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Ben Goldacre: Here’s the foreword to my new book, Bad Pharma
- oracuk 14y agoBen Goldacre was on the Today programme on BBC Radio 4 this morning discussing his book with a representative of the pharma industry. Platitudinous and evasive answers from the industry rep while referring to Goldacre's 'extremist' views. He's hit a nerve and they don't appear to have a good rebuttal. For those with iPlayer access you can here it again here: http://www.bbc.co.uk/programmes/b01mw2d4 http://www.bbc.co.uk/programmes/b01mw2d4 Edit: Ben Goldacre piece was at 08:34. Excerpt of just that section is here: http://news.bbc.co.uk/today/hi/today/newsid_9754000/9754505.stm http://news.bbc.co.uk/today/hi/today/newsid_9754000/9754505....
- rwmj 14y agoAlso a good overview and introduction in the Graun a few days ago: http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-ben-goldacre http://www.guardian.co.uk/business/2012/sep/21/drugs-industr...
- sjmulder 14y agoNote that iPlayer for radio is available outside the UK as well.
- yen223 14y agoIt's interesting that once upon a time, he was being called a shill for big Pharma, thanks to his anti-quackery (read: anti-homeopathy) stance.
- ZoFreX 14y agoWhich is hilarious, because "big pharma" own the big "alternative" "medicine" companies too - it's a multi-billion dollar business, of course they want a slice of that pie!
- Joeboy 14y agoI didn't know that. Is there something I can read that'll back it up?
- ZoFreX 14y agoI can't recommend any text on the subject more highly than "Bad Science" by Ben Goldacre. It covers a lot more topics than just this, but it still covers the basics very well and I believe it has references for its claims (it has been a while since I read it and I don't have a copy to hand to check).
- stordoff 14y agoIn the ePub version I have (from the iTunes store), there are a decent number of references in the back of the book, as well as some pointers to further reading. I would assume they are also contained in the print version.
- shrikant 14y agoYeah, I have a copy of the print version (not at hand though..) and I can confirm this. The last few pages have a large number of references in them, and made me think for a few seconds that the book was longer than it actually was :)
- illuminate 14y agoI'm not entirely sure that's correct, but you're still talking about a multibillion dollar industry ("big nutri") claiming oppression whenever they're expected to show objective results.
- DanBC 14y agoAlso confusing because of his work with CBT and other talking therapies, which help reduce the use of medication.
- loxs 14y agoThis is one of the reasons I left Medicine for computing... He is not right that doctors are oblivious to these mechanisms. Most of the things he is talking about are very well known to the doctors, but most of them become obvious only when you start practicing, and (for most) there is no turning back. Most people (unlike me) don't feel very comfortable abandoning 6-10 years of time money and effort investments and switching jobs, and they choose to play the game...
- bmj 14y agoI'm curious to read the book--I write software used to collect data during phase 2 and 3 clinical trials, so I have some understanding of both how trials are designed as well as what the regulators are looking for in the data. In my experience, there is a strong push for both good data and preserving the "voice of the patient" from many of the scientists who develop the trials (not necessarily the drugs, but the trials on the drugs). Whether pharma follows this advice is a different story. Another anecdote: in the 15 or so years my employer has been around, we've only seen a handful of NDAs (new drug applications) go through on the hundreds of studies to which we've supplied software. All that said, despite receiving my paycheck from big pharma, I'm sympathetic to Goldacre's criticisms. As I mentioned, the founders of my employer (both software folks and clinical scientists) have worked to change the way trials are run in order to provide better data. Whether the sponsors properly use this data is another story.
- kokey 14y agoI've also done a stint in big pharma, on the R&D side, running computational clusters for bio and chemistry modeling. The impression I got was that the majority of work was for improved science in order to create drugs that saves lives or improve it dramatically. The biggest money makers were things that deal with diabetes and heart disease, not things like antidepressants and ED. I think some focus was lost on the business/marketing side where opportunities were pushed and exploited in certain drug lines beyond what was reasonable. I get the impression that most of these issues were before 2006, it's actually not in the best interest of the pharmaceuticals to operate in this manner either if they want to remain in business. The regulators have also caught up. That said, it's easy to see the mistakes in retrospect, this has happened over the history of many drugs that have come and gone.
- bmj 14y agoElectronic data collection in trials (what we do) also has limited reach in clinical trials as a whole right now. Most of the studies we support tend to be for pain medications (think post-operative pain) and more serious conditions, and that lets me sleep a bit better at night. I agree that certain drugs lines tend to be exploited more than others, and it can be easy to paint very broad strokes about pharma generally because of that exploitation.
- tehwalrus 14y agoBen Goldacre is a legend. Buy this book for your friends for Christmas!
- boothead 14y agoIt's getting some great reviews on Amazon: http://www.amazon.co.uk/review/RIBC5ED8IUT4X http://www.amazon.co.uk/review/RIBC5ED8IUT4X > Despite this book being an excellent take down of the pharmaceutical industry which everyone should read it completely fails as a flickbook. I'd expect a writer of Goldacre's calibre to be able to stick small pictures in the bottom right of the book's margin creating an animated effect of himself, astride a unicorn, vigorously stroking the horn until finally, a moment of satisfaction
- gjm11 14y agoWhat actually happened: It got one absolutely idiotic review from someone who hadn't read it but wanted to complain that it wasn't an anti-climate-science book (yes, really), and now all the other reviews are making fun of that one.
- droithomme 14y agoPR firms get paid a lot to splatter the net with those sorts of reviews of books that aren't even for sale yet.
- tokenadult 14y agoIt's important to note that Goldacre is writing from Britain, relying mostly on British examples. The regulatory system is somewhat different in the United States, so while some of his critique of new drug approvals generalizes to the whole world, the specifics of what countries are already doing to reduce the problems in regulation (which have been well known to many research-oriented physicians for years) vary from country to country. As usual, I have to recommend here the edited group blog Science-Based Medicine, http://www.sciencebasedmedicine.org/ http://www.sciencebasedmedicine.org/ which like any blog includes some daily articles that are duds, but which also features some of the best discussion in popular language by statistically astute medical researchers on what needs to be reformed in regulation of new drugs, and what is already working better than some possible alternative approaches. A recent post there, in this instance by a lawyer, http://www.sciencebasedmedicine.org/index.php/stem-cell-therapy-regulation-plays-catch-up-2/ http://www.sciencebasedmedicine.org/index.php/stem-cell-ther... is a thoughtful discussion of some of the regulatory trade-offs. AFTER EDIT: Two things to add here. The clinical trials registry http://clinicaltrials.gov/ http://clinicaltrials.gov/ hosted by the U.S. National Institutes of Health is one response to some of these concerns that precedes the publication of Goldacre's new book (which I intend to read cover to cover). It has a lot of information about human patient clinical trials being conducted all over the world. Reviewing another recent post to Science-Based Medicine, http://www.sciencebasedmedicine.org/index.php/news-flash-doctors-arent-all-compliant-pharma-drones/ http://www.sciencebasedmedicine.org/index.php/news-flash-doc... I see it mentions Goldacre's new book (favorably) and also analyzes a very recently published study about physician influence by drug companies. I have submitted that here to HN http://news.ycombinator.com/item?id=4569970 http://news.ycombinator.com/item?id=4569970 for thoughtful comments by all of you.
- Alex3917 14y ago"It's important to note that Goldacre is writing from Britain, relying mostly on British examples." At least judging from this example, the majority of his book is sourced from two earlier books that were written about the FDA and the American drug system: The Truth About Drug Companies by Marcia Angell Overdosed America by Jonathan Abrams Those were published in 2004 and 2005, so there are a few studies published since then on the influence of pharma funding on trial outcomes, but nothing that contradicts the earlier results. In general though the problems are exactly the same between the US and the UK. There are a couple drugs that are legal here and not there and vice versa, but the underlying system corruption is identical, because it's literally the same studies (or at least the same methodology) that is used to get the drugs approved in both countries. Also, as I've said before, that science-based medicine blog is mostly industry propaganda. There is overwhelming evidence that drug companies have a massive influence on doctor's prescribing habits, e.g. http://jama.jamanetwork.com/article.aspx?articleid=192314 http://jama.jamanetwork.com/article.aspx?articleid=192314 Here they are literally arguing that doctors aren't influenced by the file drawer effect because doctors can tell the difference in methodological rigor between good studies and bad studies. That has to be one of the dumbest and most intellectually dishonest arguments I have ever heard. Science-Based Medicine (the blog) reminds me a lot of Brawndo. Their basic argument in every article is just "but it's what plants crave!!1"
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- stbullard 14y agoHardcover/Paperback/ePub available now in UK; not available in the US until January 8th (3 1/2 months). It's a shame; I would have bought 2 copies as Christmas gifts. He's going to lose a lot of US sales to piracy.
- alexkus 14y agohttps://twitter.com/bengoldacre/status/249918250962530306 https://twitter.com/bengoldacre/status/249918250962530306 " @bengoldacre If you're frustrated by later publication in other countries, register your Kindle at 1 Road Street, London W1A 1AA http://amzn.to/Uhr0p4 http://amzn.to/Uhr0p4 "
- tocomment 14y agoI've always been curious why clinical trials are so expensive. Does anyone know an approximate cost breakdown of a typical clinical trial say for a new drug? Really you're just having a few hundred people take a pill and monitor their progress. I always wonder why that should cost more than 10 or 20K per patient even with overhead.
- shrikant 14y agoI'm guessing a combination of liability insurance cover for the body conducting the trial and health insurance for the trial participants would drive up the costs significantly.
- Alex3917 14y ago"Does anyone know an approximate cost breakdown of a typical clinical trial say for a new drug?" No one knows exactly because drug companies are allowed to count many of their marketing expenses are part of their R&D. For example, phase IV trials are mostly done as marketing as an excuse to bribe doctors with tens of thousands of dollars to put patients on the drugs in exchange for answering one or two questions about their opinions on the drug that are completely unscientific and unpublishable. That said to get a drug through phase III trials shouldn't cost more than about $20 million. You can go to MAPS webpage and see their budget and how much they are projecting it's going to cost to get MDMA approved. The reason the pharma companies claim that it takes billions per new drug to develop is that they're basically counting marketing expenses, other failed drugs, regulatory fines, etc.
- rchi 14y agoI wonder if Goldacre's solutions would actually help. If it's so easy to fix the system, people would have already done it.
- urbanautomaton 14y ago> If it's so easy to fix the system, people would have already done it. This doesn't follow at all. The difficulty of fixing a system is just one possible reason it might remain as it does; regulatory capture is another, as is well-financed lobbying at the legislative level. Pharmaceutical companies have a very clear financial interest in seeing as broad as possible use of their products, and demonstrably have the lobbying reach to forcefully advance this interest. If reform of medical trial data regulation is not a vote-winning platform (and it's hard to argue that it's uppermost in many voters' minds), then it's perfectly plausible that a broken system would persist despite the availability of easily-implemented solutions.
- rchi 14y agoYou are proving my point. There are many difficulties to fixing the system. Broken system persists because 'solutions' cannot be easily/successfully implemented.
- stef25 14y agoIt's fair to look at this industry with a critical eye, but let's not forget that many of these companies have spent billions of dollars to develop drugs that cure many very serious diseases. I can't take serious the statement "the way medecine works is ludicrously appalling" if you consider people can now live a fine life with the AIDS virus and there are hundreds of diseases that can now be managed and cured, thanks to medicine.
- danielharan 14y agoWhat very serious disease have they cured recently?
- marze 14y agoHere is a way to bribe journals, by purchasing large quantities of "reprints": http://blogs.bmj.com/bmj/2012/07/03/richard-smith-medical-journals-a-gaggle-of-golden-geese/ http://blogs.bmj.com/bmj/2012/07/03/richard-smith-medical-jo... With so much money at stake, all this should surprise no one. And anyone with an ounce of brains should be very cautious about drugs.
- DanBC 14y agoElsevier have done some dodgy things in the past, such as printing fake journals which appeared to be peer reviewed but not disclosing sponsorship. (http://classic.the-scientist.com/?articles.view/articleNo/27383 http://classic.the-scientist.com/?articles.view/articleNo/27...) Pharmaceutical companies used to spend vast amounts promoting their medications to English GPs. (Estimates suggest over £10,000 per GP, with 40,000 GPs in England.) And, because of our tight regulation that sum was probably less than in the rest of Europe. I'm pretty sure that has now stopped. (http://news.ycombinator.com/item?id=3700513 http://news.ycombinator.com/item?id=3700513) > And anyone with an ounce of brains should be very cautious about drugs. Bob is taken to hospital. Bob is unconscious. Or Bob has a learning disability. Or Bob is going through psychiatric crisis. Or Bob speaks a different language than all the clinicians. Or Bob is under the influence of drugs / alcohol. Or Bob is not that bright. I agree that people should be careful with medication, but it's a shame that we have to do so. I trust doctors, and I sort of trust pharma (I wish there was better regulation), but I'm still wary of meds. (In the UK about 10,000 people die each year because clinicians make mistakes with medications. Compare that figure to Road Traffic Accidents (about 3,000))
- Alex3917 14y agoThis is one of the things I chose to leave out of my massive post before, but since you mention it: "According to the editor of the British Medical Journal, Dr. Richard Smith, 'The major journals try to counterbalance the might of the pharmaceutical industry, but it is an unequal battle -- not least because the journals themselves profit from publishing studies funded by the industry.' The journals benefit from the publicity gained from publishing large drug company-sponsored studies. This increases the value of their advertising and enables them to sell back to the drug companies reprints of articles, which the drug companies then distribute as marketing tools to doctors. According to Dr. Smith, this can amount to more than $1 million for a single article. At the same time that medical journals are given incentives to please the drug companies, they are also given strong disincentives to go against drug company interests. According to Dr. Marcia Angell, former editor of NEJM, editors of medical journals exercise self-censorship -- trying to avoid offending their chief advertisers, the drug companies. Dr. Robert Fletcher learned about this firsthand. In 1992, he was editor of the Annals of Internal Medicine when it published an article reporting that 44 percent of drug ads in medical journals were written in a way that would lead doctors with no other source of information to prescribe improperly. The article also reported that 92 percent of those ads were in some violation of FDA rules. Writing in The Lancet in 2003, Dr. Fletcher said that as punishment for publishing this article, the pharmaceutical industry 'withdrew many adverts' and showed that it was 'willing to flex its considerable muscles when it felt its interests were threatened.' This is a price that medical journal editors would prefer not to pay." Source: Overdosed America, p. 113
- kamaal 14y agoIndian here, One of my uncle is a nephrologist in the US. He recently came to India for a vacation and my talks with him were all about these issues. About how doctors work, their protocols, procedures and ethics etc and things like that. From what I could decipher doctors are not super humans how have miracle cures for every disease to exist on earth. What doctors are generally taught in medical school is to first learn about healthy bodies so that they can later to distinguish between a healthy and unhealthy body. Then they are taught pathology, stuff like dissecting dead humans and learning their internals. And then there are things like anatomy, metabolism, physiology etc. After all this they then go on to diseases and their cures. In an ordinary medical school course. With all that heavy syllabus the actual disease-cure part is taught in a no more procedure than if-then-else decision tree scenarios. Its something like this, Imagine you are taught 100 different symptoms for fever. Combination of all those 100 scenarios in 'OR' and 'AND' conditions lead to various conditions of fever with various diseases. That's what we are talking about here. Imagine you having to remember all this, will it really possible? May be for an year or two but with time that sort of knowledge erodes quickly. On top of this they are taught nothing much about the root cause of these diseases. Their cures. Are they addressing the root causes or just managing symptoms. When they go on to their MD. Then comes little special training and details with investigation, practice and learning about a specific organ/part of the body. This is still understandable. But in general most doctors work like a software cache. The diseases and cures they pull out are the ones cached with the recent patients they are treating. So yes in general most doctors really work only like decision trees at the most abstract levels. Most don't have people skills, most just don't listen to patients completely. Its all working at the most abstract levels with guess work at times. The break through stuff happening in medical science is not your physicians clinic. Its in things like vaccinations, surgical sciences, diagnosis and stuff like that.
- lifeisstillgood 14y agoYes, Medicine is not performing as well as it could do. But it is a million times better than medicine circa 1263 AD I am reminded of the Google logo "Don't be evil". I always heard that and wished that I really was living in a world where evil was defined as monopolistic business practises and bad UI, instead of rape, genocide and torture. I respect Ben Goldacre, and I understand the need for a little hyperbole. But forcing pharma and regulators to publish all trials, and fund independant on-the-job training will not lead to order of magnitude changes. Its an evolution not a revolution. Some day someone will find cancer's penicillin. They will probably have been badly funded, and roundly ignored by the rest of Chinese medical establishment (!) and none of the prescriptions in Ben's book will have helped. I would liken this to the car industry - If the world has not invented the internal combustion engine that is not something changing regulation will fix. Ensuring that after it is invented, the industry is honest, accountable and constantly pressured to improve - that is fixable. Welcome to Nader-hood Dr Goldacre.
- enraged_camel 14y ago>>Some day someone will find cancer's penicillin. Quite unlikely, since "cancer" is simply a term we use for a great variety of different diseases.
- lifeisstillgood 14y agoI would like to claim poetic license, plus, lets face it, we labelled out of control bacterial growth as many different diseases till we had a single medicinal approach. As a tentative example, Mina Bissell's theory on micro-environment supporting cancer growth indicates a penicillin style solution would fit her category of cancer. Please don't take this as "all cancer researchers are fools looking in the wrong direction, I know better, join Scientologists" but my utterly uninformed gut reaction is that the different cancers all have such common and overlapping indicators (uncontrolled cell growth, basically) that there being multiple different root causes that all trigger the same feature seems, unlikely without other factors. We may spend a long time treating the different cancers differently according to which is most effective. But saying that such commonality does not or even cannot have a common cause seems too early. I will of course defer to anyone who knows of better (hell, any) evidence to tear down my layperson POV.
- d0de 14y agoI suspect I've missed the boat on this one, but in any case: About a year ago, I began an (overly) ambitious project to build a database of the scientific evidence behind the use of herbal supplements to treat a variety of conditions. I sank my nights and weekends into it for a couple of months but only got as far as one test section. It's sat more or less derelict ever since. Aside from a mostly ignored Reddit submission, no-one has ever really seen it. If you have a minute, take a look and please let me know any thoughts you have about it at all. http://herbevidence.com/data/Erectile_Dysfunction http://herbevidence.com/data/Erectile_Dysfunction (Forgive me, the section on ED happens to be one I wrote up as a test section because I was researching it anyway as a writing gig. Click on the name of each supplement in the first table to go to the full page for it.)
- droithomme 14y agoThat is extremely nice and useful site. I would love to see the other sections and encourage you to continue work on it.
- d0de 14y agoThanks, I appreciate your comment. Unfortunately, barring a change in my circumstances or a sudden upsurge in interest from the public, I just don't think it will be possible. It may not look like it but the research involved even in that one modest test section was (by my standards at least, possibly I'm just workshy) a massive undertaking.
- droithomme 14y agoIt definitely looks like a thousand hours or more of research to track all that down just for the one category. Very admirable.
- xanados 14y agoYou may be interested in http://examine.com/ http://examine.com/ which is a project similar to yours but focused mostly on fitness supplements specifically (although it has articles on major other supplements like fish oil). Their editors have actually provided a lot of write-ups even though they are just volunteers originally from reddit's Fitness subreddit.