A recent ruling of the District of Columbia United States Court of Appeals
weakened the Food and Drug Administration (FDA) drug-approval monopoly.
In the case of Abigail Alliance v. von Eschenbach, the court ruled "in some
circumstances there is a constitutional right" to use drugs not approved in
advance by the Food and Drug Administration (FDA), according to Robert F.
Nagel writing in "The Weekly Standard."
If other levels and branches of the federal government maintain this ruling,
it would put some additional meaning to Americans' unalienable right to life
and liberty, as articulated in our Declaration of Independence.
UCLA law professor Eugene Volokh believes that access to medicines not yet
approved by the FDA could be defended under a right to "medical
self-defense."
Although Volokh describes the use of this right in several other scenarios,
in this article we are only looking at it in the context of medicines not
approved by the FDA for prescription or sale in the United States.
In an article forthcoming in the April 2007 Harvard Law Review, Volokh
writes, "Lethal self-defense - protecting one's life against humans or
animals (or preventing serious injury, rape, or kidnapping) - has long been
a general exception to nearly all criminal laws, including laws against
murder, weapons possession, and the like."
Therefore, Volokh reasons, "why shouldn't I be presumptively free to protect
my life using medical procedures that don't involve killing, such as ... the
use of experimental drugs?"
He hopes that others "who feel strongly about the right to lethal
self-defense (as do I) ... will agree that the moral case for medical
self-defense is at least as strong as the case for lethal self-defense."
Volokh prefers the term medical "self-defense" over medical "necessity"
because each of the United States recognizes self-defense in state law,
whereas only half the states recognize a necessity defense.
Under the law of lethal self-defense, Americans can defend themselves
against being murdered by someone else by killing the threatening person,
whether or not the person has an evil intent or is blameless because of
insanity.
Likewise, the law of self-defense protects a person killing a threatening
animal, even if the Endangered Species Act would otherwise protect the
animal.
The right to medical self-defense would potentially allow a patient to use
whatever potentially life-saving medical means desired. In contrast with
lethal self-defense, patients using their own resources to acquire the
potentially life-saving medicine would not kill or harm other people.
How did the FDA get between patients and medicines in the first place? This
history now goes back a century, with the government first taking upon
itself the authority to make sure that food and medicines were pure.
Next, the government took the authority to define whether medicines were
safe.
More recently, federal laws called on the FDA to identify whether or not
drugs were "effective" for proposed medical uses.
We've questioned the premise of FDA regulation of drug safety and
effectiveness for some time. See
http://www.jewishworldreview.com/0205/medicine.men1.asp .
Some people want drugs that have no side effects and are almost certain to
have the desired effect. Others, such as patients with advanced cancer, are
willing to try drugs that have a minimal chance of benefit, even less than
10 percent, and a high likelihood of bad side effects.
And people change their minds, sometimes from day to day, about the degree
of safety and risk that they want to accept.
The only way to be 100 percent drug-safe all the time is very simple: no
drugs, not ever. Of course, this also means no benefits, not ever.
So we look on medical self-defense as a possible new way to allow Americans
more freedom (and concomitant responsibility) in their personal medical
treatment.
We don't know what all the constitutional, political, and medical-practice
side effects or complications of this initiative might be. But we think it's
an experiment worth considering.
Editor's Note: Robert J. Cihak wrote this week's column.
