A government task force on cancer drug development issued dozens of recommendations yesterday aimed at enhancing patient safety, ensuring prompt reporting of adverse reactions, and strictly enforcing sanctions on institutions and investigators who violate federal regulations.
The task force, concluding a three-month study, said that "great strides" have been made by both the National Cancer Institute (NCI) and the Food and Drug Administration in "tightening up the monitoring of clinical investigations using anticancer drugs."
Much of the 120-page report discussed informed consent by patients, animal testing and the relationship between NCI and FDA. It concluded that "cancer patients have been aided and will in the future benefit from the anticancer drug development program."
It also said implementation of its recommendations "will help to correct existing problems as the agencies continue to carry out effectively their respective roles." Some specific problem areas were cited. Among them:
* Too many patients have been enrolled in some initial phases of drug experiments "even though results to date in a given drug have been consistently negative." The panel's recommendation: Limit the number from the outset.
* NCI's inability to control or account for drugs after it ships them to investigators has been a "serious defect." The panel's recommendation: Log the precise amounts shipped and ship only what is needed for authorized tests.
* NCI has been slow to impose sanctions against those who have misused the drugs. "NCI should more actively impose sanctions against wrongdoers," the panel recommended, including sanctions against institutions where repeat offenses occur.
* There have been delays by investigators in reporting adverse drug reactions. The report cited one instance in which investigators were preparing an article for a medical journal describing the suspected adverse reaction even before NCI or other investigators were notified. The report spoke of "critical misunderstandings on the part of investigators and NCI about requirements of ADR's [adverse drug reaction] reporting with new drugs." The panel said NCI itself remedied much of the problem recently by instructing investigators to immediately notify NCI of such reactions.
* Some investigators have failed to conduct tests required by the experiments. In 38 of 42 human experiments examined, researchers had failed to perform at least three-quarters of the required tests. In one-third of the human experiments examined, reports were delayed an average of 100 days or more. The panel's recommendation: Institute mechanisms for prompt review and instruct investigators of their obligations.
The 11-member panel, composed of government health experts, was formed last October to examine the nation's cancer-drug development program. The panel focused on issues of patient protection and how well the FDA monitors NCI's program.
There are about 37,000 cancer patients each year who take part in these experiments. Most of these patients have advanced stages of cancer, have failed to respond to standard therapies and see the experimental drugs as their last hope.
Assistant Secretary for Health Edward N. Brandt Jr. told a Senate subcommittee yesterday that while the panel "found no systematic mismanagement" of the program, "problems have arisen and some still do exist."
NCI Director Vincent T. DeVita said in an interview yesterday that the report confirms that the drug development program is working well. He said many of the recommendations contained in the report already have been implemented.
DeVita said many of the conclusions were supportive of the program. He cited the task force's finding that initial drug tests in humans are in fact conducted with "therapeutic intent," a subject of controversy in recent press reports and congressional hearings.