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January 25, 2005

QUALITY: Now cancer is top killer, let's attack it using common sense, by Greg Pawelski

Greg Pawelski has posted frequently on THCB about cancer care. On the occasion of cancer becoming the nation's biggest killer for those under 85, he appeals for sensible use of scientific funding to go after the process behind metastasis.

The Associated Press reported that Cancer is the Top Killer for Those Under 85. There has been no real progress in the treatment of most common forms of cancer. Recent NCI data showed that U.S. cancer mortality rates have increased and age-adjusted cancer mortality rates in response to treatment have not improved in several decades, despite the introduction of many new drugs. There is a mind-set of cancer culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication over all else.

The January 10, 2002 issue of the New England Journal of Medicine noted that 20 years of clinical trials yielded survival improvement of only 2 months for patients with advanced lung cancer. It also pointed out that oncologists at a single institution may obtain a 40-50% response rate (not cure) in a tightly controlled study, but when these same studies are administered in a real world setting, the response rates (not cure rates) decline to only 17-27%.

In the March 15, 2004 issue of the Journal of Clinical Oncology, an editorial stated that a review of all the large, prospective, randomized trials published comparing the newer taxane-based regimens, none of these regimens have increased either complete response rates or overall survival, with median survivals remaining at two years or less. This is precisely the same results which were being obtained 30 years ago.

The results of nearly 30 years of clinical investigation in the treatment of patients with cancer, neither standard or high-dose regimens had done a great deal to improve the outcome of patients. For over the past 20 years, they relentlessly combined chemical agents in various regimens with ever-increasing dose intensity and the survival for patients is exactly the same, less than two years. Not a hint of significantly improved survival.

In the March 22, 2004 issue of Fortune, an extensive expose of why there has been no progress in drug treatment of cancer in three decades, the author writes that it is not localized tumors that kill people with cancer, it is the process of metastasis, 90% of the time. Aggressive cells spreading to the bones, liver, lungs, brain or other vital areas, that are wreaking havoc. You'd think cancer researchers would be bearing down on the intricate mechanisms of invasion and spread? However, according to a Fortune examination of NCI grants going back to 1972, less than 0.5% of study proposals focused primarily on metastasis, trying to understand its role in cancer or just the process itself. Of nearly 8,900 NCI grant proposals awarded in 2003, 92% didn't even mention the word metastasis.

So pharmaceutical companies don't concentrate on solving the problem of metastasis (the thing that really kills people); they focus on devising drugs that shrink tumors (the thing that doesn't). There is a national problem in the way we treat the problem. It is time to set aside empiric "one-size-fits-all" treatment of cancer for "individualized" treatment based on testing the individual properties of each patient's cancer.

January 25, 2005 in Quality | Permalink


M.D. Anderson Cancer Center is taking a new look at how to evaluate new medicines and treatments for cancer. They are rethinking how they design and conduct clinical trials by turning the 'statistical method' used to evaluate new drugs on its head, because it limits innovation and learning.

They are adopting the Bayesian method of science because it is more in line with how science works. They are putting this approach to the test with more than 100 cancer-related phase I and II clinical trials being planned or carried out using the Bayesian approach. Of course, the Bayesian method is no stranger to the technology of Cell Culture Assay Testing (Chemosensitivity Testing). In fact, it is what gives credit to the accuracy of assay testing.

Clinical trials test the efficacy (not the accuracy) of a drug. The efficacy of a drug is to produce a desired effect, which is tumor response (shrinkage). Single arm clinical trials provide the tumor response evidence that is the basis for approving new cancer drugs. The Bayesian methology can bring some much-needed "accuracy" to the forefront of clinical trials.

Clearly, more effective cancer therapies are desperately needed, and after 30 years of investigation aimed at intensified multi-agent chemotherapy, we should look for other avenues of study. In an era of ever-increasing numbers of partially effective cancer therapeutics, there is an obvious need for more accurate methologies. We cannot afford any more 'trial-and-error' treatments.

Posted by: Gregory D. Pawelski | Apr 25, 2006 6:44:10 AM

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