dmcanzi@watdcsu.waterloo.edu (David Canzi) (10/11/89)
Volume 2, Number 37 October 9, 1989
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Editor: David Dodell, D.M.D.
St. Joseph's Hospital and Medical Center
10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA
Telephone (602) 860-1121
Copyright 1989 - Distribution on Commercial/Pay Systems Prohibited without
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Medical News
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Medical News for Week Ending October 8, 1989
Copywrite 1989: USA TODAY/Gannett National Information Network
Reproduced with Permission
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Oct. 2, 1989
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AIDS TRANSMITTED BY ORAL SEX:
Gay and bisexual men have become infected with the AIDS virus through oral
sex, reports San Francisco's Health Department. Facts: Two documented cases.
Also, a report says the HTLV One virus, related to AIDS virus, is spread more
commonly from men to women, but men with other venereal diseases can be
infected by women.
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Oct. 5, 1989
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BLOOD SUPPLY SAFER:
The nation's blood supply is safer, said American Red Cross researchers.
Odds of getting blood tainted with the AIDS virus from a transfusion were down
to one in 28,000 by 1987 and continue dropping. That's lower than the federal
Centers for Disease Control's best estimate that one in 40,000 units contains
the virus. (From the USA TODAY Life section.)
NEW FORMULA FOR AIDS DRUG:
Burroughs Wellcome Co. expects to market a strawberry-flavored syrup
version of its anti-AIDS Retrovir brand zidovudine (formerly AZT) in 4 to 6
weeks. Reason: Flexibility in adjusting dosage, better for patients who have
difficulty swallowing capsules due to lesions in the throat, mouth. The syrup
is bioequivalent to Retrovir capsules.
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Oct. 6-8, 1989
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DRUG STOPS AIDS REPRODUCTION:
Acemannan inhibits replication of the AIDS virus when given in vitro to
blood cells of healthy subjects who've taken oral doses of the drug, according
to a study presented Wednesday at the International Symposium on Antiviral
Chemotherapy. The drug is being tested under the Food and Drug
Administration's investigative new drug exemption.
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Center for Disease Control Reports
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CDC CALENDAR OF MAJOR EVENTS
Rev. Aug. 4, 1989
(For more information, contact Iris Lansing, 404/639-3243)
[This is a selected subset of the events listed -- DMC]
1989
August 13-17 National Conference on HIV Infection and AIDS Among Racial
and Ethnic Populations; Wash., DC
September 6-8 National Pediatric AIDS Conference, Fifth Annual, &
September 8-9 Followup Workshop; Los Angeles, CA
November 12-17 2nd Pan-American Congress on AIDS; Santo Domingo, Dominican
Republic
November 19-21 4th National Forum on AIDS & Hepatitis B; Wash., DC
1990
June 17-20 1990 National STD Conference; San Francisco, CA
June 19-23 VI International Conference on Acquired Immunodeficiency
Syndrome; San Francisco, CA
1991
June 16-21 VII International AIDS Conference; Florence, Italy
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Food & Drug Administration News
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News from the Food and Drug Administration
ddl
P89-40 Elaine Baldwin/NIAID
FOR IMMEDIATE RELEASE (301) 496-5717
Sept. 28, 1989 Brad Stone/FDA
(301) 443-3285
Secretary of HHS Louis W. Sullivan, M.D., today announced that the Food
and Drug Administration (FDA) and the National Institutes of Health (NIH) have
developed a comprehensive plan for clinical evaluation and expanded
availability of ddI (dideoxyinosine). This promising antiviral agent has
shown activity against the AIDS virus in laboratory studies and in limited
human studies although in some persons there have been potentially serious
side effects. Under this plan, clinical trials designed to determine the
safety and effectiveness of ddI will be conducted by the AIDS Clinical Trials
Group (ACTG) of the National Institute of Allergy and Infectious Diseases
(NIAID) in collaboration with the drug manufacturer, Bristol-Myers Company of
New York. These clinical trials will enroll approximately 2,600 persons with
AIDS or AIDS related complex (ARC). Simultaneously, the FDA has granted
Bristol-Myers permission to distribute ddI through a Treatment IND
(investigational new drug) for patients with AIDS or advanced ARC who cannot
take zidovudine (commonly called AZT) because of serious drug toxicity. The
FDA has also granted the company permission to distribute ddI under an open
safety protocol for AIDS patients whose disease has substantially progressed
despite zidovudine therapy and who have no other treatment options.
"This plan offers some additional options for people with AIDS, and
particularly for the thousands of AIDS patients who cannot tolerate therapy
with AZT," Dr. Sullivan said. "This plan for expanded testing and earlier
availability of ddI, developed through the cooperation of several Public
Health Service agencies and Bristol-Myers, reaffirms our commitment to
speeding both the development and the availability of promising new drugs for
patients with AIDS whenever possible."
Assistant Secretary for Health James O. Mason, M.D., Dr.P.H., commended
FDA and NIH for their work in developing and implementing these protocols for
ddI. "This successful collaboration among FDA, NIH, and Bristol-Myers is
indicative of the Public Health Service's continuing efforts to combat AIDS,"
he said.
HHS is developing procedures to expand availability of investigational
therapeutic agents through a parallel track mechanism. Today's announcement
that ddI will be available through a Treatment IND and open safety protocol is
consistent with the parallel track concept and is an interim measure to make a
promising investigational therapy available for people with AIDS who do not
have satisfactory treatment options.
Dideoxyinosine, which was initially developed by Samuel Broder, M.D., and
Robert Yarchoan, M.D., at the National Cancer Institute (NCI), is one of a
group of drugs, including zidovudine, that inhibit replication of the AIDS
virus. Phase 1 safety trials of ddI were recently completed by NCI and ACTG
investigators at the University of Rochester and New York University.
These studies showed that, while ddI appears promising, it has toxicities
related to the dose taken; thus, its use requires careful monitoring.
Although studies reported earlier this year indicated that ddI could be
tolerated by most AIDS patients, more recent data indicate that some patients
taking ddI, particularly at higher doses, have experienced painful nerve
damage to the feet and, less commonly, damage to the pancreas. These
toxicities appear to be reversible if detected early and if the drug is
discontinued. The protocols announced today take these most recent data into
account by selecting doses that appear to be well tolerated and have evidence
of activity against the AIDS virus.
Despite the promising early results with ddI, it is important to emphasize
that zidovudine is the only drug with proven efficacy for the treatment of
patients with AIDS and advanced ARC.
Three Phase 2 clinical trials of ddI in people with AIDS and ARC will be
conducted by NIAID's nationwide network of ACTG units. The studies are
designed to provide definitive data on whether the drug is useful in treating
patients with AIDS or ARC. Protocol 116 will be a randomized, double-blind
comparison of ddI and zidovudine in 1,500 persons, 900 of whom have had little
or no previous treatment with zidovudine and 600 of whom have taken zidovudine
from 2 months to a year. Protocol 117 will compare ddI and zidovudine in 750
persons who have been on zidovudine for at least 1 year. Protocol 118, which
will include 360 persons with AIDS and ARC who cannot take zidovudine because
of serious drug toxicity, will compare 3 different doses of ddI.
Results of the Phase 1 studies served as the basis for granting Treatment
IND status. The Treatment IND mechanism was established by FDA to allow
patients suffering from serious or life-threatening conditions for which there
is no satisfactory treatment to obtain promising experimental drugs while
research continues.
Under the Treatment IND, AIDS patients who have experienced severe anemia
or other dose-limiting adverse reactions to zidovudine will be eligible to
receive ddI through a program administered and funded by Bristol-Myers. The
patients on this protocol will be monitored by their physicians for evidence
of toxicity also.
In addition, an open safety protocol sponsored by the company, will allow
ddI to be studied in AIDS patients whose disease has progressed substantially
despite zidovudine therapy. Entrance criteria for the protocol will continue
to be evaluated, and appropriate adjustments made, as data are accumulated,
and more information on safety and efficacy becomes available.
The operation of the clinical trials, Treatment IND, and open safety
protocol will be closely monitored so that the most current information about
the drug is provided to patients, physicians, and researchers. The
continuation of the Treatment IND and open safety protocol depends on
satisfactory results with respect to the drug's safety and efficacy as well as
adequate enrollment in the clinical trials.
Although Bristol-Myers is not charging for the cost of the drug in any of
these programs, there are likely to be physician and laboratory charges
associated with receiving ddI through either the Treatment IND or open safety
protocols.
FDA Commissioner Frank E. Young, M.D., Ph.D, said, "The epidemic of AIDS
is extraordinary, and must be met with extraordinary measures. Since ddI is
still an experimental drug, it must be tested carefully and must demonstrate
safety and efficacy before it can be approved. We believe, however, that it
is important to offer the drug now to people with AIDS for whom the standard
treatment of zidovudine is not an option even though there are some
potentially serious side effects."
Anthony S. Fauci, M.D., NIAID Director and Associate Director for AIDS
Research at the NIH, said, "I am pleased that ddI will be entering Phase 2
clinical trials to determine definitively its efficacy in people with AIDS and
ARC, and to gain further information regarding safety and optimal dosage. In
addition, it is appropriate that simultaneously the drug is being made more
widely available to those individuals who cannot take AZT or whose disease has
substantially progressed despite AZT therapy."
Physicians, patients, and others interested in the clinical trials,
Treatment IND or open safety study can call 1-800 TRIALS-A, a toll-free
service offering information about AIDS clinical trials from 9 a.m. to 7 p.m.,
Eastern Time, Monday through Friday.
Physicians interested in details of the Treatment IND and open safety
protocol can call the Bristol-Myers toll-free number at 1-800-662-7999 daily
from 8 a.m. to 8 p.m., Eastern Time. The company will immediately begin
processing applications from physicians for their patients for the Treatment
IND and open safety protocol. Bristol-Myers estimates that physicians with
patients eligible for participation in these protocols should begin to receive
the drug in about 2 weeks.
--
David Canzi