Sonia Shah

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Articles, Disease and Ecology, Science and Politics, The Body Hunters

Disease journalism

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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.

Articles, Science and Politics, The Body Hunters

FDA and international research ethics

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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

Articles, Science and Politics

Gawande and the NEJM

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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.

Articles, Crude

Bicultural feminism revisited

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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.

Articles, Science and Politics, The Body Hunters

Inhaled insulin and drug marketing practices

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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

Articles, Science and Politics

Billy Tauzin on buying drugs in Canada

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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?

Articles, Crude

My review in Washington Post (Lives per gallon)

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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.” © 2006 The Washington Post Company

Articles, Science and Politics, The Body Hunters

Experimenting on prisoners

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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?

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