When Treatments Go Untried

The HIV pandemic is fourteen years along, affecting at least
that many millions of lives, with no certain end in sight.
New treatments are winding their way through laboratory
studies and clinical trials, but not at a pace that reassures
people who now have AIDS. For many, it is a situation defined
by anxiety.

Yet long-time observers have seen some true progress in HIV
research and clinical care. Four antiretrovirals are
available in developed countries. Though certainly inadequate
in the long run, they can at the least delay HIV progression
for many people, especially when used in combinations. And
almost every opportunistic illness can be controlled to some
degree with one or more treatments. Moreover, significant
progress has been made in the treatment of wasting, and
dementia is finally receiving the sort of attention that
could make a difference in outcome.

But we are concerned that potential treatments often lie idle
on pharmacy shelves, that useful treatment strategies are
languishing on the printed page, and that for many people the
hard-won progress in research and care generally is being
squandered. This impression grows out of years of
conversations with readers of AIDS TREATMENT NEWS, with
activists and physician friends, and with people who care for
someone with HIV.

Why do potentially valuable treatments go untried? Lack of
availability is the simple answer for millions of people,
especially in developing countries. Where availability is not
the problem, however, lack of motivation often is. Following
are the most common problems, in our view, and some potential
remedies. Some of the problems are nearly solved simply by
being acknowledged.

* Insufficient information

An enormous percentage of treatment decisions seem to be made
with only a limited number of options on the table.

For example, one reader told us that his doctor had no
treatment for a KS lesion on his eyelid that had grown so
much that his vision was impaired. Other lesions had
responded well to radiation, but his doctor said that
radiation would be dangerous focused directly toward the eye.
However, we had heard that a small lead shield could be
placed between the eye and the lid during radiotherapy. He
brought that information to his doctor and was successfully
treated within a few weeks.

Only coincidence and timing brought that information from an
unrelated treatment setting to AIDS TREATMENT NEWS and
through the patient back to his doctor. How could the process
be more dependable?

When faced with an apparent treatment dead-end, the physician
and the patient should consider whether all options have been
uncovered. The first resort could be a literature search
which calls up all relevant journal abstracts for the last
several years. Next, community news sources should be
surveyed, because a lot of potential treatments are tried in
the community before they attract well-funded research
backing. At some point, a specialist with HIV experience
should be consulted. Our friend's doctor had effectively
treated KS before, but only a radiation oncologist would be
likely to know about seldom-used techniques like the lead
shield.

* Acceptance of the "terminal" prognosis

Many people, including some who should know better, continue
to regard HIV infection as a terminal condition, rather than
a chronic, life-threatening disease. The distinction is
important for shaping public policy. But there are also
scientific reasons for dumping the word "terminal."

(1) According to data from the San Francisco Clinic Study,
which has tracked long-term HIV infection in hundreds of gay
men, among people who have been infected for ten to 16 years,
6.9% continue to have CD4 counts above 500; another 8.7% have
counts below 500 but above 200. No one can dismiss the
possibility that many of them will fulfill their natural life
expectancy. (2) For people with declining CD4 counts, the
antiretroviral drugs now on the market can delay the
progression to opportunistic illnesses for months or years.
(3) New treatments for opportunistic illnesses can extend
lives well beyond the first symptoms of AIDS.

Beyond inaccuracy, the "terminal" label can itself be life-
threatening, since a choice of words implies a choice of
action. The word "terminal" fosters a sense of resignation
for both the patient and provider, such that when a health
crisis presents itself, neither party is motivated to pursue
more than the minimal, most conservative diagnostic work-up
and treatment. It is an approach that certainly simplifies
life but, almost as certainly, shortens it. One does not get
more than what one settles for.

* Disinterested health care providers

Too many people with HIV are finding themselves under the
care of physicians who are simply unenthused about HIV
medicine. Sometimes there is little choice in the matter for
the patient; for reasons of geography, or health-care
coverage, they cannot easily switch doctors. Nor is it a
choice of every physician to assume the responsibility of
managing an unpredictable, complex disease for which
treatment recommendations are constantly changing.

Yet that is the situation faced half-willingly by physicians
and patients who meet each other in one of two contexts:
health-maintenance organizations (HMOs) and teaching
institutions.

HMO subscribers are limited to seeing only physicians who
participate in that health plan. Within this limit,
fortunately, it is often possible to find a good,
collaborative "match."

But people who do not have private insurance in the U.S.
often get their care in teaching institutions, where they are
followed by young interns who rotate through various clinical
situations as part of an extended residency program. Such
teaching programs are an important vehicle for taking medical
students from school into the real world of patients. But
they are also a great money-saver for large institutions,
which would otherwise have to pay enormous salaries to more
experienced physicians.

The interns can be caring and attentive and are sometimes
more willing than older, established physicians to try
innovative treatment approaches. But they are just as often
exhausted and hurried and prone to inappropriate assessments.
It is a system that can only guarantee minimal HIV training
to a new doctor and minimal health care to their patients.

Moreover, many people who get their care in teaching
institutions come from trying or troubled social settings,
and they tend to delay health care until the need is acute.
And so, in many instances, individuals with the most urgent
personal concern are tracked into a health-care setting with
the least eager professional concern.

One solution would be to exempt interns and residents from
patient care that they truly are unprepared for. Another,
parallel, solution is the HIV-focused clinic, where the care
is largely provided by experienced physicians, with some
uncomplicated patients managed by residents genuinely
interested in HIV medicine.

HIV infection should not, in our opinion, be considered just
another responsibility of general internal medicine. It
presents too many complexities that cross over many medical
disciplines, including immunology, hematology, dermatology,
infectious disease, gastroenterology, oncology, psychiatry
and neurology. HIV medicine warrants a distinct setting of
expertise, where each patient receives individualized care.

* Hyper-cautious providers

There are other health care providers who are both informed
about HIV and interested in treating it, but who adhere to an
oppressively conservative clinical approach.

What may be a well-worn strategy in some disease models can
be ill-applied to HIV. Diabetes, hypertension, heart disease
or liver disease usually have well-understood causes and
prognoses. They may best be managed with behavioral changes
and cautious observation. But other health crises, like
cancer and HIV disease, are fundamentally different. Caution
and behavioral counseling may prevent them but will not treat
them. Exam room philosophies like "watchful waiting," "if it
ain't broke...," and "do no harm" can have a legitimate
place, but miss the mark in contexts where progress has been
achieved with innovative, aggressive intervention.

One example of excessive caution is the unwillingness to
prescribe drugs off-label. Off-label refers to the use of an
FDA-approved drug for a purpose that was not part of the
original treatment indication, or "labeling." All physicians
have the professional discretion to prescribe any drug off-
label, and many drugs have been found to be invaluable for
new uses, such as mexiletine for neuropathy. To adhere
arbitrarily to the original labeling can deprive patients of
the treatment they need. This is an ethical, not a
regulatory, problem.

Another example of misplaced caution is the avoidance of
anecdotal or empirical evidence of treatments. A number of
indispensable HIV therapies started out as anecdotal reports
from physicians and patients who pioneered new treatment
approaches out of necessity. In many HIV-related situations,
there is no established treatment or the established
treatment just does not work for everyone. Today's anecdotal
report may be tomorrow's treatment.

* The artificial polarity between "conventional" and
"alternative" treatments

The U.S. has a large and vital alternative health culture.
Depending on how the word 'alternative' is defined, this
culture may encompass holistic or naturopathic medicine,
Chinese medicine and acupuncture, nutritional
supplementation, homeopathy, herbal medicine, chiropractic,
and other forms of treatment.

Unfortunately, alternative therapies are not taken very
seriously by many traditional physicians; and allopathic, or
conventional, "Western" medicine is often posed in the
community as the "other," a mercenary devil, the problem for
which alternatives exist. There is on both sides a propensity
toward unreasonable exclusion of the other.

The most productive approach would probably integrate
everything that works, with an eye toward dropping the
distinctions of alternative vs. conventional. If a treatment
works when nothing else has, what about it is "alternative"?
This idea was well presented in the following excerpt from a
manifesto by the New York activist Jon Greenberg, who died of
AIDS in 1993.

"The AIDS community tends to fall into two separate camps
regarding alternative therapies. Some dismiss all alternative
treatments, regardless of evidence demonstrating efficacy,
and others defend all alternative treatments, regardless of
evidence demonstrating toxicity or lack of efficacy. The
reality of most alternative therapies probably lies somewhere
between these two extremes . . . The goal of alternative
treatment activists is to advocate for controlled clinical
trials of alternative treatments, so that approval and
acceptance can be gained for those treatments which are found
to be effective. Our goal is to make the term 'alternative'
obsolete."

* Over-eager concerns about expense

We have met physicians who hesitate to use a potentially
valuable treatment if they think it is very expensive or will
not be reimbursed by the insurer. This is partly a symptom of
the inefficient, commerce-driven system of healthcare in the
United States. Doctors are forced to spend inordinate amounts
of time worrying about money instead of medicine.

At least some of the concern, however, may be inflated. We
know of instances in which a treatment was avoided by
physicians who assumed the cost could not be covered by the
insurance company, when in fact the same treatment had been
covered by that insurer when prescribed with convincing
documentation by other physicians.

Furthermore, many pharmaceutical companies have assistance
programs for patients who are underinsured. No treatment
should be automatically considered out of reach.

* The culture of rumor consumers

Many people will not take the approved antiretrovirals-AZT,
ddI, ddC, and d4T-because they heard the drugs do not work,
or even that they are "poison." The truth, less dramatic but
widely accepted, is that these drugs can inhibit HIV
progression to some limited degree, and also can cause some
side effects. But ever since it became clear the drugs were
not the final answer, and that not everyone has the same
experience with each drug, a subculture of misinformation has
been simmering.

This subculture is characterized by inconsistency. Some
people who absolutely refuse to try AZT are inexplicably open
to the other nucleosides (some of which have potentially more
serious toxicities). Others will not use any nucleoside
analog whatsoever but are famous for tying up community
hotlines each time the words 'AIDS' and 'treatment' appear in
a television newscast.

No one should be faulted for having legitimate qualms about
drug toxicities, or a legitimate interest in new research
developments. But mainstream news sources rarely get a story
straight, and someone who will not consider a reasoned
treatment approach from their doctor is ill-prepared to
interpret a patchwork story from an evening newsmagazine.

The community-generated news media, where the stakes are more
personal than mercantile, can be a more dependable source of
HIV news, but can also display more subjectivity than
objectivity. Some community news sources have allowed very
irresponsible opinions to be set forth as newsworthy. These
include the discredited idea that HIV is harmless, the claims
that AZT is a prohibitively toxic drug with no redeeming
benefit, and the advice that everyone can or should manage
AIDS exclusively through non-medical therapies.

There is a disingenuous approach to medical news throughout
the larger culture that is fueled by a contemporary anti-
science trend in America and that has unfortunately found
some friends in HIV treatment circles. Mostly this trend just
obstructs a presentation of the news in its entirety. But at
its worst, anti-science thrives on promotions which tug
selectively at people's cynicism: HIV is the product of a
government plot and pharmaceutical drugs are an extension of
this plot, or AIDS is simply an imbalance of oxygen or energy
in the body, or the U.S. research establishment can't be
trusted but a clinic in Switzerland or Kenya or Mexico has a
cure. Promotions, or evasions, like these are not always
mistruths so much as manipulated bits of the larger truth.

Anti-science often shares company with the superstitions of
right-wing ideology, including creationism, anti-
environmentalism, and the demonization of homosexuals. All
anti-science ideology endangers the fight against AIDS in one
way or another. Not the least of these are the paranoias
keeping some people from medical therapies that could extend
the length and quality of their lives.

* * *

Running through all of these problems is the lack of a
widely-accepted, coherent treatment strategy for HIV. Piece-
meal management by conflicting agendas does not serve the
AIDS community well. The problems above should be solved with
long-term strategies that anticipate and not merely react to
crises, strategies that are generated together by people with
HIV and the health professions.