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How to Keep HIV Cure-Related Trials Ethical: The Benefit/Risk Ratio Challenge

While high or unknown risks are a mainstay of early-phase trials in areas like cancer research, cure study participants typically have a safe and efficacious alternative to those risks: remaining on antiretrovirals. Can we justify asking patients who are doing well on antiretrovirals to accept the risk and uncertainty of many HIV cure-related trials? If we cannot, we might need to give up on the hope of curing HIV, or of achieving controlled remission.

Published
22 February 2017
From
BMJ Blogs
New NNRTI doravirine shows good efficacy in phase 3 study

Doravirine, an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) from Merck, reduced HIV viral load as well as boosted darunavir in a phase 3 clinical trial of

Published
19 February 2017
By
Liz Highleyman
Vaccine trial: Community trust is key

Dr. Linda-Gail Bekker knows from more than 20 years in the field that researchers have to work hand in hand with the communities most affected if they want to halt an epidemic. And the townships are ground zero for HIV/AIDS in Cape Town.

Published
17 February 2017
From
Fred Hutch
Pharma industry shuns Trump push for radical shift at FDA

President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.

Published
15 February 2017
From
Reuters
In the search for an HIV cure, David Evans explains “freedom” and how to better involve women & people of color

David Evans, director of research advocacy at Project Inform, talks about an ambitious HIV cure social science research project that will investigate some of the ethical and moral dilemmas cropping up in HIV cure research.

Published
09 February 2017
From
BETA blog
Trump wants to blow up the FDA. The drug industry? Not so much.

President Donald Trump wants to remake the Food and Drug Administration. But does anyone really want a deregulated FDA? STAT canvassed biopharma insiders, physicians, Wall Street analysts, and FDA veterans. Their verdict: Trump’s plan sounds like a solution in search of a problem.

Published
01 February 2017
From
STAT
The FDA Should Approve Drugs Based on Evidence, Not Emotions

A new bill and Donald Trump could come together to undermine the FDA’s ability to safeguard the public from dangerous new drugs.

Published
15 December 2016
From
Slate
Winners and Losers in the 21st Century Cures Act

Obama signs the biggest health legislation since the Affordable Care Act. What strings are attached?

Published
15 December 2016
From
Poz
Trump is considering a dangerous radical to lead FDA. Here’s why that’s bad news.

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.

Published
12 December 2016
From
STAT
NHS England fudges PrEP access and delays on-demand access to PrEP by years; blocks doctors from prescribing PrEP now

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.

Published
04 December 2016
From
HIV i-Base
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.