Nigerian Suit Against Pfizer Revived in U.S.

There is more to the Nigerian Trovan trial debate than has been mentioned in the Washington Post and similar articles. First, it is important to note that some illnesses are more common in developing countries—e.g., the “meningitis belt” in Africa, and thus studies need to be conducted in these settings, rather than in the U.S.

For example, in the 1996 meningococcal meningitis outbreak in Nigeria, ~12,000 children died over 6 months. (Three or four cases in a U.S. community would be considered an “outbreak.”) Pfizer’s study compared Ceftriaxone, given by intramuscular injections, to Trovafloxacin, given orally. Pfizer has been criticized regarding their informed consent documentation and IRB approval–not without justification, from the second-hand reports I’ve read, but…

What is rarely mentioned is that the survival rate was reportedly 94.4% Trovan vs. 93.8 Ceftriaxone. Nor is it widely known that Trovan was also being studied for meningitis in the US by well-respected pediatric infectious diseases specialists. The outcome in the US was clinical success in 79% of the Trovan patients vs. 81% in the Ceftriaxone group, and the longer-term sequelae showed no difference between the groups. (The Pediatric Infectious Disease Journal:Volume 21(1) January 2002, pp 14-22)

Nor is the value of developing oral treatments for infections generally discussed. Doctors Without Borders was treating other meningitis with intramuscular injections of Chloramphenicol—a wonderful drug that is now rarely used because it kills ~1/30,000 patients who receive it.

Multiple IM injections are painful, require sterile technique and more skilled health care workers than do oral medications. Supplies for injected drugs are more difficult and expensive to handle and administer, particularly in poorer, tropical countries.

Pfizer may not have not conducted this trial perfectly or with adequate informed consent—I don’t know, as I wasn’t there. But I do know the horror of watching young people die from meningococcal disease, and I do understand the rationale and goal of developing an oral drug for a devastating disease that episodically kills thousands of children. While I am often critical of this company, they deserve a fair trial.

Thanksgiving...

Ironically, Dr. Hotez’ new book, “Forgotten People, Forgotten Diseases” was part of my Thanksgiving fare this year, and served as an excellent reminder of all we do have to be thankful for in our economically more developed countries. Even now, with the rapid decline in our own country’s economic health and a pall on Christmas cheer, his book serves up a valuable dose of perspective.

Dr. Hotez skillfully introduces readers to an array of “neglected tropical diseases” which devastate the world’s poorest populations—2.7 billion of whom live on less than $2 per day. Because of their poverty, these people lack a voice and are largely ignored. Some of the diseases that affect them, such as worms, schistosomiasis, or filarial (elephantiasis) cause debilitating illnesses, are less dramatic and attention fetching than malaria and HIV/AIDS. Dr. Hotez calls much needed attention to a dozen of these diseases.

One of the striking things about this book is how clearly and simply Dr. Hotez explains these diseases and their impact. He also excels at helping readers to understand non-obvious links between poverty, parasitic infections, and HIV/AIDS. This book is therefore surprisingly appropriate for high-school to post-graduate levels of readers. It is an excellent primer, with numerous references for more detailed exploration. For example, Dr. Hotez explains how schistosomiasis, a water-transmitted worm, increases a person’s susceptibility to HIV infection. Anemia from the parasites can impair learning and subsequent income-earning ability. This book is an excellent primer, with numerous references for more detailed exploration.

Each chapter provides an overview of the organism, the illness it causes, and the social and economic impact of each of these illnesses. The accompanying photographs make a striking impression, and they, as well as the other helpful illustrations, have great visual impact.

I had the pleasure of hearing Dr. Hotez and a number of his colleagues speak two years ago at the Global Network for Neglected Tropical Diseases conference. One of the major conference themes, which was new to me although I am an infectious diseases physician, is that 7 major neglected tropical diseases could be eradicated for less than 50 cents per person/per year. Since learning that, I have incorporated some of this material about NTDs into my talks, and the slides for these are available at my site's links.

This book is clearly written and inspirational, and is a call to action. What are we waiting for?

OLPC's XO Makes History

Uruguay has just become the first country to begin widespread deployment of the revolutionary XO laptop to all of it's children. An inspiring personal story and moving pictures about the historical moment is recounted by Ivan Krstic, OLPC's brilliant director of security architecture, who was shipped off to Uruguay along with the first laptops, as a just in case trouble shooter. My congratulations to all at OLPC!

I hope other countries will join this move, as the laptop is incredible. Shame on Intel and Microsoft for trying to sabotage this nonprofit's venture!

I had the opportunity to try exploring the OLPC XO a bit last week and was extraordinarily impressed by some of it's features. The design is incredible--intelligent, attractive (an eye-catching kid magnet!) and extremely durable. Makes me ask why my other laptops don't have some of these features. The machine appears to be almost indestructible under normal use conditions--dust, dirt, pet hair, and liquid spills won't harm it. The carrying handle is an incredible plus I would love to have on my slick laptop. The ability to view the screen in bright sunlight is impressive. The machine will clearly be able to be repaired by most older kids and adults with 1 (supplied) screwdriver.

Yes, the XO software is slower than what I normally use. And yes, there are occasional software glitches, as with any new product. The difference, however, is that this is all open source and thus can be accessed and fixed by mere mortals. And soon there will be a large community of interested individuals who can readily support and teach each other.

One of the most impressive features is the mesh-networking, which allows the XOs to see others and link to them to work collaboratively on projects. This is ideal for a classroom, but also will be great for families or small group projects.

It is sad, though not surprising, that Intel and Microsoft have tried to undercut the OLPC XO and have thus far done so in Nigeria and Libya (see 11/24 Wall St Journal). The Classmate and Windows, priced temporarily at enticingly low prices, will not be able to be upgraded without considerable investment in support and software. In contrast, all the XO software is open source and can be down-loaded for free--and change as the child's needs do over years. That long-term view is where the real cost-savings are, as there will be no licensing issues or bait and switch tactics with the XO.

My initial motivation for supporting OLPC is that they are a worthy non-profit, with a very valuable project for educating kids in developing countries and reducing the global disparities between the haves and have-nots. Now after seeing the XO, I also see it as a valuable back up for my business/home needs as well. I have been encouraging my friends and colleagues to support the Give One, Get One program or to make charitable donations for children in developing countries. It is an irresistible gift for the holidays. Please help spread the word!

Disparities: Global Health and Clean Water

An idealistic and hard-working group of young women are sponsoring the Disparities: Global Health and Clean Water conference on March 2-3, 2007 @ Smith College. Check it out at www.gaape.org or at Smith College's news.

I’ll be moderating as well as giving a talk on Ethical Aspects of Global Care & Drug Development. Being somewhat OCD, I googled moderating panels and came up with some great sites.

Perhaps the best suggestions are from Barry Eisler’s “The Moderator’s Manifesto.” Great info and visually stunning website.

Check it out for useful tips on marketing as well.

More coming about ethics and global care soon.