
Ben Goldacre: Here’s the foreword to my new book, Bad Pharma - bootload
http://www.badscience.net/2012/09/heres-the-intro-to-my-new-book/
======
oracuk
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....](http://news.bbc.co.uk/today/hi/today/newsid_9754000/9754505.stm)

~~~
yen223
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.

~~~
ZoFreX
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!

~~~
Joeboy
I didn't know that. Is there something I can read that'll back it up?

~~~
ZoFreX
I 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
In 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
Yeah, 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 :)

------
tokenadult
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...](http://www.sciencebasedmedicine.org/index.php/stem-cell-therapy-
regulation-plays-catch-up-2/)

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...](http://www.sciencebasedmedicine.org/index.php/news-flash-doctors-
arent-all-compliant-pharma-drones/)

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.

~~~
Alex3917
"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"

~~~
tokenadult
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.

~~~
Alex3917
"But it's an exaggeration [...] to say that the enterprises that develop new
drugs for prescribed medical treatment are corrupt in general beyond what
Goldacre claims with specific evidence."

edit: Response moved to pastebin: <http://pastebin.com/cniysd82>

(Didn't realize how long that was going to get.)

~~~
hahainternet
You've damaged this comment page and shown your immaturity to the public.

~~~
pstuart
I think you're being dramatic. Posting a too long comment in trying to make a
point?

------
bmj
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.

~~~
kokey
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.

~~~
pstuart
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.

~~~
DanBC
Medication non-compliance is a big problem.

About half the English medication budget (£4.5 billion of £9 billion) is
wasted because people don't take their medication correctly. This isn't just
the medication for little things either. A major cause of transplanted organ
problems is people not taking the meds correctly.

Not great sources, but:

(<http://www.bbc.co.uk/radio4/science/casenotes_20040817.shtml>)

(<http://www.bbc.co.uk/radio4/science/casenotes_20060509.shtml>)

------
loxs
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...

------
lifeisstillgood
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.

~~~
mhax
>> 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...

~~~
lifeisstillgood
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.

------
boothead
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
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.

------
stef25
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
What very serious disease have they cured recently?

------
marze
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...](http://blogs.bmj.com/bmj/2012/07/03/richard-smith-medical-journals-a-
gaggle-of-golden-geese/)

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
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...](http://classic.the-
scientist.com/?articles.view/articleNo/27383))

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))

------
d0de
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.)

~~~
xanados
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.

~~~
d0de
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.

~~~
aaxe
<http://examine.com/health-goals/>

------
kamaal
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.

------
tocomment
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.

~~~
Alex3917
"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.

~~~
tocomment
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?

~~~
Alex3917
"So in theory a startup might be able to get that 20 million figure down to 5
million if they're lean?"

Not likely, MAPS is already as lean as you can get. And they have a big
advantage since there have already been dozens or hundreds of previous studies
done on MDMA to establish safety.

------
stbullard
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
<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> "

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

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

