Another Key Opinion Leader Confesses

The Milwaukee Journal-Sentinel published another story in their series on physicians' entanglements with health care corporations. This one tells the story of a single university faculty member who was seduced by pharmaceutical companies, then eventually became disillusioned.

[Dr James] Stein, now a professor at the University of Wisconsin School of Medicine and Public Health, was a 29-year-old cardiology fellow in Chicago in 1994 when his faculty mentor asked him to fill in for him at a drug company-funded lecture to a large group of doctors.

It would be his first taste of life as a drug company speaker and consultant.

Stein got first-class airfare to Dallas. A limousine took him to a luxury hotel for the talk.

He walked off the stage, and a doctor from the conference handed him an envelope containing a $500 check.

'I got a pat on the back and he said, 'There's more where that came from, son.' I had no idea what that meant, but I went home and paid off part of my student loans,' Stein said in a presentation at UW this month.

Stein's first drug company talk led to more than a decade of work for drug companies before he gave it up for ethical reasons. Now he is speaking out.

Over the years, many of the big names in the drug industry would hire Stein to give speeches or serve as a consultant, eventually leading to fees of $2,000 to $3,000 per talk.

About a month after his first talk in 1994, Stein was asked by another drug company to give a lecture on cholesterol at a small hospital in Chicago, just as blockbuster statin drugs were coming on the market.

'I was really flattered because over and over again I was told that I was a future thought leader,' he said. 'I did my talk. I got a $750 honorarium and I was hooked.'

Stein said he now realizes that the speech at the hospital was just an audition.

'They wanted to know what I would say and how I would deliver,' he said. 'And I think they also wanted to know what I would say about their product.'

He joined speakers bureaus for several drug companies. It was a kind of badge of honor, he said. The more companies a doctor spoke for, the more highly he or she was regarded.

Stein, now 44, came to UW in 1996. Over the years, he would give talks and do other work for many of the top names in the pharmaceutical industry.

For instance, in 2005 Stein did work for six drug makers, according to a disclosure form filed with UW. That year, Pfizer paid him between $10,000 and $20,000 for four days of work as a speaker and advisory board member.

LipoScience, a firm that markets a cholesterol test, paid him $10,000 to $20,000 for four days of similar work.

Another firm, Schering-Plough, paid him about $12,000 for two days as a lecturer.

Although he said he had concerns about the propriety of his work, Stein said he was assured by his superiors there was nothing wrong with it as long as he did it on his own time. Indeed, they said it enhanced the reputation of the university.

And, he said, he considered himself an educator, not a salesman.

He said he tried to manage any conflicts of interest by disclosing who paid him, controlling the content of what he said and doing the work on personal time.

Things started to change rapidly beginning several years ago.

Drug companies began referring to the talks as promotional. They wanted him to use their slides; he refused. Then, medical journals and the lay press began printing articles questioning the ethics of the relationships.

A 2006 article in a Madison newspaper listed Stein as being among the UW doctors who reported the most money from the drug industry. Stein said he was embarrassed.

But, he said, he continued to try to manage his relationships with drug companies. He sent letters to patients disclosing his ties to industry. As of December 2006, he donated all the money from his talks to charity.

Why didn't he just stop doing the work?

He said he believed he could save more lives lecturing than by working in the emergency room. Stein said he saw no harm in being paid. But he admitted that giving the talks also made him feel important.

At the same time, new scientific articles suggested that it is impossible for doctors to be unbiased when they receive gifts or payments from drug companies.

'I have learned that human beings, physicians included, are incapable of recognizing bias in themselves, and even when you try not to be biased it is impossible to avoid it, especially when money is involved,' he said.

He said he came to realize that drug and medical device firms were no longer trustworthy partners in medical education.

He also said it has become obvious that patients have the least power and drug companies have the most power.

'I was wrong,' he said.

Stein said he stands by what he taught.

But, he added, 'I was naïve to think I was not influenced by the money and power of the drug and device companies.'

As of last December, he said, he stopped all drug company speaking and consulting other than bona fide research.

It is nice that a few commercially paid "key opinion leaders" have realized what they were really doing. Maybe, Dr Stein will follow in the footsteps of Dr Daniel Carlat, and try to atone for his previous role in drug marketing disguised as education. (See Dr Carlat's excellent blog here, and his now classic article, "Dr Drug Rep.")

This compelling narrative reinforces some points about relationships among physicians and health care corporations.

Health care corporations do not pay for nothing, and are not charitable organizations. If a company pays a physician to give talks, it is almost certainly because those talks will help market company products or services.

Pharmaceutical and device companies have argued that they only pay the best and the brightest physicians as speakers and consultants. But this story (and others, e.g. here) suggest that they recruit young physicians who seem to be malleable and likely to go along with the company line, and groom them to do marketing in the guise of education.

The company's money thus helps mold "key opinion leaders." Worse, at many medical schools, being a commercially supported speaker or consult was a badge of honor. Thus, faculty chosen by commercial firms as most tractable and sympathetic to the companies' viewpoints, came to be regarded as the best and the brightest.

Why getting money from commercial firms was regarded as indicative of honor and intelligence, rather than gullibility, naivete, or worse, is not clear. I wonder whether it correlated with increasing alignment of the leadership of medical schools with commercial interests, and domination of the very top leadership, that is, the universities' board of directors, by those formerly regarded as Masters of the Universe (but now often seen as stupid, arrogant, greedy, or even corrupt. See posts about how the boards of Dartmouth, Harvard, and Yeshiva were disproportionately populated by leaders of [faux] finance).

At any rate, this is truly a cautionary tale of seduction of academia into hucksterism.

Hat tip to Margaret Soltan at University Diaries.

ADDENDUM (30 April, 2009) - See also the comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Paying More for Worse Outcomes - the Wyeth/ DesignWrite/ University of Wisconsin Hormone Replacement Therapy Course as Microcosm

The Milwaukee Journal-Sentinel just published a remarkable investigative report about continuing medical education courses provided (after a fashion) by the University of Wisconsin. Here are the main points,

The course was created by a medical education and communications company (MECC), paid for by Wyeth

The course material was developed largely by DesignWrite, a New Jersey-based firm paid by Wyeth.

The company is being investigated along with Wyeth by a U.S. senator looking into the practice of ghostwriting in scientific articles as a way to market hormone therapy drugs.

Together, Wyeth, DesignWrite and UW formed the Council on Hormone Education - the name of the educational organization stamped on course material for the class.

Thirty-four of the 40 council member physicians have financial ties to Wyeth, including the course director, Julie Fagan, a UW doctor and associate professor of medicine.

The course put hormone replacement therapy (HRT) for post-menopausal women in a very favorable light, at a time when results from a prominent randomized controlled trial sponsored by the Womens Health Initiative (WHI) had just become available, suggesting that HRT does more harm than good:

Rigorous studies involving thousands of women showed that hormone therapy increases the risk of heart disease, stroke, breast cancer, blood clots and dementia. They also showed quality-of-life benefits are short-lived.

In May 2002, a major clinical trial that was part of the Women's Health Initiative was suspended because medical investigators were worried they were subjecting women to too much risk.

In the fall of 2002, just months after the health initiative was stopped, the Council on Hormone Education launched its first UW hormone therapy medical education course.

'There were millions of women impacted by that information, and physicians and women really needed to have that information,' said Doug Petkus, spokesman for Wyeth. 'We felt we were providing a service to them by helping them . . . understand the significance.'

Over the next several years, Wyeth poured $12 million into the course.

According to the first newsletter published by the Council on Hormone Education, the goal of the course was 'to develop and disseminate balanced, accurate, timely and consistent information about hormone therapy' so doctors could "better serve women."

Other newsletters, which included patient handouts and multiple-choice exams in the back for physicians, urged doctors to consider the bonuses of hormone therapy.

For instance, in a newsletter titled 'Menopause and Quality of Life,' Wyeth-funded researcher JoAnn Pinkerton wrote: 'Undesirable skin changes associated with aging can have a deleterious impact on both physical and mental health. These changes include lines, wrinkles and dryness that affect Quality of Life.'

'American women attach to youthful, attractive skin,' she wrote, explaining that the age-induced changes are in large part the result of estrogen loss. There is no scientific consensus that estrogen supplements will reverse the aging process in skin.

The University of Virginia Health System doctor also suggested that depression, insomnia and mood issues could be the result of estrogen and other hormone imbalances.

Her conclusion: 'Hormone therapy treats menopausal symptoms more effectively than any other single agent.' And a physician must weigh those benefits against a woman's risk for 'coronary heart disease, deep vein thrombosis, pulmonary embolism, stroke, breast cancer, and gall bladder problems, which hormone therapy may be associated with.'

Fagan, the UW course director, defended the program, saying nothing in the course material was scientifically inaccurate. However, she said the material was presented in a 'more positive light' than she would have preferred.

Some experts who reviewed the material thought that the "positive light" it placed on hormone replacement was very bright.

The Journal Sentinel asked several doctors, including Jacques Rossouw, chief of the Women's Health Initiative branch of the National Institutes of Health, to review course material. The initiative is the largest clinical trial of hormone therapy drugs.

He said the views expressed in the course are not those of the general scientific community and are not suitable for a university medical education course.

'There is a history of this kind of thing from Wyeth,' Rossouw said. 'The materials regurgitate lines that I have heard and read many times, and I have come to believe (though I do not know) that this is part of an overall marketing strategy to the profession. It is not good science because it fails to strive for any kind of balance.'

Raymond Gibbons, a professor of medicine at the Mayo Clinic and former president of the American Heart Association, said he also found material relating to heart disease one-sided.

He noted that the materials inappropriately gave observational data equal weight to rigorously done, randomized clinical trials.

'It's a lot of post hoc analysis,' he said. 'I don't see the other side of the argument.'

This is the second time that the University of Wisconsin medical school has received media attention for the cozy relationships with industry enjoyed by the school and its faculty members. We posted about some University of Wisconsin faculty's lucrative industry relationships, which they often did not fully disclose.

This, of course, is another story about how the web of conflicts of interest that now so enmesh academic medicine can enable stealth marketing, the disguising of marketing of commercial health care goods or services as medical education.

But because of the timing and subject matter of this course, this case has become a microcosm of much of what has gone wrong with US (and global) health care. Note this progression:

- Wyeth paid DesignWrite to design the course, which then paid the University of Wisconsin and its faculty to produce it. Thus considerable money flowed to the MECC and its employees, and to the university and its faculty. Ultimately, this came out of the pockets of patients or the public, adding to health care costs.
- The course they produced was viewed by numerous physicians. It is likely at least some were influenced by it to prescribe long-term HRT.
- Yet there is now (and there was in 2002) reason to believe that long-term HRT does more harm than good. A review in 2002 (see this link for summary, and links to the review) suggested that it produces increased risks of breast cancer, stroke, and pulmonary embolism which outweigh decreses in colorectal cancer and fracture. The WHI trial in JAMA had similar results (link here.)
- Therefore, more patients prescribed HRT by these physicians may have been harmed by it than were helped. Thus, the course not only added to health care costs, but likely worsened health care outcomes.

So in this case, deceptive practices presumably condoned by the leadership of a drug company, by the leadership of an academic medical institution, and by particular medical faculty, all of whom may have benefited personally by money spent to conduct these practices, likely did patients no good, and possibly did them serious harm. Deceptive practices and conflicts of interest resulted in increased health care costs and probably worse health care outcomes.

This suggests, as we have said before, that bad leadership of health care organizations causes these organizations to employ ethically questionable tactics, and these tactics in turn can systemically increase costs and worsen outcomes.

But up to now, there has been little public discussion of bad leadership and governance of health care organizations, the unethical tactics that bad leaders may employ, and how these tactics threaten physicians' professional values, and lead to bad outcomes for patients and society. Up to now, those interested in health care policy and health systems research have ignored these issues, which appear to be the herd of elephants in the health care living room.

But maybe if we improved the leadership and governance of health care organizations, and prevented the unethical practices they may employ, we could improve patient outcomes while actually controlling costs, improving access, and improving professional morale.

Of course, doing so would threaten many vested interests and fat wallets.

See also Dr Daniel Carlat's comments on the Carlat Psychiatry Blog, and Margaret Soltan's comments on University Diaries. Hat tip to PharmaGossip and the Schwitzer Health News blog.

On Wisconsin's "Talking Heads"

Last week, the Milwaukee Journal-Sentinel ran an investigative series on conflicts of interest affecting faculty at the University of Wisconsin medical school, one of the better known and more prestigious US state supported institutions. (The two main articles were "Doctors Face Pressure to Disclose All Side Pay," and "Drug Firms Wine, Dine and Pay Up for Doctors' Speeches.") Several of our fellow bloggers have discussed this excellent series already, including Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and Prof Margaret Soltan on the University Diaries blog.

So I will not go over the series in detail. Suffice to say that while the Journal-Sentinel's reporting is fresh, the problem may be tediously familiar to Health Care Renewal readers.

Although the University of Wisconsin (UW) is said to have an unusually stringent policy for "managing" conflicts of interest, the reporting requirements are vague, particularly about the financial magnitude of conflicts. The Journal-Sentinel report noted that some faculty who disclosed making only "more than $20,000" a year, a range prescribed by UW, made much more than that. Some faculty were paid by multiple companies. Some faculty were paid by medical education and communication companies (MECCs), which were presumably in turn paid by drug, device, or biotechnology companies whose identities were not disclosed. Some faculty were paid thousands to gave promotional talks which were not accredited as continuing medical education.

One orthopedic surgeon, Dr Thomas Zdelblick, disclosed yearly payments from device manufacturer Medtronic of over $20,000. The Journal-Sentinel reporters found he actually received as much as $400,000 a year in consulting payments, supposedly for working about eight days (that is, at a rate of $50,000 a day). A subsequent article in the Wall Street Journal found that Dr Zdelblick got even more than that. His total compensation from Medtronic was over $2 million a year, and as much as $4.6 million a year.

So again the picture is of a web of conflicts of interest affecting many faculty at one medical school. This adds to the now voluminous evidence that large numbers of medical academics have financially significant conflicts of interest. These financial arrangements are rarely fully disclosed, even as part of the university's attempts to "manage" them.

I spot-checked a few publications of two of the faculty named in the article, finding that they were no more explicit in their disclosures to readers of scholarly journals.

For example, Dr James Gern (who was, according to the Journal-Sentinel, a speaker and consultant for Merck from 2003 to 2007, who made about $35,000 - $70,000 a year for 28 days of work, and who was funded by Merck in a study of the effects of montelukast on people infected with the cold virus,) provided the following disclosures:
- In a 2008 single-author review of the linkages between viral respiratory infections and asthma(1), "the author has received honoraria from Merck Inc...."
- In a 2008 multi-author research paper on rhinovirus infections and asthma(2), he did not mention his relationship with Merck.

More strikingly, Dr Thomas Zdelblick, the orthopedic surgeon who got millions a year from consulting fees and royalties, provided the following disclosures:
- In a 2007 multi-author report of a clinical trial of the Medtronic Sofamor Danek cervical disc device(3), "the authors have received or will receive benefits for personal and/or professional use from Medtronic Sofamor Danek in relation to products named in this article."
- In a 2004 multi-author clinical research article on managing spine fractures,(4) "one or more author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position."

Thus, while the usual approach of most universities to such conflicts of interest is to proclaim how they will "manage" them, this "management" often did not even include disclosure of the conflicts, and certainly not disclosure in detail sufficient for its audience to appreciate the degree to which the conflict might have biased seemingly authoritative academics.

Also, often financial arrangements between medical faculty and industry are proclaimed necessary to foster collaboration necessary to "innovation" and the development of miraculous new drugs and devices (for example, the Journal-Sentinel reported the Dean of the UW medical school said "consulting with the pharmaceutical industry can accelerate drug development and lead to job creation....") However, despite these ostensible benefits, many faculty seemed uncomfortable with and reluctant to talk about their relationships.
- Dr Barry Fox, who "worked for seven different drug companies in just one year," "would not discuss his drug company work...." When reached by telephone, he initially said, "I have nothing to hide," but when asked "what kind of work he did for a drug company, he said, 'I'm not comfortable with this conversation,' and hung up."
- Dr Zdelblick "did not return phone calls."
- 3 doctors who gave talks sponsored by drug companies would not discuss their work (see this side-bar article)

One doctor who gave approximately 20 drug talks did speak with the reporters, and was very frank.

It's promotional. We all know why we are there and what we are going to hear. You are going to hear about that drug.

We're just talking heads.

As the series noted, faculty and the university stand to benefit when drug and device companies pay doctors.

Medical schools have good reason not to prohibit such activities.... It [sic] allows them to pay their star faculty less because they can make substantial money working on the side for a drug or medical device company....

The school may also benefit, of course, when the companies who pay faculty on the side also give the school research or educational grants.

But while faculty and schools make money, they sacrifice the trust of community physicians, patients, and the public. As long as academics take big money from industry, often without much honesty about what they are doing, their independence will be suspect. Who knows when the talk, the article, the glitzy program is meant to disseminate the truth, or to help in marketing? Who knows whether the research study was manipulated? Who knows whether the policy pronouncement mainly would benefit vested interests?

Maybe academics and academic administrators would sleep better if they no longer had to dodge reporters' calls, twist rationalizations, or admit to being "talking heads." Those who used to depend on academic medicine to seek and disseminate the truth might sleep a lot better if it became independent once again.

References
1. Gern JE. Viral respiratory infection and the link to asthma. Pedi Infect Dis J 2008; 27: S97-103.
2. Jackson DJ, Gangnon RE, Evans MD et al. Wheezing rhinovirus illnesses in early life predict asthma development in high-risk children. Am J Respir Crit Care Med 2008; 178: 667-672.
3. Mummaneni PV, Burkus K, Haid RW et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 2007; 6: 198-209.
4. McDonough PW, Davis R, Tribus C, Zdelblick T. The management of acute thoracolumbar burst fractures with anterior coprectomy and Z-Plate fixation. Spine 2004; 29: 1901-1909.