Corruption at FDA Highlights Need for a Strong Civil Justice System

Christopher Nace
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Posted by Christopher NaceJanuary 09, 2009 10:16 AM

The AP has reported that nine FDA scientists have written a letter to the Obama Transition Team that FDA decisions are not always based on facts:

"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.

According to the AP,

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."

This is particularly troubling given recent Supreme Court Opinions and Bush Administration efforts to "preempt" state tort laws under the guise that the FDA and other federal agencies regulate industries such as the medical device industry.

The FDA scientists' letter calls out for a strong civil justice system. If consumers cannot rely upon the federal government to protect them from dangerous products, then the civil justice system remains the only check on corporate greed.

Consumers need to rely either on the government or the civil justice system to assure that only safe products are marketed. According to at least nine FDA scientists, we certainly can't rely on the FDA.

2 Comments

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Mary Smith
Posted by Mary Smith
January 09, 2009 2:22 PM

I agree that scientific research can and routinely is slanted. I worked as an Investigations Scientist for a medical devices manufacturer, and became aware of the investigative process. Now I want to get someone's attention to evaluate my root cause for Toxic Shock Syndrome, which is a medical mystery to this day, twenty some years after the outbreak and deaths. Everyone was to content to pull the suspected main culprit from the market instead of finding the cause. Why? And why won't they continue the investigation?

Debbie
Posted by Debbie
January 10, 2009 12:54 AM

This is typical of our government in general and the complicity with criminal corporations, be they banks or food manufacturers or whatever. If this is revealed in the Device and Radiological section, then it stands to reason it extends into other departments.

I am ill, probably for life, from the Peter Pan Peanut Butter debacle and resulting severe and chronic Reiter's syndrome. It has been revealed that the FDA was in the ConAgra factory in October 2004 due to rat poop, hairs and plastic found in the product. They left instructions with the factory and planned to return for a follow up. They never did. The first tainted peanut butter was distributed right after that. Later in August of 2006, it was revealed to the FDA and ConAgra that Salmonella was present in the product from that factory. The public was not informed until mid-February 2007 and by then, people had died. By then, I had consumed at least 3 bad jars and had been ill since Early 2005 after buying my first bad jar. When I found out in February, I was so sick and exhausted from the chronic illness that I wanted to die. Over a period of about 2 years, I continued to eat peanut butter because it was easy and I would be too sick to cook or care what I ate. It was presumed to be harmless and healthy. Four years of hell and the lawsuit is still in process after hiring the firm 2 years ago. And after the horrific conditions and bacteria were confirmed and stipulated to by all parties; including ConAgra. They found leaking rusty sprinkler systems, bird nests, leaking roof, birds, rat poop, piles of moldy peanuts sitting in puddles of water and the sprinklers had gone off at least twice in that food production area. THAT, is arguably the conditions of more factories that produce your food than we would all like to consider. And the agencies our taxes support to protect us neglect their jobs or participate in corrupt practices while our lives are decimated and people like me lose everything in the process. Home, car, credit, business, health and hope for the future all gone while Peter Pan is back on the shelves and the powers that be argue about restitution. I have no medical insurance and no medical care for life-threatening and life-disrupting illness(es). Too many clients on a mass lawsuit and long distance representation insures people like me don't even get good assistance and representation.

The FDA just gave out $ 700 bonuses to boost morale...how nice for them.

Now, there are 400 more people sick from Salmonella which is presumed to be caused by King Nut Peanut Butter. Here we go again....

No accountability for the agencies we employ and the punishment/restitution is not large enough or swift enough to deter continued abuses.

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