But my gut told me the inconceivable was about to take flesh. Sure enough LRB turned down the review. Because, they said, their readers would be baffled by it — piquant given that LRB specializes in complex reviews of the esoteric and the obscure. But it needs something like this to flag up how perilous our position is and how paradoxical — seemingly beyond the capacity of the editors of LRB to follow. The review Ben Goldacre made his name with an earlier book Bad Science.
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But my gut told me the inconceivable was about to take flesh. Sure enough LRB turned down the review. Because, they said, their readers would be baffled by it — piquant given that LRB specializes in complex reviews of the esoteric and the obscure. But it needs something like this to flag up how perilous our position is and how paradoxical — seemingly beyond the capacity of the editors of LRB to follow.
The review Ben Goldacre made his name with an earlier book Bad Science. Bad Pharma is equally well written. It will be accessible to anyone interested in health and its politics.
It strikes the right note of outrage. It tackles the problems pharmaceutical companies pose to medical care and Evidence Based Medicine. The risk is that the solutions it proposes will aggravate rather than resolve our problems.
Data gone missing The central problem it targets in the opening section is the clinical trial data missing in company vaults. The more of this data academics like Peter Doshi and Tom Jefferson have got hold of the more questionable this decision to buy the drug has looked. Regulatory capture The next section deals with what is widely called regulatory capture. After outlining how RCTs and EBM should work, Ben offers a compendium of ways in which companies game RCTs including selected reporting, selected patients, and selected comparators, in trials that are too short, too long or too small, that yield outcomes that are surrogate, composite, incomplete, or stem from subgroup analysis, with clinicians misled by talk of dramatic relative risk reductions when the absolute risk reduction is close to non-existent.
It outlines how advertising to patients works, how companies recruit celebrities to endorse products, sell diseases to sell medication, create patient groups, and employs PR agencies to get their message out and bury their critics. It covers drug adverts in medical journals, the tune to which journals profit from drug company articles, the corrupting power of trinkets and free lunches, how sales reps track the personalities of doctors, and how companies like IMS Health sell data on the scripts that doctors write so companies know exactly what pitch will work with your doctor.
This leads to the knotty issue of conflict of interest. He draws complex distinctions between situations and behaviors, and the merits of greater or lesser puritanism, and to his credit is not an extreme puritan. The wrap The book ends with a scene, a question and a plea. The question is, how will industry respond to the challenge he poses? The plea is to any of us who have any other ideas on how to solve all this, to let him know.
Where is the problem in re-iterating it eloquently? The central problem is the premium Ben puts on controlled trials not found in other books. It confuses sales for marketing.
Marketing means understanding doctors better than they understand themselves, and shaping their thinking so that the drug becomes the unquestioned answer to any problem a doctor faces. There is no better way to do this than with clinical trials in eminent journals. Bad Pharma cites all the research showing that companies get the results they pay for but ignores the research showing that on all quality metrics, whether adequacy of trial design, transparency of procedures, or declaration of conflicting interests, industry trials routinely come out better than academic studies.
Doctors say they follow the evidence. Ben believes they are influenced by the gifts sales , and would prefer them to be influenced by the evidence. Andrew believes that swayed by books like Bad Pharma, doctors are increasingly influenced by the evidence marketing. Andrew uses gifts as decoys. Bad Pharma spots the sneaky little sales gnats and swallows the marketing camel, and while the advocates of evidence based medicine do just this, the only outcome can be growing perplexity at worsening indigestion and ever shriller calls for more regulation and policing of conflicting interests — which pleases Andrew.
Regulation Bad Pharma calls for more regulations but the more regulations there are the stronger industry becomes. This is elementary good sense. But when a strong thief comes along he picks up the whole lot, puts it on his back, and goes on his way with only one fear; that ropes, locks and bolts may give way. These were later adopted everywhere else. They had three critical components to them: 1.
Congressional staffers in had demonstrated that process patents led to more innovation in pharmaceutical development and produced cheaper drugs than product patents but instead the Germans were persuaded to change to product patents.
Universal product patents laid the basis for the development of blockbuster drugs pioneered by Glaxo two decades later. Blockbusters are drugs that earn a billion dollars or more per year for a company.
They are not life-saving compounds. They are highly marketable products that are literally worth more than their weight in gold. This distorts company priorities. It puts a premium on hyping the benefits and concealing the hazards of a few unimportant drugs like: Prozac for depression, Lipitor for cholesterol lowering, and Fosamax for osteoporosis, all of which we could have easily managed without. But companies can now go out of business if a significant hazard of their blockbuster comes to light.
So company ingenuity is funneled into hiding hazards. Bad Pharma is silent on the role of patents in creating this perverse incentive. But prescription-only was a mechanism designed to control addicts and it makes doctors rather than their patients the consumers of medicines.
When they slip on the Ring of Prescription Privileges, doctors become visible to Eye of Sauron and shrivel. Ditto with tobacco and alcohol. In contrast, the significant hazards of prescription drugs now take 15 — 20 years to be accepted.
The combination of trials and prescription-only status has fashioned doctors into a risk-laundering service for companies. Bad Pharma mentions nothing about this. Louis Lasagna was the Ben Goldacre of his day. He was the first Professor of Clinical Pharmacology, the author of the version of the Hippocratic Oath that many doctors take on qualifying, and one of the earliest exponents of controlled trials.
In , almost by accident, he slipped the use of controlled trials as a test for efficacy into the FDA amendments and set us on the road to tragedy. Regulations up till had been about safety. Forcing companies to show a drug worked for something was intended as an additional safety step.
All of a sudden this new scientific tool, whose uses and quirks are still not fully understood, became a tickbox for bureaucrats — if there are some positive studies regulators can let a drug on the market and no-one can criticize them afterwards no matter what goes wrong. This is the point at which Bad Pharma makes a category mistake. It treats a box ticking exercise as though this could inform the practice of medicine. Regulators deal with both food and drugs.
All they want is a way, in the case of food, of determining if this yellow slab that could be lard colored to look like butter meets criteria for butter. If it does they can let companies label their product as butter. For drugs, the criterion is two positive trials. These regulations were not designed to have anything to do with the practice of medicine, they regulate adverts. The FDA in the US, along with regulators in the UK and elsewhere, are ticking boxes perfectly well — and as the law stands cannot do otherwise.
It is hardly surprising that pharma have found many ways around the regulations. Consumer groups and physicians step up to the plate when it comes to butter but not when it comes to medicines. Introducing trials into the regulatory apparatus has created a mess. This can rein in the unscrupulous huckster, the credulous physician and protect the vulnerable patient. But RCTs can also be unhelpful. For many conditions they simply do not produce a meaningful outcome.
Rather than being used as initially intended — to first do no harm — trials have given rise to an efficacy fetish.
As a result we are now all put on an increasing number of drugs that have been approved by regulators and there seems to be no way to limit the number of drugs we end up on. End up on because these drugs that work have not been shown to save lives. The result is that drug induced death is now the third leading cause of death. This is a tragedy of mythic proportions.
RCTs tell us almost nothing about cause and effect. They discover nothing. They likely block the discovery of many treatments. But for the fact that Barry Marshall in took a laboratory rather than a clinical trials approach to showing ulcers were caused by h pylori and could be cured by antibiotics, Glaxo would have used RCTs to bury the evidence that antibiotics cure ulcers to defend the very first blockbuster drug, their H2 antagonist for ulcers, Zantac.
More generally in a page book about treating illnesses and drugs, Bad Pharma has only 3 pages that come close to dealing with biology, even though biology is the primary driver of the superficial associations that controlled trials throw up.
This element restricted companies to selling medicines to doctors for diseases only. In , no-one foresaw that if constrained in this way companies would convert what had been a series of vicissitudes of everyday life and normal variation in terms of beauty and functionality into a set of diseases.
And so we have all become depressed, osteoporotic, with hypercholesterolemia where otherwise we might have had burn-out, aging bones that could be managed by exercise, and a diet-related issue that is only significant against a background of more important cardiac risk factors. Companies now speak the language of medicine to an extent that doctors fail to appreciate. Not only have vicissitudes been transformed into illnesses, but acute illnesses have become chronic and the moral imperative to treat that is brought to tuberculosis has been co-opted to sell products for restless legs and fibromyalgia.
In , the drive was to temper patient enthusiasm for treatment with medical skepticism. Fifty years later skeptical patients try in vain to temper the zeal of doctors following the supposed evidence embodied in the latest guideline based on published trials. Fixing a bad system Bad Pharma describes the superficial features of the problem but it fails to analyze how we got here.
It just assumes Pharma is Bad and that everything else follows from this. This analysis in contrast appeals to an historical moment — things that might have been otherwise. Some might argue the insertion of controlled trials into drug regulation was an accident waiting to happen.
Others might say this is an unparalleled demonstration of the perils of interfering with the market. Whatever frame you opt for, the result is the strangest market on earth in which mega-corporations spouting a rhetoric of market freedom operate in a totalitarian way to control the least free market ever seen.
Ben locates missing data as the key problem and access to the data as the solution. This is a hot issue in Europe with the British Medical Journal leading a campaign for access to clinical trial data. Is Andrew feeling nervous?
Not So Bad Pharma
This unpicked the claims of several forms of alternative medicine, and criticized certain physicians and the media for a lack of critical thinking. Unsurprisingly, these trials tend to produce results that favour the manufacturer. 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.
Bad Pharma by Ben Goldacre – review