The Wall Street Journal-20080111-A Different -Right to Life-
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A Different 'Right to Life'
Today the Supreme Court will consider a petition to hear a case raising profound issues regarding the right of individuals to make their own health-care decisions. The case is Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach.
The suit claims that FDA violates the due process rights of terminally-ill patients, who have exhausted all approved options and are unable to enter a clinical trial, by prohibiting access to promising investigational drugs.
Consider the plight of such patients. They search for clinical trials of new drugs that might extend their lives. Nearly all are ineligible. Of the few who do qualify, many learn the trial is fully enrolled and closed, or too far away. Others face a 50-50 chance of getting a placebo (a sugar pill) under blinded conditions (meaning neither they nor their doctors know what they are getting). Many are allowed to die without being told about or offered the active drug.
The FDA commonly insists on statistically comparing the timing and severity of the deaths of untreated (placebo) patients with those of patients who receive the potentially effective drug. This renders the FDA's vaunted "science" for drugs intended to treat terminal illnesses little more than a crude measurement of the height and accrual rate of two piles of bodies. There are better, less ethically challenged trial methods available to test drugs, but the FDA has consistently refused to accept them.
The FDA has ignored our Citizen's Petition for more than four and a half years. This petition is the FDA's administrative mechanism for public challenges of its decisions and policies. It is little more than a cruel joke for the sick.
The agency is required to respond to a petition within six months but rarely does, and often never responds at all. One's only recourse is to sue and then fight the inevitable FDA motion for dismissal claiming the plaintiff hasn't exhausted all administrative options -- meaning the FDA hasn't yet acted on the Citizen's Petition.
If the suit survives, the plaintiffs find that lower courts have so rarely allowed a patient to challenge an FDA decision or policy that they have no legal basis to get to trial -- as was recently learned by a group of cancer patients challenging the FDA's mishandling of a new therapeutic vaccine called Provenge for terminal prostate cancer. The federal judge in that case dismissed all parts of the suit directed at FDA's decision to delay the drug for years because patients had no "right" to challenge a decision the FDA claimed was not yet "final." The judge's decision will be lethally final for thousands of men with prostate cancer.
No terminal patient has the time needed to wrestle with the FDA in court if they first have to establish a right to do so. Consider that the Abigail Alliance case was filed in 2003. Over the ensuing years, it has carried the names of three defendants, tracking the musical- chairs nature of the highly-politicized job of FDA commissioner. At every turn the FDA stalled, then claimed we had lost our standing because the patients named in the original suit had died.
The appeals court didn't buy that cruel argument, but it took months to resolve. During this slow dance choreographed by the FDA, more than 2.4 million Americans have died from cancer alone.
The majority opinion of the appeals court suggested that this is an issue for Congress to solve. A great idea if one has a full lifetime to work on it.
In the last session, a bill called the Access Act designed to fix some of the problems was introduced in Congress with multiple sponsors, but any significant reform takes years to enact. The stopgap FDA reform bill passed last year contained none of the Access Act provisions, addressing only the more politically expedient and high- profile issues swirling around FDA's handling of drug safety. The omission was in part the result of the difficulty faced by terminal patients when they try to get the attention of Congress. They simply don't live long enough to connect and organize into a political force.
No matter one's judicial philosophy, it is inconceivable that the framers of the U.S. Constitution intended unelected, tenured career bureaucrats to hold absolute power over American lives without prospect of challenge in the courts. The framers understood that the pursuit of life is an inalienable right that should not be abridged without due process of law.
The FDA and a majority of the D.C. Circuit Court of Appeals think terminally-ill Americans are excluded from the fundamental right to pursue life. The Supreme Court now has the opportunity to take this case and correct those egregious misjudgments.
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Mr. Walker is cofounder of the Abigail Alliance for Better Access to Developmental Drugs.
