So, as mentioned, the DC Circuit Court of Appeals came down with an interesting ruling (PDF available here). Here's the background of the case, as summarized in the majority opinion:
The Abigail Alliance for Better Access to Developmental Drugs ("the Alliance") seeks to enjoin the Food and Drug Administration ("FDA") from continuing to enforce a policy barring the sale of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (hereafter "post-Phase I investigational new drugs"). More specifically, the Alliance seeks access to potentially life-saving post-Phase I investigational new drugs on behalf of mentally competent, terminally ill adult patients who have no alternative to government approved treatment options . . .
The Alliance contends that the FDA's policy violates the substantive due process rights to privacy, liberty, and life of its terminally ill members. The complaint presents the question of whether the Due Process Clause protects the right of terminally ill patients to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational new drugs that the FDA has yet to approve for commercial marketing but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing on a substantial number of human beings. . .
As you may be able to tell from the direction that's taking, the majority opinion says that yes, the FDA does violate due process in these cases. They're reasoning from the Glucksberg case, in which the Supreme Court laid down some guidelines for such claims, but not being a con-law scholar, I'm not qualified to address this line of thinking. They also work from precedents which hold that patients have a due process right to refuse life-saving treatments, and hold that there's a similar right to access potentially life-saving ones. "In both cases", the majority opinion says, "the key is the patient's right to make her decision about her life free from government interference. . .the Alliance seeks for its members the same right of access enjoyed by those terminally ill patients lucky enough to secure a spot in Phase II trials. Accordingly, we hold that the district court erred in dismissing the Alliance's complaint . . ."
I'm torn by this line of reasoning. My libertarian streak likes the talk about being free from government interference, but my drug-industry experience keeps suggesting some practical difficulties. (For one thing, if we're telling the government to get lost, why mandate Phase I trials in the first place?) There's a pretty strong dissenting opinion from the recently-appointed Justice Griffith that goes into these problems. First off, he has a problem with the line of reasoning that the majority used:
. . .It does not help the majority's cause that the Supreme Court has rejected several similar challenges. . .To be sure, the Supreme Court has not addressed the constitutional argument raised by the Alliance. But contrary to the tradition asserted by the majority, there is a tradition of courts rejecting arguments that the Constitution provides an affirmative right of access to particular medical treatments reasonably prohibited by the Government.
It's the last paragraph of his dissent that I find rather persuasive, though:
The majority's new right to procure and use experimental drugs raises a number of vexing questions that are now constitutional issues, potentially insulated from the tug and pull of the political process. If a terminally ill patient has such a right, are patients with serious medical conditions entitled to the benefit of the same logic and corresponding access? If an indigent cannot afford potentially life-saving treatment, would the Constitution mandate access to such care under the right recognized by the majority? Can a patient access any drug . . .if she believes, in consultation with a physician, it is potentially life-saving? Would the majority's right guarantee access to federally-funded stem cell research and treatment? Perhaps most significantly, what potential must a treatment have in order for the Constitution to mandate access? Because the majority does not answer this last question, the District Court faces an impossible task on remand.
These are just the sort of problems that I think are glossed over by Justices Ginsberg and Roberts. Where do we draw the line? There are all sorts of things that make it through Phase I that wipe out in Phase II and beyond for lack of efficacy. It's all very well to talk about potentially life-saving therapies, but that potential is, in many cases, pretty damn well hidden. What sort of Phase I study is enough to trigger this right to treatment? (And who pays for it, for that matter, and how is that figure arrived at?) And it's important to realize that Phase I only studies acute safety, for the most part. Keep in mind that compounds drop out in Phases II and III for safety problems that only showed up in larger samples and longer trials. The threat of lawsuits is bad enough already, with drugs that have made it through a lot more than Phase I. How are we going to fare with even earlier compounds?
Justice Griffith is correct in seeing this as a practice that can only expand. The demand is certainly there. I'm more willing than I was a few years ago to see what a safety-trial-only system for pharmaceuticals would look like, but this isn't, to my mind, the way to get there. We're not running Phase I trials in a such a way that they can stand on their own for drugs to go right into patients - perhaps not even patients that are dying. If we want to change that, let's change it - but from the ground up, not by going through a hybrid regime that might give us the worst of both approaches.