Cell Culture Drug Resistance Testing (CCDRT) Cell Death Assays:
Misconceptions Versus Objective Data
- Chapter 15 -
I am sure that the use of these assays prolongs life in individual patients (e.g. Scientific American 280,No.2, pp. 19-20,'99), in the same way that I know that the use of empiric chemotherapy prolongs the life of some individual patients with commonly drug resistant neoplasms, despite the lack of proven efficacy of empiric chemotherapy in prospective randomized trials. I know that empiric therapy sometimes works, because I have seen dramatic results with empiric chemotherapy in individual patients. Where this is the best hope or the only hope of prolonging life, patients are entitled to receive such treatment, and they are entitled to receive insurance reimbursement for this treatment, if they diligently payed their premiums in accord with the terms of their insurance contract or if they have diligently paid their taxes in the case of Medicare. Likewise, I know of many individual cases in which patients were clearly and unambiguously helped by having active treatments identified through the use of our assays after empiric treatments had failed. Lacking proof of population (not individual) efficacy (because of all of the barriers described above), these numerous clear-cut instances of individual benefit, lack of any evidence at all of any harm, and persuasive clinical correlation data (showing that the patients treated with drugs active in the assays enjoy superior response rates and survival compared to patients treated with drugs not active in the assays) make an overwhelming case that subscribers/beneficiaries are entitled to the benefit of the information provided by these tests, if they have paid their insurance premiums/taxes, irrespective of whatever the cost-benefit turns out to be. It is what I would want (and have obtained) for my family and what I would want for myself; and it is what I want for my patients.
In the final analysis, however, the decision of whether or not to use these tests in a given situation is, or should be, a matter to be decided between the individual patient and her/his physician. My hope is that physicians, insurance carriers, and government agencies can all be objectively respectful of the judgement of expert physicians and their patients to make use of these tests on a case by case basis. An additional hope is that skeptical physicians, insurance companies, and/or government agencies will justify their skepticism with objective facts or give me the opportunity to participate in studies of good design which will answer the questions which they deem to be of the greatest importance.
For the time being, I think that I can fairly summarize the situation as follows. It depends on whether it is more appropriate to apply the "criminal justice standard" or the "civil justice standard."
Proof beyond reasonable doubt: Argues against the use of the assays (but also argues against the majority of diagnostic and prognostic tests in cancer and against a large number of commonly used cancer treatments)
Preponderance of currently-available evidence: Argues persuasively in favor of the use of the assays (see "Milestone Publications," Table 3, and other data summarized in Tables 1-3, Figs. 1-6).
Larry Weisenthal August 31, 1999