Ethics and biomedical research

Arthur Caplan

February 26, 1993|By Arthur Caplan

THERE is no dispute that America leads the world in biomedical research. As President Clinton tries to restructure an economy built on 19th- and 20th-century products to meet the demands of the next century, American pre-eminence in biomedicine holds out the best hope of serving as the engine capable of driving that economy.

That is why every American ought be deeply concerned about the cancer that is quietly weakening the foundations of biomedical research -- conflict of interest. Recent events at the University of Minnesota's medical school illustrate just how serious the problem of conflict of interest has become and just how ineptly government, universities and legislators are dealing with it.

On Feb. 18, University of Minnesota President Nils Hasslemo asked for and received the resignation of Dr. John Najarian as the chairman of the department of surgery.

Dr. Najarian, a doctor of international renown both for building one of the premier surgery programs in the nation and for his pathbreaking research in the field of organ transplantation, was forced to quit the job he had held for 25 years. His colleagues, peers and students were aghast that a physician of his achievement and reputation was summarily stripped of his leadership role.

The reason given for the forced resignation was that Dr. Najarian had presided over two decades of administrative mismanagement of a program run through his department to manufacture a widely used drug, ALG. ALG helps stop organs from being rejected by recipients.

There is no doubt that ALG works. There is also no doubt that it never got the requisite approval from the U.S. Food and Drug Administration required for new drugs and that ALG generated tens of millions of dollars in revenue.

Minnesota's surgery department went into the ALG business back in the 1970s because no commercial company was willing to gamble on the drug. ALG turned out to work so well that by 1986 the university approved the construction of a building on university property to manufacture and distribute it around the world.

The FDA, which was aware of the evolving success of ALG through the papers about the drug that were published in many medical journals, pushed the surgery department to obtain approval for ALG. But Dr. Najarian and his associates, knowing that the entire field of transplantation was convinced that the drug saved lives and that the drug was a minor sideline to the main activities of the department, did not fulfill the paperwork requirements necessary for FDA approval.

The drug worked, it sold in large quantities, it was the object of many publications in professional journals and it was the source of a large enough stream of funds into the surgery department that everyone involved did not pay much attention to the bureaucratic requirements of the FDA.

ALG became a problem for Dr. Najarian, the university administration and the federal government when sources in the surgery department began to leak allegations to the media about possible mismanagement of the ALG program. The Twin Cities media reported the ALG story with all the nuance of an ax murder.

Readers had to wipe away the drool from front-page stories frothing with glee at the prospect of landing a fish as big as Dr. Najarian in the net of scandal. The steady drumbeat of allegations in the press caused the FDA and university officials to bestir themselves. Eventually, the president put Dr. Najarian's head on the block, and the FDA halted the manufacture of ALG.

The net outcome of this mess is that one of the few surgeons in the world who actually believed in the importance of clinical research is out of a chairmanship and patients are at risk of dying because they cannot get a drug that works.

The ALG case at the University of Minnesota is not the only example of conflicts over what to do when money, commerce and academia mix. Such conflicts are being played out in dozens of universities around the United States.

At one school a researcher holds back on negative findings he has on a drug until he can dump the stock he owns in the company that makes it. At another, university doctors begin routinely using a new test to identify early signs of cancer without telling patients or their community doctors that the test has never been approved by the FDA or that they hold patents on it and stand to make a fortune if it is widely adopted. At still another university, doctors ally themselves with a pharmaceutical company to make a drug useful in transplantation but refuse to let other transplant teams who want to check their claims of success have access to it because the company will not allow it.

Relationships between industry and universities are proceeding in an ethical vacuum. There are no federal policies, and university policies -- when they exist at all -- vary widely from school to school. Administrators and lawyers are familiar with the policies; researchers are not.

If the alliance between business and the academy in biomedicine is to be the motor driving America's economy in the years to come, then someone had better get busy now writing the rules for traveling along this new road.

Universities cannot long withstand the kind of tragedy represented by the Najarian case.

Arthur Caplan is director of the Center for Biomedical Ethics at the University of Minnesota Medical School.

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