A new bill and Donald Trump could come together to undermine the FDA’s ability to safeguard the public from dangerous new drugs.
15 December 2016 | Slate
Obama signs the biggest health legislation since the Affordable Care Act. What strings are attached?
15 December 2016 | Poz
Imagine being prescribed a medicine when neither your doctor nor the manufacturer has any clue whether it will actually work — because the government never required it to be tested for effectiveness.
12 December 2016 | STAT
It is difficult to be impressed with this compromise. Rather than meet the real need of people currently at highest risk, it will further delay access to an option to prevent HIV transmission that has clearly passed the criteria for safety, efficacy and effectiveness laid out for other NHS treatments.
04 December 2016 | HIV i-Base
Our team is conducting one of the largest studies to date in Europe, and the first ever in the UK, looking at how the menopause affects the health and wellbeing of women living with HIV.
02 December 2016 | National Institute for Health Research
Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration? The agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials.
22 November 2016 | STAT
Fact sheet explaining the background to the DISCOVER trial
17 November 2016 | AIDS Foundation of Chicago
A group of U.S., Canadian, and European community advocates and HIV NGO workers have written a letter exrpesing "deep dismay" that Gilead Sciences have proceeded with the DISCOVER trial PrEP"without engaging stakeholders in a substantial or meaningful way.". DISCOVER will compared Gilead's new comination pill, Descovy against Truvada as PrEP. In 2007, the HIV/AIDS field adopted Good Participatory Practice (GPP), a formal set of guidelines approved by UNAIDS for stakeholder engagement in HIV prevention clinical trials.
"It is astonishing," says the letter, "that Gilead has failed to follow GPP guidelines in the design and implementation of DISCOVER, since GPP was developed partly as a response to the failure of previous prevention trials involving tenofovir."
17 November 2016 | HIV Prevention Justice Alliance
Gilead is not following the accepted standard for community engagement in its new pre-exposure prophylaxis (PrEP) trial, and we are among a coalition of HIV activists and organizations from Europe and North America calling them out on their bad corporate behavior. We root our criticism in the Good Participatory Practice (GPP) guidelines that were inspired, in part, by controversies in earlier PrEP trials.
17 November 2016 | The Body
Gilead Sciences released this statement after considerable interest and concerns abut the forthcoming study of their new tenofovir formulation, TAF, for use in PrEP. The TAF/FTC pill is called Descovy(R). "Gilead Sciences is sponsoring a clinical trial, known as the DISCOVER study, to test whether a combination of emtricitabine and tenofovir alafenamide (F/TAF) is as safe and effective as Truvada® (emtricitabine and tenofovir disoproxil fumarate, F/TDF) at reducing the risk of HIV infection when used as pre-exposure prophylaxis (PrEP). F/TAF was recently approved for HIV treatment, but it is not yet known whether it is effective as PrEP...."
16 November 2016 | Gilead Sciences