CANHELP: Alternative Cancer and Chronic Disease Treatment Options

This Bill of Rights arises from a desperate need to improve the lot of cancer patients, whose situation differs radically from that of other sick people. Life after a cancer diagnosis can be painful and brief: a few months or a year. Most patients are diagnosed too late for surgical cure, or for effective radiation and chemotherapy. Victimized both by disease and an unfriendly system of patient care, they are desperate for real help. And they need that help today.

The system works against the patient. As billions of dollars have been exacted from taxpayers to fund a "War Against Cancer", hospital and doctors' fees have soared to astronomical levels. (A "Medicare-approved" Midwestern hospital specializing in cancer treatment, for example, charges its patients over $3000 per day. It is not uncommon for a year's treatment in many hospitals -- usually unsuccessful -- to run into six figures.) The "war" has enriched phenomenally the health care "providers", with precious little benefit trickling down to cancer patients. Many patients have been bankrupted trying to pay for specious treatments. Still others, unwilling to impoverish their spouses and families, have declined all treatment.

Even patients with advanced, refractory disease have been deprived of the right to fight for their own lives. As ultimate control over treatment has drifted into the hands of an amorphous bureaucracy of regulators, physicians are forbidden to exercise their professional discretion. True, some patients still have the right to choose their physicians, but fewer and fewer physicians choose to challenge the therapeutic authority emanating from the Beltway. Treatment options have dwindled drastically. More and more, cancer doctors find themselves working exclusively from obsolescent protocols -- with results as grotesque as ever.

As the renowned French oncologist Dr. Lucien Israel has noted, the cancer patient has far less to lose than other patients from bold attempts at salvage. Yet, instead of a right to salvage, the patient is given the dubious privilege of participating in risky, low-yield government-sponsored trials of untried agents -- often mainly to test fine points of drug activity. A deadly triage begins with a selection process called randomization in which half of the patients are consigned to inferior controls, often placebos. Not that it makes that much difference.

Maurie Markman, M.D. reported in CA: A Cancer Journal for Clinicians, that in a series of Phase I clinical trials coordinated by the National Cancer Institute, "the complete plus partial response rate (a 50% or greater decrease in the product of the perpendicular diameters of measurable tumor masses) was only two percent."

The once sacred patient-physician relationship is now compromised by a host of overseers, including well-meaning hospital tumor boards, fat and frightened pharmaceutical companies, a thoroughly confused Food & Drug Administration, greedy, withholding insurance companies, and arbitrary Medicare and health-maintenance organization (HMO) regulations.

Many cancer patients never discover a real doctor along the treatment trail. They are visited by a plethora of people in white coats, all of whom have the meter running during their brief, mute visits. If a crisis arises late at night or on a Friday or over the weekend, it is often impossible to locate any physician. It is well and good for the state to insist that decisions regarding patient care should reside with those who are licensed to practice medicine, but too frequently the licensed practitioners are simply not there. When they are, they have been instructed to ignore their intuition and their knowledge and their skills, and conform to unbending conventional practices.

The other side of the coin is a failure by the National Cancer Institute to provide funds to test the several low-toxicity therapies that have achieved dramatic remissions among many of the most refractory cancers. Good therapies abound here and abroad, but without powerful government or pharmaceutical company sponsorship they remain underused, underexposed, unexplored, unrefined, and primitive. The home-grown treatments are pompously condemned out-of-hand as "unproven methods" or "quackery", while those from abroad are either similarly suppressed or, more often than not, just ignored. In neither case are they given a fair trial.

Some guidelines have been relaxed. Some patients may now import unapproved prescribed medications for personal use from abroad and the government has initiated a timid "parallel track" program whereby some patients are allowed experimental treatments "off-study". Still, unconscionable delays in getting new therapies to cancer patients are the rule, not the exception.

For nearly two decades, European medical journals have described the unique remissions obtained in some of the most difficult-to-treat tumors by an extraordinarily versatile alkylating agent called ifosfamide. Finally, its pioneer developer, Dr. med. Wolfgang Scheef of Bonn, West Germany, showed in the March 1979 Cancer Treatment Reports, the National Cancer Institute's most prestigious journal, that the major urinary tract toxicity associated with this drug could be eliminated with Mesna, a rescue agent. Yet it was not till 10 years later that the Food & Drug Administration finally approved this lifesaving agent for use in the United States. Two precious years were lost as unsophisticated FDA officials tested Mesna for tumor-killing power and concluded it was worthless. National Cancer Institute experts, aghast at this blunder, informed the agency that Mesna's only claimed purpose was protection of the urinary tract -- which function it performed superbly.

There are many other examples of proven valuable therapies which today are being withheld from cancer patients, either by suppression, condemnation, ignorance or neglect.

The inability of the FDA and the NCI to make available promptly useful new therapies has hurt cancer patients in many ways. The Federal government's enforcement of medical conformity has encouraged state and local bodies to follow suit and persecute medical dissidents on their own.

Many cancer patients must rely upon what a chauvinist Medicare (Medicare refuses to reimburse Americans for treatments they may find only abroad) or their HMO can provide or their insurance company will allow.

Today, the insurers increasingly are declining to reimburse patients not only for unorthodox remedies, but for the various government-sponsored experimental chemotherapy combinations. None of the commonly used polychemotherapy schemes, by the way, has ever been approved by the FDA.

National Cancer Institute spokespersons claim that approximately one half of cancer's victims live at least five years after diagnosis. Many experts, including the country's most respected epidemiologists, challenge this figure as grossly exaggerated. Indeed, the United States General Accounting Office in March of 1987 accused the National Cancer Institute of presenting statistics with "biases [that] can artificially inflate the actual improvement in patient survival."

Our health care system has ridden roughshod over such basic human rights as the right to choose one's own medicine. Patients who insist on other than the orthodox recipes are compelled to serve as guinea pigs in order to obtain a last ditch chance at survival.

Randomized, double-blinded, controlled clinical trials are not necessary to identify "breakthrough" treatments. As proof of efficacy, they are entirely superfluous. Treatments that bring about statistically significant improved remissions in normally refractory, resistant tumors in small cohorts deserve the most serious attention and prompt assay in larger trials. Randomized, blind trials have an important role to play in determining fine points of protocol definition later on. But should a qualified doctor ever be instructed to turn his patient population into guinea pigs if he wishes to try a new treatment method?

Doctors and patients need to be liberated from the medical bureaucracy's politics. When there is no curative conventional treatment, doctors should be free to try the unconventional. Innovative therapies do not always succeed on patients with advanced disease, but even when they fail, patient and physician may enjoy the soul-felt satisfaction of having given their best to the battle for life.

As a start toward improving the patient's welfare, CANHELP herewith proposes adoption of the following basic rights for the cancer patient:

Every cancer patient shall have an inalienable right to choose any therapy, regardless of provenance, regardless of experimental status, and regardless of approval or lack of approval by any third party. The physician is the patient's expert medical surrogate and counselor.

With informed patient consent, the physician thus should be able to prescribe any diagnostic test or treatment, which may prove beneficial. This does not relieve the physician of the obligation to treat the patient with competence, caution and compassion, or to provide upon request a documented therapeutic rationale. But no longer should a physician be required to restrict his or her practice to locally popular or "approved" treatments and protocols.

The Right to Information About One's Disease

Patients shall have the right to know as much as they care to know about their condition. Physicians shall stay in touch with their patients and inform them of their progress and answer their reasonable questions; failure to so inform them should constitute grounds for disciplinary action or for charges of fraud and malpractice.

At all times, the patients' medical records shall be available to patients upon their request. Physicians shall scrupulously inform their patients about:

Since the cancer patient has the sole right to decide how he or she shall be treated, the Kefauver-Harris amendments to the federal Food, Drug and Cosmetics Act of 1938 should be repealed. This ambiguous legislation has encouraged a stifling conformity and discouraged innovation. Toxic and ineffectual treatments from powerful pharmaceutical companies have been approved, while nontoxic, effective treatments from independent investigators have been spurned. Time-wasting, inefficient, and extravagant testing procedures do not protect the public; they keep helpful therapies from them and needlessly increase morbidity and mortality.

The current drug-testing program should be scrapped and replaced by one more consonant with real patient needs. Powers usurped by the FDA should be returned to the physician and the patient, whence they were expropriated. This agency's proper function should be to collect and disseminate accurate information about all cancer treatments. It should, further, actively assist scientists and physicians of modest means to assess and develop their therapies, as several of the European regulatory agencies do. Although the FDA denies that it dictates to physicians what they may and may not do for their patients, its well-documented history of oppressing innovative researcher-physicians belies its piety. This oppression should cease in all of its subtle and non-subtle forms.

The Right to Humane and Efficient Medical Care

Patients shall have the right not to be forced to enroll in randomized experimental trials in order to obtain new therapeutic agents. This would prevent scarce new treatments from being used as a means of blackmailing patients. Any physician using such experimental options, however, should be obliged to report results promptly and comprehensively.

While government agencies may recommend protocols, any physician should have the right to modify those protocols for the patient's benefit. The present clinical therapy testing system has turned out to be a nightmare of pseudoscientific arrogance. It is impossible to pinpoint a single treatment breakthrough issuing from this system which could not have been produced from more humane and efficient testing procedures.

    Current methodology is predicated on a mistake and a sin. The mistake lies in the false assumption that the randomized, blind-control design alone produces significant scientific results. The sin lies in treating human beings as laboratory animals. In addition to informing their patients of probable results and side effects from such experiments, participating physicians should disclose any possible conflict of interest, including and particularly, any compensation they or their sponsors or institutions may receive for enrolling patients in these trials.

The Right to Comprehensive Insurance Coverage

    Third-party insurance carriers, including Medicare and HMO plans, shall reimburse cancer patients for any reasonably priced cancer therapies -- be they conventional, experimental, alternative or complementary therapies -- when prescribed by licensed treating physicians. Criteria of treatment propriety shall be the province exclusively of patient and physician, not the insurer or any government agency or any advocacy group.

    The decision to choose a cancer therapy is one no patient takes lightly or capriciously. An erroneous selection can cost the patient's life. The right to choose one's own treatment is the cornerstone of civilized cancer care.

The Right to Have One's Physician Held Free From Inappropriate Civil Lawsuits

    The patient's right to humane treatment depends upon the physician's right to be free to treat the patient conscientiously, without harassment, without relentless second-guessing by third parties, and without the burden of having to parry malicious and nuisance lawsuits. Litigation is a poor way to solve patient care-related problems, albeit rarely the only way.

    Unfortunately, the resort to litigation has not succeeded in eliminating the impaired or venal physician, but it has grossly increased health care costs, shrunk the supply of capable doctors in high-risk categories, and encouraged mutual cynicism and mistrust.

    Legislation should protect physicians and hospitals from frivolous legal action.

    The constant threat of litigation often discourages physicians from providing inspired treatment. It creates an irresistible temptation to work instead from a fatuous official cookbook and overlook possibilities for innovative and successful healing.

Cancer should be a legally reportable disease. Physicians should be obliged to monitor the progress of their cancer patients and submit regular reports to a universal tumor registry. This will provide a deeper, more accurate view of cancer epidemiology and clarify which treatments work or do not work. Without such a universal registry, treatment validity will continue to remain subject to political and economic manipulations and a matter of guesswork, distortion, and propaganda. The public's access to these data should be unrestricted, save for safeguards protecting individual identities.

    Patients participating in clinical research have the right to know that they must be the primary benefactors of trials and not serve merely as guinea pigs.

    The Helsinki Declaration to which this country is signatory stipulates that, among other things, "the doctor must be free to use a new therapeutic measure, if in his judgment it offers hope of saving life, reestablishing health or alleviating suffering" and, further, "the doctor can combine clinical research with professional care...only to the extent that clinical research is justified by its therapeutic value for the patient."

    Violations of the Helsinki Declaration's protections against patient abuse shall constitute grounds for the imposition of disciplinary sanctions and provide a cause of action for civil lawsuits.

CANHELP, Inc. 32220 Rainier Ave., NE Mailing: P.O. Box 103 Port Gamble, WA 98364	(360) 297-5221 Fax: (360) 297-6667
email: canhelp@centurytel.net or madeleen@canhelp.com