News from the Cancer War: "Back to Square 1 on the CAM
Therapy" Advances on the Mainstream Line
At lunch with my good friend Bob Houston
in April, he showed me an article from the latest issue of the American
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.
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
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.)
From 1985 to 1990, Wiewel led Burton's support group, and was a key
player in convincing Congress to authorize the OTA study. (Originally, the
study was to focus on Burton's therapy.) Since then, Wiewel has been
a major voice in urging government evaluation of nonconventional cancer treatment.
He now directs People Against Cancer (PAC), headquartered in Otho, Iowa, a
grass roots organization that remains at the forefront of political activities
to obtain clinical trials of nonconventional medical approaches. PAC also provides
information on cancer treatment on a fee basis.
Interview with Frank Wiewel
I reached Frank Wiewel by phone a few days later. "There's definitely
something happening here in Iowa," he remarked. "We've
got Senator Tom Harkin, a liberal Democrat, and Senator Chuck Grassley, a conservative
Republican with libertarian leanings in health care. Both are statesmen who
can be counted on to do the right thing. Both support alternative medicine
and use it. Then, there's former Congressman Berkeley Bedell, who's
been taking unconventional therapies for years: he's established a foundation
devoted to alternative medicine."
Cutting in, I said, "Let's return to 1990, Frank. What's
happened of consequence politically after publication of the OTA report? What
did you hope the report would accomplish?"
"We thought the OTA report would help codify studies of alternative cancer
treatment. There was a need for that in the early 1990s. When Congress established
the Office of Alternative Medicine (OAM) in the NIH in 1992, largely through
the efforts of Harkin and Bedell, we felt it might promote the organized evaluation
of alternative cancer therapies, might broaden the base for later evaluations.
Harkin, with Grassley and Bedell pitching in, worked on the NIH to help the OAM
set up pilot trials. Ralph Moss and I spent six years in Washington pushing for
such trials, but the NIH never gave the centers the OAM started in different
areas of medicine a chance to do a real study."
Wiewel went on with the history lesson: "When Congress created the National
Center for Complementary and Alternative Medicine (NCCAM) in 1997, enlarging
its budget and providing greater autonomy within the NIH, the NIH frustrated
attempts to make NCCAM an effective substitute for the OAM. Referring the projects
planned by NCCAM, which the NIH showed no real interest in backing, the NIH
said, 'We do things in different ways.' One sensed, however, that
the NIH didn't want even the preliminary best case studies of alternative
cancer treatment to get off the ground, because they might find something positive.
"We told them, 'Look, it's a win-win situation. If these
studies point to promising alternative treatment, everybody wins — the public
most of all. If nothing effective comes out of the preliminary trials on unconventional
care, you win.' The NIH wouldn't budge!
"Senator Harkin hauled the NIH director, then Dr. Harold Varmus, into
his office and for two hours he tried to convince Varmus to do the right thing
with NCCAM. Varmus refused, later quitting the NIH to become director of Memorial
Sloan-Kettering. His successors at NIH have also stalled."
"So where do we go from here, Frank?"
"Back to square 1, back to grass roots calls for change, back to individual
alternative cancer therapists seeking funds for pilot studies on their own."
Wiewel paused to tell me about a recent meeting with Grassley, who chairs the
Senate Finance Committee: "I suggested to the Senator that the weight
of the whole, insane system of testing new drug treatments might soon bring
about its collapse. 'The cost of researching and developing a single
drug through the FDA's safety and efficacy requirements, through clinical
trials, is now 700 million dollars,' I told him. He replied, 'Think
1 billion, Frank.'"
Interview with Mark Noble, PhD
I phoned Dr. Mark Noble at the University of Rochester, New York. Noble, a
cell biologist, specializes in research on the development of cancers of
the nervous system. The government research institutions clearly had no appetite
for nonconventional approaches to cancer treatment. I wanted to know if the
mainstream had been pursuing any new, truly promising, exciting avenues of
investigation. Noble keeps an open mind about alternative medicine. He's
familiar with therapies pioneered by a number of alternative physicians,
Emanuel Revici among them.
"Generally," he said, "there have been advances in treatment
for low-grade tumors, really solid progress, but advances in therapy for high-grade
cancers have just been incremental."
"What about Dr. Judah Folkman and his colleagues, studying angiogenesis
factors?" I asked. "At one time the potential of these agents interested
(Angiogenesis is a process through which cancers form blood vessels that supply
them with nourishment. Folkman's "factors," isolated by
him over 20 years of research, are various substances that tumors produce which
can promote or inhibit tumor and metastatic growth.)
"A wide range of antiangiogenesis drugs are under investigation, still
in the first stages of testing," he said. "The final results of
these trials are not yet in."
"Can you give me an example of a hot new chemotherapy, one more effective
and less toxic than standard chemo?"
"Yes," he said. "Gleevec, in chronic myelogenous leukemia
(CML). It's been tested for about three years, and in CML that hasn't
reached blast crisis the results have been fantastic. An enormous number of patients
go into remission. Once the leukemia goes into blast crisis, though, Gleevec
hasn't been very useful. It has shown less toxicity, so far, than earlier
chemotherapy, cisplatin, for instance."
("Blast Crisis" or "cycle" refers to the phase
of CML in which the number of immature, abnormal white blood cells in bone
marrow and blood is extremely high. It is the terminal event in the clinical
course of CML.)
"Who developed Gleevec? How does it work?"
"Oregon Health Sciences," Noble answered. "Gleevec emerged
from NCI research on signaling pathways involved in cell division, and, by extension,
abnormal cell division."
"Anything else noteworthy in the mainstream?" I asked.
"Some members of the CAM community have used low-dose chemotherapy for
years. Now, many trials of low-dose therapy are underway at mainstream institutions.
It seems a promising, less toxic method of treatment. Its major site of action,
like Folkman's angiogenesis agents, are endothelial cells." (Endothelial
cells make blood vessels.)
"Does it have a name?"
"The ability to give frequent exposures in low doses."
In a future column, I'll interview Peter Barry Chowka, an independent
investigative journalist who has published articles on nonconventional therapies
since the 1970s; Michael Lerner, PhD, director of Commonweal (Bolinas, California),
a special consultant to the OTA during its study of unconventional cancer treatment;
and Ralph Moss, PhD, author of The Cancer Industry (and numerous other books
on cancer), whose on-line service (www.cancerdecisions.com) provides information
on alternatives to conventional care for a fee.
All three are veterans of the cancer wars and may have hopeful news about action
along the battlefront to share with readers of the Townsend
Marcus A. Cohen
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