It takes only three words to sum up the key message of Ben Goldacre's new book, Bad Pharma: Missing data kills.
In other words, what we don't know about the drugs we take every day can hurt us, even cause our deaths. 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.
One example Goldacre uses is antidepressants. From 1987 to 2004, researchers found 74 studies in the U.S. Food and Drug Administration archives covering all major antidepressants from most of the world's big drug manufacturers. Of these, 38 were positive trials, which showed a benefit of the drug being studied; 36 were negative. All but one of the positive trials were published, "often with much fanfare," but only three of the negative trials were published, the rest essentially lost to history or spun to appear positive.
The implications of this are huge, and forms the central focus of his book. Published research informs our health systems and our doctors, and determines how patients receive treatment. Using similar examples across many drug classes, including cancer treatments and drugs for high cholesterol, Goldacre finds that missing, twisted and skewed data shape the practice of medicine in devious ways. As he writes, "It's hard to imagine a betrayal more complete."
Antidepressants are only the appetizer in Goldacre's scathing critique of the modus operandi of drug research, where, he writes, "Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analyzed 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."
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients could very well be the book that initiates a game-changing global rethink of what we expect from medicine. The author, Dr. Ben Goldacre, is a golden boy, star physician and epidemiologist, a rare breed of doctor who knows how to take a simple but powerful message and turn it into a franchise. Other academics talk about how bad things are, but are painfully aware that "shaking things up" is a tenure-killing dance move. Goldacre moves to a different rhythm. He speaks in tweets, delivers captivating TED talks as easily as brushing his teeth, and carries a modest "I don't care if my hair needs combing" insouciance that is terribly attractive to the many, mostly thirtysomething followers who love him.
Goldacre was in Toronto this month and spoke to enthusiastic audiences, including many young people (I suspect mostly medical and pharmacy students came to catch some of his telegenic charm), as part of his whirlwind North American book tour, raising awareness of the problematic system of skewed and missing data, and delivering a prescription of action and change.
Some will call Bad Pharma a "me-too" book after the spate of pharma critiques that started appearing in the mid 2000s by people such as John Abramson (Overdosed America), Marcia Angell (The Truth About the Drug Companies), and Jerry Avorn (the excellent Powerful Medicines). Bad Pharma might give a sort of déjà vu jolt to those of us who have already sampled the current canon of books that ask hard questions about the way the drug industry creates and markets diseases, skews the science and then uses biased reporting to bamboozle regulators, doctors and patients into dangerous medicine.
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.
I'd call Goldacre a radical, certainly brave, entertaining, willing to hoist his message vigorously and humorously in the social-media universe. As an epidemiologist, he has delved deeply into the underworld of data manipulation, and comes back, ever the doctor, ready to hand out prescriptions. His "Things You Can Do" pointers make Bad Pharma feel like a handbook for activists – with lists and bullets telling you such things as: "If you are a doctor or an academic, lobby for your Royal College or academic society to have a strong code forbidding involvement in ghostwriting."
Goldacre does extend an olive branch to the pharmaceutical industry, saying that if there only better regulations guiding their behaviour, things would vastly improve. This seems naive in the same way it's naive to think you can train a cat to stop killing mice. It's what the cat does. You can no more blame the cat for its hunting DNA than you can blame the $600-billion (U.S.) global pharmaceutical industry for doing exactly what the shareholders and investors want: Make money by selling something.
In the early 1990s, when most everyone in the research world was beginning to get on the "evidence-based medicine" bandwagon, extolling the virtues of randomized controlled trials, systematic reviews of evidence and prescribing guidelines for physicians, Good Pharma was way out front, doing what a good cat should do: using the new paradigm to catch mice (and producing immense wealth for shareholders). Where we go wrong is in assuming that big pharma and the many well-meaning researchers in its employ are in the health business. They are not. They are in the wealth-creation business.
That 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. 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 is a pharmaceutical policy researcher at the University of Victoria and the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease.