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Issue #129: June 15, 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 AIDS Action Council, Associated Press, Chicago Defender, Pride Weekly.
FDA warns of diabetes risk of protease drugs
State threatens TPAC on board changes; $400G in new funds awarded amidst complaints
Study: 1/3 black men don't trust their doctors
FDA "reform" again in Congress
FDA warns of diabetes risk of protease drugs
In letters to doctors and health care providers nationwide, the U.S. Food and Drug Administration has warned that thousands of people with HIV/AIDS taking protease inhibitors should be closely watched for an unexpected side effect: diabetes.The FDA stressed that the estimated 150,000 Americans taking protease inhibitors should not stop, because the diabetes risk appears fairly small.
But the FDA, investigating after complaints from pioneering AIDS researcher Dr. Michael Gottlieb and from Japan's drug regulators, discovered 83 patients who contracted diabetes or high blood sugar -- or had those diseases suddenly worsen -- after they began taking protease inhibitors. Six cases were life-threatening, and 21 other patients needed hospitalization.
The FDA called the cases disturbing enough that it is relabeling all four protease inhibitors now sold in the United States to warn about the potential side effect.
And the agency urged patients to immediately report to a doctor such symptoms as increased thirst, unexplained weight loss, increased urination, fatigue and dry, itchy skin.
As many as 1 in 1,000 to 1 in 100 patients who take protease inhibitors may be at risk, said FDA medical officer Dr. Jeff Murray. Many of those may be treated for diabetes successfully without stopping their AIDS therapy, he said.
But half of the 83 patients discovered so far had to quit taking protease inhibitors, which have revolutionized AIDS care in the last year.
"I don't take this as a cause for alarm," said Dr. Sandra Palleja of Hoffman-La Roche, maker of the nation's first protease inhibitor, Invirase. "It just says we need to be vigilant when we monitor patients."
The surprise warning comes just as the government is completing its first guidelines on how doctors and patients should use the complicated protease inhibitors.
According to a draft obtained by the Associated Press, the standard of AIDS care should be one protease inhibitor -- either Roche's Invirase, Merck & Co.'s market-leader Crixivan, Abbott Laboratories' Norvir or Agouron Pharmaceuticals' Viracept -- taken in combination with two older AIDS medicines.
How and when to use these potent drugs has proved a mystery for many doctors, and AIDS groups were horrified recently to discover patients still taking the granddaddy AIDS drug AZT alone, which merely causes the fatal virus to resist treatment. Nor do many patients know each drug's quirks -- that Crixivan, for instance, must be taken on a virtually empty stomach, with no more than a light meal such as toast.
Among the guidelines, which the government expects to publish next week:
--Test the HIV in patients' blood every few months, and consider changing therapies if HIV is still detectable after six months.
--When changing therapy, switch to at least two drugs the patient has never used, not just the one-drug switch doctors typically try today.
--Avoid switching from Crixivan to Norvir or vice versa if therapy has failed; cross-resistance is likely.
--No patient should be on single-drug therapy. Substituting the drug nevirapine in the medical cocktail or taking just two drugs instead of three "should be used only if more-potent treatment is not possible."
--Advise patients that stopping drug treatment for even several weeks could render the drugs useless when therapy restarts. Protease therapy costs about $12,000 a year per patient, and many patients struggle to afford continual treatment. Mississippi just cut over 600 poor HIV-infected patients out of a program that provided the drugs, because the state was not receiving enough federal money to keep up with demand.
Those guidelines will come just as doctors are advising patients about the FDA's diabetes warning.
The problem: It is unclear how, biologically, protease inhibitors would cause diabetes, which develops when the body cannot properly use sugar for energy and glucose builds up in the blood.
It is treatable with diet, oral drugs and/or daily shots of insulin, but can be deadly if people do not know the warning signs and get medical help.
The 83 patients are not proof that protease inhibitors alone actually cause diabetes, the FDA cautioned. Some of the patients were taking, in addition to the AIDS medicines, other drugs that have been associated with the disease.
On average, diabetes symptoms struck about 76 days after patients began taking protease inhibitors, although some patients had the first symptoms a mere four days into treatment.
Last month, it was reported that a University of California found that five people living with HIV/AIDS taking protease inhibitors had developed cytomegalovirus retinitis, which affects 40 percent of patients with advanced HIV disease, and can lead to blindness. While the drug treatment successfully fought HIV infection in the five patients in the study, it did not protect them from developing the eye disorder.
Dr. Mark Jacobson of the UCSF AIDS Program at San Francisco General Hospital says doctors had thought that AIDS patients with improved immune system cell counts would decrease their odds of developing the eye disease. The study results indicate that that does not appear to be the case for all of those taking the drugs, he said.
$400G in new funds awarded amidst complaints
State threatens TPAC on board changes
Philadelphia AIDS Consortium (TPAC) executive director Larry Hochendoner reported to the group's board of directors this week that state officials have told him that they are not interested in negotiating further on how TPAC will protect its funding process from conflicts of interest -- which the state has demanded for over three years.Hochendonr told the TPAC board that state AIDS official Bonnie Brautigan said she would consider finding another group to serve as the state planning coalition for the region in 1998 if it did not comply with the new requirement, according to several board members who spoke with fastfax. A final decision must be made in the very near future, since the state's new contract with TPAC begins on July 1st.
TPAC is responsible for allocating about $5 million of state AIDS education funds (called 106 funds) and federal Ryan White CARE Act Title II funds. The dispute with the state involves a demand that TPAC remove members of its board who are paid staff, board members, or volunteers with organizations which receive Title II or 106 funding, Hochendoner told fastfax.
The TPAC executive committee had intended to question the state on the requirement, noting that neither federal rules nor other state Title II planning councils were subject to the provisions. The board delayed action on contacting the state after Hochendoner's report.
"The reality is that the Philadelphia AIDS Consortium holds its contract with the Commonwealth of Pennsylvania, who has the legal right to place any restrictions on its contracts that it sees fit. It also has the right to remove all of its funding from the Consortium," Hochendoner said.
TPAC underwent a almost total reorganization just last year, when most of its prior board of directors were removed from office and its first director resigned, it lost its responsibility for managing over $10 million in Title I funds, and a new board was elected. At that time, a formal regulation was implemented which removed direct influence over allocations from the board, which was limited only to determining the priorities for the funding as required under the federal Ryan White legislation.
A draft letter to the state was developed by Hochendoner under instructions from the TPAC executive committee, which questioned the need to remove all providers from the board, even though it no longer makes funding decisions. The letter noted that the state contract does not specifically exclude providers from the board but calls for "a mechanism to enforce appropriate management of the perception of conflict of interest," according to Hochendoner. The letter also noted that federal requirements do not preclude provider participation in planning councils, nor do most other states receiving Title II funds.
Some TPAC board members are concerned that the state is not fully aware of the changes TPAC has made to eliminate the "perception" of conflicts of interest. They have also complained that negotiations with the state on the issue were pursued by TPAC staff without the knowledge of board members, most of whom were not on the TPAC board when the issue was first raised in 1994. Hochendoner said that the state, which had granted exemptions to the conflict of interest requirement to TPAC for three years, only informed TPAC that it would not do so again on April 21st, and that he reported the state's position at the next TPAC meeting in May.
The state contract also states that the exclusion of staff, board and volunteers of groups receiving state or Title II funds extends to "committees and work groups whose responsibilities include making decisions in any way related to funding." Some board members, including consumer members, are concerned that this provision will exclude not only providers but consumers of services who volunteer at AIDS service agencies from participation in priority-setting and planning processes, which determine the amounts of money awarded to particular categories of service.
Several leading PWA advocates would also be affected by the state's requirement. Roy Hayes of the Craig Foundation, Kiyoshi Kuromiya of Critical Path, and several board members and volunteers at We The People would be forced off the TPAC board under the state rules.
We The People asked state AIDS director Janice Kopelman in 1994 to exempt PWAs who participated as volunteers or board members of PWA-run agencies from the conflict-of-interest provisions. WTP noted that hundreds of the most active PWA advocates in the city, especially in communities of color, were volunteers for the all-PWA organization, and that its board members were the only PWAs actually elected by PWAs to represent them. The complaint also noted that the most experienced and responsive PWAs would be forced out of important AIDS planning decisions under the provision, and only those who have no involvement in helping other PWAs would be allowed to participate.
Kopelman did not respond to the request at that time, since the state decided to exempt TPAC from the provision for that year.
Hochendoner confirmed to fastfax that "paid staff and Board of Directors and volunteers" of We The People and other PWA organizations would not be permitted to serve at TPAC under the state requirement, although members who do not volunteer or serve in board of staff capacities would be permitted. He said that despite the state provision that volunteers, staff and board members not be permitted to participate in "committees and work groups whose responsibilities include making decisions in any way related to funding," he believed that "any member of the community that expresses an interest in participating in the [community planning] process would be allowed to do so.
The conflict of interest issue has been debated between TPAC and state officials since it was named the Title II "planning council" in 1991. Until 1994, board members themselves decided which organizations received funding. Beginning in 1995, outside evaluators have been asked to make funding decisions according to priorities and guidelines set by the board, and that policy was formally adopted last year.
$400,000 in new funds awarded
Meanwhile, as the TPAC board continued to debate its options on the conflict issue, the group formally ratified the decisions of its latest independent panel in allocating over $400,000 of Title II "underspending" which was given to the organization for services through next June. The review panel for applications for this funding was drawn from Title II planning councils in other areas of the country, according to TPAC, in order to reduce the impact of local biases or conflicts.
Highlighting the group's conflict of interest problems, only four board members were eligible to vote on ratifying the review panel's decisions, since all other board members were either recipients of the funding or associated with agencies that had applied for it.
The new funding was concentrated in the areas of emergency needs funding, case management services, translation services, day and respite care, food, and transportation.
Emergency needs funding was awarded to Congreso de Latinos Unidos ($28,800), which also received $12,279 for its food program. The Craig Foundation received $12,000 and We The People's LifeSavers Emergency Fund was awarded $55,000. Family Service of Montgomery County -- the only suburban group to request emergency needs funding -- also received $4,000.
Originally, $40,000 had been allocated to emergency needs in suburban Philadelphia counties. The $36,000 which was not applied for was re-allocated to case management services.
ActionAIDS ($42,433), AIDS Services in Asian Communities ($37,927), The Colours Organization ($43,156), ChesPenn Health Services ($30,000), Family Service of Bucks County ($6,676) and the YWCA ($20,819) received funding to extend the availability of case management services. The award to ASIAC is the first significant AIDS service funding for direct care services to Asians and Pacific Islanders with HIV ever awarded in the region. The Colours grant also is the first direct service grant for that African American sexual minority organization. Both groups have previously been funded for HIV prevention and education activities.
ASIAC also received $12,513 for translation services, as did Asociacion de Puertorriquenos en Marcha ($7,587). Respite care grants went to the Ecumenical Information AIDS Resource Center ($39,587) and St. Mary's Respite Center ($19,723).
Other grants awarded by TPAC included $1,380 to Family Service of Montgomery County and $9,165 to the YWCA for transportation services; $10,971 to MANNA for its home-delivered meals program; and $10,000 to the Holistic AIDS Project for natural food products for people with HIV/AIDS.
The grants are for a one-year period and will need to be re-applied for next year, when all of TPAC's state funding will be subject to a new competitive bidding process.
In keeping with TPAC's commitment to give priority to investing in minority AIDS organizations, almost 65% of the new funding was awarded to groups operated by people of color. The priority categories had been previously established through a process which allowed only people living with HIV disease to determine what service areas should receive funding.
"De-funding" complaints to be investigated
TPAC is also struggling with the second round of complaints from organizations which lost their funding this year, who say they were not treated fairly by TPAC's process.
Earlier this year, former TPAC contract manager Miriam Peterman resigned after four organizations were told they were suddenly losing their funding in violation of TPAC contract procedures. The funding was later restored by then-TPAC president Joseph Cronauer, who now serves as interim co-director of the city's AIDS Activities Coordinating Office.
The new complaints come from seven organizations which lost almost $200,000 in state AIDS education funds in 1996, after the former TPAC board left funding decisions to the city's Resource Allocations Advisory Committee (RAAC). The groups complained that the RAAC was not adequately prepared to review applications for the funding and was not aware that its decisions led to the elimination of existing programs.
The organizations affected by the defunding included Blacks Educating Blacks About Sexual Health Issues; Children's Hospital; Gay and Lesbian Latino AIDS Education Initiative; Southwest Community Services; Voyage House; We The People's Positive Health television program; and the Youth Health Empowerment Project, a program of the AIDS Information Network.
Representatives of the organizations said that Hochendoner promised to restore the funding if new money became available this year. However, when the state offered $400,000 to TPAC for the current year, the money was allocated to other services such as viral load testing, the HealthChoices hotline, computer purchases and technical assistance activities. It is unclear how decisions were made on the expenditure of the funds, with some TPAC officials claiming that the state determined what the money would be spent on and others saying that the decisions were made by TPAC staff without consultation with the board.
The organizations have also complained to state health officials, who said they intend to meet with the groups to discuss their concerns. At its meeting this week, the TPAC board called for its Operations and Management Committee to investigate how the groups' complaints have been handled by TPAC.
Hochendoner told Pride Weekly that the decision to defund the groups was made prior to last year's reorganization of TPAC and that "we have corrected the system so this won't happen again." He said that the bottom line is that there is no money available to rectify the situation at this point, and that he hoped the groups would compete in 1998 when all TPAC funding will be reallocated.
Study: 1/3 black men don't trust their doctors
by Tasha NicholsChicago Defender
Why many African American men choose not to visit doctors on a regular basis remains an unanswered question to many.
But a recent study by Men's Health magazine and CNN, in conjunction with National Men's Health Week, set out to find some answers.
African Americans were targeted to compare their responses to their counterparts in other segments of the male population.
In order to secure that the population was adequately represented, an oversample of African American men was used.
Time and time again, most men waited until the last minute to go to the doctor, the study showed.
Nobody has the real answer or reason as to why, but most men feel that they just don't get sick, according to the study, which added that 34 percent of African American men said that they do not trust doctors as a factor for keeping them away from regular visits.
The cost of going to the doctor was also a factor for all of the surveyed men.
53% of African American men rated their health own health status as positive, compared to 63 percent among white men.
Although the nation's 10 million African American men were less trusting of their doctors than white men, African American men were more concerned about male-related health issues than their white counterparts.
FDA "reform" again in Congress
Food and Drug Administration (FDA) reform is again on the congressional agenda this year, according to the AIDS Action Council.After patients and consumer groups successfully fought devastating reform proposals last year, Congress once again is planning on making dramatic changes to the Food, Drug, and Cosmetic Act (FDCA), one of the nation's most important and fundamental pieces of consumer protection legislation. The FDCA created the FDA to protect all Americans by making sure that medicines are both safe and effective.
The Council said that the Senate Labor and Human Resources Committee, chaired by Senator James Jeffords (R-VT), has begun consideration of a bill that will propose changes to the FDA and reauthorize the Prescription Drug User Fee Act (PDUFA), a program that helps speed the review and approval of new drugs. AIDS Action and patient advocates are supportive of reauthorizing PDUFA quickly.
"However, we are extremely concerned that the PDUFA reauthorization is tied to changes to the FDA - changes that could be harmful to persons living with HIV and AIDS," the group said.
"Unfortunately, patients and groups including AIDS Action were knowingly and actively excluded from the negotiations on the bill that took place between Labor Committee staff, industry, and the FDA. Since changes to FDA will ultimately affect patients and consumers, more public discussion is needed so patients, consumers, and groups like AIDS Action can have a chance to publicly comment on these vital and dramatic changes to the drug and device approval process."
AIDS Action said that a number of proposals contained in the current version of the bill would dramatically lower the standards and processes used to approve new drugs and devices. "These proposals threaten to weaken the mission of the FDA to protect the American public by making sure drugs and devices are safe and effective, they said.
Two of the group's "gravest" concerns are with lowering the standards for drug safety and effectiveness by permitting fewer or no well-controlled studies of drug safety and effectiveness, and by permitting FDA approved drugs to be used for new and unapproved uses without studies to determine their appropriateness. The second concern is about the bill's provisions which eliminate or weaken most regulatory protections against unsafe medical devices by allowing manufacturers to select and pay for-profit reviewers to certify that their products are safe and effective and by repealing mandatory post-approval observation for all devices which is needed to ensure that devices do not cause serious injury or death to patients.
"These provisions lower the safety and efficacy standards for our drugs and could endanger the health of people living with HIV/AIDS and other people who rely on prescription drugs and devices to maintain health. People living with HIV/AIDS rely on safe and effective drugs to keep them alive and healthy. These 'reform' proposals threaten the safety and effectiveness of the medicines PWA's take," they said.
"Additionally, by tying these reforms to reauthorizing PDUFA, the program that helps get drugs to market quickly is also threatened."
For information on helping on this issue, call Chad Lord at 202-986-1300, ext. 3062.
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