Ben Goldacre has a new book coming out, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
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.
This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.
Drugs that don’t work, dangerous side-effects concealed by legalistic loopholes, blatant biases in drug testing…and the data are hidden away from the conscientious doctors who try to give informed recommendations. It’s all scary stuff.
Can’t wait to see how the Anti-Vax crusaders celebrate this.
I’ve commented before (back on Sb) about this issue in the specific area of psychopharmaceuticals. Oddly enough, the first responses from the regulars was to accuse me of being a Scientologist. One does not need to jump on couches to see problems with big pharma here–nor does seeing problems with big pharma ally one with Scientologists. I will, though, wager that Goldacre gets accused of similar motivation.
One of the worst effects of the deception is that it emboldens all the diet-can-cure-everything folks and the anti-vaxers.
I really don’t understand this. It’s not like you can hide a drug side effect forever. It WILL come out if your drug is unsafe or ineffective. And it will end up costing your company, both monetarily and in reputation. Why not just cut your losses and not apply for FDA approval if it’s not what you were hoping it would be?
Also, the advise I’ve gotten on dealing with drug companies is that you, as the academic physician who might enroll patients on clinical trials, should play the proper Victorian maiden with drug companies: No matter how much you want it, don’t put out until you’ve got an agreement in writing that includes the right to publish no matter what the results show and adequate funding to do the study right.
As an MSer I am all too familiar with this. The situation with MS drugs is shameful; the interferons, which have long been prescribed as the first-line treatment, have recently been shown in two large studies to be no better than placebo. Another injectable, Tysabri, shows some efficacy, but also comes with a not-insignificant risk of contracting a killer brain virus. The recent oral med, released to much fanfare, is already showing signs of trouble (11 people dying leads to some questions being asked). But trying to shift the neurological establishment away from thinking that only drugs are the solution is nearly impossible.
Dianne;
If one academic physician won’t play ball with the drug companies they’ll just find another who will.
I am shocked–shocked!–to hear that a corporation–a person, according to the SCOTUS–would put profit ahead of the well-being of its customers.
Smells like “nitro fuel for wingnuts”
Gardengnome, this is why those of us in highly specialized fields get together and conspire to have the same answer when the drug companies come calling…Plus, no academic wants her name on a paper that’s going to be held up as a standard of what not to do and no hospital wants to be sued for a dangerous study. Obviously, you’re right and these protections are imperfect-there’s nearly always someone desperate enough to play. But the harder it is to find that person, the more cost efficient it becomes for the drug companies to just play it ethically up front.
dianne, short term share price increase leads to bonuses and getting it to market does the same while leading to short term profits which means lots of bonuses. By the time it comes to light those in charge have either moved on or are given a golden umbrella because of their contracts to get rid of them. Why do they care if it costs the company further down the line.
I work at a clinical trials research organization (aka CRO–who the pharma companies farm out the running of their trials to). I see lots of data, and an amazing amount of ridiculous stuff. Some sponsors run good trials, others don’t really care as long as it’s good enough the FDA won’t notice. They sign up research naive sites and let them enroll 50 patients before the first monitor visit, then we discover they didn’t enroll subjects with proper inclusion/exclusion criteria. They make up subjects, make up data for real subjects, etc. Most sites are decent, but many don’t have the adequate resources to run trials *well* and try and enroll more subjects than they can handle.
Then you have the issue where the sponsor company wants things done cheaply, so the CROs bid and they go with the lowest offer, and then the people actually running/monitoring the trial are overworked/understaffed/undertrained (at some CROs). There is always sponsor oversight, but some sponsors don’t proactively deal with problems. They’ll just fix it if the FDA catches them :-/
I think the idea of Independent Data Monitoring Committees has some hope, but since they are paid by the pharma company, and their pay stops if they end the trial prematurely due to safety or data issues, right now it’s hard to imagine how they are very ‘independent’ at all.
Didn’t Goldacre say in Bad Science that pharmaceutical industry studies tend to be the best and most well-designed studies out there, but that the bias comes from them burying the negative or inconclusive studies and publishing just the positive ones?
It seems like any medical research on humans should be required to be published, regardless of the outcome. Otherwise you can just go fishing until you get the data you were looking for, and there’s no way for the rest of us to tell if those two big studies on that new drug were the only two studies done, or if they were just the only two of seven that had a good result.
Why do you think the costs will be enough to matter, or that the negative information will even get out there quickly enough to cost sales? Just suing GlaxoSmithKline over paroxetine took a couple of decades and media coverage in books and a BBC documentary, while GSK was running ad campaigns and sending misinformation to doctors. And that’s only one very famous instance.
http://en.wikipedia.org/wiki/Paroxetine#Controversy
Ben: The proper thing to do in that case would be to inform the FDA of all side effects identified and ask for approval with a black box warning. There are tons of drugs out there with black box warnings. They can kill if misused. They’re usually on the market because not having them can also kill. (See, for example, essentially every chemotherapeutic drug in existence.)
There is a clinical trials registry in the US, http://www.clinicaltrials.gov. Any trial involving humans has to be registered with the government and posted on this site or it won’t be approved by any IRB. In principle, the FDA can look up all clinical trials on this site (actually, hopefully, they have a in house database with complete info) and call the drug companies out on any trials that were posted but the results of which are not included in the approval request. The problem, of course, is the usual: Too few people working for the FDA, too much pressure to approve without careful review, too many loopholes, too many opportunities for drug companies to influence decision makers in the FDA. For example, if you can call it a “natural” product and not make specific claims of action, FDA approval is suddenly moot. It can be sold over the counter without further examination.
By the time the stuff turns up, the patent protection is likely to have run out and the drug company should have moved on to the next big thing. In other words, they won’t care.
So why, when what we have here is a regulatory failure(for instance, the context of required studies among studies showing lack of safety and effectiveness is often lost when the latter are withheld from publication and scrutiny), do you think it should work drastically different for the regulated drug industry than it does for the unregulated drug industry? Homeopathy is proof of how you can sell an ineffective drug forever. The same is probably true, to a lesser extent, about safety or else dangerous quack treatments would not exist.
See http://www.plosone.org/article/info:doi/10.1371/journal.pone.0005192 for how ineffective therapies spread just fine.
By the time the stuff turns up, the patent protection is likely to have run out and the drug company should have moved on to the next big thing. In other words, they won’t care.
That seems to be what they’re hoping anyway. Vioxx suggests that it’s not always a good gamble…Perhaps I’m ridiculously naive, but it seems to me that drug companies that put out a product they know is bad are gambling against reality. Sometimes you can win that for long enough to suit your needs (i.e. until the patent runs out), but you’ll never win it forever and trying it strikes me as ridiculous, futile, and unethical. How do you live with yourself knowing you’ve intentionally poisoned people anyway? No, I’m not denying that people do it-the evidence against such a position being overwhelming-just that it’s completely stupid and evil and I don’t understand the motives.
Homeopathy is proof of how you can sell an ineffective drug forever.
Homeopathic “medicine” don’t have to prove to the FDA’s satisfaction that they are effective. And, of course, they kill people once in a while. Not sure how their manufacturers live with themselves either.
The human cost of corporate run pharmaceutical research is fucking enormous. Emboldening woos is a low priority concern in light of the problems caused. The tragedy of medical woo is usually that a person could have gotten treatment and did not, there were options available that were not taken and likely could have helped. The death or pain was avoidable and needless. The same cannot be said of people victimized by these companies. They have no viable alternative system to avoid the harm inflicted. The problems caused for patients of modern medicine affect so many more people as well- woo about medical treatment may be harmful, but at least its the minority.
The science behind vaccines is very good and no serious problems have come to light despite decades of use in a variety of populations. That is plenty of argument, really. There isn’t any real reason to defend these companies on other fronts, is there? Is it really that nuanced to say a company has both good and bad products, both ethical and unethical behaviors perpetrated within it? Seems like common sense to me. A person committed to a viewpoint will be able to make *any* event a rationalization to continue the behavior anyway, I doubt that fence sitters are going to have much of an issue with a more realistic tone being taken by skeptics regarding the problems highlighted in Goldacre’s book. Its about fucking time if you ask me- I got sick and tired of seeing “skeptics” in vaccine debates defending corporations because it made their argument look better. Its always been bullshit.
a different poster said
huge corporations aren’t allowed to think in the long term. If your company doesn’t think in the short term it isn’t likely to survive the other companies that do. Its a system engineered to reward sociopathic behavior.
Because typically the profits are so obscene they outweigh any possible adverse verdict that will come from an inevitable lawsuit. It really is about bean counting.
dianne, Vioxx is a good example, for I, along with some friends/acquaintances, would have happily continued to take it even knowing the risk up front, as would some of those acquaintances in the much higher risk group. For after they withdrew it I took me over two years trying replacements that were either next to useless compared to Vioxx or had unwanted side effects of their own. In the end I gave up when I finally found a related drug that was about 70% as effective as Vioxx. However, that 30% loss of effectiveness means a significant difference to my general well being and quality of life as well as now having to top up with a much stronger pain killer than when on taking Vioxx, itself an added risk factor.
@20: And Vioxx could completely be on the market with a black box warning if the people running Merck hadn’t acted like fucking idiots. Oh, excuse my language. I mean Kniefickende Scheisskopfe.
But, of course, Vioxx as a niche product used in patients with intractable pain and low cardiac risk isn’t as appealing as Vioxx as the drug everyone goes to first, so I suppose from the simple money making point of view, they had a point.
huge corporations aren’t allowed to think in the long term. If your company doesn’t think in the short term it isn’t likely to survive the other companies that do. Its a system engineered to reward sociopathic behavior.
Why, it sounds as though you don’t think that capitalism is perfect and the invisible hand will fix every problem! What sort of commie are you? (Translation: Your argument seems to me pretty unanswerable.)
Yet ironically, IIRC, some 99% of the people previously taking Vioxx could have continued taking it with little risk. Even some in the higher risk groups could still take it for limited periods. So to me, all it would have meant, was more careful marketing. Though I suppose few people truly understand risk, so perhaps it was easier to fudge the initial figures, make a quick buck, and hope costs down the line wouldn’t be too onerous compared to profits.
Consumers aren’t people.
No, really. Humans are very good at shutting down empathy for distant people.
Ellabella, & others, you have highlighted an example where the free market economics system fails the consumer, while the consumer remains largely unaware of being screwed.
I’ve pretty well given up practising my profession because of a similar market failure, & my refusal to screw clients, leading to poor fee rates. Unfortunately, there are plenty of practitioners who have no such scruples.
Like Millicent @ #5, I deal with autoimmune issues and constant pain. I’ve found that the rheumatologist and the neurologist really don’t seem to have a clue as to what can really help me. They just randomly throw different meds at me, and I have to be very aware of what they are prescribing, since I react violently to any opiate, and the docs just keep prescribing those for me.
I’ve noticed something else, too. As a woman, I have a much more difficult time getting decent care than my husband does.
When I came from a different state, my former PCP told me to print out a list of symptoms, diagnoses, meds, allergies, etc. to give to my new PCP right away before she could send him my records. He took one look at the list and told me “You might be a hypochondriac”. I later found out that he never bothered to request my records from the other doc.
My husband went to the same PCP. All he had to do was run through a quick list of his symptoms and mention the internet research that he had done. He was immediately told “yes, sir” and was given a prescription and a referral to a specialist – no questions.
I’ve seen the same thing happen with my rheumatologist. If I ask questions or mention studies that I have read, she tells me “You read too much”. My last appointment lasted four minutes flat – and she collected $30 from me and $190 from my insurance! I’ve read reviews about the same doc written by men, and they all praise how well she takes care of them.
So, here’s another place where misogyny is alive and well.
But that is what it sounds like to someone ignorant of the valid criticisms! For example, the only people I’d heard pushing that line before (that pharmaceuticals are bunkum) were Scientologists (the whole Tom Cruise vs. Brooke Shields thing), and it turns out that their reason for doing so has to do with them still holding a grudge against the psychiatry and psychology industries for not approving Dianetics as a fruitful endeavor. It is the broken clock phenomenon; Scientologists for the most part aren’t against drug therapies because of scientific reasons but because they have their own religious therapy they use in place of drugs (however, they have been known to piggyback on valid criticism of pharmaceuticals to “win” the argument).
Not only that, but many of us have used the more prescribed pharmaceuticals and believe they have helped us. The idea that the (sometimes awful, sometimes good) side effects of the drugs did little more than enhance the placebo effect was not mentioned to us by the people prescribing the drugs to us, and the idea that they don’t work seems to contradict our personal experience with them. So you are also running up against a lot of personal experience with that information.
So people will be less ignorant…:
suggestions for skeptical and social justice readings in psychiatry
Joanna Moncrieff, The Myth of the Chemical Cure
More generally,
“Why psychiatry is an important skeptical and social justice issue”
“On skeptical priorities: CAM and Big Pharma”
Your comment reminded me that I’ve been meaning to check to see whether any of Barbara Ehrenreich’s older books on this are available for Kindle. They are! I’m excited to read Complaints and Disorders.
It’s depressing how easy it is for someone who’s already suspicious of multiple “thems” (as in “they don’t want you to know”) to take these kind of findings and twist them to suit their conspiracy theories (several examples in the comments above, the most obvious being Scientologists and anti-vaxxers). The trouble is that the truth is a lot more complicated, and a lot more detailed and kind of boring. So people go with these cartoon conspiracies in which the monolithic bad guys are responsible for all evils because they just are evil, rather than the messy mix of profits, pride, and laziness that actually results in this.
@1. Just read the comments on the guardian article. They have already started.
This is exactly why I only go to a pharmacist who’ll sit down and have one with me right there in the store so I know xe’s not selling me adulterated shit. I’m not waiting until I get home to find out if my dimebag’s full of TicTacs®.
On the other hand, sometimes I just want to pick up my stuff and go home, bake some nachos, pop in Grandma’s Boy, suck back an erythromycin, and kick back. Those days it’s a pain in the ass to have to call hir pager to see if it’s a good time to swing by, then make idle chit-chat for ten minutes before asking if xe’s got anything for sale like it just occurred to me that I’m out of haemorrhoid suppositories and BTW could I grab a half-ounce? but that’s the price I pay for the good shit.
@RevBigDumbChimp – I expect the anti-vaxxers will be quite happy to cite this ad nauseam, while still calling Goldacre a shill of Big Pharma any time he talks about vaccination, and not even slowing down for the dissonance bump.
@26 magistramarla:
Oh boy do I ever hear you on the difference in the way male and female patients are treated, and listened to, and believed. About twice as many women as men are diagnosed with MS. For many years, doctors believed that chronic pain was not an MS symptom, and that if patients complained of pain, it was all in their heads. These two things are very much related.
Don’t even get me started on how no real progress has been made on cannabinoid pain relievers/anti-smasmodics because pharmaceutical companies can’t see a way to make money from it…
Or “spasmodics,” even.
@Millicent — because the source plant can be grown in any roadside ditch without much effort. Seriously.
And on that note, back to the bong for me.
It’s more complicated than that and even more evil than you think. It’s very hard to get permission to work with cannabioids in humans so most drug companies won’t even try, not even for something that they could patent. It’s not just pharma company greed, but also the drug war stupidity coming into play.
Of course most of the vaccine studies were not industry sponsored but funded by government sources. Not that the anti-vaxxers would notice such subtleties.
Cuttlefish, it’s a game of hot potato! Personal-You wins as long as Corporate-You isn’t discovered until Personal-You has taken the glory & the money and moved to safety. Having a larger army of lackeys is best: one or three of them can take the fall for Personal-You. And both You gotta keep up with the Joneses, they are all doing it so you better too. (And one of them may give Personal-You a better job if the moves are timed right). Sickening system I say.
Now, the big question for me is, then how do we know which drugs are more than just glorified placebo effect?
Brownian,
Where do you start? I mean, I don’t know what I’d ask of a pharmacist. Does a consumer need to check online first and come up with some drug-specific questions, or is “hey is this stuff garbage” sometimes effective?
And yet Ayn Rand and Alan Greenspan assured us that no corporation would ever act irresponsibly because it would damage their reputations and people wouldn’t buy from them. They can’t have been wrong, can they?
tbp1, wasn’t it Milton Friedman & the Chicago school of economics that pushed that ‘philosophy’ on Regan & Thatcher? (Along with a volunteer army & unlicensed doctors, which didn’t get taken up.)
And he, (Milton Friedman), got a Nobel Prize in economics. No wonder it’s called the dismal science.
Or that the original study that started the nonsense WAS an example of biased industry sponsored research.
Skeptifem @ 18
QFT, repeated for truth and to recommend a book on the subject by Joel Bakan The corporation: The pathologiocal pursuit of profit and power
Actually in the case of vaccines and the non-link with autism it was not the pharmaceutical industry than funded Wakefield but no-win no-fee legal industry, or rather one practitioner within that industry.
Matt Penfold, plus one who was also trying to push a single crank measles vaccine of his own, so Wakefield had a dual conflict of interest.
Re @18; @46;
It’s the Tragedy of the Commons, writ large.
“Hey man, are you like, down to party, or what?” And then you tell hir that you’re friends with [common friend] so xe knows you’re cool.
Of course most of the vaccine studies were not industry sponsored but funded by government sources. Not that the anti-vaxxers would notice such subtleties.
But the unique thing about anti-vaxxers is that it is branch of anti-science that seems to attract both the left and the right. Many right wing anti-vaxxers are John Birch types who believe that the government is deliberately making them ill through vaccinations. Andy Schlafly and Alex Jones are good examples of anti-vax wingnuts.
But the unique thing about anti-vaxxers is that it is branch of anti-science that seems to attract both the left and the right. Many right wing anti-vaxxers are John Birch types who believe that the government is deliberately making them ill through vaccinations. Andy Schlafly and Alex Jones are good examples of anti-vax wingnuts.
I preordered the book yesterday, thinking I had until next year to clear my backlog of books to read (I’m in Australia, but my books usually come from America). To my surprise the eBook downloaded onto my iPad last night, so I spent several hours browsing.
It looks very good. I’ll have to read it in depth starting from the beginning when I have the time this weekend …
Money in science is worse than money in politics!
These disgraceful activities by big pharma are chipping away at the confidence people had in the medical profession 20-30 years ago. I’m very skeptical of the prescription pad. I do my homework and never pop anything in my mouth without research. I currently take only occasional ibuprofen for arthritis pain, and an occasional hit on the bong. I just don’t trust anything else right now.
That, from ibyea. Is there some where in Goldacre’s book, or anywhere else, a list of pharmaceuticals properly trialed? Enquiring minds want to know.
Great, yet another essential book gets added to my reading list…
On that note, I really should reread Bad Science. And catch up on Quackcast.
Also, Ben Goldacre should debate Mark Crislip on the merits of the placebo effect. Goldacre sings its praises, while Crislip dismisses it (at least in early Quackcast episodes) so it would be nice to hear them both go over where the contention lies.