How optimism creates conflicts of interest

It is appropriate that academic physicians who work with for-profit entities are under scrutiny for having potential conflicts of interest. I would like to broaden the focus to include the conflicts that physicians face who work wholly in industry or wholly in academics.

For example, allow me to present a theoretical situation. A physician, industry or academic, is attending a national meeting in which new data are to be presented. In the presentation — poster or oral — it is easy enough to present the data and in the discussion and conclusions adhere to the norms of scientific restraint. Some authors are more optimistic than others, but nearly everyone uses the same set of cliches to describe the results:

“Promising, but needs to be confirmed in a (take your pick; any or all) larger, blinded, randomized trial.”

“Encouraging, but needs further testing in (again, any or all) larger, less selected, sicker population.”

Michael N. Needle

What happens next is where it gets dicey. In post-presentation discussions with the investment community or the press, scientific restraint may be lost to an audience that may be looking for something else. Sometimes, a leading question or a follow-up question that begs for a more succinct response results in an answer that is a little less circumspect and a little less reserved. It may be correct to anyone who takes the time to look back at the poster or the slides, but if taken out of context, it becomes a little too optimistic.

Back in the office of the pharmaceutical company, a physician working for the company reports the highlights of the national meeting to the company leadership, which may include a spectrum of people whose disposition ranges from the very circumspect to the unbridled booster. The chief scientific officer who needs to allocate limited funds among many competing programs may be at one extreme of the spectrum, whereas the head of investor relations or public relations may be at another.

Maybe an optimistic chief scientific officer will get more funding from the CEO and board of directors than a pessimist. Maybe the head of investor relations has had a bad experience with disappointed investors. Anything is possible.

Shaping the message

Depending on the circumstances, the report may quickly move from the details of the scientific presentation to the quick and digestible sound bites from the conversations with the press or the investment community. Subtlety can easily be lost. As the sound bite gets passed around a bit, the message may drift further. In time, the message may have drifted to a point beyond comfort, but it is difficult to correct or retract at that point without calling into question earlier statements by the physicians involved.

Even for the academics involved, the pressures are similar. Investigators with the most promising results will garner the most media attention. Television, and to some extent the print media — to say nothing of the audience — have little patience for subtlety. A quick, upbeat story is often the best received. Not that there isn’t room for a negative story, as long as it upends a well-known and established fact, or which carries unsavory undertones (money and greed, preferably).

The most striking observation is that nowhere during this process did anyone set out to misinform or mislead.

Rewarding optimism

Even if the original message has morphed into something different, the positive feedback from outside the company may raise the standing of the team working on the study. Companies feed on good news (as do academic medical centers) and reward the teams of employees who provide it. Teams working on the most promising programs get the most support in terms of company resources and, as a result, have the most job security. Phrases such as “planning for success” depend on optimism, and a naysayer can be labeled as such. Similarly, companies will go back again and again to investigators that collaborate on successful projects.

Optimism is academic

There are many analogous situations within the academic community; a bias against the publishing of negative data is clearly evident. If there are a number of studies being conducted on a single disease or the effects of a particular drug, there is a lot at stake beyond what is best for patients and medicine. The investigator, particularly the leads, of the “winning” study will garner the most attention, will be invited to give the most talks and may become the target of recruitment from other institutions or promotion within the home institution.

The same may happen to those who conduct negative studies, but not nearly as often.

Often the “winner” is not clear. Different choice of endpoints, different toxicity patterns and factors such as convenience and cost can muddle the picture. The more muddled the result, the more subjective the outcome, the more the investigators and interested bystanders promote their chosen winner. It can be hard to see something an individual has spent years planning, executing and then analyzing in a totally objective light.

Revenue and science

Money may have an influence within the academic setting as well. Competition between different specialists are about the best patient care, but they are also about which department gets to bill and grow, and maybe influence within the institution, as departments that bring in the most revenue can get favored status. Pediatric oncologists and radiation oncologists have been cooperating and competing in patient care for my entire career. Of course, this is healthy, but it is not pure.

The use of autologous stem cell transplant for the treatment of breast cancer is a nice example. The procedure gained widespread use without the benefit of a randomized trial as evidence of effectiveness. Nonetheless, hospitals were busy, departments were making money and the patients were satisfied. Everything was brought to a halt when a series of studies were presented in a plenary session of the American Society of Clinical Oncology meeting that demonstrated that chemotherapy without the autograft was just as good. I would venture that the rush to autologous bone marrow transplantation was in part fueled by optimism and the effect it had on revenue and careers.

No one can argue that the discussion regarding conflict of interest and the protection of the integrity of the profession is of utmost import. I would suggest that, at the moment, the discussion is focusing on one aspect and perhaps it could be a bit broader. Conflicts exist in the private sector, the public sector and the interaction between the two.

Further, maybe in that focus some subtlety is lost. Is it really necessary for professional societies to sever all ties with industry? Is there no middle ground? Being a little bit facetious, how much harm was really done by the distribution of stethoscopes to first-year medical students?

To my mind, the collaboration between the pharmaceutical and device industry and the academic medical community is a shining example of enormous potential in the collaboration between the public and private sector. I’d hate to see it severed completely. I’ve worked on both sides, and for the most part, people want to and try to do the right thing. Occasionally, things get drawn off course. Rather than banning specific interactions, how best can we help all individuals maintain their integrity? Standards, guidance and vigilance are crucial, but we should avoid a cure as bad as the disease.

Michael N. Needle, MD, practices at the Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center.