SPBP expands list of covered prescription drugs
Paralyzed TPAC splits on motion to continue operations
Study challenges claims that HIV does not cause AIDS
Clinton caves in to ban on HIV+ soldiers
Vitamin C, beta carotene lower the death risk of men
3TC said to work against hepatitis B
Genital herpes more infectious in HIV-positive women
Herpesvirus tied to KS found in semen
Chesco PWA sues doctors and hospital
SPBP expands list of covered prescription drugs
Pennsylvania's Special Pharmaceutical Benefits Program has expanded its coverage of prescription drugs utilized by people living with HIV/AIDS. Covered services now include 54 prescription drugs, as well as other services.
People with HIV/AIDS whose annual incomes are $30,000 or less are eligible for support under the SPBP program, provided that they are either uninsured or that the drugs are not covered under other insurance. Income requirements are different for people with dependents.
In addition to the covered drugs, SPBP covers te cost of aerosolized pentamidine treatments in an outpatient setting or doctor's office. It also pays for the Respirgard II Nebulizer and a 12-piece IV supply package used with ganciclovir/foscavir therapy.
For more information on the program, contact an AIDS case manager, WTP's Thamon Pierce (215-545-6868), or the SPBP directly at 1-800-922-9384.
The complete list of drugs covered under the program follows. New drugs added to the list are noted with an asterisk (*).
Acyclovir
Alpha Interferon
Amikacin*
Amphotericin B*
Azithromycin
Bactrim/Septra
Biaxin
Bleomycin*
Capreomycin*
Ciprofloxacin
Clindamycin*
Clofazimine*
Clotrimazole
Cycloserine*
Dapsone
Dexamethasone*
Doxorubicin*
Epivir (3TC)*
Ethambutol*
Ethionamide*
Etoposide*
Fluconazole
Flucytosine*
Foscavir
Ganciclovir
Hivid (ddC)
Itraconazole
Isoniazid*
Kanamycin Sulfate*
Keotconazole
Leucovorin
Marinol
Megace
Mepron
Neutrexin
Nystatin*
Ofloxacin*
Paramomycin Sulfate*
Pentamidine
Predisone*
Prmiaquine Phosphate*
Pyrazinamide*
Retrovir (AZT)
Rifabutin
Rifampin*
Rifater*
Sulfadiazine*
Sulfadoxine/Pyrimethamine*
Terconazole*
TMP SMX
Triple Sulfa*
Videx (ddI)
Vinblastine Sulfate*
Vincristine*
Zerit (d4T)
Motion passes 17-12 -- with 34 absent
Paralyzed TPAC splits on motion to continue operations
By a narrow two-vote margin, the embattled board of directors of The Philadelphia AIDS Consortium has adopted a motion to continue its current operations and resist an effort by almost half of board to dissolve the corporation.
At a board meeting held Wednesday, the board voted 17-15 (with 34 board members, a majority, not even present) to "continue to perform all functions and provide all services for which it is currently missioned, chartered and contracted, as recommended in the Final Draft of the Strategic Planning Committee on October 20, 1995."
The board meeting was the first held by TPAC since November, after meetings in December and early January were cancelled because a quorum of one-third of the board members could not be achieved. The last meeting, which was an emergency meeting scheduled on January 11th at the demand of the group's HIV-Positive Caucus, had only eleven out of sixty-six board members show up.
As with almost every board meeting held over the past year, this meeting as well found board members angrily denouncing each other and engaging in heated debate. The primary issue dividing the board is continued charges of insensitivity to concerns of minorities and people with HIV/AIDS, and conflict of interest in TPAC's allocations of federal and state AIDS funding.
Almost all of TPAC's allocations have been made to organizations represented on its board of directors, despite a state contract provision prohibiting such allocations.
"In other words," said Joe Cronauer, a member of the TPAC board of directors representing We The People, "it's business as usual. The problem for a lot of us is that business as usual just doesn't work at TPAC. The problem won't go away just because a slim majority of only half the board members wished it away with this vote. There's just too much conflict of interest when agencies who receive the money sit on a board that controls how the money gets spent and sometimes even who gets to spend it. It may work for big AIDS services providers, but it doesn't work for poor people, for people of color, or for people living with AIDS."
Three other motions adopted at the meeting dealt with the composition and function of the board. The board, which currently has sixty-six members, would be reduced to thirty. Nine of the members would be consumers of services, nine would be provider representatives, and twelve would be individuals who were from the community and "non-aligned" with either consumers or providers. However, these non-aligned members would be recruited and chosen by consumers and providers.
Steve Pina, TPAC board member from One Day At A Time, asked that the motions be changed to specifically include African Americans as a part of the new board structure, since this community has historically been left out of planning processes, including TPAC's, and is the community most heavily impacted by the epidemic. The board, however, did not address his concerns as they narrowly passed all of the motions in their original form without any specific references to the African American community.
The committee structure of the new board would include an executive committee and other standing committees. A timeline was also adopted, although the timeline adopted had scheduled work beginning on December 13th and concluding with board elections on February 14th. It was unclear at the meeting how the timeline would be altered to accommodate the fact that it was not approved until January 24th.
Leonard West, a PWA representative on the board, said that he could not accept the board structure with only 33 percent consumer representation. "The new (Philadelphia HIV) Commission has 50% consumers," he told the board at the meeting, "and I fought hard in the beginning of TPAC to get consumer representation. I won't accept a step backwards now."
Upon hearing of the board vote, Gregory Hardy, Co-Chair of TPAC's HIV-Positive Caucus and Chair of WTP's board of directors said, "In TPAC, consumers and the HIV-Positive Caucus were never allowed to be in a position to have any real meaningful input, and it looks like we never will."
There have also been ongoing questions raised by some board members as to how possible it would be to find truly "non-aligned" people who are not connected to either consumers or providers of HIV/AIDS services, and if they are not aligned why they might want to serve on the board. A related process question that has been raised is how to get non-aligned board members on the board who are recruited and selected by consumer and provider "aligned" board members. To date, these questions have not been addressed by the full board.
"It's so easy to fix," said Cronauer in a discussion afterwards with other representatives of minority organizations. "Just give up the planning and allocations, give up the conflict of interest. Why can't they just do the other things they do best, and keep their hands out of the money jar. If they do that, we can all live with some peace. If they don't, I don't know how we can continue to participate."
Study challenges claims that HIV does not cause AIDS
Doctors researching the links between hemophilia and AIDS have cast further doubts on assertions that the HIV virus does not cause AIDS.
A few doctors and researchers, dubbed rebels by the orthodox medical and science community, say HIV does not cause AIDS and may simply be a benign "passenger" virus.
Some theories say that hemophiliacs, at high risk of HIV from contaminated blood products, actually developed AIDS from some of the drugs they get to make their blood clot.
But Dr. Caroline Sabin and colleagues at the Royal Free Hospital School of Medicine in London said their study showed this could not be.
They compared 17 hemophiliacs with HIV infection and 17 HIV-free hemophiliacs. They found that only the HIV-positive men developed diseases associated with AIDS, including Pneumocystis carinii pneumonia.
"Present data reject the hypothesis that high usage of clotting factor concentrate, rather than HIV infection, is the cause of immunodeficiency and AIDS in men with hemophilia," they wrote in the British Medical Journal.
They pointed out that many hemophiliacs got HIV from infected blood clotting factor concentrates that had not been heated, and thus not purified of the virus. Thus there was a link between the use of such drugs and AIDS infection -- but this did not mean the drugs themselves caused it.
Dr. Peter Duesberg of the University of California in Berkeley said he was not convinced. "HIV cannot be enough for AIDS because six of their 17 HIV-positive patients remained healthy for 10 years," Duesberg wrote in his own article in the BMJ.
Duesberg repeated his theory that foreign proteins cause AIDS. "Non-HIV hypotheses must be studied more carefully," he concluded.
Clinton caves in to demand to ban HIV+ soldiers
President Clinton will sign a revised $265 billion defense bill despite congressional mandates including the forced discharge of troops who test positive for HIV, the Pentagon said Thursday.
Clinton vetoed an earlier version of the fiscal 1996 defense authorization bill, but both the Pentagon and the White House said the Republican-led Congress had made acceptable changes in key areas, including missile defense.
"I can confirm that the secretary (Defense Secretary William Perry) has recommended that the president sign it, and the President will, in fact, sign it," Pentagon spokesman Ken Bacon told reporters.
The House Wednesday passed the compromise version of the bill, which is $7 billion more than the total sought by Clinton, and the Senate could give its approval as early as Friday.
Bacon said the Pentagon still objected to several items in the bill, including a ban on funds for abortion overseas and the forced removal of nearly 1,050 troops from the military who have tested HIV positive.
Under current law, military personnel testing HIV positive can remain in the service as long as they can perform their duties.
Bacon said the Pentagon objected to stipulations in the bill, which will deny use of defense funds to perform abortions in hospitals overseas and will also force the armed forces to buy only U.S.-made defense products in some cases.
He told reporters the department may try to seek relief on the HIV and abortion issues in separate legislation later.
"Right now, people with all sorts of maladies can stay in the military as long as they can do their jobs," Bacon said.
At the White House, spokesman Mike McCurry said Clinton felt the measure contained "alot of micro-managing of the Defense Department," but that the Republican-led Congress had made enough changes for him to sign it.
Back to Top Vitamin C, beta carotene lower the death risk of men
Middle-aged men who consume a diet of foods rich in vitamin C and beta carotene have a significantly lower risk of death than their peers who eat less of the nutrients, a new study shows.
In the late 1950s, researchers interviewed 1,556 men ages 40 to 55 who were employed by the Western Electric Co., asking them about food intake and other health-related factors. Over the next 24 years, men with the highest intake of vitamin C- and beta carotene-rich foods were 40 percent less likely to die of cancer - and 30 percent less likely to die of heart disease - than men with the lowest intake of these foods.
Overall, men who ate a healthier diet had a 31 percent lower risk of dying during the study period, according to the report, published last month in the American Journal of Epidemiology.
Men with the healthier diet ate 72 milligrams more of vitamin C per day (the amount found in one to two oranges) than men with the lowest intake of the vitamin, the study showed. They also ate 3 milligrams more of beta carotene per day (the equivalent of one to two carrots), according to study co-author Dr. Richard Shekelle of the University of Texas-Houston School of Public Health.
Overall, men with the healthiest diets consumed about 138 milligrams of vitamin C each day - about double the recommended dietary allowance - and 5.3 milligrams of beta carotene, for which there is no RDA.
Smokers appeared to benefit more from a diet high in antioxidants than did non-smokers, but the results were not statistically significant, according to the study.
Dietary antioxidants such as vitamin C and beta carotene are thought to prevent cancer, because they interact with free radicals - highly reactive oxygen molecules that damage DNA. And by preventing oxidation of LDL or 'bad' cholesterol, antioxidants also are thought to lower the risk of heart disease.
``The study is quite consistent with a variety of studies on dietary intake of fruits and vegetables related to heart disease and cancer,'' said Dr. Ronald Krauss, head of molecular medicine at Berkeley National Laboratory at the University of California, Berkeley.
But while many people take supplements to increase their dietary intake of vitamins, no studies have shown that supplements can substitute for a diet rich in fruits and vegetables, said Krauss, who heads the nutrition committee at the American Heart Association.
In the new study, vitamin C and beta carotene consumption was estimated only from the men's food intake, because few men in the late 1950s took such supplements.
``There are thousands of plant chemicals that may contribute to disease prevention,'' Krauss said. ``We can justify quite strongly the importance of trying to get these substances from real food.''
Back to Top
3TC said to work against hepatitis B
by Denise Mann
Medical Tribune
Already used to treat HIV, the nucleoside analogue lamivudine, commonly known as 3TC, also appears to suppress the hepatitis B virus in the DNA of patients with the chronic form of the disease, Harvard researchers report.
In the study of 32 chronic hepatitis B patients, traces of the virus disappeared in the DNA of all patients who took 100-mg or 300-mg doses daily of lamivudine (Epivir, 3TC, Glaxo Wellcome) for 12 weeks, according to Jules L. Dienstag, M.D, of the Gastroenterology Unit and Liver-Biliary-Pancreas Center at the Massachusetts General Hospital and the department of medicine at Harvard Medical School in Boston.
Dr. Dienstag and colleagues noted that while hepatitis B virus (HBV) DNA reappeared in most patients after completion of therapy, six patients (19%), including five who had been unresponsive to interferon, had sustained suppression of HBV DNA, along with a normalization of transaminase elevations.
Moreover, hepatitis B e antigen disappeared in four of these six patients (12%), he said.
But a longer course of the drug could suppress the virus indefinitely and prevent subsequent liver disease, said Raymond Koff, M.D., chairman of medicine at MetroWest Hospital in Framingham, Mass.
The findings are "an exciting new observation, and in a small number of people, we can start thinking about the notion of a cure," Dr. Koff said.
In the double-blind trial, the patients were assigned to either a 25-mg, 100-mg or 300-mg oral dose of lamivudine daily for 12 weeks.
Levels of the hepatitis B virus in genetic material became undetectable (≤ 1.5 pg/ml) in 70% of the chronic hepatitis B patients who took 25-mg doses of lamivudine, and 100 % of those taking the higher doses, Dr. Dienstag reported in The New England Journal of Medicine (1995;333: 1657-1661).
"It may be premature to get extraordinarily excited," Dr. Koff said. "But if longer term follow-up studies are done, we may really be talking about a cure."
Though lamivudine was well-tolerated, all participants in the trial experienced an increase in alanine aminotransferase.
In the study, alanine aminotransferase levels at least doubled in five patients given the 25-mg dose and eight patients given the 100- or 300-mg dose.
"Although this substance does have a toxic effect on the liver, in most cases it is usually a mild [effect]," said Alfred Prince, M.D., director of virology at the New York Blood Center in New York City.
Lamivudine, also known as 3TC and part of a new class of drugs called nucleoside analogues, seems to be more effective in treating chronic hepatitis B than interferon, which only works in about 40% of hepatitis B patients.
"It looks as if nucleoside analogues work in people who fail to respond to interferon," Dr. Koff said, because 17 study participants had no response to earlier therapy.
Larger multicenter trials involving 12-month courses of treatment with lamivudine are now underway, the study authors noted.
A trial involving the treatment combination of interferon and lamivudine may yield interesting results as well, Dr. Koff said.
The researchers monitored patients in the study every other week for 12 weeks and performed liver biopsies before or after each treatment. They continued their observations for 24 more weeks after suspending drug treatment.
Genital herpes more infectious in HIV-positive women
by Jacqueline Stenson
Medical Tribune
Women who are infected with both genital herpes and HIV are more likely to spread the herpes virus than women who have herpes alone, a new report shows.
In a study of 176 women, those who were infected with both sexually transmitted diseases were almost four times as likely to shed herpes virus particles as those who only had herpes (13.2% versus 3.6%), Michael Augenbraun, M.D., of the State University of New York-Health Science Center at Brooklyn reported in the Annals of Internal Medicine (1995; 123:845-847).
Nearly 80% of viral shedding in the HIV-infected women occurred when they were asymptomatic, according to the researchers. The rate of shedding increased as the women's CD4-cell counts decreased, they found.
Asymptomatic shedding of the herpes virus is common in infected women, and almost all women with the disease will shed the virus asymptomatically at one time or another, the researchers said.
H. Hunter Handsfield, M.D., director of the STD Control Program at the Seattle-Kings County Department of Public Health in Seattle, said the new findings are not surprising because HIV suppresses cell-mediated immunity, which is one of the things that keeps herpes in check.
"There is undoubtedly an increased opportunity to transmit genital herpes in HIV-infected folks than in HIV-uninfected folks," he said. "And it's probable that a person who has both [infections] also may be more efficient at transmitting HIV."
In addition to always using latex condoms during sex, people with one or both diseases should inform their sexual partners of their infections before engaging in sexual activity, the Seattle expert said.
Condoms, when used correctly and consistently, can be very effective against HIV, but they are somewhat less effective against herpes, Dr. Handsfield said.
"Condoms are clearly most effective at preventing infections that go from a mucous membrane to a mucous membrane," such as HIV, he said, adding that they are less effective at preventing infections that can be transmitted from skin to skin, such as herpes.
Herpesvirus tied to KS found in semen
A herpesvirus linked to Kaposi's sarcoma has been found in the semen of both HIV-infected and uninfected men, strengthening the theory that the virus is sexually transmitted, researchers from the Centers for Disease Control and Prevention report.
Over a year ago, scientists found a new form of herpesvirus, called Kaposi's sarcoma herpesvirus (KSHV), in 90% of skin-tissue samples of AIDS patients with Kaposi's sarcoma and 15% of those of HIV patients without the cancer.
Now, researchers led by Jung-Chung Lin, Ph.D., have found KSHV DNA sequences in the semen of 30 of 33 HIV-infected homosexual men. Thirteen of the 30 men developed Kaposi's sarcoma within five years, but none of the men who tested negative for KSHV developed the cancer, they reported in The Lancet (1995;346:1601-1602).
Evidence of the herpesvirus also was found in the semen of seven of 30 men who were not infected with HIV, suggesting that KSHV infection is common, but may lead to cancer only in people with weakened immune systems, such as those with AIDS, Dr. Lin said. The HIV-negative men were not followed, and more research on the potential effects of KSHV in healthy people is needed, he said.
"It's not surprising to find the virus in persons who don't have Kaposi's sarcoma," said Steven Miles, M.D., associate professor of medicine at the University of California at Los Angeles.
"We've believed for a long time that there are multiple steps that are required before development of Kaposi's sarcoma, and merely being infected with the virus is probably not sufficient to result in disease.
"Other features such as immune suppression, immune activation, co-infection with other agents and perhaps even malignant transformation might be required to get clinical manifestation," he said.
Yuan Chang, Ph.D., assistant professor of pathology at Columbia University in New York and an author of the earlier study on KSHV, said "the fact that Kaposi's sarcoma is an extremely rare cancer in individuals [with healthy immune systems] suggests that it is not easily transmitted, and that HIV-uninfected people really don't have a high risk of getting Kaposi's sarcoma at all."
The new findings are intriguing, Dr. Chang said, but they need to be corroborated by other groups. "If these figures hold up, this may suggest a mechanism for sexual transmission," she said.
Research has shown that Kaposi's sarcoma afflicts HIV-infected homosexual and bisexual men 20 times more often than HIV-positive hemophiliacs. It also is much less common among HIV-infected children and heterosexuals, which led the CDC researchers to suspect that "specific sexual practices among gay men may increase the probability of transmitting this new virus," they reported.
Bernard Roizman, Sc.D., professor of virology and an expert on herpes at the University of Chicago, said more research is needed to determine whether KSHV is "a cause or a passenger" of Kaposi's sarcoma.
Chesco PWA sues doctors and hospital
Kenneth Brown, a man who received a blood transfusion at Phoenixville Hospital in 1988 and says he later contracted AIDS from it, has sued the hospital and several of its physicians, accusing them of malpractice. Brown claims that the doctors refused to allow him or his family to donate their own blood and that the blood subsequently used was tainted with HIV. The suit contends that the physicians "failed to inform themselves...as to current medical and non-medical knowledge, data, recommendations, and other information regarding the risks of AIDS virus transmission posed by the transfusion of blood." Brown received three blood transfusions after being admitted for gastrointestinal problems on Jan. 18, 1988. He alleges that the transfusions were unnecessary and that the doctors ignored or failed to respond to certain symptoms, delayed a diagnosis, and performed inappropriate tests. The suit seeks $50,000 from each of seven defendants on each of three counts.