0329 GMT September 23, 2018
Hundreds of children took part in three potentially risky government drug trials, but Public Health England (PHE) breached the law by failing to add the findings to the official register set up to allow the scientific community to scrutinize the outcomes, telegraph.co.uk reported.
Experts have accused PHE of an ‘incomprehensible’ violation of the trust of parents who gave their consent for their children to take part in the tests.
The largest trial involved 640 participants under the age of 16 whose parents gave consent for them to be selected at random to try a new meningococcal and whooping cough booster vaccine.
While dangerous side-effects in a trial at this stage are rare, a risk does exist. Participants also take a gamble by offering themselves up for selection for a new drug which might not protect them as well as the standard therapy.
The trial concluded in 2016, but the results have not yet appeared on the EU Clinical Trials Register (EUCTR), in breach of EU law which requires registration within 12 months, nor published anywhere else.
The failure to register means there is currently no way for the public to know how those children fared.
Last night Dr. Ben Goldacre, the Oxford academic whose analysis revealed the PHE omission, told The Sunday Telegraph: “It is incomprehensible to me that Public Health England of all the trials it could leave unreported to have failed to comply with the legal requirements to report trials of vaccines.
“When patients participate and they take a risk with their own health. We have to respect their contribution by publishing the results properly. If we don’t, that is a betrayal of trust.”
The EUCRT was set up partly to counter the tendency of many scientific journals, which is the traditional mode of publication, to polish the results, downplaying the therapies that failed.
The transparency it affords is supposed to promote confidence in science at a time where the ‘anti-vax’ movement, those who argue vaccines are useless and actually cause disease, is buoyant.
Andrew Wakefield, the discredited British doctor whose fraudulent research prompted a scare that the MMR vaccine causes autism, is enjoying widespread support in the US and a boost from sympathetic comments by President Trump.
“Withholding the results of a clinical trial makes a mockery of all our efforts to promote trust in medicine, and I’m particularly sad to see vaccine trials going unreported,” said Dr. Goldacre.
A second PHE trial, which concluded in 2010, investigated effectiveness of a meningitis C vaccine in a group of 130 one-year-olds, while a third, which concluded in 2011, involved 75 adults trialing a meningitis B vaccine.
PHE said the results of these studies had been published in academic journals, while results of the larger 640-patient trial are “still being analyzed”.
The omissions by PHE forms part of a bigger picture of widespread disregard for the registration law.
Dr. Goldacre’s research via his EU.trialstracker.net website shows that over the 7,274 trials where results have been due, only 49.5 percent reported the results.
However, no organization has ever been sanctioned for breaching the law.