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Issue #176: May 10, 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 information in this issue include Associated Press, The Lancet, Philadelphia Inquirer, Reuters.2 more drug chains drop Mercy HMO
Feds veto approval of crypto drug
40% of PWAs don't take drugs correctly: study
New test for HIV drug resistance coming
Coburn criticizes high salaries at AIDS agencies
Protease drugs linked to artery disease
Arnold Jackson, early AIDS leader, dies at 40
2 more drug chains drop Mercy HMO
Eckerd Drugs and CVS have joined many neighborhood pharmacies in refusing to honor prescriptions for patients covered by Keystone Mercy Health Plan, one of the four Medicaid HMOs which comprise the state's HealthChoices program.With the decision of the two chains, people with HIV/AIDS and others covered by Keystone Mercy will no longer be able to get their prescriptions filled at affiliates of two of the three largest drugstore networks in the Philadelphia region.
Eagle Managed Care, a Rite Aid subsidiary which manages Keystone Mercy's prescription plan, has announced that it will significantly lower reimbursement rates for the largest of the HealthChoices Medicaid managed care companies. The pharmacy chains said that they cannot accept the lower reimbursement rates because they lose too much money on the drugs, with the result that they will not be able to provide AIDS medications to Keystone Mercy subscribers.
"Pharmacy reimbursement rates continue to decline and there comes a point when the rates fall so low that it's just not viable to continue," said Fred McGrail, a CVS spokesman.
Keystone Mercy spokesman Matthew Cabrey told the Philadelphia Inquirer that the plan had no choice but to reduce reimbursement rates, because of low funding from the state Department of Public Welfare (DPW). AIDS advocates have long complained that DPW's effort to save money through Medicaid managed care would lead to cost-cutting that results in lower-quality care, with the result that Medicaid recipients will be unable to benefit from the new medical advances which are improving the health status of thousands of people with HIV/AIDS.
A Rite Aid official said that Rite Aid stores will continue to accept Keystone Mercy prescriptions. But Marc Garber, owner of Haussmann's Pharmacy, told the Philadelphia-based Working Group on HealthChoices and HIV several weeks ago that he often receives referrals from Rite Aid pharmacies when a patient presents a prescription for AIDS-related medications. He said that the referrals indicate that while Rite Aid is reducing reimbursement rates through Eagle Managed Care, they are then referring patients elsewhere so that their own pharmacies won't lose money on the new policy.
Because of the new reimbursement rates, "many pharmacists cannot, and will not, fill prescriptions for people with HIV or AIDS," Garber said. "Access will be limited and patients will suffer and die." Haussmann's serves about 100 people with HIV/AIDS, Garber said.
"A lot of my patients are upset and nervous about the new reimbursement rates, and many are too sick to understand," he said. "Their HMO is giving up on them."
In a letter to the Philadelphia Inquirer, Sam Brog, director of the Philadelphia Association of Retail Druggists, said that "managed health care's inadequate reimbursement rates to pharmacy providers...cause many pharmacists to sell to the chains and close down in communities where they are most needed."
Feds veto approval of crypto drug
The Food and Drug Administration's Antiviral Drugs Advisory Committee has recommended that the FDA not approve Unimed Pharmaceutical's new drug application (NDA) for Cryptaz (nitazoxanide, or NTZ), a broad-spectrum anti-infective/antiparasitic compound, for the treatment of cryptosporidial diarrhea in people with AIDS.Unimed officials presented data from three clinical trials that involved a total of 226 patients with AIDS plus 2 other patients with severe immune deficiencies of other causes. Approximately two-thirds of the patients in the three studies had CD4 counts below 50.
Treatment resulted in a 50% reduction in stool frequency in about 40% of patients with AIDS, the researchers told the FDA panel. "Given the severity of the disease and the lack of effective treatments, this is a relatively promising response rate," Unimed officials said.
In addition to a reduction in severity of diarrhea, patients in the 3 studies reported reductions in nausea, abdominal cramping and pain, fecal incontinence, rectal pain and sleep disturbance secondary to frequent bowel movements. Long-term data show that treatment reduces the amount of Cryptosporidium parvum in stools.
Considering the extremely poor health of the patients in the trials, Unimed researchers believe that Cryptaz is relatively safe. "While there were 62 deaths among the 228 patients, none of the deaths was directly attributable to NTZ treatment," they say.
Nearly two-thirds of patients developed adverse events, which included metabolic and nutritional disorders (14.9%), increased alkaline phosphatase levels (3.9%), dehydration (3.1%) and abnormal liver enzymes (between 2 and 3%). The investigators believe that "approximately 35% of these adverse events were determined to be possibly related to NTZ, raising the possibility that NTZ has some hepatobiliary toxicity."
The Advisory Committee asked for more data before recommending Cryptaz for marketing. Following the decision, Unimed issued a statement indicating that it will pursue its application. "We will closely examine the issues raised by the committee and take needed steps to ensure Cryptaz can be cleared for marketing as soon as possible," said president and CEO Dr. Richard L. Goode. "We will work very hard to make it available to patients as rapidly as possible."
There is currently no FDA-approved drug for treating AIDS-related cryptosporidial diarrhea.
40% of PWAs don't take drugs correctly: study
More than 40 percent of Americans infected with HIV do not take their drugs as directed, according to a survey published this month.The survey found that 43 percent of HIV patients polled admitted that they did not take all of their drugs as prescribed -- even though multi-drug cocktails have been shown to keep the virus at bay when taken properly.
When patients do not take their drugs properly, the virus can quickly mutate into drug-resistant forms.
"Resistance to HIV medications can quickly occur because of inadequate drug combinations or inadequate adherence to therapy," Dr. Joel Gallant, an AIDS researcher at Johns Hopkins University in Baltimore, said in a statement. "Even mild degrees of noncompliance can lead to resistance. Once resistant strains of HIV are present, the patient's treatment options are narrowed and sometimes entirely exhausted."
The telephone survey of 665 people infected with HIV was conducted by Johnston, Zabor and associates on behalf of DuPont Merck Pharmaceutical company.
It found that doctors have even less faith in their HIV patients. The 100 doctors surveyed estimated that 54 percent of their patients do not take their medicine properly.
The findings could explain why while clinical tests have shown that drug cocktails can suppress the virus to unmeasurable levels in the body and keep patients well, the plan does not always work in the real world.
Most people do know that the drugs work if used properly -- 93 percent, according to the survey. But more than a quarter, 26 percent, admitted they had failed to take their drugs as directed just the day before they were questioned, and 43 percent admitted to it in the week before.
And some do not even buy their drugs, let alone take them. The doctors surveyed estimated that six percent of prescriptions they write for HIV drugs are never filled.
According to the survey, patients are giving themselves drug holidays -- taking themselves off the drugs for anywhere between a few days to several weeks. Twenty-three percent of the patients said they had done this.
The average drug holiday was two weeks, long enough for some symptoms to start coming back. Most of the doctors, 84 percent, said they limited who they gave certain drugs to because of this.
Patients who do not take drugs properly affect more than themselves. If the virus they are infected with becomes resistant to certain drugs, they can pass that resistant strain on to others.
Doctors and patients alike complain that the current regime of HIV drugs is hard to stick to. Patients must take sometimes dozens of pills a day, at set times, some with food, some without, and side-effects include nausea and diarrhea.
New test for HIV drug resistance coming
Laboratory Corporation of America has announced plans to market Antivirogram, an HIV drug resistance test.Antivirogram, which is designed to assess the sensitivity of various HIV strains to antiretroviral drugs, is scheduled for release in July of this year. "We believe that this new technology will permit LabCorp to offer the broadest array of testing services to clinicians treating HIV/AIDS patients," Thomas P. MacMahon, LabCorp CEO commented.
"The combination of genotypic and phenotypic resistance testing will provide the most comprehensive guide for physicians choosing anti-retroviral therapy for patients with HIV/AIDS," Dr. John Mellors of the University of Pittsburgh added. "It is another tool to help physicians and patients map out long-term treatment strategies."
Coburn criticizes high salaries at AIDS agencies
Some officials at charitable AIDS organizations are doing well by doing good. At least nine groups pay their top officers more than $100,000.And that has upset both AIDS activists and at least one member of the House, who spoke out on the floor of Congress.
"I was shocked to discover how many AIDS organizations pay their executives excessive salaries at the expense of those living with HIV," said Rep. Tom Coburn, R-Okla., a physician who, although he has treated patients with HIV, has proposed federal legislation mandating HIV testing and restricting the rights of PWAs.
"At a time when direct services and medically necessary care is being severely curtailed, many AIDS charity executives have put lining their own pockets above saving many lives."
The president of the board of directors of Washington's Whitman-Walker Clinic insisted the salaries are not out of line.
Whitman-Walker's executive director, Jim Graham, was paid $143,690 in 1996.
"This is a salary that's nowhere out of sync with everything else," board president Dace Stone said.
In New York, the National Charities Information Bureau, which tracks charitable organizations, noted a lack of guidelines about how much a charity should pay its leaders. "It is up to the board of directors to figure out how much compensation it takes to improve or maintain the organization's revenues, and more importantly, their programs," bureau spokesman Dan Langan said.
Directors of the nine AIDS organizations, which receive $53 million a year from federal, state and local governments, are in charge of operations, budgets and staff.
At the top of the list: Jerome Radwin, chief executive officer of the New York-based American Foundation for AIDS Research, a national group known as AmFAR. He was paid $191,729 in 1996, the group said in its financial disclosure form filed with the Internal Revenue Service.
Radwin said AmFAR brought in an outside firm to recommend salaries under a philosophy of hiring good people and paying them "not at the top but in a competitive framework to attract the talent we need."
The Gay Men's Health Crisis, also based in New York City, had two employees who earned more than the $130,000 salary of New York Gov. George Pataki in 1995: Executive Director Mark Robinson, paid $144,782; and the deputy executive director for development, Addie Guttag, $139,337. The group did not return a phone call from the Associated Press for comment.
On the West Coast, Los Angeles-based AIDS Healthcare Foundation had at least six employees with salaries exceeding $100,000 in 1996 -- five physicians paid $127,375 to $172,366, and the foundation president, Michael Weinstein, paid $126,548.
"We're a medical provider and our top salary earners are doctors," said Cesar Portillo, the organization's director of government affairs. "We provide the highest-quality medical care to people with AIDS. The only way we can do that is to make sure we're competitive in the market in terms of physicians."
Graham, of the Whitman-Walker clinic, said his salary increased as the clinic grew, from a budget of $280,000 and six employees when he arrived 14 years ago to a budget of $21 million and 280 employees today.
Records show the clinic still spends just 2 percent of its budget on administrative costs.
"It is not a situation where money is being diverted to fat salaries over the back of people who need help," Graham said.
In Philadelphia, directors of AIDS service agencies generally make between $60,000 and $80,000 per year, although some, such as We The People, are significantly lower. WTP executive director Curtis Osborne currently earns $45,000 per year, and smaller agencies can pay as little as $25,000-30,000.
Protease drugs linked to artery disease
Severe premature coronary artery disease may be a complication of protease inhibitor therapy in some HIV-positive patients, according to a Minnesota-based team.Dr. Keith Henry of Regions Hospital in St. Paul and colleagues describe two such cases in the May 2nd issue of The Lancet, along with the results of a review of 124 HIV-positive patients who were treated at their clinic with protease inhibitors.
The two case histories described involved two men, aged 26 years and 37 years, both of whom were severely immunocompromised. The first patient was admitted for angina, and a large occlusive thrombus within the right coronary artery was subsequently detected. Four weeks prior to admission, the patient began a combination regimen that included ritonavir, saquinavir, lamivudine and stavudine.
The second patient, who had a family history of heart disease but no history of smoking, also presented with angina. Before he began treatment with indinavir his cholesterol was 4.28 mmol/L, which doubled 5 months after treatment. The patient had also developed a fat pad in the cervical area. Results of arteriography indicated occlusion of the left anterior descending artery, along with severe atherosclerosis in the right coronary artery.
Dr. Henry's group also found that of the 124 patients treated with protease inhibitors, 41 developed hyperlipidemia and were referred for intervention based on National Cholesterol Education Program (NCEP) guidelines. Of these patients, 15 were put on a diet and exercise program and 26 were prescribed cholesterol-lowering drugs.
"Peripheral lipodystrophy has been reported in patients receiving protease inhibitors," they write. Also, one study reported metabolic abnormalities, including high triglycerides, cholesterol and insulin resistance scores, in 64% of patients receiving protease inhibitors.
"Clinicians need to be aware of the potential for accelerated atherosclerosis in patients treated with protease inhibitors," Dr. Henry's group recommends. They suggest that fasting lipid profiles be obtained at baseline and again at 3 to 6 months in all patients prescribed protease inhibitors. If abnormalities develop, NCEP intervention guidelines should be followed.
Arnold Jackson, early AIDS leader, dies at 40
Arnold Jackson, the first Administrative Coordinator of We The People Living with AIDS/HIV of the Delaware Valley, died on May 3rd from AIDS complications.He was 40 years old.
Jackson also served as WTP's first Education Director, its first Member Services Director, and the founder and host of Positive Health, its weekly television broadcast on WYBE Channel 35. He was an active leader of both the AIDS and African American gay communities, being a member of a variety of early black gay organizations, including Philadelphia Black Gays and InnerPride; a charter member of the board of directors of Unity, Inc.; and a volunteer for a long list of other organizations, including The Colours Organization, BEBASHI, and various organizations dedicated to educating people with AIDS about complementary and alternative therapies for AIDS. This year, he was elected as Secretary of Adodi Philadelphia, an African American gay support group.
Jackson received a citation from Mayor Edward Rendell in 1992 honoring him for his work on behalf of people with AIDS and the black gay community.
In addition to his work at We The People, Jackson also served as the first co-director of the Ecumenical Information AIDS Resource Center, a short-term case manager at ActionAIDS and as an Intake Advocate at the AIDS Law Project of Pennsylvania, where he counted his fellow employees as among his closest friends.
An avid sports fan, Jackson also was a star outfielder for the 247 softball team, part of the City of Brotherly Love Softball League, for several years. He also acted in several plays in regional theaters and was a regular contributor to various publications, including We The People's Alive & Kicking!, Colours Magazine and Au Courant. A man of wide interests and opinions, he recently published articles in the Philadelphia Daily News on the Clinton scandals and in the Philadelphia Gay News on racism in the gay community. At his death, he was finishing work on a novel about the black gay experience set in Philadelphia. Jackson graduated in 1980 from Temple University's School of Communications.
He is survived by his mother, Christine Jackson, a sister Tina, three brothers, Kenneth, Milton and Leonard, of Philadelphia; his father, Louis, of Jacksonville, Florida; his partner of four years, Darryl Upshaw, and David Fair, who shared a home with Jackson for the past eleven years.
A memorial service will be held at 11:00 a.m. Saturday, May 9, 1998, at the Church of St. Luke and the Epiphany, 330 South 13th Street, Philadelphia. In lieu of flowers, Jackson wished that contributions be made to the AIDS Law Project of Pennsylvania, 1211 Chestnut Street, Philadelphia, PA 19107.
PWA spiritual retreat set
A Spiritual Retreat for People with HIV/AIDS, sponsored by the Quaker ministry on AIDS, will be held on May 19 at Pendle Hill, a Quaker Center near Philadelphia. The day will be devoted to non-denominational spiritual support to draw on inner resources for physical and emotional renewal. Transportation is available from center city. There is no charge. Call Ray Bentman, 215-985-1314 or e-mail for information.
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