Under proposed changes to federal research ethics standards, the Environmental Protection Agency will no longer accept studies that use people as guinea pigs in chemical tests.

In 2006, under chemical-industry pressure, and over arguments that the studies were scientifically and ethically bankrupt, the EPA declared such data acceptable. On June 16, the EPA reversed its decision.

“What we were really concerned about is toxicity studies, where they’re trying to do a study on humans to determine the dose response of a chemical,” said Jennifer Sass, a senior scientist at the Natural Resources Defense Council, a liberal nonprofit. “If the EPA stops accepting them, there’s no motivation for companies to conduct them.”

Almost every standard code of medical ethics — including the Nuremberg Code, written in response to Nazi doctors’ nightmare studies — forbid human tests of drugs or chemicals that may cause harm, but can provide no direct benefit.

The chemical industry, however, has long argued that the EPA should accept data from tests in which healthy volunteers are paid for exposing themselves to pesticides and other known toxins. The industry says such data provide a more accurate picture of chemical effects than animal studies.

Critics say the resulting science is worthless, with companies running tests on small, non-representative groups of people, such as healthy young men, in order to create a false impression of safety. More importantly, the tests put people at potentially grave physical risk, with no benefit but a cash payment.

“These pesticides are intentionally designed to be toxic. Their whole purpose is to kill insects and invasive plants,” wrote senator Barbara Boxer (D-CA) and representative Henry Waxman (D-CA) in a 2005 report (.pdf) on the industry’s tests. “Yet in the experiments, test subjects swallowed insecticide tablets, sat in chambers with pesticide vapors, had pesticides applied to their skin, had pesticides shot into their eyes and noses, and were even exposed in their homes for six months at a time.”

Continued Waxman and Boxer: “The subjects were not told of the dangers of exposure to the pesticides. Sometimes, they weren’t even told the substances being tested were pesticides. They were misled into believing that they were participating in ‘drug’ trials, not pesticide experiments.”

Nevertheless, the Bush-era EPA — led by Stephen Johnson, a former tobacco-industry scientist — said they’d accept data from those studies. The NRDC, along with liberal nonprofits Pesticide Action Network and Earthjustice, filed suit in federal court.

Proposed rule changes announced by the EPA on June 16are the result of negotiations that accompanied the legal battle. They extend protections from the Common Rule (a widely accepted set of medical ethics that forbid intentional-dosing studies that have no benefit) to all people involved in EPA-accepted studies. Extra protections are given to children and pregnant women.

“EPA expects its tougher new rules will decrease the number of systemic intentional dosing toxicity studies conducted for pesticides,” reads the EPA website. “We expect the number of systemic toxicity studies to drop to as few as zero or one per year.”

The rules will be opened to public comment in January of 2011, and will need court approval to finally become law.

The American Chemistry Council, the major chemical industry trade group and an advocate of expanded human testing, did not respond to requests for comment.

According to Sass, Some data on human exposures to chemicals may still be used. Reports from accidental poisonings, worker exposures and other unintentional dosing exist, and “EPA could incorporate a lot of that unfortunate, real-world data,” she said.

“Pesticide companies should not be allowed to take advantage of vulnerable populations by enticing people to serve as human laboratory rats,” said Pesticide Action Network senior scientist Margaret Reeves in a press release.

Image: Flickr/Michelle Tribe

See Also:

• Dow: Our Unethical Tests Show That Nerve Poison is Safe
• Scientists Stop EPA From Pushing Toxic Pesticide
• Why Testing Pesticides on People is Wrong, Part 1: Unwitting College Students
• Why Testing Pesticides on People is Wrong, Part 2: Devilish Details and the Greater Good

Brandon Keim’s Twitter stream and reportorial outtakes; Wired Science on Twitter. Brandon is currently working on a book about ecological tipping points.

A new strain of swine flu shows that the pandemic version has jumped from humans back to pigs, where it’s evolving in new and unpredictable ways.

The new strain, identified in a Hong Kong slaughterhouse, isn’t especially virulent. But the findings emphasize the need for continued vigilance. Swine flu isn’t going away.

“Hoping for the best while preparing for the worst seems a sensible strategy,” said University of Hong Kong virologist Malik Peiris. The strain is described June 18 in Science.

Peiris and study co-author Yi Guan are best known for identifying the SARS virus and helping to contain its 2003 outbreak. They were also among the researchers who identified swine flu’s origins after its outbreak last year.

Technically known as H1N1/2009, swine flu’s popular name hinted at its ancestry: a fusion of two swine strains, one from Asia and another that had erupted in the 1990s on U.S. factory farms.

Swine flu spread rapidly around the world, infecting tens of millions of people, and exposing profound flaws in the ability of governments and companies to handle pandemic flu. Fortunately, the strain was far less virulent than originally feared, killing about 19,000 people.

But virologists warned that H1N1/2009 was now a major new player in the global flu scene, and would continue to evolve — not just in humans, but once again in pigs, who proved susceptible to the pandemic strain. That’s exactly what the latest findings show.

“Everyone talks about viruses that go from animals to people, but it’s a two-way street. We reintroduce them to animals, where they reassort and become pathogenic,” said Columbia University epidemiologist Ian Lipkin, a member of the World Health Organization’s virus surveillance network. Lipkin was not involved in the study.

Peiris and Guan found the new strain in January in a Hong Kong slaughterhouse, where they regularly sample pigs arriving from farms in southeast China. It contains a gene from the pandemic swine flu, plus genes from the two strains that originally mixed to create the pandemic flu.

Having sequenced the new strain’s genes, the researchers recreated it in a laboratory and exposed it to pigs. The strain proved contagious but only mildly virulent.

In their surveillance efforts, the researchers have not found evidence of swine flu recombining with H5N1 avian influenza, an eventuality that Guan once said would prompt him to “retire immediately and lock myself” in a high-security lab. That’s reassuring, but Peiris warned against complacency.

“If this pandemic virus was marginally more virulent than it turned out to be, the discussion right now would have been [about] why the pandemic preparations failed to protect the population, rather than why global health authorities over-reacted,” said Peiris.

“Flu is unpredictable. People have been saying that we should expect a new pandemic every 30 years, and we had one last year, so we can rest. That’s not true,” said Lipkin. “This virus evolves rapidly. We have to stay vigilant.”

Image: H1N1/2009/Centers for Disease Control and Prevention.

See Also:

• Swine Flu Ancestor Born on U.S. Factory Farms
• Google Could Have Caught Swine Flu Early
• Old People May Be Immune to Swine Flu
• Swine Flu Lacks Killer Molecule

Citation: “Reassortment of Pandemic H1N1/2009 Influenza A Virus in Swine,” by D. Vijaykrishna, L.L.M. Poon, H.C. Zhu, S.K. Ma, O.T.W. Li, C.L. Cheung, G.J.D. Smith, J.S. M. Peiris, Y. Guan. Science, Vol. 328 No. 5984, June 18, 2010.

Brandon Keim’s Twitter stream and reportorial outtakes; Wired Science on Twitter. Brandon is currently working on a book about ecological tipping points.

• Link (via Lifehacker)

Five years ago, Oxford University zoologists showed that the parasite Toxoplasma gondii alters the brain chemistry of rats so that they are more likely to seek out cats. Infection thus makes a rat more likely to be killed and the parasite more likely to end up in a cat—the only host in which it can complete the reproductive step of its life cycle. The parasite also lives in the brain cells of thousands of species, including about 60 million supposedly symptom-free Americans. Studies over the past few years have suggested that toxoplasmosis infections in humans, too, may cause behavioral changes—from subtle shifts to outright schizophrenia. Two studies this year add even weirder twists.

• Link (via Boing Boing)
• Parasites on the Brain [damninteresting.com]

Shunting blood to your core and away from your extremities is accomplished through vasoconstriction of your peripheral circulation. This allows the outer portions of your body to become better at insulating your core, since it is losing less heat to the outside world.

And now the key to what causes paradoxical undressing. Vasoconstriction occurs when the smooth muscles within the vasculature contract. This effort requires a steady input of energy in the form of glucose from the body’s energy stores. However, due to a lack of blood now traveling to these muscles, they eventually tire. As the muscles of the constricted blood vessels run out of energy, they fatigue, relax, and open up. This is known as vasodilation.

With vasodilation of the blood vessels, an infusion of warm blood from the core of the body rushes into the peripheral extremities. This causes the hypothermia victim to feel overly warm and to start shedding layers of clothing, contrary to the reality that their body temperature is continuing to drop.

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In an article to be published in Psychological Science, they have shown that people who played action video games for a few hours a day over the course of a month improved by about 20 percent in their ability to identify letters presented in clutter—a visual acuity test similar to ones used in regular ophthalmology clinics.

In essence, playing video game improves your bottom line on a standard eye chart.

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In the interest of coffee drinkers everywhere, here are the latest thoughts from leading researchers about coffee and whether it can enhance—or not—our health. We are “spilling the beans” on who should and shouldn’t be drinking coffee, especially if you suffer from certain conditions.

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