Elizabeth Austin’s article “You Bet Your Life” [Sept. 10] portrayed clinical trials in a highly negative light. The illustrations and tone of the article would dissuade anyone from participating in a trial. In reality, these trials are highly regulated under the FDA.
As a clinical trials monitor, my responsibility is to verify that the rights and well-being of human subjects are protected; that the reported trial data are accurate, complete and verifiable from source documents; and that the overall conduct of the trial is in accordance with regulatory requirements. The physicians and staff involved in these trials are compensated for their professional time evaluating potential patients, providing study-specific care, and all follow-up required. There is also a tremendous amount of auditable documentation that accompanies this process.
There are many safeguards, even in a double-blind trial. A physician can break the blind at any time if he or she feels the patient’s safety is at risk. Blinded lab results are also reviewed by an unblinded third party.
These trials are vital to the development of new drugs and devices that allow treatments and, potentially, cures to be available to everyone.
— Sherri Janousky, President, Clinical Options Inc., Chicago
The Y-ME National Breast Cancer Organization supports and encourages the use of clinical trials. Breast cancer treatment has changed over the last 20-some years because of the brave women who participated in clinical trials on breast cancer. We would not be able to tell women that the survival rates for mastectomy and lumpectomy with radiation are the same without the findings of a randomized clinical trial. We might still be treating most women with mastectomy, if the women in that clinical trial had not let the computer decide their treatment.
Austin also confused treatment and prevention trial. The caption under the picture of a gun, “A double blind study means that neither patient nor doctor knows who is taking active medication and who is going untreated,” was not only inflammatory but also inaccurate. This is not the definition of a double blind treatment study. In treatment studies, new drugs or combinations of drugs are compared to “standard of treatment.” No person with a diagnosed disease goes without treatment in a clinical trial. Austin’s experience was with a prevention trial. Austin is correct that there may be more risks in a prevention trial.
People considering a clinical trial need to know what to look for and what questions to ask. We wish Austin had used the valuable media space to write a more constructive article focusing on what would help the process, instead of needlessly frightening people. We strongly agree with Dr. Dickersin’s comment, “The bottom line is, how are we going to get the real answers?”
— Susan Nathanson, Executive director, Y-ME National Breast Cancer Organization, Chicago
Elizabeth Austin provided a compelling, and at times frightening, account of the risks involved in clinical trials. Nevertheless, this research remains one of medicine’s best and most accurate tools for assessing the safety and effectiveness of new medications and treatments. The goal, therefore, is to make clinical trials safer for those patients who participate.
One answer is to reduce our dependence upon animal testing. Time and time again, animal testing has failed to accurately predict outcome in human clinical trials, sometimes with severe if not fatal outcomes for the human patients. Consider this statistic from the FDA Drug Review: “Over half of all new medications the FDA approved in a decade were recalled or relabeled because of side effects not observed in animal experiments.”
Non-animal alternatives such as in vitro research, autopsies, mathematical and computer modeling, epidemiology, and genetic research can more accurately predict reliable human reactions and lead to safe, effective treatments.
— Peggy Cunniff, Executive director, National Anti-Vivisection Society, Chicago
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