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AIDS Treatment News
November 15, 1996

Contents:

  1. Birmingham UK Drug Therapy Conference -- Early Report
  2. Federal Team Developing Treatment Principles for HIV Infection
  3. 1592: Two Studies Recruiting
  4. The New Antiretroviral Arsenal
  5. Medical Marijuana Wins in California and Arizona
  6. FDA Internet Regulation? Public Comment Accepted until December 16
  7. AZT Twice-Daily Tablets Approved; Dosing Concerns
  8. Retroviruses Conference: Press Deadline December 6
  9. Qigong Program on San Francisco KQED TV, Beginning December 7

Birmingham UK 
Drug Therapy Conference 
-- Early Report

by John S. James
The important 3rd International Congress on Drug Therapy in HIV Infection took place in Birmingham, UK, November 3-7; we could not attend and are still gathering information as we go to press November 12. There was much interest in studies relevant to the complete suppression of HIV replication by drugs.

A small but widely discussed study at the University of Amsterdam found that antiviral treatment which reduced viral load to undetectable levels in the blood, also reduced viral load to undetectable levels in lymph tissue. This was found in six out of six patients in a substudy of a larger trial. The lymph tissue was taken by a biopsy of the tonsils (which is much less invasive than the conventional procedure of removing a lymph node), before starting treatment and again after six months of treatment.

Researchers at the University of Minnesota developed the methodology to measure HIV in lymph tissue from tonsils; see recent paper by Haase AT, Henry K, Zupancic M and others, "Quantitative Image Analysis of HIV-1 Infection in Lymphoid Tissue," SCIENCE, November 8, 1996, pages 985-989.

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Undetectable HIV viral load in the lymph nodes does NOT mean that the virus has been eradicated -- only that it is not actively reproducing. This viral load test only looks for viral particles; it does not detect the viral DNA that is still in the patients' cells -- ready to start up the infection again if the drugs are stopped. No one knows whether or not all these cells will eventually be eliminated by the body, if replication can be stopped for long enough.

While the growth of the virus is being completely suppressed, drug resistance apparently does not develop. The virus develops resistance when it is able to reproduce to some degree in the presence of the drugs, since then the viral variants which happen to be resistant to those drugs have a selective advantage, and can replace the more susceptible virus.

These results are not surprising, as there have long been indications that if viral replication is being suppressed in the blood by antiretroviral drugs, it is also suppressed in the lymph nodes (where there is much more HIV than in the blood, and where the virus is more important in the development of disease). And no one would expect the drug resistance of the virus to increase if the virus is not reproducing. But it is important to get direct evidence, since these questions are central to the interpretation of viral load tests and the management of therapy.

Note: The drug combination used in this University of Amsterdam study was ritonavir, AZT, and 3TC, in volunteers who had not used any antiretroviral before. However, there is nothing special about this particular combination; all evidence suggests that what is important is reducing the viral replication essentially to zero and keeping it there, using whatever drugs can do so for a particular patient. Similar suppression of replication has also been achieved with other combinations using a different protease inhibitor -- or even no protease inhibitor at all.

The main problem now is that some patients are more difficult to treat -- especially those with more advanced HIV disease, those who have already developed resistance to existing antiretrovirals, and those who cannot tolerate the drugs. This is why the problem of HIV treatment is not solved, despite the good results in some people. We need continuing development of better drugs -- with stronger and more durable antiviral effects, and/or less toxicity, and/or different resistance profiles than existing treatments, and/or drugs which may not be superior on the average but do work for some people when others treatments do not. And then of course there are still the economic barriers of getting effective treatments to those who need them.

More work is also needed on measurement of HIV in lymph tissue, since the most sensitive tests are quite difficult to do at this time.

There has long been an ongoing debate about the importance of aiming specifically for complete suppression of viral replication, vs. being willing to compromise on partial suppression due to practical concerns of toxicity, cost, and onerous compliance with regimens of three drugs or more. Professional opinion now seems to be moving more strongly toward the importance of complete suppression whenever antiviral therapy is used, because of the danger that otherwise the patients' virus will develop resistance to the drugs one by one, and each drug in turn will be lost for that person. This probably means that when therapy is begun, it will usually be with three or more drugs started together (instead of starting with one or two, then adding other drugs when the first ones fail); those who have already used antivirals will need to start or add combinations of at least two new drugs they have not seen before. What counts is keeping the viral load essentially at zero, whatever treatment that requires, because otherwise the virus will eventually escape the control of the drugs.

Extending and applying these principles to the treatment of many different patients in different situations, given the limitations of the drugs available and the practical limitations imposed by the difficulties of therapy, will be a central challenge in AIDS medicine for the next several years.


Federal Team Developing 
Treatment Principles 
for HIV Infection

by John S. James
The Office of AIDS Research (OAR) of the U.S. National Institutes of Health has selected a panel "to make recommendations regarding initiation of treatment; suppression of HIV replication; minimizing or preventing emergence of drug-resistant HIV variants; prolonging effectiveness of therapy; and addressing the public health consequences of transmission of multi-drug resistant variants."

"The panel's activities will involve a series of meetings and analysis of the most recent available data. The panel is expected to work over the next several months to develop these recommendations, which will help health care practitioners and HIV-infected individuals make informed decisions about treatment options. It is also anticipated that the recommendations of this panel will assist public and private health care payers in providing reimbursement for essential care for HIV-infected patients."

The "NIH Panel to Define Principles of Therapy of HIV Infection" has 24 members and is chaired by Charles Carpenter, M.D., of Providence, Rhode Island; its executive secretary is Mark Feinberg, M.D., Ph.D., of OAR. There are two community representatives: Dawn Averitt, of Women's Information Service & Exchange (WISE) of Atlanta, and Mark Harrington of Treatment Action Group (TAG) of New York. Three panelists are from Europe and Australia, with most of the U.S. members from the East Coast.

The panel's first meeting is November 13 and 14 in Washington, during which the panelists will hear more than 30 presentations on the current state of scientific knowledge, focusing mainly on recent information learned too late for presentation at the Vancouver international conference in July.

The meeting occurs after this issue of AIDS Treatment News goes to press, and OAR does not plan to issue a report of this particular meeting (clearly there will be a report from the panel eventually). But the list of presentations (from the draft agenda released by OAR) gives an excellent overview of the state of the science today, of some of the issues considered most relevant to designing the best possible treatments for HIV disease. The titles are listed chronologically from a November 11 draft agenda, but because of lack of space we did not include the names and affiliations of the presenters.

Wednesday November 13, 1996:

Session I: Virus and T Cell Population Dynamics in HIV Infection

  • HIV Replication Dynamics: Virus Turnover and Implications for Antiviral Therapy
  • Analysis of Tissue Reservoirs of HIV Infection
  • Human T Cell Populations in HIV-Infected and Uninfected Individuals
  • Regenerative Potential of Human T Cell Populations
  • Natural History of T Cell Depletion in AIDS
  • Maintenance and Loss of T Cell Homeostasis in HIV Infection
  • T Cell Replication Senescence in HIV Infection

Session II: The Relationship Between HIV Replication and Disease Progression

  • Performance Characteristics and Variability of the Quantiplex (bDNA) Assay for Plasma HIV-1 RNA
  • Performance Characteristics and Variability of the Amplicor (RT-PCR) Assay for Plasma HIV-1 RNA
  • Primary HIV-1 Infection and the Establishment of the Replication "Set Point"
  • Serum HIV-1 RNA Levels and Progression to AIDS
  • Relationship between Plasma and Cellular HIV-1 RNA Levels and Progression to AIDS
  • Population-Based Studies of Plasma HIV-1 RNA Levels
  • Plasma HIV-1 RNA Levels Predict Risk of Disease Progression and Survival

Section III: Relationship between Therapy-Induced Decreases in HIV-1 Replication and Protection from Disease Progression

  • Correlation Between Decline in HIV-1 RNA Levels and Clinical Outcomes (2 presentations)
  • Cross-Study Comparisons of Therapy-Induced Changes in Viral Load, CD4 T Cell Counts and Clinical Progression

Thursday November 14, 1996:

Session IV: Therapy-Induced Changes in CD4 T Cell Levels and Recovery of Immunologic Function

  • The Magnitude and Limits of Therapy-Induced CD4 Cell Increases
  • Recovery of T Cell Numbers and Function Following Antiviral Therapy

Session V: Strategies to Delay or Prevent Antiviral Drug Resistance

  • Understanding and Overcoming HIV-1 Antiviral Drug Resistance
  • Combination Antiviral Therapy and Antiviral Drug Resistance
  • Detection of Drug-Resistant HIV Variants (2 sessions)

Session VI: Protease Inhibitors Resistance and Cross Resistance

  • HIV-1 Protease Inhibitors Resistance (2 sessions)

Session VII: Combination Antiviral Therapy of Established HIV-1 Infection

  • Combination Therapy of Primary HIV-1 Infection
  • Antiviral Therapy of Primary HIV-1 Infection
  • Combination Nucleoside Analog Therapy
  • Combination Nucleoside Therapy: Recent Experience and Future Prospects
  • Combination Therapy and Non-Nucleoside RT Inhibitors
  • Long-Term Suppression of HIV-1 Replication by Combination Therapy
  • Recent Results with Protease Inhibitors
  • New Antiviral Therapies (2 presentations)
  • Closing Remarks


1592: Two Studies Recruiting

1592U89, usually called 1592, is an experimental nucleoside analog drug (in the same class as AZT) with much community interest, for several reasons. First, research has shown that under some conditions at least, it can produce a 2-log (100 fold) viral reduction with just one drug. Also, it has good penetration of the blood-brain barrier, suggesting potential use for treating AIDS-related dementia. And a third reason for the intense interest is that 1592 is a new possible treatment for persons who do not have other options.

[Note: On November 12 THE WALL STREET JOURNAL published a major article on 1592, "Why Isn't Glaxo's New AIDS Drug Ready Yet," by Michael Waldholz, page B1; it asks why 1592 has been in research much longer than other new AIDS drugs but is not expected to be marketed until almost two years from now, and is not being made available through expanded access for those with no other treatment options. Activists suspect that the drug is being delayed to avoid competing with AZT and 3TC; Glaxo says it did not know until about a year ago how much more powerful this drug is than others. It is remarkable how Glaxo's arguments against expanded access resurrect those that were used years ago against other AIDS drugs, and long ago abandoned.]

Glaxo Wellcome is now running two preliminary trials of 1592:

Protocol 2003

This trial will test the antiretroviral activity of 1592 in 40 persons nationally who are already using certain approved nucleoside analog drugs. Forty persons will be enrolled in this study, and all will receive the same dose of 1592 (300 mg orally twice a day), in combination with other nucleoside analogs. There is no placebo. In order to enter this study, volunteers must be at least 13 years old, must have a CD4 count of at least 100, and must have a viral load of at least 30,000.

But there are complex entry criteria based on pre-existing antiretroviral therapy; for example, anyone who has used a protease inhibitor, or a non-nucleoside reverse transcriptase inhibitor (e.g. nevirapine) is ineligible. In order to enter this study, a person must fit in at least one of the four following categories:

  • At least 12 months of AZT monotherapy;
  • At least 6 months of 3TC and 12 months of AZT;
  • At least 6 months of ddI monotherapy;
  • At least 6 months of d4T and 12 months of AZT.

Anyone who has had other antiretroviral treatments is not eligible for this trial.

The trial is being run in eight cities; we list the state, city, study coordinator, institution, and phone number at each site. For more information, call the contact person listed:

  • California: Greenbrae (Alison Clayton, Marin County Specialty Clinic, 415/499-7377);
  • California: Los Angeles (Scott Brooks, Kraus Medical Partners, 213/930-2324);
  • California: San Francisco (Debbie Hildebrandt, ViRx, Inc., 415/353-5623 or 415/474-4440);
  • Florida: Ft. Lauderdale (Keith Huber, R.N., North Broward Hospital District, 954/467-3006 ext. 240);
  • Florida: Maitland (Neena Griffin, R.N., Central Florida Research Initiative, 800/868-3483 ext. 3, or 407/647-3960);
  • Georgia: Atlanta (Laura Ray, AIDS Research Consortium of Atlanta, 404/876-2317 ext. 329);
  • Kentucky: Lexington (Karen Meekins, R.N., University of Kentucky Medical Center, 606/323-3933);
  • New York: New York (Ann Marshak, Beth Israel Medical Center, 212/420-4519).


Protocol CNAB3001

This is a 90-patient phase III study for persons with HIV- associated dementia. Volunteers will be able to continue their current antiretroviral treatment in most cases, and will be randomized to receive 1592 or placebo for 12 weeks. After the 12 weeks, all participants will receive 1592 for 40 weeks. The dose of 1592 used in this study is 600 mg twice a day.

To be eligible, persons must be between 18 and 65 years old, and must have been stable on their current antiretroviral treatment for at least six weeks. There are a number of exclusion conditions, especially for certain abnormal laboratory tests, or for certain unrelated illnesses.

For more information, call the contact person at a site which you could attend:

  • Baltimore (Tish Nance, 410/955-7464);
  • Chapel Hill (Wendy Robertson, 919/966-6727);
  • New York - Columbia University (Ronda Freedman-Clouse, R.N. 212/960-2230);
  • New York - Mt. Sinai (Jessica Moise, 212/241-0784);
  • San Diego - (Mary Anne or Mary McCarthy or Dr. Stephen Brown, 619/543-5059);
  • San Francisco (Dr. Richard Price, 415/206-3208);
  • St. Louis (Meridith Glicksman, 314/362-9733).


The New 
Antiretroviral Arsenal

by Denny Smith

In less than one year, the options for managing HIV have more than doubled. The number of drugs approved to treat HIV infection has risen to nine, with two others now available to qualifying persons under expanded-access programs. We prepared this quick guide to help people orient themselves to the various drugs and their different names; these brief descriptions could not possibly be complete, and people with HIV must work with their physicians to be aware of the different possible side effects, and the other instructions which are essential for using these treatments correctly.

Generally no anti-HIV drug should be used alone, given the ease with which HIV develops resistance. Some drug combinations have been proven more effective--or have fewer side effects--than others. But much is still unknown about combination therapy, and most people must experiment intelligently with different combinations to see what will keep both their viral load and treatment-related toxicities as low as possible.

Most clinicians we know are now making treatment recommendations based on drug tolerance and viral load, rather than CD4 cell counts. The CD4 count is now used largely for deciding when to use prophylaxis therapies to prevent opportunistic infections.

We have listed the reverse transcriptase inhibitors first, followed by the protease inhibitors, followed by hydroxyurea, which was originally developed as an oncology drug, but which may work in a unique manner against HIV. Important note: The side effects described for each entry below are only the most common or important ones. Physicians and patients should always be prepared for other toxicities, which are described at length in the product inserts available at any pharmacy.

Reverse Transcriptase Inhibitors

These drugs work by inhibiting an enzyme -- reverse transcriptase -- which the virus needs to replicate.

  • AZT, also called zidovudine, is marketed under the brand name Retrovir(R). AZT has been combined with all other antiretrovirals and may work especially well in combination with 3TC, indinavir, nevirapine or delavirdine. AZT is valuable for treating cognitive problems caused by HIV because it penetrates the central nervous system better than most of the other drugs. It can cause headaches and stomach upset, but these often go away after a couple weeks. Over extended periods of use, it can cause anemia (low production of red blood cells), neutropenia (low white cells) and myopathy (damage to muscle fibers). These problems resolve if the drug is discontinued. The usual prescription for AZT has been two capsules (200 mg) taken three times a day, but Glaxo-Wellcome will soon be offering a 300 mg capsule that can be taken twice daily. The dose used for treating cognitive or motor slowing or dementia is twice the regular dose: 1200 mg a day.
  • ddI, also known as didanosine, is sold under the brand name VIDEX(R). ddI can be combined with any other antiretroviral, but may work especially well with d4T, nevirapine or hydroxyurea. However, ddI, ddC, and d4T can each cause peripheral neuropathy and pancreatitis, so any combination of these drugs must be carefully monitored. If you experience abdominal pain or tingling and numbness in your toes or fingers, stop taking these drugs and call your healthcare provider; otherwise, long-term damage may result. The usual prescription for ddI is two tablets (125 or 200 mg, depending on body weight) taken twice a day on an empty stomach with water.
  • ddC, also called zalcitabine, is sold as HIVID(R). ddC can be combined with any other antiretroviral, but must be used cautiously with ddI or d4T, since all three drugs can cause neuropathy or pancreatitis. If you experience abdominal pain or tingling and numbness in your toes or fingers, stop taking these drugs and call your provider; otherwise, long-term damage may result. The usual prescription for ddC is one tablet (0.75 mg) taken three times a day.
  • d4T, also known as stavudine, is marketed as Zerit(R). d4T can be combined with most other antiretrovirals and may work especially well with ddI or nevirapine. However, d4T must be used cautiously with ddI or ddC, since all three drugs can cause neuropathy and pancreatitis. If you experience abdominal pain or tingling and numbness in your toes or fingers, stop taking these drugs and call your provider; otherwise, long-term damage may result. The usual prescription for d4T is one capsule (30 or 40 mg, depending on body weight) taken twice a day.
  • 3TC, also called lamivudine, is marketed as Epivir(R). 3TC can be combined with any other antiretroviral and may work especially well with AZT, nevirapine or delavirdine. 3TC may resensitize HIV to AZT in people whose virus has become resistant to AZT. It can cause headaches and insomnia in some people, but these usually go away after a few weeks. The usual prescription for 3TC is one tablet (150 mg) taken twice a day.

Non-Nucleoside Reverse Transcriptase Inhibitors

  • Nevirapine is sold under the brand name Viramune(R). Nevirapine can be combined with most other antiretrovirals, but has not been widely studied in combination with delavirdine, hydroxyurea or the protease inhibitors. It may work especially well with AZT, ddI, d4T, or 3TC. Nevirapine can cause a serious rash, but this may be avoided by starting with a low dose, one tablet taken once a day for two weeks, and then doubled to the usual prescription: one tablet (200 mg) twice a day.
  • Delavirdine is available only to people with CD4 counts of 300 or less through an expanded-access program run by Upjohn, which calls the drug Rescriptor(R). An FDA advisory committee will consider full approval on November 22. Delavirdine can be combined with most other antiretrovirals, although it has not been widely studied in combination with nevirapine, hydroxyurea or the protease inhibitors. It may work especially well with AZT and 3TC. Like 3TC, delavirdine may resensitize the virus to AZT in people who have become resistant to that drug. Like AZT, delavirdine may be useful for HIV-related cognitive problems because it can penetrate the central nervous system. And like nevirapine, it can cause a rash in some people. The prescription for delavirdine is four pills (400 mg) taken three times a day.

Protease Inhibitors

These drugs target a different enzyme of the virus -- the HIV protease -- which is essential for HIV to make working copies of itself. More than with most drugs, it is very important not to miss doses of the protease inhibitors.

  • Indinavir is sold under the brand name Crixivan(R). Indinavir can be combined with most other reverse transcriptase inhibitors, but has not been widely studied in combination with nevirapine or delavirdine, or hydroxyurea or the other protease inhibitors. It should definitely not be combined with ritonavir. Indinavir can cause stomach upset, kidney stones and generalized discomfort, although drinking plenty of fluids may prevent the kidney stones. It should be used with caution with certain other medications, so make sure your provider knows about everything you are taking. The usual prescription for indinavir is two capsules (800 mg) taken three times a day on an empty stomach with a large glass of water. Try not to miss any doses of this drug, or the virus could quickly become resistant.
  • Ritonavir is marketed as Norvir(R). Ritonavir can be combined with most other antiretrovirals, but has not been widely studied in combination with nevirapine, delavirdine, or hydroxyurea. Ritonavir may work especially well with saquinavir, but only at doses tested in combination trials, and it should definitely not be combined with indinavir. There are many other medications that should be used with caution or not at all with ritonavir, so tell your provider exactly what you are taking. Ritonavir can cause stomach upset, generalized discomfort and tingling or numbness around the mouth. These might by avoided by starting with a low dose, three capsules taken twice a day with food, and adding one capsule each dose every couple days until the usual prescription is tolerated: six capsules (600 mg) taken twice a day. The capsules should be stored in a refrigerator. Try not to miss any doses of this drug, or the virus will quickly become resistant.
  • Saquinavir is sold under the brand name Invirase(TM). Saquinavir can be combined with most other antiretrovirals, and may work especially well with ritonavir, but only using the low doses tested in combination trials. It has not been widely studied with hydroxyurea, nevirapine, delavirdine, or the other protease inhibitors. It should also be used with caution with certain other medications, so make sure your provider knows about everything you are taking. Saquinavir can cause mild stomach upset and sun sensitivity, but these are unusual. The usual prescription for saquinavir--unless combined with ritonavir--is three capsules (600 mg) taken three times a day with food. The current formulation of saquinavir is very poorly absorbed, but taking it with grapefruit juice helps to increase blood concentrations. A better formulation will probably be available next year. Try not to miss any doses of saquinavir, or the virus may become resistant.
  • Nelfinavir was developed by Agouron Pharmaceuticals; its brand name is VIRACEPT(TM). It is available only through an expanded-access program to people with CD4 counts of 50 or less who can no longer tolerate or benefit from the other three protease inhibitors. Nelfinavir can be combined with most reverse transcriptase inhibitors, although it has not been studied in combination with delavirdine or nevirapine, or hydroxyurea. And because it is so recently available, we do not know anyone who has tried novel combinations with this drug. The criteria by which it is dispensed essentially prohibit the combination of nelfinavir with other protease inhibitors. It can cause stomach upset or headaches in some people, and should used with caution with certain other medications. The prescription for nelfinavir is three tablets (750 mg) taken three times a day with food.

Miscellaneous

  • Hydroxyurea is marketed as Hydrea(R) and is used to treat melanoma, leukemia, ovarian, and head and neck cancers. It may fight HIV by partially inhibiting a human enzyme, called ribonucleotide reductase, which HIV needs. Hydroxyurea may work especially well with ddI. Like AZT, hydroxyurea can cause anemia and neutropenia, although this is unlikely using the low dose usually prescribed for HIV: one capsule (500 mg) daily. Note: While hydroxyurea is an approved drug for certain cancers, its use with HIV is experimental.


Medical Marijuana Wins 
in California and Arizona

by John S. James
By 55.7% to 44.3%, California voters passed Proposition 215 to allow medical use of marijuana. Arizona voters passed Proposition 200 by a much larger margin, 65.3% to 34.7%. The Arizona measure is broader than California's; in addition to allowing medical marijuana, it may lead to release of persons already in prison for certain nonviolent offenses. It is much less well known than the California initiative, because supporters in Arizona did not want outside help, due to sensitivity of Arizona voters to interference in their affairs.

Californians for Medical Rights, the official sponsor of the 'Yes on 215' campaign, is preparing a brochure for patients and doctors "who need to know what Proposition 215 means to them. By the same token, we will help to inform people who are NOT sick as to why Propositions 215 will not apply to them. We don't want anyone to get the wrong idea about this new law, and end up putting themselves at risk unnecessarily." To leave your name and address to receive a copy of the free brochure, call the Proposition 215 Patient Information Hotline, 1-888-YES-4-215 (toll free).

No county in California had less than 40% of voters supporting the medical marijuana measure, according to a voter survey of over 2,000 voters published the day after the election (we do not have the final official figures, which would include absentee ballots and may differ somewhat from the survey). The highest support was in San Francisco, with 78% of voters interviewed. Los Angeles supported Proposition 215 by 56%. See the SAN FRANCISCO EXAMINER, November 6, page A-24, for a vote breakdown for all counties, and statewide by demographics, political beliefs, etc.

Comment

Despite exaggerated statements from both sides suggesting that California marijuana laws are now unenforceable, we suspect that the main immediate effect of Proposition 215 will be to create a limited legal defense in court. A state proposition cannot overrule Federal laws against marijuana for medical or other use. It will be necessary to build a national campaign to change Federal laws.

The biggest ultimate impact of these votes may be to open doors to rational discussion about the war on drugs. And here it is clear that the country desperately needs other policy options besides prohibition or official indifference. This writer has strongly supported Proposition 215, but would never want to see massive television and billboard promotion of marijuana. Today with tobacco, companies sanctimoniously agree to help keep it from children, while knowing full well that their future centrally depends on getting children and teenagers to smoke, since few smokers begin as adults -- leading to highly sophisticated, lavishly financed corporate promotions to children, cleverly designed to stay mostly under the radar of civil society.

We need a new category between legal and illegal, for activities where adults are clearly allowed to make their own decisions, but where public policy is not neutral, discouraging an activity by other means than by making it a crime (such as by prohibiting routine or large-scale promotion). The Supreme Court has made such policies difficult, by defining advertising as Constitutionally-protected "speech" -- making it hard to regulate promotion of products such as alcohol, tobacco, or marijuana, without first making them a crime and invoking all the deadly baggage of prohibition, for no public purpose.

The Proposition 215 demographic breakdowns in the EXAMINER survey are fascinating. Sex made little difference, with females slightly more supportive of medical marijuana. There were big differences by race, with Black most supportive of proposition 215, Asian least supportive, and White in the middle. By age, support was lowest among voters over 60. Voters who currently were paid full-time workers were considerably more supportive than those who were not.

But what may be most important was the breakdown by whether the voter has children under 18. There was almost no difference in support -- only a 2% difference, and the survey had a margin of error of 3%. We would have thought that the basis of opposition to this proposition would have been parents worried that their children could get in trouble with drugs. But that is not what happened.

What, then, IS the basis of the opposition to medical marijuana, or to this particular initiative? Polls have repeatedly shown strong support for the right to use marijuana for legitimate medical needs; in view of this consistent support, the 55.7% vote in California seems disappointing. Supporters should ask the 44.3% who voted against Proposition 215 what was on their minds. Addressing their objections will be an important part of making this initiative work well enough to be an effective national model.


FDA Internet Regulation? 
Public Comment Accepted 
until December 16

On October 16 and 17 the FDA held a public meeting, "FDA and the Internet: Advertising and Promotion of Medical Products," near Washington D.C.; several hundred people attended, mostly from industry (apparently there were no more than two AIDS community or activist representatives). This meeting has been widely reported in the press, but these articles did not tell their readers that anyone can submit written comments until December 16.

Background about the meeting was published in the Federal Register, September 16, volume 61, number 180, pages 48707- 48710. That Federal Register notice included the following summary:

"The Food and Drug Administration (FDA) is announcing a public meeting to discuss issues related to the promotion of FDA-regulated medical products on the Internet. FDA is seeking participation in the public meeting and written comments from all interested parties, including, but not limited to, consumers, patient groups, information vendors, manufacturers of FDA-regulated medical products, and health care professionals. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of biologics, human and animal drugs, and medical devices on the Internet and the World Wide Web (the Web)."

The meeting was divided into five discussion groups: Investigational product information; Chatrooms and newsgroups; Additional regulatory issues; Website links; and International issues.

A complete transcript of the two-day meeting is available on the FDA Web page, http://www.fda.gov.

How to Submit Comments

"Submit written comments on the questions to the Dockets Management Branch (DMB) (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. After the meeting, a transcript will be available at DMB (address above) between 9 a.m. and 4 p.m., Monday through Friday."

We suggest that persons preparing comments examine the meeting transcript, available either worldwide through the Web or at the FDA's Rockville office, or at least read the Federal Register announcement of the meeting, which includes the FDA's specific questions for each discussion group.

Comment

From what we have heard after the meeting, it seems unlikely that the FDA will make major attempts to regulate the content of medical information on the Internet -- but there is no way to know for sure. We are concerned about a number of issues, for example:

  • Pharmaceutical and other companies may be pressured to restrict more of their material to medical professionals -- rolling back the movement toward patient empowerment (some online material is already restricted). Also, requiring registration as medical professionals could greatly limit information flow to developing countries, even to medical professionals, because doctors there would probably not show up as licensed in the databases in the U.S. or other home country of the pharmaceutical company.
  • Even aside from Internet issues, restriction of information about experimental drugs has greatly hindered recruitment in clinical trials. Why will doctors refer patients, if they do not understand the rationale of the treatment or the trial (which companies are often afraid to include in their trial announcements, lest they be accused of promotion)? The main problem is not in the FDA's intent, nor in the regulations themselves, but in overreaction by industry personnel who do not know the system very well, and are overly fearful of getting their companies, and therefore their own careers, in trouble. Formal regulations, or even informal standards and expectations, could inadvertently extend and exacerbate this problem, unless great care is used.
  • The rapidly developing "global village" world has both advantages and disadvantages; one of the advantages is a kind of world medicine built on local traditions. There have long been much greater differences internationally in medical care (even between seemingly comparable industrialized countries) than the public realizes. Traditionally, if the medicine of one's own country does not work for a patient's condition, that patient is out of luck. But with world medicine, the locally approved treatments will still be tried first, because physicians are most familiar with them; but when local drugs or procedures are unsuccessful, others can be borrowed from countries which have different approved protocols, drugs, indications, and diagnostic tests -- increasing the overall chance of a successful outcome. Today, individual educated patients and activist movements are at the leading edge of this change; as world medicine develops, it will need to become more institutionalized in order to serve more people. But clearly the benefits of world medicine are seriously threatened either by medical uniformity imposed everywhere, or by blocking information about drugs and indications in those countries where they are not approved.


AZT Twice-Daily Tablets 
Approved; Dosing Concerns

by John S. James
On October 25 the FDA approved a 300 mg AZT tablet, intended for twice-daily dosing. (AZT is commonly taken as 200 mg three times a day in the U.S.) The new dose is intended to be more convenient by reducing the three daily doses to two -- hopefully improving patients' compliance with their physicians' instructions.

There are concerns that twice-daily dosing may not work as well as giving the same amount of drug at more frequent intervals, because of the greater variation in blood levels throughout the day. These concerns are (1) that low trough levels could allow viral resistance to develop faster, and (2) that higher peak levels after each dose could increase side effects. In defense of twice-daily dosing, Glaxo-Wellcome notes that 250 mg twice daily is the standard AZT dose in Europe, that most clinical trials using AZT today use twice-daily dosing, and that no differences in safety or efficacy was seen in a trial of 320 volunteers which compared 100 mg every four hours vs. 300 mg every 12 hours for 48 weeks (the trial was not powered to find differences in efficacy, however, and it did not measure viral resistance). Glaxo also notes that the new dose is only an option, since the previous formulation remains available, and that trials to measure the development of viral resistance are now in progress or being planned.


Retroviruses Conference: 
Press Deadline December 6

by John S. James
The 4th Conference on Retroviruses and Opportunistic Infections, January 22-26, 1997 at the Sheraton Washington Hotel in Washington, DC, will probably be the most important AIDS conference in the U.S. in 1997. The deadline for "community based newsletters" (most AIDS-related newsletters) to register as press is December 6. For "all other press," (newspaper and TV reporters, freelance writers on assignment, etc.) the deadline is January 10, and applications will be processed first come first served. Many industry publications may not be allowed to register as press in either category. There is no on-site registration.

The Community Liaison Subcommittee will review and approve the community press applications, and applicants will be notified in mid December. This Subcommittee is excellent, but only has a limited number of slots to approve.

The bottom line is that anyone who wants to attend this conference needs to start making arrangements as soon as possible. For more information, obtain the Press Registration packet from the Retrovirus Conference Secretariat, c/o Infections Diseases Society of America (IDSA), 703/299-0200, fax 703/299-0204.

Press rules include no photography, video recording, or formal interviews in session rooms or the poster hall, and no photography elsewhere except with prior approval. Audio recordings are allowed, but not for republication or rebroadcast.

For those not going, the published abstracts are scheduled to be available on the Internet on January 22, at http://www.idsociety.org. The printed abstract book will be sent two weeks in advance to all registered press.

Comment

As we have noted in previous articles, some of the press rules for this conference are highly unusual and a major impediment to rapid, accurate reporting. For almost ten years we photographed poster presentations and occasional slides at AIDS conferences without ever being told not to. At the Vancouver conference we found that a good-quality video camera was exceptionally useful, both for recording posters and for recording key slides with the accompanying discussion. We have taken these pictures only to assure the accuracy of our own reporting, never for republication. Traditionally, only FLASH photography in oral sessions has been banned, for good reason. But at the retroviruses meeting the cameras will apparently be limited to interviews in the press room, damaging accurate technical reporting for no public benefit.

Another major press problem at the Retroviruses conference is the requirement that mainstream media register in advance. We do not know of any effective way to communicate this requirement to those who need to know. Enforcement will mean that press is turned away, as happened last year. The public has a legitimate interest in AIDS research, and is more likely to provide support if it can see the results.

The happenstance dynamics of one major and prestigious conference must not be allowed to establish a general pattern of dysfunctional impediments to the communication of AIDS research information.


Qigong Program 
on San Francisco KQED TV, 
Beginning December 7

A course in Qigong (a traditional Chinese therapeutic exercise) will be presented on public television in the San Francisco area, starting Saturday December 7, 6:00 a.m. to 6:30 a.m. for four weeks. It will start again on January 4 and repeat for another four weeks.

This course is also available on videotape through the Immune Enhancement Project in San Francisco, 800/835-6555; all proceeds from the sale of this tape are contributed to serve people with HIV. The course grew out of a Qigong class which meets twice a week in San Francisco; for information about this class, call Emilio Gonzalez, 415/255-0265, or George Wedemeyer, 415/661-2080.

Other public broadcasting stations wanting to broadcast this series can contact Qigong for Health, through the Immune Enhancement Project at the 800 number above.


Copyright 1996 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.




  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 

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