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AIDS Treatment News
AIDS Trestment News
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Glossary
ShareRetroviruses Conference Scholarship Deadline Nov. 3 |
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Requirements: Applicants must 1) be affiliated with a local AIDS treatment organization, 2) be involved in community outreach activities, and 3) have a commitment to share what was learned at the conference. Preference will be given to individuals representing diverse and under- For additional forms (registration/housing, press
credentials, and scholarship applications) and program
updates, contact the Retrovirus Conference 24-hour Fax-on- For questions, contact the Retrovirus Conference Secretariat:
Westover Management Group, Inc., 211 N. Union Street., Suite
100, Alexandria, VA 22314, telephone: 703-684-4876, fax: 703-684-4841, email: info@retroconference.org
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AmFAR RFPs: Immune Reconstitution, HIV VaccinesGrants $75,000 to $150,000
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These grants are only for national or international not-for- For either RFP, the letter of intent consists of the cover
page, abstract, description/research plan of three pages or
less, relevance description (one page maximum), and
biographical sketch (not more than two pages). This "letter"
is a pre- All requests for immune reconstitution grants must be
assigned to one and only one of five topics:
"Exploration of innovative approaches to therapy that
potentially will both control HIV replication and restore or
maintain immune function;
"Role of peripheral lymphoid tissue in selecting antigen- "Innovative mechanisms to enhance T lymphocyte diversity and
function;
"Innovative mechanisms to expand the number and function of
memory and naive T lymphocytes. Research topics could include
the role of specific immunotherapies, including vaccination,
in concert with anti-HIV drugs." The vaccine RFPs must be in one of the following areas:
"Studies of the mechanisms of HIV antigen presentation and
processing that will result in improved methods for enhancing
the cellular and antibody responses to HIV antigens. This may
include studies with novel vectors.
"Studies on the structure and characterization of HIV
antigens that will enhance understanding of immunogenicity,
for example, glycosylation of HIV antigens.
"Small well- Obtain full information and the cover- The original letter of intent and eight copies must be
received by 5:00 p.m. Wednesday November 4, at the AmFAR
grants department in New York City; fax or email copies will
not be accepted.
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Oakland, California: Oct. 22 Panel on Alternative Treatments |
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The panel is scheduled for 6:00 p.m. to 8:30 p.m. Thursday,
October 22, at the African Methodist Episcopal Church, 476 -
34th Street (between Elm and Telegraph), Oakland, California.
For more information, call 510-869-6514.
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Help Wanted, AIDS Treatment Writer, New York |
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The ideal candidate will have a history of writing medical news articles and being familiar with AIDS treatment activism. A demonstrated ability to translate complicated pharmaceutical and medical data into popular language is essential. Salary is in the high 30s. Send applications, including resume, writing samples, and salary requirements, to CJ Bacino, Human Resources Dept., Gay Men's Health Crisis, 119 W. 24th St., New York, NY 10011 (fax: 212/367-1527).
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Nelfinavir (Viracept®) Price Increase 4.6% |
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The probable cause of the price increase is large research
and development costs for new products (the RemuneTM vaccination strategy studies, and experimental antiretrovirals AG 1549 and AG 1776, and an experimental cancer treatment AG 3340) -- plus the unfavorable financial market, which would make it difficult and expensive to raise investment funding for this research if necessary. At this time the company's only marketed product is nelfinavir.
The Johns Hopkins AIDS Service Web site has basic information
on over 160 drugs used in HIV medicine, including prices
(average wholesale price, per pill); the prices are from the
January 1998 edition of the Medi Span Hospital Formulary Pricing Guide. This information also appears in print in 1998
Medical Management of HIV Infection, by John G. Bartlett,
M.D. The Web edition, which will be updated more frequently
than the printed book, is at http://www.hopkins-AIDS.edu; select "Publications," then "Medical Management of HIV Infection." The prices are in Chapter 6, "Drugs: Guide to Information"; the prices are included with the drug listings, which are alphabetical by generic name.
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11th National HIV/AIDS Update ConferenceAbstract Submission Deadline November 1 |
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Association of Nurses in AIDS CareNovember 15-18, San Antonio |
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Cultural diversity will be highlighted at this year's
conference. Sessions listed in the advance program include:
Funding for HIV Care in the Future; Achieving Cultural
Competency in HIV/AIDS Nursing; and The Future of HIV Care -- Community- For more information contact the Association of Nurses in
AIDS Care, 11250 Roger Bacon Drive, Suite 8, Reston, VA
20190. Telephone 703-925-0081, fax 703-435-4390, email
AIDSNURSES@aol.com, http://www.anacnet.org/aids.
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San Francisco: Hepatitis C Community Forum, Oct. 20 |
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Pre-registration is requested, phone 415-923-3155.
A non-profit, physician- |
Cannabis and CannabidiolInterview with Robert Gorter, M.D.by Fred Gardner |
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Fred Gardner: What is your interest in cannabis?
Dr. Gorter: My interest in cannabis goes back to the early
1970s. I studied medicine in Amsterdam in the 1960s and I lived in a commune where almost everybody "blowed" every day -- but I never did. And usually in the middle of the night, people would meet in the kitchen and have fried eggs and snacks; they said that when you smoke, it stimulates your appetite.
When I settled down as an Anthroposophical family practitioner in Amsterdam in 1973, I had many cancer patients in my practice. Many had loss of appetite and severe weight loss. Many older people from Holland had never smoked pot. So we made an oral preparation for them. We grew cannabis in a city park, until it was discovered.
We made an alcohol extract of cannabis, and my patients took
half a teaspoon a day twice a day, and they loved it. Almost
all reported appetite stimulation after about a week. There
was a clear mood elevation -- they felt better. And many
patients who were using opiates for pain control said they
needed much less opiates with small amounts of cannabis. Most
people gained weight, but not all. If patients were close to
dying, weight gain was not seen.
Gardner: For how many years were you treating cancer patients in Amsterdam with cannabis?
Dr. Gorter: From 1973 to 1983. At that time cannabis was also available as an injectable from Weleder, an Anthroposophical company that distributes natural medicines. I've used it as an injectable for backaches and muscle cramps and people with insomnia. But for stimulating appetite the injections did not work well; the patients needed a larger dose, delivered orally.
Gardner: And then you came to UCSF in 1983?
Dr. Gorter: In the Nancy Reagan years, I felt insecure about
telling patients about medical effects of cannabis. But if people asked me, of course I would tell them what I knew. Then, in 1986, Marinol® (dronabinol) was developed, so right away I could prescribe Marinol for appetite stimulation. I have also tried it with patients with chronic pain. But many people had side effects. My patients who had experience with both cannabis and Marinol almost always preferred cannabis, because Marinol had more side effects, including headaches and a hung-over feeling. In 1989 I set up an efficacy trial of Marinol as an appetite stimulant in AIDS patients.
Gardner: What happened?
Dr. Gorter: After a delay it was conducted in Texas. In 1991
Marinol received approval of an additional indication for
appetite stimulation in HIV infection.
In 1992 I took a sabbatical and went to Europe to conduct a
clinical trial of Iscador in HIV patients. To make a long
story short, I was offered an opportunity to establish the
European Institute for Oncological and Immunological Research
in Berlin, and since then I have been flying back and forth.
Gardner: What became of your cannabis-vs.- Dr. Gorter: We decided to start a clinical trial in Europe to study Marinol against placebo and then compare cannabis
against placebo and then cannabis against Marinol for its
efficacy, toxicity and so on. It took me about two years of
lobbying, but then the German government and the Dutch
government agreed that it was time to have these studies
done. Both governments have given me an official okay to
conduct such a trial in about 800 AIDS and cancer patients.
Our institute has developed an oral preparation of cannabis
which we have named Cannador -- from "cannabis" plus
"dor/doron" for gift.
Gardner: You will not be testing smoked cannabis?
Dr. Gorter: For the elderly, in a hospital setting or a
hospice, smoking raises all kinds of problems. And smoking
cannabis is so strongly associated with recreational drug
use, that it is not palatable to people in the government. A
clean, standardized extract works better. Ours will be a
whole-plant extract made from male and female plants, and
standardized for its THC and other cannabinoid contents by
thin-layer chromatography. We will process it in a fatty
medium for packaging in a soft-gel capsule. [Note: THC, or
tetrahydrocannabinol, is the main psychoactive ingredient in
marijuana.]
Gardner: Do the male and female plants have significantly
different components?
Dr. Gorter: Yes. Cannabis contains at least 600 different
components; among them 64 different cannabinoids have been
identified, and everybody agrees that there are more. And
there are 10 times as many other substances. They differ from
year to year depending on the soil, the weather, the degree
of sexual separation, and other factors. The highest
concentration of THC is in the glands of the female plant.
Gardner: Donald Abrams, M.D., told SYNAPSE you were planning
a study in the U.S. involving cannabis and appetite in HIV
patients.
Dr. Gorter: As soon as the German government approved our
protocol I sent it to the FDA, and in September of last year
they accepted us under the Investigational New Drug program.
But one of their pharmacists said "You can never standardize
plant extracts." We said, "Maybe not for all the components,
but for the main components, we can." They wanted more proof
of that, which we have delivered, and they have accepted.
It was decided that we could go straight to a phase III
trial, because so much is known already about safety.
But in February of this year we had a conference call from
the same FDA committee but with a different chair; she said,
"You have to do a phase I trial." We ended agreeing to do a
combined phase I/II trial. I am now raising money for that
trial and hopefully it will be conducted in the spring of
next year. In the late fall we will start with the phase III
trial at 18 universities in Germany, the Netherlands, Austria
and Switzerland. There will be 360 cancer patients and 360
AIDS patients who have lost at least 5% of their body weight
in the last six months, and who are candidates for appetite
stimulation, and have been free of cannabis for at least four
weeks (so we can test the efficacy of our preparation). So
soon we will have both studies running parallel -- a phase III
trial in Europe and a phase I/II in the US. [Phase I tests
toxicity in humans; phase II tries to determine an optimum
dose. Phase III is an efficacy trial against placebo or other
medications -- the key step in obtaining a license to market
the drug. Phase IV trials, conducted after market approval,
involve thousands of patients followed over time to assess
long-term toxicity.]
Gardner: From what source are you obtaining your cannabis?
Dr. Gorter: The cannabis used in the U.S. will come from NIDA [the National Institute on Drug Abuse, which has authorized
Professor Mahmoud ElSohly, a commercial grower employed by
the University of Mississippi, to cultivate marijuana on
their farmland for sale to the federal government.] The
cannabis to be used in Europe will be purchased by the Dutch
government, also from NIDA.
Gardner: NIDA's marijuana is reportedly weak and stale.
Dr. Gorter: I trust ElSohly to provide a suitable product. In any case, the concentrations we get in the extraction process
are what matters, and we can control that.
We will soon start in Amsterdam and in England trials of
Cannador on multiple sclerosis patients.
Gardner: There were references at the International
Cannabinoid Research Society meeting to the immunosuppressant
activity of THC.
Dr. Gorter: Only in high doses in animal studies that do not
correspond to the pattern of human use. After a while you see
a drop of blood pressure and immune dysfunction. Animals are
generally given 125 milligrams of THC per kilogram body
weight. That would be for humans 7 or 8 thousand milligrams
per day. The average amount in a joint is about 10-15
milligrams; so 8 thousand milligrams is beyond every form of
human use.
Dr. Gorter: In Berlin we will develop another form of
Cannador with a much higher content of CBD (cannabidiol), and
do a pilot project on patients with epilepsy. CBD counters,
to some extent, the psychoactive effects of THC.
Gardner: How do you adjust to get a plant heavy on CBD and
light on THC?
Dr. Gorter: You grow plants with high content of CBD. No
problem.
Gardner: Does ElSohly have that kind of sophistication?
Dr. Gorter: We will collaborate and share our expertise.
For more information, you can search the AIDSLINE and MEDLINE
databases free through the World Wide Web, at http://igm.nlm.nih.gov. You can contact Dr. Robert Gorter at the European Institute for Oncological and Immunological Research, email robertgorter@compuserve.com, fax +49-30-315-
744-44.
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California ADAP Alertby John S. James |
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Unfortunately, few California ADAP recipients have been warned in advance that their eligibility is about to expire. Usually they first learn about this when their pharmacist tells them that their prescription was not approved -- and often no one they are working with knows what is going on, or what needs to be done to assure continued drug supply. If your prescription is rejected on the grounds that you are no longer eligible for California ADAP -- even if you have an ADAP card which gives a later expiration date -- you should:
If necessary, PMDC can refer you to an ADAP enrollment center in your area. You can also call the same number 24 hours a day to verify your own eligibility electronically, using your ADAP identification number (which is usually the same as your Social Security number). Use the voicemail to select the electronic verification system. According to the PMDC Pharmacy Provider Manual, a pharmacy which gets a "not eligible" message should call PMDC before turning the patient away. But there is no way to know how often this is done. The rest of this article has background on why the problem has surfaced now, and on the process of applying or re-applying for ADAP.
Background: California ADAPThe Federal ADAP program is run separately by each state, which makes its own rules (subject to Federal regulations). To be eligible to receive prescription drugs under this program, you must have HIV, be a resident of the state, and have income within limits which are set by that state. The drugs which can be covered by ADAP vary tremendously by state. This article applies only to California.
Why Now?California's current blizzard of prescription rejections started on September 1, and became much worse on October 1. There are likely to be many additional rejection notices in November (although a new procedure may handle them more smoothly). By next year this problem will largely correct itself automatically. Why did it happen now? About a year ago California fundamentally changed the administration of its ADAP program. Before, each county (or other ADAP jurisdiction -- for example, the city of Berkeley has its own program, separate from Alameda County in which it is located) was responsible for administering its program. California's ADAP data was kept in about 60 different file formats scattered throughout the state, which usually made it impossible to provide usage statistics quickly enough to project the need accurately when funding decisions were made. And patients had to use the same pharmacy every time. For these and other reasons, California centralized its ADAP program last year. Now a central office (PMDC) maintains the eligibility records for everyone in the program, and tells pharmacists when they can fill prescriptions and be paid for them. Enrollment of patients is still handled at the local ADAP jurisdictions (not by PMDC), but PMDC provides one-day training and certification to the local eligibility workers, so that the process will be uniform throughout the state. ADAP prescriptions can now be filled throughout the state at any California pharmacy which participates in the ADAP program (more than two thirds of them do). Last year all the ADAP jurisdictions were given several months to get their databases to PMDC; the deadline was November 1. Much of the data was in poor condition. If the eligibility expiration date was not available, PMDC was given permission to set this date to one year after the county's records were centralized -- which gave the patient the benefit of the doubt (federal rules require that eligibility be re-established every year.) Now, one year later, those expiration dates are arriving. For example, Berkeley got its records to PMDC early, by September of last year, so eligibility for those clients expired this year on September 1. (Berkeley's ADAP program made a commendable, but rare, effort to notify its clients in advance.) San Francisco had many ADAP clients lose eligibility on October 1, and did not notify them. In many areas, patients will get the rejections from their pharmacies in November. PMDC has estimated that about 1500 to 1800 patients will have prescriptions initially rejected this fall; that is about 15% of the 12,000 to 13,000 who are currently using the system. Persons who signed up for ADAP within the last year, after the centralization of the program, are less affected. They have an ADAP card from the new, centralized system, and this card includes their expiration date, so at least they can mark their calendars and know when it is necessary to re-apply. Before, some counties did not have cards, and some of the cards that did exist were inaccurate. And clients did not receive the new cards when their records were centralized, but only when they re-enrolled in ADAP after that time. Why are California ADAP clients (patients) not notified ahead of time when their eligibility is about to expire, and told what they need to do to remain in the program? There are several reasons. Many have asked not to receive calls or mail from the program, to guard their confidentiality. And PMDC itself is not set up to notify clients, even those willing to be contacted. It does notify the counties and other ADAP jurisdictions, but even San Francisco did not pass this warning on to its clients. Perhaps the best solution would be for PMDC to fax a notice to be provided to the client with their prescription, one month before the eligibility period ends.
California ADAP Hints
Applying or Re-Applying to California ADAPEach enrollment center will use the same 15-page Enrollment Procedures and Guidelines for Determining ADAP Eligibility manual, and will have an eligibility worker trained in its use. Some points to note:
Contacting PMDCIf you are denied eligibility or services which you believe you should receive, the problem can often be resolved quickly by PMDC, the management contractor for the California ADAP. PMDC can be called toll-free at 888-311-7632 (888-311-PMDC), fax 800-848-4241). PMDC is open 9 a.m. to 7 p.m. Monday through Friday, 9 a.m. to 5 p.m. Saturday, and 11 a.m. to 4 p.m. Sunday. (Before calling, you might want to check for additional information at a Web site, http://www.pmdc.org [not available yet as this article goes to press]. The Web site will be more current than this article, and may have answers which will help you understand and state the problem better.) At PMDC, most enrollment problems can be handled by an Enrollment and Eligibility Specialist (select on the main menu of the voicemail). There is also a Pharmacy Technician choice (usually fused by the pharmacist or pharmacy worker). If you are not satisfied with the answer of the eligibility specialist, you can appeal to the Enrollment Eligibility Coordinator (and CFO) of PMDC, Eric Flowers. Choose the Executive Directory submenu on the PMDC voicemail. Pharmacy issues can be appealed to Sylester Flowers, a pharmacist and president and CEO of PMDC.
Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. |
This article was provided by AIDS Treatment News.
