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.
Monday, May 5, 2008
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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