A federal appeals court has denied the right of patients to the use of cancer drugs prior to their complete assessment of safety and efficacy. The case was filed against the US FDA in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, who argued that patients have a constitutional right to any drug in clinical trials.
The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe and effective before they are made available.
The decision preserves the current regulatory system. If it had gone the other way “it would have undermined the entire drug approval process,” said William B. Schultz, a former deputy commissioner of the Food and Drug Administration, who wrote an amicus brief arguing against the early access to drugs.
The case illustrates the precarious position in which the FDA operates. There are highly-publicized cases of the FDA approving drugs that later show untoward side effects when released to a population of millions of patients; on the other side are patient advocacy groups like the Abigail Alliance who wish for there to be access to cancer drugs before formal approval and assessment of whether they are safe or not.
The issues of desperate cancer patients are certainly emotional and compelling but would require that the FDA and drug companies take on many additional risks for drugs that have been incompletely evaluated. In fact, some have argued that allowing free access to experimental drugs would be an advantage to drug companies:
He [Schultz] and others say that if drugs were made available after only preliminary testing, drug companies would have little incentive to conduct full clinical trials to determine if a drug really works. That would allow companies to “profit from offering empty hope,” said Robert Erwin of the Marti Nelson Cancer Foundation, a patient advocacy group.
My colleague, Orac, at Respectful Insolence posted a lengthy consideration in February of the stance of the Abigail Alliance and the constitutional right to experimental drugs balanced against issues of drug safety. Here’s one key quote from this surgical oncologist referring to the use of incompletely tested drugs:
If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit and having to pay for the medications causing the complications yourself.