Posted on 01/13/2008 8:11:01 AM PST by FormerACLUmember
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.
(Excerpt) Read more at online.wsj.com ...
That’s your FDA for you, operating on on two fears:
(1) The fear that a terminal patient might get deadly complications from a drug;
(2) The fear that someone taking a drug might get a buzz off of it.
Sorry, but it's quite sane, at least from one persepctive.
Consider the case of a patient, whose prognosis is six months to live.
He takes this experimental XYZ-3000, not FDA approved, and keels over in two weeks.
Can't you smell the lawyers salivating over that?
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