Don't bet on this cancer communique

In our initial commentary it was stated that this blog will be devoted to truth in medicine and exposing misrepresentations wherever they exist.

Some months ago almost every cancer doctor in the Syracuse, New York area--11 oncologists in a group private practice and others in an academic setting--jointly published a letter-to-the-editor in The (Syracuse) Post-Standard calling attention to the pending cancellation by the National Cancer Institute--the federal government--of a nationwide study of drugs "that could reduce breast cancer incidence by more than 50 to 70 percent."

What? Prevent up to 70% of all breast cancer? But this is astonishing! If there were any drug or drugs or treatment that could prevent even one-tenth that amount of breast cancer--5% to 7%--that would be considered a major victory!! But 50% to 70%? And the National Cancer Institute (NCI) itself--this country's and the world's bastion of defense against cancer--cancelling a study that could virtually wipe out breast cancer? That doesn't even make sense.

Lest you think this was an isolated letter in a single newspaper, similar letters appeared in newpapers throughout the country, submitted by oncologists in all locales. These were spurred by chairman and principal investigator Norman Wolmark, M.D., of the National Surgical Adjuvant Breast and Bowel Project (NSABP), which had charge of this proposed study. Dr. Wolmark stated, "We believe [this study] has the potential to prevent the incidence of breast cancer by up to 70%," and any decision not to go ahead with this study could wreak havoc with the nation's ability to test new drugs.

The name of the drug study was "P4-STELLAR"--"P-4" for short--which sought to test two drugs, letrozole and raloxifene. The letter detailed that although the proposed study, which "could ultimately prevent thousands of cases of breast cancer," underwent a "rigorous review process" at the NCI, including "seven different approvals" by various NCI committees, "the NCI's director abruptly halted activation of the [P-4] trial and now continues to delay trial commencement."

The doctors stress that "200,000 American women will be diagnosed" with breast cancer this year and "more than 40,000 will lose their lives to this disease." It urges women to contact the NCI, to demand that this study be activated. "Time is of the essence," the letter urges. "We must persuade the NCI to release funding for this critically important [drug] trial...or risk losing...this opportunity to dramatically reduce the toll of breast cancer....forever." Thousands of women, taking heed of the oncologists' letters, responded by writing letters of their own to the NCI urging that the study be activated.

But the NCI--apparently not in agrement with the letter writers' exhortation that the P-4 study could "dramatically reduce the toll of breast cancer"--did indeed cancel this $130 million clinical study, citing its exessive cost ("there are other priorities that are very [more] important," an advisory panelist stated), as well as "troubling complications."

The study would have entered 12,000 women who would have received either letrozole or raloxifene, but not both together. Each drug acts to target--to reduce--the production of estrogen, which promotes the growth of cancer cells. However, each of these drugs had already been tested individually and many of their effects were already known. For example, raloxifene had already been tested in 37,000 postmenopausal women in the STAR (Study of Tamoxifen and Raloxifene), RUTH (Raloxifene Use for the Heart), MORE (Multiple Outcome of Raloxifene Evaluation) and CORE (Continuing Outcome Relevant to Evista [Raloxifene]) trials. Tamoxifen, an anticancer drug used for many years in breast cancer, and raloxifene were compared in a large trial and found to have about the same level of effectiveness in preventing cancer. Letrozole, also, had undergone clinical testing in thousands of women--in comparison to the anticancer effectiveness of tamoxifen (BIG 1-98 Trial) and by itself. It was found in one study that letrozole was only slightly more effective than tamoxifen.

In its cancellation letter of June 19, 2007 to the study's principal investigators at the University of Pittsburgh (as reported one day later in The Washington Post), the NCI cited the "relatively small number of women--3 or 4 out of 100--who benefit from [the proposed two test drugs]."

Only 3 or 4 out of 100? That's nowhere near "50% to 70%." That's nowhere even near 5%. What about the potential "virtual obliteration" of breast cancer, as indicated in the NSABP chairman's statement and as set forth in the doctors' letters?

The NCI letter of June 19 also cited the "troubling complications of the two cancer prevention drugs [letrozole and raloxifene] in its cancellation decision. "The danger of introducing these drugs," the letter stated, "with their many side effects [sudden chest pain, coughing up of blood, sudden change or loss of vision, vomiting, diarrhea, breast and stomach pain, headache, vaginal bleeding and irritation, dizziness, etc.] outweighs their potential until we are better able to determine who will benefit from [them]."

Could it be that the chairman of the NSABP and the letter writers did not know that the P-4 trial's two drugs, raloxifene and letrozole, had no hope of preventing--could not possibly prevent--"50 to 70 percent" of breast cancer? Could it be that these individuals did not know that these two drugs had many and significant side effects and their introduction into the general population constituted a potential hazard until it could be determined who might benefit from them?

But the chairman of the NSABP and the letter writers were privy to the same information--the same prior study results--as the director of the NCI and his panel of advisors. They well knew that there wasn't a chance that the two test drugs could prevent '50 to 70 percent' of breast cancer--or anywhere near these figures. Then what was their motivation in stirring up the hopes of the American people that so great a proportion of breast cancer could be prevented? What was their motivation in mobilizing the women of America to contact the NCI and demand that the P-4 trial be activated?

Dr. Wolmark, the NSABP's chairman, provides an answer. "Due to the cancellation of this trial," he writes, "the infrastructure of more than 500 trial centers we have built up over the last 15 years will cease to exist."

500 trial centers? These are the test sites where oncologists, members of the NSABP, test drugs on cancer patients. Dr. Wolmark's remarks in essence state that activation of the $130 million P-4 study guarantees that the NSABP nationwide network of trial centers--established over the last 15 years and characterized as of "importance" to the "advancement of science"--will be maintained. "The National Surgical Adjuvant Breast and Bowel Project has been successfully conducting multi-center breast cancer prevention trials since 1992, advancing the knowledge base and testing new prevention options through its clinical trials," the doctors' letter in The Post-Standard reiterates. "We must persuade the NCI to release funding for this critically important P-4 trial."

Critically important? It can't be critically important to the prevention of 50% to 70% of breast cancer--both the NSABP chairman and the doctors know that's an impossibility. Clearly, it is critically important to the maintenance of the NSABP's trial centers. That they don't melt away. That these testing mills--processing millions of dollars annually--remain functioning. That these money machines keep on rolling.

And this is the real reason for the doctors' letters. The real reason for mobilizing the public to pressure the NCI into "activating" the P-4 study. The crass motivation for making shabby use of millions of American women, raising their hopes and medical aspirations that the disease of breast cancer might be largely silenced forever by this P-4 study, only to guarantee the maintenance of the NSABP's trial centers--its "centers of excellence"--that have produced no treatments that have significantly altered the course of breast or bowel cancer since their inception.

This commentary, as stated previously, is devoted to truth in medicine and exposing misrepresntations wherever they exist. The shameful orchestration of power by the NSABP and its affiliates, presented here, illustrates perhaps most indelibly the degree to which the medical profession is capable of a lack of truth. How--falsely portraying the therapeutic potentials of a study--elements of the cancer establishment literally wipe their behinds with the public.