THIS WEEK'S QUESTION

Q. Are gene therapy clinical trials for cancer safe?

A. A recent article in New York magazine touted gene therapy as a safe and effective new form of treatment. A Sloan-Kettering scientist, quoted on the cover, even promised a cure for cancer in five (or at most ten) years. However, at the same time, gene therapy has been rocked by scandals that call into question the whole enterprise. Whom should one believe?

In January, 2000, the government suspended clinical trials at the University of Pennsylvania after an 18-year-old patient died in its gene therapy experiments. The boy's father told a Senate hearing, "It looked safe. It was presented as being safe. "Since it would benefit everybody, I encouraged my son to do this. I was misled. That's what hurt the most. This was not as it was presented." This is all the more shocking since the University of Pennsylvnia is the nation's 14th highest rated cancer hospital.

Then, in late January, two volunteers being treated for colon or rectal cancer with gene therapy at Beth Israel-Deaconess Medical Center, Boston (a Harvard-affiliated hospital) died as a result of gene treatment. Doctors initially tried to cover up the problem but later suspended their gene therapy trials {ABC News, 1/31/00). Deaconess is the 53rd highest ranking cancer hospital in the US.

VIOLATING PROTECTION LAWS

In general, the government does a poor job of monitoring abuses in clinical trials. One thousand FDA spot checks from 1996 to 1999 resulted in the following citations:

--213 researchers failed to obtain proper consent from subjects;

--364 failed to stick to their approved research plan; and

--140 did not report adverse reactions from test drugs.

The NIH found that 50 institutions violated "human subject protection laws" in cancer trials alone. The National Cancer Institute's audit of its own trials from 1995 through 1999 found that one third of the 23,455 cases reviewed had noteworthy problems

I would say that gene therapy is more dangerous than we have been led to believe. Patients should think twice before enrolling in such clinical trials.

We have a Moss Report on the topic of colon and rectal cancer. Please see my book Questioning Chemotherapy for a detailed discussion of the clinical trial controversy.

If you wish to obtain a Moss Report for a particular kind of cancer, you can call our office at 718-636-4433 or order BY CLICKING HERE via our secure order form,.

Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.

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