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In This Issue:
HIV drugs linked to heart risk
Wistar responds to claims on AIDS origin
HMO frees doctors to make treatment decisions
French activist fired for showing female condom
Gore proposes generic drug plan
People living with HIV who take strong cocktails of drugs may be keeping themselves free of AIDS, but they may be running the more long-term risk of heart disease, researchers have announced.
They said they found more evidence that protease inhibitors, the drugs credited with making the cocktails work against the virus, cause changes that can lead to heart disease.
"Patients are clearly getting tremendous benefits from the use of HIV protease inhibitors, but (heart disease) appears to be a significant side-effect to that benefit," Dr. James Sosman of the University of Wisconsin, who worked on the study, said in a statement.
The researchers told a meeting of the American Heart Association that they found evidence the drugs were affecting the lining of the blood vessels, called the endothelium.
Doctors had feared there might be side-effects of protease inhibitors -- besides the nausea, diarrhea and other immediate side-effects -- when some patients started complaining of strange fat deposits.
They got nicknames such as "protease paunch and "buffalo hump" because of their odd distribution.
Tests showed some patients using the protease inhibitors had unusual blood sugar and blood cholesterol levels, and some gained weight.
Sosman's team used ultrasound to image blood flow in the arteries of 21 HIV patients taking protease inhibitors, and compared them to seven patients who did not take the drugs.
They found suggestions that the endothelial linings of the protease patients were not working properly, as compared to the seven not taking the drugs.
Sosman said HIV patients who take protease inhibitors might be forced to add cholesterol drugs to their already complex pill regimes.
"Up until recently, doctors have been reluctant to place their HIV patients on lipid-lowering drugs because they weren't certain the changes caused by the inhibitors were leading to heart disease," he said.
"We need to be taking the long-term cardiac care of HIV patients who are using protease inhibitors more seriously. This study tells me we should be treating their lipid abnormalities."
Sosman said he would like to do a long-term study of HIV patients on protease inhibitors to see if they do develop coronary artery disease. (Reuters)
Philadelphia's Wistar Institute, one of the most eminent US medical research centers, will release lab specimens from a 1950s polio vaccine project in Africa in hopes of dispelling claims that its scientists inadvertently caused the AIDS epidemic, officials have announced.
For more than a decade, Wistar and 2 of its leading scientists have been "dogged" by speculation that HIV was transmitted from chimpanzees to humans through an oral polio vaccine given to more than 1 million people, mostly children, in central Africa.
Officials at the private, nonprofit institute said it would allow 2 independent labs to test material from the 1957 to 1960 vaccine trials in hopes that this will end the controversy by showing no evidence of simian immunodeficiency virus (SIV), which affects chimpanzees.
Scientists believe the AIDS epidemic, which has stricken 33 million people worldwide, began after SIV was transmitted from chimpanzees to human beings in Western Central Africa. Officials at the US Centers for Disease Control and Prevention say it probably occurred during the slaughter of chimpanzees as early as the 1930s.
Recently, however, the polio vaccine theory has been thrown back into the spotlight by a new book by British journalist Edward Hooper, whose research suggests that vaccine batches may have been made from chimpanzee kidneys and tainted with SIV.
Two Wistar scientists who led the polio research, former institute director Dr. Hilary Koprowski and his former deputy Dr. Stanley Plotkin, reject this suggestion.
"The idea is a house of cards built on circumstantial evidence, and whatever doesn't fit has been ignored. It's also, frankly, an attack on people's reputations, and I feel it has to be dealt with," said Dr. Plotkin, 67 years old, who developed the modern rubella vaccine before leaving Wistar for France's Pasteur Merrieux Connaught.
Two laboratories, which will be selected by Dr. Plotkin, will conduct the tests and will have the specimens by the end of this year.
"We just feel we can put that issue to rest if it's tested. Then...we've done exactly what people feel would be necessary at least to relieve the tension over this issue," Wistar Chief Administrator Clayton Buck said. (Reuters)
HMO frees doctors to make treatment decisions
by Stacey Burling
© Philadelphia Inquirer
UnitedHealth - the nation's second-largest health insurer but not a major player in the Philadelphia market - has announced that it haa eliminated one of the most unpopular elements of managed health care by giving up its policy of approving medical treatment decisions in advance, and said it will no longer overrule a doctor's orders. UnitedHealth officials explained that the process of medical review had cost rather than saved the company money.
The pacesetting decision to give doctors final authority over medical treatment drew praise from area doctors and President Clinton, and quickly became fodder in the congressional debate over regulating HMOs. The new policy is likely to prove popular with consumers.
But the impact on the rest of the medical-insurance industry, including Philadelphia's two biggest companies - Independence Blue Cross and Aetna U.S. Healthcare - remains unclear. Those companies weren't talking to the media about UnitedHealth's plans. Aetna did say that it has been working to improve access to "physician-directed" care.
Analysts said it was not certain that other health plans would follow UnitedHealth's lead because they rely more heavily on scrutinizing the day-to-day decisions of doctors in order to keep their costs in line. They worry that abandoning that approach could lead to lower profits.
"Some HMOs are scared that they can't control the doctors," said Peter Boland, a health-care-management consultant in Berkeley, Calif. "They see this as contrary to their control-and-command philosophy."
Aetna, the largest health insurer, has a reputation for keeping a close watch on physicians and is unlikely to ease up on the reins, Boland said.
UnitedHealth officials said consumers will determine whether other insurance companies change their policies as well. "If other insurance companies lose customers to us because of this program, I'm sure they'll change," said Dr. Lee Newcomer, senior vice president for health policy and strategy for UnitedHealth. President Clinton, who supports federal legislation allowing patients to sue their HMOs, complimented UnitedHealth.
Each side in a congressional dispute over a "patients' bill of rights" saw the change of policy as evidence that its view had been vindicated.
"Our bill says doctors, not insurers, should make the 'medical necessity' call when treating patients, and should not be second-guessed by bureaucrats with the [insurance] plan," said Greg Ganske (R., Iowa), coauthor with Reps. Charles Norwood (R., Ga.) and John Dingell (D., Mich.), of a bill that passed the House 275-151 a month ago. "And we need our bill because who's to say they won't change their mind later and reverse this policy."
But the bill's opponents, spearheaded by the Republican leaders in both houses, insist that UnitedHealth's decision confirms their view that market forces are working to correct any abuses by the managed-care insurance industry. "Clearly, the market works," said House Majority Leader Dick Armey (R., Texas). "The bureaucracy intervening between doctors and patients simply wasn't worth its cost. Market forces are weeding out the middleman and returning medical decision-making to doctors and patients."
How this will all play out in Philadelphia is especially difficult to predict.
"This marketplace is always different," said Alan Hillman, professor of medicine and health-care management at the University of Pennsylvania. That is because Philadelphia is dominated by just two large companies, because it has so many hospitals and academic medical centers, and because it has no public hospitals to care for the poor.
That said, Hillman said UnitedHealth's decision should be popular. "From a marketing perspective, at least, this move . . . is giving back to doctors and patients what doctors and patients have always wanted, which is a relationship in which patients can trust that their physicians are the ones making the decisions."
UnitedHealth Group has little local influence. The Minnesota-based company is not licensed as an HMO in Pennsylvania and has only 68,000 HMO members - 3 percent of the market - in New Jersey. That includes about 1,500 patients in Burlington, Camden and Gloucester Counties.
The company has about 530,000 members in Pennsylvania and New Jersey in less strictly managed plans.
Gerald Katz, president of Katz Consulting Group in Plymouth Meeting, said he suspects UnitedHealth's move will have "tremendous" influence on the industry because it will be "very appealing to consumers."
But Alan Zuckerman, a director at Health Strategies & Solutions in Philadelphia, said the industry reaction won't be clear until there's more detail about what UnitedHealth is really up to. The situation reminded him of two years ago, when many people predicted that all managed-care plans would begin covering alternative medicine because Oxford Health Plan did. That didn't prove true, he said.
UnitedHealth, unlike some Philadelphia managed-care plans, has not required its members to obtain referrals for visits to specialists since 1984.Although they want to know details, area doctors said they liked the company's new approach. "We have long said that the clinical autonomy that physicians need to practice medicine . . . should be returned to them," said Roger F. Mecum, executive director of the Pennsylvania Medical Society.
Jeffrey Lenow, a lawyer and family physician at Thomas Jefferson University Hospital who teaches a course in managed care, is not surprised that UnitedHealth has decided to stop exercising so much control over its doctors. "In 1994, I predicted micromanagement would fade away," he said. "I think doctors are reclaiming their domain of utilization management. UnitedHealth Group is sounding the clarion call that enough is enough." Jacqueline Gutmann, a reproductive endocrinologist and fertility specialist in Center City, said that while she doesn't know exactly how UnitedHealth's new system will work, any system that reduces HMO red tape is a step forward.
New Zealand is implementing a ban on all HIV-positive immigrants because the country "can't afford to save the world," Immigration Minister Tuariki Delamere has announced.
Senior government ministers decided that, effective July 1 next year, all new immigrants, refugees and anyone wanting to live or work in the country for more than two years would be subject to an HIV/AIDS test to be taken before arrival in New Zealand.
Anyone failing the test will be barred entry. The move brings New Zealand in line with Australian immigration policy.
"These people do pose a risk to New Zealanders," Delamere told Radio New Zealand.
Delamere said the ban included refugees recommended under a United Nations quota program and that such dangers must be considered ahead of any humanitarian obligations.
"I feel this is a very valid form of discrimination," he said. About 750 refugees enter New Zealand under the program each year and undergo a test voluntarily.
New Zealand AIDS Foundation executive director Kevin Hague said New Zealand shouldn't be "picking and choosing, saying we'll only take the nice ones."
"If the government couldn't afford all the services associated with taking refugees, it should take fewer in order to provide the care," the Evening Post newspaper reported him as saying.
Of 105 people freshly identified as HIV-positive in New Zealand last year, 43 were refugees, the Dominion newspaper reported, adding that no refugees had refused to take the voluntary screening test. (Reuters)
A French AIDS activist has lost his job in a blood transfusion centre because he showed colleagues a female condom, his association said.
Christophe Porot, head of the Lyon chapter of a national AIDS awareness group called Aides, showed the female condom last month during a discussion with fellow laboratory workers, a spokesman said.
"That was on a Friday, and on Monday he got a letter from the staff manager saying this gesture had shocked the head doctor and they would no longer need his services," he told Europe 1 radio.
"We don't know whether to laugh or to cry about this," said the spokesman, adding the association had lodged a protest with the Health Ministry.
First introduced in 1996, the female condom has been widely distributed by the United Nations AIDS agency in Africa and Asia in the fight against the deadly disease. (Reuters)
Vice President Al Gore, under attack from AIDS activists for his role in preventing the importation of generic AIDS drugs by South Africa, is now proposing several new measures to get generic versions of costly prescription drugs on the market quicker.
Gore said he wants to see legislation that would make it harder for drug companies to get extensions on drug patents, which delay the ability of other companies to market generic versions of the drugs.
In remarks delivered at a Washington pharmacy, the Democratic presidential candidate said he wants Congress to enact legislation that would require an independent analysis of the effects extensions would have on Medicaid and veterans programs costs, as well as the implications for consumers.
"Today, when unfair patent extensions are granted, consumers pay the difference in higher drug prices," said a written statement by Gore's office. "Before gaining such exceptions, Congress should assess the real costs to the American taxpayer."
Gore said he would work with Congress to assure that patent extensions be considered as separate legislation, not as part of another bill.
"Today many patent extensions are attached to larger pieces of legislation in the middle of the night by special interests," the statement said. "Al Gore believes that patent extension should be granted only after full consideration by Congress as stand-alone legislation."
The vice president also supports enacting a prescription drug benefit for all Medicare participants of up to $5,000 a year.
Clarification: In last week's issue of fastfax, we reported on an article in the Philadelphia Gay News which said that Philadelphia HIV Commission co-chairs Dale Grundy and Michael Hinson had criticized former Commission manager Bernard Warren for an expenditure for decorating the offices of the HIV Commission. Hinson has since contacted fastfax and stated that he had not made this statement to PGN. We regret any misunderstanding.