Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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Appendix C Scenarios and Rapporteur Summaries
Appendix C Scenarios and Rapporteur Summaries
Pages 110-124
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From page 110... ...
and private sector third party payers for statements regarding procedures and related guidelines for appropriate use.
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From page 111... ...
In most instances, panel members in appropriate medical specialties provide consultation regarding a variety of issues related to insurance claims and related coverage issues referred to them by the medical director of Piecerock. On occasion, panel members are called upon to review new or revised company policies on the coverage of medical and surgical procedures.
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From page 112... ...
The regular university rule, which is true of my academic institution, as well as many others, that you are allowed a certain number of consulting days seemed to go down pretty well with everybody. There seemed to be ready acceptance of the idea that it is acceptable for faculty members to exceed time rules concerning conflict of commitment—such as the 50 days a year ruler in the case of a closely affiliated non-profit organization.
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From page 113... ...
Some felt that PORT investigators had to be scrupulous not to share with commercial employers any unpublished study results. Since this would require constant vigilance on behalf of a consultant, commentators asked whether it was practical for the right and left brains, as it were, of the consultant to remain detached in this way—in other words, whether this non-disclosure standard could be met.
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From page 114... ...
The discussion of this scenario also addressed some questions related to what technical terms should be incorporated into a consulting relationship. How do you protect a university's right to information?
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From page 115... ...
The PORT will require one year to get started and to identify and enroll patients to collect health status and quality-of-life measures not generally found in medical records or claims data; it will take the last year of the grant to analyze its data. CARDPAK Start of Study In addition to data from insurance claims files and medical records, a key component of this 5-year study~pecified in the AHCPR notice of grant award—is to test the utility of the computer software package CARDPAK in the study of arteriosclerosis.
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From page 116... ...
Cathco management knows that at least one major health care product corporation is considering acquiring Cathco, and that success of its new catheter would significantly enhance the company's asking price. As the Golden PORT is nationally recognized in the study of the management of arteriosclerosis, Cathco has approached the PORT concerning a proposed research contract.
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From page 117... ...
Hart is convinced that prospective data on invasive techniques" collected over many years at his center supports laser atherectomy as a preferred technique, particularly since recent advances in the technique seem to have improved survival rates. He is attempting to persuade the other PORT investigators that his prospective RCI data on eight-year suIvival rates should outweigh the findings of their three years of Case-control observational data in the PORT study and that publication should be delayed pending longer-term survival data.
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From page 118... ...
Stenose -- this is quite a cast of characters -- who was offered the two and a half million dollars to study the Cathco's catheter and who in the scenario -- Alex didn't mention this -- sits on an FDA panel reviewing a Cathco application. His daughter, furthermore, owns stock in Cathco.
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From page 119... ...
There was no attention given to the fact that Stenose, with his PORT hat on, was going to be evaluating a competitor, who was not paying him, but with his Cathco hat on, he was going to be evaluating the Cathco catheter and getting paid for it. Now, there was some talk about how many catheters one can evaluate at once, and there was some kind of scientific concern that if one were evaluating too many devices or drugs at once, it might somehow affect how objective one could be.
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From page 120... ...
He also mentioned—I thought this was interesting—that researchers were too valuable a commodity to waste as hired guns doing whatever research private companies pay them to do.
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From page 121... ...
BMI recently entered into a joint venture with Unicorn, Inc., a U.S.based third party claims processor, and Mega Pharmaceuticals, the largest U.S.-based pharmaceutical company with a full line of top selling therapeutic agents, including agents for the management of all major chronic diseases such as hypertension and diabetes. The joint venture will install computers in 5,000 physicians' offices in the United States and will sell data on physicians' prescribing patterns to pharmaceutical companies, contract with insurers to develop patient and physician profiles, and contract with health maintenance organizations to assist with implementing their utilization controls.
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From page 122... ...
The Mega Pharmaceuticals Foundation, a not-forprofit, grantmaking institution established by Mega Pharmaceuticals, makes grants of approximately $1 million annually to medical researchers on the faculty of Prestige University Medical School. Discussion of Scenario III Michael Pollard, Esq.
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From page 123... ...
With regard to the Mega Pharmaceutical Foundation support, the initial reaction by some panel members was that this was not an overt conflict of interest, but we returned to this question, thanks to Mr. Hutt, in terms of the so-called laundering issue - whether it makes a difference if the support flows to the university or goes directly to the individual researcher under some kind of consulting arrangement.
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