The EPA and the FDA

The uproar in the EPA’s ten regional offices on April 4, 2006, if collected and combined, would have drowned out even the most raucous Green Day concert. April 4th was the day the EPA’s proposed changes to current emission law were leaked to the press. The draft would roll back earlier regulation that required oil refineries, chemical plants, and other industrial operations to apply the best technology available to minimize toxic emissions. Remarkably, the EPA’s own satellite offices had loudly denounced the proposal as a change that would harm the environment. Such candor from the EPA is rare.

The EPA, charged with protecting the public welfare and keeping harmful and deadly chemicals from entering the marketplace, has become more of a mediator between chemical companies and environmentalists: it does not have the funding, for example, to research the chemicals on the market, so it relies on tests and research performed by the companies on their own products to determine whether or not the chemical is dangerous.

In 1991, the EPA offered amnesty to chemical manufacturers that turned in health studies and research they should have provided to EPA earlier—the EPA offices received more than ten thousand studies that indicated the chemicals on the market could pose “a substantial risk of injury to health or the environment.” This is the kind of data that, by law, corporations must present to the government immediately.
But it’s the story of the FDA that is truly salacious: rocked by controversy over the last few years, the FDA has become the most highly-politicized government agency in federal government. In 2004, The FDA rejected an application from pharmaceutical company Barr Pharmaceuticals to make Plan B, the morning-after bill, available to consumers over the counter. The rejection came after the FDA’s scientific advisory board voted overwhelmingly (23-4) to approve the switch. As Michael Specter reported in The New Yorker, “the agency had never rejected a similar request against the advice of its scientific advisers and its own staff.”

In fact, over the past five years, the agency has demonstrated an overall disregard for the recommendations made by its scientific advisors. The New England Journal of Medicine accused the FDA of making “a mockery of the process of evaluating scientific evidence” and that it had “squandered the public trust and tarnished the agency’s image.” USA Today found that while federal law prohibits the FDA from using experts with staked interest in companies seeking approval, the agency has waived that law nearly a thousand times since 1998. The reason, according to the agency, is that there are simply no good researchers without industry connections. The financial connections between industry and science are pervasive. But in 1992, the FDA stopped making details of financial conflicts among its advisory board members and the companies seeking approval; that year, the agency had been rocked by controversies over conflicts of interest regarding decisions on breast implants, Prozac, and other medicines.

The EPA’s review process of hazardous chemicals relies on research conducted by the chemical companies on their own products to determine its level of safety and its effects on the environment and on populations. For the FDA’s review process, more than half of the experts hired to advise the federal government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies whose medicines are up for review. USA Today found that while federal law prohibits the FDA from using experts with staked interest in companies seeking approval, the agency has waived that law nearly a thousand times since 1998.
Why? Because there is now a catch-22: the “best” scientists are often employed by, or at least consultants to, interested companies coming before these boards; these scientists are leaders in their fields. Yet at the same time, by having a financial interest in the companies for which they consult, and for the companies seeking FDA approval and avoiding EPA regulation, objectivity is unavoidably in question.
Financial conflicts include stock ownership, consulting fees, research grants, a spouse's employment and payments for speeches and travel. The conflict could be a tie to the company whose drug is under consideration or to a company that sells a competing drug.

Protocols are particularly important. With FDA approval the pharmaceutical Holy Grail, companies may work for years on the development of a medicine, investing millions of dollars hoping for a huge pay day once the product hits the market. A company seeking this approval often designs a clinical trial in its own research division and brings in independent investigators, in that field, to oversee the protocols, or sometimes even to design the study in its entirety. Or at least that’s the way it used to be. More and more, companies are writing the protocols themselves, then bringing in investigators, even though they have no intention of changing the study design. What does this mean? It means that companies will test a drug on a healthier and younger population than the population most expected to use the drug in the real world. Companies’ marketing departments—which play a crucial role in decisions about which research studies will be conducted on a product—often nix clinically important studies if the results might reduce sales of the drug or jeopardize FDA approval.

Front Group Confidential

The International Life Sciences Institute is a Washington-D.C-based lobby group with a convincing and decidedly academic-sounding name. The ILSI is an accredited non-governmental organization, allowed to observe at World Health Organization meetings. But in early 2006, the WHO barred ILSI from taking part in WHO activities “setting microbiological or chemical standards for food and water.” Why?

Perhaps it is because the WHO finally got wise. Approximately sixty percent of the institute’s funding comes from its members: Coca-Cola, Dow Chemical, General Mills, Kraft, Merck, Monsanto, Novartis (formerly Ciba-Geigy), Pfizer, Proctor & Gamble, Bayer AG, DuPont, ExxonMobil, and other corporate citizens. Or the Air Qualities Standards Coalition, which is made up of more than five hundred businesses and trade groups created for the express purpose of defeating clean air proposals. Its leadership is composed of top executives of the auto, utility and petroleum industries.

The most famous industry front group in history is probably The Center for Indoor Air Research. Initially formed and funded by tobacco companies Philip Morris and R.J. Reynolds, the Center for Indoor Research was created to “sponsor and foster research in indoor air issues with emphasis on environmental tobacco smoke.” But in plain English, the Center was created to spearhead deceptive industry efforts. It was shut down in 1998. The Center for Indoor Research is a kind of archetype for modern-day front groups. From there, I will discuss front groups in the pharmaceutical, oil, pesticide, and chemical industries, including the Council for Agricultural Science and Technology (CASTS).

Take a look at the following front groups, and the companies behind them:
• Alliance for the Prudent Use of Antibiotics is funded by Bristol-Myers Squibb, GlaxoSmithKline, AstraZeneca, Ortho-McNeil, Procter & Gamble, Roche Pharmaceuticals, Wyeth-Ayerst, and others
• Center for the Study of Carbon Dioxide and Global Change: funded, in part, by ExxonMobil
• Citizens for a Sound Economy: funded by Philip Morris, ExxonMobil, DaimlerChrysler, Microsoft, and others
• Foundation for Clean Air Progress: formed in 1995 to “provide public education and information about air quality progress”, the Foundation for Clean Air Progress is made up mainly of energy, transportation, and manufacturing companies (which are disguised by their respective front groups), including the Chemical Manufacturers Association, the American Petroleum Institute, and the American Trucking Institute.
• Consumer Alert: heavily funded by the liquor industry and associated interests, Consumer Alert is also funded by ExxonMobil, Eli Lilly, Pfizer, Chevron, and others, and is a significant source of consumer information.
• Environmental Sensitivities Research Institution: this organization is dedicated to discrediting multiple chemical sensitivity, which is widely believed to be caused by exposure to formaldehyde in wood paneling and particle board (mostly found in mobile homes), percholorethlyne (perc, the chemical used by dry cleaners to clean clothes), and other noxious household chemicals. Multiple Chemical Sensitivity, which affects people in the forms of crippling migraines, asthma, skin rashes, and more, have become the basis for lawsuits against chemical manufacturers, who did not allow the research science, which indicated that the chemicals could cause such physical reactions, to see the light of day. The Board of Directors of the ESRI include executives from Dow, Procter & Gamble, Colgate-Palmolive, and other chemical manufacturers, as well as university researchers from colleges heavily funded by the same companies.
• Federal Focus: dedicated to influencing science policy issues, Federal Focus aggressively lobbies the EPA in order to protect is major members from regulation, including the American Paper Institute (paper mills are among the worst polluters in the country), Philip Morris, Society of Plastics Industries, National Paint and Coatings Association, and others.
• Greening Earth Society: This organization promotes the “benign effects of carbon dioxide on the earth’s biosphere, and humankind.” It was created by the Western Fuels Association, and promotes the use of fossil fuels, because “economic activity is as desirable as a green earth.”

Link to James Hansen's testimony to Congress

Thanks to my dad for sending me this link to James Hansen's testimony to Congress regarding White House interference with scientific documents and research into global warming. Remember the infamous and profoundly stupid line-editing by one of the White House flacks, who later resigned to work for--an oil company? This document was released yesterday.

Testimony by James Hansen: Political Interference with Government Climate Change Science

Climate Change and the Single Scientist

She could’ve gone by the name “The Shadow.” During NASA climate scientist James E. Hansen’s interview with 60 Minutes, a dark-haired woman with a notepad sat behind correspondent Scott Pelley, furiously scribbling notes. She was a NASA representative, sent by the federal government to sit in on Hansen’s interview.
Her presence didn’t stop Hansen from saying that “in my more than three decades in the government, I’ve never witnessed such restrictions on the ability of scientists to communicate with the public.” In fact, two years earlier, London’s Guardian published an investigation asserting that “White House officials have undermined their own government scientists' research into climate change to play down the impact of global warming.”

“My Administration’s climate-change policy will be science-based.” These were George W. Bush’s words to hundreds of groups and allies in 2001 when he withdrew American support for the Kyoto Protocols. Four years later, sixty-three year old Hansen began receiving calls telling him that there would be “dire consequences” if he continued saying publicly that 2005 was the warmest year in at least a century. After an earlier lecture in which he told a meeting of the American Geophysical Union that significant reductions in emissions were possible with technologies that already exist—and that “without leadership by the United States, climate change would eventually leave the earth”, in Hansen’s words, “a different planet”, Hansen’s public appearances and interviews would be much more closely monitored. Hansen’s point of view is, of course, at odds with that of the Bush Administration, that climate change is best combated by voluntary measures (and, in some quarters, that global warming is a myth.) And he was getting media attention. Lots of it.
Since the mid-eighties, Hansen had been on top of the long-term threat from carbon dioxide emissions, widely believed to cause global warming. But in the last few years, the climate wars have reached a fever pitch, and Hansen has lately found himself in the middle.

“Communicating with the public seems to be essential,” Hansen told the New York Times in early 2006. “Because public concern is probably the only thing capable of overcoming the special interests that have obfuscated the topic.”
“This administration has tried to restrict the very elements of scientific success: free and open inquiry,” said Margaret A. Hamburg, who worked with Clinton as a health policy adviser.

Companies like Exxon Mobil, which spent eight million dollars between 2000 and 2003 to fund forty global warming debunkers, are trying what was once deemed unthinkable: undermine what was once a broad consensus on global warming through a campaign. Interestingly, President Bush’s former Chief of Staff of the Council on Environmental Quality—Phil Cooney—hand-censored a report called “Our Changing Planet”, written for Congress. His edits softened or eliminated any mention of global warming. Months later, he left government for a job in the private sector. With ExxonMobil.

These stories illustrate what is perhaps the most contentious scientific debate we are engaged in today: climate change and global warming. For example, the New York Times reports that five years ago, scientists at the climate labs of NOAA used to take calls from science beat reporters; today, they may do so only if Bush administration officials have approved the interview—and only if the interviewee is chaperoned by a government public affairs officer. However, if the views of the scientist align with the stated policy of the Bush administration, few restrictions exist. These rules governing scientists’ interaction with the public were created by the Bush Administration.

The New York Times reported on June 9, 2006 that the National Science Board publicly stated that the quality and credibility of government research “are being jeopardized by inconsistent policies for communicating scientific findings to the public.” The NSB’s report was instigated after scientists at NASA and other science agencies complained that “political appointees had interfered with efforts to discuss global warming and other controversial issues.”

Front groups also come into play here, with misleadingly named organizations like the Foundation for Research on Economics and the Environment, Greening Earth Society, and the Foundation for Clean Air Progress funded solely by oil companies, the auto industry, and chemical manufacturers. The war between the different scientific and political factions when it comes to climate change is remarkably vicious and illustrates as no other topic can just how science can be manipulated for political expediency.

Spills, Drills, and Big Money

In 1962, a sixty-three year old biologist published three essays in The New Yorker. These groundbreaking articles about the danger of pesticides and other chemicals appeared at a time when the chemical industry was at the top of its game: the miracle of plastics, the promise of chemicals, and the splendor of synthetic materials had coalesced into a kind of state religion for some time during the fifties and early sixties. Rachel Carson’s work, of course, changed all that. In her New Yorker articles, Carson, a biologist, warned that pesticides were deeply dangerous and used without discretion. Two months later the articles were published in book form, and titled Silent Spring. The book flew off the shelves, and the chemical industry realized it was embroiled in its first major public relations emergency.

The chemical industry’s response to Silent Spring became infamous, the quintessential attack by industry on a scientist whose research threatens the bottom line. E. Bruce Harrison engineered the attack on Carson by paying other scientists to disparage and discredit Carson in press interviews and in negative reviews of Silent Spring published in scientific journals across the country. Lavelle and Fagin report in Toxic Deception that chemical giant Monsanto distributed 35,000 copies of “an acerbic rebuttal” of Carson’s work in its company magazine. “Called ‘The Desolate Year’, the article described a pesticide-free world in which insects ran rampant, spreading famine and disease.”

This incident put into place the architecture for corporations threatened by science: attack the scientist and discredit the science. Carson’s story sets the stage for the other examples of corporate and government-led attacks on scientists. This tactic of attacking scientists whose research tells a different story than the one the corporation wants told is employed by corporations—and, sometimes, the federal government. It was played out with Carson and has continued with the battles between scientists Jeff Short and Steven Picou and ExxonMobil and James Hansen and the Bush White House.

The word "junk science" is a term many corporations use to describe the work of independent scientists that threatens a particular industry’s bottom line. The term is actually an invention in fact though there is hardly a worse pejorative that can be used against a scientist, and the media has adopted it just as industries hoped they would. Its widespread use and the negative connotations it conjures is a victory for the chemical and pharmaceutical industries. ExxonMobil, for example, calls Jeff Short’s research “junk science.” The story of Jeff Short and ExxonMobil and the science of Prince William Sound, as well as the story of sociologist Steven Picou and ExxonMobil, are prime examples of a corporation’s attempts to control research on its product. The oil giant has good reason to denigrate the research conducted by Short, and other scientists studying the after-effects of the 1989 spill. In 1991, Exxon and the federal government, along with the State of Alaska, settled the civil and criminal lawsuits resulting from the spill (a $4.5 billion punitive award to the tens of thousands of fishers and Native Alaskans affected by the spill has been in appeals for nearly seventeen years.) Exxon fears one section of the settlement, called “Reopener for Unknown Injury.” This section allows the federal and state governments to claim another one hundred million from Exxon by September 2006 if they can demonstrate that the environment has suffered ongoing harm from the spilled oil. The money would pay for restoring wildlife or fisheries that suffered substantial loss or decline. These sorts of environmental injuries were, of course, impossible to foresee in 1991.

Dr. Steven Picou, a professor of sociology from the University of South Alabama, has spent the last sixteen years studying the effect the Exxon spill has had on the towns of the Sound. Those sixteen years have convinced Picou that litigation as a means of resolving environmental disasters gives the parties responsible—i.e. an ExxonMobil or an Amoco, in the case of the Cadiz disaster—legitimate opportunities to escape their liability and responsibility for the damage they caused.
In a keynote address presented at the Earth Charter Summit in 2002, Picou outlined what he considered Exxon’s legal strategy for avoiding payment of the punitive damage decision.
“Hire the best attorneys money can buy, and aggressively attack plaintiffs in every manner possible, while also delaying court proceedings by any legal means necessary for as long as possible, no matter how frivolous the challenge. Hire your own scientists to evaluate ecological damages and pervert the process of science by hiding behind any degree of uncertainty that may and will always characterize independent scientific damage assessments.” [emphasis added] Picou’s assertion that ExxonMobil was perverting science drew the oil giant’s attention and launched Picou into a four year odyssey. It was an odyssey that ended with one of his research subjects committing suicide out of fear that the oil giant’s attempts to seize confidential details about Picou’s interview subjects would be successful.
Picou’s story will be treated in-depth in Chapter Eight, not just for its drama but because it represents an important element of industry’s attempts to shape science—industry is invading the world of sociology to justify invasive production techniques.

Then there is the story of four scientists who, working independently on biotechnology research, made the same discovery, one which could, if accepted, rock the powerful and profitable biotech industry.
• Arpad Pusztai, conducted research that showed that transgenetically modified potatoes caused immediate tissue and immunological damage in rats. After reporting his findings, Pusztai’s home was burglarized: his research files were stolen. A few months later, he was fired from his job at Rowett Institute in Scotland, and, according to the San Francisco Chronicle, “suffered an orchestrated international campaign of discreditation, in which Prime Minister Tony Blair played an active role. “
• Cornell Professor John Losey faced similar retribution from Novartis and Monsanto when his research showing that monarch butterfly larvae that ate milkweed leaves dusted with genetically modified corn pollen died at alarmingly high rates. The two chemical and biotech companies openly discredited his work.
• Ignacio Chapela, an ecologist at UC Berkeley, suffered perhaps the worst attacks of al four scientists. After discovering that pollen from genetically modified corn in Mexico had penetrated the last reserve of biodiverse maize on earth—possibly destroying maize biodiversity for good—Chapela published his findings in the respected journal Nature. Monsanto immediately launched what could fairly be termed a smear campaign: they sent an email to the editors of Nature, pretending to be two scientists who were outraged at the lack of scientific rigor in Chapela’s research. Based on this fake email, Nature retracted part of Chapela’s article. As a result, Chapela was denied tenure. His teaching assignments for that call were terminated.

Retribution for research is not limited to the corporate world: The Bush Administration fired cell biologist Elizabeth Blackburn from the President’s Council on Bioethics because she supported stem-cell research; she was replaced by a political science professor who opposes the research.

Slathering on Phthalates: Drop the lipstick and slowly walk away

I recently reconnected with an old friend from my Columbia MFA days, Jen Uscher. She was one of the few students in the writing program who was working on the same sort of material as me--journalistic, investigative nonfiction. She is a successful freelance journalist now, focusing on environmental and scientific issues, and I've followed her career with interest. She sent me a link to her website: www.jenuscher.com. On her website, I found a piece she recently wrote for Consumer Reports about a topic I had heard about but had not learned nearly enough about: chemicals in cosmetic products. Titled "What You Should Know About the Chemicals in Your Cosmetics", it can be found at:
http://www.consumerreports.org/cro/promos/shopping/shopsmart/winter-2007/what-you-should-know-about-chemicals-in-your-cosmetics/overview/0701_cosmetics_ov.htm

(If anyone knows how to hyperlink on blogger, let me know: the insert link function doesn't seem to work for me. You can also click on the title of this post and be taken directly to Jen's article.)

I think the issue of chemicals in cosmetics has been easily dismissed because people connect cosmetics with lipstick, foundation, etc. But the truth, as pointed out by Jen in her article, is that noxious phthalates are found in everything from nail polish to aftershave to body lotion and beyond. More, companies are not required to disclose the presence of phthalates in their products--they can be included under the umbrella term "fragrance" on the list of ingredients. The presence of phthalates have been linked to reproductive and developmental disorders, and yet companies say that because the phthalates in their products occur in such small amounts that there is no reason for worry.

One particularly upsetting revelation in Jen's article was the fact that Aveda, probably the most trusted cosmetic company among those who choose environmentally and bodily-friendly products, lied about the contents of at least one of its products:

Two products-Aubrey Organics Jade Spice Eau de Parfum and Aveda Love Pure-Fume Essence-went into the test group because the companies say they don't contain any phthalates. But we found DEP, DEHP, and diisodecyl phthalate (DIDP) in the Aubrey Organics product. Aveda's perfume contained DEP and DEHP.

Please read Jen's article and its accompanying sidebars (including a link to Environmental Working Group's site, where you can order or download a brochure outlining how to shop for safe cosmetics):