published by We The People Living with AIDS/HIV of the Delaware Valley, Inc.
HMOs won't reveal AIDS doctors
Merck will delay increased access to Crixivan
FDA approves test of nontoxic AIDS treatment
Medical marijuana measure passes in California
Criminal charges again in the news
HMOs won't reveal AIDS doctors
People with HIV/AIDS who have sought to sign up for the state's new HealthChoices Medicaid managed care program are reporting that they are unable to find out which plans their current doctors participate in, or how to find an AIDS doctor if they don't have one.
Under HealthChoices rules, participating managed health care insurance companies are required to publish lists of physicians who accept AIDS patients and special "benefits counselors" are supposed to help an individual with HIV make an appropriate selection.
However, members of We The People who have sought to join HealthChoices have been told in all cases that no such lists exist and that they have to telephone the HMOs directly to find out who -- if anyone -- specializes in AIDS care. In at least one case, the benefits counselor referred an individual to an HMO, which then referred the client back to the benefits counselor for the information.
HealthChoices, which starts in January, will require all Medicaid recipients in the five-county southeastern Pennsylvania area to join special Medicaid HMOs, including people with HIV who are not formally disabled. Disabled people, including those disabled by HIV disease, will not be required to select a plan until next July.
People with AIDS and AIDS service providers have been united in their opposition to the implementation of HealthChoices for people living with HIV/AIDS, asking that the state delay their inclusion until the HMOs identify their panels of AIDS physicians, establish a quality standard of care, and assure that more effective quality assurance and grievance mechanisms are in place.
The AIDS Law Project of Pennsylvania and CHOICE, which runs the Philadelphia AIDS Hotline, provided an intensive training to benefits counselors on helping people with AIDS in September. They reported to an ad hoc advocacy group on HealthChoices that the benefits counselors had previously received no information about the special needs of people living with HIV/AIDS. At a follow-up meeting of the benefits counselors, most of those present were still unable to help a person with AIDS in a "role-playing" exercise, because none of the HMOs had identified which physicians had experience in AIDS care as required by state regulations.
Philadelphia Health Commissioner Estelle Richman told about 70 people with AIDS at a meeting sponsored by We The People and Philadelphia FIGHT last week that she would raise the issue in a meeting with HMO executives this month.
Meanwhile, a report in Treatment Update, a publication of the Community AIDS Treatment Information Exchange (CATIE), says that a team of doctors which has been monitoring 1,000 men with HIV/AIDS to find out the effect managed care has on their health found that survival rates decreased for participants in managed care plans.
The doctors found that 50% of men who had AIDS at the time they entered the study or who developed AIDS while in the study lived for 17 months under managed care. The equivalent figure for men who were in the traditional fee for service system was 30 months. This difference -- an increase in survival time of 60% -- was "statistically significant," the doctors said, that is, "not likely caused by chance alone."
PhilCARE out of HealthChoices
Pennsylvania welfare department officials have prohibited PhilCARE, a new health maintenance organization formed by controversial, politically-connected physician Eugene Newton, from participating in HealthChoices.
DPW said that the firm would not get a contract to provide managed care services to hundreds of thousands of low-income Philadelphians because it was unable to come up with $10 million in financial backing required by the state. The requirement had been placed because PhilCARE had no track record of providing managed care services, unlike the other HMOs participating in the new system.
Newton, a major campaign contributor to Governor Ridge and other politicians from both parties, has been blamed by the state and advocates for poor quality medical services at the Philadelphia Nursing Home. The state health department has several times suspended the Home's license in response to complaints about mistreatment of patients by Newton at the facility. As far back as 1989, then-AIDS Activities Coordinating Director David Fair physically removed a patient from the Home when it became clear that Newton could not provide him the care he needed.
Last year, Newton paid a $400,000 settlement to avoid charges of Medicare fraud.
PhilCARE had already been in trouble with DPW on its application for participation in HealthChoices. Noting Newton's previous indictment for fraud, the state had required that a trustee be appointed to hold 2% of PhilCARE shares so that Newton would not be the majority owner of the company. At the time of the company's application, he held 51% of the shares. The remaining 49% was owned by United American Healthcare Corp., a Detroit firm.
Newton was also prohibited from being involved in any financial or management control of the firm, although he would have been permitted to retain any profits he made from his remaining investment.
Three other HMOs have signed HealthChoices contracts with the state: Keystone Mercy Health Plan, OakTree Health Plan, and Healthcare Management Alternatives, which currently runs the HealthPass program in West and South Philadelphia. A contract with HealthPartners, a consortium of five area hospitals, is expected soon. All four companies currently provide Medicaid managed care programs in a voluntary program, which over 60% of Medicaid recipients already participate.
QualMed, which had originally sought a HealthChoices contract, pulled out last month, noting that it did not think it could make any profit through the state's program. Oxford Health Plan is also expected to pull out from the program later this month.
Merck will delay increased access to Crixivan
Crixivan (indinavir), which was scheduled to be available through retail pharmacies by the end of the year, will not be distributed until sometime next year, according to the drug's manufacturer, Merck & Co.
The company attributes the delay in expanding the distribution of their protease inhibitor on production limitations and a higher than anticipated demand. More than 60,000 patients in the U.S. currently receive indinavir, surpassing Merck's predictions, commented a company official. "As a result, Merck hasn't been able to build enough inventory to begin distribution through retail pharmacies," he said. Merck received FDA approval to market indinavir in March of this year.
Merck has sold indinavir in limited quantities exclusively through Stadtlander's Pharmacy in Pittsburgh. This has allowed the company to strictly control the number of patients who receive the drug and to ensure the availability of drug supplies for refills.
AIDS activists have protested this exclusive arrangement, saying that Stadtlander's is too expensive. Excluded retail pharmacies have lobbied Congress and federal regulators in protest. And according to Robert Marshall, head of the California Pharmacists Association, the exclusive distribution policy is unnecessary and Merck could have offered patients expanded access to the drug in the first place.
FDA approves test of nontoxic AIDS treatment
The U.S. Food and Drug Administration has given CytoDyn clearance to test Cytolin, the first in a new class of nontoxic AIDS drugs.
Unlike current AIDS drugs, which attack HIV directly, Cytolin aims to correct the self-destruct mechanism of the immune system that is triggered by an HIV infection.
The progress of the new drug's development is notable in part because CytoDyn's efforts have been funded on a tight budget of $1.25 million -- a small sum by pharmaceutical standards. Most of that amount was raised from HIV-positive, gay male professionals and businessmen with a personal stake in fighting AIDS.
Cytolin is a monoclonal antibody designed to prevent one part of the immune system -- a particular type of "killer" CD8 cells -- from attacking CD4 cells, the destruction of which results in most symptom of AIDS. Cytolin is designed to protect the immune system's natural defenses while antiviral drugs take the offensive against HIV itself.
"What distinguishes Cytolin is its apparent ability to restore the body's defenses," said David N. Hart, M.D., CytoDyn's medical director. "It works to repair a chink in the immune system's armor that HIV managed to expose."
Many experts believe that both offensive and defensive strategies will be required for the long-term control of HIV/AIDS, according to R. Scott Hitt, M.D., a Los Angeles area physician who chairs the Presidential Advisory Council on HIV/AIDS.
"Some Americans believe that the fight against AIDS is practically over, now that combination drug therapy has shown us a break in the clouds," said Hitt, "but the storm is far from over. More options as well as less-toxic treatments are needed."
"We are encouraged by the growth of knowledge about this disease and by the efforts of companies like CytoDyn to develop new therapy approaches based on this knowledge," he said. "We look forward to the evaluation of this therapy by way of FDA sanctioned clinical trials."
Cytolin is designed as an injection to be given in a doctor's office, most often as an adjunct to a combination of antiviral drugs.
Combinations, or "cocktails," of antiviral drugs have helped some patients significantly reduce the level of their HIV infection, improving their health. However, the side effects of antiviral drugs can be so significant that at least 15 percent of patients cannot take them. Even some patients who can tolerate antiviral therapy have continued to face declining health.
The FDA's action clears the way for a Phase I/II clinical trial in which 16 AIDS patients will receive Cytolin. Dr. Victor L. Beer, a prominent Los Angeles area AIDS specialist, will conduct the trial.
Medical marijuana measure passes in California
A California ballot initiative to legalize the use of marijuana by the sick won the support of voters Tuesday despite warnings from opponents that it could undermine the fight against drugs.
California's Proposition 215, "The Medical Marijuana Initiative," was one of the most closely watched ballot measures in the nation, drawing support from George Soros, the billionaire financier, and fire from President Clinton.
The measure had the support of about 56 percent of voters versus 44 percent against, with nearly 60 percent of electoral precincts reporting, state election officials said.
The measure would allow sick people and their "primary caregiver" to legally possess and grow marijuana for medical use when recommended by a doctor.
Supporters said marijuana often eased nausea in cancer patients undergoing chemotherapy, reduced the pain of AIDS patients and lowered eye pressure in glaucoma sufferers.
Opponents, who included many state law enforcement officials, said the proposal was an attempt to legalize marijuana through the back door.
Clinton's drug policy chief, retired Gen. Barry McCaffrey, denounced the proposition as a "hoax" and said the federal government would prosecute doctors who prescribed marijuana.
Doctors were split on the issue due in part to a lack of conclusive studies to prove whether marijuana was safe and effective as a medicine.
Emboldened by their victory in California, supporters of the measure said
they would pursue similar efforts in other states. A similar measure was also passed in Arizona.
During the high-profile campaign, proponents of the measure argued that thousands of ill Californians already used marijuana despite the law and that the initiative would give them a legal defense if they were arrested. Non-medicinal use of marijuana would still be illegal, they said.
"This bill was designed for people who use marijuana for legitimate medical purposes and we intend to see that it is implemented in that manner," said Scott Imler, one of the authors for the measure. He added that he expected the controversial initiative to survive any court challenge.
Opponents of the initiative had warned that it would create legal loopholes to protect drug dealers from prosecution. They said it was so loosely worded that headaches, an upset stomach or a stiff neck could be cited as reasons for its use.
Criminal charges again in the news
ActionAIDS abruptly withdrew its appointment of A. Billy S. Jones as its new executive director after publication of a report in the Philadelphia Gay News that Jones had served a year in prison for embezzlement of $57,000 from a San Francisco youth agency. Jones had been expected to start his new job in January.
Jones would have been the first African American in the organization's ten-year history to serve in a senior management capacity at the organization. He was set to replace Ennes Littrell, the organization's director since 1988. Jones had also been involved in a controversy about allegedly mis-used funds related to the first National Gay and Lesbian March on Washington in 1979, but no charges were ever filed.
David Blum, ActionAIDS board president, announced after the decision to withdraw Jones' appointment that the group will offer the job to Kevin Conare, a former hospital administrator who has been deputy executive director of ActionAIDS for three years and who has been acting as interim executive director since Littrell's departure in September.
Meanwhile, Fran Stoffa, the former director of Philadelphia Community Health Alternatives (PCHA) has pleaded "no contest" to charges that he stole $52,000 from the organization. He was sentenced to four years' probation and ordered to repay the money. Stoffa, who was accused by a grand jury in March 1995 of embezzlement, resigned in April 1994.