Mount Sinai Journal of Medicine

456 Pages·2001·40.4 MB·English

by  Mount Sinai Hospital (New York, N.Y.)

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JOURNAL
^aOGNT SINAI
OF MEDICINE
VOLUME 68 NUMBER JANUARY 2001
1
CONTENTS
GENERAL ARTICLES
In Memoriam: Fenton Schaffner, M.D. Paul D. Berk, Henry C. Bodenheimer, Jr,
and Franklin M. Klion 2
ClinicalTrials in Developing Countries: A Review of the Moral Issues
Douglas P. Lackey 4
DERMATOLOGY NOTES
AIDS-Related Kaposi's Sarcoma Donald Rudikoffand Mark G. Lebwohl 13
THEME
ISSUE
METHADONE SYMPOSIUM
Herman Joseph, guest editor
Part 2
The Key Extended Entry Program (KEEP): A MethadoneTreatment Program for
Opiate-Dependent Inmates Vincent Tomasino, ArthurJ. Swanson,
James Nolan, and Harry Shuman 14
I.
The Key Extended Entry Program (KEEP): From the Community Side of the
Bridge Bryan M. Fallon 21
continuedinside
SAINT BARNABAS Veterans
HEALTHCARESYSTEM
Affairs
Tl_IIJIp—i" The Mount SinaiJournal ofMedicine is published by the Mount Sinai Medical Center of Mew York and has trie
1 < following affiliates: Veterans Affairs Medical Center, Bronx, MY; EInnhurst Hospital Center, Queens, MY;
_ r>¥lW¥ A ¥ Queens Hospital Center, Queens, MY; Saint Barnabas Health Care System,
/VlCJCIINT S^1I1INAI Livingston, MJ; Mewark Beth Israel Medical Center, Mewark, MJ; Liberty
* * 1/ \i. Healthcare System, Inc., Jersey City, MJ.
JOURNAL OF
MEDICINE
Editor-in-Chief Administrative Assistant
Sherman Kupfer, M.D. Ron Stein
Associate Editors Assistant Editor for Housestaff
Harriet S. Gilbert, M.D. Meredith F. Lash-Dardia, M.D.
Leslie A. Kuhn, M.D.
Philip S. Ledereich, M.D. Assistant Production Assistant
Kenneth V. Lieberman, M.D. Mel Meyer
Assistant Editors
Scott H. Barnett, M.D. Steven Fruchtman, M.D. Lynda R. Mandell, M.D., Ph.D. Henry Sacks, M.D.
J. Hugh Baron, D.M. James N. Gladstone, M.D. Steven Markowitz, M.D. Ira Sanders, M.D.
David H. Bechhofer, Ph.D. James H. Godbold, Ph.D. BernardMehl, D.PS. Martin H. Savitz, M.D.
Constantin A. Bona, M.D.. Ph.D. Richard S. Haber, M.D. Myron Miller, M.D. HarrySchanzer. M.D.
Edward J. Bottone, Ph.D. Moam Harpaz, M.D. Richard Panush, M.D. StuartC. Sealfon, M.D.
James L. Breen, M.D. Tomas Heimann, M.D. Barbara E. C. Paris, M.D. Michael Serby, M.D.
Donald Brief, M.D. Fred M. Jacobs, M.D., J.D. JeromeG. Porush, M.D. Janet B. Serle, M.D.
Daniel Buchbinder, D.M.D, M.D. SheldonJacobson, M.D. Georges R. Ramalanjaona, M.D., D.Sc. Phyllis Shaw, Ph.D.
Lewis Burrows. M.D. BarryW. Jaffin, M.D. Elliot J. Rayfield, M.D. Alex Stagnaro-Green, M.D.
Christopher P. Cardozo, M.D. Joseph L. Kannry, M.D. Allan Reed, M.D. Barry D. Stimmel, M.D.
Mark R. Chassin. M.D., M.P.H., M.P.P. Suzanne Carter Kramer, M. Sc. Gregory J. Rokosz, D.O., J.D. Nelson N. Stone, M.D.
William H. Constad, M.D. Mark G. Lebwohl, M.D. Joshua Rosenblatt, M.D. Max Sung, M.D.
Joseph S. Eisenman. Ph.D. Zvi Lefkovitz, M.D. Clive Rosendorff. M.D., Ph.D. Jules A. Titelbaum, M.D.
RichardA. Frieden, M.D. Dana M. Lewis, M.L.S. Fred Rosner, M.D. ThomasA. Oilman, M.D.
Frederick Friedman, M.D. Tariq K. Malik, M.D., M.P.H. Allan E. Rubenstein, M.D. RichardP. Wedeen, M.D.
Editorial Board
BBaarrrryy SS.. CCoolllleerr,, MM..DD.. Charles K. McSherry M.D. Arthur H. Rubenstein, M.B.B.Ch. Alvin S. Teirstein, M.D.
BBaarrrryy FFrreeeeddmmaann,, NM.\B..BAJ. Jack G. Rabinowitz, M.D. Alan L. Schiller, M.D. Rosalyn S. Yalow, Ph.D.
Panayotis G. Katsoyannis, Ph.D.
TheMountSinaiJournalofMedicine (ISSM No. 0027-2507; USPS 284-860) is published 6 times a year in January, March, May Septembei
October, and November in one indexed volume by The Mount Sinai Medical Center, Box 1094, One East 100th Street, New York, NY 10029
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One East 100'"Street, NewYork, NY 10029-6574.
THE
MOGNT JOGRNAL
SINAI
Number
OF MEDICINE 1
Ja„uarv20«l
CONTENTS
continued
Integrating the Methadone Patient in theTraditional Addiction Inpatient
—
Rehabilitation Program Problems and Solutions Steven S. Kipnis,
Anne Herron, John Perez, and Herman Joseph 28
An Alternative Program for Methadone Maintenance Dropouts: Description
and Preliminary Data Marjorie F. Goldstein, Sherry Deren, Marl< Beardsley,
and Beverly L. Richman 33
A Mandatory Short-Term Methadone-to-Abstinence Program in NewYork City
Charles Winick 41
Analysis of Behavioral Patterns in Five Cohorts of Patients Retained in
Methadone Maintenance Programs Alan Kott, Eric Habel,
and William Nottingham 46
Selected In-Treatment Outcomes of Long-Term Methadone Maintenance
Treatment Patients in NewYork State Philip W. Appel, Herman Joseph,
Alan Kott, William Nottingham, Edward Tasiny and Eric Habel 55
Leaving MethadoneTreatment: Lessons Learned, Lessons Forgotten,
Lessons Ignored Stephen Magura andAndrew Rosenblum 62
Methadone Advocacy:TheVoice of the Patient Jocelyn Woods 75
Information for Authors
i
Required Form for Authors C3
The Journal thanks Boehringer Ingelheim Roxane Laboratories and
Mallinckrodt for educational grants in partial support ofthe cost of
pubHcation ofthe methadone theme articles listed above.
Memoriam:
In
Fenton Schaffner, M.D.
December 8, 1920-January 24, 2000
r
Dr. Fenton Schaffner.
Dr. Fenton Schaffner, an internationally with Hans Popper that lasted for four decades and
renowned hepatologist who made pioneering brought hepatology to the forefront of the
discoveries in the field of liver diseases and was intellectually active disciplines of medicine.
a distinguished member of the Mount Sinai Following his friend and colleague, who had been
community for more than forty years, died at appointed to the directorship ofthe Department of
his home in Washington, Connecticut, on Pathology at The Mount Sinai Hospital, Dr.
January 24, 2000. Schaffner accepted a position at Mount Sinai, in
Born in Chicago, Dr. Schaffner earned BS and 1958, to establish the Division of Liver Diseases
MD
degrees at the University of Chicago and an and to serve as its first director. Mount Sinai
MS degree from Northwestern University. After opened its medical school in 1968, and Dr.
serving as a physician in the United States Navy, Schaffner was among its first distinguished faculty
he returned to Chicago, where he joined the members. During his exceptional career at the
faculty of Northwestern University School of Mount Sinai School of Medicine, he held full
Medicine and practiced internal medicine. He also professorships in both medicine and pathology,
began an extraordinarily productive collaboration and was acting chairman of the Department of
2 ©TheMountSinaiJournalofMedicineVol.68No. 1 January2001
Vol. 68 No. 1 IN MEMORIAM: FBNTON SClIAM NliK, M.D. 3
Medicine from 1972 to 1974. Dr. Schaffner scene, he was one of the founders of ALF's
was named the George Baehr Professor of highly successful Greater New York Chapter.
Medicine in 1973 and held that distinguished The Chapter honored him in 1997 with the
chair until his retirement in 1991. Mary Lea Johnson Richards Research Institute
Dr. Schaffner was an astute clinical Award.
observer, and his extensive clinical practice was The author or co-author of more than 4(){)
the source of many of his insights, which were papers and books. Dr. Schaffner was recognized
amplified by his expertise in light and electron as an exceptional educator, teacher, and
microscopy. Although his clinical knowledge innovator in the study of liver diseases. His
was virtually encyclopedic, he was especially devotion to the dissemination of knowledge and
interested in primary biliary cirrhosis, chronic specifically to the education of physicians was
hepatitis, and hepatic injury from drugs, areas exemplified by his role in co-editing the classic
to which he made important scholarly series Progress in LiverDiseases over a 29-year
contributions. A clinician-scientist, he never period. He was also appointed one of the first
lost sight of the primary responsibilities of a associate editors of Seminars in Liver Disease
physician. His commitment to patient care was when that journal was founded in 1980,
evident in his extraordinary devotion to each of participated regularly in its annual editorial
his patients. A master clinician who attended to board meetings for two decades, and remained
the needs of individual patients from around the active in this capacity virtually until his death.
world, he was also devoted to advancing the Dr. Schaffner's legacy, however, is not
delivery of quality health care and held the measured solely by the extraordinary volume of
position of governor of the New York his scholarly contributions. It survives in the
Downstate Chapter of the American College of many fellows whom he trained, and who now
Physicians. represent a community of senior hepatologists
As a founding member of the American both at Mount Sinai and around the world.
Association for the Study of Liver Diseases Dr. Schaffner is survived by his wife,
(AASLD) and an early supporter of the Rosanne Kerby Schaffner, and four children,
International Association for the Study of the Roberta Schaffner of Dallas, Texas, Dr. John
Liver, Dr. Schaffner's impact on the field of Schaffner of Rochester, Minnesota, Dr. Andrea
hepatology has been global and enduring. He Schaffner of Madison, Connecticut, and Marjorie
served as secretary ofAASLD for fifteen years Schaffner of Chicago. Illinois. He is also
and was elected its president in 1976. He was survived by five grandchildren, and a brother,
also a vigorous supporter of the American Gerald Schaffner of San Diego, California.
Liver Foundation (ALF). His early support and
leadership came at a critical time in the
MD
evolution ofALF, and continued throughout his Paul D. Berk,
MD
life. Working to bridge the inter-institutional Henry C. Bodenheimer, Jr.,
rivalries that had characterized the New York Franklin M. Klion, MD
Clinical Trials in Developing
Countries:
A Review of the Moral Issues
Douglas P. Lackey, Ph.D.
Abstract
Several ethicists have raisedcriticisms ofvarious placebo-controlled clinical trials conducted in devel-
oping countries between 1995 and 1998. Thisessayreviews andrejects theargumentsthatthesetrials
violated basic canons ofmedical ethics, orconstituted exploitation by scientists in advanced countries
ofsubjects indevelopingcountries. Auniform international standardfortheevaluationofsuchtrialsis
proposed, replacing the old standard ofvoluntary and informedconsent with a more focused standard
ofuncoercedandundeceivedconsent.
KeyWords: Clinicaltrials,developingcountries,moralissues,ethics.
The September 18. 1997 issue of The New therapies to block transmission of HIV from
England Journal of Medicine exploded like a mother to child. Expectant mothers in active
bombshell over the medical ethics community. trial arms got azidothymidine (AZT); expectant
Not since Harry Beecher's assault in 1966 on mothers in placebo arms got nothing. Had the
the ethics of clinical research scientists (1) had trials been conducted with two active arms, it
such accusations been hurled about on those was charged, hundreds of cases of infant HIV
cream-colored pages. The subject in question infection could have been prevented. For
was the conduct of fifteen clinical trials in physicians to permit such events seemed to
developing countries (2-5), trials that typically violate elementary canons of human morality.
included a placebo arm. Critics charged that The "Sounding Board" case for the
patients in placebo arms had been denied prosecution was made by Drs. Lurie and Wolfe
needed medical treatment, contrary to medical from the Public Interest Health Research Group
ethics and to international conventions (6); the ethics of the trials was defended (two
governing such studies. The article presented weeks later) by Drs. Varmus and Satcher from
the spectre of Western scientists looking for the NIH and the CDC (7). The New England
quick publication and Western drug companies Journal of Medicine itself, which might have
looking for quick profits, of exploitation of been expected to maintain some neutrality
weak governments and impoverished people by between the warring camps, assigned an editorial
the strong and heartless. The most disturbing to Associate Editor Marcia Angell, who weighed
charges were pressed vis-a-vis trials for new in heavily on the side of Lurie and Wolfe (8).
Angell compared the controversial trials to the
Tuskeegee syphilis study (9, 10), suggesting that
Address correspondence to Douglas P. Lackey, Ph.D., Professor. researchers conducting the trials were engaged
DepartmentofPhilosophy, BaruchCollegeandtheGraduateCen- in acts of racist condescension (11).
ter, City University ofNew York, Baruch College, Box 1437 G, The controversy subsided somewhat in
17LexingtonAvenue, NewYork,NY 10010. 1998, when most of the AZT studies ended,
Adapted from a presentation made at the Oxford-Mount
.Sinai-King'sCollegeConferenceon BioethicsatTheMountSinai with hasty proclamation of successful results
SchoolofMedicine,NewYork,NYonApril 14. 1999. (12). Through 1999, further controversy
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