Lawsuits against Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, claiming its Actos diabetes drug causes bladder cancer will be consolidated before one judge in federal court in Louisiana, a judicial panel said.
The federal Judicial Panel on Multidistrict Litigation sent the lawsuits to the Western District of Louisiana, in Lafayette, to be overseen by U.S. District Judge Rebecca Doherty. Doherty will coordinate pretrial proceedings, including evidence- gathering.
“Centralization in the Western District of Louisiana will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the panel ruled yesterday. It will also allow “the panel to assign the litigation to an experienced judge who sits in a district in which no other multidistrict litigation is pending.”
The lawsuits claim that patients who use Actos, a prescription drug approved for the use in treating type 2 diabetes, increases the risk of bladder cancer. The plaintiffs also claim that Takeda and co-defendant Indianapolis-based Eli Lilly & Co. (LLY) withheld information about the risk and failed to provide adequate warnings.
Saturday, December 31, 2011
Takeda Actos Cancer Suits Combined in Louisiana Court, U.S. Panel Rules - Bloomberg
Arise Sir Andrew Witty, CEO of GSK
Friday, December 30, 2011
Wishing You A Happy New Year!
Here's hoping we all have a great 2012 and that Mayan thing is just BS!
But remember Big Pharma - I'm still watching.....
GE Healthcare to pay $30 million to settle False Claims Act - The Economic Times
General Electric Co's healthcare equipment unit paid more than $30 million to settle allegations that a company it bought in 2004 provided false information to overcharge Medicare for a drug used to diagnose heart disease, the Justice Department said.The Justice Department on Thursday said the government alleged Amersham Health Inc violated the False Claims Act as it misled Medicare by showing artificially inflated rates of the drug Myoview.
The False Claims Act allows governments to join lawsuits filed by whistle-blowers who spot fraud involving taxpayers dollars. It also gives a share of the recovery to the whistle-blower.
The whistle-blower in the lawsuit, James Wagel, would receive $5.1 million from the recovery, the DOJ said
Thursday, December 29, 2011
Patient dies after rats bite him on the .... | The Asian Age
At a time when chief minister Mamata Banerjee is repeatedly urging the doctors and nurses to serve the patients with a human face, a patient died at the SSKM Hospital in Kolkata on Friday after his penis was allegedly nibbled by rats.
Arun Sandhukha, 53, from Sreerampore in Hooghly, was admitted at the new emergency ward of the hospital since December 11 with pneumonia. In the morning, when his family came to visit him, he was lying on the bed in a pool of blood. “No nurse was found at the scene and he was writhing in pain. His penis had been nibbled by rats,” on his relatives Bishwanath alleged. At around 4.15 pm, Sadhukha died of his injuries. The hospital authorities have admitted the presence of rats at the ward, Bishwanath claimed.
Earlier in the day, in another case, a government doctor was found treating patients in an inebriated state at the Bolpur sub-divisional hospital in Birbhum. Kalipada Das was found in a druken state in the emergency department by a patients’ family. Facing protests, Dr Das admitted: “I drank on Thursday night due to domestic problem.”
Another blow for Genentech as Avastin fails in tests on ovarian cancer - San Jose Mercury News
Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks disappointing against ovarian cancer, too. Two studies found it did not improve survival for most of these patients and kept their disease from worsening for only a few months, with more side effects.
The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its South San Francisco-based maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, "we do not believe the data will support approval," although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.
Results of the studies are in Thursday's New England Journal of Medicine.
Wednesday, December 28, 2011
Actavis to Pay $84 Million to End Medicaid Drug-Pricing Suit brought by Ven A Care - Businessweek
Dec. 28 (Bloomberg) -- Two units of Actavis Group Hf will pay $84 million to settle a lawsuit over drug pricing, Texas officials said, less than half the amount an Austin jury said the company should pay.
The state accused Actavis Mid-Atlantic LLC and Actavis Elizabeth LLC, subsidiaries of the Iceland-based company’s U.S. division, of inflating billings to the Texas Medicaid program by falsely reporting drug prices. The state court jury in February ordered the units to pay the state $170 million.
The settlement resolves that litigation, Texas Attorney General Greg Abbott said today in a statement. The settlement includes a $29.2 million recovery for the state’s general fund, Abbott said.
“Actavis denies any and all wrongdoing, and denies that it has any liability relating to the Texas judgment,” the company and the state said in the settlement agreement. The parties reached a settlement “to avoid the delay, uncertainty, inconvenience and expense of continuing the litigation.”
The lawsuit is one of multiple claims by Texas and other states alleging that pharmaceutical companies inflated Medicaid billings for drugs through inaccurate price reporting.
The Actavis suit was the only Texas claim to reach trial, Abbott said. His office has recovered almost $450 million from pharmaceutical companies in drug-pricing suits.
Gerard Farrell, a spokesman for Actavis, declined to immediately comment.
The case is State of Texas ex. Rel. Ven-A-Care of the Florida Keys Inc., D-1-GV-08-1566, District Court of Travis County, Texas (Austin).
--Editor: David E. Rovella
To contact the reporter on this story: Margaret Cronin Fisk in Detroit at mcfisk@bloomberg.net.
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.
Abbott to drop work on cancer treatment - chicagotribune.com
Emergent Biosolutions Inc. (EBS) said Abbott Laboratories (ABT) will terminate its co-development and co-commercialization agreement for the TRU-016 drug, as Abbott told the biopharmaceutical company it is changing its portfolio priorities.TRU-016 is a potential treatment of B-cell malignancies, including chronic lymphocytic leukemia and non-Hodgkin's lymphoma, as well as for autoimmune and inflammatory diseases, according to the National Institutes of Health.
Tuesday, December 27, 2011
The day a drug company boss saw the light - FT.com
The day a drug company boss saw the light
Greeks Reeling From Health Care Cutbacks - NYTimes.com
At public hospitals, doctors report shortages of all kinds of supplies, from toilet paper to catheters to syringes. Computerized equipment has gone unrepaired and is no longer in use. Nurses are handling four times the patients they should, and wait times for operations — even cancer surgeries — have grown longer.
Access to drugs has also been affected, as some drug manufacturers, owed tens of millions of dollars, are no longer willing to supply Greek hospitals. At the same time pharmacists, afraid that the government might not reimburse them, are asking for cash payments, even from those with insurance.
Painkiller 10 times stronger than Vicodin worries addiction experts - HealthPop - CBS News
Four companies have begun patient testing on the pills which contain a pure version of the highly addictive painkiller hydrocodone, and one of them - Zogenix of San Diego - plans to apply early next year to begin marketing its product, Zohydro.
If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.
Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, and methadone.
Critics are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it for an intense, immediate high.
Monday, December 26, 2011
Who Ya Gonna Call?
Judge rules on GlaxoSmithKline's status in product liability cases
A judge has again rejected GlaxoSmithKline's arguments that its corporate citizenship is different completely from several plaintiffs in drug product liability cases because the drugmaker converted to a limited liability company based in Delaware.
U.S. District Court Judge Timothy J. Savage of the Eastern District of Pennsylvania had ruled in the spring that GSK cannot claim Delaware citizenship for purposes of federal diversity jurisdiction because the drug company's true "nerve center" is in Philadelphia.
Judge Savage held to that position in an opinion released Dec. 14, which remands nine Paxil cases to Philadelphia Common Pleas Court.
The judge wrote in his opinion that GSK did not form the limited liability company with the "intent to manipulate jurisdiction," but he said "post-litigation conduct" reflected the intent to manipulate jurisdiction.
Sunday, December 25, 2011
Wishing you a Happy Christmas
Saturday, December 24, 2011
Disease Creep: How we're fooled into using more medicine than we need. | NewAmerica.net
Disease creep, or our drive to catch disease early, and the counterintuitive nature of waiting for symptoms, are pushing more and more of us onto medicines we may not need. In addition to “pre-heart disease,” which is in effect what having elevated cholesterol amounts to, we now have pre-hypertension and pre-diabetes. We catch cancers too early to know if they are ever going to cause a problem. And we put a million stents a year in people’s hearts – yet elective stent placement offers no benefit at all in terms of reduced heart attacks or deaths. Nearly half the population in the U.S. is taking at least one prescribed drug, according to the Centers for Disease Control and Prevention. More than one in ten is taking five or more medicines. Yet we are sicker and don’t live as long as people in Canada or England – or 35 other nations where they generally take fewer medicines and undergo fewer tests.
Friday, December 23, 2011
Dr. Peter Breggin: The Psychiatric Drugging of America's Foster Children
There were approximately 662,000 children in foster care in the United States in 2010.
Now there is a Government Accounting Office (GAO) report confirming that foster children in five states -- Florida, Massachusetts, Michigan, Oregon and Texas -- are receiving shocking amounts of psychiatric drugs. In the words of ABC News, they are "being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together." The ABC News report shows one 7-year-old holding a bag filled with 13 psychiatric medications that she had taken.
Thursday, December 22, 2011
SC judge upholds $327M verdict for J&J marketing | NewsOK.com
A South Carolina judge has upheld a $327 million civil penalty against health giant Johnson & Johnson, which in March was found guilty by a jury of overstating the safety and effectiveness of its former blockbuster antipsychotic drug, Risperdal. Read more: http://newsok.com/sc-judge-upholds-327m-verdict-for-jj-marketing/article/feed... for the state said Wednesday that it's the biggest verdict in the country over the marketing of Risperdal. The pill for schizophrenia and bipolar disorder once brought J&J more than $3.4 billion in annual sales.
But it's been mired for years in litigation over alleged kickbacks, promotion for unapproved uses and other efforts to boost Risperdal over competing drugs. Dozens of pending state and federal cases allege illegal marketing practices for Risperdal, including one set for trial on Jan. 9 in which Texas is seeking more than $1 billion.
Texas has joined a whistle-blower's lawsuit over alleged kickbacks paid more than a decade ago to several doctors who were state officials in the state's mental health department to give Risperdal preference over other antipsychotic drugs. One is accused of accepting honoraria from J&J to fly around the country urging doctor colleagues in other states' Medicaid and mental health programs to use Risperdal over other drugs, said Thomas Melsheimer, who represents whistle-blower Allen Jones and is co-counsel with the Texas Attorney General in the case.
In the South Carolina case, Circuit Court Judge Roger Couch in Spartanburg on Tuesday denied Johnson & Johnson's motions asking him to order a new trial or overturn or amend the verdict.
"This paves the way for the company to file an appeal," Mark Wolfe, a spokesman for New Brunswick, N.J.-based J&J, wrote in an e-mail. "The company acted responsibly and believes it did not violate the South Carolina Unfair Trade Practices Act."
On March 22, a jury in the Spartanburg Court of Common Pleas found after a monthlong trial that Johnson & Johnson and subsidiary Janssen Pharmaceutica Inc., which makes Risperdal, violated that law by giving doctors deceptive information about the drug's risks and effectiveness.
"During the trial, there was compelling evidence in the form of internal e-mails from J&J employees and officials" that the marketing staff was promoting the drug as better than what the science showed, said John B. White Jr., one of the attorneys who presented the case for South Carolina.
White told The Associated Press that a competing antipsychotic drug, Eli Lilly & Co.'s Zyprexa, had become the top-selling drug in the class, so J&J ratcheted up its marketing.
"There was tremendous pressure for Johnson & Johnson ... to make claims that Zyprexa has all of these problems and Risperdal doesn't," White said.
In November 2003, Janssen sent "letters to doctors indicating it was safer than other drugs" in the same class, White said. "They indicated the side effects were much less common than they were."
Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar, plus many more common but less-serious side effects.
Risperdal, approved in 1993, was one of Johnson & Johnson's top-selling drugs until the mid-2000s, when the company launched a twice-a-week injection called Risperdal Consta. Doctors switched most patients to the injected version and sales of the daily pills declined, then dropped off even further when original Risperdal got generic competition in June 2008.
On June 3, Judge Couch ordered J&J to pay civil penalties amounting to $327.1 million.
That's the total of fines of $4,000 for each of more than 43,000 letters touting Risperdal that Johnson & Johnson distributed to doctors, plus $300 each for 509,000 free samples given to doctors that contained detailed package inserts describing the medication's effects and safety.
Wolfe, the J&J spokesman, wrote that the company doesn't believe disseminating a package insert approved by the Food and Drug Administration violates South Carolina's unfair trade law, adding, "We do not believe the ruling can be upheld on appeal."
In January 2010, federal prosecutors joined two other whistle-blower cases against J&J. In their complaint, Assistant Attorney General Tony West and U.S. Attorney Carmen Ortiz in Boston alleged J&J paid tens of millions of dollars in kickbacks and rebates so nursing homes would put more patients on Risperdal, including dementia patients for whom the drug was not approved, and on other J&J drugs. A spokeswoman for Ortiz said Wednesday the two sides are still exchanging documents and taking depositions.
Meanwhile, Risperdal marketing and promotion is the subject of other criminal and civil federal investigations. Likewise, states including Alaska, Arkansas, Louisiana, Massachusetts, Mississippi, Montana, New Mexico, Pennsylvania, Texas and Utah have pending cases against J&J, according to a recent company regulatory filing. Those cases seek reimbursement of Medicaid payments for Risperdal, compensation for treating patients who suffered adverse reactions, penalties for violations of state consumer fraud statutes, damages for "overpayments" or other fines or penalties.
In the Louisiana case, which was tried in October 2010, a jury found that J&J violated the state's Medicaid Fraud Act and the company was fined about $258 million in damages, plus $73 million for the state's legal expenses. Johnson & Johnson's appeal of that verdict is pending.
In the Pennsylvania lawsuit, related to the sale of Risperdal to its Medicaid program, a trial judge dismissed the case after the state presented its evidence in June 2010. Pennsylvania in April 2011 filed an appeal, which is pending.
The regulatory filing also noted that the attorneys general of about 40 states "have indicated a potential interest in pursuing similar litigation against" J&J and have obtained agreements to stop the clock on the statute of limitations "while they pursue a coordinated civil investigation ... regarding potential consumer fraud actions in connection with the marketing of Risperdal."
Ranbaxy settles with FDA over manufacturing - Yahoo! Finance
Indian pharmaceutical giant Ranbaxy Laboratories Ltd. said Tuesday that it has signed a settlement with the U.S. Food and Drug Administration, committing to bolster its product manufacturing practices.
The company also said it intends to set aside a provision of $500 million to cover any potential criminal and civil liability stemming from an investigation by the U.S. Department of Justice.
Wednesday, December 21, 2011
J&J Must Defend Securities-Fraud Lawsuit Over Drug Recalls, Judge Rules - Bloomberg
Johnson & Johnson (JNJ), the world’s largest health products company, must defend a lawsuit claiming it misled investors about quality control-failures at manufacturing plants that led to recalls, a judge ruled.
U.S. District Judge Freda Wolfson in Trenton, New Jersey, ruled Dec. 19 that the securities fraud suit against J&J, Colleen Goggins, the former head of its consumer group, and another executive may go forward. She dismissed claims against Chief Executive Officer William Weldon and Peter Luther, president of the McNeil Consumer Healthcare division. The judge didn’t rule on the merits of the class-action, or group, lawsuit.
The case focuses on recalls of over-the-counter drugs made at McNeil plants in Las Piedras, Puerto Rico, and Fort Washington, Pennsylvania. Investor Ronald Monk said that J&J and its executives made misleading statements about details of the recalls and that he suffered stock losses after the true reasons for the recalls became public. As part of a so-called phantom recall, J&J even hid its recall of a batch of Motrin tablets, Monk said.
AstraZeneca signs two deals to boost pipeline after recent disappointments | Business | guardian.co.uk
A day after its shares slumped following two drug trial disappointments, AstraZeneca has announced moves to bolster its pipeline of new products.
It has signed deals with two Asian companies, although the drugs involved are both in the very early stages.
Firstly Astra said it would co-develop Volitinib, a cancer treatment from Hutchison China MediTech, for which it will pay $20m upfront. Hong Kong-based Chi-Med will get up to $120m if the drug is successful, plus more if it reaches certain milestones and from royalty payments.
Astra has also bought options on a possible new class of diabetes drugs from Japan's Astellas Pharma.
Record Number of Federal Criminal Health Care Fraud Prosecutions Filed in FY 2011
The latest available data from the Justice Department show that federal health care fraud prosecutions reached an historic high last year. During the twelve months of FY 2011, the government reported 1,235 new health care fraud prosecutions — the largest number reported since separate tracking of this offense began twenty years ago. This number is up 68.9% over the past fiscal year, when the number of criminal prosecutions totaled 731 (see Table 1).Numbers were pushed higher in part by the volume of activity in Puerto Rico, where assistant U.S. attorneys charged 548 defendants with health care fraud in FY 2011. Even if the unusually active record of prosecutors in Puerto Rico was set aside, health care fraud prosecutions nationally would still have reached their highest level in over a decade. The Southern District of Florida (Miami) led the nation in activity, accounting for nearly one out of every nine health care fraud prosecutions, followed by the Southern District of Texas (Houston). Together, these two districts accounted for over one out of every five health care fraud prosecutions.
The comparisons of the number of defendants charged with health care fraud offenses are based on case-by-case information obtained by the Transactional Records Access Clearinghouse (TRAC) under the Freedom of Information Act from the Executive Office for United States Attorneys.
The long term trend in health care fraud prosecutions going back twenty years is shown more clearly in Figure 1. The vertical bars in Figure 1 represent the number health care fraud prosecutions of this type recorded each fiscal year. Each presidential administration is distinguished by the color of the bars. To view trends month-by-month rather than year-by-year, see TRAC's monthly report series for the latest data.
Tuesday, December 20, 2011
Merck to pay Mass. $24M in Medicaid fraud settlement - Boston Business Journal
Pharma giant Merck & Co. Inc. (NYSE: MRK) will pay $24 million to the state of Massachusetts, according to a news release from the state Attorney General’s Office. The payment is part of a $47 million Medicaid fraud settlement involving 13 drugmakers.
In a statement, Merck confirmed the details of its share of the settlement, but denied wrongdoing, saying the firm settled to eliminate “uncertainty of ongoing litigation.”
According to Attorney General Martha Coakley, Merck and a generic drugmaking subsidiary agreed to pay the $24 million following a jury verdict in Federal District court in Boston last year.
The lawsuit complained that Merck and Warrick reported inflated prices for an asthma drug, albuterol, to industry price reporting services such as First Data Bank , used by state Medicaid programs to determine reimbursement rates for pharmacies. Twelve other generic drugmakers were accused of similar fraud, and settled before trial, the AG said, agreeing to pay the state $23.4 million in aggregate.
Pharma Fraud Continues To Fill The US Treasury // Pharmalot
In all, the Justice Department recovered nearly $2.2 billion in civil claims against drugmakers last fiscal year, including $1.76 billion in federal recoveries and $421 million in state Medicaid recoveries (here is the Justice Department statement).
Monday, December 19, 2011
US regulators warn of heart risks of Sanofi's Multaq - Yahoo! News
US regulators on Monday ordered French pharmaceutical giant Sanofi to change the label of its heart drug Multaq after it was found to double the risk of death in some patients.
Patients with permanent abnormal heart rhythm, or atrial fibrillation, should not take the drug -- also known as dronedarone -- because of a two-fold higher rate of cardiovascular death, stroke, and heart failure, the US Food and Drug Administration said.
The change is based on results of a clinical trial of the drug in patients with permanent atrial fibrillation that was halted early, in July, due to the increased risk of adverse events.
However, another clinical trial in patients with a different type of heart flutter, known as non-permanent atrial fibrillation, has shown the drug "provides a benefit," and may continue to be prescribed, the FDA said.
Since the FDA approved the drug in July 2009, 1.3 million prescriptions have been dispensed in the United States, US regulators said.
Drug shortages hit an all-time high – - CNN.com Blogs
Between 2006 and 2010, drug shortages increased by more than 200%, according to a Government Accountability Office report released Thursday. There were a record 196 shortages last year, and even more are expected in 2012.
“These shortages often force Americans to go without treatment,” Senator Tom Harkin said.
Renee Mosier is one of those patients who has been forced to forgo treatment and look for alternatives. The 61-year-old was first diagnosed in 2006 with ovarian cancer. After several successful surgeries and chemotherapy treatments, the cancer came back this past June.
Her doctor suggested a chemo regimen that included Doxil, one of the most successful drugs to help keep ovarian cancer at bay. The only problem? Doxil wasn’t available. It is one of the drugs on the drug shortage list, and has not been available for several months. On average, the GAO report found that most shortages last more than 9 months.For Mosier, it’s not just about waiting for the drug. “It’s a life and death thing,” she says.
More than half of the drugs of the shortage list are considered critical, meaning there are no other alternatives for them. Doxil has no generic equivalent. The drugs most often in short-supply included anesthetics and oncological drugs.
The report pointed to manufacturing issues, such as shutdowns, and technical difficulties as being some of the biggest reasons for the drug shortages.
In addition, many drugs, like Doxil, are very difficult to technically replicate. So, once there is a shortage, it is almost impossible for another manufacturer to start producing a similar drug to relieve the shortage.
The report suggested that the Food and Drug Administration could better respond to the shortages if manufacturers were required to report to the FDA of potential shortages, allowing the FDA to find alternatives to deal with the potential shortage. Currently there is no such legislation requiring drug manufacturers to do so, and the FDA most frequently finds out about shortages from doctors and patients.
In addition, the FDA does not maintain its own drug shortage data, which would better enable the FDA to monitor trends.
A result of the drug shortage has been price gouging and the creation of a “grey market” for hard-to-find drugs. “Aggressive measures are necessary to crack down on anti-consumer practices promoted by so-called 'gray markets' that inflate prices, creating a public health menace," Senator Richard Blumenthal said. "There should be zero tolerance for profiteering or price gouging in these essential drug markets.”
President Obama did sign an executive order this past October requiring the FDA to expedite regulatory reviews of drug manufacturers and investigate price gouging.
Building on the Executive Order in October, the White House also announced on Thursday that they will immediately begin requiring some drug manufacturers to report production interruptions to the FDA. The manufacturers that have to report to the FDA are those drug manufacturers that have no generic equivalent and are critical to maintaining life.
In addition, there are currently two bills before Congress that address the issue. But while Congress tries to create some sort of solutions, patients like Renee Mosier are forced to wait.
“You just don’t expect it to happen here."
Labour: UK NHS chiefs asked to resign
Hundreds of senior NHS figures have been sent letters asking for their resignation as part of the move towards controversial health reforms, Labour has revealed.
Shadow health secretary Andy Burnham said chairs and directors of primary care trusts (PCTs) across England have been sent pro-forma resignation letters, even though reforms have not yet made their way through Parliament.
Letters include an explanation of what is required, as well as pre-written resignation letters.
Mr Burnham said the move threatened to create a leadership vacuum and accused Health Secretary Andrew Lansley of "steering the NHS towards the rocks".
Sunday, December 18, 2011
A Man in Tunisia, a Movement on Wall Street, and the Soldier Who Ignited the Fuse | MichaelMoore.com
It's Saturday night and I didn't want the day to end before I sent out this note to you.
One year ago today (December 17th), Mohamed Bouazizi, a man who had a simple produce stand in Tunisia, set himself on fire to protest his government's repression. His singular sacrifice ignited a revolution that toppled Tunisia's dictator and launched revolts in regimes across the Middle East.
Three months ago today, Occupy Wall Street began with a takeover of New York's Zuccotti Park. This movement against the greed of corporate America and its banks -- and the money that now controls most of our democratic institutions -- has quickly spread to hundreds of towns and cities across America. The majority of Americans now agree that a nation where 400 billionaires have more wealth than 160 million Americans combined is not the country they want America to be. The 99% are rising up against the 1% -- and now there is no turning back.
Twenty-four years ago today, U.S. Army Spc. Bradley Manning was born. He has now spent 570 days in a military prison without a trial -- simply because he allegedly blew the whistle on the illegal and immoral war in Iraq. He exposed what the Pentagon and the Bush administration did in creating this evil and he did so by allegedly leaking documents and footage to Wikileaks. Many of these documents dealt not only with Iraq but with how we prop up dictators around the world and how our corporations exploit the poor on this planet. (There were even cables with crazy stuff on them, like one detailing Bush's State Department trying to stop a government minister in another country from holding a screening of 'Fahrenheit 9/11.')
The Wikileaks trove was a fascinating look into how the United States conducts its business -- and clearly those who don't want the world to know how we do things in places like, say, Tunisia, were not happy with Bradley Manning.
Mohamed Bouazizi was being treated poorly by government officials because all he wanted to do was set up a cart and sell fruit and vegetables on the street. But local police kept harassing him and trying to stop him. He, like most Tunisians, knew how corrupt their government was. But when Wikileaks published cables from the U.S. ambassador in Tunis confirming the corruption -- cables that were published just a week or so before Mohamed set himself on fire -- well, that was it for the Tunisian people, and all hell broke loose.
People across the world devoured the information Bradley Manning revealed, and it was used by movements in Egypt, Spain, and eventually Occupy Wall Street to bolster what we already thought was true. Except here were the goods -- the evidence that was needed to prove it all true. And then a democracy movement spread around the globe so fast and so deep -- and in just a year's time! When anyone asks me, "Who started Occupy Wall Street?" sometimes I say "Goldman Sachs" or "Chase" but mostly I just say, "Bradley Manning." It was his courageous action that was the tipping point -- and it was not surprising when the dictator of Tunisia censored all news of the Wikileaks documents Manning had allegedly supplied. But the internet took Manning's gift and spread it throughout Tunisia, a young man set himself on fire and the Arab Spring that led eventually to Zuccotti Park has a young, gay soldier in the United States Army to thank.
And that is why I want to honor Bradley Manning on this, his 24th birthday, and ask the millions of you reading this to join with me in demanding his immediate release. He does not deserve the un-American treatment, including cruel solitary confinement, he's received in over eighteen months of imprisonment. If anything, this young man deserves a friggin' medal. He did what great Americans have always done -- he took a bold stand against injustice and he did it without stopping for a minute to consider the consequences for himself.
The Pentagon and the national security apparatus are hell-bent on setting an example with Bradley Manning. But we as Americans have a right to know what is being done in our name and with our tax dollars. If the government tries to cover up its malfeasance, then it is the duty of each and every one of us, should the situation arise, to drag the truth, kicking and screaming if necessary, into the light of day.
The American flag was lowered in Iraq this past Thursday as our war on them officially came to an end. If anyone should be on trial or in the brig right now, it should be those men who lied to the nation in order to start this war -- and in doing so sent nearly 4,500 Americans and hundreds of thousands of Iraqis to their deaths.
But it is not Bush or Rumsfeld or Cheney or Wolfowitz who sit in prison tonight. It is the hero who exposed them. It is Bradley Manning who has lost his freedom and that, in turn, becomes just one more crime being committed in our name.
I know, I know, c'mon Mike -- it's the holiday season, there's presents to buy and parties to go to! And yes, this really is one of my favorite weeks of the year. But in the spirit of the man whose birth will be celebrated next Sunday, please do something, anything, to help this young man who spends his birthday tonight behind bars. I say, enough. Let him go home and spend Christmas with his family. We've done enough violence to the world this decade while claiming to be a country that admires the Prince of Peace. The war is over. And a whole new movement has a lot to thank Bradley Manning for.
Thomas H. Lee Is Said to Be in Lead to Buy Glaxo Consumer Assets - Bloomberg
Thomas H. Lee Partners LP is in the lead to buy consumer-health assets from GlaxoSmithKline Plc (GSK), and may announce a deal as soon as this week, said two people with knowledge of the matter.
THL is close to entering exclusive talks with Glaxo, said the people, who declined to be identified as the matter is private. The companies have yet to agree on price and may not reach a deal, the people said. Bain Capital LLC also submitted an offer for the assets, and Blackstone Group LP (BX) and Prestige Brands Holdings Inc. (PBH) put in a joint bid, they said.
Glaxo is selling products including the Alli diet pill, Lactacyd soap, FiberChoice diet supplements and Nytol sleep aid. Chief Executive Officer Andrew Witty plans to keep brands such as Sensodyne toothpaste and Panadol pain reliever as he expands Glaxo’s oral health, wellness and nutrition businesses in the consumer division.
“Glaxo is focusing on consumer assets it can globalize,” said Gbola Amusa, a London-based analyst at UBS AG. “These assets being sold are worth more to other companies with more of a regional focus.”
Friday, December 16, 2011
Ke'onte, 12, tells Congress how he was drugged for 4 years in foster care | Mail Online
Ke'onte's plight came to light as a Government Accountability Office report was released that found the federal government had not done enough to oversee the treatment of foster children with powerful drugs.
The study found cared-for children were up to 13 times more likely to be prescribed anti-psychotics and anti-depressants than other children.
Ke'onte, who was adopted in 2009, said he had tantrums as a foster child and was inaccurately diagnosed as bipolar and having ADHD.
'I’ve been in the mental hospital three times during foster care, and every time I had to get on more meds or new meds to add to the ones I was already taking,' he said.
Read more: http://www.dailymail.co.uk/news/article-2069119/Keonte-12-tells-Congress-drug...
Thursday, December 15, 2011
Amgen's CEO is off! - The Associated Press
NEW YORK (AP) -- Amgen Inc., the world's largest biotech drugmaker, says Chairman and CEO Kevin Sharer will retire in 2012 and will be replaced by President and Chief Operating Officer Robert Bradway.
Amgen says Bradway will become its CEO on May 23 and he will replace Sharer as chairman at the end of 2012. Sharer, 63, has been Amgen's CEO since May 2000 and was elected chairman in January 2001. He was the president of the company from 1992 to 2010.
Amgen hired Bradway as vice president of operations in 2006. He was named CFO the following year and became chief operating officer and replaced Sharer as president in 2010.
The Thousand Oaks, Calif., company also said Roger Perlmutter will retire as head of research and development Feb. 13
Pfizer Settled About Half of Prempro Cases, Adds to Reserve - Bloomberg
Pfizer Inc. (PFE), the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.
Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.
“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.
More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.
Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill. Pfizer, based in New York, acquired Wyeth in 2009.
10,000 Claims
At the height of the litigation, Pfizer faced more than 10,000 claims that its menopause drugs caused breast cancer, according to lawyers for former users. Those lawsuits included more than 8,000 cases consolidated in federal court in Arkansas and suits in state courts in Pennsylvania, Nevada and Minnesota.
Pfizer in May disclosed the $772 million reserve and said it had resolved a third of the cases, or about 3,300. The November filing indicates Pfizer officials have now settled almost 5,000 of the suits.
“Pfizer continues to have a strong record of success in defending these cases,” Chris Loder, a company spokesman, said in an e-mailed statement. “While we will continue to look for opportunities to enter into favorable settlements where appropriate, we will also continue to vigorously defend these medicines in litigation.”
Jury Verdicts
Wyeth and Upjohn have now lost 10 of the 18 Prempro cases decided by juries since 2006. Pfizer got some of those verdicts thrown out or had the awards reduced. It resolved some of the verdicts through settlements, while other decisions are on appeal. Pfizer also has had cases thrown out before trial.
Earlier this month, a Philadelphia jury ordered the Pfizer units to pay $72.6 million in compensatory damages to three women who blamed the drugs for their breast cancers. Pfizer agreed to settle the case before jurors were asked to decide whether the company should face punitive damages. Terms of the settlements weren’t released.
The $260 million Pfizer has reserved for the remaining Prempro cases is only “an estimate” and “additional charges may be required,” the company said in the Nov. 10 filing.
Zoe Littlepage, a lawyer representing women suing Pfizer over the menopause drugs, said that reserve doesn’t provide enough compensation to spur settlements of outstanding claims.
“Based upon the size of the jury verdicts to date, and the fact that multiple appellate courts have now affirmed some of those verdicts, this new amount of money set aside by Pfizer seems grossly insufficient to resolve the remaining claims,” Littlepage said in an e-mailed statement.
The consolidated case in Arkansas is In Re Prempro Products, 03-CV-015070-WRW, U.S. District Court, Eastern District of Arkansas (Little Rock).
To contact the reporter on this story: Jef Feeley in Wilmington at jfeeley@bloomberg.net
To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net
Tales from the PMCPA contd. The Case of the Unsolicited Email
The complainant alleged that the email had been sent unsolicited. The complainant did not request any such information and had not given his email address to any party in connection with either Pradaxa or any other medicine. The complainant could not find a link to unsubscribe from the distribution list. The complainant stated that his complaint was about a breach of both UK law and the Code.
The Authority advised that it could only consider complaints within the context of the Code.
The detailed response from Boehringer Ingelheim is given below.
The Panel noted Boehringer Ingelheim’s submission that the database provider obtained consent from the complainant when he completed his registration. An email to the complainant in February 2011 described the registration process for another service and explained that from time to time information would be sent ‘… by e-mail about our associated/affiliated companies and their clients’ product and services, which may include updates on specialist services, conferences and seminars, diagnostic, medical and pharmaceutical promotional materials as well as official information’. This was followed by a new paragraph ‘However, please be advised that we will not share your e-mails with any third parties’. The unsubscribe facility which stated ‘If you do not wish to receive such information please click the box*’ appeared at the very end of the email after the signature and contact details. Additionally, members of the database had been emailed an opt-in policy which included the following: ‘All our e-mail communications to healthcare personnel, in accordance within the Data Protection Act 2001 include an ‘unsubscribe’ option which allows recipients to ‘opt-out’ if they wish. They can ‘opt-out’ of receiving promotional material only and still receive official information. If a recipient chooses to ‘opt-out’ of receiving promotional material we will stop sending messages to that person’. The policy also referred to contact by email and telephone to update and validate information wherein recipients would be told they had opted-in to receive emails from the service provider and their affiliates which might contain promotional information. The Panel did not have a copy of the covering email providing a copy of the policy to the complainant.
The Panel noted that the database was used to email campaigns on behalf of government departments and agencies which many NHS employees would consider important information and want to receive. The Panel considered that it was not at all clear on the registration email sent to the complainant in February 2011 that he could consent to receive official information by email but choose not to receive promotional material. It was not acceptable to rely on the opt-in policy which was sent separately in this regard. Although it was clear on the registration email that the complainant would receive, inter alia, promotional material for medicines on registration, recipients might choose not to unsubscribe given the impression from the wording of the email and the positioning of the unsubscribe option that they would otherwise not receive any material by email including official information. This was not satisfactory and in the Panel’s view should be improved. The Panel queried whether the recipient was given a bona fide choice. Nonetheless the Panel considered that by registering on the site and failing to unsubscribe, the complainant had given prior permission to receive, inter alia, promotional material by email and no breach of the Code was ruled.
The Panel noted Boehringer Ingelheim’s submission that the unsubscribe facility was omitted in error from the Pradaxa email. The Panel noted that the unsubscribe option did not appear in the version of the email certified by the company. This was a serious error. A breach of the Code was ruled as acknowledged by Boehringer Ingelheim.
http://www.pmcpa.org.uk/files/2437%2013%20Dec.pdf
