I read with interest an op-ed in Saturday’s Wall Street Journal by the Cato Institute’s VP for Legal Affairs Roger Pilon applauding the D.C. Circuit’s opinion in the “little noticed” Abigail Alliance case (which I discussed in aMay 30 post). Mr. Pilon explains that
“If there is a fundamental right to refuse life-sustaining treatment, as the Supreme Court had found in 1990, there is, equally, a right to seek life-sustaining medication free from government interference. That’s hardly pulling a right “out of thin air,” as the Washington Post charged editorially in its defense of FDA bureaucrats. It is not the freewheeling stuff of Roe v. Wade, but rather the careful mining of Locke, Blackstone and Madison.”I don’t often find myself agreeing with the Washington Post editorial page, but I do on this issue.
My concern with the Abigail Alliance decision is a practical public health issue best framed by the National Breast Cancer Coalition in a September 3, 2003, letter to the FDA commenting on the Abigail Alliance’s petition:
“Public policy should discourage access to investigational drugs outside of clinical trials. Investigational treatments made available outside of clinical trials have the potential to undermine the clinical trials system. There is little incentive for a patient to participate in a clinical trial if she can obtain the investigational drug outside of the trial. This makes trial accrual difficult, and may significantly undermine the ability of the investigators to determine the efficacy and safety of the intervention. That was certainly the case with bone marrow transplant for breast cancer – because it was so widely available outside of clinical trials it was extremely difficult to accrue patients to trials, and it took many years longer than it should have to learn that the high-risk and expensive procedure provides no benefit to women with breast cancer. “Investigational treatments are by definition unproven; even the most promising data in earlier stages of trials often do not hold up. Further, there may be significant safety issues that do not emerge until well into a phase III trial. For example, the cardiotoxicity of Herceptin was not apparent in the phase II data, but emerged in the much larger phase III trial.”I cannot imagine how the district court on remand could not find this public health concern to be a compelling government interest.