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

Actually no

[rsilvergun]

most of the (expensive) basic research is still done on the public dime. Then big pharma comes in, runs a few (cheap) clinical trials, patents the whole shabang and blamo, new drug. You didn't think mega corps actually paid for things like us little people, did you?

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.

[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.