
How to Slash the Cost of Drug Development - prostoalex
http://www.scientificamerican.com/article/busting-the-billion-dollar-myth-how-to-slash-the-cost-of-drug-development/
======
sbierwagen
Unlikely.

    
    
      It has done this with US$290 million—about one-quarter of what 
      a typical pharmaceutical company would spend to develop just 
      one drug. The model for its success is the product development 
      partnership (PDP), a style of non-profit organization that 
      became popular in the early 2000s. PDPs keep costs down 
      through collaboration—with universities, governments and the 
      pharmaceutical industry.
    

So, was the $290 million the _total_ amount for all 26 trials? Or did the
collaborators kick in money? Because otherwise this is like claiming you've
found a way to buy a new Tesla for $1000-- as long as your parents pay the
other $69,000!

    
    
      Drug development from scratch is arduous and expensive. It 
      begins with experiments on hundreds of thousands of 
      chemicals in the lab, looking for one that kills a pathogen 
      without harming the host. 
    

The article does not go out of its way to mention that this _isn 't_ the
expensive and arduous part. The clinical trials are what's expensive, since
you have to pay thousands of people, who have the disease you're targeting, to
take your experimental drug. In many cases, they have to take your drug
_instead_ of a drug that's known to work. And you have to follow these people
for years, just in case they don't all suddenly get liver cancer and die a
year after they stop taking your drug. (Something like this cost Merck $4.85
billion dollars in 2004:
[https://en.wikipedia.org/wiki/Rofecoxib](https://en.wikipedia.org/wiki/Rofecoxib)
)

    
    
      The final trials on fexinidazole conclude this year, and 
      Wourgaft is hopeful that the data will earn regulators' 
      stamp of approval. The project has so far cost the DNDi 
      about $45 million—and it stands to help 21 million people at 
      risk of the disease in Africa.
    

_Which_ regulators? There is a rather huge difference between the FDA and the
Central African Republic's FDA-equivalent. Is this how they're saving money on
clinical trials, by running clinical trials on Africans, and only getting
regulatory approval from African states?

~~~
daxfohl
Running unregulated clinical trials in impoverished nations is demonized and
illegal when done by big pharma, but championed when done by some little
company "trying to make a difference". I like the ideal but so much of this
seems like marketing.

Granted, motivation makes a big difference here. However it's often hard to
tell profit motive from innate motive, especially in a legal context. What
starts off as innate can quickly become profit-oriented (or even worse "I told
you so"-oriented) behind closed doors when stuff hits the fan.

~~~
sandworm101
>> unregulated clinical trials in impoverished nations is demonized

It is, but _regulated_ trials in such countries have real scientific
advantages. The average US patient (older, overweight, probably diabetic)
swims in a cocktail of drugs ranging from painkillers[1] to cholesterol
reducers. By some estimates 60% of American adults are on one or more
prescription drugs, a percentage that no doubt climbs with age. That makes
them difficult guinea pigs for the study of new treatments. But the average
African cannot afford such cocktails and so is most likely clean of other
drugs. Costs and poverty aside, if you are looking for a drug-free study
population, Africa is easier than the west.

[1] "In 2010, enough prescription painkillers were prescribed to medicate
every american adult every 4 hours for 1 month."

[https://www.drugabuse.gov/related-topics/trends-
statistics/i...](https://www.drugabuse.gov/related-topics/trends-
statistics/infographics/popping-pills-prescription-drug-abuse-in-america)

~~~
Thriptic
It's not important that the medication works on an ideal population, it's
important that it works on the actual target population. If you can't show
efficacy and safety in your target population who may have several
comorbidities and could be taking many other drugs which may interact poorly
with your drug, then your drug is a failure in the real world. It therefore is
not sensible to test for safety and efficacy on a population that poorly
mirrors your target population.

~~~
pixl97
Eh, it's both.

You need a baseline for any testing. When testing physical equipment with a
difficult to diagnose problems the easiest way to figure out what is going on
is to take the hardware down to a base state and then add one component at a
time to see where things go wrong. When you have one population that is
positively effected by your drug and takes no other medications it gives a
great deal of insight when another population is negatively effected that is
highly medicated.

We have a problem here in the U.S. that almost all of our old drugs would
never be approved these days because of interactions with other drugs and side
effects. With the huge amount of medications taken we need the baseline to
tell doctors to stop giving patients drugs X, Y, and Z because they would be
much better off only taking A.

~~~
refurb
_We have a problem here in the U.S. that almost all of our old drugs would
never be approved these days because of interactions with other drugs and side
effects._

That's a huge exaggeration. There are maybe a handful of drugs where the side
effects/interactions are so bad that they wouldn't be approved by today's FDA.

------
refurb
_And it has put another 26 drugs into development. It has done this with
US$290 million—about one-quarter of what a typical pharmaceutical company
would spend to develop just one drug_

They are comparing two different things with this statement. You can't compare
"bringing something into development" and bringing it to market. Hell, if I
move some crap drug into phase one i've "brought it into development". It
means nothing.

Also, the one example of a marketed drug they successfully brought to market
was a combination of two already approved drugs. The risks are much lower when
you don't have to worry about toxicity and ADME.

I'll give them credit for working on a noble cause, but I've seen nothing to
suggest they've fixed the challenges of R&D.

------
DanielBMarkham
I was uncomfortable reading this. I kept waiting for some assurance from the
writer that they understood the complexity of the drug manufacturing
landscape. Instead I got a blanket statement that the "expensive drug" thing
is a myth, and a pro forma contrarian view 80% of the way down the page --
which was quickly shot down.

(By the way, this story format is getting a little old. The writer obvious has
a pitch to make. They make the pitch by talking to selected subjects and using
their quotes. Then, in order to somehow assure the reader of balance, they
bring in a fall guy about 80% of the way in to say something cranky. Then they
dismiss it. It's okay in argumentation, I guess, but really should be rare in
straight reporting.)

Note that I'm not saying there isn't something cool here. Beats me. I read the
article and have no more of an understanding about drug development than when
I began. This felt like one of those articles where an editor runs into a
booster at a social event and is told how really cool X is. They get excited.
So they tell a writer to go write a story telling folks how really cool X is.

Mission accomplished. But not such a good article, sadly.

~~~
randcraw
Daniel, I _do_ work in drug development, and I have no better idea than you
how this "new and better way" to make drugs will really work.

The author mentions repeatedly that DNDi got reduced cost access to both high
throughput screening, clinical trials, and drug regulation, so they can
develop a drug for less cost. No surprise, but how is this a sustainable model
for developing most new drugs? What processes have they improved to save
money/time that is _not_ dependent on freebies from generous for-profit drug
corporations, universities, and governments? Somehow I missed that part.

Personally, I'd dearly love to reduce the cost of drug development and prices.
But until DNDi pays the full cost for all of the reagents, processes, and
rules in their drug development process, they have no business claiming to
have cured the ills that bedevil big pharma. No business at all.

~~~
msandford
What I read is that they aren't looking for a multi-billion dollar profit.
Which means that they don't have to work on a drug that they can sell to
everyone. Which means that they can focus on neglected areas of medicine for
which the existing treatments are non-existent or terrible.

It's the difference between "proving" that changing a button color at Amazon
makes people buy 1% more stuff (worth billions, probably) and "proving" it at
a start-up. The start-up won't care about 1% more, but if you can triple
sales, awesome! Even though tripling sales at a start-up might only be worth
$500k, not billions.

When you're making HUGE inroads on efficacy it's much, much easier to
demonstrate and you don't need thousands or tens of thousands of patients in
the trial in order to get a statistically significant result.

~~~
randcraw
1) However chasing unserserved markets doesn't reduce the cost of making a
drug, it just diminishes the financial reward.

2) The regulatory threshold for efficacy doesn't change just because the drug
maker isn't trying to make a profit. They'll still need the same rate of
postive outcomes for a drug to get FDA approval. Yes, if a drug is deemed
life-saving, the approval criteria may ease to expedite the approval process
and lessen the thresholds for efficacy and toxicity. But such fast tracking
applies only to critical care drugs and without regard for their potential
market size or profitability. The need must be dire and unserved.

------
mrleinad
Big pharmas don't set the price for drugs based on their cost. They base the
price on what people on different regions can pay, thus maximizing their
profit. Cost is not a variable for the price, how much money people have in
that sector is really the basis of it.

~~~
hga
That's _the_ most very basic principle of marketing and sales, so why "big
pharmas" wouldn't engage it would be curious.

In field where marketing and pricing are much less understood, like ours, the
trick is that after you establish acceptable pricing for your widgets, you
then compare that to all your production, etc. costs to to see if you should
keep selling them etc

Note that in many "regions" "big pharma" negotiates the price with a penny
punching government

Note also some drugs _are_ inherently expensive to produce, I'm thinking one
anti-HIV one that had the usual suspects screaming, but it has 3 chiral
centers (ouch!; for a layman's analogy illustration, Derek Lowe wrote a good
one using ballons...).

~~~
hx87
> Note that in many "regions" "big pharma" negotiates the price with a penny
> punching government

That's one of the reasons why drugs are so expensive in the US--we are one of
the few countries to not have government negotiating our side, so
pharmaceutical companies have to make their profit here.

~~~
hga
Indeed, and if we "fix" that, well, I satisfy myself with the thought that
many of the people supporting that policy, and/or their loved ones, will
needlessly suffer and/or prematurely die because they stopped the development
of a drug that would have saved them.

------
pella
related:

"Open Source Drug Discovery" \- "collaborative drug discovery platform for
neglected tropical diseases like leishmaniasis, which draw limited attention
of research, based pharmaceutical enterprises"

[https://en.wikipedia.org/wiki/Open_Source_Drug_Discovery](https://en.wikipedia.org/wiki/Open_Source_Drug_Discovery)

\--or --

"Crowdsourcing in pharma: a strategic framework"

[http://dx.doi.org/10.1016/j.drudis.2015.01.011](http://dx.doi.org/10.1016/j.drudis.2015.01.011)

pdf: [http://csmres.co.uk/cs.public.upd/article-
downloads/Crowdsou...](http://csmres.co.uk/cs.public.upd/article-
downloads/Crowdsourcing-in-pharma.pdf)

------
dannylandau
If you could run a drug development company like you do a start-up, then you
could probably speed up drug development 1000x fold. Of course, still need to
have some safety mechanisms in place to prevent serious injury/death, but
there is a gigantic room for improvement that will benefit humankind.

~~~
Thriptic
Do you want your drug company to move fast and break things? I agree that
there probably are ways to shorten various aspects of drug development, but
fundamentally you are talking about a highly regulated, potentially dangerous
product. At the end of the day, the businesses cannot behave like software
startups as the stakes are totally different and the systems they are
operating in (humans) are orders of magnitude more complex than computers.

~~~
2close4comfort
But humans are treated worse, how many drugs have killed people because the
Company exploited a problem and underestimated the affects on larger
popualtions (or just didnt care).

~~~
Ralfp
This isn't an excuse to carry on.

~~~
2close4comfort
No it is a reason to change

