While the greater part of clinical trials are started with the true objective of NDA endorsement in the US and in Western Europe, most by far of potential review subjects live outside of these areas.
Ben Goldacre After graduating in with a first-class honours degree in medicine from Magdalen College, OxfordGoldacre obtained an MA in philosophy from King's College Londonthen undertook clinical training at UCL Medical Schoolqualifying as a medical doctor in and as a psychiatrist in Pharma industry growth unpicked the claims of several forms of alternative medicine, and criticized certain physicians and the media for a lack of critical thinking.
Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.
When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects.
Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government.
This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals.
And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company.
Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all. For example, in a journal article published in PLOS Medicineresearchers studied every published trial on statinsdrugs prescribed to reduce cholesterol levels.
In the trials they looked at, industry-funded trials were 20 times more likely to produce results that favoured the drug. Sometimes the industry-sponsored studies are flawed by design for example by comparing the new drug to an existing drug at an inadequate doseand sometimes patients are selected to make a positive result more likely.
In addition, the data is analysed as the trial progresses. If the trial seems to be producing negative data it is stopped prematurely and the results are not published, or if it is producing positive data it may be stopped early so that longer-term effects are not examined.
He writes that this publication biaswhere negative results remain unpublished, is endemic within medicine and academia. As a consequence, he argues, doctors may have no idea what the effects are of the drugs they prescribe. Governments spent billions of pounds stockpiling this, based in large part on a meta-analysis that was funded by the industry.
Bad Pharma charts the efforts of independent researchers, particularly Tom Jefferson of the Cochrane Collaboration Respiratory Group, to gain access to information about the drug.
The rate of growth for clinical trials in India is 20 percent a year, in Argentina 27 percent, and in China 47 percent, while trials in the UK have fallen by 10 percent a year and in the US by six percent.
There are both social and physical differences: Goldacre asks whether patients diagnosed with depression in China are really the same as patients diagnosed with depression in California, and notes that people of Asian descent metabolize drugs differently from Westerners.
In in Kano, Nigeriathe drug company Pfizer compared a new antibiotic during a meningitis outbreak to a competing antibiotic that was known to be effective at a higher dose than was used during the trial.
Goldacre writes that 11 children died, divided almost equally between the two groups. Goldacre writes that this happens for a number of reasons, including the revolving door of employees between the regulator and the companies, and the fact that friendships develop between regulator and company employees simply because they have knowledge and interests in common.
The chapter also discusses surrogate outcomes and accelerated approvaland the difficulty of having ineffective drugs removed from the market once they have been approved.
Goldacre writes that this happens by design and by analysis, and that it has the effect of maximizing a drug's benefits and minimizing harm.
There have been instances of fraud, though he says these are rare. More common are what he calls the "wily tricks, close calls, and elegant mischief at the margins of acceptability. For example, he writes, if four people out of 1, will have a heart attack within the year, but on statins only two will, that is a 50 percent reduction if expressed as relative risk reduction.
But if expressed as absolute risk reductionit is a reduction of just 0. For example, to compare two statins, atorvastatin and simvastatindoctors would randomly assign patients to one or the other.
The patients would be followed up by having data about their cholesterol levels, heart attacks, strokes and deaths taken from their computerized medical records.
He cites as examples the statins atorvastatin Lipitor, made by Pfizer and simvastatin Zocorwhich he writes seem to be equally effective, or at least there is no evidence to suggest otherwise. Female sexual dysfunction was highlighted in by a study published in the Journal of the American Medical Association, which alleged that 43 percent of women were suffering from it.
After the article appeared, the New York Times wrote that two of its three authors had worked as consultants for Pfizer, which at the time was preparing to launch UK,known as female Viagra.D2L Pharma Research Solutions is a leading force in opinion leader engagement.
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Patients and physicians (and the rest of the world) have embraced digital tools for learning and connecting with one another; the pharmaceutical industry’s commercial and . Guest post by Matthew Arnold of DRG Digital This year’s Digital Pharma East conference was a buffet of food for thought about digital health and pharma — we’re still recovering!