News (Updated April 30,
2004)
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Wed Apr 21, 2:15 PM ET
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PARIS (AFP) - An international team of scientists says it has refuted a theory that AIDS originated in a contaminated oral polio vaccine used in the then Belgian Congo in the 1950s.
The
team, headed by an American biologist Michael Worobey of the University of
Arizona, says that it has direct proof to back its findings, which are to be
published in the British scientific review Nature Thursday.
The theory, put forward in the 1990s, argues that the polio vaccine was contaminated by a virus carried by chimpanzees. The vaccine was given between 1957 and 1960 to about a million people in the Belgian Congo, which later became Zaire and then the Democratic Republic of Congo.
An American journalist, Edward Hooper, argued that the tissue of chimpanzees, potentially contaminated, was used in the manufacture of the vaccine.
Scientists agree that the Human Immunodeficiency Virus (HIV), which can lead to AIDS, derives from its counterpart among chimpanzees, Simian Immunodeficiency Virus (SIV), though there is no consensus on how the virus crossed the species barrier.
But the research team, made up of African, British and American researchers, found a new variant of SIV (SIVcpzDRC1) in chimpanzees which belongs to a different family tree from the virus found in chimpanzees which is related to HIV.
In the light of this discovery and of the earlier analysis of samples of vaccine from the period which show no sign of SIV, HIV or the DNA of chimpanzees the team says the theory of a link between the vaccine and AIDS should be abandoned.
"Belief that polio vaccine can spread AIDS has hampered the World Health Organisation's efforts to stamp out polio," said Nature.
"In Nigeria, several states recently banned the use of the vaccine. Nigeria now has the highest number of polio cases in the world," it added.
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Thu Apr 29, 8:34 PM ET
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PARIS (AFP) - Women who are beaten or dominated by their partner are nearly half as likely to become infected by HIV when compared with women who live in non-violent households, a South African study says.
The research was carried out among 1,366 women who attended health centres in Soweto, Johannesburg, and who agreed to be tested for the AIDS virus and be interviewed about their home life.
After being adjusted for factors that could skew the outcome, such as whether the interviewees had engaged in casual sex or prostitution, the figures showed women who were beaten by their husbands or boyfriends were 48 percent likelier to become infected by HIV than their counterparts.
And those who were emotionally or financially dominated by their partner were 52 percent likelier to catch the virus.
"Women with violent or controlling male partners are at increased risk of infection," say the authors, led by Kristin Dunkle, a University of Michigan epidemiologist.
"We postulate that abusive men are more likely to have HIV and impose risky sexual practices on partners."
Feminists have long warned that gender violence and gender inequality are major, but tragically unpublicised, factors in spreading the global AIDS epidemic.
But facts to back this contention have, until now, been rare.
In their annual update last December, UNAIDS and the World Health Organisation (WHO) estimated the global tally of people infected with AIDS or the human immunodeficiency virus (HIV) in 2003 to be around 40 million.
Two-thirds of this total live in sub-Saharan Africa, of which an overwhelming majority are women and girls.
The research is published in Saturday's issue of The Lancet, the British medical weekly.
South African organisations who took part included the Gender and Health Group of the Medical Research Council and the Chris Hani Baragwanath Hospital at the University of Witwatersrand.
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Wed Apr 28, 4:38 PM ET
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NEW YORK (Reuters Health) - Ten US military personnel vaccinated against smallpox and later found to be infected with HIV appear to have experienced no adverse consequences, according to a report in Clinical Infectious Diseases.
This lack of complications may stem from the fact that all of the subjects seemed to be in the early stages of HIV infection and did not have markedly impaired immune systems.
Although the smallpox vaccine is highly protective against the virus, its use in people with impaired immune systems can lead to progressive vaccinia, a rare but potentially fatal complication, senior author Dr. John D. Grabenstein, from the US Army Medical Command in Falls Church, Virginia, and colleagues note.
Few studies are available that address the safety and effectiveness of the vaccine in HIV-infected patients, the researchers point out. As such, current public health guidelines recommend that smallpox vaccination be avoided in HIV-infected patients.
Despite this recommendation, recent estimates suggest that over the years several hundred military personnel have received the vaccine before finding out that they were infected with HIV. Presumably, most of these individuals did well, but there was one case of progressive vaccinia that responded to treatment.
In the current study, Grabenstein's team reviewed the cases of 10 subjects who received the smallpox vaccine in early 2003 and were later found to be infected with HIV at the time of vaccination.
At 1 to 3 months after vaccination, the subjects' CD4+ cell counts ranged from 286 to 751 cells/microliter with a mean of 483 cells/microliter.
In all subjects, the immune response to vaccination was normal and robust without any complications, the researchers report.
Still, Grabenstein and colleagues note that it is premature to conclude that smallpox vaccination is safe and effective for all HIV-infected patients.
They point out that the study involved a small series of patients who due to their relatively intact immune systems may not be representative of the larger population of HIV-positive individuals. Also, many of the subjects had been vaccinated against smallpox in the past, so they may have had some degree of protective immunity against the current vaccine.
SOURCE: Clinical Infectious Diseases, May 1, 2004.
WASHINGTON (Reuters) - The National Institutes of Health will hold a public hearing next month on a request to allow cheaper, generic copies of an Abbott Laboratories Inc. AIDS drug, the U.S. government announced Wednesday.
Essential Inventions Inc., a nonprofit firm run by consumer activists, has asked the Department of Health and Human Services for a license to produce copies of the drug, Norvir, while it is still under patent.
Norvir was developed with support from taxpayer funds and now is being sold at an unreasonable price, the activists argue.
Last December, Abbott raised the price for 100-milligram capsules of Norvir to $8.57 from $1.71--a 400 percent jump.
The company says the price hike was long overdue and was necessary to help fund future drug development.
Norvir is a protease inhibitor used to fight HIV that causes AIDS. It is unique in its class because it can boost the effectiveness of other AIDS medicines.
Essential Inventions says the 1980 Bayh-Dole Act gives the health secretary power to grant licenses to other producers of patented medicines developed with support from taxpayers.
Abbott spokeswoman Jennifer Smoter said the Bayh-Dole Act was intended for use when the public did not have access to an invention supported by taxpayer funds. That is not the case with Norvir, she said.
"We make sure people have access" to Norvir, she said.
The NIH, in a notice published Wednesday, said it would hold a public meeting May 25 for invited speakers to give input.
Abbott expects to be invited and, if so, will send representatives, Smoter said.
James Love, founder of Essential Inventions, said he was delighted the Bush administration was granting a public hearing on the licensing issue. The company requested the license in January.
"At this point, this is progress," he said.
© Reuters 2004. All Rights Reserved.
By David Douglas
NEW YORK (Reuters Health) - Writing about emotional topics appears to reduce stress in HIV-infected patients and may improve immune responses, according to researchers in New Zealand and the US.
Dr. Kevin J. Petrie of the University of Auckland and colleagues note that a review of studies involving such emotional disclosure by patients with diseases such as asthma and arthritis has shown "consistent and significant improvements in health outcomes after written emotional expression."
To investigate whether this strategy might also help HIV patients, they studied 37 such subjects. Their findings are published Psychosomatic Medicine.
The subjects, who were randomly assigned to an emotional writing group or to a control group, were assessed individually and then assigned to write for 30 minutes on 4 consecutive days in a small, private, dimly lit room.
All writing was anonymous and those in the emotional group were encouraged to explore deep feelings that they had not previously expressed. "Subjects were told they could write about HIV-related topics or any other issues of emotional importance to them."
Control participants were asked to write objectively about how they occupied their time.
Subjects in the emotional group rated the experience as being more valuable than did those in the control group.
Moreover, Petrie told Reuters Health, "the CD4+ positive lymphocyte count increased gradually and continuously in the emotional writing group in the 6 months after the sessions. However, there was no change in the control group."
The findings, he concluded, are consistent with those of other studies which indicate that patients with HIV infection, "who don't get to discuss their feelings, have a faster decline in their health."
SOURCE: Psychosomatic Medicine, March/April 2004.
© Reuters 2004. All Rights Reserved.
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Sun Apr 25, 9:50 PM ET
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By THERESA AGOVINO, AP Business Writer
NEW YORK - When the new AIDS drug Fuzeon was launched last year, it was touted as a major breakthrough, with expectations so high it was feared the drug would be in short supply as patients clamored for it.
Instead, Fuzeon sales are below estimates and analysts are slashing revenue projections. Fuzeon's $20,000-a-year price tag, painful side effects and changing AIDS treatment strategies have made sales a disappointment, one that some experts expect will continue.
Hoffmann-La Roche Inc. which markets Fuzeon for the drug's developer, Trimeris Inc., is taking steps to increase sales, expanding distribution and launching an advertising and public relations campaign. Nurses will visit patients to teach proper injection techniques to help avoid some of the drug's side effects.
But the outlook for Fuzeon remains uncertain.
Fuzeon works differently from other AIDS medicines; it prevents the HIV virus from entering a cell, while other drugs prevent the virus from replicating. Yet Fuzeon is not intended to be a first or second line AIDS therapy — it is supposed to be used when patients are resistant to some AIDS drugs, but before all other drug options have been exhausted.
"I think Fuzeon is underutilized," said George Abercrombie, president and chief executive of Roche. "I think it is important to note we are still in the early stages of the launch. The learning curve is going to take a while."
That curve is going to be steep. Roche has been criticized for the drug's high price — Fuzeon costs three times more than any other AIDS drug, and its cost is an impediment for many patients. And a recent policy change by the Roche limiting the number of people who could get Fuzeon free has brought more complaints.
The change results from a dispute between Roche and government-funded AIDS Drug Assistance Programs, known as ADAPs. Nearly a third of AIDS patients receive their drugs through ADAPS, but only the 37 of the country's 56 ADAPs pay for patients' Fuzeon. Late last year, Roche stopped giving the drug to patients in states where ADAPs, concerned about the cost of Fuzeon, refused to cover the drug.
That decision has further limited use of Fuzeon, and upset many patients.
In Texas, while the local ADAP plans to cover Fuzeon, resident John Willingham said he was rejected from the Roche free-drug program last December because the ADAP hadn't begun coverage yet.
"I was really upset. The ADAP program has nothing to do with me," said Willingham, who can't afford Fuzeon and has no private insurance. "It hit me as so unfair that drug companies are doing this to people with so few options."
Abercrombie said patients who live in states where ADAPS don't cover Fuzeon should lobby legislators for additional funds.
"We cannot afford to become a backup insurance plan," he said.
Besides cost, there is the issue of side effects. Physicians said some patients balk at the prospect of the injections, which can cause severe pain, welts and nodules.
"If this was a pill, it would be a totally different story," said Dr. Howard Grossman, who specializes in treating AIDS patients in New York.
Tom Morgan said taking Fuzeon was so difficult he halted treatment last Christmas. He resumed two months later because the amount of virus in his body soared.
Even after learning proper injection techniques, Morgan is constantly sore. "I do this because I have no choice," he said.
This month Roche started a program to send nurses to patients' homes to teach injection techniques.
A further challenge is a shift in AIDS treatment practices. AIDS patients take several medicines simultaneously, but the regimen must be changed as patients become resistant to the drugs. Doctors are becoming more conservative about modifying treatment because they don't want to go through all the available drugs too quickly, leaving patients with no options.
Dr. Nicholas Bellows, who has about 5,000 AIDS patients in his Dallas-based practice, said that change is likely hurting Fuzeon sales because doctors are waiting before they begin to use it.
Sanford C. Bernstein analyst Gbola Amusa thinks the patient population that will benefit from Fuzeon may be smaller than anticipated — one reason why he lowered his sales forecast. Last year, he expected Fuzeon sales to reach $140 million; they totaled $35.9 million. He thought Fuzeon revenues would reach $1 billion by 2007 but has revised that number to $590 million.
There are about 850,00 to 900,000 people living with HIV in the United States, and about 40,000 new infections a year. Initially, Amusa thought one-quarter of AIDS patients would be candidates for Fuzeon; now his estimate is about 10 percent to 15 percent.
Deutsche Bank analyst Dennis Harp initially projected Fuzeon's U.S. sales between $500 million and $700 million by 2008. He halved that estimate.
Harp said Roche made a mistake by not launching an ad campaign when the drug was introduced. He thinks the company's failure to cement a place in treatment regimens means its future performance will be hurt by drugs coming out in the next couple of years.
"It was a mistake to think a good product would sell itself," Harp said.
He worries Roche may lose interest in Fuzeon if sales don't pick up. That could spell doom for tiny Trimeris because Fuzeon is its only product. Trimeris recently laid off 30 employees out of a staff of 130 after the follow-up drug to Fuzeon was not proving as effective as hoped.
Trimeris CEO Dani Bolognesi, who co-discovered Fuzeon, understands analysts concerns and concedes he was surprised by Fuzeon's lackluster revenues. He said that because Fuzeon's clinical trial was relatively small only a few hundred doctors felt comfortable using it.
But the number is expanding as Roche's outreach continues, and Bolognesi said he's confident Roche's new public relations and ad campaign will increase sales.
Abercrombie contends it would have been foolhardy to launch an extensive campaign to promote Fuzeon earlier when there were initial concerns about meeting demand — Fuzeon is a very complicated drug to produce, requiring 44 ingredients, about three times the norm, and 106 steps, more than four times the average.
Initially, Roche said it would only be able to treat 12,000 to 15,000 patients in the first year. Advances in manufacturing means it is making enough for 39,000 patients.
Roche won't say how many patients are taking the drug, but NDC Health, a health care information company, said the total number of prescriptions written have hovered around 2,100 a month since last August. New prescriptions are slowly increasing, growing 11 percent from January to February.
The ad campaign debuted last month in the spring issue of Poz, a magazine for HIV-positive people. A corresponding ad campaign was launched in medical journals, and other consumer ads are slated to appear publications targeting a gay audience such as Bay Area Reporter, Dallas Voice, and New York Blade.