Bush Administration Policy Why is Food and Drug FAILING Blog 8 of 8
to protect the public’s health
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. .Why is the Food and Drug so inept?
Most Bush appointments come from the industry that is being regulated or inspected. Critics question the objectivity of these people. This source of appointments may well set up a conflict of interest for the appointee.
Bush administration thinking is that government oversight is bad. In many areas that effect the public the Bush policy is to let the industry police and/ or inspect itself. Those areas that have government regulation are so under funded and under manned that they can not accomplish their mission. The personnel that is in charge is a believer in this approach. In the case of consumer protection of toys the person in charge tried to reject additional funds and personnel to help the agency’s do its supposed job.
Tuesday, July 29, 2008
Conflictsof interest, Why FDA failing
INDUSTRY APPOINTMENTS-CONFLICT OF INTEREST?
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. .Why is the Food and Drug Admi so inept?
Fourth, most Bush appointments come from the industry that is being regulated or inspected. Critics question the objectivity of these people. This source of appointments may well set up a conflict of interest for the appointee.
Lastly the companies that have had troubled products are trying to avoid legal and financial responsibility. They claim that because the FDA approved their product they are protected against any claims. Formerly the courts did not favor this approach. However recently the Supreme Court gave this protection to some medical devices. A case is coming up soon before the Supreme Court that may determine if FDA approval will shield drug products as well. Considering the present condition of Food & Drug this seems like a very dubious proposition.
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. .Why is the Food and Drug Admi so inept?
Fourth, most Bush appointments come from the industry that is being regulated or inspected. Critics question the objectivity of these people. This source of appointments may well set up a conflict of interest for the appointee.
Lastly the companies that have had troubled products are trying to avoid legal and financial responsibility. They claim that because the FDA approved their product they are protected against any claims. Formerly the courts did not favor this approach. However recently the Supreme Court gave this protection to some medical devices. A case is coming up soon before the Supreme Court that may determine if FDA approval will shield drug products as well. Considering the present condition of Food & Drug this seems like a very dubious proposition.
Lack of plant inspection-FDA fails
A LARGE FOOD AND DRUG PROBLEM
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. .Why is the Food and Drug so inept?
Another reason the FDA is failing is a lack of timely plant inspections. Most domestic firms are inspected every two years according to Rep. John Shimkus® Illinois. As more ingredients come from outside the US the picture is very different. There are 3,200 foreign drug sources according to gov’t auditors. Last year the FDA inspected 30 of these drug sources, less than 1%. At this rate it would take 100 years to inspect the whole 3200. Most of these sources have never been inspected. This fiscal year the FDA plans to inspect 50 foreign sources. At this rate of inspection it would take 60 years to inspect the whole list. This fiscal year about $10 mil has been allocated for foreign inspections.
Rep John L. Barton® Texas said ballpark estimates from Republican aides are that the FDA needs 500 more inspectors. The Cov’t Accountability Office said the cost of such by- yearly inspections would be about $70 mil annually. Whatever the actual cost or number of inspectors, we see an agency grossly undermanned and under funded.
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. .Why is the Food and Drug so inept?
Another reason the FDA is failing is a lack of timely plant inspections. Most domestic firms are inspected every two years according to Rep. John Shimkus® Illinois. As more ingredients come from outside the US the picture is very different. There are 3,200 foreign drug sources according to gov’t auditors. Last year the FDA inspected 30 of these drug sources, less than 1%. At this rate it would take 100 years to inspect the whole 3200. Most of these sources have never been inspected. This fiscal year the FDA plans to inspect 50 foreign sources. At this rate of inspection it would take 60 years to inspect the whole list. This fiscal year about $10 mil has been allocated for foreign inspections.
Rep John L. Barton® Texas said ballpark estimates from Republican aides are that the FDA needs 500 more inspectors. The Cov’t Accountability Office said the cost of such by- yearly inspections would be about $70 mil annually. Whatever the actual cost or number of inspectors, we see an agency grossly undermanned and under funded.
Foreign plant inspection lag, FDA fails
MORE REASONS FOR PROBLEMS-FACTS
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. Why is the Food and Drug Admi so inept?
Another reason the FDA is failing is a lack of timely plant inspections. Most domestic firms are inspected every two years according to Rep. John Shimkus® Illinois. As more ingredients come from outside the US the picture is very different. There are 3,200 foreign drug sources according to gov’t auditors. Last year the FDA inspected 30 of these drug sources,less than 1%. At this rate it would take 100 years to inspect the whole 3200. Most of these sources have never been inspected. This fiscal year the FDA plans to inspect 50 foreign sources. At this rate of inspection it would take 60 years to inspect the whole list. This fiscal year about $10 mil has been allocated for foreign inspections.
Rep John L. Barton (R) Texas said ballpark estimates from Republican aides are that the FDA needs 500 more inspectors. The Cov’t Accountability Office said the cost of such by- yearly inspections would be about $70 mil annually. Whatever the actual cost or number of inspectors, we see an agency grossly undermanned and under funded.
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Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. Why is the Food and Drug Admi so inept?
Another reason the FDA is failing is a lack of timely plant inspections. Most domestic firms are inspected every two years according to Rep. John Shimkus® Illinois. As more ingredients come from outside the US the picture is very different. There are 3,200 foreign drug sources according to gov’t auditors. Last year the FDA inspected 30 of these drug sources,less than 1%. At this rate it would take 100 years to inspect the whole 3200. Most of these sources have never been inspected. This fiscal year the FDA plans to inspect 50 foreign sources. At this rate of inspection it would take 60 years to inspect the whole list. This fiscal year about $10 mil has been allocated for foreign inspections.
Rep John L. Barton (R) Texas said ballpark estimates from Republican aides are that the FDA needs 500 more inspectors. The Cov’t Accountability Office said the cost of such by- yearly inspections would be about $70 mil annually. Whatever the actual cost or number of inspectors, we see an agency grossly undermanned and under funded.
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Why is Food and Drug FAILING 6
WHy THESE PROBLENS?---FACTS BEHIND THE NEWS
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. Why is the Food and Drug Admi so inept?
There are several reasons. One is how the FDA operates. The FDA structural system is deeply flawed. The FRA does not have its own laboratories. The FDA DEPENDS ON THE MANUFACTURERS TO NOTIFY IT WHEN THERE ARE QUESTIONS OR POSSIBLE TROUBLES WITH MEDICINES.
This is a common method used by the Bush Adm. Their thought is to minimize the role of gov’t. The idea is to let the industry police itself. This method of oversight creates an OBVIOUS CONFLICT OF INTEREST. After a company has usually invested several million dollars and perhaps several years of time it is very difficult for the management to admit to large health problems.
Generally a company will publicize the good results and minimize the questionable or trouble parts. In some cases if appears that the company has deliberately hidden results that they feel may cause trouble to patients and alert gov’t regulators. See next blog..
Mistakes or omissions by the FDA have caused serious physical and mental problems to the public and have even been fatal in many cases. Why is the Food and Drug Admi so inept?
There are several reasons. One is how the FDA operates. The FDA structural system is deeply flawed. The FRA does not have its own laboratories. The FDA DEPENDS ON THE MANUFACTURERS TO NOTIFY IT WHEN THERE ARE QUESTIONS OR POSSIBLE TROUBLES WITH MEDICINES.
This is a common method used by the Bush Adm. Their thought is to minimize the role of gov’t. The idea is to let the industry police itself. This method of oversight creates an OBVIOUS CONFLICT OF INTEREST. After a company has usually invested several million dollars and perhaps several years of time it is very difficult for the management to admit to large health problems.
Generally a company will publicize the good results and minimize the questionable or trouble parts. In some cases if appears that the company has deliberately hidden results that they feel may cause trouble to patients and alert gov’t regulators. See next blog..
FDATrouble with more DRUGS
STILL MORE FACTS BEHIND THE NEWS
The list of troubled medicines goes on. After 19 sudden deaths and 26 reports of other problems such as strokes and fast heart rates The American Heart Association has recommended that children given Ritulin, Adderal and Concertin for attention deficit disorder be screened. The Heart Association now recommends a through exam with an electrocardiogram and family history. About2.5 million children and 1.5 million adults take medication for attention deficit hyperactivity disorder.
On Friday, April 25,”In fury and despair people harmed by Lasik eye surgery told federal advisors of severe eye pain and blurred vision. The advisors recommended that the gov’t worn more clearly about the risks of the hugely popular operation”. About 700,000 Americans yearly undergo this operation. Most people do benefit according to the Chicago Tribune article. However about 25% are not good candidates. One percent report serious difficulties. The FDA is promising a major study to better understand who has had bad outcomes.
What are the reasons FDA is failing us? SEE Blog 6
The list of troubled medicines goes on. After 19 sudden deaths and 26 reports of other problems such as strokes and fast heart rates The American Heart Association has recommended that children given Ritulin, Adderal and Concertin for attention deficit disorder be screened. The Heart Association now recommends a through exam with an electrocardiogram and family history. About2.5 million children and 1.5 million adults take medication for attention deficit hyperactivity disorder.
On Friday, April 25,”In fury and despair people harmed by Lasik eye surgery told federal advisors of severe eye pain and blurred vision. The advisors recommended that the gov’t worn more clearly about the risks of the hugely popular operation”. About 700,000 Americans yearly undergo this operation. Most people do benefit according to the Chicago Tribune article. However about 25% are not good candidates. One percent report serious difficulties. The FDA is promising a major study to better understand who has had bad outcomes.
What are the reasons FDA is failing us? SEE Blog 6
Monday, July 28, 2008
MORE VIOXX AND THE FDA
VIOXX AND OTHERS--MORE FACTS BEHIND THE NEWS
Dr. Eric Topal, chief of cardiovascular medicine at the Cleveland Clinic, in a column posted the week of April 8th on the New England Journal of Medicine’s web site called for a congressional review of the “catastrophic” events”. “The senior executives at Merck and the leadership of the FDA share responsibility for not having taken action and not recognizing they are accountable for the public health.” Dr. Topal has also stated, “The FDA didn’t do anything. They were passive here.” Remember Dr. Graham linked Vioxx to 27,000 deaths.
There are other interesting aspects of the Vioxx case. Dr.David Graham the. Lead scientist mentioned in Blog 2, told the Senate Finance Committee investigators that the FDA tried to BLOCK publication of his findings, according to Senator Grassly chair of the Senate Finance Committee. “Dr. Graham described an environment where he was ‘ostracized’, ‘subject to veiled threats’ and”intimidation’. Dr Graham showed Senator Grasslay e-mails that appear to support Dr. Graham contention that his superiors suggested watering down the conclusions.
It APEARS THAT THE SUPERIORS AT THE FDA WERE MORE INTERESTING IN PROTECTING THE MERCK CO THAN INPROTECTING THE PUBLIC.
More on Merck and other troubled drugs in Blog 5
Dr. Eric Topal, chief of cardiovascular medicine at the Cleveland Clinic, in a column posted the week of April 8th on the New England Journal of Medicine’s web site called for a congressional review of the “catastrophic” events”. “The senior executives at Merck and the leadership of the FDA share responsibility for not having taken action and not recognizing they are accountable for the public health.” Dr. Topal has also stated, “The FDA didn’t do anything. They were passive here.” Remember Dr. Graham linked Vioxx to 27,000 deaths.
There are other interesting aspects of the Vioxx case. Dr.David Graham the. Lead scientist mentioned in Blog 2, told the Senate Finance Committee investigators that the FDA tried to BLOCK publication of his findings, according to Senator Grassly chair of the Senate Finance Committee. “Dr. Graham described an environment where he was ‘ostracized’, ‘subject to veiled threats’ and”intimidation’. Dr Graham showed Senator Grasslay e-mails that appear to support Dr. Graham contention that his superiors suggested watering down the conclusions.
It APEARS THAT THE SUPERIORS AT THE FDA WERE MORE INTERESTING IN PROTECTING THE MERCK CO THAN INPROTECTING THE PUBLIC.
More on Merck and other troubled drugs in Blog 5
Monday, July 21, 2008
ADVICE TO THE NATION
Rep. Deborah Price-
ADVICE TO THE NATION
The purpose of our blog
Rep. Deborah Price, a republican from Ohio, was elected to the US House of Representatives four times. She is not running in 08. She said she has family obligations and finds it not as interesting as a member of the minority.
Her comments on politics were very interesting. She has little hope of a shift in campaign tactics unless there is a public backlash. The last campaign convinced her that negative ads work.
“I don’t think anything will change until Americans revolt and get it into their heads they need to be informed voters instead of just listening to the paid political ads.”
We hope our blog will help you to be a more informed voter BY GIVING YOU SOME OF THE FACT BEHIND THE NEWS.
ADVICE TO THE NATION
The purpose of our blog
Rep. Deborah Price, a republican from Ohio, was elected to the US House of Representatives four times. She is not running in 08. She said she has family obligations and finds it not as interesting as a member of the minority.
Her comments on politics were very interesting. She has little hope of a shift in campaign tactics unless there is a public backlash. The last campaign convinced her that negative ads work.
“I don’t think anything will change until Americans revolt and get it into their heads they need to be informed voters instead of just listening to the paid political ads.”
We hope our blog will help you to be a more informed voter BY GIVING YOU SOME OF THE FACT BEHIND THE NEWS.
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