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Despite Pelosi Flip-Flop on Drilling Vote, GOP Energy Revolt Continues

Mike Lillis — Wed, 13 Aug 2008 17:39:04 GMT

House Speaker Nancy Pelosi (D-Calif.) this week might have softened her opposition to an offshore drilling vote, but GOP leaders want to see some proof of sincerity. From a Tuesday statement from House Minority Leader John Boehner (R-Ohio):

If you meant what you said last night, we welcome you and your Democratic colleagues to join us in our historic call to action on American energy. End your five-week break early and call Congress back into session now so we can vote for more American-made energy and lower gas prices without any further delay.

Republicans are pushing for a vote on their own energy bill -- the American Energy Act -- which would remove the congressional moratorium on new offshore drilling and open protected areas of Alaska for exploration. Democrats, however, will want to place more emphasis on the development of renewable fuels and other party priorities, some of which are hardly popular with the oil industry. That could include controversial "use it or lose it" language, The Hill reported last night, which pushes oil companies to produce more quickly on leased lands or lose those leases.

With more than three weeks remaining in Congress's vacation, there's plenty of time left for jockeying. What happens in September, at this point, is anyone's guess. But you can bet that environmentalists are more than a bit nervous about how this saga ends. After all, Democrats have a record this year of caving on issues dear to the hearts of liberal voters.

Global Warming Battle Heats Up

Matthew Blake — Wed, 13 Aug 2008 17:04:08 GMT

Four Democratic senators demanded late last month that the head of the Environmental Protection Agency must go. Their call for EPA Administrator Stephen Johnson's resignation -- after eight months of looking into his actions as agency chief -- is largely due to Jason K. Burnett, Johnson's former deputy in developing global warming policy.

Since resigning in May as the No. 3 official at EPA, Burnett has helped congressional investigators build a compelling case that the White House strong-armed Johnson into denying California a waiver to police greenhouse gas tailpipe emissions and also stopped the EPA from setting a national greenhouse gas standard.

Illustration by: Matt Mahurin

In stepping forward -- no one has directly challenged his statements -- Burnett, 31, has won over Johnson's many critics in Congress. For example, Sen. Barbara Boxer (D-Calif.), chairman of the Senate Environmental and Public Works Committee, praised him at a hearing. "We need good, caring people like Jason Burnett," Boxer said.

But while Boxer and her allies cite Burnett's sworn statements in their continuing battles with the Bush White House, Burnett says he wants to move on. His high-profile whistleblower role ends seven years of first shaping and then dissenting from some of the administration's most contentious environmental policies.

Burnett supplied the scientific basis for business-friendly arsenic and mercury policies considered so controversial that they were soon reversed. But he quit EPA over a disagreement with Johnson in 2006, only to return in a more important job, and then resign again because, he says, the administration failed to set a global warming policy.

It is this negligence on global warming, Burnett said in an extended telephone interview, that caused him to decide to become a whistleblower. Burnett resisted detailing the battles he waged with Johnson and the White House. Instead, he expressed optimism that, at the very least, his work on global warming will be of use to the next administration.

"This was a policy disagreement I had with Administrator Johnson, who is in a very difficult situation," Burnett said. "I respect the administrator though I do disagree with the policies he has pursued."

"I was invited back [to EPA] to do a job and I did all this administration wanted me to do. This administration has declined to decide what to do about the profound policy challenge of global warming. ... This administration has decided to make itself irrelevant."

Close observers of the EPA are skeptical about Burnett's recent turn against the Bush White House. "I do not know what motivated him to say that he suddenly realized that this administration wasn't going to do anything," said David Bookbinder, chief climate counsel at the Sierra Club. "He's not dumb."

"Nobody knows for sure why he went public and started ratting out his colleagues," said Frank O'Donnell, president of Clean Air Watch. "He was one of the political insider's at EPA. People [on staff at EPA] are stunned that he's trying to rewrite history and say that he was a good guy all along."

Burnett's second time with EPA began in May 2007, following the Supreme Court decision, Massachusetts v. EPA. The court ruled that if greenhouse gases do, in fact, cause a dangerous level of climate change, then EPA must, under the Clean Air Act, curb their emissions. The court also ordered the president to publish a scientific finding from EPA on whether greenhouse gas pollutants merit regulation.

After the decision, Johnson hired Burnett as the point person to work on the scientific finding and overall issue of initiating a global warming policy. This came a year after Burnett left EPA, over what he said had been a policy disagreement with Johnson on a standard for soot particles in the air. "While he and I ultimately didn't agree on the right way to set an air quality standard," Burnett said, "He liked how I operated. He liked my expertise and experience in applying economic analysis to environmental policy-making."

But a flurry of activity by Johnson last December prompted Burnett to once again leave EPA.

Burnett told the House Committee on Oversight and Government Reform in May that, throughout 2007, Johnson wanted to give California a partial waiver to regulate tailpipe emissions. Burnett said that Johnson altered his position sometime in December, after communicating with the White House.

Johnson had testified before Congress in January that the White House hadn't pressured him to deny the waiver.

In July, Burnett told the House Select Committee on Energy Independence and Global Warming that Johnson, as well as officials from the White House and Office of Management and Budget, had originally supported an EPA staff finding that greenhouse gases pose a public-health danger sufficient to require regulation.

But Burnett said their position abruptly changed in December 2007, when he sent an email to the White House with the scientific finding that greenhouse gases cause global warming and must be regulated. The White House literally didn't open the email, and instead called Burnett, instructing him to say that he sent the email "accidentally."

The email still has not been released. Instead, EPA extended the comment period on whether greenhouse gases should be regulated.

The White House did, however, allow Boxer, and three of her colleagues, to briefly look at the email. Burnett declined to relate the email's content. He said that he cannot release the findings, because this is still EPA property. But he did say that the email will have future relevancy. "It will have legal significance requiring EPA to then issue the first federal greenhouse gas regulations. I believe that much of the work we did will help the next administration."

Indeed, between his whistleblowing and the potential use of the email, some good has likely come out of Burnett's second time with EPA. The same probably can't be said for his previous involvement with environmental policy.

The grandson of the late billionaire David Packard, co-founder of Hewlett-Packard, Burnett got his start in Washington with the right-leaning think tank, American Enterprise Institute-Brookings Joint Center, now known as the AEI Reg-Markets Center.

There, he wrote a series of papers on cost-benefit analysis -- including one arguing that economic costs trumped a Clinton-imposed EPA standard limiting arsenic, a carcinogen, in drinking water. In light of this, the Bush administration briefly did away with the standard in 2001. But sharp public backlash caused a reversal of the decision.

Burnett joined EPA as political appointee in 2004, working with the Office of Air and Radiation on a new standard for the acceptable level of mercury metal, a neurotoxin that comes out of power plant smokestacks.

When EPA established a "cap-and-trade" mercury emission program in 2005, environmentalists immediately called it a gift to industry. "It was environmentally bad and flagrantly illegal on its face," said Bookbinder of Sierra Club.

A federal appeals court agreed. In February of this year, the D.C. circuit court of appeals ruled that EPA violated its congressional mandate that all plants must reduce mercury emissions. The judge caustically compared EPA to the Queen of Hearts character in "Alice in Wonderland" -- who made rules by whim and without justification.

"The mercury rule was typical of the Bush EPA," said Bookbinder, "which, at the time, Burnett fit right into."

"He came into a lot of ill repute at the agency during the mercury battles," said O'Donnell. "He was one of the principle architects for a policy that proved to be a total disaster from an air pollution standpoint."

Burnett said his opinions on mercury and arsenic regulation are consistent with cost-benefit analysis. "My basic philosophy of the regulation is fairly straight forward," he said. "Some regulations are quite beneficial to the well-being of our country and some of them aren't. I've tried to apply a consistent set of principles to each inquiry."

In 2006, Burnett said it was these principles that caused him to leave EPA. Johnson had overruled a staff recommendation on regulating soot, a minute particle that can cause lung cancer. "One of the primary reasons I first left EPA," Burnett said, "was that Administrator Johnson declined to provide a stronger soot standard."

How much of a difference Burnett has made by publicly dissenting from Johnson is not clear. Burnett has detailed EPA's denial of the California waiver. But he's confident that regardless of his revelations, the courts will reverse the California decision. "California has met the test of the Clean Air Act," he said.

And Burnett's talk about the next administration likely means it will be at least two years before a president appropriately addresses Massachusetts v. EPA.

"Sure, he's giving corroboration that the leader of EPA is a scoundrel," said O'Donnell, of Clean Air Watch. "But what's being done about it? The career [EPA staff] people have been keeping their heads down for seven years. They figure they might as well keep them down for another five months."

Nonetheless, Burnett has been an essential asset to lawmakers whose job is to hold the executive branch accountable. "What Burnett is doing is important," said Bernie Sanders (I-Vt.) at a Senate environmental committee hearing. "Because he's confirming what many of us have known for years -- that Bush and Cheney have been especially disastrous on environmental matters."

Burnett's revelations about this administration could make him a player in the next one. Along with campaigning for Rep. Sam Farr (D-Calif.), Burnett's current political activity includes maxing out donations for Sen. Barack Obama (D-Ill.), the presumed Democratic nominee.

Burnett said that he doesn't have "any plans or expectations" of working in an Obama administration, which he seems to feel is likely. But his prospects for being in a future administration are, at the very least, better than Johnson's.

More Green Affordable Housing Successes

Suemedha Sood — Wed, 13 Aug 2008 13:55:00 GMT

Just wanted to flag this informative comment from one of our readers regarding our story, Affordable Housing Goes Green. Reader pierced talks about an affordable housing project in Rohnert Park, Calif., about 40 miles north of San Francisco:

Green affordable housing seems so rare that I wanted to mention another project in California called Sonoma Mountain Village. Sponsored by One Planet Communities and a local developer, Codding Enterprises, this project will have about 380 affordable for-rent/sale units in a 1900-unit mixed-use development.

Like Trolley Square, this project puts residents within a five minute or less walk of community and commercial places. In Seattle, High Point, New Holly and Rainier Vista are green mixed-income communities that also have commercial and open space amenities.

A unique goal of Sonoma Mountain Village (and other One Planet Communities) is to reduce the community ecological footprint by 80% from a conventional development by using on-site renewable energy, reducing waste, using alternative transportation, creating a local food and materials network, and creatively working with local businesses and residents to create an extremely diverse green community.

Find out more about Sonoma Mountain Village here.

Endangered Species Overhaul Is NOT About Climate Change

Suemedha Sood — Tue, 12 Aug 2008 21:18:19 GMT

Some media outlets and environmental groups may be missing the point on the Bush administration's proposed overhaul of the Endangered Species Act by making the issue about global warming. And I tend to think that's exactly what the administration wants them to do.

The Interior Department said in a press release that its new rule "will help avoid misuse of the ESA to regulate climate change" (in light of Interior Secretary Dirk Kempthorne simultaneously declaring the polar bear a "threatened species" and refusing to address climate change, the phenomenon that threatens it). At Monday's press conference addressing the new endangered species rule, Secretary Kempthorne said, "It is important to use our time and resources to protect the most vulnerable species. It is not possible to draw a link between greenhouse gas emissions and distant observations of impacts on species."

Much to my dismay, some reporters and advocates are taking this idea -- that the new ESA rule is about climate change -- and running with it. This troubles me not because I don't agree that climate change is harming wildlife. (I do.) It troubles me because the proposed changes to the ESA are much, much more sweeping than that. The Bush administration seems to be using climate change as a distraction from the fact that its proposal could potentially gut wildlife protections altogether.

News Flash: The proposed rule as it is written has NOTHING to do with climate change. There is no language in the rule that even so much as mentions the words "climate change" or "global warming." Interior Department spokesman Frank Quimby verified that for me. (You can even search the pdf of the draft leaked to the AP yesterday.)

Yet, Quimby seemed to want me to think that the rule does relate to climate policy. When I interviewed him today for my forthcoming piece on the proposed ESA regulations, he talked about global warming and greenhouse gas emissions.

"Some are arguing," he said, "[that] any new emissions that are permitted, whether from a new highway or anything like that, should require consultation [with independent scientists] because they affect polar bears. No. Science cannot show a direct causal link between emissions 2,000 miles or 5,000 miles away." (Climate scientists might have something to say about that, but I suppose that's another point for another post.)

So, Quimby concluded, the modifications set by the proposed ESA rule would say that "a federal agency cannot be required to hold consultations because those emissions could affect climate change."

Actually, the modifications would say that federal agencies will no longer be required to hold consultations with independent scientists, period. No matter what the circumstances. It goes that far.

National Wildlife Federation attorney Karla Raettig says the Interior Department is using the climate connection as an excuse. "It's absolutely not related," she said. "They're using it as an excuse, but the changes they're doing have very little to do with climate change, if anything. They're not revising regulations to deal with global warming...[They're using] it as an excuse to put through some [endangered species] changes that the administration wanted."

The American Way: 'Bigger, Stronger, Faster'

Arthur Allen — Fri, 08 Aug 2008 21:38:43 GMT

When Mike, Chris and Mark Bell, were striving to become champion iron pumpers in Poughkeepsie, N.Y., the brothers never dreamed that Arnold Schwarzenegger, Hulk Hogan and their other idols were juiced. Steroids were for commies --like Dolph Lundgren in Rocky IV. Rocky himself was clean and sober. He chopped wood to get buff.

But, as they got older, the Bells learned the dirty little secret: their heroes were on ‘roids. The Bells would have to take them too, if they wanted to compete. Years later, Mark—who went by “Mad Dog” when he wrestled for World Wresting Entertainment, the WWE, and “Smelly” Mike – who can bench press 700 pounds-- are still using the stuff.

Chris, the middle brother, tried steroids for a few months, stopped and decided to make a movie about them instead. His documentary film, “Bigger, Stronger, Faster: The Side Effects of Being American,” is a hilarious, poignant and thought-provoking look at the hypocritical culture of competition.

“I was brought up to believe that cheaters never prosper,” he narrates, over footage of President George W. Bush speaking against steroid use -- though his Texas Rangers used them. “But in America, they always prosper.”

With the Olympics beginning Friday and millions of kids primed to watch their U.S. heroes compete with the world, Bell sadly reflected on what he learned about the clandestine doping that goes on beyond the noble striving for national glory. Bell, 35, spent three years working on the film, which incorporates dozens of interviews and other footage.

“I used to think the Olympics had the best drug testing, but it’s a big façade,” he said in a phone interview. The Balco scandal -- in which a San Francisco steroid producer provided hundreds of baseball players with hard-to-trace steroid shots -- revealed some of the tricks that trainers use to evade testing. Olympic committees have done little to keep pace with the cheaters, Bell said. “You can skirt the rules on hormones. There’s no test for human-growth hormone. There’s an improved test for Epo [which increases oxygen in the blood], but it won’t be ready for the Olympics.”

“I don’t want to be one of those conspiracy-theory guys, but there are a lot of people juicing,” he said. “You’re never going to have a 100-percent clean Olympics. It’s sad. Kids look up to these people.”

News accounts indicate a certain vigilance against doping Olympic athletes. But the history of such scandals, Bell suggests, is that only the unlucky get caught. During the 1988 games, Jamaican sprinter Ben Johnson lost his gold medal in the 100 meters for steroid use. Carl Lewis, to whom the gold was awarded, had also tested for banned substances in his blood during training. Rather than disqualify him, according to Bell’s well-documented account, the U.S. Olympic Committee changed the rules.

Anabolic steroids became controlled substances in 1990, and are banned by most professional sports associations, but it’s an open secret that you can’t be the best bodybuilder, weight lifter or homerun hitter (or swimmer ?) without them. And so, people cheat.

Bell's film, which incorporates his own interviews, news footage and cartoons in a hilarious gallop through the issue, makes two main points about steroid use. The first is that steroids, as bodybuilder Gregg Valentino puts it during the film, "are as American as apple pie" -- that the American drive to win trumps the American sense of fairness every time. This, Bell is saying, is what really bothers Congress, which held more hearings about steroids in 2006 than it did on the war in Iraq. Steroids aren't nearly as dangerous as tobacco, alcohol or dozens of other legal substances, but their use reveals something ugly about America, and not just its athletics industry.

“There’s this assumption that steroids kill, but no one can find the bodies,” Bell said. Valentino has biceps that look like a python swallowing a pig. But Bell shrugs. “Some people just want big arms. If people want to look like freaks, why can’t they? Is it any worse than piercing strange parts of yourself?”

Or as Valentino himself puts it, “I wanted to be big. I couldn’t get taller, so I got wider.”

Bell may be underplaying the potential side effects of steroid use. While it's true that the scientific evidence of liver damage and hyper-aggressive "roid rage" is mixed, longterm steroid use definitely raises your bloodpressure and unhealthy cholesterol levels, shrinks your testicles and gives you "bitch tits," in the ineffable phrase of the Bell brothers. It probably also stunts the growth of teenagers. Bell, to be sure, isn't exactly promoting steroid use. “I know people who’ve been abused by steroids. If you think one minute my brothers are fine and not screwed up in the heads from fact they rely on steroids … when you rely on a drug to do anything, you’re looking for trouble.”

Too, juicing goes against the American sense of fair play. But if Tiger Woods can get laser eye surgery, and students can take legal speed to ace tests, why shouldn’t athletes improve their torque with chemistry? Bell manages to make even Barry Bonds look sympathetic, as the slugger tells the press, “All of you have lied. How would you like it if there were asterisks by your names?”

“Bigger, Stronger, Faster” united Chris Bell’s two obsessions: movies and body-building. A music video he made at community college got him from Poughkeepsie to film school at the University of Southern California. While studying there, he worked as a bouncer, lifted at the famous Gold’s Gym in Venice Beach,and later wrote for the WWE. A short film about tobacco addiction got the attention of the producers of "Farenheit 911" and "Bowling for Columbine."

The film achieves something unusual -- it manages to convey respect and affection toward subjects whose foibles are hilarious. The narration makes it happen. Bell is schlubby in a Michael Moore kind of way, but unlike Moore, he’s sincere, because the pain is personal. A regular guy in gym clothes and a backwards baseball cap, he depicts America’s identity confusion through his own family’s struggle with obesity, drug use and obfuscation.

In a section about how the wildly under-regulated dietary-supplements industry uses juiced lifters to deceptively sell its products, Bell hires some Mexican guys to make a supplement in his kitchen. “It was all perfectly legal -- except for the illegal aliens.”

His brothers are symbolic stand-ins for the conflict. “Smelly’’ is emotionally stable, a loving father who coaches high school football. “Mad Dog” is bipolar, has tried to kill himself, hates his job, drinks too much and takes drugs. They’re both lifetime steroid users.

Ultimately, in this film, we see steroids as just another substance that Americans use to fill emptiness. Bell’s mother is shocked to hear how dependent on them her boys are. “Why did our boys feel like they were not good enough?” she asks. “Mad Dog” responds that he can’t handle a life in which he’s just OK. “I need to attain greatness,” he says. “I know there’s something in here that the rest of the world needs to know about.”

“In my experience, bodybuilders are like little kids in a gorilla suit,” Bell told me. “They pack on armor so nobody can hurt them. When I was lifting weights, I thought I’d be the coolest kids in school if I could bench press the most. It felt good.

“But I found out from the film," Bell said, "that I’m a much better filmmaker than I am power lifter.”

Of Course Ivins Might Have Been Innocent

Arthur Allen — Fri, 01 Aug 2008 19:00:00 GMT

Which his lawyer says here. It wouldn't be the first time the Feds had railroaded an innocent man. Hopefully we'll learn more about the evidence soon.

Suicide May Clarify Anthrax Mystery

Arthur Allen — Fri, 01 Aug 2008 18:30:00 GMT

An Army scientist named Bruce Ivins committed suicide this week as the Feds were preparing to indict him for the October 2001 anthrax attacks, according to news reports Friday. If Ivins' guilt in the attacks is confirmed, it would mean that the bioterror scare, which whipped the country into hysteria and in doing so helped pave the way for the invasion of Iraq, was generated by a self-interested American (assuming Ivins did it, and was acting alone).

Ivins, 62, had worked in the development of anthrax vaccines and therapeutic drugs at Fort Detrick, Maryland, with publications going back to 1984. He had participated in 14 published studies on anthrax since the 2001 attacks; his latest paperwill be published Tuesday in the journal Vaccine.

Investigators have long suspected that a government scientist or contractor was responsible for the anthrax mailings to Democratic senators and the news media, which killed five people and crippled the postal service. After initial suspicions of a link to al-Qaeda or other foreign terrorists failed to materialize, the FBI focused on a former colleague of Ivins named Steven Hatfill. Those suspicions also did not pan out, and the government earlier this year paid Hatfill more than $5 million for damaging his reputation.

If, as suspected, Ivins mailed the anthrax spore-laden letters to raise the alarm and generate more resources for bioterrorism defense, his attack can only be considered a dramatic success. Billions have poured into industry contracts and government work aimed at preventing such attacks in the future. Some have speculated that the anthrax mailings were not meant to kill, but only to show how possible it was to send deadly anthrax spores through the mail.

How Did FDA Get it Wrong on Tomatoes?

Arthur Allen — Thu, 31 Jul 2008 21:39:06 GMT

After announcing Wednesday that the “smoking jalapenno ” had been found on a farm in Mexico, witnesses at a hearing Thursday continued to dance around the key problem with the salmonella investigation, which we identified three weeks ago: early mistakes by the New Mexico department of health and the Centers for Disease Control doomed the investigation.

Members of Congress and their witnesses from the world of public health and the food industry spent most of the two days of hearings this week debating whether new FDA regulations were needed for tracing produce. There was also some snark exchanged over the fact that the food industry itself had lobbied for less stringent tracing requirements when Congress issued new food safety guidelines in 2002 as part of the bioterror legislation. At this week's hearings, the industry called for the FDA to do more.

But there were occasional moments of clarity. “The real place where this started was the identification of tomatoes as the culprit at the CDC,” said Thomas Stenzel, president of the United Fresh Produce Association, at a hearing of the House Energy and Commerce subcommittee on oversight and investigations. While the FDA may have been slow and failed to release information fast enough, Stenzel said, its investigation into the contaminated produce was narrowed to tomatoes based on the CDC’s analysis. This in turn was based on early, apparently flawed epidemiological work done by New Mexico investigators on Navajo Indian reservations. “We didn’t make a mistake,” said an exasperated David Acheson, the FDA’s point man on the crisis. “Our investigation was based on what the states and the CDC told us.”

The culprit was narrowed early to tomatoes, but after more than 1,400 tomato samples had been tested, none turned up positive for Salmonella saintpaul. “The hearing today should be about the CDC and state public health departments,” noted John Shimkus (R-Ill.) the ranking GOP subcommittee member. “That’s where the system failed us.” It's not a question of pointing fingers--New Mexico reportedly has a small, underfunded public health department, and even the best epidemiologists make mistakes. Tim Jones, state epidemiologist of Tennessee, noted that state public health budgets have sunk over the past decade, despite occasional surges of federal money spurred by scares such as anthrax or pandemic flu. But if the government is to learn anything from this problematic outbreak, which has now caused more than 1,300 cases of illness in 43 states, it ought to begin by looking in the right places.

FDA Bobbles, Minnesota Finds the Red Hot Pepper

Arthur Allen — Fri, 25 Jul 2008 15:50:41 GMT

Nice piece of reporting by the AP's Lauran Neergaard about how shoe-leather Minnesota epidemiologists traced the contaminated jalapenos that seem to be responsible for the supposed tainted-tomato Salmonella outbreak. Alerted about an outbreak in late June in Minnesota, public health officials there interviewed the sick, traced the Salmonella Saintpaul to a particular restaurant, and used credit card receipts to see who had or had not gotten the jalapeno relish on their food, thereby confirming jalapenos as the prime suspect. Then they traced the jalapenos back to a farm in Mexico--where they found Salmonella on a pepper--and from there to a distributor in McAllen, Texas. It took about 10 days to do all this. Michael Osterholm, who has become a big-shot consultant in the bio-terror world, directed the Minnesota public health department for years and seems to have left behind a solid institution. The obvious question: Why were a handful of Minnesota scientists able to quickly resolve an outbreak that stumped the FDA and CDC for four months?

To be sure, no one is positive that all 1,100+ Salmonella Saintpaul infections are jalapeno-related, though there's no concrete evidence of anything else. Meanwhile, the FDA continues to be accused of providing partial and confusing information about the scare, infuriating the produce industry, which has suffered hundreds of millions in losses.

War Criminal's Guide to Autism Treatment

Arthur Allen — Thu, 24 Jul 2008 16:08:00 GMT

If you were unlucky enough to have to call upon Radovan Karadzic in the 1992-1994 period, as I was on one occasion while a reporter for the Associated Press, the expression "physician, heal thyself" will have a special meaning. Karadzic was a nutty psychiatrist who spent the war spouting lies, fantasies and racist horrors from the village of Pale, the mountain center of the Bosnian Serb enclave. One January I had to travel through snow and ice and Chetnik checkpoints--artillery bases from which shells and sniper bullets rained down upon the residents of Sarajevo--to visit Karadzic at Pale. The great poo-bah was indisposed, so I got his daughter Sonja, his "press spokesman" who was fat as Shelob and just as crazy and vicious. She tore up my Bosnian Serb "visa" and threatened to sic her dogs on me. Lovely family.

So what does a war criminal in hiding do to keep the wolf from the door? Alternative medicine is a good career path, since it's full of credulous people who mistake the placebo effect for healing hands. Today's British Guardian, under the headline, 'Karadzic gave a massage to my wife and my daughters,' tells how a Begrade family was duped by "Dr. David," a bearded, Dumbledore-looking fella who told them he'd been a faith healer in the United States. Among the details was that Karadzic supposedly helped an autistic boy become more sociable with his peers. To be sure, notes another Guardian columnist, "Just because Karadic was a war criminal, it doesn't follow that all alternative practitioners are genocidal maniacs, and indeed many practitioners sincerely believe in what they are doing and want to help their clients. But there have surely been enough cases now of blatant recklessness if not outright deceit to confirm that practising alternative medicine is very often the last refuge of the scoundrel."

Is Wal-Mart Playing FDA?

Suemedha Sood — Tue, 22 Jul 2008 15:10:21 GMT

Fortune Magazine has an opinion piece up blasting advocacy groups, retailers and politicians for working to get a chemical found in baby bottles and infant formula cans, called Bisphenol A (BPA), off the shelves. In the piece, Marc Gunther accuses retailers like Wal-Mart, CVS and Toys R' Us of playing FDA by refusing to sell products containing the chemical. But retailers say their reasoning is that consumers do not want to buy them.

As we've reported, the National Institutes of Health and the House Energy and Commerce Committee have been investigating the chemical's safety. A recent draft report from NIH suggests it might harm babies and young children.

Nonetheless, Gunther argues that the chemical must be safe because the FDA says it is.

"Bisphenol-A has been widely used since the 1950s," he argues. Yeah, well, so has lead. But let's let him finish:

The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move purely precautionary.

To be sure, other scientists worry because animal studies have linked small doses of BPA to cancer and other health problems. But scientific debate isn't driving the baby bottle war; a hard-hitting push by activist groups, politicians and trial lawyers is.

Okay, wait a second. The non-partisan Environmental Working Group -- composed of expert scientists and analysts -- is at the forefront of the activist groups Gunther mentions. In addition, some of the loudest voices on this matter are independent scientists.

More importantly, Gunther seems to argue that Americans have no reason to question federal actions (or inaction) on public health. And that agencies don't need to be held accountable. We should just assume that, hey, they're probably doing an OK job! But then, he says this:

...[T]he FDA typically uses industry research because it doesn't have the money to conduct independent studies of the thousands of chemicals on the market. It then reviews what industry produces.

Yet another reason that consumers are right to scrutinize the FDA. The agency judges the safety of Bisphenol A (and other chemicals) by examining reports conducted by the people who manufacture and sell Bisphenol A. Naturally, that presents a conflict of interest.

Finally, when Gunther asked Wal-Mart why it's no longer going to sell products with BPA, spokeswoman Linda Blakley said, "We sell products our customers want to buy. Our customers are telling us they want this option." Businesses like Wal-Mart are certainly not making a moral choice by banning BPA products -- they're doing what they do best: focusing on the bottom line. But in this case, their bottom line revolves around consumer concerns. And shouldn't consumers have the right to demand the safest products they can get?

Celebrity Mommy Wars Over Vaccines Rages On

Arthur Allen — Wed, 16 Jul 2008 17:10:00 GMT

Move over, Jenny McCarthy. The former Playboy playmate-turned vaccine basher has competition from a Hollywood newcomer, Amanda Peet. In a profile featured on the cover of this month's Cookie magazine, Peet discloses that Dr. Paul Offit, inventor of an important rotavirus vaccine and public enemy-number one of the anti-vaccination crowd, assuaged her anxieties over vaccination after the birth of her baby in 2007. She has fully vaccinated the tot, is quite happy about it, and says that parents who don't vaccinate are "parasites." Peet's comment, and her decision to do a pro-vaccine promotional ad infuriated the vaccine skeptics, some of whom wrote menacing letters to Peet and her retinue. Has the public zeitgeist turned on the activists who, blaming vaccines for autism, urge parents to delay or avoid vaccinating their kids?

Recent reports indicating that we're in the midst of the worst measles outbreak since at least 1997 haven't helped. Some recent commentators (including me, in an upcoming issue of Mother Jones magazine) note that the decision not to vaccinate your kid has implications beyond the health of your own family. Also, while Handley and others are apoplectic at Offit for daring to stand up for vaccines while owning a patent on one (I'm shocked--shocked!--that someone is allowed to own their intellectual property!), fact is that Offit's Rotateq vaccine seems to be doing some wonderful things for public health. A recent Morbidity and Mortality Weekly Report shows that Rotateq, which Offit and his colleagues developed, and Merck produces, has prevented tens of thousands of cases of the painful and sometimes dangerous gastrointestinal disease. As a further annoyance to his critics, Offit has a book coming out in September that lays bare the legal, scientific and public relations campaigns behind the vaccines-cause-autism theory (full disclosure: I'm quoted in it).

Jalapenos, the Real Culprit?

Arthur Allen — Mon, 07 Jul 2008 11:30:00 GMT

It’s been nearly three months since the first of more than 900 people fell ill with salmonella poisoning in the outbreak that the Food and Drug Admin. has linked to tomatoes. Now, it seems likely that it wasn’t tomatoes that done it. But, it could be the jalapenos.

“Unfortunately, I’m becoming increasingly confident in saying this outbreak is going to end up being one in which the initial data got the regulatory folks going down the wrong path,” said Dr. Tim Jones, the state epidemiologist of Tennessee, which has had a handful of cases linked to the outbreak. “There’s a decent chance it’s not tomatoes at all.”

At a news conference last week, officials from the Food and Drug Admin. and Centers for Disease Control said they were expanding the probe beyond tomatoes, “to include items that are eaten with tomatoes.” When asked if, in other words, the culprit might not be tomatoes, CDC spokeswoman Lola Russell demurred. “We’re not saying that.” She added, “It would be premature to list any other particular food item.”

FDA officials hinted strongly that some other component of salsa might be the source of the bacteria. If that's the case, it could well be jalapenos, which are stored and kept long enough to keep infecting people for months. Tomatoes -- and for that matter, cilantro -- are usually thrown away within a few weeks. The Wall Street Journal had some of the story here and NPR followed up here.

Federal warnings about tomatoes have cost the food industry upward of $250 million thus far, so it isn’t surprising that CDC isn’t eager to point fingers at another vegetable. Restaurant owners, tomato growers and packers are up in arms over this drubbing. “They killed an industry,” said Batista Madonia, president of East Coast Brokers and Packers, a major tomato grower based in northern Florida. “My business is off 75 percent, and who knows if it will recover. Look at the spinach thing. It ended a year ago. But whenever I eat spinach, there’s still something in the back of my mind that says it’s dangerous.”

Many have complained about the FDA’s lack of transparency, and fault officials for failing to consult industry and academic experts. FDA and CDC needed to publicize more of their data during such investigations, and “take advantage of outside expertise that could speed these investigations," said Roberta Cook, a tomato marketing expert at the University of California-Davis. "These things are important for protection of public health -- and to avoid devastating entire commodity industries for no reason.”

“So little information is being released by FDA," said Tony Dimare of Dimare Fresh, a major Florida-based tomato producer, "that you, me, no one outside of the inner circle of FDA, knows what’s going on. Meanwhile, in Florida, we’ve been tainted, thrown under the bus and guilty by association for being in production at the time of the outbreak. My fear is if the investigation lingers long enough, it’ll affect the start of the next Florida season, in September. This thing is just a total blunder by FDA.”

CDC and FDA haven’t disclosed the data they’re looking at, but state epidemiologists I spoke with say that most of the cases -- by no means all -- have been traced to Mexican restaurants, where salsa and chips flow freely. In addition, most of the evidence points to Mexican crops.

Tracking a disease involves a laborious, time-consuming culturing and typing of the bacteria, followed by interviews in which sick or recovered patients are asked to remember what they ate two weeks earlier. This may be where federal investigators got off on the wrong foot.

The first investigations were done in New Mexico, where people on Navajo reservations got sick. Most remembered eating tomatoes, but it’s possible that state public health officials narrowed the target too soon. This mistake — if it turns out to have been a mistake — was passed along to the CDC. It then designed questionnaires for those sickened with Salmonella saintpaul based on the premise that it came from tomatoes -- not what the tomatoes were eaten with.

Epidemiologists at CDC and state public health agencies frequently express impatience with the length of time it takes the FDA to do trace-backs, and the agency’s close-to-the-vest style when carrying out such investigations. But in this case, epidemiologists may have led FDA down the wrong path.

“Trace-backs are hard enough," said Jones, of Tennessee, "They are virtually impossible if things aren’t narrowed down accurately at the beginning.”

The longer the investigation goes on, the more likely it is to turn up red herrings. There is probably always a low-level background rate of Salmonella saintpaul poisoning in the U.S. — cases that may be being counted now as part of the outbreak. Another confounder, in a long outbreak, is secondary cases spread by someone already sickened with the disease.

“Let’s say you trace a couple cases to an Italian restaurant,” said Jones. “But maybe the waiter ate salsa at a Mexican place a few days earlier, then stayed on the job because he didn’t feel that sick.”

Last week, the CDC quietly revised the questionnaire that state health officials are using in the salmonella investigation to include other foods -- particularly those served in tomato-based salsa and pico de gallo.

Jones suspects -- he calls it nothing more than a hunch -- that peppers are the most likely culprit. The outbreak has gone on nearly three months -- far longer than any one batch of tomatoes would be on the market, especially since most restaurants and stores ditched tomatoes that were for sale when the FDA first announced the outbreak. New Mexico health officials have repeatedly cultured tomatoes eaten by sick citizens there, but they have been unable to culture Salmonella saintpaul.

The outbreak hasn’t been linked to any particular chain -- which bolsters the idea that it was a fresh produce item, rather than a finished product, that is responsible. And trace-backs to Mexican and Florida tomato operations appear not to have found any evidence. Adding this up points the finger to jalapenos. Maybe.

“Tomatoes and cilantro go bad pretty quick. But I can keep jalapenos in my fridge a month and a half and they’re still edible, said Jones, "So that floats higher on my list.”

When asked for comment, FDA spokeswoman Kimberly Rawlings referred this reporter to the FDA Website.

In the climate of budget-cutting and politicization that has characterized the federal bureaucracy under President George W. Bush, many are eager to point the finger of blame at the White House. But, so far at least, there’s no evidence that the investigation’s troubles have anything to do with politics.

Investigating food-based disease outbreaks is difficult. Produce isn’t generally labeled or tracked from the field to the store or restaurant. And tomatoes take a particularly circuitous route to market. They often go from farm to packing house to repackagers, who remove tomatoes from the 25-pound boxes the packers put them in, then ship them in containers arranged by shape, size and color, to meet the demands of different retailers. Some are processed further before going to restaurants.

The increase in food-related disease outbreaks in recent years may be nothing more than the result of better detection. Molecular fingerprinting allows scientists to link sicknesses that occur across the country to a single contaminated field. That does make an outbreak seem worse that it would have seemed at a time when not all the cases were picked up by sensitive tests.

“In the past, you’d get a bad case of diarrhea and you’d say, ‘I got the flu, I ate something bad,’” said Mark Munger, an official with Andrews and Williamson Fresh Produce in San Diego. “I’m not criticizing the way things are now. But these outbreaks should be put into perspective. We’re dealing with major obesity crisis in this country. It’s bad for consumers to think they can’t eat fresh fruits and vegetables. Wash them, sure. But, for the most part, keep eating them.”

The produce industry is demanding hearings in Congress and tomato growers are expected to ask for financial relief. Florida’s tomato industry was already hurting because of high fuel and fertilizer costs, tomato diseases and labor conflict.

To think that a little pepper could lay them so low.

Celebs Rally for Vaccine Reform

Arthur Allen — Thu, 05 Jun 2008 20:10:38 GMT

I spent a bright and lovely morning doing anthropology among the vaccine skeptics, an angry group who blame the government for their children’s medical and psychiatric conditions. The occasion was Wednesday’s “Green our Vaccines” rally, a march on Washington led by the the actor Jim Carrey and his photogenic girlfriend, Jenny McCarthy, the TV personality and mother of an autistic 6-year-old boy named Evan.

McCarthy, Carrey and an untold number of other people -– there were maybe 1,500 at the rally -– believe that something in vaccines causes autism. Science has laid to rest a theory blaming the measles-mumps-rubella shot, and the evidence also points away from the mercury-containing preservative, thimerosal. But Carrey and McCarthy have moved the goalposts. At Wednesday’s rally, the marchers chanted, “Too many, Too soon!” The new theory of the vaccine haters is that "too many" of these disease preventives somehow overwhelm the child's immune system — a thesis there is no evidence to support.

The anger has deep roots, though. About 1 in 150 U.S. children is diagnosed with a form of autism, compared to perhaps 1 in 3,000 two decades ago. The higher diagnoses are mainly due to changes in psychiatric codings and increased educational and therapeutic programs for autistic kids, but there may be other explanations for part of the increase. The parents of these children have difficult lives and spend hundreds of thousands of dollars to care for their kids. Feeling ripped off, they blame the government and industry, and say that environmental toxins and vaccines are responsible.

Over the decade I’ve reported on this issue, the believers have grown more and more entrenched in their convictions, to the point that it’s difficult to have a discussion because we’ve obviously been reading different material. Google University has many campuses and I’ve been attending a different one.

Blaming vaccines for autism is a small cottage industry backed by certain lawyers, alternative medicine practitioners and peddlers of dietary supplements that allegedly cure the damage done by vaccines. But whether their kids are getting better with such therapies or not, these parents' convictions are unshaken.

Erika Stone, of Dallas, came to the rally with the righteous anger of a mother dealing with a severely ill child. She carried a sign that said, “We are your scientific evidence.” It had photographs of her 2 ½ year old son, Maxwell, and his mates from a special therapy program. Maxwell began to lose his language skills at 12 months. He’s sickly and mute and entirely dependent on her. “My child can’t say a word. He can’t hold a crayon, he can’t feed himself. If you play loud music next to him, he doesn’t even turn around.”

When Maxwell was about 20 months old, his mom heard about the vaccine theory. While the evidence of a vaccine link to her son’s condition didn’t convince me--regressive autism, of the type she describes, was known to occur long before the vaccine schedule increased -- Stone said, “I believe it in the bottom of my heart – it’s something called mother’s instinct.”

If it wasn’t for the Internet, would you have been led to this conviction? I asked. “Probably not,” she said.

The group walked from its rally point under the Washington Monument, down Independence Ave (stopping to jeer at the Dept. of Health and Human Services) before filing on to the west lawn of Congress. It heard speeches from people like Rep. Dan Burton (R-Ind), Boyd Haley, a University of Kentucky chemist, and Robert F. Kennedy Jr., an environmental lawyer who displayed his ignorance of the issue in a sensationalist, error-filled 2005 article in Rolling Stone magazine.

As someone who has been following this hair-tearing controversy for a decade, I try to keep my cool, but I lost it once.

I was talking with a group of people (including a large fellow with “CDC Sucks” stitched on his shirt where the alligator should have been) when I was introduced to Wendy Fournier, an anti-vaccine activist I’ve debated on the radio. “Oh, it’s you,” I said. “I want to talk to someone less full of shit.”

No sooner had “shit” passed my lips than the people around Fournier called the rally monitor, who got on her radio and shouted, “Get a policeman over here!” The cop told me that since this was the Green People’s rally, they had the power to tell me to go away, even if I was a journalist.

I walked over to the little retaining wall around the monument and greeted Dan Olmstead, a former UPI editor who runs Age of Autism, a Website that champions the vaccines-cause-autism line and belittles those who disagree. Despite our profound differences, Dan’s an old journalist like me, and he thought it was wrong they’d sic’d the cops on me. We chatted for a while and then Terri Arranga, a “journalist” for Autism One, another vaccines=autism media outlet, came over, stuck a mike in my face and tried for a while to get me to comment about something I said on her program three years ago.

Then, McCarthy and Carrey appeared. The green-clad crowd went wild. “Jenny! Jenny!” they chanted, as the couple reviewed their troops on the lawn.

McCarthy agreed to what she called a “sound bite,” and a guy from “Access Hollywood” started to spoonfeed her questions. I was surprised -- OK, disappointed: I love the actor Jim Carrey! -- to note that Carrey did a lot of the talking. He offered many theories: evil drug companies, conspiratorial government scientists, etc. “How dumb does the CDC think we are?” (An intemperate question from a guy who, as Orac says, presumably doesn’t want us to think that "Dumb and Dumber" is a documentary.) Kids can’t assimilate all the vaccines, he said. We need more research that isn’t paid for by the pharmaceutical industry. “We don’t call that research, we call it propaganda.”

After asking his questions, the Access Hollywood guy suddenly became a promoter. “Jim and Jenny," he said, "I’m proud to announce that you’ve been named Access Hollywood’s green couple of the week!”

At which point I saw my opportunity and after checking for rally monitors, asked, “How many vaccines, exactly, is too many?”

“In 1983," McCarthy said, "our kids only got 10 vaccines. Now it’s 36” (actually, it's 28, max, by age 2). I asked, “So should they only be getting 10? Which ones shouldn’t they get?” I saw McCarthy turning and asking someone, “Who is this guy?” Carrey responded, gamely. “Kids aren’t a bottomless pit you can pour toxins into, there has to be a limit,” he said.

“So what’s a vaccine they shouldn’t get?” I asked. “A lot of parents of autistic children would have opted not to get the tetanus shot,” he said.

Tetanus? Do they realize what it’s like to live in a pre-tetanus shot society, in villages where unvaccinated kids get tetanus --also called lockjaw. It causes your spine to arch as you writhe in agony for days and then die unless you are fortunate enough to get antitoxin. But then, Carrey and McCarthy haven't been studying microbiology for the past 20 years.

The organizers were telling everyone to get off the grass, so I fell into step with McCarthy’s pediatrician, Dr. Jay Gordon, who’s a celebrated, or notorious, I guess, Santa Monica doctor because of his outspoken vaccine skepticism. Gordon has been an tiny thorn in the side of the pediatrics profession since 1979, and he takes obvious pride in going against the grain. I can see the appeal to going that way, too, but I don’t quite get his logic.

For example: “I think it’s good for you to get measles,” he told me. “It’s good for the immune system.”

He thinks all kids should get the measles?

“Yes, I do. The measles vaccine might be doing more harm than good.” This although, he tells me, “I know all the numbers.” (In the pre-vaccine era, measles killed 500 American children every year, caused 5,000 cases of permanent brain damage and innumerable hospitalizations. It still kills about 500,000 people each year in the Third World.)

The unvaccinated children in his practice are healthier, Gordon said. Not that he’s indiscriminately opposed to vacination. “Nobody wants a whooping cough epidemic." He gives the DTP -- diphtheria-tetanus-pertussis (whooping cough) -- vaccine, but he delays the shots until the babies are a year old.

One way to tell that preconceived belief, rather than rationality, is guiding someone’s actions is by determining whether a change in the evidence affects their outlook. Two plausible theories for autism were weighed by science and found wanting. But those who remain convinced of the link have a way of rationalizing their belief, almost extemporaneously.

Like most of the people I met at the rally, Gordon wasn’t impressed by the epidemiological studies showing that mercury in vaccines hadn’t caused an upswing in autism. But like a lot of the vaccine skeptics, he’s moved on to a new culprit, another element present in tiny amounts in vaccines, where it is used as an adjuvant to boost the immune response: Aluminum.

Bush Definition of 'Transparency'

Arthur Allen — Tue, 27 May 2008 04:20:47 GMT

The Bush administration has a pet word to describe its regulatory policy. The word is "transparent." Last Tuesday, Environmental Protection Agency chief Stephen Johnson used it to describe an ozone ruling in which the White House at the last minute reversed EPA recommendations for limiting smog. “It’s been a very transparent process,” Johnson told Chairman Henry A. Waxman (D-Ca.) and the House Oversight and Government Reform Committee.

At a House Science subcommittee hearing the next day, Susan Dudley, the top White House regulatory officer with the Office of Management and Budget, used it in reference to EPA’s toxic chemical regulations. Critics, including the Government Accountability Office, the investigative arm of Congress, claimed that toxics assessment had been paralyzed by new EPA guidelines that allow the Pentagon, industry and other actors to stop EPA evaluation of toxics without offering any rationale. “OMB,” Dudley said, “supports EPA’s efforts to provide greater transparency.”

To most of us, “transparent” means something you can see into. If the ozone regulations were transparent, for example, one might expect that President George W. Bush would explain why he overturned EPA’s scientific evidence-based recommendations. When brought up to describe toxics regulation, “transparent” might mean that the public could see the paper trail providing the scientific justification behind it.

But the White House seems to have found another definition of “transparent.” It means a process that the White House can see into.

Take the case of ozone. This particle, a principle component of smog, is supposed to remain less than 84 parts per billion in the air under a 1997 law. The scientific committee that advises EPA on air pollution recommended, based on newer studies, that the allowable level be reduced to 60-70 ppb, a step that the scientists expect would prevent hundreds of deaths from asthma, lung and heart disease.

They also recommended that an even lower standard be set for the growing season, in order to protect certain crops that can be harmed by excess ozone. EPA scientists recommended the limit be set at 60 ppb, and Johnson recommended a 75 ppb standard when he sent the rules on to the OMB. Though he compromised on the particle level, Johnson also recommended the secondary standard for summertime.

But a week before the deadline for the rules, Dudley notified EPA that the secondary standards were unacceptable, because they didn’t take into account the economic costs of the regulation -- though EPA is not supposed to take cost into account when regulating under the Clean Air Act. Eventually, Bush stepped in and “re-decider-ed,” without providing any rationale. (Read an amusing account of this story here and a more straightforward analysis here.)

As in an earlier decision, on California’s request to regulate greenhouse gas tailpipe emissions, the paper trail clearly shows that the White House has reversed Johnson on important EPA regulations after industry groups lodged strong protests. “Your decisions were right on, yet in each case you backed down, you took your directions from the White House,” Waxman said Tuesday, working himself into a gavel-pounding rage at the giddily stonewalling Johnson. “That’s not how our government is supposed to work.”

Johnson smiled and gave his rote response. “I evaluated the OMB and the presidents’ comments and I made a decision,” he said. There were many “uncertainties that I factored in ... With input in this case from the president. It’s been a very transparent process. I’m very proud. I think that’s good government.”

The White House has been similarly transparent in its handling of the Integrated Risk Information System, or IRIS, the EPA’s database of toxic chemical assessments. When pondering how to manage industrial pollution, Superfund sites, farm runoff and the like, thousands of state, local and foreign governments rely on this critical source of impartial science, which gets 9 million visits a year.

But according to a report presented last month by the General Accountability Office, the IRIS assessment process has been strangled bureaucratically. In the past two years, only four of the EPA’s 32 draft toxics assessments have made it past Dudley’s Office of Information and Regulatory Affairs, which has the power to intervene in important agency rules.

How is this happening? According to the GAO, EPA has a new IRIS assessment process that includes two opportunities for OMB oversight. OMB often invites in the Pentagon, the Dept. of Energy and others to review these assessments, and it considers their comments “internal executive branch documents that may not be made public,” the GAO reported. In the cases of five potentially toxic chemicals, following these interagency reviews, OMB ordered EPA to stop the assessments.

In testimony on his report, the GAO’s John Stephenson said the EPA is setting lengthy deadlines to finish evaluations of the hundreds of toxic chemicals. There are always additional studies one could wait for but “if you take 10 years’’ to complete an assessment “it's obsolete’’ when it is published, Stephenson said. As he pointed out, “If you wait until the science is perfect, you will never regulate.’’ He said that the EPA staffers he interviewed “felt they couldn't move forward without OMB blessings several times along the way. A scientific agency is being obstructed by other agencies without science as their mission."

The OMB has long played an obstructive role in regulation. This may not be a bad thing all the time, since regulations can be costly, scientific information isn’t always precise and at some level it probably should be the prerogative of the president to decide that the cost of regulating a given hazard is not worth the cost.

What’s different about the current OMB, says Rick Melberth, a policy analyst at watchdog group OMB Watch, is that it’s gotten deeply involved not just in deciding what to do about potential risks, but in the risk assessment itself. “There has always been a clear separation between the information that goes into a decision, and the decision-making process,” he said. “This administration is not content with making the decisions the way they want to. They have a strategy of interfering with the science before it gets to the decision-making stage.”

An example discussed in the GAO report is naphthalene, an apparently carcinogenic chemical that’s used by the military. EPA began assessing naphthalene in 2002, but OMB in 2006 brought the Pentagon in to comment on the risk assessment, delaying it for at least six more years.

EPA’s new review process, said House Science subcommittee chairman Brad Miller (D-N.C.) “effectively kills IRIS without honestly acknowledging that purpose.” Dudley disputed that, saying her office coordinates other agencies' input into IRIS assessments: “Interagency coordination allows EPA to take advantage of the broad scientific expertise that exists throughout the government.”

Listening to the GAO testimony transposed against that of Dudley and EPA officials, Melberth said, gives the impression “that we’re living in parallel universes. Orwellian is the word that comes to mind.”

In Orwellian terms. as in the novel, "1984," transparency refers to the elimination of privacy. But that's another story of our times.

Burger King to Tomato Pickers: Have it Your Way

Arthur Allen — Fri, 23 May 2008 15:03:34 GMT

After its executives spied on immigrant farmworkers and slandered them on-line to fight a grass-roots campaign for better pay and working conditions, Burger King Corp. abruptly reversed course Friday. The company caved into the workers' demands, agreeing to pay them an extra penny a pound for tomatoes that go on Whoppers and other BK products, according to a joint news release with the Coalition of Immokalee Workers.

The grass-roots group, aided by church and student activists, has been fighting for more than a decade to improve the appalling conditions of immigrants who pick tomatoes and other crops in southern Florida during the winter and up the East Coast in the summer and fall.

Frustrated in its direct talks with Florida tomato growers, the coalition has used the tactic of attacking the "brand." It has been demanding that big-name retailers directly pay the workers a penny more per pound of tomatoes. This translates to a wage increase of up to 75 percent, since the standard piece-rate for a 33-pound bucket of tomatoes is 45 cents.

Three fast-food giants have now agreed to the demands of the coalition--the others being Yum! Brands (Taco Bell, KFC etc) and McDonald's. Burger King and the Florida Tomato Exchange had joined together in resisting the coalition's demands. In November, the tomato growers claimed the agreements with Yum! and McDonald's were illegal, and threatened to fine farmers who agreed to honor them.

Burger King said today it would encourage grower participation in this increased wage program by funding "incremental payroll taxes and administrative costs incurred by the growers as a result of their farmworkers' increased wages." This will bring its total payment to 1.5 cents per pound of tomatoes, BK said. It's been estimated that the pay increase will cost Burger King less than $500,000--presumably a lot less than they were paying lawyers and PR specialists to stonewall the coalition.

HHS Hollers Back

Arthur Allen — Mon, 19 May 2008 20:20:00 GMT

In a response I received after my anthrax vaccine story had been posted, Health and Human Services spokesman Bill Hall denied that his agency had erred in withdrawing the Vaxgen contract. Vaxgen missed its deadlines and failed to fix its problems, he said, and HHS was still pursuing a recombinant anthrax vaccine (as I noted in the story, Emergent is likely to win this contract). Hall said I had been remiss in not interviewing some of the companies that were successfully working on Bioshield. "No one ever bothers to report on all our successes or ask those companies who have successfully worked with the BioShield program about their experiences," he said, "such as Human Genome Sciences (eds note: HGS is making monoclonal antibody against anthrax), BioPort/Emergent Biosolutions, Cangene (botulinium antitoxin), Bavarian Nordic (new-generation smallpox vaccine), Akorn Inc. (anti-radioactive isotope chelator), Fleming & Company Pharmaceuticals (anti-radiation medicine), etc." A list of all HHS Bioshield procurements can be found here.

I still insist that HHS botched the recombinant anthrax vaccine contract.

Anthrax Vaccine Loses to Lobbying

Arthur Allen — Mon, 19 May 2008 19:22:47 GMT

Update: The Department of Health and Human Services sent a response after this story was originally posted. The department's comment has been inserted.

Six-and-a-half years after someone mailed finely milled anthrax spores to the U.S. Capitol, the industry created to respond to that attack has received billions in cash but produced little protection. A little-noticed news item last week reveals the most dramatic failure of the $5.6 billion Bioshield program, which was supposed to provide drugs and vaccines against terror agents--its cornerstone being the creation of a safe, effective vaccine against anthrax.

As demonstrated by the anthrax mailings—a case the FBI has yet to crack—deadly anthrax bacteria are a real potential threat. The most likely assailant in the October 2001 attack was an American scientist, perhaps someone who wanted not to kill, but to focus Congress' attention on the bioterror threat.

If that's the case, the attack was extremely successful. But in the so-far fruitless effort to get a better vaccine, the government has ruined one company that was developing an inventive solution while it has allowed another, politically well-connected firm to reap the benefits.

Last week, Emergent Biosolutions, which has been making a crude anthrax vaccine since the 1960s, under various names, quietly purchased recombinant anthrax vaccine technology for the bargain-basement price of $2 million. It bought the vaccine from Vaxgen, a sophisticated, San Francisco-area company that the government drove out of business through its bungled management of the Bioshield program. Vaxgen, which once had more than 300 employees, now has six, and is basically in the process of selling off its assets.

Emergent, which is based in Rockville, Md., but makes the old vaccine at a plant in Lansing, Mich., used an army of lobbyists to undercut Vaxgen’s relationship with the Dept. of Health and Human Services. In late 2006, HHS canceled a $878 million contract with Vaxgen, leaving the company holding the bag for more than $150 million it had spent to develop the vaccine. HHS said Vaxgen had failed to meet production deadlines; Vaxgen executives said they were delayed by minor technical problems that have since been clarified.

Vaxgen continued to improve its recombinant anthrax vaccine after HHS cut it loose, but it was unable to find a major drug company to buy it. After witnessing what HHS had done to Vaxgen, former company officials say, none of the major vaccine makers wanted to enter a contract with the government.

Emergent, on the other hand, was nothing if not politically connected. Its chief executive and his wife, for example, alone donated more than $220,000 to lobbying and political campaigns. Emergent had lobbied for years to paint Vaxgen as unreliable, and it ended up buying its vaccine for a song.

The story of the recombinant anthrax vaccine stands as the most poignant fiasco of the Bioshield program. President George W. Bush announced the program in 2003, during a visit to the National Institutes of Health. Bush said the program would “put NIH squarely in the midst of our war to defend America and to defeat international terrorism.”

The idea was to provide government stimulus to get drug companies to make products that had no market other than the government. Many scientists and public health officials believed it could have the secondary benefit of stimulating the development and manufacturing of much-needed civilian vaccines, at a time when the nation’s vaccine industry had been reduced, effectively, to five companies.

But five years later, companies that signed deals with HHS to produce anthrax vaccines, as well as drugs to fight radiation sickness, have dropped out of the program after acrimonious disagreements. One company, Acambis, has delivered a successful new vaccine against smallpox--a disease that was eradicated in 1980 and is believed to exist only in two secure laboratories. Except for a related effort to make pandemic flu vaccines, none of the big vaccine manufacturers have bought into the biodefense program.

Perhaps the most egregious fallout from Bioshield, however, was the destruction of Vaxgen, a company that included some of the country's most talented and experienced vaccine manufacturers. It was led by Lance Gordon, a scientist who helped create more than a dozen vaccines -- including a groundbreaking meningitis shot now given to all children in the United States, Europe and Latin America.

“It’s a horrible story,” said Donald Francis, the former president of Vaxgen. “We spent $150 million of our own money and $100 money in NIH to develop a vaccine. We miss a deadline and they jerk the contract and destroy the company. And there aren’t many vaccine companies. They took a high-tech company capable of making vaccines and killed it!

“This is a symptom of a government that doesn’t know what it’s doing when it comes to interacting with the private sector,” said Francis, who now leads a non-government organization that promotes vaccination in poor countries. “The Pentagon knows how to do things like this. Health and Human Services had never contracted out anything this big, and they didn’t know what they were doing.”

Under the terms of its contract with HHS, Vaxgen was obligated to use an aluminum-based adjuvant, or immune-stimulator, in the vaccine. But the adjuvant and the anthrax protein interacted in a way that caused the vaccine to lose potency. As a result, the company wasn’t able to meet its deadline for delivering the vaccine. “With trial and error we could have fixed the problem,” another former Vaxgen executive said. “It wasn’t a fundamental safety or efficacy problem.”

But Emergent, which was already producing an outdated anthrax vaccine, spent large sums of money on a lobbying campaign against Vaxgen, including hiring two former aides to Vice President Dick Cheney. Congressmen like Michael McCaul (R-Texas) and Mike Rodgers (R-Mich.), both recipients of Emergent executives’ campaign donations, attacked the Vaxgen contract in committee hearings, while Emergent’s lawyers wrote newspaper op-eds attacking the company.

What’s more, HHS frequently changed officials in charge of overseeing the contract, and none seemed to understand the complexities of making vaccines, the Vaxgen officials said. This impression was echoed by two other officials -- one at another company, the other at the Centers for Disease Control -- who asked not to be named.

While HHS has said it followed the letter of the law in canceling the contract, Vaxgen officials say it caved to political pressure. “We were under the illusion that if we did good science, we’d win out,” the official said. “That’s not how this works. Politics played a more important role than science." A government scientist familiar with the deal said that while Vaxgen was not blameless, its problems were typical of the trial-and-error nature of the vaccine-making process.

HHS spokesman Bill Hall denied that the agency had erred in withdrawing the Vaxgen contract. Vaxgen missed its deadlines and failed to fix its problems, he said, and HHS was still pursuing a recombinant anthrax vaccine.

The Vaxgen vaccine uses a refined anthrax protein and is designed to require three doses for long-term immunity. HHS signed the deal with Vaxgen to place the 1950s-vintage vaccine produced by Emergent, formerly called Bioport. The older vaccine, made from material extracted from living bacteria, requires six doses -- and yearly boosters.

In 1998, Bioport took over the Michigan state biologics laboratory, the nation’s sole manufacturer of anthrax vaccine. Starting with the Gulf War, all U.S. service members have received the vaccine. Many have blamed it for a variety of health problems, including autoimmune disorders. While expert panels have refuted claims that the vaccine causes seriously problems except in rare cases, resistance to the vaccine created a morale problem on some military bases. In 1998, for example, pilots at Dover Air Base in Delaware refused the vaccine, forcing their commander to suspend vaccination against anthrax.

After signing the 2004 contract with HHS, Vaxgen had two years to come up with 25 million doses of vaccine. In November 2006, the vaccine was not ready, and the contract was canceled.

But since the Vaxgen fiasco, the government has relaxed the rules, so that Emergent -- which, according to its Website, expects to seek an HHS contract for the vaccine soon -- will have several years to deliver it. The government will also provide milestone payments and cover development costs -- something it didn't do for Vaxgen.

“If we had had that system two years ago," said Gordon, "Vaxgen would probably already have provided millions of doses of a vaccine already to the national stockpile.”

But the Emergent company spokeswoman, Tracey Schmitt, said, "We believe that Emergent has both the experience and expertise to pursue development of this important medical countermeasure to meet the United States government's stated need." She declined to comment on the rest of this article.

Perhaps the worst fallout of the affair is the loss of Vaxgen. Over the past 30 years, most vaccine manufacturers have gradually gotten out of the business. The United States has to import all of its whooping cough vaccine, as well as more than half the 110 million doses of flu vaccine it uses every year. “If there were a bad flu year—not to speak of a pandemic—we would need hundreds of millions of doses,” says Gordon. “And during bad flu years, most countries prohibit export of their flu vaccine.”

Vaxgen had built a factory in South Korea, originally to make an HIV vaccine (which failed), and has another state-of-the-art factory in South San Francisco sitting idle. “We were becoming a company that could develop and manufacture a number of vaccines,” says Gordon, who recently started a new biotech company. “As a result of the cancellation of contract, that was thrown away.’’

Gordon tries to view the latest twist in a positive light. “I’m glad that someone picked up our recombinant vaccine,” he said. “From my perspective, it’s a good product. I’m hopeful that the huge investment and time and effort that went into it won’t go to waste.”

For $2 million, Emergent bought enough vaccine antigen to make millions of doses, along with the recipes it needs to make the vaccine. Including NIH and other funds, more than $250 million was spent to develop it.

“I hope we never find out whether it’s really effective in humans,” added Gordon. “God willing, another major anthrax attack will never happen.”

Ignorance Spreads Measles

Arthur Allen — Thu, 01 May 2008 19:01:50 GMT

The United States is suffering its worst measles outbreak in at least seven years, health officials announced Thursday, because parents who fear the measles-mumps-rubella (MMR) shot aren't vaccinating their kids--in Israel, Switzerland, and here in the U.S. So far this year at least 70 cases have been reported, more than any year since the 116 cases of 2001. That number will easily be topped by the end of the year, said Dr. Anne Schuchat, head of the CDC's Center for Immunization and Respiratory Diseases. There have been measles cases reported in 10 states this year. In the latest outbreak, eight unvaccinated children in a Washington state family fell ill after relatives attended an international church conference.

Nearly all the cases have been tracked by molecular fingerprinting to outbreaks of disease in Europe, Israel and Asia. An outbreak in Switzerland that has struck more than 2,000 people, and one in Israel affecting 1,000-plus patients, began in communities who don't vaccinate for philosophical or religious reasons. These threads of belief have also fed the outbreaks here. At least a quarter and as many as half of the patients were not vaccinated because their parents had exempted them from vaccination.

Twenty of the patients were too young, or barely old enough to be vaccinated. It is in these young children, under 15 months of age, in which the disease is most serious. Many of these babies and toddlers were hospitalized. Measles is extremely contagious--you can get it sitting in a room where a sick child sat two hours earlier--and potentially deadly. The vaccine, when given in two doses, is 99 percent effective. Only one of the 72 cases reported Thursday occurred in a fully vaccinated person.

The measles vaccine became available first in 1963. In the pre-vaccine era, 3-4 million American kids contracted measles each year; about 500 died, 48,000 were hospitalized and another 1,000 suffered permanent brain damage. In the last big outbreak, in 1989-1991, there were 122 deaths. Then, most of the measles struck inner-city kids too poor to afford vaccines. Now, vaccines are free to those who need them, and the patients tend to be well-to-do people who think vaccination is dangerous. A British doctor claimed in 1998 that the MMR shot caused autism, creating a scare that has diminished vaccination rates around the world, though he's been conclusively proved wrong.

Safety of Chemicals in Baby Products in Question

Suemedha Sood — Thu, 17 Apr 2008 14:06:22 GMT

Bisphenol A, one of the chemicals we talk about in today's story on the EPA and children's health, has been in the news this week for its potential harm to children. The chemical -- used in the manufacturing of plastic baby bottles and baby formula cans -- can harm the development of a child's brain and reproductive organs, a federal health agency said in a report released this week.

The National Toxicology Program, of the National Institutes of Health, released its draft report after 18 months of reviewing BPA, a chemical that's been under investigation by the House Energy and Commerce Committee. There is "some concern" that even low levels of BPA can harm fetuses, babies and children, the NTP said. In light of these findings, Rep. John D. Dingell, chairman of the Energy and Commerce Committee, called on the Food and Drug Administration to reconsider its conclusion that BPA is safe.

Canada is expected to make a similar announcement soon. Health Canada, the country's federal health agency, has been reviewing concerns surrounding BPA for some time.