- The Washington Times - Saturday, May 16, 2009

ANALYSIS/OPINION:

COMMENTARY:

Federal approval of new drugs usually triggers jubilant stories about the masses of people whom a given compound will rescue from premature death. Seldom seen, however, are those who die waiting for pharmocrats to authorize fresh cures.

Honor student and homeless-shelter volunteer Abigail Burroughs was diagnosed with head and neck cancer. After she could not join a clinical trial, the Food and Drug Administration stymied a seven-month effort by Miss Burroughs, her parents and her doctor to secure Erbitux, which could have helped. Instead, she died in November 2000 at age 21.

“When access to the most innovative drugs is denied, patients suffer and die,” says Bart Madden. “The result is an invisible graveyard of enormous size.”

Mr. Madden, a policy adviser to Chicago’s free-market Heartland Institute, promotes Free-to-Choose Medicine, a common-sense reform that could stop thousands of preventable deaths annually among the terminally ill and comfort potentially millions more who experience serious ailments.



Mr. Madden outlined this concept at an April 25 Los Angeles meeting of the Atlas Economic Research Foundation, of which I am a senior fellow:

c Under physicians’ supervision, seriously ill patients could take experimental pharmaceuticals that have survived Phase I FDA safety tests. Once the drugs have been ruled safe, patients and doctors could determine the drugs’ effectiveness, rather than wait years for the FDA to make that judgment.

c Patients and doctors could consult a Tradeoff Evaluation Database, independent of the FDA. Test results from others using Free-to-Choose Medicines would foster informed decisions based on observed risks and rewards of not-yet-approved therapies.

c Pharmaceutical companies would enjoy significant protection from litigious patients dissatisfied with investigational drugs.

This policy would reduce the staggering numbers of sick people who silently expire while enduring FDA intransigence. Between June 2004, when the pro-reform Abigail Alliance championed approval of a drug called Tykerb, and the FDA’s March 2007 endorsement of this breast-cancer treatment, almost 28,000 women died waiting - about equal to 18 sinkings of the Titanic. Tykerb could have added eight months to these women’s lives. As Abigail Alliance activists Ronald Trowbridge and Steven Walker wrote in the Wall Street Journal, “Long enough, perhaps, to see a child graduate from college or get married, or to meet a new grandchild.”

In 2007, the FDA ordered three more years of tests on Provengene, a promising prostate-cancer remedy. Prostate cancer kills about 28,600 American men annually. Even if the FDA approves Provengene next year, 85,980 American men will have died without being permitted to try it - roughly 30 times the body count on Sept. 11, 2001.

Sen. Sam Brownback, Kansas Republican, and Rep. Diane Watson, California Democrat - the oddest pair of political bedfellows alive - want to stop this madness. Their Access Act would accelerate Free-to-Choose Medicine. Congress should pass it with all deliberate speed.

Alas, that is not soon enough for Anna Tomalis. The soccer-loving Maryland seventh-grader fought soft-tissue sarcoma. A trial treatment called Deforolimus offered her some hope. But the FDA decided clinical-study patients for this drug had to be at least 13. Anna, then 12 1/2, sought special permission to join the test. By the time FDA granted her exemption, she was too sick to benefit. She died Aug. 15.

This concept would shield people like Abigail Burroughs and Anna Tomalis who pass away because federal functionaries protect them to death from drugs deemed more dangerous than the lethal maladies that finally kill them.

“Every American has the right to medical self-defense,” says Scott Riccio, founder of Accelerate Progress, which promotes Free-to-Choose Medicine. “If an attacker breaks into your house, you have the right to defend yourself by whatever means necessary. But if cancer invades your body, we allow a faceless, distant bureaucracy to say, ‘No, no. You may not use this drug to fight for your life.’ How bizarre.”

The ultimate beauty of this lifesaving idea is that it also simply, elegantly and inexpensively expands individual freedom and personal sovereignty: See your doctor. Then, if you choose to take an experimental drug, do so. If not, don’t.

Deroy Murdock is a columnist with Scripps Howard News Service and a media fellow with Stanford University’s Hoover Institution.

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