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Issue #205: November 27, 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 DVHC Update, Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, The Lancet, Philadelphia Inquirer, Reuters Health Information Service, Washington Blade.
AACO to use codes for CD4 lab reports; Board of Health may endorse HIV code reporting
Treatment at PNH being monitored by feds
FDA approves pediatric use of Viramune
Women IDUs may need different treatment strategies
Norvir shipping problem raises cost for PWAs
Medicaid enrollment continues decline in region
Texas dumps codes, switches to HIV name reporting
Provider attitudes limit minorities in trials: study
AACO will use unique identifiers for CD4 reports
The Philadelphia Board of Health, which sets public health policy for the City of Philadelphia, is considering a resolution calling on the Pennsylvania Health Department to use anonymous codes in tracking new cases of HIV infection in Pennsylvania.
At its November 23rd meeting, the Board considered a joint recommendation from the Philadelphia EMA HIV Commission and its prevention Community Prevention Group, which was presented by Joe Cronauer, co-director of the city's AIDS Activities Coordinating Office (AACO). Board of Health policy is that new motions are heard at one meeting and voted on at the next; observers expect no opposition from board members to adoption of the recommendation.
In other action, the Board was informed of a plan submitted by Cronauer to resolve a four-year debate on extending AIDS surveillance to include laboratory reports of CD4 counts of 200 or less - one of the official indicators which determine that an individual has progressed from HIV infection alone to a formal AIDS diagnosis.
Lab reporting of CD4 counts has been a source of contention between city officials and advocates since 1994, when Richman announced that the city would begin requiring the reports be submitted by labs with the names of those tested as previously authorized by the Board of Health. Most advocates opposed using names for the lab reports, citing concerns about confidentiality.
The timing of Richman's original proposal followed closely on an incident in which four people with HIV serving on the HIV Prevention Community Planning Group had their names published by AACO in an internal report that was accidently distributed at a public meeting, leading to heightened sensitivity to AACO's ability to respect confidentiality concerns of consumers.
AACO has noted, however, that no confidential information formally collected on AIDS case reports, however, has ever been revealed inappropriately since the city began collecting the data seventeen years ago. AIDS case reports are made when an individual is diagnosed with any of 17 conditions; the inclusion of CD4 counts will bring the number of indicator conditions to 18.
At the time of the original CD4 reporting controversies, We The People proposed using unique identifiers for the reports, since most labs already code their test results in any case. This is the system which AACO has ultimately adopted.
Cronauer told the Board that the use of unique identifiers rather than names for the CD4 count reports is meant to avoid any potential for breach of confidentiality on those reported.
Cronauer also noted that low CD4+ counts are the most common factor leading to an AIDS diagnosis among Philadelphians. Two-thirds (66.2%) of new AIDS cases reported over the past year were defined by low CD4 counts, the statement noted.
"Without adequate surveillance of this condition, Philadelphia stands to seriously undercount its epidemic," he said. "Such undercounting can have a devastating effect on the quantity, targeting and availability of resources for those now living with HIV disease and AIDS.
He also noted to the Board that lab reporting of CD4 counts has been in place in most health jurisdictions around the country for six years "without incident and without a single breach of confidentiality."
Meanwhile, state officials are still silent on when they intend to announce a new state-wide HIV reporting requirement, or whether it will be by name or code. State officials, responding to requests from the U.S. Centers for Disease Control and Prevention (CDC) for better data on the number and demographics of people living with HIV disease in the state, have said they will be making an announcement in the near future. Governor Tom Ridge, in his 1994 gubernatorial campaign, pledged not to institute HIV names reporting, but he refused to repeat that pledge during his successful campaign for re-election this year.
Since 1981, the state has only required that the names of those formally diagnosed with AIDS be reported to the health department. Most public health officials agree that to track today's epidemic, better systems for monitoring those diagnosed with HIV infection but not full-blown AIDS need to be in place.
Most AIDS advocates also support HIV reporting, but have strenuously objected to collecting names and other identifying information on those reported. They say that the risk of confidentiality violations and discrimination are too high, and that the same epidemiological goals can be reached through a coded reporting system.
The CDC has said that while it is encouraging states to implement HIV reporting mechanisms, it is up to each state to determine whether to use names or codes for the process.
Nursing and medical care at the Philadelphia Nursing Home (PNH) - one of only two institutions in the region providing long-term nursing care to people with HIV/AIDS - is being monitored by the federal government under an agreement reached with the city after a three-year Justice Department investigation.
PNH was the first nursing facility in the Philadelphia region to admit people with AIDS, in 1986. The home admitted AIDS patients only after months of protests by people with AIDS and other advocates, and strong opposition from city unions and neighborhood groups representing elderly residents.
City health officials agreed to the monitoring in order to settle a federal civil complaint against the city arguing that the residents of the home were routinely receiving poor care, including neglect and physical abuse by staff. The Justice Department said that the low level of care was a violation of the civil rights of residents of the home.
Advocates for people with AIDS have long complained at the ignorance of PNH medical staff on the treatment of HIV disease, and the poor living conditions facing the residents. Most complaints have focused on medical care provided by Dr. Eugene Newton, who has been criticized by AIDS advocates for insensitivity to people with AIDS and for not being aware of treatment advances.
Many of PNH's younger patients are people with AIDS or victims of gang wars in the 60s and 70s, and in the past these residents were mixed with the general population of the home, leading to complaints by elderly residents. City health commissioner Estelle Richman now says that younger, more active patients are separated from older patients in order to minimize problems.
In the civil complaint, federal attorneys said that the care of residents at PNH was so poor that millions of dollars of reimbursements under the Medicaid and Medicare programs received by the home amounted to a "false claim."
Under the settlement, the city paid the federal government $50,000 to resolve the false-claim allegation.
The agreement allows the Justice Department to post a monitor at PNH for a year, beginning last September, when the settlement was submitted to U.S. District Court Judge Stewart Dalzell for approval.
The city agreed to make sure that all residents will be "free from mistreatment, abuse and neglect." If the monitor finds any violations of that commitment, the city could face contempt of court citations.
"The heightened scrutiny will enhance the care that is being rendered at PNH," said David Hoffman, an assistant U.S. attorney.
The Rendell administration privatized the nursing home in 1994, part of a broad effort to save money and improve services by turning some government functions over to private vendors. The nursing home, at Girard Avenue and Corinthian Street in the city's Fairmount section, is operated by Episcopal Long-Term Care, an arm of Episcopal Hospital, under contract with the city.
During an inspection in mid-1995, state Department of Health investigators found what they described as deplorable conditions at the home. They reported that a nursing assistant had allegedly hit and kicked a 97-year-old female patient, and that a 43-year-old male patient had oral sex with a frail, 89-year-old female suffering from dementia.
One nursing unit, they wrote, was in a state of "total chaos."
The state probe triggered the Justice Department inquiry. The department sent its own medical experts into PNH in late 1995 and early 1996 and summarized its findings in a letter to Mayor Rendell that was attached to the complaint.
The 21-page letter, dated Dec. 19, 1996, described "a systemic failure to protect residents from harm."
The letter cited multiple instances of residents hitting one another and one case where a PNH aide slapped a resident in the face.
"Other injuries and harmful situations have resulted from unsupervised residents who...abuse alcohol while in the facility," according to the letter, signed by Deval Patrick, an assistant attorney general in the Justice Department's Civil Rights Division.
Basic needs were ignored, the letter said. Some patients were living in rooms that reeked of urine. Others were dressed in filthy clothes. One of the doctors who examined the home at the Justice Department's request described such neglect as a form of "passive abuse."
City, Episcopal and Justice Department officials maintain that conditions have improved in the last few years.
PNH is operating under a one-year state license that expires this month.
Richman, saying that major improvements have been made at the home as a result of the federal inspection and state oversight, said that she doesn't "anticipate our doing anything different than we have been doing" as a result of the settlement. Richman said. " . . . Current conditions are pretty good."
She said she did not anticipate that living up to the agreement would require extra city spending.
Hoffman said: "There has been a lot of progress, and that is important to stress."
In a prepared statement, Episcopal Long-Term Care said that a subcontractor was in charge of day-to-day operations at the nursing home at the time of the state's withering inspection report. Episcopal fired the company shortly after the report, according to the statement. "For the most part, the settlement agreement merely adopts and validates policies and procedures that have been already developed and independently implemented by ELTC over the last three years," Episcopal said.
The Rendell administration wrote the $50,000 check to the Justice Department, but the city will be reimbursed by Episcopal, according to Richman.
The U.S. Food and Drug Administration has approved a pediatric formulation of Roxane Laboratories' Viramune(R) (nevirapine) to treat infants and children infected with HIV.
Viramune is the seventh AIDS medication to be cleared by the FDA for use in the treatment of pediatric HIV/AIDS. Fourteen agents are currently available for adults.
"The availability of Viramune's pediatric formulation represents a great advance for the treatment of HIV-positive children, particularly for those children who are in need of new treatment options," said John Sullivan, MD, professor of pediatrics at the University of Massachusetts Medical School, in a Roxane press release. "Some of the currently available agents are very effective, but taste terrible. Getting kids to swallow such drugs is very difficult. Viramune, in comparison, is a pleasant-tasting liquid suspension taken twice daily. We have found that Viramune is easy for children to take and is generally well tolerated."
Viramune is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be approved for use in children. The FDA said its decision was based on clinical trials that provide safety, tolerability and pharmacokinetic data supporting Viramune's use in children.
To date, more than 360 children have been treated with Viramune in clinical trials. Some have remained on therapy for as long as six years.
Viramune has been shown to suppress HIV in adults when used in combination with other antiretrovirals.
Findings from a decade-long study of HIV-infected injection drug users indicate that HIV-positive women who have used injection drugs may need a different schedule for anti-AIDS therapy from current practice.
The research, published in the November 7 issue of The Lancet, show that, among study subjects who developed AIDS, levels of HIV were significantly lower in the women than in the men. This suggests that rates of disease progression are more rapid in HIV-infected women who have used injection drugs than do men with the same viral load. For example, according to three different methods of assessment, the women in this study who progressed to AIDS had viral loads measuring 38% to 65% of those in the men.
The men and women participating in the study developed AIDS equally quickly after infection, indicating that women who use injection drugs develop the disease with as little as half the viral load of men. In addition, at viral loads that equal mens', the women had 1.6 times greater risk of progressing to AIDS than are men.
"These findings could be an important first step in understanding the course of HIV/AIDS in each gender," said Dr. Alan I. Leshner, Director of the National Institute on Drug Abuse (NIDA), National Institutes of Health, which funded the study. "Continued research needs to answer whether this HIV progression holds for a non drug-using population as well. Further, it can be concluded that if a given viral load measurement differs in clinical significance in drug-injecting women, treatment strategies using these measurements may have to be optimized separately from those of men."
Led by Dr. Homayoon Farzadegan, a team of researchers at Johns Hopkins School of Hygiene and Public Health studied specimens from 650 HIV-infected, injection drug users participating in a continuous study at a Baltimore clinic. HIV load was assessed during an initial (baseline) visit, and again on followup visits 3 years later. The study was designed to analyze the relationship between gender using three different methods of measuring HIV viral load. Results demonstrated significantly lower median viral load measurements in women by all three methods.
"These results were surprising," noted Dr. David Vlahov of the Hopkins research team. "We expected lower viral loads to be associated with slower progression of the disease, and this was not the case."
Explanation for the lower viral load counts in women in the study remains elusive, with researchers considering several alternatives: different HIV dynamics in men and women, and/or gender-linked behavioral differences that might influence viral load, and hormonal differences.
The change in the production method of the AIDS drug ritonavir from capsule to liquid form has prompted at least two giant mail-order pharmacies to discontinue shipping the drug directly to patients. The halt in shipping has caused at least one insurance carrier -- Blue Cross-Blue Shield -- to require patients to fill their prescriptions for the drug at retail pharmacies, forcing them to pay as much as $100 a month or more for the drug in "out of pocket" co-payments.
The shipping changes began last month after Abbott Laboratories, which manufacturers ritonavir under the commercial name Norvir, discovered that "crystalline structures" were forming within the ritonavir capsules. The company said the structures prevent the human body from properly absorbing the drug, although they are not harmful to patients taking the drug. Ritonavir is a type of drug known as a protease inhibitor that, when used in combination with other drugs, has been shown to prevent HIV from reproducing in the body.
Abbott said it would supply ritonavir in a liquid form while it takes steps to correct the problems with the capsules. Abbott informed health care providers and pharmacies that the liquid form of the medication must be stored at room temperature and that the drug could be rendered ineffective if kept in temperatures outside the range of between 68 degrees and 77 degrees.
The temperature restrictions prompted the large pharmaceutical mailing firm Merck-Medco to discontinue shipping ritonavir to patients. Merck-Medco serves as the exclusive shipping agent for Blue Cross-Blue Shield's health insurance plan for federal government employees. That plan provides health insurance coverage to 3 million people -including 45 percent of the federal workforce, according to Bill Pierce, a Blue Cross-Blue Shield official.
Faith Hannon, a health insurance contract specialist with the U.S. Office of Personnel Management, said at least one other pharmaceutical delivery firm, Caremark, has also discontinued shipping ritonavir to patients. Hannon said Merck-Medco and Caremark told OPM they could not guarantee the integrity of the drug if they ship it by mail.
One Blue Cross-Blue Shield customer, who spoke to the Washington Blade on condition of anonymity, said that, prior to the change, his specific plan required him to pay an $8 "out-of-pocket" co-payment each month for ritonavir capsules under the mail order program operated by Merck-Medco. He said that, under his plan, the co-payment for buying the liquid ritonavir at his local pharmacy was set at 20 percent of the retail price for the drug, or $233.33 per month. The monthly increase from $8 to $233 created a severe financial hardship for him, the patient said.
Fortunately, he said, the federal employee plan for Blue Cross-Blue Shield has negotiated a discounted price for the ritonavir liquid that will result in a co-payment of $78 a month. The customer said, however, that he believes Blue Cross-Blue Shield should continue to charge only the $8 co-payment, saying he believes it is the responsibility of his insurance carrier to maintain its original co-payment rate for prescription drugs.
At least two shipping companies that specialize in distributing AIDS drugs said they have the ability to use special packaging materials to enable them to safely ship liquid ritonavir to patients. But because Blue Cross-Blue Shield has an exclusive contract with Merck-Medco, Blue Cross-Blue Shield official Pierce said the insurer cannot use other shipping firms. Pierce said Merck-Medco manages Blue Cross-Blue Shield's entire pharmacy benefit program for federal employee customers and that it would not be possible to allow some patients to use other drug delivery firms.
Gordon Vanscoy, chief clinical officer for the Stadlander's, a Pittsburgh-based pharmaceutical shipping firm, said his firm has worked with Abbott to develop a packaging and delivery system that safely dispatches ritonavir to patients within 24 hours. Vanscoy said Stadlander's uses private parcel delivery firms such as Federal Express and United Parcel Service because such firms, unlike the U.S. Postal Service, guarantee overnight delivery as well as special handling techniques for packages. Abbott Laboratories spokesperson Melissa Broats confirmed that Abbott and delivery firms have devised a system to safely ship liquid ritonavir directly to patients.
Judy Richter, chief executive officer of Med-Express, a supplier of AIDS drugs affiliated with the National Association of People With AIDS, said Med-Express also provides for direct delivery of ritonavir to patients at prices far lower than what the patients would pay at their retail pharmacy. Richter said that anyone encountering difficulty in obtaining ritonavir at a reasonable price should contact Med-Express at 800-808-8060. © The Washington Blade, 1998
Data analyzed by the Delaware Valley Healthcare Council and the Hospital and Healthcare Association of Pennsylvania illustrates that the number of recipients in the Medical Assistance program continues to decline in the region with a decrease of 2.5 percent since January, and a 5.6 percent decrease since October 1997, according to DVHC Update.
The number of Medical Assistance enrollees in the region has declined by almost 100,000 since January 1996, a 16.4 percent decline. The region's MA recipients now total 496,800; 816,507 elsewhere in the state. While some of the decrease can be attributed to a healthy economy, much of it is a response to changes in public policy such as the state's passage of Act 35 and "recipient confusion over HealthChoices and welfare reform," according to the newsletter.
Many people currently on Medicaid will be losing their welfare cash payment eligibility in March of 1999, and it is expected that many will also lose their Medicaid coverage as well because they are unaware that they may still qualify even after losing their eligibility for cash payments.
Declining Medical Assistance enrollment and increases in the number of "uninsured lives" in the Delaware Valley was the focus of a U.S. Department of Health and Human Services (HHS) seminar "Envisioning a Healthier Philadelphia," held in Philadelphia in November. The meeting was convened by HHS Regional Director Lynn Yeakel to assist the region align resources to enable families to navigate the sea of changes coming in 1999 that will remove many area welfare recipients from the rolls, and emerge with "insurance and assurance of healthcare," especially for children.
At the HHS seminar, Pat Redmond from Philadelphia Citizens for Children and Youth (PCCY) presented information regarding the decrease in the number of children enrolled in Medical Assistance in Philadelphia. She pointed out that although families are transitioning from welfare to work, many children continue to be eligible for Medical Assistance. Redmond pointed out that while efforts to enroll children in CHIP have been very successful, increasing by over 13,000 statewide, there has not been a similar increase in MA.
Part of the problem has been identified through a series of surveys conducted with families that have been on MA and with providers. Approximately 40 percent of the people interviewed by PCCY falsely believe that you are no longer eligible for MA once their eligibility for cash assistance ends. While parents must prove eligibility in order for their children to continue receiving MA benefits, they may supply this information by mail.
DVHC and HAP are encouraging healthcare providers to assist families to enroll in MA and to inform them that children may continue to be eligible for MA even after their parents gain employment.
Further, the children many remain eligible for MA or CHIP even if their parents are not eligible for MA.
The Texas Board of Health has unanimously approved a switch to a names-based HIV tracking system after it deemed its four-year-old unique identifier-based system a failure.
The new system will start January 1.
Sharilyn Stanley, chief of the health department's Bureau of HIV/STD Prevention, the unique identifier system was only providing "about 25% of the total number of cases of HIV reported." She said, "You cannot begin to get a handle on the size of the epidemic when you are seeing such a small number of reported cases."
In response to privacy concerns from HIV/AIDS advocates, state officials noted that under Texas' names-based AIDS reporting system, in place since 1983, 45,000 names have been reported without "a single security breach in the system." Health Board Chair Dr. Walter Wilkerson said, "Reportable does not mean releasable. The names will only be used for public health purposes. They will not be released to the media, insurance companies, employers or other government agencies."
The state will continue to mandate the availability of anonymous testing.
Jamie Schield of the AIDS Resource Center said his testing center "has seen a sizable increase in the number of requests for anonymous tests since the health department proposed its name reporting rules earlier this year." He predicted that the "majority of people will still ask to be tested anonymously."
Many Texas AIDS advocates remain opposed to names-based reporting, and predict it could discourage some people from getting tested.
Schield said, "I don't believe the Health Department will get better numbers with this requirement, and the likelihood is this will have a chilling effect on populations that are at higher risk of getting the virus."
The attitudes and perceptions of healthcare providers may, at least in part, contribute to the under representation of women and people of color in AIDS Clinical Trials, according to a report in the November 1st issue of the Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology.
Despite the disproportionate impact that the HIV epidemic has had on women and minority groups in the US, their level of participation in clinical trials is still relatively low, Dr. Valerie E. Stone of Memorial Hospital in Rhode Island in Pawtucket and colleagues explain.
To investigate the reasons for this, Dr. Stone's group conducted a cross-sectional survey of 64 physicians and nurses working at a large ambulatory HIV center serving a multicultural urban population. The facility was also the site of an AIDS Clinical Trials Unit.
"Our results suggest that providers are significantly less comfortable discussing trials with their patients of color, especially those whose first language is not English," the investigators write. The healthcare providers were also "...more likely to believe that women and patients of color would not be interested in trials."
All respondents "...reported that they [were] just as likely to inform women and African Americans about available clinical trials." However, 6% were less likely to inform Latinos and 11% were less likely to inform Haitians about clinical trials.
The race, gender, number of languages spoken, level of HIV experience and specialty of the healthcare provider did not appear to affect survey response.
Dr. Stone's group notes that these findings were obtained at only one institution, and that larger studies will be needed before the results can be generalized. However, if the findings are confirmed, they "...suggest that efforts designed to improve providers' skill and comfort explaining clinical research to women and patients of color may help increase diversity in AIDS clinical trials enrollment."
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