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Borrow From The HIV Battle Plan To Help Win War Against Cancer

Tomas Philipson
Investor's Business Daily
March 16, 2009

President Obama's call to defeat cancer "in our time" is a bold idea backed up by an infusion of new money: $6 billion in new funding for cancer research at the National Institutes of Health.

The problem is that more money isn't all we need. The Food and Drug Administration needs to be much less cautious in its regulations affecting cancer drug development so we can give patients suffering from deadly ailments like lung and pancreatic cancer faster access to new treatments.

First, the good news. In a forthcoming study, my colleagues and I show that gains in survival (minus treatment costs) far outweigh U.S. investment in cancer research, suggesting that we've made important strides in the war on cancer.

The American Cancer Society recently reported that, for the first time, cancer incidence and cancer deaths have declined in the U.S. Cancer mortality rates have declined by about 1% per year since the early 1990s, with 2% declines more recently.

Moreover, five-year survival rates for all newly diagnosed cancers now stand at 66%, up from just 50% in the mid-1970s. For a handful of cancers—breast and testicular, some types of leukemia, and childhood cancers—the gains have been nothing short of astonishing.

Sadly, the war on cancer is far from over. The second leading cause of death in the U.S., cancer killed over 500,000 Americans in 2008, researchers estimate. According to the NIH, the U.S. spends about $90 billion on direct costs for cancer care, or approximately 5% of total health care spending, but the indirect costs of the disease are much higher.

Researchers at the National Cancer Institute recently estimated that cancer's total economic cost in the year 2000 alone, including lost productivity and the value of leisure time, was $960 billion.

The FDA has several programs in place to help speed up review of, and access to, promising cancer drugs. But companies still spend more time testing oncology drugs in clinical trials than other types of medicines in order to pass muster with the FDA.

Companies also report that cancer trials are getting more complicated and time-consuming than ever before. As a result, many cancer patients alive when a promising drug is discovered will likely die long before it reaches the market.

With the help of Congress, the FDA should take concrete steps to shorten clinical development times for cancer treatments and speed up drug development. These would include:

First, where few effective treatments exist—such as lung or pancreatic cancer—the FDA should approve more drugs based on clinical parameters (like tumor response or slowing the spread of the disease) or biomarkers (like cholesterol for heart disease) that act as probable surrogates for improved survival. Patient registries can then be used to follow patients and track how well the drugs work in the real world.

Second, the FDA should set clear standards allowing companies to test cancer drugs in "adaptive" clinical trials that are potentially faster and cheaper, and require fewer patients than traditional designs.

Normal clinical trials randomly assign patients to either treatment or placebo, and success is measured based on overall response. Adaptive clinical trials allow researchers to "learn as they go" and alter the trial to account for varying responses among subgroups of patients.

Adaptive trials can potentially identify which patients are most likely to respond to treatment, allowing the trial to show results sooner. The FDA has suggested that it's open to such trials, but until clear standards are in place, companies will shy away from using them.

Third, Congress needs to increase the FDA's funding so it can keep pace with the latest scientific developments likely to streamline the cost and time required to bring innovative new therapies to market.

In particular, Congress must devote significant funding to the Reagan-Udall Foundation and the Critical Path initiative at the FDA, both of which aim to modernize the science of drug development.

The fight against cancer should be based on the FDA's response to the HIV epidemic, when regulators, under intense pressure from patients' groups, rapidly worked to approve new surrogate markers for evaluating drugs, scaled back their lengthy approval processes and worked closely with academic researchers and pharmaceutical companies to develop new approaches.

Before HIV changed the landscape at the FDA, infection was a death sentence, just as many cancers are today. HIV drugs now offer patients decades of relatively healthy life after diagnosis.

If we speed up access to innovative cancer treatments in the same way, we might achieve a similar outcome. Cancer patients and their families deserve nothing less from their government.

Philipson is the Daniel Levin Professor of Public Policy at the University of Chicago and chairman of Project FDA of the Manhattan Institute.

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