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EU new drug approval studies "have too few patients to evaluate safety"

For medicines intended for chronic use, the number of patients studied before regulatory approval in the European Union (EU) is insufficient to properly evaluate safety and long-term efficacy, and this points to a need for new EU legislation, say researchers writing in this week's PLOS Medicine.

Published
12 hours ago
From
Pharma Times
Testing HIV Prevention Tools: Other Ways Up the Alley

We need to design prevention trials that ask, “Is this test product better than nothing?” rather than, “Is this test product better than the best available prevention combination we have?”

Published
15 March 2013
From
Poz
Panel Urges NIH to Reduce HIV, Hep C Research on Primates

The National Institutes of Health (NIH) should reduce its use of chimpanzees for medical research, according to an NIH-commissioned working group.

Published
06 February 2013
From
Poz magazine news
HIV trial under scrutiny

A potential breakthrough in the quest to prevent HIV and AIDS has collided with sensitivities about testing expensive drugs in poor parts of the world.

Published
17 January 2013
From
Nature.com
Industry Funding Changes Study Results, Research Shows

Drugs and medical devices tend to appear more beneficial in scientific papers if they were manufactured by the company that sponsored the study, showing that who pays for the clinical trial has a direct impact on the reported outcome, according to a new analysis by researchers at UCSF and the Cochrane Collaboration.

Published
20 December 2012
From
University of California press release
Low-dose stavudine study debated between South African researchers and activists

A proposed trial of low-dose stavudine (also known as d4T) sparked a heated debate between South African researchers and activists at the opening of the first Southern

Published
11 December 2012
By
Lesley Odendal
As drug industry’s influence over research grows, so does the potential for bias

Arguably the most prestigious medical journal in the world, the New England Journal of Medicine regularly features articles over which pharmaceutical companies and their employees can exert significant influence.

Published
26 November 2012
From
Washington Post
Doctors tread warily over insider trading

Two years ago US authorities arrested and charged Yves Benhamou, a French doctor, with insider trading linked to passing on his confidential knowledge of clinical trials of Albuferon, a hepatitis drug. That was one of a growing series of criminal investigations in the healthcare sector, many of which start with connections via “expert networks”, essentially companies which convene meetings, for a fee, between investors and medical experts.

Published
24 November 2012
From
Financial Times
New fixed-dose combination pills measure up to Atripla - corrected version*

Several studies, or updates of studies, comparing newer against older drug regimens were presented at the Eleventh International Congress on Drug Therapy in HIV Infection last week.

Published
20 November 2012
By
Gus Cairns
(PrEP) The ANRS-IPERGAY study should be discontinued : prevention research in France is in disarray

French HIV prevention activist group The Warning has issued a press release saying that the placebo arm of the French IPERGAY randomised controlled study of intermittent PrEP should be dropped. This is in response to a 31 October press release by the French National HIV Research Agency, ANRS, that said it should continue - see http://public.adequatesystems.com/pub/link/203893/034296629555571351674647159-anrs.fr.html . The Warning's position does not reflect the position of other French community organisations, which take positions from support of the IPERGAY trial as it is, to demanding PrEP be made available alongside the trial, to total rejection of it. See http://www.ipergay.fr/Les-avis-des-comites-sur-la-poursuite-de-l-essai-Ipergay_a91.html for a sumary of community reports to the trial co-ordinators (in French).

Published
09 November 2012
From
The Warning
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