What Is Open Source Pharma (and Why Should You Care)?

Andy Updegrove writes: Humanity today is almost completely dependent on huge pharmaceutical companies to create the drugs we need. But these companies focus exclusively on drugs that can be sold at high prices to large populations — in other words, to patients in developed nations. This means that those who live in the emerging world that suffer from the remaining 'neglected diseases,' like Malaria and drug resistant TB, have no one to depend on for relief except huge charities, like the Gates Foundation. They also have no way to afford many of the patented drugs that do exist. But there is another way, modeled on open source software development, which relies on crowd sourced knowledge, highly distributed, volunteer efforts, and advanced open source tools. That methodology is called Open Source Pharma, and it has the potential to dramatically drive down drug development while saving millions of lives every year.

Comments

Re:This won't be allowed to happen

[ScentCone]

I have Chinese neighbours and they're showing me new (to me) stuff all the time

You mean like how grinding up the horn of a rhinoceros and eating it will fix erectile dysfunction because, you know, horns are sort of phallic looking, and if there are only a few of the animals left in the world, it's a sure sign that their horns must be really really effective? Yeah, that's how Chinese medicine operates. It's almost entirely placebo effect, and ... shocking! ... Chinese people die of cancer every day.

Sorry but I'm going to have to cite Dara O'Brian

[Sycraft-fu]

"Oh herbal medicine has been around for thousands of years. Indeed it has and then we tested it all and the stuff that worked became 'medicine' and the rest of it is just a nice bowl of soup and some potpourri."

https://www.youtube.com/watch?...

Your statement about pot curing cancer also has to be one of the stupidest, most easily disproven thoughts I've seen in awhile. Turns out that when people get cancer often they need help managing pain and apatite and marijuana DOES help with those, so a good portion use it. Guess what? They don't get cured. I've had two people close to me who got cancer and died, both who use marijuana to manage symptoms.

You dumbass potheads do more harm to getting it legalized than any of your opponents could by making shit up. The more you lie about what it actually does, how it actually works and the actual risks (yes there are risks, everything has risks) the less people are going to listen to you about the real benefits.

Grow up.

Re:Actually no

[ShanghaiBill]

Then big pharma comes in, runs a few (cheap) clinical trials

Clinical trials are not "cheap". They are usually the most expensive part of bringing a new drug to market.

Pharma development is hard and expensive

[hawkeyeMI]

Here's approximately how the drug development process works, to the best of my knowledge. I'm not in pharma but I've discussed some research projects with pharma folks and done a few projects on contract with them. I am not a pharmacologist or chemist. I am involved in medical device development and clinical trials for that purpose.

1. Pick a target condition (based upon need, existing treatments, size of market, whatever)
2. Based upon pharmacology, look at possible pathways to address said condition
3. Develop/find compounds that might address those pathways
4. Do whatever possible to narrow down these compounds by screening for safety before doing any trials, animals or otherwise. Select very carefully for screening techniques that won't give you false dangerous results becuase even if the compound is actually safe in the end, if you have a screen that looks bad at this stage the FDA is not going to like it down the road and it exposes you to liability.
5. Do animal trials with the promising compounds and hope some both work and don't cause harmful effects. Depending on the animal model this can get very expensive and time consuming.
6. Do human trials with promising compounds. A well-powered study will be VERY expensive (easily tens of millions of dollars or more), and depending on the condition being targeted, may also be very time consuming. Hope that what worked in animals works in humans, and no harmful effects crop up.
7. Assuming you make it through FDA approval, and they don't make you do more trials or enroll more patients before you get it, now you can produce the drug.
8. Try to sell enough of the drug to recoup your R&D expenses on ALL the compounds you checked out for the condition, all the trial expenses, etc, before the IP protection expires and the drug goes generic.

This "open source" model is neat and it may help a lot, especially in places where you can get away with less regulatory approval, but the way it's done is not because pharma companies are evil. It's because drug development is hard and expensive, and anything less than a blockbuster drug carries a high risk of never recouping the R&D expenses.

I think there's a lot of hubris to the idea that it can be done so much better this other way, but I will be happy to be proven wrong, because it really is a problem that needs solving.

Re:Pharma development is hard and expensive

[RandCraw]

I do work in pharma, and your sequence of steps sums up the process nicely.

I'd add that for every drug that succeeds, roughly another 20 fail, often after 5 or 10 years of development and costs incurred. That's why the estimated development cost of each new drug is widely acknowledged to be a minimum of $1 billion US (though most cite $2B as the norm). However after you include the cost of all failed drugs, the cost of producing each drug that succeeds effectively rises to between 4 and 5 billion. This is why each new drug needs to be a big selling blockbuster. It has many mouths to feed.

Obviously open software and volunteerism has their work cut out for them if they are to make drugs affordable. But I *would* be curious to know where their advocates believe these forces could have significant impact. It'd have to be in the clinical trial phase, where 80% of cost is incurred.

(BTW, to compute the net average cost of each new drug, you divide pharma company annual R&D budgets by the number of approved drugs/year. Matthew Herper of Forbes has covered this topic extensively, as has pharma chemist chemist Derek Lowe in his blog "In the Pipeline").

Re:There's more to it than developing the drugs.

[currently_awake]

Reasons for government to do all drug research: #1-drug companies do research for profit only, unprofitable drugs don't get developed no matter how many lives it would save. #2-high cost and risk of developing new drugs. #3-developing a cure is less profitable than a treatment, so corporations would only make the treatment. The drug companies should only do production and distribution.

Re:There's more to it than developing the drugs.

[ArmoredDragon]

Reasons for government to do all drug research: #1-drug companies do research for profit only, unprofitable drugs don't get developed no matter how many lives it would save. #2-high cost and risk of developing new drugs. #3-developing a cure is less profitable than a treatment, so corporations would only make the treatment. The drug companies should only do production and distribution.

Ok I'll need you to take off your rose tinted government issue glasses for a minute. Consider the fact that the US has a smaller GDP than the combined EU, and the EU governments take in more taxes than the US government.

Now ask yourself, why is it that the world's most advanced medications always come from for profit corporations in the US, and nowhere else? Why is it that the US is by far the most popular destination for medical tourism, even though in the US, hospitals are owned by private, for profit corporations?

Clearly because government run medicine is so much better, right?

Re:There's more to it than developing the drugs.

[sjames]

Too bad you're wrong. India and Singapore are the hot medical destinations. Mexico is popular for Americans who need expensive dental work. There ARE people who travel to the U.S. for medical care, but more people travel FROM the U.S. to get medical care.

I have no idea where you got the idea that all of the drug development happens in the U.S.

Re:There's more to it than developing the drugs.

[sackvillian]

Clearly because government run medicine is so much better, right?

The US pays its doctors some of the highest salaries in the world, publishes the most and best medical research in the world, and also charges its patients the most in the world.

You can find the best and worst care in the US. For the rich who want the best care -- American or not -- the US is their destination of choice. It's just that the rest of the developed world gives a damn about providing decent care to the vast majority of citizens who are not rich. By focusing on that, they take care of the rank and file and still leave the opportunity for the richest to travel abroad to pay through the nose for better care, so nobody really suffers.

And as the poster below points out, medical tourism is not exactly the best metric of your system's quality. India and Mexico aren't exactly shining models of medical care.