3 ms·

The article does a bad job of explaining what the Cochrane report finds to be flawed about the clinical trials.

by motbob 13y ago

gwern 13y ago
It's hard to tell because the latest version of "Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children" doesn't seem to be out (just the 2012) version, and the OP's citation breaks on the wiley site! Even Cochrane's own materials aren't very clear. The best seems to be http://www.cochrane.org/features/neuraminidase-inhibitors-preventing-and-treating-influenza-healthy-adults-and-children http://www.cochrane.org/features/neuraminidase-inhibitors-pr... "Questions about the accuracy of these claims and the efficacy of both preparations prompted an international team of researchers, led by Dr Tom Jefferson, a Cochrane Review author and independent epidemiologist based in Rome, Italy, to examine newly available evidence and amalgamate two previously published Cochrane Reviews focusing on the efficacy of these interventions into one comprehensive, updated review, published in the January 2012 issue of The Cochrane Library. In carrying out this research, the Cochrane team was reluctant to focus their efforts on published trial reports available in scientific journals, because while many trials have been conducted around the world, only a few have been published. “We identified that a large number of studies, including data from 60% of the people who have been involved in randomised, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir that on its own included just over 1,400 people of all ages,” noted Jefferson. "We are concerned that these data remain unavailable for scrutiny by the scientific community." Following a public pledge by the manufacturer of oseltamivir, Roche, to make full study reports available to scientific investigators, the Cochrane team decided to focus instead on manufacturers’ clinical study reports (typically submitted to regulators) and regulators’ comments. They called reports and comments “regulatory information”. Availability of documents generated by national and regional regulatory bodies during licensing processes in the UK, USA, continental Europe and Japan, along with partial trial reports from the manufacturer of oseltamivir, Roche, and from the European regulator European Medicines Agency (EMA), enabled the researchers to verify information from the trials. When the team compared published data with the more complete unpublished trial records, they found apparent inaccuracies in the published record of the trials. For example, while unpublished trial reports mentioned serious adverse events (some even classified as possibly related to oseltamivir), one of the two most cited publications makes no mention of such effects, and the other states “... there were no drug-related serious adverse events”. Having pieced together information from more than 16,000 pages of clinical trial data and documents used in the process of licensing oseltamivir, the Cochrane team raises critical questions about how well the drug works, as well as about its reported safety profile. While the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment. Results from the reanalysis of data also raise questions about how the drug works as an influenza virus inhibitor."
nairteashop 13y ago
I believe this is the news release from Cochrane that the BBC article is based on. There is more detail there on why they believe Tamiflu is ineffective: http://www.cochrane.org/features/tamiflu-relenza-how-effective-are-they http://www.cochrane.org/features/tamiflu-relenza-how-effecti...

The article does a bad job of explaining what the Cochrane report finds to be flawed about the clinical trials.

by motbob 13y ago

The article does a bad job of explaining what the Cochrane report finds to be flawed about the clinical trials.

gwern 13y ago

It's hard to tell because the latest version of "Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children" doesn't seem to be out (just the 2012) version, and the OP's citation breaks on the wiley site! Even Cochrane's own materials aren't very clear. The best seems to be http://www.cochrane.org/features/neuraminidase-inhibitors-preventing-and-treating-influenza-healthy-adults-and-children http://www.cochrane.org/features/neuraminidase-inhibitors-pr... "Questions about the accuracy of these claims and the efficacy of both preparations prompted an international team of researchers, led by Dr Tom Jefferson, a Cochrane Review author and independent epidemiologist based in Rome, Italy, to examine newly available evidence and amalgamate two previously published Cochrane Reviews focusing on the efficacy of these interventions into one comprehensive, updated review, published in the January 2012 issue of The Cochrane Library. In carrying out this research, the Cochrane team was reluctant to focus their efforts on published trial reports available in scientific journals, because while many trials have been conducted around the world, only a few have been published. “We identified that a large number of studies, including data from 60% of the people who have been involved in randomised, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir that on its own included just over 1,400 people of all ages,” noted Jefferson. "We are concerned that these data remain unavailable for scrutiny by the scientific community." Following a public pledge by the manufacturer of oseltamivir, Roche, to make full study reports available to scientific investigators, the Cochrane team decided to focus instead on manufacturers’ clinical study reports (typically submitted to regulators) and regulators’ comments. They called reports and comments “regulatory information”. Availability of documents generated by national and regional regulatory bodies during licensing processes in the UK, USA, continental Europe and Japan, along with partial trial reports from the manufacturer of oseltamivir, Roche, and from the European regulator European Medicines Agency (EMA), enabled the researchers to verify information from the trials. When the team compared published data with the more complete unpublished trial records, they found apparent inaccuracies in the published record of the trials. For example, while unpublished trial reports mentioned serious adverse events (some even classified as possibly related to oseltamivir), one of the two most cited publications makes no mention of such effects, and the other states “... there were no drug-related serious adverse events”. Having pieced together information from more than 16,000 pages of clinical trial data and documents used in the process of licensing oseltamivir, the Cochrane team raises critical questions about how well the drug works, as well as about its reported safety profile. While the drug did reduce the time to first alleviation of symptoms by an average of 21 hours, it did not reduce the number of people who went on to need hospital treatment. Results from the reanalysis of data also raise questions about how the drug works as an influenza virus inhibitor."

nairteashop 13y ago

I believe this is the news release from Cochrane that the BBC article is based on. There is more detail there on why they believe Tamiflu is ineffective: http://www.cochrane.org/features/tamiflu-relenza-how-effective-are-they http://www.cochrane.org/features/tamiflu-relenza-how-effecti...