[opensourcepharma] a open source cure for Ebola?

Wed Aug 6 22:53:47 UTC 2014

I like that idea – let’s launch a crowdsourcing initiative to gather (and share) all knowledge/data of what is out there already.
Preference is of course to look for data of already approved drugs that may have shown activity against ebola or related viruses.
But let’s also collect info from ongoing or “aborted” drug development programmes, eg:

http://online.barrons.com/news/articles/SB50001424053111904329504580072041992787302
Sarepta Ready to Provide Ebola Drug if Needed
“Two years ago, the Department of Defense decided to continue funding the development of Sarepta's drug for Marburg, another deadly tropical virus similar to Ebola, while funding Tekmira's drug for Ebola. At the time, Sarepta said the government decision to end funding for its ebola drug was based on budgetary considerations and not the effectiveness of its drug.”

Once all the data are available and shared openly, it may become easier to see which are the more promising avenues, and what would be next steps to pursue

Els

From: Bernard Munos [mailto:bhmunos at gmail.com]
Sent: Wednesday, August 06, 2014 6:44 PM
To: Tomasz Sablinski
Cc: Els Torreele; opensourcepharma at lists.okfn.org
Subject: Re: [opensourcepharma] a open source cure for Ebola?

My advice would be to position it as a crowdsourcing initiative to find badly needed treatments quickly, among the store of already-approved drugs. Once such potential treatments have been identified, I would consult with MSF, DNDi, and other NGOs to identify the next steps.

b

On Wed, Aug 6, 2014 at 6:19 PM, Tomasz Sablinski <tomasz at transparencyls.com<mailto:tomasz at transparencyls.com>> wrote:
Dear All,

I am making this suggestion with a bit of trepidation, because it is such enormous task, and politically charged topic.

What if we used Transparency Life Sciences platform to engage the crowd to:
1/ identify the most suitable candidate(s) for clinical testing, along the lines suggested by Bernard via a "reversed" TLS Indication Finder
2/ design the simplest and most feasible clinical research protocol using TLS Protocol Builder

We know how to curate and make sense of crowd contributions counting hundreds. I imagine that the name Ebola would attract thousands. Our survey technology can handle such numbers, we just haven't done it yet. This effort would require some $$ for IT, etc, and expert(s) from CDC (?), WHO (?), etc to "curate" the crowd.

I would see this as joint Open Source Pharma and TLS project. I think it fits both organization visions nicely, and the social impact and example to th world could be tremendous.

Please let me know what you think, and also understand that I am throwing this idea ad hoc, and can not make a firm commitment before we figure out details.

Regards,

Tomasz

On Wed, Aug 6, 2014 at 5:58 PM, Bernard Munos <bhmunos at gmail.com<mailto:bhmunos at gmail.com>> wrote:
There are several publications in PLoS and Science TM suggesting that at least half a dozen approved drugs have some degree of efficacy against Ebola (here<http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0060579&representation=PDF> and here<http://stm.sciencemag.org/content/5/190/190ra79.abstract?sid=ecf907f6-a4ae-4b37-a29d-474963a53068> and here<http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0060579>). However, they have never been tested in humans (hard to find patients outside epidemics). By law, FDA may not disclose which drugs have been submitted for approval. However, this is not a problem because any application has to rely on human trials that must be registered on clinicaltrials.gov<http://clinicaltrials.gov>. In this case, a quick search<http://www.clinicaltrials.gov/ct2/results/displayOpt?flds=a&flds=b&flds=f&flds=c&submit_fld_opt=on&cond=Ebola&show_flds=Y> shows 9 trials -- 5 phase 1 vaccine trials sponsored by NIH; 4 phase 1 drug trials sponsored by Sarepta, Tekmira, and NIH. No human trials on repurposed dugs yet, although that could change, with the situation. Since no phase 2 and 3 trials have been registered, no Ebola drug could have been submitted for approval in the US.

Sending unapproved drugs to Africa is fraught with ethical concerns about using Africans as guinea pigs. US was correct to treat its own citizens first to avoid that charge. My guess, however, is that it might respond favorably if it were to receive a request from African government(s) for experimental treatments. These governments can also offer repurposed drugs to their patients, if they wish, since they are generic, inexpensive and widely available.

The positive development in all that is that the drug developed by Mapp Biopharmaceutical is a monoclonal antibody produced in genetically-modified tobacco plants. This is a new technique that can produce kilo quantities rather cheaply, as opposed to the very expensive gram quantities produced by traditional cell culture. So this Ebola disaster might end up validating a new technique that will upend the economics of monoclonals, by far the most expensive drugs today. The impact on biosimilars, oncology, inflammation, etc, could be huge.

b

On Wed, Aug 6, 2014 at 4:33 PM, Els Torreele <els.torreele at opensocietyfoundations.org<mailto:els.torreele at opensocietyfoundations.org>> wrote:
It’s been fascinating to read some of the commentaries on the fact that we don’t have a treatment against Ebola virus, eg:
http://www.vox.com/2014/8/4/5963751/the-real-cause-of-the-ebola-outbreak-its-not-what-you-think

As well as that there seem to be a few experimental treatments around, but all is shrouded in secrecy
http://www.aljazeera.com/news/africa/2014/08/experts-give-new-us-ebola-drug-africans-201485233636516828.html
http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html
“ The FDA cannot comment on the specifics of ongoing drug development programs and cannot reveal information that is not otherwise public concerning submissions covering such programs such as IND applications submissions.”

Wouldn’t this be a great opportunity for open source drug R&D, including crowdsourcing ideas, to speed up the discovery of a desperately needed new drug. Instead of having a few companies working privately on their own (with US gov support often), we could imagine opening it all up, share what we know about the virus, about the potential drug candidates out there, and then together build upon shared knowledge and progress?

Els Torreele, PhD
Director, Access to Essential Medicines Initiative
Public Health Program
Open Society Foundations
224 West 57th Street I New York, New York 10019
Tel: (+1)-212-548-0351<tel:%28%2B1%29-212-548-0351> I M: (+1)-646-262-2053<tel:%28%2B1%29-646-262-2053>
els.torreele at opensocietyfoundations.org<mailto:els.torreele at opensocietyfoundations.org>
http://www.opensocietyfoundations.org/topics/access-medicines

_______________________________________________
opensourcepharma mailing list
opensourcepharma at lists.okfn.org<mailto:opensourcepharma at lists.okfn.org>
https://lists.okfn.org/mailman/listinfo/opensourcepharma

--
Follow me on Forbes<http://blogs.forbes.com/bernardmunos/> and Fastercures<http://fastercures.tumblr.com/post/62722481036/give-me-your-innovators-yearning-to-breathe-free#!>

_______________________________________________
opensourcepharma mailing list
opensourcepharma at lists.okfn.org<mailto:opensourcepharma at lists.okfn.org>
https://lists.okfn.org/mailman/listinfo/opensourcepharma

--
Follow me on Forbes<http://blogs.forbes.com/bernardmunos/> and Fastercures<http://fastercures.tumblr.com/post/62722481036/give-me-your-innovators-yearning-to-breathe-free#!>
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.okfn.org/pipermail/opensourcepharma/attachments/20140806/ce0fe5f0/attachment-0002.html>