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State Clears Prof Of Ethics Charges

Case of Med School Fellow Also Dropped

By Laura M. Murray, Contributing Reporter

The state medical board recently dismissed all charges against two physicians for their conduct during research of an eye drug at a Harvard- affiliated hospital.

Associate Professor of Ophthalmology Dr. Kenneth R. Kenyon '65 and former research fellow Dr. Scheffer Tseng were accused of violating Harvard's conflict of interest policy by holding stock in a drug company--Spectra Pharmaceuticals--which sponsored their study of the medication.

The medical board dismissed the charges, brought against the doctors by the Board of Registration in Medicine during May 1990, after considering magistrate Joan F. Fink's recommended ruling of the case. The board reached its decision march 11 and, according to The Boston Globe, publicly disclosed it last week.

The disclosure of the doctors' investment in Spectra Pharmaceuticals, the company which sponsored research of the eye medication, sparked a controversy two year ago which resulted in a change in Harvard's conflict of interest policy.

The new policy, approved by the Medical School's Faculty Council in March 1990, requires that doctors obtain approval from a Medical Center committee if they wish to hold stock in a company for which they are doing clinical research.

Although the state medical board expressed "concerns" about the conduct of both doctors, the board concluded that the neither physician's conduct "constitutes a violation of statute or regulation," according to the written record of the board's March 11 decision.

According to her January 31 ruling, Fink found that Harvard's policy at the time of the study did not "contain any prohibition which would have barred [the doctors] from owning stock in Spectra" while performing the study.

Fink also considered allegations that Tseng administered an experimental drug without consulting the appropriate hospital committees and altered his research protocol without consulting a hospital oversight committee.

Although Fink did find Tseng's actions in violation of hospital policy. she urged the Board in her ruling to consider that "at no time during the course of the study was patient safety ever compromised."

She also found that Tseng administered the unapproved medicine "in a sincere attempt to help a desperately ill patient," the ruling stated.

In addition to these charges, Tseng was also accused of publicly exaggerating the results of his study by implying that the eye ointment he researched as a Harvard fellow was more effective than his studies indicated.

But Fink said in her ruling Tseng's remarkswere in relation to earlier research he performedat Johns Hopkins and did not "in any way"misrepresent the results of the study he conductedas a Harvard fellow.

Kenyon was also charged with failing to ensurethat Tseng adhered to protocol, and neglecting to"promptly and accurately" publicize the study'sresults, the ruling said.

Fink said that no evidence suggested thatKenyon "conducted himself in an unethical orfraudulent manner" as the study's principalinvestigator.

Medical school faculty members disclosedearlier this year that 16 doctors affiliated withthe Medical School were on review for possibleconflicts, a situation which many researchers sayhinders productive partnerships between researchand industry

But Fink said in her ruling Tseng's remarkswere in relation to earlier research he performedat Johns Hopkins and did not "in any way"misrepresent the results of the study he conductedas a Harvard fellow.

Kenyon was also charged with failing to ensurethat Tseng adhered to protocol, and neglecting to"promptly and accurately" publicize the study'sresults, the ruling said.

Fink said that no evidence suggested thatKenyon "conducted himself in an unethical orfraudulent manner" as the study's principalinvestigator.

Medical school faculty members disclosedearlier this year that 16 doctors affiliated withthe Medical School were on review for possibleconflicts, a situation which many researchers sayhinders productive partnerships between researchand industry

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