Our View - Saturday

The grim regulator

Feds keep punishing terminal patients

The Court of Appeals for the District of Columbia Circuit apparently believes bureaucracies have powers so absolute that they trump the traditional right of free people to control their own bodies and protect their own lives. If that’s not the case, it’s difficult to see how the court arrived at the 8-2 decision in Abigail Alliance v. Eschenbach, which denies terminal patients and their doctors access to medications that have passed safety tests required by the Food and Drug Administration, but not the full battery of tests to prove efficacy.

Restrictions on access to partially tested drugs leads to “thousands of people dying because of the FDA’s bureaucratic know-it-all attitudes,” says Paul Kamenar of the Washington Legal Foundation, which was co-plaintiff in the case. Kamenar says an appeal will be filed before the end of the month. That will give the U.S. Supreme Court a chance to reverse this misguided ruling.

The Abigail Alliance for Better Access to Developmental Drugs was founded in 2001 by Frank Burroughs after his daughter, Abigail, a University of Virginia honors student, died of cancer after being denied a new cancer drug her oncologist believed could save her life. The drug was later approved and is saving lives now, but it’s too late for Abigail Burroughs.

The Abigail Alliance was not requesting access to experimental drugs that have not undergone any clinical testing. It wanted to establish a right for terminal patients to have access to new drugs that have passed Phase I of the FDA’s required battery of clinical trials, which establishes that a drug does not pose undue safety risks. Subsequent trials establish whether drugs are effective for the diseases for which they were developed.

Since those subsequent trials may take years and many of the Abigail Alliance’s members have been told they have six months or so to live, waiting for the full trials amounts to a death sentence.

If we had our way, the FDA would be able to keep drugs off the market only if they failed to pass safety tests. Efficacy tests could be required to provide valuable information to doctors and patients, but would not be grounds to ban the use of medications. Even if that reform is not politically feasible, however, surely there should be a different standard for terminally ill patients than for patients seeking a new treatment for corns or bad breath. We don’t know if that’s a constitutionally guaranteed right or not, but it’s simple compassion and common sense.

As Judge Judith Rogers put it in a powerful dissent, “Denying a terminally ill patient her only chance to survive without even a strict showing of government necessity (for denying access to the drugs) presupposes a dangerous brand of paternalism.”

You might even call it cruel and unusual punishment — except that it’s not so unusual in this country.

The Supreme Court should take up this case and reverse it as quickly as possible.

The good news . . . and bad news

There’s actually evidence that the U.S. military “surge” in Iraq has reduced violence in some parts of the country. But all observers, from President Bush to commanders in the field to severe war critics, agree that the most important goal in Iraq is a functioning government able to reconcile or at least paper over the sectarian differences that make Iraq so difficult to govern.

This is an exceedingly difficult goal, given that modern Iraq, while it has some aspects of a national identity, is in some ways an artificial country, cobbled together by the British after World War I. For most of its modern history (it was three separate provinces under the Ottoman Empire) the Sunni minority has ruled — usually ruthlessly — over a country with a Shia majority and a Kurdish enclave in the north.

Because Sunnis foolishly boycotted early elections, and the country’s religious demographics, the government is dominated by Shia politicians. Since the Shia were repressed under Saddam Hussein, they have more experience being in opposition than governing, seeking consensus and making pragmatic compromises. Iraq’s politicians of all stripes, understandably so, are more loyal to sect, clan, tribe and region than to the nation as a whole, which remains something of an abstraction.

In this context, the fact that Iraq’s parliament, like the U.S. Congress, is taking a recess during the critical month of August is a minor distraction, rather than the outrage some have portrayed. It is unlikely that another month of meetings would bring a breakthrough on contentious issues such as constitutional reform, oil revenue sharing and protection of minority rights.

More significant is the fact that five members of the Iraqiya coalition, a moderate, secular-oriented group headed by former prime minister Ayad Allawi, suspended participation in Prime Minister Nouri al-Maliki’s Cabinet meetings on Monday. Last week, six ministers from the Sunni Iraqi Consensus Front quit the Cabinet, and in March six ministers allied with the radical Shia cleric Moqtada al-Sadr left. This leaves Maliki isolated and largely impotent.

Perhaps these defections will be a wake-up call that will impel Iraqi politicians to get their act together. Unless they do, Iraq may cease to exist as a unified country. That might not be as tragic as it sounds: a number of experts have recommended partitioning the country into three or more sectors.

Gen. David Petraeus may have encouraging news about the military aspect of the U.S. occupation in his September report. The equally important political aspect, however, is almost certain to be discouraging.