[opensourcepharma] a open source cure for Ebola?

[Bernard Munos]

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. 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> 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 I M: (+1)-646-262-2053
>
> els.torreele at opensocietyfoundations.org
>
> http://www.opensocietyfoundations.org/topics/access-medicines
>
>
>
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>
>


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