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"Faltering Cancer Trials" -- A Challenge to the Obama Administration

Posted Apr 25 2010 12:00am

The New York Times publishes a tough editorial this morning, under the headline, "Faltering Cancer Trials," concerning the sorry state of the National Cancer Institute--and casting further light on the Obama administration's efforts in the healthcare field.

In a nutshell, it seems as through the Obamans have been so focused on expanding the size of government that they have lost sight of the effectiveness of government. A big but incompetent government is what Americans have come to expect, but they don't like it. And they certainly don't want more of it. As the Times puts it:

The nation’s most important system for judging the clinical effectiveness of cancer treatments is approaching “a state of crisis.” That is the disturbing verdict of experts assembled by the National Academy of Sciences to review the performance of clinical trials sponsored by the National Cancer Institute.

"A state of crisis." Hmm. For a disease, cancer, which is the second-leading cause of death in the US">claiming more than half a million lives every year. And a cost of more than $100 billion a year in direct outlays, to say nothing of indirect costs, including lost work and productivity.

And yet, as the Times details, the National Cancer Institute seems to be in chaos:

The most shocking deficiency highlighted by the report, issued by the academy’s Institute of Medicine, is that about 40 percent of all advanced clinical trials sponsored by the Cancer Institute are never completed. That is an incredible waste of effort and money, and a huge obstacle at a time when researchers are developing promising new therapies that must be rigorously tested.

These large, government-sponsored studies are supposed to be the gold standard — and very different from the narrow, occasionally biased studies sponsored by manufacturers seeking approval of a new drug.

The government-sponsored trials can be invaluable in comparing one therapy against another (manufacturers rarely want to put their products up against a competitor’s), combinations of therapies, or therapies for rare diseases with little commercial potential.

So it is especially worrying to hear the experts say that the system — run by the Cancer Institute at the National Institutes of Health — is so mired in cumbersome procedures that it needs to be completely overhauled.

The Cancer Institute funds clinical trials primarily through 10 “cooperative groups” of experts. They generate ideas for testing new therapies and conduct the trials through networks of cancer centers and community oncology practices. More than 25,000 patients, 3,100 institutions and 14,000 investigators participate each year.

Yet a series of reviews in recent years found that the testing operation is mired in bureaucracy and poorly coordinated. A typical trial must navigate past dozens of overlapping reviews by different boards and agencies that must approve the original concept for the trial and then the protocol that will govern how it is conducted before the investigators can start enrolling any patients.

The average time between developing the concept for a study and getting it started is about 2.5 years. The longer a study takes to get started, the more likely it is to become scientifically out of date, and the less likely it is that doctors or patients will want to participate.

Other factors, including failure to pay investigators and their institutions the full costs of a trial, can also impede enrollment. And if not enough patients are enrolled, the study lacks the statistical power to generate meaningful results and cannot be completed.

The Institute of Medicine panel, headed by John Mendelsohn, president of the M.D. Anderson Cancer Center in Houston, offered a range of suggestions for improving the prospects for success.

It called for reducing and consolidating the number of cooperative groups, committees and reviews; increasing the money to support the trials; increasing the academic rewards to encourage researchers to run clinical trials; setting strict deadlines for each step in the process; and prioritizing the studies most likely to be successful. All that should be done even if money has to be transferred from other research activities.

The need for improvement looms especially large now that the Obama administration is pouring substantial sums into “comparative effectiveness research.” That is essential to helping doctors determine which treatments work well and which do not — and holding down the cost of medical care.

Yes, it will be interesting to see what the Obama administration proposes to do about this issue. Speeches and rhetoric will not do.

So will the President call a top-level meeting to consider management reforms at the National Cancer Institute? Will he take time away from his other pending priorities, such as financial reform, "cap and trade," and "comprehensive" immigration reform to focus on improving the administration of vital health programs? Or will he be content to let the same bureaucracy that allowed the problem to get worse to work on it--read: worsen it--further?

It is also interesting that this cancer crisis seems to have grown worse during the year that the Obama administration fought so diligently to give the government still more power over healthcare. But a focus on "quantity"--that is, the size of government--seems to be a different thing than a focus on "quality"--the effectiveness of government. But perhaps the Obama administration does not agree.
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