Ben Goldacre writes the Bad Science column for the Guardian newspaper in the U.K. and mostly he writes about pseudo-science because, as he puts it, “pulling apart bad science is the best teaching gimmick I know for explaining how good science works”. He has just put out a book called Bad Pharma, putting the foreword on his blog, an excerpt appeared in the Guardian and he put up a video of a TED talk he gave. So he is getting it out there.
The book, as a brief summary, takes the pharmaceutical industry to task for its clinical trial practices, wherein it skews the trials to favor their candidate, hides the results of unfavorable trials, covering up side effects and persuading doctors to prescribe their drug once it comes to market with misleading data published in industry sponsored journals. The game is rigged in favor of the big companies who then rake in the enormous profits.
Some people dispute this claim and John LaMattina put up his own take on the book and its contents.
So before my comments, my disclaimer. I suppose I am one involved in the pharmaceutical industry , though I have never worked for one directly, working for a industry contractor on research projects for several years, but these days I am more an interested observer, as I am at a non-profit research institute. I am also not by any means an expert on how clinical trials are run, exactly how things get approved for use or indeed very much at all about the ins and outs of the process. But I have a general idea.
Now the pharmaceutical industry have not done themselves any favors here. They have done all the things that Dr. Goldacre accuses them of, but the blanket statement that the whole industry is out to trick doctors and patients into taking their drugs is extreme to say the least. Pharmaceuticals in various forms have improved the lives of millions of people, saved them from death. Drug candidates are carefully vetted for efficacy and safety – more and more these days as there are so many treatments already available. Clinical trials are not just run against placebo but for approval, drugs need to show an improvement over a standard treatment. In short, that the system is occasionally circumvented does not mean the system does not fundamentally work.
If you look at it from the pharmaceutical company’s view, you can see why these sorts of things happen. Projects begin because there is a medical need for a treatment – essentially a gap in the market. So scientists work to come up with something that will meet that need. But the process of working that out is long and difficult and so many things can go wrong along the way. Worse still, the further along the path you get the more expensive the next step. A phase I failure is a disappointment for sure but it is a minor inconvenience compared with a late stage Phase III failure. Drug development is a high risk venture and there is no pay-off without a final marketable product. So at a certain point, the aim becomes the finish line of FDA approval. Anything that can lower the obstacles in the way would seem like an obvious route to take. Far from the drug companies preying upon the vulnerable and pushing through drugs that should not be, they suffer some dramatic failures – ask anyone in the Alzheimer’s field. Indeed if the system is set up to favor the drug companies, why is there so much talk of the barren drug pipelines and lack of new drug approvals? Pharmaceuticals have always been a high risk high pay-off investment but the risk seems to have risen and the prospect of a big pay-off seems to be receding.
Interestingly, as I was writing this (and re-writing it – curse that wordpress log-off), I came across Matt Herper’s post on Glaxo’s greater clinical trial transparency. This shows two things to me: firstly, that the pharmaceutical industry is aware of its image problem and are prepared to do something to counteract that perception. But also, that there are the problems talked about by Dr. Goldacre, with prominent doctors paid to talk up a new drug from GSK or pushing unapproved uses. That they are taking steps to reassure the general public can only be a good thing.
Quick addition: Ben Goldacre posted his response to GSK’s proposal and he voices some doubts about whether they will actually go through with it.
Chemical Space 
Great post. Thanks! Boy howdy this is a topic that’s always on my mind. I am fascinated by the world of medicine but have found that over the years my fascination has been tainted by reality. I now have a jaded fascination with medicine.
Once profit enters the equation…any equation….corruption and fraud follow. I believe that’s where we are now. An industry ripe with fraud and corruption.
Communication from “Big Pharma” seems to imply that there’s a pill for every ill, we market drugs on TV like we do tennis shoes. Well, we know that ain’t true. I don’t know if you’ve ever gotten to listen to drug reps give their talks…but uh…the talks are generally just a infommercial with good food and free pens…drug reps are people persons. They are sales people…nothing more. See what happens when you ask about something that isn’t included in the canned talk. Big eyes, open mouth and a blank stare.
The SSRI scandal comes to mind among other things. The back and forth on statins also come to mind. When I was in school, the statin studies were stopped early because of increases in traumatic death. Within a few years however, physicians wanted the stuff in the water…and I guess that has happened as our sewage is treated and returned to us to drink. Metabolites anyway. (Lots of metabolites from various drugs in what we drink…and eat). Now all of the sudden they are finding that folks who are noncompliant with their statins do better than those who are religious about taking their meds. Why is that? I think that sometimes we forget that the difference between a medicine and a poison is dose…for the most part. The pharmakos.
Another example is the flu vaccine…the pet of the industry, pushed on everyone, touted as a life saver. The only thing it has been found to do is decrease missed work days by 0.13 days or something ridiculous like that. It doesn’t decrease death or hospitalization. Yet…that’s not the information that gets out to physicians, pharmacists or the public.
We know what some meds do in part to the particular system we are looking at, but we have no idea about the total effects on our body. For some meds, we have no clue at all. We just know that the symptom we are trying to control is helped by the drug…so we use it.
The truth is, there really is no “expert” out there on the use of prescription drugs. Essentially, we are all guinne pigs. You can’t expect anyone to know everything about the thousands of drugs out there. Just the drug interractions, individual metabolic differences and disease state interractions alone mess up our equations. The statistics on prescription drug deaths in this country alone, where we are supposed to be “educated” is pretty impressive. Then there’s the differences between in vitro and in vivo. Even a clinical pharmacist who has years of schooling and practical experience in this stuff is no “expert”. Neither are physicians. Neither are the chemists. We’re just people with educated guesses and theories really. The sad thing is that physicians, chemists and pharmacists don’t make the rules. People with money make the rules. People with business degrees. I understand that we all start out with good intentions, but even those with good intentions and a sincere desire to help can be duped by a good argument…especially when the heart strings are tugged.
Our biggest improvements in health have had to do with sanitatation and hygeine which includes simple things that clean water, washing the hands and cleaner surgical procedures. Antibiotics. The rest of this stuff, well, I’m not so sure I buy into it anymore. I certainly understand that people have been helped symptomatically, but the truth is that we don’t cure much of anything with drugs. We control symptoms, we prolong the inevitable and we help the body along to heal itself (I’m thinking about antibiotics as far as help the body along type meds). Curing by drug is bad business…we need people coming back for more.
With all that babble above, I would say I do believe there is a time and place for everything, it’s just that we have made every time and place a place for pills and potions.
I agree with you about no true experts, but that is hardly surprising. Think about a computer program released onto the market. Any fairly complex piece of software will have some bugs and unexpected crashes and the like. This is something that we can look at the inner workings of in minute detail but it still does not work as expected when released into the general population. And human biology is orders of magnitude more complex. We just can’t know all of the consequences of what we do when we administer a drug.
Excellent comparison and thanks again for the post.