Despite lawsuits, whistleblowers and government investigations, the FDA continues to ignore its mission of protecting consumers against dangerous food and medicine products. Senate Finance Committee Chairman Charles Grassley, R-Iowa, recently criticized the Food and Drug Administration for failing to adequately monitor the safety of drugs after they are approved for the market, saying:
"We get press releases listing accomplishments rather than a meaningful revamping of the way things work inside the FDA. My staff investigators continue to hear from FDA employees who believe in their agency and ... want to do the right things, but experience intimidation, suppression and reassignments when they raise concerns about the integrity of the FDA's work."
Grassley and House Energy and Commerce Committee Chairman Joe Barton, R-Texas, requested an investigation by the Government Accountability Office (GAO) into the FDA's drug oversight practices after hearing complaints that the FDA was sluggish to pull harmful drugs -- like Vioxx -- off the market. The GAO finished its study in mid-April and came to the conclusion that the "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues. The process has been limited by a lack of clarity about how decisions are made and about organization roles, insufficient oversight by management and data constraints. GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them."
The GAO report suggested that authority be given to the FDA to require drug makers to conduct safety studies on drugs already approved and on the market. Grassley also urged passage of legislation that would allow FDA researchers to conduct independent post-market studies of drugs.
The FDA's response to the investigation and criticism was a statement from its Center for Drug Evaluation and Research, calling the report "well done," and saying the "conclusions reached are reasonable and consistent with actions we already have underway or planned."
The FDA is "too cozy" with drug companies
However, one might wonder if those actions would ever come to fruition if it wasn't for Grassley's investigation shedding light on the FDA's inefficiencies. In fact, the GAO study isn't the first time Grassley has delved into the deep-rooted troubles of the FDA. Back in late 2004, when news of the damages caused by the drug-safety catastrophe known as Vioxx was just beginning to reach the public, Grassley led a Senate Committee on Finance hearing, calling into question the FDA's role in the Merck/Vioxx fiasco.
In his opening statement for that hearing, Grassley said, "One of my concerns is that the FDA has a relationship with drug companies which is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern."
As it stands now, the FDA's "first and only concern" seems to be protecting the financial interests of the pharmaceutical industry at seemingly any cost -- including the lives of the American citizens it is supposed to protect.
Grassley went on to say, "When the FDA approves a drug, it's considered a 'Good Housekeeping Seal of Approval.' However, what's come to light about Vioxx since Sept. 30, 2006 (when Merck withdrew Vioxx from the worldwide market) makes people wonder if the FDA has lost its way when it comes to making sure drugs are safe ... The bottom line is consumers should not have to second guess the safety of what's in their medicine cabinets. The public should feel confident that when the FDA approves a drug, you can bank on it being safe, and if a drug isn't safe, the FDA will take it off the market."
Vioxx whistleblower Dr. Graham says the FDA not only doesn't protect consumer interests, but cannot
During Grassley's November hearing, Dr. David Graham, senior drug safety researcher at the FDA, (and Vioxx whistleblower) testified before the Committee that the FDA was "incapable of protecting America from unsafe drugs or from another Vioxx." In an interview with Manette Loudon, lead investigator for Dr. Gary Null, Dr. Graham said that since his testimony before the Committee, "...very little has changed on the surface [of the FDA] and substantively nothing has changed. The structural problems that exist within the FDA, where the people who approve the drugs are also the ones who oversee the post-marketing regulation of the drug, remain unchanged. The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur. America is just as at-risk now, as it was in November, as it was two years ago, and as it was five years ago."
Sen. Grassley's GAO investigation results were announced in April 2006. Dr. Graham's interview with Loudon was published in August 2005. The troubles with Vioxx began in September 2004. The FDA says it has actions planned to fix its critical drug safety failures, but given the amount of time passed since its shortcomings were first noticed nearly three years ago, shouldn't it have remedied some of its more crucial faults already? Perhaps, even in light of all the recent criticisms raining down on it, the FDA will simply issue another press release to Sen. Grassley listing more of its so-called accomplishments rather than any significant changes that would improve public safety.
The troubles at the FDA run deep. In his interview with Loudon, Dr. Graham put it nicely: "As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of the industry. It views industry as its client, and the client is someone whose interest you represent."
The Government Accountability Office has said the FDA must change to protect the public. Sen. Grassley and the Senate Committee on Finance came to the same conclusion. Even members of the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee have addressed the need for the FDA to do its job and protect public health. And with 11,500 lawsuits filed against Merck by former Vioxx users, even the public is telling the FDA to do its job correctly and protect them from dangerous drugs like Vioxx.
Vioxx was one drug -- one single drug for one single health problem. Look at the damage it caused, and is still causing today. Think about how many deaths could have been prevented if the FDA had done its job and stopped Vioxx from reaching the market, or at least quickly pulled the drug from the market once its dangers were apparent. Think about how many more deaths could have been prevented if the FDA didn't blatantly push for the drug's approval in spite of its health hazards.
The bottom line is the FDA must change, or be gutted and rebuilt from the ground up. It must reform in ways much more far reaching than what was outlined in the GAO report, though those changes will no doubt make a difference. Perhaps the FDA should take its own slogan to heart: "Do it right the first time."
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