Wrong Way in the War on Cancer

By Merrill Goozner, Gooznews. Posted May 25, 2009.

President Obama wants to double the National Cancer Institute’s budget and representatives in Congress on both sides of the aisle are supportive. But before our elected leaders escalate the long-running war on cancer, the Obama administration might want to review the past performance of cancer research, which emphasized finding new cures, not fine-tuning existing oncology treatments.

By the most objective measure of progress—improved overall survival—the results from the hunt for new cures are meager. “The age-adjusted mortality rate for cancer is about the same in the 21st century as it was 50 years ago, whereas the death rates for cardiac, cerebrovascular, and infectious diseases have declined by about two-thirds,” laments Harold Varmus, the Nobel Prize-winning cancer researcher and former head of the National Institutes of Health, in his otherwise upbeat assessment about the future prospects for cancer research.[1]

This is why a redrawn battle plan—one that focuses on turning the treatment system into a research and learning system that can teach oncologists the best use of the weapons they already have—is long overdue. To understand why this shift in focus is essential, let first examine our record to date in hunting for new cures.

First of all, there has been some progress, of course. About 66 percent of people diagnosed with cancer today survive five years, up from 50 percent in 1975. And mortality rates for some cancers are falling.

The outcomes are never gathered. The data is never analyzed. And the findings are never disseminated.

But even that progress is under intense scrutiny. While the drug and biotechnology industries are lavishing increased attention on cancer (861 drugs and vaccines in clinical trials, according to a recent announcement[2]) most of the newly approved agents that squeeze through the pipeline extend the lives of patients for only a few weeks or months, often at great expense.

The evidence suggests the greatest strides in reducing cancer deaths in recent years have come not from better drugs but from the nation’s war on smoking. What’s more, most of the improved longevity for cancer patients is an artifact of early diagnosis rather than improved care.[3]

There’s no shortage of blue-ribbon committees wrestling with the problem of slow progress in the medical fight against cancer. The Institute of Medicine has a panel evaluating the government-funded clinical trial network. The National Cancer Institute has pulled together its own team for an in-house review.

But an obsessive focus on flaws in the government-funded clinical trial system may be missing the core problem. Government-funded trials are a minuscule portion of the overall clinical research enterprise. Most clinical research today is sponsored by industry, and those trials are focused largely on getting new drugs through the U.S. Food and Drug Administration approval process. While firms do test their approved drugs for new indications, it’s usually in limited populations, which may be large enough to generate a medical journal article but rarely reach the size needed to win FDA approval for that new use.

Even rarer are the head-to-head clinical trials that compare different chemotherapy regimens since few companies are willing to risk having their drug proved less effective than a competitor’s drug. Post-approval trials aimed at fine-tuning the best use of new drugs are equally rare since by definition such trials would limit their use to subsets of individuals with a particular form of cancer. Saving money for patients and their insurers—the total health care cost tab for cancer came to an estimated $93.2 billion last year[4]—is not a very high priority for industry-funded research.

The result is that many of the nation’s 30,000 oncologists are engaged in what could be described as an unobserved and uncontrolled science experiment, especially when it comes to treating the 560,000 Americans who die each year from the more than 100 forms of the disease. As these patients’ cancers advance, their physicians try regimens they read about in journals or hear about from colleagues. The outcomes are never gathered. The data is never analyzed. And the findings are never disseminated.

Indeed, an estimated 70 percent of all cancer drugs are used off-label. In other words, most prescribed chemotherapy regimens have not been approved by the Food and Drug Administration for that particular use. Much of the off-label use is supported by the slimmest of evidence, often just a single trial in the medical literature of limited size and duration.

See more stories tagged with: cancer, obama, health care reform, medical research

Merrill Goozner spent more than 25 years in the news business as a foreign correspondent, economics writer and investigative reporter for the Chicago Tribune and other publications. He is the author of The $800 Million Pill: The Truth Behind the Cost of New Drugs and blogs at Gooznews.com.

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