There seems to be a gathering head of steam for the remarkable idea that people have a "moral obligation" to be the subjects of research. To which bioethicist Carl Elliott responds with characteristic vigor:
"Only 16 percent of academic health centers in this country will pay the medical bills for research subjects who are injured in clinical trials. None will pay for lost wages and suffering. And an ethicist is arguing that we all have a duty to sign up for these trials? Give me a break."
Science policy expert Gina Maranto discussed the problems with this idea at Biopolitical Times in March, taking off from a critical analysis by Stuart Rennie, and law professor Jonathan Kahn has also addressed the question, but evidently the advocates are not deterred. The University of Minnesota recently hosted a conference discussing whether there is a moral obligation to be research subjects. There is a report by Bill Gleason in the Chronicle of Higher Education, including links to four presentations. Among those present, for part of the time, was the mother of a young man who committed suicide during an AstraZeneca-funded clinical trial at the University for which he should never have been accepted. Particularly in light of that scandal, Gleason is scathing:
But what really frosted me was the "moral obligation" business. Thou shalt not steal, thou shalt not kill, thou shalt not covet thy neighbor's wife, thou shalt participate in clinical research?
Two recent reports provide even more context for this discussion. Pro Publica has been tracking "Dollars for Doctors" and their work drew the attention of CBS:
A dozen pharmaceutical companies have given doctors and other healthcare providers more than $760 million over the past two years - and those companies' sales comprise 40 percent of the U.S. market.
Insofar as there is good news, it is that such payments will have to be listed publicly, beginning in 2013, under the Physician Payments Sunshine Act (part of President Obama's healthcare reform). However, it's still essential that doctors and researchers report their findings accurately. So this recent report in the Milwaukee-Wisconsin Journal Sentinel is really disturbing:
Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company's spine surgery product in a 2009 paper about results of a large clinical trial. The surgeons left out important data and claimed there was no significant link between the product and cancer.
The millions of dollars were not paid for work on this particular product, but the numbers are astounding: A firm "associated with" two of the co-authors received $9 million from Medtronic in 2010. Another author's firm got $800,000 from the company in 2010. The three other co-authers received either nothing or less than $10,000 that year.
The FDA's reviewers "expressed serious concerns about the cancer risk." George Lundberg, former editor of JAMA, was asked for comment:
"The authors by virtue of how little attention they paid to it, ... they didn't want it to be there," he said. "And the company especially didn't want it to be there - out where everybody would see it. They also knew that nobody much reads the FDA reports."
Weren't the authors morally obliged to highlight evidence that went against their patron's interest? Isn't that, in practice, a more important moral question than whether the laity should be guilt-tripped into taking part in clinical trials?
The "moral obligation" to participate seems to presume a perfect world, in which research is performed only for the benefit of future patients, who would be prescribed treatments based only on their health needs. Setting aside the other arguments against it, such as competing responsibilities (including other ways to contribute to the community), it's all too clear that we do not live in an ideal society. There is a serious mismatch between the moral imperative asserted for the subjects and the financial imperative demonstrated by all too many of those using the data.
In closing, a worthwhile suggestion for consumers from Dr. John Santa, head of the Consumer Reports Health Ratings Center:
"Doctors who have relationships with drug companies will often have ... information that they give patients that comes from the drug company. You should be wary of that ... First of all, you shouldn't hesitate to ask, 'Do you have a relationship with a drug company? Is it your policy and your practice to take money from drug companies?' More and more, I think, it's good for consumers to ask those kinds of questions. What you should especially ask, though, is, 'What are my other options?'"