Jacob writes:
Bristol-Myers Squibb is paying the government more than half a billion to settle charges that the company inflated the prices of its drugs, paid kickbacks to doctors and promoted its anti-psychotic drug Abilify for unapproved uses.
The broad outlines of the settlement were announced last December, but the specific accusations weren’t laid out until today. Here’s the AP story.
Given all the recent attention to industry money and off-label uses of atypical antipsychotics, we were particularly struck by the Abilify issue. The drug is approved only for bipolar disorder and schizophrenia in adults, but the Department of Justice accused the company of promoting its use for children and for elderly patients with dementia. In a press release issued today, DOJ said:
BMS directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients. BMS also created a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder.
The release also notes that the drug’s label carries a black-box warning highlighting the increased risk of death for elderly patients with dementia-related psychosis who are treated with atypical antipsychotics.
The company’s spent a lot of time in the doghouse in recent years. It paid $300 million to settle a shareholder lawsuit in 2004, spent the past two years in a deferred-prosecution agreement and paid a $1 million fine earlier this year to settle the generic Plavix debacle.
The whistleblowers in this case will share around $50 million!
Sunday, September 30, 2007
Sorry!
Never mind Northern Rock, look at what's happening in Japan.
Japanese Banking crisis continues on the back of the US Sub Prime collapse.
The knock-on effect from the US sub prime market in Japan shows no signs of letting up.
In the last 7 days, Origami Bank has folded, Sumo Bank has gone belly up and Bonsai Bank plans to cut back some of its branches. Yesterday it was announced that Karaoke Bank is up for sale and will go for a song. Shares in Kamikaze Bank were suspended after they nose-dived and 500 back-office staff at Karate Bank also got the chop. Analysts report that there is something fishy going on at Sushi Bank, and staff fear they may get a raw deal.
Japanese Banking crisis continues on the back of the US Sub Prime collapse.
The knock-on effect from the US sub prime market in Japan shows no signs of letting up.
In the last 7 days, Origami Bank has folded, Sumo Bank has gone belly up and Bonsai Bank plans to cut back some of its branches. Yesterday it was announced that Karaoke Bank is up for sale and will go for a song. Shares in Kamikaze Bank were suspended after they nose-dived and 500 back-office staff at Karate Bank also got the chop. Analysts report that there is something fishy going on at Sushi Bank, and staff fear they may get a raw deal.
Friday, September 28, 2007
MIT get $65 million from Novartis
Drug giant Novartis says it will give its Cambridge neighbor, MIT, $65 million over 10 years to create a research program, likely to be the biggest in the world aimed at revolutionizing the way drugs are made.
The goal is to help companies move from making drugs in batches to using a continuous high-tech process that will save time and money.
More
The goal is to help companies move from making drugs in batches to using a continuous high-tech process that will save time and money.
More
AstraZeneca - new CFO to join on Bonfire Night
Anglo-Swedish drugmaker AstraZeneca said on Friday it had appointed Simon Lowth, former finance chief at energy group Scottish Power, as its new chief financial officer with effect from November 5th.
Lowth, who previously worked for management consultancy McKinsey & Company, will replace Jon Symonds, who unexpectedly announced in June that he was leaving AstraZeneca to join investment bank Goldman Sachs.
More at Reuters
Lowth, who previously worked for management consultancy McKinsey & Company, will replace Jon Symonds, who unexpectedly announced in June that he was leaving AstraZeneca to join investment bank Goldman Sachs.
More at Reuters
Another great quote
"Pharma was an industry in which it was almost too easy to be successful. It was a licence to print money. In a way, that is how it lost its way.
"It lost contact with the people it was supposed to serve," Dr Tachi Yamada told the FT in an interview at the Clinton Global Initiative.
More
Could this be the same Tachi Yamada mentioned in this post?
You bet!
Oh, and make that "Sir Tachi"!
"It lost contact with the people it was supposed to serve," Dr Tachi Yamada told the FT in an interview at the Clinton Global Initiative.
More
Could this be the same Tachi Yamada mentioned in this post?
You bet!
Oh, and make that "Sir Tachi"!
Thursday, September 27, 2007
The Garden State vs Big Pharma
It's no secret that some drug companies pay for doctors to attend medical conferences in exotic locales. Others treat them to pricey meals and pass out pens and Post-it notes branded with product names.
All told, drug and medical-device makers dole out an estimated $19 billion worth of gifts to physicians every year--a practice that worries New Jersey Attorney General Anne Milgram, among others.
On Sept. 19 she summoned a task force to consider putting limits on this orgy of gratuities. Although New Jersey wouldn't be the first state to pass laws, any action there would have a huge symbolic impact: The Garden State is home to many of the world's largest pharmaceutical companies, including Merck and Johnson & Johnson.
More at BusinessWeek
All told, drug and medical-device makers dole out an estimated $19 billion worth of gifts to physicians every year--a practice that worries New Jersey Attorney General Anne Milgram, among others.
On Sept. 19 she summoned a task force to consider putting limits on this orgy of gratuities. Although New Jersey wouldn't be the first state to pass laws, any action there would have a huge symbolic impact: The Garden State is home to many of the world's largest pharmaceutical companies, including Merck and Johnson & Johnson.
More at BusinessWeek
SiCKO - Moore on Oprah today
Michael Moore will be appearing again on Oprah today, Thursday, September 27th.
Oprah has received thousands of letters from viewers since Mike's appearance in June -- viewers who wanted to share their own health care horror stories. So she invited a number of them to come on today's show, which will feature not only Mike but the head of the health insurance lobby in D.C.
The theme of the show is, 'It Can Happen to You.' And, unfortunately, it can. Joining Oprah and Michael on the show will be Steve Skvara, the steelworker who famously popped the health care question at the Democratic presidential debate in August, and Civia Katz, a Pennsylvania woman who saw 'SiCKO' and decided to send her health care story to MichaelMoore.com.
Tune in today (Thursday) or set your TiVo. Check local listings for show times.
Oprah has received thousands of letters from viewers since Mike's appearance in June -- viewers who wanted to share their own health care horror stories. So she invited a number of them to come on today's show, which will feature not only Mike but the head of the health insurance lobby in D.C.
The theme of the show is, 'It Can Happen to You.' And, unfortunately, it can. Joining Oprah and Michael on the show will be Steve Skvara, the steelworker who famously popped the health care question at the Democratic presidential debate in August, and Civia Katz, a Pennsylvania woman who saw 'SiCKO' and decided to send her health care story to MichaelMoore.com.
Tune in today (Thursday) or set your TiVo. Check local listings for show times.
NPCi ask for feedback
NPCi, http://www.npci.org.uk/ is a new NHS e-learning resource designed specifically for busy health care professionals and managers. The content covers prescribing, therapeutics and medicines management.
Current therapeutics areas include: cardiovascular (including diabetes), CNS and mental health, common infections, pain management and respiratory tract conditions. Other areas are devoted to information mastery and medicines management — including developing people and organisations, general medicines management, improvement skills and tools, patient safety and risk, patients and their medicines, review of medicines, and service efficiency and reducing waste.
The site also includes recorded workshops, quizzes to test your knowledge, regular blogs and podcasts and even the facility to join a discussion forum.
They are continuing to load content but would value comments via their online feedback form on the existing subject matter so that adjustments can be made to the site before the wider launch early in 2008.
Merck - Gardasil: a quote to remember
''Our company is fully committed to making Gardasil available to those who need it,'' Margaret McGlynn, head of Merck Vaccines and Infections Diseases, said in a statement.
Story
More about Margaret.
Story
More about Margaret.
Wednesday, September 26, 2007
AstraZeneca are great says Working Mother
AstraZeneca was named one of the "100 Best Companies" to work for by Working Mother magazine for the sixth consecutive year.
AstraZeneca, which has its U.S headquarters in Fairfax, received recognition from Working Mother for its flexible work arrangements and day care benefits.
Employee network groups for parents and caregivers, telecommuting options, parental leaves and compressed workweeks are other programs identified for the recognition.
Comments welcomed.
AstraZeneca, which has its U.S headquarters in Fairfax, received recognition from Working Mother for its flexible work arrangements and day care benefits.
Employee network groups for parents and caregivers, telecommuting options, parental leaves and compressed workweeks are other programs identified for the recognition.
Comments welcomed.
Tuesday, September 25, 2007
AstraZeneca - sunny smiles for Verus
A smile will have been on the face of Verus Pharmaceuticals yesterday after UK giant AstraZeneca ploughed $310 million into its coffers to acquire its paediatric asthma development programmes.
Included in the transaction are the North American rights to a Captisol (enabled budesonide solution), a proprietary short-acting beta agonist solution (rescue medication), a customised version of a nebulizer delivery device eFlow for use with both medications, and other intellectual property and related assets from Verus.
Under the terms of the agreement, Verus is to receive an upfront payment of $30 million, development expense reimbursements, and a potential earn-out payment of $280 million. No further terms have been disclosed.
Included in the transaction are the North American rights to a Captisol (enabled budesonide solution), a proprietary short-acting beta agonist solution (rescue medication), a customised version of a nebulizer delivery device eFlow for use with both medications, and other intellectual property and related assets from Verus.
Under the terms of the agreement, Verus is to receive an upfront payment of $30 million, development expense reimbursements, and a potential earn-out payment of $280 million. No further terms have been disclosed.
According to Robert Keith, President and Chief Operating Officer of Verus, the deal will allow Verus to refocus its resources on other emerging development programmes, particularly in the areas of paediatric atopic diseases and other conditions related to asthma.
Asthma is the most common chronic childhood illness affecting almost 10% of children in the USA; the prevalence rates have more than doubled since 1980. The estimated annual cost of treating asthma in children under the age of 18 is $3.2 billion.
AstraZeneca has been on the acquisition trail of late as it seeks to prop up its pipeline following a number of late-stage setbacks. It already has a significant presence in the respiratory therapy area, headed by key growth driver Symbicort (budesonide/formoterol), which was launched in the USA in June and has already surpassed the $1 billion a year mark outside of this market.
Source: PharmaTimes
Asthma is the most common chronic childhood illness affecting almost 10% of children in the USA; the prevalence rates have more than doubled since 1980. The estimated annual cost of treating asthma in children under the age of 18 is $3.2 billion.
AstraZeneca has been on the acquisition trail of late as it seeks to prop up its pipeline following a number of late-stage setbacks. It already has a significant presence in the respiratory therapy area, headed by key growth driver Symbicort (budesonide/formoterol), which was launched in the USA in June and has already surpassed the $1 billion a year mark outside of this market.
Source: PharmaTimes
Kiddie Care - feel the rush, cure the rash
Agency life stripped to the bare truth.
So funny! So true!!
Amgen to cut 675 HQ jobs
Amgen announced Monday that 2,200 employees will lose their jobs under a restructuring plan that includes about 675 layoffs at its headquarters in Thousand Oaks.
The total was close to what the biotech company estimated when it announced last month that 2,200 to 2,600 job cuts were needed as part of a plan to reduce costs.
More
The total was close to what the biotech company estimated when it announced last month that 2,200 to 2,600 job cuts were needed as part of a plan to reduce costs.
More
Monday, September 24, 2007
Help please
http://blogi.gootti.net/pharmagossip/
This url seems to have "borrowed" the PharmaGossip tag off me at Technorati.
Any suggestions as to what I should do?
Thanks.
Jack
This url seems to have "borrowed" the PharmaGossip tag off me at Technorati.
Any suggestions as to what I should do?
Thanks.
Jack
The biotech feeding frenzy continues
Drug maker Bristol-Myers Squibb said Monday it will acquire privately held Adnexus Therapeutics in a $430 million all-cash deal.
Biotechnology company Adnexus Therapeutics will become a subsidiary of Bristol-Myers and remain based in Waltham, Mass.
The companies said the acquisition of Adnexus will help advance Bristol-Myers's role in biologics and includes an early stage trial for cancer treatment candidate Angiocept. Angiocept is designed to be a so-called anti-angiogenic drug, or one that tries to stop cancerous tumors from developing new blood vessels.
More at Forbes
Biotechnology company Adnexus Therapeutics will become a subsidiary of Bristol-Myers and remain based in Waltham, Mass.
The companies said the acquisition of Adnexus will help advance Bristol-Myers's role in biologics and includes an early stage trial for cancer treatment candidate Angiocept. Angiocept is designed to be a so-called anti-angiogenic drug, or one that tries to stop cancerous tumors from developing new blood vessels.
More at Forbes
Sunday, September 23, 2007
Erasing the past?
Laura Hathaway initially had no regrets after getting a tattoo on her lower back when she was 21. But now, 10 years later, she wants it gone. The pharmaceutical sales representative from Atlanta, Georgia, says it doesn't fit in with her current lifestyle as the mother of a 2-year-old boy who just started to talk. "The other day I bent over and he said, 'What's that?' and it just confirms why I'm having it removed."
Dr. Scott Karempelis of Atlanta Dermatology Associates is performing a multitreatment laser procedure that will gradually erase Hathaway's tattoo with little or no scarring. The process is painful, expensive and time-consuming.
Karempelis says that in spite of the drawbacks, "business is booming." He and three other dermatologists in his office see more than 30 patients a day who want tattoos removed by laser.
Watch Ms Hathaway's tattoo beginning to disappear »
Hathaway expects to go through 10 sessions several weeks apart, each lasting less than a minute. She admits it's a lot more painful than getting the original tattoo. "It's prickly," describes Hathaway. "It feels like a bee is sitting on your back stinging time and time again. Afterwards, the pain does go away and you're a little sore for a few hours."
More at CNN
Dr. Scott Karempelis of Atlanta Dermatology Associates is performing a multitreatment laser procedure that will gradually erase Hathaway's tattoo with little or no scarring. The process is painful, expensive and time-consuming.
Karempelis says that in spite of the drawbacks, "business is booming." He and three other dermatologists in his office see more than 30 patients a day who want tattoos removed by laser.
Watch Ms Hathaway's tattoo beginning to disappear »
Hathaway expects to go through 10 sessions several weeks apart, each lasting less than a minute. She admits it's a lot more painful than getting the original tattoo. "It's prickly," describes Hathaway. "It feels like a bee is sitting on your back stinging time and time again. Afterwards, the pain does go away and you're a little sore for a few hours."
More at CNN
I don't think Laura's met Dr Dave (pic)!
Dr. Dave is a medical doctor with private general medicine practice in New York City.
Many of Dr. Dave’s tattoos have a medical theme. A caduceus, the symbol of medicine, sits on his right arm - although a woman replaces the traditional staff. The letters "MD" are tattoed on his back, while a skull with a red medical cross (the symbol of Dr. Dave’s motorcycle club of health professionals) decorates his left shoulder.
Hat tip: Neatorama
Covance put on a show
Covance today announced that it will present at the UBS Global Life Sciences Conference on September 24 at 3:30 pm ET. Investors may access a live webcast of the presentation at their website.
Here's the conference agenda.
Insider is looking forward to it!
Here's the conference agenda.
Insider is looking forward to it!
Saturday, September 22, 2007
Friday, September 21, 2007
The "Wal-Mart Effect"
Stephanie Saul at the NYT writes:
As overall health care costs continue to rise sharply, prescription drugs have emerged as a surprising exception.
She suggests one reason could be the so-called Wal-Mart effect. Last fall, Wal-Mart began offering many generic prescriptions at $4 a month. Target quickly announced a similar plan, and Kmart expanded its program, which offers a 90-day supply of generic drugs for $15. Other retailers have followed with their variations. Publix, a grocery store chain with 684 pharmacies in five states in the Southeast, announced last month that it would not charge for prescriptions for seven commonly used antibiotics.
Wal-Mart’s current list of discounted generics includes fewer than 350 drugs.
But, on Tuesday, Wal-Mart announced that, beginning next year, 2,400 generics would be available to its employees at $4 a month. The company has also indicated that later this month it may make an announcement regarding its generic drug program for consumers.
Go here to read the rest of this excellent article.
As overall health care costs continue to rise sharply, prescription drugs have emerged as a surprising exception.
She suggests one reason could be the so-called Wal-Mart effect. Last fall, Wal-Mart began offering many generic prescriptions at $4 a month. Target quickly announced a similar plan, and Kmart expanded its program, which offers a 90-day supply of generic drugs for $15. Other retailers have followed with their variations. Publix, a grocery store chain with 684 pharmacies in five states in the Southeast, announced last month that it would not charge for prescriptions for seven commonly used antibiotics.
Wal-Mart’s current list of discounted generics includes fewer than 350 drugs.
But, on Tuesday, Wal-Mart announced that, beginning next year, 2,400 generics would be available to its employees at $4 a month. The company has also indicated that later this month it may make an announcement regarding its generic drug program for consumers.
Go here to read the rest of this excellent article.
FDA bill passed to Bush for signature
Legislation expanding the Food and Drug Administration's drug-safety oversight won final congressional approval, but its impact on the pharmaceutical industry will depend largely on how the agency opts to use its new powers.
The bill, which the Senate passed yesterday following House approval Wednesday, increases the fees that drug makers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market.
It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated.
More at the WSJ
The bill, which the Senate passed yesterday following House approval Wednesday, increases the fees that drug makers pay the FDA to review their drugs and allots a portion of the money for the agency to monitor the safety of drugs after they go on the market.
It also solidifies the agency's authority to mandate changes to drug labels, require additional safety studies and limit the distribution of medications when safety concerns arise -- powers that have existed informally but haven't always been clearly delineated.
More at the WSJ
Missing - Lilly drug rep Nailah Franklin
Police have launched a missing persons investigation for a 28-year-old Chicago woman last heard from earlier this week. Nailah Franklin, a pharmaceutical representative for Eli Lilly & Co., was last seen Sunday evening, Sgt. Virginia Zic said.
Franklin, who lives in the 1500 block of South Sangamon Street, was last heard from about 8:15 p.m. Tuesday when she sent a text message to her boyfriend, who lives in Milwaukee, Zic said.
Franklin is African-American and described as about 5 feet 2 inches tall, weighing 110 pounds, with brown hair and brown eyes, according to a police alert. She drives a company-owned gray 2005 Chevrolet sedan with Illinois license plate 1957855, police said.
Sad update:
Thursday, September 20, 2007
Allergan spend money to make money
Allergan has announced plans to acquire privately-held Esprit Pharma in a $370 million all-cash deal that gives the former access to the overactive bladder therapy Sanctura.
In addition to Sanctura (trospium), a twice-a-day anticholinergic which Esprit licenses from Indevus Pharmaceuticals, Allergan is also getting hold of the extended-release, once-daily version of the drug.
The FDA recently granted approval for Sanctura XR and it is this version of the drug that could be a big earner for Allergan.
Source: PharmaTimes
In addition to Sanctura (trospium), a twice-a-day anticholinergic which Esprit licenses from Indevus Pharmaceuticals, Allergan is also getting hold of the extended-release, once-daily version of the drug.
The FDA recently granted approval for Sanctura XR and it is this version of the drug that could be a big earner for Allergan.
Source: PharmaTimes
AstraZeneca - more on that whole outsourcing thing
It all started here.
Ed at Pharmalot was right on the money as usual!
Yesterday he wrote:
The drugmaker was in overdrive this week after one of its own execs was quoted in The Times of London as saying that manufacturing will be outsourced over the next decade, primarily to India and China. Like others, we carried an item. But then yesterday, AstraZeneca was in a titter and e-mailed select media to denounce the report. Curiously, the publicity team never insisted that its own David Smith, exec vp of operations, was misquoted.
Rather, they alluded to a misunderstanding.
But wait. There's more:
At the end of the day, the AZ effort to disavow Smith’s remarks appears disingenuous and resembles the worst kind of lawyerly parsing.
Ouch!
Meanwhile, in todays' Times, their business editor James Harding wrily notes:
AstraZeneca, it seems, wants to inject new life into the Big Pharma business model, but it wants to do it quietly. This week, unexpected details emerged of a bold new strategy to focus on R&D and marketing while outsourcing basic manufacturing.
The news may have led to red faces in the boardroom, but in fact David Brennan, the chief executive, deserves credit for such a move. Amid ruthless competition, rising costs and looming patent expiries, monolithic drug giants urgently need to reinvent themselves.
Outsourcing has transformed virtually every other consumer industry. If it can ensure quality control, why not pharmaceuticals?
Wise words!
Ed at Pharmalot was right on the money as usual!
Yesterday he wrote:
The drugmaker was in overdrive this week after one of its own execs was quoted in The Times of London as saying that manufacturing will be outsourced over the next decade, primarily to India and China. Like others, we carried an item. But then yesterday, AstraZeneca was in a titter and e-mailed select media to denounce the report. Curiously, the publicity team never insisted that its own David Smith, exec vp of operations, was misquoted.
Rather, they alluded to a misunderstanding.
But wait. There's more:
At the end of the day, the AZ effort to disavow Smith’s remarks appears disingenuous and resembles the worst kind of lawyerly parsing.
Ouch!
Meanwhile, in todays' Times, their business editor James Harding wrily notes:
AstraZeneca, it seems, wants to inject new life into the Big Pharma business model, but it wants to do it quietly. This week, unexpected details emerged of a bold new strategy to focus on R&D and marketing while outsourcing basic manufacturing.
The news may have led to red faces in the boardroom, but in fact David Brennan, the chief executive, deserves credit for such a move. Amid ruthless competition, rising costs and looming patent expiries, monolithic drug giants urgently need to reinvent themselves.
Outsourcing has transformed virtually every other consumer industry. If it can ensure quality control, why not pharmaceuticals?
Wise words!
GSK - Avandia: Daily Mail readers beware
Jerome Burne at The Daily Mail asks if the UK medicine regulators are protecting the public sufficiently. He uses an Avandia case as an example:
Bob Bowen had been diabetic for 18 years when his doctor switched him to a newly licensed drug called Avandia. The effect was devastating.
'After a month, my feet, legs and thighs suddenly swelled to twice their normal size and I was diagnosed with heart failure,' he says.
'The doctor told me to keep taking the Avandia. Two months later, I passed out.'
Bob spent 10 days in hospital and was diagnosed with heart valve damage, a heart blockage, fluid on the lungs and kidney failure. Neither Bob nor any of his family has a history of heart problems and his doctors now believe these were triggered by the drug.
More at The Daily Mail
Bob Bowen had been diabetic for 18 years when his doctor switched him to a newly licensed drug called Avandia. The effect was devastating.
'After a month, my feet, legs and thighs suddenly swelled to twice their normal size and I was diagnosed with heart failure,' he says.
'The doctor told me to keep taking the Avandia. Two months later, I passed out.'
Bob spent 10 days in hospital and was diagnosed with heart valve damage, a heart blockage, fluid on the lungs and kidney failure. Neither Bob nor any of his family has a history of heart problems and his doctors now believe these were triggered by the drug.
More at The Daily Mail
Wednesday, September 19, 2007
Introducing NPCi (they have a blog as well!)
The UK's National Prescribing Centre (NPC) website has been redesigned and the new educational portal NPCi has been launched.
The NPCi site is “a new and radically different NHS learning resource designed specifically for busy health care professionals and managers“. The site provides access to a host of information including:
- Existing NPC materials including MeReC and On The Horizon publications
- Detailed information covering therapeutic topics
- Detailed information covering medicines management topics
- Discussion rooms
- A blog providing rapid commentary on a recent newsworthy health topics
Hat tip: Matt Robinson
The NPCi site is “a new and radically different NHS learning resource designed specifically for busy health care professionals and managers“. The site provides access to a host of information including:
- Existing NPC materials including MeReC and On The Horizon publications
- Detailed information covering therapeutic topics
- Detailed information covering medicines management topics
- Discussion rooms
- A blog providing rapid commentary on a recent newsworthy health topics
Hat tip: Matt Robinson
The Safe Rx Act of 2007
The pharmaceutical sales representatives who regularly peddle their merchandise to Washington D.C. physicians would have to be licensed under a bill to be considered by the D.C. Council.
“The person who cuts your hair is subject to more government regulation than the person pitching drugs to your doctor,” said Council Member David Catania, chair of the health committee.
Catania on Tuesday introduced the Safe Rx Act of 2007, which he claims will “lead to a safer environment, a more informed environment” for consumers of prescription medications.
More
“The person who cuts your hair is subject to more government regulation than the person pitching drugs to your doctor,” said Council Member David Catania, chair of the health committee.
Catania on Tuesday introduced the Safe Rx Act of 2007, which he claims will “lead to a safer environment, a more informed environment” for consumers of prescription medications.
More
Anyone know who was buying?
A company that distributed human growth hormone to "well known athletes and entertainers" has agreed to pay a $10.5 million penalty and cooperate with law enforcement in ongoing investigations, federal prosecutors said Tuesday.
Under the terms of the agreement, Specialty Distribution Services Inc., a subsidiary of Express Scripts Inc. will not face prosecution for three years if it fully complies with terms of the agreement.
Steve Littlejohn, a spokesman for St. Louis-based Express Scripts, said the company fully cooperated in the federal investigation and has already implemented procedures to prevent the illegal distribution of human growth hormone.
"Express Scripts does not condone the use of human growth hormone for anti-aging, cosmetic or performance enhancement purposes," the company said in a news release.
Specialty Distribution Services "knowingly distributed human growth hormone to certain well known athletes and entertainers, including a well known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement, cosmetic or anti-aging," in violation of federal law, the U.S. attorney's office said in a news release.
Prosecutors did not mention any names of those believed to have bought HGH from the firm.
The drug in question was approved by the Food and Drug Administration only for specific purposes, including treatment of children with growth failure due to inadequate growth hormones, prosecutors said.
Source
Under the terms of the agreement, Specialty Distribution Services Inc., a subsidiary of Express Scripts Inc. will not face prosecution for three years if it fully complies with terms of the agreement.
Steve Littlejohn, a spokesman for St. Louis-based Express Scripts, said the company fully cooperated in the federal investigation and has already implemented procedures to prevent the illegal distribution of human growth hormone.
"Express Scripts does not condone the use of human growth hormone for anti-aging, cosmetic or performance enhancement purposes," the company said in a news release.
Specialty Distribution Services "knowingly distributed human growth hormone to certain well known athletes and entertainers, including a well known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement, cosmetic or anti-aging," in violation of federal law, the U.S. attorney's office said in a news release.
Prosecutors did not mention any names of those believed to have bought HGH from the firm.
The drug in question was approved by the Food and Drug Administration only for specific purposes, including treatment of children with growth failure due to inadequate growth hormones, prosecutors said.
Source
J&J - Ortho Evra: a smoking gun letter?
Johnson & Johnson improperly claimed its Ortho Evra birth-control patch posed a low safety risk to women, a product-safety executive told Chief Executive Officer William Weldon in a 2005 letter, court records show.
The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.
J&J, the world's largest maker of health-care products, faces lawsuits by more than 1,500 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn't publicly identified reserves for the Ortho Evra litigation.
The author investigated an ``unusually high number'' of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. J&J is based in New Brunswick, New Jersey.
The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized ``partial and incomplete'' results of the one that found the patch no riskier than birth control pills. The writer resigned because the company's conduct undermined his ability to evaluate product safety, the letter said.
``I was faced lately with what I considered an inability to exercise this responsibility, which led me to consider a job opportunity outside the company,'' the writer said in the letter dated Oct. 31, 2005, after he left the company.
Much more at Bloomberg
The writer was a vice president who spent seven years at Johnson & Johnson, overseeing benefit and safety risk analysis in reproductive medicine and oncology, according to the letter.
J&J, the world's largest maker of health-care products, faces lawsuits by more than 1,500 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company hasn't publicly identified reserves for the Ortho Evra litigation.
The author investigated an ``unusually high number'' of blood clots caused by the patch and cited more than 20 reported deaths, according to the letter, made public on Aug. 25 by a New Jersey judge who oversaw some of the lawsuits. J&J is based in New Brunswick, New Jersey.
The executive, whose name was removed from the letter, said J&J conducted two studies and emphasized ``partial and incomplete'' results of the one that found the patch no riskier than birth control pills. The writer resigned because the company's conduct undermined his ability to evaluate product safety, the letter said.
``I was faced lately with what I considered an inability to exercise this responsibility, which led me to consider a job opportunity outside the company,'' the writer said in the letter dated Oct. 31, 2005, after he left the company.
Much more at Bloomberg
Tuesday, September 18, 2007
Open Letter to ABC's John Stossel ... from Julie Pierce, American SiCKO
Dear John,
My name is Julie Pierce. My husband was Tracy Pierce. I am featured in Michael Moore's documentary 'SiCKO.' In the movie, I share my deceased husband's story — his unsuccessful battle with our insurance company to receive what could have been life-saving treatments for kidney cancer.
I just read your Wall Street Journal article written on Sept. 13, 2007, titled "Sick Sob Stories." You begin by talking about Tracy's role in 'SiCKO,' and claim the bone marrow transplant denied by our insurer would not have saved him. You also accuse me of "sneering" over our situation.
In your 'reporting' of this story, you did not contact me, and you did not contact my husband's doctors. I cannot believe that a publication like the Wall Street Journal would print such an accusation without talking to anyone involved — especially in such a personal matter, which resulted in the death of my 37-year-old husband and the father of my child.
If you had contacted me, I would have told you that bone marrow transplants became a last option, only after our insurer denied many other treatments again and again and again.
I would have shown you a letter from our doctors at the Blood and Marrow Transplant Program at the University of Kansas Hospital, in which they argued strongly for the bone marrow transplant, citing "strong evidence" supporting the past success of that treatment — they wrote that it could "give him a chance to achieve complete remission." In fact, they called the bone marrow transplant "his only chance of survival."
Instead of calling me up and doing real reporting, all you can do is throw around studies from 1999 about the supposed inefficiency of bone marrow transplants for breast cancer patients — even though Tracy didn't have breasts. He had kidney cancer! I understand that you want to try to prove that private insurance in this country really isn't that bad. And I can see that you won't let the facts get in the way.
You go on to claim that Tracy wouldn't have received his transplant in a country with socialized medicine, either. Where is the evidence? Not only are more bone marrow transplants performed every year in Canada, but they invented the technology! So much for your ridiculous claim that "profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed."
You are simply carrying water for the for-profit insurance industry that killed my husband. And then you have the nerve to accuse me of "sneering" about it. My husband has only been dead since January 18th, 2006. It is still fresh to me and my family, and comments like this are inhumane.
I have since tried to contact you via email, but you have not responded. I don't expect an answer. People like you just write with an agenda, without coming to the source or getting any facts, because your main goal is to try to discredit Michael Moore and universal health care. I understand it's a game — you did it without thinking about how you would hurt a family who have suffered — and are still suffering — such a tragic loss.
My family is not a "Sick Sob Story." We are a normal, American family that has had a significant member die from a horrible cancer that ravaged his body due to repeated denials from a health insurance company. We will never know for sure what would have worked because Tracy was never given a fighting chance. Over 18,000 Americans die each year because they don't have health insurance. I suppose theirs are "sob stories," too.
I don't want a hit-piece. I want answers. Why does our wonderful profit-driven system of medicine kill 18,000 Americans each year? Why do we pay far more for our health system than any other country, but have some of the lowest life expectancies and highest infant mortality rates in the Western world? Would you discredit the work of your late colleague Peter Jennings who, while suffering with lung cancer, did an excellent report titled "Breakdown: America's Health Insurance Crisis"?
I hope you have answers, but I am not optimistic. I pray that you will never have to go through what we went through — if you did, you wouldn't be so quick to cheerlead the system we were victimized by.
Julie Pierce
Mission,
Kansas
More SiCKO news
My name is Julie Pierce. My husband was Tracy Pierce. I am featured in Michael Moore's documentary 'SiCKO.' In the movie, I share my deceased husband's story — his unsuccessful battle with our insurance company to receive what could have been life-saving treatments for kidney cancer.
I just read your Wall Street Journal article written on Sept. 13, 2007, titled "Sick Sob Stories." You begin by talking about Tracy's role in 'SiCKO,' and claim the bone marrow transplant denied by our insurer would not have saved him. You also accuse me of "sneering" over our situation.
In your 'reporting' of this story, you did not contact me, and you did not contact my husband's doctors. I cannot believe that a publication like the Wall Street Journal would print such an accusation without talking to anyone involved — especially in such a personal matter, which resulted in the death of my 37-year-old husband and the father of my child.
If you had contacted me, I would have told you that bone marrow transplants became a last option, only after our insurer denied many other treatments again and again and again.
I would have shown you a letter from our doctors at the Blood and Marrow Transplant Program at the University of Kansas Hospital, in which they argued strongly for the bone marrow transplant, citing "strong evidence" supporting the past success of that treatment — they wrote that it could "give him a chance to achieve complete remission." In fact, they called the bone marrow transplant "his only chance of survival."
Instead of calling me up and doing real reporting, all you can do is throw around studies from 1999 about the supposed inefficiency of bone marrow transplants for breast cancer patients — even though Tracy didn't have breasts. He had kidney cancer! I understand that you want to try to prove that private insurance in this country really isn't that bad. And I can see that you won't let the facts get in the way.
You go on to claim that Tracy wouldn't have received his transplant in a country with socialized medicine, either. Where is the evidence? Not only are more bone marrow transplants performed every year in Canada, but they invented the technology! So much for your ridiculous claim that "profit is what has created the amazing scientific innovations that the U.S. offers to the world. If government takes over, innovation slows, health care is rationed."
You are simply carrying water for the for-profit insurance industry that killed my husband. And then you have the nerve to accuse me of "sneering" about it. My husband has only been dead since January 18th, 2006. It is still fresh to me and my family, and comments like this are inhumane.
I have since tried to contact you via email, but you have not responded. I don't expect an answer. People like you just write with an agenda, without coming to the source or getting any facts, because your main goal is to try to discredit Michael Moore and universal health care. I understand it's a game — you did it without thinking about how you would hurt a family who have suffered — and are still suffering — such a tragic loss.
My family is not a "Sick Sob Story." We are a normal, American family that has had a significant member die from a horrible cancer that ravaged his body due to repeated denials from a health insurance company. We will never know for sure what would have worked because Tracy was never given a fighting chance. Over 18,000 Americans die each year because they don't have health insurance. I suppose theirs are "sob stories," too.
I don't want a hit-piece. I want answers. Why does our wonderful profit-driven system of medicine kill 18,000 Americans each year? Why do we pay far more for our health system than any other country, but have some of the lowest life expectancies and highest infant mortality rates in the Western world? Would you discredit the work of your late colleague Peter Jennings who, while suffering with lung cancer, did an excellent report titled "Breakdown: America's Health Insurance Crisis"?
I hope you have answers, but I am not optimistic. I pray that you will never have to go through what we went through — if you did, you wouldn't be so quick to cheerlead the system we were victimized by.
Julie Pierce
Mission,
Kansas
More SiCKO news
The Scientist - thank you Ed Silverman
The Scientist has been asking people to vote for their fave life science blogs.
Ed Silverman at Pharmalot wrote:
Which blogs do I turn to each day? To be honest, I look at a couple of dozen, and I look at each of them more than once. Why? I'm always curious to find newly unearthed stories (whether it's an originally reported scoop or a link to one); fresh insights into important topics, and a dollop of irreverence. For me, a good blog has a mix of all three, but will also post frequently. More blogs offer these virtues all the time, so choosing just three is difficult.
But over the past few months, I would say the following trio are consistent must-reads for what I do and enjoy....
PharmaGossip: The sly Insider may be anonymous, but we know he's an experienced industry marketing veteran and speaks with the kind of authority that makes clear he's seen it all -- and more. Sure, he can be all over the map with music, political videos and posts that some may find sexist. But Jack Friday -- his nom de pharma -- has a knack for finding cutting-edge items to read and watch. And he has a wicked sense of humor, which is often what's needed to digest some of the news.
The Health Blog from the Wall Street Journal: This blog is a bit of an odd duck. The voice is constrained because the site hews very closely to the tone of the newspaper. As a result, there's little personality, but what makes the site worthwhile is the regular supply of fresh news and analysis. And this is helped along by contributions from WSJ staffers. As a result, this sometimes reads like an extension of the mothership. But the posts -- which veer back and forth between hardcore pharma news and a wide array of health items -- are often timely and reliable.
KevinMD: The doc doesn't blog so much as aggregate. But he's a darned good aggregator. He has a sharp eye for interesting and amusing tales that offer a much-needed peek into the machinations of the medical community. The posts are typically introduced with a pithy line before a link takes you elsewhere. But the variety, frequency and volume of posts makes for an educating and, often, entertaining visit. This is the place to go to learn what doctors are thinking and saying about patients, insurers, drugmakers and even each other.
Thanks Ed. Much appreciated.
Go here to vote.
Ed Silverman at Pharmalot wrote:
Which blogs do I turn to each day? To be honest, I look at a couple of dozen, and I look at each of them more than once. Why? I'm always curious to find newly unearthed stories (whether it's an originally reported scoop or a link to one); fresh insights into important topics, and a dollop of irreverence. For me, a good blog has a mix of all three, but will also post frequently. More blogs offer these virtues all the time, so choosing just three is difficult.
But over the past few months, I would say the following trio are consistent must-reads for what I do and enjoy....
PharmaGossip: The sly Insider may be anonymous, but we know he's an experienced industry marketing veteran and speaks with the kind of authority that makes clear he's seen it all -- and more. Sure, he can be all over the map with music, political videos and posts that some may find sexist. But Jack Friday -- his nom de pharma -- has a knack for finding cutting-edge items to read and watch. And he has a wicked sense of humor, which is often what's needed to digest some of the news.
The Health Blog from the Wall Street Journal: This blog is a bit of an odd duck. The voice is constrained because the site hews very closely to the tone of the newspaper. As a result, there's little personality, but what makes the site worthwhile is the regular supply of fresh news and analysis. And this is helped along by contributions from WSJ staffers. As a result, this sometimes reads like an extension of the mothership. But the posts -- which veer back and forth between hardcore pharma news and a wide array of health items -- are often timely and reliable.
KevinMD: The doc doesn't blog so much as aggregate. But he's a darned good aggregator. He has a sharp eye for interesting and amusing tales that offer a much-needed peek into the machinations of the medical community. The posts are typically introduced with a pithy line before a link takes you elsewhere. But the variety, frequency and volume of posts makes for an educating and, often, entertaining visit. This is the place to go to learn what doctors are thinking and saying about patients, insurers, drugmakers and even each other.
Thanks Ed. Much appreciated.
Go here to vote.
J&J - Belgian job cuts
Belgian pharmaceutical maker Janssen-Cilag will eliminate 688 jobs, the company said Tuesday, as it seeks to put more money into research and development, and as exclusive patent rights to top-selling drugs expire.
The job cuts come less than two months after US parent company Johnson & Johnson said it would reduce its global work force by up to 4%, or up to 4,820 jobs, due to slumping sales of heart stents, its No. 2 anemia drug, Procrit, and looming patent expirations.
Janssen spokesman Stefaan Gijssels said the Belgian unit's decision to cut support services was prompted by the need to focus on research and a shift to more "volume-based" sales.
"We need money to invest in research. Costs in research are increasing rapidly," he said.
Shedding 521 permanent employees and 167 temporary contractors from plants in Beerse and Geel would help the company shave 15 percent off its costs, he said.
Janssen employs 4,723 people in Belgium with over a thousand working for the unit elsewhere in the world.
More
The job cuts come less than two months after US parent company Johnson & Johnson said it would reduce its global work force by up to 4%, or up to 4,820 jobs, due to slumping sales of heart stents, its No. 2 anemia drug, Procrit, and looming patent expirations.
Janssen spokesman Stefaan Gijssels said the Belgian unit's decision to cut support services was prompted by the need to focus on research and a shift to more "volume-based" sales.
"We need money to invest in research. Costs in research are increasing rapidly," he said.
Shedding 521 permanent employees and 167 temporary contractors from plants in Beerse and Geel would help the company shave 15 percent off its costs, he said.
Janssen employs 4,723 people in Belgium with over a thousand working for the unit elsewhere in the world.
More
Profile - AstraZeneca's David Smith
Here's what AZ say about David:As the member of the AstraZeneca Senior Executive Team responsible for Operations, David Smith leads the global Manufacturing and Supply organisation. His aim is to ensure that AstraZeneca becomes the recognised industry leader through sustained supply excellence. David is also responsible for the AstraZeneca Group Safety, Health and Environment, Regulatory Compliance, Purchasing and Engineering functions.
David spent his early career in Pharmaceuticals initially with the Wellcome Foundation in the UK. In 1995 he moved to the US and spent 9 years in the consumer goods sector working for Estee Lauder Inc in New York and the Timberland Co as SVP Global Supply Chain. In 2003 he returned to the pharmaceutical sector and joined Novartis AG based in Switzerland.
David joined AstraZeneca in April 2006 as Executive Vice President of Operations.
Here's what The Times say David said to them:
“Manufacturing for AstraZeneca is not a core activity,” Mr Smith said. “AstraZeneca is about innovation and brand-building . . . There are lots of people and organisations that can manufacture better than we can.”
Looking to AstraZeneca’s ultimate aim, Mr Smith said: “We would own the IP [intellectual property], the research, branding and the quality and safety issues . . . but [everything else] would be outsourced. The idea is to take out as many stages as you can.”
Here's what an AZ PR spinmeister then said:
Staffan Ternby, Director of Public Relations, AstraZeneca Sweden claims there has been a misunderstanding, and that the company only plans on outsourcing manufacturing of the chemicals that go into tablets, which is the first step of manufacturing, not the entire manufacturing process.
Hmmmm!
Well, glad that little misunderstanding has been cleared up!
Merck - Vioxx: "irresponsible and duplicitous"
Seeking to recoup tens of millions spent by government-financed health programs on prescriptions for Vioxx, New York State and New York City joined yesterday in filing a lawsuit against Merck, the drug’s maker, which withdrew the painkiller from the market in 2004 because of dangerous side effects.
The lawsuit, filed yesterday in State Supreme Court in Manhattan, accuses Merck & Company of intentionally concealing the dangers of Vioxx, and therefore defrauding the state Medicaid program, which paid for the prescriptions. The drug was used to treat arthritis and migraines but led to a high risk of heart attacks and strokes.
Several other states have filed similar lawsuits against Merck — more than 25,000 suits have been brought so far — seeking reimbursement for taxpayer dollars spent on purchasing Vioxx and on treating patients for its side effects. The suits have focused on drug pricing and safety, involving both consumer and Medicaid fraud.
“Merck’s irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars,” Attorney General Andrew M. Cuomo said in a statement.
“Even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else.”
More at NYT
The lawsuit, filed yesterday in State Supreme Court in Manhattan, accuses Merck & Company of intentionally concealing the dangers of Vioxx, and therefore defrauding the state Medicaid program, which paid for the prescriptions. The drug was used to treat arthritis and migraines but led to a high risk of heart attacks and strokes.
Several other states have filed similar lawsuits against Merck — more than 25,000 suits have been brought so far — seeking reimbursement for taxpayer dollars spent on purchasing Vioxx and on treating patients for its side effects. The suits have focused on drug pricing and safety, involving both consumer and Medicaid fraud.
“Merck’s irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars,” Attorney General Andrew M. Cuomo said in a statement.
“Even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else.”
More at NYT
Monday, September 17, 2007
Who's data is it anyway?
When he worked in New York City as a pharmaceutical sales rep, Shahram Ahari said he would review the prescribing patterns of psychiatrists in his territory every day.
From his laptop, he would glean the names of the largest prescribers overall and even the doctors giving out the most drugs in a class, such as antidepressants. He would then focus on those high-prescribing doctors, offering them dinners, drug samples, trips and grants.
"I was plying doctors with gifts, and I was seeing changes in their prescribing because they felt indebted to me," said Ahari, now a pharmacy researcher at the University of California, San Francisco, who regrets his past. "This prescribing data is a crucial weapon in the drug rep's arsenal."
That weapon - which is both legal and commonplace - is part of a growing controversy. Critics say the data provide a key opening for drug firms' marketing of doctors.
"It's a critical piece in a machine that is really set up by the pharmaceutical industry to move physicians toward newer and more expensive drugs," said Robert Restuccia, executive director of the Prescription Project, an advocacy group in Boston financed by the Pew Charitable Trusts.
Three states led by New Hampshire have passed laws since mid-2006 restricting the use of this data, and several others are considering such laws.
More at The Philly Inquirer
AstraZeneca to stop making drugs
AstraZeneca, Britain’s second-largest pharmaceutical company, is planning to outsource all its drug manufacturing activities within ten years.
David Smith, AstraZeneca’s executive vice-president of operations, said that the company aimed to become a pure research, development and marketing organisation.
“Manufacturing for AstraZeneca is not a core activity,” Mr Smith said. “AstraZeneca is about innovation and brand-building . . . There are lots of people and organisations that can manufacture better than we can.”
More at The Times .
OK.
But Insider would suggest that, given your recent track record with Exanta and Crestor (to name but two), you're not that hot at innovation or brand-building either!
David Smith, AstraZeneca’s executive vice-president of operations, said that the company aimed to become a pure research, development and marketing organisation.
“Manufacturing for AstraZeneca is not a core activity,” Mr Smith said. “AstraZeneca is about innovation and brand-building . . . There are lots of people and organisations that can manufacture better than we can.”
More at The Times .
OK.
But Insider would suggest that, given your recent track record with Exanta and Crestor (to name but two), you're not that hot at innovation or brand-building either!
Sunday, September 16, 2007
Margaritagate contd. - kerching for Keys firm
Back stories here.
French pharmaceutical giant Sanofi-Aventis agreed to pay $190 million to settle allegations of fraud in the pricing and marketing of a drug used for cancer treatment side effects, the U.S. Justice Department announced Monday.
The case arose from a lawsuit filed under the False Claims Act by Ven-A-Care of the Florida Keys Inc., which will receive about $32 million under the settlement.
Ven-A-Care is a small specialty pharmacy created in the late 1980s that provides infusion, inhalation, and injectable pharmaceuticals to seriously ill outpatients, such as people suffering from AIDS.
The civil settlement involves an alleged scheme by Sanofi-Aventis to artificially inflate the price of the drug Anzemet, increasing the cost of government reimbursements for the drug. U.S. officials say the result was that false Anzemet claims were submitted to federal health programs.
“Corporations cannot continue to mislead the government into paying vastly exaggerated prices by exploiting a health care system based on trust and fair play,” Miami U.S. Attorney R. Alexander Acosta said.
Sanofi-Aventis, based in Paris, said in a statement that the case involved predecessor company Aventis Pharmaceuticals Inc. from September 1997 to June 2004, before the formation of the new company. Sanofi-Aventis acknowledged no wrongdoing.
The bulk of the settlement will be paid to the federal government, with a $10.2 million fund created for states and the District of Columbia to pursue potential Medicaid overpayment claims for the drug. Medicaid is the government-funded health care program for the poor.
In addition, Sanofi-Aventis' subsidiary in the U.S. reached a five-year agreement with the Health and Human Services Department to report sales and manufacturer's prices for its drugs covered by federal programs.
Ven-A-Care is no stranger to whistle-blowing - and big bucks because of it.
In the past, its four partners accused a global pharmaceutical powerhouse of selling drugs to the federal government at illegally inflated prices.
The four split $26 million of the $150 million that GlaxoSmithKline agreed to last September to pay the government to settle claims that it overcharged for two drugs used to treat cancer.
Whistle-blowing - filing lawsuits that expose rip-offs against the government - has paid off before for the pharmacy owners, resulting in rewards now totaling more than $100 million.
“You just start digging, and it starts coming out,” Luis Cobo, a Key West pharmacist who co-owns Ven-A-Care, told the Miami Herald in September.
Source
French pharmaceutical giant Sanofi-Aventis agreed to pay $190 million to settle allegations of fraud in the pricing and marketing of a drug used for cancer treatment side effects, the U.S. Justice Department announced Monday.
The case arose from a lawsuit filed under the False Claims Act by Ven-A-Care of the Florida Keys Inc., which will receive about $32 million under the settlement.
Ven-A-Care is a small specialty pharmacy created in the late 1980s that provides infusion, inhalation, and injectable pharmaceuticals to seriously ill outpatients, such as people suffering from AIDS.
The civil settlement involves an alleged scheme by Sanofi-Aventis to artificially inflate the price of the drug Anzemet, increasing the cost of government reimbursements for the drug. U.S. officials say the result was that false Anzemet claims were submitted to federal health programs.
“Corporations cannot continue to mislead the government into paying vastly exaggerated prices by exploiting a health care system based on trust and fair play,” Miami U.S. Attorney R. Alexander Acosta said.
Sanofi-Aventis, based in Paris, said in a statement that the case involved predecessor company Aventis Pharmaceuticals Inc. from September 1997 to June 2004, before the formation of the new company. Sanofi-Aventis acknowledged no wrongdoing.
The bulk of the settlement will be paid to the federal government, with a $10.2 million fund created for states and the District of Columbia to pursue potential Medicaid overpayment claims for the drug. Medicaid is the government-funded health care program for the poor.
In addition, Sanofi-Aventis' subsidiary in the U.S. reached a five-year agreement with the Health and Human Services Department to report sales and manufacturer's prices for its drugs covered by federal programs.
Ven-A-Care is no stranger to whistle-blowing - and big bucks because of it.
In the past, its four partners accused a global pharmaceutical powerhouse of selling drugs to the federal government at illegally inflated prices.
The four split $26 million of the $150 million that GlaxoSmithKline agreed to last September to pay the government to settle claims that it overcharged for two drugs used to treat cancer.
Whistle-blowing - filing lawsuits that expose rip-offs against the government - has paid off before for the pharmacy owners, resulting in rewards now totaling more than $100 million.
“You just start digging, and it starts coming out,” Luis Cobo, a Key West pharmacist who co-owns Ven-A-Care, told the Miami Herald in September.
Source
Saturday, September 15, 2007
Now AstraZeneca are accused of sloppy science
Poor AZ.
They just can't get a break.
First it was "buckets of money"!
Then comes "bringing the industry into disrepute"!
Now it's "worrying flaws in their animal testing" .
They just can't get a break.
First it was "buckets of money"!
Then comes "bringing the industry into disrepute"!
Now it's "worrying flaws in their animal testing" .
Friday, September 14, 2007
GSK - Avandia: yet more bad news
The push by two British local authority pension funds to lead a US class-action lawsuit against GlaxoSmithKline reveals not just investor impatience with the poorly performing drugs company, but also a new pugnacity among some UK institutions.
The Avon and North Yorkshire funds want to sue the company for allegedly misrepresenting the prospects for its troubled diabetes pill, Avandia.
The Times reports:
It is time to reassess the reputation of Jean-Pierre Garnier.
The chief executive of GlaxoSmithKline, who is set to retire next May, has undoubtedly helped to create one of the world’s biggest pharmaceutical companies. He has also worked hard to find new ways to imbue the company’s research programme with the kind of entrepreneurial spirit usually so lacking at large corporations. And he has been one of the few charismatic showmen of the global healthcare industry, making the public case for greater investment in the treatment of diabetes and cancer and greater government preparedness for potential epidemics such as bird flu.
However, for all his achievements, GSK’s share price has been comatose for years. His company is inundated by problems. Calls for bold action have gone unheeded and the model he has championed – developing drugs from primary research in the laboratory to end use in the hospital – is being questioned.
The scandal over Avandia – the diabetes medicine which in May was linked to a raised risk of heart problems, triggering a slide in sales of the group’s second-best selling product – has concentrated minds.
The Avon and North Yorkshire funds want to sue the company for allegedly misrepresenting the prospects for its troubled diabetes pill, Avandia.
The Times reports:
It is time to reassess the reputation of Jean-Pierre Garnier.
The chief executive of GlaxoSmithKline, who is set to retire next May, has undoubtedly helped to create one of the world’s biggest pharmaceutical companies. He has also worked hard to find new ways to imbue the company’s research programme with the kind of entrepreneurial spirit usually so lacking at large corporations. And he has been one of the few charismatic showmen of the global healthcare industry, making the public case for greater investment in the treatment of diabetes and cancer and greater government preparedness for potential epidemics such as bird flu.
However, for all his achievements, GSK’s share price has been comatose for years. His company is inundated by problems. Calls for bold action have gone unheeded and the model he has championed – developing drugs from primary research in the laboratory to end use in the hospital – is being questioned.
The scandal over Avandia – the diabetes medicine which in May was linked to a raised risk of heart problems, triggering a slide in sales of the group’s second-best selling product – has concentrated minds.
ImClone - mazal tov
ImClone Systems Inc said on Wednesday it was "pure coincidence" that its new chief executive bought $500,000 worth of company stock just days before the value of the shares soared on positive news about ImClone's cancer drug Erbitux.
John Johnson, a former senior executive of Johnson & Johnson, took the helm of ImClone on Aug. 27 after signing a 4-year employment agreement with the New York-based biotechnology company.
Johnson on Friday, Sept. 7, paid $500,000 for 13,609 shares of ImClone, at an average price of $36.74 each. The value of the shares soared 18 percent -- or $6.97 per share -- on Tuesday, Sept. 11, when ImClone reported that Erbitux prolonged the lives of lung cancer patients in a trial sponsored by its European partner Merck KGaA.
"This is 100 percent pure coincidence," ImClone general counsel Daniel O'Connor said in an interview, referring to arrival of the lung cancer data so soon after Johnson's purchase of his ImClone stake, and the speedy return on his investment.
More
John Johnson, a former senior executive of Johnson & Johnson, took the helm of ImClone on Aug. 27 after signing a 4-year employment agreement with the New York-based biotechnology company.
Johnson on Friday, Sept. 7, paid $500,000 for 13,609 shares of ImClone, at an average price of $36.74 each. The value of the shares soared 18 percent -- or $6.97 per share -- on Tuesday, Sept. 11, when ImClone reported that Erbitux prolonged the lives of lung cancer patients in a trial sponsored by its European partner Merck KGaA.
"This is 100 percent pure coincidence," ImClone general counsel Daniel O'Connor said in an interview, referring to arrival of the lung cancer data so soon after Johnson's purchase of his ImClone stake, and the speedy return on his investment.
More
Thursday, September 13, 2007
GSK - Avandia: here comes "Hotshot" Mark Lanier
GlaxoSmithKline hid the risks of its Avandia diabetes drug to protect more than $2 billion in annual sales, according to a lawsuit filed by a lawyer who has won multimillion-dollar verdicts against other drugmakers.
Officials at Glaxo, Europe's biggest drugmaker, knew research showed Avandia users faced an increased risk of heart attack and failed to warn them, attorney Mark Lanier said in the suit filed Sept. 7 in federal court in New York.
Officials at Glaxo, Europe's biggest drugmaker, knew research showed Avandia users faced an increased risk of heart attack and failed to warn them, attorney Mark Lanier said in the suit filed Sept. 7 in federal court in New York.
Lanier, who won a $253 million verdict against Merck & Co. over its withdrawn Vioxx painkiller, sued Glaxo on behalf of Avandia user Frank Curley. Curley suffered a heart attack in 2004.
``Avandia poses significant safety risks due to defects in its design and inadequate labeling,'' Lanier said in the suit, which is seeking more than $100 million in damages.
More at Bloomberg
``Avandia poses significant safety risks due to defects in its design and inadequate labeling,'' Lanier said in the suit, which is seeking more than $100 million in damages.
More at Bloomberg
All aboard the gravy train
Ben Goldacre, a London-based doctor and writer, was a little "surprised" by a recent offer posted in an email on a science writers' mailing list: "It was from the Aspirin Foundation, a group funded by the drug industry, and it was offering -- on behalf of Bayer Healthcare -- to pay expenses for journalists to attend the European Society of Cardiology's conference in Vienna."
On contacting some of his peers, Goldacre discovered that it is "extremely common for journalists to take money from drug companies" some of whom dismissed the suggestion that it could affect how they reported an event. Drug companies, he noted, "wouldn't pay for journalists to attend their events if they didn't think it would affect media coverage of their product.
After all, a journalist's article is far more credible than a paid advertisement, for anybody's money, and more likely to be read by potential consumers."
Source
Insider's view: This was probably the story that was being pushed.
If they write about the junket they should declare who paid for them to go.
It might be worth someone looking to see who wrote what and if they did declare any conflicts of interest!
On contacting some of his peers, Goldacre discovered that it is "extremely common for journalists to take money from drug companies" some of whom dismissed the suggestion that it could affect how they reported an event. Drug companies, he noted, "wouldn't pay for journalists to attend their events if they didn't think it would affect media coverage of their product.
After all, a journalist's article is far more credible than a paid advertisement, for anybody's money, and more likely to be read by potential consumers."
Source
Insider's view: This was probably the story that was being pushed.
If they write about the junket they should declare who paid for them to go.
It might be worth someone looking to see who wrote what and if they did declare any conflicts of interest!
BMS - more big words
Bristol-Myers Squibb, the maker of the most prescribed diabetes pill, is developing three new drugs to target the world's fastest growing disease, each of which carry a $1 billion-a-year sales potential.
The company is teaming with Pfizer and AZ to create two novel medicines that may change how diabetes is treated. A third candidate, now in final testing, is in the same family as Merck & Co.'s Januvia, a drug approved in October that analysts say may bring in $2.5 billion a year.
The first of the new pills could go on sale in two years and by 2011 may generate revenue of $1 billion, adding about 20 cents a share to profit, analysts said. Each holds the promise of surpassing the $2.7 billion in peak revenue from Glucophage, the Bristol-Myers drug available in cheaper generic forms since 2002.
Success could boost shares in a company that only six analysts now rate a buy, among 23 surveyed by Bloomberg.
Insider's view: this from the company that, nearly, brought you....... Pargluva!
The company is teaming with Pfizer and AZ to create two novel medicines that may change how diabetes is treated. A third candidate, now in final testing, is in the same family as Merck & Co.'s Januvia, a drug approved in October that analysts say may bring in $2.5 billion a year.
The first of the new pills could go on sale in two years and by 2011 may generate revenue of $1 billion, adding about 20 cents a share to profit, analysts said. Each holds the promise of surpassing the $2.7 billion in peak revenue from Glucophage, the Bristol-Myers drug available in cheaper generic forms since 2002.
Success could boost shares in a company that only six analysts now rate a buy, among 23 surveyed by Bloomberg.
Insider's view: this from the company that, nearly, brought you....... Pargluva!
Vernalis - big words
Robbie Williams - I dont feel proper
If you go to a hairdressers you end up with a haircut.
Hat tip: Black Kitty
Wednesday, September 12, 2007
Congratulations AstraZeneca UK!
For the number of upheld complaints to the PMCPA recorded for a single promotional item; 27 in all:
• Three breaches of Clause 2 (for bringing the industry into disrepute)
• Five breaches of Clause 9.1 (for not maintaining high standards)
• Five breaches of Clause 10.1 (for conducting disguised promotion)
• One breach of Clause 7.10 (for failing to encourage the rationale use of a medicine)
• Three breaches of Clause 4.1 (for not including prescribing information in the insert)
• Eight breaches of Clauses 7.2 (for making various misleading claims)
• Two breaches of Clause 7.4 (for making claims that were not capable of substantiation).
Is this a record, we ask?
Read all about it here.
GSK - Avandia: bad news, good news
``Whatever statistical study you use, you find that rosiglitazone still increases the risks of heart attack and heart failure,'' said Yoon Loke, a clinical pharmacologist at the University of East Anglia in Norwich, England, and a co-author of another Avandia study in JAMA ``If you get the same results with different methods, this implies the finding is quite robust.''
Meanwhile......
In the same journal comes some possible good news for Takeda's glitazone, Actos.
Hmmm. Lets see!
Time to break out the stress balls, perhaps?
Lee Einer - "mission accomplished"
Ex- insurance company employee and SiCKO movie star Lee is now writing a series of articles for Honest Medicine :
"As I described in SICKO, this is the point at which the insurer will go after you “like it’s a murder case.” They will contact every medical provider they believe treated you, and will request medical records. They will contact every pharmacy which you are believed to have used, and request their records. They will go into your health history as far back as five years before you applied for coverage.
If they find anything -- ANYTHING -- which they determine that you did not fully disclose, and which could conceivably have been captured by the questions on your application, they have you.
Example: Did you have rectal itch, constipation, a belly-ache or heartburn four years ago? Did you tell your doctor? If so, did you remember to disclose this seemingly trivial and forgettable fact fully on your application under “conditions affecting the digestive tract”? If not, the insurer could use this as a pretext to dump you, jack your rates beyond that which you are able to pay or exclude coverage for your present problem.
You will, at that point, have been screwed.
Mission accomplished."
Read the whole article here.
"As I described in SICKO, this is the point at which the insurer will go after you “like it’s a murder case.” They will contact every medical provider they believe treated you, and will request medical records. They will contact every pharmacy which you are believed to have used, and request their records. They will go into your health history as far back as five years before you applied for coverage.
If they find anything -- ANYTHING -- which they determine that you did not fully disclose, and which could conceivably have been captured by the questions on your application, they have you.
Example: Did you have rectal itch, constipation, a belly-ache or heartburn four years ago? Did you tell your doctor? If so, did you remember to disclose this seemingly trivial and forgettable fact fully on your application under “conditions affecting the digestive tract”? If not, the insurer could use this as a pretext to dump you, jack your rates beyond that which you are able to pay or exclude coverage for your present problem.
You will, at that point, have been screwed.
Mission accomplished."
Read the whole article here.
Pfizer - Animal Pharma?
Colin Seller, Pfizer's manufacturing site leader in Kent, UK said of the 420 job cuts: "This decision is no reflection on the performance of our talented and skilled workforce at Sandwich."
Source
Tuesday, September 11, 2007
Medicines: useful poisons
The number of serious adverse drug events reported to the US Food and Drug Administration more than doubled between 1998 and 2005, as did related deaths, according to a new report.
Pain killers and immune-modifying drugs were singled out as the worst culprits by Thomas Moore and colleagues of the Institute for Safe Medication Practices, Huntingdon Valley, Pennsylvania, who analysed all the information obtained by the FDA through its Adverse Event Reporting System during this period.
Their report, in the Archives of Internal Medicine, found that a total of 467,809 serious adverse events were recorded. The annual number of reports increased 2.6-fold between 1998 and 2005, from 34,966 to 89,842 and the number of fatal adverse reactions increased from 5,519 to 15,107 – a 2.7-fold increase.
The FDA defines a serious adverse drug event as one that results in death, a birth defect, disability, hospitalisation, or is life-threatening or requires intervention to prevent harm. Such reports come to the agency directly from health professionals, or from drug manufacturers who are required to forward them.
"The overall relative increase was four times faster than the growth in total US outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion," the authors write. A total of 1,489 drugs were associated with adverse events but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6% of the total adverse event reports in the study.
However, "contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time," the authors write. In the subset of 51 drugs with 500 or more reports in a year, the percentage of reported events associated with drugs related to safety withdrawals declined from 26% in 1999 to less than 1% in 2005.
"Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system," they added, noting that “these data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period".
The authors conclude: "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."
By Michael Day
Source: PharmaTimes
Pain killers and immune-modifying drugs were singled out as the worst culprits by Thomas Moore and colleagues of the Institute for Safe Medication Practices, Huntingdon Valley, Pennsylvania, who analysed all the information obtained by the FDA through its Adverse Event Reporting System during this period.
Their report, in the Archives of Internal Medicine, found that a total of 467,809 serious adverse events were recorded. The annual number of reports increased 2.6-fold between 1998 and 2005, from 34,966 to 89,842 and the number of fatal adverse reactions increased from 5,519 to 15,107 – a 2.7-fold increase.
The FDA defines a serious adverse drug event as one that results in death, a birth defect, disability, hospitalisation, or is life-threatening or requires intervention to prevent harm. Such reports come to the agency directly from health professionals, or from drug manufacturers who are required to forward them.
"The overall relative increase was four times faster than the growth in total US outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion," the authors write. A total of 1,489 drugs were associated with adverse events but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6% of the total adverse event reports in the study.
However, "contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time," the authors write. In the subset of 51 drugs with 500 or more reports in a year, the percentage of reported events associated with drugs related to safety withdrawals declined from 26% in 1999 to less than 1% in 2005.
"Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system," they added, noting that “these data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period".
The authors conclude: "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."
By Michael Day
Source: PharmaTimes
Pfizer - it's tough at the top
``Pfizer's really a slow-moving boat,'' said analyst Les Funtleyder of Miller Tabak & Co. in New York. ``Kindler's got a tough deal. There's not a lot he can necessarily do.''
Source
Erm. OK. So remind me again why he's paid all that money please?
Source
Erm. OK. So remind me again why he's paid all that money please?
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