The Body Hunters (28 page)

Subduing these “side effects” requires mothballing the mythology around medical research that sets them up as “side effects” in the first place. As bioethicist Solomon Benatar explains, “Research being done in developing countries . . . is not really for the benefit of those people [the subjects]. It may happen to be, for the few people lucky enough to get into the trial. But the reason the researcher is coming to that country is more often than
not because somebody is willing to pay for the study. Somebody wants an answer to a question. The data is valuable either academically or commercially.”
¹

In other words, the main business of clinical research is not enhancing or saving lives but acquiring stuff: data. It is an industry, not a social service. The people who sponsor and direct clinical trials do it for the data, not to please patients or to help bolster ailing health facilities, although they may point to these side effects to justify their activities. Their motives don't make them corrupt or mercenary, either, just regular, self-protective humans like the rest of us.

But if clinical research is a self-serving industry, then there's no reason to allow it special leeway, to look the other way when it bends and even breaks the rules. If we think that trial subjects should be informed and their participation should be consensual, we should require that informed consent gets checked and confirmed. If it's impossible, then we should require the research be stopped. We should require that the deals for subjects—access to study drugs after the trial ends, for example—be fair and good right here and now, not in some speculative future when prices fall, or poverty ends, and other people apply better solutions.

Such requirements, which could be incorporated into FDA rules, would be logical correctives to the profit-driven, competitive industry that clinical research has now become. But that begs the question as to whether we really want to accommodate this model in the first place.

Rather than simply dispelling the myths, we could start to demand that drug companies and medical researchers actually live up to them. The promise of medical research is that it will alleviate ill health and save lives, but clinical researchers only take on a tiny slice of that job: getting the data. When it comes to implementation, shoulders are shrugged: that's someone else's job. The disconnect might be acceptable for basic science, but if we want medical research to truly alleviate ill health and save lives,
then we have to hold it accountable when it renders little more than interesting papers and “me-too” drugs, whether it does so ethically or not.

Achieving this kind of accountability is no easy task. The public has no mechanism for setting priorities in research in the first place, no way to articulate what it is that we most want from medical research, and how we would use it if we had it. Aside from a few targeted programs, either the market decides and research goes into whatever drug companies think will sell, or sponsors decide on a case-by-case basis and whichever grant applications look most interesting get funded. Imagine instead a systematic review and a robust, independent, open public debate on where medical research has gotten us thus far and where it is that we want it to take us, not just among specialists and advocates, but all of us. It is hard to say where such an exercise might lead. Perhaps we'd see that research on the shelf has little meaning. Poor countries may well prioritize the implementation of old research over the pursuit of new experimentation.

Opportunities to exploit the gap between the haves and have-nots would shrivel.

There are obvious pitfalls in these suggestions. Drug companies can easily find loopholes in stricter informed consent and other rules. Researchers can easily mount convincing arguments that millions will die if research is delayed or burdened with greater accountability. But there is one suggestion for slowing the body hunt that is fairly airtight, and that is to require that new drugs prove themselves better than already available ones, not just better than nothing.

This would trigger a profound shift in drug development and the clinical research it entails. Not only would it maximize the potential for drug trials to render public health benefits, but such trials would prove less risky for subjects, too. Investigators would, by necessity, provide all of them with active treatments. More important, higher FDA standards for new drugs would cut much of the fat out of the drug industry, favoring companies that produced
useful new drugs rather than hypermarketed copycats. The pace of new drug development would inevitably slow, as would the concomitant hunt for bodies. The competitive urgency that leads researchers to dilute ethical standards or transgress them entirely might start to abate.

Of course such a change would likely require an act of Congress and the drug industry would fight it tooth and nail, enlisting sympathetic patient groups to support them. We're not nearly there yet. But to get us on the road, we can start supporting drug developers that are already doing something similar: nonprofit outfits that develop drugs aimed at public health. If public and nonprofit drug companies can show they can develop worthwhile drugs efficiently, public confidence in the idea of making medicines not as a business but as a public health effort might grow. It may not seem so radical, then, to raise the bar on FDA rules, too.

It used to bother me that people could be so squeamish about human experimentation but yet have no problem capitalizing on the products it renders. It is the same kind of “not in my backyard” attitude that sends toxic waste and open-pit mining to Asia and Africa while Americans enjoy disposable plastics and aluminum foil. But I've come to believe it signifies something deeper: an understanding that there is something unsettling about using people for their tissues, blood, and metabolism. Turning the body into a thing rightly offends our sensibilities about what it means to be human. Experimentation depersonalizes us: trial subjects no longer have humor, style, habit, ideas. And we like to think of ourselves as more than just mushy machines.

But medicines are not just commodities, they are social goods, and their development requires experimentation on humans. So long as that remains true, we need to find ways to do it right, and to do it fairly.

 

1
. Daniel Callahan,
What Price Better Health? Hazards of the Research Imperative
(Los Angeles: University of California Press, 2003), 3.

2
. Jon Cohen,
Shots in the Dark: The Wayward Search for an AIDS Vaccine
(New York: W.W. Norton, 2001), 100.

3
. Ibid., 251.

4
. Julie Schmit, “Costs, Regulations Move More Drug Tests Outside USA,”
USA Today
, May 16, 2005; Marc Kaufman, “Clinical Trials of Drugs Fewer, Study Says: Report Also Notes Decline in Number of Principal Investigators in U.S.,”
Washington Post
, May 4, 2005, A2.

 

1
. See “Drop in Death Rates for Diseases Treated with Pharmaceuticals, 1965–1996,” available at
www.quintiles.com
, citing U.S. National Center for Health Statistics 1998.

2
. John Wurzlemann, “Presentation on Eastern Europe,” in Globalization of Clinical Trials panel, Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).

3
. Mark McLellan, “The Current Status of Clinical Trials,” in Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).

4
. Andrew Pollack, “Three Universities Join Researcher to Develop Drugs,”
New York Times
, July 31, 2003.

5
. David Horrobin, “Are Large Clinical Trials in Rapidly Lethal Diseases Usually Ethical?”
The Lancet
, February 22, 2003, 695–97.

6
. Stan Bernard, “The Drug Drought: Primary Causes, Promising Solutions,”
Pharmaceutical Executive
, November 2002, 7.

7
. Bonnie Brescia, “Better Budgeting for Patient Recruitment,”
Pharmaceutical Executive
, May 2002, 86; Andrew Pollack, “In Drug Research, the Guinea Pigs of Choice Are, Well, Human,”
New York Times
, August 4, 2004.

8
. The bubble of goodwill burst within weeks, when a faulty batch of vaccine was released, infecting 220 children with polio. Laurie Garrett,
Betrayal of Trust: The Collapse of Global Public Health
(New York: Hyperion, 2000), 330. The public recoiled in horror. Salk's vaccine, it was later revealed, also contained monkey tissue, a potential source of other pathogenic viruses, some of which could have triggered certain cancers. Anita Guerrini,
Experimenting with Humans and Animals: From Galen to Animal Rights
(Baltimore: Johns Hopkins University Press, 2003), 129.

9
. Garrett,
Betrayal of Trust
, 330; Sarah Marie Lambert and Howard Markel, “Making History: Thomas Francis, Jr., MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial,”
Archives of Pediatrics and Adolescent Medicine
, May 2000, 512; Marcia Meldrum, “‘A Calculated Risk': The Salk Polio Vaccine Field Trials of 1954,”
BMJ
, October 31, 1998, 1233–36.

10
. Kathleen B. Drennan, “Pharma Wants You: Clinical Trials Are Agencies' New Proving Ground,”
Pharmaceutical Executive
, April 2003, 83–84.

11
. Dan Moskowitz, “What Stops Cancer Patients Enrolling?”
Scrip
, November 2002, 13.

12
. In the original randomized, double-blind, placebo-controlled trial some subjects with metastatic breast cancer would get ninety minutes of infusion with Herceptin. Other, equally ill women would get ninety minutes of infusion with some inert substance. Then the researchers would watch to see which group got sicker faster. Patients couldn't have been less interested in participating. A year later the trial was still underenrolled. To entice more patients into the trial the CRO running the Herceptin trial dropped the placebo group. Despite the fact that for all anyone knew Herceptin could have been worse than a placebo, enrollment skyrocketed 500 percent over the original lethargic rate. “Patients
were also much more willing to travel to the clinic each week to receive treatment,” the CRO exulted on its Web site. See
www.covance.com/clinical/content/pg_clin_case-onc.html
. Interview with Dennis DeRosia, 2001.

13
. Horrobin, “Are Large Clinical Trials in Rapidly Lethal Diseases Usually Ethical?”

14
. Harsha Murthy, “The Use of Innovative Strategies in Patient Recruitment: Best Practices and Success Stories from Pharma and Biotech,” Maximizing Clinical Efficiency Phases conference, (Washington, DC, October 10, 2003).

15
. Horrobin, “Are Large Clinical Trials in Rapidly Lethal Diseases Usually Ethical?”

16
. Bernard, “The Drug Drought.”

17
. Roy Porter,
The Greatest Benefit to Mankind: A Medical History of Humanity
(New York: W.W. Norton, 1997), 67.

18
. Thomas Bodenheimer, “Uneasy Alliance—Clinical Investigators and the Pharmaceutical Industry,”
New England Journal of Medicine
, May 18, 2000, 1539–44.

19
. Ibid.

20
. See Quintiles Web site at
www.quintiles.com
.

21
. Sonia Shah, “The Globalization of Clinical Research,”
The Nation
, July 1, 2002.

22
. Public Citizen, “Comments on the Draft Health and Human Services Inspector General's Report,” Washington, DC, July 5, 2001.

23
. U.S. Department of Health and Human Services,
Report of the Office of Inspector General: The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects
, September 2001, iii.

24
. “In an average year, we estimate that approximately 1,140 foreign clinical trials . . . are conducted under IND review and oversight. . . . [W]e can . . . estimate that 575 non-IND foreign trials are conducted annually for eventual submission to FDA for research or marketing applications.” From “Human Subject Protection; Foreign Clinical Studies Not Conducted under an Investigational New Drug Application,”
Federal Register
, June 10, 2004.

25
. U.S. Department of Health and Human Services,
Report of the Office of Inspector General: The Globalization of Clinical Trials
, iii.

26
. Marc Kaufman, “Clinical Trials of Drugs Fewer, Study Says,”
Washington Post
, May 4, 2005, A2.

27
. Julie Schmit, “Costs, Regulations Move More Drug Tests Outside USA,”
USA Today
, May 16, 2005.

28
. Pfizer press release, reprinted from “India Hub to Lead Pfizer's Clinical Studies in Asia,”
Times of India
, October 3, 2003; “The Trial Trail,”
Business India
, March 3, 2003.

29
. See
www.quintiles.com/Corporate_Info/Regions/south_africa_and_india
.

30
. Interview with Bradley Logan, October 2003.

31
. “Treating Study Volunteers as Customers,”
CenterWatch Industry Reports
, March 2003, 1, 4.

32
. Yuri Raifeld and John Wurzlemann, Globalization of Clinical Trials panel, Maximizing Clinical Efficiency Phases conference (Washington, DC, October 9, 2003).