com m e n ta ry

nature medicine volume 17 | number 4 | april 2011 437

Thomas P. Stossel is in the Department of

Medicine, Harvard Medical School, Boston,

Massachusetts, USA, and Lance K. Stell is in the

Department of Philosophy, Davidson College,

Davidson, North Carolina, USA.

e-mail: tstossel@partners.org

Overwhelming evidence that relationships between universities, physicians and the medical products industry benefit patients explains the ubiquitous calls to encourage such relationships. Yet accumulating ‘conflict of interest’ regulations in academic health centers, government and industry have had the opposite effect. Justifications underlying the regulations lack quantitative rigor, and the rules they enforce impose costly bureaucratic requirements of dubious benefit. Evidence shows that they have diminished the collaborations deemed beneficial to health enhancement.

Every policy governing the relationships between academic medical centers and the medical products industry ‘talks the talk’, forthrightly affirming that these relationships are essential for drug and device innovation. But product innovation is in serious trouble when the same academic institutions profess to defend industry-physician collaboration while apologetically genuflecting to a con-flict of interest (COI) regulation movement, the effect of which has been to suppress such collaborations.

Nearly twenty years ago, Kenneth Rothman warned of “a new McCarthyism” in relation to COI policy1, but instead of listening to him and rising to fight it, we invited onto our campuses moralizing avatars dedicated to purging them of corruption, the seeds of which were suppos-edly sown by industry’s insidious exploitation of the freedom of association and of speech.

Time to ‘walk the walk’ about industry ties to enhance healthThomas P Stossel & Lance K Stell

Their white-glove inspections found traces of conflict in our pockets, on our desks, in our sample cabinets, in our food, in the programs of our professional meetings—everywhere. Instead of critically evaluating and rebutting their allegations, chagrined, we acquiesced to round after round of prophylactic COI regula-tions, each iteration more intrusive than the last, delineating what must not be said, what types of association must not occur and what hard-earned rewards for excellence cannot be accepted by researchers and educators in our most prestigious halls of medical learning.

Nevertheless, we have still been apologizing for relationships, the vast majority of which have been free of corruption and, more importantly, have produced value for patients. Beginning in the 1970s, unencumbered by regulation, aca-demic researchers founded biotechnology com-panies and entrepreneurial surgeons invented devices, and these doctors worked with indus-try to translate their ideas into useful products, resulting in stunning innovations in patient care. Two among many examples are a vaccine to prevent hepatitis B, a major cause of cancer worldwide, and percutaneous catheters enabling physicians to gain access to diverse organs for diagnostic and therapeutic procedures with great speed and minimal morbidity.

Insinuations of corruption by those who call for increased oversight and regulation of the interaction between academia and indus-try require quantitative evidence—for a start, providing a denominator as well as a numera-tor. Everyone has heard the stories composing the numerator: the same cases alleged corrup-tion due to industry influence, many laced with hindsight wisdom, dredged up repeatedly and assembled into a narrative framework. But the storytelling suffers from serious ‘denominator neglect’—the non-nefarious, noncorrupt, ben-eficial collaborations, over decades that dwarf the comparatively few cases that populate the numerator. When we attend to the numerator,

the misconduct rate is negligible. The numera-tor of supposedly substantive adverse outcomes due to industry relationships (excluding rela-tionship disclosure lapses discussed below) barely adds up to two digits2. Surveys reporting that over 90% of physicians have some type of financial interaction with industry, with 18% of them engaged in consulting arrangements3, indicate that the denominator is orders of mag-nitude greater.

Indeed, on further review, many of the sup-posedly problematic cases have turned out to be not as initially advertised. The laundry list of adverse consequences of commercial relation-ships consistently invoked by COI policy fram-ers—degraded research, neglect of teaching commitments, excessive secrecy, loss of pub-lic trust—has not materialized4. Speculation that commercial support of education inflicts undue bias, leading some universities to reject such support, is belied by extensive surveys reporting little impression of such bias5.

The COI movement casts a jaundiced eye on failures to disclose payments from industry. It uncritically has put stock in the marketing of a need for greater transparency—‘sunshine is the best disinfectant’. But this seemingly plausible mission is not so straightforward; its outcome measures are not defined, nor is its price con-sidered. The opportunity costs of a now feder-ally mandated (as part of the Patient Protection and Affordable Care Act) ‘sunshine’ exercise—assembling physician payment data to the $10 level, reviewing, reporting, analyzing, auditing and ultimately disclosing the payments to the public—will be substantial.

Supposedly, this expensive effort will enable the public to make informed judgments about whether their healthcare providers have been compromised, are biased or likely to be dis-loyal. But the data cannot reliably support such inferences.

It must be emphasized that innovation is not academic research. No Rosetta Stone enables

© 2

011

Nat

ure

Am

eric

a, In

c. A

ll ri

gh

ts r

eser

ved

.

com m e n ta ry

438 volume 17 | number 4 | april 2011 nature medicine

panies to surgeons have decreased 50%, with 75% fewer surgeons receiving such payments11. Arguably, some such payments were akin to bribes, but to suggest that bribery applies to three quarters of all surgeons is not credible. Device approvals by the FDA have plum-meted (http://www.fda.gov/MedicalDevices/P r o d u c t s a n d M e d i c a l P r o c e d u r e s /DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm073327.htm). Patients desperate for new and better treatments should be appalled—we all should be appalled.

Abandoning this desultory course requires that our academic leaders return to walking the walk. Rather than shrinking before poorly justified, slogan-ridden allegations of critics, sensation-seeking media and demagogue poli-ticians, they should subject them to the same rigorous analysis they demand from their sci-entific endeavors. The clarity of the findings will steer them to recommitting their institu-tions to collaboration and cooperation with their industry partners. Our goal should be excellence in research, education and patient care. Our fellow citizens expect it. We should pursue it with no apologies.

COMPETING FINANCIAL INTERESTSThe authors declare competing financial interests: details accompany the full-text HTML version of the paper at http://www.nature.com/naturemedicine/.

1. Rothman, K.J. J. Am. Med. Assoc. 269, 2782–2784 (1993).

2. Stossel, T.P. Perspect. Biol. Med. 50, 54–71 (2007).3. Campbell, E.G. et al. N. Engl. J. Med. 356, 1742–1750

(2007).4. Stossel, T.P. N. Engl. J. Med. 353, 1060–1065

(2005).5. Kawczak, S., Carey, W., Lopez, R. & Jackman, D. Acad.

Med. 85, 80–84 (2010).6. Zycher, B., DiMasi, J. & Milne, C. Am. J. Ther. 17,

101–120 (2010).7. Stell, L.K. J. Law Med. Ethics 37, 431–443 (2009).8. Osborn, J.E. Yale J. Health Policy Law Ethics 10, 299–

356 (2010). 9. Silverglate, H. Three Felonies a Day: How the Feds

Target the Innocent. Ch. 3 (Encounter Books, 2009).10. Accreditation Council for Continuing Medical

Education. Annual Report. http://www.accme.org/dir_docs/doc_upload/f2e89864-b4c1-428f-8ebe-1ba197a31928_uploaddocument.pdf (2009).

11. Healy, W.L. & Peterson, R. J. Bone Joint Surg. Am. 91, 1791–1805 (2009).

aligns hat-wearing incentives perfectly. Physicians wear many hats, and industry workers do, too. Myriad descriptions char-acterize the complex, nuanced relationships between academic physicians and workers in the medical products industry. To impress onto this complexity and, by fiat, the taint of ethical toxicity requires strong justifica-tion. Stamping them all with COI indulges an arbitrary bias, insinuating that physicians’ relationships with industry need toxicity management—eliminate, reduce, minimize or disclose, rather than proliferate, increase and maximize. We challenge the linguistic legerdemain that substitutes ethically suspect for mutually beneficial7.

Nevertheless, this poisonous language has promoted damaging policies in academic health centers in some states and in the federal government. The damage is not merely rhe-torical. It has discouraged academic-industry collaboration because both parties fear media opprobrium. Worse, burdensome compliance requirements burn precious resources that would better go to collaboration, research and education.

Barriers to collaboration are proliferating within industry itself, thanks to the exploita-tion of COI rhetoric by prosecutors in league with whistleblowers, maladaptive US Food and Drug Administration (FDA) law and draconian penalties. When faced with the equivalent of a corporate death penalty—no sales of any prod-uct to Medicare—companies have little choice but to settle accusations of illegal off-label product promotion and resulting false claims, in spite of an absence of proven damages8 and the fact that indicted individuals not subject to the same draconian penalties as their employ-ers have successfully defended themselves in court9.

What has this harvest reaped? A culture of fear has elevated prosecutors and compli-ance lawyers to running the medical products industry. As a result, industry support of med-ical education has declined by 30% over the past three years10. Payments from device com-

industry to mechanically translate research dis-coveries made by academics into useful prod-ucts6. Academic institutions, especially elite ones, are incompatible with the mass-produc-tion and quality-control requirements of prod-uct development. Nevertheless, academia and industry have much to offer one another—if given the chance. The chance requires a lot of trial and error to accommodate the unpredict-ability of biology and adaptation to serendipity associated with innovation. Minute oversight and contractual specification of every interac-tion and staples of COI regulations are inimical to such flexibility.

Innovative products can help patients only if clinicians know about them. Derision of industry marketing as qualitatively different from and morally inferior to academic educa-tion stigmatizes practically useful information (and academic health centers market their ser-vices aggressively with far less regulation than industry). Worse, banning such marketing from campuses drives a care-impairing wedge between producers of drugs and devices and prescribing physicians.

The same economic dictum influences aca-demic health centers and industry—no margin, no mission. Bottom lines for each institution reflect value tradeoffs, risk tolerance and oper-ating costs. The COI movement insinuates that industry cares only about returns on invest-ments and nothing about the appropriate use of their products, a charge not only disrespect-ful but wrong. The COI movement perpetuates the prejudice that the medical products and academic medical industries inhabit separate moral universes: the former unprincipled and greedy, the latter altruistic and dedicated solely to science and service. The evidence is to the contrary: research misconduct has been more common in academic settings where work-ers are subject to far less oversight than in the medical products industry4.

Demanding regulation of COI represents a pejorative, framing bias. No party to any relationship wears the same hat at the same time and in the same way; no relationship

© 2

011

Nat

ure

Am

eric

a, In

c. A

ll ri

gh

ts r

eser

ved

.