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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: Oliver & Co who wrote (2083)10/8/1997 7:47:00 AM
From: Henry Niman   of 6136
 
Here's the JAMAarticle on HIV specialists:

Controversies - October 8, 1997

'HIV Specialists': The Time Has Come

Abigail Zuger, MD; Victoria L. Sharp, MD

THE PLACE OF acquired immunodeficiency syndrome (AIDS) in the structure of medical care
delivery is still evolving. One important consideration is whether the care of persons infected with the
human immunodeficiency virus (HIV) should be part of general practice or specialty care. Like many
specialists (physicians with advanced training and/or certification in an area of medicine), physicians
who care for patients infected with HIV face a spectrum of conditions that are rare, complicated,
difficult to manage, and require familiarity with a rapidly expanding medical knowledge base. Still,
commentary has emphasized that "AIDS is a primary care disease," citing the need to destigmatize
patients, improve disease recognition and prevention, and forestall any shortage of appropriately
trained specialists as HIV infection becomes more prevalent nationwide.[1-3] "Because patients
with AIDS can be cared for effectively by primary care physicians," maintains one policy statement,
"they [the physicians] should acquire the necessary skills and provide care to such patients, if any
meaningful notion of the practice of medicine as an honorable profession is to be preserved."[1]

Recent developments suggest that this vision of AIDS as a primary care disease should be formally
reexamined. These events include (1) advances in the understanding of HIV infection pathogenesis;
(2) a new appreciation of the potential and limitations of antiretroviral therapy; and (3) increasing
penetration of managed care into clinical medicine. A few years ago, the issue of whether AIDS was
or was not a primary care disease was largely an ethical and philosophical one. Now it has the most
practical consequences, as managed care organizations seek to establish workable patterns of care
for members who are infected with HIV.

The clinically asymptomatic period, lasting a decade or more in persons infected with HIV, is not
one of viral latency. Continuous high-level viral replication persists for the duration of this period,
with evolution of viral mutants and destruction and replenishment of large populations of
lymphocytes despite continued well-being of the infected person.[4,5] Only when relentless viral
replication exceeds host capacity for regeneration do gross immune deficiency and AIDS-indicator
conditions supervene.

This scenario has revolutionized the conceptual approach to treatment of HIV infection. The
"primary care" algorithms of the early 1990s, in which asymptomatic persons were largely
candidates for "health monitoring" rather than medical intervention, now seem quite outdated. Most
experts agree that effective anti-HIV treatment probably requires maximal antiviral chemotherapy as
early as possible in infection, almost certainly with a combination of agents.[6] Bisecting HIV disease
into the simple, asymptomatic stage managed by the primary care clinician and the complex
symptomatic stage requiring specialty consultation has become virtually obsolete.

Seven years ago, azidothymidine was first marketed as an effective single agent for individuals
infected with HIV. Now double and triple anti-HIV combinations are considered state-of-the-art
therapy, although many of the data supporting them have been presented only in oral and abstract
form. Similarly, some new antiretroviral agents are now quickly approved for release with little or no
clinical efficacy and toxicity data on them available in the general medical literature. The toxicities
and complex interactions of these drugs tend to resemble those of chemotherapeutic agents rather
than drugs in the standard primary care armamentarium.

Research protocols or expanded access for Investigational New Drug programs offer patients infected with HIV access to even more promising drugs than those on the market-but only when
the physician has access to these programs. Meanwhile, consumer networks in print and electronic
media for the dissemination of HIV-related information routinely "scoop" more conventional medical
channels in assessing promise and toxicities of experimental medications. As a result, inexperienced
physicians may find themselves being instructed by patients in "state-of-the art" antiretroviral care,
and may be confused by conflicting health care-related practices in the community, virtually none of
which may have been validated through conventional academic channels. The perspective of the
specialist in sorting through these tangles of therapeutic fact and rumor has become invaluable even
in the management of healthy, clinically asymptomatic patients infected with HIV.

Can these changing therapeutics of HIV infection be incorporated into a primary care-based health
care delivery system, in which specialty consultation is a rationed commodity? Several
considerations suggest that this effort has not been and will continue not to be a successful one.

The daunting quantity of information available on HIV infection and its complications now exceeds
that of some other common "primary care" diseases and shows little sign of abating. The number of
drugs released for specific HIV indications is also increasing. While generalists now in training may
become familiar with these data in the course of their education, those in practice may have difficulty
doing so without specifically allocated continuing medical education time for HIV-related training. A
recent study supports this hypothesis, indicating that generalists approach some common physical
findings of HIV disease with considerably less diagnostic accuracy than other physical findings.[7]

However, the success of HIV primary care training programs, particularly when purely didactic, may
be limited. In 1 study, a brief HIV "course" benefited only those trainees who already had substantial
interest and expertise in HIV infection and did not change the expertise of the less interested.[8]
Hands-on training in clinical settings may be more successful, but may have to be intensive and
prolonged to qualify as "specialty training" in HIV.

An increasing body of literature suggests that the bottom line of patient outcome is almost certainly
affected by the clinical experience of medical practitioners, an observation confirmed for an array of
medical disorders,[9-11] and now for HIV infection. According to a recent report,[12] even
minimal practitioner experience with HIV correlated with significantly prolonged survival times in
their patients infected with HIV.

Diseases as complex and severe as AIDS-leukemia and metastatic solid tumors of lung and breast,
for instance-are not generally categorized as "primary care" diseases. They are unquestionably in
the purview of the primary care physician, but almost exclusively for prevention, diagnosis, and
referral. For treatment and subsequent management, a specialist's continuous expertise is essential. It
is unlikely that many primary care physicians would maintain otherwise-or would suggest that if
they were diagnosed as having one of these illnesses, they would not immediately seek care from a
specialist for their own treatment.

Current managed care models for patients with chronic medical conditions rely heavily on primary
care physicians to provide the bulk of medical care. Specialist advice is episodic and discontinuous:
specialists may be discouraged or prohibited from providing subsequent care for referred patients,
forced by terms of their employment into a choice between a strictly consultative or primary care
practice.[13]

While policies for the managed care of persons infected with HIV are not formally available from
managed care organizations, indications suggest that they will adhere to precedent established for
other conditions. Emphasis has been placed on delineating acceptable "risk-adjustment" strategies
for HIV disease, which will make the significant expenses involved financially neutral to the plan and
thus help ensure that plan members with HIV infection do not receive curtailed care for financial
reasons.[14] However, little commentary on optimal provider qualifications can be found. Some
proposals acknowledge that both educational and attitudinal barriers to AIDS care among primary
care practitioners may need to be "surmounted" before effective care can be given.[15] The means
for doing so are not addressed.

The static knowledge base of HIV medicine implied by the word "surmounted" is, unfortunately, an
entity yet to be achieved. More compatible with present rapidly changing standards of HIV care is
an alternative proposal that specialists should be designated as "principal care providers" for patients
with conditions in the physician's area of expertise.[13] In this system, the distinction between
primary care and consultative care is purposely blurred, integrating all aspects of an ill patient's care
into a seamless whole.

Managed care systems tend to envision a consultant providing only "treatment," while the primary
practitioner provides continuous "care." But for patients with complicated chronic diseases, including
AIDS, both treatment and ongoing care are necessary. Invariably, their medical care proceeds
coherently only if both entities are provided by a single practitioner. Only in this way are the multiple
time-wasting, patient-fatiguing, income-producing referral pathways generated by other systems
avoided.

Scientifically and practically, HIV infection simply does not fit well into the neatly dichotomized
boxes of "general care" and "specialty care." We suggest that the difficulty may actually be one of
semantics. The truth is that many generalists have become, over the years, expert practitioners of
HIV care. At the same time, many infectious disease specialists have remained both disinterested
and inexpert. The solution may be to acknowledge that a different categorization of care is required.

Other authors have suggested that HIV medicine may soon transcend the boundaries of present
medical subspecialties and force creation of a new one.[16,17] We take the suggestion further:
AIDS should be the first disease for which the caricatures of "consultant" and "generalist" are finally
retired and, instead, suitably qualified physicians are allowed and encouraged to provide all
necessary facets of medical care.

How should "HIV specialists" be trained? Soloway[18] has nicely summarized the bottom line:
"Regardless of their past formal training, they must educate themselves thoroughly about HIV."
Many means to this end are available: courses, workshops, and general residency programs as well
as specific apprenticeship programs may all play a role. For some physicians, ongoing familiarity
with the medical literature will suffice. As is the case for other specialties, competence in HIV
medicine may wind up most efficiently gauged by a written examination taken after 12 to 24 months
of suitable inpatient and outpatient clinical work, with criteria for competence continuously
reexamined as the field evolves.

All physicians should be as familiar with the prevention and diagnosis of HIV infection as they are
with these facets of other endemic, preventable, and life-threatening diseases. However, full care is
necessarily the realm of expert physicians with ongoing clinical expertise. Whether they are called
specialists, subspecialists, or primary care physicians is, ultimately, immaterial. Patients infected with
HIV deserve physicians who know what they are doing and are substantially disserved by any other
approach. The medical complexities of their disease should not be trivialized by well-meaning efforts
to mainstream them.

From the HIV Comprehensive Care Clinic, Beth Israel Hospital, and the HIV/AIDS Center, St
Luke's-Roosevelt Hospital, New York, NY (Drs Zuger and Sharp); and the Department of
Medicine, Albert Einstein College of Medicine, Bronx, NY (Dr Zuger).

Reprints: Victoria L. Sharp, MD, HIV/AIDS Center, St Luke's-Roosevelt Hospital, 1000 Tenth
Ave, New York, NY 10019 (e-mail: vsharpny@aol.com).

References

1. Northfelt DW, Hayward RA, Shapiro MF. The acquired immunodeficiency syndrome is a
primary care disease. Ann Intern Med. 1988;109:773-775.

2. American College of Physicians, Infectious Diseases Society of America. Human
immunodeficiency virus (HIV) infection. Ann Intern Med. 1994;120:310-319.

3. Laurence J. A primary care condition. AIDS Reader. 1995;5:110.

4. Wei X, Ghosh SK, Taylor ME, et al. Viral dynamics in human immunodeficiency virus type 1
infection. Nature. 1995;373:117-122.

5. Ho DD, Neumann AU, Perelson AS, Chen W, Leonard JM, Markowitz M. Rapid turnover of
plasma virions and CD4 lymphocytes in HIV-1 infection. Nature. 1995;373:123-126.

6. Ho DD. Time to hit HIV, early and hard. N Engl J Med. 1995;333:450-451.

7. Paaue DS, Wenrich MD, Curtis JR, Carline JD, Ramsey PG. Ability of primary care physicians
to recognize physical findings associated with HIV infection. JAMA. 1995;274:1380-1382.

8. Lewis CE, Freeman HE, Kaplan SH, Corey CR. The impact of a program to enhance the
competencies of primary care physicians in caring for patients with AIDS. J Gen Intern Med.
1986;1:287-294.

9. Bennett CL, Garfinkle JB, Greenfield S, et al. The relation between hospital experience and
in-hospital mortality for patients with AIDS-related PCP. JAMA. 1989;261:2975-2979.

10. Schreiber TL, Elkhatib A, Grines CL, O'Neill WW. Cardiologist versus internist management of
patients with unstable angina: treatment patterns and outcomes. J Am Coll Cardiol.
1995;26:577-582.

11. Jollis JG, DeLong ER, Peterson ED, et al. Outcome of acute myocardial infarction according to
the specialty of the admitting physician. N Engl J Med. 1996;335:1880-1887.

12. Kitahata MM, Koepsell TD, Deyo RA, Maxwell CL, Dodge WT, Wagner EH. Physicians'
experience with the acquired immunodeficiency syndrome as a factor in patients' survival. N Engl J
Med. 1996;334:701-706.

13. American Society of Internal Medicine. Reinventing Managed Care. Washington, DC:
American Society of Internal Medicine; 1995.

14. Kahn JG, Luft H, Smith MD. HIV risk adjustment: issues and proposed approaches. J AIDS
Hum Retrovirol. 1995;8(suppl 1):S53-S66.

15. Wilson IB. Quality of care and HIV infection: theory and practice. J AIDS Hum Retrovirol.
1995;8(suppl 1):S31-S44.

16. Sande M. Health care reform: implications for professions related to infectious diseases. J Infect
Dis. 1994;169:1197-1200.

17. Verghese A. AIDS-ology. Clin Infect Dis. 1993;16:459-462.

18. Soloway B. Primary care and specialty care in the age of HAART. AIDS Clin Care.
1997;9:37-39.

(JAMA. 1997;278:1131-1132)
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