I had already thought about doing this, but reading David Healy‘s most recent post means that I’ll probably go through with it. The "it" is to read Ben Goldacre‘s Bad Pharma and David Healy‘s Pharmageddon in tandem, one right after the other. I like both of them, but their takes on this topic are not so much just different, but maybe from different planets. In his recent post, Dr. Healy makes the case that Dr. Goldacre is playing into the hands of the pharmaceutical industry by suggesting that the true path is reforming clinical trials. His take is that clinical trials themselves are the problem. Something like once you accept randomized clinical trials [RTC] as the gold standard, you’re finished, and PHARMA has you in their clutches. Says Healy:
Bad Pharma calls for more regulations but the more regulations there are the stronger industry becomes. The Chinese sage Chuang Tzu caught the dilemma beautifully in 323 BC:
“For security against robbers who snatch purses, rifle luggage, and crack safes, one must fasten all property with ropes, lock it with locks, bolt it with bolts. 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.”The problem for healthcare worldwide goes back to a set of regulations – the 1962 amendments to the US Food and Drugs Act put in place following Thalidomide.
The stimulus for Dr. Healy’s post was a request that he write a review of Bad Pharma. When he did, they turned it down:
The invitation from the London Review of Books to review Ben Goldacre’s Bad Pharma™ reads:
“We were unsure, at first, what a review could add that isn’t already in the book – scrappy summaries and bits of praise are not for us. The book is of sufficient importance that the main thing is to get someone who knows what they’re talking about to present the material confidently.. frame the discussion”.My head said it was inconceivable that the LRB wouldn’t take a review, even if it was at odds with the invitation to praise Bad Pharma. 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.
Now it is unfair to say that if Ben Goldacre didn’t exist, Andrew Witty, the CEO of GlaxoSmithKline, might have had to invent him. 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. This rejected review will puzzle some, and perhaps annoy those it doesn’t puzzle because it leaves answers for another day.
His review follows in his post, and you’re on your own here. Having read his book, I sort of get his point, but I’m only on the edge, not totally un·puzzled, thus my resolution to reread both books. There is some dialog between the two in the comments to the post.
I don’t have any problems personally with their disagreements. I agree with both Ben’s determination to make the clinical trial world play things straight and David’s point that RTCs aren’t the do-all and be-all of scientific truth [being a case study person all on my own]. But I still think the right thing to do is read their books back to back. Can two right-thinking people who are approaching the same problem but have radically different approaches to the solution both be right?
Sure. And this, to me, is a fine example of a case where that seems to be true. Make the clinical trial world play it straight, and, by the way, don’t over-value clinical trials. There, it’s solved…
With all due respect to Dr. Healy, that review was not as well-written as many of his other pieces. I felt it did lack context for an audience that was not in the know.
I think that’s right, which was part of my reason for holding off. His book is more nuanced. It’s a hard history to follow even in the best of narratives
Registering all trials and making the information open source after a year or so, is much more about having all relative data made public for the good of science as a whole. The open-source movement for scientific studies and data is much larger than just the regulation of pharmaceutical companies.
Regulating industry is in many ways like law enforcement or war, there is always a need to make changes to keep up with the latest technologies and tactics on either side of any given battle for control.
This kind of a review of Bad Pharma will likely generate more publicity than a positive one. One has to wonder whether that figured into Healy’s thinking as he has, at least to some extent, now made a profession of being a gadfly.
“the “n=1” topic, “How can you say anything about human psychology if you only look at one case at a time? There’s no control group. No experimental group.” And you’ll be pleased to learn that I’ve exceeded my lifetime tolerance for those discussions and am not bringing it up for that reason.”
I suspect that it may be difficult to address Goldacre vs Healy’s views without returning to this issue.
If you have not already read Dr. Goldacre’s Bad Science might I suggest you include this in the tandem reading as it will further clarify his view of multiple n of 1 experiences.
I find Dr. Healey writing has many wonderful points in an oddly confusing writing style, mixed with statements that seem rather extreme. I initially thought i just wasnt smart enough to get it all in the first read. After all, everyone thought his studd on suicide was extreme until he was proven right.
However, the more i reflect, the less i think the problem is with his writing style, and the more i think it is with his reasoning. Namely, he tends to rely on a lot of inductive reasoning to make leaps of generalisations.
I have met and like both Ben and David. They are good men whose views on Big Bad Pharmageddon have more similarities than differences. Both are good writers but their styles are different.
Mickey – your last para says it all. You should write a book!
A hundred (or thousands) ignorant selfappointed experts in chamber, consulting, voting on “discreet diagnoses” and treatment protocols produce nothing but ignorance cloaked as science, useful to global Big Pharma, enormous wealth and capacity to influence government politics, doctors’ decisions and treatment outcomes. In this scenario The Patient is risking being least and last, not helped, worse, injured, dead.
That’s my not-so-humble opinion after close encounters with the System, after trying to understand by reading Marcia Angell, Jerome Kassirer, John Read, Robert Whitaker, Richard Bentall, Loren Mosher, Joanna Moncrieff, Ben Goldacre, madinamerica.com,1BOM and David Healy’s blog – not forgetting Björn Andersen, Peter Götzche, Peter Lehman …
When the base is skewed to professional and industrial vested interests and treatment results – the bodies – are hidden, a person with health issues is fodder for the corrupt, oligarchic churches of medicine and psychiatry, instead of being seen by an honest doctor as a fellow human being and sufferer.
My trust in doctors is no more, just trust in the honest fellow traveller I consult with when I must, as he is the gatekeeper to some basic services.
Goldacre advocates reforming the System. Healy seems less certain. I’m not a doctor and to me the System is too flawed, too corrupted, to be trusted by The Patient. Change comes from independent outsiders.
I think they are very different in their orientation. I get the sense that Ben either isn’t familiar with some side effect issues or he is and is not convinced of them, issues that David has been writing about for some time. Ben is a great popular explainer, and it has been great to see him get the spotlight on clinical trials, but this seems like a small subset of a set of larger issues David has been talking about for a long time. While he sometimes can make you work to follow his arguments, it’s hard not to be more persuaded by David’s view, that focusing on the conflicts, trials and data access is a rearranging the deck chairs. The notion that the LRB, which my issue tells me focuses this month on Francis Bacon, Mussolini, twin studies and leaves, can’t digest the problems with patented compounds and prescribing privileges is crazy.
“Side effects” is a euphemism created to conceal the many unwanted, dangerous, potentially deadly effects of most effective drugs, maiming and killing more people than registered. There may be benefits, there are risks. All are effects.
I agree about Dr. Healy’s writing style. Sometimes it is crystal-clear and sometimes too metaphorical (for me, at least).
Dr. Healy wants more emphasis on post-marketing reports, as he says, rightly, that RCTs are poor at predicting adverse effect patterns.
“Don’t over-value clinical trial?”
How easy is that?!
Duane
“Make the clinical trial world play it straight.”
We’ll need a *real* U.S. Attorney General….
We don’t have one at the present time.
Duane
http://teachingbattleground.wordpress.com/2013/03/29/a-response-to-ben-goldacres-building-evidence-into-education-report-part-1/
http://teachingbattleground.wordpress.com/2013/03/30/a-response-to-ben-goldacres-building-evidence-into-education-report-part-2/
healy and goldacre have different goals
what i valued in healy’s review was that he framed goldacre’s battle in a larger and more historical context
as though one general was talking about a tactical conflict and another general talked about the tactical conflict in the strategic context of a larger war