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The impact of medical censorship on patient care: part 2

Marcus A. Cohen

My first column on censorship in medicine (Aug./Sept.) spotlighted defects in the peer review system that block the circulation of information about novel treatment. It focused on hindrances to publication in medical journals and barriers to presentations at scientific conferences, because these periodicals and meetings serve as primary outlets for reports on research that could improve patient care.

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"When the government fears the people, you have liberty. When the people fear the government, you have tyranny."
Thomas Jefferson

This column reviews instances of dogma in clinical practice and looks at bars to obtaining grants for studies that challenge prevailing theories of treatment or explore nonconventional approaches. A third column about censorship will center on the blacklisting by the American Cancer Society of doctors who radically depart from majority norms.

Dogmatic Medicine: Radical Mastectomies, An Historical Example

The college dictionary atop a stack of cartons behind my desk gives two meanings for "dogmatic." The first: "Relating to or typical of dogma." The second: "Marked by an authoritative, arrogant assertion of unproved or unprovable principles." Referring back to this dictionary's definition of "dogma," I read that it equates "principle" with "belief, idea, or opinion, esp. one authoritatively considered to be absolute truth."

WOW! In three short definitions, my handy general dictionary hits the essence of dogmatism in clinical practice right on the head. Let's go to a close-up of a now notorious' example in Western allopathic medicine--the treatment of breast cancer from the late 19th century through the last decade of the 20th century.

Samuel Hellman, a radiation oncologist, published a thorough history and analysis of this period in modern cancer management in the journal CANCER (April 1, 1993). Broadly titled "Dogma and Inquisition in Medicine," it zeroed in on breast cancer treatment.

Hellman dated his history back to publication of independent reports by Halstead and Meyer on radical mastectomies in 1894. Underlying this surgical intervention was an untested hypothesis: Cancer spread from the primary site through the lymph to distant sites. Cutting off the entire breast, cutting away adjacent tissue, and cutting out nearby clusters of lymph nodes, was the surest way to prevent metastasis.

No one has stated the hypothesis in its original form as succinctly as Hellman. Breast cancer, his wording went, "was an orderly disease progressing in a contiguous fashion from a primary site by direct extension through the lymphatic vessels to the regional lymph nodes and then to distant sites."

In less than two decades, Halstead and his disciples had expanded the hypothesis of contiguous spread in carcinoma of the breast to other cancers. "This hypothesis," observed Hellman, "became fixed in medicine, and its acceptance was similar to that of the acceptance of religious dogma. That is to say, it was stated categorically, with fervor and authority. It was no longer a hypothesis; it became Truth. Deviation from these principles ... was punished."

Two factors lent plausibility to the extension of the hypothesis, noted Hellman. (1) The early results of radical mastectomies were good enough to suggest that the theoretical underlying mechanism of metastasis might be correct. (2) Surgery had developed to a point enabling surgeons to perform extensive operations.

"Thus, radical mastectomy became the central dogma of disease spread," Hellman's account held, "giving license for the expansion of surgery that used principles of cancer pathogenesis to develop similarly conceived operations as the appropriate treatment for cancers in many sites. Radical extirpative en bloc surgery became the apex of curative cancer treatment.... These operations demanded much of the surgical team, and their successful completion attested to the prowess of the practitioners. As a result, oncologic therapy became the primary province of surgeons."

Considering factors which may have contributed to dogmatic adherence to the hypothesis of lymphatic spread, Hellman proposed two: "the implied characteristics of the surgeon and surgery under these circumstances."

He elaborated: "The operation became a battle with disease in which victory or defeat often could be determined as the result primarily of the operator's skill, perhaps combined with some risk taking (though the operator was not at risk). This way of looking at outcomes suggests that doctors can influence the course of malignant disease. The importance of the doctor was clearly established, and the notion that the clinical outcome was determined before therapy began was rejected soundly."

According to Hellman, Geoffrey Keynes in 1937 and Fitzwilliams in 1940, English physicians, published the first challenges to doctrinaire use of radical mastectomies. In 1955, McWhirter, a Scottish radiation oncologist, published a proposal for less extensive surgery with postoperative radiation. The American surgeons George Crile in 1964 and Bernard Fisher in 1976 published results indicating that simpler, breast-conserving surgery could be effective.

Orthodox oncology denounced them all as apostates, pointed out Hellman, who likened the accusations of medical "heresy" to the very public auto-da-fes of the religious inquisitions, where individuals sentenced for unrepentant apostasy were executed at the stake.

"None of us has been burned at the stake," Hellman quoted Keynes as saying, "but feelings have run pretty high." Hellman also quoted Fitzwilliams, who cautioned: "Those who have been brought up in the atmosphere of the radical operation with no experience of anything less extensive must remember that they are repeating dogma and not speaking from formed judgment. Medicine is never advanced by such action."

While radical mastectomies and the dogma of contiguous spread ruled supreme in oncologic practice in the US--the height of acceptance was the middle third of the 20th century--it was not uncommon for women to be scheduled for surgical biopsy, wheeled into the operating room anesthetized, and wheeled to the recovery room to regain consciousness minus a breast and numerous lymph nodes. Removal usually followed examination or a quick test of diseased tissue during surgery that suggested cancer, with no requirement for the patient's signed consent.

Publication by Fisher and his colleagues of data suggesting an alternative model for metastasis led to a gradual reduction in radical procedures. Around 1980, where appropriate, surgeons began to perform modified radicals, or lumpectomies (removal of a localized tumor) with follow-up localized radiation therapy. These surgical alternatives provided patients with acceptable treatment options.

Fisher's alternative paradigm for the pathogenesis of neoplastic disease, based on lab studies, hypothesized two types of breast cancer: one that seldom spreads, which can be treated locally with radiation, and retreated with radiation upon reappearance without risking metastasis; and another that has spread before clinical detection of the primary tumor, which doesn't respond adequately to radical therapy because occult micrometasteses have developed. The Fisher hypothesis called for systemic treatment to wipe out the presumed but undetectable micrometasteses.

Fisher's approach entered, slowly. Halstead's exited, more slowly. (A few diehard surgeons haven't abandoned radicals at this writing.) Some states now have laws mandating informed consent by patients prior to any breast surgery. Science has booted dogma from the breast cancer scene. Right?

Wrong! Regarded initially as heretical, the new breast cancer paradigm became the new dogma, argued Hellman. I'll summarize two that seem central.

When Fisher's hypothesis first circulated, adjuvant systemic therapies, chemical and hormonal, were easing into vogue. Meant to kill hidden micrometasteses, they supported a key component of the new paradigm--most breast cancer is metastatic prior to discovery.

Because Fisher's hypothesis viewed breast cancer as a systemic disease, it elevated, underscored the role of the hematologist/oncologist, making it decisive in keeping cancer at bay. As Hellman expressed this second reason: "Cancer therapy and its success requires skill, courage, and risk taking (again the risks are the patient's). Most importantly, medicine is potent and, if skillfully applied, can 'defeat' cancer. The medical oncologist now supplants the surgeon as the central figure in cancer management."

Recognizing that acceptance of the new dogma was "as complete and uncompromising as that of the previous one," Hellman picked a recent illustration of the effect of the new dogma on public health policy. I quote again from his "Dogma and Inquisition in Medicine":

"So important, it seems, are the results of new studies confirming or expanding the use of adjuvant therapies that the normal mechanisms of peer review have been abrogated to apply these results immediately. For the first time, a 'Clinical Alert' was released by the National Cancer Institute [NCI]. It reached physicians before the peer-reviewed publications and without the full presentation of data to be published in the journals. What was presented was a governmental recommendation based on evaluation by the National Cancer Institute, which was outside the established processes by which medical information is evaluated and presented. This truly is dogma, rather than hypothesis generation and testing. Forgotten is the notion that, although the scientific method is powerful in rejecting untrue hypotheses, it cannot prove something to be true. The most that can be hoped for are successively better approximations of the truth. Current practices seem more consistent with religious excesses than with the conditional nature of scientific hypotheses and learning."

CANCER carried this article by Hellman 11 years ago. The NCI issued its clinical alert 16 years ago. A third hypothesis about breast cancer has since been proposed; Hellman is among the originators. This third hypothesis, currently prevalent, sees breast cancer as three separate diseases whose boundaries aren't clear. (1)

Type one, perhaps 10 to 15% of breast carcinomas, are indolent, reproducing so slowly that simple excision handles them. Type two, at the other extreme, perhaps 13 to 17% of breast cancers, are extremely lethal, developing and metastasizing between annual mammograms. Even state-of-the-art technology can't detect or treat them. Type three increase at a rate that may turn them into spreading troublemakers within five to ten years. No current test can accurately discriminate between the three types.

A report about the latest hypothesis appeared in The New York Times in 1997. (1) The report included a discussion of why regular mammography hadn't appreciably lowered the breast cancer mortality rate. The reporter quoted Hellman on the use of systemic therapy--in accordance with Fisher's hypothesis--to prevent disease spread:

"Giving all these women adjuvant chemotherapy when the majority don't need it puts us in an awkward circumstance, 'Dr. Hellman said. Because doctors don't want to harm the many women who do not need the treatment, they tend to 'water it down,' he said. Yet that means that those who do need it may not be getting enough. 'We end up with a poor mix in the middle,' Dr. Hellman said."

Medical Dogmatism in the Rejection of Research Grants

My first column on censorship in medicine cited two examples of how peer review can stop innovative ideas about treatment from gaining a foothold on their climb toward acceptance. They were among 18 such instances supplied by the late Dr. David Horrobin in a paper published in the Journal of the American Medical Association (JAMA), 3/9/90.

Here are three more examples from Horrobin's piece involving turn-downs of grant applications, and two examples of rejection by journals, all largely ascribable, I submit, to elements of dogmatism in the peer review system.

In England in the 1950s and 1960s, the Medical Research Council repeatedly denied grants for studies on renal transplantation, based on earlier English research investigating immunological tolerance. Peer reviewers opposed to the clinical concept were deeply involved in the "relevant basic science."

The peer review process in the US repeatedly denied grants for research on in vitro fertilization in the early 1980s. To pursue their studies, the researchers personally had to fund their research, which ended, Horrobin noted, in "practical success."

Prior to 1970, mainstream journals repeatedly rejected papers on the movements in and out of cells of ions and small molecules, based on a state of intracellular ordered water; the papers flew in the face of the established concept, based on cell membranes and pumps.

A Finnish pathologist, with a distinguished record of publication in US journals in the 1940s and 1950s, reported observations conflicting with the views of prominent Americans in the same field. Thereafter, said Horrobin, "his abstracts were not accepted for presentation at conferences, even for meetings where almost all abstracts were taken." Horrobin stated that he didn't know whether the Finn was right. "I do know," he said, "that he deserves a hearing."

The final instance supplied by Horrobin in JAMA in March 1990 merits quotation in full, it's so telling with respect to qualifying for research grants:

"Peer-review in the grant-giving process is so restrictive that most innovative scientists know they would never receive funding if they actually said what they were going to do. Scientists therefore have to tell lies in their grant applications. Such views have been explicitly stated by at least two Nobel laureates."

Unless one constantly holds in mind the fundamental aim of medical research--improving patient care--the influence of dogmatic factors in grant-giving may appear minor. But the impact of medical dogmatism on care is always major when it denies patients access to effective novel treatment through rejection of research grants and papers.

Dogmatic Tendencies In Clinical Research: Recent Examples

Over the past decade, a trace of dogma has seeped into the treatment of Lyme disease, where research clinicians have broken into majority and minority groups, with some in the majority attempting to prevent publication and presentation of information about the minority approach to diagnosis and care.

Lyme is hard to diagnosis because it can mimic the manifestations of many illnesses, the telltale signs don't always show, and antibody tests are problematic. Up to 15 % of patients' are estimated to suffer long-term complications, especially if misdiagnosed or diagnosed months or years after infection. With timely diagnosis and adequate antibiotic therapy, early Lyme, if not acute at the onset, is a mild condition that resolves after four or six weeks.

Mainly, it is the optimal way to treat persistent or recurrent Lyme that has split Lyme specialists into two camps. One camp, academically oriented, theorizes that in "a small percentage of patients with well documented Lyme disease," chronic symptoms result from a post-Lyme syndrome, triggered by "immunologic or neurohormonal processes in the brain that cause persistent pain, neurocognitive, or fatigue symptoms, despite spirochetal killing with antibiotic therapy." (2)

A leader of this camp recently characterized the opposite camp as an emerging "counterculture." His description of that "counterculture" read: "In contrast with the findings of evidence-based medicine, some people believe that the tests for Lyme disease are often inaccurately negative, and that antibiotic therapy is necessary for months or years to suppress the symptoms of this often incurable illness." (2)

Publication this July of the Lyme Disease Update, which I wrote for the Lyme Disease Association (LDA), has bundled me in bed, so to speak, with the "counterculture." As a formal response, I'll quote from my introduction to the Lyme Disease Update. "All papers chosen for the science sections ... have appeared in journals respected for publication of evidence-based, peer-reviewed findings."

"At this juncture in the history of Lyme disease, a number of specialists believe Lyme is overdiagnosed, that something other than active infection causes late manifestations in many cases. A number of specialists believe infection can persist or recur, and feel that Lyme is underdiagnosed. Reflecting this divergence of opinion, two standards of care have emerged in the clinical community."

"Following the recent publication of evidence-based guidelines for the management of Lyme disease in the scientific literature by the International Lyme and Associated Diseases Society (ILADS), a professional medical society, two sets of recommendations on diagnosis and treatment exist.... This situation is neither unprecedented nor uncommon in clinical practice, where 'there is seldom a single correct answer to a medical problem.'"

The Lyme Disease Update was conceived with the following hope, that the evidence gathered here, casting a reliable light on pieces of the Lyme puzzle still out of place, might help patients and physicians combat an infection that has escalated--in a single human--generation--into the most--prevalant vector-borne disease in the US; of the total number of vector-borne diseases now reported to the CDC, 95% are new Lyme cases.

Now, because of my association with the Lyme "counterculture," I anticipate charges of heresy on two counts. Yet here I am, about to conclude a second column on censorship in medicine, and I'm tempted to toss in my two cents on HIV and AIDS. Professor Peter Duesberg, an eminent virologist, bravely stands at the head of a distinguished corps of scientists who don't buy the official line on AIDS--that HIV is the cause. They think life style and highly immuno-suppressive chemotherapy cause it. Once the darling of the virology community, a recipient of a host of research grants, Duesberg can't wrangle a penny from mainstream institutions for studies that undercut the establishment's position on AIDS. His latest paper, 2003, was published by the Indian Academy of Sciences. (3)

He basically claims that money, conflicts of interest, etc., have turned AIDS studies and treatment dogmatic. He also points a finger at peer review, and here, by way of explanation, I should quote from the epilogue of Duesberg's 2003 paper: "The probable answer to the question, why HIV-AIDS researchers do not study or fund non-HIV-AIDS theories, lays in the structure of the large, government-sponsored research programs that dominate academic research since World War II.... Such programs favor individual investigators who contribute to the establishment a maximum of data and a minimum of controversy. However, if individual investigators move into new directions, that threaten the scientific and commercial investments of the establishment, the establishment can impose various sanctions via the 'peer review system.' The most powerful of these are denial of funding and of publication." (3)

Duesberg then offers an insider's account of how the peer review system does not operate "as the equivalent of a jury system--free of all conflicts of interest." (3) Having twice exposed myself to accusations of medical heresy, I want to be dead certain before being damned again that I'm comfortable in acquiring a new set of fellow apostates. For now, then, I'll chime in on AIDS and Duesberg with Horrobin's remark about the Finnish researcher whose papers he published. "I do not know whether Setala is right or wrong," he said, "I do know that he deserves a hearing."

The ACS and the NCI aren't interested in people, they're interested in money and grantsmanship. They condemn anyone who doesn't play their game. I call them "The Cancer Church" because they establish the official gospel and then excommunicate all the heretics who don't follow it.

--Patrick McGrady, Jr. (1932-2003), "The Lone Ranger Of Cancer Care," 50 PLUS, April 1987.

References

  1. Kolata G, New view sees breast cancer as three diseases, The NY Times, 7/1/97.
  2. Steere A et al, The emergence of Lyme disease, J. Clin. Invest. 113:1093-1101 (2004).
  3. Duesberg P et al, The chemical bases of the various AIDS epidemics: recreational drugs, anti-viral chemotherapy and malnutrition, J. Biosci. Vol. 28 [No. 4] June 2003.

by Marcus A. Cohen

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Dr. Schaller neither supports nor opposes the material above. He neither supports not opposes the rights of this physician to offer ideas according to his perscective. Any questions of content or idiology can be directed to the author. All medical recommendations can be discussed with your personal physician(s).



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