« Blinky strikes again! | Main | The Daily Memo - 8/13/07 »

Can’t you just curl up and die already?

prescriptionPills.jpgThe Court of Appeals for the District of Columbia Circuit has ruled that “patients with terminal illnesses do not have a constitutional right to use medicines that have not yet won regulatory approval.” This decision stems from a lawsuit filed back in 2003 by the Abigail Alliance for Better Access to Developmental Drugs against the FDA. This group argued that folks with terminal illnesses can’t wait for drugs and medical treatments to work through the multi-year regulatory process. They’re obviously willing to accept the risks that come with trying out pre-regulation drugs still in their testing phases, and the group argued that denying them access to these things was tantamount to violating the Fifth Amendment clause by depriving them of life, liberty or property without due process.

The Abigail Alliance lost in the lower courts, and while that was originally reversed by a panel on appeal, the full appellate court affirmed the District Court decision, ruling that there was no deep-rooted right to experimental drugs in our country’s history. A former deputy commissioner of the FDA said that a decision the other way “would have undermined the entire drug approval process,” while a dissenting judge found this decision a “startling” one which winds up leaving the right to save one’s life “out in the cold.”

This is definitely a thorny issue. I totally get why terminal patients want access to things that aren’t yet approved and regulated, and I support that access, but I’m also not so sure they have a Constitutional right to those drugs. I think we need to see the FDA set up some type of formal system or program that would allow terminal patients access to drugs that are still in the clinical phases, as long as these patients are going in with a full knowledge and understanding of all the risks involved. That’s probably a pipe dream, since the FDA, like most governmental agencies, seems unable of getting its head out of its ass, but a girl can dream.

| Comments (2)


Comments

"but I’m also not so sure they have a Constitutional right to those drugs." I wasn't aware that the lawsuit included taxpayer funding for the terminally ill to take the drugs. I thought it just sought to give an adult the right to choose medical treatments. Nope, doesn't sound like the kind of right the constitution covers at all.

The lawsuit does not require taxpayer funding, nor does it require insurance coverage. It asks only that patients suffering from terminal disease with no remaining approved treatment options and unable to get in to clinical trials for the drug they seek, be allowed to access the drug outside clinical trials without undue interference from the FDA. It does not even require necessarily that the FDA be completely removed from the process, only that FDA involvement should not infringe on a patients right to pursue life without due process of law.

The en banc court recently decided that the FDA could infringe as much as it wants, overturning an earlier decision by a panel of the same court granting the right, and under what is called "rational basis review" (because the court said terminal patients do not have the right to pursue life - instead the FDA has the "right" to control terminal patient's lives without restriction so they can potentially be used, and often used up, in clinical research), the FDA does not even need a good reason for interfering with their pursuit of life.

You should know that the very large majority of these terminal patients never manage to get in to a clinical trial because they don't qualify, there isn't enough room, or there simply isn't an ongoing trial for their specific condition.

The only means these people have to pursue life is access to investigational drugs that haven't yet cleared all the hurdles erected by the FDA, but that have cleared at least the first phase (dose, safety and initial efficacy testing) of the FDA's process, and been found safe and potentially effective enough to be given to hundreds or thousands more patients in later phase clinical trials.

Ours is a very real Constitutional claim with sound legal and precedential basis. I suggest you find and read the dissent to the court's majority opinion. I suspect you will find it a lot more in line with what you think your fiundamental rights are than, as the diseent puts it, the "tragic wordplay" of the majority opinion.

Steve Walker
Abigail Alliance