No 'right' to save lives without the FDA's OK


The Abigail Alliance for Better Access to Developmental Drugs was named in honor of Abigail Burroughs, a 21-year-old University of Virginia student who died of cancer in 2001 -- denied the use of two new anti-cancer drugs then undergoing testing and recommended by her oncologist.

In 2003, the alliance petitioned the FDA to allow drug firms to make available to dying patients "investigational drugs" that had won a preliminary OK. The FDA rejected this challenge to the stringency of its "strong clinical trial system."

The alliance sued the FDA, arguing the Constitution should be read to "embrace the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor ... to seek access to investigational medications that the FDA concedes are safe and promising."

The lawsuit focused on the Fifth Amendment guarantee that "no person shall be ... deprived of life, liberty or property, without due process of law."

In 2004, a federal judge rejected the lawsuit, finding "There is no constitutional right of access to unapproved drugs."

The group appealed. Last year, a three-judge appeals court panel ruled 2-1 that a "terminally ill, mentally competent adult patient" has a right to "potentially life-saving investigational new drugs" that have been found to be safe for humans.

But before that decision could take effect, the full U.S. Court of Appeals for the District of Columbia reheard the case, and reversed. In an 8-2 decision, that court said Tuesday that federal drug regulators get to make these decisions.

"We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," wrote Judge Thomas Griffith, citing a hideous Supreme Court decision that rejected any constitutional "right to die," holding the vassals of the modern state can't even leg it out of this vale of tears without Big Brother's permission.

Tuesday, two dissenting judges argued the ruling ignores the Constitution's protection for individuals and their "right to life," instead bowing to "a dangerous brand of paternalism."

Julie Zawisza, spokeswoman for the FDA, said the agency was pleased with the ruling. "On a limited basis," she noted, some patients and doctors are permitted to obtain new drugs that are undergoing clinical trials.

Ah. So the agency admits it may be OK for doctors to give promising drugs to dying patients some of the time -- but only when the bureaucrats give the supplicants their blessing. "Paternalism" is a good word.

With all respect to the plaintiffs, there may be no need to ask the Supreme Court to now discover a new implied "right," here.

Instead, the proper question may be where the Congress finds any delegated power to restrict consensual commerce between well-informed doctors and patients who want to try these medicines, and manufacturers willing to sell them.

In vain do we peruse the 18 paragraphs of Article I, Section 8 of the U.S. Constitution -- the full list of all the congressmen's powers -- seeking any delegated power for the Congress to "regulate the practice of medicine, determining which medicines shall be legal to manufacture and sell, when, to whom, and for what purpose."

Of course, the FDA may not wish to see the court answer that broad a question. How much easier it would be to simply set up the protocols the plaintiffs seek, allowing the experimental use of drugs already confirmed as reasonably safe for human use, in specific cases where a mentally competent patient is otherwise at death's door.

As they should have done in the first place.

 

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