Subject: CMV; Disability Benefits; Dextran; Ganciclovir Date: Mar 24 1989 (682 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1989 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue # 76, March 24, 1989 CONTENTS: [***** appears here at each new item] * HPMPC: Possible CMV (Cytomegalovirus) Treatment * Preserving Your Medical and Disability Benefits * Dextran Sulfate: Confusion Continues * Physicians: FDA Seeks Ganciclovir Information (Deadline April 21) * San Francisco: Major Lesbian and Gay Health Conference, April 5-9 * San Francisco: Weight Loss/Megace Study * San Francisco: Community Research Alliance Press Conference, Benefit, April 5 * San Mateo County, CA Seeks PWA/ARC Volunteers * Opinion Survey on U. S. Drug-Approval Process: Study Seeks Volunteers ***** HPMPC: Possible CMV (Cytomegalovirus) Treatment by John S. James A major struggle continues over access to ganciclovir (DHPG) and foscarnet, the only accepted treatments for CMV retinitis, which can cause blindness in persons with AIDS -- or with serious immune deficiencies from other causes, such as medications given to organtransplant recipients. (For more information, see AIDS Treatment News # 71, December 16, 1988). CMV can also infect many other organs. Some experts believe it is the most common cause of death in persons with AIDS (Snoeck and others, 1989). Both ganciclovir and foscarnet, however, have important drawbacks. Therefore the AIDS community should also know about HPMPC (also called "(S)-HPMPC"), a chemical developed by Belgian researchers, which appears in test-tube studies to be much more active then either ganciclovir or foscarnet against CMV. While HPMPC has not yet been given to humans and therefore is not an immediate treatment option, community awareness, investigation, and involvement may be necessary to make sure that it is not lost by lack of followup before clinical trials, or in the usual five-year to eight-year "drugjam" of new treatments going through clinical trials for U. S. approval. HPMPC is also effective against some other viruses, includ- ing herpes simplex. It may be part of a new class of broad- spectrum antivirals. A major article on HPMPC was published last December in Antimicrobial Agents and Chemotherapy (Snoeck and others, 1988). These are the major points from that article: * The scientists measured an "inhibitory index", the ratio of the drug concentration which inhibited cell growth by 50 per- cent to the concentration which inhibited the virus by 50 per- cent. This ratio provides an early indication of the possible usefulness of the drug. A large value suggests that there may be a wide margin between effective and toxic doses, increasing safety and also allowing physicians to increase doses when neces- sary without unacceptable toxicity. In tests against CMV, the ratios for foscarnet, ganciclovir, HPMPA (a relative of HPMPC), and HPMPC were 14, 150, 200, and 1,500, respectively. (Using another strain of CMV, the ratios were 20, 200, 100, and 1,000.) These results suggest that HPMPC might have about ten times the range between effective and toxic doses as ganciclovir -- and even more when compared to foscarnet. * HPMPC completely suppressed the growth of CMV at concen- trations of 0.1 microgram per milliliter, about ten times lower than required for ganciclovir. * Like ganciclovir, HPMPC suppressed CMV plaque formation when added two, 24, or 48 hours after infection. Both failed to do so when added after 72 hours. But the two differed in that HPMPC protected cells even after it had been removed from the culture, while ganciclovir did not. * For those who are interested, the full chemical name of HPMPC is (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine. It is not known exactly how it works. In one experiment, several natural nucleosides were tested to see if they could inhibit the antiviral effect of HPMPC. None of them did. * Based on their results, the researchers suggested testing HPMPC in animals as a CMV treatment. They pointed out that appropriate "animal models" for CMV infection are available -- for example, the mouse or guinea pig. * All funding for the above research was from institutions in Belgium. The researchers synthesized their own HPMPC, by a procedure outlined in the article. We do not know of any phar- maceutical company involved in this work, although Bristol- Myers researchers have also published a paper on synthesis of HPMPC (Webb and others, 1988). Comment We suggest that the AIDS community follow HPMPC, and become familiar with its current status and future prospects. Are there any financial or other obstacles to further research, which community awareness could help to overcome? It would be inexcus- able for this drug to take the usual five to eight years or more to become available in the United States. Except for red tape, enough preliminary testing could be completed in a few weeks or months. Volunteers for whom noth- ing else works would be willing to try the drug, after brief tests in animals. Only cultural inertia stands in the way -- in particular, the unwillingness to respond to AIDS as an emer- gency, instead of business as usual. References De Clercq E., Holy A., Rosenberg I., Sakuma T., Balzarini J., and Maudgal P. C. A novel selective broad-spectrum anti-DNA virus agent. Nature volume 323 number 2, pages 464-467, October 1986. De Clercq E., Sakuma T., Baha M., Pauwels R., Balzarini J., Rosenberg I., and Holy A. Antiviral activity of phosphonylmethox- yalkyl derivitives of purine and pyrimidines. Antiviral Research number 8, pages 261-272, 1987. Snoeck R., Sakuma T., De Clercq E., Rosenberg I., and Holy, A. (S)-1-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine, a Potent and Selective Inhibitor of Human Cytomegalovirus Replication. Antimicrobial Agents and Chemotherapy volume 32 number 12, pages 1839-1844, December 1988. Webb R. R. II, Wos J. A., Bronson J. J., and Martin J. C. Syn- thesis of S-N-1-3 Hydroxyl-2-Phosphonylmethoxypropylcytosine S- HPMPC. Tetrahedron Lett. 29 (43) pages 5475-5478, 1988. ***** Preserving Your Medical and Disability Benefits by John S. James Many persons with serious illnesses lose insurance and medi- cal benefits to which they are entitled, because of the complex rules governing these programs. We asked benefits counselors what are the most important traps to avoid, the most important things people may need to know as "first aid" to preserve their access to benefits, even before they get to an expert adviser. Audrey K. Doughty, executive director of AIDS Benefits Coun- selors, a new San Francisco organization which specializes in Social Security and employee benefits and advises other organiza- tions as well as individual clients, suggests, "To be a friend to a person who has tested HIV positive, encourage him or her to start early on financial planning. "Many have panicked after testing HIV positive (and espe- cially after an AIDS or ARC diagnosis), then quit their jobs, losing benefits for which they have worked and to which they are entitled. Others lose their benefits by staying on the job longer than they are physically able and getting fired for poor performance. "You must familiarize yourself with the provisions of your benefits package. Obtain a copy of your company's actual con- tract with their insurance firm. Frequently a shorter, simpli- fied version is handed to employees, and it may not give you the precise and complete information you need." Diana Kuderna, a benefits counselor in Alameda County, CA (near San Francisco) and chair of the East Bay AIDS Response Organization, makes the same point and adds other suggestions: "If you illness is beginning to interfere with your work, rather than leave or allow yourself to be terminated from a job that includes benefits, you and your doctor need to consider a disability leave, as benefits can be lost otherwise. In order to retain access to extended health-care benefits, and short- or long-term disability plans, you must be employed when deemed dis- abled." Ms. Kuderna added that many people also lose benefits by going part-time without checking on requirements or negotiating retention of benefits. A physician can declare a patient disabled entirely, or only for full-time work but still able to work part time. The employer does not need to know that disability is being con- sidered until after the determination has been made. If you are found to be disabled only for full-time work, then if you con- tinue to work part time, you may still receive up to 100 percent of State disability income (in California at least), in addition to your part-time earnings, providing that the total does not exceed your income before applying for disability. (For more detailed information, see the article by Ms. Kuderna described below.) There are many more important points to know, for example: * In most (but not all) jobs, if you leave the job for any reason, you can keep the medical insurance for up to 18 months by paying premiums yourself. However, you must make arrangements to do so within the allowed time -- and pay all the premiums when due. (This right to extend a health-insurance policy by paying the premiums oneself is provided by a Federal law, known as COBRA. Unfortunately, the insurance period expires six months before the two-year disability requirement for Medicare, leaving a six-month gap in coverage. This gap needs to be fixed by legislation.) A few employers will continue to pay premiums for about six months after an employee leaves. The employee must begin paying when the employer stops, in order to maintain the health bene- fits. Usually, however, the employee should apply for COBRA immediately. Businesses of less than 20 employees are not required to offer the COBRA extension of benefits. * If you qualify as disabled under Social Security, you may then qualify under either of two programs for disability income: - SSDI (Social Security Disability Income, sometimes called "SSA") does not require low income and assets. But you must have paid into the system for five of the last ten years (less for those age 24 and under). And no benefits will be paid until after five months of disability. - SSI (Supplemental Security Income) requires low income and assets, as well as disability. But you do not need to have paid into the system to qualify. And there is no five-month waiting period. Benefits usually take a couple months to kick in, but then they are retroactive to the initial by-phone benefits request -- your "protective filing date". (SSDI is not retroactive.) * Persons with CDC-defined AIDS are usually presumed by Social Security to be disabled. But persons with ARC are often denied disability, even if they are equally or even more dis- abled than many persons with AIDS. AIDS Benefits Counselors has an excellent record in appealing these denials and getting them reversed. Careful record keeping (including very detailed descriptions from physicians) is often required. (See below about getting help on benefits from AIDS service organizations.) * There are other health-care and disability-income possibilities, including Medicaid (Medi-Cal in California), and state disability insurance. Medicaid may be valuable even for persons who have private insurance. However, the program varies greatly from state to state. Ms. Kuderna described some advantages of Medi-Cal (California's Medicaid program) even for those who have other insurance: "While essential for the uninsured, the program is also use- ful as a supplement to insurance. It will pay for care not covered in your policy -- dentistry, chiropractic care, mental health services, drug detox, supplies ordered by a doctor, and nursing home care. Medi-Cal allows you to use health-care pro- viders -- those that accept Medi-Cal as partial or full payment -- outside of your HMO (Health Maintenance Organization) provider list. If your policy has deductible amounts and percentages that are not payable, Medi-Cal can cover them. Some care providers and pharmacies expect you to pay now and bill insurance yourself. Medi-Cal can be used to avoid the difficult cash outlays. If your condition makes it difficult for you to take public transportation, cabs to medical appointments can be paid for by Medi-Cal. Note that there is no cash reimbursement, only [text lost]. * Do not overlook miscellaneous programs available in some areas, such as private or religious AIDS emergency funds, free or low-cost food programs, greatly reduced fares on public transit for persons with disabilities, and others. * Ms. Kuderna emphasized some practical hints which could be overlooked: (1) In California at least, In-Home Support Services can be used to pay for anyone of your choosing, including a lover, spouse, or family member, to help with home chores -- up to 283 hours of help per month at minimum wage. You must require chore service in your home (the number of hours is determined by a home visit) and be eligible for SSI, except that your income can be somewhat higher. Those paid to do the work can have any income. Other states may have similar programs. This program may also enable you to qualify for Medi-Cal even if your income would otherwise be too high. By an arrange- ment with your chore helper not to bill for the first certain number of hours per month (i.e. to pay for them yourself), you can reduce your income for Medi-Cal eligibility purposes. (2) Payment for cost of experimental treatments is often a problem. But for meeting SSI income limits, you should be able to deduct the cost of experimental treatment supervised by a phy- sician from earned income. (We do not know about states other than California.) (3) Ms. Kuderna encourages people to consider State disabil- ity insurance. One fact the disability office may not tell you is that you can collect disability income for more than one year maximum. If your physician releases you to go back to work for more than a 14-day period (even if you do not actually find work in that time) and then re-imposes restrictions, a new claim can begin. (Again, we do not know how eligibility varies in dif- ferent states.) Where to Get Help and Advice * Check with your local AIDS service organization. If you do not know what is available in your locality, start by calling the National AIDS Hotline, 800/342-AIDS. (This excellent referral service has up to 40 information specialists available 24 hours a day, so usually there is no wait to get through. It has one of the largest AIDS referral databases in the country. Unfor- tunately, this hotline is not well known.) Spanish speakers can call the National AIDS Hotline at 800/344-SIDA, to reach a Spanish-speaking information special- ist. * As an example of the kinds of assistance which may be available from local AIDS service organizations, the San Fran- cisco AIDS Foundation has weekly benefits workshops for persons with AIDS or ARC, both morning and evening sessions. The workshop includes all Federal, State, and local disability bene- fits, employer-sponsored benefits, and insurance. It also includes other social services available through the Foundation, and elsewhere in San Francisco. To register for the workshops, call the San Francisco AIDS Foundation, 864-5855, and ask to speak to the on-duty social worker. Clients can also meet individually with a social worker for a benefits review. The Foundation also sponsors a twice-monthly benefits sem- inar for Federal employees with AIDS or ARC. To register, call the on-duty social worker, 864-5855. * Chris Alexander, a benefits expert at the Foundation, emphasizes how much can be done early -- while one is HIV- positive, before receiving an AIDS or ARC diagnosis -- to preserve one's access to medical care, disability income, and insurance. * Persons with ARC have special difficulty qualifying for Social Security disability. The San Francisco AIDS Foundation has a program for them, using a team of volunteers to explain what is required and how persons can improve their chances of qualifying. The team follows up with clients, and with the Social Security Administration. It cannot guarantee accep- tance, but it can guarantee that Social Security has a complete picture of a client's background. * On ARC disability, Diana Kuderna adds, "Documentation sub- mitted to assist in determining the severity and probable dura- tion of disability can include reports written by anyone closely familiar with your daily routine. Several such descrip- tions of limitation of function resulting from your illness can help, including what you can and cannot do as a result of fatigue, pain, mental changes, nausea, diarrhea, confusion, drug side effects, sleep interruptions, weakness, depression, rashes, anxiety or forgetfulness." * Persons with ARC can also obtain a 95-page manual, Guide for Social Security Disability Insurance Claims for HIV Disease (AIDS and ARC), by Patrick James, a founder of AIDS Benefits Counselors. In San Francisco, New York, and Los Angeles the book is available at A Different Light bookstore; it can be ordered from AIDS Benefits Counselors, 415/673-3780. This book includes forms and sample medical narratives which show the level of detail with which physicians should document ARC disabilities. It includes a checklist to be used by persons with ARC, and their friends, family, and physicians, which has been very help- ful in documenting disability. It tells what sections must be changed for users in California but outside the San Francisco Bay Area, or by those outside of California. From AIDS Benefits Counselors the book costs $25.00 (plus $5.00 handling) for agencies, but is free to persons with AIDS or ARC who cannot afford it. * Diana Kuderna has prepared a ten-page writeup "AIDS/ARC Benefits Counseling in Alameda County". This article, full of detailed information about eligibility criteria and other aspects of many disability, insurance, and other benefits programs, was written primarily for training benefits counselors. Applicants may also find it useful, however; and even persons outside of Alameda County or outside of California may find valuable hints and ideas in the article, although the details will differ. You can obtain a copy by sending a self-addressed stamped envelope (with two ounces of postage) to: Diana Kuderna, 871-1/2 52nd St., Oakland, CA 94608. * We spoke with a hospital intake worker, who urged people to have medical insurance information with them (such as the name of their insurance company or HMO, and policy numbers) in case they need to be admitted to a hospital. Many plans require pre- authorization in order to reimburse for certain procedures (or notification within a certain time afterwards, in case of emer- gency). Sometimes people do not know the name of their company, and while they are in the hospital there may be no one at home or at work to find out. * Chris Alexander emphasized the importance of becoming fam- iliar with your local AIDS service organization, and of finding out what is available in your area (including emergency funds, money to pay certain bills, and county benefits such as food stamps or general assistance which vary from county to county). Insurance and benefits problems can be overwhelming when one is dealing with everything else about an AIDS or ARC diagnosis, so be aware of how an AIDS service organization can help, for exam- ple by assistance in filing applications, or by explaining the paperwork requirements. People do not need to go it alone. ***** In Memoriam: Patrick James, a founder of AIDS Benefits Counselors and author of the book on ARC disabilities mentioned above, died of AIDS on March 17, 1989. His work is described in a remarkable interview in the San Francisco Sentinel, January 12, 1989. ***** Dextran Sulfate: Confusion Continues During the past year dextran sulfate has become one of the most widely used "underground" HIV treatments -- based on labora- tory tests showing that the drug stopped HIV in the test tube, plus the fact that oral dextran sulfate has been used for other purposes for 20 years in Japan, where it is available without a prescription. (For background, see AIDS Treatment News #50, February 12 of last year.) But despite the widespread use in Japan, there have long been questions of whether dextran sulfate is absorbed from the intestines into the bloodstream well enough to be effective. Recently, new data has increased these doubts about the "bioavailability" of the drug. The new information has been widely reported in the press, beginning with a story in the February 19 Los Angeles Times. But experts disagree on how cer- tain or conclusive the new data is. At least until recently it has not been possible to measure dextran sulfate levels in the bloodstream. So at first an indirect test was used. Six people took 1800 mg each of the drug, and then were given before and after measures of a blood- clotting parameter known to be affected by dextran sulfate. Later, a direct chemical test was devised. Both studies con- cluded that less than one percent of dextran sulfate taken orally was absorbed into the bloodstream. All seem to agree that these findings cast doubt on dextran sulfate. But questions remain. Was a single dose of 1800 mg enough for the test? Could even a small amount absorbed be of some benefit -- especially if combined with AZT or other drugs? Is the new blood-level test accurate? Could the Japanese have been taking a useless drug for 20 years and not noticed? How do we explain the apparent benefit seen in some of the data col- lected by physicians whose patients are using dextran sulfate? And even if the drug is not absorbed into the bloodstream, might it still benefit some people by treating HIV infection in the intestinal lining itself, by direct contact? At this time, the case for oral dextran sulfate seems weak. But confusion remains because solid answers are not yet avail- able. We hope that the clinical trials now in progress will be completed so that physicians can answer the bottom-line question: Does the drug help patients? There has been some controversy about the early release of preliminary information on dextran sulfate absorption, before formal publication. We think it was right to tell people early. Final analysis and publication of the results may take months -- and meanwhile thousands of people are making vital decisions about their health care. They need the best informa- tion available. We hope that this controversy does not deter other scientists and officials from releasing unpublished results when there is an urgent need to do so. For more information, see: the Los Angeles Times, February 19, 1989 (home edition), page 1; statement by Martin Delaney of Project Inform, to be published in PI Perspectives this month (415/558-9051 to be added to Project Inform's mailing list); and an investigative article by Tim Kingston to be published in Coming Up! newspaper in San Francisco, April 1989. ***** Physicians: FDA Seeks Ganciclovir Information (Deadline April 21) On May 2, the FDA's Anti-Infective Drugs Advisory Committee will review the status of ganciclovir -- a review which could lead to approval of the drug. Health-care providers with sum- maries of data or other clinical information about ganciclovir should contact the Committee preferably by April 10; however information will be accepted as late at April 21. If you have any information which might be useful, please contact Tom Nightingale, the executive secretary of the Anti- Infective Drugs Advisory Committee, at 301/443-5455. Send sum- maries as soon as possible to him at the Center for Drug Evaluation and Research (HFD-9), Food and Drug Administration, 5600 Fisher Lane, Rockville, MD 20857. Ophthalmologists are encouraged to address the Committee; anyone who wants to present data must call ahead of time. The meeting is open to the public, but seating is limited so attendees must preregister to assure access. ***** San Francisco: Major Lesbian and Gay Health Conference, April 5-9 The 11th National Lesbian and Gay Health Conference and 7th National AIDS Forum will take place April 5-9 at the Cathedral Hill Hotel in San Francisco. Registration is $170; registration for April 5th Institutes only is $45. Continuing education credits are available. More than 550 presentations are scheduled. For more information, call 202/797-3708. ***** San Francisco: Weight Loss/Megace Study The San Francisco County Community Consortium is currently recruiting patients for a phase III study of megestrol acetate (Megace), a drug which may be useful in reversing HIV-related wasting syndrome (cachexia). Marked weight loss is a serious problem for some people with HIV disease. It can further impair an immune system already damaged by the virus, resulting in an increased susceptibility to opportunistic infections. The rationale for this study is based on observations from another study conducted at the University of Maryland which found that 28 of 30 patients being treated for breast cancer with Megace experienced increased appetite and weight gain. Although this side effect was beneficial for the patients, it was also unexpected, so that important nutritional data was not col- lected. The trial, conducted by Consortium physicians through their private practices, is one of the first community-based trials in the greater Bay Area. The trial seeks to determine if the weight gain associated with Megace is comprised of protein or fat, or merely water retention, and what relationship there is between immune status and general or specific nutritional status. This is a placebo-controlled study, but it is also a "cross-over" study, which means that halfway through (after eight weeks), the treatment/placebo arms will be switched, so that by the end of the study everyone will have received active drug. Note that Megace is a prescription drug; if someone is now seriously anorectic, they could discuss the immediate use of Megace with their physician. Last December, AIDS Treatment News #71 reported on the good results with Megace for AIDS-related cachexia published in the November 15, 1988 issue of Annals of Internal Medicine. We were assured that participants will be closely monitored by physicians, nurses and nutritionists to watch for any weight loss severe enough to warrant withdrawal from the study. Megace and all laboratory tests required by the study are provided free of charge. In addition, all patients will receive monthly feed- back on their nutritional status by a registered dietitian. Eligibility criteria for the study include either asymp- tomatic HIV infection or ARC and a documented loss of at least 5% of usual body weight. Persons with AIDS-defining diagnoses are excluded. To determine whether your physician is a member of the San Francisco County Community Consortium, or for more information about the study, call Helen Mudie at 415/821-5495, or Ann Conroy at 415/565-6649. ***** San Francisco: Community Research Alliance Press Conference, Benefit April 5 The Community Research Alliance (CRA), a new organization to conduct community-based trials in San Francisco, will hold a press conference on April 5. For more information, call Tom Wil- cox, 415/626-2145. For background on the CRA, see AIDS Treatment News # 70, December 1, 1988. That evening there will benefit performance for the CRA by The Flirtations, a New York a cappella singing group which includes well-known AIDS activist Michael Callen. The benefit is 10 PM at the New Performance Gallery, 3153 17th Street (at Shotwell) in San Francisco. All tickets are $10. and are avail- able from STBS-Union Square, all BASS outlets, 762-BASS, or at the door one hour before the performance. For reservations, call 863-9834. The Flirtations will also perform through Sunday, April 9. ***** San Mateo County, CA Seeks PWA/ARC Volunteers The AIDS Project of the Department of Health Services of San Mateo County, CA is seeking persons with AIDS or ARC to volunteer to share their experiences with high-school students, as part of a three-day presentation in the classroom. This prevention/education program is modeled after The Wedge, an out- standing program in San Francisco. A two-day training session for volunteers will be held April 14 and 15. If you are interested in participating, please call Jonathan Mesinger at 415/573-2588 by Wednesday, April 12. ***** Opinion Survey on U. S. Drug-Approval Process: Study Seeks Volunteers Persons with AIDS or ARC or who are HIV-positive can parti- cipate in a survey of attitudes and opinions toward the FDA and the new-drug approval process in the United States. This study began as an undergraduate project by Kenneth James and Ira Nydick at Worcester Polytechnic Institute, Worces- ter, MA, but it has gone well beyond the usual student project. Assistance is being provided by the AIDS Center at the University of California Los Angeles, where most of the research will be conducted. AIDS organizations which assist in the study will receive a copy of the results. You can participate by filling out a three-page anonymous questionnaire. To obtain a copy, write to: AIDS Study, c/o Professor Ruth Smith, Humanities Dept., Worcester Polytechnic Institute, 100 Institute Road, Worcester, MA 01609. ***** Statement of Purpose AIDS Treatment News reports on experimental and complemen- tary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists physicians, and other health practitioners, and per- sons with AIDS or ARC. Long-term survivors have usually tried many different treat- ments, and found combinations which work for them. AIDS Treat- ment News does not recommend particular therapies, but seeks to increase the options available. We also examine the ethical and public-policy issues around AIDS treatment research. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display