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Thursday, March 7, 2013

Quacks, Hacks, and Big Pharma Flacks Are So "Damned Good"

“I’m going to tell you how medicine works, in one paragraph that will seem so ludicrously appalling that when you read it you’ll probably assume I’m exaggerating...
“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of 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 favor the manufacturer.”
(Ben Goldacre, Bad Pharma: How Drug Companies
Mislead Doctors and Harm Patients, 2013)

Dr. Ben Goldacre, British physician, academic and science writer, is a Wellcome research fellow in epidemiology at the London School of Hygiene and Tropical Medicine. Goldacre has won several awards for his journalism, including:
  •  Association of British Science Writers Award for Best Feature 2003 for his article "Never mind the facts"
  • Association of British Science Writers award for Best Feature 2005 for his article "Don't dumb me down," and
  • Freelance of 2006 at the Medical Journalism Awards
In his new book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, he employs a global perspective to reveal the shocking truth about the drugs that doctors prescribe.
In his work, Goldacre claims thanks to aggressive manipulation from the pharmaceutical companies and passivity from regulators, doctors often don't know that the drugs are ineffective (or harmful) in a majority of their clinical trials.
Goldacre believes it isn't necessarily what you and I know about a drug, that can hurt us. He thinks it is what neither you or I, nor even our doctor, can find out about a drug that can complicate things.

Why Does This Happen?

According to Goldacre...
* Because pharma companies set up their trials so that they have the right to terminate ones that look unpromising
* Because pharma companies use "poorly designed trials on hopelessly small numbers of weird, unrepresentative patients" (Sometimes patients even drop out of them and are never factored in again)
* Because pharma companies use techniques which are "flawed by design" in such a way that they exaggerate the benefits of treatments
* Because pharma companies stop trials early if they look promising and report on the results partway as though their findings reflect a full trial

Thus, Big Pharma routinely buries unflattering trial results and prematurely published good ones. Meanwhile, medicine’s guardian -- the regulators, the scientific journals, the professional bodies and the academic establishment -- either collude with such practices or turn a blind eye.

The net result is that doctors must prescribe in ignorance, patients are harmed, and vast amounts of money are wasted. Goldacre finds that missing, twisted and skewed data shape the practice of medicine in devious ways. He writes, “It’s hard to imagine a betrayal more complete.”

Even good, conscientious doctors who do their homework by paying close attention to the published trials and examining their methodology carefully may prescribe useless (or harmful) medicines.  And according to Goldacre, this is true of all doctors in every country because regulators in every country allow pharmaceutical companies to manipulate research outcomes to increase their profits. It is possible for good people in bad systems to do things that inflict enormous harm.

Goldacre points out, a 2010 Harvard/Toronto study showed that "85% of the industry-funded studies were positive, but only 50% of the government-funded trials were positive." In another analysis, industry-funded trials of statins "were 20 times more likely to give results favoring the test drug."

When scientists blow the whistle on this life-threatening criminality, they're smeared by the pharma companies. In other words, most are afraid to jeopardize their careers.Where are the safeguards today?

Ben Goldacre prunes his message:"Medicine is broken." Period.

The predictable conclusion? Just look at the crossover between the quack alternative medicine business and drug companies. Goldacre claims they both use the same tricks and tactics to bamboozle people into buying their pills, but drug firms can afford to use slightly more sophisticated versions. So in one sense, “Bad Pharma” is the continuing saga—the advanced version—of the simpler tricks outlined in “Bad Science."

Here is an extended quote from Goldacre 2012 publication:
"Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them. ' 
"Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it's dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.  
"And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug's effectiveness that's been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.  
"In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we'd expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder."

(Ben Goldacre, Bad Pharma: How Drug Companies
Mislead Doctors and Harm Patients, 2013)

Reviving the Industry

It's time for more transparency in medicine and more public detail.

According to Alan Cassels, pharmaceutical policy researcher at the University of Victoria and the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease, it takes only three words to sum up the key message of Ben Goldacre’s new book, Bad Pharma:

Missing data kills.

In reporting on Ben Goldacre's book, Cassels considers Goldacre to be a "radical" but also a needed alarmist. Cassels says..

"'Goldacre writes that “there would be no medicine without medicines,' and those medicines, the fruit of the worlds’ research-based pharmaceutical companies, will keep us healthy and well, but only when the drugs’ worth has been proved by science, by data. Where pharmaceutical research is hidden from sight, skewed or plain wrong, the implications for everyone’s health can be dire...
"Probably the most insightful sentence in Goldacre’s book is: 'The most dangerous tactic of all is the industry’s enduring claim that these problems are all in the past.' The pharmaceutical companies and their many apologists will say major reforms are already under way, so why is Goldacre getting so huffy? We heard that when Selling Sickness (by Ray Moynihan and myself) came out in 2005, and that all the nasty tricks we documented were all part of a bygone era. Well, they are not. As Goldacre’s book shows, we’ve been through so many 'fake fixes' in the past that we are all starting to look like dupes.
"Wealth has enabled Big Pharma to employ some of the best minds in persuasion, marketing, psychology and yes, even medicine, to use every (mostly legal) means to create, harness and distort evidence in the service of increasing investor returns ($600-billion U.S. global pharmaceutical industry). When you see how clever they’ve been, so well documented in Bad Pharma, how slick, how focused, how Machiavellian those minds are, you can only sit back and say, Ooooh, they’re good. They’re damned good. Just not so good for the rest of us."

 (Alan Cassels, "Ben Goldacre and Big Pharma's Big Betrayal,"
The Globe and Mail,

I would add: Amen and amen.

(Click to Enlarge.)
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