August 12, 2007
Court Rules Against Experimental Drug Access For Terminally Ill

Imagine you have a fatal disease (for a few of you the imagining is unfortunately not necessary). You are going to check out of the Life Hotel. You are either going to cease to exist or move on to some sort of afterlife. Imagine that before you die every day you continue to live you will become weaker, more incapacitated, lose control of more bodily functions, and experience increasing pain. Imagine that, like most people, you'd rather not die of that fatal disease. But no approved drug or other treatment can save your life or even extend it very much. Faced with a painful downhill slide to death would you want to try experimental therapies? Count me in the "Yes! Hell Yes!" column on that one.

In the United States the Food & Drug Administration does not want you to try unapproved drugs outside of clinical trials. Effectively, for most people that means you won't be able to try unapproved drugs at all. At best you'll be able to use just one unapproved drug. A federal court ruled 15 months ago that, contra the FDA, American citizens have a fundamental right to try drugs when they are going to die. But a (dare I say stupid and imperious? yes, I do) D.C. Circuit Court of Appeals have decided you do not have the right to try to save your life in ways not approved by the FDA. (commentary here by Roger Pilon of the libertarian Cato Institute)

The wheels of justice turn slowly, especially for the dying. On Tuesday the D.C. Circuit, sitting en banc, reversed a 15-month-old decision by a panel of the court that had recognized a constitutional right of terminally ill patients to access potentially life-saving drugs not yet finally approved by the Food and Drug Administration. Given the poor quality of Tuesday's opinion in Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach "startling," said the dissent one wonders why it took so long. The opinion's one virtue is that it brings out clearly how far modern "constitutional law" has strayed from the Constitution, a document written to protect liberty, not federal regulatory schemes.

Represented by the Washington Legal Foundation, Abigail Alliance is named for Abigail Burroughs, a 21-year-old college student who died of cancer in 2001. Their argument could not be more simple or straightforward, nor could Tuesday's dissent, written by Judge Judith Rogers and joined by Chief Judge Douglas Ginsburg, the majority in the earlier opinion. Citing the Fifth Amendment's right to life, the Ninth Amendment's assurance to the Constitution's ratifiers that the rights retained by the people far exceed those named in the document, and the Supreme Court's "fundamental rights" jurisprudence, Judge Rogers argued that the right to life, the right to self-preservation, and the right against interference with those rights which the FDA is guilty of are of one piece. They are deeply rooted in common law and the nation's history and traditions, implicit in the concept of ordered liberty, and thus "fundamental."

Indeed, it is startling, she noted, that the rights "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body have all been deemed fundamental, but the right to try to save one's life is left out in the cold despite its textual anchor in the right to life." Because the rights at issue here are "fundamental," she concluded, the court must apply, in judicial parlance, "strict scrutiny." The burden is on the FDA to show why its interference is justified to show that its regulatory interests are compelling and its means narrowly tailored to serve those interests.

Here's what I want to know: Who do the FDA and these judges think they are protecting and from what exactly? Think of the downsides to using experimental treatments. You might spend more money on treatments and leave your heirs with less money. You might die sooner. But earlier death not always a bad thing if your cancer has spread to your bones and just getting touched causes excruciating pain. You might suffer pain from the way the experimental treatments are administered. But you've decided to accept that pain or else you wouldn't get the treatments.

The upsides to allowing people to try experimental drugs are considerable. First off, how about the value of letting each individual make personal decisions about what they can control over their ultimate fate? Even if you are going to die might you die with more peace of mind if you die knowing that you tried everything possible and died fighting the good fight?

At The Huffington Post Adam Freedman thinks the DC Circuit misrepresented the nature of the right that is at stake.

The first panel of the DC Circuit found that the FDA's actions (in denying drugs to terminally-ill patients) interfered with the "right to life," which implicitly includes the right to preserve one's life through medication. Stated this way, the right is "fundamental" because it is - as constitutional jurisprudence requires - "deeply rooted in the nation's history and traditions." So in the first Abigail decision, the DC Circuit held that the FDA could not justify its meddling with this fundamental right.

But in the second Abigail holding, the DC Circuit described the contested right differently: "the right to access experimental and unproven drugs in an attempt to save one's life." Stated in these terms, the right hardly seems fundamental - indeed, the court's words conjure up the image of some deluded sicko grasping for the nearest bottle of snake oil. So much for respect for the terminally ill.

Sounds like the court is saying that the odds that experimental drugs will help are so low that attempts to save one's life with experimental drugs don't have to be counted as exercises of one's right to life.

Yaron Brook of the Ayn Rand Institute says patients aren't just guinea pigs for clinical trials.

Some claim that allowing individuals to take unapproved drugs will make effective clinical testing impossible, since, as they say, no rational person would willingly submit to the double-blind, randomized tests that are currently used in clinical trials required by the FDA. In such tests, some of the participants are unknowingly given a placebo, which, it's said, no one would chance if he could ensure that he received the drug by paying for it. But, contrary to those who make this argument, individuals are not lab rats who may be blackmailed by the government into becoming test subjects. It is chilling that defenders of the FDA's current trial system are, in effect, advocating as an incentive to take part in such trials: 'join or die.'

Yes, those placebo recipients are basically human sacrifices for future patients who get the same diseases.

I see utilitarian arguments for the right to try experimental treatments. First off, if developers of new drugs can start selling them at earlier stages they can get revenue sooner to develop more drugs and to do so faster. We will get effective treatments sooner if the terminally ill can try new and unproven drugs. Also, for each new drug since more patients will take it sooner we'll find out if it works sooner and if it doesn't we can abandon it and move on to other drugs sooner.

Share |      Randall Parker, 2007 August 12 12:58 PM  Bioethics Treatment Rights

Libertarian Joe said at August 12, 2007 5:19 PM:

Time to get behind Ron Paul yet?

Tj Green said at August 15, 2007 4:42 PM:

The average child is born with around three hundred copying errors. These errors in our information storage system(DNA),is for the benefit of our species. Every child born is been experimented on for the benefit of our species.

Tom said at August 17, 2007 3:42 PM:

I thought that the convention in cases where life is at risk is to compare the experimental therapy to the conventional therapy - not to a placebo. Is this not the case? Don't ethics demand that?

ThePresidentOfTwelvepackistan said at November 6, 2009 1:36 PM:

Whoah, whoah, whoah... There is a serious logical flaw in the last paragraph.

"We will get effective treatments sooner if the terminally ill can try new and unproven drugs."

What the author fails to realize here is that most drugs can only be effectively judged through rigorous, clinical testing. Rushing drugs to the marketplace before they are tested only increases the likelihood that drugs with seriously adverse effects (short and long term) make it through and maim people who may not have taken the drugs had they known the potential for harm.

Also, it is very easy to say that it's no one else's business what a terminal patient puts into their body. For many drugs this may well be true. But what about a drug that involves genetic manipulation or treatments delivered via hijacked virus? Or what about a treatment that put a patient at risk of contracting a serious and very contagious disease? Wouldn't it be prudent to make sure that we are not putting many people at risk in the name of saving one person?

I personally believe that while the FDA probably should not have final say over what treatments we may or may not have in terminal cases, there need to be safeguards in place. The issue is not as simple as most people would have you believe.

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