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Peter Holub,
DPM., MS.
Ethics
United States |
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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