In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a 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 has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."
Whenever I hear the claim made that the Bush administration has "protected" Americans ever since 9-11 it makes me gag. Just because nobody has flown anymore planes into anymore buildings does not mean we have been safe.
The truth is that the Bush administration has traded away public safety in the name of higher profits for the private sector. It is no secret that the political coffers of Republican politicians (as well as Democrats) are bulging with contributions from drug companies as well as medical insurance companies. This has resulted in our government giving a virtual free pass to the drug manufacturers and allowing more and more dangerous drugs to flood the market.
NOBODY has been protecting the American people from dangerous drugs and over prescribed medications. One of the worst things we have seen recently is the direct-to-consumer advertising that drug manufacturers have engaged in for the last ten years, and which has seen a dramatic increase since the Bush administration took power.
These commercials convince consumers to pressure their doctors to prescribe drugs that are unnecessary or that have not been adequately tested despite approval by a "broken" FDA.
The fact is that Americans are asking for, and taking drugs, that are causing them far more harm then good. Consumers are diagnosing themselves while sitting in front of their televisions and demanding drugs that will only poison their system and ultimately make them even sicker.
Doctors are trading away their Hippocratic oath in favor of lunches with pretty female drug representatives and the chance to attend conventions in tropical locations. Ethics and morals have no chance against golf trips in Hawaii and whiny patients demanding that drug on television that makes the people in the commercial so happy.
We need a return of responsible grownups in this country and I certainly hope the incoming Obama administration will help to usher that in.
Very good...I agree..we also need an investigation into how someone like Sherry Johnston could get the amount of pain meds that she was getting. And I am not just saying her. But according to her story she is on a pain pump...plus she is getting pain pills, that she was selling, therefore that tells me she was over medicated. Someone needs to be checking on her doctor. If she was on a pump she should only be getting a few pills in order to cover what they call break through pain....maybe at the most 5 to 7 pills a week...but she was evidently getting way more than that. I get 2 a day and I am not on a pump...that's all I get..it's also all I want. So something is wrong with that picture...see what I mean.
ReplyDeleteBingo!
ReplyDeleteAnd I hope so as well.
I don't recall any other president elect being talked to by government people prior to being in the White House. Maybe they did and we just didn't hear about it but it seems like a clear indication of how desperate good, professional people are to be allowed to do their jobs.
ReplyDeleteChief among these direct-to-consumer commercials that convince consumers to pressure their doctors....?
ReplyDeleteYeah. Viagra and Cialis.
I cannot stand the ads for those two products ANY MORE, and the ads for Enzyte and Sinrex are just as nausea-inducing.