The Cancer Industry:
The Classic Expose on the Cancer Establishment
New Updated  Edition
© 1996 by Ralph W. Moss, Ph.D.
Published by Equinox Press
(All rights reserved. Please see Copyright
Note: This section concerns The Office of Technology
Assessment (OTA) 1990 Report on "Unconventional Cancer Treatments."
Because of its length we have broken it into two files. This is
the first of the two files.
Happily, the OTA Report itself is available online from
the OTA site for 1990. (OTA itself was put out of business by the U.S.
Congress in 1995.)
1. The OTA Report
The most momentous week in the modern history of cancer alternatives began
on July 15, 1985. As will be described in this book [i.e., The Cancer Industry],
it was during a few fateful days that two of the leading alternative cancer
clinics in North America--that of Dr. Burzynski of Houston,
Texas and of Lawrence Burton, Ph.D. of Freeport,
Bahamas--were raided by government agents. Burzynski's papers and records were
seized by the FDA, never to be returned. Burton suffered an even more frightening
ordeal: his Immunoaugmentative Therapy (IAT) clinic was physically padlocked
by Bahamian authorities, acting at the behest of U.S. health authorities. (For
more on Burton and IAT, see chapter 12.) Burzynski and his patients fought it
out in the courts, which provided some legal relief. But Burton's patients took
their struggle directly to Congress, which turned out to be an even more effective
The Congress they encountered in 1985 was hardly friendly towards alternative
cancer treatments. But Congressmen get cancer, too, and were fascinated
to hear their constituents' stories of the unusual treatment in Freeport.
Also, Congress's confidence in the "war on cancer" was waning.
As the years rolled by, the elusive cure never materialized. By 1985, Congress
was in the mood for change.
Burzynski never stopped treating patients. But the IAT clinic remained
shut for months, disrupting a treatment that many believed was saving their
lives. In face-to-face encounters, constituents made a compelling case to
Congressmen to help reopen the clinic.
Rep. Guy Molinari (R-NY) was one of these representatives. A reporter
at the Staten Island Advance wrote an illuminating series on the closure.
(Her husband was a Burton patient.) Intrigued, Molinari flew down to Freeport.
In January, 1986 he held tumultuous public hearings in lower Manhattan.
Shortly thereafter, the Burton clinic reopened.
But matters didn't end there. On June 27, 1986, Molinari and 23 other
Members of Congress formally requested that the Congressional Office of
Technology Assessment (OTA) carry out a study of Dr. Burton's treatment.
Similar requests were received from Senator James Abdnor (R-SD) and Congressman
Matthew J. Rinaldo (R-NJ). An additional 14 members of the House and Senate
subsequently endorsed Molinari's original letter, bringing the total number
to 40. Most of these were also inspired by constituents taking the treatment.
In his letter to Dr. John H. Gibbons, director of the OTA, Molinari and
his colleagues requested a "comprehensive evaluation" of the Bahama-based
treatment. "While there has been much controversy revolving around
the efficacy of IAT, the truth of the matter is no one at this time can
say with assuredness whether IAT works or not," they said. "The
result of OTAs investigation may open a new door and possible avenue of
hope for thousands of terminally-ill cancer patients."
Later that summer, Rep. John D. Dingell (D-MI), then the powerful chairman
of the House Committee on Energy and Commerce, also wrote to Gibbons, requesting
a report on alternative cancer treatments in general. "Some [alternative
treatments] are offered by respected members of the medical community,"
he wrote, "and others by what many would term charlatans. Many of these
treatments may be without benefit, some may actually be harmful, and some,
probably a small number, may have value. However, there is a general lack
of objective information..." (letter of August 12, 1986).
Dingell asked that his own request be merged with Molinari's and that
OTA use the BurtonIAT treatment as a "case study of the general issues
involved." In September, this project was approved by OTAs oversight
body, the Technology Assessment Board (TAB), of which Dingell himself was
a member. OTA promised the case study on IAT by late 1987 and a final report
on alternative treatments by the summer of 1988.
The OTA (which was dismantled by Congress in 1995) had an excellent reputation
for objectivity. It had been established in 1972 to provide political leaders
with clear, objective, and unbiased information on technical issues. Over
the years, it had conducted many controversial studies, but this was to
be their most controversial ever. Most members of the alternative cancer
community were guardedly optimistic about the choice of OTA to conduct such
a study. They foresaw a possibility that OTA would expose a cancer coverup,
the way that a respected Justice Department attorney, Benedict Fitzgerald,
had done for a similar Congressional investigation in 1953.
The OTA had also carried out a number of other studies that augured well,
including one on the question of controlled clinical trials that ended with
a call for a "greater emphasis on cancer prevention" (OTA-BP-H-22,
August 1983). The author of those words was Hellen Gelband, who was now
appointed Project Director of OTA's study on unconventional cancer treatments.
OTA began by appointing an 18-member Advisory Panel for the project.
Rosemary Stevens, Ph.D., a historian of science at the University of Pennsylvania
who had worked with Gelband on the previous study, was appointed its chair.
It was a non-controversial choice. But the panel itself was an odd amalgam,
hopeless entangled in ancient antagonisms. On the one hand, there were strong
defenders of alternative methods such as Gar Hildenbrand, then vice president
of the Gerson Institute, and John Fink, author of Third Opinion, and a leader
of the International Association of Cancer Victors and Friends.
They were cheek by jowl with sworn enemies of such methods such as the
chairman of the ACSs Unproven Methods Committee. Also present was Grace
Powers Monaco, then the president of Emprise, Inc., a company which had
earned the enmity of many in the alternative field for attempting to create
a totally one-sided data base on unconventional cancer treatments. Barrie
Cassileth, Ph.D., a psychologist from the
University of Pennsylvania, was another panelist. She had carried out, but
then failed to publish, a study on Burton's patients which advocates said
proved that they lived longer than the norm. Dr. Herbert Oettgen of Sloan-Kettering
Institute, who had a marginal interest in alternative medicine, was also
At the same time, the OTA staff systematically excluded those who could
have truly balanced the vehemently anti-alternative forces on the panel:
articulate critics of the cancer establishment, such as research analyst
Robert G. Houston or journalist Peter Barry Chowka. It also went out of
its way to downgrade the importance of this advisory council. The board
was there simply as "a giver of general advice, a source of contactsäand
a quality control mechanism," but could not "sign off on reports,
provide minority opinions, or come to a consensus" ("Facts Concerning
OTA's Study of Unorthodox Cancer Treatments," September 9, 1987). In
any case, consensus under the circumstances would have been impossible,
and it seemed like a gratuitous putdown.
Almost immediately, problems also arose between the OTA staff members
who were writing the report (principally Ms. Gelband and her assistants)
and the alternative medical community. The alternative people saw themselves
as a beleaguered minority, who needed to use public pressure of various
kinds even to get a fair hearing. The OTA staff saw themselves as dedicated
public servants, trying to conduct a difficult study under pressure from
both sides, but particularly from advocates of methods that, on the face
of it, were dubious and strange.
So for the first year there was a notable lack of progress towards either
designing the IAT study or writing the broader report. At the first meeting
of the Advisory Panel in July, 1987 (almost a year after beginning) the
OTA staff was still outlining its plans for the study.
"The meeting was notable for bringing the unconventional treatment
supporters together with the mainstream in a neutral forum," the staff
later reported. "Discussion was generally non-confrontational and informative."
But "no clear direction for the report as a whole emerged." This
was to remain true for several years.
In that same year (1987), Dr. Burton submitted to OTA a case study of
11 patients who had been treated at his clinic for a deadly form of cancer
called mesothelioma. This small study claimed that patients treated with
IAT lived three to four times the national average of conventionally-treated
patients. Some were in fact long-term survivors.
This was important news, for mesothelioma is almost uniformly and rapidly
fatal. But OTA never even commented on these findings. And two years later,
its sister agency, the NCI, was still demanding that Burton present them
with a "best case" series, as if they had never heard of his mesothelioma
paper. These were the sorts of experiences that intensified Burtons already
well-established paranoia. But in this case he wasnt alone in his misgivings.
Burtons supporters forcefully reminded the OTA staff that it was their Congressionally
mandated task to compile exactly such retrospective analyses.
But by this time, Burton's mood and health were slipping, fed by his
disappointments. By December, 1987, many people feared that another coverup
was in the making. At that juncture, a handful of activists, led by Clinton
Miller, long-time lobbyist for the National Health Federation, took actions
that almost scuttled the whole report process. They released information
to influential reporter Jack Anderson that Dr. Roger C. Herdman, head of
OTA's health and life sciences division, had previously been employed as
Sloan-Kettering's vice president.
"Sloan-Kettering is the enemy of non-traditional cancer therapies,"
they were quoted as saying. "It is unthinkable that OTA would place
a necessarily biased former vice president of Sloan-Kettering in charge
of this study and expect anyone to give it credibility" (Washington
The group also charged that Dr. Herdman owned $75,000 worth of stock
in Oncogene Science, Inc., which had interests in the cancer diagnostics
marketplace. They also reported that his boss, Dr. Gibbons, owned stock
in Genentech Clinical Partners (Washington Times, December 22, 1987). (They
might have added that Lewis Thomas, M.D., the president of Memorial Sloan-Kettering,
was on the advisory panel of the OTA.)
Both scientists denied that this represented a conflict. In fact, there
was no evidence that they had committed any crime or that their previous
associations or investments had anything more than a marginal connection
to the present study. The alternative communitys dealings with Dr. Herdman
and Dr. Gibbons had always been satisfactory. (Dr. Gibbons became Pres.
Clintons science policy advisor.) Busy as he was, Dr. Herdman was quite
accessible and always gave a fair hearing to complaints. Because of this,
I joined a group of activists who hurriedly sent a telegram of apology to
Dr. Herdman for this and other insults directed at him personally. The report
survived the storm.
The most serious problems stemmed from relations with the lower-level
staff members, who were actually writing the report. There was simply no
reservoir of trust between them and the subjects of their inquiry. The staff
writers routinely downplayed or even suppressed information that was at
all favorable towards alternative treatments. The most egregious example
involved Patricia Spain Ward, Ph.D., campus historian of the University
of Illinois, Chicago, who had been hired as a contractor by the OTA. Dr.
Ward was perceived as a skeptic about alternative medicine because she had
written a negative paper on Andrew Ivy, M.D., proponent of the unconventional
drug Krebiozen, who had once been president of her medical school.
But Dr. Ward took the assignment because she was concerned about the
lack of adequate evaluation of such treatments. She thought that OTA >with
its sterling reputation for courage and fairness, would again capture the
gratitude of the nation by producing a truly disinterested, unbiased treatment
in the troubled realm of unconventional cancer treatment.< By 1987, she
reflected, >hostility and distrust so thoroughly pervaded both sides
of this chasm...that only an agency of OTAs standing could hope to bridge
it< (Speech to OTA Advisory Board, March 9, 1990).
In good faith, Dr. Ward prepared reports for the office on three controversial
treatments--the Gerson diet, the Hoxsey herbal treatment, and the more conventional
immune stimulant, BCG. She herself was surprised to find that there was
considerable scientific support for the potential benefit of all three of
these treatments. But the OTA staff apparently had a different sort of conclusion
in mind, and refused to circulate these reports to its own Advisory Council
members. In a letter to Ward, they claimed these were too positive in tone.
Under protest from board members, the reports were finally released.
Yet internal reports that were downright hostile to alternatives were
circulated to panel members unimpeded. The attempted suppression of Wards
reports was a defining moment. Not surprisingly, hostility towards the staff,
and between various board members, broke out into the open at the advisory
panel meeting of September 28, 1988. The staff had circulated a partial
draft of the final report to the advisors but >had asked the panel not
to circulate this draft to others.< As it turned out, they later complained,
"it was widely copied and circulated, and a large number of observers
at the panel meeting had copies."
So did Robert G. Houston, a long-time critic of the cancer establishment,
and this gave him the chance to write a stinging rebuttal, "Objections
to a Cover-up: The OTA Report on Alternative Therapies." This he distributed
at the meeting, much to the consternation of OTA staff members. (The public
was allowed to attend, but not address, that meeting.) In fact, throughout
this entire OTA struggle, Houston played an important role as both research
analyst and strategist for the alternative side. He produced two other short
but brilliant works: Misinformation from OTA on Unconventional Cancer Treatments
and Repression and Reform in the Evaluation of Alternative Cancer Therapies,
which was published by a patients rights organization, Project Cure, Inc.
The OTA staff later complained that "the tense atmosphere and combative
nature of many of the observers and panel members strained the discussion"
at this 1988 meeting. "There was a great deal of criticism of the draft,
largely from the panel members on the unconventional side." But from
the perspective of some panel members such as Hildenbrand and Fink, this
first draft could have been written by any group of not particularly well-informed
quackbusters, not objective government investigators.
After these events, Michael Evers, J.D., president of Project Cure, who
was himself an OTA contractor on the legal dimensions of the problem, invited
16 leaders of the alternative cancer movement to a private conference dubbed
the Coolfont Conclave: The Turning Point. This was held at a Berkeley Springs,
WV conference center from August 26 to 29, 1988.
Evers called this emergency meeting in response to growing alarm that
OTAs report was turning into an unprecedented disaster for the alternative
cancer movement. The meeting discussed the first draft in detail, with a
chapter-by-chapter analysis. It identified what it perceived as its major
flaws and then elicited proposals for improving it. (Several pro-alternative
OTA panel members and consultants were in attendance.) It also analyzed
the various policy options that had been presented by OTA at the July 28
meeting and discussed a "comprehensive plan of action for grass roots
campaign and lobbying of Congress."
The mood at the meeting was upbeat and militant and a decision was made
to vigorously fight against any attempt by OTA to suppress alternative treatments,
IAT in particular. It was at this meeting that I decided to launch a newsletter
to cover developments in the field of cancer politics, especially OTA. And,
in fact, the first issue of The Cancer Chronicles came out less than a year
After the Coolfont meeting, publicity on the developing fiasco intensified.
Gar Hildenbrand, John Fink, Frank Wiewel of People Against Cancer, and I
made numerous television and talk radio appearances on the topic; there
were mail-in campaigns directed at OTA itself, at Members of Congress, and
especially at its parent body, the Technology Assessment Board. Throughout
the following year, in fact, Congress continued to feel pressure on this
issue, and to pass that pressure along to OTA. The final report revealed
that more than half of all Congressmen telephoned or wrote to OTA expressing
concern about the study.
One glaring omission from the draft report was any progress in actually
testing IAT. In July, 1989, representatives of Dr. Burton met with the OTA
in Washington; on August 29, 1989 there was a follow-up meeting in Freeport,
Bahamas between Dr. Burton himself, his representatives, and OTAs "IAT
Working Group" (who were mainly mainstream academic scientists). Burton
was in a conciliatory mood and agreed to test IAT in patients with Dukes'
C and Dukes' D colon cancer. This would have been a difficult patient population,
The Burton side proposed a three-stage evaluation process: a review of
his center's clinical records; a "pre-trial" of patients who were
already coming to the clinic; followed by a full-scale randomized controlled
trial in the U.S., to be performed in accordance with all of FDAs stringent
requirements for new drug approval.
The most innovative part of the proposal was the so-called "pre-trial."
Its purpose was, according to one of Burtons representatives, "to provide
the necessary evidence to cut through the massive governmental red tape
now required for New Drug Approval." NCI would not need to recruit
the patients for this trial, but could simply perform before and after evaluations
of patients, such as CAT scans in order to verify their diagnoses. OTA could
then simply observe and record what happened to patients who took the treatment.
Did they live longer? Did they feel better? Did their tumors shrink? This
is what is known as a field study or outcomes research, and is one way of
assessing the value of a treatment.
Then on October 20, Dr. Herdman sent Dr. Burton a ten-page "General
Description of a Clinical Trial of IAT Agreed Upon by Dr. Burton and OTA."
This draft caused consternation in Freeport, and confirmed Burton's worst
fears. Among other things, it contained no mention of the "pre-trial,"
which had been Burton's own contribution.
"I have not agreed to much of what you have chosen to include in
your report," Burton replied angrily on November 17, 1989. "Your
report reflects little more than an outline to obtain negative results."
Congress had asked OTA to develop a statistical analysis of IATs efficacy,
utilizing existing data and to develop a clinical protocol of the treatment.
Yet, after three-and-a-half years, OTA had failed on both counts and now
sent him this deficient outline.
In its proposal, OTA wrote that "no single clinical trial can produce
an answer to the question 'Is IAT a safe and effective treatment for any
type of cancer?' " This was technically true, if only because FDA routinely
requires at least two well-controlled trials. It seemed like a disingenuous
"NCI trials produce answers about other substances," I pointed
out in The Cancer Chronicles at the time. "IAT is a biological treatment,
susceptible to clinical trials. Given enough patients, the answer could
be forthcoming. Yet OTA precludes in advance the effectiveness of any clinical
trial, thus turning its back on the scientific method."
OTA next said, "Clearly, what we would like to know is whether IAT
produces any clinical benefit to one of the main types of cancer patient
for whom it is commonly prescribed, and, in particular, whether it may improve
the chances of survival."
Fair enough: improved survival is certainly one of the most important
parameters and everyone wants to find a cure for a statistically important
cancer. (In Questioning Chemotherpy, I argue that
life extension has not been proven for the vast majority of instances in
which chemotherapy is employed.) But OTA then added that it "approached
the task of an IAT clinical trial design with the aim of maximizing the
likelihood of getting a clear answer to a narrower question, but one that
is of obvious importance: does IAT shrink tumors?"
That was sheer legerdemain: by 1988 it was abundantly clear that IAT
did not conspicuously shrink many tumors, but, if anything, stabilized patients'
immune systems and increased their quality survival time. As Burton himself
told '60 Minutes,' IAT controlled, but didn't cure, cancer. "I dont
think there is a cure," he told reporter Harry Reasoner. "There's
no such thing. We'd rather talk about a control. The patients control their
own cancer...(in) a symbiotic relationship. The body is living with the
(Continued in "OTA Report, Pt.
The Cancer Industry Introduction:
1. Intro | 2. OTA Study Pt.
1 | 2a. OTA Study Pt. 2 | 3. Office
of Alternative Medicine | 4. Underlying Problems
| 5. Role of FDA
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