Smoke Screen - How a Conflict of Interest Muddled the Debate on the Smoke-Free Initiative at the University of Michigan

As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the Smoke-Free Initiative at the University of Michigan, as promoted by the University President, Mary Sue Coleman. 

A Conflict of Interest: University President and Johnson & Johnson Board Member

It turns out, though, that this initative has provoked debate on that campus, not so much about its possible benefits and harms, but about whether the Ms Coleman's promotion of it had to do with a conflict of interest.  The debate broke out with an op-ed in the Michigan Daily:

It’s clear, then, that University President Mary Sue Coleman is the architect of the Smoke-Free Initiative, which will take effect in July of 2011. The initiative will prohibit smoking on all outdoor University property. Coleman and University administrators have been embarrassingly vague about why such a ban is necessary. Instead, they keep insisting that the smoking ban will improve public health.

Interestingly enough, the smoking ban may also improve Coleman’s salary.

That’s because Coleman isn’t just a college president. In her spare time, she moonlights as a businesswoman, sitting on the board of directors for major pharmaceutical company Johnson &  Johnson, as well as the Meredith Corporation, a magazine publisher. According to Forbes.com, her position at Johnson & Johnson netted her an income of $229,000 last year.

Among Johnson & Johnson’s many marketed brands are smoking cessation products like Nicorette and Nicoderm — products that University smokers will feel encouraged to use once smoking becomes unwelcome on campus in July 2011. Indeed, administrators have already announced that smoking cessation products may be offered at discounted prices to students who are trying to quit.

Obviously, this is a sizeable conflict of interest for Coleman. Even if her Johnson & Johnson salary didn’t actively influence her decision to ban smoking, it makes it substantially harder to take her at her word that the University needs this ban — especially when representatives of her administration can’t come up with a specific reason for it.

But Coleman’s corporate troubles run deeper than this. As the University’s College Libertarians pointed out in a press release this weekend, Johnson & Johnson has an affiliated non-profit group, the Robert Wood Johnson Foundation, which lobbies for the adoption of certain health-related policies through research and grant money. RWJF is notoriously anti-smoking, as its website explains: 'At the state and community level, we support advocacy for proven tobacco control measures, such as smoke-free air laws, funding of prevention and cessation programs and increases in tobacco taxes.'

While it’s no surprise that RWJF would fight for laws that restrict smoking and lead to increased use of Johnson & Johnson products, such an aggressive lobbying force should not hold financial sway over the president of a public university. Students, faculty and staff must be able to trust that their president is working in the best interests of the University community, not a profit-motivated corporation. Even the perception of a conflict of interest is embarrassing for this institution.

And then, in another op-ed in that paper:

Granted, some of Coleman’s reasons for the Smoke-Free Initiative are likely motivated by good intentions like lowering the University’s health care costs. But these justifications are severely compromised by her compensation from a corporation that will likely benefit from the smoking ban. Coleman sits on the board of directors for Johnson & Johnson, from which she earned nearly a quarter of a million dollars in 2009, and holds 11,159 shares of common stock, 10,777 shares of common stock equivalent units and 7,600 exercisable stock options in the company. Johnson & Johnson is the producer of a host of nicotine replacement products, including Nicoderm and Nicorette. Coleman explains, 'the University will offer free behavioral sessions and selected over-the-counter smoking cessation products to faculty and staff, along with co-pay reductions for prescription tobacco cessation medicines (and) discounts on tobacco cessation aids.'

In other words, under the proposed Smoke-Free Initiative, the University would subsidize products made by Johnson & Johnson. The University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson and, consequently, Coleman.

In reply, a letter by Dr Robert W Winfield, University of Michigan Chief Health Officer, asserted:

Some have raised concern about the appearance of a conflict of interest between President Coleman’s service on the board of directors of Johnson & Johnson, a company that produces some smoking-cessation products.

Simply put, there is no conflict. Prescription-only drugs for smoking cessation are generally considered the most effective and most widely used. Johnson & Johnson does not make any prescription-only smoking-cessation products.

A report of a meeting of the Michigan Student Association noted:

In a press release and columns in The Michigan Daily, members of the College Libertarians have identified Coleman as having an apparent conflict of interest due to her position on the board of Johnson & Johnson — a company that manufactures and markets smoking cessation products.

Kozack said if the allegations prove to be true, they could have large implications as Coleman is compensated for sitting on the company’s board.

He said the main reason for the resolution and the accusation of Coleman’s conflict of interest is that there is not enough information provided to the whole campus about the origin of the Smoke Free Initiative.

But in defense of President Coleman, the following appeared in the Michigan Capitol Confidential:

The University of Michigan's student newspaper - The Michigan Daily - wrote an opinion piece last week suggesting a conflict of interest involving University of Michigan President Mary Sue Coleman.

Coleman also earned a $230,000 salary in 2009 for sitting on the board of Johnson & Johnson. Alza Corporation, a subsidiary of Johnson & Johnson, markets Nicorette and Nicoderm, smoking cessation products.

Three ethics experts say Coleman is not in conflict.

'She is doing a public health service,' Peter Rost, a former vice president of Pfizer who has testified before Congress on the business practices of drug companies, wrote in an e-mail. 'The possible income by J& J from this campus is completely and utterly negligible and will have no impact on J&J income statement. Same thing if she opened public health clinic for depressed students and happened to sit on board of (a company) selling antidepressants. Conflict of interest should normally have some undue influence on either party. Since that is not the case I'm not troubled.'

Aine Donovan, the executive director of the Ethics Institute at Dartmouth College who teaches business ethics, said she didn't see a conflict.

'This is very reasonable,' Donovan said. 'Johnson & Johnson has a large range of products. This is a very reasonable position she is taking and it is a very laudable one.'

Timothy Keane, director of the Emerson Ethics Center in St. Louis, said it was 'a bit of a stretch' to say Coleman had a conflict of interest.

'Johnson & Johnson is not trying to set up shop and sell something to the University,' Keane said. 'They are not being a supplier to the University. It doesn't matter if you are a smoker or not, research indicates it is bad for you.'

A Hazy Debate

Smoke gets in your eyes. Maybe it should not be a surprise that once President Coleman's relationship with Johnson and Johnson was noted, opponents and proponents of the Smoke-Free Initative used arguments about that relationship to bolster their positions, rather than debating the smoking ban on its merits. The result, however, shows how conflicts of interest seem to always produce confusion, if not smoke and mirrors.

Most of the debate seemed to be about whether Ms Coleman would personally profit from the smoking ban, and if so, how much. For example, the second op-ed above argued, "the University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson, and consequently, Coleman." On the other hand, one expert quoted in the Michigan Capital Confidential argued that the income to J&J from the Michigan campus would be "utterly negligible," and another argued that "Johnson & Johnson is not trying to set up shop and sell something to the University."

On one hand, however much use of J&J nicotine replacement products there is at the University of Michigan, the amount is unlikely to change the profits of J&J, or the salaries or values of stock owned by its directors. On the other hand, J&J may not run a retail store at the University, but it is in the company's interest to sell more of all its products on university campuses, and everywhere else.

But in my humble opinion, the issue is not about the degree President Coleman's salary and assets derived from her position with Johnson and Johnson would be affected by a specific policy she may advocate. The issue is whether her judgments and decisions as President could be unduly influenced by her relationship with the company.

Definition of Conflicts of Interest


This provides a good opportunity to review a good working definition of conflict of interest as it applies to medicine, health care and health policy. Last year the Institute of Medicine published a thorough and well-balanced report, Conflict of Interest in Medical Research, Education, and Practice. It defined conflict of interest (p. 6):

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

Furthermore,

The severity of a conflict of interest depends on (1) the likelihood that professional decisions made under the relevant circumstances would be unduly influenced by a secondary interest, and (2) the seriousness of the harm or wrong that could result from such an influence.

But,

a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly infuenced by considerations that should be irrelevant.

Thus, a conflict of interest should be seen as a situation which increases the risk of bad judgments or decisions, but does not necessarily cause them, much less cause a particular bad judgment or decision.  (Thus, it makes no sense to try to argue, as the experts did above, that because a person made a good decision, he or she does not have a conflict of interest.)

I assert that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates.  Many of the judgments of or actions performed by  the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced.

However, that she has such a conflict does not prove that any particular judgments or decisions were made badly because of it. Conversely, that particular judgments or decisions were made well does not disprove the existence of the conflict. 

So I beg to differ with all the experts cited in the Michigan Capital Confidential article.  On the other hand, while the President may have a conflict of interest, it is impossible to tell how or whether this influenced her particular decision to support the Smoke-Free Initiative.  Neither does it speak to the benefits or harms of such a policy.  The main effect of the President's conflict of interest seems to have been to muddle the debate about the policy.

Conflicts of interests' general tendency to muddle and confuse provide one argument for their elimination.  Another is that they may affect judgments and actions that are not so readily debated as, and more likely to produce bad results than smoke-free initiatives.  Maybe the hazy debate about the University of Michigan Smoke-Free Initiative will lead to a clearer discussion of whether academic and academic medical leaders should also be corporate leaders.

Guidelines in Whose Interest? - Smoking Cessation

Physicians are frequently exhorted to follow clinical practice guidelines. Guidelines are now being given "teeth" by the currently fashionable "Pay for Performance" (P4P) movement. Yet, as we have discussed, guidelines may be written by people with financial ties to organizations that have vested interests in products or services that the guidelines might recommend.

The latest example of this comes from an article in the Wall Street Journal. The Journal reported that US government sponsored guidelines about smoking cessation (helping people quit cigarettes) were written by people with financial ties to companies that make drugs intended to aid smoking cessation, and that the guidelines recommended these drugs as first line therapy.

Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies.

Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies.

The Public Health Service, part of the Department of Health and Human Services, issued guidelines in 2000 calling for smokers to use nicotine patches, gums and other pharmaceutical aids to quit, with a few exceptions such as pregnant women. Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products.

The panel is now working on a revision of the guidelines, scheduled for completion early next year. Dr. Fiore, an internist, is again chairman. He says this time only seven of 26 members have industry ties.

As the federal government weighs the data in making new recommendations, many of its advisers are receiving money from companies with a stake in the outcome. Dr. Fiore holds a chair at Wisconsin that is funded by GlaxoSmithKline. He directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005. Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005.

However, the evidence that supports using drugs to help people quit smoking may not be so clear. First, as the Wall Street Journal article pointed out, new observational studies have failed to show that using drugs leads to higher quit rates in the long run. These studies, however, can be confounded by differences among people who choose to quit "cold turkey" versus those who choose to use drugs.

Second, the evidence from controlled trials of drugs versus placebos may not be unequivocal. For example, I reviewed a prominent article that reported a trial that compared placebo with the nicotine patch, sustained-release buproprion, and both the patch and buproprion. [Jorenby DE, Leischow SJ, Nides MA. A controlled trial of sustained-release buproprion, a nicotine patch, or bot for smoking cessation. N Engl J Med 1999; 340: 685-691.]

The article had two major problems. First, it excluded patients with any serious medical problems, who were on any psychoactive drug, or who had substance abuse problems. Thus the study's results may not apply to many of the patients who most need to stop smoking.

Second, many patients enrolled in the study dropped out before completion of follow-up. Fully 19.8% were completely lost to follow-up. We do not know whether the patients who dropped out quit cigarettes in the long run, and whether the quit rates in such patients randomized to different treatments may have varied. Thus, given that the magnitude of the drop-out rate was similar to the magnitude of the difference in the quit rates among the treatment groups, it is possible that were we to learn whether the patients who dropped out quit, this data could completely reverse the results.

For example, the one-year quit rates for the patients who stayed in the study were 15.6% for the placebo group, 16.4 for the nicotine patch, 30.3 for buproprion, and 35.5 for both buproprion and the patch. Suppose that all the patients on placebo who dropped out quit long term, and that none who were on buproprion and the patch who dropped out quit. Then the quit rates for those two groups would have been 64.4% versus 35.5%, a complete reversal compared to the published results. Such a high drop out rate appears to be a fatal flaw in this study.

Finally, the Wall Street Journal article noted that many experts in smoking cessation have failed to reveal their financial ties to companies that make smoking cessation drugs when speaking or writing. For example,

Those who advocate medication sometimes fail to disclose that they have financial ties to companies. In an article on Voice of America's Web site last year, Jack Henningfield, identified only as a smoking-cessation expert, urged smokers to 'go to the consumer-friendly Web site that I like, which is www.quit.com.'

Dr. Henningfield is a principal of Pinney Associates, a consulting firm whose largest client is GlaxoSmithKline, operator of the quit.com site. Other articles citing Dr. Henningfield's views on smoking have identified him as a professor at Johns Hopkins School of Medicine without mentioning the GlaxoSmithKline connection. Dr. Henningfield, who holds a doctorate in psychology, is an adjunct professor at Johns Hopkins. He says only 10% of his income comes from Hopkins.

Dr. Henningfield says he always tells journalists about his financial ties to industry. But in an interview with The Wall Street Journal last summer, Dr. Henningfield promoted the use of stop-smoking medicine without volunteering any information about those ties. He says he thought GlaxoSmithKline's public-relations firm had already provided the information.

In at least two medical-journal articles that Dr. Fiore wrote or co-wrote promoting the use of stop-smoking medicine, no mention was made of his financial ties to the makers of those treatments. Dr. Fiore says the editors of those journals may have ignored his disclosure or he may have failed to provide it. If the latter, 'I am sorry about that,' he says, adding that those are two of more than 150 medical-journal articles he has published.

In summary, some authors of the guidelines for smoking cessation had financial ties to companies that make drugs used to help smokers quit. The guidelines favored first-line use of these drugs, yet the evidence supporting such use may not be crystal clear. Smoking cessation experts have failed to disclose such financial ties when speaking or writing about relevant issue.

As I have concluded before, just because a set of recommendations is called a guideline, or is written under the auspices of some august academic or scientific organization does not guarantee that its recommendations are based on the best evidence, or are not influenced by vested interests.And yet guidelines remain a buzz word for those who say they want to control health care costs, and improve quality and access. And giving guidelines teeth, otherwise known as "pay for performance," (P4P) is now the most fashionable solution to the cost, quality, and access problems. (See post here.)We need to remain very skeptical about how guidelines are developed, and whose vested interests they may serve, and very careful about giving guidelines teeth through P4P.