The Editor’s Corner: A Question of Ethics

Harold Alexander

Fraud. . . misconduct. . . conflict of interest. . . Who would have thought a few short years ago that these would be sub- jects for discussion in a biomaterials journal? And yet we are now forced to take a long, hard look at these issues, for they underlie a steady stream of recent events, the most re- cent of which is the National Institutes of Health’s proposal last fall to institute new guidelines on conflict of interest.

If any reader needs to be brought up to date on the NIH proposal, let me summarize: Investigators who receive NIH funding, according to the recommended guidelines, would be barred from (1) having financial intestest “in any company that would be affected by the outcome of the research or that produces a product or equipment being evaluated in the research project” as well as from (2) receiving “honoraria, fees for service, or a management position from a private source if that individual is involved in an NIH-supported project that is evaluating or testing a product of the source.”

My guess is that by the time this issue is in print, the pro- posal will most likely have been abandoned. An informal sampling by this party last fall revealed that the biomedical community was strongly against these restrictive rules, for reasons that I will discuss shortly. My main purpose here, however, is not to argue against the guidelines. Rather, I want to point out their significance in the context of a larger pattern-of a progression of restrictions on the activities of biomedical investigators that, while understandable and per- haps even commendable in their origins and intentions, are both shortsighted and inefficient.

Biomaterials research and development professionals have for many decades investigated, developed, and introduced into clinical use countless replacement and repair devices and materials that have revolutionized surgery. This activity involves a serious public trust. Indeed, at first the public’s only protection was the conscience of the professional. As the field developed and the number of knowledgeable inves- tigators increased, other levels of control came into play: peer pressure, the general response of the marketplace, and eventually the threat and reality of malpractice and product liability actions. The last part of this picture to be put into place has been government’s regulatory mechanisms.

Despite these many pressures to be honest, not to men- tion the inherent morality of most biomaterials profession- als, there have been a number of prominent cases of fraud and misconduct in the biomedical community in recent years. In response to this, several actions have been taken. NIH required that all institutions receiving federal funds institute a policy on fraud and misconduct by December 31, 1989. Respected journals, among them the Journal of Biomedical Materials Research and the Journal of Bone and Joint Sur-

Journal of Applied Biomaterials, Vol. 1 , 91-92 (1990) 0 1990 John Wiley & Sons, Inc. CCC 1045-486 1 19010 1009 1 -02$04.00

gery, have for some time required authors to sign a statement indicating whether they have received anything of benefit from a commercial party associated with the reported work (alternatively, authors may indicate that they choose not to make such a disclosure). And most recent is the NIH’s pro- posal to promulgate its extremely restrictive guidelines on conflict of interest.

All this amounts to a steady escalation in restrictive guide- lines. True, the NIH guidelines on fraud and misconduct now in effect are eminently reasonable; indeed, they codify universally accepted policies of professional behavior. But the journals’ conflict-of-interest disclosures are a bit more onerous in their implication that the objectivity of the inves- tigator may be impaired by receipt of something of value from a commercial party. The problem with this approach is that there are all too many possible sources of impaired objectiv- ity, and no way to guard against all of them. What of the need to “publish or perish”? Indeed, the very need to acquire fed- eral grants might be construed as compromising the integrity and objectivity of investigators supported by such monies. There is no ultimate safeguard against all such dangers. Con- sequently, I have never required a disclosure statement from authors in Applied Biomaterials.

As for the NIH proposal: Although the stated purpose of the regulations is to “provide guidance concerning safeguards needed to ensure unbiased performance and reporting of re- search results,” one obvious effect of the proposed policy would be to deprive the scientisthnvestigator of any economic benefit from his research efforts. The potential economic benefit of the invention would not, however, be diminished. Companies would still be allowed to obtain licenses for technologies, universities and research institutes to collect royalties and/or equity interests in companies which are de- veloping university-based developments. Ironically, the only person who would not be entitled to enjoy a financial re- ward for his invention would be the inventor! A major con- sequence of this policy, if implemented, would be to create serious new barriers to and disincentives for technology trans- fer in the biomedical area. As adequate federal funding be- comes harder to get, investigators have been seeking additional sources of research support, particularly from industry. In- dustry has been seeking investigators to test new equipment and medical devices. Restrictions in allowable financial awards, such as honoraria and consultation or service fees paid by companies to researchers testing their products, will reduce incentives and make the terms and conditions of bio- materials research financially unrealistic.

Why has this happened to biomedical investigators any- way? NIH policies that are already in effect coupled with the proposed new ones would put NIH-funded biomedical re- searchers in a category by themselves, apart from researchers who receive federal support from the Departments of Defense,

92 EDITORIAL

Agriculture, and Energy, as well as NSF and NASA, to name only the most prominent funding groups. Is fraud, miscon- duct, or conflict of interest less significant if it is committed by an investigator contributing to a new weapons system, or to agricultural, energy, or space research, rather than by a biomedical investigator? Is there some unstated bias on the part of those who have proposed these regulations?

Are we really deserving of this wrath that has been vis- ited upon us? I think not. But where should WE draw the

line? Some among us will argue that the requirement for disclosure of financial interests and the institutional review of such disclosures are reasonable. But here, I believe, is where the line should be drawn. Further restrictions on fi- nancial awards would be counterproductive, and their nega- tive effect on biomaterials research and development stand to far outweigh the benefits arising from guarding against a possible perception of conflict of interest.