9-26-05, 9:15 am
Mired in controversy, Food and Drug Administration (FDA) Commissioner Lester Crawford became the second Bush-appointee to a major federal agency to resign in less than three weeks. FEMA boss Michael Brown was the first to go as revelations that his appointment was a gesture to political patronage rather than expertise. Much like Brown, Crawford won his job because of his willingness to sacrifice the responsibilities of the position to the mandates of right-wing ideology and the Republican Party agenda.
Crawford, trained as a veterinarian, was widely regarded as a political appointee that favored right-wing ideology over science. His opposition to women's reproductive rights and to government regulation, two cornerstones of the Republican Party platform, governed his actions as an FDA official. In the Crawford-Bush worldview, religious views about birth control prevail over science. And when it comes to corporate donors to the Bush campaign and the Republican Party, the right-wing dislike for regulation prevails over health.
This became especially evident to supporters of safe birth control products when, despite two FDA advisory committee votes in 2003 to approve the use of the 'morning-after pill' (Plan B) over the counter, Crawford denied the manufacturer’s application. Crawford’s rejection, which came just weeks after his appointment as interim head of the FDA, was not based on scientific studies of the drug’s safety but on trumped up concerns about adolescents understanding how to use the drug properly.
Since 2004, Crawford delayed making an announcement about the use of Plan B until this past August when the FDA said that it couldn’t decide whether or not to approve the drug because it was still concerned that young women wouldn’t understand how to use it properly. For this reason, the FDA planned to exclude girls under 17 from future over-the-counter sales. But, the agency added in twisted logic, Plan B couldn’t be approved for adult women either over-the-counter, because the FDA couldn't figure out how to keep women under 17 from buying it.
In a statement excoriating Crawford for his failure to approve the drug, the National Organization for Women called Crawford’s indecisiveness and poor logic a delaying tactic. Crawford failed to live up to his promise to the Senate committee that confirmed him that he would decide by September 1 on the whether or not Plan B could be sold over the counter.
NOW called the FDA's reasoning for delay 'ridiculous' and pointed out that directions for taking Plan B (just two doses) could be followed by anyone who could read at a 6th grade level. Further, Crawford again ignored studies had showed that the drug was safe and would cause 'no adverse health consequences.'
NOW called Crawford's claim 'merely an excuse to deny young women access to the means to prevent pregnancy.' NOW also denounced Crawford’s exclusion of girls under 17 from over-the-counter use of the drug, but pointed out that Crawford’s reasoning for denying it to adult women seemed disingenuous as other items sold in drug stores over the counter, such as cigarettes and alcohol, didn’t seem to bother him.
NOW concluded, 'This administration is determined to turn the FDA into an arm of the Republican Party – carrying out the fondest desires of Bush allies who oppose women’s use of contraception.'
Vioxx may have been a bigger scandal for Crawford, however. The FDA came under sharp attack in late 2004 with the revelation that Crawford’s agency, fueled by an ideological aversion to government regulation, especially for companies that pumped millions into the Republican Party’s campaign coffers, failed to withdraw Merck & Co Inc.’s painkiller Vioxx from stores despite strong warnings about deadly side-effects.
David Graham, an FDA reviewer who had warned about the heart risks of the Merck product, told a Senate inquiry in November of 2004 that 'a study of patient insurance records [showed] that Vioxx users had a 50 percent greater chance of heart attacks and sudden cardiac deaths.'
Crawford's agency knew about the study and merely helped Merck bypass public scrutiny.
Further, FDA managers pressured Graham to water down the results of his study. And when he refused, Crawford personally led a smear campaign against Graham.
Several members of Congress, including some moderate Republicans, wrote a letter to Crawford saying that if reports of Crawford’s actions against Graham are true, then they are 'out of line and may very well be illegal.'
'Your treatment of Dr. Graham,' the letter said, 'undoubtedly has had a chilling effect on the willingness of FDA employees to speak up and disagree when they believe the public’s health is at risk.'
According to data compiled from Federal Elections Commission reports by the Center for Responsive Politics, a non-partisan group that tracks money in politics, Merck is one of the largest pharmaceutical donors to the Republicans, giving about $450,000 every campaign cycle since 2000. Merck also gives much more indirectly through the industry lobbying group, the Pharmaceutical Research and Manufacturers of America. Overall, the pharmaceutical industry has given more than $53 million to the Republican Party since 2000 (outpacing donations to Democrats by about 3 to 1).
Ultimately, bad publicity forced Merck to pull Vioxx from stores, not the FDA.
Crawford wasn’t above using his position to intervene in other ways, however. Just weeks before the Vioxx scandal broke, Crawford used the FDA to help the Bush campaign in the run-up to the 2004 elections.
The dominant theme of the Bush campaign was the issue of terrorism, promoting fear and assuring the public that Bush’s policies would keep Americans safe. The general argument was that if Americans didn’t vote for Bush, the country would be susceptible to terrorist attacks.
In September 2004, Crawford, producing no evidence then or since, claimed that Al Qaeda may try to attack Americans by contaminating imported prescription drugs. It just so happened that the Bush administration was struggling to find a way to counter widespread public demand that prescription drug prices could be controlled by importing less expensive drugs from Canada or Mexico.
While Crawford failed to protect public health by making decisions on Vioxx or Plan B, his agency did prematurely move to approve the use of silicone breast implants. Just days before Crawford’s resignation, the FDA sent an approval letter to Inamed Corporation for the use of silicone breast implants, previously linked to different forms of cancer.
Breast implants often rupture after 10 to 12 years of wear and because silicone leaks slowly and silently into the lymph nodes, brain and major organs through the blood stream, women need to be aware of the long-term health risks. Silicone gel contains toxic substances such as platinum and National Cancer Institute studies (2001) have shown higher rates of brain and lung cancer among women with implants (both silicone and saline implants).
Another complication is the need for re-operation. Re-operation is often required because of infections, hardening of tissues around the implants, migration of the implant, rupture and other complications. One Canadian study found that more than half of the women with implants needed a subsequent operation, while 23 percent had undergone two operations and 17 percent had four or more additional surgeries. Insurance companies often deny coverage to any illness or injuries that could be related to implants.
The FDA’s approval letter came just weeks after it granted preliminary approval to Mentor Corporation to sell silicone breast implants.
These approvals were granted despite the lack of any new evidence that silicone breast implants are safe. Approval seems to have been granted based solely on the promise of the companies to monitor the health of the women who purchase the implants.
Unfortunately, experience suggests that companies who promised to provide health monitoring failed to do so and have ignored women who have complained about health complication believed to be caused by leaking implants.
NOW President Kim Gandy charged the FDA with a 'willingness to trade off public health for Bush administration priorities.' The agency ignored studies that questioned the long-term safety of implants and accepted biased industry studies.
Gandy added, 'The drug and device companies own the FDA and it is the companies’ profit potential that rules the review and approval process – except when the profit motive is overridden by the White House morality police, as with the morning-after pill.'
--Joel Wendland can be reached at jwendland@politicalaffairs.net.
