apollojet

“The most notorious story is the Trovan antibiotic study conducted by Pfizer in Kano, Nigeria, during a meningitis epidemic. An experimental new antibiotic was compared, in a randomised trial, with a low dose of a competing antibiotic that was known to be effective. Eleven children died, roughly the same number from each group. Crucially, the participants were apparently not informed about the experimental nature of the treatments, and moreover, they were not informed that a treatment known to be effective was available, immediately, from Médecins sans Frontières next door at the very same facility. Pfizer argued in court – successfully – that there was no international norm requiring it to get informed consent for a trial involving experimental drugs in Africa, so the cases relating to the trial should be heard in Nigeria only. That’s a chilling thing to hear a company claim about experimental drug trials, and it was knocked back in 2006 when the Nigerian Ministry of Health released its report on the trial. This stated that Pfizer had violated Nigerian law, the UN Convention on the Rights of the Child and the Declaration of Helsinki.”
― Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients

“So what steps can a regulator take when it has established that there is a problem? In very extreme cases it can remove a drug from the market (although in the US, technically drugs usually stay on the market, with the FDA advising against their use). More commonly it will issue a warning to doctors through one of its drug safety updates, a ‘Dear Doctor’ letter, or by changing the ‘label’ (confusingly, in reality, a leaflet) that comes with the drug. Drug-safety updates are sent to most doctors, though it’s not entirely clear whether they are widely read. But, amazingly, when a regulator decides to notify doctors about a side effect, the drug company can contest this, and delay the notice being sent out for months, or even years.”
― Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients