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Issue #230: May 21, 1999
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include AIDS, Bay Area Reporter, Journal of AIDS, Las Vegas Sun-Times, Los Angeles Times, Reuters
In This Issue:
Panel recommends end to Salk trial
FIGHT seeks AIDSVAX volunteers
US releases guidelines on marijuana research; DC vote still secret
Low literacy linked to poor adherence
California Senate defeats names bill; Wash. State battles county
Several states act on needle exchange programs
Rite Aid awards $10,000 grant to WTP
TPAC seeks PWA suburban board members
Panel recommends end to Salk trial
The Phase III trials of Remune, the HIV therapy originally developed by the late Dr. Jonas Salk to boost the immune systems of people with HIV, will be concluded as a result of an analysis by an independent Data Safety Monitoring Board (DSMB), according to a joint statement issued by the Immune Response Corporation and Agouron Pharmaceuticals, Inc.
The panel members found no differences in clinical endpoints between those receiving the drug and those receiving placebos in the 2,500-subject trial, and concluded that it was unlike that any statistically significant differences would emerge in the near-term if the trial were extended.
Philadelphia FIGHT was one of the original sites for the Remune trial.
"The number of HIV-associated clinical endpoints observed in the trial was far less than originally anticipated," the statement continued.
Remune, an immune-based therapy which is added to patients' other drugs for HIV infection, was being studied by Immune Response, a company co-founded by Salk, who discovered the polio vaccine. In June 1998, Immune Response and Agouron said that they agreed to collaborate on developing and commercializing the drug, in a pact worth up to $77 million to Immune Response over two years. The company said it believes that the lack of significance between the groups was the result of increasing use of Highly Active Antiretroviral Therapy (HAART) including HIV protease inhibitors, after the trial was initiated.
However, in a separate evaluation of 250 subjects, who were randomly pre-selected for surrogate marker analysis, company investigators detected significant differences. After 48 and 96 weeks, they found significant reductions in viral load and increases in lymphocyte proliferation among subjects receiving Remune.
The US Food and Drug Administration previously agreed that a marketing application for Remune could be submitted based on favorable virologic endpoints. Therefore, Agouron is planning two more phase III surrogate marker trials of Remune.
"While HAART, which became the standard of care after we initiated this trial, has been an enormous benefit to HIV patients, it has made it exceedingly difficult to conduct a trial based upon reaching clinical endpoints," Dr. Dennis J. DeCarlo, Immune Response CEO, commented. The company hopes to initiate a rollover study, pending FDA clearance, within 2 to 3 months.
It is unknown whether people currently served in the trial will be able to continue to have access to the drug. (Portions of this article were obtained from Reuters Health Information Service.)
FIGHT seeks AIDSVAX volunteers
Philadelphia FIGHT has renewed its call for volunteers to participate in its AIDSVAX trial, the only major vaccine trial taking place in the Philadelphia area.
Sexually-active, HIV-negative gay men are targeted for the trial. Jane Shull, executive director of FIGHT, said that the Philadelphia trial site is closing in on its target of 150 participants, and over 130 have been screened for participation. Ninety-three have been formally enrolled in the trial. For more information, call 215-985-4448.
Meanwhile, the Sacramento Bee reports that researchers in Sacramento and elsewhere are having trouble recruiting volunteers to take part in the nation's first large study of a potential vaccine against AIDS.
Nearly a year into the effort to test AIDSVAX, research centers have enrolled about 2,500 people, half of the number needed to complete the trial, said Nicole Lynch of VaxGen, the San Francisco biotechnology company that manufactures the vaccine.
Researchers are trying to find out how effective the experimental vaccine will be in fending off the HIV in people who engage in risky sexual practices. They are looking for people, primarily gay men, who are at high risk for HIV but who test negative for the virus.
Participants are inoculated with the vaccine, made from a purified copy of a protein from the surface of HIV, seven times over three years in an effort to determine whether the material works to prevent infection.
Lynch said that among the reasons why the trial is having difficulty obtaining a sufficient number of participants is that some are under the mistaken impression that it is possible to get HIV from the vaccine, or are unwilling to make a three-year commitment to the study. She stressed that AIDSVAX is not made from a "live" virus and is completely safe.
Another factor, Lynch and others said, is a lessening sense of public urgency about AIDS now that it can be effectively treated with drug therapy. Even five years ago, Lynch said, recruiting would probably have been much easier. Some believe that as the epidemic has waned among white gay men, they are less concerned about combating it, even though it still rages among gay men of color. But in all parts of the gay male community, the daily tragedy associated with an AIDS diagnosis has lessened with the introduction of more effective long-term therapies.
"You don't see really sick people walking down the street anymore. People are not dropping dead left and right," she said. "There is less of a sense of urgency."
Dr. Franklyn Judson, director of the Denver Department of Public Health and an expert on public health and infectious diseases, said one thing motivates people to take part in vaccine trials more than anything else.
"It's good old American altruism," he said. "Wanting to give something back to the community, to medical science, a desire to protect others."
Judson said his agency has had little trouble recruiting volunteers for the vaccine study. Since August, he said, 210 people have signed on.
"I don't think the problem is excessive," he said. "These are pretty daunting studies that require an awful lot of subjects. What we have going for us is very good long-term contacts with people in the gay community." (Portions of the article are reprinted from the Sacramento Bee.)
US releases guidelines on marijuana research; DC vote still secret
The Clinton administration has released new guidelines to ease the availability of marijuana for medical research, in a move that officials believe will quicken the pace of studies into the drug's possible beneficial uses.
The new guidelines, "an extension of an existing process," will make it easier for academic researchers to obtain samples of research-grade marijuana grown by the government, said Campbell Gardett, a spokesman for the Department of Health and Human Services.
The guidelines were endorsed by the White House Office of National Drug Policy as part of an effort to more thoroughly understand the benefits and risks of using marijuana to treat medical conditions.
"Such research will allow us to better understand what benefits might actually exist for the use of cannabinoid-based drugs," the drug policy office said in a statement.
"This decision underscores the federal government's commitment to ensuring that the discussion of the medical efficacy and safety of cannabionoids takes place within the context of medicine and science."
The drug policy office, in the past, has resisted efforts by some groups to make medical marijuana more readily available, but officials at the agency insisted today that the new directive is "not a reversal of policy."
There has been increasing pressure from organizations, researchers and physicians for more research into the medical uses of marijuana.
In California, voters passed an initiative in 1996 that would allow patients to grow and use marijuana if it was prescribed by their doctors. The federal response was to warn that doctors could be penalized if they helped their patients get the drug.
Some federal scientists have conducted marijuana research in the past, but many academic and private researchers have complained of the difficulty of getting research-grade marijuana from tightly controlled government supplies.
The new guidelines will ease the process, while assuring that the drug is available only to legitimate researchers, Gardett said.
The guidelines say that HHS has determined that it will make research-grade marijuana available "on a cost reimbursement basis," which means that researchers or their sponsors will help defray the government cost of raising the weed on government lands.
The intent of the policy, also, is to ensure that the marijuana used in research is of high quality.
Valid research, the guidelines say, requires that "the substance ... must have a consistent and predictable potency, must be free of contamination and must be available in sufficient amounts to support the needs of the study."
In the last few months, committees of experts have recommended in two major studies a more extensive program of scientific research into marijuana.
Committees for both the National Academy of Sciences and the National Institutes of Health concluded there is evidence that marijuana can be useful in the treatment of some patients who have not responded well to other therapies.
Many cancer patients and people with AIDS have said that marijuana, often obtained illegally, is able to relieve nausea and to restore appetite. Other patients have used marijuana to combat glaucoma, the sight-robbing disease caused by a buildup of pressure in the eye.
Meanwhile, in DC, vote results still secret
Meanwhile, the results of a referendum on the medical use of marijuana in the District of Columbia are still being kept secret and will not be revealed until a court case defending the proposal has been settled.
Initiative 59 was legally placed on the ballot as the result of a citizens' petition. But 2 weeks before Tuesday's election, Rep. Robert Barr (R-GA), who gained national prominence as a leader of the Clinton impeachment effort and for his support for white supremacy groups in Georgia, made a move to block the initiative by banning it under the appropriations bill that partially funds the District's government.
But the ballot was already printed, and voters were able to make their choice on the issue. Congress instructed the DC Board of Elections and Ethics to keep the results secret.
On October 30, the American Civil Liberties Union (ACLU) of the National Capital Area filed an injunction in US District Court to force the Board to certify the results, but there has been no action yet.
The ACLU says Congress's move infringes on residents' First Amendment rights. "They are specifying what we can vote for," says Mary Jane De Frank, executive director of the National Capital ACLU.
"Congress is asserting their parochial interest," she says.
De Frank notes that medical marijuana questions were on ballots in five states, but Congress did not interfere in those battles.
Initiatives passed in Arizona, Nevada, and Washington State, but were defeated in Alaska and Oregon.
If passed, the DC initiative would only allow use of marijuana by a doctor's prescription, and only in patients with serious illnesses such as AIDS, cancer, and glaucoma.
De Frank says she is not sure how long it will take for the court to rule, but adds, "we hope they will move quickly." (This article is based on reports from the Associated Press and Reuters.)
Low literacy linked to poor adherence
Health literacy appears to be a significant independent predictor of adherence to combination antiretroviral therapy regimens among HIV-infected patients.
Failure to strictly adhere to complex highly active antiretroviral drug (HAART) regimens can lead to the emergence of viral resistance, Dr. Seth C. Kalichman of the Medical College of Wisconsin in Milwaukee and colleagues note. "Factors that negatively influence adherence to HAART therefore pose considerable threats to both individual and public health."
Dr. Kalichman's group evaluated levels of treatment adherence and related factors in a community-based sample of 182 HIV-infected men and women on antiretroviral therapy. Most of the subjects were men (138 individuals), had a diagnosis of AIDS (73%), and were ethnic minorities (60%).
Overall, 20% of the subjects missed at least one dose of antiretroviral therapy over a 2-day period, they report in the May issue of the Journal of General Internal Medicine. "Persons of low literacy were more likely to miss treatment doses because of confusion, depression, and desire to cleanse their body than were participants with higher health literacy," they write.
After controlling for several factors, including age, ethnicity, income, and substance abuse, they found that "education and health literacy were significant and independent predictors of 2-day treatment adherence."
"Those with less than 12 years of education were over 3 times more likely to be nonadherent than those with at least a high school education." Individuals with lower literacy levels were also "...nearly 4 times more likely to be nonadherent."
Based on these findings, Dr. Kalichman's group suggests that "...interventions to assist people in adhering to antiretroviral therapies must be adapted for persons of lower literacy with specific attention given to relevant treatment barriers." (Reuters)
The California Senate Health and Human Services Committee has defeated a bill that would have required name-based reporting for HIV-positive individuals, a move that brought praise from AIDS advocates who further pressed for passage of a bill that would rely on unique-identifier codes to report cases of HIV.
Sponsored by state Sen. Ray Haynes (R), SB 1029 would have required the state Department of Health Services to "develop and implement a uniform statewide reporting system, partner notification and contact tracing system employing name-based identifiers for persons testing positive for HIV." However, AIDS advocates contend that names-based reporting deters high risk groups, such as gay men and intravenous drug users, from being tested, and have long supported efforts by Assemblywoman Carole Migden (D) to pass legislation requiring the use of a unique-identifier code to track HIV. Although an identical bill was vetoed last year by former Gov. Pete Wilson (R), Migden's bill, AB 103, was passed out of the appropriations subcommittee on March 23 and contains no partner notification provision (AB103 text).
San Francisco AIDS Foundation Policy Director Regina Aragon said that name-based reporting is not necessary for partner notification, and said that it "could, in fact, undermine such efforts by making individuals less likely to disclose such information." She added, "Given the continued discrimination and stigmatization associated with HIV disease, public health efforts can only be successful if they maintain public trust. For this reason, names-based reporting must be rejected."
Meanwhile, in the state of Washington, a dispute has arisen between the Washington State Board of Health and Pierce County, which includes the city of Tacoma, over how to implement HIV reporting.
The final vote won't come until July, but the signs are now clear: The Washington State Board of Health doesn't plan to let Pierce County make its own rules for collecting the names of people with HIV.
Insisting their policy is the best way to protect public health, Pierce County health officials told the state board this month that they plan to hold onto the names even if new rules mandate destroying any record of them within 90 days.
But the state board voted 5-3 against changing its draft language to allow for the local exceptions Pierce County had sought.
That appears to set the state and county on a collision course.
The state's proposal would assign a unique identification code to each Washingtonian who tests positive for HIV. In the interest of privacy, the record of the person's name would be regularly purged from local health department files. The codes, not names, would be sent to the state health department.
When the Tacoma-Pierce County Board of Health held its own meeting, officials briefly discussed a scenario in which they might sue the state over the name-collection rules. They expressed hope, however, that they could avoid a court fight by convincing the state board to give Pierce County an exemption.
After the meeting, three local board members asked the state board for the exemption. They told the board that Pierce County would "continue to implement" its own policy even if the state bans it, but they did not specifically raise the specter of a lawsuit.
Instead, they stressed that their policy, which went into effect Jan. 1, has been a successful means of tracking the spread of HIV.
They also urged the state board to respect local will, exemplified by strong support from groups such as the Pierce County AIDS Foundation.
That argument suffered a blow, however, when a clearly irked Jeannie Darneille, the longtime executive director of the AIDS foundation, addressed the board.
"The only collaboration the Pierce County AIDS Foundation provided during that process was to confront it and try to make it better," Darneille told the state board.
Testimony critical of Pierce County's policy of keeping names "as long as people are infected" also came from representatives of the Governor's Advisory Council on HIV/AIDS, the Northwest AIDS Foundation, Positive Voice Washington and a group known as Resist the List.
Former Milton Mayor Leonard Sanderson, who served on the local health board, testified in support of letting Pierce County go its own way.
With its vote against allowing exceptions, the board effectively told its staff to stick with plans to use a privacy-minded King County compromise as the model for Washington's tracking of HIV.
Ultimately, the standoff between the state and the county may hinge on how the more aggressive local policy is seen in relation to the proposed state rule.
Pierce County health officials argue that the state will be setting a minimum standard for collecting names. The county has every right to exceed that minimum, they say.
But others, including state Secretary of Health Mary Selecky, counter that the minimum standard the state health board will be setting is a minimum standard for privacy. Pierce County's policy will be in violation of that standard, they say. (This article is based on reports from the Kaiser Daily HIV/AIDS Report, http://www.kff.org/aidhiv/ and the Tacoma News Tribune)
California injection drug users could receive clean hypodermic needles from state-approved programs under a controversial bill that has made it through the state Assembly.
The measure is intended to reduce the sharing of contaminated needles, one way that HIV, hepatitis and other infectious diseases are transmitted. Critics say such programs don't work and give the impression that the government approves of drug use.
"This bill is not about promoting drug use, this bill is about public health," said Assemblywoman Kerry Mazzoni, D-San Rafael, the measure's sponsor. "Drug addiction is a disease and the people who are addicted will do anything to get what they need and jeopardize people's health to do it."
Under California law, it is illegal to distribute or have hypodermic needles or syringes without a doctor's prescription. Mazzoni's bill, approved 43-29, would allow local governments to establish programs that distribute the supplies without such permission.
Despite the current ban, about 17 clean-needle programs currently flaunt the law, operating via permission of emergency measures enacted by counties, Mazzoni said.
Nationally, injection drug users are the second largest group at risk of becoming infected with HIV and developing AIDS. Those infected commonly pass on the disease to their partners and children, Mazzoni said.
In California, nearly one-third of new AIDS cases reported last year were associated with injection drug use, according to the San Francisco AIDS Foundation.
But Assemblyman Tony Strickland, R-Thousand Oaks, was joined by other Republicans who argued that the bill would do more damage than good.
It sends the wrong message to the youth of California, Strickland said. The bill says it's OK to use drugs as long as you don't get AIDS.
Assemblyman Steve Baldwin, R-El Cajon, also contended that legalizing clean needle programs would increase the amount of drug users.
Studies show that needle exchange undermines the one thing that restrains addictions: fear of AIDS, Baldwin said.
Bills to authorize needle exchange programs have been proposed and defeated or vetoed repeatedly since 1992. Former Gov. Pete Wilson vetoed similar bills three times.
Mazzoni told reporters that Gov. Gray Davis has given her indications that he may support her bill.
Davis's press office had no comment on the bill after the Assembly vote.
If approved, the bill would allow drug users to pick up hypodermic needles or trade used supplies for clean ones. The cost of operating a local safe-needle program would be about $160,000 a year, Mazzoni said.
Assemblyman George House, R-Hughson, bristled at the idea that the state would support such a thing.
"It's time that we stopped trying to make all of the responsible people responsible for the decisions that irresponsible people make," he said.
Meanwhile, in North Carolina, six members of the House Public Health Committee effectively voted to kill a bill that would have allowed counties to conduct their own needle exchange programs, and replace it with a study commission. Despite the testimony of several local public health officials, who said that the programs would help stop the spread of HIV, the committee could not overcome its concerns that promoting needle exchange programs is tantamount to condoning illegal drug use. State Rep. Thomas Wright (D), who also chairs the North Carolina Minority Health Advisory Council, "has tried twice before to push a pilot program through, failing both times in committee." Wright said the study may be ready in time for a vote during the state Assembly's short session, but he was not optimistic. Nor was Durham Public Health Director Brian Letourneau, who said, "There's not a lot of conservative support for this bill. I'm not surprised, but I am disappointed."
And in Florida, James McDonough, Gov. Jeb Bush's (R) appointed director of the Office of Drug Control, announced that a proposed needle exchange program in Jacksonville "likely would not decrease the HIV infection rate among injecting drug users, and its location would become a magnet for crime and addicts," according to a report in the Florida Times-Union.
Noting that he has "recommended to the governor that Florida not support needle exchange programs with funding," McDonough said to a group of community leaders organized by the Jacksonville Community Council Inc., "I think it will increase HIV, and drug addiction, and crime." He provided the group with depictions of needle exchange programs in Vancouver and New York, where he said addicts grab "the needles and use them to shoot up just yards away, then slump into a stupor, with other addicts sometimes reusing the needles to get the residue."
He said, "This is very ugly, very vile stuff. I recommend you not bring it to Jacksonville." He said that as an alternative, he is seeking more state funds for treatment and "'drug courts' - forums in which non-violent people who are arrested for drug possession can be ordered to treatment." (This article was prepared from reports in the Florida Times Union, the Raleigh News-Observer, the Los Angeles Times, and the Kaiser Daily HIV/AIDS Report.)
WTP, ActionAIDS to sponsor treatment workshop
With the support of a special grant form DuPont Pharma, ActionAIDS and We The People will jointly sponsor a "Lunch and Learn" discussion called "Choices, Choices, Choices: A Discussion of the Current Standard of Care for Persons Living with HIV Disease."
The event, which will feature a talk by Heshie Zinman, the founder and former director of the AIDS Information Network and now a representative of DuPont Pharma, will take place on Wednesday, June 23rd, from noon until 2 p.m. at the Church of St. Luke and the Epiphany, 330 South 13th Street in central Philadelphia.
A free lunch will be provided by MANNA. For more information, call 215-545-6868.
Rite Aid Corporation, long under attack by AIDS advocates because of concerns that some of its pharmacies did not carry an adequate supply of AIDS-related medications, has awarded a $10,000 general operating grant to We The People.
Rob Capone, executive director of We The People, said that WTP had applied for the award under the company's corporate giving program. He said that Rite Aid had not asked for publicity for the award and had put no pressure on WTP to lessen its support of advocacy on issues related to access to prescription drugs for PWAs.
Rite Aid has consistently claimed that the charges against it are not true but reflect temporary shortages at certain pharmacies. Several months ago, Rite Aid announced an extensive training program for its pharmacists and set up several mechanisms to assure that each pharmacy was able to fill AIDS-related prescriptions in a reasonable period of time.
The Philadelphia AIDS Consortium has announced that it has four vacancies on its Board of Directors, and that it is searching for people living with HIV/AIDS from the Southeastern Pennsylvania region of Bucks, Chester, Delaware, and Montgomery Counties to fill the slots.
TPAC is responsible for overseeing the allocation of Title II Ryan White CARE Act funding and other Pennsylvania state funding for AIDS education and care services.
"The Consortium is invested in having a representative body who are making decisions that impact the HIV/AIDS service delivery system," the group says in a statement. "These educated decisions need to represent all people infected and affected by HIV/AIDS. The Consortium is committed to meet the practical needs of consumers."
The minimum requirements for Board members are 1) participation in two Board committees, and 2) attendance at the Board retreat. Applications can be mailed and faxed to prospective applicants, and are readily available at the Consortium office. For more information, call 215-985-6200.
Clarifications: In a recent report on a new Nevada law allowing police and other public officials to require HIV testing in certain circumstances, fastfax reported that there had been no reported incidents where an individual contracted HIV by being splashed with HIV-infected blood. However, we have been informed by Cary Savitch, MD, that it has been reported that at least eight nurses have become infected from blood-splash injuries, and that at least one incident involved a splash against intact skin. Dr. Savitch also noted that in Germany, it has been reported that two-thirds of health care workers who became HIV-infected on the job were from mucocutaneous splash injuries, not percutaneous needle sticks. We appreciate Dr. Savitch's efforts to correct our report.
Also, in another recent issue of fastfax, in a report on a reverse discrimination case against the city's AIDS Activities Coordinating Office, we noted that the complainant, Philip DiBartolo, had objected to an assignment given to AACO staffer Coleman Terrell, noting that, according to DiBartolo, it was part of a pattern of discrimination against him as a heterosexual white male. Terrell, it was reported in the article, is gay and HIV+. For the record, the DiBartolo complaint identifies Terrell as a "gay white male" but did not reference his HIV status; that was added by We The People, which has appreciated Terrell's activism as an openly gay, publicly-identified PWA leader for over a decade.