GESTIÓN EN SALUD PÚBLICA: Oxford researchers accused of giving babies unsafe TB drug

domingo, 17 de septiembre de 2017

Oxford researchers accused of giving babies unsafe TB drug

Oxford researchers accused of giving babies unsafe TB drug

Bioedge

Oxford researchers accused of giving babies unsafe TB drug

by Xavier Symons | 16 Sep 2017 |

A team of Oxford University researchers have been accused of deception and misconduct during a large-scale tuberculosis trial on African infants that began in 2009.

Professor Peter Beverley, a former senior academic at Oxford, told the BBC that scientists tested a new tuberculosis vaccine on more than a thousand infants without sharing data suggesting that monkeys given the immunisation “die rapidly”.

According to Beverley, the new vaccine, known as MVA85A, was trialled on six monkeys 10 months before a funding application was made for the clinical trial on over 2,800 babies near Cape Town, South Africa.

The preclinical monkey trial involved over a dozen monkeys who had been infected with TB. One group was given the widely used Bacillus Calmette-Guérin (BCG) jab (a standard immunisation), the second was given no immunisation and a third was given BCG plus new vaccine. By the time the human trials began, five out of six of those that received the BCG jab and the new booster vaccine together had to be put down, while just two out of the six monkeys who received only the BCG injection had died.

Despite this, an information sheet given to families in South Africa participating in the trial said the vaccine had been tested on animals and humans and was “safe and effective” in animals.

An inquiry at the University found that there had been no wrongdoing, though the report stated that it “would have been good practice for the potentially adverse reaction observed in the monkey experiment to be reported to the authorities in a more timely fashion.”

Sunday, September 17, 2017

For better or worse, this week’s newsletter seems largely dedicated to topics revolving around euthanasia. Belgium’s system is finally getting the close critical scrutiny it deserves in a new collection of essays from Cambridge University Press.

Coincidentally, the doyen of euthanasia there, Dr Wim Distelmans, has just released statistics about child euthanasia. “Nothing to see here; please move along,” seems to be his message. In three years, only two children have been euthanised. Perhaps that is an index of how normal euthanasia has become in his country.

Assisted dying is a hot topic, too, in Australia, in the states of Victoria and New South Wales. BioEdge has organised a free forum on NSW’s Voluntary Assisted Dying Bill on this coming Thursday in Sydney. It will be held at Parliament House, on Macquarie Street, from 9.30am to 12.30pm. A number of medical and legal experts will be discussing the possibility of legal euthanasia in New South Wales. For more details, please check our Facebook page.