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QUALITY/PHARMA: Chemosensitivity Testing and its relation to the Chemotherapy Drug Concession, by Greg Pawelski

Contributor Gregory Pawelski is back with another look at the chemotherapy market. He’s writing about a wrinkle in the use of chemo drugs that has some big implications. The Sept 1 Press release at this site has the science behind the issue. I’m in no position to judge any of the science being disputed, but the implications for pharma, Medicare, insurers, the taxpayer and oncologists are obvious.

Without information provided by Chemosensitivity Testing (assay-testing), oncologists have the freedom to choose between a multiple of different drug regimens, all of which have approximately the same probability of working. Some of these regimens are highly profitable to oncologists. Other regimens are much less profitable. Assay-testing takes away a lot of this freedom to choose and narrows the selection to those drugs that have the highest probability to be successful but may have lower profitability for the oncologist. This cuts into the oncologist’s bottom line, though it benefits the patient.

Many of these less profitable regimens are oral-dose. As I reiterated in my previous article in office-based oncology practices the core activity in medical oncology is the provision of infusional chemotherapy. The entire structure of the practice revolves around this activity and is what distinguishes medical oncology from most other specialties.

The new Medicare bill offered patients benefits they did not have before. There is now “some” coverage for oral-chemotherapy drugs, which were not available before. Since April of this year, $200 million was available so that some Medicare cancer patients would have transitional coverage for these drugs, until the bill goes into full effect in 2006. Providing some compensation for oral-chemotherapy drugs was a major emphasis for a number of cancer support groups. Although some benefit was realized, more might have been achieved if ASCO (American Society of Clincial Oncology) and other groups had lobbied as much for the oral-chemotherapy drug issue as they did for office-practice expense reimbursement.

ASCO fought long and hard to retain the Chemotherapy Drug Concession and never once suggested the need for a clinical trial to show when drugs were selected with and without the presence of profit differential (which included oral-dose drugs), clinical outcomes would be the same. It is a real credit to oncologists who utilize assay-testing in their management of their cancer patients, despite the fact that their use constrained their freedom to choose and doubtlessly reduced their incomes.

Take an example of ovarian cancer. After 25 years of prospective, randomized clinical trials to identify the best treatments to give to the average patient, there has been absolutely no progress. A meta-analysis of all trials showed that there was no difference. During those 25 years, Taxol came along. Two large clinical trials showed that Taxol/Platinum combinations were better than single platinum regimen. And Taxol became one of the most remunerative cancer drugs of all time. So Taxol/Platinum became “standard” therapy.

But then two more very large trials were done, showing that there was no advantage to giving Taxol/Platinum over single agent platinum (like Carboplatin). And Taxol/Platinum also wasn’t any better than another non-Taxol combination (not previously tested against Taxol/Platinum). But Taxol/Platinum remained “standard” therapy. Now that Taxol is going off patent, some academic oncology groups have (as their major ovarian cancer project) clinical trials to show that Platinum/Taxotere (a drug like Taxol, but still on patent) can now be the new “standard” therapy.

All the while doing this, ASCO is refusing to suggest clinical trials of “cell death endpoint” chemosensitivity testing, because, lacking something patentable or proprietary, all assay-testing laboratories can offer is free assays and not the millions of dollars that someone like Bristol-Myers-Squibb can offer to push its Taxotere trials.

The present system exists to serve the clinical investigators and the clinical oncologists, but not to serve the best interests of the cancer patients. I think it is time to set aside empiric one-size-fits-all treatment in favor of recognizing that breast, lung, ovarian and other forms of cancer represent heterogenous diseases, where the tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient’s cancer.

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The best work in Cell Culture Assays with “cell death” endpoints for the last 24 years has been in the area of what is referred to as Cell Culture Drug Resistance Testing (CCDRT), Chemosensitivity Testing, or Chemotherapy Sensitivity and Resistance Assays (CSRAs). The concept is to obtain a biopsy of a patient’s solid cancer (or leukemia, etc.) and isolate the cancer cells from the biopsy, culture these cells in the laboratory, and test them to determine if they are likely to be “sensitive” or “resistant” to different forms of chemotherapy. There are two main endpoints for these tests. The first… Read more »