Ben Goldacre: Here’s the foreword to my new book, Bad Pharma

http://www.badscience.net/2012/09/heres-the-intro-to-my-new-book/

by bootload • 14 years ago

146 85 14 years ago

oracuk• 14 years ago

Ben 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

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....

rwmj• 14 years ago

Also a good overview and introduction in the Graun a few days ago: http://www.guardian.co.uk/business/2012/sep/21/drugs-industr...

sjmulder• 14 years ago

Note that iPlayer for radio is available outside the UK as well.

yen223• 14 years ago

It'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.

ZoFreX2• 14 years ago

Which 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!

DanBC3• 14 years ago

Also confusing because of his work with CBT and other talking therapies, which help reduce the use of medication.

loxs• 14 years ago

This 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...

bmj2• 14 years ago

I'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.

kokey2• 14 years ago

I'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.

bmj2• 14 years ago

Electronic 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.

pstuart2• 14 years ago

Anecdotal "data point": my wife works in the biotech field. For one very large company they had a drug developed that worked but had to be dosed dependent upon weight.

Marketing felt that doctors would only use the product if it was simple enough, so they made it a one-size-fits-all dose.

tehwalrus• 14 years ago

Ben Goldacre is a legend. Buy this book for your friends for Christmas!

boothead• 14 years ago

It's getting some great reviews on Amazon: 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• 14 years ago

What 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.

droithomme4• 14 years ago

PR firms get paid a lot to splatter the net with those sorts of reviews of books that aren't even for sale yet.

tokenadult2• 14 years ago

It'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/

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-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/

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-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

for thoughtful comments by all of you.

Alex391715• 14 years 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

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"

tokenadult2• 14 years ago

Alex, I have lived in more than one country, so I have made specific observations of precisely how little influence the FDA has on the drug regulations of other countries. And I previously provided numerous examples to you of the FDA keeping drugs off the market or removing drugs from the market based on evidence of safety and effectiveness.

http://news.ycombinator.com/item?id=4245571

I would submit that the underlying system corruption is probably stronger among enterprises that sell schedule I controlled substances here in the United States than among those that sell government-regulated, physician prescribed medications. Both regulatory systems, the system that makes some drugs I've seen you speak up for contraband, and the system that makes some newly invented drugs legal items of commerce, may indeed need further reform. But it's an exaggeration (contradicted by thoughtful comments by drug industry researchers who have already posted replies in this thread) to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general beyond what Goldacre claims with specific evidence.

pessimizer• 14 years ago

Please delete it. Post a link to it, but don't post the entire thing.

demallien• 14 years ago

Woah, you're way off when talking about sciencebasedmedicine.org. That's Steve Novella's site - and he's about as respected as you get in the sceptic community. If you want to claim that it's mostly industry propaganda, you'd better have some good evidence to back up the claim!

unix-dude• 14 years ago

You raise a good point by highlighting that this book focuses on British examples (not to mention provide really nice links!).

However, I think the most important lesson in this book and other publications like it, is not in its specifics, but in its general message.

Too many people blindly trust pharmaceuticals, too many don't even consider them "drugs", because "drugs are bad" but pharmaceuticals are good. Books/Articles/etc like this are essential if people are ever going to realize that just because a doctor hands them a pill, it doesn't mean that pill is safe.

The lazy and apathetic will never shift their focus, but hopefully books like these will inspire more people to do their own research before popping an unknown,name-branded chemical into their mouths.

All it takes is a google search of "Active Ingredients of 'X'", and then five minutes of searching "Side Effects of 'X'", or "Interactions with 'X'" to prevent potentially harmful ingestion.

stbullard• 14 years ago

Hardcover/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• 14 years ago

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 "

tocomment3• 14 years ago

I'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.

shrikant3• 14 years ago

I'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.

Alex391715• 14 years 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.

tocomment3• 14 years ago

That's really interesting. Thanks. So in theory a startup might be able to get that 20 million figure down to 5 million if they're lean?

mikeash• 14 years ago

Shouldn't other failed drugs count, though? If you have to develop e.g. five drugs for each one that you find to be successful, the R&D costs for the four that failed should be counted as part of the costs for the successful one.

refurb4• 14 years ago

"That said to get a drug through phase III trials shouldn't cost more than about $20 million."

I would have to seriously disagree with that statement.

I've spoken to a number of CROs that run clinical trials. They estimate that it's somewhere between $10K and $20K per patient per year to run a phase III clinical trial (the exact number depends on what kind of data you are collecting).

For example, if we look at a cardiovascular drug where you're trying to get data to support improved patient outcomes (not just reduced cholesterol, but fewer deaths), you'd need to run a trial of 20,000 patients or more, for several (think 3 to 5) years.

For example, look at the JUPITER trial http://en.wikipedia.org/wiki/JUPITER_trial

Figure out the math on that: 20,000 patients * $10K/pt/yr * 3 years. I get $600M for ONE trial.

Keep in mind that the FDA requires TWO pivotal trials to gain approval for a drug.

Of course, this is an extreme example. CV drugs and the trial described above are pretty much the largest trials you'll ever see. However, to say that getting a drug approved through phase III should cost more than $20M is clearly wrong.

stef252• 14 years ago

The cost is millions or billions. Pharma companies develop molecules that never even make it to the animal testing stage. Only one out of so many molecules makes it to the market and brings in money. If it's discovered that, after perhaps a decade of animal, volunteer and patient testing the drug can not be marketed, the cost that went in to that needs to be recuperated from the next one that can be marketed. It's a very expensive process.

Alex391715• 14 years ago

"Pharma companies develop molecules that never even make it to the animal testing stage."

In the US the vast majority of pre-clinical work is done by universities. Pharma companies usually license the patent from the universities once it is ready for clinical testing, under the Bayh-Dohl act:

rchi3• 14 years ago

I wonder if Goldacre's solutions would actually help. If it's so easy to fix the system, people would have already done it.

urbanautomaton• 14 years 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.

rchi3• 14 years ago

You are proving my point. There are many difficulties to fixing the system. Broken system persists because 'solutions' cannot be easily/successfully implemented.

stef252• 14 years ago

It'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• 14 years ago

What very serious disease have they cured recently?

marze• 14 years ago

Here is a way to bribe journals, by purchasing large quantities of "reprints":

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.

DanBC3• 14 years ago

Elsevier 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/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)

> 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))

Alex391715• 14 years ago

This 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• 14 years ago

Indian 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.

lifeisstillgood3• 14 years ago

Yes, 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• 14 years 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.

lifeisstillgood3• 14 years ago

I 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.

mhax• 14 years ago

>> But forcing pharma and regulators to publish all trials, and fund independant on-the-job training will not lead to order of magnitude changes.

No, but it will allow people to make more informed decisions about what medicine they should take, and give a more realistic picture about its effectiveness. There is no justifiable reason to withhold trial data...

lifeisstillgood3• 14 years ago

I quite agree and beleive that we should have all trials published openly. I think Goldacreas book is a good salient point in a tidal change coming. I am hopeful.

However my point was that the hyperbole was a little too much - Goldacre has a difficult tightrope to walk - to stir people up enough that he (sells books and) convinces them action is necessary, and yet does not actually go over the top and accuse a generally beneficial-to-society pharma industry of being one step above arms dealers.

I think he will pull it off and look forward to putting it on my Xmas reading list.

d0de3• 14 years ago

I 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

(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.)

droithomme4• 14 years ago

That is extremely nice and useful site. I would love to see the other sections and encourage you to continue work on it.

d0de3• 14 years ago

Thanks, 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.

xanados• 14 years ago

You may be interested in 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.

d0de3• 14 years ago

Yeah, I've been following them for a while. Aside from the obvious difference in focus, my biggest gripe with that site is that the basic taxonomy is per supplement. The typical use case is the user hears about supplement A, hears it's good for purpose X, then searches for "A" or "A fox X", finds the examine.com page, and sees if A is really good for X.

With my project, the basic taxonomy was always per-complaint (or per-illness if you prefer). It doesn't presuppose the user has ever heard of any particular supplement. The idea is the user can browse to the page that documents their condition and quickly see a summary of all the evidence for all the different tested herbal treatments.

Now, I'm not at all sure that this difference in structure justifies starting all the research etc. from scratch. It may be the case that examine.com could trivially switch over to the structure I used. But I do think that my structure is superior.

aaxe2• 14 years ago

I'm from Examine - contact me via http://examine.com/contact/ please.

Just want to be in touch :)

Ben Goldacre: Here’s the foreword to my new book, Bad Pharma

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