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Saturday, January 31, 2009
Pfizer - Trovan: bringing it home
Back stories here.
Nigerian families can sue the Pfizer drugs giant in the US over its alleged role in the deaths of children, a US appeals court has ruled.
The decision overturns ruling by a lower court that the case must be heard in Nigeria.
Pfizer is accused of killing 11 children and injuring 181 others when an experimental antibiotic, Trovan, was tested on them during a meningitis epidemic in 1996.
The Nigerian government alleges that Pfizer researchers selected 200 children and infants from crowds at a makeshift epidemic camp in Kano and gave about half of the group Trovan.
Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.
The lawsuit says that the researchers did not obtain consent from the children's families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use."
Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria.
BBC
Nigerian families can sue the Pfizer drugs giant in the US over its alleged role in the deaths of children, a US appeals court has ruled.
The decision overturns ruling by a lower court that the case must be heard in Nigeria.
Pfizer is accused of killing 11 children and injuring 181 others when an experimental antibiotic, Trovan, was tested on them during a meningitis epidemic in 1996.
The Nigerian government alleges that Pfizer researchers selected 200 children and infants from crowds at a makeshift epidemic camp in Kano and gave about half of the group Trovan.
Researchers gave the other children what the lawsuit describes as a dangerously low dose of a comparison drug made by Hoffmann-La Roche. Nigerian officials say Pfizer's actions resulted in the deaths of an unspecified number of children and left others deaf, paralyzed, blind or brain-damaged.
The lawsuit says that the researchers did not obtain consent from the children's families and that the researchers knew Trovan to be an experimental drug with life-threatening side effects that was "unfit for human use."
Parents were banned from the ward where the drug trial occurred, the suit says, and the company left no medical records in Nigeria.
BBC
"It was a very clever sort of con"
"Almost the whole scientific community was conned into thinking — as a consequence of good marketing — that this was a different and better set of drugs. The evidence, as it's all added up, has shown this to be untrue." Dr. Peter Tyrer, a leading psychiatric researcher at Imperial College London
"We have been paying $16 billion a year instead of $2 billion a year for drugs that seem to be no better and might be worse." Douglas Leslie, a researcher at the Medical University of South Carolina
Read the article
"We have been paying $16 billion a year instead of $2 billion a year for drugs that seem to be no better and might be worse." Douglas Leslie, a researcher at the Medical University of South Carolina
Read the article
Friday, January 30, 2009
Lilly / Daiichi Sankyo - Effient: Clot Wars continue
Back stories here. And here.
Food and Drug Administration medical reviewers said the agency should approve Effient (prasugrel), a proposed anti-clotting drug being developed by Eli Lilly and Co. and Daiichi Sankyo Co., but should carry tough warnings about bleeding and cancer risks.
Reviews of Prasugrel by different FDA divisions were posted on the agency's Web site Friday.
The drug faces a review Tuesday by medical experts who serve on the agency's cardiovascular and renal drugs advisory committee. The panel is being asked to recommend if prasugrel should be approved for use in certain patients at risk for a heart attack and, if so, what warnings should be placed on the drug.
Last month, a European Medicines Agency committee issued a positive opinion recommending approval of prasugrel. That opinion will be forwarded to the European Commission which grants approval for drugs in the European Union. The commission usually follows that agency's advice.
More at WSJ
Food and Drug Administration medical reviewers said the agency should approve Effient (prasugrel), a proposed anti-clotting drug being developed by Eli Lilly and Co. and Daiichi Sankyo Co., but should carry tough warnings about bleeding and cancer risks.
Reviews of Prasugrel by different FDA divisions were posted on the agency's Web site Friday.
The drug faces a review Tuesday by medical experts who serve on the agency's cardiovascular and renal drugs advisory committee. The panel is being asked to recommend if prasugrel should be approved for use in certain patients at risk for a heart attack and, if so, what warnings should be placed on the drug.
Last month, a European Medicines Agency committee issued a positive opinion recommending approval of prasugrel. That opinion will be forwarded to the European Commission which grants approval for drugs in the European Union. The commission usually follows that agency's advice.
More at WSJ
Support the "FDA 9" dissident scientists
“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!”
NYT
NYT
Thursday, January 29, 2009
Now GSK stump up for dodgy marketing
GlaxoSmithKline is the latest drugmaker to pay the price for a government investigation of off-label marketing. The company said it’s taking a $400 million hit over a Justice Department investigation of the way Glaxo marketed top drugs.
Glaxo said it would take the charge in its fourth-quarter results due to an investigation initiated by the U.S. attorney’s office in Colorado over “marketing and promotional practices for several products” from 1997 to 2004.
WSJ
Glaxo said it would take the charge in its fourth-quarter results due to an investigation initiated by the U.S. attorney’s office in Colorado over “marketing and promotional practices for several products” from 1997 to 2004.
WSJ
AstraZeneca's job cuts - 6,000 more (or is it 7,400?)
AstraZeneca has reported a 9 percent rise in net profit for 2008 but announced it will cut 6,000 jobs globally by 2013.
In its full-year results, AZ's net profit in 2008 rose to $6.10 billion from $5.60 billion the year before.
Coupled with the cost-cutting measures announced over the last couple of years, these actions will deliver cost savings of $2.5 billion a year at a total cost of $2.9 billion, the company said.
In total, 15,000 jobs will be eliminated over the five-year period. Link
In its full-year results, AZ's net profit in 2008 rose to $6.10 billion from $5.60 billion the year before.
Coupled with the cost-cutting measures announced over the last couple of years, these actions will deliver cost savings of $2.5 billion a year at a total cost of $2.9 billion, the company said.
In total, 15,000 jobs will be eliminated over the five-year period. Link
50 Ways To Leave Big Pharma by Adriane Fugh-Berman, (with apologies to Paul Simon)
The problem’s over-promoted meds, she said to me
You know we’ve got to treat our patients carefully
I'd like to help you to become pharma- free
There must be fifty ways to leave Big Pharma
She said it isn’t education reps provide
And what they know about you they’re unlikely to confide
What they want to do is to control what you prescribe
There must be fifty ways to leave Big Pharma
Fifty ways to leave Big Pharma
Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just get yourself free
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free
Oooh, Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just listen to me
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free
She said it grieves me so that you’re a KOL
Masking marketing as education doesn’t serve us well
I said I resent that but would you please explain
About the fifty ways
She said we owe it to our own integrity
Together we can throw industry out of CME
And then she pinched me and I realized she probably was right
There must be fifty ways to leave Big Pharma
Fifty ways to leave Big Pharma
Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just get yourself free
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free
Oooh, Have the reps take a hike, Mike
Buy your own pen, Jen
You don't need a free meal, Neil
Just listen to me
Throw the samples away, Kay
You don't have to use new drugs
Pay your own CME, Lee
And get yourself free
Lilly - Zyprexa: “How does a company defend itself after pleading guilty?”
Eli Lilly & Co., after pleading guilty and agreeing to spend more than $2.6 billion to settle government and individual claims over its antipsychotic Zyprexa, still faces lawsuits over the drug that might cost the company another $2 billion.
Not part of the settlements were suits by 12 states and a class-action case brought by pension funds, insurance companies and labor unions seeking as much as $6.8 billion. Two state trials are set for this year. Settling all 12 might cost the company another $2 billion, and going to trial would cost more, said Patrick Burns, a spokesman for Taxpayers Against Fraud.
“The total nut on this could be four or five billion” if the company settles, Burns, who tracks the suits, said in an interview. “Their cheapest way of clearing the decks is to settle.”
Burns’s Washington-based group promotes lawsuits to fight fraud against the U.S. government.
The states claim Lilly withheld information about the side effects of Zyprexa, such as diabetes, and encouraged sales of the drug for unapproved, or off-label, purposes. The states asked for damages and fines for violation of laws against deceptive practices and false claims.
More at Bloomberg
Yet part of the previous plea bargain included:
-- While knowing the significant risk for weight gain posed by Zyprexa, Lilly minimized the connection between Zyprexa and weight gain in a widely disseminated videotape called "The Myth of Diabetes" which used "allegedly scientific studies of questionable integrity as well as the haphazard reporting of adverse events;" Link
Not part of the settlements were suits by 12 states and a class-action case brought by pension funds, insurance companies and labor unions seeking as much as $6.8 billion. Two state trials are set for this year. Settling all 12 might cost the company another $2 billion, and going to trial would cost more, said Patrick Burns, a spokesman for Taxpayers Against Fraud.
“The total nut on this could be four or five billion” if the company settles, Burns, who tracks the suits, said in an interview. “Their cheapest way of clearing the decks is to settle.”
Burns’s Washington-based group promotes lawsuits to fight fraud against the U.S. government.
The states claim Lilly withheld information about the side effects of Zyprexa, such as diabetes, and encouraged sales of the drug for unapproved, or off-label, purposes. The states asked for damages and fines for violation of laws against deceptive practices and false claims.
More at Bloomberg
Yet part of the previous plea bargain included:
-- While knowing the significant risk for weight gain posed by Zyprexa, Lilly minimized the connection between Zyprexa and weight gain in a widely disseminated videotape called "The Myth of Diabetes" which used "allegedly scientific studies of questionable integrity as well as the haphazard reporting of adverse events;" Link
Sepracor separate from a fifth of its people
Sepracor, the maker of the Lunesta sleeping pill, said it will cut 530 jobs, or about 20 percent of its workforce.
The Marlborough, Massachusetts-based company plans to eliminate 180 corporate and 350 field-based positions, reducing operating expenses by $210 million through the end of 2009, Sepracor said today in a statement on Business Wire. The company also will eliminate about 410 contract sales positions, according to the statement.
More at Bloomberg
The Marlborough, Massachusetts-based company plans to eliminate 180 corporate and 350 field-based positions, reducing operating expenses by $210 million through the end of 2009, Sepracor said today in a statement on Business Wire. The company also will eliminate about 410 contract sales positions, according to the statement.
More at Bloomberg
Wednesday, January 28, 2009
Time to buy?
The BBC's Robert Peston (aka The Harbinger of Gloom) is in Davos:
The gloom here from business leaders, private-equity specialists, hedgies, bankers, management consultants and economists is deep and unrelenting.
They are immensely pessimistic about the economic outlook and about the ability of governments to lessen the pain.
I'd be tempted to come home immediately and climb under the duvet, except for one thing: when the herd is charging in a particular direction, the herd is normally wrong.
So on the basis that the best time to buy (metaphorically speaking) is when everyone else is selling, just maybe we're near the darkest hour for the global economy.
The gloom here from business leaders, private-equity specialists, hedgies, bankers, management consultants and economists is deep and unrelenting.
They are immensely pessimistic about the economic outlook and about the ability of governments to lessen the pain.
I'd be tempted to come home immediately and climb under the duvet, except for one thing: when the herd is charging in a particular direction, the herd is normally wrong.
So on the basis that the best time to buy (metaphorically speaking) is when everyone else is selling, just maybe we're near the darkest hour for the global economy.
Abbott - Vicodin CR: evergreen fail
Abbott Laboratories fired 200 sales representatives preparing to market Vicodin CR (Continued Revenue) after the company stopped plans to introduce the drug this year, people familiar with the matter said.
The drugmaker said in October that the drug, an extended release form of Vicodin, failed to gain U.S. Food and Drug Administration approval. The company hasn’t released details of the so-called complete response letter from the FDA.
More at Bloomberg
The drugmaker said in October that the drug, an extended release form of Vicodin, failed to gain U.S. Food and Drug Administration approval. The company hasn’t released details of the so-called complete response letter from the FDA.
More at Bloomberg
Astellas go after CV Therapeutics
Astellas Pharma, one of Japan's largest drugmakers, went public yesterday with a $1.1bn bid to buy CV Therapeutics, driving shares of the US biotechnology company above Astellas's offer price as investors bet the unsolicited approach would eventually yield a higher bid.
Astellas is looking to build critical mass in the cardiac treatment area by acquiring CV Therapeutics, which discovers and develops drugs that treat cardiovascular diseases.
More at FT
Astellas is looking to build critical mass in the cardiac treatment area by acquiring CV Therapeutics, which discovers and develops drugs that treat cardiovascular diseases.
More at FT
Tuesday, January 27, 2009
Pharma Giles writes...... in a parallel universe far far away
NEW YORK, NY and MADISON, NJ--January 26, 2009 – Phoni Pharm Inc. and Whyus Co. today announced that they have entered into a python/dead rat “merger” agreement under which Phoni Pharm Inc. (the “python”) will acquire Whyus Co. (the “dead rat”) in a cash-and-stock transaction that is guaranteed to make both Boards of Directors even richer than they are now.
The combined company will ensure that Phoni Pharm Inc. will continue to be the World’s largest intellectual parasite of the global health care industry. Operating through the leveraged take-overs of small, focused enterprises by use of its massive scale and ruthless financial and legal resources, the company will continue to destroy long-term human healthcare innovation solely to support short-term fiscal rewards for its executives and shareholders.
Strategic Overview
Johnny B. Sinister, Chairman and Chief Executive Officer of Phoni Pharm Inc., said, “The combination of Phoni Pharm Inc. and Whyus Co. provides a powerful opportunity to make lots more money for our executives whilst destroying yet another productive R & D-based pharmaceutical company. It will produce the world’s richest biopharmaceutical company whose distinct blend of bureaucracy, greed, and ruthless corporate dishonesty positions it for massive financial success in a dynamic global health care environment.”
“The new company will continue to be an industry leader in downsizing, outsourcing and asset-stripping. With our combined biopharmaceuticals business, it will continue with further leveraged buy-outs of healthy and productive companies in order to make up for its own complete lack of innovation. Its geographic presence in most of the world’s poorest countries will be unrivalled, enabling it to shut down US and EU operations and exploit alternative cheap third-world labour and lax regulation on an unprecedented global scale.”
Bertrand Poisson, Chairman, President and Chief Executive Officer of Whyus Co., said, “Whyus Co.’s commitment to scientific innovation has enabled us to build a diversified biopharmaceutical company with leadership in attractive growth areas such as vaccines, nutritionals and biologics. In addition, because we were early to see the potential of biotechnology to create life-changing medicines, we now have a strong franchise which includes the number one biotechnology product in the world.”
“Our employees should be enormously proud of what we have built, and now they can be confident that by combining with Phoni Pharm Inc., we will accelerate our Board’s pursuit of personnel wealth by selling both them and our unique and innovative culture down the river. So long suckers, and thanks for all the cash...”
Mr. Sinister continued, “With this combination, Phoni Pharm Inc. will reduce patient choice around the world by increasing its stranglehold on broader portfolios of major biopharmaceutical products. By the sheer weight of its financial leverage, Phoni Pharm Inc. will advance its mission of helping its executives toward a wealthier world.”
“Over the last two years, Phoni Pharm Inc. has become a leaner, meaner, and far smaller company that has demonstrated superior and consistent downsizing, demonising and abuse of its existing employees.”
Mr. Sinister added, “Over the last several years, Whyus Co.’s leadership and its employees have done an outstanding job creating a strong, diversified biopharmaceutical company. That made them a prime target for takeover, and we’d like to thank them for that. You can rest assured that the people, products, and technologies that Whyus Co. brings to the new company will be asset-stripped and assimilated in record time.”
A Broad Portfolio of Health Care Solutions and Treatments
The product portfolios of Phoni Pharm. and Whyus will be brought together to offer customers and patients a broad range of products for an unprecedented spectrum of human healthcare requirements,” Mr Sinister continued.
“ For instance, Frantix, Phoni’s blockbusting smoking cessation treatment, offers patients a wide choice of side-effects, such as suicide idealisation and weight gain, in exactly the same way as Whyus’s Effluvium, its largest-selling anti-depressant product, does”.
“And not only that, but Effluvium comes off-patent at exactly the same time as Phoni’s biggest-selling product, our cholesterol-lowering agent Lucrative. So you can see that there is a huge synergy between our major product ranges.”
“It’s the same story with our exciting R&D portfolios,” added Whyus’s Mr. Poisson. “We don’t have any new products, and neither do Phoni. Phoni’s acquisition of Whyus thereby creates a company with an unprecedented absence of global R&D success and innovation.”
For Patients Tomorrow – More “me-toos” and lower quality medicines
The new company will have more resources to invest in research and development than any other biopharmaceutical company and access to all leading scientific technology platforms, including vaccines, small and large molecules, nutritionals and consumer products.
Instead, it will use those resources to pay off tens of thousands of employees to reduce costs and broaden profit margins for the benefit of investors. It will also have to settle a vast legacy of legal settlements for a lengthy list of past illegal activities and product liability actions.
“In fact, news of the take-over gave us a chance to bury the fact that most of last year’s profits at Phoni went on a record legal settlement of our latest off-label marketing scam,” quipped Mr. Sinister.
The new company will have an enhanced ability to close even more sites. Each business unit will oversee product development from clinical trials to commercialization, all in far-eastern subsidiaries. This approach will allow for rapid downsizing and a more financially efficient use of resources and, as a result, will enhance the company’s ability to continue to reward its executives and shareholders with the huge bonuses to which they have become accustomed.
The combination will allow the closure of expensive-to-run high quality and high volume manufacturing capabilities in US and European territories, including the largest integrated biotechnology manufacturing facility in the world, and the transfer of these operations to cheaper and less-heavily regulated subsidiaries in China and Korea.
For Employees Everywhere – no pain, no gain
“The new company will be called ‘PHONI!!!’, to reflect the value placed on its constituent parts,” explained Mr. Sinister, “although we did consider the idea of ‘Whyni’, which in many ways describes our future employees.”
“Regrettably, it is inevitable that some lay-offs will occur in any hostile take-over, sorry, merger, such as this one. Indeed, the only way we were able to persuade the banks to loan us tax-payer’s bail-out cash was to guarantee massive cost-saving redundancies in order to pay the enormous interest rates.”
“However, employees of both companies can be assured that we will be applying our well-established and consistent approach to lay-offs, in line with our corporate policies of Respect, Fairness and Diversity. Thus, all employees who used to work for a company whose name began with a “W” will be downsized, irrespective of race or gender, as against only half of those employees who work for a company whose name begins with a “P”. What could be fairer than that?”
“Given the current economic climate, we will naturally do everything to support those employees who will be selected to participate in our forthcoming salary-withdrawal scheme, “ continued Mr. Sinister.
“As part of our “Shining Path” initiative, we have already begun distribution of free black plastic bags to enable people to clear their desks into, for example. In addition, our highly-trained corporate security staff will escort former employees off site with Dignity and Respect, and have been instructed not to snigger or shout “nee-ner, nee-ner, bye bye loser” at downsizees.”
“It’s practices like these that place Phoni at the forefront of pharmaceutical HR management and will make PHONI!!! such a Great Place To Work, “ enthused Sinister. “Until the next take-over, anyway…”
The combined company will ensure that Phoni Pharm Inc. will continue to be the World’s largest intellectual parasite of the global health care industry. Operating through the leveraged take-overs of small, focused enterprises by use of its massive scale and ruthless financial and legal resources, the company will continue to destroy long-term human healthcare innovation solely to support short-term fiscal rewards for its executives and shareholders.
Strategic Overview
Johnny B. Sinister, Chairman and Chief Executive Officer of Phoni Pharm Inc., said, “The combination of Phoni Pharm Inc. and Whyus Co. provides a powerful opportunity to make lots more money for our executives whilst destroying yet another productive R & D-based pharmaceutical company. It will produce the world’s richest biopharmaceutical company whose distinct blend of bureaucracy, greed, and ruthless corporate dishonesty positions it for massive financial success in a dynamic global health care environment.”
“The new company will continue to be an industry leader in downsizing, outsourcing and asset-stripping. With our combined biopharmaceuticals business, it will continue with further leveraged buy-outs of healthy and productive companies in order to make up for its own complete lack of innovation. Its geographic presence in most of the world’s poorest countries will be unrivalled, enabling it to shut down US and EU operations and exploit alternative cheap third-world labour and lax regulation on an unprecedented global scale.”
Bertrand Poisson, Chairman, President and Chief Executive Officer of Whyus Co., said, “Whyus Co.’s commitment to scientific innovation has enabled us to build a diversified biopharmaceutical company with leadership in attractive growth areas such as vaccines, nutritionals and biologics. In addition, because we were early to see the potential of biotechnology to create life-changing medicines, we now have a strong franchise which includes the number one biotechnology product in the world.”
“Our employees should be enormously proud of what we have built, and now they can be confident that by combining with Phoni Pharm Inc., we will accelerate our Board’s pursuit of personnel wealth by selling both them and our unique and innovative culture down the river. So long suckers, and thanks for all the cash...”
Mr. Sinister continued, “With this combination, Phoni Pharm Inc. will reduce patient choice around the world by increasing its stranglehold on broader portfolios of major biopharmaceutical products. By the sheer weight of its financial leverage, Phoni Pharm Inc. will advance its mission of helping its executives toward a wealthier world.”
“Over the last two years, Phoni Pharm Inc. has become a leaner, meaner, and far smaller company that has demonstrated superior and consistent downsizing, demonising and abuse of its existing employees.”
Mr. Sinister added, “Over the last several years, Whyus Co.’s leadership and its employees have done an outstanding job creating a strong, diversified biopharmaceutical company. That made them a prime target for takeover, and we’d like to thank them for that. You can rest assured that the people, products, and technologies that Whyus Co. brings to the new company will be asset-stripped and assimilated in record time.”
A Broad Portfolio of Health Care Solutions and Treatments
The product portfolios of Phoni Pharm. and Whyus will be brought together to offer customers and patients a broad range of products for an unprecedented spectrum of human healthcare requirements,” Mr Sinister continued.
“ For instance, Frantix, Phoni’s blockbusting smoking cessation treatment, offers patients a wide choice of side-effects, such as suicide idealisation and weight gain, in exactly the same way as Whyus’s Effluvium, its largest-selling anti-depressant product, does”.
“And not only that, but Effluvium comes off-patent at exactly the same time as Phoni’s biggest-selling product, our cholesterol-lowering agent Lucrative. So you can see that there is a huge synergy between our major product ranges.”
“It’s the same story with our exciting R&D portfolios,” added Whyus’s Mr. Poisson. “We don’t have any new products, and neither do Phoni. Phoni’s acquisition of Whyus thereby creates a company with an unprecedented absence of global R&D success and innovation.”
For Patients Tomorrow – More “me-toos” and lower quality medicines
The new company will have more resources to invest in research and development than any other biopharmaceutical company and access to all leading scientific technology platforms, including vaccines, small and large molecules, nutritionals and consumer products.
Instead, it will use those resources to pay off tens of thousands of employees to reduce costs and broaden profit margins for the benefit of investors. It will also have to settle a vast legacy of legal settlements for a lengthy list of past illegal activities and product liability actions.
“In fact, news of the take-over gave us a chance to bury the fact that most of last year’s profits at Phoni went on a record legal settlement of our latest off-label marketing scam,” quipped Mr. Sinister.
The new company will have an enhanced ability to close even more sites. Each business unit will oversee product development from clinical trials to commercialization, all in far-eastern subsidiaries. This approach will allow for rapid downsizing and a more financially efficient use of resources and, as a result, will enhance the company’s ability to continue to reward its executives and shareholders with the huge bonuses to which they have become accustomed.
The combination will allow the closure of expensive-to-run high quality and high volume manufacturing capabilities in US and European territories, including the largest integrated biotechnology manufacturing facility in the world, and the transfer of these operations to cheaper and less-heavily regulated subsidiaries in China and Korea.
For Employees Everywhere – no pain, no gain
“The new company will be called ‘PHONI!!!’, to reflect the value placed on its constituent parts,” explained Mr. Sinister, “although we did consider the idea of ‘Whyni’, which in many ways describes our future employees.”
“Regrettably, it is inevitable that some lay-offs will occur in any hostile take-over, sorry, merger, such as this one. Indeed, the only way we were able to persuade the banks to loan us tax-payer’s bail-out cash was to guarantee massive cost-saving redundancies in order to pay the enormous interest rates.”
“However, employees of both companies can be assured that we will be applying our well-established and consistent approach to lay-offs, in line with our corporate policies of Respect, Fairness and Diversity. Thus, all employees who used to work for a company whose name began with a “W” will be downsized, irrespective of race or gender, as against only half of those employees who work for a company whose name begins with a “P”. What could be fairer than that?”
“Given the current economic climate, we will naturally do everything to support those employees who will be selected to participate in our forthcoming salary-withdrawal scheme, “ continued Mr. Sinister.
“As part of our “Shining Path” initiative, we have already begun distribution of free black plastic bags to enable people to clear their desks into, for example. In addition, our highly-trained corporate security staff will escort former employees off site with Dignity and Respect, and have been instructed not to snigger or shout “nee-ner, nee-ner, bye bye loser” at downsizees.”
“It’s practices like these that place Phoni at the forefront of pharmaceutical HR management and will make PHONI!!! such a Great Place To Work, “ enthused Sinister. “Until the next take-over, anyway…”
Pfizer - Bextra: how to hide $ 2.3 billion
FiercePharma writes:
News of the Pfizer-Wyeth merger this morning drowned out some not so good news for the company. Just after announcing its $68 billion buyout of Wyeth, Pfizer published its 2008 fourth quarter earnings report. In it, Pfizer reveals a $2.3 billion charge to end investigations into allegations of off-label promotions of the company's COX-2 meds, including Bextra.
That settlement caused a 90 percent reduction in Pfizer's 2008 net income, according to its financial report.
Pfizer settled another set of lawsuits involving Bextra for $894 million last October. But the company seems to have been hiding this news in plaint sight, says BNET, pointing out that Pfizer reported the DOJ investigations to the SEC, but never revealed them in press releases.
News of the Pfizer-Wyeth merger this morning drowned out some not so good news for the company. Just after announcing its $68 billion buyout of Wyeth, Pfizer published its 2008 fourth quarter earnings report. In it, Pfizer reveals a $2.3 billion charge to end investigations into allegations of off-label promotions of the company's COX-2 meds, including Bextra.
That settlement caused a 90 percent reduction in Pfizer's 2008 net income, according to its financial report.
Pfizer settled another set of lawsuits involving Bextra for $894 million last October. But the company seems to have been hiding this news in plaint sight, says BNET, pointing out that Pfizer reported the DOJ investigations to the SEC, but never revealed them in press releases.
Pfizer Wyeth contd. - 19,500
Pfizer said it would eliminate about 19,500 jobs from the combined companies over the next three years if the deal is consummated. Pfizer’s chief executive, Jeffrey B. Kindler, said that even without the deal, the company planned to cut 8,000 jobs by 2012. The company has about 4,500 employees in the city, about 1,600 in New Jersey and 5,000 in Connecticut.
Monday, January 26, 2009
Pfizer Wyeth contd. - Pharma Giles writes
The business analysts like the deal so it must be OK... Just like they thought lending money they didn't have to people who couldn't pay it back was a good thing...
Sunday, January 25, 2009
The bankers who broke Britain
Chairman Sir Tom McKillop, Sir Fred Goodwin, Andy Hornby and Dennis Stevenson
Wyeth's Bernard Poussot
Pfizer kind of operates like the aliens from Independence Day: they’re like locusts. They’re moving from pharma to pharma… their whole organization. After they’ve consumed every natural resource they move on… and Wyeth’s next.
Wyeth - Prempro and Premarin: medical education or drug pushing
The conclusions were clear: Women who took hormone therapy drugs were at increased risk for breast cancer, heart disease, stroke and blood clots.
The findings were so strong that researchers stopped a clinical trial in 2002, five years early, because it would have been unethical to continue giving the drugs to women.
But that same year, the University of Wisconsin-Madison's School of Medicine and Public Health began a medical education program for doctors that promoted hormone therapy, touted its benefits and downplayed its risks.
For the next six years, thousands of doctors from around the country took the online course that was funded entirely by a $12 million grant from Wyeth Pharmaceuticals, which makes the hormone therapy drugs used in the study, Prempro and Premarin.
The university received $1.5 million of that total, and university faculty received money as well.
Even after the course was no longer available, the Web site and course material remained on the Internet, accessible to consumers and doctors.
The university dropped the site Jan. 15, one day after the Journal Sentinel began questioning UW officials about the propriety of the program.
More
The findings were so strong that researchers stopped a clinical trial in 2002, five years early, because it would have been unethical to continue giving the drugs to women.
But that same year, the University of Wisconsin-Madison's School of Medicine and Public Health began a medical education program for doctors that promoted hormone therapy, touted its benefits and downplayed its risks.
For the next six years, thousands of doctors from around the country took the online course that was funded entirely by a $12 million grant from Wyeth Pharmaceuticals, which makes the hormone therapy drugs used in the study, Prempro and Premarin.
The university received $1.5 million of that total, and university faculty received money as well.
Even after the course was no longer available, the Web site and course material remained on the Internet, accessible to consumers and doctors.
The university dropped the site Jan. 15, one day after the Journal Sentinel began questioning UW officials about the propriety of the program.
More
Pfizer Wyeth contd. - who said this?
"If one big company makes a move, I can absolutely imagine that triggering off a series of moves. The industry has historically habitually demonstrated its inability to sit on its hands when someone moves. "
Answer
Answer
Saturday, January 24, 2009
Friday, January 23, 2009
Are Pfizer buying Wyeth?
Pfizer the world's largest drug maker by revenue, is in talks to acquire rival Wyeth in a deal that could be valued at more than $60 billion (44 billion pounds), the Wall Street Journal reported on its website, citing people familiar with the matter.
Thursday, January 22, 2009
Extra extra, read all about it!
The National Prescribing Centre (NPC) has published MeReC Extra 37 (PDF).
This MeReC discusses recent concerns regarding the cardiovascular safety of anticholinergics in chronic obstructive pulmonary disease (COPD). These concerns were raised in a recent meta-analysis however the data are not conclusive and more work is required. The article recommends discussing the risks and benefits of treatment with patients and provides numerical data for heart attacks in comparison to reductions in exacerbations and hospital admissions.
This publication also discusses recent research that indicated a lack of benefit for aspirin in primary prevention of cardiovascular events in patients with diabetes. The study in question was too small to definitively rule out a benefit for aspirin however it is still important to manage cardiovascular risk factors in people with diabetes mellitus including smoking cessation, blood pressure management and treatment with a statin.
Hat tip: http://www.prescriber.org.uk/
This MeReC discusses recent concerns regarding the cardiovascular safety of anticholinergics in chronic obstructive pulmonary disease (COPD). These concerns were raised in a recent meta-analysis however the data are not conclusive and more work is required. The article recommends discussing the risks and benefits of treatment with patients and provides numerical data for heart attacks in comparison to reductions in exacerbations and hospital admissions.
This publication also discusses recent research that indicated a lack of benefit for aspirin in primary prevention of cardiovascular events in patients with diabetes. The study in question was too small to definitively rule out a benefit for aspirin however it is still important to manage cardiovascular risk factors in people with diabetes mellitus including smoking cessation, blood pressure management and treatment with a statin.
Hat tip: http://www.prescriber.org.uk/
The patent cliff
Over 100 pharmaceutical patents are set to expire by end-2009, including those for 13 major products, and the Big Pharma firms which will be most affected are GlaxoSmithKline and Pfizer, followed by Novartis and Takeda. However, only a few of the newly off-patent products will show sufficient viability and market potential for generic drugmakers to pursue, according to new forecasts from Global Insight.
2008 saw some high-value drugs go off-patent - including Merck & Co's Fosamax (alendronate), Pfizer's Camptosar (irinotecan) and Wyeth's Effexor XR (venlafaxine) - widening the market presence of generics drug makers and creating an unexpected dent in the revenue structure of several Big Pharma players, says the report.
More
2008 saw some high-value drugs go off-patent - including Merck & Co's Fosamax (alendronate), Pfizer's Camptosar (irinotecan) and Wyeth's Effexor XR (venlafaxine) - widening the market presence of generics drug makers and creating an unexpected dent in the revenue structure of several Big Pharma players, says the report.
More
Wednesday, January 21, 2009
No free convention
A major medical group has canceled a multimillion-dollar convention in Boston, citing the state’s new law cracking down on free gifts, meals and other goodies handed out to doctors by the pharmaceutical industry.
Other life-sciences groups, meanwhile, are sending strong signals that they also won’t hold conventions in Boston as long as the state’s new law remains unclear and out of sync with industry gift-giving standards.
In a letter to the Massachusetts Convention Center Authority, the executive director of the American Academy of Allergy, Asthma & Immunology said it was pulling out of its 2015 convention contract in Boston because it’s “very difficult” to find sponsorships and to provide education courses under current legal conditions.
More
Other life-sciences groups, meanwhile, are sending strong signals that they also won’t hold conventions in Boston as long as the state’s new law remains unclear and out of sync with industry gift-giving standards.
In a letter to the Massachusetts Convention Center Authority, the executive director of the American Academy of Allergy, Asthma & Immunology said it was pulling out of its 2015 convention contract in Boston because it’s “very difficult” to find sponsorships and to provide education courses under current legal conditions.
More
Tuesday, January 20, 2009
"Offshoring" drug trials to India
Medical experiments are being conducted on society's most vulnerable, says Indian doctor Amar Jesani in Wemos' internet film on clinical drug trials in developing countries.
Amar Jesani is a medical doctor from India with expertise in medical ethics and human rights. He is a founder member of the Indian Journal of Medical Ethics (IJME), the Centre for Studies in Ethics and Rights (CSER) and the Centre for Enquiry into Health and Allied Themes (CEHAT).
In 2005 and 2007, Dr Jesani coordinated the 1st and 2nd National Bioethics Conferences in India. He is a national faculty member of the Indian Council of Medical Research and teaches bioethics at various Indian institutions. He also serves as a member of several ethical review committees. His work on human rights includes being a member of the former Human Rights Steering Group of the British Medical Association.
Dr Jesani and Wemos have been working together to address the issue of unethical drug testing in developing countries since 2007.
This film was made during a visit of Dr Jesani to Wemos in September 2008 and produced for Wemos by Lookright films.
AstraZeneca - Seroquel: "Paging Dr Pepper - you're wanted on the diabetes ward"
Patients taking AstraZeneca’s antipsychotic Seroquel have an almost 400% increased risk of developing diabetes, an endocrinologist has told a US court.
The court case is the first case to trial of about 9,000 US lawsuits against the Anglo-Swedish drugmaker over claims Seroquel (quetiapine) is linked to diabetes and other conditions.
Jennifer Marks, a Miami-based endocrinologist, is testifying in a pre-trial hearing on behalf of Linda Guinn, who claims the use of Seroquel caused her diabetes. “Seroquel is a substantial factor in diabetes and weight gain,” Marks told the court, a Bloomberg.com report said.
According to a 2004 study, published in a journal of the American Psychiatric Association, which compared newer antipsychotics with first-generation drugs, males who took Seroquel for at least 60 days had an increased risk in diabetes. Meanwhile, a US Food and Drug Administration study in 2004 found reports of high glucose levels matched an increase in Seroquel prescriptions between 1997 and 2002. Both studies, along with four others, were cited by Marks as evidence of a link with diabetes.
AstraZeneca defended the drug in an interview with Bloomberg. “This is a minute selection of the scientific data available on Seroquel. The totality of the evidence that has been presented to the FDA shows that Seroquel is safe and effective,” said spokesman Tony Jewell.
The company is aiming to bar the testimony on the grounds of contradictory studies. However, the company is facing problems in getting its once-daily extended-release version of the drug approved in the US for major depressive disorder after the FDA requested more information before it would consider approving the new indication.
Further details have not been disclosed.
By Katrina Megget
PharmaTimes
The court case is the first case to trial of about 9,000 US lawsuits against the Anglo-Swedish drugmaker over claims Seroquel (quetiapine) is linked to diabetes and other conditions.
Jennifer Marks, a Miami-based endocrinologist, is testifying in a pre-trial hearing on behalf of Linda Guinn, who claims the use of Seroquel caused her diabetes. “Seroquel is a substantial factor in diabetes and weight gain,” Marks told the court, a Bloomberg.com report said.
According to a 2004 study, published in a journal of the American Psychiatric Association, which compared newer antipsychotics with first-generation drugs, males who took Seroquel for at least 60 days had an increased risk in diabetes. Meanwhile, a US Food and Drug Administration study in 2004 found reports of high glucose levels matched an increase in Seroquel prescriptions between 1997 and 2002. Both studies, along with four others, were cited by Marks as evidence of a link with diabetes.
AstraZeneca defended the drug in an interview with Bloomberg. “This is a minute selection of the scientific data available on Seroquel. The totality of the evidence that has been presented to the FDA shows that Seroquel is safe and effective,” said spokesman Tony Jewell.
The company is aiming to bar the testimony on the grounds of contradictory studies. However, the company is facing problems in getting its once-daily extended-release version of the drug approved in the US for major depressive disorder after the FDA requested more information before it would consider approving the new indication.
Further details have not been disclosed.
By Katrina Megget
PharmaTimes
"Buying the Pharm" - Cashenin XR
Watch the video clip!
A clip from the documentary "Buying the Pharm" in which actor Jason Klamm improvises as pharma salesman Dan Jarvis selling the all-purpose drug "Cashenin XR."
Here's how Jason was trained!
A clip from the documentary "Buying the Pharm" in which actor Jason Klamm improvises as pharma salesman Dan Jarvis selling the all-purpose drug "Cashenin XR."
Here's how Jason was trained!
Nissen on the FDA
"I think the FDA has lost its way in terms of its mission. ... It is truly a failed agency. We have to change the culture." -- Dr. Steve Nissen, chairman of Cleveland Clinic's department of cardiovascular medicine.
Attention drug reps
The overall size of the drug industry's U.S. sales force declined 10% to about 92,000 last year from a peak of about 102,000 in 2005, according to SDI. Pharmaceutical companies had built up giant sales forces throughout the 1990s and early 2000s.
ZS Associates, a sales strategy consulting firm, predicts the size of the U.S. sales force industrywide will drop by another 20% to as low as 70,000 by 2015.
Monday, January 19, 2009
Lilly - Viva Zyprexa contd.: "5 at 5pm"!
These two ex-Lilly drug reps have become multi-millionaires!
The qui tam Complaints were filed on behalf of Steven Woodward, a former Lilly Long Term Care ("LTC") Zyprexa sales representatives from Florida and Jaydeen Vicente a former Lilly LTC representative from California. The Complaints were the first qui tam claims to focus on off-label marketing in Lilly's Long Term Care Sales division.
The Complaints allege that Lilly established a LTC sales force created for a singular purpose - to promote Zyprexa exclusively off-label by extolling the drug's efficacy for a litany of non-indicated uses to control through sedation elderly nursing home residents exhibiting symptoms of agitation, anxiety, insomnia. Lilly staffed the LTC sales force with 180 "specialty" sales representatives, chosen for their special skill sets that translated into heightened aptitude for selling. Lilly's aggressive LTC sales approach succeeded. According to the Woodward and Vicente complaints, the off-label Zyprexa revenues generated per LTC sales representative far exceeded the revenues generated per representative in any other Zyprexa sales division.
According to Deming, Lilly had no legitimate purpose in creating a sales force to call upon nursing homes and other elder care facilities because Zyprexa is not approved for any use in that patient population in addition to the fact that the typical residents of these homes were not schizophrenic or bipolar. "Our clients questioned their superiors about the legality of Lilly's Zyprexa marketing practices," explained Deming, "but they were instructed that as long as they adhered to Lilly's LTC marketing message, the LTC marketing tactics were not illegal."
Because of the lack of any FDA-approved use in the LTC demographic, LTC sales representatives were instructed to focus on "behavior treatment," i.e., Zyprexa's efficacy in treating disruptive and combative patients and patients exhibiting signs of anxiety, depression, and loss of concentration who were demanding of caregiver time and effort. Lilly's Zyprexa marketing arm, the Zyprexa Brand Team, created marketing tools tailored to the LTC symptom-based sales message, such as colorful visual detail aids that stressed Zyprexa's ability to "restore calm" in elderly patients.
Because one of Zyprexa's primary side effects is somnolence or drowsiness, Zyprexa was often used to sedate patients, a practice that was commonly referred to as "snowing." According to Kenney, "Lilly even devised a LTC sales slogan used nationwide - '5 at 5 pm,' which was shorthand for dosing elderly patients with 5 milligrams of Zyprexa at 5 pm to keep patients calm throughout the night." "It's particularly disturbing that such a potent drug, with so many serious adverse side effects, was so blatantly abused in a vulnerable patient population whose health is already at risk," stated Kenney. Kenney added that "at many nursing homes this potent antipsychotic was essentially used as a 'chemical restraint' for the elderly for whom Zyprexa had no other health benefit."
The Zyprexa's label currently bears a black box warning, the FDA's strongest warning, cautioning of the increased risk of death when Zyprexa is used to treat elderly patients with dementia. According to Deming, "prescribing atypical antipsychotics like Zyprexa off-label to treat behavioral disorders in elderly patients with dementia has been shown in clinical studies to be associated with nearly a two-fold increase in mortality, primarily due either to heart-related events, such as heart failure and sudden death, or to infections such as pneumonia."
More
The qui tam Complaints were filed on behalf of Steven Woodward, a former Lilly Long Term Care ("LTC") Zyprexa sales representatives from Florida and Jaydeen Vicente a former Lilly LTC representative from California. The Complaints were the first qui tam claims to focus on off-label marketing in Lilly's Long Term Care Sales division.
The Complaints allege that Lilly established a LTC sales force created for a singular purpose - to promote Zyprexa exclusively off-label by extolling the drug's efficacy for a litany of non-indicated uses to control through sedation elderly nursing home residents exhibiting symptoms of agitation, anxiety, insomnia. Lilly staffed the LTC sales force with 180 "specialty" sales representatives, chosen for their special skill sets that translated into heightened aptitude for selling. Lilly's aggressive LTC sales approach succeeded. According to the Woodward and Vicente complaints, the off-label Zyprexa revenues generated per LTC sales representative far exceeded the revenues generated per representative in any other Zyprexa sales division.
According to Deming, Lilly had no legitimate purpose in creating a sales force to call upon nursing homes and other elder care facilities because Zyprexa is not approved for any use in that patient population in addition to the fact that the typical residents of these homes were not schizophrenic or bipolar. "Our clients questioned their superiors about the legality of Lilly's Zyprexa marketing practices," explained Deming, "but they were instructed that as long as they adhered to Lilly's LTC marketing message, the LTC marketing tactics were not illegal."
Because of the lack of any FDA-approved use in the LTC demographic, LTC sales representatives were instructed to focus on "behavior treatment," i.e., Zyprexa's efficacy in treating disruptive and combative patients and patients exhibiting signs of anxiety, depression, and loss of concentration who were demanding of caregiver time and effort. Lilly's Zyprexa marketing arm, the Zyprexa Brand Team, created marketing tools tailored to the LTC symptom-based sales message, such as colorful visual detail aids that stressed Zyprexa's ability to "restore calm" in elderly patients.
Because one of Zyprexa's primary side effects is somnolence or drowsiness, Zyprexa was often used to sedate patients, a practice that was commonly referred to as "snowing." According to Kenney, "Lilly even devised a LTC sales slogan used nationwide - '5 at 5 pm,' which was shorthand for dosing elderly patients with 5 milligrams of Zyprexa at 5 pm to keep patients calm throughout the night." "It's particularly disturbing that such a potent drug, with so many serious adverse side effects, was so blatantly abused in a vulnerable patient population whose health is already at risk," stated Kenney. Kenney added that "at many nursing homes this potent antipsychotic was essentially used as a 'chemical restraint' for the elderly for whom Zyprexa had no other health benefit."
The Zyprexa's label currently bears a black box warning, the FDA's strongest warning, cautioning of the increased risk of death when Zyprexa is used to treat elderly patients with dementia. According to Deming, "prescribing atypical antipsychotics like Zyprexa off-label to treat behavioral disorders in elderly patients with dementia has been shown in clinical studies to be associated with nearly a two-fold increase in mortality, primarily due either to heart-related events, such as heart failure and sudden death, or to infections such as pneumonia."
More
Attention UK KOL's - time to get your tax returns in order
The UK might soon follow US pharma companies by publicly declaring payments made to key opinion leaders.
David Gillen, Pfizer UK's medical director, has said industry leaders in the UK and Europe now at least have to consider making public the payments in order to disprove impropriety or undue influence.
Speaking in an exclusive Pharmafocus interview, Gillen admits the UK pharma industry has made errors around transparency over the years, and that it must find a way to restore its image. He hints that this is incompatible with the current model of funding for medical education.
"It seems to me that we put money in [to medical education] and we get criticised for it. So something there has got to change," said Gillen.
The US operations of Pfizer and rivals GSK, Lilly and Merck have announced plans to declare such payments, ahead of new legislation that will oblige companies to do so, and it seems companies in the UK and Europe may follow suit.
Pressure for change has grown considerably in recent years. Suspicions that pharma-doctor relationships are tainted by large payments have damaged pharma's reputation, despite protestations that the relations are ethical.
Gillen is a member of a working party made up of Royal College of Physicians members and representatives from UK pharma.
Here's PharmaGossip's submission to the working party.
The group has met regularly over the past 12 months to examine the challenges involved in creating the ideal relationship between doctors and industry.
A report written by Lancet editor and the working party's chairman Richard Horton due in February will reveal their conclusions.
"It's about trying to reconstruct this relationship, which has got to a place where it shouldn't be," said Gillen.
He believes the findings of the project will have an impact on a global level. "If you look at where this reputational change can start, it can start here, and we can maybe change the industry's reputation around the world."
Gillen also believes the industry needs to improve transparency around clinical studies.
More
David Gillen, Pfizer UK's medical director, has said industry leaders in the UK and Europe now at least have to consider making public the payments in order to disprove impropriety or undue influence.
Speaking in an exclusive Pharmafocus interview, Gillen admits the UK pharma industry has made errors around transparency over the years, and that it must find a way to restore its image. He hints that this is incompatible with the current model of funding for medical education.
"It seems to me that we put money in [to medical education] and we get criticised for it. So something there has got to change," said Gillen.
The US operations of Pfizer and rivals GSK, Lilly and Merck have announced plans to declare such payments, ahead of new legislation that will oblige companies to do so, and it seems companies in the UK and Europe may follow suit.
Pressure for change has grown considerably in recent years. Suspicions that pharma-doctor relationships are tainted by large payments have damaged pharma's reputation, despite protestations that the relations are ethical.
Gillen is a member of a working party made up of Royal College of Physicians members and representatives from UK pharma.
Here's PharmaGossip's submission to the working party.
The group has met regularly over the past 12 months to examine the challenges involved in creating the ideal relationship between doctors and industry.
A report written by Lancet editor and the working party's chairman Richard Horton due in February will reveal their conclusions.
"It's about trying to reconstruct this relationship, which has got to a place where it shouldn't be," said Gillen.
He believes the findings of the project will have an impact on a global level. "If you look at where this reputational change can start, it can start here, and we can maybe change the industry's reputation around the world."
Gillen also believes the industry needs to improve transparency around clinical studies.
More
Saturday, January 17, 2009
AstraZeneca's IP "meltdown"
Shares in AstraZeneca were under pressure yesterday after analysts at ING said the Anglo-Swedish drugs giant was on the brink of an intellectual property meltdown.
The broker said that while many investors are aware that the pharmaceuticals industry is facing challenging patent expires, with tough generic competition, the situation is much more serious than investors realise.
ING believes Astra will be the single worst-affected company over the coming years and is forecasting a 40 per cent decline in earnings between 2009 and 2013. It said the group’s early-stage pipeline of products is unlikely to be profitable, even if successful, before 2015, and that cuts in infrastructure and research and development may be necessary, which in turn could force the company to license promising R&D candidates to other groups.
The broker said that while many investors are aware that the pharmaceuticals industry is facing challenging patent expires, with tough generic competition, the situation is much more serious than investors realise.
ING believes Astra will be the single worst-affected company over the coming years and is forecasting a 40 per cent decline in earnings between 2009 and 2013. It said the group’s early-stage pipeline of products is unlikely to be profitable, even if successful, before 2015, and that cuts in infrastructure and research and development may be necessary, which in turn could force the company to license promising R&D candidates to other groups.
Friday, January 16, 2009
Pfizer rips reps
Pfizer the world’s biggest drugmaker, may fire almost a third of its U.S. sales force, or as many as 2,400 workers, in a plan under consideration by senior management, people familiar with the discussions said.
The firings, which will include middle managers, add to more than 14,000 jobs already chopped by Kindler in two years, as he has closed research labs and broken the company into smaller units. Pfizer needs to reduce spending because it doesn’t have enough new products to replace the more than $12 billion in revenue it will begin losing in three years when its top-selling Lipitor cholesterol pill loses patent protection.
More at Bloomberg
The firings, which will include middle managers, add to more than 14,000 jobs already chopped by Kindler in two years, as he has closed research labs and broken the company into smaller units. Pfizer needs to reduce spending because it doesn’t have enough new products to replace the more than $12 billion in revenue it will begin losing in three years when its top-selling Lipitor cholesterol pill loses patent protection.
More at Bloomberg
Dr Peter Wilmshurst - an appeal
Dr Peter Wilmshurst is a previous recipient of the HealthWatch Award (in 2003) for his courage in challenging misconduct in academic medical research.
He is now being sued for libel and slander by NMT Medical, based in the US, who are the manufacturers of a device (STARFlex).
He was one of two principal co-investigators in a clinical trial to test whether using the STARFlex device to close a hole between the right and left atriums of the heart (patent foramen ovale) would reduce the incidence of migraine, particularly migraine with aura.
The published results of the trial were negative. Dr Wilmshurst, who supported the idea that closing such shunts might affect migraine, later put forward several ideas why the results were negative, with which the company disagreed. He is now being sued in a British court. See the full news story from the BMJ.
HealthWatch offers an Award annually to the person we think has done most to explain why clinical trials, which are usually very valuable, may sometimes be unreliable. One of the reasons is that the researchers may falsify their data. Exposing this bad practice usually requires a whistleblower who thereby puts his own career in peril. In 2003 we honoured Peter Wilmshurst for doing exactly that, and we hope it may have encouraged others to do likewise. He has now done a similar service concerning the device promoted by NMT.
HealthWatch is supporting Peter Wilmshurst, and we are appealing for funds to meet his very considerable legal expenses. All donations will be held as a ring-fenced fund in the HealthWatch accounts.
Please send donations (cheques payable to HealthWatch) to the Treasurer, Anne Raikes, 89 Elm Bank Gardens, London SW13 0NX.
http://www.healthwatch-uk.org/
If you are a UK taxpayer, please also complete and sign the gift aid form, available by clicking here. This will allow HealthWatch to reclaim basic rate income tax on your donation, and so increase its value. If you are a higher rate tax payer, you can reclaim the difference between higher and basic rate tax on your donation.
Pharma Giles writes
Question is, was she on the executive committee who devised Pfizer's latest R&D cost-saving initiative?
Police are not looking for anyone else connected with the incident, needless to say.
Thursday, January 15, 2009
Lilly - Zyprexa: whistleblowers will get 18% and become millionaires
Pharmaceutical giant Eli Lilly & Company ("Lilly") will pay federal and state governments more than $1.4 billion to remedy a wide-ranging, off-label marketing scheme for its prescription drug, Zyprexa(R). This settlement is the largest qui tam settlement in the history of the False Claims Act.
Stephen A. Sheller, a well-known mass tort and class action lawyer from Philadelphia, filed the first Complaint in the case in February 2003, bringing the off-label drug allegations to the government under seal as required by law. Today, after six years, the Department of Justice settled with Lilly the allegations that six former Lilly drug marketing representative whistleblowers brought to Sheller.
Lilly will pay more than $1.4 billion for its illegal off-label marketing of the antipsychotic drug, the U.S. Attorney's Office for the Eastern District of Pennsylvania announced. Zyprexa is Lilly's top-selling drug with worldwide sales of nearly $40 billion since its approval in 1996.
In today's settlement, Lilly will pay $800 million in civil penalties and plead guilty to criminal charges, paying an additional $600 million fine. The six whistleblowers who brought the Complaint against the drug company will share in approximately 18 percent of the federal and qualifying states' recoveries, Sheller said.
Related complaints filed by other law firms in 2005, 2006 and 2007 were ultimately consolidated into Sheller's first-filed Complaint.
"The reason the settlement and fine are record-breaking is because Eli Lilly perpetrated an outrageous fraud on the American government and taxpayers" said Sheller.
The whistleblowers represented by Sheller, two with 27 or more years' service at Lilly, expressed concern through proper channels about Lilly's improper marketing practices. All six whistleblowers were eventually fired or forced to resign. One sales representative, who also is a pharmacist, contacted the company hotline regarding unethical sales practices but received no response, according to the Complaint.
Zyprexa is approved by the U.S. Food and Drug Administration ("FDA") for very limited conditions - schizophrenia and a specific type of bipolar disorder. Under FDA rules, prescription drug manufacturers and marketers may only promote their products for approved uses.
To boost sales, Eli Lilly marketed Zyprexa for numerous off-label uses including Alzheimer's, depression and dementia according to Sheller's Complaint.
Eli Lilly's off-label sales strategies were very effective. The government's investigation found that a substantial amount of Zyprexa sales were for off-label uses, particularly in children and the elderly.
For years, Lilly has been accused of influencing doctors to prescribe Zyprexa to treat disruptive children and tranquilize nursing home patients. The FDA has not approved the drug for children or the elderly and the side effects of the drug are significant: inducing heart failure and pneumonia in the elderly and increasing the risk of significant weight gain and diabetes in children.
According to the Sheller Complaint, some of the tactics used by Eli Lilly to push Zyprexa sales beyond the drug's approved use were:
-- During off-label lectures and audio conferences for physicians
Lilly sales people posed as persons in the audience who were
interested in Zyprexa's expanded use and asked "planted
questions;"
-- While knowing the significant risk for weight gain posed by
Zyprexa, Lilly minimized the connection between Zyprexa and
weight gain in a widely disseminated videotape called "The Myth
of Diabetes" which used "allegedly scientific studies of
questionable integrity as well as the haphazard reporting of
adverse events;"
-- Providing evidence that, in the summer of 2003, Lilly
management ordered the destruction of sales literature with
misleading information, "core sales aids, flip charts and
acetates;" and
-- Promoting the sublingual version of Zyprexa, called "Zydis," by
claiming that it did not have the same weight-gain effects as
Zyprexa.
Federal and state False Claims Acts allow private individuals to sue companies that knowingly defraud national or state governments. They also protect whistleblowers from demotion, suspension, harassment and discrimination for cooperating with the investigation of their employer.
"I applaud the courage of these whistleblowers. They came forth at personal and professional risk to protect the American people and expose corporate fraud," Sheller said.
Sheller also lauded the cooperation among federal prosecutors, investigators, the National Association of Medicaid Fraud Control Units and whistleblowers' attorneys that led to today's settlement. "The collaborative efforts we all took to bring this case to a conclusion is an affirmation of how experienced whistleblower lawyers can work with authorities to reach a satisfactory conclusion," Sheller said.
Acting United States Attorney Laurie Magid and Civil Division Assistant U.S. Attorneys Joseph Trautwein, Virginia Gibson, Peg Hutchison and Kathy Votaw of the Eastern District of Pennsylvania managed and oversaw the investigation. The criminal case was managed by Linda Hoffa, Criminal Division Chief. Sheller was effusive in his praise for the government attorneys, "The U.S. Attorneys' Office in Philadelphia did exemplary work on this case. As a citizen, I was thrilled to see such an effective team."
Joining Sheller in the case are attorneys Gary Farmer, Esq. of Rothstein Rosenfeldt Adler in Fort Lauderdale, Florida and Philadelphia attorney Michael Mustokoff, Esq. of Duane Morris.
The settlement is detailed in a 37-page Settlement Agreement, as well as in a Corporate Integrity Agreement executed by Lilly and the Office of Inspector General of the Department of Health and Human Services.
United States of America ex rel Robert Rudolph, et al. v. Eli Lilly & Company, Civil Action No. 03-943 (E.D. Pa.)
About Sheller, P.C.
Sheller P.C. (http://www.Sheller.com) is among the preeminent plaintiff and qui tam whistleblower law firms in the United States. Stephen A. Sheller, Esq., Managing Partner, has been an effective advocate for victims for nearly three decades. Sheller has litigated groundbreaking cases ranging from premises liability and automobile litigation to defective drugs, products liability and whistleblower lawsuits. The firm also practices in complex mass tort and commercial litigation involving business disputes and consumer fraud. Mr. Sheller began the Palm Beach County, Florida litigation involving the 2000 U.S. Presidential election and the "butterfly ballots" which launched him into national media prominence as a lead attorney challenging the voting count. Sheller frequently appears on "The American Law Journal," the television talk program on the law that airs on The Comcast Network.
Stephen A. Sheller, a well-known mass tort and class action lawyer from Philadelphia, filed the first Complaint in the case in February 2003, bringing the off-label drug allegations to the government under seal as required by law. Today, after six years, the Department of Justice settled with Lilly the allegations that six former Lilly drug marketing representative whistleblowers brought to Sheller.
Lilly will pay more than $1.4 billion for its illegal off-label marketing of the antipsychotic drug, the U.S. Attorney's Office for the Eastern District of Pennsylvania announced. Zyprexa is Lilly's top-selling drug with worldwide sales of nearly $40 billion since its approval in 1996.
In today's settlement, Lilly will pay $800 million in civil penalties and plead guilty to criminal charges, paying an additional $600 million fine. The six whistleblowers who brought the Complaint against the drug company will share in approximately 18 percent of the federal and qualifying states' recoveries, Sheller said.
Related complaints filed by other law firms in 2005, 2006 and 2007 were ultimately consolidated into Sheller's first-filed Complaint.
"The reason the settlement and fine are record-breaking is because Eli Lilly perpetrated an outrageous fraud on the American government and taxpayers" said Sheller.
The whistleblowers represented by Sheller, two with 27 or more years' service at Lilly, expressed concern through proper channels about Lilly's improper marketing practices. All six whistleblowers were eventually fired or forced to resign. One sales representative, who also is a pharmacist, contacted the company hotline regarding unethical sales practices but received no response, according to the Complaint.
Zyprexa is approved by the U.S. Food and Drug Administration ("FDA") for very limited conditions - schizophrenia and a specific type of bipolar disorder. Under FDA rules, prescription drug manufacturers and marketers may only promote their products for approved uses.
To boost sales, Eli Lilly marketed Zyprexa for numerous off-label uses including Alzheimer's, depression and dementia according to Sheller's Complaint.
Eli Lilly's off-label sales strategies were very effective. The government's investigation found that a substantial amount of Zyprexa sales were for off-label uses, particularly in children and the elderly.
For years, Lilly has been accused of influencing doctors to prescribe Zyprexa to treat disruptive children and tranquilize nursing home patients. The FDA has not approved the drug for children or the elderly and the side effects of the drug are significant: inducing heart failure and pneumonia in the elderly and increasing the risk of significant weight gain and diabetes in children.
According to the Sheller Complaint, some of the tactics used by Eli Lilly to push Zyprexa sales beyond the drug's approved use were:
-- During off-label lectures and audio conferences for physicians
Lilly sales people posed as persons in the audience who were
interested in Zyprexa's expanded use and asked "planted
questions;"
-- While knowing the significant risk for weight gain posed by
Zyprexa, Lilly minimized the connection between Zyprexa and
weight gain in a widely disseminated videotape called "The Myth
of Diabetes" which used "allegedly scientific studies of
questionable integrity as well as the haphazard reporting of
adverse events;"
-- Providing evidence that, in the summer of 2003, Lilly
management ordered the destruction of sales literature with
misleading information, "core sales aids, flip charts and
acetates;" and
-- Promoting the sublingual version of Zyprexa, called "Zydis," by
claiming that it did not have the same weight-gain effects as
Zyprexa.
Federal and state False Claims Acts allow private individuals to sue companies that knowingly defraud national or state governments. They also protect whistleblowers from demotion, suspension, harassment and discrimination for cooperating with the investigation of their employer.
"I applaud the courage of these whistleblowers. They came forth at personal and professional risk to protect the American people and expose corporate fraud," Sheller said.
Sheller also lauded the cooperation among federal prosecutors, investigators, the National Association of Medicaid Fraud Control Units and whistleblowers' attorneys that led to today's settlement. "The collaborative efforts we all took to bring this case to a conclusion is an affirmation of how experienced whistleblower lawyers can work with authorities to reach a satisfactory conclusion," Sheller said.
Acting United States Attorney Laurie Magid and Civil Division Assistant U.S. Attorneys Joseph Trautwein, Virginia Gibson, Peg Hutchison and Kathy Votaw of the Eastern District of Pennsylvania managed and oversaw the investigation. The criminal case was managed by Linda Hoffa, Criminal Division Chief. Sheller was effusive in his praise for the government attorneys, "The U.S. Attorneys' Office in Philadelphia did exemplary work on this case. As a citizen, I was thrilled to see such an effective team."
Joining Sheller in the case are attorneys Gary Farmer, Esq. of Rothstein Rosenfeldt Adler in Fort Lauderdale, Florida and Philadelphia attorney Michael Mustokoff, Esq. of Duane Morris.
The settlement is detailed in a 37-page Settlement Agreement, as well as in a Corporate Integrity Agreement executed by Lilly and the Office of Inspector General of the Department of Health and Human Services.
United States of America ex rel Robert Rudolph, et al. v. Eli Lilly & Company, Civil Action No. 03-943 (E.D. Pa.)
About Sheller, P.C.
Sheller P.C. (http://www.Sheller.com) is among the preeminent plaintiff and qui tam whistleblower law firms in the United States. Stephen A. Sheller, Esq., Managing Partner, has been an effective advocate for victims for nearly three decades. Sheller has litigated groundbreaking cases ranging from premises liability and automobile litigation to defective drugs, products liability and whistleblower lawsuits. The firm also practices in complex mass tort and commercial litigation involving business disputes and consumer fraud. Mr. Sheller began the Palm Beach County, Florida litigation involving the 2000 U.S. Presidential election and the "butterfly ballots" which launched him into national media prominence as a lead attorney challenging the voting count. Sheller frequently appears on "The American Law Journal," the television talk program on the law that airs on The Comcast Network.
Roche to cut 780 jobs
ZURICH -- Swiss drug maker Roche plans to cut 780 production jobs over the next two to three years, Chief Financial Officer Erich Hunziker said Thursday.
WSJ
WSJ
Lilly - Viva Zyprexa contd..... the payoff
Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.
Multimedia
Today's Business: Gardiner Harris on the Eli Lilly SettlementDetails of the agreement were provided by people involved in the negotiations.
Among the charges, Lilly has been accused of a scheme stretching for years to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.
In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,” according to court documents. Like other antipsychotic drugs, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.
Wednesday, January 14, 2009
Tuesday, January 13, 2009
Pharma Giles writes
Pfizer drop Zoloft for OCD indication...
In an unusual move, Pfizer today announced that it would be withdrawing Zoloft as a front-line treatment for Obsessive Compulsive Disorder. "We appreciate that having a substantial body of clinical evidence that a drug doesn't work for a particular application isn't usually a reason for withdrawing it from that market segment,"
Pfizer spokesman Jim Spong said earlier today, "but in this instance, it's so blatantly obvious that Zoloft offers no clinical benefit to OCD sufferers, that even we had to take notice." Spong was referring to recent trials data derived from a clinical study of its own boardroom executives. The Zoloft patent expiry has seen sales slump from over $2 billion dollars to less than $800 million within a year, and the OCD market was seen as a potentially lucrative niche opportunity to offset loss of Pfizer's Zoloft sales to generics. "We've noted a lot of obsessive and illogical behaviour from some of our executives in the past few years," Spong said, "and so we thought we'd surreptitiously administer Zoloft to them to see if their behaviour improved."
"For example, our recent CEOs have clung to an obsessive belief that massive takeovers and mergers increase profits and boost earnings, despite a complete absence of industry evidence of anything of the kind. So we've been secretly administering Zoloft to the new guy for the past 18 months and yet only a week or so ago, he said that he had not ruled out yet another massive merger. It's clear that the treatment has been ineffective."
"Even worse, our Head of R&D has just announced a further wave of R&D redundancies, in the bizarre and thoroughly discredited belief that downsizing R&D staff improves R&D productivity and morale. Repeating an action with a 100% track record of failure and yet still expecting success really is a condition beyond the ability of Zoloft to ameliorate."
"It's clear that Zoloft really is just no good at treating this sort of mental disorder," admitted Spong. "Oh well, I guess it's back to pushing Lipitor For Everything..."
Drug reps and the Gold's Gym connection
Gold's had plenty of other secrets. Zumpano knew pharmaceutical reps from the major drug companies who stopped by periodically to make side money selling drug samples to the lifters.
A wild read!
A wild read!
FDA fail contd.
Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.
The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors -- even when they involve uses that have not been federally approved.
The FDA document, posted online Monday, comes just days before the Bush administration turns over power to President-elect Obama's government.
Score 1 for the Big Pharma moles inside the FDA
The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors -- even when they involve uses that have not been federally approved.
The FDA document, posted online Monday, comes just days before the Bush administration turns over power to President-elect Obama's government.
Score 1 for the Big Pharma moles inside the FDA
"In the final hours of this administration, political appointees at FDA have given drug companies a long-coveted parting gift," said Rep. Henry Waxman, chairman of the House of Representatives Energy and Commerce Committee.
"This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective. I hope this policy will be carefully re-examined by the new administration," added Waxman, a California Democrat.
Monday, January 12, 2009
Pharma Giles writes
PhRMA issues nude charity calendar…
The eagerly awaited 2009 Pharmaceutical Research and Manufacturer’s of America (PhRMA) Charity Calendar finally went on sale yesterday, sparking controversy in healthcare circles about the decision to allow famous pharmaceutical executives to be photographed naked. Each of the twelve pages features senior pharmaceutical executives in a ‘relaxed and artistic’ pose, carrying out his or her managerial duties completely in the buff.
The eagerly awaited 2009 Pharmaceutical Research and Manufacturer’s of America (PhRMA) Charity Calendar finally went on sale yesterday, sparking controversy in healthcare circles about the decision to allow famous pharmaceutical executives to be photographed naked. Each of the twelve pages features senior pharmaceutical executives in a ‘relaxed and artistic’ pose, carrying out his or her managerial duties completely in the buff.
One industry critic said, “This is yet another cynical bit of pharmaceutical industry hype if you ask me. The sight of Dan Vasella is a challenge at the best of times, let alone when all he is wearing is a smile.”
PhRMA’s President Billy Tauzin defended the calendar however, saying, “The shots are very tasteful. It was very courageous of our members to pose naked for charity. We think that it shows our softer, fun-loving, and not at all price-gouging/whistleblower persecuting/Medicaid-defrauding, clinical-trials-rigging side.”
A particular favourite is the “Mr. April” page featuring AZ’s CEO Dave Brennan, in which his modesty is protected only by AstraZeneca’s famous “bucket of money”, whilst the ensemble photograph for December features the entire Abbott executive management team posed tastefully around Miles White’s boardroom table.
Pfizer CEO Jeff Kindler and General Counsel Amy Schulman appear naked together in a ‘corporate legal department setting’, whilst the shot of Schering Plough’s Carrie Cox recreating her 2007 stock option exercise celebrations prior to the Vytorin trials results also stands out.
This alone caused a number of critics to express their relief that Pfizer’s Karen Katen has long since retired.
“I can’t see what all of the fuss is about,” said Merck’s CEO Dick (Mr. October) Clark. “Anyone can see that we’re all wearing fine suits of clothes in the calendar. Only a fool would think that we are appearing in the ‘all together’…”
Johann Hari experiments with Provigil
I sat down and took one 200mg tablet with a glass of water. It didn't seem odd: for years, I took an anti-depressant. Then I pottered about the flat for an hour, listening to music and tidying up, before sitting down on the settee. I picked up a book about quantum physics and super-string theory I have been meaning to read for ages, for a column I'm thinking of writing. It had been hanging over me, daring me to read it. Five hours later, I realised I had hit the last page. I looked up. It was getting dark outside. I was hungry. I hadn't noticed anything, except the words I was reading, and they came in cool, clear passages; I didn't stop or stumble once.
More at his HuffPo blog
More at his HuffPo blog
FDA fail
The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.
Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.
In 42 percent of clinical trials, the agency did not receive forms disclosing doctors' financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.
More
Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.
In 42 percent of clinical trials, the agency did not receive forms disclosing doctors' financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.
More
Saturday, January 10, 2009
Wynonna Judd - the mugshot of alli
StoryCountry singer Wynonna Judd was arrested in November 2003 for drunk driving. Following a traffic stop, Nashville cops detected the smell of booze on the 39-year-old performer, whose eyes were watery and dilated. After consenting to a Breathalyzer, Judd blew a .175--more than twice the Tennessee limit.
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