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Ethics

I read a newspaper advertisement which solicited volunteers for a Phase I clinical trial: a one-month study of an antibiotic which offered subjects $1200 to "volunteer.” Interviews were to be conducted at the old Holiday Inn. Ten years ago nearly all drug research was conducted by academic researchers at medical schools and teaching hospitals. In the last decade, pharmaceutical companies grew impatient with academic bureaucracy and university IRBs, shifting over 70% of their research trials to private labs such as PPD (Pharmaceutical Product Development) and SFBC.1 I’m still trying to figure out what SFBC stands for, but it certainly isn’t San Francisco Boys Choir. SFBC ran the largest clinical trial site in North America. SFBC’s Miami operations, based in an old ramshackle Holiday Inn, were recently condemned and demolished.1,2 It seems that SFBC (which has since changed its name and practices) was running what University of Miami bioethicist Kenneth Goodman calls "a human-subjects bazaar.”1 Besides the money offered to volunteers, private researchers are often paid tens of thousands of dollars for each subject they can enroll in a trial.3,4 Most research sponsors have policies and procedures to make sure clinical investigators give full financial disclosure to the IRB. Pfizer, for example, sets guidelines with respect to compensation during recruitment and trials.5 They require senior management approval and documentation of any request for compensation that goes beyond the performance of "specific and necessary services.”5

The shift away from academic to corporate research labs means that pharmaceutical and biotech companies now deal with for-profit IRBs. These for-profit IRBs are built for speed and profit in a highly competitive market. In contrast, university-based IRBs consist of volunteer faculty who meet a few times each year (The Nova Southeastern University IRB meets monthly). If a study is not approved by the university IRB, the academic researcher cannot take it to another IRB. It is easy to imagine the potential conflict of interest that can exist between research sponsors and for-profit IRBs. Unethical behavior is often invited by these kinds of environmental circumstances and financial incentives, and some for-profit IRBs need to look at the way leading university-IRBs conduct ethical reviews.

Academic centers provide clinicians and researchers who are held accountable to the highest standards of medical ethics. Universities, after all, are the source of experts in research design, bioethics, peer-reviewed writing, and service to the community. Nova Southeastern University is planning to build one of Florida’s largest research labs.6 When completed, NSU’s Center for Collaborative Research (CCR) will house medical, pharmaceutical, dental, and oceanographic research.7 It is important for universities to court pharmaceutical and other research sponsors. They have a lot to offer: mainly, a partner who doesn’t view research primarily as a way to make money. Universities answer to a higher calling - an ethically-based calling that seeks to understand the world around us in order to better serve mankind. This approach is actually on par with the policies and goals of most research sponsors.5

This reminds me of the story about a journalist who was comparing churches across the country. In California, he noticed a gold phone with a sign that said, "Direct line to God: $10,000 a minute.” A week later, at a church in North Carolina, he notices a gold phone that says, "Direct line to God: 35 cents.” The pastor at the church in North Carolina tells the journalist it’s a local call because he is in God’s country now. University-based research is only a local call from expert teachers, clinicians, ethicists and academic researchers. It is the best place for pharmaceutical and biotech companies to do the kind of research that reinforces public trust.

  1. Elliott, C. (2008, January 7). Guinea-pigging. The New Yorker, pp. 36 - 41.
  2. Evans, D. (2006, June 12). SFBC ordered to demolish Miami drug test center. Bloomberg. Retrieved January 8, 2008, from http://drugsafety.ca/
  3. Eichenwald, K & Kolata, G. (1999). Patients for hire, doctors for sale. The New York Times. Retrieved January 8, 2008, from http://query.nytimes.com
  4. U.S. Department of Health and Human Services (2007, August 20). Fact sheet. Retrieved January 8, 2008, from http://www.hhs.gov/news/facts/infusiontherapy.html
  5. Pfizer (2007). Policy on compensation to investigators in clinical trials. Pfizer Research & Development. Retrieved January 9, 2008, from http://www.pfizer.com
  6. NSU (2007, July 11). Nova Southeastern University to build one of Florida’s largest research laboratories. News Release. Retrieved January 9, 2008, from http://www.nova.edu/cwis/pubaffairs/news/july-sept2007/research_lab.html
  7. NSU (2007, December 10). Dr Gary S. Margules appointed vice president for research and technology transfer for Nova Southeastern University. News Release. Retrieved January 9, 2008, from http://www.nova.edu/

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