When Experimental Drugs May Be the Only Hopeby Lindsey Kay, MD | February 1, 2008
While the treatment options available for fatal diseases have expanded greatly in recent years, many patients do not respond to conventional therapy and are left with no therapeutic options. As an example, despite the millions of dollars that are poured into investigational research each year, cancer remains one of the most common causes of death in the U.S.
Two advocacy groups are fighting for patient access to experimental drugs, but their appeal to the Supreme Court was recently rejected. The groups argued that denying patients who had no further treatment options access to investigational drugs was unconstitutional, depriving them of life and liberty without due process. The Court justices refused to hear the case, stating that there is no constitutional right of access to experimental drugs.
That is probably true. The Constitution does not address, directly or indirectly, this right. But even without constitutionally protected access, terminally ill patients deserve the chance to try investigational therapies, with the consent and care of their doctor. While available treatment options are effective in most patients (otherwise they would not be on the market), in every disease category there are a large number of people who receive no benefit from FDA-approved options. When these patients are terminally ill, they should have the right to at least consider the use of experimental drugs.
In December of 2006, the FDA proposed changes to the regulation of experimental drugs, widening access to include individual patients and small groups of patients who failed conventional therapy. Since that announcement, the FDA has not released any further information regarding this proposal.
Many patients have access to experimental therapies through enrollment in a clinical trial. But most patients will remain unaware of this option unless their doctor offers it to them. Patients who do not live near a major academic hospital will likewise be unable to enroll in clinical trials. The FDA’s proposal to expand access is a huge step in the right direction, but the regulatory changes must go into effect, and both patients and healthcare providers must be made aware of this option.
Hundreds of patients are told each day that they’ve run out of options, that our healthcare system has nothing left to offer them. There is no reason why these patients, given clearance by their doctor and full disclosure of the risks involved, should be denied experimental therapies and the chance, however small, of receiving some benefit from them.
James Vicini. U.S. court rejects appeal seeking unapproved drugs. Reuters. January 14, 2008.
FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs. FDA News. P06-19, December 11, 2006.
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