Psyche, Science, and Society

Secret clinical trials research puts patients at risk for no benefit

April 30th, 2008

[UPDATED with link to article] An article in the Canadian Press raises serious new questions about the dangers posed to research participants by our corporate-dominated drug development system. Patients were enrolled in clinical trials of a type of blood replacement product despite previous research indicating that these products posed serious risks. The Canadian Press reports that new article in the Journal of the American Medical Association [Available here. Also see accompanying editorial.] pooled data from 13 published studies and three unpublished ones. Their review “showed people who got blood substitutes were 30 per cent more likely to die than those who did not.” These researchers were unable to obtain data from other unpublished studies conducted by companies.

There appear to be several major ethics issue here.

Participants in these studies, who supposedly give informed consent, were not told that prior research suggested these products were harmful. Nor, apparently, were the ethics committees [IRBs] that approved these studies and the informed consent procedures told about the dangers.

The results of several clinical trials were never published, presumably because they produced results indicating the products were harmful. Thus, important information was withheld from the public, putting patients recruited for additional clinical trials at risk.

Lead author Dean Fergusson, a clinical trials expert, said the withholding of the negative results meant ethics boards and trial participants could not accurately weigh the risks and benefits of the research.

“How can patients or their decision makers make truly involved consent without all this information? I think that’s a huge message,” said Fergusson….

The lack of disclosure suggests company stock prices were placed at a higher priority than the safety of people being asked to go into clinical trials, experts suggest.

An additional concern is whether ir is ethical to recruit people for clinical trials, placing the participants at potential risk — which is always the case in drug trials — and then not publish the results. A critical consideration in obtaining approval for research from IRBs is supposed to be a balancing of risks and benefits. Often, the benefits are not to individuals, but to society. If the results are not published, these benefits are not realized. So people are put at risk for no benefit, which is supposedly unethical. It would seem that a commitment to publish the results should be required of any study where there is a serious risk to participants. Otherwise these studies should not be allowed. Note that this argument is different than the argument, with which I also agree, that these studies should be published for the good of the public and that corporate profit should not be allowed to trump public good.

Finally, there is a question of whether these trials should have been undertaken in the first place, given the bad track record of this type of blood replacement products in prior research. The JAMA authors apparently believe the answer is “no”:

The authors were critical of the FDA for not requiring the companies to publish their findings, and for allowing additional trials to be conducted after the risk should have been apparent.

“At some point, somebody should have realized that we’ve tried it in trauma patients, we’ve tried it in surgical patients, we’ve tried it in stroke patients, we’ve tried many different formulations and we keep finding the same result,” said Dr. Charles Natanson, lead author of the meta-analysis, a technique in which data from a number of trials are combined and re-analyzed.

“At some point, and we sort of argue in the paper that may have been the year 2000 . . . it was time to put a halt” to additional trials, Natanson said.

This information raises profound questions about our entire drug development system. The corporate dominance of drug development creates inherent conflicts of interest that put both clinical study participants and the public at risk. Either we need to find ways of overcoming those conflicts of interest or we need to develop a new system for drug development. How many scandals will it take till the health professions, policy-makers, and the public are fed up?

Entry Filed under: Medicine, Science