Research Fraud and Reporting Fraud (Published April 9, 2001)

I just watched a 60 Minutes segment that correctly cautions the public about doctors conducting research projects for lucrative contracts and willing to compromise patient eligibility. What was disturbing to me, as a medical researcher for 27 years, was the flagrant disregard for the safeguards that protect patients who volunteer to participate in developing new medications and procedures to help others with similar conditions.

60 Minutes showed a case of a doctor who falsified data to get otherwise ineligible patients into research projects so he could make considerable profit from their participation. He was only caught because one of his employees, after knowingly participating for some time, finally reported him.

What's wrong with this presentation of a clearly egregious situation? Let's review why and how clinical research is done. After all, the wonder drugs we take for granted didn't just appear in the pharmacy. The pharmaceutical industry is always looking for new patentable medications to treat common conditions. There's gold in them thar ills. Once potential drugs are examined in animals and healthy human volunteers for safety, efficacy and dosing, they are tested in larger populations of patients with the condition of interest. That's where you come in.

Clinical investigators recruit qualified patients by informing them of the nature, risks and procedures involved. If consent is obtained, the patient participates under close supervision of the investigator and the staff. If the medication works better than the comparison treatment, the sponsoring company may then proceed to the Food and Drug Administration will all of their data and ask that this medication be allowed for defined conditions. If the drug works far better (or far worse) than the comparison treatment, the internal safety board stops the study prematurely.

What was wrong with the 60 Minutes segment? It did not tell you everything. They let you think that any Dr. Tom, Dick or Harry can do research, and without any oversight whatsoever. Research fraud for any reason, but especially for the money, is a criminal offense. Although isolated, bizarre incidents occur in any circumstance (look at the November election); these are clearly rare events.

First, the pharmaceutical companies have a responsibility to select the best researchers available based on their résumés and experience. The consent forms that patients read to consider participating need to be in plain speak, and accompanied by a Research Patient's Bill of Rights (yes, this does exist). The organization responsible for monitoring the project needs to make sure the patients truly exist and meet all the inclusion and do not have any of the exclusion criteria. And the investigator and staff need the intellectual and moral courage to inform and select the appropriate patients, and then perform the research program as designed.

I have been doing clinical research for 27 years and the Ventura Heart Institute has proudly contributed to the development of many of the almost miraculous agents patients take for granted. I would shudder to think that shabby reporting, even done with the literary license so overplayed by the media in order to entertain its audience, exemplified by this 60 Minutes segment (done appropriately on April Fool's Day) would cause patients to not want to participate in new drug development studies. It is only through these research projects that we, as clinical investigators, will improve patient outcome and quality of life. And those goals are most important to me, as a physician.



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