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The pros and cons of halting research


By Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

(CNN) -- The National Institutes of Health recently halted a large study of hormone replacement therapy, or HRT, for menopausal women.

Many thousands of women were in the years-long clinical trial in which some got hormone replacement and others received placebos -- inactive pills.

An independent board was monitoring the outcome of the study as it proceeded, and it recommended stopping the study because the rates of some cancers in the group receiving the hormones were higher than the rates in women not taking the drugs.

That is not to say HRT had no benefits, but the safety oversight board argued that the benefits were outweighed by the increased risks of the hormones.

The NIH agreed, sending letters to all the women in the study advising them to stop taking the pills they were given.

The HRT study raises important questions.

When should research be stopped? Who should decide? And when it is stopped, how can the information be delivered so that both research subjects and patients currently on the treatment receive the information promptly, with adequate support and other resources?

The value of research

One of the byproducts of activism in the 1980s and '90s around diseases such as HIV/AIDS and breast cancer was a shift in policy that requires the inclusion of historically underrepresented population groups in medical research.

This has meant the NIH requires that women and ethnic minorities must be included in research projects, and there is a move to include more children in drug research too.

The change in policy was driven by the realization that there is real benefit to the groups on whom research is carried out.

For example, an aspirin a day to reduce heart disease was shown to be effective in men, but the study yielded little information on women's health and heart disease.

The HRT study was among the first large-scale studies that focused on women's health, and while there was little benefit to participants (and some harm), the trial yielded important information that will help treat millions of women in the future.

The uncertainty about whether a new approach actually works or may in fact be harmful is what distinguishes research from accepted therapy.

Risk is inherent in research, and those who participate in it must be willing to undertake some potential harm and uncertainty to help create knowledge that will be useful down the road.

Good news and bad news

The good news in this story is that the study was stopped once it became clear that subjects were being harmed, and that the independent safety monitoring board was willing and able to halt the trial knowing that it would have a huge impact both in and out of the study.

In other words, the data safety and monitoring system used by the NIH works.

One of the issues that surfaced when the trial was stopped was that it took 10 days between the time the NIH decided to end the trial and the time research subjects were notified.

Even with that lag time, there were precious few resources -- such as Web sites, toll-free numbers, etc. -- available for study participants, patients already taking HRT and their doctors once the decision was announced.

The bad news in all this is that the study was stopped because HRT seems to offer more harm than benefit over the long term, which leaves open the question about what women already taking hormones ought to do now, and what is best for patients in the future.

In the end, the HRT trial reminds us that there is a tradeoff inherent in medical research: Risk to the few should lead to benefits for the many.

As long as there is a trustworthy system in place to protect subjects as research proceeds, it is a deal that we can all understand and that many will accept.

Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.

"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.




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