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Commentary

Breast Cancer Breakthroughs
Dr. Scott Gottlieb, Wall Street Journal, 3-26-07

Gottlieb describes the enormous strides that have been made in the treatment and diagnosis of breast cancer in recent years, with the result that "nearly 98% of women with early-stage breast cancer survive at least five years" and "many will live long, full lives."

Unfortunately, advances in the U.S., particularly access to new cancer drugs, have not been mirrored in the E.U. where patients are often made to wait months or even years before getting access to the latest treatments.

Yet these improvements are not being realized around the world. Europe should be sharing in the progress against cancer, but large bureaucracies have been erected to contain costs, by slowing the introduction of new drugs and restricting how doctors can use them.

Unfortunately, some people want to import the European model here into the U.S.—and in some cases it has already arrived. One current bill on "sole-source" or very unique drugs would make Medicare more like Europe, tying access to decisions on pricing.

Since European drug regulators do not allow new medicines to reach patients until government negotiators have extracted a favorable price from sponsors, cancer drugs are often available in the U.S. months if not years earlier. In 2003, when 31 new drugs were launched worldwide, about 60% were available here months before Europe. Between 1995 and 2001 the 15 cancer drugs approved in Europe and the U.S. took 468 days to reach patients in Europe versus 273 days in America. Herceptin was tangled up in a 550-day approval process as the Europeans fought for a lower price, while the U.S. approved it in fewer than 120 days.

Driving hard bargains also means imposing conditions on who can access new drugs by refusing to pay for many uses, even those approved by world regulatory authorities.

There is a price for these policies. A study done in 2003 for Britain's National Health Service found that, long after its approval, more than 1,000 eligible British women with breast cancer were still not receiving Herceptin. Five-year survival for breast cancer caught early in England is 78%, compared to 98% in the U.S. In Germany, a study found that 41% of German physicians were treating early breast cancer with taxanes, compared to 60% in America at the time. German breast cancer mortality decreased by 9% from 1990 to 1998, while mortality in the U.S. dropped more than twice as much. Overall, between 2004 and 2006 European deaths from breast cancer increased about 1.5% while the number of deaths from colorectal cancer increased 1.8%. New research by Columbia University economist Frank Lichtenberg, looking at cancer statistics in Europe, found use of newer cancer drugs correlates closely with improvements in survival.



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