UNDERMINING SCIENCE

Dr. Lester Crawford, acting FDA commissioner. Criticized Dr. David Graham for not submitting his work on Vioxx to internal review prior to sending a manuscript to the British medical journal The Lancet. Dr. Steven K. Galson, FDA's acting director of drug-evaluation division, told reporters that Dr. Graham's work on Vioxx was "junk science" and e-mailed an editor at The Lancet, disputing the integrity of his data. Previously, unnamed FDA officials had even tried to get Dr. Graham to resign.

(Dr. Graham found that Vioxx increased the risk of cardiac problems and if prescribed in high doses could in fact triple the risk of heart attack. But the FDA appeared more concerned with protecting pharmaceutical giant Merck's annual $1 billion in revenues from the popular painkiller than with public health. They took no action to pull Vioxx from the market.)

FDA managers had tried to silence Dr. Graham from the beginnning and even tried to get him to resign. He went to the Government Accountability Project (GAP) for help, and GAP's legal director Tom Devine reported getting an anonymous phone call saying that Graham had bullied other staffers into approving his flawed study. Devine later traced this call to the offices of FDA's management. Devine also reported that Dr. Graham had submitted his manuscript for internal approval several weeks before sending it to The Lancet.

Ultimately, other researchers confirmed Dr. Graham's findings. Under intense public pressure, Merck withdrew its flawed product.

Unlike Vioxx, this drug is not a painkiller; it is an emergency contraceptive: Hence the name "Plan B" under which levonorgestrel is marketed, suggestive of its use in cases where conventional contraceptives fail. Manufactured by Barr Pharmaceuticals of New York, it had been available under prescription in the U.S. since 1999. France, Great Britain, and 30 other countries make it available without a prescription. Millions of women have used it without problem; few drugs are safer.

The reason that Dr. Galson declared Plan B "non-approvable" is apparently moral rather than medical. This reflects the ardently held views of one Dr. W. David Hager, a member of the FDA's Reproductive Health Advisory Committee. Dr. Hager, a Kentucky-based ob-gyn, refuses on moral grounds to prescribe Plan B to his own patients. It was he who first came up with the spurious argument that adolescent girls would not understand how to use the drug properly. Hager's real concern, which Galson apparently shares, is promiscuity. This is also a discredited argument.

Barr Pharmaceuticals responded to Galson's letter by requesting approval to sell Plan B behind the counter so that pharmacists could deny it to underage women. But in August 2005, the FDA decided to postpone a decision indefinitely. Two members of its advisory panels resigned in protest as a result.

Jeffrey R. Holmstead, EPA assistant administrator for air and radiation. Redefined the New Source Review threshold for routine maintenance of power plants as up to 20% of each generator's value, after Sylvia Lowrance, deputy administrator for enforcement, had recommended a value of 0.75 percent.

Holmstead was an associate White House counsel for George H. W. Bush. During the Clinton administration he worked for Latham & Watkins, a firm representing several electric utilities fighting air pollution regulations.

William Wehrun, a senior advisor to Holmstead. Advised a meeting of a dozen EPA staffers intending to begin studies on the impact of new power-plant mercury-emission regulations that the studies would be postponed indefinitely.

Holmstead had presided at the meeting. He later told two EPA staffers who complained that there would be no studies because of "White House concerns."

Wehrum later replaced Holmstead as EPA assistant administrator for air and radiation. Like his former boss, he had worked as a lawyer for Latham & Watkins.

The proposed rules are much weaker than those of the Clean Air Act. They were found to contain twelve paragraphs lifted from a document prepared by industry lawyers at Latham & Watkins. The administration released them in final form in March 2005. Eleven states have already sued the EPA on the basis that they violate the Clean Air Act.

J. Steven Griles, a deputy secretary at the Interior Department. Altered the Environmental Impact Statement (EIS) process relating to mountaintop-removal coal mining, making it easier for coal companies to dump the waste in situ.

A memo from Griles to the White House Council on Environmental Quality directed that a new draft EIS should "focus on centralizing and streamlining coal-mining permitting" and not on ways to limit the environmental damage caused by the waste dumping. Prior to joining Interior, Griles was a mining industry lobbyist.

The species was the bull trout, listed as endangered in the Pacific Northwest since 1998. Per a 2003 court settlement, the FWS contracted with a private firm to do the cost-benefit analysis of protecting the fish. That firm found that protection would cost $230-$300 million over a decade, but would likely yield $215 million in benefits from sport fishing and related activities.

When the report was released, the 55-page section describing the benefits was simply missing. An anonymous FWS employee leaked it, and it was published in a Montana newspaper. Diane Katzenberger, an information officer at the Denver FWS office, said the censorship had not occurred in a regional office but "was a policy decision made at the Washington level." Hence the justification by Mr. Nolin — a justification which fails because the same methodology has in fact been used for other benefits analyses, notably one which estimated $113 billion in benefits from the Clear Skies Initiative.

The principal basis of Williams's decision was a study by James Dubovsky and John Cornely. These two scientists did not submit their work for peer review, and their conclusions run counter to the preponderance of scientific analysis.

Williams also cited a 1987 study by wildlife biologist Ruth Gale Shea — and she says that the FWS position is diametrically opposite to her paper's actual conclusions.

Following the initial FWS ruling, the nonprofit group Public Employees for Environmental Responsibility (PEER) filed a complaint under the Data Quality Act of 2000. PEER asked Williams to review his ruling. He turned them down. It was later learned (through FOIA requests) that he had done a review, but did not like its answer. In March 2004 he overrruled the review panel, denied PEER's appeal, and continued to refuse endangered status for the Trumpeters.

A team of scientists tasked by the National Marine Fisheries Service with reviewing the status of endangered salmon stocks found their scientific recommendations missing from the official report. Team leader Robert Paine, a world-renowned ecologist, said, "We were told to either strip out our recommendations or see our report end up in a drawer." The NMFS is part of the National Oceanic and Atmospheric Administration. Paine further maintained that the NOAA policy of lumping wild and hatchery fish together into one population distorted the scientific picture.

A federal district court had ruled in 2001 that counts of Oregon coho salmon should include hatchery-bred fish. Prior to that date, the NMFS had set protection policies based on solely the numbers of wild fish. But Paine's group found a scientific basis for segregating the two populations.

NOAA instructed the scientific team to follow "consistent ecological principles." However, its true priorities were different. Many interest groups including farmers, ranchers and logging companies opposed protected status for the salmon. Mark Rutzick, appointed special advisor to the NOAA general counsel by President Bush in 2003, was formerly a lawyer for the timber industry, and strongly opposed regulations protecting fish and wildlife that the loggers viewed as overly burdensome. He oversaw the strategy of including hatchery fish with all 26 listed populations of Northwest salmon — a measure that would take them off the endangered species list.

The draft policy did not call for de-listing any salmon population. But its census data virtually invited legal challenges that would accomplish this. Jim Lichatowich, a salmon expert and former NMFS scientist, likened the strategy to lumping humans and chimpanzees into one population. He charged that this policy was "setting salmon recovery back about one hundred years."

The stories these people tell have three factors in common: They are all highly qualified for the positions they were denied; during the selection process they were asked political questions such as whether they liked President Bush, supported his policies, or had voted for him; they either admitted less than total support or refused to answer.

Note that while two of these people (Myers and Sterk) had their rejections reversed, it happened only because of the intervention of high-ranking individuals. The pattern is indisputable. Political litmus tests are the order of the day thoughout the Bush administration.

The case of engineer William E. Howard III is especially reprehensible. He was rejected for a Department of Defense advisory position for contributing to the 2004 presidential campaign of Senator John McCain (R-AZ). In fact the real contributor to McCain—a Republican, but an opponent of Bush—was one William S. Howard.

Sixty prominent scientists had just released a statement questioning the scientific integrity of the Bush administration. The Union of Concerned Scientists had issued the companion report Scientific Integrity in Policymaking to document the basis for the well-publicized "scientists' statement." The White House personnel office chose this month to notify Elizabeth Blackburn and William May that their appointments to the bioethics council would not be renewed.

This case stands out because Dr. Blackburn is one of the world's top biomedical researchers. One of only three scientists on the council, she was dismissed after expressing disapproval of the fact that her views were omitted from the council's report. Chosen to replace her, William May, and another member who had previously resigned were two more nonscientists and Ben Carson, a pediatric neurosurgeon at Johns Hopkins Medical Center. All three of these new members held to the views of council chair Leon Kass, which is to say those of President Bush.

Bush sought little scientific advice before taking this position. (He might have consulted his science advisor; but, six months into his first term, he had yet to submit a candidate to the Senate.) Two problems resulted. First, there were in fact only nine genetically distinct lines. Second, all of these existing cells had been grown in live mice, which means they contain mouse viruses and are unsuitable for implantation in humans.

A related issue is that the restriction on federal funding for stem cell research makes it likely that the best researchers will leave the country and America will fall behind in this important field.

Bush's position raises a moral quandary as well. If he believes the destruction of a blastocyst is murder, he must also condemn private stem-cell research. For that matter, he cannot in good conscience allow in vitro fertilization — or even sexual intercourse, for some 80 percent of the blastocysts so created never survive.