Just 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.
Afraid 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.”
Of 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.
Congress’s 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?
There 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.
In 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.
The 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 acting.
Pharmaceutical 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.
Of 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.
Whether 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.
Drug 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.