DPW stiffs Mercy: Betak closes admissions
ACT UP plans demo at Houstoun home
AZT study supports prenatal use
FDA's Kessler announces resignation
Hemophiliac cases finally settled
DPW stiffs Mercy: Betak closes admissions
Feather O. Houston, secretary of the Pennsylvania Dept. of Public Welfare, has failed to act on an early commitment to help the financially-struggling Mercy House (formerly Betak), and as a result Mercy Health Corporation has closed new admissions to its boarding home and begun plans to close the facility within the month.
Mercy's decision does not affect its skilled nursing unit, which was moved to St. Joseph's Hospital when the company took over operations of the former Betak facility earlier this year. At that time, Mercy committed to expanding Betak's 11-bed personal care boarding facility -- which provides services of lower intensity than skilled nursing -- to 40 beds, operating out of the West Mt. Airy Betak location until a less costly physical plant could be located.
Houstoun pledged earlier this year that DPW would investigate ways it could enhance an annual $415,000 direct grant for these services so that the desperate need for AIDS-specific personal care facilities could be maintained. Mercy House, along with Calcutta House in North Philadelphia and Rainbow Home in Reading, are the only AIDS-specific personal care facilities in the southeastern Pennsylvania region. Mercy is the largest such facility.
Sources said that Mercy is looking for at least $1.6 million from DPW to help it meet the costs of special care required for people with AIDS needing personal care services. Unlike in traditional boarding homes, people with AIDS in personal care often require much more intensive medical and nursing interventions to remain stable and to prevent their need for even more expensive skilled care.
"Once again, DPW is choosing to waste the taxpayers money by forcing people with AIDS into hospitals and skilled facilities by pretending it's holding the line on personal care costs," said Joe Cronauer, executive director of We The People. "It just doesn't make sense to force people into levels of care that are more expensive and that they don't really need. And it's absolutely criminal to force others into Feather Houstoun's other, and apparently preferred, solution to the AIDS crisis: simply letting them die uncared for."
As when the former Betak faced similar crises, state officials are claiming that they have no evidence that care for people with AIDS is more costly than other personal or skilled care. As with Betak's former operators, Lutheran Home at Germantown, the state is also criticizing what it calls high administrative and indirect costs for operating the Mt. Airy facility. The facility was purchased and renovated with a loan from Montgomery County in 1989, and still carries a debt of at least $2 million, which must be repaid with proceeds from the services provided there.
Philadelphia health department officials have advocated to DPW in support of an enhanced rate for nursing care for people with AIDS since 1987, when they proposed a special intermediate care rate in recognition of the changing nature of medical needs of people with AIDS. Most other states with high numbers of AIDS cases have established such rates, relying on detailed analysis of Medicaid payments for medical care. State DPW officials have said that they are unable to evaluate their Medicaid data to determine appropriate rates.
Pennsylvania DPW ranks lowest among all U.S. jurisdictions in most of its Medicaid reimbursement levels, which will likely go even lower with the beginning of HealthChoices, its new Medicaid managed care program scheduled to begin on January 1st. Skilled nursing and personal care reimbursements are not presently included in the HealthChoices program itself, state officials said, but such reimbursements will not be increased in the future and face numerous bureaucratic and legislative efforts to reduce them.
ACT UP plans demo at Houstoun home
ACT UP Philadelphia, noting that a final decision on whether to delay enrollment in Medicaid managed care for people with HIV disease is only days away, has announced a demonstration at the home of DPW Secretary Feather Houstoun on World AIDS Day, Sunday, December 1st.
Houstoun has ignored pleas from people with HIV/AIDS and their advocates to address numerous problems with the implementation of the new HealthChoices program, which, although it begins in only five weeks, is still unable to identify which of its physicians are specialists in AIDS care. HealthChoices has also failed to establish a procedure through which people with HIV/AIDS can choose an AIDS specialist as their primary care physician -- the "gatekeeper" of access to all medical services through HealthChoices -- or to set a reasonable standard of care, quality assurance standards, or accessible grievance procedures.
DPW has told the federal Health Care Financing Administration, which must approve the state plan for HealthChoices by December 31st, that such protections are in place, however.
The ACT UP demonstration will include "non violent civil disobedience" at Houstoun's private residence, located in center city Philadelphia. Demonstrators will meet at Love Park at 16th Street and JFK Boulevard to commemorate World AIDS Day at the Day Without Art ceremony, and follow the event with a "Day Without Health Care" March to Houstoun's townhouse at around 2:30 pm
"Tell Feather to delay enrollment of people with HIV/AIDS into HealthChoices, or she'll get more than just coal for Christmas," the group said.
ACT UP cautioned that although the action includes civil disobedience, it is extremely unlikely that anyone will be arrested that does not want to be. Legal representation and observers will be present.
With the announcement by We The People of Houstoun's refusal to prevent the imminent closure of Mercy House, the region's largest personal care facility for people with AIDS, demands at the demonstration will likely include that issue as well.
Houstoun has sent a flyer to her neighbors informing them of the demonstration and telling them that she will not be home on Sunday. She also told them that she would be willing to explain the issues to her neighbors at their request -- more than she has offered people with HIV/AIDS, advocates noted.
"Perhaps if we move on to her block we can finally get the truth," said one activist.
Anyone with questions or who is considering risking arrest to stop HealthChoices should contact ACT UP at .731.1844, or by E-mail at "jdavids@critpath.org."
AZT study supports prenatal use
If current public health recommendations to give AZT to all pregnant women infected with HIV are followed, fewer babies will contract the virus during pregnancy or labor and delivery, government researchers reported this month.
Although women with little or no detectable HIV in their blood have been thought to pose little risk of infection to their fetuses, the new study finds that transmission of the virus is possible even at the earliest stages of HIV infection.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases said that although HIV transmission to the fetus is most likely to occur when a woman has large quantities of HIV in her bloodstream, the new study published in The New England Journal of
Medicine shows that there appears to be no absolute threshold below which transmission never occurs. In other words, if the mother is known to be infected, there is always a risk that she will transmit the virus to her fetus.
In the study, 7.6% of fetuses whose mothers took AZT in their last trimester of pregnancy were born infected with HIV compared with 22.6% of fetuses whose mothers did not receive AZT, according to Dr. Rhoda S. Sperling, of Mount Sinai School of Medicine in New York.
The study was a follow up to a previous study of pregnant HIV-infected women and their babies published three years ago. The Public Health Service issued guidelines for the use of AZT in pregnant HIV-infected women as a result of the first study.
AZT, also known as zidovudine, was effective at preventing transmission of the virus regardless of the mother's HIV status. Sperling and colleagues theorize that AZT may prevent replication of HIV at the time the infant is exposed to the virus. It is estimated that 50% to 70% of all mother-to-infant transmission of HIV occurs around the time of delivery.
Therefore, giving AZT or another antiretroviral during labor and delivery may be an effective way of reducing the high transmission rates in Third World countries where long-term drug therapy -- such as the regimen used in this study -- is not feasible or is too expensive.
Advocates have cautioned, however, that in addition to its potential effectiveness against HIV, AZT also prevents the replication of other cells, which ultimately causes serious damage to the health of the recipient. This factor has led many women to resist taking AZT during pregnancy, or the continue the treatment for themselves after the baby is born.
No studies have yet been completed on the long-term impact on the newborn of prenatal AZT treatment.
In an editorial accompanying the study, Dr. Catherine M. Wilfert, of Duke University Medical Center, said the study adds to a growing body of information that will hopefully lead to optimal prevention of transmission in the United States and the rest of the world.
Prenatal care is another crucial factor in preventing mother-to-infant transmission. In May, federal legislation was passed requiring all states to show a 50% reduction in the number of infant HIV cases by March, 2000.
Other legislation, including the Ryan White Care Act, also require states to develop programs aimed at reducing the number of babies with AIDS.
Newborn AIDS cases down nationally
Meanwhile, U.S. health officials announced this month that the number of newborn infants who contracted AIDS from their mothers declined 27 percent between 1992 and 1995, reports Reuters.
The Centers for Disease Control and Prevention says the change came because more pregnant women were tested for HIV and, if the test was positive, took the drug AZT to reduce the chance of transmitting it to their babies. It estimated that 663 newborn infants acquired AIDS from their mothers in 1995. The figure has been declining every year since 1992, when 905 infants were diagnosed.
FDA splits over delavirdine
Scientific advisers have deadlocked over whether to allow people with HIV/AIDS to buy a new drug, citing conflicting evidence over whether it works and who should use it.
Pharmacia & Upjohn had argued that delavirdine would help kill the HIV virus in early-stage patients' blood and slightly boost their immune system when used in combination with older medicines.
But the improvement was so slight -- and the drug failed to do any good for late-stage patients -- that advisers to the Food and Drug Administration were left wondering how any doctor would know how to prescribe delavirdine.
"We're in a tough position," said Dr. Wayne Greaves of Howard University Hospital, before the panel voted 4-4 on whether the drug should be approved. "There are still patients who need additional drugs."
"A year ago, I would have viewed this very differently," said Dr. Christopher Mathews of the University of California, San Diego, who questioned approving a drug that showed such minimal effect when just this year three powerful new medicines began selling, promising patients significant improvement.
But the panel urged the FDA not to make a final decision until doctors finish analyzing an additional study to confirm the drug's impact, data due to be completed in mid-January.
The tie vote came after mothers tearfully protested that Pharmacia, like almost every AIDS drug manufacturer, had not even begun testing to determine whether delavirdine would help HIV-infected children.
Of the nine AIDS drugs sold presently, only three are approved for children's use -- and they do not include the newest, most potent AIDS therapies. The mothers accused drug makers and the FDA of ignoring children's desperate need in the race to sell AIDS medicines to adults.
"Love will not stop the virus," said Deborah Scheer of Sonoma County, Calif., as her HIV-infected son, Dylan, gazed at the panelists. "I cannot protect him alone and I need your help."
The panel issued a stern warning to drug makers not to seek approval for any more AIDS therapies without at least preliminary testing in children.
But for delavirdine, the issue was whether the drug even works in adults.
One study of 720 patients showed it modestly helped adults who were not yet seriously ill, when used in combination with the oldest AIDS drug, AZT. Patients who took both drugs saw a slight rise in important immune cells called CD4s, gaining about 30 cells per milliliter of blood after a year of therapy while those who took AZT alone lost CD4 cells. The delavirdine patients also lost about twice as much of the virus in their blood as did those who took just AZT.
But a study of severely ill patients found delavirdine taken with another older medicine, ddI, found that small benefit lasted only 12 weeks. By year's end, not only were delavirdine patients doing no better but 66 of them had died, compared with 61 who took ddI alone.
Worse, the scientists said, delavirdine hasn't been tested in combination with the three newest AIDS drugs, a new class of drugs called protease inhibitors that has proved so potent that a three-drug combination including one of these medicines has become standard care for advanced patients.
Delavirdine doesn't attack HIV in the same manner as protease inhibitors, working instead more similarly to AZT.
But Pharmacia argued delavirdine does have potential. Genetics testing of 34 patients suggested when the drug is combined with AZT, it can halt or even reverse HIV's dangerous ability to mutate until AZT is useless. That study showed delavirdine caused an 85-fold increase in patients' susceptibility to AZT treatment.
And the panelists agreed that delavirdine is "leaps and bounds safer" than most other AIDS drugs. Its chief side effect was a skin rash.
FDA's Kessler announces resignation
Food and Drug Administration (FDA) Commissioner David Kessler has announced his resignation, after an administration which dramatically increased the speed with which new AIDS drugs are approved and earning the enmity of U.S. tobacco companies.
Kessler developed a national reputation for tenacity, regulatory audacity and shrewd
political instincts. He said that he is leaving his post voluntarily for personal and family reasons and because he had accomplished his major goals.
During his tenure at the FDA, Kessler became a major focus of the anti-regulatory mood in Washington and his agency had become the target of broad regulatory reform efforts. Analysts noted that his departure could free the Clinton administration to broker agreements on contentious issues from FDA reform to the controversial plan for the agency to regulate tobacco sales and production in the U.S.
In an interview with ABC News, Kessler said, "We focused on the things that make a difference in people's lives, those things that have the greatest impact on the public health: the diet and health, the food label, tobacco -- that's how you prevent illness and death." When asked if he has satisfied critics who say the FDA takes too long to approve drugs already available in other countries, Kessler said, "Look at all nine AIDS drugs that are now available, they were all approved here first. And it's not just AIDS, it's across the board. We are faster than other countries today." And, when asked if the GOP will get its "radical reform" of the FDA, Kessler responded, "The American people want their foods to be safe. Sure we can streamline the process, but when it comes to health and safety you can't deregulate."
In addition to tobacco regulation, Kessler will be remembered for standardizing nutrition labels and taking steps to speed the federal drug approval process. Kessler also created the Office of Criminal Investigation to improve the agency's enforcement capabilities, as well as the adverse drug reaction reporting system, information for patients on drug packages and the labeling of over-the-counter drugs. The agency also speeded up the approval process for veterinary medications, tightened up mammography regulations and restricted the use of silicone breast implants to clinical studies until their safety is proven.
Kessler said that he would leave his post as soon as a successor is named, noting that several top FDA officials are capable of heading the agency. Media reports indicate that possible candidates include deputy commissioners Mary Pendergast, William Schultz and Michael Friedman, and former FDA official Michael Taylor, who currently heads the food safety program at the Department of Agriculture. Already many Republicans in the Senate say they'll never approve an FDA commissioner as aggressive as David Kessler."
Hemophiliac cases finally settled
Four drugmakers accused of distributing HIV-tainted blood products have announced that they have agreed to a $640 million settlement for the nearly 6,000 hemophiliacs who contracted HIV from their products.
Baxter International Inc., Armour Pharmaceutical/Rhone-Poulenc Rorer Inc., Bayer AG and Alpha Therapeutic Corp. will pay the hemophiliacs or their survivors $100,000 each. The settlement also includes $40 million for legal and administrative fees.
While unhappy with the money offer, a vast majority of AIDS-infected hemophiliacs favor settling the class-action lawsuit over the tainted blood products, according to media reports. More than 90% of hemophiliacs or their families have accepted the settlement. An additional 540 people have opted out of the settlement and may pursue individual lawsuits.
Unresolved issues include determining who is eligible to receive the settlement and claims against the payouts that hemophiliacs will receive for past and future Medicare and insurance payments. A drug company spokesperson said progress had been made with private insurers on the latter issue. Federal court judge John Grady has pledged to rule on the settlement "as quickly as possible."