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Drug trials under the microscope

July 23, 2006

Re "Drug Trials With a Dose of Doubt," July 16

Every scientific report of medical research ever written has been criticized in writing. This discussion is the heart and soul of the peer review process.

It is disingenuous to imply that Dr. Thomas J. Walsh's two studies were designed poorly or with ulterior motives simply because of criticisms. Were we to allege scientific impropriety against every study so criticized, there would be no acceptable medical literature.

The relationship between the pharmaceutical industry, the development of drugs and medical scientists has been imposed on the medical system by politically driven funding decisions. Once a drug appears to have clinical utility, the federally funded agencies tend to pass on development to the private sector. The responsibility for this policy decision lies with our political leadership.

It is entirely appropriate for a scientist in Walsh's position to render advice to both the industry and regulatory agencies.

In fact, the cooperation between federally funded scientists and industry is largely responsible for many of the advances in modern medicine.

HOWARD BELZBERG MD

Associate Professor of Surgery

USC Keck School of Medicine

Los Angeles

*

As a former federal appointee to a Food and Drug Administration advisory committee, I find Walsh's actions unacceptable.

In my committee meetings, members regularly recused themselves from commenting or voting on drugs that they had investigated in approved studies before FDA release.

Although Walsh may have known more about the drug in question than other researchers, he should have recused himself due to the conflict of interest.

HANS G. ENGEL MD

Mission Hills

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