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..
Tuesday, July 29, 2008
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.
Monday, May 5, 2008
Food and Drug-The VIOXX STORY
MORE FACTS BEHIND THE NEWS
One of the largest and most well known failures of the Food and Drug is the Vioxx .case. An April 8, 2008 article in USA TODAY reports that FDA researcher David Graham, a lead scientist on a Vioxx study linked Vioxx to 27,000 “heart sudden cardiac deaths nationwide from the time Vioxx came on the market in 1999 through 2003”.
Vioxx was one of several medicines developed to be safer than traditional anti-inflationary drugs that sometimes cause gastrointestinal hemorrhages and can result in death. However a study completed in 1999 shortly after FDA approval showed better GI safety than naproxen but ”an alarming increase in cardiovascular problems”.
For the next five years Merck manufacturer of Vioxx continued to minimize unfavorable findings. Finally, upon completion of David Graham’s database analysis of 1,400,000 patients that showed a substantially higher risk of heart problems with Vioxx, the Merck Co. then removed Vioxx from the market.
One of the largest and most well known failures of the Food and Drug is the Vioxx .case. An April 8, 2008 article in USA TODAY reports that FDA researcher David Graham, a lead scientist on a Vioxx study linked Vioxx to 27,000 “heart sudden cardiac deaths nationwide from the time Vioxx came on the market in 1999 through 2003”.
Vioxx was one of several medicines developed to be safer than traditional anti-inflationary drugs that sometimes cause gastrointestinal hemorrhages and can result in death. However a study completed in 1999 shortly after FDA approval showed better GI safety than naproxen but ”an alarming increase in cardiovascular problems”.
For the next five years Merck manufacturer of Vioxx continued to minimize unfavorable findings. Finally, upon completion of David Graham’s database analysis of 1,400,000 patients that showed a substantially higher risk of heart problems with Vioxx, the Merck Co. then removed Vioxx from the market.
The Ortha Evra Tragedy A
Why is the FDA failing To protect the public’s health?
GET THE FACTS BEHIND THE NEWS
The Ortho Evra case is the latest in a series of failures to protect he public against the serious health hazards of powerful medicines. This situation has caused experts and others to question the Food and Drug’s commitment, and the present Federal Administration’ s commitment to protect and preserve the nation’s health.
It was six years after the companies’ own researchers found that the Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, even before Ortho had been approved by the FDA, At last six years later the public was notified.. In the six-year interval, the larger amount of estrogen increased the risk of blood clot’s and strokes. The Food and Drug Agency received reports of at least 50 deaths associated with the drug according to an article in the April 6. 2008
New York Times.
In addition it appears that the Ortho people deliberately camouflaged the increased estrogen by reducing the actual figures by 40% .This correction was mentioned only once in a 435 page report to the FDA and then in a complex mathematical formula according to an April 14, 2008 New York Times article..
3,000 Women and their families have sued Johnson and Johnson claiming that ORTHO EVRA patches caused heart attacks, strokes, and in some cases death.
How could this happen? Why didn’t the FDA no catch this error and do something about It.?
In Blog 2,3,4 and 5 we discuss several other hazardous mistakes. by the FDA. In Blog 6 we have a brief look at the FDA and its support from the Federal gov’t. Blog 7 explains how the Johnson & Johnson Co, makers or Ortho, are trying to avoid any legal and financial responsibility for the deaths and illnesses caused by the larger estrogen dosage.
GET THE FACTS BEHIND THE NEWS
The Ortho Evra case is the latest in a series of failures to protect he public against the serious health hazards of powerful medicines. This situation has caused experts and others to question the Food and Drug’s commitment, and the present Federal Administration’ s commitment to protect and preserve the nation’s health.
It was six years after the companies’ own researchers found that the Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, even before Ortho had been approved by the FDA, At last six years later the public was notified.. In the six-year interval, the larger amount of estrogen increased the risk of blood clot’s and strokes. The Food and Drug Agency received reports of at least 50 deaths associated with the drug according to an article in the April 6. 2008
New York Times.
In addition it appears that the Ortho people deliberately camouflaged the increased estrogen by reducing the actual figures by 40% .This correction was mentioned only once in a 435 page report to the FDA and then in a complex mathematical formula according to an April 14, 2008 New York Times article..
3,000 Women and their families have sued Johnson and Johnson claiming that ORTHO EVRA patches caused heart attacks, strokes, and in some cases death.
How could this happen? Why didn’t the FDA no catch this error and do something about It.?
In Blog 2,3,4 and 5 we discuss several other hazardous mistakes. by the FDA. In Blog 6 we have a brief look at the FDA and its support from the Federal gov’t. Blog 7 explains how the Johnson & Johnson Co, makers or Ortho, are trying to avoid any legal and financial responsibility for the deaths and illnesses caused by the larger estrogen dosage.
GET THE FACTS BEHIND THE NEWS
Title VII of the Civil Rights Act of 1964 prohibits employment discrimination based on race, color, religion, sex and national origin. The Equal Pay Act of 1963 protects men and women who perform substantially equal work in the same establishment from sex based wage discrimination.
Lilly Ledbetter worked for 19 years at the Goodyear Tire and Rubber Co. plant in Gadsen, AL. She received an anonymous tip that she was making $6,500 less than the lowest paid man who had her job... Lilly sued. This looked like an open and shut case. (see above)
However the law said she had to file her discrimination complaint wthin 180 days of the alleged unlawful discrimination. Since the 1990’s nine federal circuit courts and the Equal Employment Opportunity Commission had ruled that the 180s started every time the employee received an unequal paycheck.
The Supreme Court ruled that the 180 days began with Lilly’s first discriminatory payment about 20 years earlier. This is very unfair. Wages are a subject that is usually not discussed particularly when there is discrimination between employees, Secondly the Supreme Court’s interpretation means that if an employer discriminates for six months without getting caught they are exempt from future discrimination lawsuits for that individual. Supreme Court Justice Ginsberg in her dissent asked Congress for new legislation to clarify and restore the original intent of the 1964 Act.
Senator Edward Kennedy(D) of Massachusetts prepared “The Fair Pay Act”. The Act reinstated the 180 days would begin whenever a discriminatory paycheck was made. The bill passed the House of Representatives. President Bush THREATENED TO VETO the bill. Without republican support there was not enough support in the Senate to override a veto SO THE VOTE FAILED.
President Bush said the bill would cause a flood of lawsuits. Legislation should pass or fail on the merits of its content and NOT ON THE NUMBER OF LAWSUITS SMALL OR LARGE THAT IT GENERATES. Actually it would not have caused a flood of lawsuits because the law never had.
This is another instance where President Bush used a lame excuse to show his lack of concern to protect the public, and favor corporate interests over American workers.
Title VII of the Civil Rights Act of 1964 prohibits employment discrimination based on race, color, religion, sex and national origin. The Equal Pay Act of 1963 protects men and women who perform substantially equal work in the same establishment from sex based wage discrimination.
Lilly Ledbetter worked for 19 years at the Goodyear Tire and Rubber Co. plant in Gadsen, AL. She received an anonymous tip that she was making $6,500 less than the lowest paid man who had her job... Lilly sued. This looked like an open and shut case. (see above)
However the law said she had to file her discrimination complaint wthin 180 days of the alleged unlawful discrimination. Since the 1990’s nine federal circuit courts and the Equal Employment Opportunity Commission had ruled that the 180s started every time the employee received an unequal paycheck.
The Supreme Court ruled that the 180 days began with Lilly’s first discriminatory payment about 20 years earlier. This is very unfair. Wages are a subject that is usually not discussed particularly when there is discrimination between employees, Secondly the Supreme Court’s interpretation means that if an employer discriminates for six months without getting caught they are exempt from future discrimination lawsuits for that individual. Supreme Court Justice Ginsberg in her dissent asked Congress for new legislation to clarify and restore the original intent of the 1964 Act.
Senator Edward Kennedy(D) of Massachusetts prepared “The Fair Pay Act”. The Act reinstated the 180 days would begin whenever a discriminatory paycheck was made. The bill passed the House of Representatives. President Bush THREATENED TO VETO the bill. Without republican support there was not enough support in the Senate to override a veto SO THE VOTE FAILED.
President Bush said the bill would cause a flood of lawsuits. Legislation should pass or fail on the merits of its content and NOT ON THE NUMBER OF LAWSUITS SMALL OR LARGE THAT IT GENERATES. Actually it would not have caused a flood of lawsuits because the law never had.
This is another instance where President Bush used a lame excuse to show his lack of concern to protect the public, and favor corporate interests over American workers.
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