5
" 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
14
" Some have estimated that the pharmaceutical industry overall spends about twice as much on marketing and promotion as it does on research and development. Regardless of how those two figures compare to each other, the fact that they are in the same ballpark gives one pause, and this is worth mulling over in various contexts. For example, when a drug company refuses to let a developing country have affordable access to a new AIDS drug it’s because – the company says – it needs the money from sales to fund research and development on other new AIDS drugs for the future. If R&D is a fraction of the company’s outgoings, and it spends a similar amount on promotion, then this moral and practical argument doesn’t hold water quite so well. The scale of this spend is fascinating in itself, when you put it in the context of what we all expect from evidence-based medicine, which is that people will simply use the best treatment for the patient. Because when you pull away from the industry’s carefully fostered belief that this marketing activity is all completely normal, and stop thinking of drugs as being a consumer product like clothes or cosmetics, you suddenly realise that medicines marketing only exists for one reason. In medicine, brand identities are irrelevant, and there’s a factual, objective answer to whether one drug is the most likely to improve a patient’s pain, suffering and longevity. Marketing, therefore, one might argue, exists for no reason other than to pervert evidence-based decision-making in medicine. "
― Ben Goldacre , Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
16
" 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
17
" So should patients born under Libra and Gemini be deprived of treatment? You would say no, of course, and that would make you wiser than many in the medical profession: the CCSG trial found that aspirin was effective at preventing stroke and death in men, but not in women;30 as a result, women were undertreated for a decade, until further trials and overviews showed a benefit. That is just one of many subgroup analyses that have misled us in medicine, often incorrectly identifying subgroups of people who wouldn’t benefit from a treatment that was usually effective. So, for example, we thought the hormone-blocking drug tamoxifen was no good for treating breast cancer in women if they were younger than fifty (we were wrong). We thought clotbusting drugs were ineffective, or even harmful, when treating heart attacks in people who’d already had a heart attack (we were wrong). We thought drugs called ‘ACE inhibitors’ stopped reducing the death rate in heart failure patients if they were also on aspirin (we were wrong). Unusually, none of these findings was driven by financial avarice: they were driven by ambition, perhaps; excitement at new findings, certainly; ignorance of the risks of subgroup analysis; and, of course, chance. "
― Ben Goldacre , Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
18
" different subject. The story of the serotonin hypothesis for depression, and its enthusiastic promotion by drug companies, is part of a wider process that has been called ‘disease-mongering’ or ‘medicalisation’, where diagnostic categories are widened, whole new diagnoses are invented, and normal variants of human experience are pathologised, so they can be treated with pills. One simple illustration of this is the recent spread of ‘checklists’ enabling the public to diagnose, or help diagnose, various medical conditions. In 2010, for example, the popular website WebMD launched a new test: ‘Rate your risk for depression: could you be depressed?’ It was funded by Eli Lilly, manufacturers of the antidepressant duloxetine, and this was duly declared on the page, though that doesn’t reduce the absurdity of what followed. The test consisted of ten questions, such as: ‘I feel sad or down most of the time’; ‘I feel tired almost every day’; ‘I have trouble concentrating’; ‘I feel worthless or hopeless’; ‘I find myself thinking a lot about dying’; and so on. If you answered ‘no’ to every single one of these questions – every single one – and then pressed ‘Submit’, the response was clear: ‘You may be at risk for major depression’. "
― Ben Goldacre , Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
20
" Like many doctors, I was frankly traumatized by some of the experiences I had early on in my career. When you lean over a patient in an emergency room, trying to bring a dead body back to life, you are entirely focused on the job at hand. On the other side of a thin curtain, you can hear that person’s husband or wife howling and wailing, knowing that the person they loved and lived with for fifty years is dying, begging the staff to do all they can, phoning their children, struggling to speak through tears to form the words and communicate the horror, telling them to come, quickly. I have memories from cubicles that I will never be able to deal with, and they upset me even now. "
― Ben Goldacre , Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
