Drug trial cut-offs

Townsend Letter for Doctors and Patients,  May, 2004  by Jule Klotter

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Tens of thousands of patients--some for altruistic reasons, many in hope of a cure--take part in clinical drug trials each year. When a trial ends, patients who have benefited from a test drug often lose access to the new treatment. The government has special programs for patients who want to continue taking an experimental drug after a trial ends, but these programs require the consent of the drug's manufacturer and the patient's doctor. Most drugs fail clinical trials, and companies save money by producing limited amounts. Sometimes, drug manufacturers only produce enough of the test drug for the trial itself. Even if companies do have additional supplies of a test drug, hospital boards, which are responsible for regulating clinical trials, are reluctant to ask manufacturers for additional doses. They fear alienating these companies since clinical trials bring money and prestige to a hospital.

In other cases, researchers are reluctant to let patients continue taking a test drug after a trial ends because negative side effects may arise. The Wall Street Journal reported the case of a 12-year-old boy with an aggressive brain tumor that shrunk by a third after he received three injections of a radioactive Novartis drug. When the trial ended, the researcher who led the trial refused to give the boy another dose. She suggested that the parents take the boy to Europe where a similar treatment was undergoing testing. Unlike in the US, patients taking part in European drug trials pay for the treatment. In this case, it would cost $10,000 plus travel expenses. The boy's father began lobbying the FDA, Novartis, congressmen, and the media for help. The combined pressure led the researcher to agree to a fourth dose of the drug. She later admitted that she was afraid that the FDA would shut down her on-going trial if the boy reacted badly to additional doses. Like this boy's father, it is often up to patients and their families to push for continued access to an experimental drug.

An international physician's group that sets ethical standards, the World Medical Association, has stated that clinical trial participants should be able to continue treatments that benefit them. However, an advisor to hospital boards and drug companies, New York lawyer Mark Barnes, says that the cost of providing experimental drugs to patients for free could mean less money for the development of other drugs.

Anand, Geeta. How Some Patients In New-Drug Trials Can Get Cut Off. The Wall Street Journal. December 8, 2003

briefed by Jule Klotter

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