28 Mar (DAVID HEALY) – 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.
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 story is bang up to date, covering Roche’s withholding of key data on Tamiflu, leading governments worldwide to hand over billions of dollars of your money to stockpile Tamiflu in recent years. 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.
The next section deals with what is widely called regulatory capture. The regulatory agencies that approve drugs, such as the US Food and Drugs Agency (FDA) contain many bright and good people. But somehow the system fails patients and doctors, and simply can’t be trusted to ensure that medications on the market are safe and effective.
RCTs & EBM
The third section introduces randomized controlled trials (RCTs) which form the basis for evidence based medicine (EBM). RCTs and EBM sound as good as motherhood and apple pie to most people. 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.
The big picture – RCTs are critical to good medicine and everything would be fine if only companies didn’t “game” them.
The final section entitled “Marketing” contains the juiciest details and the reddest meat. 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.
Ben’s searchlight switches to ghostwriting and how companies now run the continuing education of doctors. 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 book ends with a scene, a question and a plea.
- The scene is Ben being told at a party that Andrew Witty, GSK’s current CEO, is a good guy, who bangs the table in his efforts to ensure things are done better.
- 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.
FRAMING THE ISSUE
Many readers of Bad Pharma will know much of what is here from books such as Marcia Angell’s The Trouble with Drug Companies or Jerome Kassirer’s On the Take. 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.
For complete article go to Dr. David Healy.