In this issue:
Pfizer meeting disrupted over Diflucan price
DuPont expands Sustiva access to kids
HAART discontinued more frequently than thought
Switching drugs improves viral load briefly
95% adherence seen as critical to improvement
Alcoholism put blacks at greater risk of infection
Senate committee approves suicide bill
Depression beats HIV as top gay health concern
LA hospital for poor stops clinical studies
China will require HIV tests for marriage
AIDS activists shouting "Pfizer's Greed Kills" tried to interrupt Pfizer Inc.'s annual meeting April 27th at a New York City hotel, protesting the high price of the company's antifungal drug Diflucan, a life-saving therapy for many suffering from HIV infection.
The 10 activists from ACT UP were forced down a back staircase before they could enter the meeting room. Police said there were no immediate arrests. A larger crowd of activists stood outside the hotel, passing out fliers to shareholders.
Pfizer has agreed to donate Diflucan to South Africans with cryptococcal meningitis, an otherwise fatal brain infection that afflicts up to 8% of those with AIDS. But activists said many more of those with HIV infection throughout the world need the drug to fight off systemic fungal infections called candidiasis, or thrush. They want Pfizer either to lower dramatically the price of its own drug or allow generic manufacturers in developing countries to make it.
"We say, thank you for the donation, but we don't want to be begging. We want sustainable access to the drug," said Zackie Achmat, who came from Johannesburg, South Africa, to storm the Pfizer meeting. Mr. Achmat said he discovered he was infected with HIV in 1990, and he nearly died from a systemic fungal infection because he couldn't afford Diflucan. Friends finally collected enough money to buy him the medicine, which he says costs more than $12 a day in South Africa.
The price is about the same in the U.S.
A generic version of the drug made illegally in Thailand costs a tenth of Pfizer's branded version, Mr. Achmat said.
Asked about the protesters' demands, Pfizer Chairman William C. Steere Jr. said, "The pharmaceutical industry lives or dies on intellectual property rights," and he insisted Pfizer had no interest in allowing generic manufacturers to make the drug. But Mr. Steere said giving the drug away in some instances is proper, adding that "the kinds of philanthropy we do help us dramatically with regulators and legislators."
A Pfizer spokeswoman said the company met just last week with South Africa's minister of health to design a program to donate the drug. (Wall Street Journal)
DuPont Pharmaceuticals Company has announced that it has begun an expanded access program intended to enable HIV-infected children and adolescents to receive an oral, liquid form of Sustiva (efavirenz) in conjunction with other HIV treatment regimens.
"The availability of the liquid formulation will allow children and adolescents, who cannot take Sustiva in a capsule form, to possibly benefit from the drug," Dr. Stuart Starr, professor of pediatrics at the University of Pennsylvania School of Medicine, said.
According to DuPont, the program is designed as an open-label, multi-center study of children and adolescents, ranging from 3 to 16 years of age.
Study participants who have not received antiretroviral therapy before will begin liquid therapy in combination with two nucleoside reverse transcriptase inhibitors (NRTIs). Treatment-experienced participants who are failing their antiretroviral regimen and are deemed likely to benefit from Sustiva treatment will begin the liquid therapy along with at least one more NRTI and/or protease inhibitors with which they have no prior experience.
DuPont said that the program will be made available in all regions where the company maintains early access marketing rights on Sustiva.
A new drug application for the liquid formulation will be filed with the US Food and Drug Administration and Canadian regulatory authorities later this year, DuPont added. A marketing authorization application has recently been filed in Europe. (Reuters)
More than one third of HIV-infected patients using antiretroviral therapy for the first time discontinue highly active antiretroviral therapy (HAART) within 45 weeks due to either toxicity or treatment failure.
These numbers are "for the most part higher than those reported in clinical trials," Dr. Antonella d'Arminio Monforte, of the University of Milan, Italy, and colleagues report in the March 31st issue of AIDS.
The investigators studied the rate of discontinuation of HAART, as well as the reasons for discontinuation, in 862 patients who initiated such regimens after enrollment in the Italian Cohort of Antiretroviral-Naive Patients. Patients were followed for a median of 45 weeks after treatment initiation.
During this period, 36.2% of patients discontinued treatment, primarily due to toxicity. Conversely, only 5.1% of patients discontinued HAART because of treatment failure. At 1 year, the probabilities of discontinuing treatment due to toxicity and failure were 25.5% and 7.6%, respectively.
"Non-adherence was a cause of therapy discontinuation in approximately 7% of cases," Dr. Monforte's team reports.
Compared with men, women were twice as likely to discontinue treatment because of toxicity. Indinavir- and ritonavir-containing regimens were also more likely to be discontinued because of toxicity than were regimens containing hard-gel saquinavir. The likelihood of discontinuation due to toxicity also increased with length of time on therapy.
Discontinuation due to treatment failure was also associated with the type of regimen. Indinavir- and ritonavir-containing regimens were less likely to be discontinued for this reason than were regimens containing hard-gel saquinavir.
The researchers note that "if the current HAART regimen caused no toxicity, less than 10% of naive patients [discontinued] their initial treatment because of failure after 1 year from starting therapy."
The authors point out that, despite these data, protease inhibitor-containing regimens remain the safest choice for the treatment of HIV-infected patients. However, they stress the importance of continued monitoring of patients, particularly women, using indinavir- and ritonavir-containing regimens. (Reuters)
In HIV-infected patients extensively treated with antiretroviral therapy, adding a drug from a previously unused class of drugs or changing at least two medications reduces viral load in the short term, according to a report published in the March 31st issue of AIDS.
"In people who are heavily pretreated with antiretrovirals--have been on them for many years--it's difficult to manage them and keep their viral load undetectable or even reduced for a substantial amount of time," Dr. Paul J. Weidle of the Centers for Disease Control and Prevention in Atlanta, Georgia, pointed out in an interview with Reuters Health.
He added that guidelines put out by the US Public Health Service and the International AIDS Society recommend changing all or at least two medications if a person is failing therapy, but these guidelines have not been tested in a controlled way.
Dr. Weidle and colleagues with the HIV Outpatient Study examined the records of 96 patients from two clinics who had a viral load of 10,000 log copies/mL or greater and were taking at least two antiretroviral drugs. The investigators looked at the effect of drug regimen modification on viral load 3 to 12 weeks later.
A favorable response was associated with the use of at least two new medications, the use of a medication from a new class of drugs, or the initiation of a nonnucleoside reverse transcriptase inhibitor. In contrast, initiating a new nucleoside reverse transcriptase inhibitor or protease inhibitor did not lead to a response.
Dr. Weidle noted that the study looked only at a short-term response to switching therapies, and it is unclear how this strategy will work in the long term. "We were trying to analyze one switch in therapy, not necessarily the whole sustainability of general management," he said. "It doesn't necessarily suggest that it will translate into long-term benefit, but presumably you have to have the short-term effect before you can get any sustainable effect." (Reuters)
To achieve undetectable blood levels of HIV at the rate seen in clinical trials, people with AIDS need to take at least 95% of their medication at the prescribed schedule and dosage, according to research presented here on Wednesday at the National Institutes of Health.
A number of factors can interfere with that goal, including alcohol, heroin and cocaine use, depression, low literacy, and lack of understanding of the relationship between adherence and viral resistance.
Overall, rates of adherence to drug regimens, which are vital for combating HIV, fall critically short, Dr. Laura W. Cheever reported at the conference on Alcohol Use and HIV Pharmacotherapy.
"Given that only 50% of patients with chronic disease, including HIV, adhere to their medication, intervention to improve adherence is critical to the long-term success of HAART (highly active antiretroviral therapy)," said Cheever, chief of the HIV Education Branch at the Health Resources and Services Administration in Rockville, Maryland.
Cheever stressed that HIV's ability to quickly mutate and become resistant to medication is the major reason why it is important to take the correct combination of drugs on schedule.
Dr. Victoria A. Cargill of the National Institutes of Health presented studies showing that community-based intervention programs may help people infected with HIV.
"What we are talking about here is providing a safe place for high-risk populations to come and talk about HIV, drinking and drug use," Cargill said. "Only after providing a nonjudgmental, loving environment, will people begin to tell their stories and open up." But they have to trust you before they will even consider seeking help, Cargill added.
Cargill stressed the importance of early detection, education, and treatment for HIV.
"The sooner you know you have HIV and the faster you begin aggressive treatment, the better outlook you have, " Cargill said, adding that health insurance providers need to focus on early detection, as they do with mammograms, because it is ultimately more cost effective for them.
Both presenters stressed the importance of finding new drugs with fewer side effects. "Ultimately, in the long run, it is unreasonable to expect patients to adhere to a medication regimen that is expensive, disruptive and causes side effects. We are going to have to come up with better drugs that can be tolerated and adhered to over a long time," said. Cheever. (Reuters)
Long term alcohol dependence appears to have a more damaging effect on the immune systems of blacks than whites, putting them at increased risk for infection and death from a number of diseases, researchers report.
According to their study, alcoholism reduced the activity of immune system cells known as natural killer (NK) cells and decreased the production of certain immune system proteins known as interleukins.
These changes were more pronounced in African American than in white alcoholics and may be the reason why African-American alcoholics appear to be at greater risk for infectious diseases.
It is known that "African-American alcoholics are at greater risk for certain infectious diseases such as tuberculosis, hepatitis C and HIV," lead author Dr. Michael Irwin of the San Diego Veterans Affairs Medical Center and the University of California, San Diego, said in a statement. His study appears in the April issue of Alcoholism: Clinical & Experimental Research.
In an interview with Reuters Health, Irwin said behavior and not biology may help to weaken the immune function of African-American alcoholics.
The researchers measured the activity of natural killer cells, which can attack cells that have been infected by a virus, in both alcoholics and non-alcoholics. And they measured the production of interleukins, which regulate the intensity and duration of an immune response to an invading organism.
The results show that the natural killer cells of African-American alcoholics were less active than those of white alcoholics and less active than those of non-alcoholics of either race. The overall duration and intensity of the immune response was also lower in black alcoholics.
The study indicated that "alcohol dependence and ethnicity predicted (natural killer cell) activity," conclude Irwin and co-author Claudine Miller.
"African-American alcoholics had significantly lower levels of NK activity than the other three groups," they add.
The authors caution that their results should be interpreted carefully and point to several limitations. First, the non-alcoholics were more educated than alcoholics, suggesting a higher socioeconomic status. Previous research has linked higher socioeconomic status with better health.
Additionally, the sample size was small and may not reflect the entire African-American population. The results may not apply to women or other ethnic groups.
While the implications of these immune system alterations are not yet known, it appears that "efficient control of virus infections may depend on NK cell responses," Irwin said.
"What is now needed is an assessment of disease specific immune responses in African-American alcoholics who are at increased risk for certain viral and other infectious disease outcomes," he added. (Reuters)
After a month of delays, the Senate Judiciary Committee on April 27th approved legislation that would effectively block Oregon's first-in-the-nation assisted suicide law.
The vote on the "Pain Relief Promotion Act" was 10-8. One Republican, Arlen Specter of Pennsylvania, voted against the bill, while one Democrat, Joseph Biden, voted for it. But the measure's future is uncertain, as two Democratic committee members all but promised to join Oregon Democratic Sen. Ron Wyden in launching a filibuster to block the bill if it reaches the Senate floor.
The bill, a version of which passed the House last October, would overturn a 1998 ruling by Attorney General Janet Reno that Oregon physicians who prescribe drugs on the federal government's list of controlled substances to aid a suicide would not be in violation of federal law if they abided by that state's "Death with Dignity Act."
Noting that federal controlled substances are to be used only for "legitimate medical purposes," Sen. Jeff Sessions (R-AL), said, "The Attorney General, through tortured logic, has said that can be construed to kill people." The question, said Sessions, "is will we collude with [Reno's interpretation] by not acting here."
But opponents of the measure said that subjecting physicians not only in Oregon, but nationwide, to the possibility of investigation by the Drug Enforcement Administration to determine if drugs were prescribed to relieve pain or to aid death, would make adequate pain relief less likely.
"It will have a chilling effect," said Sen. Dianne Feinstein (D-CA), who told the committee of holding her husband dying of cancer in her arms while he "begged for pain medication." Said Feinstein, "Once you put this intent in there, any large dosage puts a physician in danger of investigation by the DEA."
The medical community has split on the bill. The American Medical Association has endorsed it, particularly after changes were made that would make it more difficult for the DEA to revoke physicians' ability to prescribe controlled substances. The AMA also supports language in the bill establishing a legal "safe harbor" by stating that use of controlled substances for pain relief is legitimate, even if those drugs may hasten death.
But many state medical associations, as well as the American Academy of Family Physicians, continue to oppose it. The AAFP opposes the bill, the organization said in testimony submitted at a hearing, "not because it attempts to outlaw physician-assisted suicide, but because in its attempt to do so, it may put at risk for criminal investigation physicians who are aggressively and appropriately prescribing narcotics to patients who are in great pain." Continued the testimony, "Such scrutiny of physicians, performed within the construct of DEA by DEA agents, may well create a chilling environment for the physician whose goal is appropriate medical treatment of a patient's pain."
Wyden, who delayed the Senate committee vote at least twice in the past month, has vowed to try to block its enactment in the Senate. At the committee meeting, Feinstein and Sen. Edward Kennedy (D-MA), each said that they planned to speak at length on the Senate floor, code for threatening a filibuster. (Reuters)
In Miami-Dade County, there were 512 AIDS deaths in 1999, up from 444 the year before. In Broward County, 210 people died of AIDS last year, the same as the year before.
The steep three-year decline in AIDS deaths in Florida may be over. Deaths in Miami-Dade County actually rose 15 percent last year.
The state Department of Health released preliminary data April 26th indicating that 1,631 Floridians died of HIV-related diseases last year, up about 5 percent from 1998. State officials say that represents just a leveling off of the trend and not a true increase because the definition of an HIV-related death was changed in a way that increased the number by about 5 percent.
In Miami-Dade County, there were 512 AIDS deaths in 1999, up from 444 the year before. But researchers cautioned that could be due to a one-time fluctuation and might not represent an important trend. In Broward County, 210 people died of AIDS last year, the same as the year before.
The news came as no surprise to AIDS experts, who had seen the rate of decline dropping off nationally as well as locally. The death rate is down 62 percent for the state since the peak of 4,336 deaths in 1995. But the new statistics prompted fears that AIDS deaths could once again begin to climb.
"It's a call to arms that this epidemic is not over," said Rick Siclari, executive director of Care Resource in Miami, which cares for HIV-positive patients and does research. "We need to redouble our effort."
The causes for the reversal aren't clear, and the state Department of Health plans to study death certificates to get a better handle on what's going on, said Tom Liberti, chief of the Bureau of HIV/AIDS. The state will focus particularly on the increase in Miami-Dade because it has a third of the state's AIDS deaths.
Part of the problem is probably due to the changing face of an epidemic that is now hitting hardest among poor and minority residents. Because of the demographics of Miami-Dade, that may be what's driving the problem here, several local experts said.
Those patients are more likely to lack regular health care and therefore delay seeking treatment. As a result, they often don't seek care until they have full-blown AIDS, when it may be too late for doctors to help them.
"There's part of the population that's not getting evaluated early, is not getting on the newer medications and is still dealing with severe disease," said Margaret Fischl, director of the AIDS clinical research program at the University of Miami.
Statewide racial disparities remain a problem, but 1999 marked the first year that they began to narrow. While black people accounted for 58 percent of AIDS deaths and only 14 percent of the population, deaths among black women declined 8 percent and stayed the same among black men. All other groups had increases.
But the stabilizing of deaths from AIDS shows the limits of the new generation of drugs, experts said.
"The AIDS cocktail is not the final answer," said John Weatherhead, director of CenterOne, Broward's largest AIDS service organization. "It gave us some breathing room, but that breathing room is running out." (Miami Herald)
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Depression tops the list of health concerns for lesbian and gay men, according to an exclusive gay health survey just released by GayHealth.com (http://www.gayhealth.com). The site, which launched April 15th, is the first worldwide source of health and wellness information for the gay community created and operated by lesbian and gay medical professionals.
The GayHealth.com survey ranked depression as the top health concern, even surpassing HIV, for both lesbians (35 percent of those surveyed) and gay men (32 percent of those surveyed). This figure is even more striking when compared with a similar survey of heterosexuals also conducted exclusively for GayHealth.com. Results showed that gay men and lesbians are approximately two times more likely than their heterosexual counterparts to be concerned about depression.
"Depression in the lesbian and gay community is an ongoing problem fueled by anti-gay discrimination and hate," said Dr. Stephen E. Goldstone, MD. "Dr. Laura Schlessinger is a prime example of why gays and lesbians feel alone with few places to turn. Homosexuality does not cause depression; a sense of isolation does. Our survey showed that gays and lesbians long for a resource that will give them a sense of community, and GayHealth.com provides it."
According to the gay health survey, prostate and testicular problems, HIV, sexually transmitted disease (STDs) and hepatitis followed depression respectively as the top five health concerns of gay men. For lesbians, breast cancer, cervical cancer, menstrual pain and estrogen replacement followed depression as major health concerns.
"Through no fault of their own doctors have been conditioned to think of HIV as the sole aspect of gay healthcare, and patients have been reluctant to discuss other problems they face," said Dr. Susan C. Ball, MD. "We at GayHealth.com want to help the medical community learn how to better care for their gay, lesbian, bisexual and transgender patients and understand the many issues these men and women confront on a daily basis." (PR Newswire)
A medical center that serves primarily poor neighborhoods in Los Angeles has halted hundreds of clinical research studies after federal investigators found more than 24 violations of rules designed to protect patients.
The Charles R. Drew University of Medicine and Science and its affiliated county-run health center, Martin Luther King Jr. Hospital, suspended research two weeks ago, the Los Angeles Times reported today.
"No subject has ever had an adverse effect" from research at the medical center, said Dr. Tony Strickland, associate dean of research.
The university's voluntary action will affect 250 studies, though hospital officials could not determine how many human subjects took part in the projects. About 20 research studies will continue because stopping them could be harmful to patients.
The Drew facilities were founded in 1966 after the Watts riots to provide care to residents in south Los Angeles. Past studies have gained national attention, including projects that tested new treatments for HIV and hypertension and those examining different diagnoses of dementia in the black and Hispanic population.
Inspectors with the U.S. Office for Protection from Research Risks this month found that projects at the Willowbrook school were not reviewed by an internal committee - considered a "major violation."
Other violations included a lack of required guidelines at the medical center for conducting research on vulnerable subjects, such as prisoners and children. Forms given to patients also were not translated into Spanish, the native language of many in the area.
The problems may be tied to the increase of human subject research at Drew and King-Drew, Strickland said.
"We used to be just a clinical campus and now our thrust has been toward being leaders in urban medical research," he said. (Los Angeles Times)
HIV tests for people getting married will become mandatory in Beijing by July, according to the Beijing Birth Control Research Institute.
Doctors at 28 pre-marriage check-up centers have started training to conduct HIV tests, reported today's "Beijing Morning Post".
At a health care center for women and children in Xicheng District, AIDS tests on people planning to get married was introduced two years ago.
The "Beijing Morning Post" carried a story which said that an unidentified young woman in Beijing became the first person to test positive for the HIV virus during a routine pre- marriage medical check-up.
Since 1994, the incidence rate of HIV/AIDS in China has been on the rise. But people's awareness of the disease is slow to catch on.
By the end of last year, China registered 17,316 AIDS patients, 677 of which were women. (Xinhua)