Almost no one reads ''1984'' anymore, and more's the pity. A case now pending in the Supreme Court evokes George Orwell's ominous vision of a brave new world. This time around, it is the Food and Drug Administration, like Big Brother, that seeks to overregulate our lives.
The facts are not in dispute. At some point in 1999, Abigail Burroughs learned that the painful constriction in her throat was cancer. For the next 19 months she fought the tumor with chemotherapy. It wasn't working. Let me turn to the petition for appeal:
"Abigail was told in March of 2001 that she had run out of FDA-approved options. Her cancer cells had very high levels of a receptor called EGFR, and her renowned oncologist at Johns Hopkins believed there was a significant chance of saving her life if she could get the new EGFR cancer drug Erbitus. Early trial results presented at the May 2000 meeting of the American Society of Clinical Oncology showed a remarkable response rate in patients with head and neck cancer for whom chemotherapy no longer worked."
Indeed, "All observable signs of the cancer were eliminated in 13 (87%) of the 15 patients who received the drug in combination with radiation therapy. In the remaining two patients, the tumors shrank but did not completely disappear."
In the absence of FDA approval, no doctor could prescribe Erbitus. Abigail could not get into the trials. She died of the cancer in June 2001 at the age of 21. The drug was approved in 2004. In the young woman's memory her family formed the Abigail Alliance for Better Access to Developmental Drugs. The Alliance brought a class-action challenge to the FDA's authority. The petitioners explain:
"All that petitioners seek is a right for terminally ill patients with no remaining treatment options to fight for their own lives, by taking a drug that their doctors have concluded is justified by the available scientific evidence and that the FDA itself would let them take if they were lucky or well connected enough to get a spot in the trial."
A panel of the District of Columbia Circuit sided with the Alliance, but the full circuit reversed, 8-2. Now the Alliance seeks Supreme Court review.
Speaking for the majority, Judge Thomas Griffith defined the issue: "Does the Constitution provide terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective?" In a 31-page opinion, the majority said, no, it does not.
The judge explained: "The Alliance acknowledges the risk inherent in taking experimental drugs: 'Terminally ill patients are typically willing to assume risks.' The Alliance would rather that individual patients make decisions about this risk than have the FDA decide which drugs are safe enough for limited access to the terminally ill. The FDA counters that 'without a requirement of FDA approval, patients could be exposed to unreasonable risks from investigational drugs that may be neither safe nor effective ...'
"We must conclude that, prior to distribution of a drug outside of controlled studies, the government has a rational basis for ensuring that there is a scientifically and medically acceptable level of knowledge about the risks and benefits of such a drug. We therefore hold that the FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects."
Judge Judith W. Rogers, joined by the circuit's chief judge, Douglas H. Ginsburg, strongly dissented. The majority opinion, she said, reflects "a stunning misunderstanding of the stakes." Young Abigail Burroughs had an underlying right to save her own life. Such a right is "fundamental."
In the case at hand, "A terminally ill patient seeks access to a new medication that has not yet been approved by the FDA for commercial marketing but that has been recognized by the medical community as that patient's best chance to survive. In such instances, the Fifth Amendment's guarantee of due process protects the terminally ill patient's pursuit of these medications."
Perceptive readers will rightly infer that I side with the dissenters. The facts in the sad case of young Abigail make it clear that her defenders are not seeking open access to snake oil. They are defending the right of a terminally ill person to take an informed risk. That right is about as fundamental as a right will ever be. I would send Big Brother back to 1984.
(Letters to Mr. Kilpatrick should be sent by email to kilpatjj@aol.com.)
COPYRIGHT 2007 UNIVERSAL PRESS SYNDICATE
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