News & Notes
Under pressure from the National Association for People With AIDS (NAPWA) and members of the HIV/AIDS community, the Health Care Finance Administration (HCFA) has reversed an early statement that allowed the state of Texas to deny Medicaid reimbursement for Serostim®, the first biotechnology drug ever to be approved for the treatment of AIDS wasting, based on a loophole in the United States Social Security Act. HCFA, which is the federal agency responsible for administering Medicaid policy, had previously stated that Serostim could be considered a drug for cosmetic weight gain, which gave states the option of refusing Medicaid coverage of Serostim for AIDS wasting. HCFA now confirms the clinical benefits of Serostim, a recombinant human growth hormone (r-hGH), for use in fighting this life-threatening condition, and will require Medicaid reimbursement for the drug by all states. The mandate took effect April 5.
Cornelius Baker, executive director of NAPWA, commented, "NHCFA's mandate for the Medicaid reimbursement of Serostim ensures that all AIDS patients with wasting will receive the same access to Serostim no matter where they live. Anything else would be cruel and unjust." Wasting, or cachexia, is a major contributing factor to the high mortality rate among patients with AIDS. Wasting is a destructive metabolic process that uses the patient's own tissue, muscles, and organs to feed the body's energy demands. As the condition becomes increasingly severe, the patient becomes weak, unable to perform simple physical tasks, and susceptible to life-threatening infections. "Serostim has the ability to reverse this underlying metabolic derangement," says Dr. Nancy Erickson of the University of Texas Medical School, LBJ Hospital, and the Texas HIV Medication Advisory Committee. "No one knowledgeable about this aspect of the disease could consider a drug like Serostim to be merely 'cosmetic.' For patients who are wasting away, weight gain and increased lean body mass means a significant improvement in the overall quality of life and a very real improvement in physical function."
The physical signs of AIDS wasting, severe weight loss and muscle atrophy, can sometimes be masked by the increased weight -- primarily fat rather than lean body mass -- that develops during protease inhibitor treatment.
Serostim received FDA approval in 1996 and was granted Orphan Drug status; however, a large part of the AIDS population was still without access to the drug. Texas, with approximately 20,000 people with HIV and the fourth largest HIV population in the United States, refused to cover the cost of Serostim for the management of AIDS wasting. The state's decision affected approximately 5,000 people in Texas who suffer from AIDS wasting.
The refusal by Texas to pay for Serostim was based on a loophole in the Social Security Act, which dictates how states are to manage the distribution of federal funds for healthcare benefits. Section 1927 of the Act provides states with a mechanism for denying reimbursement for products with primarily "cosmetic" outcomes. Included in this group are products that are used for the sole purpose of gaining or losing weight. In late 1997, Texas asked HCFA whether its Medicaid programs could deny reimbursement for Serostim, and HCFA responded that the state could reasonably assume that the product was solely a weight-gain drug. According to Baker, "That decision was an insult to people with AIDS that could have led to hundreds of needless deaths. We are committed to making sure that every person with AIDS has access to life-saving drugs." NAPWA, in concert with Serono Laboratories, patient advocates, political leaders, and other sympathetic angencies embarked on what would become an almost year-long campaign to reverse the HCFA decision and convince Texas to cover Serostim.
The final push was a combined appeal to the FDA. A letter from the FDA supported the role of Serostim as a therapeutic product, reminding HCFA that "Serostim is approved for the treatment of AIDS wasting, or chachexia, which is associated with increased morbidity and mortality." In February 1999, HCFA stated that, "In light of further information provided by the Food and Drug Administration, we have decided to change our policy with respect to Serostim."
On March 31, the Multicenter AIDS Cohort study, known as MACS, marked its fifteenth year following a group of 5,622 homosexual and bisexual men nationwide. The study is aimed at determining if, when, and why these men contract HIV. Among the study's achievements has been the development of guidelines for physicians regarding when to initiate antiretroviral therapy. The Public Health Service has adopted the guidelines, and they have become the standard for doctors deciding when to start this life-prolonging treatment.
MACS was initiated in 1983 as the result of warnings by B. Frank Polk, M.D., M.S., of the Johns Hopkins School of Public Health, that a major epidemic was developing. Dr. Polk based his predictions on small but growing clusters of pneumonia and Kaposi's sarcoma among homosexual men.
Study subjects were recruited from the gay communities in Washington and Baltimore. According to Joseph Marglick, M.D., Ph.D. and head of the Baltimore MACS center, "There were only a few people in the world who knew there was going to be a major epidemic. Frank Polk had the confidence in his own vision to go out on a limb and start this study." The study grew to four sites around the country, with more than 5,000 participants. For the most part highly educated and highly motivated, study subjects took an active part in giving feedback and working with the researchers. "The amount of participation takes my breath away," says Dr. Margolick.
Data collected by MACS over the years include information on how HIV enters the body, what it does over time, and what determines the onset of AIDS. Participants are evaluated every six months, and each visit includes their filling out a questionnaire about all aspects of their health status in addition to a physical examination and the taking of blood samples. Data are processed through the Center for Analysis and Management at Johns Hopkins School of Public Health.
There have been more than six hundred research articles based on the MACS data, ranging from the role of CD4 lymphocyte counts and viral load in predicting AIDS, to average incubation time, to the genetics of AIDS -- why the virus affects different people so differently. MACS has provided important data about early events in the course of HIV infection, conversion to AIDS, and factors that may be involved in transmitting the infection. The study's respository of biologic specimens has been used by other AIDS researchers around the country. MACS data are on the Internet at http://www.statepi.jhsph.edu.
Hilary O. Shelton, Director of the NAACP's Washington office, has joined AIDS Action's Board of Director's. The appointment is a move toward ensuring a stronger voice for African-American communities disproportionately affected by HIV/AIDS. Shelton's nomination to the Board was unanimously approved at an April 5 Board meeting.
"Having Mr. Shelton's extraordinary leadership and expence will enhance AIDS Action's response to the needs of communities at risk for HIV and AIDS," says AIDS Action Executive Director Daniel Zingale. "A formal partnership between the leading AIDS and African-American advocates is long overdue."
According to recent data, African-Americans comprise three out of seven new HIV infections, as well as almost 45 percent of new AIDS diagnoses. Because of the epidemic in the African-American community, the Congressional Black Caucus decisively declared an AIDS "State of Emergency" late last year. (See February 1999 Body Positive.) Shelton serves as the Director of the NAACP's Washington bureau, which is the federal government affairs and policy division of the 600,000-member, 1,700-branch national civil rights organization. His government affairs portfolio includes affirmative action, healthcare (including HIV/AIDS), ending gun violence, civil rights law enforcement, and other issues of concern to the African-American community and every American concerned about fairness and equality.
"Mr. Shelton brings dynamic political skills and moral authority that will bring an even higher level of expertise to AIDS Action's policy work," adds Zingale. "Mr. Shelton joins a growing and diverse AIDS Action Board comprised of America's leaders in the fight against AIDS. For two years, AIDS Action has worked to ensure that its Board reflects demographic changes in the epidemic across lines of age, race, and geography. Former Representative Ronald Dellums also joined AIDS Actions Board this year to work for a better fight against the disease internationally. AIDS Action Board member Ravinia Hayes-Cozier, of the Harlem Directors Group, was recently named co-chair of AIDS Action's Public Policy Committee.
"Fighting the epidemic more effectively means ensuring that those affected are at the leadership of AIDS Action," adds Zingale.
This article was provided by Body Positive. It is a part of the publication Body Positive.