June 18, 2002

Christopher Loftin
Corporate Legal Department
Wellpoint Health Networks
21555 Oxnard Street
Woodland Hills, CA 91367

Dear Mr. Loftin:

I am responding to your letter to Judge Hofmann, dated May 12, 2002. This letter attempts to state and justify the entire case against reimbursement by Wellpoint Blue Cross (WBC) for the costs of cell culture drug resistance testing (CCDRT).

The WBC position against reimbursement has now been rejected in at least eleven consecutive court cases brought against you by cancer patients with WBC health insurance contracts. You have yet to "win" one of these cases, and you are very unlikely to prevail in the future, as your position is now clearly documented to be without merit. Judge Hofmann could not have been more clear about this in his rejection of your case.

You state that the Wellpoint Blue Cross policy was "not arrived at cavalierly." Your response documents that your position defines the meaning of cavalier. For example, you refer to the "exhaustive" literature documentation provided to support your position. Yet this "exhaustive" documentation somehow missed virtually all of the peer-reviewed publications documenting the clinical accuracy of CCDRT (provided with my own letter to Judge ). This "exhaustive" documentation also missed the clinical studies most relevant to the issue of the likelihood that the use of these assays improves clinical outcomes. Finally, this "exhaustive" documentation fails to give any examples of any Wellpoint Blue Cross-reimbursed medical tests which have been shown to improve clinical outcomes, including the three directly-relevant medical tests detailed in my own letter.

The Wellpoint Blue Cross position has the following analogy. A city requires planning commission approval for new housing construction. Planning commission approval is ostensibly based on a written set of criteria. Yet, in the case of single family homes, these criteria have never once been met by a single contractor building homes for the city's residents. Furthermore, the criteria have often not been met by many contractors building condominiums and apartment buildings, as well. Rather, approval is, in reality, granted on the subjective whims of the planning commission, which selectively applies its own written criteria in the case of those contractors the commission does not (subjectively) like and fails to apply these criteria in the case of those contractors which the commission does (subjectively) like.

My use of the term "whim" was deliberate, as this word is defined as "an arbitrary and often illogical notion." This precisely characterizes the Wellpoint Blue Cross position, and it is clear that this is why the WBC position was rejected by Judge Hofmann. If you will re-read the trial transcript, you will see that Judge Hofmann understood this point very clearly.

Of lesser importance, I take personal umbrage over the way that your letter attempts to mischaracterize my own statements and positions.

You seize upon my stipulation that use of the assays has not been proven in prospective, randomized clinical trials to improve treatment outcomes and proceed to mischaracterize this statement.

to wit,

"Even Dr. Weisenthal admitted in court that the assay tests fail some of the criteria noted above. Dr. Weisenthal admitted that this technology does not improve the net health outcome of the patient. In addition, Dr. Weisenthal testified that the technology has not been proven in clinical trials. These admissions support Blue Cross' position that the test is not medically necessary. "

Later on, you state:

"However, Dr. Weisenthal himself testified that there are no proven clinical trials that shows improvement of the patients' net health outcome based on the use of these tests."

Note that I never stated or implied that "this technology does not improve net health outcome of the patient." Note that I also never stated or implied that "the technology has not been proven in clinical trials." All I ever said was that I stipulated that there were no prospective randomized trials to prove that performing these laboratory tests improves clinical outcomes. I quickly followed this stipulation by noting that none of the other laboratory or radiographic tests for which Wellpoint Blue Cross provides reimbursement under subscriber contracts have been "proven" in such prospective, randomized trials.

I then proceeded to explain (both in my testimony and in my written response) that there is a large, consistent, and unchallenged body of peer-reviewed, published evidence which documents that the tests are accurate in identifying anticancer drugs which are both active and inactive in the treatment of individual cancer patients, where the activity/inactivity was documented using criteria of both response (tumor shrinkage) and patient survival.

Furthermore, I cited clinical trials in which the use of the tests improved patient outcomes, compared to control patients managed without benefit of test results. These latter studies were non-randomized; however, BlueCross BlueShield Association TEC assessment criteria do permit the inclusion of contemporaneously-controlled, though non-randomized trials. I pointed out how these latter trials (missed by the BlueCross/BlueShield Association technology "panel of experts") provide documentation for the clinical utility of these tests which goes beyond that of all other analogous tests for which Wellpoint Blue Cross provides reimbursement, which have been documented only to be acceptably accurate and have never been documented to improve clinical outcomes.

Later on, you again mischaracterize my written response:

"He says in his letter that the 18 member Blue Cross Blue Shield advisory board has not experts who have submitted tumor specimens to him for analysis; therefore he concludes that they are not qualified to render an opinion on the test."

In point of fact, I concluded that they were not qualified experts because (1) none had any personal experience, (2) none had ever published a single paper relating to the topic, and (3) the many errors and omissions in their 37 page technical assessment was prima facie proof that they were not qualified (explained both in my letter to Judge Hofmann and in my letter to Dr. Naomi Aronsen, the TEC director who led the BlueCross BlueShield review team; copies of both of which were sent to you).

I have re-read your letter to Judge Hoffmann many times. You have, at least, abandoned the pretext (offered twice in letters to Ms. Bledsoe) that your denial was based on your contention that performance of the tests did not change the patient's treatment. You also make no attempt to defend the BlueCross BlueShield TEC review from any of my specifically-stated criticisms. Rather, your response boils down to simply restating the Wellpoint Blue Cross Corporate Policy without stating how my services failed to meet Corporate Policy. Several times in prior cases against you, the judges have stated that such statements of corporate policy do not in any way make the case against reimbursement in the absence of specific evidence against the medical necessity or appropriateness of these tests.

The only specific shortcoming ever offered is that use of the tests have not been documented to improve net health outcomes in prospective, randomized clinical trials. However, as pointed out in my oral testimony and written responses, this latter requirement has never been met by ANY of the precisely analogous tests for which Wellpoint Blue Cross routinely provides reimbursement.

The "net health outcome improvement" policy is defendable only if it is applied in a non-selective fashion; otherwise, its application on a selective basis is arbitrary and capricious. This is why you will continue to lose these cases.

I am perfectly prepared to keep supporting our patients in legal actions against you for the next 10 years. You can certainly expect the frequency of these cases to increase and media attention will be the next shoe to drop. It is all so unnecessary. I am certain that neither you nor your medical review teams intentionally wish to deprive cancer patients of medical services which may help them in their battle to remain well and remain alive. I really believe that this whole thing can be solved through dialogue and education.

I have asked Wellpoint Blue Cross on many occasions for the opportunity for a face to face dialogue. It is disingenuous to claim that your meetings with Oncotech's Dr. Fruehauf satisfied your due diligence responsibilities in this regard. As pointed out in my letters to Judge Hofmann and to Dr. Naomi Aronsen of the Blue Cross/Blue Shield Association, comparing Oncotech's cell proliferation-based assay to our cell death-based assays (and published literature relevant to each endpoint) is an odious comparison of cats to dogs. There is a vastly more persuasive literature existing to document the clinical relevance of our tests than that of previous tests, which have, in effect, served to poison the well in this field.

Let me drive up to Woodland Hills (or wherever your review committee meets). Let me talk with them; preferably in the presence of non-oncologist physicians (who have much less in the way of pre-existing biases and whose own financial livelihood is not threatened by the use of the tests, which potentially limit the ability of oncologists to choose treatments on the basis of the "spread" between cost and reimbursement) and patient representatives, as well. This is the way that both Medicare and Blue Shield carry out their reviews. This is the way to ensure a fair and objective review.

Sincerely yours,

Larry Weisenthal