Nine unions comprised of 9,000 EPA scientists maintained that multiple agricultural pesticides are dangerous for pregnant women, children, and the elderly. In a letter to EPA administrator Stephen L. Johnson, union leaders indicated that agency officials seem to believe that "the concerns of agriculture and the pesticide industry come before our responsibility to protect the health of our nation's citizens." An EPA scientist warned that the agency often ignores scientific studies that disagree with industry-funded studies. This isn't surprising, given that the EPA's own inspector general acknowledged earlier this year that the agency had failed to protect children from pesticide exposure.
Late last month the Union of Concerned Scientists released the disturbing results of its survey of FDA scientists. The survey was sent to almost 6,000 FDA scientists, of whom about one-fifth responded. The responses revealed that 20 percent had been asked explicitly by FDA administrators to provide incomplete, inaccurate or misleading information to the public. And 60 percent of the scientists reported that commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA actions.
Almost 20 percent of FDA scientists in the survey indicated that they had been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or conclusions in a scientific document. There was ample evidence of this in 2004 when the FDA prevented an agency scientist from publicly criticizing antidepressants. In February of that year agency officials prevented Dr. Andrew Mosholder from testifying at a public hearing on the increased risk of suicide among children who take antidepressants. Dr. Mosholder conducted an FDA review of 22 studies on children and antidepressant medication.
Almost half of the FDA scientists in the survey indicated that the agency isn't effectively protecting public health. The FDA's involvement in the now discredited drug Vioxx is glaring proof of this. Dr. David Graham, the associate director of the FDA Office of Drug Safety, complained in 2004 that officials attempted to suppress the results of his study on Vioxx. He found that as many as 139,000 people had suffered heart attacks or strokes and approximately 55,000 people died as a result of taking the drug.
Ironically, late in 2004 the manufacturer of Vioxx, Merck, removed the drug from the marketplace after clinical studies demonstrated an increased risk of heart attack and stroke. According to Dr. Graham, the FDA is "virtually incapable of protecting America." Merck made almost half a million dollars in political contributions in 2004, with 70 percent going into Republican coffers. It seems likely that the FDA's actions toward Vioxx were largely attributable to politics.
More than half of the agency's scientists who participated in the survey reported that the FDA doesn't routinely provide complete and accurate information to the public. The agency was certainly guilty of this concerning its involvement with the drug Ketek. In 2001 an FDA panel recommended its approval to treat pneumonia, although the panel had concerns about potential liver damage. Consequently, the drug's manufacturer, Sanofi-Aventis, agreed to conduct a study of the drug's effect on the liver. It was later discovered that the study was fraudulent.
However, FDA officials continued to cite the study as proof that Ketek was safe, and in 2004 the drug was approved. Earlier this year the agency's Office of Drug Safety found 110 cases of liver problems related to Ketek, including cases of liver failure and death, and recommended that it be withdrawn from the market. And agency scientists estimated that the drug caused liver failure at approximately four times the rate of other antibiotics. Despite all these warnings, FDA administrators approved of clinical trials using the drug on children as young as six months old.
The complaints of scientists at both the EPA and the FDA are serious and troubling. And there seems to be little doubt that their accusations are valid. The Bush administration is consistently placing political and industry interests ahead of sound science. As a result, the health, safety and welfare of the nation are being compromised.