State to add Invirase to SPBP list
New suburban AIDS consortium founded
Office of AIDS Research bypassed on grant authority
Early AZT use increases death risk after diagnosis: study
FDA opposes fast-track legislation
French Roman Catholic Church promotes condom use
New strain of HIV identified in India
FDA approval of HIV load assay expected soon
State to add Invirase to SPBP list
Pennsylvania State Public Welfare Secretary Feather O. Houstoun has announced that her department has added the drug Invirase to the list of prescription drugs available through the Special Pharmaceutical Benefits Program (SPBP) for treating people with HIV disease and AIDS.
Invirase (saquinavir mesylate) belongs to a new class of drugs called protease inhibitors, which are being touted for their significant clinical effects in combating HIV/AIDS.
The announcement came only a week after Pennsylvania governor Tom Ridge announced that he was slicing funding for the program by one-third (to $4 million) as part of his fiscal year 1997 budget proposal. Ridge also announced that he would be implementing stricter rules for poor people with HIV/AIDS and other illnesses to qualify as "medically needy" under the state's Medical Assistance program.
Ridge's SPBP cuts came under fire by advocates for people living with HIV/AIDS, who noted that the cutbacks were occurring just as promising results on the protease drugs were being announced.
With the addition of Invirase to the SPBP list, the state now pays for 56 HIV/AIDS drugs and treatments. Out of this total, more than half were added to the list by the Ridge administration.
"Today represents a new ray of hope for thousands of Pennsylvanians living with HIV and AIDS," Houstoun said. "By adding Invirase to our stockpile of drugs, we're optimistic that we can significantly prolong the quality of life for people with AIDS and their families.
"Until a cure is found, Pennsylvania will continue its fight against this deadly disease by offering a hand-up to people who otherwise could not get the medications they need to survive."
Invirase has been reported to be effective in slowing the growth of HIV-infected cells, thus reducing infections that are usually fatal. It has also been proven successful when used in combination with certain anti-viral drugs covered by the Special Pharmaceutical Benefits Program.
Currently, the state's $6.6 million drug assistance program serves nearly 2,000 people. To be eligible, individuals must reside in Pennsylvania but not in an institution where these medications are available; have an individual gross income of less than $30,000 or a family income of less than $30,000, with an additional allowance of $2,480 for additional family members; and have a medical need for the drug.
Applications are available from county assistance offices, AIDS service agencies, hospital social service departments, state health centers, hemophilia and renal dialysis centers, mental health centers and some physicians and pharmacies.
Individuals interested in more information about the program or applications can call the department's toll-free hotline at 1-800-922-9384 or by writing to: Department of Public Welfare, Special Pharmaceutical Benefits Program, P.O. Box 8021, Harrisburg, PA 17105.
New suburban AIDS consortium founded
Providers of HIV/AIDS services and people living with HIV/AIDS in Bucks, Chester, Delaware and Montgomery counties have formed a new HIV/AIDS planning coalition for the suburban Philadelphia region. The group has been meeting informally since September 1995.
The group, now known as the Suburban HIV/AIDS Consortium (SHAC), began meeting monthly last fall at the initiative of Dan Daniel, president of the board of directors of Chester County AIDS Support Services and a member of the Philadelphia-based HIV/AIDS Commission. At a meeting on February 21, Daniel was named convener of SHAC.
The group's aim is to assure fair and adequate expression of the service needs of the four southeastern Pennsylvania counties suburban to Philadelphia and to advocate for a fair and adequate response to those needs in the planning and allocations process. It is believed among SHAC participants that the CARE Act-driven planning process, which includes allocation of financial resources, is ignorant of the basic facts of the HIV epidemic as manifested in the suburban counties in spite of efforts dating back several years to remedy this situation.
At the February 21 SHAC meeting, for example, it was noted that the Ryan White supplemental application prepared by Philadelphia's AIDS Activities Coordinating Office, while several hundred pages in length, devotes less than two pages to service needs in the four participating suburban counties.
"It's clear to everyone that the overwhelming majority of reported AIDS cases in the region are in Philadelphia," Daniel told fastfax. "However, it's also clear to those of us providing services to people in the suburban counties that the HIV epidemic doesn't respect convenient geographic boundaries. Our official reporting of AIDS cases is frequently sluggish and inadequate, but we see people living with HIV and AIDS every day, and we're seeing more of them and different people, so we know that the need is there. Myopic planning hurts our ability to provide critically needed services and results in unnecessary, unwarranted hardships on the people who need services most."
A planner from The Philadelphia AIDS Consortium came to some of the SHAC meetings, but that individual has since left TPAC and, to the best of anyone's knowledge at this time, has not been replaced.
No one from TPAC, the Ryan White Title II planning council, was in attendance at the February 21 meeting. Jesse Milan, director of the AIDS Activities Coordinating Office, attended the December SHAC meeting by invitation, but no other AACO representative has been delegated to attend any other meeting.
SHAC participants expressed a unanimous belief that it is vital -- as a first step towards achieving a more regional approach to planning -- to have a representatives of each of the two regional Ryan White planning councils attend future meetings in order to gain an accurate understanding of the needs and concerns of suburban consumers and providers.
"The bottom line," Daniel said, "is that we are all supposed to be in this together and that the planning process is supposed to be regional in scope and nature. That hasn't been the case in the past, and we're looking to change that as quickly as we can."
Office of AIDS Research bypassed on grant authority
The National Institutes of Health recently decided to channel more than $1.4 billion dollars for AIDS research in the current fiscal year directly to research institutions designated to receive the grants, effectively removing control of fund allocation from the Office of AIDS Research (OAR).
However, a spokesperson for Dr. Harold Varmus, director of the NIH, said that he is still "...behind the OAR and its authority," according to an article in the February 8 issue of Nature.
The NIH said it made this decision so AIDS researchers could receive grants in a timely manner after two government shutdowns. Officials of the Clinton administration say the OAR will ultimately retain responsibility for distributing funds to the 24 AIDS research institutions and centers. These funds represent 12% of the NIH's total budget of $11.9 billion for 1996.
AIDS activists expressed concern that the OAR would be "emasculated" if this change becomes permanent. The 33-member OAR office, which is responsible for the oversight and coordination of AIDS research, is in the process of reviewing how funds are to be allocated in the future. New OAR recommendations are expected in March and fundamental changes in AIDS research are anticipated. The March report may become "a toothless tiger" if the OAR does not retain direct authority to control research funds, one researcher commented.
Panels suggest much research is "dubious"
Drafts of reports on which the March recommendations will be based reveal that the evaluation will recommend more critical evaluation of whether clinical trials for new drugs and vaccines should be started; efforts to attract better scientists to AIDS research; and the elimination of spending out of the AIDS budget for research that is not directly related to AIDS.
A panel which examined the NIH's studies on the cause of AIDS and the mechanism of HIV found that much of the research supported was "of dubious quality and relevance." The panel also found that some researchers did not cooperate with their colleagues on the use of resources.
A panel reviewing vaccine research reported that more incentive was needed to interest the private sector and that too much money was going for irrelevant research. In addition, a panel reviewing AIDS clinical trials recommended the incorporation of all four current clinical trial networks into the AIDS Clinical Trials Group. Members of the review groups say they hope to issue a tough final report, which could influence the 1997 budget request.
Early AZT use increases death risk after diagnosis: study
Early zidovudine (AZT) treatment for patients who develop symptoms of HIV infection can prolong survival, but does not decrease overall mortality rates, according to investigators affiliated with the Veterans Affairs Cooperative Study.
Team leader, Dr. Michael S. Simberkoff of the New York VA Medical Center in Manhattan, also discovered that "...treatment with zidovudine for a prolonged period prior to progression to AIDS [was] associated with an increased risk of death following that diagnosis." CD4+ counts of fewer than 100 cells/mm3 and more severe disease at initial diagnosis of AIDS were independent risk factors associated with a poorer prognosis.
However, AIDS patients treated with another antiretroviral agent had improved survival. Dr. Simberkoff now recommends that "...patients who progress to AIDS while on prolonged zidovudine monotherapy may benefit from a change to other antiretroviral therapies."
In the VA study, Dr. Simberkoff conducted an additional three-year follow-up of an original cohort of 338 symptomatic HIV-positive patients who had already been followed for four years. He randomized patients to early or late treatment with zidovudine. In the early treatment group, 67 of 170 patients progressed to AIDS during the trial, compared with 85 of 168 patients in the later treatment group. There were no significant differences in survival between the two treatment groups.
Because zidovudine did not improve overall survival in either group, Dr. Simberkoff concludes that "...the optimum time for initiation of antiretroviral monotherapy remains a legitimate subject for debate among investigators as well as for discussion between patients and their physicians." The results of this study and previous research "...give hope that the early use of antiretroviral agents in sequence, combinations or cycles or both will reduce mortality and prolong the survival of HIV-infected patients."
FDA opposes fast-track legislation
Legislation forcing the Food and Drug Administration to rule on new drugs in as few as four months could endanger Americans' health, FDA Commissioner David Kessler warned senators Wednesday, according to the Associated Press.
"We are approving drugs in very short time frames, and one day we are going to make a mistake," Kessler told a Senate committee that began debating how to reform the agency.
The FDA is responsible for ensuring Americans get safe and effective medicine, as well as safe food, cosmetics and other products.
The issue is whether the FDA approves new products fast enough - and how it can help medical manufacturers speed up drug development so it doesn't take 12 to 15 years between discovering a new medicine and selling it.
Sen. Nancy Kassebaum, R-Kan., has introduced legislation to force the FDA to review all ``breakthrough'' drugs for killer or untreatable diseases in four months, two months faster than today. Every other product, from a fat substitute for foods to a competitor for existing drugs, would be reviewed within six months.
The FDA would have to meet those deadlines by 1998 or farm out its work to private companies. The bill also would allow companies to petition for automatic U.S. sale of any therapy that is approved in certain foreign countries if the FDA misses its deadline. The FDA then would have 30 days to block the sale, by declaring the treatment unsafe or unproven.
Today, the FDA spends six months reviewing breakthrough drugs and 16 months reviewing nonessential medicines. Medical devices take much longer, an average of 20 months for the most complicated ones like mechanical heart valves.
But the FDA has set some records, approving the latest AIDS therapy in just 97 days. Why, senators asked, can't the FDA do all therapies that fast?
The FDA lets drugs for killer diseases be approved without final proof of how well they work, but won't take that big of a risk just to let a company sell a competing drug that offers no advantage over existing medicine, Kessler responded.
French Roman Catholic Church promotes condom use
The French Roman Catholic Church has broken with the Vatican with a recommendation that condoms be used in an attempt to curb the spread of AIDS. The report supported the Vatican's view against birth control, but stressed that the Church felt that condom usage as a form of prevention against AIDS was valid.
Pope John Paul II still opposes the use of condoms, and feels that AIDS is spread by irresponsible sexual behavior. The Pope believes that abstinence is the best manner to combat the illness. Vatican opposition to condom use is cited for the slow progress in many country's AIDS prevention programs, and punishment against earlier Church officials that have disagreed with the Pope has been swift and severe.
New strain of HIV identified in India
A new HIV strain that may be resistant to vaccines currently under development has been identified in Asia and Africa. A team of scientists at the National Institute for AIDS Research in Pune, India, reports that it has identified a new "C-subtype" of HIV. The strain has been detected in the majority of HIV-positive individuals in that country, according to an article in the current issue of AIDS Weekly Plus.
"Of the four or five vaccines that show some promise, there is none for the C-subtype," according to Dr. Max Essex of Harvard.
In the same issue, Dr. Essex comments that "...we have two HIV epidemics in the world...We have the epidemic in the West, which has something on the order of two million people infected and is plateauing or decreasing." In contrast, the number of infected persons in Asia and Africa is on the rise.
Close to 90% of AIDS cases in Asia and sub-Saharan Africa were transmitted by heterosexual contact, and 90% of AIDS cases in Western nations were due to homosexual contact or injection drug use. Sex education in developing countries is almost nonexistent. <P>
In India alone, the World Health Organization predicts that more than five million HIV seroconversions will occur by the year 2000.
FDA approval of HIV load assay expected soon
After much waiting, FDA approval of two new viral load assays will probably take place soon. Developers of the HIV RNA tests credit progress in the approval process to an improved consensus within the FDA on exactly what is required for test approval. A recap of what has transpired so far is presented in the January issue of the Journal of the International Association of Physicians in AIDS Care.
Roche is the developer of Amplicor HIV Monitor, a PCR assay, and Chiron is the developer of Quantiplex, a bDNA assay. Spokespersons for the drug companies attribute the progress toward FDA approval to two major influences. Roche and Chiron representatives think that FDA officials needed time to understand how the assays worked before they could put together criteria for approval. And publication of four "seminal reports" in 1995 on the assays attracted much attention. FDA officials say they will make a final decision by July, 1996.
One potential problem is whether or not health insurance providers will approve the viral load assays for payment. AIDS experts anticipate that these tests will be useful in monitoring AIDS patients at regular intervals. However, if the assays are categorized as "prognostic," insurance companies may not reimburse for use more than one time per patient.