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Issue #149: November 2, 1997
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 information in this issue include ACT UP, Boston Globe, National AIDS Fund, Philadelphia Business Journal, Philadelphia Inquirer, Reuters .
In this issue:
PA still won't pay for Viracept; call 717-772-8318
City calls back 72,000 condoms
3% in city test positive at public sites
PWAs join union in Allegheny protest
HIV discrimination feared as PWAs return to work
Study drops placebo in African study
PA still won't pay for Viracept; call 717-772-8318
Pennsylvania welfare officials continue to refuse to add Viracept (nelfinavir) to the list of protease inhibitors covered under its Special Pharmaceuticals Benefits Program (SPBP), despite mounting evidence of its effectiveness.The SPBP program in Pennsylvania provides HIV medications to people who have no health insurance. The state was among the first in the nation to promptly add protease inhibitors to the "formulary" -- the list of drugs available -- when they began to be approved by the U.S. Food and Drug Administration two years ago. However, when Viracept was approved earlier this year, state welfare department policy director Peg Dierkers said that the Ridge Administration wanted to determine the cost impact of adding the drug before proceeding.
Sources at the state Department of Public Welfare (DPW) told fastfax that Dierkers, the former director of the South Central AIDS Assistance Network, has been the primary force in delaying the addition of Viracept to the SPBP formulary. She has been severely criticized by people living with HIV disease over the past year for resisting efforts to assure quality HIV care through the state's mandatory managed care program for Medicaid recipients and delaying added cost reimbursements for highly-expensive AIDS care.
"AIDS activists in Pennsylvania fought long and hard to get essential drugs onto the list of available treatments," said a statement from ACT UP Philadelphia. "We were promised by the state that new protease inhibitors would be added as soon as they were approved. Yet, months and months after the approval of Viracept, it is still not on the list!!!
"The state says that it will cost too much to add Viracept, even though it is about the same price as other protease inhibitors. Who are they to play doctor & determine your treatment options?"
ACT UP has asked people concerned about AIDS to call Dierkers directly and demand that the state add Viracept to the SPBP by Halloween. "Say, 'Add Nelfinavir to the SPBP by Halloween, because people with HIV/AIDS can't wait any longer," the group recommended. "If you want, feel free to say 'your treat or our trick,' because ACT UP is prepared to turn up the heat if we do not get results by the end of the week."
Dierkers telephone number is 717-772-8318.
In a letter to Dierkers, ACT UP Philadelphia delivered an "ultimatum" requiring the state to add Viracept to the drug program and accused the state of refusing to add the drug because it competes directly with a drug manufactured by Merck and Company, which is headquartered in Blue Bell in suburban Philadelphia.
Merck is the most profitable corporation in Pennsylvania, as well as one of the largest. The activist group went on to promise unspecified "tricks" if the drug isn't added by Halloween.
"The state promised to automatically add each protease inhibitor to its drug program automatically after approval. We see once again that the state was lying," said ACT UP's John Bell.
Bell said, "We know that the current administration owes a lot to suburban Philadelphia, where Merck is one of the biggest employers. DPW Secretary Feather Houstoun is really bending over backward to help out Governor Ridge's friends. Why else would the state refuse for almost an entire year to add the drug when it isn't even going to cost them any extra money?"
Adding Viracept to the state's list should contribute only minimally to the growth of the SPBP program, Bell said, because the drugs are priced similarly and people with HIV use one or the other of the two drugs. Doctors are not supposed to prescribe the two together.
Viracept, manufactured by the Southern California firm Agouron Pharmaceuticals, is another protease inhibitor similar to Merck's Crixivan, except that it is much easier to take. It can be taken with food, and the rigid dose scheduling required by Crixivan is not required. In Pennsylvania, Merck's protease inhibitor Crixivan continues to hold the held the lion's share of the protease inhibitor market. However, in areas where Viracept is allowed to compete, Merck rapidly loses market share because most doctors choose to initiate therapy with Viracept, and some encourage their patients to switch to Viracept if they are already on another drug.
"Feather Houstoun [state welfare secretary] has been practicing medicine without a license," said ACT UP's Asia Russell. "She and DPW are making a decision for each person with HIV in the state which drugs they can use. Doctors have written numerous letters stating how their patient's health suffers without access to all available medications. Patients have called to complain, and all DPW says is 'We'll only take longer if you keep bothering us with these phone calls.' Everyone deserves to live, and Feather Houstoun is shortening the lives of people with HIV. We don't care about Merck's market share. DPW must add Viracept to the state's formulary by Halloween or we are going to nail them."
Access to protease inhibitors, when used in combination with other classes of anti-viral drugs, are credited with dramatic increases in survival time for some people with HIV in nations able to afford large health care budgets. There are four of the drugs on the market, three of which were
approved almost two years ago. Of these, the great majority of people seeking treatment chose to take the Merck produced Crixivan because the others either did not work well (Hoffman La Roche's Invirase) or had intolerably extreme side effects (Abbott's Norvir). A year ago, Viracept was approved by the FDA for sale in the US.
Due to the drug's short half life in the body, Crixivan requires an extremely tight dosing schedule that many people with HIV have had difficulty keeping. Every time a person taking Crixivan misses a scheduled dosing time, even by as little as an hour, there is a risk of developing resistance. Sub-optimal drug levels may lead HIV to mutate and become resistant to antiviral drugs.
It is also believed that virus resistant to Crixivan is cross-resistant to the entire class of protease inhibitors.
Crixivan must also be taken on an empty stomach. Many people with HIV are battling AIDS-related wasting, and most attempt to consume food whenever hungry. The entire day of person taking Crixivan can often be highly regimented and inflexible with regards to drug taking times as well as eating.
Viracept, while roughly as potent an inhibitor of HIV, differs from Crixivan because it can be taken with food, and has a longer half-life in the body so that minor variations in drug taking schedule do not jeopardize a person's health in the same way that Crixivan does.
Similarly, the resistance profile of Viracept is slightly different, from the other protease inhibitors, so there is some hope that the other drugs may still work if one starts combination therapy with Viracept and it eventually fails.
City calls back 72,000 condoms
Ansell Personal Products, the makers of LifeStyles, Prime and Contempo condoms, has recalled 57 million condoms from the U.S. market because lab tests indicate they deteriorate before their published expiration dates.Ansell is the primary provider of condoms to the Philadelphia Health Department, and through it to most AIDS education and service organizations in the region. Carol Rogers of the health department said that as many as 70,000 of the questionable condoms had already been distributed to city health centers and AIDS organizations by the time they were informed of the condom recall earlier last week, although it was unclear how many might have actually been distributed to the public.
It is believed that most of the condoms have not been actually distributed to the public, and city officials were taking steps to get them back before that occurred.
Rogers said that Ansell's recall is based on laboratory tests and that there have been no reported instances in which the condoms have been known to actually fail. She said that Ansell is concerned that the normal "shelf life" of the condoms in question may be shorter than the printed expiration dates, and that the kind of deterioration they believe is possible would be noticeable to the men using the condom. "This is not some microscopic hole we're talking about," she told fastfax. "The man putting on the condom would be likely to realize the condom was not good, although his partner might not."
The recall does not involve female condoms.
According to a list provided by the Health Dept., the following condoms are affected:
LifeStyles Ultra Sensitive with Spermicide (exp. date 10/97)
LifeStyles Assorted Colors with Spermicide (10/97-8/98)
LifeStyles Spermicidally Lubricated (10/97-10/98)
LifeStyles Vibra-Ribbed with Spermicide (10/97-4/2000)
LifeStyles Extra Strength with Spermicide (10/97-4/00)
Prime Spermicidally Lubricated (10/97-2/00)
Power Play with Spermicide (10/97-2/00)
Internally Assorted Colors with Spermicide (11/97)
AIDS service organizations have been asked to check their supplies of condoms and remove any which fit the above categories.
We The People Education Director Rob Capone said that none of the condoms distributed by WTP at its Life Center or through its outreach efforts were among those being recalled.
People who have obtained condoms among those listed above have been told that they should discard them, since they may not protect against sexually-transmitted diseases or pregnancy. If an individual is unsure what to do, they have been asked to call the CHOICE Hotline at 215-985-3300.
The recall was announced by the Ansell's parent company, Pacific Dunlop Inc., on October 22nd. Pacific Dunlop Managing Director Rod Chadwick said that the company had sought the recall and that the condoms all contained a spermicidal lubricant and were nearing their use-by dates. "Our people identified that there might be a deterioration so, in the interests of serving the customer well, we just decided to recall those to be on the safe side," he said.
The incident was the second time since 1991 that the city has been forced to recall condoms it had already distributed. That year, over 500,000 Crown-brand condoms which had deteriorated while sitting on a loading dock on the Delaware River were withdrawn after complaints from those who received them that they broke easily. It was later discovered that city procurement officials had ignored specifications set by the AIDS Activities Coordinating Office in making the Crown purchase, and instead purchased the Crown condoms because they were less expensive.
3% test positive at public test sites
A national report on HIV counseling testing services provided in the United States at publicly-funded test sites indicates that an even 3% of those getting tested in Philadelphia in 1995 tested HIV-positive, the eighth highest rate in the nation.According to the report, issued by the U.S. Centers for Disease Control, 768 people seeking testing at HIV test sites funded by the CDC or the city's AIDS Activities Coordinating Office (AACO) tested positive in 1995, out of a total of 25,615 tested. The proportion of people testing positive has declined annually since 1991, when 4% of those tested were found to be infected.
The CDC report also indicated that fewer people are seeking testing from public sites than in the past. In 1992, 31,209 were tested and in 1993, the number rose to 32,037. In 1994, 27,852 were tested. Participation in the testing program dropped by 20% from 1993 to 1995.
The CDC report indicated that 1.9% of the total number of Americans testing positive through public sites in 1995 were tested in Philadelphia.
AACO does not routinely release analyses of the results of its HIV testing programs. The city's application for CDC funding for 1998 indicates, however, that the numbers of people seeking testing from July, 1996 through June, 1997 began to climb again and had increased over the previous year.
Nationally, the CDC said that people of color continue to predominate among those who test positive. Of 40,606 people who tested positive in 1995, 2.4% were African American and 2.3% were Latino, compared to 0.9% who were white. Asians and Pacific Islanders tested positive in 0.5% of the cases.
Private doctor's offices and clinics had the highest prevalence of positive HIV tests, at 3.1%, closely followed by drug and alcohol treatment sites at 2.9%. At public health department and community-based HIV test sites, 1.9% of those tested were infected.
Return rates -- that is, people who actually came back for their test results and post-test counseling -- were highest at the health department and community sites, however, where almost 83% returned for a second visit. At drug and alcohol treatment sites, 68.7% returned for their results, while in private doctor's offices and clinics, only 40.4% came back for their results.
Gay and bisexual men who also are injection drug users were significantly more likely to test positive, according to the CDC's analysis. They comprised 11.6% of those who tested positive, compared to 7% who were gay or bisexual men who do not inject drugs, 4.9% who were heterosexual injection drug users, and 1.2% whose risk was through heterosexual sex.
PWAs join union in Allegheny protest
Members of We The People joined as many as 2,000 laid-off hospital workers on October 28th in a disruptive demonstration outside Allegheny University's Hahnemann Hospital to demand that city officials take action to protect patient care, which they say is being "sacrificed to Allegheny's bottom line."Allegheny sponsors a project called "Partnership for the People," an AIDS care program directed by former city AIDS director Marla Gold, M.D., WTP noted in a call for support for the demonstration issued earlier this week. "What kind of partnership is it when we're told we'll get quality care but the people who provide it are forced into the unemployment lines?"
The demonstration tied up traffic at the busy intersection of Broad and Vine Streets for over an hour.
The rally followed the layoffs this month of 1,700 people and the closing of one hospital by Allegheny Health, Education and Research Foundation, which now operates nine local hospitals. Hundreds of other Allegheny employees had their work hours reduced as part of the Pittsburgh company's cost-cutting moves.
Henry Nicholas, president of the 13,000 member hospital workers union, told the Philadelphia Inquirer that "The fallout of the announced layoffs and cutbacks threatens the economic stability of our region and therefore needs an immediate response." Nicholas said he had asked Mayor Rendell to convene a meeting of top officials from the city's major hospitals, as well as health insurers, the Delaware Valley Healthcare Council, the Greater Philadelphia Chamber of Commerce, and state and union representatives to develop a plan to respond to the crisis.
"It is indeed a crisis, and unless we act quickly it could topple the entire Philadelphia economy," Nicholas said.
The Inquirer report said that approximately one of every eight private-sector jobs in the region is in health care. The city economy is heavily dependent on its 32 acute-care and specialty hospitals, the paper said.
Allegheny officials said they shared the union's concerns but enacted the cuts "to ensure Allegheny's long-term financial strength and to preserve jobs for about 18,000 employees." They attributed the recent layoffs to "steep cuts in government funding."
In an opinion piece published in the Inquirer the day after the demonstration, city deputy health commissioner Donna Gentile O'Donnell said that Allegheny's layoff of 1700 health care workers "has left hospital staff, patients and the Philadelphia community in shock. And while spokespeople assure us that the quality of patient care has not been affected, lingering doubts continue to point toward the obvious: objective, verifiable standards of care are needed in all Pennsylvania hospitals.
O'Donnell said that the Allegheny action dramatizes the fact that "little or no information is readily available to consumers with important questions such as: How many nurses does the hospital employ on the unit to which I will be admitted? Does this hospital use unlicensed persons at the bedside?"
Meanwhile, an article in the Philadelphia Business Journal says that a major reason for Allegheny's financial problems may be its purchase of Graduate Health System, a major provider of AIDS care in the region. The purchase of Graduate's five local hospitals created the region's largest hospital chain.
While Allegheny has lowered the Graduate bond debt to about $162 million, that amount still carries annual principal and interest payments of more than $14 million, according to public records cited by the Journal.
"According to industry analysts, the unprofitable and debt-ridden Graduate hospitals played a key role in Allegheny's fiscal struggles," the Journal said.
"In my opinion, Allegheny grew too big too fast," Alan Hillman, director of the Center for Health Policy at the University of Pennsylvania's Leonard Davis Institute of Health Economics, told the Journal. "[Allegheny] wanted to win the marathon, but I think they misjudged the marketplace," he said.
The Graduate Health System, created under the leadership of Philadelphia lawyer Harold Cramer, was at one time the region's largest hospital group.
Alan Morrison, a health finance consultant, said that he expects more layoffs at Allegheny's nine hospitals because the region continues to have too many hospital beds. "The problem in Philadelphia is the market hasn't shrunk, it has just reorganized," he said. "What the market needs to do to get to a rational level is see some significant closures."
HIV discrimination feared as PWAs return to work
Despite more than a decade of public education on AIDS, and federal laws that protect the rights of HIV-positive employees, more than 30 percent of employees recently polled by the National AIDS Fund said they believe an HIV-infected employee would be fired or placed on disability by their employers at the first sign of illness. An additional 13 percent think their employer would restrict an infected employees' benefits. When employees were asked what their employers should do more than 21 percent said they favor firing or restricting the infected employee.Two-thirds of employees polled also said they believe their coworkers would feel "uncomfortable" if forced to work beside an HIV-positive employee.
The findings are the result of a survey conducted for the National AIDS Fund by Caravan Opinion Research. The survey of employee attitudes on HIV/AIDS was designed to measure change from employee attitudes last surveyed in 1992.
"Fewer employers are offering AIDS-related educational programs now than five years ago, though more than half of those employees surveyed cite the threat of AIDS as one of their top three personal health concerns," said B.J. Stiles, President and CEO of the Fund. "Unfortunately, the numbers indicate diminishing interest in HIV/AIDS as a workplace issue by employers. We find that particularly alarming in the face of an apparent increase in intolerance toward the HIV-positive employee.
"In addition, we are seeing more HIV-positive people wanting to leave the disability rolls and return to work as a result of improved HIV/AIDS drugs and therapies," Stiles said. "A supportive workplace with knowledgeable and cooperative coworkers must greet those HIV-positive employees if their return to work is to be successful."
Although personal concern about AIDS has decreased during the past 10 years, the survey found the impact of AIDS on individual lives has increased. In 1992, 28 percent of all adults and 34 percent of private-sector employees knew someone with AIDS or who was HIV positive. Today, 39 percent of all adults and 46 percent of employees know someone who is or was infected.
Results from the study were based on interviews with a representative sample of about 2,000 adults living in private households in the United Sates. Other survey findings include:
* Employees report company support of AIDS-related activities has remained steady over the past five years.
* The younger an individual, the more likely he or she is to be personally concerned about AIDS. Similarly, employees under 25 are the most supportive of company sponsored AIDS-related activities.
* In 1992 and 1997, African-American employees showed a greater personal concern about AIDS than white Americans (AIDS is mentioned as the top health concern by 45 percent of African-Americans vs. 25 percent of white Americans).
* Female employees are more likely to believe that there should be an organized AIDS education program in the workplace than male employees (80 percent vs. 67 percent).
Study drops placebo in African study
Johns Hopkins University researchers have decided to drop plans to give Ethiopian women an inert pill, or placebo, in a study of mother-to-infant transmission of HIV.A Hopkins spokesman said that the decision was based on preliminary data from a similar study in Thailand hinting at the effectiveness of very short courses of the drug AZT during pregnancy in preventing transmission of the virus.
Meanwhile, a leading official of UNAIDS, the United Nations' AIDS agency, said in an interview that future studies of maternal transmission of HIV should not give some women placebos while others get active drugs.
"I think it's too late now to do a placebo-controlled trial," said Dr. Joseph Saba, who oversees such studies throughout the world. "But this doesn't mean that the ongoing trials are unethical."
The use of placebos in studies of maternal-infant AIDS infection has sparked a fierce international debate in recent months. An estimated 1,000 infants each day are becoming infected worldwide with the human immunodeficiency virus _ but doctors in the most severely affected countries cannot dream of using a US-style AIDS drug regimen that costs $800 for every mother-infant pair.
Five studies are currently under way in Asia and Africa that employ placebos, and two are scheduled for implementation soon. One is the Ethiopian study that now will not include a placebo component. A second study planned by Hopkins researchers for Uganda is still slated to have a placebo arm, but Saba said that may need to be reevaluated.
"If they go ahead with a placebo-controlled trial and then one of the ongoing trials next year provides positive results, then they would have to stop the new trials prematurely, so it doesn't really make sense," Saba said.
But he added that the decision not to use placebos in future studies is not being forced by critics who insist that it is unethical to use a placebo. They base their argument on a 1993 US study which showed that the drug AZT, given during pregnancy, sharply reduced AIDS infections among offspring of infected women. A Washington-based advocacy group called Public Citizen, which is spearheading the attacks on AIDS studies in Africa and Asia that employ placebos, cited the Hopkins researchers' decision in a letter to US Health and Human Services Secretary Donna Shalala, and called on her to end the use of placebos in all US-sponsored AIDS studies of maternal-infant transmission.
Two Public Citizen doctors also cited unpublished data from the federally sponsored 1993 trial which, they said, shows that a short course of AZT during pregnancy was effective in reducing
mother-to-child transmission of HIV. This is the main question that a number of studies under way or planned in Africa and Asia are designed to answer.
"I think the data quite clearly show that short is better than nothing and that at least some versions of short AZT would be as good as longer ones," said Dr. Peter Lurie of Public Citizen. However, Saba and top US AIDS officials said Public Citizen's statements are highly misleading, both with regard to the Hopkins researchers' reported decision and in the critics' characterization of the unpublished 1993 data.
Dr. Jack Killen, director of the AIDS division at the National Institutes of Allergy and Infectious Diseases, said it "has always been part of the grand scheme to rethink study design" if data from trials already under way in Thailand and other parts of the world begin to show a positive effect from short-course AZT regimens.
Data from the Thai study, which includes a test of AZT given only around the time women deliver their babies, will not be available until January, Killen said.
Killen also disputed Public Citizen's contention that the 1993 US study demonstrated that short-course AZT works better than no treatment at all.
The unpublished data involve HIV transmission rates among women who received AZT for an average of seven weeks during pregnancy compared to those who received the drug for 17 weeks on average.
By contrast, Killen said, "all the regimens being looked at for developing countries are much shorter than that. The longest in the current trials is three weeks, and the shortest is several days around delivery." The 1993 trial, he said, "basically doesn't apply to a regimen that is a quick shot around the time of delivery in these developing countries."
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