From defibrillators to pacemakers, some experts say too many mistakes are making it to market. There are close to 24-thousand companies across the globe manufacturing medical devices -- many that help people live longer, healthier lives. But a group of scientists in charge of inspecting these life-saving products say a stamp of approval by the FDA doesn't mean it's safe.
Pam Alexson was surfing the web when an alert popped up. "I was so afraid. I was absolutely beside myself." A recall of the defibrillator she depends on to keep her heart beating. "It said this young boy, 21 years old from California, had died." She scheduled surgery to have hers replaced. "We're dealing with human beings. We're not dealing with animals. We're not dealing with inanimate objects." "The top officials in the devices center decided sometime within the last two or three years that they were going to stop doing inspections."
A group of nine FDA scientists sent a series of letters to federal lawmakers. They accuse FDA leaders of intimidation and discouraging others from raising safety concerns about devices going to market. They wrote the review process has been "corrupted and distorted by current FDA managers, thereby placing the american public at risk." "They see these devices going on the market that aren't adequately tested. Their supervisors are saying to them, no we should not take action."
Doctor Ned Feder is a scientist with the project on government oversight. He says the letter proves fear is fueling the approval of some medical devices. "They know very directly what the consequences are when these devices fail." In April another letter went out from FDA scientists to the administration. They write about a breast cancer detection device approved despite FDA experts' recommendations against it, a knee implant device approved without proper screening and an anti-scarring device approved even though a similar device was pulled from the market for safety concerns.
"They've got to get on the market as fast as possible, and while it's on the market they have to put the hard sell as much as possible. If it turns out it's for some use the product doesn't even work, well, that doesn't make any difference. A dollar is a dollar."
The government accountability office reported the FDA approved 228 medical devices without full complete evaluation of their safety and effectiveness from 2003 to 2007. "I had a 24-year career with the FDA. I started as a field investigator." Tim Wells knows the FDA inspection process inside and out. "They've always been short of resources the whole 24 years I was there. We were always behind but trying to keep up."
What makes it different now? Over the past 12 years nearly 60 new laws have hit the books that need the FDA's oversight … and funding hasn't kept up with the demand. "I think public health is way too important to be cutting back resources." "The reality is the agency is going to need large increases for a number of years to catch up with the work that they need to do."
FDA supporters argue scarce resources make it impossible for the agency to keep up with the exploding foreign device market. Of the nearly 700 manufacturing plants in China, the FDA inspected only 13 in 2007. "It's not like we're buying t-shirts made in China. What can happen? You throw it away, big deal, but we're talking about life-sustaining products here."
Pam depends on one of those products to keep her heart beating. "There are no do-overs. You go into fatal arrhythmia. If you don't have the device, you're gonna die." She just wants to be assured her heart is in good hands.
In a recent follow-up letter, FDA scientists pleaded with President Obama to revisit the approval of medical devices that involved questionable judgment. An FDA-wide email in March promised the new FDA commissioner will revitalize the agency and work hard to support scientific integrity.
BACKGROUND: In several strongly worded letters, a group of nine FDA scientists complained of widespread managerial misconduct in the medical device division of the Food and Drug Administration. "The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA have been corrupted and distorted by current FDA managers, thereby placing the American people at risk," the scientists wrote. The scientists go on to say that agency managers used intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
A recent report from the Government Accountability Office indicated that FDA regulators should ensure that high-risk medical devices undergo a tougher review process before entering the market. The report found FDA for years "has failed…to subject some of the riskiest devices to rigorous review mandated by Congress." According to a New York Times article, the FDA continues to use a review and approval process established in 1976 for high-risk, Class III medical devices and that the process does not ensure the safety and effectiveness of the products.
"It may be happening right now that unsafe devices are going to the clinical testing process and problems are being picked up during the clinical testing or during the manufacturing that could have been picked up and should have been picked up at an earlier stage," Ned Feder, M.D., a scientist with the Project On Government Oversight, told Ivanhoe.
PROBLEMS ABROAD: According to a New York Times article, the FDA is so understaffed that at its current pace the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States. According to FDA data, more than 23,6000 establishments that manufacture medical devices were registered as of September 2007. More than half are located in the United States As of September 2007, there were more registered establishments in China and Germany reporting that they manufacture class II or III medical devices than in any other foreign countries.
"China now has FDA offices they just built up last year," former FDA inspector Tim Wells told Ivanhoe. "I think we need a constant vigilance, a constant show of force. It's not like we're buying t-shirts made in China … We're talking about maybe life-sustaining products here. I think that there is a reason we should worry about products that are made in a part of the world that maybe doesn't have the same safety standards that we have."
FOR MORE INFORMATION, PLEASE CONTACT:
Project on Government Oversight
(202) 347-1122
http://www.pogo.org
