Billy Tauzin on buying drugs in Canada

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?

My review in Washington Post (Lives per gallon)

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

Praise for 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.

Early feedback on The Body Hunters

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

Experimenting on prisoners

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?

The Body Hunters: now available!

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

peak oil, deprivation and inequity

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.

New bill on clinical trials overseas

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 on the diseases of the poor

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

Botched experiment: TGN 1412

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.