Crowdfunding A Patent-Free Drug For Treating Cancer
from the here's-how-it's-done dept
Here on Techdirt we've been pretty scathing about the way that Big Pharma develops drugs -- often poorly -- and then uses patent monopolies to keep prices so high that only rich Westerners can afford them. Of course, it's easy to complain about the flaws of the current approach, but are there any alternatives? We've already covered one -- using prizes - and now Carl Levinson points us to another potentially powerful approach: crowdsourcing. It's already been adopted by 'Project Marilyn' to develop a patent-free anti-cancer drug:
The campaign will fund a xenograft experiment, which is the next step in developing the promising anti-cancer compound "9DS". This experiment needs to be completed before 9DS can move on to clinical trials.
Here are some more details of both the drug and the project:
The drug candidate 9DS was developed at the University of Maryland. The last work done on the drug showed that it had activity against cancer competitive with leading cancer drugs such as taxol. Moreover, 9DS is also likely to have lower side effects than most chemotherapies, since a related compound, SJG-136, seems to have low side effects in early clinical trials.
Of course, even if enough money is raised -- at the time of writing, just over a quarter of the crowdfunding target has been pledged -- there's still much more work to be done before the drug can be sold to the public. An article in the Times of San Diego explains what will happen next:
Project Marilyn involves: production of more 9DS, and submitting 9DS to a xenograft study ('curing cancer in mice'). This is the next step in drug development and an important one on the way to doing clinical (human) studies. The process we're seeking to fund should take approximately 6 months. If we receive more funding, we will add stretch goals, such as further preclinical experiments on 9DS, development 9DS analogs, or other exciting anti-cancer ideas.Provided that the xenograft study goes well, 9DS will move into further preclinical trials, possibly through a collaboration with a for-profit company. Research and development at the later stages costs between $1 million and $10 million and will likely not be crowdfunded.
It's only a small-scale project, but it's exciting to see new funding models being tried out for drug development. Moreover, the Times of San Diego reports that Yonemoto wants his site indysci.org to host further crowdfunded projects, both from himself and other researchers. Let's hope enough pledges are made, and that others do indeed start to build on the idea.
Due the drug's patent status, the threat of competition is likely to keep the price of 9DS low, regardless of a partnership with a for-profit company. Currently, when a drug loses its patent status, the price can come down ten-fold, according to [project leader Dr. Isaac] Yonemoto.
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Filed Under: cancer, clinical trials, crowdfunding, drug development, drugs, patents
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Now that's something I'm more than willing to throw my money at. As a side teaser, that's where part of the money file sharing saves me (by not buying crap) goes. You see, file sharing is saving lives!
*hides*
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I would love to believe they are honest and mean what they say, but is there anything in place to keep them honest and not submit to greed.
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Re:
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I wish them luck....
Reality says that the regulatory environment in the US is pay to play. It sucks, but good intentions and wishful thinking won't get you into the dollar amounts required to play for very long.
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The big expense of such production and testing isn't the mice phase, it's all the other testing (including human testing) which can take years, pushing through all of the FDA approval process, and finally getting it available to those who might benefit from it. Oh, let's not forget the risk related to having the drug somehow fail after it hits the market and people start suing left and right. Do you think everyone involved in crowdfunding it might be on the hook? ;)
Seriously though, something does need to be done to move the medical world forward. The current approval process and itchy trigger finger lawsuit universe makes it pretty undesirable to produce anything these days.
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Commendable approach, horrible compound
While I wish these guys the best of luck, they're not making things easy on themselves with their choice of compound. I had a quick look through the data in the linked paper, and in the best case scenarios LC50s against cancer cell lines were only in the 50-100 nM range, while against the vast majority of cell lines tested the compound didn't even register a hit. For reference, we usually try to find compounds that have activity in the sub nM range before even progressing them into animal models (in other words compounds that are over 100 times more potent than this one).
The compound also exhibits cardiotox at concentrations in the same range as the best case LC50s, and that's just in vitro (once you go in vivo you generally discover plenty of additional tox, you almost never see things improve). Based on this alone I wouldn't expect this compound to be able to get past preclinical safety assessment (a key FDA requirement before compounds can be tested in humans).
Also, to provide a bit more information on the assay they're raising money for, a mouse xenograft model is a fairly early-stage assay, and also a pretty low bar (it's one you still need to pass, but there's a long, long road after that). They'd likely need another $1,000,000+ to get enough of a preclinical package together to take to the FDA or to try to partner (and even those numbers are probably being a bit generous). Even though that's ultimately just a rounding error compared to the costs of clinical trials, it's still a fair amount to spend on a compound that's already looking as poor as this one just in in vitro assays.
So while I fully support alternative models for the development of pharmaceuticals and wish these guys the best of luck, I have a feeling they're going to be getting quite a lesson in the numerous pitfalls of drug development.
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