A Recent Case Study

David G. Kern, M.D.

Brown University School of Medicine

Delivered at MIT, Cambridge, MA, March 29, 1999.

The press release for this colloquium reported that I was suing Brown University for breach of contract and that I would discuss the effects of signing non-disclosure statements on medical research. I must say I was surprised to be characterized in these terms. I have never sued nor even threatened to sue Brown University or, for that matter, any other party.

Moreover, I had not planned to discuss the ramifications of signing non-disclosure statements on medical research because I never signed such a statement in the context of medical research. All of this brings to mind the man who was asked when he had stopped beating his dog when, in fact, he had never owned a dog. Had I actually signed such a non-disclosure statement, I would like to believe that I would have had the courage to act as did Betty Dong, Ph.D., and Nancy Olivieri, M.D., who is here with us today from the Hospital for Sick Children and the University of Toronto.

But since the topic has been raised, let me speak briefly to the consequences of signing non-disclosure statements by quoting the words of Dr. Stephen Rosenberg, a surgeon at the National Cancer Institute. A few years ago, in an eloquent commentary on "Secrecy in Science," published in the New England Journal of Medicine, Dr. Rosenberg wrote: "The goals of medical research are clear: to prevent human suffering and premature death from disease. Just as a physician has a moral responsibility to do no harm, so does a scientist engaged in medical research. Deliberately withholding useful information or reagents is a violation of this principle. If secrecy slows progress, then human suffering may be prolonged and unnecessary deaths may occur. Although these harms are not the intention of scientists who withhold information, they are a logical consequence of such secrecy. Secrecy in science is understandable, but it is not justifiable."

Allow me now to cover 120 years of history in a few minutes to provide a context for my own story. In 1882, the Norwegian playwright, Henrik Ibsen wrote "An enemy of the people". In this play, the town's physician determines that the community's springs have been contaminated. The physician is both pleased and relieved to have made this discovery in that he and his brother, the town's mayor, have been advertising that water from the springs heals sickness. In the coming weeks, the town is expecting a massive influx of ill people who will wish to drink from the springs. The town will prosper. The doctor concludes that at a modest cost the plumbing system can be modified to solve the problem. The community is unwilling to make the modification and soon the doctor is branded, "an enemy of the people".

Closer to the present, Dr. Alice Hamilton, who was both the mother of occupational medicine in the United States and the first female faculty member at Harvard Medical School, was touring a large industrial complex in New England several decades ago. Her guide at the time, an International Steelworkers Union representative, was a family friend of ours. Apparently, in an effort to impress Dr. Hamilton, the company's owner introduced her to a management team member who had previously been a dean at the Harvard Business School. When Dr. Hamilton asked the former dean what he had taught at Harvard, he replied, "business ethics". She apologized for failing to hear his response and asked him to repeat it. When he again said, "business ethics," she stepped a foot closer, explained that she was getting somewhat deaf in her old age, and asked him to repeat his answer once more. Again he said "business ethics". Dr. Hamilton, smiled broadly and said "Now, I heard you....for a moment there, I thought you were saying, 'business ethics,' which clearly is internally inconsistent."

Eighteen months ago, Dr. Stephen Rosenberg, Dr. Nancy Oliveri, and I, were asked to address the AAAS Committee on Scientific Freedom and Responsibility. Another invited guest, a representative of the Biotechnology Industry Organization, was also asked to speak. His task was to explain why a biotechnology company might wish to delay the release of its own research findings whether favorable or otherwise. He offered seven explanations but few in the room appeared able to concentrate after learning that the first reason was to "sabotage the competition". We were told that if a biotechnology company spends a million dollars developing a new drug only to find it ineffective, it is important to make certain that the company's competitors follow the same dead end. Dr. Rosenberg, interrupted, seeking clarification. He posed a scenario in which "company A" has just learned that its developmental cancer chemotherapeutic agent is not only ineffective but actually is harmful to patients. Dr. Rosenberg queried whether "company A", aware that "company B" was poised to initiate a comparable clinical investigation, would be obliged to immediately notify its competitor of the danger. Our speaker explained that the company would be under no such obligation and while he understood that as scientists and physicians we might find this disturbing, the company's only obligation was to its shareholders and venture capitalists.

While each of these stories individually is expected to elicit a wide range of responses, collectively they highlight an inescapable truth: people vary greatly in assigning priorities even in the context of life-and-death matters.

For the last 15 years, I have been teaching medical students and physicians-in-training about internal medicine and occupational disease at Brown University where I am Associate Professor of Medicine. For most of the last decade, I have directed the university's Program in Occupational Medicine as well as the Division of General Internal Medicine and the Occupational Health Service of its teaching affiliate, the Memorial Hospital of Rhode Island.

Two years ago, in the context of a consulting relationship, a local manufacturer threatened litigation if my colleagues and I informed the scientific and public health community of a new potentially fatal occupational lung disease that we had identified among the company's workers. Shortly thereafter, hospital and university administrators insisted that I withdraw a previously submitted scientific communiqué about the disease outbreak, terminated the state's only occupational health center, which I directed, and demanded that I no longer provide medical care to those of my patients working at the company.

A small group of Brown University faculty members rallied and called for university administrators to take a principled stand. Instead, the Dean of Medicine hand-picked a Committee of Inquiry comprised of two associate deans whose subsequent report side-stepped nearly every critical issue. Listed among the report's key findings was that: "The company's attempt to have the abstract withdrawn is not considered by the Committee to be an attempt to compromise the health of its employees but rather an effort to avoid bad publicity and to protect its economic position." The Committee did in fact conclude that my academic freedom had been violated but one could barely discern this from the report. Moreover, far more important issues such as the suppression of scientific findings critically important to public health and interference with a physician's responsibilities to care for his patients were not addressed at all.

A month later, my co-investigators and I had the unusual experience of presenting our findings to an international scientific assembly, while an associate dean and a public relations representative of the university stood beside us. At the meeting, important collaborative assistance was offered by both North American and European colleagues. Dr. William Beckett, who chaired the session at which we presented, later wrote to Brown University's president: "By insisting on the need to present this scientific information now, Dr. Kern was able to alert physicians and scientists from five continents of a serious occupational lung disease concern. Others may be at risk. Lives may be saved by his action."

During the week of the conference, the boards of both the American College of Occupational and Environmental Medicine and the American Thoracic Society passed resolutions supportive of our actions. The ACOEM warned: "History is replete with examples where delay or suppression in the reporting and dissemination of health risks led to serious human and financial consequences." The ATS admonished: "Barriers to the open communication of scientific information must be resisted. In particular, the threat of litigation and/or elimination of financial support to prevent the open communication of scientific information is abhorrent."

One week after I returned from the conference, I was notified by both the hospital and university presidents that my tenure-equivalent position had been terminated. Although there was an outpouring of national and international support, the local response, with several notable exceptions, was too little, too late. My contract expires in three months.

Administrators of the three involved institutions rationalize their behavior by pointing to an agreement of secrecy and confidentiality that I signed at the company. What these administrators obscure, however, is that the agreement was signed to permit Brown University medical students and physicians-in-training to make a one-hour educational visit to the company's plant; that the agreement was signed 15 months before we would later begin serving as the company's consultants; that this type of agreement, covering trade secrets, is routinely signed by visiting vendors, purchasers, and industrial consultants, and has never been construed to limit the reporting of occupational disease; that, at the time we began consulting, we provided the company with a copy of our operating principles which state that we will report to the scientific and public health communities as we deem appropriate; that we had explained that our willingness to serve as consultants was contingent upon the company's agreement to abide by our operating principles; that the company had been quite clear in articulating its real concern.....avoiding adverse publicity.....and thus there was no possibility that it would sue a physician, a hospital, and a university; and, that a dozen lawyers and legal scholars have concluded that the confidentiality agreement is both irrelevant, and unenforceable, for among other reasons, it is contrary to the public good.

But still, hospital and university administrators have continued to deceptively equate the signed confidentiality agreement with a formal research contract, and implied that the company had provided research funding in exchange for our silence.

Last August, our scientific findings were published in the peer-review medical literature together with a supportive editorial entitled: "New disease, old story." The journal's editor also asked a physician-journalist to re-explore the story in depth to provide further insight into what happened. Unfortunately, the physician-journalist chose to focus her commentary on the more general issue of confidentiality agreements in scientific research but did so in the context of my story. To maintain such a focus, however, she found it necessary to create a more balanced conflict and thus excluded the ugly aspects of the story, prettified what remained, and portrayed conflicting claims as being equally reasonable, equally truthful, and comparably founded on ethical principles when they were not. How easy it was then for her to write: "The debate essentially revolves around who holds the higher moral ground: scientists who share their findings in an effort to protect patients from harm or scientists who honor signed contracts by guarding the confidentiality of their sponsors."

Allow me to share two observations brought to mind by this so-called moral conundrum. First, while monetary profit and public health are both goals many consider worthy, to balance them in the same moral plane is pernicious. Second, life requires us to make choices. Two years go, in an article entitled "Seduced by Civility," published in the Nation, Benjamin DeMott wrote that: Democracy continues to oblige citizens to resist ...the constant pressure to undervalue others, especially those who do not inhabit our own publicly articulate world. Democracy continues to oblige citizens to render serious right-valued judgments on others as well as upon themselves. Democracy can coexist with the belief that all humans are sinners but not with the belief that all sins are equal. Democracy has within each of its camps, not excluding the civilitarian camp, thugs in number. And when you're in an argument with a thug, there are things much more important than civility."

I do not like incivility. Yet, I like thugs even less. What I am asking, rather, what I demand of us all is honesty and truth. For without honesty and truth, there is nothing. In Toronto, in the matter of Dr. Nancy Olivieri, administrators of the Hospital for Sick Children and the University of Toronto, at one point, paid homage to truth in acknowledging that the $20 million offered by the drug company in question could not be jeopardized.

In my case, representatives of the company, the hospital, and Brown University have gone to great lengths to distort the truth. Yet, even were their claims true, their points of contention are irrelevant to the critical issues that remain (a) their attempts to suppress the dissemination of scientific findings critically important to the public health, (b) their interference with my professional responsibilities to care for patients, and (c) their immediate termination of the state's only occupational health program.

And so, we are left confronting arrogance, dishonesty, and a callous disregard for the health of workers. While our medical school and university administrators continue to proclaim their dedication to truth, to the search for knowledge, and to the advancement of civilization, it is all pretense as wordsmithing triumphs over truth and as knowledge is buried. What makes such pretense infuriating goes beyond hypocrisy to the failure of these administrators to realize that people's lives hang in the balance. They either fail to appreciate or are unwilling to acknowledge that their words and actions have jeopardized the health of individual workers, have contributed to the potentially irrevocable loss of an opportunity to advance both scientific understanding and the public health, and have undermined the collective sense of trust and mission in our academic community.

We will remain forever grateful to those who have seen past the diversionary tactics and acted, not just in my case but in the cases of Dr. Olivieri and others as well. Physicians, university faculty, public health practitioners, medical students, physicians-in-training, lay people, labor unions, professional organizations, and others, here in Rhode Island, nationally, and internationally have seen the issues clearly and formally registered their outrage. In sharp contrast to the situation depicted in Ibsen's "An Enemy of the People," I am not alone.

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