"If you have a genuine firewall between the editorial and sales sides of your treatment magazine or website, you would be extremely unusual. For most journals and magazines, the pharma marketing people call the shots."
"Tenofovir/FTC Is Superior to Combivir!!" Is this really believable? Or how about "AZT/3TC equals ABC/3TC"?? Of course not. But you are led to those conclusions by the way the clinical trials are designed. There is an old adage, "How do you survive a fall out of the Empire State Building? Jump out the first floor." So too with clinical trials.
Even the researchers admit any definitive conclusions must await more rigorous investigation. But on the eve of World AIDS Day the news of a possible novel, less onerous, and much more affordable approach to the treatment of HIV infection splashed across news sites worldwide. (Well, more in Africa, Asia and Europe than in the U.S. Three days into the weekend announcement, in fact, there was nary a word from the Gray Lady, the Washington Post or even the Wall Street Journal.)
Project Inform, the country's longest serving community-based AIDS treatment information organization, has been sponsoring scientific think tanks on immune restoration since 1992. Their Immune Restoration Think Tank (IRTT) is also known as the 'Dobson Project' in honor of the prime mover behind the early meetings, the widely respected and much-loved San Francisco AIDS activist Jesse Dobson, who died on September 23, 1993. After a hiatus since the last meeting in Chicago in 1999, Project Inform recently held the ninth IRTT at the Nikko Hotel in San Francisco. A full official report of the meeting, including recommendations regarding future research priorities, will be produced by Project Inform and made available on the IRTT section of their website. This article, by Richard Jefferys, will just touch on some of the interesting talks given particularly by immunology researchers attending the meeting.
Boehringer Ingelheim filed its new drug approval applications for tipranavir in the United States and the European Union last month. The plan is to receive U.S. FDA imprimatur by May 2005 and a green light by Europe's EMEA by late summer. Meanwhile, JNJ/Tibotec's protease inhibitor and non-nuke me-toos head into their final lap. (If only they had something innovative and truly useful. But then, the same could be said of BI. Remember when that crazy Kalamazoo outfit was trying to figure out what to do with tipranavir—way back in 1998!) Rob and Mike stitched together this short update.
Popular treatment information resources for doctors and patientsand their reliance on pharmaceutical largesse [final table from September special issue]
The AIDS Vaccines 2004 Conference was held from August 30-September 1 in Lausanne, Switzerland, the first of these meetings to be held outside the US (the first two were in Philadelphia in 2001 and New York City in 2003). Unlike many recent conferences which have concluded without any clear highlights or obvious signature issues to mark them, the Lausanne conference is likely to be remembered for spotlighting several key themes of broad relevance to the AIDS vaccine field.
In early August the FDA announced the approvals of two fixed-dose combination (FDC) antiretroviral drug products. FDCs are combinations of two previously approved drugs (à la the Combivir or Trizivir model) in what is understood to be a more convenient form: in both cases, one pill a day. The two new FDCs are GlaxoSmithKline's Epzicom (abacavir+3TC) and Gilead's Truvada (tenofovir+FTC).
As our translator leaves on indefinite sabbatical, we have temporarily suspended the Spanish translation of TAGline. We apologize to our hispanohablante readership and hope soon to return to a reliable, real-time bilingual service. The silver lining to this otherwise unfortunate turn of events is that it has freed up our middle column for a new follow-on feature which ties into last month's detailed look at Big Pharma's growing stranglehold on the research and care of HIV/AIDS
In a brief July editorial, "Freedom of Choice," UK-based AIDS Treatment Update editor Edwin Bernard captures the essence of the present day therapeutic conundrum. "It's ironic," he writes, "that whilst the main focus of this summer's XV International AIDS Conference in Bangkok was on finding ways to get everyone who needs therapy onto HAART, treatment interruption has become a hot topic in well-resourced countries, as concerns over resistance and side effects are increasingly recognised as issues in managing HIV disease."
The following is the text of an address delivered by Thai AIDS Treatment Action Group director Paisan Suwannawong at the opening ceremony of the 15th International AIDS Conference which took place in Bangkok this summer. Special thanks to Paisan for his permission to reprint.
FDA's Antiviral Advisory Committee (AVAC) membership and ties to industry.
Dancing with the Devil
Who Tests (and Reports on) the Drugs You're Taking—and Formulates Your Treatment?
cf. M Angell, "The Hard Sell… Lures, Bribes, and Kickbacks"
Angell: "It is impossible to know to what extent these financial deals influence judgments about... research priorities or the interpretation of results, but they certainly are cause for concern." TTATDC, p 105
Angell: "You need to know that your doctor's decisions are based solely on what is best for you. And doctors need to be weaned from their dependence on drug company largesse." TTATDC, p 262.
Statins + HAART - Many HIV+ people are currently treated with statins to manage lipid elevations. Understanding the pharmacologic interactions between statins and HIV drugs is essential. Some statins have been implicated more than others in their potential for interactions with antiretroviral therapies.
Building on the success of the First International TB/HIV Community Education and Mobilization Workshop, held in conjunction with the 33rd International Union Against Tuberculosis and Lung Disease (IUATLD) Conference on Lung Health in Montréal in 2003, the Second International TB/HIV Community Education & Mobilization Workshop had the following objectives.
Ann, can you, as a human being, imagine what it is like for a 12-year old boy to die of starvation over a period of weeks, strangled by oral candidiasis, a disease that would have been perfectly curable with fifteen to twenty pills [of Diflucan/ fluconazole] if only his family had been able to buy them?