Banned in Europe for Causing 83,000 Heart Attacks - Are You Taking it?
A September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems.
The FDA is restricting access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy, or REMS.
Under the ruling, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons.
Current users of Avandia will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns.
But did the FDA go far enough – could it be too little, too late?
Unlike the US FDA, British regulators have ruled that GlaxoSmithKline’s diabetes drug Avandia could lead to heart attacks or strokes, and benefits no longer outweigh the risks.
And so last week, they told 90,000 British diabetes patients to stop taking it.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007, and GSK has agreed to pay $460 million in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks. But the US FDA has chosen only to monitor the drug, rather than ask for a recall. Posted ByDr. Mercola
Commissioner Goodell 'just looking for facts' in Favre case
CHICAGO -- NFL Commissioner Roger Goodell said Tuesday there isn't a timetable for wrapping up an investigation of an Internet report that Minnesota Vikings quarterback Brett Favre sent racy text messages and lewd photos to a former New York Jets game hostess two years ago.
"We're just looking for facts now," Goodell said at the NFL Fall League Meeting. "I am going to deal with it as we get the facts."
Goodell said he didn't have plans to meet with Favre, "but if it is something that would help us get to a conclusion and it is warranted, I will do so."
The investigation, announced last week, centers on a report by the sports website Deadspin that Favre, then with the Jets, sent the photos and messages to Jenn Sterger in 2008.
Sterger's manager, Phil Reese, declined to say if his client has talked with the NFL.
"This is something that allegedly happened two years ago," Reese said in an e-mail to The Associated Press. "We don't want a quick resolution, but the proper resolution."
Favre could be fined or suspended under the NFL's personal-conduct policy.
"One of the reasons we instituted the personal-conduct policy ... to make everyone understand their responsibilities," Goodell said. "We're not going down a line of speculation and hypothetical situations."
Favre hasn't responded to questions about the Deadspin report.
Deadspin also reported that Favre pursued two female massage therapists who worked part-time for the Jets. The website didn't identify the women, but the Jets have said they gave contact information about them to the league.
Two high-profile quarterbacks recently were penalized for violating the NFL's personal-conduct policy.
Former Atlanta Falcons star Michael Vick returned to the league in 2009 with the Philadelphia Eagles after missing two seasons for his role in a dogfighting ring. He served an 18-month sentence in prison. Pittsburgh Steelers quarterback Ben Roethlisberger was suspended for six games in April after he was accused of, but not charged with, sexually assaulting a 20-year-old woman at a bar in a Georgia college town. Goodell shortened that ban to four games just before the season, and Roethlisberger will return to the field for Sunday's game against the Cleveland Browns.
The Investigator's Head Was Stuffed in a Suitcase and Sent to the Mexican Military
The head of a murdered investigator who had been working on the case of missing Texan David Hartley was stuffed in a suitcase and delivered to the Mexican military earlier today.
The severed head of Rolando Flores, the head of state investigators in Ciudad Miguel Aleman, was murdered after spending weeks searching for Hartley. The American disappeared on Sept. 30 after he was shot on the Mexican side of Falcon Lake while Jet Skiing with his wife Tiffany.
Tiffany Hartley has said he was gunned down by pirates, and Hartley's family accused Mexican police of not looking for the body because they were afraid of Mexican drug gangs.
News of Flores' murder was first reported by Texas State Rep. Aaron Pena, who tweeted earlier today that the investigator had been decapitated.
Pena said on his Twitter account that he confirmed the decapitation through Zapata County Sheriff Sigifredo Gonzalez, the office in charge of the Hartley investigation. A called made to Gonzalez was not immediately returned.
Tamaulipas state prosecutor spokesman Ruben Rios told The Associated Press that Flores' murder was "unrelated to the investigation" into Hartley's death.
Earlier this week, Mexican authorities named two suspects in Hartley's murder, two Zeta drug cartel members known as Pedro Saldiva Farrias, 27, and his brother Jose Manuel Saldiva Farrias, whose age was not given.
Juan Carlos Ballesteros, an investigator with the state prosecutor's office of the Mexican state of Tamaulipas, said both were said to be suspected members of the Zeta drug cartel from Nueva Ciudad Guerrero, near the abandoned town where David and Tiffany Hartley were sightseeing before they were ambushed.
Zeta Cartel Suspected in Decapitation of Top Investigator
The Hartley case highlights the ongoing turf war between Mexican drug cartels and the country's government, which has been waging a war against the growing drug violence. More than 29,000 people have died in drug violence since December 2006, with the Zeta cartel being blamed for the majority of the deaths.
Zeta is known for smuggling billions of dollars of cocaine and other drugs into the U.S. every year.
Since the Hartley case first broke late last month, a virtual tug of war has occured between the U.S. and Mexico over which country should be searching for him.
U.S. officials said they're prohibited from entering Mexican waters to search for the body and have searched Falcon Lake on the American side, to no avail.
David Hartley's mother Pam Hartley has issued a plea to President Obama and Secretary of State Hillary Clinton asking for aid in bringing her son's body home.
Mexican police had initially cast doubt on Tiffany Hartley's account of the incident, saying they could find neither her husband's body nor his Jet Ski.
But late last week, an eyewitness come forward, claiming that he saw Tiffany Hartley fleeing in panic to the American side of the lake.
"I saw the Jet Ski come around an island," the witness told "Good Morning America." "There was something wrong actually. The way I saw her come around, it looked like something terribly wrong happened. I mean, she was jittery, frantic. ... She was crying, sobbing."
Tiffany Hartley said she and her husband took Jet Skis to the Mexican side of the lake to take pictures of a small church when suddenly a band of Mexican pirates opened fire on them with assault rifles. ABC News' Ryan Owens and Gina Sunseri contributed to this report.
Obama Beats Palin in Poll Match-Up; Palin Says She'd be "Unconventional" Candidate
(Credit: AP)
President Obama would trounce Sarah Palin in a 2012 match-up, according to a Bloomberg National Poll released today.
Fifty-one percent of respondents in the poll said they would vote for Mr. Obama if the election were held today and Palin were his GOP challenger. Just 35 percent said they would vote for Palin. Another 10 percent said they wouldn't vote at all, and 4 percent were unsure.
Most Americans, 54 percent, said they viewed Palin unfavorably, while 38 percent said they viewed her favorably. By contrast, 53 percent said they view the president favorably, and 44 percent said they viewed him unfavorably. A recent CBS News poll showed nearly half of Americans viewed Palin unfavorably, and just 22 percent said she would be an effective president.
The former Alaska governor said in a recent interview she isn't going to close the door to an opportunity to run for president. She added, "Really, it isn't my call."
"It is the people of America, whether they would be ready for someone a bit unconventional, out of the box," Palin told the conservative news outlet Newsmax. "You know -- being used to taking on the establishment, on both sides of the aisle. Or if they want someone a little more conventional maybe more electable -- and that's who they would support."
The former Republican vice presidential candidate added that she is currently "very, very focused on the midterms."
Indeed, Palin on Monday endorsed nine more congressional candidates, including Republican Senate candidate John Raese, who is in a tight race in West Virginia against Democratic Gov. Joe Manchin. The other eight candidates were GOP House candidates Dan Benishek of Michigan; Keith Fimian of Virginia; Ruth McClung and Janet Contreras of Arizona; Ray McKinney of Georgia; Alan Nunnelee and Bill Marcy of Mississippi; and Morgan Philpot of Utah.
Palin's political action committee SarahPAC raised more than $1.2 million during the last quarter, the Associated Press reports. Disclosure reports show that Palin spent about $1 million during that time, much of it for consulting. She gave money to more than a dozen candidates, including to Senate hopefuls Christine O'Donnell of Delaware, Joe Miller of Alaska, Marco Rubio of Florida and Kelly Ayotte of New Hampshire.
While Palin may be focused on the midterms, she did not hold back criticism of the president in her interview with Newsmax. She blasted the president for making health care reform "the top priority of this administration when it was supposed to be about job creation, getting the economy back on the right track."
She added that she thinks the president is "quite naive" and "stubborn," and that "whoever it is who's pulling the strings" will not let the president embrace free market principles.
When it comes to Mr. Obama's plan to let the Bush tax cuts for the wealthiest Americans expire, Palin said, "What he is talking about is slamming us to the mat."
She added, "I think people aren't quite aware of what all is involved in this tax increase that's going to hit us. Congress didn't lift a finger before they left town... to do anything about extending the tax cuts."
The former governor also addressed foreign policy, remarking that a military option against Iran should be on the table should the country acquire a nuclear weapon.
If Iran were to accomplish that, it could "lead to an Armageddon" and a world war that could "decimate so much of this planet," she said.
Looking almost as fresh as the day it was bought, this McDonald's Happy Meal is in fact a staggering six months old. Photographed every day for the past half a year by Manhattan artist Sally Davies the kids meal of fries and burger is without a hint of mould or decay. Entitled 'The Happy Meal Project', Mrs Davies, 54, has charted the seemingly indestructible fast food meals progress as it refuses to yield to the forces of nature.
Fresh: The Happy Meal on the day it was bought by artist Sally Davies in New York
Tasty: Looking a little dry and with an 'acrylic sheen', but the burger has no signs of mould - not even on the bun
Sitting on a shelf in her apartment, Sally has watched the Happy Meal with increasing shock and even her dogs have resisted the urge to try and steal a free tasty snack. 'I bought the meal on April 10 of this year and brought it home with the express intention of leaving it out to see how it fared,' she said. 'I chose McDonald's because it was nearest to my house, but the project could have been about any other of the myriad of fast food joints in New York. 'The first thing that struck me on day two of the experiment was that it no longer emitted any smell. 'And then the second point of note was that on the second day, my dogs stopped circling the shelf it was sitting on trying to see what was up there.'
Fast food: Five months into the experiment, and although the burger patty has shrunk a bit it doesn't look that different to the original
Worrying: More than three months in and the usual effects of time appear to have had no impact
Expecting the food to begin moulding after a few days, Mrs Davies' surprise turned to shock as the fries and burger still had not shown any signs of decomposition after two weeks. 'It was then that I realised that something strange might be going on with this food that I had bought,' she explained. 'The fries shrivelled slightly as did the burger patty, but the overall appearance of the food did not change as the weeks turned to months. 'And now, at six months old, the food is plastic to the touch and has an acrylic sheen to it. 'The only change that I can see is that it has become hard as a rock.'
Tucking in: Mrs Davies bought the Happy Meal and put it on a shelf in her home. She said even her dogs are no longer interested in eating it
Even though she is a vegan, Mrs Davies' experiment has brought her amusement rather than fear. 'I don't really see this experiment as scary, I see it almost as an amusement,' she said. 'Although, I would be frightened at seeing this if I was a meat eater. Why hasn't even the bun become speckled with mould? It is odd.' When asked if their food was not biodegradable, McDonald's spokeswoman Danya Proud said: 'This is nothing more than an outlandish claim and is completely false.' It comes after Denver grandmother Joann Bruso left a Happy Meal to decay for a year until March to highlight the nutritional dangers of fast food. Morgan Spurlock also made the film Super Size Me in 2004 charting the changes to his body eating just fast food for 28 days had.
Carl Paladino’s latest outrage astounds even his adviser, Roger Stone. Lloyd Grove talks to Stone about the candidate's gay gaffes, those notorious emails, and the GOP field for 2012: Why Palin can't get elected, and Romney's Reagan routine makes Stone want to "puke." Plus: 10 Fun Facts About Paladino
Eccentric Republican political consultant Roger Stone, who’s been advising rough-hewn Buffalo real-estate developer Carl Paladino while managing the New York gubernatorial protest campaign of alleged Eliot Spitzer madam sounds just about ready to give up on the GOP nominee.
“It’s astounding,” a distressed Stone told me Monday as the 64-year-old Paladino was making the morning-show rounds trying to clean up after his widely criticized homophobic speech Sunday to Hasidic Jews in Brooklyn. “Based on his anti-gay rant, any advice that I’m giving this guy is no longer having any effect.”
The 58-year-old Stone, a self-described “libertarian Republican” who sports a very large tattoo of his idol Richard Nixon on his back, spoke admiringly of Paladino’s Democratic opponent, Attorney General Andrew Cuomo, and his front-running campaign organization—which issued a statement calling Paladino’s remarks “bizarre.”
“When Cuomo first ran for governor [in 2002], I think he figured out that the more people see him, the less they like him,” Stone said. “He was viewed as too pushy, too aggressive, too out there. And this time he has developed a huge amount of political discipline, where he’s running on his name and picking his shots. He surfaces now and then for high-level press things, says what he wants to say and gets out. He doesn’t do interviews as a general rule and he limits access. I will also add an observation from Richard Nixon: The media always want more of what they can’t get.”
Stone was at a loss to explain Paladino’s “I wasn’t a party to it, and I don’t agree with it,” said Stone, who is perhaps best known for his claim—denied by Spitzer—that the then-governor wore black socks while trysting with call girls.
Stone persuaded the blond, busty Davis—who had millions of dollars confiscated by the government and spent four months of hard time on Rikers Island after pleading guilty to a felony prostitution charge—to run for governor on the Anti-Prohibition Party ticket. Her platform includes legalizing prostitution, casino gambling, marijuana, and same-sex marriage. Davis, the longest of long shots, doesn’t expect to win, but if she receives at least 50,000 votes on November 2, her political party will be legally established on state and local ballots for the next four years.
I asked Stone if he and Davis are in a romantic relationship. “No,” he answered. “I wish.”
Stone said Paladino attempted to hire him in March, but he was already committed to running Davis’ campaign, and the former “Manhattan Madam” gave her blessing to Stone’s giving informal advice to the multimillionaire from Buffalo—who won the Republican primary against Rick Lazio in a landslide.
“Carl ran a superior primary campaign, and he spent $4.5 million; Lazio ran a boring campaign, and spent $600,000,” Stone told me in a wide-ranging conversation that covered local and national politics. “But the scrutiny in a general election is much, much greater than the scrutiny in a primary… I don’t think Carl recognized that the scrutiny level is very different, and every single word you utter will now be covered.”
Paladino is hardly silver-tongued. Trying to demonstrate empathy for a gay nephew on Good Morning America on Monday, he told host George Stephanopoulos, “I sensitize with it totally.” That’s a level of eloquence somewhat below the standard one expects from a major-party statewide nominee.
“Very strange speech patterns,” Stone said. “He talks like a street guy from Buffalo. When he says to Fred Dicker [Albany bureau chief of the New York Post], ‘I will take you out,' he uses that expression all the time. ‘I will take Shelly Silver out.’ ‘I will take the Legislature out.’ It’s an idiomatic expression that unfortunately makes him sound like a mobster. But in New York state, probably more people talk like him than talk like us.”
“Based on his anti-gay rant, any advice that I’m giving this guy is no longer having any effect,” Stone says.
Before this latest flap, Paladino was forced to apologize for he apparently received and forwarded—including one depicting a sex act between a woman and a horse. “There’s a substantial chance that not all the emails are real,” Stone said, conceding that at least some—released by a Democratic loyalist—were authentic. “That’s why the campaign decided not to nitpick. But Carl really doesn’t recall any email of a woman having sex with a horse. And that’s the kind of thing you might remember.”
Stone told me he’s still mystified about Paladino’s gay gaffe, even after seeking clarification from both the candidate and his campaign manager, Stone’s old friend Michael Caputo. “It doesn’t even seem to be consistent with his ‘live and let live’ philosophy. When I asked what happened, the answer was no answer: ‘Yeah, it was a fuckup.’ ”
In his speech to the Brooklyn Hasidim, the candidate slammed Democratic frontrunner Andrew Cuomo—whom he will face in a televised debate next Monday along with four other candidates, including Davis—for bringing his daughters to a gay-pride march. Paladino warned that children should not be “brainwashed into thinking that homosexuality is an equally valid and successful option—it isn’t.” And, in a line that Paladino didn’t utter but appears in the speech text that was handed out to the press, asserted: “There is nothing to be proud of in being a dysfunctional homosexual.”
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Shockingly, Stone said Paladino’s basic speech was provided not by his campaign staff but by a group of Hasidic rabbis. The candidate and his manager found themselves furiously revising the speech in the car on the way to the event. “The rabbis provided the campaign with an uncorrected text,” Stone said. “He takes their text, he crosses a lot of it out, he uses some of it in his actual remarks, and they handed out the full text as if he said it. But that aside, the stuff he did say, many people will find that offensive. Why you would give remarks suggested by the rabbis, for any reason, I don’t understand… Obviously a candidate has to be held responsible for the words that come out of his mouth, regardless of where they came from.”
Casting his gimlet eye on national politics, Stone predicted the Republicans will take the House and pick up seats in the Senate, but not enough to win a majority. He said President Obama is damaged goods politically, but a credible Republican opponent has yet to make an appearance.
“What the party needs is their own Barack Obama,” Stone said. “They need somebody who’s new and fresh, who appeals to the party base without being too extreme. Someone like [South Dakota Sen.] John Thune, who on paper is very interesting and, I think, charismatic.” He also likes the whip-smart Mississippi Gov. Haley Barbour—who, admittedly, is not as dashing as the model-handsome Thune, and likes to offer witticisms such as “Don’t sweat much for a fat boy.”
What about Sarah Palin? “I like her a lot. I think she’s nominatable. I do not, unfortunately, think she’s electable.”
Mitt Romney? “He’s totally phony. You can’t wake up one day and say ‘I’m for gay marriage,’ and wake up the next day and say ‘I’m against it.’ Wake up one day and say, ‘I’m pro-choice,’ and the next day wake up and say, ‘I’m pro-life.’ There’s no credibility threre. Plus the Massachusetts health-care system—which was his—is an unmitigated disaster. And if the guy says, ‘Ronald Reagan, Ronald Reagan,’ one more time, I’m gonna puke.”
As for his nemesis Eliot Spitzer’s new CNN show, Stone was withering. “It’s about as interesting as dyeing your Easter eggs white. I think Spitzer should put a black sock on it.” Lloyd Grove is editor at large for The Daily Beast.
Mutilated Afghan Woman Unveils New Nose, Receives Enduring Heart Award in California Ayesha's Nose and Ears Were Severed by Her Husband; She's Now Being Treated in California
An Afghan woman whose nose was cut off by her husband under the Taliban's authoritarian rule was honored this weekend at an event in California, where she unveiled her new prosthetic nose for the first time.
With a broad smile, Ayesha received the Enduring Heart award at a benefit for the Grossman Burn Foundation, the Los Angeles area organization that provided her facial reconstruction.
"This is the first Enduring Heart award given to a woman whose heart endures and who shows us all what it means to have love and to be the enduring heart," said California first lady Maria Shriver as the award was placed around Ayesha's neck.
"Thank you so much," Ayesha said to the crowd in English.
At the benefit, Ayesha also met former first lady Laura Bush, whose work has focused on the plight of Afghan women.
The long process of reconstructive surgery continues, but this month, Ayesha was fitted with a special prosthesis, which she can apply herself every day with a special skin adhesive. Thanks to the Hollywood-style effects, Ayesha can again face the world without drawing stares.
Village Elders Order Ayesha to be Disfigured
Ayesha, who was once known simply as "Bibi," was married to a man in the Taliban when she was 12 years old.
After enduring years of abuse, including being forced to sleep in the stables with animals, Ayesha tried to run away but was caught. The village men handed down her sentence, and Ayesha's husband sliced off her nose and ears while his brother held her down.
Left for dead, she managed to crawl to her uncle's house, but he refused to help her. Ayesha kept on until a relative finally took her to a hospital run by an American military medical team. The hospital cared for her for more than two months, ensured her safety, and gave her something she had not received before -- kindness.
The safety of vaccines is at the heart of a case expected to be heard on Tuesday by the United States Supreme Court, one that could have implications for hundreds of lawsuits that contend there is a link between vaccines and autism.
At issue is whether a no-fault system established by Congress about 25 years ago to compensate children and others injured by commonly used vaccines should protect manufacturers from virtually all product liability lawsuits. The law was an effort to strike a balance between the need to provide care for those injured by vaccines, some of them severely, and the need to protect manufacturers from undue litigation.
Under the 1986 National Childhood Vaccine Injury Act, such claims typically proceed through an alternative legal system known as “vaccine court.” Under that system, a person is compensated if their injury is among those officially recognized as caused by a vaccine
That person, or their parents, can choose to reject that award and sue the vaccine’s manufacturer, but they then face severe legal hurdles created by law to deter such actions.
The case before the Supreme Court is not related to autism. But the biggest effect of the court’s ruling, lawyers said, will be on hundreds of pending lawsuits that contend a link exists between childhood vaccines and autism. Repeated scientific studies have found no such connection.
Also, in several test case rulings over the last two years, administrative judges in vaccine court have held that autism-related cases did not qualify for compensation. During the last decade, about 5,800 of the 7,900 claims filed in vaccine court, or about 75 percent, have been autism-related, federal data show.
Federal data shows that $154 million was paid in fiscal 2010 to 154 claimants involved in vaccine court proceedings. That figure was significantly higher than in preceding years and reflected several unusually high awards, officials involved in the program said.
In the five preceding fiscal years, an average of $68 million in compensation was paid out on an annual basis, federal data indicates. A compensation fund is financed by an excise tax on vaccinations.
The case to be heard on Tuesday involves an 18-year-old woman, Hannah Bruesewitz, who suffered seizures when she was 6 months old and subsequently suffered developmental problems, her parents say, after receiving a type of D.T.P. vaccine that is no longer sold. The D.T.P. vaccine protects against three potentially deadly childhood diseases: diphtheria; pertussis, which is also known as whooping cough; and tetanus.
Ms. Bruesewitz’s parents have contended in court papers that the vaccine’s manufacturer, which is now a part of Pfizer, knew at the time that their daughter was immunized that there was a safer version of the D.T.P. vaccine but did not produce it. The company rejected that contention
Initially, Ms. Bruesewitz’s parents brought a claim on her behalf to the vaccine court, but the severe injuries that she reportedly suffered were removed from the list of those that qualified for compensation a month before the case was heard. An administrative judge in vaccine court subsequently rejected her claim, so her parents filed a product liability lawsuit against Wyeth, a Pfizer unit that had acquired the vaccine’s manufacturer, Lederle Laboratories.
Lower court judges have ruled that her claims are barred by the federal Vaccine Act. As a result, Ms. Bruesewitz, who lives with her family in Pittsburgh and requires specialized care, has not received any compensation, her father, Russell Bruesewitz, said in a telephone interview.
“The cost of her care is an ongoing burden,” Mr. Bruesewitz said.
The Supreme Court review revolves around the narrow question of whether Congress in passing the Vaccine Act intended to bar lawsuits against vaccine manufacturers based on so-called design defect claims. A vaccine design defect claim essentially asserts that the manufacturer should have sold a different vaccine, which plaintiffs say would have been safer than the one used.
Those filing briefs arguing that Congress intended to permit such lawsuits include the American Association for Justice, a plaintiffs’ lawyers group, and the National Vaccine Information Center, an advocacy group.
Those filing briefs arguing that Congress intended to bar them include the solicitor general of the United States, the Chamber of Commerce and several professional medical groups, including the American Academy of Pediatrics.
James M. Beck, a lawyer in Philadelphia who defends makers of drugs and medical devices, said in a phone interview that a ruling in favor of the Bruesewitzes would allow hundreds of lawsuits asserting a link between vaccines and autism to go forward.
“If these cases go forward, it will make it economically unfeasible for anyone to make vaccines in this country,” said Mr. Beck.
Mr. Bruesewitz said that he and his wife were not opposed to vaccination. Instead, he said they pressed his daughter’s claim because he thought that vaccine producers needed to face the threat of litigation to produce safer medications.
“What we want and are concerned about is to make sure that the safety of vaccines in this country is constantly enhanced,” Mr. Bruesewitz said. BARRY MEIER
A September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems.
