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Context of 'July 20, 2006: Survey of FDA Scientists Indicates Political Interference'

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Representatives for 10,000 EPA scientists write a letter to Congress protesting the Bush administration’s plan to close the agency’s research libraries. The letter’s authors, representing more than half of the EPA’s total workforce, say that about 50,000 original research documents will become completely unavailable because the agency has no plan to digitize them. Nor does the agency have plans to maintain the inter-library loan process. The letter warns that the closures would make thousands of scientific studies inaccessible, making it more difficult to prepare for emergencies and enforce environmental laws. As an example of the impact that these measures will have, Jeff Ruch, executive director of Public Employees for Environmental Responsibility, notes that “important research on the Chesapeake Bay is locked away in boxes since EPA closed its Ft. Meade library in February, yet EPA still maintains that restoring the Chesapeake is a top priority.” The letter describes the library closures as another “example of the Bush administration’s effort to suppress information on environmental and public health-related topics.” [PEER, 6/29/2006; Saracco et al., 6/29/2006 pdf file]

Entity Tags: US Congress

Timeline Tags: US Environmental Record

A survey taken by 997 FDA scientists suggests a pervasive problem of low morale among agency employees, due in large part to political interference by appointees. Sixty-two percent of those who participated in the poll were senior scientists and almost a third had worked for the FDA for more than 15 years. The survey was conducted by the Union of Concerned Scientists and Public Employees for Environmental Responsibility (PEER).
bullet Seventeen percent said “FDA decision makers” had asked them on at least one occasion to modify conclusions in an FDA document for nonscientific reasons.
bullet More than 40 percent knew of situations where political appointees had interfered with FDA determinations or actions.
bullet Forty-seven percent knew of instances where “commercial interests” improperly engaged in efforts to modify FDA conclusions.
bullet Only 51 percent said they believe the FDA is effectively safeguarding public health.
bullet Forty percent said there were times they chose not to publicly express concerns for fear of retaliation.
bullet Almost 70 percent said the agency lacks the needed resources to fulfill its regulatory duties.
bullet Forty percent said morale is poor or extremely poor.
bullet Only 32 percent said they feel the FDA is moving in the right direction. [Union of Concerned Scientists, 7/20/2006 pdf file; New Jersey Star-Ledger, 7/21/2006]

Entity Tags: Public Employees for Environmental Responsibility, Union of Concerned Scientists, US Food and Drug Administration

Timeline Tags: US Health Care

Citing proposed cuts in its 2007 fiscal year budget, the EPA begins ordering its regional offices to cancel subscriptions to several of the technical journals and environmental publications that are used by its scientists. One internal email reveals that the agency’s Mid-Atlantic Region is being asked “to cut its journal renewals about in half.” According to the organization Public Employees for Environmental Responsibility (PEER), the subscription cancellations mean that “agency scientists and other technical specialists will no longer have ready access to materials that keep them abreast of developments within their fields. Moreover, enforcement staff, investigators, and other professionals will have a harder time tracking new developments affecting their cases and projects.” The cancellations come on top of the closures of several EPA libraries that have already cut employees’ access off from tens of thousands of documents (see, e.g., September 20, 2006 and August 15, 2006). When news of the library closures sparked protest from EPA scientists over the summer (see June 29, 2006), agency officials attempted to assuage their concerns with promises that the EPA would implement a “new library plan to make environmental information more accessible to employees.” But critics say the subscription cancellations contradict this claim and are a clear sign that the agency does not intend to improve its staff’s access to the information. [PEER, 10/9/2006]

Entity Tags: Environmental Protection Agency

Timeline Tags: US Environmental Record

On October 20, the EPA quietly closed its Office of Prevention, Pollution, and Toxic Substances (OPPTS) Library, which housed thousands of one-of-a-kind documents relating to the safety of chemicals (see October 20, 2006). Material from the library had been used by government scientists to review industry applications for new chemicals. Since the closure, the agency has asked other EPA libraries to take possession of the documents. But documents that have not been claimed by other libraries are being tossed into garbage bins. Jeff Ruch, of the organization Public Employees for Environmental Responsibility (PEER), has been an outspoken critic of the EPA library closures. According to him, it appears as if “the appointed management at EPA is determined to actually reduce the sum total of human knowledge. EPA is not an agency renowned for its speed, so its undue haste in dumping library holdings suggests a political agenda rather than anything resembling a rational information management plan.” [PEER, 11/20/2006]

Entity Tags: Jeff Ruch, Environmental Protection Agency

Timeline Tags: US Environmental Record

A survey conducted by the Union of Concerned Scientists (UCS) and the Government Accountability Project (GAP) bolsters allegations that the Bush administration is pressuring climate scientists to produce material that does not contradict its position on global warming. The survey was distributed to 1,600 climate scientists at seven federal agencies. Of those, 279 responded. The survey found:
bullet Forty-six percent of the respondents indicated that they perceived or personally experienced pressure to remove the words “climate change,” “global warming,” or other similar terms from their writings.
bullet Forty-six percent said their writings had been changed or edited by a superior in a way that changed its meaning.
bullet Forty-six percent said they perceived or personally experienced new or unusual procedural requirements that impair climate-related work.
bullet Twenty-five percent of the respondents said they know of scientists who have actively objected to, resigned from, or removed themselves from a project because of pressure to change a scientific finding.
bullet 150 climate scientists said they personally experienced political interference in the past five years, for a total of at least 435 incidents.
bullet Seventy-eight percent of the scientists who indicated that their work involves controversial climate research said that they have personally experienced at least one incident of inappropriate interference with their work. Of those, more than one-quarter said they had experienced six or more such incidents during the last five years.
bullet Sixty-seven percent said their work environment has become less enjoyable over the last 5 years ago. This figure was the highest for scientists working at NASA (79 percent). [Union of Concerned Scientists, 1/30/2007 pdf file; Reuters, 1/30/2007]

Entity Tags: Government Accountability Project, Union of Concerned Scientists

Timeline Tags: Global Warming

In a 93-1 vote, the US Senate passes the Food and Drug Administration Improvement Act of 2007 (H.R.2273), which grants the FDA broad new authority to monitor the safety of drugs after they are approved. It was based in part on the recommendations of a 2001 report by the Institute of Medicine (see September 22, 2001). The institute had been asked by the FDA to examine drug safety after it was revealed that the FDA and drugmaker Merck had permitted the drug Vioxx to stay on the market despite numerous indications that it increased patients’ risk of a heart attack. But the bill that is passed is much weaker than the original version, and ignores some of the institute’s most critical recommendations. A USA Today investigation will find that industry-friendly changes made to the bill were instigated by senators “who raised millions of dollars in campaign donations from pharmaceutical interests.” For example, 49 senators successfully defeated an effort that would have allowed US consumers to import lower-cost drugs from Canada and other industrialized countries. The senators who opposed the provision “received about $5 million from industry executives and political action committees since 2001—nearly three quarters of the industry donations to current members of the Senate,” USA Today found. Another factor contributing to the amendment’s failure was that President Bush said he would veto the bill if it permitted the imports. Also excised from the bill was language that would have give the FDA the authority to ban advertising of high-risk drugs for two years. This was one of the Institute of Medicine’s key recommendations. Senator Pat Roberts (R-Kan) argued that the change would restrict free speech. Drug interests have given Roberts $18,000 so far this year, and $66,000 since 2001. Sen. Judd Gregg (R-NH) was responsible for a change that reduced the agency’s power to require post-market safety studies. He insisted on limiting this authority so that the FDA could only target drugs when there’s evidence of harm. Gregg has received $168,500 from drug industry interests since 2001. The bill’s main sponsors—senators Edward Kennedy, (D-Mass) and Mike Enzi (R-Wyo)—agreed to water down a proposal that would have required all clinical drug studies be made public after meeting with industry officials. The senators agreed to change the language so that only studies submitted to the FDA would be available. Enzi and Kennedy have received $174,000 and $78,000, respectively, from drug interests since 2001. Amendments aimed at reducing industry conflicts of interest on FDA expert advisory panels were also stripped from the bill. One of those amendments would have made it more difficult for scientists to advise the FDA on drug approval applications from a company the scientist had received money from. Another would have required that FDA panels consist of no more than one member with financial ties to the drug industry. The Senate also rejected an amendment to establish an independent FDA office to monitor the safety of drugs after they are released on the market. The office that currently has this authority is the same one that approves new drugs, an arrangement that lawmakers and at least one FDA scientist (see November 18, 2004) believe is a conflict of interest. [WebMD Medical News, 5/9/2007; US Congress, 5/10/2007; USA Today, 5/14/2007]

Entity Tags: George W. Bush, Edward M. (“Ted”) Kennedy, Judd Gregg, Mike Enzi, US Food and Drug Administration, Pat Roberts

Timeline Tags: US Health Care

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