A controversial paper published in the 17 October issue of the Journal of the American Medical Association (JAMA) argues that patents in Africa have generally not been a factor in antiretroviral drug treatment access. And similar research by the Pharmaceutical Manufacturers Association (PhRMA) which catalogued the pate
In the United States , long-term studies of HIV-infected and high-risk people have mainly involved gay men--the group most heavily affected in the epidemic s early years. But a continent away, in the Pumwani district of Nairobi, a group of just over 100 women have become well-known to HIV researchers around the world b
On Friday, October 26, the U.S. Food and Drug Administration granted accelerated approval to Gilead s nucleotide analogue reverse transcriptase inhibitor, tenofovir disoproxil fumarate (brand name, Viread ). The labeling requested was for the treatment of HIV-1 infection in combination with other antiretroviral medicin
Weight of evidence On Tuesday, 3 October 2001 a panel assembled by the Antiviral Advisory Committee of the FDA convened to review Gilead s New Drug Application for its nucleotide reverse transcriptase inhibitor, tenofovir (trade name, Viread ). Gilead is requesting accelerated approval for tenofovir, for use in combin
Observing the race between Roche and Schering for FDA approval of the two pegylated interferons (interferon as monotherapy as well as interferon in combination with ribavirin)--and a lion s share of the hepatitis C market--makes the race in the mid-1990s for FDA approval of the HIV
Development Terminated GW420867X/HBY1293 GlaxoSmithKline JAIDS 2000; also summer IAS meeting ALX40-4C Allelix Pharmaceuticals Formulation difficulties, lack of efficacy AMD3100 AnorMed Inc. Cardiac arrhythmias at high doses, lack of efficacy at low PD-178390 Parke-Davis Casualty of
Six years of lost data David Barr revisits the changes to the federal when--to--start recommendations announced earlier this year and urges us to consider both the roots and the ramifications of this extraordinary development. While acknowleding the predicament of a Monday morning quarterback, his words are frank and
Underwhelmingly innovative The International AIDS Society inaugurated its new program of summer research meetings with a sleeper of a gathering in the southern hemisphere port city of Buenos Aires. Mark Harrington attended on behalf of TAG and sifted the new from the old to prepare this report for TAGline. At midwinte
The link between HLA types and HIV disease progression has been known for over a decade now from, among others, analyses of data from the Multicentered AIDS Cohort (MACS). McMichael and colleagues have also documented CTL escape through the mutation of viral peptides which are to be presented by HLA class I (A, B, C) t
Souped-up monotherapy When it comes to the management of a fatal infection like HIV, it has been argued that self-experimentation seldom leads to knowledge. Others in this fix are quick to point out that current approaches to treatment are all just one big experiment, anyway. Opposite ends of an authoritative continuu
Succumbing to exhaustion It s almost too minute and technical to believe. An unheralded tiny viral blip that was to signal the emergence of AZT resistance went unheeded. Harmless enough, it would seem. Then, in an unlikely chain reaction that borders on the complexity of nuclear fission, an Eagle scout of a pill taker
In early April the World Health Organization (WHO) and the World Trade Organization (WTO) held a small, secretive meeting in Hsbjr, Norway , on Differential Pricing and Financing of Essential Drugs. Initially, the meeting was stacked with representatives from the big drug companies, the International Federation of Phar
No drugs in time for her In April, Kofi Annan, the UN Secretary General, said it would take just $7-10 billion a year to mobilize the resources necessary to reverse the ravages not only of HIV, but of tuberculosis and malaria. Also in April, a group of economists, doctors and others from Harvard said that it would tak
Elusive and intangible hope Two days after Kofi Annan gave his speech in Abuja, Nigeria , proposing the creation of the Global Fund, an article appeared on the Associated Press news wire. Experts Worry Vaccine Research Overlooked in AIDS Pandemic. Which experts? Why, pass the envelope, it s Seth Berkley, president of
Mark Harrington writes, As someone who s spent the last twelve years of my life trying to encourage more and better AIDS research, and has worked with community groups to help push Congress and three Presidents to provide more resources for that research, it s profoundly disappointing that the leaders of the research e
Still could fail While a handful of companies are testing or have tested potential HIV vaccines in human volunteers, none of these trials has generated nearly the excitement of the latest announcement from officials at Merck. After shifting its vaccine screening program into overdrive some four years ago, Merck may no
The whole field energized Few monkey studies have attracted more attention than one recently published in Science (20 October 2000). Conducted by Harvard researchers and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), the study showed that monkeys immunized with a DNA vaccine and the
Imperative to go off Every now and again, it s helpful to take a reality check. The day to day world of HIV infection is rarely reflected in the halls of Congress, the plates and wells of biomedical research institutions or even the pages of Science and Nature. As the naval observatory s millennium officially draws to
Don t tell me nothin about no AIDS because that won t impact me. And if I was to get it, all I d have to do is take a pill in the morning and I ll be OK. A 15-year old girl One in every 50 black American men is now infected with HIV. Helene Gayle, Ph.D., Centers for Disease Control and Prevention Source: The Quiet Sc