Sunday, July 31, 2011
Saturday, July 30, 2011
Friday, July 29, 2011
Merck To Cut Up To 13,000 Jobs
via foxbusiness.com
Merck & Co. (MRK) said Friday that it would widen its cost-cutting measures by eliminating up to 13,000 jobs--on top of the 17,000 layoffs in prior actions--as the drug maker faces generic competition and other pressures.
Read more: http://www.foxbusiness.com/industries/2011/07/29/merck-to-cut-up-to-13000-job...
Thursday, July 28, 2011
Inside Pfizer's palace coup - Fortune Features
FORTUNE -- For Jeff Kindler, it was a humiliating moment. The CEO of Pfizer, the world's largest pharmaceutical company, had been summoned to the airport in Fort Myers, Fla., on Saturday, Dec. 4, 2010, for a highly unusual purpose: to plead for his job.
Read on .........
Cataracts, hips, knees and tonsils: NHS begins rationing operations - The Independent
Anne Ball, 71, a retired business consultant: 'I have bilateral cataracts and under the original NHS criteria I was entitled to have at least one of mine treated - but then the West Sussex health authorities decided to change the threshold level to save money'.
AstraZeneca Resolves Almost All Seroquel U.S. Litigation for $647 Million - Bloomberg
AstraZeneca Plc (AZN) has settled almost all lawsuits that claimed its antipsychotic drug Seroquel causes diabetes in some users for a total of $647 million.
AstraZeneca, the U.K.’s second-biggest drugmaker, has set aside the $647 million to resolve 28,461 suits alleging it knew Seroquel could cause diabetes in some users, the company said in its second-quarter earnings report. The settlements provide an average payout of more than $20,000 per case.
AstraZeneca’s ability to settle the Seroquel liability for less than $1 billion “may well be a positive surprise for investors,” Les Funtleyder, a health strategist and portfolio manager at Miller Tabak & Co. in New York, said in a telephone interview. “That’s a real bargain when you look at what competitors such as Lilly have paid in settlements over a similar drug.”
Eli Lilly & Co (LLY), maker of the antipsychotic drug Zyprexa, has paid at least $1.2 billion to resolve lawsuits alleging the drug caused diabetes in some users. That’s on top of $1.42 billion in fines the drugmaker paid the U.S. government to resolve claims that it illegally marketed Zyprexa.
AstraZeneca, based in London, announced last summer it had resolved about two-thirds of the 26,000 Seroquel suits that had been filed in courts around the U.S. at the time. The company won the first jury trial over Seroquel in March 2010.
250 Cases Left
“AstraZeneca is aware of about 250 Seroquel product- liability claims in the United States that have not been settled in principle,” Tony Jewell, a U.S.-based spokesman for AstraZeneca, said in an e-mailed statement today.
“We remain committed to a strong defense effort, but will continue to participate in good faith in the court-ordered mediation process for the remaining cases,” he added.
Seroquel, with 2010 sales of $5.3 billion, is the company’s second-biggest seller, after the cholesterol-reducing drug Crestor, according to earlier company filings. Of that number, $3.75 billion in sales were from the U.S., the filings said. AstraZeneca trails only London-based GlaxoSmithKline Plc (GSK) among U.K. drug companies.
AstraZeneca officials said in the earnings report that second-quarter profit fell because of increased generic competition and government price cuts.
Profit excluding restructuring and other one-time costs declined to $1.73 a share from $1.79, the company said today in a statement. That matched the $1.73 mean estimate of 21 analysts surveyed by Bloomberg.
Defense Costs
AstraZeneca officials also said in the filing that the company had paid a total of $749 million in legal fees and expenses to defend against Seroquel claims as of this month. In addition, the company agreed last year to pay $520 million to resolve U.S. allegations that it illegally marketed Seroquel for unapproved uses.
The drugmaker also agreed in March to pay $68.5 million to resolve claims that it deceptively marketed Seroquel in 37 states.
Since 2006, all Seroquel cases filed against AstraZeneca in U.S. federal courts have been consolidated in Orlando, Florida, for pretrial evidence gathering.
The cases were gathered together as part of the Multi- District Litigation program intended to save money by streamlining document exchanges and avoiding duplication. The company also faces cases in state courts in Delaware, New Jersey and New York, according to court filings.
The judge overseeing the cases asked Stephen Saltzburg, a George Washington University Law School professor, to serve as mediator in hopes of reaching settlements.
Michael Kelly, a Wilmington, Delaware-based lawyer for AstraZeneca who served as the drugmaker’s lead negotiator in the settlements, didn’t return a call seeking comment. Perry Weitz, a New York-based lawyer representing some former Seroquel users declined to comment on the settlements.
The case is In Re Seroquel Products Litigation, 06- MD-01769, U.S. District Court, Middle District of Florida (Orlando).
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
via bloomberg.com
AstraZeneca - Introducing Katarina Ageborg
via astrazeneca.com
Appointed Chief Compliance Officer on 1 July 2011, Katarina has overall responsibility for the delivery, design and implementation of the company’s compliance responsibilities.
Katarina has led the global Intellectual Property function since 2008, during which time she streamlined the organisation and launched a new patent filing strategy. Since joining AstraZeneca in 1998, she has held a series of senior legal roles supporting Commercial, Regulatory and Intellectual Property.
Prior to AstraZeneca, Katarina established her own law firm and worked as a lawyer on both civil and criminal cases.
She holds a Master of Law Degree from Uppsala University School of Law in Sweden. Katarina is married, has four children and lives in Sweden.
Study of Medical Device Rules Is Attacked Sight Unseen - NYTimes.com
The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.
But a business group and others have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks.
via nytimes.com
Wednesday, July 27, 2011
Drugmaker Merck sees loss on one-time charges - Business - Personal finance - Earnings - msnbc.com
FRANKFURT, Germany — German drug and chemicals company Merck KgaA has reported a loss for the second quarter on one-time expenses, including the costs of integrating acquisitions Serono and Millipore.
The net loss of €86 million ($125 million) compares with a net profit of €183 million in the second quarter of 2010.
Revenues rose 16 percent to €2.55 billion.
The company cited a string of one-time charges in its earnings release Wednesday, including €161 million related to an underused factory in Switzerland and €20 million for the remaining costs of halting work on multiple sclerosis drug Cladribine.
via msnbc.msn.com
EU Plans Review of Ban on Drugmakers’ Direct Communications With Patients - Bloomberg
European Union restrictions on pharmaceutical companies communicating directly with patients will be reviewed by regulators planning new draft rules, EU officials said.
The European Medicines Agency received a letter from the European Commission saying that it will review the policy, said Peter Arlett, head of the agency’s drug safety unit, at a meeting in London today. The rules are intended to make regulations more uniform across the 27-nation bloc.
“The European Commission will revise the proposals to clarify and harmonize the rules in what companies can and can’t say to patients,” Arlett said in an interview. It’s uncertain whether restrictions will be lifted, he said.
Previous debate suggests the measure probably won’t allow the type of direct-to-consumer television commercials that drugmakers air in the U.S., or general magazine or newspaper advertisements, said Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, a trade group in Brussels.
EU regulators will suggest new rules “by September/October at the latest,” Frederic Vincent, a spokesman for the European Commission, said in an e-mail. Any proposal will need the support of EU governments and the European Parliament before it can come into force.
Previous Proposal
The proposal replaces an earlier draft by regulators three years ago that failed to win the backing of governments and lawmakers. The earlier version would have limited print ads to health-related publications, Bergstrom said in a telephone interview.
Members of the trade group would welcome being able to directly communicate with patients about their medicines and more consistent rules throughout European countries, Bergstrom said.
“We in industry are largely supportive,” he said. “Today it is a patchwork. If you are in the U.K. or Sweden you can usually get high-quality information rather than relying on your doctor, whereas in southern Europe there is nothing.
‘‘Our position is, it’s bizarre that you can get all sorts of other information’’ about medicines ‘‘on the Internet but we as producers are banned from giving it.’’
To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
via bloomberg.com
Bad Medicine: If FDA Lets Drug Company Docs Advise It, Safety Will Suffer | BNET
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools.
via bnet.com
Witty's Warning - GlaxoSmithKline to boost jobs in fragile British economy - Yahoo!
"Over the next several years we will be a job creator in the UK overall," he said.
However, Witty said any further cuts to drug prices could make the UK less attractive as a base for pharmaceuticals manufacturing and research.
Who runs the country?
Tuesday, July 26, 2011
Medco and AstraZeneca get U.S. subpoenas over four drugs | Reuters
NEW YORK, July 26 (Reuters) - Medco Health Solutions Inc (MHS.N) and AstraZeneca Plc (AZN.L) were subpoenaed by the U.S. Department of Justice over their relationship involving four of AstraZeneca's drugs, including widely used acid reflux medicines Nexium and Prilosec.
The companies said separately on Tuesday they received the subpoenas this month. They were issued from the U.S. attorney's office for the District of Delaware, the state which is also home to AstraZeneca's U.S. headquarters.
News of the investigation comes at a sensitive time for Medco, which agreed last week to be bought by Express Scripts Inc (ESRX.O) for $29.1 billion. [ID:nN1E76K024]
The deal -- which combines two of the three largest pharmacy benefit managers -- is projected to have a difficult road to winning U.S. antitrust clearance, so any further regulatory issues could add to the roadblocks.
According to London-based AstraZeneca, the government wants documents relating to its relationship with Medco involving Nexium and Prilosec, as well as blood-pressure medicines Toprol XL and Plendil.
Nexium ranked as the fourth-biggest selling drug in the world last year, according to pharmaceutical information company IMS Health Inc, while Prilosec was once a major product before losing patent protection and becoming available as a generic.
In March, Medco said it received a subpoena from the U.S. Securities and Exchange Commission related to an ongoing probe of Calpers -- the California Public Employees' Retirement System.
via reuters.com
Drug Prices to Plummet in Wave of Expiring Patents – TIME Healthland
Last year, the average generic prescription cost $72, versus $198 for the average brand-name drug, according to consulting firm Wolters Kluwer Pharma Solutions. Those figures average all prescriptions, from short-term to 90-day ones.
Read more: http://healthland.time.com/2011/07/25/drug-prices-to-plummet-in-wave-of-expir...
Trainee lawyer: I'll sue over depression drug that gave me diabetes | News
The heart of the product liability cases in the US and Canada are unproven claims that Seroquel caused diabetes in individual patients.
Sanofi positive over Multaq as FDA and EMA probes are extended
via pharmatimes.com
Sanofi told PharmaTimes World News that it is working with the EMA and the FDA to provide the agencies with a full analysis of the data from PALLAS. The firm notes that some 400,000 patients have been treated with Multaq worldwide and considers that its benefit-risk profile "remains positive in its approved indication".
Patent cliff contd. - A dozen blockbuster drugs about to get generic rivals - Yahoo! Finance
These are blockbuster drugs, with more than $1 billion in annual global sales,
set to go off patent and get generic competition in the U.S. in the next two
years:Oct. 2011 Zyprexa olanzapine schizophrenia/bipolar Eli
Lilly
Nov. 2011 Lipitor atorvastatin high cholesterol Pfizer
March 2012 Lexapro escitalopram depression Forest
Labs
March 2012 Seroquel quetiapine schizophrenia/bipolar
AstraZeneca
March 2012 Avapro/Avalide irbesartan high blood pressure
Bristol-Myers/Sanofi
April 2012 Provigil modafinil narcolepsy Cephalon
May 2012 Plavix clopidogrel clot prevention
Bristol-Myers/Sanofi
July 2012 Tricor fenofibrate high triglycerides Abbott
Aug. 2012 Singulair montelukast asthma/allergies Merck
Aug. 2012 Actos pioglitazone diabetes Takeda
Sept. 2012 Diovan valsartan high blood pressure Novartis
Sept. 2012 Geodon ziprasidone bipolar disorder Pfizer
Nov. 2012 Lidoderm lidocaine pain patch Endo
Dec. 2012 Atacand candesartan heart failure
AstraZeneca
March 2013 Lovaza omega-3-acid high triglycerides
GlaxoSmithKline
Aug. 2013 Temodar temozolomide brain tumors Merck
------
Note: Patent expiration/generic arrival dates can change due to litigation or
regulatory issues.
Sources: Medco Health Solutions Inc., company Web sites.
Novo Nordisk Hit with Pharmaceutical Sales Rep Wage & Hour Overtime Class Action Lawsuit
Novo Nordisk sued in a class action lawsuit by the California employment law attorneys at Blumenthal, Nordrehaug & Bhowmik for alleged wage and hour overtime violations. The drug sales rep class action suit against the pharmaceutical company contends that the sales reps do not qualify for the outside salesperson exemption and are therefore entitled to overtime compensation under the California Labor Code.
(PRWEB) July 25, 2011
On May 18, 2011 the employment law attorneys at Blumenthal, Nordrehaug & Bhowmik filed a class action lawsuit against pharmaceutical company Novo Nordisk on behalf drug sales reps for alleged overtime wage and hour violations. The overtime complaint against the pharmaceutical giant was filed in Sacramento Superior Court and is entitled Brown v. Novo Nordisk, Case No. 34-2011-00103639.According to the wage and hour class action complaint filed against the drug company, Novo Nordisk violated California overtime laws by failing to pay pharmaceutical sales representatives for overtime hours worked. Under California law, companies are required to pay all non-exempt employees overtime compensation whenever the employees work more than eight hours in a day or forty hours in a week. The primary requirement to satisfy the outside salesperson exemption and not get paid overtime under California law and the Fair Labor Standards Act is that the sales reps are actually making sales. In the Novo Nordisk overtime class action lawsuit, the pharmaceutical sales reps allege that they were not actually making sales but rather promoting prescription drugs to physicians. At most, the physician can agree to prescribe the medicine to patients as needed, but cannot actually buy the prescription medicine from the pharmaceutical sales reps directly.
The drug sales rep overtime class action suit is one of many that has been recently filed against pharmaceutical companies. The California employment law attorneys at Blumenthal, Nordrehaug & Bhowmik are also representing pharma sales reps in overtime class action suits against Merck (Frudakis v. Merck, Case No. SACV11-00146 in the Central District of California) and Schering-Plough (Valadez v. Schering-Plough, Case No. 10-CV-2595 in the Southern District of California). The class action lawsuits all allege that the pharmaceutical sales reps should be paid overtime compensation for working more than eight hour days under the California Labor Code and/or forty hour weeks under the Fair Labor Standards Act based on the contention that the drug sales reps do not qualify for the outside salesperson exemption because they are not actually making sales.
For more information about the pharmaceutical sales rep class action suit against Novo Nordisk, visit the Novo Nordisk California wage and hour class action suit website or call (866) 771-7099.
The California employment law attorneys at Blumenthal, Nordrehaug & Bhowmik represent employees in class action and individual lawsuits involving unpaid overtime, wage and hour violations, wrongful termination, job harassment, discrimination and other illegal employment law violations.
###
Norm Blumenthal
Blumenthal, Nordrehaug & Bhowmik
(866) 771-7099
Email Information
via news.yahoo.com
Monday, July 25, 2011
Big Pharma wants to ‘friend’ you - The Globe and Mail
Married with three children, Mary Ellen lives in the Bronx, N.Y., and likes hiking in the Adirondacks. But until she learned how to manage her Type 2 diabetes, she was tired and hungry all the time.
Mary Ellen tried insulin injections and then switched to the Lantus SoloStar insulin pen, which has a push-button system with a small, thin needle. “I found the pen easier to use and much more discreet,” she confides in a video clip at WhyInsulin.com.
More related to this story
- Big Pharma's calling the shots
- The man from Pfizer: Should Big Pharma help steer health research?
- Drug R&D costs are less than estimated – so why the high prices?
The health site – run by the pharmaceutical company Sanofi-Aventis – portrays Mary Ellen as a typical middle-aged woman who put her family’s health before her own.
But the website does not clarify that Mary Ellen and other patients featured in its “insulin success stories” are paid spokespersons for the drug company, according to a formal complaint submitted in November to the U.S. Federal Trade Commission.
Prepared by four separate watchdog groups, the 144-page report cites dozens of examples of pharmaceutical marketing on the Web that “threatens consumer privacy and engages in unfair and deceptive practices.”
Johnson & Johnson Blames Staff Cuts, Pfizer Deal for Tylenol Recall Flood - Bloomberg
Johnson & Johnson’s flood of product recalls last year stemmed from poor management, staffing cuts and breakdowns in integrating the consumer unit it bought from Pfizer Inc. (PFE), J&J said in court papers.
Top executives at the world’s second-largest health-care products company, though, aren’t to blame, J&J said in the filing.
The report by a special committee of J&J board members, filed in response to investor lawsuits, said the company’s McNeil unit suffered from “an adversarial relationship” between some quality-control and production staff as well as "an emphasis on production volume” over compliance. The panel urged J&J’s board to create a new regulatory and compliance panel.
Recalls have dogged J&J the past two years, led by the withdrawal of more than 40 brands of children’s Tylenol, Motrin, and other medicines with foul odors or faulty ingredients. The New Brunswick, New Jersey-based company shut one factory for an overhaul last year and signed a consent decree in March expanding U.S. oversight at three plants.
J&J’s consumer division “should have paid more attention to” quality issues “and exercised more management oversight of McNeil,” the committee said in a 122-page report filed in federal court in Trenton, New Jersey. “With reduced central oversight and tasked with implementing the Pfizer Healthcare acquisition, some McNeil employees may have lost focus and commitment to maintain quality standards.”
via bloomberg.com
Two deaths at Coronado mansion turn spotlight on owner
via latimes.com
The Coronado home of Medicis Pharmaceutical Corp. Chief Executive Jonah Shacknai is where his 6-year-old son took a tumble down a grand staircase and his 32-year-old girlfriend was found dead in a bizarre hanging within two days of each other. The boy later died of his injuries. (Reuters / Associated Press)
Saturday, July 23, 2011
Amy Winehouse RIP
She was lovely in every way!
That's how I will prefer to remember her.
The Spirit Is Willing, and So Is the Flesh
via chronicle.com
“Viagra has become the symbol of modernity, concentrating in itself a sort of achieved utopia in which everything promptly materializes if we only manage to exclude existential complications from our lives.”
Researchers try to discover which pill is best treatment
via post-gazette.com
Two of the allocations, totaling $2.6 million, are going to the University of Pittsburgh to set up training programs to educate scholars who want to pursue comparative effectiveness research research. (Several other Pitt research projects also have been funded by HHS.)
The comparative effectiveness research training program is one of the first in the country, said Bea Herbeck Belnap, coordinator of Pitt's new program. The need to train clinicians and Ph.D.s in these research techniques is acute, Ms. Herbeck Belnap said.
"Comparative effectiveness research is very new," she said. "You need to be familiar with certain methodologies. You need to be able to compare treatments."
Read more: http://www.post-gazette.com/pg/11198/1160754-114-0.stm#ixzz1Suemci8y
Introducing Ripped-Off Britons Blog
http://www.blog.rippedoffbritons.com/
A cartoon strip and blog for these troubled times... Chris, Fee and KJ are three salespeople. They are also three citizens. Therefore, every day, they see both sides. Fee worries about her contribution to Rip-off Britain. KJ thinks everyone is fair game, even when he ends up a victim. Chris is the pragmatist and has seen it all. Our heroes know all about rip-off Britain: consumer goods, banks, jobs, pensions, benefits, tax, property, health, education, – nothing is safe...
Friday, July 22, 2011
Amazon.com: The Goose That Laid The Golden Egg eBook: Doug Bremner: Kindle Store
via amazon.com
Accutane - the truth that had to be told
In 2001 Hoffman-La Roche's drug Accutane was selling in its billions worldwide as a treatment for acne. For those who suffered from extreme scarring acne, it was something of a miraculous treatment, however evidence started to mount that for others it was a death sentence. Over the next few years it was estimated that between 300 and 3,000 young people being prescribed Accutane since its launch had committed suicide or killed others.
In 2001 the father of young man in Ireland who had committed suicide approached Dr. Doug Bremner as Professor of Psychiatry & Radiology at Emory University to see if he could find a causal link between the drug and depression. His findings were that the drug did have an effect on the brain likely to cause acute depression in some patients, which was not surprising as it is a molecular cousin of Vitamin A which is known to cause depression in excessive quantities.
One might think that Hoffman-La Roche would have welcomed these findings. After all, no-one was doubting that Accutane was an extremely effective remedy in many cases, it was just that it appeared to have lethal side-effects in others.
You might like to think again on that one.
'The Goose That Laid The Golden Egg' is the account of what Hoffman-La Roche did next, which was to prosecute a determined, energetic and vindictive campaign against Dr. Bremner designed to suppress his findings and destroy his career and livelihood.
Nonetheless, Dr. Bremner persisted and Hoffman La-Roche have since withdrawn Accutane from the US market, not only for its potentially depressive effects, but also for the likelihood of its causing birth defects and stunting growth.
From the pen of the author of 'Before You Take That Pill: Why the Drug Industry May Be Bad for Your Health: Risks and Side Effects You Won't Find on the Label of Commonly Prescribed Drugs, Vitamins, and Supplements', this is a truly riveting and emotional read detailing just what it costs to take on the full might of one of the largest corporations in the world when you have never claimed to be a saint and have no desire to become a martyr.
About the Author
Dr. Doug Bremner is Professor of Psychiatry & Radiology at Emory University and the author of 'Before You Take That Pill: Why the Drug Industry May Be Bad for Your Health: Risks and Side Effects You Won't Find on the Label of Commonly Prescribed Drugs, Vitamins, and Supplements'.
Thursday, July 21, 2011
FDA Reviewing Sanofi-Aventis Heart Drug Multaq - FoxBusiness.com
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Thursday it is reviewing clinical data involving the Sanofi-Aventis SA (SNY) heart-rhythm drug Multaq.
The company stopped a study of the product earlier this month that involved patients with permanent atrial fibrillation after it showed a two-fold increase risk of death as well as stroke and hospitalization for heart failure. The product is approved for a different group of patients in the U.S. than those in the stopped study.
The FDA said the 2009 approval of Multaq was based on a different clinical study that showed a decreased number of deaths compared to patient on a placebo medication.
In the U.S., Multaq is approved to help maintain normal heart rhythms in patients with a history of nonpermanent types of atrial fibrillation or atrial flutter, which are heart-rhythm disorders. The drug is approved to be used in patients whose hearts have returned to a normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heartbeat.
The FDA said a "critical question is whether and how the unfavorable results" of the study that was stopped earlier this month apply to patients with other types of atrial fibrillation for which the drug is approved. Earlier Thursday the European Medicines Agency also said it was reviewing the risks and benefits of Multaq.
FDA said patients shouldn't stop taking the drug without talking to their doctors. The agency said the study results are preliminary and that it would wait until final study results are available before taking any regulatory action.
The agency said about 241,000 U.S. patients have received Multaq prescriptions since July 2009.
via foxbusiness.com
Drug benefit company connected to CalPERS bribery scandal sold - Sacramento Bee
Medco Health Solutions Inc., the drug-benefit giant that's been caught up in the CalPERS bribery scandal, is being sold.
The New Jersey company agreed to a $29.1 billion sale to rival Express Scripts Inc.
CalPERS severed ties with Medco in March following disclosures that Medco paid more than $4 million to Alfred Villalobos, the Lake Tahoe businessman who's been accused of bribing pension fund officials. Medco still runs a $500 million-a-year drug-benefit contract for CalPERS, which runs out in December, but was taken out of the running for a contract renewal.
Medco acknowledged paying Villalobos, saying it was for his help in clearing up an audit of Medco's work on an earlier contract for CalPERS. An investigative report commissioned by CalPERS said Villalobos was hired to help Medco secure a new contract with the pension fund.
Either way, Medco found itself in hot water. It said it was being investigated by state and federal officials.
After losing CalPERS' business, Medco began losing even bigger customers.
via sacbee.com
Express Scripts to Buy Medco for $29.1 Billion - WSJ.com
Express Scripts Inc. agreed to buy Medco Health Solutions Inc. for $29.1 billion in cash and stock, a deal that combines two of the largest U.S. pharmacy-benefit managers at a time when health-care services companies are searching for new opportunities in the face of sweeping industry changes.
via online.wsj.com
ABPI response to Pharmaceutical Journal comment by Graham Phillips et al,
Check out this website I found at abpi.org.uk
In the article “It is about time the pharmaceutical industry stopped playing the system” Graham Phillips et al, made a number of points which are inaccurate and confuse important, complex issues.
This article appears to raise concerns about challenges within the supply chain - something the industry is keenly aware of as it continues to plug the gaps created by those pharmacists who choose to put profits above the very real needs of patients.
Whilst parallel trade is legal we have an ethical and moral obligation to make sure those medicines in the UK supply chain reach UK patients; however, current challenges cannot be solved by any part of the supply chain in isolation and will only be addressed by all healthcare partners working collaboratively to find an appropriate solution.
Steps have already been taken to improve supply chain issues with best practice guidance launched by the Department of Health earlier this year and signed up to by manufacturers, wholesalers and pharmacists. This has not yet been sufficient to drive improvement and the ABPI is looking to go further, and bring together those involved across the supply chain to work collaboratively to look at additional steps we can take to ensure that people get the right medicines when they need them.
We hope our suggestion to find a solution that benefits UK patients will be welcomed by our partners across the board.
Black Box Brilinta
via nytimes.com
The blood drug Brilinta had also been under tough scrutiny by the F.D.A., analysts said, because test results in an industry-sponsored clinical trial were far worse among patients in the United States than those from the rest of the world for reasons that remain unclear.
In December, the F.D.A. rejected Brilinta in a surprising move, opposing the views of a scientific advisory panel that had voted 7-1 in favor of the drug in July 2010. The F.D.A. asked for and received more information from AstraZeneca.
In a note to investors, Timothy Anderson, analyst for Bernstein Research, said he continued to believe commercial prospects would be limited because of the pending lower prices for Plavix. The aspirin warning may be significant, he said. “It may give physicians one more reason not to use Brilinta but to stick to gold-standard Plavix.”
Wednesday, July 20, 2011
It is about time the pharmaceutical industry stopped playing the system | PJ Online
Wed, 20/07/2011 - 16:33According to the front page of The Times on 6 June 2011, “Drugs companies must behave in step with society and put people before profits”. This assertion came neither from a social commentator nor a Government minister, but from a letter (ibid, p20) written by no less than Andrew Witty, chief executive officer of GlaxoSmithKline.
If Mr Witty was talking on behalf of the industry as a whole, then perhaps it is time the industry put its money where its mouth is.
For example, two commonly prescribed dressings recently had apparently inexplicable alterations made to their sizes: one a change from 10cm x 10cm to 10cm x 12cm and one from 7.5cm x 7.5cm to 7cm x 7.5cm. The manufacturers claimed that the change was due to “popular demand” — the most muted and voiceless of all justifications. Interestingly, both changes were made shortly after their parallel imported equivalents made their appearance on the UK market.
Moreover, we can think of many an occasion where a tablet formulation of a commonly prescribed capsule that was shortly to go off patent made its appearance, and others where preparations with an inherently long action and a “once daily” dosage were withdrawn and replaced by a modified release formulation with a dose frequency of, yes, “once daily”, just as the patent was expiring.
These are all examples of legitimate market manipulation undertaken by members of the Association of the British Pharmaceutical Industry either to prolong a drug’s patent life or to take advantage of Drug Tariff rules to protect their interests.
So you may well imagine our reaction to the recent letter to The Pharmaceutical Journal (21 May 2011, p586) from the then ABPI director-general Richard Barker. He hand-wringingly described the heroic efforts to which ABPI members have gone to supply the UK market with much-needed medicines in the face of almost insurmountable odds and constant ambushes from their enemies, but failed to explain why, when ABPI members claim already to supply more stock than is prescribed for UK patients, we pharmacists have to jump through absurd hoops to acquire supplies. He wrote that he believes that there is a definite need to cut drastically the 1,800 wholesaler dealer’s licences issued in the UK because “the system as it currently stands cannot be effectively policed”. Are we to understand then that he had irrefutable evidence of the inadequacies of the Medicines and Healthcare products Regulatory Agency (the regulator) in administering and, where appropriate, “policing” the system? Or is this more likely related to the behaviour Mr Witty wants the industry to disavow: the voice of vested interests and commercialism out of step with societal expectations?
Mr Barker’s final paragraph — “The answer, quite simply, is for the Government to tighten existing legislation and ensure that everyone downstream from the manufacturers operates within EU regulations to ensure NHS patients are the priority” — is utterly disingenuous. For a start, the EU will not regard an NHS patient as any more of a priority than anyone else and, moreover, successive UK governments have always been regarded as the most likely of EU member states to implement and enforce EU regulations to the letter.
We operate under EU law and, among other things, Mr Barker will have been well aware that the Treaty of Rome provides for the unencumbered and free passage of goods across member state boundaries.
Now, the Government is hardly likely to revalue the pound to benefit the pharmaceutical industry and, frustratingly, the Government is keeping its options open about whether to impose “a public service obligation” on drug manufacturers to guarantee a supply of medicines within 24 hours of a request. So what else can be done?
Perhaps Mr Barker might have done better to have taken a leaf from Mr Witty’s book and reflected on the reputational damage being done to ABPI members. He might also have reminded members who still insist on seeing a faxed prescription before arranging a supply that that runs contrary to their own organisations’ recommendations and that their insistence on this practice wastes our valuable time and guarantees that there will be no stock available in the dispensary to meet another prescription. Further, the existence of a monthly quota of which a pharmacy is unaware (yes — this is fact) is not only unhelpful, but means that further supplies cannot be organised in time to meet excess demand in any given month and that the rigid limits ensure that such situations are handled with utter insensitivity towards patients’ needs.
We had occasion recently to apologise to a patient who returned to collect his prostate cancer injection that we could not make his supply that afternoon as originally promised because it was the 31st of the month and one more of these injections would have been in excess of our “unknown” quota, but he would be able receive it the following day, it being the first day of a new month and a new quota.
Recently we had a further trauma regarding the supply of a crucial antipsychotic medicine. There had been a delay in obtaining the prescription from the patient’s GP and, consequently, the prescription was only printed shortly before the patient ran out of medicines.
We received the prescription at around 5.20pm and could not obtain the product from our usual wholesaler or the manufacturer. As a consequence, our patient had no evening dose. Suffice to say, the patient then self-harmed and the patient’s representative is utterly disgusted with the inadequacies of the supply arrangements for this important medicine. He has been understanding of our attempts to resolve this situation by insisting that the “direct supply” service authorised our wholesaler to release the stock for the next day’s delivery. However, not unreasonably, he does not totally believe our explanation. Doubtless he believes that our failure to supply this medicine more promptly was really due to our own inadequacies or failings. We tremendously value our relationships with patients. We think that, through no fault of our own, we are letting patients down. This is yet another contributor to workplace stress.
The truth is that pharmaceutical companies do have the option of equalising their prices across Europe, but they fear that will affect their bottom line. The failure of the current system, then, is not the failure of Government, nor the inadequacy of the DoH, and most certainly it is not our fault. Fault clearly lies with the collective decision by ABPI members to continue to protect their markets.
via pjonline.com
NHS pays £20 for a loaf that costs £2 in a supermarket - Telegraph
via telegraph.co.uk
Darren Millar, the Conservative shadow minister for health in the Welsh Assembly, found out that the NHS in Wales paid £984,185 for 47,684 gluten-free loaves last year — or £20.64 a loaf. In an answer to a question he put to the assembly, he was also told that packets of gluten-free pasta were costing the NHS £11.54 per bag.
Similar packs cost £2 in supermarkets.
Ginger snap biscuits cost £10.07, compared with £2.35 in the shops, and wheat-free gravy mix £15.21, rather than £2.59.
Mr Millar said: “It’s currently costing the NHS 10 times more for this bread than the price in a supermarket.
Tuesday, July 19, 2011
Embattled Harvard psychology professor resigns - White Coat Notes
Marc Hauser, a well-known Harvard psychology professor who has been on leave since an internal investigation found him guilty of eight counts of scientific misconduct, is leaving the university.
“Marc Hauser has resigned his position as a faculty member, effective August 1, 2011,” Harvard spokesman Jeff Neal wrote in an e-mail statement today.
Hauser was a popular professor known for his research and writing on the evolutionary underpinnings of morality and the traits that make the human mind distinct from those of other animals. He took a leave of absence after a faculty investigating committee concluded a three-year investigation -- first reported last August by the Globe. But he was due to return to the university this fall, a prospect that made many of his former colleagues uncomfortable.
A large majority of the Harvard psychology faculty had voted not to allow him to teach in the department this year, and Faculty of Arts and Sciences Dean Michael D. Smith had supported the decision.
via boston.com
FDA Advisory Panel rejects AstraZeneca, Bristol diabetes pill - Yahoo! News
SILVER SPRING, Maryland (Reuters) – U.S. advisers rejected a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb over concerns about liver and cancer risks.
A Food and Drug Administration advisory panel voted 9-6 on Tuesday against recommending approval of the drug, called dapagliflozin, for adults with Type 2 diabetes.
Panel members said the clinical data did not provide enough certainty about the drug's cancer, liver and kidney risks, as well as its efficacy -- especially for the elderly.
The FDA usually follows the recommendations of its advisory panels and is due to make a final decision on the drug by October 28.
AstraZeneca to Face 2012 Trial in Arkansas Over Sales of Seroquel - Bloomberg
AstraZeneca Plc (AZN) must face a trial over claims by Arkansas that the drugmaker hid health risks of its anti-psychotic drug Seroquel when selling it to residents covered by the state’s Medicaid program, a judge ruled.
London-based AstraZeneca, which agreed in March to pay $68.5 million to resolve claims that it deceptively marketed Seroquel in a number of states, will face a September 2012 trial of a lawsuit filed by Arkansas Attorney General Dustin McDaniel over sales of the drug, Circuit Judge Chris Piazza in Little Rock ruled today.
Arkansas officials, who opted out of the March Seroquel settlement, contend AstraZeneca defrauded the state’s Medicaid program by failing to properly outline the anti-psychotic medicine’s risks in its warning label. The state seeks a $5,000 penalty for each Seroquel prescription written in Arkansas over an 11-year period starting in 1997, according to Fletcher Trammell, one of the state’s lawyers.
via bloomberg.com
Legal bills, restructuring hit J&J profits - RTÉ News
via rte.ie
Johnson & Johnson has said profit fell sharply in Q2 under the weight of restructuring and legal expenses.
Seroquel gets a heart warning
By DUFF WILSON
Published: July 18, 2011
J.B. Reed/Bloomberg News
Warnings for Seroquel will soon recommend that the drug be avoided in combination with 12 drugs linked to arrhythmia.
The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.
Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.
Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.
The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.
As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.
Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.
The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”
The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.
The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.
James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.
“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.
Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.
Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.
Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.
Methadone use and deaths have increased drastically in recent years as more doctors prescribe it for chronic pain. The number of methadone prescriptions for pain in the United States rose to 4.3 million in 2010 from 2.2 million in 2006, IMS Health, an industry data firm, said Monday. The use for pain has surpassed that for heroin withdrawal and maintenance.
NYT
Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.
Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.
The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.
As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.
Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.
The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”
The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.
The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.
James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.
“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.
Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.
Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.
Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.
Methadone use and deaths have increased drastically in recent years as more doctors prescribe it for chronic pain. The number of methadone prescriptions for pain in the United States rose to 4.3 million in 2010 from 2.2 million in 2006, IMS Health, an industry data firm, said Monday. The use for pain has surpassed that for heroin withdrawal and maintenance.
NYT
Monday, July 18, 2011
Alzheimer's Patients Not Helped by Antidepressants - MedPage Today
PARIS -- In patients with dementia, standard antidepressants were no better than placebo at relieving depression symptoms and actually made many of them feel worse, a researcher said here.
In a randomized trial involving more than 300 depressed patients with dementia, those receiving placebo showed the same decrease in symptoms as patients assigned to mirtazapine (Remeron) or sertraline (Zoloft), reported Sube Banerjee, MBBS, MD, MSc, of King's College London.
In an oral presentation at the Alzheimer's Association International Conference on Alzheimer's Disease, Banerjee also indicated that, after 39 weeks of treatment, adverse reactions were reported in more than 40% of patients receiving either of the antidepressants, compared with 26% of the placebo group.
"Essentially there is no superiority of either drug -- over each other or placebo -- in this trial," he said, noting that it was the largest randomized study of antidepressants for this indication yet conducted.
via medpagetoday.com
What is James Murdoch doing on the GlaxoSmithKline board?
Nevermind whether James Murdoch should remain chairman of British Sky Broadcasting, how long before someone asks why he is on the board of GlaxoSmithKlein Plc (LON:GSK)?
Unnoticed amid all the headlines about Rupert Murdoch’s media empire is that his favourite son is a non-executive director of Britain’s biggest pharmaceutical company.
And if television is a business regulated by governments, so much more so are drug companies – not just in Britain, but globally. Including America. Pharm companies cannot afford to court controversy in their governance.
James Murdoch has been a Glaxo main-board director since May 2009. Yes, FTSE 100 companies tend to recruit their non-execs from the execs of other Footsie firms and James was chief executive of BSkyB before he became chairman. But shareholders might belatedly start asking what experience he brings: his whole working life has been inside his father’s empire.
The Murdoch son is a director of the Sotheby’s auction house too – and his day job is chief operating officer of the News Corporation parent. But it is his chairmanship of News International, the News Corp subsidiary that published the News of the World, that makes him controversial. He authorised the secret payments of up to £1m to the likes of publicist Max Clifford and former footballer Gordon Taylor in the hope of curtailing the phone-hacking scandal – payments he now admits were a mistake.
And after the resignation of Rebekah Brooks – and her arrest – James is now first in the firing line for questions about how that scandal was handled, both at the subsidiary level and at the parent when its share price started to slide.
MPs on the House of Commons culture committee will be quizzing James directly. But BSkyB’s independent directors are also reportedly asking whether he should remain their chairman – a role that was difficult when News Corp was bidding for Sky but which has become harder since.
True, James was re-elected to the Glaxo board in May with 97 per cert of the votes cast, but much has emerged about News Corp and its subsidiaries since. Shouldn’t investors now be asking what value his presence brings to Glaxo’s boardroom?
via dofonline.co.uk
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