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The Cancer Industry:
The Classic Expose on the Cancer Establishment
New Updated [1996] Edition

© 1996 by Ralph W. Moss, Ph.D.
Published by Equinox Press
(All rights reserved. Please see Copyright notice.)

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 strategy.

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 included.

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 Post, 12/13/87).

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 later.

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, at best.

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 objection.

"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 cancer."

(Continued in "OTA Report, Pt. 2")

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

Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.

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