THE
CANCER PATIENT'S BILL OF RIGHTS
By
the Late Patrick McGrady,
Founder of CANHELP, INC.
Preamble
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:
The
Right to Choose One's Own Medical Therapy
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:
The
reasons for selecting a particular treatment plan.
The
alternatives, and reasons for rejecting them.
The
risks and benefits of relevant therapies.
The
survival probabilities with the therapy selected for them, and whether
the treatment is designed as curative or palliative.
The
patient's physical condition, and particularly whether there is progress
or deterioration.
What
other options may be considered if their treatment appears ineffective.
The Right to Fair Treatment Evaluations
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.
The
Right to an Open, Universal Tumor Registry
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.
The
Right to Strict Observance of the Helsinki Recommendations
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.
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