Sen. Paula Hawkins (R-Fla.) announced yesterday that she will hold hearings to examine allegations that experimental anticancer drugs have been implicated in the deaths of hundreds of cancer patients.
In a statement on the Senate floor, Hawkins said she was distressed by a series of articles this week in The Washington Post, which reported that the National Cancer Institute has failed to monitor adequately the use and occasional misuse of potentially fatal anticancer drugs in human experiments. After quoting from one of the articles, Hawkins said the Senate Labor and Human Resources investigations subcommittee, which she chairs, has also looked into the subject and has found dangerous deficiencies in NCI's experimental drug program. The subcommittee will begin its hearings on the subject in two weeks, Hawkins said.
The panel's most serious finding, she said, "is the lack of an adequate program for monitoring the hundreds of NCI-sponsored human experiments with approximately 95 investigational new anticancer drugs." The preliminary evidence is so disturbing, she said, that "I wonder whether the automobile manufacturers of Detroit might have better monitoring systems for their products than does the NCI for its drug development program on human beings."
Hawkins said she wrote Richard S. Schweiker, secretary of Health and Human Services, in July and described her "fear of a potential threat to the health and safety of cancer patients who volunteer to participate in NCI-sponsored drug experiments." In response, she said, Dr. Edward N. Brandt, assistant secretary for health at HHS, has named a special task force to review the experimental program and report its findings within 90 days.
The one-year study by The Post documented 620 cases in which experimental drugs were implicated in the deaths of cancer patients. These deaths, the articles said, amount to only a fraction of the thousands of people who have died or suffered in cancer experiments in recent years.
Some of the experimental drugs given to cancer patients in experiments authorized by NCI caused a wide variety of severe adverse reactions, ranging from kidney failure and paralysis to visual hallucinations and brain damage, The Post reported. Rather than halting the development of cancer, the articles said, some of these drugs actually stimulated the growth of cancer tumors, while others were found to cause cancer themselves.
Hawkins also pointed to problems between NCI and the Food and Drug Administration in keeping tabs on such adverse reactions. She cited a letter last April from J. Richard Crout, director of FDA's Bureau of Drugs, who was "sharply critical" of NCI for having delayed the reporting of patient deaths and injuries related to treatment with three anticancer drugs. In one case, Crout said the FDA was not notified in a timely fashion that a group of chemicals called nitrosoureas had caused toxic effects on the kidneys of human subjects.
Hawkins said that Vincent DeVita, director of NCI, replied in a letter to FDA that there had been a "misunderstanding" between the two agencies which has since been resolved. But the freshman senator said she believes that "serious deficiencies" still exist in the way both NCI and FDA monitor these experiments.
DeVita said in a statement Sunday that The Post's articles provided "a slanted and distorted view of cancer research" and that unfortunate side effects often must be tolerated in an effort to prolong the lives of cancer patients.