About Private Health Emergencies?
Thursday, April 8,
By: Thomas A.
when swine flu was expected to peak, it has mysteriously faded from view. Now
that Americans are no longer queuing up for vaccine, some 71 million doses
(part of a $1.6 billion tax-funded program) are likely to be trashed upon
expiration. While baffled health experts investigate causes, it’s worth looking
back at some important but little-known decisions that the Food and Drug
Administration took amidst last fall’s crisis atmosphere.
of being held accountable for widespread sickness and death due to swine flu or
H1N1 virus, the FDA elected to bypass its labyrinthine, virtually interminable
approval process so that doctors could immediately employ promising remedies (other
than vaccines) to combat the disease. In sweeping aside regulatory obstacles,
the FDA was using authority granted by Congress back in 2004--to be used only
in the event of a “public health emergency.”
course, Congress was implicitly conceding what the FDA’s critics have known for
decades--that people die unnecessarily (millions, by some reckonings) when
denied access to drugs the agency has not yet condescended to approve. Once H1N1
was deemed a “public health emergency,” the FDA issued a series of so-called
Emergency Use Authorizations (EUAs) providing exemptions for three
antiviral drugs (Peramivir, Tamiflu, and Relenza), two “flu panels” (diagnostic
tests), and a respirator.
rationale for permitting such EUAs was to remove the FDA roadblock when unapproved
drugs (or approved drugs used in unapproved ways) might enhance national
security in the face of a chemical or biological threat to “public health.” But
wait a minute: Why does preserving “public health” justify bypassing the FDA
approval process, while private health doesn’t? Why should drug companies be
able to offer life-saving drugs to large numbers of sick people--but not
to small numbers, or even to single individuals?
is no rational answer to such questions, because there is no rational
distinction between public and private health in this context. Every life-threatening
disease presents a health emergency to the individual patient. Morally, you
have the right to seek the best treatment you can find. Yet our legal system denies
you that right when it comes to private health emergencies.
2008 the Supreme Court refused to hear the appeal in Abigail Alliance for Better Access to Developmental Drugs v. von
Eschenbach, leaving in place a lower court decision that a lone individual has
no constitutional right to escape the government approval process, even if
his life is at stake. The plaintiff in that case was a nonprofit named for Abigail
Burroughs, a 21-year-old woman who died of cancer in 2001 after a desperate,
but futile, quest for federal permission to take an experimental cancer-fighting
drug her doctor recommended.
answer to such injustices is not for Congress to tinker with
the standards by which EUAs can be issued. Instead, we need to challenge the
idea that private parties striving to preserve human life against dread
diseases should ever have to ask government permission before
products such as antivirals are the private property of their manufacturers.
Drug companies should be free to offer those products for sale on an open
market, on terms they deem proper. If a doctor views a particular drug as his
patient’s best option, then he should be free to prescribe it. And if a patient
decides it’s his best chance for health, he has a right to authorize the
treatment--indeed, his unalienable right to life is meaningless in that
situation without such freedom.
course, government must always stand at the ready, with power to redress such
objective legal wrongs as fraud, negligence, and breach of contract. But
otherwise the government should remain entirely out of the loop when drug
companies, doctors, and patients are making the all-important decision to treat
a life-threatening disease with a promising drug.
the recent EUAs freed up remedies that actually saved people from succumbing to
swine flu is an open question. But there is no doubt that individuals afflicted
by other diseases continue to die because their rights are trampled by FDA
control over pharmaceuticals.
companies should never have to look toward Washington, D.C., bowing and begging
for bureaucratic permission to save lives--a million lives, or just one.
# # #
Thomas A. Bowden is an
analyst at the Ayn Rand Center for Individual Rights.