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In this issue:
Black docs claim HMO discrimination
Drug-resistant PCP strain incidence rises
Indiana group risks funding over reporting
NY disallows look at D&A treatment records
'Immune' Kenyan sex workers now infected
New HIV/STD urine test available soon
Tenet set to close City Avenue Hospital
Glaxo is buying SmithKline Beecham
Group says gay health issues ignored
AIDS may cripple South African economy
State adds new MH drugs to free drug program
The HMOs say that independent studies of the situation do not support the black doctors' claims of racial discrimination in the hiring of HMO doctors.
"The argument that we would exclude black doctors makes no sense. We recruit physicians to serve plan members. That's business we would lose if we excluded doctors that patients want to see," said Charles M. Cutler, chief medical officer of the American Association of Health Plans. The association represents 1,000 health maintenance organizations nationally.
Cutler's comments came in response to a news conference held Monday by leaders of the National Medical Association, the nation's largest organization of black doctors. Without citing specifics, the physicians said HMOs routinely reject their applications for admission.
"This practice is not only racist but ultimately compromises patient care," said Dr. Gary C. Dennis, past president of the association, which represents 25,000 black physicians. "Patients feel more involved in their health-care decisions when they receive care from doctors of a similar race."
A University of California, San Francisco, study published in the March 4, 1998, Journal of American Medicine showed that nonwhite doctors were no more likely than white doctors to be denied or terminated from HMO contracts.
The study also showed that as many or more nonwhite doctors participated in HMOs than white doctors. The study covered 13 large urban counties in California.
Thirteen black doctors at the news conference acknowledged they have little more than anecdotal evidence of any widespread move by HMOs to keep them out. But they said they hope greater public awareness will fuel further research and documentation of what they see as a dearth of black professionals in the health maintenance industry.
Dr. Walter Shervington, chief executive officer at the New Orleans Adolescent Hospital and current president of the National Medical Association, likened the situation to that of blacks activists who insisted for decades that police officers pulled over black drivers at disproportionately high rates.
Those complaints led to studies by the Justice Department and other government agencies that confirmed in some jurisdictions the practice of police harassment of black drivers.
HMO spokesman Cutler said problems of a racial nature may exist, but if so they don't stem from discrimination by HMOs.
Cutler said the percentage of black doctors in America is dwarfed by the percentage of blacks in the general population. That disparity, he said, might give the impression that HMOs exclude blacks.
About 4 percent of the nation's 700,000 practicing physicians are black, according to figures from the American Medical Association and the National Medical Association. Blacks comprise about 12 percent of the U.S. population.
"Frankly we were taken aback by the news conference this morning, because we don't understand why anyone would think managed care organizations would do this," Cutler said. "We need a diverse network of providers because people want doctors who can relate well to them."
He said he'd be happy to talk with the National Medical Association about the matter but added: "It does not seem to be a problem of substance. It's more a problem of perception."
An official of the health care organization said her group was preparing a letter to the National Medical Association to meet and discuss the issue. (Associated Press)
In the early days of the HIV/AIDS epidemic, PCP was often the cause of death in people who had AIDS. However, effective treatments such as trimethoprim sulfametoxazole (Bactrim, Septra) prevented and treated PCP occurrences.
Investigators reported two cases of drug-resistant PCP in a small cohort study of 27 patients at the University of Michigan. Resistance occurred where sulpha-based drugs such as Bactrim usually bind.
Confirming that this strain of bacteria is resistant, would require scientists to culture it in vitro. This is not possible.
Scientists noted that 12 of 19 people within that study developed a mutant strain of PCP, but were able to be treated with Bactrim and are doing fine. As more mutations appear, however, sulpha drugs will not work.
According to researchers, this is not expected to be a problem in the U.S. because many people with HIV/AIDS are on effective combination therapies.
The loss of the funds would eliminate case management services for between 800 and 1000 people living with HIV disease, according to the center.
The information is required under the organization's contract with the Indiana Dept. of Health. The organization claims that turning over the data "would be unethical and could scare away people who want to keep their HIV status confidential."
Since 1998, the state has been attempting to enforce rules it established for agencies which receive Title II Ryan White CARE Act funds for the reporting. Now, the state has set a deadline of 90 days for the data, and says that future funding for the group will depend on how much of the data the organization submits on its clients.
Indiana used to require the center's clients to fill out a 22-page questionnaire about their criminal background, mental state and past sexual activity, with the results automatically transmitted to a state database. The state recently reduced its requirements to only include the names, social security numbers, and other basic demographic data. The state says that it needs the information to accurately monitor the services provided by the agencies it funds.
Joni Albright, an assistant commissioner at the health department, told the Associated Pres that the state spends $23 million on AIDS services. ""We just feel that there is no program where you can walk in and get services and not be a part of a system, not give a name, not prove who you are."
But Diana Gray, the executive director of the Damien Center, disagrees.
"We said 'No way, we're not going to ask clients to give consent for this to be released,'" adding that she prefers a reporting system based on numeric identifiers instead of names. Gregory Manifold, executive director of the AIDS Task Force of Northeastern Indiana, said that if the center loses its funding, "people with AIDS in Indianapolis would have to go without proper case
management. If this [funding] is taken away there will be people dying because they won't know what doctor to go to and what medicines to take."
In a letter to lawyers from the Legal Action Center, NYSDOH Medicaid chief Kathryn Kuhmerker said that DOH "is acutely aware of the sensitivity of this information and of the confidentiality requirements concerning Medicaid data generally, and specifically of alcoholism and substance abuse-related data."
Kuhmerker says that NYSDOH and the state Office of Alcoholism and Substance Abuse are reviewing HRA's plans, placing a strong emphasis on compliance with confidentiality requirements.
Turner made front-page news last fall when he admitted that HRA wanted to raid the Medicaid database to find welfare recipients who were using substance abuse treatment services and target them for the welfare drug and alcohol screening program, which has been marked by sky-high sanction rates.
Housing Works, the Legal Action Center, and other advocates for the poor and disabled called on NYSDOH and the federal Health Care Financing Administration to block the move, citing statutes and regulations that protect the identity of those seeking treatment for substance abuse and limit the use of confidential Medicaid records.
Kuhmerker's letter marks a significant victory against HRA's assault on the private medical records of poor and disabled New Yorkers, according to Housing Works.
Kuhmerker also notes that NYSDOH is preparing a new reminder of confidentiality requirements for distribution to all local social service districts in the state. Housing Works congratulated NYSDOH on their decision, and called for further oversight and monitoring of HRA's administration of the drug and alcohol screening program, which has kicked more people off of welfare than it has helped into treatment.
NYSDOH officials were less clear in their response to a December letter regarding HRA's plan to review HIV-related Medicaid records in preparation for the new New York City HIV workfare program. In a letter to lawyers for Housing Works, The Legal Aid Society, the Lambda Legal Defense and Education Fund and Legal Services for New York City, NYSDOH Medicaid chief Kuhmerker again emphasized that her Department "is acutely aware of the sensitivity" of HIV-related data, but admits that she has taken New York City's word regarding compliance with confidentiality requirements.
Last month, Housing Works called for a state and federal investigation of HRA's plans to review HIV-related Medicaid records to target participants for the new workfare program. Kuhmerker's letter notes that in "several conversations with staff in NYCHRA's Division of AIDS Services," DASIS staff "reiterated that they have no intention of using Medicaid data" in any improper manner.
However, DASIS staff did admit to NYSDOH that they "assessed the use of aggregate Medicaid data to allow them to quantify the resources that would be needed for such a program," but told DOH that "they ultimately did not use Medicaid data for this purpose."
"We're more than a little skeptical about this response, "Housing Works says in its weekly email news update. "NYSDOH should base their determination on more than "several conversations with staff," particularly when those staff have good reason to cover up any illegal or improper behavior. NYSDOH should investigate whether HRA has carried out a massive violation of HIV confidentiality laws, not just ask them whether they broke the law or not."
Kuhmerker's letter does state that NYSDOH is investigating one specific area: the existence of a code in the welfare computer system that marks the cases of individuals who are HIV-positive. AIDS advocates have noted a "HIV-199" code in the WMS records of HIV-positive welfare beneficiaries, which could itself be a violation of HIV confidentiality requirements.
Kuhmerker told Housing Works that "to our knowledge we cannot identify a code 199 but we will continue to investigate the existence of such a code." (Housing Works)
The six women were part of a group of 43 Kenyan prostitutes who had astonished AIDS researchers by remaining HIV -free for more than 15 years, despite intensive exposure to a range of virus strains.
The women all have large numbers of special white blood cells, called cytotoxic T lymphocytes, that are primed to destroy other cells in which HIV lurks.
Oxford University specialists have sought to mimic the response by devising a vaccine containing fragments of the HIV virus tucked inside a disabled cowpox virus.
Early tests have shown the vaccine to be highly promising.
Administered to monkeys, the vaccine triggered a big response of the white blood cells and protected the animals against HIV infection.
Safety trials begin this year on 30 British volunteers, which will be followed by further safety trials in Nairobi if all goes well. The next step would be a trial in Kenya within five years, involving hundreds of people.
But, the British scientific weekly says that the vaccine designers may have to go back to the drawing board.
Oxford researcher Sarah Rowland-Jones has discovered that six of the prostitutes, who have now left the business, had become HIV - positive. Their immunity apparently fell away once they were no longer being exposed to HIV on a daily basis, she said, explaining: "This implies that to maintain immunity you need to have continual exposure."
In turn, that means people would have to be given repeated shots of the vaccine in order to be protected -- something that is financially out of the question in poor countries where AIDS is most prevalent.
That would leave the Oxford vaccine in a diminished, albeit still useful role, as part of a cocktail of treatments to stimulate antibodies against HIV. (Agence France-Press)
Dr. Lut Van Damme of the Institute of Tropical Medicine in Antwerp, Belgium, and members of the COL-1492 phase II trial conducted a randomized, placebo-controlled trial with HIV-seronegative female sex workers. The volunteers, who were also participants in a condom program in Thailand or South Africa, had at least five sex partners per week.
The women underwent monthly gynecologic examinations, which included STD testing and colposcopic evaluation to monitor vaginal toxicity. In this triple-blind study, the subjects were assigned to use either a 52.5 mg N-9 gel or placebo, which were applied between 1 and 9.9 times each day.
"The incidence of lesions with or without an epithelial disruption was low" in both groups, the investigators report in the January 7th issue of AIDS. Dr. Van Damme's group observed "no significant difference" between the two groups in frequency or type of vaginal lesions.
Overall, they conclude that "multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo."
Based on a decision by the Data Safety Monitoring Board, the use of colposcopy was halted in the fall of 1997. Since then, the women have been monitored for signs of toxicity by simple visual examination. (Reuters)
Calypte will join forces with Wampole Laboratories, a division of Carter Wallace, Inc., and Clinical Reference Laboratory to offer "Sentinel," a new service that will provide a 3-day turn around for test results and will be ""priced well below the Medicaid reimbursement level."
Company officials say that the Sentinel service, which will be offered exclusively to medical clinics and physicians, will be available by the second quarter of 2000. Calypte's urine-based HIV/STD test will be marketed by Calypte and Wampole Laboratories, and the laboratory analysis will be performed by Clinical Reference Laboratory.
Calypte manufactures the "only two FDA-licensed HIV-1 antibody tests that can be used on urine samples," the statement continued.
The Sentinel service will provide a "welcome alternative" for those who avoid HIV or STD testing by traditional methods, such as blood tests or cervical swabs, Calypte President Nancy Katz said. "We believe that the benefits associated with our testing method--patient comfort, affordability and quick turn-around time--will make Sentinel very attractive to clinics and professional sites," she added.
"The medical and social impact of undiagnosed--and thus untreated--HIV and STD infections is staggering," Dr. Niel Constantine of the University of Maryland School of Medicine said. HIV, chlamydia and gonorrhea "represent the STDS of greatest concern in the US today." (Reuters)
© Philadelphia Inquirer
Tenet Healthcare Corp. told its workers on January 27th that it will close City Avenue Hospital by May 1 and convert it to another medical use, union leaders and others close to the hospital say.
"I understand from my staff that [Tenet] is going to close" City Avenue, said Henry Nicholas, president of the National Union of Hospital and Health Care Employees Local 1199C, which represents about one-quarter of the 400 workers at the hospital. The hospital was previously known as Osteopathic Hospital and the Philadelphia College of Osteopathic Medicine.
Tenet recommended closing the hospital's acute-care services - its operating rooms and patient floors - during an early-morning meeting with the hospital's board of governors, which includes City Avenue physicians and members of the community.
It is possible that a decision on the hospital could be delayed. However, three people other than Nicholas said they believe that a closure of City Avenue's acute-care services is imminent. Tenet has prepared severance packages, and has already developed plans to transfer some workers and doctors to its seven other hospitals in the Philadelphia area, said a physician and an executive close to Tenet.
Tenet spokesman Stephan Rosenfeld declined to address the reports, saying, "It would certainly not be appropriate to comment on events that haven't occurred."
City Avenue is unlikely to go dark even if its acute-care services are closed. The site could retain its emergency room and transfer patients who need hospitalization to Tenet's MCP or Hahnemann University hospitals - a pattern that other systems have adopted, analysts have said. City Avenue also could help fill the region's great need for nursing-home beds.
City Avenue Hospital's fate has been uncertain for a long time. Insiders have told The Inquirer that the community hospital lost at least $6 million last year and needs more than $12 million in capital improvements in such areas as the heating system. In November, Tenet transferred the hospital's core maternity services to Hahnemann in Center City, stripping away one-third of City Avenue's nurses and demoralizing the staff. Tenet appeared ready to decide the hospital's fate at that time, but relented. Some analysts said they thought Tenet might lose key political support in the city if the for-profit company went ahead and closed the hospital.
City Avenue's doctors responded to the fiscal peril by dramatically increasing admissions. The hospital has long been dominated by osteopathic physicians; it was built by the neighboring Philadelphia College of Osteopathic Medicine in 1967.
But the upsurge in patients apparently could not rescue the hospital. On Jan. 12, Tenet's chief operating officer, Thomas B. Mackey, told Wall Street analysts that the firm's Philadelphia operations might not make their expected profit this year and that hospital closures were being considered.
Two days later, Tenet announced the departure of its top Philadelphia executive, Lee Domanico, who had come here in November 1998 when Tenet bought eight hospitals from the bankrupt Allegheny health system.
If City Avenue closes as a hospital, it would mark the end of a rocky decade for the facility. The hospital has had four owners in eight years. The osteopathic college transferred the hospital in 1993 to the Graduate Health System because the school could not make the hospital self-sufficient.
The Allegheny system took over City Avenue in 1996 and tried to establish it as a women's hospital. Deliveries represented the hospital's most common procedure in 1997 and 1998, according to the Pennsylvania Health Care Cost Containment Council.
But Allegheny failed to invest enough in the physical plant.
The deal, announced Monday and worth about $76 billion in stock, is a clear sign that the merger trend now reshaping other industries is accelerating in the still-fragmented drug business.
Just last week, Pfizer emerged as the likely winner in a battle with American Home Products for U.S. drugmaker Warner-Lambert, while Monsanto is in the process of merging with Pharmacia and Upjohn. Industry analysts predict other blue-chip names, including Eli Lilly, Schering Plough, Novartis, Bristol-Myers Squibb and even merger-averse Merck, won't be far behind.
"I think that eventually about six to 10 companies will own the pharmaceutical market," said Hemant Shah, an independent industry analyst based in Warren, N.J.
Currently, the pharmaceutical business still has many competitors.
Indeed, the combined Glaxo and SmithKline would control just 7.3 percent of global sales, although it would dominate the markets for asthma, AIDS, migraines and vaccines.
Analysts say that consolidations are gathering momentum because drugmakers are pinched between the ballooning costs of developing new drugs and the demands of investors and shareholders that they deliver double-digit growth in profits.
Only by bulking up to pool research and development funds and by slashing costs can pharmaceutical firms avoid financial peril in an ever more Darwinian market.
"To succeed in this industry, you must be top-tier, and preferably, you must have market leadership," Glaxo Wellcome chairman Sir Richard Sykes told a news conference.
Glaxo Wellcome and SmithKline Beecham said their union would yield $1.6 billion in annual savings after three years. They said job cuts were expected, but that they were still deciding where to make them.
Shares of both companies fell on the London Stock Exchange Monday as some investors took profits following a runup Friday when the companies announced they were in talks. In addition, some analysts said they were disappointed in the cost savings predicted by the companies. Glaxo fell nearly 5 percent while SmithKline fell 6 percent.
The two British-based companies plan to keep their corporate headquarters in London, but open a new operational headquarters in or near New York.
They would keep their U.S. businesses separate. SmithKline has a research and development unit based in Philadelphia and a non-prescription drug business in Pittsburgh. Glaxo's American operations are headquartered in Research Triangle Park, N.C.
Their union comes two years after previous merger talks collapsed in a fight over which executives would run the company
The apparent success of Pfizer's hostile bid for Warner-Lambert gave new impetus to the idea, said Kevin Wilson, an industry analyst at Salomon Smith Barney in London.
"Pfizer-Warner-Lambert has acted as a catalyst," he said. "I could easily imagine them saying, 'Look, this is a good idea. We might as well get on with it now.' "
Glaxo SmithKline would have worldwide pharmaceutical sales of an estimated $24.9 billion, based on 1998 annual figures. But a combined Pfizer-Warner-Lambert would be close behind with a 6.7 percent market share, and it would be gaining fast, Wilson said.
American Home Products -- the apparent loser in the fight for Warner-Lambert -- has failed three times to combine with other drug companies and looks like an increasingly attractive takeover target for a European company such as Bayer that might be aiming to expand its U.S. pharmaceuticals business, said Andy Penman, an analyst at London brokerage Greig Middleton.
Even Merck, which has publicly sworn off mergers in the past, might have its hand forced if it wants to keep up with more financially powerful rivals.
"There's no question that Merck is the best in the business in terms of developing new drugs, but it's going to be very difficult to compete when there are companies with R and D budgets that are twice that of Merck," said Shah, the New Jersey-based analyst.
Glaxo's strength lies in its top anti-migraine drug, Imitrex, and in treatments for asthma and viral infections, including HIV.
SmithKline's top products include the antibiotic Augmentin, the antidepressant Paxil and a new diabetes drug, Avandia. It also has a strong vaccines business.
But both firms are feeling pressure because their top drugs are facing expiration of their patents, allowing cheaper generics into the market.
Glaxo's leading ulcer drug Zantac lost its patent protection in 1997, and SmithKline's lucrative Augmentin will lose its patent in 2002.(Associated Press)
"I think we're making the point to the federal government that a lot more research needs to be done about lesbian, gay, bisexual and transgender (LGBT) health issues, and a lot more research needs to be provided to the public and to providers about the needs of LGBT people," said Patricia Dunn, the director of public policy at GLMA.
The GLMA co-authored a preliminary "white paper" of guidelines regarding such issues with the Center for Lesbian, Bisexual and Transgender Health at Columbia University's Joseph L. Mailman School of Public Health in New York City. The comprehensive report was funded by the US Health Resources and Services Administration (HRSA). It was released Tuesday to coincide with the imminent release of the federal government's "Healthy People 2010" policy paper, which outlines national goals and strategies regarding healthcare over the coming decade.
The GLMA white paper details the specific nature of health problems affecting the LGBT community. The authors write that discrimination in access to care as well as stigma, prejudice, confusion, and lack of knowledge affect many in the LGBT community when dealing with healthcare providers. Specific health needs regarding HIV, drug abuse, mental health, and violence are also discussed.
The Healthy People 2010 paper is considered by most in the healthcare field to be the main framework for establishing funding priorities for health research and services at the federal level, and follows the prior 10-year plan Healthy People 2000. HRSA funded the GLMA paper after the public was given a year to comment on an early draft of the Healthy People 2010 document -- during which HRSA received over 400 comments highlighting a perceived lack of focus on most LGBT issues.
In an interview with Reuters Health, Dunn emphasized that "this is the first time that there is any relationship whatsoever to LGBT issues" in terms of policy development within the federal government's health bureaucracy. "I think it's a good start that they funded the paper and that they're willing to listen to our needs," said Dunn, adding that the GLMA plans to continue the dialogue by co-authoring an even more extensive companion document after the release of the Healthy People report.
According to Dunn, the initial exchange has so far been productive and helpful in figuring out how to address LGBT concerns. For example, Dunn said that "one of the problems the federal government brought up to us when we criticized the lack of reference to LGBT health is that there is no good data telling us what the problems are for the LGBT community. So one of the things we hope to see is more research with respect to particular health needs and general ones."
"What we need is the federal government and private researchers to fund the research and do it in a coordinated fashion," said Dunn. She added that this might not be easy to organize since "there is still some prejudice and stigma within the federal government and there is an element who might not be happy that they are addressing these issues. They think, 'we're doing things on breast cancer so that takes care of lesbians'. So it's a matter of educating the public in general and the federal and state and local governments about the fact that LGBT people have the same problems that all other people have, and we also have specific health problems beyond HIV and breast cancer that affect us."
An estimated 20% of the workforce could be HIV-infected within 5 years, rising to 22.5% in 2010, said Maureen Visage, head of Metropolitan Employee Benefits' AIDS Research Unit. "Without numerous South African companies even being aware of it, HIV is insidiously attacking their most valuable corporate assets--their human resources," she said.
"From a purely bottomline perspective, the direct costs of HIV/AIDS will continue to escalate, especially as regards the ongoing provision of employee benefits such as life, disability and medical coverage," Visage said.
In her address at an "AIDS in the Workplace" conference in Cape Town, she said that by 2005 HIV may erode the productive capacity of employees to such an extent that companies will be battling to survive.
AIDS is currently a controversial issue in South Africa, with President Thabo Mbeki's government battling to fight this epidemic, which threatens to jeopardize post-apartheid transformation plans. South Africa's population of 40 million has an HIV prevalence of about 4 million. Another 1,700 people are infected daily, making it a country with one of the most rapidly growing infection rates in the world.
Economists have warned that AIDS could also mar an expected rebound in the South African economy, Africa's largest, which is expected to grow by about 3% in 2000. If the HIV epidemic goes unchecked, it will begin to drain skilled labor across the economic spectrum.
The SPBP was established in 1987 to provide HIV/AIDS drugs through federal and state funding. In 1993, the SPBP expanded to provide the mental-health drug treatment Clozaril, a unique medication for individuals with a diagnosis of schizophrenia. The mental-health portion of SPBP serves more than 800 Pennsylvanians.
"The treatment of schizophrenia has been revolutionized during the last decade with the release of these new drugs," Houstoun said. "For many persons with schizophrenia, these drugs have given them a new lease on life. They are better able to control their symptoms, and the side effects are less debilitating, leading to an improved quality of life."
To be eligible for the program, an individual must be a Pennsylvania resident, have a diagnosis of schizophrenia, not live in a psychiatric institution, and not be eligible for prescription drug coverage through Medicaid. The individual's gross annual income must be less than $30,000, with an allowance of $2,480 for additional family members. The individual also must provide a copy of his or her Social Security card, a copy of his or her prescription for one of the four drugs and a signed physician's certificate attesting a diagnosis of schizophrenia.
Applications for the SPBP are available at all county assistance offices and local AIDS and mental-health agencies.
Additional information can be obtained by calling DPW's toll-free SPBP hotline at 800-922-9384 or by writing the Department of Public Welfare, Special Pharmaceutical Benefits Program, P.O. Box 8021, Harrisburg, PA 17105.