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Issue #138: August 17, 1997
FASTFAX is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some information in this issue include New York Times, Reuters, USA Today, Wall Street Journal.
Clinton orders pediatric testing of AIDS drugs
PCP still often untreated among poor and people of color
Rendell won't target AIDS housing programs
TPAC testifies on HealthChoices problems
Taxol approved for KS treatment
ABA backs needle exchange programs
Clinton orders pediatric testing of AIDS drugs
President Clinton is proposing new legislation to ensure that drug manufacturers test prescription medications for their specific effects on children.The new Food and Drug Administration (FDA) rules, which would go into effect next year, would affect those drugs expected to be used by significant numbers of children.
Many drugs are currently tested on adults alone, leaving doctors few clues as to pediatric dosages and possible side effects.
"The rule I announce today will put an end to this guesswork," Clinton said at a White House press conference. "It will require manufacturers of all medicines needed by children to study the drug's effect on children. The results will then be displayed on drug labels to help pediatricians and other health care professionals make good decisions about how to treat their young patients."
Health and Human Services Secretary Donna Shalala agreed, saying "Kids deserve the same access to newly developed drugs that their parents get."
White House aide Chris Jennings said the new rules would probably cover approximately 12 to 14 new drugs developed each year, as well as many drugs currently available. "The regulation itself lists 10 categories of drugs ranging from asthma to antibiotics to pediatric AIDS drugs," he said, "...particularly these protease inhibitors that are being used in [people with AIDS] in a significant way."
Jennings estimates the new testing would cost pharmaceutical companies "about 1% of the current cost of drug development."
FDA officials believe the proposed drug testing in children should not slow down approval of drugs for use in adults.
Until now, drug companies have been under no legislative obligation to test their products on children. "When drug labels do not include adequate pediatric information, health care providers are forced to play a guessing game that may compromise the care of their patients," said FDA lead deputy commissioner Dr. Michael Friedman. "Not only does this mean sick kids sometimes don't get better, but they also have the potential to get worse as a result of unexpected adverse events."
In fact, the President said that "more than 50% of the medicines that have proved helpful for children have not been adequately tested for children's use."
But Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America (Pharma), a trade organization, says that the proposal is not necessary. "We believe that there is a very extensive amount of testing of children ongoing," he told USA Today. "We question whether a formal government mandate is needed."
Industry officials say another obstacle to increased pediatric drug testing may be a shortage of possible study subjects. "FDA assumes that thousands of children are willing to be tested and that their parents are willing to have them tested," said Dr. John Seigfried, Pharma deputy vice president, speaking to the New York Times. "But in reality, there are not a lot of parents who want their kids to be in clinical tests just for the sake of satisfying the Government."
Those involved in caring for ill children are praising the new rules, however. Dr. Joseph Zanga, vice-president of the American Academy of Pediatrics, said his organization "enthusiastically applauds President Clinton's efforts to ensure that children will no longer be 'therapeutic orphans.'"
And David Harvey, executive director of the AIDS Policy Center for Children, Youth, and Families heralds the announcement as "a great day for sick children in America."
PCP still often untreated among poor and people of color
People living with HIV disease who are uninsured or who are not white are less likely to receive primary prophylaxis for Pneumocystis carinii pneumonia (PCP). That's the conclusion of researchers at the San Francisco Department of Public Health in California who report the results of a chart review in the August issue of the journal AIDS.To identify which patients are being overlooked for primary and secondary PCP prophylaxis, Dr. Sandra K. Schwarcz and her colleagues reviewed the charts of patients diagnosed with AIDS at San Francisco area hospitals in 1993. Specifically, they reviewed the medical records of the patients who had PCP as their AIDS-defining illness.
They found that only 114 of the 326 patients considered eligible for primary PCP prophylaxis actually received it. Being unaware of their HIV status and not receiving regular medical care were the most common reasons given for not receiving primary PCP prophylaxis.
"After adjustment for age, sex, and injecting drug use in logistic regression analysis, non-whites...and the uninsured...remained less likely to have received primary prophylaxis." However, they found no significant sociodemographic differences that were associated with the likelihood of receiving secondary PCP prophylaxis.
To lower the number of preventable cases of PCP, Dr. Schwartz and colleagues suggest that interventions that increase the rate of "...counseling, testing and referral to medical care for persons at high risk for HIV infection are needed." Given the relatively high level of AIDS awareness and community services in the San Francisco area, they also suggest that "...a similar study would find an even higher proportion of preventable cases of PCP elsewhere."
Rendell won't target AIDS housing programs
A recent policy directive which requires the Mayor's approval of any new "special needs" housing programs is unlikely to impact the development of new AIDS housing in the city, according to David Fair, acting co-chair of the Housing Committee of the Philadelphia EMA HIV Commission.The policy, issued last month by the Mayor's Chief of Staff, Gregory Rost, required city agencies supporting AIDS housing and other special needs projects to delay implementation of the programs pending a review by the Mayor's office of community concerns and neighborhood issues. Special needs housing advocates interpreted the new policy as an attempt by the Mayor to support neighborhood opposition to the locating of special needs housing in their communities, because of concerns about property values and increased traffic and crime sometimes said to be related to the programs.
With the exception of the establishment of Betak, the former AIDS nursing home in West Mt. Airy seven years ago, none of the AIDS housing programs have experienced significant neighborhood opposition, Fair said. He said that AIDS housing developers have always worked closely with neighborhood representatives to assure that the programs are integrated into the life of the communities where they are located.
"No person with AIDS wants to live in a neighborhood that doesn't want them there," he said. "And no housing provider has wanted to waste time on neighborhood fights to no purpose."
Fair said that a City Hall representative told him that the Mayor's directive is mostly aimed at reviewing programs for adolescents in the juvenile justice system and programs for people with mental and developmental disabilities, and was unlikely to be used to delay or prevent AIDS housing projects.
"It's great that people with AIDS won't be unreasonably hampered by the Mayor's policy," he said. "But other people with special needs have a legal right to live wherever they want to live. It's important that we be vigilant in assuring that the Mayor's efforts to respond to community concerns don't unfairly inhibit the rights of disabled people whatever their special needs are."
TPAC testifies on HealthChoices problems
Larry Hochendoner, Executive Director of the Philadelphia AIDS Consortium (TPAC), presented testimony before the state House of Representatives' Health and Human Services Committee this week, alerting legislators to the special obstacles to quality health care resulting from Pennsylvania's new Medicaid managed care program, called HealthChoices.TPAC is the state HIV services planning council, responsible for determining priorities and allocating over $6 million in federal and state AIDS services and HIV prevention funding.
The testimony was delivered at a hearing that focused on special needs populations and managed care. The purpose of the testimony was to "fulfill the Consortium's even greater responsibility -- that of advocating for, and with, the people living with HIV/AIDS, in our area and those who serve them," Hochendoner told the committee.
In his testimony, Hochendoner discussed the complications many PWAs are faced with because of the mandatory Health Choices enrollment that was implemented spring. He stressed to legislators that they must "...take on responsibility for instituting the oversight that this program so badly needs."
Hochendoner asked that four critical areas be addressed immediately. Noting that complaints of the four Medicaid managed care companies that they are not receiving a high enough reimbursement rate to compensate for the costs of AIDS care, he said that the state needs to revamp the monthly capitation payments" made to the HMOs for their patients to assure that they adequately cover the actual costs of care.
AIDS advocates have pointed out that since people with HIV/AIDS are too costly to care for under the state's reimbursement mechanism, managed care plans are discouraged from admitting people with HIV disease into their plans or developing the quality services that would attract them. One HMO, HealthPartners -- which is believed to have the highest number of HIV patients among its members -- recently suspended new enrollees in Delaware County and restricted its development of AIDS "centers of excellence," targeting its financial losses due to AIDS services as the primary reason.
Hochendoner also asked the legislature to "compel" the Department of Public Welfare (DPW), which manages HealthChoices, and the four HMOs "to meet the terms of the federal HCFA waiver with regard to provision of geographically accessible and linguistically competent care." Some PWAs, especially in suburban areas and in the Latino and Asian communities, have claimed that it is more difficult for them to access quality care under HealthChoices.
Hochendoner all called for AIDS-specific quality assurance procedures and performance measures, to "ensure that appropriate levels of care are being provided to individuals with special needs."
He also charged that DPW has failed to "to link performance and financial incentives in any way must also be corrected.
Yoshiaki Yamasaki, a staff member of the Philadelphia EMA HIV Commission, the Title I HIV Planning Council, reiterated these points in his testimony and stressed the need for culturally and linguistically competent services through Health Choices.
"To date, the Health Choices system has been ineffective in complying with the regulations that they are required to follow with regard to cultural and linguistic competency," Yamasaki said. "After a year of `working with the community' the system is failing miserably at serving anyone speaking a language other than English."
Hochendoner said that "Right now, HealthChoices constitutes neither an improvement in care at the consumer level nor a realistic cost savings to the taxpayer. This situation cannot be expected to change without dramatically increased oversight and close attention to the existing and burgeoning problems that now exist."
PWA prison group forms
A new Prison Activist Group, working on hands-on advocacy (such as letter writing and working on winning specific campaigns or projects), has been formed by a local group of people living with HIV, to improve conditions for prisoners with HIV.The group also discusses issues that are relevant to prisoners with HIV both during and after their incarceration. The group is committed to highlighting the obstacles that prisoners living with HIV face, and trying to make these issues a priority for the AIDS service system in the southeastern Pennsylvania region.
The next meeting of the group is set for September 15 at 2:00 p.m.
For more information call Agnes Harley at 985-4448.
MDs publish caregivers guide
Physicians now have comprehensive guidelines to offer the non-professional who provides home care to individuals with HIV infection or AIDS, according to a press release from the American College of Physicians (ACP).The College has published a problem-solving reference entitled the "Home Care Guide for HIV and AIDS," which "...provides step-by-step instructions for managing all aspects of home care for HIV and AIDS." The guide also includes tips on how to work effectively with physicians, nurses and social workers.
The book contains 24 chapters that focus on both the physical and emotional problems associated with HIV infection. Each chapter is broken down into sections that include understanding the problem, when to seek professional assistance and how to get help when it is needed.
A review copy may be obtained by contacting the ACP Books Department at 215-351-2618.
ODAAT denies newsletter ban
Stephen Pina, executive director of One Day At A Time, has denied a report in fastfax that his organization banned the distribution of the August issue of Alive & Kicking!, We The People's monthly newsletter, at ODAAT's neighborhood service sites and recovery houses.fastfax had reported that copies of the newsletter, distributed by United Parcel Service at over 100 sites throughout the region every month, were returned to WTP after they were refused at ODAAT's central AIDS center in North Philadelphia. A visit to the Germantown ODAAT site on August 6th after the newsletters were delivered also showed that there were none available there.
Curtis Osborne, executive director of We The People, had said that the issues were probably because of a report in the newsletter which criticized efforts by the Philadelphia EMA HIV African American Planning Group (PEHAAP) to gain control over almost $4 million utilized by African American AIDS service organizations.
Pina said that if the copies of the newsletter were refused, it was either a mistake or the action of an individual rather than organizational policy.
Osborne said despite Pina's denial, We The People still believes that the copies of Alive and Kicking! were purposely rejected by ODAAT, since it is the only organization which provides AIDS services which has supported PEHAAP's efforts. Last week, he charged that Pina "has made a career of degrading people in recovery and people with AIDS. It's no surprise to me that he wants to keep them from learning the truth about the PEHAAP scam. We all have known for many years that ODAAT just thinks of its PWA residents as a tool they can use to beat up on the system for more money -- and rarely does ODAAT bother to really educate or empower their people with AIDS to do anything except follow Pina like sheep to the slaughter."
fastfax also noted that two months ago, Pina told a meeting of the HIV Commission that he would not permit ODAAT residents with HIV disease to fill out a consumer needs assessment being conducted by the Philadelphia HIV Commission to determine the needs of people living with HIV/AIDS.
ODAAT has been severely criticized in the past for requiring its members to participate in meetings, hearings and demonstrations as a condition of keeping their residence in the program. Others have charged that ODAAT has turned out people who do not have HIV infection to events and claimed that they were suffering from the disease. Still others say that ODAAT rarely informs its residents with HIV on the issues which affect them, and tells them to keep silent at meetings and demonstrations and let Pina and other ODAAT staff do the talking.
Osborne said he was pleased that Pina had agreed to continue allowing the distribution of Alive & Kicking! at the organization's neighborhood sites.
Taxol approved for KS treatment
The U.S. Food and Drug Administration has approved Bristol-Myers Squibb's cancer drug Taxol for the treatment of AIDS-related Kaposi's sarcoma.According to the drug maker, Taxol therapy reduced the size of patients' tumors and diminished their symptoms and pain. Moreover, Bristol-Myers noted, Taxol helped a majority of patients who had failed other therapies.
ABA backs needle exchange programs
The American Bar Association (ABA), the world's largest legal group, has urged an end to legal barriers that prevent the implementation of needle-exchange programs.At its annual meeting in San Francisco, the ABA's House of Delegates voted 233 to 175 in favor of adopting a resolution stating that the group "supports the removal of legal barriers to the establishment and operation of approved needle exchange programs that include a component of drug counseling and drug treatment referrals." Proponents of the measure noted that needle-exchange programs help curb the spread of HIV and other bloodborne diseases without increasing drug use. Critics pointed out that the policy condones illegal drug use and question the ABA's involvement in the debate.
This Week: WTP on the air
We The People's weekly television program, Positive Health, will feature a powerful video about sexuality and religion called "All God's Children," this coming Tuesday (August 19th) at 7:30 p.m. on WYBE-TV Channel 35. The program also includes interviews with members of the Ecumenical Information AIDS Resource Center, a project which provides AIDS education and services through a network of church communities in North Philadelphia.Positive Health is hosted by We The People's Hassan Gibbs and the health department's Carol Rogers.
WTP's weekly radio program, on West Philadelphia's WPEB-FM, 88.1, will feature an interview next week with AIDS activist David Fair. Hosted by Ellis Morrison, the program also reports on the latest news of concern to people living with HIV/AIDS and those who care about them. The program is broadcast every Tuesday from 1:00 to 3:00 p.m.
To obtain a weekly email version of fastfax, contact with the message: "subscribe".