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Clinical Trials

Joe Giffels, MAS, has written extensively on the regulation and practice of clinical research and is here to offer information. Here he shares information and advice on what you should know before, and how to decide if you should volunteer to participate in a clinical trial.

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WebMD Health News

Monday, March 10, 2008

Putting Alternative Medicine to the Test
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Alternative, or complementary, medicine encompasses all of the therapeutic and preventive strategies which enjoy a measure of success, despite not having been developed based on solid scientific principles. They include everything from herbal remedies to acupuncture, yoga and mindful thinking. Practitioners and patients alike swear by the effectiveness of particular healing methods, even where there may not be a scientific explanation of how they work or even empirical evidence that they do really work.

That alternative medicine has been taken seriously of late is evidenced by the establishment of one of the newest units of the National Institutes of Health - the National Center for Complementary and Alternative Medicine. The web site http://nccam.nih.gov/ lists a large number of clinical trials in this arena, involving the use of such interesting therapies as magnetic brain stimulation, broccoli sprout tea, moxibustion, polarity therapy, and expressive writing.

Criticism of research on alternative medicine arises on occasion, and when it does, is met with fierce opposition from advocates. The discussion customarily goes something like this:

"Alternative medicine is baloney."

"But many patients feel they've been helped by it."

"The science that is being done to prove whether or not these things work is pretty lame and, where it's been done properly, there's not much evidence of any real clinical effects."

"But many patients feel they've been helped by it."

"Patients aren't helped by the therapy at all - it's just the placebo effect at work."

"But many patients feel they've been helped by it."

I believe rigorously conducted clinical trials can make significant contributions to the conversation about alternative and complementary medicine.

First, clinical research on particular therapy or preventive measures could demonstrate their safety and weed out those that are actually harmful to patients.

Second, clinical research could demonstrate whether or not a particular therapy had a particular effect on patients, irrespective of whether or not the patient felt better. This would provide solid scientific information useful both inside and outside the alternative medicine debate.

Third, clinical research could quantify how much better patients felt as a result of a therapy, or by how much the incidence of a particular condition was lowered in a patient population as a result of a preventive measure.

I'm not sure there needs to be a determination, using clinical trials, of which alternative and complementary approaches should or should not be allowed, except in the case where significant health safety issues are raised. Rather, clinical trials can show whether or not a particular approach can be moved out of the "Alternative" realm and be accepted by the medical establishment and the communities it serves as a scientifically proven approach. And in the meantime, those approaches that have yet to be proven to have a measurable physiological explanation or effect can continue to benefit those patients who believe in them.

-Joe

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Posted by: Joe Giffels_ WebMD at 6:18 PM

Wednesday, March 05, 2008

Who Owns Your Blood? (continued)
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Photo Credit: Shen Shi'an
The U.S. Supreme Court recently weighed in on a case involving a university researcher, Dr. William Catalona, who claimed that the tissue samples collected under clinical trials he conducted while at Washington University in St Louis belonged to him and he could therefore take the samples with him when he transferred to Northwestern University in Chicago. Not surprisingly, the university objected, and the case made its way up the through the courts. Ultimately, the Supreme Court in effect upheld an earlier ruling that the samples belonged to the university and not to the researcher.

Throughout the process, the researcher was supported by a number of the research participants. In their minds, they felt the researcher deserved ownership of the samples because he designed and conducted the research, collected the samples, and had plans for continued research involving the samples. To them, the university was simply the institution at which the research was conducted, an impersonal entity compared to the individual they knew and associated with the research.

California's Supreme Court ruled that John Moore did not own the cell line developed from his bone marrow. Mr. Moore was a leukemia patient and participant in clinical research at UCLA conducted by Dr. David Golde who was also Moore's physician. Dr. Golde and the university licensed the rights to the cell line and products derived from it to Genetics Institute and Sandoz for several hundred thousand dollars. Mr. Moore claimed rights to the cell line, but was denied those rights by the court.

Bottom Line: When you participate in clinical research, you are probably giving up any property rights you have in your blood, tissues, saliva, urine, organs, and everything else.

-Joe

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Posted by: Joe Giffels_ WebMD at 9:13 AM

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