Bits and Bytes from the Info-stream

Since I’m traveling this week and don’t have regular access to a computer, I’m dipping into the info-stream to comment on a few items that have come to my attention recently and by-passing the hard work of a more thoughtful commentary.  Here goes:

Costs of drug discovery:   I saw that a recent publication on this topic caused a bit of a stir.  A report by Light and Warburton (Light and Warburton 2011) has a catchy title, “Demythologizing the high costs of pharmaceutical research,” and stimulated the not-unexpected big pharma-bashing by a writer in Slate (Noah posting), but upon a closer look I found it was a “taking apart” (authors’ wording) of the 2003 study by DiMasi et al. (DiMasi et al. 2003) rather than what is really needed, a gathering of recent data and a thoughtful analysis of drug discovery costs.  Such an analysis is needed since cost is an important part of the guessing venture investors and established companies, big and small, do about what a return-on-investment may be for a drug or vaccine aimed at global health markets. Other than generating a sound bite for Slate, the study drew closer scrutiny from reviewers more experienced than I (thankfully saving me the effort), including Derek Lowe, an organic chemist and for-profit drug developer, who writes a blog called In the Pipeline (Lowe posting) and lots of comments at Fierce Biotech (FB article).  The general gist of the comments was that he article’s reasoning is flawed and its number ($43-59 million per drug) is way off, but that the number too-often cited by the drug lobby ($1 billion plus) is off, too (c.f., my posting of November 4, 2010).  My take:

  • drugs are a cost-effective way of avoiding/delaying more serious consequences, including death, and a robust R&D-based industry is a societal good (despite the public misunderstanding, drug costs are less than 10% of the overall annual US health care spend);
  • yes, big pharma spends too much money on marketing and lobbying and has a perhaps fatal attraction to developing life-style drugs (do we really need a once-a-day ED drug, e.g., Cialis?);
  • the biotech/pharma industry is slowly coming around to the idea that global health disease (and certainly lower-margin, emerging economies) presents a business opportunity; and
  • we should all be pushing them in that direction rather than castigating them.

My suggestion to Light, Warburton, and their fellow academics is to do the studies that are needed, to the professional drug developers is to find cheaper ways to discover and test drugs, and to biotech/pharmas (and the government and those many policy advocacy groups) is to find and use cost-effective models for rest-of-world drug development.

Yet Another Initiative:  speaking of drug development for global health, I almost missed the launch of a new initiative, the European Solutions Enterprise for Neglected Diseases (euSEND), which I had first heard about at BIO 2010 last May.  Their verbiage was promising; the group claimed it would bring rigorous technical and financial analysis, their own funding (a rarity), and for- and not-for-profit partnering to the drug discovery for neglected disease and, according to the press release of last week (euSEND press release), be a “new and unique concept in the field of neglected tropical diseases.”  Unfortunately, when I looked at their website (euSEND), I found more verbiage and few specifics.  For example:  “euSEND will focus on news ways to attract private funders to invest in Neglected Diseases, and help them to overcome investment hurdles. We do that by leveraging the surplus investments risks for development of compounds in neglected diseases” (Private Funders ).  What does this mean?  I’d love to know.  My skepticism grew when I saw that their “unique business model” was pretty much the typical give-us-money-we’ll-review-various-projects-and-then-look-for-grants-to-fund-the-work scheme (Business Model), their management and advisers have no track record in successful drug development, and their first project, with the Foundation for Innovative New Diagnostics (FIND) to develop diagnostics for leishmaniasis, trachoma, and tuberculosis, is all funded by government/foundation money and has no for-profit partners.  I’d rather that euSend use the money and effort to start a VC fund for global health companies instead of yet another “initiative.”

BVGH MIA:  I’ve been waiting with bated breath (not really) for BIO Ventures for Global Health, a seven-year-old industry- and foundation-backed effort, to demonstrate that their make-over of last year has put them on track to fulfilling their mission of “engaging companies to drive partnerships, and invest in global health initiatives [like product development?] to save live in poor countries” (BVGH).  They’ve hired new people (COO, VP, Scientific Affairs Director), moved their HQ from hot and humid DC to more clement San Francisco, assumed management of the GSK and Alnylam patent pool, redid their website to include more pictures of smiling kids and more “donate’ buttons, started a blog, and announced a new project called Global Health Connect (BVGH posting July 2010).  Granted I’m on the outside of their circle (no money to donate and no fancy credentials), but I haven’t seen much of substance.  My comments and offers to help have gone unacknowledged, my two attempts to get information on the patent pool and its management got no response, their e-newsletter has little original content, and there’s been no word on GH Connect.  Just this past week, BVHG re-launched their Global Health Primer (Primer) with a webinar (Webinar).  I wasn’t able to participate but tried to listen to the archive of the webinar and tried out the Primer.  My take is that it only goes part way.  It’s a good compilation of needs and who is developing global health products, but really doesn’t give companies access to the resources they need to develop their own products:  who is funding what research or how to get their compounds tested, their technology licensed, find collaborators or work as a contractor, propose co-development projects, or get advice.  Links are provided but not contact/point person information.  Also, I expect a business development person would like to  know what are the markets for current products, how are they distributed and priced.  I noted that others who sent in comments during the webinar had similar questions.  I’m hoping BVGH gives some answers and pulls back the curtain on its progress at its Partnering for Global Health Forum in June ( Forum).

That’s it.  Back to floating downstream.

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