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NIH Cuts ACTG AIDS research funding
  By Gregory Lopes
Washington Times
December 22, 2006
The National Institutes of Health is cutting funding for AIDS clinical trial units across the country.
The move is part of a restructuring effort in the agency's approach to AIDS research that critics contend will leave thousands of AIDS patients without needed care through clinical trials. AIDS patients who enroll in the clinical trials are treated with cutting-edge therapies that often become the standard of care for HIV treatment.
NIH officials said the new approach will modernize the research effort by coordinating several focuses of AIDS research.
"Areas of emphasis needed to change because of the changing nature of the AIDS epidemic," said Sandra Lehrman, director of therapeutics research in the Division of AIDS within the National Institute of Allergy and Infectious Disease in NIH. "These clinical trial groups began to be too individualized and did not bring other research needs into play."
Although Ms. Lehrman said NIH funding had no effect on the decision to restructure the agency's research method, Michael Flemming, executive director of the David Bohnett Foundation, a social activist organization in California, said: "The rationale behind the initiative is that there isn't enough money to fund 32 clinical trial sites across the country."
The clinical trial units to be eliminated provide about 3,000 HIV-positive patients with free AIDS medications that are in the process of being brought to the market.
Funding cuts to the clinical trial groups will likely force 10 of the 32 AIDS clinical trial units in the United States to close at the beginning of next year. Sites in New York City; Los Angeles; Philadelphia; Dallas; Galveston, Texas; Honolulu; Minneapolis; Omaha, Neb.; Sacramento, Calif.; Indianapolis; and Providence, R.I., are slated for funding cuts that will likely force the units to close.
"Site closures and funding cuts will delay or halt advancement and further progress of HIV science. This is a giant step backwards and basically means more people will become ill and die," said Eric Lawrence, co-chairman of the Network Community Advisory Board, a splinter group of the AIDS Clinical Trial Group, which is funded by NIH and oversees the clinical trial units.
Mr. Lawrence said the number of people eligible for the clinical trials will be reduced to about 1,000 after the 10 locations are closed.
Georgetown University, which runs one of the clinical trial units in conjunction with the University of Pittsburgh, was given notice that it will receive funding for clinical trials for the next seven years but that the funding will be significantly reduced.
"The new funding structure will have an effect on patient care costs," said Joseph Timpone, director of clinical research in Georgetown's division of infectious disease. "We are going to have to scrutinize the type of studies we accept for clinical trials to see if they are feasible, given the funding NIH is giving out."
Nearly 800,000 people in the United States are HIV positive or have AIDS, according to the Centers for Disease Control and Prevention.
Planning for the restructuring of NIH's AIDS research program began in October 2001 after extensive consultations with researchers, clinicians, nurses, patient advocates and people living with or at risk for developing HIV/AIDS, according to the NIH.
Note from Jules Levin: I was a member of the HIV RAC Committee in the ACTG for 4-5 years, and played roles in jump-starting discussions and initiating study of key concerns fat redistribution, hepatitis coinfection, and women's issues. Perhaps studies designed to better address patient's current and future needs and concerns would have saved funding for the ACTG. Particular complications including hepatitis C and B coinfection, diabetes, fat redistribution, women's research issues, heart disease, and aging with HIV, are major areas of concern; these areas could use well designed studies to answer important and unique questions. Would better designed studies addressing these needs helped to save funding for the ACTG? Perhaps not. Money and emphasis has switched to the international crisis due, but I think better studies may have saved funding. Could ACTG leadership have been more creative and broader and futuristic in their thinking towards designing more interesting studies? I think so. Are the times changing due to advocacy and politics regarding international issues? Yes. Will US patients lose out? Yes. Many patients received care through their involvement in studies at ACTG sites, but that was part of their agreement to participate in an ACTG study. Unfortunately, the overall quality of HIV care in the USA is in general not very good. The system is overwhelmed, particularly in big cities; doctors and care providers do not have the time to prepare patients for care and treatment; the patient population is poor and not well educated so as is the case in the US with regards to diabetes and heart disease, the poor and uneducated do not get the care they need.
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