Report says managed care weak on AIDS care
Scientists aim to recreate immune system in AIDS
Rescriptor shows promising results in study
Saquinavir works best with grapefruit juice
Prolonged ddI use limits AZT effect: study
Wider use of pneumonia vaccine urged
Supreme Court upholds AZT patents
Pataki calls for bill to force testing of suspects
GMHC loses three black board members
ACT UP challenges Project Inform
Texas finally accepts AIDS grant
Report says managed care weak on AIDS care
For the first time, large numbers of people with HIV and other chronic conditions are in managed care networks. But HMOs evolved to meet the needs of healthy people, and few have track records with AIDS and other serious chronic conditions, according to a report in The New York Times.
Even officials who favor forcing Medicaid patients into managed care are wondering whether they will need to create networks tailored for people with HIV. Last month, New York Gov. George Pataki announced $2 million in grants for health care companies to develop such plans, in hope they could be offered to Medicaid patients by next year.
"We don't have a lot of experience taking care of HIV-infected patients within HMOs," said NY State Health Commissioner, Dr. Barbara A. DeBuono. "These HMOs area all over the lot in their care."
In fact, the Federal Department of Health and Human Services insisted last fall that people with AIDS be exempt from a New York City plan to place Medicaid patients in HMOs, specifically because it felt that their AIDS services were inadequate.
A similar Medicaid "reform" plan, called HealthChoices, is scheduled to be implemented in Pennsylvania later this year. To date, no special plans to guarantee care for people with HIV disease have been included in the Pennsylvania plan.
People with AIDS in managed-care networks complain of many problems - from an inability to find doctors knowledgeable about the disease, to inadequate coverage for drugs, to long waits for appointments.
"Our clients who've been in managed care have had horrendous experiences," says Charles King, president of Housing Works, a group that helps people with AIDS in New York.
Susan Dooha, a senior policy analyst at Gay Men's Health Crisis, the country's largest AIDS services network, agrees. "I don't have any success stories about HMOs, just a lot of complaints, and I think it's a structural problem. The HMOs consistently rely on a gatekeeper to prevent overuse, which may be appropriate for healthy people like me, but is not appropriate for someone who is medically fragile."
Patients infected with HIV say they have trouble locating doctors from HMO lists who have experience treating their disease. "It is very hard choosing a physician, either because there are none who are sensitive and up to date about HIV, or because the customer service departments are not very helpful in finding them," says Devi Glazier, a development associate at Housing Works who, like 40 percent of the group's employees, is HIV-infected.
Ms. Glazier said Housing Works persuaded the Cigna Corporation, its HMO insurer, to take on a primary-care doctor who was an expert in HIV treatment.
Even when the referral process works, she said, the specialists available within the networks are often inadequate. For example, Ms. Glazier said she'd been unable to find a gynecologist in the plan who was skilled in caring for HIV-positive women, who are prone to unusual infections and gynecological cancers. "If there is someone there, it is a very well-kept secret. I have to pay to go out of the network."
Scientists aim to recreate immune system in AIDS
Scientists should refocus their AIDS research efforts and try to learn how to create a virtually new immune system in people with AIDS, two prominent researchers have said.
In an article appearing in the journal Science, Dr. Barton Haynes, chairman of medicine at Duke Medical Center, and Dr. Anthony Fauci, a top National Institutes of Health AIDS official, urge a shift in researchers' attention.
Haynes is working on an experimental remedy that involves implanting pieces of a gland into a patient that would grow into a new, stronger immune system.
With vaccine research disappointing, and only limited success so far in slowing down HIV with drugs, they said the answers may lie in the so-called "long-term nonprogressors."
Those are the relatively few people who have lived for up to 20 years after infection with the virus without getting sick. Typically people get sick after about 10 years, and some get full-blown AIDS only two or three years after infection with HIV.
Scientists believe the long-term nonprogressors have inherited proteins that do a better job of recognizing the difference between its tissue and foreign invaders like viruses and bacteria.
Haynes and his colleagues at Duke are working on a two-step process. First, a patient would get a bone marrow transplant, to clear damaged immune cells. Then, the patient would get an implant of thymus tissue. That gland is the "brain" of the immune system, helping cells distinguish foreign bodies.
Rescriptor shows promising results in study
Swedish-American pharmaceutical giant Pharmacia & Upjohn has announced that studies involving its HIV-drug Rescriptor showed it may reduce the probability of patients
developing AIDS.
The company said Rescriptor also provided a more accurate gauge of patients' reactions to experimental drugs being used to try to cure AIDS.
Patients taking the drug in a combination cocktail with other drugs, including AZT and ddI (Videx), have been able to cut the amount of HIV in the blood by around 70 percent for up to 15 months, the company said.
"This could have a major effect on the daily lives of doctors and patients," said AIDS-researcher Erik Sandstrom at Soder Hospital in Stockholm.
"It appears that Delavirdine, in combination with other drugs, has a positive effect on patients. How much we cannot say yet ... but it will probably be of use for some patients," he said.
Rescriptor belongs to the family of non-nucleoside reverse transcriptase inhibitors, which block the action of an enzyme that the virus needs in order to replicate and spread. Rescriptor attacks the virus inside the cell, but outside the cell's nucleus. Similar drugs already on the market include AZT, ddC, and ddI.
Early analysis from trials with Rescriptor also confirmed that a blood test called RNA-PCR to measure the amount of HIV in the blood -- the viral burden -- may be used to predict the course or speed of progression of the virus.
"These results suggest the threshold level of viral burden which, when reached ... may delay progression to AIDS-defining illnesses and death," said John Phair, a doctor at Northwestern University Medical School in Illinois. "It is very likely that this will help to prolong the lives of the patients," said Carola Lemne, medical director of Pharmacia & Upjohn.
Scientists advised caution, however.
"It has to be remembered that this is just one of several medicines being developed. What we will have to learn is how to combine them," said Sandstrom.
The clinical tests with Rescriptor have included more than 3,500 patients.
The company said it may seek dispensation from the U.S. Food and Drug Administration (FDA) to rush the new drug into production and bypass waiting lists.
The company said it had shared its early analysis of the drug with clinical study investigators and AIDS activists and it would be presented at an AIDS conference later this month. A Pharmacia spokesman said the company would ask for a U.S. registration of the drug as soon as possible.
Saquinavir works best with grapefruit juice
Saquinavir, one of the new class of protease inhibitors being tested for effectiveness against HIV, appears to work better if it's washed down with a glass of grapefruit juice, according to Hoffmann-LaRoche, the drug's manufacturer.
Saquinavir is one of a new generation of AIDS drugs that work by inhibiting HIV protease, an enzyme required for completion of the viral life cycle.
The inhibition of protease by drugs results in the formation of non-infectious particles in test-tube experiments, leading researchers to believe it an ideal target for slowing the progression of AIDS in humans.
In a new study, 12 HIV-negative people took saquinavir with 5 ounces of grapefruit juice made from frozen concentrate, and another 5 ounces of grapefruit juice an hour later.
The concentration of active drug in the blood - an indicator of how well it would be expected to work - was greater after the drug was taken with the juice than when it was washed down with water, according to a report in the current issue of Positively Aware: The Journal of the Test Positive Aware Network.
The improvement was even greater with juice made with less water, the study showed.
But instead of recommending that the drug be taken with grapefruit juice, Hoffmann-LaRoche is working on a new formulation of the drug that would include some of the juice's favorable properties. The reason: lack of uniformity among different batches of juice, and the possibility of stomach irritation that could make people stop taking the drug altogether, the company said.
Prolonged ddI use limits AZT effect: study
Prolonged therapy with the anti-HIV drug ddI may decrease the effectiveness of future treatment with AZT, a new study suggests.
In two patients taking only the drug ddI for more than two years, HIV mutated in such a way as to make the virus resistant to the drug AZT, New York researchers reported.
One of the patients had previously taken AZT, while the other had not, the researchers reported in the December issue of The Journal of Infectious Diseases.
The drug ddI probably caused anti-AZT viral mutations in the two patients as a side effect of conferring resistance to ddI, although the researchers could not detect any ddI-resistant mutations with the test they used, said lead study author Dr. Lisa Demeter, from the University of Rochester School of Medicine and Dentistry in Rochester, N.Y.
The anti-AZT mutations were not found in the patients' blood until after two years of ddI therapy, and the researchers noted that in previously studied patients taking the drug for one year, such mutations were not detected.
Wider use of pneumonia vaccine urged
In a snapshot view of what is taking place nationwide, a new study shows that the rate of antibiotic-resistant bacterial pneumonia has steadily risen over a three-year period at 10 Ohio hospitals.
Based on the findings, health experts called for more liberal use of bacterial pneumonia vaccines, which currently are recommended only for those over age 65 or people who have chronic diseases.
In the study of 590 patients with severe pneumonia caused by the Streptococcus pneumoniae bacteria, resistance to penicillin rose by 10 percent over the study period, while resistance to other antibiotics rose by as much as 12 percent, Ohio researchers report in the Journal of the American Medical Association.
The overall death rate from pneumonia remained steady at 19 percent over the three-year period, with the elderly being particularly susceptible - 38 percent of patients aged 85 or older died. But patients infected with drug-resistant strains of S. pneumoniae averaged four days longer in the hospital, noted lead study author Dr. Joseph Plouffe, of Ohio State University Medical Center in Columbus.
The researchers noted that in Franklin County, Ohio, where the 10 hospitals studied are located, immunization rates are as low as 19 percent in those who should have received the vaccine. Almost all - 90 percent - of the S. pneumoniae strains would have been killed by the current form of the vaccine, according to the report.
S. pneumoniae is a major cause of the roughly 500,000 cases of pneumonia that occur each year in the United States, and of the 50,000 severe cases, said the study authors.
The disorder causes filling of the lungs with fluid in addition to fever, chills and chest pain.
"In terms of drug resistance, what's happening [in this study] is probably what's happening everywhere else in the country," said Dr. Richard Wenzel, chair of internal medicine at the Medical College of Virginia in Richmond. "This is our best estimate, and the study ended in 1994, so it's probably worse now."
Wenzel urged doctors to be more aggressive in getting patients immunized, and recommended that the criteria for determining those who need the vaccine be changed. The age cutoff should be reduced to at least 55, he said, and all smokers should be targeted.
"If you look at smokers, they tend to have more S. pneumonia in their throat cultures," he said. "If we included this group, that would be a tremendous increase in immunization rates."
Wenzel explained that antibiotics are normally prescribed after a patient is treated for pneumonia in the critical care unit, to kill the S. pneumoniae bacteria. But if the microbes are drug-resistant, they will continue to grow and multiply, steadily worsening the patient's condition, he said.
Bacteria acquire resistance to specific antibiotics according to the laws governing all natural evolution: survival of the fittest. When an antibiotic attacks a bacterium, it kills off all the susceptible bacterial cells, leaving only the antibiotic-resistant bacterial cells to flourish. These resistant bacteria then replicate, or they may mutate, exchanging DNA with other bacterial cells, creating entire new generations of bacteria impervious to existing antibiotic medication.
Doctors and patients may also play a role in creating resistant bacteria, Plouffe said. Prescribing an antibiotic for an infection for which it is not effective - such as a viral infection - serves to help bacteria build resistance to the antibiotic. In addition, patients often only take their antibiotic for a few days, stopping as soon as they feel better. At this point, however, only the weakest bacteria have been eradicated; other, stronger bacteria that are able to resist the antibiotic may remain.
Supreme Court upholds AZT patents
The Supreme Court has denied appeals by two generic drug manufacturers challenging patents for AZT.
The high court rejected legal challenges by the generic drug makers, Barr Laboratories Inc. and Novopharm Inc., to five patents held by Burroughs Wellcome, the drug manufacturer acquired by Glaxo Holdings Plc last year.
The patents govern AZT, which is widely used to treat people infected with HIV. The patents do not expire until 2005.
In 1991, Barr sought approval from the Food and Drug Administration to make a generic version of AZT, and Novopharm later filed a similar request. Burroughs Wellcome responded by filing a patent infringement lawsuit in federal court in North Carolina.
Barr and Novopharm claimed two scientists from the federal government's National Institutes of Health were co-inventors of AZT, making the Burroughs Wellcome patents invalid. But after more than three weeks of trial, a federal judge held that the patents were valid, and a U.S. Court of Appeals last November upheld that decision.
The two generic drug makers filed separate appeals to the Supreme Court, asking the justices to hear the case and overturn the lower-court ruling. Barr in its appeal warned the decision "will enhance monopoly drug pricing" and have dire consequences.
But Glaxo defended the patents, saying Burroughs Wellcome scientists discovered AZT to treat HIV disease as a result of careful and painstaking research. The Justice Department, in support of Glaxo, told the justices the appeals court decision was consistent with the underlying principles of patent policy.
The department also rejected suggestions by Barr Laboratories that the decision would likely impede development of new medical treatments for AIDS and other diseases.
Pataki calls for bill to force testing of suspects
New York Gov. George Pataki plans to propose a law to allow judges to order HIV tests for people charged with certain offenses, from violent felonies to disorderly conduct, if victims request the tests, according to The New York Times.
AIDS experts say the proposal would be the most sweeping example of such a policy in the country. Democrats in the state assembly have disagreed on a similar bill.
Opponents argue that such a policy would be an invasion of privacy, would further stigmatize people with AIDS, and would not help people find out if they were infected. They also say the law would violate the Constitution because officials would be able to draw blood for HIV tests before an innocent or guilty verdict was made.
GMHC loses three black board members
In the culmination of an ongoing controversy similar to that which has rocked Philadelphia AIDS service organizations for ten years, three black board members of the Gay Men's Health Crisis (GMHC), a private Manhattan AIDS organization, have quit, saying that the group was not attentive to the needs of minority community members.
Across the country, poorer black, Hispanic, and Asian people with AIDS are questioning how their communities are being served. The Gay Men's Health Crisis was founded by six white men in 1982 and offers financial, legal and practical help to 7,300 people with AIDS. More than half of the clients are black, Hispanic or Asian. The board now has four black, two Hispanic and one Asian member. Dr. Billy E. Jones, executive director of the Kingsboro Psychiatric Center in Brooklyn, was the most well-known black board member who quit. Jones noted, "Much work needs to be done at GMHC to make it truly inclusive and welcoming of diversity."
ACT UP challenges Project Inform
On January 11th, seven members of ACT UP San Francisco disrupted the Project Inform Town Hall Meeting held in San Francisco that featured speakers Martin Delaney, Dr. Steven Deeks and Dr. Thomas Merigan.
The disruption was the first in a planned series of attacks on "mainstream" AIDS organizations in San Francisco that ACT UP SF has identified as embroiled in conflict of interest through their acceptance of pharmaceutical industry contributions.
At the protest, ACT UP distributed a flier which said that since "Project Inform receives drug company money...the information they dispense is not objective. Following their treatment advice can be hazardous to your health and can cause serious damage to your already weakened immune system."
The group said, "Project Inform uses research findings from outdated and flawed clinical trials to support their assertion that people with HIV and AIDS initiate therapy with antiretrovirals or protease inhibitors. For example, in their AZT Fact Sheet, seven of the ten studies they reference as support for antiviral intervention are at least five years old. Several of these cited studies, like the widely denounced initial AZT trial by Maragret Fischl, tested their respective agents for less than 6 months and gave no indication of compounds' long-term harmful effects on people with AIDS. In fact, early results from a clinical trial (ACTG 019) by San Francisco's Paul Volberding was cited as proof in 1990 by Project Inform that the HIV-infected should immediately take AZT. However, final results of this trial in 1995 found that although AZT did 'slow the decline in laboratory markers like CD4 counts, it did not prolong either AIDS-free or overall survival.' The study's researchers then admitted that 'these results do not encourage the use of AZT' in asymptomatic, HIV-infected adults. (NEJM, August 17, 1995)."
ACT UP charged that Project Inform "consistently misrepresents CD4 counts as indicators of disease progression, survival time and quality of life for those with HIV despite scientific evidence to the contrary ("Concorde Study", The Lancet, April 1994). Martin Delaney, in cooperation with pharmaceutical industry insiders, was a key player in convincing government officials early in the course of the AIDS crisis to elevate T-cell counts to the status of a 'standard' in determining the supposed effectiveness of antiviral drugs. Project Inform now uses lab markers like CD4 counts and the equally unreliable peripheral blood viral load counts as weapons to intimidate the AIDS community into taking it's pharmaceutical employer's profitable, unproven therapies."
Project Inform "continues to ignore the characteristics virtually universal among long-term survivors of AIDS: that these HIV-infected individuals refrain from using antivirals and that they have elevated levels of CD8 cells ("Long-Term Nonprogressive HIV Infection", NEJM, Jan. 26, 1995)," ACT UP said. "Despite this important evidence, Project Inform reps continue to urge PWAs to dose themselves with combination antiviral therapy that temporarily increases CD4 counts but in the long run destroys patients' CD8 cells ("Administration of zidovudine during primary HIV-1 infection may be associated with a less vigorous immune response", AIDS 1993, Vol. 7, No. 1)
The group said that Project Inform, "as paid drug company representatives," has shown "incredible contempt for the health and well-being of people with AIDS. They prey on a frightened, desperate community by attempting to pressure HIV-infected individuals into initiating toxic antiviral therapy. If adverse side effects arise in the HIV-infected from use of these compounds, Project Inform blames the patient."
Project Inform had not issued a formal response to the ACT UP statement at the time this issue of fastfax was being prepared.
Texas finally accepts AIDS grant
Texas State Education Commissioner Mike Moses, whose rejection of a $1.3 million AIDS education grant sparked demonstrations last year, says he is now willing to accept the funds.
Moses told the State Board of Education he has been assured by federal officials at the Centers for Disease Control, which offers the grant, that the money will come with no strings attached with regard to sex education requirements in public schools.
"The CDC has not and will not dictate the type of curriculum that is to be established for each grantee," Sharron P. Orum, the CDC's grant's management officer, said in a letter to Moses.
"This language is strong enough for me, and I hope strong enough for the severest critics of these funds," Moses said. "As a result of this letter, I have directed our staff to move forward with our application for the continuation of the grant."
Gov. George W. Bush, who supported Moses' initial decision last year, applauded the commissioner for "sticking to his guns and winning freedom for Texas schools."
"He accomplished exactly what he set out to do and as a result, Texas schools will get federal funds without federal mandates on how to teach health education," Bush said.
Moses stirred up a hornets' nest last November when he announced he was canceling the remaining three years of the grant, which was designed to train school counselors about AIDS and other sexually transmitted diseases. He said the money was restricted, and that accepting the grant could force Texas public schools to accept federal guidelines on sex education.
The decision angered some legislators, educators, family planning groups, civil rights groups and students, some of whom staged a protest outside his Austin office.