Wednesday, September 30, 2009
A little bit of Ben
Merck - Vioxx: the last lawsuit?
The Supreme Court of New Jersey backed a $4.5 million award to the widow of a man who suffered heart problems after using Merck's painkiller Vioxx, ending of the last unresolved lawsuits related to the drug.
The court dismissed Merck's appeal and upheld the award in the case McDarby v. Merck, according to the law firm Weitz & Luxenberg. The firm said the ruling was issued on May 7. A jury found that Merck and Co. failed to warn patient John McDarby about Vioxx's cardiac risks, which later caused the drug to be taken off the market.
MoreElan - Tysabri: Elan probed by SEC over MS drug - shares tumble after subpoena is served
Elan received the subpoena in connection with the disclosure last year, the company said yesterday.
The Athlone-based company said the subpoena also requests records and information about its July 29, 2008 discussion of clinical trial data for its bapineuzumab drug intended to treat Alzheimer's.
Elan shares fell 21c to $7.13 (€4.90) during trading in New York yesterday. The company disclosed the subpoena in a filing outlining a plan to sell $600m of seven-year senior debt as part of a plan to restructure the company's borrowings.
Tuesday, September 29, 2009
Monday, September 28, 2009
Get yer knowledge here!
Clinical Knowledge Summaries (CKS) has been updated in September 2009 for the following clinical areas:
- Angina – stable
- Candida – oral
- Diarrhoea – antibiotic associated
- Diarrhoea – prevention and advice for travellers
- Gastroenteritis
- Gonorrhoea (new)
- Urethritis – male
Capitalism does well
Read more at: Huff Po
Sunday, September 27, 2009
Wyeth - Premarin/Prempro: time to settle?
Jurors deliberated about two hours and 15 minutes before concluding that Wyeth’s drug was a proximate cause of Connie Barton’s breast cancer. Barton, 64, was diagnosed with cancer in 2002, five years after she began taking Prempro to treat menopausal symptoms.
Jurors will hear arguments on Wyeth’s liability and possible punitive damages at a second phase of the trial starting on Oct. 1. Wyeth, which is being acquired by Pfizer Inc., has said that it faces more than 9,000 lawsuits over its menopause drugs, along with Pfizer’s Pharmacia & Upjohn unit.
The company has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006. Some of the verdicts were set aside, and others are on appeal. This is the company’s third straight loss.
Looks like Abbott have got Solvay in the bag
It wouldn't happen to Ray Mears!
"Lucky for me I'm in the desert, where life-saving syringes of adrenaline grow in abundance."
Saturday, September 26, 2009
Moore's magnum opus
Friends,
The time has arrived for, as Time magazine called it, my "magnum opus." I only had a year of Latin when I was in high school, so I'm not quite sure what that means, but I think it's good.
I've spent nearly two years on this new movie, "Capitalism: A Love Story," and have poured my heart and soul into this project. Many early critics and viewers have called it my "best film yet." That's a hard call for me to make as I'm proud of all of my films -- but I will tell you this: What you are about to see in "Capitalism" is going to stun you. It's going to make some of you angry and I believe it's going to give most of you a new sense of hope that we are going to turn the sick and twisted mess made by the last president around. Oh, and you're going to have a good laugh at the expense of all the banking and corporate criminals who've made out like bandits in the past year.
I'm gonna show you the stuff the nightly news will rarely show you. Ever meet a pilot for American Airlines on food stamps because his pay's been cut so low? Ever meet a judge who gets kickbacks for sending innocent kids to a private prison? Ever meet someone from the Wall Street Journal who bluntly states on camera that he doesn't much care for democracy and that capitalism should be our only ruling concern?
You'll meet all these guys in "Capitalism." You'll also meet a whistleblower who, with documents in hand, tells us about the million-dollar-plus sweetheart loans he approved for the head of Senate Banking Committee -- the very committee that was supposed to be regulating his lending institution! You'll hear from a bank regulator why Timothy Geithner has no business being our Treasury Secretary. And you'll learn, from the woman who heads up the congressional commission charged with keeping an eye on the bailout money, how Alan Greenspan & Co. schemed and connived the public into putting up their inflated valued homes as collateral -- thus causing the biggest foreclosure epidemic in our history.
There is now a foreclosure filed in the U.S. once every seven-and-half SECONDS.
None of this is an accident, and I name the names others seem to be afraid to name, the men who have ransacked the pensions of working people and plundered the future of our kids and grandkids. Somehow they thought they were going to get away with this, that we'd believe their Big Lie that this crash was caused by a bunch of low-income people who took out loans they couldn't afford. Much of the mainstream media bought this storyline. No wonder Wall Street thought they could pull this off.
Jeez, I guess they forgot about me and my crew. You'd think we would've made a better impression on these wealthy thieves by now. Guess not.
So here we come! It's all there, up on the silver screen, two hours of a tragicomedy crime story starring a bunch of vampires who just weren't satisfied with simply destroying Flint, Michigan -- they had to try and see if they could take down the whole damn country. So come see this cops and robbers movie! The robbers this time wear suits and ties, and the cops -- well, if you're willing to accept a guy in a ballcap with a high school education as a stand-in until the real deal shows up to haul 'em away, then I humbly request your presence at your local cinema this weekend in New York and Los Angeles (and next Friday, October 2nd, all across America).
In the meantime, you can catch us on some of the TV shows that have been brave enough to let me on in the past week or so:
- Nightline (as we take a stroll down Wall Street to Goldman Sachs)
- Good Morning America (where they let me talk about Disney employees who don't get medical benefits)
- The View (where the Republican co-host told everyone to go see it! Whoa!)
- The Colbert Report (this guy is a genius, seriously)
- Larry King (where a spokesperson for the Senator who got the sweetheart loans responds for the first time)
- Keith Olberman (where we both wonder just how long these media corps are going to let us get away with what we do)
- Wolf Blitzer (yes, he's back for more abuse - and lovin' it)
... And the amazing Jay Leno. This man called me after seeing the movie and asked me to be his only in-studio guest on the second night of his new prime-time show. I said, "Jay, shouldn't you be thinking of your ratings in the first week of the show? Are you sure you didn't misdial Tom Hanks' number (the area code where I live is 231; 213 is LA)?" He told me he was profoundly moved by this film. So I was the guest on his second show, and he told all of America it was my "best film" and to please go see "Capitalism: A Love Story." That was Jay Leno saying that, not Noam Chomsky or Jane Fonda (both of whom I love dearly). The audience responded enthusiastically and, after 20 years of filmmaking, it was a moment where I crossed over deep into the mainstream of middle America. Jay's bosses at General Electric musta been... well, let's just say I hope they didn't place a reprimand in his permanent record. He's one helluva guy (and following the example he set with his free concerts for the unemployed in Michigan and Ohio last spring, I've gotten permission from the studio to do the same with my film in ten of the hardest-hit cities in the U.S. next week).
Oh, and he made me sing! Prepare yourself!
Thanks everyone -- and see you at the movies!
Yours,Michael Moore
MMFlint@aol.com
MichaelMoore.com
Twitter.com/MMFlint
Friday, September 25, 2009
How Dr Dennis Mangano won a battle against Pfizer — but lost the war.
Mangano says he can't afford another round with Pfizer, which had $44 billion in sales last year. At 66, with four young children, Mangano says he ransacked his retirement account and spent $15 million for the first trial.
His nonprofit foundation, which had 80 employees, is down to three; it's running millions of dollars in the red.
"We're out of money," said Mangano, who was contacting a lawyer this week about filing bankruptcy for the nonprofit. "We had enormous legal fees and we have very little recourse. Maybe I was too headstrong."
Pancreatitis - just Januvia?
Sitagliptin, the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 16, 2006 and February 9, 2009.
FDA
Insider's view: what about the other gliptins (Onglyza)?
Also remember Byetta.
Astrazeneca loses
The First Circuit of the United States Court of Appeals upheld a 2007 ruling by the U.S. District Court in Massachusetts. That ruling said AstraZeneca PLC and Bristol-Myers Squibb Co. inflated the "average wholesale price" of drugs. The case had originally been filed in 2002, claiming AstraZeneca inflated the price of its cancer drug Zoladex.
London-based AstraZeneca was ordered to pay $12.9 million in damages in that original decision. New York-based Bristol-Myers was ordered to pay $695,594 in damages.
Plaintiffs in the case are seeking a national class-action lawsuit.
Newsday
Desperate Pharmas - the fight for new molecules
“Some of our competitors are desperate because they pay just an incredible price for some medicines. And if it’s a matter of life or death for them, then maybe it makes sense for them, but not to us. So sometimes we may lose some partnerships for financial reasons, which is frustrating.”
Thursday, September 24, 2009
Who's gonna get Solvay?
Germans gouged
Ouch!
Wednesday, September 23, 2009
Lundbeck axes 200
Lundbeck said in a statement the job cuts would support existing initiatives such as insourcing and changing the travel activities of its employees.
AstraZeneca - Seroquel: Dan Carlat cuts to the quick
Tuesday, September 22, 2009
AstraZeneca admitted Seroquel-diabetes link in Japan, then denied it in U.S.
Nancy White, the saleswoman, and a colleague met in July 2006 with an unidentified doctor who reported “getting a lot of flak” from patients about Seroquel’s diabetes links, according to a note unsealed as part of a lawsuit. AstraZeneca wrote in November 2002 to Japanese doctors that it received a dozen reports of diabetes-related cases tied to Seroquel “where causality with the drug could not be ruled out.”
White said in the 2006 note that she told the physician that “there has been no causative effect” found between Seroquel and diabetes. The doctor “said he would not quit writing” prescriptions for Seroquel “due to this at this time,” White reported.
More than 15,000 patients have sued London-based AstraZeneca, claiming the company withheld information about links between diabetes and Seroquel. Many of the suits also claim AstraZeneca promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses.
A federal judge in Orlando, Florida, ordered AstraZeneca to unseal the sales-call notes by Sept. 11 after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. The judge allowed AstraZeneca to withhold physicians’ names on privacy grounds.
All federal-court cases over Seroquel, a so-called atypical or second-generation anti-psychotic medicine, have been consolidated in Orlando for pre-trial proceedings.
More at Bloomberg
CASPPER - "The name of the program? In hindsight, it was a horrible idea,"
Says who?
Are GSK cleaning house?
Lilly - Effient: sluggish launch?
The latest data for U.S. prescription volumes "reinforce our view that Effient's U.S. launch will be muted," Leerink Swann analyst Seamus Fernandez wrote in a research note Monday.
Fernandez, citing data from health-information provider IMS Health, said there have been 1,823 new prescriptions written for Effient since shortly after its August launch, which puts it significantly behind the most successful new drug launches of the past seven years.
Monday, September 21, 2009
KOLWatch - meet the very busy Dr Maria-Carmen Wilson
Lilly's top earner in the Tampa Bay area is Dr. Maria-Carmen Wilson, a neurologist who is director of Tampa General Hospital's Headache & Pain Center and a professor at USF College of Medicine. She also is director of USF's headache medicine fellowship program, co-director of the division of pain medicine and associate director of both the neurology residency program and pain medicine fellowship program.
Despite her busy schedule at the university, Wilson found time to moonlight for Lilly, which paid her $54,400 in the first quarter.
Nonetheless, Wilson failed to follow USF policy to get prior approval before making presentations on behalf of a drugmaker. Wilson also failed to inform USF when she took free trips to Scotland and Spain for drugmaker AstraZeneca.
Today's new word: plutonomy
Analysts at Citigroup have coined a new term for this phenomenon: plutonomies. Ajay Kapur, Citigroup's head of global equity strategy in New York, has identified three countries - the US, Britain and Canada - that he calls plutonomies, where economic growth is powered by and largely consumed by the wealthy few.
Plutonomies are nothing new: they occurred before in 16th century Spain, 17th century Holland, and the Roaring Twenties in the US.
"Asset booms, a rising profit share and favourable treatment by market-friendly governments have allowed the rich to prosper and become a greater share of the economy in the plutonomy countries," says Kapur in a recent strategy update.
SourceMeeting notice
GSK - Paxil: “I don’t know who made that assessment, but it’s there,”
The former Glaxo official stated, under oath during a Philadelphia state court trial, that the birth defect was revealed in the unborn baby of a woman taking Paxil when pregnant, said Bloomberg.com. That particular adverse event took place in 2001. Officials with the drug giant apparently indicated in Glaxo’s files that, after reviewing an email received from the woman who aborted her fetus because of a heart defect, it was “almost certain” Paxil was associated with the defect, said Bloomberg.com, citing Jane Nieman. Nieman is a former drug safety executive with Glaxo, said Bloomberg.com.
According to Nieman’s testimony, “I don’t know who made that assessment, but it’s there,” quoted Bloomberg.com. The testimony was videotaped from her deposition and played for jurors in a case involving another family in which a three-year-old boy—Lyam Kilker—allegedly suffered birth defects due to his mother’s Paxil use, reported Bloomberg.com. According to Philly.com last week, the plaintiff’s attorney claimed Glaxo ignored information that the antidepressant caused birth defects. The boy has undergone some cardiac surgeries and is expected to have to undergo at least one more operation.
