News from the cancer war: "back to square 1 on the CAM front"; "metronomic therapy" advances on the mainstream line

Townsend Letter for Doctors and Patients, July, 2004 by Marcus A. Cohen

At lunch with my good friend Bob Houston in April, he showed me an article from the latest issue of the American Cancer Society's pseudo-scientific monthly, Ca, a Journal for Clinicians. The article was a tedious put-down of nonconventional cancer therapy, written by a junior associate of Dr. Barrie Casseleth, the director of the integrative treatment program at Memorial Sloan-Kettering Cancer Center, New York.

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My nose told me that the contents were ripe with age; the misinformation about the late Dr. Emanuel Revici, which I turned to first, dated from the mid-1960's. I know a thing or two about Revici's treatment; the few sentences which the writer allotted to it revealed total ignorance. Bob advised me that the rest of the article showed the same rot, so I read no further.

I take Bob Houston's advice seriously. He's been publishing articles and letters in magazines and medical journals since the late 1960s. One of his specialties is nutritional therapies. He also admits to a fair amount of knowledge about the design and conduct of clinical trials, particularly the ways in which they can be jiggled to give optimal results in mainstream studies and minimal or no positive findings in studies on alternative medicine.

When Congress authorized the late Office of Technology Assessment to report on unconventional cancer treatment in 1987, the alternative "camp" chose Houston to write its position paper. Then, they split over what they felt the paper should say. Bob wrote a large part of what he had in mind anyway, and two patients on alternative therapy modestly compensated him for his independent labor. Issued as a reduced typescript by the Immuno Augmentative Therapy Patients Association (IATPA) in 1987 under the title, Repression and Reform in the Evaluation of Alternative Cancer Therapies, Houston's monograph still applies. Its insights into how the evaluative process is biased against unconventional treatments are just as true today.

These days, though, Bob prefers to write music, a muse-driven activity practiced from childhood--decades before he joined the front rank of the defenders of CAM. But he keeps up with CAM developments, occasionally sticking a figurative finger in the air to catch which way the wind blows in the world of health care. At our April lunch, I interviewed him between mouthfuls of Chinese food. The broad subject: Changes in clinical trial design that might speed up the evaluation of unconventional approaches to treatment for a range of diseases.

Interview with Robert G. Houston

"The OTA published its report in September 1990," I led, following with two questions: "Did evaluative criteria for trials at the National Cancer Institute (NCI) change afterward? Did the FDA relax its criteria for the approval of new drugs?"

"In 1989, even before the OTA report came out," Houston recalled, "Dr. Frank Young, the FDA commissioner, initiated a fast-track system for approvals. It bypassed large-scale, randomized trials where smaller, less rigorous trials gave dramatic results. The system was mainly for AIDS drugs. A few new cancer drugs got market approvals, too. Young was responding primarily to political activism by AIDS patients. Breast cancer patients played a lesser role."

Houston continued: "Back in 1990, some cancer activists joined the AIDS patients in calling for more flexible criteria for approval of new treatments. In the context of therapies based on natural substances, flexibility made sense; these substances generally have a high safety factor. In relation to such toxic drugs as AZT for AIDS, though, putting hugely toxic drugs on the fast track was disastrous! Remember that AZT was first tested at NCI, where it proved too toxic for further trials. AZT can cause or exacerbate immune deficiencies in humans. It causes immune deficiency in healthy animals."

"So your conclusion about fast tracking?" I broke in.

"It killed thousands of AIDS patients." Houston said. "With a fast-track system, there has to be far more concern for safety issues."

I touched on the NCI reaction to the OTA study. "Did the OTA report have any effect?"

Houston drew on his memory again: "The OTA recommended a best case study of at least ten patients as a feasible first step in evaluating unconventional cancer treatments. But the NCI offered no promises to follow up, no guarantees that successful best case studies would lead to clinical trials--or to any interest by the government in these cases. Intrinsically, it was a risky step for unconventional innovators who might submit treatment data. Placing all their paperwork on record exposed them to prosecution, invited reprisal by the FDA."

Houston looked at his wristwatch at this point, excusing himself to do an errand. He directed me to Frank Wiewel, in Iowa. "We're getting political," Bob said, "and Frank's the best person to speak to about government involvement in alternative cancer treatment."

Wiewel is also a musician. He played with a rock band in the early 1980s, before his father-in-law developed cancer and sought immuno-augmentative treatment at the Burton clinic in the Bahamas. Closure of the Burton clinic in 1985 by the Bahamian government turned him into a performer on the congressional stage. (According to Bob Houston in Repression and Reform, the NCI and other US agencies instigated that temporary shut-down.)