|
 |
|
|
|
Issue #200: October 23, 1998
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 articles in this issue include Akron Beacon-Journal, Chicago Tribune, DVHC Update, Journal of AIDS and Human Retrovirology, Kaiser Daily HIV/AIDS Report, Reuters, US Newswire.
New budget increases AIDS funding by $350m
State holds hearing on HealthChoices drug programs
Glaxo seeks FDA nod for new protease inhibitor
Study says PWAs overestimate adherence
PWA homelessness grows in LA; $13 million unspent
Study reveals misperception of transmission risk
Chicago rejects call to test high schoolers
New budget increases AIDS funding by $350m
The fiscal year 1999 budget signed by President Clinton this week includes a $350 million increase for HIV/AIDS prevention and treatment.
Funding for the Ryan White CARE Act will be at $1.6 billion, including a 61% increase in funding for state AIDS drug assistance programs such as Pennsylvania's special pharmaceuticals program. The Centers for Disease Control and Prevention will receive about $630 million for HIV prevention efforts.
After intense lobbying by members of the Congressional Black Caucus, the budget also includes an additional $130 million to be allocated for HIV/AIDS prevention and treatment in minority communities, focusing on prevention programs in high-risk groups and increased access to antiretroviral drugs.
The fiscal year 1999 budget also increases the budget of the National Institutes of Health by 14%, or $1.9 billion. Increased funding is to go to research on diabetes, cancer, genetic medicine and development of an AIDS vaccine.
In a statement issued by the Gay Men's Health Crisis, the New York-based AIDS advocacy group welcomed the budget news and commended the "...bipartisan commitment to AIDS care and support shown by the Congress and Administration during these last few weeks."
However, the FY99 budget has "...failed to boost the nation's overall HIV prevention efforts, according to GMHC's Derek Link, Director of Federal Affairs. The group also objects to "last minute" riders to the spending bills, which include HIV testing of federal inmates at the request of correction officers and restrictions of needle exchange programs in Washington, DC.
At the urging of Reps. Tom Coburn (R-OK) and Gary Ackerman (D-NY), the new budget also contains $10 million for the previously unfunded "Baby AIDS" program contained in the Ryan White CARE Act to "assist states in reducing the perinatal transmission of HIV," sources in Coburn's office said. The Baby AIDS program was authorized by the Ryan White CARE Act Amendments of 1996 but was not previously funded. The amendment contains language to provide funding for states that develop counseling and outreach programs to pregnant women who are at high risk of contracting HIV.
The language would also provide funding for states that choose to enact either a voluntary HIV testing program for pregnant women or a mandatory HIV testing program for newborns.
Both Coburn and Ackerman assert that the amendment "would not mandate HIV testing." They say it would merely provide states with the funding to implement testing and counseling programs which they believe would best reduce perinatal HIV transmission.
However, some advocacy groups opposed the measure in light of a recently issued Institute of Medicine report that urges standard, but voluntary, testing of all pregnant women.
AIDS Action Executive Director Daniel Zingale said Coburn is "out of step." He said Coburn is "now prioritizing testing of babies rather than pregnant women," although the IOM report only emphasizes the testing of women. He said the report stresses interventions that focus on HIV-positive pregnant women, such as AZT administration, but that Coburn wants testing "after the fact." Zingale said, "It doesn't make sense medically to me."
The budget bill also denies authority to the District of Columbia to permit the distribution of clean needles to injection drug users. But the Whitman-Walker Clinic, which sought funding for its syringe exchange programs, has set up a private group to run the program.
The budget bill bans DC from using either local and federal funding for any needle-exchange program in the District of Columbia. This is on top of a ban on federal funding of needle exchanges anywhere in the country.
The Whitman-Walker Clinic, which gets $7 million a year in federal and local government dollars, has operated a clean-needle exchange for three years. It got $210,000 from the district this past year for the effort and raised $50,000 from private donors. Last month, its van distributed 17,000 needles.
The clinic, one of the nation's largest, has created a private, nonprofit group to run the program, transferring equipment, supplies and $50,000 in private funds to the new operation. The Washington-based Drug Policy Foundation gave the new group, Prevention Works Inc., an additional $25,000.
"Sounds like they've got some pretty sharp lawyers," Rep. Todd Tiahrt, R-Kan., who sponsored the ban, said on hearing the news.
Prevention Works should have enough resources to keep the needle-exchange van running for four or five more months, said Jim Graham, Whitman-Walker's executive director, who is running for the DC City Council.
"This law is intrusive," Graham said. "It not only tells D.C. how we can spend our own local tax dollars, but it tells charities like Whitman-Walker how we can spend private funds."
Needle exchanges programs are operating in about 100 U.S. cities. Supporters say such programs help prevent the spread of AIDS by allowing addicts to exchange contaminated needles for clean ones. Opponents contend the programs encourage drug abuse.
In other congressional news, the Senate has approved Sen. Mike DeWine's (R-OH) version of the Ricky Ray Hemophilia Relief Act, which authorizes payments of $100,000 apiece to compensate hemophiliacs or their survivors for the government's failure to aggressively screen tainted blood products.
Sen. James Jeffords (R-VT) dropped his insistence that non-hemophiliacs who contracted HIV through blood transfusions also be included in the bill, after it became clear that he could not develop consensus to include the transfusion victims, which was expected to double the cost of the measure.
Jeffords' spokesperson Joe Karpinski said, Jeffords will try again next year to include transfusion victims.
The measure does not put the checks in the mail, however, because it does not allocate any money. However, with the authorization in hand, the bill's backers can lobby Congress to appropriate the estimated $750 million it would cost.
HIV/AIDS activists expressed cautious approval of the bill. AIDS Action Executive Director David Zingale said in a release that the "Senate's passage ... is a great victory for those who suffered at the hands of a negligent federal health bureaucracy. We are pleased that the families of those who died from government negligence will once and for all get restitution."
However, Zingale warned that his group "will work to ensure that the approximately $750 million in funding is not drawn from life-saving AIDS programs, including the Ryan White CARE Act. Don't rob from Ryan to pay for Ricky."
Katherine Muir, president of the National Hemophilia Foundation, said, "This is a great day for the bleeding disorders community. This money will help offset medical bills that have accumulated over many years. The cost for HIV and hemophilia treatment is quite expensive and this compassionate payment will help address ongoing medical cost[s] which have often resulted."
State holds hearing on HealthChoices drug programs
The Pennsylvania HealthChoices program was the focus of a local hearing held in the region in early October by the Pennsylvania House of Representatives' Health and Human Services Committee, chaired by Rep. Dennis O'Brien (R-Philadelphia) to gather facts about the adequacy of access to pharmaceutical services for Medicaid recipients in the HealthChoices program.
All of the major drugstore chains in the region, with the exception of Rite Aid, have dropped out of all or some of the HealthChoices HMOs because of low reimbursement rates. This has made it much more difficult for people with HIV/AIDS and other chronic diseases to routinely get their medications.
Representing CVS Pharmacy, Regional Healthcare Manager George Tomaino testified to the panel regarding the company's decision to discontinue its relationship with Keystone Mercy Health Plan's pharmacy program. While acknowledging that Keystone Mercy represented the largest share of the Medicaid market and that the decision was tied to significant revenue loss for CVS, Tomaino said the company could not justify accepting negotiated terms that would result in filling prescriptions at a loss. Tomaino also noted that Eckerd Drug made an identical decision.
Given that the two pharmacy chains comprise approximately 25 percent of the region's market, Tomaino noted that a "definite lack" of access to pharmacy services exists for the area's Medicaid beneficiaries.
Other pharmacists, including many who are community-based and self-employed, testified on concerns for patients in the community they serve and their ability to remain in business given the four HealthChoices HMO plans' low reimbursement rates, burdensome administrative hurdles and restrictive drug formularies.
Joseph Mogil, pharmacist and proprietor of M.D. Pharmacy, told the panel that "pharmacies in our poorest neighborhoods continue to close" as a result of the plans' rates.
Community and public health advocates, including Mary Hurtig of the Mental Health Association of Southeastern Pennsylvania and Bruce Flannery of the Pennsylvania Coalition of AIDS Service Organizations, also offered testimony to the panel on a host of concerns from the denial of approval for behavioral health medications to the needs of special needs populations, most notably those with AIDS.
Glaxo seeks FDA nod for new protease inhibitor
Glaxo Wellcome has submitted a new drug application for the HIV protease inhibitor amprenavir (Agenerase) to the FDA, according to an announcement from the company.
Designated as a "fast-track" product by the FDA, Glaxo officials anticipate an expeditious review by the agency.
In clinical trials, amprenavir has shown significant antiretroviral activity and is administered two-times daily, as opposed to the three-times daily dosing required by currently available protease inhibitors.
Amprenavir has been successfully used in a number of two-, three-, and four-drug regimens with nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and in combination with other protease inhibitor drugs. The new drug application includes data on the safety and efficacy of amprenavir from 20 clinical trials involving about 1,500 patients, Dr. Lynn Smiley, vice president of the company's antiviral clinical research division, said in a statement.
The preliminary results of phase III clinical trials, reported at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego in September, indicated that amprenavir, used in combination with Epivir (compound containing lamivudine and zidovudine), reduced viral load to undetectable levels in 65 out of 74 patients for 16 weeks.
An early access program for amprenavir was approved in mid-September for patients who have failed a regimen containing a protease inhibitor. Physicians can call 1-800-248-9757 for more information on how to register their patients for the expanded access program.
Amprenavir is administered in eight 150 mg capsules twice daily, and can be taken with or without food or water. Pediatric capsule and liquid formulations have also been developed.
Study says PWAs overestimate adherence
Self-reports alone do not appear to provide an accurate assessment of adherence to drug regimens among HIV-positive people, according to a recent study.
In particular, patients tend to inadvertently fail to report fluctuations in their dosing schedule, the study's authors claim.
Dr. Kathleen M. Melbourne of the University of Rhode Island in Providence presented these findings at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego last month.
To better understand the rates of drug adherence among HIV-positive patients, Dr. Melbourne and her colleagues compared the results of self-reports with those obtained using an electronic monitoring system, which is considered the "gold standard" in measuring compliance with treatment regimens.
Overall, they found that both methods indicated high rates of drug compliance.
Self-reports of compliance were "consistently higher" compared with those obtained using electronic monitoring. The results of electronic monitoring indicated that up to 43% of subjects actually did not take their protease inhibitors within 2 hours of the self-reported time.
Only 1 of the 44 patients took 100% of doses during the 3-month study period; and 24% of the patients "...overestimated how many doses they actually took by more than 10%."
Based on these results, Dr. Melbourne's group concludes that when used alone self-reporting is "...not a reliable method of accurately measuring this study population's overall medication adherence."
PWA homelessness grows in LA; $13 million unspent
The AIDS Healthcare Foundation (AHF), a Los Angeles advocacy group, says that while L.A. Mayor Richard Riordan's Housing Opportunities for People with AIDS (HOPWA) program sits on over $13 million dollars in federal funds to house people with AIDS in Los Angeles, a city study reports two-thirds of persons with AIDS surveyed had recently been homeless.
AHF has called for a federal investigation of the city program, which has 130% of its annual budget unspent, and also call on the city to adopt an AIDS Housing Bill of Rights.
"It's an outrage for anyone with AIDS in Los Angeles to go homeless while millions of federal AIDS housing dollars sit untapped in city coffers," said Michael Weinstein, AIDS Healthcare Foundation President. "For people with AIDS, homelessness is a medical emergency that leads to lapses in treatment, which can lead to death. The city is creating both a private and public health emergency with its gross mismanagement of this program."
According to findings from the city's own AIDS housing survey, nearly two- thirds (65 percent) of PWAs in the survey report they were homeless at least two times during the past three years. The report, titled Preliminary Findings on the Housing Study for Persons Living with HIV/AIDS in the City and County of Los Angeles, was prepared for the city of Los Angeles by Shelter Partnership, Inc.
Despite the fact that the city pays itself one million dollars a year to administer the program out of the approximately ten (10) million dollars allocated annually by the federal government to provide housing for people with AIDS in Los Angeles, a report by the city controller's office shows that L.A.'s HOPWA office "has failed to do its job" and that 13 million "unspent and unencumbered" federal dollars have not been put to work in Los Angeles as mandated by the Department of Housing and Urban Development (HUD), according to Weinstein.
If not used as mandated, federal regulations stipulate that the money eventually be returned to the federal government.
The city survey, the first comprehensive study on housing for PWAs in Los Angeles, consisted of 785 client interviews with PWAs who had been assisted by the program in some manner and were thus already in the system. Weinstein said that since those surveyed were already receiving some kind of AIDS services, the results should have slanted the statistics in favor of the housing program. "Remarkably, the survey results present a stinging indictment of the HOPWA AIDS housing program's shortcomings," he said.
Among the statistics:
--Two-thirds (510 people) of the PWAs interviewed reported being homeless in the previous three years (an average of two times for each person)
--45 percent (233 people) of these were currently homeless (almost one- third of the total 785 people surveyed)
--68 percent of all those surveyed were people of color, mirroring an increase in AIDS among minorities.
At a vigil held earlier this month, activists called for implementation of an emergency 3-point plan to "fix this crisis in AIDS homelessness" in Los Angeles. Highlights of the plan include calling for a federal investigation of the local management of the $13 million federal AIDS housing dollars; freeing this funding from the jurisdiction of the City Housing Dept. so that it will be used for its federally-mandated purpose of housing people with AIDS; and calling for immediate implementation of the "AIDS Housing Bill of Rights," a document which seeks legal protections for PWAs right to secure housing.
"We call on Mayor Riordan to immediately review this critical program and put these wasted dollars to work," said AHF's Weinstein.
"These federal dollars were sent to L.A. not only to ensure the health and safety of L.A.'s homeless PWAs, but to protect the public health of all Angelenos."
Study reveals misperception of transmission risk
A recent study found that "a small but significant proportion of more people with HIV believes that safe sex is less important for those receiving antiretroviral therapy."
The study, published in the Oct. 1 issue of Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, questioned 147 people infected with HIV about their perceptions of the need for safe sex practices and the risk of transmission.
The study found that for those receiving protease inhibitor therapy, 19% of respondents believed there was less need for safe sex practices, and 20.4% of respondents felt the risk of transmission was reduced. For those receiving reverse transcriptase inhibitors, 9.5% believed safe sex was less important and 10.2% perceived a reduced risk of transmission. For those receiving no therapy, 98.6% of respondents thought anal sex was "very risky," and 96.6% thought vaginal sex was "very risky."
But for patients receiving protease inhibitors, the percentage of respondents who believed anal sex was very risky fell to 90.9%, and only 86% believed vaginal sex was very risky.
Lead author Dr. Stephen Kravcik of Ottawa General Hospital said the findings suggest that transmission of HIV may increase "if changes in knowledge and attitudes toward HIV risk lead to a change in sexual and drug use behaviors and practices."
He concluded, "HIV researchers, pharmaceutical manufacturers and marketers, and the media must take great care in reporting the results of clinical trials, and reconsider the use of terms such as 'undetectable' and 'eliminated' to describe virologic responses to antiretroviral therapies."
Chicago rejects call to test high schoolers
Chicago city health officials say they have "no intention" to initiate mandatory testing for HIV and other sexually transmitted diseases among the city's high school students, as proposed by Alderman John Buchanan.
Buchanan proposed that the testing become part of the physicals required of all public high school freshman. Students testing positive would receive treatment, but would not be "kicked out of school," Buchanan said.
Buchanan said he struck upon the idea after learning that STD and HIV rates among the city's youth had reached "epidemic" proportions. City Health Commissioner Sheila Lyne said, however, "An examination of STD rates among the adolescent population at large does not indicate the need for mandatory, universal testing." She said the statistics Buchanan referred to were "misleading" because they reflected the rates among "only a small part of the city's adolescent population, namely those in jail and those who came to health clinics" seeking treatment for STDs.
The American Public Health Association said the group knew of no such mandatory testing in any of the nation's school systems and that obtaining parental consent would be a major obstacle to any such program.
Meanwhile, the US House of Representatives has passed a bill requiring that all federal inmates whose bodily fluids come into contact with corrections officers would have to be tested for HIV. The Senate cleared the measure by a voice vote, and President Clinton will likely sign it.
The measure also requires HIV testing for high-risk inmates. Results of the tests would be made available to the facility administrator and the tested inmate. According to Rep. Gerald Solomon (R-N.Y.), who sponsored the bill, "Potential exposure to the deadly HIV virus is a truly serious matter that should not ride on the consciences of our correctional and law enforcement officers and their families."
Philadelphia FIGHT and Abbott Laboratories will present an update on the status of Norvir on Wednesday, October 28th at the DoubleTree Hotel at Broad and Locust Streets. The event begins at 6:30 p.m. with a buffet dinner, followed by a report and question and answer section from 7:00-9:00 p.m.
The program is free to the public, but participants are asked to pre-register by Monday, October 26th, by calling Petr Pronsati at 215-985-4448.
Abbott recently announced that manufacturing problems with the capsule form of Norvir forced it to no longer produce the capsules, forcing those on the drug to switch to a liquid formulation. Some PWAs have resisted the liquid form because of its bad taste and complicated storage requirements.
The update will feature a report from an Abbott spokesperson through a video hookup, and will be moderated by Dr. F. Nicholas Ifft.
To obtain a weekly email version of fastfax, contact with the message: "subscribe" or fill in the box on the fastfax index page.