Month: March 2006

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.

March 8, 2006

March 8, 2006

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.

March 6, 2006

March 6, 2006

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.

© 2024 Sonia Shah

Site by NormanUp ↑