also led to believe that the newest, most costly brand-name drugs are better to older drugs or generics, although there is seldom any evidence to the effect because sponsors do not usually compare their drugs with old drugs at equivalent doses.

Physicians learn to use drugs for off-label uses without good evidence of effectiveness.

Keep in mind that the same considerations apply to devices, so that physicians also learn to practice a test- and procedure-intensive style of medicine; are led to believe that the newest tests, devices, and procedures are superior to older ones without any evidence comparing the new to the old; and doctors learn to extend the use of tests, devices, and procedures far beyond what the evidence would support.

In addition, I agree with Dr Angell’s advocacy of an independent body that would administer all clinical trials of drugs. Dr Angell suggested it be an Institute within the NIH. I think it might be possible to form a not-for-profit body that would be independent of government that would do the same thing. Furthermore, that body, or another in parallel should also administer all clinical trials of diagnostic tests, devices and procedures, for analogous reasons.

Finally, Dr Angell urged academic investigators and their institutions to “be at the forefront of efforts to reform the system of clinical research and not leave it to the government and legal profession.” However, as Dr Angell previously noted, a majority of medical school faculty have financial ties to drug, device, biotechnology and other health care companies, as do a majority of department chairs. As we have noted, some top leaders of academic medicine serve also as top leaders of for-profit health care corporations (see this post), and other corporations whose products have profound effects on health, even tobacco companies (see this post). Many academic leaders make a small fortune working on the side for such companies. It might be too much to anticipate that such leaders would be at all interested in reforming a system that has so effectively lined their pockets. For better or worse, we may need a wholesale change in the leadership of academic organizations before we can anticipate any real cooperation from them in transforming clinical research from being mainly a marketing exercise to once more being real clinical science.

[Source : Health Care Renewal]