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Monday, February 07, 2011

Rare and Neglected Tropical Diseases

I am in Austin, Texas, at a place that, were I a golfer, would mean something to me. I am not a golfer and so the best way to describe where I am is a cross between The Grove Park Inn in Asheville, NC, and one of any number of interchangeable Marriott properties in Orlando, Florida. The place is huge. It is surrounded by 5 golf courses, each of which is apparently famous. It has a spa for "the wives." It has a shop where you can buy cowboy boots and Callaway clubs. Everyone looks retired and no-one is my age.

I am here to attend the International Conference on Drug Development which takes place every year in Austin. So tucked away in one tiny corner of The Number 1 Golf Destination in Texas are a handful of FDA officials (including the Commissioner), a handful of big pharma executives, a handful of biotech executives, a very nice man from The Gates Foundation, a handful of people from the UT-Austin College of Pharmacy, and me. I am the only lawyer. I am the only girl. I am the only one not saying anything. My fellow conference goers are all scientists and they are one-up-ing each other on their qualifications. "Oh yeah? Well I'm an epidemiologist AND a pathologist!" "Really? I discovered levaquin BEFORE I cured every African infant of river blindness!" Etc. I am sitting in the back next to the tech support guys squinting at the slides that show all kinds of disgusting diseases and little blobs of amoebas and microbes. I practice trying to say the long complicated scientific words silently to myself and then wait for the speaker to say them too so I can see if I was right.

The speakers have no idea there is a non-scientist among them. Today a Pakistani pharmacometricist (I think that's what he said he was) waved out at the audience and said, "and, of course, you all know the story of Fix-it-All (chemical name, fixitallupomycin), so I don't have to remind you all that it was the first inverted-purple-goo-eating-spiral-form-parthenogenetic-doo-hickey to treat pediatric piano leg syndrome." That's what it sounded like to me, anyway. I took notes feverishly like I haven't done since college. Scratch that -- I never took notes in college. I took notes feverishly like I haven't done since I was a baby lawyer.

I learned a few things about drug development -- such as the fact that FDA is considering opening a review division devoted exclusively to neglected tropical diseases -- but I was surprised to learn how many other useful, sort of mundane, and unexpected facts. Such as:
  • The Chile earthquake moved the Earth's mass enough to permanently shorten the length of each day.
  • The first quantum machine nano-thing is so small it can never really sit still, from a molecular perspective, and so is literally in two places at once.
  • We had the first successful full facial transplant in 2010. Somehow I missed that.
  • Health care reform and government settlements combined will cost the pharmaceutical industry $5.4 billion in 2011.
  • Every dollar a pharmaceutical company spends on those annoying TV ads generates $4.20 in sales.
  • FDA has approved only two new antibiotics since 2008.
  • The last new TB treatment was approved 40 years ago.
  • 97 out of every 100 newborns this coming decade will be born in a developing country.
  • Unipolar depression is number 3 on The Gates Foundation's list of diseases that impose the highest public health burden on low- and middle-income countries. Number 9 is road accidents.
  • 86 percent of all unipolar depression trials fail. 50 percent of those trials are in drugs already on the market.
  • There is a disease that has a"'prevalence of zero." The FDA epidemiologists thought that was very funny and laughed uproariously about their scientific joke. (The lawyer equivalent is the story about the lawyer who demanded that his associate find him the pattern jury instruction for promissory estoppel. HA! HA! HA!) But the disease that has a prevalence zero is not very funny -- it's terrorism-induced anthrax.
I also made a long list of things to learn more about:

  • What is Muckle-Wells Syndrome?
  • What is Maroteaux-Lamy Syndrome? 
  • What is Prader-Willi Syndrome?
  • What does the Novartis Institute for Tropical Diseases in Singapore really do and how do I found out if it needs any help?
  • Master the topic of CMS J codes (consider delegating this one)
  • Look up the African Vaccines Regulatory Forum
  • Learn more about MenAfriVac, the first vaccine ever developed in the third world (meningitis in the Sahel).
And I decided on a good project to pass the time. FDA complained that the natural history of rare and neglected diseases is not well known. I've had a few rare and neglected diseases myself, courtesy of my childhood in the developing world. Bilharzia, giardia, malaria, etc. I could write a natural history of a rare or neglected disease! That would be fun! Like the story of the anopheles mosquito during the building of the Panama Canal. Or the story of ebola getting into a CDC research facility -- accidentally. Or our very scientific efforts to avoid contracting "hoof and mouth disease" in Zambia (answer, drive your vehicle through a thin soupy puddle and get out and swish your shoes around in it -- all for naught anyway because you don't get sick from it unless you are a cow (ergo, "hoof" and mount disease). I could travel around with a butterfly net catching neglected microbes. I could sit at bedsides and ask wilting patients things like, "but how do you FEEL?" I could wear a silly hat. It would be fun.

I would bring someone else along with me to do the science part, of course. Maybe the Pakistani pharmacometricist.

I have two more days of this so think how much I'll have learned by then!

P.S. There is no pattern jury instruction for a promissory estoppel claim. You are not entitled to a jury at all.

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