My latest article, on the role of pesticide exposure on emerging newwildlife diseases--including white nose syndrome in bats, chytridfungus in amphibians, and colony collapse disorder in bees--is coming soon on Yale's e360. Stay tuned for the URL!

Attention all! I have (finally) created a Facebook page for my writing. Please come visit! http://www.facebook.com/pages/Sonia-Shah-Author/228608852387?v=wall

There is also now a Youtube channel on my work. Check it out at:
http://www.youtube.com/user/soniashahauthor

My story on climate and the spread of new diseases is now online! Check it out at e360.

So my new book is now officially titled, "The Fever: How Malaria Ruled Humankind for 500,000 Years." Hoowee! Meanwhile I'm working on a new piece on emerging infections from animals (called "zoonoses"), such as Ebola, Nipah virus, Hanta and West Nile. It'll be appearing in a cool new online enviro magazine called "e360" which features some of my favorite writers--Carl Zimmer, Elizabeth Kolbert and others. Check it out at e360.com

Thrilled to announce that my new book on the political history of malaria has been completed and is slated to come out from Farrar, Straus & Giroux in the late spring of 2010! Check here for more details, forthcoming. Tentative title: "The Half-Million Year Fever: The Story of Malaria." Got a better idea? Email me at sonia@soniashah.com.

My op-ed reflecting on World Malaria Day (April 25) appeared on Alternet, Z Net and on The Mutiny. Enjoy!

Just did several interviews for the Spanish press, and received positive reviews on the Spanish edition of The Body Hunters from El Pais, Cambio 16, and Marie Claire magazine. Nice!

My review of Dambisa Moyo's provocative new book, Dead Aid, appears on The Nation online. Moyo is a fascinating person and her book is well worth reading. Check it out at  http://www.thenation.com/doc/20090330/shah

The Spanish edition of The Body Hunters (Cazadores de Cuerpos) recently came out and is getting some good press in Spain. To wit: a long review (and five stars!) in Publico. Check it out here.

I attended the launch of a new Science and Human Rights Coalition at the American Academy for the Advancement of Science in Washington, DC last week, where I witnessed an amazing spectacle: a bunch of top scientists grilling scruffy human rights activists...on possible collaborations. It's an interesting time for scientists to be throwing their hat into the human rights struggle, after eight years of science being perverted by our political leadership to serve right-wing ideology! Look for my story on the coalition, and what it means for public debate around human rights, in an upcoming issue of The Nation.

I just finished a very pleasant half-hour radio interview with Jeff Farias of Phoenix's Jeff Farias Show. I was a little nervous, having spent the last 6 months writing non-stop, that I'd be a bit foggy but it appears that I can, in fact, still talk in sentences (sort of). Check it out here. There should be a podcast up soon, too.

I was pleased to find a commentary about CRUDE in the Athens daily Kathemerini this morning, in part because I could honestly say, it is all Greek to me....My crude translation (ha!) suggests a fairly positive summary, but if anyone out there can say for sure, please drop a line: sonia@soniashah.com. Check it out here.

Look out for the January edition of Ms magazine. They're running a special feature in which leading feminists offer their thoughts and suggestions on how our new president can improve the lot of women at home and overseas. I was honored to contribute a paragraph or two myself!

Also this month, the History Channel is re-airing a documentary on oil called CRUDE, which features a certain author and shopper....yes, that's me at Stop & Shop cruising the aisles and talking smack about oil. (A blogger wrote about my appearance in the film and called me "youngish." Thanks. Better than "oldish," right?) Question is: does anyone care anymore, now that the price of gas has fallen to two bucks a gallon? I fear not, but OPEC is tightening the taps so I'm guessing the price may yet rise, again. It hurts but it's the only way forward.

The French-language edition of my book, The Body Hunters, has been awarded the 2008 Prescrire prize for books on medicine and pharmaceuticals! Every year, the nonprofit journal Prescrire awards a handful of books among the many it reviews for the prize. My understanding is that The Body Hunters was one among five chosen from around 300 titles. Merci!

Also, the German newspaper Der Spiegel ran a nice commentary about the German-language edition of The Body Hunters. They're recommending the book on their website. Check it out here.

ABCNews.com featured a story on a problematic Glaxo clinical trial in Argentina (and quotes me a few times,badly--the last time I do a phone interview for a print piece?!). Theallegation is coercion and lack of informed consent. The piece doesn'tpoint out one of the major factors of the story, which is that thevaccine GSK was testing may well be aimed at preventing relativelytrivial conditions such as ear infections, but was tested onimpoverished Argentinian kids with pneumonia. That's not uncommon--Idescribe a similar trial in my book, aimed at a drug for inconvenientcases of diarrhea in the West but tested on malnourished, HIV-positivechildren in Zambia. Check out the ABC story here.

Some like to say that people have "right" to participate in clinical trials. People have a right to proven care, not to experiments. Trials are risky for subjects, which is often the whole point of doing the trial. A new review shows the extent.

In a survey of 739 international drug trials published between 1996 and 2002, University of Nottingham researchers found that 71 percent reported adverse events, with 20 percent reporting serious adverse events. Nearly 40 percent reported adverse drug reactions, with 11 percent reporting severe adverse drug reactions. Six were terminated early because of drug toxicity; subjects died in 11 percent of the trials. In two of those trials, the deaths could be attributed to the experimental drug.

And these, dear readers, were trials that might have been expected to minimize risks, for the subjects involved were all children.

See more here.

Today's TIME magazine ran a feature on the clinical trials boom in India. It's a good one, and not only because it quotes me at both the top and bottom of the piece! Check it out here. 

My critical review of Lara Santoro's book on international health journalism appears in The Lancet sometime this month. Link will be forthcoming. In other news from The Lancet, a new study found that 6 weeks of daily nevirapine given to the breast-fed babies of HIV-positive mothers reduced the babies' risk of getting the virus from their moms by 15%...but six months later, as many were infected as controls.

The reason to even consider giving nevirapine (which has adverse effects in over 30 percent of infants and also can complicate AIDS therapy if it becomes necessary later on) to these babies is because their families lack access to safe drinking water with which to feed them, and so must be fed mothers' milk despite its contamination with HIV virus. Some of the authors say, it's a terrible situation, but the drug kind of works, a little bit, so let's do it, it is better than nothing.

But why is it that it is possible to go to rural and impoverished places and provide tiny little babies with sick mothers pricey, sophisticated foreign-made pills EVERY DAY for weeks on end....and NOT possible to clean up the water?

In a highly unusual move, some of the study's own authors asked the very same question. Check it out here.

My opinion piece on the FDA's scrapping of the Declaration of Helsinki, and with it adequate protection for the human rights and safety of clinical trials subjects in the developing world, appeared in The Nation online a couple weeks ago. Check it out here.

Late last month, a small notice in the Federal Register announced that after more than thirty years, the FDA will summarily excise the World Medical Association's "Declaration of Helsinki," the internationally recognized gold-standard for principles of ethical medical research, from its codes. It's a shocking departure, and one that has hardly made a dent in the mainstream media. Here's a guest blog I wrote about it for the national consumer rights group Prescription Access Litigation:

http://prescriptionaccess.org/blog/?p=273

There have been seven foreign language translations of both CRUDE and THE BODY HUNTERS, but until now, none of my books has been available in Spanish. Now, at long last, 451 Editores will be publishing a Spanish edition of The Body Hunters, translated by Ricardo García. I'm not sure when the publication date is, but Ricardo recently sent me some very thoughtful queries about the book, so I expect a wonderful translation. Updates to follow.

The sixth foreign-language translation of CRUDE will be released this week. The Dutch version is called "Ongeraffineerd," which I love for being so very much longer than the English version.

Apparently, there's been a lot of interest in the book in Holland. A magazine called Greenpeace Krant, with a circulation of 500,000, is featuring the book, and the Dutch equivalent of the Financial Times (Financieele Dagblad) will, too. I wrote a new chapter for this edition, focusing on Holland's fascinating petro-history. I'm looking forward to a flood of provocative feedback from Dutch readers. Stay tuned for more.

My new website, ResurgentMalaria.com, launched this week in advance of World Malaria Day on April 25. ResurgentMalaria.com explores the politics and history of malaria, one of humankind's most fierce scourges. This is a disease we've known how to prevent and cure for over 100 years, but which still infects 500 million a year and kills over 1 million. Why that is is the subject of ResurgentMalaria.com. (Clue: it's a bigger problem than just a failure of donations for bednets or grants for vaccine research.)

Check out a podcast about ResurgentMalaria.com from the UN Millennium Campaign here. And a blog post from Prescription Access Litigation (PAL) here.

Today's Calcutta Telegraph carried a nice review/summary of The Body Hunters, published in India by Pearson. I'm thrilled that the Indian press is covering the book, since I did much of my reporting from India, where there is a real problem with unethical clinical trials. Check it out at: http://www.telegraphindia.com/1080328/jsp/opinion/story_9059631.js

The Sepia Mutiny, a very witty blog run mostly by second-generation Indian Americans (like myself) posted a lovely piece about my involvement in CRUDE (the movie) and CRUDE (the book). I'd never read Sepia Mutiny before so took the opportunity to browse and laughed out loud several times. I doubt I'm hip enough to write for them, but knowing they exist makes me happy. If only such things were around in high school...!

See http://www.sepiamutiny.com/sepia/archives/004996.html#more

The History Channel is re-airing CRUDE on Friday Feb 22 at 8 am. You can also watch it online here.

Crude: The Movie!

A few years ago, a documentary fillmmaker from the ABC in Sydney (that's the Australian public television network) spent a day with me in Boston, talking about oil politics. His film, which he dubbed "Crude" (after kindly discussing it with me), came out in Australia a few years ago, and won a slew of awards. It has some amazing footage in it, the least of which are some clips from that day in Boston with me. (A film crew followed me around at the grocery store while I pretended to shop. Slightly embarassing.)

This Sunday, the film airs on the History Channel here in the US. The New York Sun previewed it and mentioned the appearance of yours truly:

"The investigative journalist Sonia Shah,who wrote the equally sweeping 2004 book "Crude: The Story of Oil,"lends an ever-so-slight analytic edge with trenchant demonstrations of oil's inescapability: Plastic-wrapped supermarket veggies from distant farms, for example, pack the double whammy of petroleum-based packaging and gas-guzzling truck transport."

The film CRUDE airs on the History Channel on January 27, 2008 at 8 pm.

In a couple weeks, I'm off to be a guest-in-residence at University of Illinois in Urbana, Illinois. The program that invited me is called Unit One, an educational model established in the 1970s. Basically, some 650 students live, eat, and learn together within the confines of a single facility on campus called Allen Hall. And then they invite journalists, filmmakers, and others to hole up in an apartment in the hall and give nightly presentations about their work. Apparently the fillmmaker behind Hoop Dreams gave a yoga workshop! Not me--straight up lectures, plus film showings and Q&A. I was pleased to learn that all the events in the hall are open to the public. More details here.

Well, kind of. The OHRP shot out an email responding to Gawande this week. They say that the "program" was actually a research study,the results of which were published in the NEJM. That is, the peoplewho impemented the intervention didn't actually know whether it wouldwork or not. Maybe the patient would start seizing on the table whileall the staff were huddled over the checklist, ticking boxes. Whoknows? With that kind of uncertainty, surely patients had a right to beinformed and consenting. And yet, the researchers had gotten no ethicscommittee review (IRB) or their subject's informed consent.

But that wasn't quite it, either. The "study" had no control group,because nobody wanted to NOT use the checklists. In other words, theerstwhile researchers felt they knew that it WOULD work. In which case,they were simply trying to improve patient care with a provenintervention and no IRB or informed consent was required.

So was it really a "study" or was it actually a "program"? Did they know it would work or didn't they? How confused were they?

Well, in the actual doing of the thing, the clinicians conductedthemselves as if it were a program of improved care, but then when theywrote up their results in the NEJM, they cast their work as anexperimental 'study.'

That's not right, either: you can't have it both ways. Someonecomplained to the OHRP, which opened some kind of investigation, whichthen led to Gawande's complaint, and a flood of angry letters to theOHRP. Phew!

All of which is to say: there's a shifting line between what we say weknow and what we say we need more research on. When there's somethingwe want to do, when there's political will and money to do it, wedispense with "research" quickly and move on to implementation. Inother areas--say, the administration of expensive drugs to poorpeople--there are endless calls for studies and experiments to provethe same thing over and over again, putting subjects at some risk everytime, because intransigent authorities (drug companies, healthministries) find it politically more expedient to say "we need moreresearch" instead of "sorry, no" (or "absolutely not, who cares aboutpoor people who don't buy lots of stuff.")

Fyi, these were the checklisted items, as reported in the NEJM, used inthe ICU on patients with catheters: hand washing, using full-barrierprecautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, andremoving unnecessary catheters. The implementation of these procedurescoincided with a precipitous drop in the number of catheter-relatedinfections, but without the control group, no cause and effect can bedetermined, at least not by this study.

Today I randomly came across a long thoughtful pieceabout an essay I wrote over a decade ago...about  the issues thatoccupied me for the first five years of my writing life--biculturalism,feminism, and sexuality. Who knew those old essays were still makingthe rounds? 

Canada.cominterviewed the curator of a new exhibit on energy and oil, who verykindly mentioned my book CRUDE as one of 2 interesting books on thehistory of oil....the other being Yergin's The Prize! Good company.Thanks for that.

I'm thrilled to report that the Body Hunters has been translated into six languages, besides English (Japanese, Italian, French, German, Portuguese, Korean.) The French edition, in particular, appears to be making a splash. It's been selected a "book of the month" by a prominent popular science magazine, and was covered in the French version of Time magazine, "Le Nouvel Observateur," along with coverage in the dailies and national radio.

I find this interesting, given that the French actually have some of the very best laws protecting clinical trial subjects in the world. Could reader interest in this topic be viewed as some version of rubbernecking? Perhaps so.

I've spent the last month putting together material for a new websiteon the topic of my next book: resurgent malaria. MalariaResurgent.comwill be a provocative, opinionated take on humankind's oldest disease,why it still plagues us, and what can be done about it. There'll bestories, history, videos, and most of all, conversation. The site shouldbe live soon after the New Year. Stay tuned for more...

Inhaled insulin: Here's a great illustration of how disconnected the drug industry has become from public health....or even individual peoples' health. When I went to a industry conference a few years back, Pfizer execs were gloating over their great new experimental product, a form of inhaled insulin. The drug was still in clinical trials--meaning they couldn't have known whether it was truly safe and effective or whether it was any better than injected insulin--but they were certain that it would be a blockbuster. Because, of course, whether the drug was effective or any better than what we already have was irrelevant. Inhaled insulin is a great idea, in principle, and the obvious plan was to harangue patients with marketing so they'd switch to it on that basis alone.

Well, Pfizer's drug, Exubera, was a bust. They "only" sold $12 million worth of it, and so now they are going to stop selling it! First it was the best thing since sliced bread, but now...since they aren't making the billions they foresaw, they're dumping it. So much for those users who did switch and actually liked it. They're screwed.

Basically, the drug was a bust because it was no better than injected insulin and on top of that, it messed up patients' lungs. A total disaster.

Now, a new company called Mannkind, backed by a billionaire investor, is launching a new inhaled insulin called Technosphere Insulin, similarly gloating--while the drug is still in clinical trials--that they will make billions on the thing. The New York Times business section featured their glossy PR in an article this morning, replete with a large pic of the billionaire investor looking smug in his grand digs. He might as well have had dollar signs tattooed on his eyeballs.

Buried near the end of the story we learn that--already!--more patients taking the inhaled insulin have dropped out of clinical trials than patients taking the old standby, injected insulin! "For reasons that are not yet clear"! Well, there can't be any reason, in my mind, that doesn't bode poorly for the inhaled insulin. They didn't like it, they had adverse effects, or whatever.

And, the chief medical officer has accused the company of hiding information about the drug from the FDA! The company, in response, fired him. But we'll never learn about the dirt he found because his wrongful termination suit has been settled out of court!

This thing seriously stinks. And it is all the more remarkable for the fact that all of this dirty laundry about the drug is tucked into what is overall a glowing business story.

Check it out: http://www.nytimes.com/2007/11/16/business/16mannkind.html?_r=1&oref=slogin

The New York Times ran a piece on distributing insecticide-treated nets for malaria today. It is an old story. There were long and tedious workshops on it at the last malaria conference I went to in Cameroon two years ago. I agree that bednets should be considered a social good, but it isn’t right to assume that every net distributed is a net used (and a life saved). It may be true that the very poorest don’t buy nets, but it is also true that many people (rich and poor) don’t use free nets, either. It isn’t just a technical problem of distribution, there are larger cultural, economic, and health issues.

When I went to Cameroon, I visited villages where ExxonMobil had said it had distributed thousands of free nets; and yet the people I met at the malaria clinic there said they didn’t know a single person who actually used one. I got the same response when I asked people at a malaria clinic in Malawi, and in Panama. They said the nets are hot, that people have different priorities (like using the netting for fishing, wedding veils, curtains), that the nets get holes in them, that malaria isn’t taken seriously enough, and so on.

It sounds nice for donors to be able to say they distributed lots and lots of free nets (marketing the nets is slower), but they should also track how many people actually use the nets.

Will the Nigerian charges against Pfizer change how drug companies conduct clinical trials in developing countries? I don't think so. The Nigerian authorities seem to be more interested in sensationalizing the charges and catering to their own disgruntled populace. (And can we really expect the Nigerian government and an American company to come clean about what happened during that mengingitis epidemic in 1996? Evidence suggests that the Nigerian authorities were complicit in some way, just as they've been complicit for decades in Western oil companies' exploitation of their citizenry in the Niger delta.)

What's really needed is greater transparency, but the Nigerian authorities are not asking for that. They're asking for payback. The bad PR that Pfizer will inevitably get may very well make drug companies more secretive about their activities in poor countries--which will make clinical trials more dangerous for trial subjects everywhere.

Nigerian authorities have threatened to send Interpol to capture Pfizer staffers, after the nine Pfizer employees brought up on criminal charges in Nigeria failed to show up in court on Wednesday, after being served not just one but two summons.     
    "If they fail to appear in court" on November 6, the judge said, "we will have no option but to seek the help of Interpol in arresting them and bringing them to court." 
    One suspects this is a ruse to appease a restive public--protests against Pfizer were in the works--while pumping up pressure to extract big dollars in a settlement. Out-of court talks to settle the case started in September, and are scheduled to resume on November 17...after the Pfizer folks stand trial.
    The federal lawsuit against Pfizer was also adjourned, to October 22; and a final civil lawsuit was adjourned to December 5.
    Stay tuned for more...

For years, the drug industry has been plagued with the problem of finding enough human subjects to take experimental drugs. Each new drug they develop requires about 4,000 patients in clinical trials, who must undergo some 141 separate medical procedures. Increasingly, Americans and Western Europeans are just not that interested. Eighty percent of clinical trials in the West fail to recruit sufficient numbers of subjects, stalling the pace of drug development—and bleeding drug companies of some $1 million each day their potential blockbuster remains locked up in R&D.
    Since the late 1990s, drug companies have routed this dilemma by exporting their clinical trials for new drugs to developing countries, where the sick and desperate abound. Last year, GlaxoSmithKline, Wyeth and Merck conducted at least half of their clinical trials for new drugs outside the major markets of the United States and Western Europe. In poorer countries, recruitment is rapid. In South Africa, for example, leading clinical trials company Quintiles reports it recruited 3,000 trial subjects in 9 days, and over 1,300 pediatric subjects in 12 days.
    Easy, fast access to lots of sick, untreated patients is what drew Pfizer to Nigeria, too, where no informed consent forms were signed and where no witnesses could attest to the verbal consent the company alleges took place. Pfizer’s lack of documentation may be unusual but there’s plenty of evidence to suggest that the quality of consent in developing countries is generally poor, even when the forms are filled out. In studies in Bangladesh and South Africa, up to 80 percent of subjects enrolled in trials reported that they were unaware that they were free to leave the trial—a clear violation of the standard of voluntary informed consent.
    In the West, up to 45 percent of subjects drop out of trials, providing post-factum confirmation of their voluntary consent. Dropouts are disturbingly scarce in trials in poor countries. One New-Delhi-based clinical trials company boasts, in its promotional literature, that it retains “99.5 percent” of enrolled subjects. “Russian subjects don’t miss appointments….and only very rarely do they withdraw their consent,” enthused a typical promotional Applied Clinical Trials article, “Discover Russia for Clinical Research.” “What a phenomenon!”
    Pfizer didn’t have to alert the FDA and allow the agency to scrutinize its protocol before its scientists jetted off to Nigeria. Neither the FDA nor its counterpart in Europe requires prior review of trials that are conducted beyond US and EU borders, as they do with domestic trials. In the case of Pfizer in Nigeria, the ethics committee “approval” that the company provided to the FDA—and which the agency silently accepted, in its approval of the drug—was later shown by journalists to have been backdated, because there was no ethics committee at the local hospital when the trial took place.
    But the most alarming part about drug company experiments overseas is how very little we know about them. Most drug companies aren’t sued by foreign governments for their unethical clinical trials. Most clinical trials overseas never see the light of day: after all, about 90 percent of drugs that enter clinical trials fail to gain market approval. No scientific papers or newspaper stories are written about them. Our regulators don’t know about them. These failed experiments effectively vanish as soon as they close down.
    But while we blithely pop our prescription pills, a generalized sense of exploitation at the hands of Western drug companies grows, from South Africa where antiretroviral drugs are condemned to Nigeria where the polio vaccine was rejected. Unless we start to get serious about regulating these trials, Pfizer’s troubles in Nigeria will only inflame it, with public health impacts for us all.
    Over the past few decades, pharma companies have circumvented complaints that they overprice their drugs and ignore the ills of the poor with subsidized drugs and private-public partnerships to spur drug development. But charitable works will not shield them from charges that their conduct of clinical trials on the poor is shoddy. Pfizer, rather than ducking the charges against it, should lead the call for increased regulation of overseas trials—for its own benefit, as well as the rest of us.

Newsweek's short piece on malaria in Africa (September 24, 2007) is full of misinformation and mythology. For example, there has never been any continent-wide malaria control in Africa, as the lead sentence brazenly states; mosquitoes develop resistance to DDT by exposure to brand-name pesticides sold by Western chemical companies like BASF and others, not just by African farmers illegally using DDT on their fields; the main reason DDT wasn't used in Africa for so long is because the EU and others told African farmers they wouldn't buy their farm products if they did; and there's evidence to suggest that malaria problem in Zambia has not gotten better, it has been worsening, and the mining companies' whose work the article lauds have been the subject of riots.   
    None of these counter-points are speculative but near-consensus opinions in the malaria field. It is strange to see the mainstream press diverge so much from expert opinion: smells to me like politics eclipsing science.
    Check it out: The Doomsday Spray: To fight malaria, African nations are turning to DDT.

Nigerian authorities slapped criminal charges on Pfizer this month, alleging that the company's infamous 1996 botched antibiotic trial there was "rash and negligent," and endangered lives.
    Some of the subjects in the trial died, others suffered permanent disability, and the prosecutors say it's Pfizer's fault for providing a too-low dose of its comparator drug. (Listen to stories on NPR and ABC Australia, which feature a few quotes from me, for details.)
    That's a medical question on which the experts are not unanimous. Kids die from meningitis and are permanently disabled by it, too.
    Less debatable is the fact that Pfizer violated international ethics standards and their subjects' human rights. In a separate class-action suit against the company, the subjects said that they didn't know they were in an experiment, and the company did not produce signed informed consent forms. The ethics committee "approval" the company produced later turned out to have been backdated.
    This is the first time a state has filed criminal charges against a drug company, but I doubt it will be the last. With 80 percent of clinical trials failing to meet recruitment deadlines in the West, major drug companies are today conducting half or more of their trials outside the major markets, often in countries--like Nigeria--with poor human rights records and weak regulatory infrastructures. Pfizer's Nigeria trial is unusually sensational and high profile, but its bending of the rules may be more the rule than the exception.

A short but pointed interview with me appears in The Internationalist this week, along with a cool watercolor portrait (!). Check it out at The Internationalist.

This bit of entomological ecology—despite its crucial significance tothe problem of malaria--isn’t particularly well-known, even to thosemost intimately involved with the disease. I recently asked a bunch ofnurses at a NIH-funded malaria research clinic in Malawi where all thelocal malarial mosquitoes bred, and they answered in unison--“in theswamp.” Not so, said the mosquito biologist in the next building over.In fact the bugs that were killing their patients nursed their young inthe puddles right outside the hospital’s unscreened windows.   
    To think that we could develop a man-made mosquito--our ownsuper-mozzie--more adept than those in the wild, with their greatdiversity of habits and lifestyles greatly underestimates the wilinessof these dappled flies. Stalked by pathogens, relied upon by no creature,these insects have thrived for over 100 million years, in almost everyplace where the sun shines and the rain falls, however seldom. They'refantastically good at it. Some GM mosquito might beat a few of thesehardy survivors, in some places, at some times, but they couldn't beatthem everywhere.
    GM mosquitoes surely will teach us somethingabout the spread of malaria but they won’t end it. As with DDT, there'sno one-size-fits-all solution to malaria, our most ancient scourge, tryas we might to find one.

From this week's New England Journal of Medicine: a review of The Body Hunters by Johns Hopkins University's Jeremy Sugarman, MD, MPH:

"An accessible account... important...powerful...derive[d] from a rich set of sources.... It is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories." —NEJM, December 7, 2006

The Frontline Club in London is a wonderful venue--part bar, part restaurant, and part theater--devoted to independent journalism. I gave a talk about The Body Hunters there last week, and you can see the video here: www.frontlineclub.com

When I was 18 years old or so, I arrived at the frosty, elegant Chicago offices of JAMA: the Journal of the American Medical Association, in hopes of securing an unpaid journalism internship at the esteemed publication. It was a terrifying experience, and I failed to make the cut. Two decades on, vindication in the form of this wonderful review:

"Investigative journalist Sonia Shah has written a lucid, well-researched work on professional and governmental corruption and mismanagement associated with clinical trials conducted by the pharmaceutical industry in the developing world," Thomas A. Faunce writes in a review of The Body Hunters (JAMA, Nov 1, 2006, 2149-2150). "It deserves the attention of leaders of the medical profession and policy analysts concerned about the human consequences of US health care costs rapidly approaching the point of unsustainability."

No sympathy from Tauzin—a cancer survivor himself—for those sickly elders compelled to hobble onto buses to Canada to buy affordable medicines, either: according to Tauzin, these unfortunates are no better than Al-Quaeda conspirators “opening our borders…to future terrorist attacks.” (And for those concerned about the potential for abuse in tens of thousands of secretive clinical trials conducted on the untreated poor of the world, Tauzin points to PhRMA’s toothless “principles” on ethical research as indicative of the industry’s “more responsible role” in “clinical trial transparency and openness.”

As another legislator-turned-lobbyist J. Bennett Johnston observed, “everybody should have a job where they use the knowledge, talents and skills they have.”Quite. Nexium, anyone?

From my Washington Post review of a new book by Terry Tamminen, former head of the California EPA, which ran today:

"The corollary to the new truism that Americans are "addicted" to oil is that we can kick the habit just as we did with Big Tobacco -- by penalizing the producers of the drug. So says California Gov. Arnold Schwarzenegger's former environmental adviser, Terry Tamminen, in Lives Per Gallon.

Just like tobacco companies, Tamminen writes, oil and car companies have deceived us into consuming addictive products that pollute the airand make us sick. Describing how automakers and oil companies dismantled the electric trolley systems of numerous American cities in the 1920s, tricked us into using the most polluting fuels and stymied development of cleaner alternatives, Tamminen calls for a fusillade of lawsuits similar to the one that California's attorney general filed against auto-makers last month for the "public nuisance" of selling greenhouse-gas-spewing cars.

Curtailing tobacco use wasn't easy,but quitting oil -- lifeblood of the economy -- would seem quite a bit harder. And yet the Big Tobacco-style approach to slashing oil consumption works for Tamminen because he believes that hydrogen can easily replace oil's BTUs.

 He tries to sell us on hydrogen's promise with stories about California's model hydrogen-filling stations and enthuses about hydrogen zapped into being by solar and wind power. His rhetoric --"How many square kilometers of flat roofs are there at just the Kmarts, Costcos, and Wal-Marts of the world?" -- would probably sound great ina speech, but significant technical and political challenges are involved in scaling up these technologies. These Tamminen sidesteps, along with the crucial question as to whether making hydrogen from coal or nuclear power -- as President Bush, James Lovelock and a host of others advocate -- would be any better for the environment than burning oil.

Nevertheless, shifting to hydrogen may well be less burdensome than continuing with ever-scarcer crude. Skeptics, however,won't be convinced by Tamminen's accounting, which reads more like the cost of oil to him, not the rest of us. "Perhaps the greatest threat from our oil addiction," he announces, "is cancer." That's a strange assessment, given the threats of petro-fueled terrorism, global instability and climate change. But then again, Tamminen considers diesel exhaust to be "one of the greatest threats to human health" and blames automakers, whom he battled in the Schwarzenegger administration, for his own father's smog-induced death from emphysema.

Lives Per Gallon's portrait of a corporate conspiracy foisting invisible poisons upon us will certainly inflame public anxiety over dependence on oil, but messages of victimization won't help us solve our energy dilemmas. Crude is, sadly, much more than a fad, and our energy-intense lifestyleis more than the handiwork of deceitful oil and car companies. If only it were so easy.

Sonia Shah is the author of "Crude: The Story of Oil" and "The Body Hunters."

Jude Ike Nwokike is a pharmacologist at the public health research institution, Management Sciences for Health. I was especially pleased to hear his thoughts on The Body Hunters:

"Sonia! Your book is marvelous! I have not finished yet, but already feel that you did a great job. Lots of research must have gone into it; your coverage of Xigris is particularly spectacular."

It always is nice to hear positive feedback, but it is especially gratifying to hear from experts in the field. Thanks, Jude.

Some early feedback from readers of The Body Hunters, both near and far:

"Thank you so much for sending me your book. It is excellent and will
have a special place on my shelf." —A formerly high-ranking physician with Pfizer

"I really enjoyed reading your book, The Body Hunters. ( Did you base the
title on Paul de Kruif's book, The Microbe Hunters ?)" —Dr AniruddhaMalpani, Medical Director, HELP - Health Education Library for People, Mumbai, India

"I just read Body Hunters for a review. As an investigative reporter for more than 20 years, I thought it was a very shrewd piece of work. Bravo. I look forward to reading your next book." --Charles Rusnell, Staff Writer, The Edmonton Journal

"There's nothing I love more than a good book, unless it is a free good book...Last week I was sent The Body Hunters by Sonia Shah...I can recommend that folks read the book--it's a well-documented and clearly presented examination of an industry that many of us depend on." —fenris.org

Exposing prisoners to experimental drugs would be allowed only after the completion of early toxicity testing. This will hardly restrain drugmakers because they don't need prisoners for early toxicity testing anyway. Students and homeless people line up in droves for the $200 daily fee, plus room and board, on offer at the industry test clinics. It's ``money for doing almost nothing," as one test subject, a former law student, told me.

The bottleneck for drugmakers is in recruiting warm bodies for late-phase trials that establish a new product's effectiveness with statistical certainty. These ``Phase 3" trials can require tens of thousands of patients to complete, and most drug-saturated Americans are reluctant to take part. Eighty percent of trials fail to meet recruitment deadlines, bleeding drugmakers of $1 million a day while their blockbuster wanna bes remain locked up in development.

To solve the dilemma, many drugmakers have rushed overseas, to places like India and Poland, where sick, desperate patients are abundant. Now, if the institute's recommendations hold sway, they'll be able to access the 7 million souls captive to the US correctional system as well. The institute's proposed caveat -- that prisoner experiments include subjects from outside prison walls as well -- will make little practical difference in such trials. Few, if any, drugmakers would want to restrict these huge trials to prisoners anyway.

The institute also recommends that prisoners help oversee prison experiments. Unfortunately, often in resource-constrained environments, most everyone has an interest in the resources that well-funded research can bring in. ``It generates quite a bit of hard-earned money," one clinical investigator in South Africa explained to me. According to the institute, prisoners shouldn't be deprived of this by a ``myopic" obsession with informed consent.

The rationale, according to the institute, is that ``access to research may be critical to improve the health of prisoners and the conditions in which they live."

This is a bit fuzzy. Research breakthroughs alone don't change conditions, as anyone who has seen stockpiles of vaccines rotting in tropical warehouses can tell you. Change requires the implementation of research, which most researchers are neither responsible for nor interested in. Sadly, there's no guarantee that helpful research on prisoners will be promptly -- or ever -- applied to improve prison conditions.

In fact, the institute can scarcely ensure that research on prisoners offers the ``potential benefit" that their proposed regulations call for. Pediatric trials are supposed to offer ``potential benefit" to children. Why, then, do clinical-trials registries list just one trial on pediatric AIDS (a fatal disease for which few pediatric formulations of needed medicines are available), compared with no fewer than 70 on high blood pressure in children?

These experiments are not designed for their potential benefit to children, although drugmakers effectively argue that some subset of children will benefit from them. Rather, children are rounded up for such trials because blood-pressure drugs bring in $25 billion a year for drug companies, and testing these primarily adult medications on children extends drugmakers' brand-name patents by several lucrative months.

Since 2000, Food and Drug Administration officials and drug executives have led a movement to restrict the rights of human subjects in medical research: from making substandard care to the poor acceptable, to gutting strict curbs on the use of placebos. The institute's stance seems part of the trend. But once the experimenters are given the keys to the lockup, the choice for the imprisoned will be stark.

Behind bars, ``death at random is a way of life," according to one prisoner who spoke to government advisers prior to bans in the 1970s. ``The only place in this prison that people don't die is in the research unit," he said. ``Just what is it that you think you are protecting us from?"

For this prisoner, at least, the choice was clear: Be experimented upon or die.

Important bans protecting prisoners from medical experimentation are on the verge of dissolution.
    As reported by the New York Times today in a front-page story, last month the Institute of Medicine recommended that federal agencies drop the bans. The bans, long justified by the fact that people behind bars can scarcely be viewed as voluntarily consensual, stanched a once-booming industry of experimenting on the incarcerated. Drug companies disassembled the testing labs they'd built next to the prison gates.
    If lawmakers take up the IOM's recommendations as expected, the floodgates may once again be opened.
 The IOM takes pains to detail researchers' transgressions against prisoners in scientific experiments--see this NYT video on the Holmesburg trials, for example--but considered that the hypothetical benefits of prisoner research outweigh the certain and well-documented risks.

These lauded benefits, unlike clearly detailed risks, sound wonderful but are curiously vague.

More details to come...For now, chew on the fact that many of the authors of the IOM recommendations conduct prisoner research (to answer various social science and epidemiological questions) themselves. A conflict of interest, perhaps?

I'm thrilled to report that Amazon.com has started to fill orders for The Body Hunters. A fall speaking tour that includes stops in Boston, New York, Washington DC, Tuskegee AL, Athens GA, Spokane, Seattle and London is in the works. I'm really looking forward to hearing what readers think about the book. Please do contact me with your comments or if you are interested in sponsoring an event, at sonia@soniashah.com

Today the New York Times reports on weekly consumer reports conducted by University of Michigan. According to director Richard T. Curtin, many people are suffering from pricey oil--and are changing their spending because of it: just not the rich.

"Cutbacks in spending have been concentrated among households with less than $50,000 in annual income, according to Mr. Curtin’s surveys. That is roughly half of all households. Most of those with incomes above $50,000, which contribute to the bulk of consumer spending, are still managing to absorb the higher energy costs without cutting back much elsewhere. 'Rising gasoline prices are really driving a wedge between lower- and higher-income households,' Mr. Curtin said." —Louis Uchitelle, "Reluctantly adjusting to oil cost," New York Times, July 20, 2006

Half of us are "cutting back" in spending, that is, doing without. Along with increasing political instability overseas and intensified environmental disruption in oil regions, here is another cost of peak oil: more deprivation and inequity at home.

Last week’s front-page Washington Poststory detailing a long-suppressed Nigerian government report on Pfizer’s botched 1996 experiment on Nigerian children shines much needed light on a dark corner of globalization: the drug industry’s human experiments overseas. But those who are now calling for stricter regulations on the practice aren’t goingnearly far enough.

According to the May 7 Washington Post, California Rep. Tom Lantos plans to introduce a bill that would require U.S. investigators to detail their planned trials in developing countries to federal regulators. Right now, researchers must provide regulators with such details only if they plan to enroll American patients into their trials.

It’s an important provision, especially considering that most trials render negative results—a drug doesn’twork, or doesn’t work well enough, for examples. Industry scientists rarely trumpet such failed trials in medical journals, advertisements, and the like, so unless there’s some external record of the trial, those experiments just fade into oblivion. That’s especially troubling in the case of trials conducted in poor countries, because many are for drugs that are rarely accessible to the patients who filled the test clinics in the first place. Worse, if something goes awry in such trials—for example, if the drug is revealed as dangerous, or if subjects are unduly harmed, or uninformed—it is unlikely anyone will ever know about it.

Lantos isn’t the only one calling for more early details on such trials. In September 2004, the International Committee of Medical Journal Editors, fed up with drug companies’ selectively publishing only the good news about their products without the bad, announced that they’d only consider publishing those trials registered at inception on a publicly available database, such as the NIH’s ClinicalTrials.gov. The WHO plans to finalize another such effort on May 20, which they are dubbing “international clinical trials day.”

It would be hugely helpful for scientists, patients, regulators, ethicists and journalists to know in advance of the kinds of trials being conducted around the world. But is it enough? After all, hundreds of clinical trials, run by both drug companies and academic researchers, have been routinely listed on government and industry websites for years. Thousands are published each year in the medical literature. These include many condemned as unethical, such as experiments in which pregnant Ugandan women with HIV and malnourished Zambian children with AIDS, for examples, are given placebos rather than active treatments.

Some researchers have justified such experiments on the basis that impoverished, sickly patients in poor countries can’t afford anything better than a placebo anyway, a double-standard that a 2004 Journal of Medical Ethics paper defended as “not the optimal ethical standard…[but] at least not clearly unethical.” In such cases, trial details were readily available, described as ethically dubious, and sanctioned anyway. Clearly, just knowing about overseas trials is nowhere near sufficient to protecting the human rights and dignity of trial subjects abroad.

What we need even more urgently than greater oversight is greater restraint. Unless drugmakers are producing medicines that will be beneficial and accessible to patients in developing countries, let them stay home for their experimentation. After all, what poor, sick patients in developing countries need more of is medical care, not medical experimentation.

Until the benefits of the last hundred years of medical research are readily available in poor countries, why not require that those who benefit from new drugs—the major drug consumers in the United States, Europe, and Japan—shoulder the burden of experimentation that new drug development requires?

Tina Rosenberg’s long opinion piece in today’s New York Times brings much needed attention to the plight of “poor people’s diseases,” from sleeping sickness to tuberculosis (“The Scandal of ‘Poor People’s Diseases,’” New York Times, March 29, 2006). But her argument about malaria—that more DDT would vanquish the disease—is all wrong.

The basic gist of the argument is thus: Americans wiped out malaria using DDT, but because über-green Rachel Carson crusaded against the insecticide in Silent Spring, we self-righteously deprived the rest of the world of the miracle toxin. Two conclusions can be drawn from this little tale. One: post-Carson environmentalists have the blood of Africans dripping from their hands. Two: To quote from the title of a previous Rosenberg story on the subject, “What the world needs now is DDT (New York Times, April 11, 2004)

There are several problems with this story. The first is that DDT didn’t wipe out malaria in the United States.

For the rest of this piece, please see http://www.thenation.com/doc/20060417/shah

Something went horribly wrong in an early experimental trial of a German start-up drug company's new cancer-and-arthritis med.  Sometime last week, the drug—TGN 1412—was given to 6 healthy volunteers in a routine Phase 1 trial, designed to test the drug's safety. Today, all six of those volunteers are laid up in intensive care wards in Britain, fighting for their lives.

The volunteers "experienced adverse events," the company stated in its press release. I'll say. One young man's head and neck ballooned to three times the normal size. The others suffered multiple organ failure. See the BBC story here.

Here's how big the drug business is. This company has no drugs in its portfolio. A former Roche exec launched the company, TeGenero, specifically to develop TGN-1412 (and, presumably, other drugs like it.) They got drug giant Boehringer Ingelheim on board to manufacture their as-yet-undeveloped drug. They got the  European drug authorities to bestow their unborn med with "orphan" drug status (because along with cancer and arthritis, the drug might also be used for rare diseases.) They raised no less than 14 million Euros...and all this with no proven-effective drug in hand. Until nearly killing some volunteers this week,  all the drug had been proven to do was help some artificially sickened rats.

One can only imagine the financial and scientific pressure on the first human test of the drug.  On the other side of the test bed, the usual cohort of cavalier and cash-starved students would have lined up. For these kinds of tests, it is students and homeless people who generally bear the burden of risk. Drug companies purposely set up their early testing centers near universities to entice them. Do they understand the risks involved? Who knows? At a payrate of around $100 to $200 a day, including room and board, “it’s money fordoing almost nothing,” as a trial volunteer once explained to me.

Never mind that early trials are, arguably, the mostdangerous of all experimental drug trials. Toxic reactions occur in about 40 percent of all Phase One trials. And as we can see from this botched experiment, sometimes those toxic reactions are a whole lot worse than a minor skin rash.

This time news leaked out. But generally, the public never hears anything about failed early drugs. The experimental drug poisons a few test subjects and is quietly dropped from development, with nary a drop of ink about it, just one in a line of failed drugs lying in the wake of each and every blockbuster. We await the results of the investigation, now ongoing.

A cartoon man looks through his binoculars at a mist-covered mountaintop in the distance, but the peak is obscured by clouds. "Peak oil?" intones the caption. "Contrary to the theory, oil production shows no sign of a peak."

Good news from ExxonMobil, as featured in this prominent ad in the New York Times last week. "According to the U.S. Geological Survey," the ad reads, "the Earth was endowed with over 3.3 trillion barrels of conventional, recoverable oil...Since the dawn of human history, we have used a total of one trillion barrels of oil." That is to say, worried friends, "there is a lot of oil yet to be tapped," and "abundant oil resources" are "still available" and will be for "decades to come."

Phew! And here I was worrying.

Only...isn't the U.S. Geological Survey the same outfit that said, in a 32,000 page report released in 2000 that there was 47 billion barrels of oil still to be found in...Greenland?

That number was calculated by figuring there was a 95 percent chance of 1 barrel of oil lurking under the hitherto-neglected continent—a fair assessment given the conventional wisdom—as well as a 5 percent chance of finding some 112 billion barrels of oil. Add the two together, divide by two and presto, the government geologists had conjured up an oil reserve half the size of Iran's. Truly.

I like how ExxonMobil couched our oil consumption to date using the calming phrase, "since the dawn of human history." It makes it sound as if homo habilis was driving around in a Lexus or something. In fact, we hardly used any oil whatsoever during the overwhelming majority of human history. We evolved from apes say about half a million years ago or so? The first oil well was drilled not even 150 years ago. And we didn't start consuming much oil until after the second World War, since before then we had trolleys and bicycles and used crude primarily for lighting. So maybe 99 percent of those 1 trillion barrels were consumed in the last .0001 percent of human history.

So what's with the rosy picture, Exxon? Peak oil has entered the public lexicon, and people are snapping up hybrid cars (fat lot of good that will do, but it's the symbolism of the thing). Meanwhile, the world's biggest oil company, which in 2004 posted the highest one-year operating profit of any company ever in all of U.S. history is busy investing its bulging treasure chest not in hydrogen, ethanol, or any of the touted alternatives to crude but in...more oil. The company's single largest investment in a new project ever was launched this year: a $7 billion project to turn natural gas into diesel. Don't worry. Be Happy. Drive Diesel.

Before you add "The Constant Gardener" to your Netflix queue--Rachel Weisz won an Oscar for her role in the film last night, please note: the issues are real, but much of the movie is pure fantasy. No activist challenging the unethical practices of Big Pharma has it this good—or this bad.

The film revolves around the transformation of mild-mannered career diplomat Justin Quayle, played by Ralph Fiennes. Quayle’s wife Tessa, played by Rachel Weisz, has exposed a botched experimental trial conducted by a Western drug company upon unsuspecting African villagers. After she is found mysteriously murdered, Justin is infected with his firebrand wife’s righteous indignation.

The film couldn’t be timelier. According to the May 16 2005 USA Today, giant drug outfits such as Wyeth and Merck are now conducting up to 70 percent of their clinical trials outside the U.S. and Western Europe, their main markets for new drugs. Across Latin America, Eastern Europe, Asia, and Africa, the sick are abundant, desperate, and doc-trusting, and so recruitment into clinical trials is rapid. As one executive from an outfit specializing in running drug trials in Asia putit: “They are more willing to be guinea pigs."

The industry’s new experimental bodies in the developing world only rarely enjoy the benefits of the research they participate in. Sometimes the new drugs are unlicensed in their countries or priced out of reach, but more often the drugs are irrelevant to the health priorities of their communities to begin with. After all, 90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world’s disease burden.

Not surprisingly, ethical lapses are strikingly common. In one inquiry, out of 33 subjects enrolled in an experiment trial in Thailand, all of whom had signed forms stating their informed consent, 30 were found to be dangerously misinformed. “Informed consent is a joke,” said one industry researcher in an anonymous survey sponsored by the National Bioethics Advisory Commission.

But challenging these practices is not nearly as black-and-white as this film would have it. Tessa stands up to yell “bullshit” at public lectures, shaking her lovely dark mane while she’s at it.  At cocktail parties, she loudly embarrasses the health minister, who marches off in a huff. Good stuff, but the reality is that uncompromising activists—even if they look like Rachel Weisz --rarely enjoy this kind of privileged access to power so effortlessly.

Tessa has it too good and too bad,too. She ends up paying for her exposure of the botched trial with her life; in real life, bad drugs and unethical research practices often continue unhindered despite mountains of data and reports detailing their defects. As I found while researching my book, experimental protocols that would be condemned as unethical in the West—including placebo trials among ailing AIDS patients—are frequently described in the medical press; when the subjects are poor Africans or Asians, nary an eye is batted. (Recall that papers describing this country’s most egregious scientific study, the Tuskegee Syphilis Study, in which government doctors denied treatment to black syphilitics, regularly appeared in the medical press from the 1930s onwards. That study wasn’t terminated until 1972.)

In part that’s because new drugs aren’t uniformly deadly, rendering unequivocal data showcasing their killer properties. Rather, new drugs do work—just not very well, or not for everyone, or not without side effects, or most frequently, not any better than older, safer drugs. What that means is that the difference between a miracle drug and a poison lies not in the drug itself but in who uses it, how they useit, and when—decisions increasingly steered not by patients and clinicians but by the marketing departments of multinational drug companies.

And there in lies the real problem.
 
For my complete review, see The Nation online.

Leave it to a twelve-year-old to come up with this cheeky experiment: comparing the levels of bacteria in ice cubes from fast food restaurants...to the water in their toilet bowls. And her result? The toilet bowl water was cleaner. See the story here.

This science fair experiment is currently making the rounds on Jay Leno, ABC, and the rest. According to "Good Morning America"'s David Katz, this is "not cause for panic, although it is alarming."

I'll say! But the problem isn't that our ice cubes are so dirty, it's that our toilet water is so damn clean. We're shitting and peeing in this pristine water—cleaner than our own ice cubes!—while around the world, 6,000 children die every day for lack of adequate sanitation. See the BBC story here.

Surely there's a tale to be told there.

As for science whiz Jasmine Roberts, she's not letting her friends chew on ice anymore.

News flash: “Too much contemplation gets in the way of good decision-making”! (Greg Miller, Science, February 17,2006). “Thinking too hard about complex decisions…may lead to worse choices”! (Newsday, February 17, 2006). “New advice for anyone who is struggling to make a difficult decision: Stop thinking about it”! (Boston Globe, February 17, 2006) Dimwits everywhere rejoice!

A new study in today's Science magazine says that thinking too much is bad for you. I think not.

I admit I was intrigued by these new findings. But the spin is all wrong.

Psychologists at the University of Amsterdam studied different ways people make decisions about things like buying shampoo or a new car. Some of their subjects evaluated all the relevant information—price,size, what have you—and then made a decision. Others evaluated all the relevant information, then killed sometime distracting themselves, and then made their decision.When faced with only a few variables, surrounding the choice to buy shampoo,for example, the first method worked better (judged subjectively as well as objectively). But when faced with a larger array of variables, surrounding buying a house or car, the second method worked better. Why? Because, the researchers say, the second method allows the brain to do some unconscious processing, which is probably better than the conscious mind at synthesizing complex variables.

To me this study underlined how important it is for people to have downtime—time away from rapid-fire, always-on computer and television screens, instant messaging, cell phones, deadlines, one damn just-in-time thing after another. The need for contemplation! For relaxation! For all the things that allow one to descend below conscious thought into (hopefully) deeper levels of processing. Say, like…sleep! Music! Literature!

And so the spin that the press is putting on it—"Stop thinking!"—is all wrong. What the study suggests is: Think Deeper.

But it is suggestive that the "stop thinking" angle has such appeal. What does it mean? Nothing good, I'm afraid. Seems like yet another sign of a society in decline, one that elects cowboys as presidents and considers contemplation suspicious.

As the Times series has amply shown, our health suffers when we rely on fast foods and sugary drinks to sustain ourselves. But in places where malnourishment and poverty are rampant, the ramifications are even more profound.

In Western countries the transition from hardscrabble malnourishment to today’s drive-through, fast-food cornucopia occurred over centuries, with the happy result that our societies were able to control infectious diseases spread by hunger and poverty before facing the maladies of richly calorific diets, including diabetes, obesity and heart disease. As anyone who has seen the KFCs and Pizza Huts sprouting along the alleys of Mumbai and Cape Town knows, in developing countries, no such time lag exists. What experts call the “nutrition transition” is taking place within a single generation.

According to recent research, malnourished mothers tend to bear babies predisposed to storing excess energy as fat. This is a useful adaptive advantage in communities where calories are often scarce, enabling babies to survive nutritional deficits. But when such babies grow up to consume Western-style diets chock-full of fatty, sugary foods, that benefit turns into a deadly curse, leading them to gain disease-causing extra fat much more rapidly than they would have otherwise. And so, hot on the heels of the multinational soft drink and fast food companies in poor countries has been an epidemic of chronic disease.Today, four of out five people who die of chronic, noncommunicable diseases such as diabetes and heart disease perish not in New York or California but in developing countries, according to the World Health Organization. More Indians and Chinese suffer cardiovascular disease than Americans, Japanese, and Europeans put together.

Diabetes and coronary heart disease are epidemic in India, which is home to the greatest concentration of Type II diabetes sufferers in the world. In some areas of Africa, as many as one in five has diabetes. Nearly 20 million Africans suffer from hypertension. Worse, while diabetes in rich countries is primarily a condition of the elderly, in developing countries the disease strikes those in the prime of life, aged forty-five to sixty-five, slashing their average life expectancy by ten to fifteen years. For developing countries barely treading water amid the flood of malnutrition, HIV infection, malaria, and tuberculosis, “the public health implications of this phenomenon are staggering,” the WHO has noted, “and are already becoming apparent.”

The era of strings-attached IMF and World Bank loans, which forced the dismantling of many indebted countries’ public-health infrastructures, is partly to blame. Global trade agreements forged throughout the 1990s eased the entry of soda makers and fast-food companies into the emerging markets of the developing world. As we start to address the deadly legacy of hyper-marketed fast foods and sodas here at home, we should remember that the problem does not end at the corner Burger King. We’ve spread the problem beyond our borders, where its effect is likely to be much worse.

proving pesticides are safe by testing them on humans is harder than proving them safe by testing on animals, so the new standards are actually higher, not lower--i.e. more likely to protect public health! so long as pesticides are being used, i think it is good that the EPA is requiring human testing. why should chemical companies get off with animal testing alone? we're all exposed to pesticides all the time. either prove the stuff safe for humans or get rid of it altogether, i say.

Aid is a potent drug. It can help or hinder, depending on the circumstances. If you don’t have cancer, for example, a cancer drug will kill you. That’s why the maxim that is meant to guide medicine is to first do no harm. Don’t rush to “help” because your help (being faulty, partial, subjective) could very well be hurtful. First, just don’t actively hurt the patient. So what does that mean for aid in Africa? Debating the pros and cons of “help” is premature. First, let’s stop actively hurting the place: despoiling West Africa for oil; logging rainforests; exploitative mining; dumping toxic waste and cheap, unsellable goods and all the rest of it.

Enviro Bill McKibben has written a new book which, according to Publishers Weekly "contends that there is no boundary to human ambition or desire or to what our very inventions may make possible." Bill McKibben is very smart and writes beautifully--and I haven't read his new book-but I have an opinion anyway. (A bad habit I picked up working as an editor for 10 years.) It seems to me that a lot of these alarms about the high-tech future are misplaced. We still have 2 billion people on the planet who don't have electricity or running water! How far can a few biotech companies and their ultra-elite customers (certainly in a global sense) get with resource-intensive robotics and nanotechnology while the rest of the world descends into conflicts over resource scarcity amid an abruptly changing climate?

To think that we could develop a man-made mosquito--our own super-mozzie-- more adept than those in the wild, with their great diversity of habits and lifestyles greatly underestimates the wiliness of these dappled flies.
    Stalked by pathogens, needed by no creature, these insects have neverthless thrived for over 100 million years, in almost every place where the sun shines and the rain falls, however seldom. They're good at it. Some GM mosquito might beat a few out, in some places, at some times, but they couldn't win everywhere. As with DDT, there's no one-size-fits-all solution to malaria, try as we might to find one.

The news media is in a big kerfuffle over reports of a new geneticallymodified mosquito that is resistant to malaria, and all the strongerthan wild mosquitoes for it. Sounds perfect, right? Stronger bugs thatfight off the parasite would easily eclipse the local weaklings thatfall prey, and soon enough, there'd be no more malaria.
    And yet...each malarial locale is as unique as a snowflake, withparasites specifically adapted to local mosquitoes, which are of acertain breed, a just-so strain, with their own uniquely finickyhabits. There are over a dozen different species of Anophelesmosquitoes that effectively transmit human malaria. Some thrive inshady running water, some in still sunny puddles, others in saltymarshes, some in forests, others in deserts. Some bite at night, othersat dusk, some feed on cows and horses, others solely on humans. We knowprecious little about this great diversity of anopheline habits, andcan barely tell the critters apart, but genetic studies tell us thatthey're continuing to break into ever more species. Even as I write,wild malarial mosquitoes are transforming themselves to more fullyexploit their local environs, like water to a cup, in ways we can onlydimly grasp. 
    To think, then, that we could develop our own mosquito, one thatwould be stronger and more adept in all of these specific localhabitats--our own super-mozzie--greatly underestimates the resilienceof these dapple-winged flies. The GM mosquitoes currently developed arejust a proof-of-concept, and they've been tested only against mousemalaria, but even if their development progressed, they could onlyconceivably work in some places, at some times. They couldn't workeverywhere. Just as with DDT, there's no one-size-fits-all, try as wemight to find one.

Well, kind of. The OHRP shot out an email responding to Gawande this week. They say that the "program" was actually a research study, the results of which were published in the NEJM. That is, the people who impemented the intervention didn't actually know whether it would work or not. Maybe the patient would start seizing on the table while all the staff were huddled over the checklist, ticking boxes. Who knows? With that kind of uncertainty, surely patients had a right to be informed and consenting. And yet, the researchers had gotten no ethics committee review (IRB) or their subject's informed consent.

But that wasn't quite it, either. The "study" had no control group, because nobody wanted to NOT use the checklists. In other words, the erstwhile researchers felt they knew that it WOULD work. In which case, they were simply trying to improve patient care with a proven intervention and no IRB or informed consent was required.

So was it really a "study" or was it actually a "program"? Did they know it would work or didn't they? How confused were they?

Well, in the actual doing of the thing, the clinicians conducted themselves as if it were a program of improved care, but then when they wrote up their results in the NEJM, they cast their work as an experimental 'study.'

That's not right, either: you can't have it both ways. Someone complained to the OHRP, which opened some kind of investigation, which then led to Gawande's complaint, and a flood of angry letters to the OHRP. Phew!

All of which is to say: there's a shifting line between what we say we know and what we say we need more research on. When there's something we want to do, when there's political will and money to do it, we dispense with "research" quickly and move on to implementation. In other areas--say, the administration of expensive drugs to poor people--there are endless calls for studies and experiments to prove the same thing over and over again, putting subjects at some risk every time, because intransigent authorities (drug companies, health ministries) find it politically more expedient to say "we need more research" instead of "sorry, no" (or "absolutely not, who cares about poor people who don't buy lots of stuff.")

Fyi, these were the checklisted items, as reported in the NEJM, used in the ICU on patients with catheters: hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. The implementation of these procedures coincided with a precipitous drop in the number of catheter-related infections, but without the control group, no cause and effect can be determined, at least not by this study.

According to the BBC, the Nigerian authorities have now issued warrants for the arrest of several Pfizer staffers! Their case against Pfizer, regarding the botched 1996 Trovan trial on meningitis patients, has been preposterously slow. There are several lawsuits pending and all have been adjourned, postponed, delayed etc etc more than twice. This latest twist probably has more to do with intensifying pressure on the much more important--but less talked about--settlement talks, which have been ongoing throughout in London.

The Nigerian authorities aren't after greater transparency in clinical trials, which would go a long way toward preventing the kinds of violations that occurred in the Trovan trial. They're dialing for dollars. Can't blame them, exactly, but it hardly advances the cause. 

This journal features commentary on science and politics from independent investigative journalist Sonia Shah. Sonia Shah is the author of Crude: The Story of Oil (Seven Stories Press, 2004) and The Body Hunters: Testing New Drugs on the World’s Poorest Patients (The New Press, 2006.) Sonia Shah’s articles appear in print in Orion, Salon, The Nation and have been widely anthologized. A former writing fellow of the Nation Institute and the Puffin Foundation, Sonia Shah hosts the website ResurgentMalaria.com and is currently working on a book about the politics of malaria, to be published by Farrar, Straus & Giroux. For more information, email sonia@soniashah.com.