Women More Likely To Die After Heart Attack
March 17, 2010
WebMD
By: Charlene Laino
Better heart treatment of women could help close the gender gap in heart deaths. Women would be more likely to survive a heart attack if they were treated more like men, French researchers say.
In a study of more than 3,500 people admitted to the hospital for a heart attack, women were far less likely than men to get angiography to visualize heart artery blockages or angioplasty to open up blocked arteries.
Women were about twice as likely to die within a month of having the heart attack, according to the study, presented at the American College of Cardiology’s annual meeting.
The higher death rate in women “is related to the fact that they don’t get the same treatments as men,” says Maria Rosa Costanzo, MD, an American Heart Association spokeswoman who was not involved with the study.
“If women had the same access to procedures and medication as men, they would derive the same benefit,” says Costanzo, of Midwest Heart Specialists in Naperville, Ill.
Study researcher Francois Schiele, MD, chief cardiologist at the University Hospital of Besancon in France, says that when possible, “women should be treated with all recommended strategies, including invasive ones.”
Closing the Gender Gap
Costanzo tells WebMD that it’s been known for some time that women fare worse after a heart attack than men, but it’s been unclear why. Some studies point to biological differences such as women’s smaller blood vessels that raise the risk of complications during angioplasty, she says.
Also, women tend to be older and have poorer overall health when they have heart attacks, and wait longer to seek medical care than men, research suggests.
But other studies suggest that women are undertreated, Costanzo says.
The new study attempted to level the playing ground by using statistical techniques that took into account women’s and men’s different characteristics and treatments when they had heart attacks.
The researchers analyzed data from a regional registry that included more than 3,500 patients, about a third of whom were women, treated for a heart attack between January 2006 and December 2007.
Women were, on average, nine years older than men, had more health problems, and received fewer effective treatments for heart attack. They were nearly twice as likely to die, both during the initial hospital stay and over the following month.
When the analysis was adjusted to take into account the differences in the women’s ages, blood pressure, kidney function, and other characteristics as well as the treatments they received, there was no difference in death rates, either in the hospital or at 30 days.
“Once they compared apples to apples, it shows women get the same benefit from [procedures to open blocked arteries] and medication as men,” Costanzo says.
Drugmakers GlaxoSmithKline, Novartis, and Sanofi-Aventis helped fund the registry.
Click here for the full report.
Court to Decide if Vaccine Makers can be Sued
March 10, 2010
Google News
By Associated Press
The Supreme Court will decide whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines.
The justices on Monday agreed to hear an appeal from parents in Pittsburgh who want to sue Wyeth over the serious side effects their daughter, six months old at the time, allegedly suffered as a result of the company’s diphtheria, tetanus and pertussis vaccine.
The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled against Robalee and Russell Bruesewitz, saying a 1986 federal law bars their claims.
That law set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.
Wyeth, now owned by Pfizer, Inc., prevailed at the appeals court but also joined in asking the court to hear the case, saying it presents an important and recurring legal issue that should be resolved.
The Obama administration joined the parties in calling for high court review, although the government takes the side of the manufacturers.
Only one state appeals court, the Georgia Supreme Court, has ruled that families can sue in a vaccine case. The vaccine industry has fiercely opposed the Georgia ruling in the case of Marcelo and Carolyn Ferrari. They claim their son suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.
The family has since withdrawn its lawsuit, possibly in an effort to avoid an unfavorable Supreme Court ruling, although the Georgia court’s opinion allowing similar lawsuits remains in force.
The court did not act on the companies’ appeal Monday, but the decision in the other case almost certainly will apply to the Georgia case.
According to the lawsuit, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Now a teenager, Hannah suffers from residual seizure disorder, the suit says.
The vaccine court earlier rejected the family’s claims.
Wyeth lost another high court fight last year over whether federal law barred lawsuits against drug makers. That case, involving a botched injection, asked whether federal law included an implicit prohibition on the lawsuits. The court said it did not.
In this appeal, however, Congress clearly laid out how claims over vaccines were to be made, and the court has repeatedly ruled against plaintiffs when Congress has explicitly sought to bar lawsuits.
Other than the Georgia court, state and federal courts have uniformly invoked a provision of the 1986 federal law, which seems to bar most lawsuits against vaccine makers.
The idea behind the National Childhood Vaccine Injury Act was to ensure a stable supply of childhood vaccines by shielding drug makers from most lawsuits, and setting up a federal vaccine court to handle disputes. The law would serve to block state laws that otherwise would give families the ability to sue the manufacturers.
In recent years, the legal fight has frequently come from families of autistic children claiming that mercury-based thimerosal is linked to autism. Numerous studies have addressed vaccines and autism and found no link, including with the preservative.
Thimerosal has been removed in recent years from standard childhood vaccines, except flu vaccines that are not packaged in single doses.
Last year, special masters appointed by the vaccine court concluded that vaccines aren’t to blame for autism, disappointing thousands of families hoping to win compensation and others who remain convinced of a connection.
But the vaccine court still must rule on additional cases that argue that vaccines with thimerosal are to blame, if the mercury reached and damaged brain cells.
Click here for the full report.
Court To Hear About Vaccine Side Effects
March 10, 2010
Associated Press
The Supreme Court will decide whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines.
The justices on Monday agreed to hear an appeal from parents in Pittsburgh who want to sue Wyeth over the serious side effects their daughter, six months old at the time, allegedly suffered as a result of the company’s diphtheria, tetanus and pertussis vaccine.
The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled against Robalee and Russell Bruesewitz, saying a 1986 federal law bars their claims.
That law set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.
Wyeth, now owned by Pfizer, Inc., prevailed at the appeals court but also joined in asking the court to hear the case, saying it presents an important and recurring legal issue that should be resolved.
The Obama administration joined the parties in calling for high court review, although the government takes the side of the manufacturers.
Only one state appeals court, the Georgia Supreme Court, has ruled that families can sue in a vaccine case. The vaccine industry has fiercely opposed the Georgia ruling in the case of Marcelo and Carolyn Ferrari. They claim their son suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.
The family has since withdrawn its lawsuit, possibly in an effort to avoid an unfavorable Supreme Court ruling, although the Georgia court’s opinion allowing similar lawsuits remains in force.
The court did not act on the companies’ appeal Monday, but the decision in the other case almost certainly will apply to the Georgia case.
According to the lawsuit, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Now a teenager, Hannah suffers from residual seizure disorder, the suit says.
The vaccine court earlier rejected the family’s claims.
Wyeth lost another high court fight last year over whether federal law barred lawsuits against drug makers. That case, involving a botched injection, asked whether federal law included an implicit prohibition on the lawsuits. The court said it did not.
In this appeal, however, Congress clearly laid out how claims over vaccines were to be made, and the court has repeatedly ruled against plaintiffs when Congress has explicitly sought to bar lawsuits.
Other than the Georgia court, state and federal courts have uniformly invoked a provision of the 1986 federal law, which seems to bar most lawsuits against vaccine makers.
The idea behind the National Childhood Vaccine Injury Act was to ensure a stable supply of childhood vaccines by shielding drug makers from most lawsuits, and setting up a federal vaccine court to handle disputes. The law would serve to block state laws that otherwise would give families the ability to sue the manufacturers.
In recent years, the legal fight has frequently come from families of autistic children claiming that mercury-based thimerosal is linked to autism. Numerous studies have addressed vaccines and autism and found no link, including with the preservative.
Thimerosal has been removed in recent years from standard childhood vaccines, except flu vaccines that are not packaged in single doses.
Last year, special masters appointed by the vaccine court concluded that vaccines aren’t to blame for autism, disappointing thousands of families hoping to win compensation and others who remain convinced of a connection.
But the vaccine court still must rule on additional cases that argue that vaccines with thimerosal are to blame, if the mercury reached and damaged brain cells.
The case, to be argued in the fall, is Bruesewitz v. Wyeth, 09-152.
Click here for the full report.
Dutch Government Trying to Sell Back Vaccines
March 10, 2010
Reuters
The Dutch government wants to sell 21 million unused H1N1 flu vaccine doses back to their manufacturers after they proved unnecessary and no other country wanted to buy them, the Health Ministry said on Saturday.
A spokeswoman for the ministry said it had approached manufacturers GlaxoSmithKline and Novartis about buying back the doses.
She added that it was not clear what their total value was. She also declined comment on the status of the talks, saying the ministry would inform parliament of the details at a later date.
At the height of the H1N1 scare, the ministry ordered 34 million doses of pandemic flu vaccine — enough to give two shots to every person in The Netherlands.
Of the original order, about 11 million doses were administered and another 2.2 million are being kept in reserve for emergencies.
Click here for the full report.
Paxil Trial Update – Experts Battle
March 2, 2010
Natural News
By Evelyn Pringle
In the first Paxil birth defect trial that resulted in a $2.5 million verdict against GlaxoSmithKline in October 2009, the infant, Lyam Kilker, was born with three heart defects; an atrial septal defect, a ventricular septal defect, and an interrupted aortic arch, after his mother took Paxil while pregnant.
Pregnant women cannot participate in clinical trials on drugs due to the risk of harm to the fetus. But after a drug has been on the market for a while, epidemiology studies can review the medical records of women who have taken a new drug while pregnant and the records of women who were not exposed to the drug while pregnant and compare the outcomes of the infants.
The plaintiff’s experts, Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian, all testified that they believed Paxil (paroxetine) caused Lyam’s defects, based in part, on the scientific literature on studies available on Paxil to date.
Battle of the Experts
During her September 15, 2009 opening statement, Glaxo’s lead attorney, Chilton Varner, told the jury, the “experts in the case diverge sharply on how they interpret that body of scientific literature.”
The “plaintiffs’ experts say that these scientific studies prove causation, they prove that Paxil causes cardiac defects and IAA,” she noted.
“They get there by … lumping all cardiac defects together and looking at the numbers for cardiac defects as a group,” she said, “They also get there by rejecting any application of the tool of statistical significance.”
“The plaintiffs’ experts will tell you they believe that as long as there is a difference between the two groups, and the Paxil group is higher than the control group, that’s enough,” Varner told the jury.
“GSK’s experts, on the other hand, are anti-lumping,” she said. “They say that you can’t lump all heart defects together because they form for different reasons at different times by different processes and that you can’t use evidence as to one kind of defect to imply that it also applies to another kind of cardiac defect.”
“And GSK’s experts will tell you that statistical significance matters,” she stated, “that without applying the tool of statistical significance, you have no idea whether the difference between the two groups is real and meaningful or whether it is simply the operation of chance or coincidence.”
Studies Designed to Fail
During his September 15, 2009 opening statement, the family’s lead attorney, Sean Tracey, told the jury: “You are going to hear from experts in this case that there are ways to design studies to fail.”
“If you truly don’t want to know the truth,” he said, “very smart people can design studies that won’t show you the truth.”
Dr Shira Kramer, an epidemiologist, testified as an expert for the plaintiffs. Kramer was asked to explain what is meant by “inclusive by design.” It’s “a very, very serious problem that has been written about quite a bit,” she told the jury.
The reason for “the tremendous amount of concern and literature on this topic,” she said, “is many of these studies look like they have been designed to fail.”
It’s the “deliberate design of epidemiological studies in such a way as to make it, if not impossible, extraordinarily difficult to detect relationship between an exposure and an outcome or a disease,” Kramer explained.
In the Paxil studies, many of the “designed characteristics have been such that they would minimize or make it more difficult to detect an increased risk,” she said. “And despite that, these studies have shown consistency in showing an increased risk of cardiac malformations associated with first trimester Paroxetine exposure.”
“The pressure is always against the ability to detect increased risk in the way these studies are designed,” Kramer said. “And, yet, despite that, we are seeing consistently elevated risks associated with Paxil, which is very, very important, very compelling, and very alarming actually.”
Kramer described the difference between association and causation as meaning that a single study with a finding of an elevated risk of birth defects would only show an association. “When you have a body of literature which shows through multiple studies consistently elevated findings, then you move from association in one study to causation, that this factor causes the disease,” she told the jury.
During closing arguments on October 8, 2009, Tracey told the jury that, “Defense lawyers can’t stand the word ‘causal.’”
“Causal” is the “kiss of death” for a defense lawyer, he said, because they know that is one of the questions the jury will be asked.
“The second question you are going to be asked,” he told the jury, is “Do you find that Michelle David’s ingestion of defendant’s drug Paxil was a factual cause in bringing about the heart defects?”
To continue reading this report, click here.
Toyota VS Big Pharma
February 24, 2010
Natural News
By Mike Adams
Even as Toyota now finds itself the target of an increasingly hyped-up inquisition about “public safety,” skeptical consumers are asking the commonsense question: If public safety is so important, then why isn’t Congress asking about the dangers of Big Pharma’s deadly drugs?
Toyota’s problems with throttle controls and brakes haven’t actually killed anyone as far as we know. Even if deaths have occurred, their number would be extremely small compared to the number of deaths caused by Big Pharma’s products. FDA-approved pharmaceuticals kill nearly 270 people each day in the United States alone, and that’s according to conservative calculations published in the Journal of the American Medical Association. That’s equivalent to a jumbo jet airliner falling out of the sky and crashing in a giant ball of flame every single day in the U.S.
If you’re concerned about public safety in the United States, there’s no industry that’s more dangerous than the pharmaceutical industry. All the automobile manufacturers combined can’t even begin to approach the body bag count produced by Big Pharma. So why is the U.S. Congress and mainstream media all of a sudden so gung-ho to accuse Toyota of compromising public safety while ignoring the far greater threat posed by Big Pharma? Because Toyota is an easy, convenient target that can distract people from the far worse dangers that no one dares speak of. As long as Americans can be distracted into focusing their fear and anger on Toyota, Big Pharma keeps on committing its crimes without being called to task.
And remember: Toyota is a foreign company while the giants of Big Pharma are American companies. Congress is quick to defend U.S. companies like General Motors and Merck, even if those companies pose a very real danger to public safety.
Just yesterday, NaturalNews.com published a story about the deliberate cover-up of deaths caused by Avandia, a top diabetes drug made by GlaxoSmithKline. According to FDA scientists, this drug is linked to 83,000 heart attacks. The company knew about this increased risk — and so did the FDA! Yet both the FDA and GSK conspired to hide this information from the public, says the U.S. Senate committee report (http://www.naturalnews.com/028233_G…).
As a result of this effort to deliberately mislead the public over the lack of safety for its drug, Avandia remained “FDA approved” and now causes an estimated 500 heart attacks and 300 cases of heart failure every month in the USA alone.
That’s the body count from just one medication. Add up the fatalities from all the other thousands of medications sold by the drug industry and you start to get the picture of just how large this threat to public health really is. People are dying every day in America due to dangerous prescription medications that the FDA knew were dangerous years ago!
To continue reading this report, click here.
GlaxoSmithKline Knew of Drug Dangers
February 23, 2010
Natural News
By Mike Adams
GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpr…)
This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists.
The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006.
According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates.
This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks.
GlaxoSmithKline intimidates scientists
This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
“Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?)
A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”
The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA.
The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.”
Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”
The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.
Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie).
To continue reading this report, click here.
The Kevin Trudeau Show: 2-23-10
Today, Kevin risks his own freedom to give YOU the truth! Find out why the FTC is going after him and not McDonald’s or Big Pharma and why the first amendment apparently doesn’t apply to him.
Plus, get the headlines you won’t hear from the mainstream media:
Big Pharma Researcher Admits to Faking Research!
GlaxoSmithKline Hid Evidence of Avandia Harm
Pfizer Found Guilty of Criminal Fraud
Hospital Infections Have Killed Over 48,000 People
Acne Drug has Side Effect of Death
Take Trudeau on the Go! Click here to download this show to your iPod, mp3 player, or PC through iTunes!
Click below to hear The Kevin Trudeau Show RIGHT NOW!!!
GlaxoSmithKline Hid Evidence of Avandia Harm
February 23, 2010
Natural News
By Mike Adams
GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpr…)
This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists.
The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006.
According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates.
This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks.
GlaxoSmithKline intimidates scientists
This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
“Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?)
A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”
The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA.
The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.”
Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”
The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.
Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie).
Analysis: What does it all mean?
Are you kidding me? A drug company hid data that its high-profit drug was linked to increased risk of heart attacks? A drug company intimidated physicians and got away with hoodwinking the public while raking in billions of dollars in sales for a drug that the FDA’s own scientists said should be pulled from the market?
Sounds like business as usual at the FDA, the “sweep it under the rug” division of the pharmaceutical industry. Once again, Dr David Graham turns out to be the sharpest guy in the room while having the courage to tell the truth even when surrounded by an agency full of morons and criminals.
The drug industry must hate this guy. But they can’t get rid of him because he’s one of the very few scientists in the FDA who is actually committed to protecting the public. Gee, what a concept, huh? The FDA as a whole abandoned that idea so long ago that virtually nobody there even remembers what it means. Protect the public? What do you mean? As in, lose profits by banning dangerous drugs that just happen to be making big money?
That’s unthinkable at the FDA as we know it today. The agency exists to promote pharmaceuticals, not to limit their sales just because a hundred thousand people happen to drop dead each year from taking FDA-approved drugs.
When it comes to safety vs. profits, the FDA chooses profits for Big Pharma time and time again.
Do the math on this: If Avandia is linked to 83,000 heart attacks, and if roughly 50% of those are fatal (that’s just an estimate), then Avandia could conceivably be the cause of 40,000 deaths. The terrorist attacks of 9/11 killed roughly 3,000 Americans, and yet just one drug that has been mysteriously kept on the market by the FDA appears to have killed more than ten times as many Americans as the terrorists.
So what does that make the FDA? More dangerous than the terrorists, of course!
So why is the FDA still allowed to operate in America if it’s such a dangerous organization that’s killing so many American citizens? Because it’s profitable, of course!
There’s one thing that’s true about both WAR and MEDICINE: As long as the right corporations are making money, it really doesn’t matter how many people die in the process.
And for all those diabetic Americans struggling to find improved health right now, there’s something you desperately need to know: There’s a price to putting your faith in the FDA, the drug companies and your pill-pushing doctor. That price may very well be your own life.
Diabetes has a cure, you know. You can reverse it in as little as four days by changing your diet. Read the books on diabetes by Dr Gabriel Cousens or Dr Julian Whitaker. Or read more about diabetes right here on NaturalNews: http://naturalnews.com/diabetes.html
Click here for the full report.
Paxil on Trial for Birth Defects
February 17, 2010
Natural News
By Evelyn Pringle
GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.
Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.
First Trial A Bust for Glaxo
The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.
After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.
On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”
Glaxo’s lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.
Over 600 Trials To Go
A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.
“Although one might worry that this would cause a jury to blame the prescribing doctor,” says Vickery, “in this case, we can show that GSK encouraged this use, by sending out over 1500 “medical information” letters touting the benefits of Paxil for migraine headaches, and by leaving “approved WLF reprint” articles with the prescribing doctors.”
Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.
In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised:
“Despite this categorization,” says Vickery, “in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects.”
“Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia,” he notes.
To continue reading this report, click here.
