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March 14, 2009Introducing new international blog to discuss issues relevant to human tumor assays: CancerTest.org  First post  considers an excellent article in the current issue of Internal Medicine News, relating to an emerging controversy over the regulation of cancer tests.

February 19, 20095FU activity in MTT assay predicts for long-term patient survival in metastatic colorectal cancer. Presentation at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium January 17, 2009. Click here for slide presentation on ASCO website.

September 10, 2008Lapatinib enhances the antivascular activity of bevacizumab and has superior antivascular activity compared to sorafenib. Presentation at the American Society of Clinical Oncology Breast Cancer Symposium September 5, 2008. Click here for slide presentation on ASCO website.

August 10, 2008New method reported for testing anti-angiogenic/anti-microvascular agents, such as bevacizumab (Avastin) and for testing for synergy between different anti-microvascular agents on an individual patient, individual tumor basis.

Click here for technology example

An article appearing today in the Journal of Internal Medicine reports the discovery of the first practical laboratory test to guide the use of new-generation drugs that kill cancer cells by cutting off their blood supply. The new test was developed at the Weisenthal Cancer Group in Huntington Beach, CA, and is called the Microvessel Viability (MVV) Assay.  It identifies the activity of both single drugs and also combinations of drugs in human cancer at the level of individual patients and individual cancers.  It works by measuring drug effects upon endothelial cells which make up blood vessels. Use of the test has the potential to identify new cancer treatments, prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective treatments.  The MVV test is also a powerful development tool which can identify effective new drug combinations, potentially streamlining new drug development and leading to new and better treatments for cancer patients.  It is probable that major advances will come from the use of anti-blood vessel drugs in combination, analogous to the treatment of HIV/AIDS.  A major problem to date has been the lack of a relevant and practical system for testing anti-microvascular drugs against human tumors in which to discover synergistic anti-microvascular drug combinations. The MVV test is both relevant and practical for use in discovering synergistic drug combinations and identifying which patients are most likely to benefit from which drug combinations. (Weisenthal, LM, Patel, N, and Rueff-Weisenthal, C. Cell culture detection of microvascular cell death in clinical specimens of human neoplasms and peripheral blood. J Intern Med 264:275-287, September 2008).

doi: 10.1111/j.1365-2796.2008.01955.x

Link to ongoing blog discussion/debate concerning the MVV Assay in particular and cell culture testing in general.

June 12,  2007Emerging data on a continuing problem: The corruption of medical oncology by a system which rewards doctors for being pharmacists: Choosing drugs for cancer patients based on profits to the oncologist.


1. The idea that we have been successful in identifying the best available treatments through "well designed, prospective, randomized trials" is a fiction.

e.g. breast cancer ( click here )

2. Faced with a large number of choices of otherwise equally acceptable therapies, owing to the situation described in #1, oncologists select the treatments which generate the most income for themselves (in the case of private practices) or which generate the least inconvenience for their clinical research clinics (in the case of academicians). ( click here )

The latest developments in this saga are recent data chronicled in a two part New York Times series:

Representative excerpt:

"Industry documents that have emerged in a federal civil lawsuit in Boston show that big pharmaceutical companies sometimes calculated to the penny the profits that doctors could make from their drugs. Sales representatives shared those profit estimates with doctors and their staffs, the documents show.

"In one PowerPoint presentation from 2000, a Bristol-Myers Squibb executive told employees that oncologists’ biggest concern was “Reimbursement Today, Reimbursement Tomorrow, Reimbursement!”

"Dr. Robert Geller, an oncologist who worked in private practice from 1996 to 2005 before leaving to join a biotechnology company, said that cancer doctors knew the profits they could make and in some cases would change treatment regimens or offer unnecessary care to make extra money.

“It’s clear that physicians stopped making decisions based on what made scientific or clinical sense in lieu of what made better business sense,” Dr. Geller said."


http://www.nytimes.com/2007/06/12/business/12cancerside.html?ref=business  (requires free registration)

http://www.nytimes.com/2007/06/12/business/12cancerpay.html?ref=health (requires free registration)

Why is the above relevant to the content of this website?  Simple; it explains why the American Society of Clinical Oncology has done everything in its power to discourage the utilization of well documented cell culture assay technologies for use in drug selection.  Absent the use of tests to characterize the drug resistance of individual tumors, clinical oncologists have freedom to choose the drug(s) which are most profitable to the oncologist.  And the above articles (and other data cited on this website) indicate that this is precisely how drugs are being selected in the real world of cancer medicine, as it exists today in the U.S.A.

May 19,  2007Functional profiling with cell culture-based assays for kinase inhibitors and anti-angiogenic agents. Presentation at the 41st Annual Meeting of the European Society for Clinical Investigation in Uppsala, Sweden April 18, 2007.  Literature citation: Eur J Clin Invest 37 (suppl. 1):60, 2007. Click here for PDF export (18 MB, if downloaded) of slide presentation.

March 31,  2007Functional profiling with cell culture assays for targeted drug therapy. Presentation at the American Society of Clinical Oncology (ASCO) GI cancer symposium (Orlando, FL, January 27, 2007). ASCO web site link (click on "Slides")  to slide presentation relating to  testing for antitumor and antiangiogenic activity of gefitinib, erlotinib, sunitinib, sorafenib, and bevacizumab in primary cultures of fresh human tumors.

Feb. 19,  2007Medicare coverage for cell culture drug resistance testing (CCDRT) officially effective February 19, 2007. Click here for full explanation of favorable coverage decision for cell culture drug resistance testing, encompassing both what were semantically referred to as "chemosensitivity" and "chemoresistance" testing (for PDF mirror of above website document, click here).

Jan 7,  2007Favorable local coverage decision regarding Medicare payment for cell culture drug resistance testing (CCDRT). (For background and details click here). The Medicare contractor responsible for California has completed an extensive review of all available information, including the recent ASCO reviews/position statements, and has finalized an official Local Coverage Decision (LCD) providing Medicare payment for "human tumor in vitro assays"  (CCDRT).

At the page below, click on FUTURE EFFECTIVE policies.


As part of this favorable coverage decision, the contractor (National Heritage Insurance Company) carefully documented the historical progression of Medicare policy dating from the "colony assays" of the 70's to the (noncoverage) National Coverage Decision regarding "stem cell" assays (1980), to the 1999 National Medicare Coverage Advisory Committee review (discussed and documented below on this website), to the initial coverage by National Heritage in late 2000 (in the absence of a formal LCD), to the present comprehensive review, culminating in this favorable Local Coverage Decision.

Jan 5,  2007Oncologist perspectives on pharmacologic intervention versus lifestyle intervention in breast cancer treatment (relevant to appropriate levels of evidence required to support tactics and interventions in cancer management)

    Nov 25,  2006Plenary lecture on cell culture functional profiling in cancer treatment and research presented at the 5th International Symposium on Cancer Research and Treatment, presented in Tokyo, Japan November 25, 2006. Click for PDF file containing the PowerPoint slides and click for a 4 minute "tourist-travelogue" type video clip also shown at the meeting (requires Quicktime media player).

    June 5, 2006Long term survival in relapsed non-small cell lung cancer (NSCLC) is predicted by (EGFR transduction inhibitor) gefitinib (Iressa) - induced cell death in (fresh human tumor) cell culture drug resistance testing (CCDRT). American Society of Clinical Oncology (ASCO) meeting abstracts, June, 2006 (click here). All patients in the study had received prior chemotherapy with 1-3 different chemotherapy regimens. Gefitinib activity in the fresh tumor cell cultures correlated strikingly with the survival of the patients from whom the biopsies were obtained, as shown in representative examples for patients surviving 35 days, 131 days, 414 days, 616 days, and 864 days, respectively (New! July 19, 2006click here for news story).

May 19, 2006Medicare open meetings report. Open meetings regarding continued Medicare reimbursement for Cell Culture Drug Resistance Testing (CCDRT) were held April 17 and 19, 2006.  Consideration of the relevant issues is ongoing. At this point, I'm hopeful for a fair and well-reasoned outcome.  Full details will follow, once the issue has been settled. (For background and details click here). (Update January 7, 2007: FAVORABLE Local Coverage Decision announced.  Details above).

March 31, 2006 Clinical oncology's failure: Why we need cancer cell profiling to match treatment to patient and why we are dropping the ball

1. The idea that we have been successful in identifying the best available treatments through "well designed, prospective, randomized trials" is a fiction.

e.g. breast cancer ( click here )

2. Faced with a large number of choices of otherwise equally acceptable therapies, owing to the situation described in #1, oncologists select the treatments which generate the most income for themselves (in the case of private practices) or which generate the least inconvenience for their clinical research clinics (in the case of academicians). ( click here )

3. For more than 2 decades, ASCO has been of the opinion (based only on preconceived bias and not on any actual data) that it is impossible to take freshly biopsied human tumors, place them in tissue culture, and obtain any useful information whatsoever concerning the likelihood of different drugs working against the very same tumor in the patient.  ASCO-affiliated investigators and reviewers have not only refused to support work in this field, but they have also done everything within their power to extinguish work in this field. (Extensively documented elsewhere on this website).

4. Most recently, ASCO has claimed to have reviewed the data pertaining to the application of "chemosensitivity and resistance testing" and concluded that tests should not be used in drug selection (
See "ASCO controversy," Nov. 10, 2004, below). In their review, they specifically excluded from consideration all published studies (i.e. scores of studies, comparing assay results with treatment outcomes in literally thousands of patients) which documented "only" test accuracy, heretofore the only criterion used to validate any test ever used (and currently used) in all of cancer medicine.

5. Now, having (two decades ago) abandoned all interest in obtaining information from intact, functioning, cancer cells, the NCI and ASCO have embarked on a quest to characterize the forest by looking at the individual trees; in this case gene mutations (DNA structure) and/or gene expression (RNA content). 

To begin with, it must be realized that DNA structure is only important insofar as it predicts for RNA content, which is only important insofar as it predicts for protein content, which is only important insofar as it predicts for protein function, which is important only insofar as it predicts of cell response, which is only important insofar as it predicts for tumor response and function.

In 50 more years, cancer scientists will look back on us and wonder why on earth we totally abandoned studies on cell response for 20 years in the misguided quest to identify the best treatment for the average patient through spectacularly unproductive clinical trials of empiric therapies.  Then they will shake their heads and wonder why we decided to devote 99.9% of our resources to studies of the "trees" (DNA, RNA, and protein) and virtually nothing to the study of the forest (intact, living cancer cells).

It's one of the greatest lost opportunities in all of cancer medicine, and the efforts to extinguish work in this area continue unabated, because ASCO refuses even to look at data showing that patients are 7 times more likely to benefit from treatment with CCDRT active drugs than from treatment with CCDRT inactive drugs, in scores of studies, involving thousands of patients.

(For continuation of this discussion, click here).

In the coming weeks, I'll take a closer look at "molecular" assays vis a vis cell culture assays.

Open letter to participants in NCI-Sponsored Ovarian Cancer State of the Science Meeting,Bethesda, MD September 16-17, 2005

At the afternoon session (Sept 16), the following question was asked: "Who needs Taxol?"

That's actually fairly easy to answer (click here).

August 11, 2005 Chemotherapy Response Rates and Survival in Metastatic Cancer: Implications of the Cree Study of Assay-Directed Chemotherapy

As discussed in the editorial referenced below, the clinical trial of Cree, Kurbacher and associates achieved exceptional chemotherapy response rates in platinum-resistant ovarian cancer, but with no clear improvements in overall patient survival.  This study, in the context of the existing clinical trials literature, points to the need for changes in our approach to the chemotherapy of the most common forms of adult cancers (continued, click here).

New! August 7, 2005 Critical review of  (1) the  Cree, et al, prospective randomized trial of assay-directed therapy in platinum-resistant ovarian cancer and (2) the planned Gynecologic  Oncology Group prospective, randomized study in platinum-resistant ovarian cancer.
At the May, 2005 annual meetings of the American Society of Clinical Oncology (ASCO), Cree and associates presented their long-awaited findings from a study began in the late 1990s. 81 patients received chemotherapy selected by the results of a cell death assay (ATP endpoint) and 78 patients received "clincian's choice" chemotherapy (continued; click here).

May 23, 2005 Prospective, randomized trial of "physician's choice" chemotherapy versus ATP assay-directed chemotherapy in non-surgically debulked, platinum-resistant ovarian cancer. Study by Cree, Kurbacher, and associates, presented at the May, 2005 ASCO meeting in Orlando.  Click here to view and listen to actual presentation (requires Windows Media Viewer and may not initialize properly with browsers other than late versions of Internet Explorer). I hope to post a critical analysis of this study within a day or two. - L. Weisenthal
April 21, 2005 Editorial: Lack of impact of prospective, randomized clinical trials on drug selection in metastatic breast cancer

In the pre-chemotherapy era of the 1960s, the median survival of patients with metastatic breast cancer was a little less than two years. Since then, the greatest cancer centers in the world have performed hundreds of prospective, randomized clinical trials, involving tens of thousands of patients, in an attempt to identify the best treatment to give to the average patient, to improve treatment outcome.  The results of these trials have been summarized by Dr. Lawrence Shulman, of Harvard's Dana Farber Cancer Center (click here , reference given here). In short, there has been not a hint of progress, with median survivals remaining exactly the same, just under two years... (continued: click here).

December 8, 2004   Detailed letter from the husband of a patient with metastatic breast cancer, concerning questions which were raised in his mind by the recent Wall Street Journal series of articles on cancer sensitivity and resistance assays (cell culture drug resistance testing).

November 10, 2004   Introduction to American Society of Clinical Oncology (ASCO) controversy. (The material on this website relating to the ASCO/"CSRA"/CCDRT controvery has become unwieldy and confusing. The following is a brief introduction.)

The American Society of Clinical Oncology (ASCO) is a trade organization, representing the interests of its membership, who are largely medical oncologists in both academic and private practice. ASCO has recently drawn scrutiny and criticism (described below) for its attempts to maintain a reimbursement system in which oncologists derive most of their income not from being doctors but from running a retail pharmacy concession, which encourages the maximal use of chemotherapy (as opposed to other treatment modalities), which encourages infusion chemotherapy over oral dose chemotherapy, which encourages certain (more financially lucrative) forms of chemotherapy over other (less financially lucrative) forms of chemotherapy, and which discourages the individualization of drug selection through the use of cell culture drug resistance testing (CCDRT).  ASCO has never supported either the study or use of CCDRT, because of short-sightedness and unwarranted dedication to a failed clinical research paradigm (the identification of the "best" treatment to give to the average cancer patient, through endless generations of prospective, randomized clinical trials pitting one form of empiric therapy against another form of empiric therapy).  The failings of this paradigm were recently exposed, in an investigative report (PDF file) in the March 22, 2004 issue of Fortune Magazine, written by the Executive Editor of Fortune, himself a cancer survivor.

In the September 1, 2004 issue of the Journal of Clinical Oncology (the official organ of ASCO), there were two (hopelessly inept and misleading) "technology reviews" published on CCDRT (referred to in the articles as "chemosensitivity and resistance assays" or CSRAs).  Appearing below on this website are various discussions and writings relating to ASCO's position on CCDRT/CSRAs, based on the controversial September 1, 2004 Journal of Clinical Oncology papers.

Starting with the section below (dated November 9, 2004), it is easy to see that the concepts of information control and censorship are much in evidence at the Journal of Clinical Oncology, official organ of the American Society of Clinical Oncology (ASCO).

November 9, 2004   Weisenthal's correspondence to the Journal of Clinical Oncology concerning the September 1, 2004 JCO reviews relating to "chemotherapy sensitivity and resistance assays" (also known as Cell Culture Drug Resistance Testing, or CCDRT).  Click for (1) Weisenthal's cover letter, which accompanied manuscript submission, (2) manuscript submitted to the Journal of Clinical Oncology, and (3) decision of Dr. Daniel Haller, Editor in Chief, regarding publication of the submitted manuscript.

October 4, 2004  Public Interest Watch Calls for Government Investigation of  American Society of Clinical Oncologists (ASCO)

As described elsewhere on this website, ASCO has worked shamelessly to preserve a system which presents an impossible conflict of interest for both cancer centers and treating oncologists.  This is a system in which there is a financial incentive to choose certain forms of chemotherapy over certain others and to administer infusion chemotherapy as opposed to providing other forms of patient care (click here for full report).

September 27, 2004  Developments in ASCO versus COFIT Controversy:
American Society of Clinical Oncology ("ASCO") Responds to Criticisms by the Clinical Oncologists for Individualized Therapy ("COFIT") 
September 21, 2004  Follow-up:  Health Mailbox section of Wall Street Journal, Sept. 21st edition, page D4.

Wall Street Journal health columnist Tara Parker-Pope answers a reader's question: "I was very interested in your article about chemosensitivity and resistance assays, and would appreciate [knowing more] about having the test done."  Ms. Pope provided detailed and helpful information in two paragraphs and then concluded as follows:  "To get started, patients should discuss [cell culture] testing with their doctors. Several patients wrote to say their doctors initially resisted the idea, but the patient insisted or found a different doctor."  The columnist went on to quote me: "The most important thing is to have both surgeon and pathologist on board in advance." She concluded by noting that "a list of labs that do the tests can be found on weisenthal.org under frequently asked questions."

September 14, 2004  Wall Street Journal article (full article available/clickable only to WSJ subscribers after Sept. 21) on cell culture drug resistance testing .
From the Wall Street Journal
Health Journal   September 14, 2004; Page D1

8/26/2002European collaborative research challenges superiority of Platinum/Taxol as first line                     chemotherapy for ovarian cancer

Progress in improving chemotherapy treatment regimens in ovarian cancer has been more a matter of illusion than fact. For example, it has not been proven that platinum-based combinations are superior to the single agent alkylators used since the 1960s, and it has not been proven that platinum/Taxol combinations are superior to single agent cisplatin or single agent carboplatin. The only clear conclusion is that there are no meaningful differences between cisplatin and carboplatin, except for carboplatin being generally more tolerable. We are left with a multitude of drugs and combinations with clear-cut activity in ovarian cancer, with clear-cut therapeutic outcome differences at the level of the individual patient, but with no proven best "one size fits all" chemotherapy. During this period, there has been virtually no attention paid to the potential of cell culture drug resistance testing (CCDRT, using apoptotic, cell death endpoints), world-wide, and absolutely no attention paid within the USA. In point of fact, the major opinion leaders have objectively done nearly everything possible to bury this path of inquiry, ignoring what is now a large and unrefuted body of data pointing to the clear utility of CCDRT identifying the most clinically-promising therapies in a wide range of neoplasms, including ovarian cancer, and not cooperating with attempts to prove this utility in the US taxpayer-funded clinical trials system. Appearing on this website are abstracts , data reviews , editorials , and news articles (see below) relevant to the above issues.

For the point of view of a clinical investigator who still favors platinum/Taxol as "standard" therapy, in the face of  the lack of convincing data from controlled trials, please review the following lecture
http://www.medscape.com/viewarticle/416489_1 .  In reviewing this lecture, two points are striking: firstly, how the author flat-out states that platinum-based first line therapy has been proven to be superior to single agent alkylator therapy,  in the face of the very data cited by the author , which show no such thing , and, secondly, how platinum/Taxol should still be considered "standard" therapy in the face of two large, unrefuted studies (GOG-132 and ICON-3) which showed that single agent cisplatin and single agent carboplatin were at least as good and in some respects better. Click below for an excellent streaming audio summary of the ICON-3 study, by the principal investigator, Dr. Peter Harper, from Guy's Hospital, in London: http://www.audiomedica.com/oncology/ajo105.htm. (nb: once on the website, click on the "listen" icon just beneath the "ICON-3" headline in the interviews section).

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Latest update: March 13, 2009