-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
Showing posts with label FDA The Real Story. Show all posts
Showing posts with label FDA The Real Story. Show all posts
Wednesday, November 26, 2008
Saturday, November 15, 2008
The Real Ortho Eva Story
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 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 Co, makers of Ortho, are trying to avoid any legal and financial responsibility for the deaths and illnesses caused by the larger estrogen dosage.
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 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 Co, makers of Ortho, are trying to avoid any legal and financial responsibility for the deaths and illnesses caused by the larger estrogen dosage.
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, 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.
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