 | « on: August 20, 2009, 11:04:01 PM » |  Quote |
UPDATE 2-U.S. health officials back safety of Merck vaccine
http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUSN2052127820090820
Thu Aug 20, 2009 3:11pm EDT
WASHINGTON, Aug 20 (Reuters) - U.S. health officials again backed on Thursday the safety of Merck & Co Inc's (MRK.N) vaccine to prevent infection by a virus that causes most cases of cervical cancer.
The Gardasil vaccine "continues to be safe and effective, and its benefits continue to outweigh its risks," the Food and Drug Administration and the Centers for Disease Control and Prevention said in a statement.
Gardasil protects against infection with four strains of the human papillomavirus (HPV), a common sexually transmitted virus that causes genital warts and most cases of cervical cancer.
Merck distributed more than 23 million doses of Gardasil in the United States since its approval in June 2006 through the end of 2008, the FDA and CDC said. It is one of Merck's top-selling products but sales have been hurt by competition from a rival vaccine from GlaxoSmithKline PLC (GSK.L). Second-quarter Gardasil sales were $268 million.
On Tuesday, CDC and FDA researchers wrote in the Journal of the American Medical Association that problems such as fainting and nausea remained rare among females who received Gardasil and the vaccine did not appear to be causing unusual side effects.
The researchers said 32 deaths were listed in a government database that collects reports of health problems seen in people after vaccination.
The reports show only that a patient became ill or died after receiving a vaccine, not that a vaccine was the cause.
The FDA and CDC statement said "concerns have been raised about" the reports of deaths of people who received Gardasil.
"There was not a common pattern to the deaths that would suggest they were caused by the vaccine," the agencies said.
Also, "there is no evidence that Gardasil has increased the rate of" Guillain-Barre Syndrome, a rare neurological disorder that causes muscle weakness, the agencies said.
Cervical cancer kills 3,870 women a year in the United States and 280,000 globally.
Merck shares fell less than 1 percent to $31.20 in afternoon trading on the New York Stock Exchange.
The FDA and CDC statement was posted on the FDA website here. (Reporting by Lisa Richwine, Editing by Gerald E. McCormick and Gunna Dickson)
"In addition to the four cases of death from blood clots, there was also one reported
death due to myocarditis, which is an inflammation of the heart, as well as one death
from arrhythmia and one death from meningitis. Both the arrhythmia and meningitis
cases occurred months after the patients received the Gardasil vaccine; the myocarditis
death occurred six days after vaccination but was a pre-existing condition. Even
excluding these deaths though, there are still fourteen cases that occurred within three
weeks of receiving the vaccine. One was from anaphylactic shock:
occurred within three weeks of receiving Gardasil, and six occurred within three days.
Below are additional excerpts from deaths with no apparent cause reported to VAERS:
* * *
* * *
* * *
Perhaps all these deaths are simply coincidence, but given the unknowns about Gardasil
and its overall safety, it is far too important an issue to simply ignore."
From the Judicial watch investigation on HPV vax
(never mind, i can't edit)
from the stupid article:
"The reports show only that a patient became ill or died after receiving a vaccine, not that a vaccine was the cause."
That's like someone who just shot you in the head saying that you didn't die from the bullet or the gun, you just died from "blood loss".
Here's an old WP article from back when they first started giving the vaccine out
"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said FDA Acting Commissioner Andrew von Eschenbach.
He predicted that the vaccine -- the first ever designed specifically to prevent a cancer -- will have a "dramatic effect" on the health of women worldwide."
(Oh, Mr. Eschenbach, you don't know how right you are.)
http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUSN2052127820090820
Thu Aug 20, 2009 3:11pm EDT
WASHINGTON, Aug 20 (Reuters) - U.S. health officials again backed on Thursday the safety of Merck & Co Inc's (MRK.N) vaccine to prevent infection by a virus that causes most cases of cervical cancer.
The Gardasil vaccine "continues to be safe and effective, and its benefits continue to outweigh its risks," the Food and Drug Administration and the Centers for Disease Control and Prevention said in a statement.
Gardasil protects against infection with four strains of the human papillomavirus (HPV), a common sexually transmitted virus that causes genital warts and most cases of cervical cancer.
Merck distributed more than 23 million doses of Gardasil in the United States since its approval in June 2006 through the end of 2008, the FDA and CDC said. It is one of Merck's top-selling products but sales have been hurt by competition from a rival vaccine from GlaxoSmithKline PLC (GSK.L). Second-quarter Gardasil sales were $268 million.
On Tuesday, CDC and FDA researchers wrote in the Journal of the American Medical Association that problems such as fainting and nausea remained rare among females who received Gardasil and the vaccine did not appear to be causing unusual side effects.
The researchers said 32 deaths were listed in a government database that collects reports of health problems seen in people after vaccination.
The reports show only that a patient became ill or died after receiving a vaccine, not that a vaccine was the cause.
The FDA and CDC statement said "concerns have been raised about" the reports of deaths of people who received Gardasil.
"There was not a common pattern to the deaths that would suggest they were caused by the vaccine," the agencies said.
Also, "there is no evidence that Gardasil has increased the rate of" Guillain-Barre Syndrome, a rare neurological disorder that causes muscle weakness, the agencies said.
Cervical cancer kills 3,870 women a year in the United States and 280,000 globally.
Merck shares fell less than 1 percent to $31.20 in afternoon trading on the New York Stock Exchange.
The FDA and CDC statement was posted on the FDA website here. (Reporting by Lisa Richwine, Editing by Gerald E. McCormick and Gunna Dickson)
"In addition to the four cases of death from blood clots, there was also one reported
death due to myocarditis, which is an inflammation of the heart, as well as one death
from arrhythmia and one death from meningitis. Both the arrhythmia and meningitis
cases occurred months after the patients received the Gardasil vaccine; the myocarditis
death occurred six days after vaccination but was a pre-existing condition. Even
excluding these deaths though, there are still fourteen cases that occurred within three
weeks of receiving the vaccine. One was from anaphylactic shock:
An 11-year-old female was vaccinated “within the
past month” in approximately May 2007 with a first
dose of Gardasil. Subsequently, 3 days after
vaccination the patient presented to an ER . . . the
physician from the hospital said that “the death was
due to an anaphylactic reaction to Gardasil.”
VAERS ID: 280163-1 (D)
The remaining deaths reported to VAERS all have unknown causes; however, all but onepast month” in approximately May 2007 with a first
dose of Gardasil. Subsequently, 3 days after
vaccination the patient presented to an ER . . . the
physician from the hospital said that “the death was
due to an anaphylactic reaction to Gardasil.”
VAERS ID: 280163-1 (D)
occurred within three weeks of receiving Gardasil, and six occurred within three days.
Below are additional excerpts from deaths with no apparent cause reported to VAERS:
A 18-year-old female patient was vaccinated with the first
dose of Gardasil . . . In the evening of the same day she was
found unconscious (or liveless) [sic] by the mother.
Resuscitation was performed by the emergency doctor but
was unsuccessful, i.e. the patient finally died . . . The cause
of death of this patient remains totally unclear.
VAERS ID: 300741-1 (D).
* * *dose of Gardasil . . . In the evening of the same day she was
found unconscious (or liveless) [sic] by the mother.
Resuscitation was performed by the emergency doctor but
was unsuccessful, i.e. the patient finally died . . . The cause
of death of this patient remains totally unclear.
VAERS ID: 300741-1 (D).
A 19-year-old female with no previous medical history
reported, who on 19-Sep-2007 was vaccinated with the 1st
dose of Gardasil . . . On the morning of 12-Oct-2007, the
patient was found dead in her bed . . . Contraception was
stopped 3 months before vaccination. No reason for the
death was detected in autopsy.
VAERS ID: 299377-1 (D)
[/b]reported, who on 19-Sep-2007 was vaccinated with the 1st
dose of Gardasil . . . On the morning of 12-Oct-2007, the
patient was found dead in her bed . . . Contraception was
stopped 3 months before vaccination. No reason for the
death was detected in autopsy.
VAERS ID: 299377-1 (D)
* * *
Information has been received from a physician’s assistant
concerning a 12-year-old female with no reported medical
history who on approximately 15-Sep-2007 was vaccinated
with Gardasil . . . On 06-OCT-2007 the patient died in her
sleep. No further information was provided.
VAERS ID: 297528-1 (D)
[/b]concerning a 12-year-old female with no reported medical
history who on approximately 15-Sep-2007 was vaccinated
with Gardasil . . . On 06-OCT-2007 the patient died in her
sleep. No further information was provided.
VAERS ID: 297528-1 (D)
* * *
Sudden unattended death [February 22, 2007] . . . patient
[17-year-old female with no medical history or known
allergies] last seen in office by nurse only on 2/20 for HPV
#3 . . . The autopsy was negative for all findings. Scene
indicated sudden death from collapse and fall.
VAERS ID: 305606-1 (D)
[/b][17-year-old female with no medical history or known
allergies] last seen in office by nurse only on 2/20 for HPV
#3 . . . The autopsy was negative for all findings. Scene
indicated sudden death from collapse and fall.
VAERS ID: 305606-1 (D)
* * *
Information has been received from a physician concerning
a 20-year-old female with no medical history reported, who
on 01-APR-2008 was vaccinated with a dose of Gardasil.
On 05-APR-2008, the patient died four days after receiving
Gardasil . . . An autopsy was performed which ruled out
suicide and anything suspicious. The cause of death is
currently unknown.
VAERS ID: 310262-1 (D) 49
[/b]a 20-year-old female with no medical history reported, who
on 01-APR-2008 was vaccinated with a dose of Gardasil.
On 05-APR-2008, the patient died four days after receiving
Gardasil . . . An autopsy was performed which ruled out
suicide and anything suspicious. The cause of death is
currently unknown.
VAERS ID: 310262-1 (D) 49
Perhaps all these deaths are simply coincidence, but given the unknowns about Gardasil
and its overall safety, it is far too important an issue to simply ignore."
From the Judicial watch investigation on HPV vax
(never mind, i can't edit)
from the stupid article:
"The reports show only that a patient became ill or died after receiving a vaccine, not that a vaccine was the cause."
That's like someone who just shot you in the head saying that you didn't die from the bullet or the gun, you just died from "blood loss".
Here's an old WP article from back when they first started giving the vaccine out
"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said FDA Acting Commissioner Andrew von Eschenbach.
He predicted that the vaccine -- the first ever designed specifically to prevent a cancer -- will have a "dramatic effect" on the health of women worldwide."
(Oh, Mr. Eschenbach, you don't know how right you are.)
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