Wednesday, March 21, 2007

More on Financial Entanglements of Physicians and Health Care Academics

We have written extensively about physicians' and health care leaders' financial entanglements with other health care organizations. This week, several important articles providing new insights into this problem appeared.

First, the Journal of the American Medical Association, (JAMA) published an article about pharmaceutical payments to physicians in two states. [Ross JS, Lackner JE, Lurie P et al. Pharmaceutical company payments to physicians: early experience with disclosure laws in Vermont and Minnesota. JAMA 2007; 297: 1216-1223. ] Vermont and Minnesota, as well as several other states, have laws in place requiring pharmaceutical companies to report payments made to physicians for a variety of purposes, and the information from these reports is supposed to be made public.

The main lesson from this study was that problems with the laws and how they were operationalized meant that the data they provided about financial interactions between physicians and the pharmaceutical industry was very incomplete. Ross and colleagues only were able to get access to some of the pharmaceutical companies' reports, and with considerable difficulty. It took considerable negotiation to obtain computerized information from Vermont. Minnesota's records were available, but only in the form of paper forms that the investigators had to laboriously copy. Then they found that considerable data was missing or incomplete. Some companies failed to provide any data during particular years. The Vermont data was linked to specific payment recipients in only a few instances. Finally, it turned out that Vermont allowed companies to withhold information about payments to physicians as "trade secrets."

Even so, what data was available suggested that considerable numbers of physicians have substantial financial interactions with pharmaceutical companies. Based on the Minnesota data, which provided information about individual recipients, 14% of physicians with active medical licenses received payments from pharmaceutical companies of at least $100. Although the median number of payments to individual physicians was one, the range was from 1 to 88. the median amount was $1000, but the range was $100 to $1,178,203.

The JAMA article was accompanied by a commentary [Brennan TA, Mello MA. Sunshine laws and the pharmaceutical industry. JAMA 2007; 297: 1255-1257.] Note that one author, Dr Brennan, is currently a full-time executive with a commercial managed care organization, Aetna Inc. Nonetheless, the commentary provided some important summary points.

What these investigations have found is discouraging. First, numerous payments to physicians exceeded the $100 limit that has been suggested by the American Medical Association. Because this amount was also endorsed by the major pharmaceutical industry trade group, the finding undermines faith in industry self-regulation. Second, and worse, there are many holes in the reporting.

Nonreporting undermines hospitals' and medical societies' own efforts to police conflicts of interest among physicians.

Most importantly, efforts to circumvent the law make the drug companies look silly at best and arrogant at worse. To call small payments to individual physicians 'trade secrets' or offer 'doctor' as the name of a recipient can only create mistrust.

To be clear, for-profit industries do not share the same ethical norms to which physicians and other health care professionals must adhere. Their primary commitment is to create shareholder value, not maintain an altruistic commitment to patients. But at some point the leadership of the pharmaceutical industry and their boards of directors must begin to recognize that growing public and professional mistrust could substantially detract from that value.

Finally, the New York Times did its own analysis of the Minnesota data. It focused on a few academic physician leaders who had substantial financial entanglements with the pharmaceutical and biotechnology industry. First, Dr Allan Collins:

Dr. Allan Collins may be the most influential kidney specialist in the country. He is president of the National Kidney Foundation and director of a government-financed research center on kidney disease.

In 2004, the year he was chosen as president-elect of the kidney foundation, the pharmaceutical company Amgen, which makes the most expensive drugs used in the treatment of kidney disease, underwrote more than $1.9 million worth of research and education programs led by Dr. Collins, according to records examined by The New York Times. In 2005, Amgen paid Dr. Collins at least $25,800, mostly in consulting and speaking fees, the records show.

In an e-mail message, Dr. Collins said he personally received in 2004 less than $10,000 from Amgen for educational presentations. 'The contract amount of $1.9 million from Amgen was paid to the Minneapolis Medical Research Foundation (MMRF) for the research contract, on which I am the designated senior researcher,' Dr. Collins wrote. He wrote that he did not work for or serve on the board of directors of the foundation. Dr. Collins discloses on his Web site and research papers that he is a consultant to Amgen, among other companies.

Dan Whelan, an Amgen spokesman, said the company paid the Minneapolis Medical Research Foundation 'to conduct sophisticated research and data analyses that have enhanced the understanding of health care delivery' for kidney patients.

Then Dr Richard Grimm

This list of top doctors in Minnesota includes Dr. Richard Grimm of the Berman Center for Outcomes and Clinical Research in Minneapolis, who has twice served on government-sponsored hypertension panels that create guidelines about when to prescribe blood pressure pills. Last year, he served on a National Kidney Foundation panel that wrote guidelines about when kidney patients should be given cholesterol pills.

Between 1997 and 2005, Dr. Grimm earned more than $798,000 from drug companies, according to records. In 2003 alone, Pfizer paid Dr. Grimm more than $231,000. Pfizer markets Lipitor, a cholesterol drug that last year had $12.9 billion in sales, more than any other drug in the world. It also markets Norvasc, a hypertension drug that last year had $4.9 billion in sales. Guidelines that suggest greater use of these drugs would be a huge boon to Pfizer.

'Drug companies are like lions,' Dr. Grimm said of his sponsored talks. 'For lions, it’s their nature to kill zebras and eat them. For drug companies, it’s their nature to make money. They’re not really trying to improve anybody’s health except if it makes them money.'

'On your side, you’re making a bit of money, but you’re also trying to educate the doctors. And in my view, the doctors need a lot of educating.'
Finally, Dr Donald Hunninghake:

Dr. Donald Hunninghake served on a government-sponsored advisory panel that wrote guidelines for when people should get cholesterol-lowering pills. The panel’s 2004 recommendations that far more people get the drugs became controversial when it was revealed that eight of nine members had financial ties to drug makers. The full extent of those ties have never been revealed.

In 1998 alone, Pfizer paid Dr. Hunninghake $147,000, and he earned at least $420,800 from drug makers between 1997 and 2003. He left the University of Minnesota in 2004 to become a full-time industry consultant. He is now retired.

'Most of my talks did not relate to drugs but the guidelines for treatment,' Dr Hunninghake said.

The Times article also quoted a number of critics of the financial relationships between drug companies and some doctors and academic medical leaders.

'When honest human beings have a vested stake in seeing the world in a particular way, they’re incapable of objectivity and independence,' said Max H. Bazerman, a professor at Harvard Business School. 'A doctor who represents a pharmaceutical company will tend to see the data in a slightly more positive light and as a result will overprescribe that company’s drugs.'


'The vast majority of the time that we did any sort of paid relationship with a physician, they increased the use of our drug,' said Kathleen Slattery-Moschkau, a former sales representative for Bristol-Myers Squibb and Johnson & Johnson who left the industry in 2002. 'I hate to say it out loud, but it all comes down to ways to manipulate the doctors.'

Jamie Reidy, a drug sales representative for Pfizer Inc. and Eli Lilly & Company who was fired in 2005 after writing a humorous book about his experiences, said drug makers seduced doctors with escalating financial inducements that often start with paid trips to learn about a drug.

'If a doctor says that he got flown to Maui, stayed at the Four Seasons — and it didn’t influence him a bit? Please,' Mr. Reidy said.

The lectures earn doctors more than cash.

'You’re making him money in several ways,' said Gene Carbona, who left Merck as a regional sales manager in 2001. 'You’re paying him for the talk. You’re increasing his referral base so he’s getting more patients. And you’re helping to develop his name. The hope in all this is that a silent quid quo pro is created. I’ve done so much for you, the only thing I need from you is that you write more of my products.'

A few of the doctors who took drug company money admitted it was for marketing purposes.

Drug companies 'want somebody who can manipulate in a very subtle way,' said Dr. Frederick R. Taylor, a headache specialist in Minneapolis who earned more than $710,000 between 1997 and 2005, much of that from GlaxoSmithKline, the maker of the migraine drug Imitrex.

Dr. George Realmuto, a psychiatrist from the University of Minnesota, said most of the marketing associated with his lectures was packaged around his talks.

'It’s at a wonderful restaurant, the atmosphere is very conducive to a positive attitude toward the drug, and everyone is having a good time,' said Dr. Realmuto, who compared the experience to that of buying a car in a glitzy showroom. He earned at least $20,000 between 2002 and 2004 from drug makers.
As the man says, read the (several) whole things.

These articles collectively add to our information about the pervasiveness of conflicts of interest within the health care system.

In summary, physicians or other health care academics who take money from drug (or biotechnology, or device or other health care) companies ought to disclose who paid them, how much, and for what whenever they speak, write, or otherwise attempt to communicate about any subject relevant to the companies' vested interests. Failing to do so means they are participating in deceptive marketing practices.

If disclosure might be uncomfortable, then perhaps that discomfort is saying something about the nature of the relationship created by the payments received.

A better solution might be for individual physicians and health care academic to forego all individual payments from commercial firms with vested interests related to the individuals' clinical and academic work. For this to work, of course, medical schools and academic medical centers would have to stop putting so much pressure on their faculty to bring in external funding, whatever the source, and whatever the ostensible reason, used by the institutions for whatever the purpose.

Meanwhile, physicians and the public need to look very hard to see if what people in academic medicine are saying is based on the their clinical and academic expertise, or their financial relationships with commercial firms with vested interests in having these communications come out a certain way.

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