- The Washington Times - Tuesday, March 27, 2007

The news this week that two public figures, Elizabeth Edwards and White House press secretary Tony Snow, now face a recurrence and spread of their cancer has prompted an outpouring of concern for their well-being which transcends politics. It is also a good occasion to observe the fact that cancer — as with many diseases — is curable, and that increasingly chronic illnesses can be controlled, allowing millions to live longer, more productive lives. More people have cancer because people are not dying from other illnesses. However, a combination of earlier detection, new medicines and speedier drug approvals has increased life expectancy and reduced death rates.

Unfortunately, progress is in danger of eroding. The rate of cancer drug approvals is still low. Researchers know that most cancer drugs work for a small group of patients based on genetic profiles. Yet the FDA increasingly demands that cancer trials be designed to include responders and non-responders so that studies are virtually guaranteed to demonstrate marginal benefits. Meanwhile, Rep. Henry Waxman is readying legislation that would require such clinical trials for approval and post-market followup even as he pushes for weaker safety standards for generic versions of biotech products. This will result in many cancer drugs that could otherwise save the lives of many being scrapped at the expense of patients with incurable illnesses.

Worse, many in Congress want to impose a cost-effectiveness standard on access to cancer drugs similar to one used in Great Britain and Canada as a way to drive down drug prices. This is an approach being pushed hard by Professor Gerard Anderson of Johns Hopkins University, who confidently is telling legislators that doing so will not harm patients.

We would not bet Mr. Anderson’s tenure on that claim. Gleevec is frontline therapy for stomach cancer in America, causing remission of the disease in thousands of patients. Britain’s health-system cost-effectiveness board, the National Institute for Clinical Excellence, recommends taking the drug away from patients after four months if there is no progress despite the fact that some people take longer to respond. Revlimid — a drug that eliminates the use of expensive blood transfusions for nearly 75 percent of patients with myelodysplastic syndromes that causes underproduction of red blood cells — has been available in the United States since 2005. Canada has yet to make it available while it “negotiates” a “cost-effective” price. Avastin, a drug used to extend the lives of people whose cancer has re-emerged like Mrs. Edwards and Mr. Snow, is not on the Veterans Affairs formulary that many in Congress want to impose on the rest of us based on the same cost-effectiveness benchmark.

The next medicine that could prolong or save the lives of cancer patients could be rejected, delayed or rationed because of policies being pushed in the name of “safety” and “cost-effectiveness.” Besides our prayers, Mrs. Edwards, Tony Snow and others with cancer deserve the right drug for their particular form of cancer as quickly as possible. Congress and the FDA still have time to move in that compassionate direction.

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