Ridge budget cuts AIDS drugs, threatens Medicaid coverage
Richman seeks advice on CD4 reporting
AZT declines in treatment of HIV+ kids
Baboon marrow transplant appears to fail
Clarithromycin seen useful in prevention of MAC
Study claims no benefit for "nontraditional" therapies
Famciclovir shown effective in genital herpes
Syphilis cases almost double in Baltimore
Repeal to HIV military ban introduced
JAMA, Glaxo Wellcome announce HIV/AIDS site on WWW
Critical Path challenges censorship of AIDS information on the Internet
Group challenges New York condom ban
Ridge budget cuts AIDS drugs, threatens Medicaid coverage
The $6.6 million Special Pharmaceutical Benefits Program, a Pennsylvania state fund that gives uninsured people with AIDS and others access to free prescription drugs, would be cut by almost one-third under the new state budget proposed by Governor Tom Ridge earlier this week.
The Ridge budget plan also calls for eliminating Medical Assistance coverage for almost 133,000 low-income Pennsylvanians, including over 30,000 in Philadelphia alone. Even low-income people who are working, but unable to afford health insurance coverage on their incomes, would be denied Medicaid benefits under the Ridge plan.
Ridge said that "able-bodied" single adults -- who last year were dumped from eligibility for cash welfare assistance -- would not be able to qualify for Medicaid unless they were unable to work because of illness or disability.
People with HIV/AIDS have historically qualified for Medicaid coverage if their incomes were low and they showed symptoms of disease that required regular medical treatment. Under the new Ridge plan, a more rigorous standard to determine disability would be established, and many people with HIV who currently rely on Medicaid would lose their coverage altogether because they were not sufficiently disabled.
A state welfare department source told fastfax that the ultimate plan is to deny Medicaid coverage to any person who has not yet qualified as disabled under the federal standard utilized by the Social Security Administration.
"What this means is that many poor people with HIV will not be able to obtain preventive care that will keep them from getting sick," said David Fair, executive director of We The People Living with AIDS/HIV. "Governor Ridge is saying that you can only get coverage once you're very ill -- and his plan will guarantee that for many people with HIV by preventing them from getting the care that would keep them healthy."
"There's no question that this action has the effect of increasing the number of Pennsylvanians who do not have health care insurance," Feather O. Houstoun, secretary of the state welfare department, told the Philadelphia Inquirer.
The potential $1.9 million reduction in the SPBP, which late last year was expanded to cover almost 50 commonly used AIDS drugs, could mean that protease inhibitors--a new class of drugs that are both effective and costly--would have to be rationed among needy patients.
According to Houstoun, the SPBP cut was proposed prior to the recent announcement by scientists about the efficacy of the new drugs. "If it turns out we'll be pinched [to pay for the new drugs], we will take another look at it," Houston said.
HealthChoices program back on track
Meanwhile, the HealthChoices program, aimed at shifting Pennsylvania's Medicaid recipients to health maintenance organizations and eliminating the current statewide Medicaid "fee-for-service" structure, has been resurrected by the Ridge Administration after a similar plan drafted by former governor Robert Casey never got off the ground.
The new plan is very similar to the original Casey proposal, and would dismantle the current Medicaid system -- in which eligible participants can seek care from any provider who accepts Medicaid reimbursement -- and replace it with state contracts with health maintenance organizations who would be paid a set fee to provide care to the poor.
Supporters of the HMO plan say that it is likely to be more cost-effective than the current fee-for-service Medicaid system because it includes an incentive to control costs, and would allow poor people to access the same quality of care as those who privately pay for participation in HMO plans.
Critics say that the HMOs would have an incentive to deny or limit access to care to low-income participants, since their only income for Medicaid patients will be a monthly state fee. The only way an HMO can make a profit in such an arrangement is to keep its costs significantly lower than the state fee, advocates claim.
Concern about the impact of Medicaid HMOs on people with HIV/AIDS is based on the belief that highly-expensive HIV/AIDS care will be seen by HMOs as a threat to their profit margins, and will lead them to discourage people with HIV/AIDS from joining their plans. While active discrimination against HIV+ people is unlikely, plans can discourage participation by failing to include competent HIV/AIDS specialists on their provider panels or making procedures to access specialized care difficult or cumbersome.
A similar Medicaid HMO plan in New York State was rejected by the federal Health Care Financing Administration because it failed to guarantee appropriate care for people with HIV/AIDS and other chronic diseases. The Pennsylvania plan must also receive HCFA approval before it can be implemented.
Richman seeks advice on CD4 reporting
After suspending a city health department plan to require laboratories to report the names of individuals with CD4 counts of less than 200 to the city's AIDS office late last year, health commissioner Estelle Richman has invited people with HIV and AIDS service providers to suggest "alternate" plans that might address concerns raised by community advocates about confidentiality and cost.
"Only those procedures that are cost-neutral and well-formed will be considered," Richman said in a letter to several hundred concerned individuals and organizations on February 1st. She asked that suggestions for alternate plans "include as much detail as possible" and be submitted to AIDS Activities Coordinating Office director Jesse Milan by March 31st.
At press time, We The People Living with AIDS/HIV and the Critical Path AIDS Project were planning a public meeting to discuss options that might be presented in response to the Commissioner's request.
The original city plan required mandatory name reporting by local labs of individuals whose blood contains a CD4 count of 200 or under. With this information the city's AIDS epidemiology department planned on contacting the doctors who ordered the blood work and requiring them to formally report the individual to the health department.
Lab-based reporting was done extensively throughout the city on a voluntary basis until 1993. The city's board of health approved the process several years ago for formal inclusion in the city's mandatory reporting policy, but labs have never been forced to participate.
According to Erica Gollub, the city's AIDS epidemiologist, the intention of requiring local labs to report by name any individual who has a CD4 count of 200 or below is to make it easier for her office to more accurately count the number of people in the city who have AIDS. It is currently believed that the number of people with AIDS in the city is actually as much as 28 percent higher than the amount currently reported, the result of which is a loss in federal funding for AIDS care and prevention programs which are awarded in part based on AIDS cases in the region. Officials estimated that loss at about $2.7 million over the last two years.
Name reporting of people diagnosed with AIDS in the state of Pennsylvania is already legal and in practice, as well as name reporting of those people diagnosed with one or more of seventeen opportunistic infections closely related to AIDS. Gollub stated that this system leads to under-reporting because area doctors are either unwilling or unable to report AIDS cases to the city in a timely way, either because of their constraints such as time, or the doctor's efforts to protect their patients' confidentiality.
It was unclear how lab reporting would result in an improvement on this problem, since it still ultimately requires the doctor to make the case report. The AIDS office would also have to sift through an unknown number of lab reports of low CD4 counts that were not related to HIV infection.
Two years ago this issue was raised by the health department and was roundly opposed by a wide array of organizations including, over 40 organizations represented by The Philadelphia AIDS Consortium (TPAC), We The People and ACT UP Philadelphia. Then-health commissioner Bob Ross promised that a workgroup would be convened that included community representatives as well as people living with AIDS/HIV to look into the issue and explore alternatives. The workgroup was never convened, however.
Two years ago, We The People proposed a modification to the lab reporting model which would require labs to report CD4 test results under 200 with the name of the doctor who ordered the test, but with an identifier (such as initials and last four digits of the patient's social security number) for the patient that would probably be unique in that doctor's office, but not specific enough to risk a breach of confidentiality. As with Gollub's proposed system, the AIDS surveillance office at AACO would still have to follow up with the doctor to obtain an actual case report, but there would not be the risk of hundreds of test result reports with full names of people with AIDS floating around the city bureaucracy.
Discussions on this modification to the lab reporting system ceased when then-health commissioner Robert Ross and then-AACO epidemiologist Daniel Fife left their posts.
Confidentiality concerns about the city health department were heightened last year when former AACO director Richard Scott inadvertently published the names of four HIV+ members of the city's HIV prevention Community Planning Group. In her February 1st letter, Richman noted that the "AIDS Epidemiology and Surveillance Unit has successfully maintained the confidentiality of every AIDS case reported to it since AIDS became a mandatory reportable disease."
AZT declines in treatment of HIV+ kids
Rapid advances in the treatment of AIDS in children is making use of the drug AZT obsolete, researchers report.
Although AZT is still widely used in the United States, more recent drugs lower the amount of HIV in the body, increase the number of immune cells, and are less prone to viral resistance and uncomfortable side effects.
At the Third Conference on Retroviruses and Opportunistic Infections in Washington last week, a panel of specialists in the treatment of children suffering from HIV disease recommended abandoning AZT as the sole therapy for medicating this vulnerable group of patients.
Instead of AZT, manufactured by Glaxo-Wellcome, Inc., the doctors suggested that young patients start on didanosine (ddI) or stavudine (d4T), both manufactured by Bristol-Myers Squibb, or a combination such as AZT and 3TC, also made by Glaxo-Wellcome.
Dr. Janet Englund of the Baylor College of Medicine in Houston, one of the coordinators of the just-completed AIDS Clinical Trials Group (ACGT) 152 study, said her decision to use ddI as the treatment of choice in children is based on preliminary results of that study.
ACGT 152 compared AZT to ddI alone or a combination of AZT and ddI in treating children as young as three months and as old as 18 years. While results of the study are still being analyzed, the AZT arm was discontinued when trial monitors found that patients in the AZT
treatment group were doing far worse than one of the other arms of the study.
Mark Kline, also of Baylor College of Medicine, said his choice for a first line treatment for his pediatric patients would be ddI or d4T, a drug which he studied extensively during a trial of its toxicity among children.
"I am comfortable with initiating therapy either with didanosine (ddI) or stavudine (d4T) in most children," he said, although he prefers stavudine because it is well tolerated and is easily administered.
Both Kline and Englund said one reason for seeking monotherapy for children is the need to simplify treatment for children who are often being raised in chaotic dysfunctional families with multiple caregivers.
However, Dr. Ross McKinney of Duke University Medical Center in Durham, N.C., said he preferred combining AZT and 3TC for initial treatment of HIV infection among the young. "I'm more aggressive with combination therapies, and we tend to use AZT/3TC," McKinney said, although he also said didanosine was also a viable single drug option.
The panelists discussed recent drug trials among pediatric patients at a program moderated by Dr. Catherine Wilfert, also of Duke University.
Wilfert put the panelists on the spot, asking not for their take on clinical trials but rather how they would apply that knowledge to their patients. She also polled the room of pediatric clinicians and found AZT was no one's first choice for treatment. But there was no consensus on which drug patients should take first.
Wilfert also asked the panelists when they would start treatment with a child newly diagnosed with HIV infection. McKinney said he would begin treatment as soon as he discovered that a patient was HIV-positive. He cited new studies at the conference that indicated control of the viral load in a patient's body was a key element in preventing progression to AIDS and drug resistance.
"I currently would favor now starting treatment as soon as we identified that the child was infected," McKinney said. "I think that with the agents that we have available the goal is to preserve immunologic function for as long as possible."
But Kline and Englund disagreed, citing the number of children who are HIV-infected, yet show no symptoms for years. She said she was worried about problems of viral resistance, although she would treat any child that showed symptoms, "and I might define my symptoms very generously. But I don't think that every newborn child born with HIV seropositivity needs immediate treatment."
In early 1994, a study showed administering AZT to an HIV-infected mother cut the risk of transmitting the virus to the fetus from 24 percent to 8 percent. But since then, studies in the United States and Europe have demonstrated that AZT as a single therapy is not as effective as combinations, and AZT is being further eclipsed by newer classes of drugs.
Although attendees at the conference were in agreement that AZT as a single therapy is no longer the treatment of choice for children -- or adults -- the drug is still being administered to many HIV-infected people.
"The word has not yet reached the clinician at the level at which a lot of people are being treated," said Ann Collier of the University of Washington at Seattle.
Baboon marrow transplant appears to fail
Doctors announced Wednesday that the baboon marrow transplanted into person with AIDS Jeff Getty has apparently failed to take hold.
Getty is in good condition, though, possibly because of the chemotherapy he is receiving. The baboon marrow, which was meant to bolster Getty's immune system, was used because baboons do not get AIDS. The transplant was performed two months ago, and doctors say there is no sign of the baboon cells. Dr. Steven Deeks, who performed the transplant at San Francisco General Hospital, says Getty has improved despite the failed transplant, and that the experiment will yield new areas of study. Deeks said that he plans to repeat the transplant with what he learned from Getty's experience, and that the procedure was proven safe.
Clarithromycin seen useful in prevention of MAC
A trial involving people with advanced AIDS symptoms has found that clarithromycin may be an effective prophylactic treatment for disseminated Mycobacterium avium complex (MAC). When combined with other drugs, clarithromycin appears to reduce the rate of MAC and has few side effects. The trial, which was conducted at the Community Research Initiative on AIDS in New York City, included 39 late-stage AIDS patients. During the study period, none of the patients developed any signs of disseminated MAC infection.
Study claims no benefit for "nontraditional" therapies
A retrospective study of 56 men with HIV at a VA hospital in Pittsburgh found that nontraditional therapies offered no benefit in preventing disease in those studied.
The therapies, including acupuncture, megavitamin therapy, herbal preparations and visualization, did not show any positive effect on disease progression, CD4 cell count or mortality, the study found.
Dr. Nina Singh, who led the study, said that the patients who used nontraditional therapies tended to be more assertive and tried to be more in control of the outcome of their disease.
Famciclovir shown effective in genital herpes
A clinical trial conducted with oral famciclovir demonstrated the antiviral drug to be safe, well tolerated, and effective in significantly reducing recurrent genital herpes in HIV-infected persons. The findings were presented at the Third Conference on Retroviruses and Opportunistic Infections.
"HIV infection appears to increase the frequency of recurrences of herpes simplex infections by compromising an individual's immune system which can make treatment of these diseases more difficult," said Timothy V. Schacker, M.D., principal investigator of the study conducted at the University of Washington in Seattle. "These data are impressive because famciclovir therapy was associated with significantly less overall herpes simplex viral (HSV)
shedding (presence of infectious herpes simplex virus), shedding without apparent herpes lesions (subclinical HSV shedding) and days with herpes lesions reported for patients infected with both HSV-2 and HIV."
This randomized, double blind, placebo-controlled study was conducted with 48 individuals infected with HIV and HSV. Using a crossover study design, patients were randomized to receive either famciclovir (500 mg, twice daily) or placebo for eight weeks, followed by a week-long wash-out period and eight weeks of treatment with the alternative treatment.
Patients completed daily home infusion HSV cultures of the mouth, genitals and rectum each day of the study.
HIV infected persons often experience painful sores, as well as tenderness and burning in the genital area during a recurrence of genital herpes. Infected individuals can spread the disease to others by shedding infectious virus (viral shedding) whether or not signs of symptoms of genital herpes are present. Famciclovir appears effective in reducing the frequency and severity of HSV infection in HIV-infected persons.
HSV-2 reactivation is common in HIV-infected persons and these data demonstrate the efficacy of famciclovir in significantly reducing these reactivations. Famciclovir is also being studied for a number of other herpes virus infections.
Syphilis cases almost double in Baltimore
Health officials in Baltimore are alerting doctors and health care workers about a syphilis outbreak that they think could be followed by a rise in AIDS cases.
The number of syphilis cases in the city has increased by 83 percent in the last year, an increase that is linked to growing use of crack cocaine. People with syphilitic lesions are at a greater risk of contracting HIV or transmitting it to their sexual partners. Public health experts are starting to view the syphilis outbreaks as a warning of increased AIDS cases. The syphilis increase seems to be limited to parts of Baltimore and has not been seen to affect surrounding areas.
Officials from the Centers for Disease Control and Prevention have studied the situation in Baltimore and said they were not able to prove that a decrease in the city health department staff played a role in the outbreak.
Repeal to HIV military ban introduced
A bill to repeal the Dornan provision of the Department of Defense authorization bill -- which banned HIV+ people from serving in the U.S. military -- was introduced in the House last week.
The bill, H.R.2959, sponsored by Representatives Peter Torkildsen (R-MA), Jane Harman (D-CA), and Ronald Dellums (D-CA) has a total of 43 cosponsors. On the Senate side, Senators William Cohen (R-ME) and Edward Kennedy (D-MA) are expected to introduce an identical bill.
There are currently 28 senate cosponsors of this bill. The conference report for the DoD bill passed in the Senate 56-34, January 26, and President Clinton has signed the bill despite his objections to the Dornan provision.
JAMA, Glaxo Wellcome announce HIV/AIDS site on WWW
The Journal of the American Medical Association (JAMA) and Glaxo Wellcome Inc. have announced the creation of a World Wide Web site featuring a collection of peer-reviewed HIV/AIDS information and other resources for health care professionals and the public.
The JAMA HIV/AIDS information Center, made possible by an unrestricted educational grant from Glaxo Wellcome, offers clinical updates, news and information on a broad range of social and policy questions relating to HIV/AIDS. The site is produced and maintained by JAMA editors under the guidance of an editorial review panel of top HIV/AIDS authorities. It
is accessible through the AMA and JAMA Web Sites (http://www.ama-assn.org).
Critical Path challenges censorship of AIDS information on the Internet
Critical Path AIDS Project, and 19 other organizations, have filed a class action suit in Federal Court in Philadelphia challenging certain amendments to the telecommunications bill which President Clinton signed this week.
Congressional Amendments to the telecom bill make it a felony to put "indecent" or "patently offensive" material on the Internet where it may be accessible to a person under 18.
This law will effectively ban explicit AIDS prevention information to both adults and teenagers on the Internet even though identical printed materials will not be affected.
Critical Path AIDS Project, according to its founder Kiyoshi Kuromiya, has been providing AIDS treatment and prevention information and referrals in Philadelphia since 1989 through a nationally distributed 96-page newsletter, a 24-hour telephone hotline, a computer bulletin board system (BBS) and a complex of Web pages on the Internet (http://www.critpath.org). Critical Path Project also offers its clients and related agencies free access to the Internet.
Kuromiya says that, "Such a law will put a permanent damper on the world-wide dissemination of explicit AIDS prevention information. Over 300,000 persons have already died in this country alone and millions more will get sick and die without widespread, innovative, and explicit AIDS prevention measures. This law will stifle such efforts, subjecting AIDS service providers to frivolous threats of arrest, confiscation of equipment, and fines."
The AIDS epidemic is currently threatening communities which lack access to even rudimentary AIDS information, such as the Asian-Pacific Islander communities in Philadelphia and elsewhere, an area of expertise for Kuromiya, who, as a person with AIDS, sits on several Federal research, clinical trials, and treatment panels. Kuromiya says: "Most Asians in the United States with AIDS are in their 20s and presumably many were infected while still teenagers. To deny teenagers and other underserved communities safer sex information would be a tragic public health mistake."
Critical Path in collaboration with AIDS Services in Asian Communities (ASIAC) is currently constructing a large database of AIDS prevention and treatment literature in 8 or more Asian languages on its web page.
Critical Path AIDS Project's life-saving AIDS prevention information is currently utilized by teenagers as well as adults. The organization states that it intends to continue to provide this life-saving service to the public and, with that in mind, has joined in the complaint in Federal Court challenging the constitutionality of the new law.
Group challenges New York condom ban
The New York Civil Liberties Union has challenged the city's ban on condom demonstrations and restrictions on condom distribution in public parks, saying it violates the public's right to free speech.
NYCLU counsel Yueh-ru Chu presented oral arguments in state civil court for a lawsuit challenging the city ordinances.
The Civil Liberties Union is representing All Saints Lutheran Parish, which is suing the city for the right to send volunteers into the city's parks without a permit to teach the public, including teenagers, how HIV is spread and how to prevent its transmission.
"The (U.S.) Supreme Court has held time and time again that the government cannot prohibit free speech just because some people may find it offensive," Chu said. "But there is no evidence that anyone does find it offensive."
But city defense lawyer Albert Fredericks said the restrictions help protect park property and the public's enjoyment of park facilities, including those that may be offended by the demonstration and distribution of prophylactics.
"It exposes the public to unwanted activities -- for example, condoms," Fredericks said. "It creates a whole new set of intrusions on the park environment."
Fredericks said current city statutes allow the distribution of written materials in parks, but anytime a group holds a special event -- defined as a gathering of more than 20 people -- they must apply for a permit from the Parks Commissioner. The Parks Commissioner may impose restrictions on the distribution of products -- including condoms -- to ensure that such activities are consistent with park conservation efforts and the public's use of the park, Fredericks said.
But Civil Liberties Union officials say the First Amendment does not authorize the Parks Commissioner, or any other public official, to act as a censor.
"Parks Department regulations still impermissibly ban condom demonstrations -- a classic free speech violation -- and give the Parks Commissioner the authority to prohibit condom distribution as well," said Donna Lieberman, director of the New York Civil Liberties Union Reproductive Rights Project. "This case will determine whether those working to prevent the spread of HIV will be muzzled as they try to bring their life-saving message to the community."
Judge Alice Schlesinger said she would render her decision on the case in two weeks.