Supreme Court Justice Thurgood Marshall once famously quipped, “The Constitution does not prohibit legislatures from enacting stupid laws.” Nor, apparently does it prohibit stupid judicial decisions, as the Court reaffirmed last week, when it denied a petition by patient advocates to allow for access to experimental treatments for terminal patients that are still undergoing the process of FDA approval.
In denying the petition by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs, the Court let stand a decision by the U.S. Court of Appeals for the D.C. Circuit, which ruled in an 8 to 2 decision that terminally ill patients have no constitutional right to access experimental treatments currently under preliminary testing by the FDA.
Like many courts before it, the D.C. Court of Appeals, in reaching its decision, overlooks the text of the Ninth Amendment: “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.” Apparently, the rights to life, liberty and the pursuit of happiness are not as inalienable as once thought – especially when they run afoul of the prerogatives of a government agency.
The Bush administration, acting on the behalf of the FDA, petitioned the high court not to hear the case. Solicitor General Paul Clement (representing the administration) cited among his arguments that allowing terminal patients access to treatments currently still in investigational stages posed serious risks to public health.
There’s just one problem with this line of reasoning: in medical parlance, “terminal” typically means “dying.” In this sense, the very worst case scenario is that an experimental treatment proves either ineffective or hastens an inevitable outcome. Thus, the argument that allowing dying patients access to drugs not yet approved by FDA gatekeepers somehow endangers the broader public health would be laughable, were the consequences not so dire.
Critics contend that to allow patients access to experimental drugs before they meet with full FDA approval would undermine the process of regulation, thereby allowing drug companies to bypass the expensive and lengthy process of approval altogether.
Yet this ignores the fundamental issue at stake, which is in accessing treatments in the absolute worst cases, wherein all other treatment options have failed. This issue is clearly no substitute pathway to mainstream approval. No physician or patient would consent to experimental treatment lightly and certainly no responsible doctor would ever recommend unproven treatments except for in the most serious cases where all other approved treatments have failed.
Yet this decision by the D.C. Circuit, with the Supreme Court’s blessing, completely usurps this process of medical care from patients and their doctors; handing over life-and-death decisions about treatment to federal agencies. The FDA and this administration, it would seem, are more willing to condemn thousands of terminal patients to a painful and hopeless death while Congress and the courts stand watching, rather than to risk their iron grip upon the regulatory process.
Benjamin Franklin once wrote that there is nothing certain in life but “death and taxes.” Nowadays, it would appear that both are squarely in the province of government control.
Tell Steve what your stance is on the use of experimental treatments for terminally ill patients. E-mail him at [email protected]
