If you pay taxes in the US (and many other countries), you are helping fund HIV/AIDS research, including the development of HIV vaccines. This includes my research project, so, YAY! Thank you!

What happens, is, we pay taxes. Part of that cash goes to various government agencies to dole out to researchers. When researchers think they have a cool idea, they write up their cool idea, explain it, add preliminary data and previous publications showing they know what they are doing. Then other scientists read those proposals and go ‘Hey, that looks like a good idea! I think they can pull it off!’ and then they get a set amount of cash to fund exactly what they outlined in their proposal. Or, the scientists dont like the idea or dont have the money to fund anything else, and the person with the idea has to try again.

You can also go through a similar process from non-governmental agencies, like the Bill and Melinda Gates Foundation, to get research money.

Is this process perfect? Absolutely not. Nowhere near perfect. I dont know anyone who would argue that.

So some labs are looking into crowdsourcing, Kickstarter and such, to get specific projects funded, or to get specific pieces of equipment and such. Some labs are also working out ways of accepting donations. People are getting creative, and thats the state of science research these days: Cash is limiting, not the ideas.

I dont judge a lab that gets ‘creative’ to get cash at all.

 

But then there is this:

http://www.immunityproject.org/  (dont miss the video)

I *really* disagree with this groups approach.

 

1– The PI, Reid Rubsamen, is an MD with no relevant publications in HIV or any kind of vaccine research. Unless he is publishing under another name, that is the only paper PubMed could find at all.

 

2– This company, ‘The Immunity Project’, has no history whatsoever. It was created September last year. Going from zero to ‘ENDING HIV AND AIDS’. I admire their enthusiasm, but I would not be giving them over $50 million dollars for enthusiasm.

 

3– I am an HIV vaccine researcher, and I only have a vague guess as to what they are proposing. Im guessing (GUESSING) they want to generate a CTL response. Instead of producing the proteins endogenously and having those proteins induce a CTL response, they appear to want to deliver the peptides. I have a number of major issues with this, even as a casual CTL researcher (side project I did for an HLA lab), I can only imagine the major players in the CTL side of HIV World have even more concerns. I can delve into these if readers want to know.

 

4– Because there is no clear research proposal available, I wonder if science is ‘not the point’. Average Joes and Janes are potential donors, not scientists. Scientists have apparently already evaluated this research and said ‘No’, so now this group is appealing to the emotions of people who dont understand the science crowdsourcing. Science is there for a ‘GEE WIZ MAGIC!’ factor (again, watch the video). HIV controllers are not magic. Some people infected with HIV-1 are able to control infection better than others (aka not progress to AIDS as fast as others). This is due to a multitude of reasons, but one of the strongest correlates to ‘controller’ vs ‘non-controller’ is what your genetics looks like. But just because you have a ‘protective’ allele it does not mean you arent going to progress to AIDS. Its dumb luck, not magic. And you cant alter someones HLA allele with peptides. God please dont get me started on HIV and HLA.

 

6– Mixed messages. What the heck is going on with Immunity Project? What have they done? What are they going to do with the cash? From the looks of their website, they want to do a phase I clinical trial.

We’re raising $25 million to begin Phase l FDA human trials.

WHEN DO YOU HOPE TO BEGIN A STUDY IN HUMANS?

Our HIV vaccine is now ready for a phase 1 human trials in the US and South Africa. As soon as we raise adequate funding, we can begin the study.

HOW MUCH IS NEEDED?

We need to raise $25 million to fund the phase I human trial. Once phase 1 is funded and the FDA deems us safe, we will need to raise another $20 million for the phase II trials in order to test the efficacy in sub-Saharan Africa (Durban).

From an article on Washington Post:

As of now, the company is seeking to raise $482,000, Mr. Cinnamon said, which is the expected cost of completing animal trials that will see mice infused with human blood. The study is a necessary milestone in reaching human trials, which the company hopes to do by the end of this year.

But December of last year, there was this:

Here at Startup Socials, we are thrilled to announce a partnership with the Immunity Project. This is an incredible not-for-profit organization that has developed a HIV vaccine prototype through a machine learning algorithm. The Immunity Project HIV vaccine prototype has yielded positive results in animals and is now ready for Phase I Human Trials.

What is going on?

 

7– One word: Accountability. If I buy anything, I have to get a green-light from a few people. We have to tell my Uni what we are spending money on (and we cant spend money on anything. we can buy a $75,000 piece of equipment but we cant buy a $75,000 car). We and the Uni have to tell the government what we are spending money on. And I dont have over $50 million dollars.

Who will be holding the Immunity Project accountable? I didnt see that word on their webpage.

 

8– Major, MAJOR red flags. There is nothing about this project that indicates any kind of ethos in any kind of vaccine design. I would not be giving these folks cash unless they piggy-backed on with an established HIV lab of some kind, and even then, they have *got* to get some publications under their belt.

But no, no thats not why they arent getting money the usual ways. This is why:

… Furthermore, private equity investors don’t like HIV vaccine plays because the real money in HIV is in developing new lifelong therapies that people living with HIV will have to take for the rest of their lives.

Big science controls most of the rest of the funding that is available, and our breakthrough, IT-based approach to HIV vaccine development is still too early to resonate through the old boys funding network…

This is where I stopped. Big Pharma, Big Science, Old Boys Network– These claims are the last refuge of scoundrels, not scientists.

 

No history, no science, bad attitude.

Will I be backing Immunity Project with funds or support?

No.

 

Comments

  1. #1 Phil S
    January 27, 2014

    It looks like the PI has started up a bunch of different companies (http://rubsamen.com/).

    On their “Meet the team” page, they do have some actual HIV researchers… but a lot of the people on that page appear to be marketing people.

    I think it’s possible that this is a good team who is trying a really novel approach to a novel fundraising mechanism. Getting very technical is probably poor marketing for crowdfunding to the public. And you have to oversell things. Promising realistic results from your laundry detergent is a good way to make people buy a competitor’s laundry detergent who promises to get radioactive paint out of fur coats.

    As for the anesthesiologist, you’d want someone with experience in starting biotech firms making the business decisions and connections while some “director of research” would be deciding which labs to give money to. And since this appears to be primiarily a money moving enterprise, it makes sense you’d have more marketers.

    On the other hand, this could be a sophisticated, legal scam by people who are good at this type of thing, with a few credentialed researchers duped into making it look legit.

    Someone more experienced with the HIV field should tell us if those researchers associated with it are people who are more likely to be scam artists or actual researchers, and someone more motivated than me should look up whether any of this guy’s other companies have been more than scams for venture capital.

  2. #2 ERV
    January 27, 2014

    No, I have no reason to think we are in scam-country, here.

    This just looks like some people who might very well have a cool idea, but they are unwilling to do basic, foundational research to establish credibility.

    Because they have no credibility, they cant get $$ from the field. Instead of saying “Okay, we need to get this tissue culture paper *OUT*. We need some basic preliminary data from some mice to get an R01 to do a full study on that. If the mice work, we need to collaborate with Group X to see whether this protects non-human primates. Then we need to figure out how to move into humans.” I mean there are years and years and years of work between what they appear to have (maybe a tissue culture paper coming out. maybe.) and shooting this stuff into people!

    But no, they cant get money for human trials because of TEH MAN!

    What?

    So they go to people who dont know any better, Average Joes and Janes, to get cash?

    Boo.

    Booooooo.

  3. #3 Reid Rubsamen
    San Francisco
    January 27, 2014

    Hi Abbie,

    I’d love to connect with you about your concerns with our project and the crowd funding method of raising funds. If you’d like to chat over the phone, please email press@immunityproject.org, and we’ll set something up ASAP!

    Best,

    Reid Rubsamen

  4. #4 Robert
    January 27, 2014

    Reid: Could you perhaps explain the “positive results” in animals (mentioned here: http://www.poz.com/articles/salim_abdool_karim_2676_24826.shtml)? Could you point to the relevant paper, or explain why you chose not to publish?

  5. #5 Sannica
    January 27, 2014

    Yes, there was an AMA (“ask me anything”) by these folks on Reddit a few days ago, and as I recall when I skimmed through it, while many commenters/askers were excited and offered congratulations (and got responses from the team), those who were skeptical or just curious of the actual science got no response or brush-offs. Particularly when it was pointed out that they had nothing anywhere that was any different than what has been tried – and failed – in HIV vaccines before.
    I agree with your comment, Abbie, I don’t think they’re outright scammers, but I do think that they are woefully unprepared and terribly, naively optimistic about their idea. Nevermind how they are going to get the ultimate product to reach at-risk people for free (they couldn’t really answer the logistics of that, when asked, either)…

  6. #6 Robert
    January 27, 2014

    Thanks for mentioning the AMA, Sannica. Skimming it, I see they have a paper under submission to Vaccine. Luckily, Elsevier think a “Preprint of an article doesn’t count as prior publication” (http://www.elsevier.com/journal-authors/preprints), so, Reid, could you please post a preprint of your paper on the ArXiv so we can all take a look?

  7. […] I will admit, I’m not an HIV/AIDS researcher, though I was peripherally involved in the research early in my career. So, let me turn to a real AIDS researcher, Dr. Abbie Smith, and see what she says about developing a vac…: […]

  8. #8 ERV
    January 27, 2014

    Robert– Under normal circumstances, I would say that is not a fair request. We might share pre-publication data and hunches between one another/colleagues, but Im sure not blogging my stuff before its accepted.

    That being said, Im not asking for $25 million (or $400,000, depending on which article you read).

    At this point, we are supposed to take everything here (which is nothing) on faith. I mean this is like the total opposite of Science.

  9. #9 Robert
    January 27, 2014

    Hi Dr ERV!
    That reluctance is field-specific. In many mathematical/computational fields it is more than standard to post preprints on the ArXiv as soon as soon as they are written coherently enough. If you’ve submitted a paper to a journal (and, as you say, are asking for donations!!) it’d better be well beyond a “hunch”, so there should be no concerns about posting it on the ArXiv, subject to the understanding that it might change during the review process.

    Anyway, fair request or not, if these guys really had good reason to be as confident as they seem, they should be jumping at the chance to let people see their results, right?

  10. #10 Reid Rubsamen
    Oakland
    January 27, 2014

    Hi all,

    Regarding the results, they have been submitted to a peer-reviewed journal, and I anticipate that they will be published in the coming months. In the meantime, we have a white paper that goes into some depth about the research up on the site now: http://bit.ly/1ebKRTP.

    Regarding the AMA, I’m linking to it here because I we made an effort to answer as many questions as possible – http://www.reddit.com/r/IAmA/comments/1w29dx/we_are_creating_the_hivaids_vaccine_to_give_away/. The response to the AMA was rather overwhelming, and I spent 6 hours answering people’s questions. Even with that, I wasn’t able to get to all of them!

    If there are further questions, we are happy to try to answer them. Just email team@immunityproject.org.

    Best,

    Reid Rubsamen

  11. #11 Robert
    January 28, 2014

    Hi Reid. Thanks for putting the white paper up. I think the problem people are having with all this is that there is a large focus on formulation and manufacturing, with little explanation of why we should expect this thing to actually work. If I’m feeling optimistic, I can believe you could 1) elicit a decent HLA response, and, 2) this response may actually have some functional consequences for the virus (that could be seen in the form of escape mutations and, maybe, lower viral loads etc), but it is quite a leap to 3) the response actually conferring any protection whatsoever.

    I’m also puzzled about Prof Abdool Karim’s involvement in this. The MRC in South Africa (of which he is the president) currently has an RFA out for exactly this kind of thing: http://ship.mrc.ac.za/rfaTBHIV.htm
    Have you got a South African team applying for funding through that route?

    Do you understand why it seems downright suspicious to ask the public for money? You’re going to annoy the hell out of other scientists, because every time anyone says anything well-publicised and confident about creating a working vaccine, the public loses a little faith in us when it fails, and having solicited donations will only make this worse. We really don’t want an HIV vaccine to become like a pill to make your penis larger, in that, when someone finally creates one that works, nobody will ever believe them.

  12. #12 ERV
    January 28, 2014

    Thank you, Reid. I think you have made it clear that you are passionate about this. But then, I dont work with anyone who isnt also passionate about their projects, who dont believe in their projects. I got my degree in a lab with insanely novel ideas (two chapters of my dissertation are Mad Scientist Level. you think youre ‘outside the box’? no offense but your peptide pulsing *is* The Box compared to my shit) which ultimately shut down due to low funding and politics.

    I get it, man. I get it.

    But you know how I reacted? I learned from the interactions. I understand I have to Pay My Dues and prove to The Old Boys (who are not ‘old’, nor are all of them ‘boys’) my ideas have merit. Know what my boss did? Picked himself up and kept going. He knows what he has to do, too.

    What do you do? Insult people with *decades* more experience and knowledge than you, declaring theyre all corrupt, just in it for the money. Paint yourself and your team as People Who Actually Care about people dying of HIV/AIDS (not like those people in Big Science). Man, who the hell are you? You think its weird that you have zero HIV publications, and funding agencies wont give you cash? Seriously? I mean do you want me coming into a surgery suite and acting as the anesthesiologist for open heart surgery? AWWW The medical field is just an Old Boys Club! They wont let outsiders try novel approaches!

    There is a difference between hacking a system, and throwing the system out of the pram when you dont get your way.

    May the Force be with you, man, but I wish you and your ‘new media team’ hadnt made the decision to be jerks about this. There are plenty of labs who have had to resort to alternative ways to get cash for their lab, but you all are the first to insult entire fields of researchers while doing so.

  13. #13 Daniel whelan
    January 28, 2014

    Can we also remember the terrible hurt this kind of false hope creates? As a person who is living with HIV I’d rather not read the endless tirade of claims made by individuals and organisations until there is something actually worth sharing.

  14. […] como la DNDi; sin embargo, hay que cuidarse de no apoyar cualquier iniciativa, ya que existen propuestas sospechosas que posiblemente estén buscando lucrarse con la indignación antifarmacéutica sin desarrollar […]

  15. #15 Marty Crane
    tri state area.
    February 5, 2014

    Im just tired of being sick. Wish the cure was here already.

  16. #17 Roger (www.incidence0.org)
    London
    February 10, 2014

    Isn’t crowdsourcing anything else than fundraising in the 21st century?

    Though I agree with a number and even many of the points made in your posting I think that many are relevant to other research projects (remember the canadian PR of last year?) or even fundraising in general. Many people give to charities without much infomation about how their money is used and with minimal accountability and transparency.

    I was one of the first reacting to this on the IRMA list were I noted the following:

    PRO:
    • Direct engagement with the public
    • Raises public awareness
    • Increases scientific exposure
    • Potential to communicate science, its process, progress and its cost
    • Reduces fundraising costs and management costs
    • May fasten research by providing funds faster (thought the total cost of the project is estimated at $23,800,000)

    CON:
    • No scientific review of the proposed research (as noted “The landscape is very political and most [funders] are focused on creating a neutralizing antibody vaccine.” And indeed, T-Cell vaccines are not the flavour of the month these days)
    • No information about monitoring of expense or research performed with funds
    • No accountability to funders (but that’s not really specific to this enterprise)
    • PR exercise that may affect the credibility of research in general (Planning a Phase 3 in 2016 is foolish, to see what it takes to develop a vaccine for Phase I/III).

    I then had a very nice chat with Dr Rubsamen who came out rather overwhelmed with what his initiative triggered and was clearly not prepared to deal with the hyper reactive online crowd.

    In my view crowdfunding could offer an interesting approach to funding research but it should not remove the need for monitoring what is proposed and how it is done.

    Roger

  17. #18 Robert
    February 12, 2014

    I see the Immunity Project made it into Nature! My congratulations to them:
    http://www.nature.com/news/crowd-funded-hiv-vaccine-project-sparks-debate-1.14675

  18. […] It wasn’t just me, but other scientists, ones with actual credentials in AIDS vaccine research, also appeared to be highly skeptical. For example, one of those real AIDS researchers, Dr. Abbie Smith, said the following about developing a vaccine for HIV non-pr…: […]

  19. #20 Hector
    Buenos Aires
    May 27, 2014

    How nice will be to see a free vaccine develop in front of the noses of all those proud scientist that spit on IP!