February 12, 2008
The FDA has proposed allowing the testing of experimental drugs on terminally ill patients once the drugs have passed the first safety testing phase, but before they have received final approval. The plan has already sparked controversy, with physicians staking out positions both for and against the proposed rule change.
Cancer doctor Dean Gesme, of the Minnesota Oncology Hematology Professional Association, charged that the rules will engender false hope in patients, when less than 10 percent of drugs beginning phase I safety trials are eventually adopted as viable treatments. Among these, most provide only incremental benefits; few are life-savers.
Testing these drugs on terminally ill patients would be unfair to the patients, and would potentially delay approval by obscuring the drugs’ long-term effects.
"False hopes for unproved drugs can also erode the clinical trials system by substituting clinical enthusiasm and wishful thinking for evidence based medicine," Gesme said.
But Emil Freireich, a professor of Special Medical Education Programs at the University of Texas, believes the new rule would actually speed up the process of drug development. Most cancer drugs, he says, are tested only on the healthiest patients, making more critically ill patients ineligible and making it hard to know how well the drugs would work on that demographic.
"It is tragic that regulatory bodies have created a circumstance where people have to live in an aura of hopelessness even though they have the will, the resources and the ability to expose themselves to the risk of participating in investigational studies and to enjoy the potential for benefit," he said.
Consumer health advocate Mike Adams characterized the plan as, "…yet one more way that Big Pharma and the FDA are conspiring to exploit the terminally ill." Adams, who is an outspoken opponent of conventional cancer drugs, said, "I find it inexcusable that the FDA would support the use of unproven, potentially deadly cancer drugs while still maintaining staunch opposition to the use of much safer and more affordable natural anti-cancer therapies based on anti-cancer phytonutrients from herbs and foods. This kind of proposal by the FDA clearly demonstrates yet again that the agency acts solely in the interests of Big Pharma while ignoring the true medical needs of cancer patients."
In the United Kingdom, doctors can make the decision to import or prescribe unlicensed drugs on a case-by-case basis. However, investigators into a drug trial that almost led to the deaths of six young participants have recommended to the British Medicines and Healthcare Products Regulatory Agency that certain drugs might be better tested on patients who are more, rather than less, ill.