Saturday, December 31, 2005
NEJM calls for a boycott of secretive drug trials
The editor of New England Journal of Medicine, Dr Jeffrey Drazen, has called on doctors who engage in drug trials to boycott any studies sponsored by Big Pharma that do not fully live up to the spirit of legal requirements to register such research efforts.
In a study that appears in this weeks Journal, researchers from the National Institutes of Health report that many of the registered trials fail to give critical information. Sometimes not even including the name of the drug being studied.
For Drazen, that type of corporate evasion is unacceptable.
Insider agrees absolutely. Big Pharma registered clinical trial information should be complete, accurate and accessible.
'In our opinion, it is unacceptable for a trial sponsor not to register its trial in a complete, meaningful and timely fashion. We call for all clinical investigators and patients to participate only in fully registered trials."
This call has recently been echoed by the major organization representing academic medical centers in the United States -- the Association of American Medical Colleges.
'We demand complete compliance, because trial registration makes moral sense,' Drazen said. 'When patients put themselves at risk to participate in clinical trials, they do so with the tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor.'
Hear hear, says Insider.
Insider would be happy to publicise any secret or forgotten clinical trials Big Pharma would like to keep under wraps.
Monsters and Critics
In a study that appears in this weeks Journal, researchers from the National Institutes of Health report that many of the registered trials fail to give critical information. Sometimes not even including the name of the drug being studied.
For Drazen, that type of corporate evasion is unacceptable.
Insider agrees absolutely. Big Pharma registered clinical trial information should be complete, accurate and accessible.
'In our opinion, it is unacceptable for a trial sponsor not to register its trial in a complete, meaningful and timely fashion. We call for all clinical investigators and patients to participate only in fully registered trials."
This call has recently been echoed by the major organization representing academic medical centers in the United States -- the Association of American Medical Colleges.
'We demand complete compliance, because trial registration makes moral sense,' Drazen said. 'When patients put themselves at risk to participate in clinical trials, they do so with the tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor.'
Hear hear, says Insider.
Insider would be happy to publicise any secret or forgotten clinical trials Big Pharma would like to keep under wraps.
Monsters and Critics
Friday, December 30, 2005
Insiders' personal favourite posts of 2005
Now that the New Year is nearly here we should just take a few moments to savour the high and low lights of 2005. And Big Pharma has not been short of low lights (or should that be low-lifes).
Insider is still a blogging newby and only started in September but has just broken through the 500 posts barrier and the site has received over 45,000 hits in just four months!
Thank you to all who have visited. Please add PharmaGossip to your "favourites". My webstats suggest that around a third of visitors become regular repeat visitors.
Not too shabby! Here's to 2006!
Here are links to some of Insiders' fave "funny" posts:
Halloween Pics (including the one above):
Halloween
Pfizersaurus Rex:
Dinosaur
The whole cheerleader rep thing:
Perky
and here:
Yes please
And one for the ladies (or gay guys):
Rugby Guy
Feel free to feedback what you liked in 2005 and what you would like to see more of in 2006.
Happy Hogmanay!
Thursday, December 29, 2005
First the book - now the website!
This is the spy novel Big Pharma, through its PhRMA mouthpiece, first tried to commission, then control and finally kill!
Now there is a website!
http://www.thekarasikconspiracy.com/
Read the emails between PhRMA and Spivak/Chrystyn and see the story behind the story!
What has so scared the Pharmaceutical Research and Manufacturers of America (PhRMA) that Ken Johnson, its most senior communications executive has taken to calling Valerie Volpe, its deputy vice president a "yo-yo?" When is a cover up worse than the original crime (and when isn’t it)? What did the higher-ups at PhRMA know and when did they know it?
Read all about it! It is truly a story that could not have been made up.
Previous PG posts here:
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
http://pharmagossip.blogspot.com/2005/11/pill-fiction-continued.html
Now there is a website!
http://www.thekarasikconspiracy.com/
Read the emails between PhRMA and Spivak/Chrystyn and see the story behind the story!
What has so scared the Pharmaceutical Research and Manufacturers of America (PhRMA) that Ken Johnson, its most senior communications executive has taken to calling Valerie Volpe, its deputy vice president a "yo-yo?" When is a cover up worse than the original crime (and when isn’t it)? What did the higher-ups at PhRMA know and when did they know it?
Read all about it! It is truly a story that could not have been made up.
Previous PG posts here:
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
http://pharmagossip.blogspot.com/2005/11/pill-fiction-continued.html
Wednesday, December 28, 2005
New Year - New you?
Need that "cheerleader look"?
Three different views. Start with your cupsize then see what upto an additional 500mls of saline would do. Needs Macromedia Flash. Dont worry about the Japaneese language. You will get the hang of it, quickly enough.
AZ - Brennan's Christmas shopping continues
AstraZeneca has signed a $300 million (172 million pound) research and licensing agreement with Targacept, its fourth deal this month as it seeks to broaden its depleted pipeline of new drugs.
Europe’s third-largest drugs maker said in a statement it was to develop and commercialise Targacept’s phase II compound, TC-1734, aimed at treating Alzheimer’s disease, cognitive deficits in schizophrenia and other cognitive disorders.
"Targacept’s long-standing leadership position in NNR (neuronal nicotinic receptors) research will build upon our existing strengths and open up new opportunities for AstraZeneca," the company said.
Targacept will receive an initial payment of $10 million and a further $20 million on successful completion of mid-stage clinical trials. AstraZeneca is also paying $26 million in research support payments over the four years of the deal.
Together with stepped double-digit royalties dependent on sales following regulatory approval, Targacept is eligible to receive about $300 million overall.
Insiders' comment: AZ's "dynamic" new CEO, David Brennan, has been busy over the Christmas shopping period! He has now agreed four deals worth up to $1.85 billion in December alone, just days before he officially gets his feet under the CEO's desk in the companys' Stanhope Gate, Mayfair, head office.
No more "hot desking" now Dave! Come Jan 1st you the man.
The spread of pipline bolstering projects is interesting: CV, cancer and now neuro. It looks like Dynamo Dave has been covering all the main bases to help convince investors that AZ has a pipline worth somthing!
Lets see which projects turn into products.
Source: tiscali.business
Europe’s third-largest drugs maker said in a statement it was to develop and commercialise Targacept’s phase II compound, TC-1734, aimed at treating Alzheimer’s disease, cognitive deficits in schizophrenia and other cognitive disorders.
"Targacept’s long-standing leadership position in NNR (neuronal nicotinic receptors) research will build upon our existing strengths and open up new opportunities for AstraZeneca," the company said.
Targacept will receive an initial payment of $10 million and a further $20 million on successful completion of mid-stage clinical trials. AstraZeneca is also paying $26 million in research support payments over the four years of the deal.
Together with stepped double-digit royalties dependent on sales following regulatory approval, Targacept is eligible to receive about $300 million overall.
Insiders' comment: AZ's "dynamic" new CEO, David Brennan, has been busy over the Christmas shopping period! He has now agreed four deals worth up to $1.85 billion in December alone, just days before he officially gets his feet under the CEO's desk in the companys' Stanhope Gate, Mayfair, head office.
No more "hot desking" now Dave! Come Jan 1st you the man.
The spread of pipline bolstering projects is interesting: CV, cancer and now neuro. It looks like Dynamo Dave has been covering all the main bases to help convince investors that AZ has a pipline worth somthing!
Lets see which projects turn into products.
Source: tiscali.business
Tuesday, December 27, 2005
Seronovartis - a new name in Big Pharma?
Novartis declined to comment today on a newspaper report that it would offer a premium to take over biotechnology firm Serono.
Sources familiar with the situation have told Reuters that major pharmaceutical companies, including Novartis, have been asked by Serono to prepare bids for an auction of the Geneva-based firm that could take place early in 2006.
Over the weekend, Switzerland's SonntagsZeitung newspaper reported that Novartis would offer $799.39 a share to public holders of Serono stock. It quoted insiders at Serono's headquarters.
Chief Executive and Chairman Ernesto Bertarelli and his family, who own around 64 percent of the company, would be offered $913.76 a share, the newspaper reported. Under Swiss takeover law it is acceptable to make a higher offer to the holder of a majority of a company's shares. Serono stock was 0.2 percent higher, while the Swiss Market Index was little changed. Novartis was 0.2 percent lower.
Serono has declined to comment on any takeover speculation beyond its confirmation that it had hired bankers from Goldman Sachs to help it investigate its strategic options.
Looks like Christmas for the Bertarelli family will be a little late, but well worth waiting for! Insider believes that the merger is ON. However, the name for the new company (Seronovartis)...... that is just Insiders' little joke!
Source: Reuters
Monday, December 26, 2005
Big Pharma in 2006 - survival of the fittest
How will Big Pharma fare in 2006? The markets have been trying to drum up some positive sentiment for the sector.
Forbes
But, as Insider has pointed out previously, it's not going great for the drug company dinosaurs at the moment. A LOT of blockbusters are approaching patent expiry and there just aren't the molecules in the pipeline to take their place!
So. What will happen?
Insider predicts:
1. A lot of activity in biotech and "small to medium Pharma" as these minnows are gobbled up by Big Pharma for their hopeful molecules in development.
2. A lot of "stealth layoffs" in Big Pharma salesforces. These will be kept as quiet as possible.
3. More public downsizing of Big Pharma production and research staff and facilities.
4. A few mergers - but not frantic activity. That's unless another "Vioxx issue" rears its head.
Merck seem to be on the comeback trail and AZ have recently tried to bolster their pipeline. Let's see if that is enough.
Should be a great year for PharmaGossip!!
Saturday, December 24, 2005
Friday, December 23, 2005
Just in time for Christmas
Scroll down.....maybe it should be "Cheer Reps"!?
Idea from CafePharma : The Darkened Sample Closet
AZs' Brennan - the new sheriff in town
Move over Sir Tom McKillop. AstraZeneca has a new boss and his cheque book is out! Watch out everyone: David Brennan is the new sheriff in town!
Just one day after AZ announced their "blockbuster" deal for a cardiovascular drug they now buying a cancer company.
Europe`s third-largest drug maker, will pay $210 million to buy Britain`s KuDOS Pharmaceuticals Ltd.
KPL makes cancer drugs based on enzymes that trigger repairs of damaged DNA. Such enzymes are believed to hold potential as cancer cell killers.
Of particular interest to AstraZeneca is an oral enzyme inhibitor known as KU 59436, which is in phase I clinical development, the Times of London reported Friday.
The deal is seen as a way for the big Anglo-Swedish pharmaceutical firm to boost a cancer drug pipeline that investors have complained of as being somewhat thin.
Insiders view. Good for Brennan! This "action man" is just what lazy AZ needs! Now lets see if this ex-US ops head can make the deep cuts that are so needed in the the companys' overweight European operations.
Look at the manpower: turnover ratios for their US vs EU businesses!
Well, somthing or someone will have to go to pay for the deals......wont they?
Blumsohn, P&G and Sheffield University contd.
This case has been reported previously here:
http://pharmagossip.blogspot.com/2005/12/pg-whistleblower-gag-attempt-fails.html
Universities have long accepted funding from Big Pharma to conduct clinical drug trials. But in the past, their professors insisted on running those trials independently of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down.
Earlier this month, the Wall Street Journal reported on the growing willingness of some academics to sign their names—and lend their prestige—to articles and editorials penned by drug-company ghostwriters.
In addition to the Vioxx episode, recent reports indicate that published academic studies related to the drugs Celebrex, Paxil, and Zoloft appear to have been skewed when their authors permitted the suppression of negative results.
The Blumsohn case is still ongoing. The latest update is here:
http://www.slate.com/id/2133061/?nav=fo
http://pharmagossip.blogspot.com/2005/12/pg-whistleblower-gag-attempt-fails.html
Universities have long accepted funding from Big Pharma to conduct clinical drug trials. But in the past, their professors insisted on running those trials independently of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down.
Earlier this month, the Wall Street Journal reported on the growing willingness of some academics to sign their names—and lend their prestige—to articles and editorials penned by drug-company ghostwriters.
In addition to the Vioxx episode, recent reports indicate that published academic studies related to the drugs Celebrex, Paxil, and Zoloft appear to have been skewed when their authors permitted the suppression of negative results.
The Blumsohn case is still ongoing. The latest update is here:
http://www.slate.com/id/2133061/?nav=fo
Cheerleader reps - Insiders' No 1
Kristin of the 49ers. Whatever she is selling, Insider is buying!
http://www.sf49ers.com/cheerleaders/bio-kristin.asp
More cheerleader reps
Traci of the Tennessee Titans! (that's enough alliteration, ed.)
http://www.titansonline.com/team/cheerleaders/bio.php?PRKey=44
USA - Land of the free but home of expensive medicines
Big Pharma mouthpieces applauded the decision by a judge that D.C. legislation recently passed to rein in prescription-drug prices is unconstitutional.
U.S. District Court Judge Richard Leon ruled the Prescription Drug Excessive Pricing Act of 2005, passed unanimously by the D.C. Council in September, was unconstitutional in a blow to Council members such as David Catania, I-at large, who authored the bill.
The bill would make it illegal to sell patented medicines for an "excessive price" in the District. The D.C. government or any person affected by excessive prices could initiate legal action against a drug company if the wholesale price of a patented prescription drug in D.C. is 30 percent higher than the same drug's price in Australia, Canada, Germany or the United Kingdom.
In late October, the D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA), which represents biotech and pharmaceutical companies, filed a lawsuit against the council seeking declaratory and injunctive relief.
"Today's decision ... protects both patients and the quality healthcare we enjoy in this country," says PhRMA President and CEO Billy Tauzin in a statement. This is the same PhRMA who adopted a "scare novel" approach to importing Canadian medicines.
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
Source: Washington Business Journal
U.S. District Court Judge Richard Leon ruled the Prescription Drug Excessive Pricing Act of 2005, passed unanimously by the D.C. Council in September, was unconstitutional in a blow to Council members such as David Catania, I-at large, who authored the bill.
The bill would make it illegal to sell patented medicines for an "excessive price" in the District. The D.C. government or any person affected by excessive prices could initiate legal action against a drug company if the wholesale price of a patented prescription drug in D.C. is 30 percent higher than the same drug's price in Australia, Canada, Germany or the United Kingdom.
In late October, the D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA), which represents biotech and pharmaceutical companies, filed a lawsuit against the council seeking declaratory and injunctive relief.
"Today's decision ... protects both patients and the quality healthcare we enjoy in this country," says PhRMA President and CEO Billy Tauzin in a statement. This is the same PhRMA who adopted a "scare novel" approach to importing Canadian medicines.
http://pharmagossip.blogspot.com/2005/10/pill-fiction.html
Source: Washington Business Journal
Thursday, December 22, 2005
Merck and BMS quit Pargluva deal
Bristol-Myers Squibb said Thursday it has reached an agreement with Merck & Co. to end their collaboration on Pargluva (muraglitazar), an investigational oral drug for the treatment of type 2 diabetes.
Under the mutually brokered agreement, all rights to the drug return to Bristol-Myers Squibb. The deal also covers the reversion to Bristol-Myers of a back-up compound to muraglitazar.
Bristol-Myers said it is considering a range of options on how to best proceed with the diabetes treatment, including conducting additional studies or terminating further development of the drug.
Insider says: Pargluva is a dead duck! Go here to find out why:
http://pharmagossip.blogspot.com/2005/11/pargluva-illusion-of-safety.html
Under the mutually brokered agreement, all rights to the drug return to Bristol-Myers Squibb. The deal also covers the reversion to Bristol-Myers of a back-up compound to muraglitazar.
Bristol-Myers said it is considering a range of options on how to best proceed with the diabetes treatment, including conducting additional studies or terminating further development of the drug.
Insider says: Pargluva is a dead duck! Go here to find out why:
http://pharmagossip.blogspot.com/2005/11/pargluva-illusion-of-safety.html
AZ - "blockbuster" purchace price
AstraZeneca has just created a "blockbuster" by signing a drug deal worth up to $1 billion with U.S. biotech firm AtheroGenics Inc. on Thursday, as it stepped up efforts to restock a pipeline depleted by past product setbacks.
The alliance gives Europe's third biggest drug maker rights to AGI-1067, a novel pill in final Phase III tests that is designed to selectively block the inflammatory process in atherosclerosis, or hardening of the arteries, that can lead to heart attacks and strokes.
AtheroGenics will get an upfront fee of $50 million, with the potential of an additional $300 million in regulatory and development milestones and a further $650 million depending on how much the product sells, assuming it gets to market.
The deal comes just two weeks after AstraZeneca licensed an experimental sepsis drug from Protherics Plc in a collaboration worth up to 195 million pounds ($338.7 million).
Like other "big pharma" companies, the group has been active in early research alliances but until now has done relatively few late-stage deals for drugs that have already passed through Phase II development.
But, Insider notes, their two Phase III products (Cerovive and Galida) are very high risk bets and may not make it to market.
Hence the "blockbuster" price paid for AGI-1067!
However, that assumes that the drug will work.
The drug's performance in midstage studies has been murky, mainly because of the design of those experiments. Last year, Atherogenics didn't release one much-awaiting midstage study until it had taken an unusual--and scientifically dubious--step. The company called in a second researcher to reanalyze the data. The first set of results didn't show a result in how much plaque built up in the arteries, but the second showed a clear benefit.
The unorthodox study preparation made some researchers skeptical. At the time, one researcher called the approach "not entirely kosher" (see: "Fuzzy Drug Company Math").
The one and only Eric Topol of the Cleveland Clinic wrote an opinion piece on the study for Forbes.com, saying, "Virtually every faux pas of clinical trials was committed" (see: "How Not To Do A Clinical Trial").
Insider cant wait to see how this one turns out!
Sources: Reuters and Forbes
The alliance gives Europe's third biggest drug maker rights to AGI-1067, a novel pill in final Phase III tests that is designed to selectively block the inflammatory process in atherosclerosis, or hardening of the arteries, that can lead to heart attacks and strokes.
AtheroGenics will get an upfront fee of $50 million, with the potential of an additional $300 million in regulatory and development milestones and a further $650 million depending on how much the product sells, assuming it gets to market.
The deal comes just two weeks after AstraZeneca licensed an experimental sepsis drug from Protherics Plc in a collaboration worth up to 195 million pounds ($338.7 million).
Like other "big pharma" companies, the group has been active in early research alliances but until now has done relatively few late-stage deals for drugs that have already passed through Phase II development.
But, Insider notes, their two Phase III products (Cerovive and Galida) are very high risk bets and may not make it to market.
Hence the "blockbuster" price paid for AGI-1067!
However, that assumes that the drug will work.
The drug's performance in midstage studies has been murky, mainly because of the design of those experiments. Last year, Atherogenics didn't release one much-awaiting midstage study until it had taken an unusual--and scientifically dubious--step. The company called in a second researcher to reanalyze the data. The first set of results didn't show a result in how much plaque built up in the arteries, but the second showed a clear benefit.
The unorthodox study preparation made some researchers skeptical. At the time, one researcher called the approach "not entirely kosher" (see: "Fuzzy Drug Company Math").
The one and only Eric Topol of the Cleveland Clinic wrote an opinion piece on the study for Forbes.com, saying, "Virtually every faux pas of clinical trials was committed" (see: "How Not To Do A Clinical Trial").
Insider cant wait to see how this one turns out!
Sources: Reuters and Forbes
Wednesday, December 21, 2005
Lilly - coughing up for Evista marketing violations
Poor Lilly. They have plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act and paid $36 million to settle charges of off-label promotion of its Evista osteoporosis treatment in 1998.
Government regulators charged the company with promoting its Evista product for two other uses -- the prevention of breast cancer and for reducing cardiovascular risk -- neither of which have been approved by the Food and Drug Administration.
Chairman and Chief Executive Sidney Taurel said in a statement that the company regrets the conduct and plans to "continue to take steps designed to assure that Lilly's promotional activities remain fully compliant."
In addition to the misdemeanor charge, the government has an ongoing civil complaint alleging that similar Evista-related conduct continued into 2000. Eli Lilly said it disagrees with the charges but has agreed to settle the dispute.
So thats alright then!
Source: theindychannel.com
Government regulators charged the company with promoting its Evista product for two other uses -- the prevention of breast cancer and for reducing cardiovascular risk -- neither of which have been approved by the Food and Drug Administration.
Chairman and Chief Executive Sidney Taurel said in a statement that the company regrets the conduct and plans to "continue to take steps designed to assure that Lilly's promotional activities remain fully compliant."
In addition to the misdemeanor charge, the government has an ongoing civil complaint alleging that similar Evista-related conduct continued into 2000. Eli Lilly said it disagrees with the charges but has agreed to settle the dispute.
So thats alright then!
Source: theindychannel.com
AZs' McKillop to be Chairman of Royal Bank of Scotland
Royal Bank of Scotland Group PLC said chairman Sir George Mathewson will retire next April 28 and that Sir Tom McKillop, currently chief executive of AstraZeneca PLC, will take over the role.
McKillop, who is also deputy chairman at RBoS, is set to retire from AstraZeneca on Dec 31. See here for more info:
http://pharmagossip.blogspot.com/2005/12/azs-mckillop-one-hell-of-retirement.html
The bank also said Guy Whittaker will succeed Fred Watt as finance director on Feb 1. Whittaker is currently Group Treasurer at Citigroup. In June 2005, Watt announced his intention to leave the group.
Source:Interactive Investor
Tackling CV disease the UK way
A hat tip goes to "Prescribing advice for GPs" for telling Insider that the Joint British Societies (JBS) have published Guidelines on the prevention of cardiovascular disease in clinical practice.
The publication has been reported by the BBC and is available in full online or as a PDF.
The guidelines suggest a consistent multidisciplinary approach to the management of people with established cardiovascular disease (CVD) and those at high risk of developing CVD. This statement is clarified to include people:
with established CVD
with a CVD risk of > 20% in 10 years
with diabetes (Type 1 or 2)
In addition, people with particularly elevated single risk factors are considered at high risk, specified as people:
with blood pressure above 160/100mmHg (or lower with target organ damage)
with total cholesterol to high density lipid ratio (TC:HDL) above 6 (300 in US money)
with familial dyslipidaemia
The guideline goes on to recommend lifestyle advice and treatment targets in the key areas of blood pressure management, blood lipid management, blood glucose management and antiplatelet therapy.
Drug choice in each of these areas has already been covered.
All UK clinicians should receive a copy of the guidelines.
NICE are expected to publish Cardiovascular Disease - Statins guidance in January 2006 and to review the Hypertension guideline in May 2006. In the meantime doctors should continue to follow the formulary advice and the NICE Hypertension Guideline.
At last, wayward prescribing by rogue medical elements in the UK (usually under the influence of Big Pharma) is being brought to heel! This is leading to real cost savings and better treatment outcomes..........everybody wins (except Big Pharma).
The publication has been reported by the BBC and is available in full online or as a PDF.
The guidelines suggest a consistent multidisciplinary approach to the management of people with established cardiovascular disease (CVD) and those at high risk of developing CVD. This statement is clarified to include people:
with established CVD
with a CVD risk of > 20% in 10 years
with diabetes (Type 1 or 2)
In addition, people with particularly elevated single risk factors are considered at high risk, specified as people:
with blood pressure above 160/100mmHg (or lower with target organ damage)
with total cholesterol to high density lipid ratio (TC:HDL) above 6 (300 in US money)
with familial dyslipidaemia
The guideline goes on to recommend lifestyle advice and treatment targets in the key areas of blood pressure management, blood lipid management, blood glucose management and antiplatelet therapy.
Drug choice in each of these areas has already been covered.
All UK clinicians should receive a copy of the guidelines.
NICE are expected to publish Cardiovascular Disease - Statins guidance in January 2006 and to review the Hypertension guideline in May 2006. In the meantime doctors should continue to follow the formulary advice and the NICE Hypertension Guideline.
At last, wayward prescribing by rogue medical elements in the UK (usually under the influence of Big Pharma) is being brought to heel! This is leading to real cost savings and better treatment outcomes..........everybody wins (except Big Pharma).
Tuesday, December 20, 2005
Can drug stocks bounce back in 2006?
CNNs view here:
Insiders' view: It depends if Big Pharma tackles its Big Problem.
Merck - "treading a fine line"
A federal appeals court has upheld the dismissal of a lawsuit against Merck even though the drugmaker had been "treading a fine line".
In June 2001, Merck's share price fell after The Wall Street Journal reported that its subsidiary Medco Health Solutions Inc. had overstated revenues by more than $4.6 billion. Not surprisingly, investors later sued the company for concealing the accounting scandal.
The judge ruled that the drugmaker was "treading a fine line" by failing to disclose the details of accounting problems, but said that analysts and investors should have been able to do the math.
http://www.cfo.com/article.cfm/5332750/c_5327347?f=home_todayinfinance
In June 2001, Merck's share price fell after The Wall Street Journal reported that its subsidiary Medco Health Solutions Inc. had overstated revenues by more than $4.6 billion. Not surprisingly, investors later sued the company for concealing the accounting scandal.
The judge ruled that the drugmaker was "treading a fine line" by failing to disclose the details of accounting problems, but said that analysts and investors should have been able to do the math.
http://www.cfo.com/article.cfm/5332750/c_5327347?f=home_todayinfinance
Wyeth Discovery Review Board - come on down!
Talk about self congratulation! RSA’s sponsorship of the ‘Management Team of the Year’ category of the inaugural Scrip Awards culminated in a spectacular awards ceremony held on December 7th, at London’s Grosvenor House where the Wyeth Discovery Review Board were announced as the winners.
Teams from all pharmaceutical and biotechnology business disciplines were invited to enter and the Wyeth team was selected by the judges from a short-list.
Keith Hobson, Chief Operating Officer of RSA who presented the Wyeth team with their award says "It is an honour to be part of this initiative involving the highest calibre individuals across the whole spectrum of the pharmaceutical and biotechnology industries and to present this award to the Wyeth Discovery Review Board.
They have demonstrated true leadership skills and outstanding team work in achieving their primary goal.”
Insider will present his award after he has finished laughing.......
Monday, December 19, 2005
Just in time for Christmas
An anonymous email card to tell someone they might have an STD! Six designs to choose from.
www.inspot.org
"Goliath" Pfizer stomp "David" Ranbaxy in US courts
Insider predicts a share rally for Pfizer (and possibly Big Pharma) today.
A US federal judge ruled for Pfizer in its patent dispute with Ranbaxy Laboratories Ltd. over Lipitor, the world's top-selling prescription medication, in a move expected to send shares of the New York-based drug giant as well as the rest of the sector higher on Monday.
Judge Joseph J. Farnan of the U. S. District Court for the District of Delaware upheld the exclusivity of two Pfizer patents covering atorvastatin, the active ingredient in the cholesterol-lowering drug. The decision means it will be entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for or marketing its generic version of Lipitor until 2011.
Bombay-listed Ranbaxy shares fell 6% on Monday. They say they plan to appeal.
In October, a British court also upheld Pfizer's patent on atorvastatin. See full story.
Lipitor was introduced in the U.S. in 1997. According to New York-based Pfizer, more than 18 million people in the U.S. have been prescribed Lipitor, which had sales of about $12 billion in 2004.
Insiders' view: Just before the cheering becomes deafening remember the recent IDEAL study results at the AHA.
http://pharmagossip.blogspot.com/2005/11/lipitor-less-than-ideal-results.html
Generic simvastatin looks a great cost saving option for many people.
A US federal judge ruled for Pfizer in its patent dispute with Ranbaxy Laboratories Ltd. over Lipitor, the world's top-selling prescription medication, in a move expected to send shares of the New York-based drug giant as well as the rest of the sector higher on Monday.
Judge Joseph J. Farnan of the U. S. District Court for the District of Delaware upheld the exclusivity of two Pfizer patents covering atorvastatin, the active ingredient in the cholesterol-lowering drug. The decision means it will be entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for or marketing its generic version of Lipitor until 2011.
Bombay-listed Ranbaxy shares fell 6% on Monday. They say they plan to appeal.
In October, a British court also upheld Pfizer's patent on atorvastatin. See full story.
Lipitor was introduced in the U.S. in 1997. According to New York-based Pfizer, more than 18 million people in the U.S. have been prescribed Lipitor, which had sales of about $12 billion in 2004.
Insiders' view: Just before the cheering becomes deafening remember the recent IDEAL study results at the AHA.
http://pharmagossip.blogspot.com/2005/11/lipitor-less-than-ideal-results.html
Generic simvastatin looks a great cost saving option for many people.
Sunday, December 18, 2005
Saturday, December 17, 2005
Friday, December 16, 2005
P&G - Whistleblower gag attempt fails
The whistleblower who raised the alarm about the conduct of a Sheffield University study with the drug company Procter & Gamble rejected a £145,000 payoff from his university.
Aubrey Blumsohn, senior lecturer at Sheffield University's Bone Metabolism Research Unit, said that signing a gagging clause and handing over research data would have compromised the debate over the issue. He is now likely to face disciplinary action by the university.
Dr Blumsohn was suspended in September this year after co-operating with an investigation by The Times Higher Education Supplement into his concerns. It has now emerged that Dr Blumsohn was offered £120,000 compensation for loss of employment and a further £25,000 for "injury to feelings" if he agreed to part company with Sheffield.
The deal, which Sheffield this week tried to keep secret by threatening The Times Higher Education Supplement with an injunction, would have given Dr Blumsohn little scope to discuss concerns about P&G and would have required him to return all clinical and research data.
It would also have stopped him from making "detrimental or de-rogatory statements" regarding his employment at Sheffield and about any of Sheffield's staff, including Tony Weetman, the medical school dean, and Robert Boucher, the vice-chancellor.
In a letter to the university rejecting the offer, dated December 1, Dr Blumsohn says: "Effectively, I would be accepting £145,000 in exchange for allowing part of the jigsaw of clinical and scientific debate to remain uncorrected, and this would be unconscionable."
Insider says: Dr. Blumsohn is to be applauded for this stand. Who on earth is advising Sheffield University?
Read the full story here:
http://www.thes.co.uk/current_edition/story.aspx?story_id=2026780
and here:
http://pharmagossip.blogspot.com/2005/12/pg-ghostwriters-boning-up-on.html
AZs' McKillop - one hell of a retirement party!
Poor Sir Tom McKillop, the outgoing chief executive at drug giant AstraZeneca. He had hoped to leave the company this Christmas on a high note with a huge retirement party and the company fit for the future.
Instead, he leaves AZ is in relatively poor shape.
Crestor their "blockbuster" (LOL) that Tom promised would have 20% of the statin market (and he would do "whatever it takes" to get it there), is languishing in the doldrums with only single figures market share.
In addtion their late stage pipeline is bone dry. AZ have only two very risky products in Phase 3 development: Cerovive and Galida. Both could still fail.
Still, lets not feel too upset for poor old Tom.
He has just sold 40 per cent of his holding in AZ for £2.1 million, the company has just revealed.
Europe's third biggest prescription drug maker said Sir Tom - who will earn upwards of £200,000 a year in his new role as deputy chairman at Royal Bank of Scotland - sold 77,774 shares at £27.49 each.
He also holds still options over 678,481 more shares.
So that should be enough cash for him to stand his friends and colleagues a "wee dram" at the bar to celebrate his leaving. However, the toadys will already be sucking up to their new boss, David Brennan. Good Luck Dave.......you will need it!
Instead, he leaves AZ is in relatively poor shape.
Crestor their "blockbuster" (LOL) that Tom promised would have 20% of the statin market (and he would do "whatever it takes" to get it there), is languishing in the doldrums with only single figures market share.
In addtion their late stage pipeline is bone dry. AZ have only two very risky products in Phase 3 development: Cerovive and Galida. Both could still fail.
Still, lets not feel too upset for poor old Tom.
He has just sold 40 per cent of his holding in AZ for £2.1 million, the company has just revealed.
Europe's third biggest prescription drug maker said Sir Tom - who will earn upwards of £200,000 a year in his new role as deputy chairman at Royal Bank of Scotland - sold 77,774 shares at £27.49 each.
He also holds still options over 678,481 more shares.
So that should be enough cash for him to stand his friends and colleagues a "wee dram" at the bar to celebrate his leaving. However, the toadys will already be sucking up to their new boss, David Brennan. Good Luck Dave.......you will need it!
Thursday, December 15, 2005
Naked News - Gia Gomez
Gia Gomez, 27, appeared on the Naked News from February to September of 2003, then rejoined in March, 2005, reporting on a variety of subjects. With her diverse experiences and sharp intelligence, she is a natural addition to the Naked News anchor team.Born in Canada to Filipino parents, Ms Gomez was bitten by the performing bug early, beginning with school plays and theatre. She continues to act and dance, including in roles in two Hollywood movies.
Just in time for Christmas
At Big Pharma Headquarters, the boss always seems to know what we're up to. For a while we thought he had super powers, but Helen the Cleaning Lady discovered his real secret...
SPY EAR Secret Agent Listening Device!
Yep, the boss has been using Spy Ear to listen in on us. When we confronted him, he said "I'm merely testing out a new product given to senior manaagement." We tried to fire him, but he reminded us that he's the boss, so we crawled back to our cubicles like the spineless drones that we are.
But, more about Spy Ear:
This inexpensive electronic marvel is cool. Pop the headphones in your ear, turn it on, and you can hear people talking across the room, out in the hallway, in the neighboring bathroom stall, and so on. It's basically just a micro-amplifier, but its size makes it remarkably inconspicuous.
Spy Ear comes complete with headphones, batteries, and even a spare set of batteries. It only costs $4.99, so you can be a spy for the cost of a sandwich.
Get it here:
http://www.stupid.com/stat/SEAR.html
Wednesday, December 14, 2005
Celebrex trial - any volunteers?
Pfizer has enlisted one of Celebrex's first critics to run the 20,000-patient PRECISION study, which could determine the drugs future..
Steven Nissen of the Cleveland Clinic, who co-wrote with his boss Eric Topol a 2001 journal article that raised the alarm on both Celebrex and Vioxx, will be running the show.
It will compare Celebrex to two other popular arthritis drugs, the active ingredients in Aleve and Advil, in patients who are already at high risk for heart attacks.
Alastair Wood, associate dean at Vanderbilt University Medical School has commented, "That's the study Merck said couldn't be done."
The trial may not be finished until the middle of 2009, but when it wraps, Nissen says patients will have finally answered raging questions about which arthritis drugs are safest for those in pain. "If you have arthritis, you're going to have to take something," says Nissen. "So what do you take? Celebrex, ibuprofen or naproxen?"
Volunteers for the study form a line, please!
http://www.forbes.com/sciencesandmedicine/2005/12/13/pfizer-celebrex-vioxx-cx_mh_1213celebrex.html?partner=rss
Steven Nissen of the Cleveland Clinic, who co-wrote with his boss Eric Topol a 2001 journal article that raised the alarm on both Celebrex and Vioxx, will be running the show.
It will compare Celebrex to two other popular arthritis drugs, the active ingredients in Aleve and Advil, in patients who are already at high risk for heart attacks.
Alastair Wood, associate dean at Vanderbilt University Medical School has commented, "That's the study Merck said couldn't be done."
The trial may not be finished until the middle of 2009, but when it wraps, Nissen says patients will have finally answered raging questions about which arthritis drugs are safest for those in pain. "If you have arthritis, you're going to have to take something," says Nissen. "So what do you take? Celebrex, ibuprofen or naproxen?"
Volunteers for the study form a line, please!
http://www.forbes.com/sciencesandmedicine/2005/12/13/pfizer-celebrex-vioxx-cx_mh_1213celebrex.html?partner=rss
Hard sell? - Novartis launch Prexige in the UK
The secret to good comedy is, as Insider understands - but his Teutonic friends do not,........ a matter of timing. Poor Novartis; they have just launched a new Cox2 inhibitor, lumiracoxib (Prexige) in the UK for symptomatic relief of osteo-arthritis and short term relief of moderate to severe acute pain associated with primary dysmenorrhea, dental surgery or orthopaedic surgery.
The Summary of Product Characteristics draws attention to the cardiovascular effects of Cox-II NSAIDs by warning that the risk of thrombotic events is raised in comparison to placebo and other NSAIDs.
Clinicians are advised in the SPC to use lumiracoxib for the shortest duration and at the lowest effective dose in order to minimise these risks.
The SPC wording is as follows:
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAID’s. As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used. The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
The SPC also states:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks.
Insider notes that "Prescribing Advice for GPs" is already suggesting that overall risk includes assessment of cardiovascular, gastrointestinal and renal risk. A stepped approach to analgesia has already been reported that recommends paracetamol based analgesics first with NSAIDs used where risk is low or use of additional pain killers is necessary. Use of the NSAID of lowest risk is recommended, usually ibuprofen.
Gastrointestinal risks can be lowered by concurrent use of omeprazole.
It is gently suggested that, at this time, it is therefore difficult to foresee a place in therapy for lumiracoxib.
Insiders' view: buy the Brand Manager a big drink!
The Summary of Product Characteristics draws attention to the cardiovascular effects of Cox-II NSAIDs by warning that the risk of thrombotic events is raised in comparison to placebo and other NSAIDs.
Clinicians are advised in the SPC to use lumiracoxib for the shortest duration and at the lowest effective dose in order to minimise these risks.
The SPC wording is as follows:
Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAID’s. As the cardiovascular risks of lumiracoxib may increase with dose and duration of exposure, the shortest duration and the lowest effective daily dose should be used. The patients need for symptomatic relief and response to therapy should be re-evaluated periodically, especially in patients with osteoarthritis.
The SPC also states:
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient’s overall risks.
Insider notes that "Prescribing Advice for GPs" is already suggesting that overall risk includes assessment of cardiovascular, gastrointestinal and renal risk. A stepped approach to analgesia has already been reported that recommends paracetamol based analgesics first with NSAIDs used where risk is low or use of additional pain killers is necessary. Use of the NSAID of lowest risk is recommended, usually ibuprofen.
Gastrointestinal risks can be lowered by concurrent use of omeprazole.
It is gently suggested that, at this time, it is therefore difficult to foresee a place in therapy for lumiracoxib.
Insiders' view: buy the Brand Manager a big drink!
Just in time for Christmas
Camera flask. Ideal for boring sales meetings.
Made out of high–polish steel, the faux–camera hold 4 oz. and comes with a mini–funnel.
$14.99 here.
Tuesday, December 13, 2005
Top Ten sayings by patients during colonoscopies
10. “Take it easy Doc, you’re boldly going where no man has gone before.”
9. “Find Bum Farto yet?”
8. “Can you hear me NOW?”
7. “Are we there yet? Are we there yet? Are we there yet?”
6. “You know in Arkansas we’re now legally married.”
5. “You put your left hand in, you take your left hand out…”
4. “Hey! Now I know how a Muppet feels!”
3. “If your hand doesn’t fit, you must quit!”
2. “Hey Doc, let me know if you find my dignity.”
And the best one of them all…
1. “Could you write a note for my wife saying that my head is in fact not up there.”
Hat tip: Doc around the Clock
9. “Find Bum Farto yet?”
8. “Can you hear me NOW?”
7. “Are we there yet? Are we there yet? Are we there yet?”
6. “You know in Arkansas we’re now legally married.”
5. “You put your left hand in, you take your left hand out…”
4. “Hey! Now I know how a Muppet feels!”
3. “If your hand doesn’t fit, you must quit!”
2. “Hey Doc, let me know if you find my dignity.”
And the best one of them all…
1. “Could you write a note for my wife saying that my head is in fact not up there.”
Hat tip: Doc around the Clock
Musical medication
Musical Medication
Check out this music video. It is set to the Billy Joel's song "We Didn't Start the Fire". It is about our medication obsessed population and is pretty much self explanatory. All the great brands get a mention! Hat tip to "Doc around the Clock"
Enjoy!
Check out this music video. It is set to the Billy Joel's song "We Didn't Start the Fire". It is about our medication obsessed population and is pretty much self explanatory. All the great brands get a mention! Hat tip to "Doc around the Clock"
Enjoy!
Cerovive - No bad news, yet
Poor AZ. Developing the stroke treatment Cerovive must be no fun at all. The pressure must be intense, given that it's half of all their Phase 3 development options (the other being the PPAR agonist Galida!!).
So when Tomas Odergren, who heads the development programme for the drug at AstraZeneca, said the news that the SAINT studys' independent safety board has OK'd the trial to continue he was inferring that this was another encouraging sign that Cerovive is well tolerated in acute ischemic stroke patients, who have tended to be highly vulnerable to adverse effects of many other drug candidates tested to date.
A case of no bad news being good news? Maybe?
So when Tomas Odergren, who heads the development programme for the drug at AstraZeneca, said the news that the SAINT studys' independent safety board has OK'd the trial to continue he was inferring that this was another encouraging sign that Cerovive is well tolerated in acute ischemic stroke patients, who have tended to be highly vulnerable to adverse effects of many other drug candidates tested to date.
A case of no bad news being good news? Maybe?
BMS - post Pargluva slimming
NEW YORK - BMS plans to cut costs by at least $500 million in 2007 through unspecified "productivity plans" and reiterated its intention to return the company to earnings growth that year.
Bristol-Myers said the future savings will build on the estimated $200 million a year it cut in expenses in both 2004 and 2005. The company would not elaborate on the nature of its new cost-cutting plans. The New York-based company has its research headquarters in Princeton.
Bristol-Myers said reducing costs is more imperative now than ever since the FDA required further data in October for the approval of diabetes drug Pargluva - information that would take years to put together.
With Pargluva out of the picture, BMS said it was "considering a range of options" on how to use the freed up capacity within its sales force that had been slated for the diabetes drug. In the last five years, Bristol-Myers has reduced its U.S. sales force by 30 percent to 2,800.
Insiders view: Pargluva is a dead duck. Are the other PPARs in development also dead in the water? Yep, unless their side effect profiles are addressed as per the FDAs' proposals.
http://www.startribune.com/stories/535/5778589.html
Bristol-Myers said the future savings will build on the estimated $200 million a year it cut in expenses in both 2004 and 2005. The company would not elaborate on the nature of its new cost-cutting plans. The New York-based company has its research headquarters in Princeton.
Bristol-Myers said reducing costs is more imperative now than ever since the FDA required further data in October for the approval of diabetes drug Pargluva - information that would take years to put together.
With Pargluva out of the picture, BMS said it was "considering a range of options" on how to use the freed up capacity within its sales force that had been slated for the diabetes drug. In the last five years, Bristol-Myers has reduced its U.S. sales force by 30 percent to 2,800.
Insiders view: Pargluva is a dead duck. Are the other PPARs in development also dead in the water? Yep, unless their side effect profiles are addressed as per the FDAs' proposals.
http://www.startribune.com/stories/535/5778589.html
Monday, December 12, 2005
Vioxx - British Justice?
What a day for Merck and Vioxx! A US federal court case turns into a mistrial, whilst in the UK over 200 people loose a legal aid appeal. The ruling will mean many will no longer be able to mount compensation claims in British courts.
However, Insider remains a believer in British Justice!
http://news.bbc.co.uk/1/hi/health/4481248.stm
ABPI - Viva el Presidente!
The Acomplia Product Manager at Sanofi-Aventis must be cursing their luck! Nigel Brooksby, Sanofi-Aventis UK's managing director has been named as the ABPI's next president.
Brooksby will take over from the current ABPI president, Vincent Lawton (who has his own problems....scroll down a couple of stories), of Merck Sharpe & Dohme, in April next year, and will serve for two years.
Brooksby will work alongside ABPI director general Richard Barker in promoting the interests of the UK pharmaceutical industry in its domestic market and within a European context.
"With health services across Europe facing difficult times, it is essential that the pharmaceutical industry works in close co-operation with the government to ensure patients get the best possible treatment," said Brooksby.
Formerly head of Sanofi-Synthelabo in the UK, Brooksby oversaw its merger with Aventis in 2004 and was appointed the managing director of the new company, with responsibility for 3,200 staff.
And why is the Acomplia PM cursing, you ask? Well, they must now try harder to ensure its launch (coming soon, aka - rimonabant) does not break the ABPI Code of Practice for promotion. It wouldn't look too good if it did, would it?
Brooksby will take over from the current ABPI president, Vincent Lawton (who has his own problems....scroll down a couple of stories), of Merck Sharpe & Dohme, in April next year, and will serve for two years.
Brooksby will work alongside ABPI director general Richard Barker in promoting the interests of the UK pharmaceutical industry in its domestic market and within a European context.
"With health services across Europe facing difficult times, it is essential that the pharmaceutical industry works in close co-operation with the government to ensure patients get the best possible treatment," said Brooksby.
Formerly head of Sanofi-Synthelabo in the UK, Brooksby oversaw its merger with Aventis in 2004 and was appointed the managing director of the new company, with responsibility for 3,200 staff.
And why is the Acomplia PM cursing, you ask? Well, they must now try harder to ensure its launch (coming soon, aka - rimonabant) does not break the ABPI Code of Practice for promotion. It wouldn't look too good if it did, would it?
Hey signor - need some weed?
Britain's GW Pharmaceuticals Plc( Profile) has agreed to a deal for Spain's Almirall to market its pioneering cannabis-based medicine, Sativex, in European countries excluding the UK, sending its shares higher on Monday.
GW Pharma said it would receive a signature fee of £12 million ($21 million), within total potential milestone payments of £46 million, and that it would maintain a significant share of long-term product revenues.
Almirall is Spain's largest pharmaceutical company and one of Europe's biggest private drug companies, with 2005 sales approaching 1 billion euros ($1.2 billion).
GW Pharma grows thousands of marijuana plants at a secret location in the English countryside (Insider knows this as he stumbled upon one of the sites once!), having been granted a dispensation by the government to use the plant for medical research.
Canada became the first country to approve Sativex, an under-the-tongue spray, for sale in April 2005 as a treatment for neuropathic pain in multiple sclerosis patients.
Sativex was initially expected to be approved in Britain by the end of 2003, but has suffered numerous delays. However it can now be imported into the UK from Canada.
German drugmaker Bayer ( Profile, Research) is GW Pharma's marketing partner in Canada and the UK.
Source: Reuters
Sunday, December 11, 2005
Merck UK - hitting a nerve
Merck UK has begun a consultation process that looks certain to end in the closure of its Harlow-based Neuroscience Research Centre (NRC) and the loss of 330 of Merck’s 1,900 UK jobs.
The move is part of a massive global restructuring programme aimed at saving billions in Merck’s manufacturing operations and will result in approximately 7,000 redundancies worldwide.
Though NRC is actually a basic research facility, the site will bear the brunt of the UK restructure with almost its entire workforce of 260 expected to lose their posts.
MSD managing director, Vincent Lawton, said: "These are difficult times for employees, their families and our communities, but especially for those individuals whose positions are directly affected. We will be consulting widely and intend to offer support through our Employee Assistance Programme, as well as dedicated outplacement and financial advisory services."
The move is part of a massive global restructuring programme aimed at saving billions in Merck’s manufacturing operations and will result in approximately 7,000 redundancies worldwide.
Though NRC is actually a basic research facility, the site will bear the brunt of the UK restructure with almost its entire workforce of 260 expected to lose their posts.
MSD managing director, Vincent Lawton, said: "These are difficult times for employees, their families and our communities, but especially for those individuals whose positions are directly affected. We will be consulting widely and intend to offer support through our Employee Assistance Programme, as well as dedicated outplacement and financial advisory services."
Lanier vs Reicin - a battle royal to come?
Even if Merck no longer calls its vice president of clinical research as a witness, the attorney, Mark Lanier, has said he will put Dr. Alise Reicin on the stand to contrast her previous testimony with information revealed by the NEJM. Lanier is scheduled to try the fourth Vioxx case in late February in Atlantic City.
''I plan on using it to show she's been less than honest with other juries," Lanier said.
The trial described in the Journal article was designed to show whether Vioxx could treat pain without causing stomach bleeding associated with older painkillers. The scientists running the trial also tracked serious cardiovascular side effects caused by Vioxx and naproxen, a painkiller sold as Aleve.
A Merck biostatistician, Deborah Shapiro, had alerted Reicin about additional heart attacks caused by Vioxx in a July 5, 2000 memo, Lanier said. Reicin and Shapiro were among the 13 authors of the Journal manuscript. Shapiro's memo reported 11 serious cardiovascular side effects that the company learned about after a study cutoff date, but before the article was published. Four of the five confirmed events were due to Vioxx. Three were heart attacks suffered by patients at low cardiovascular risk.
In addition, closer scrutiny of a computer diskette the authors submitted to the Journal revealed that a Merck computer was used to delete data from the manuscript, downplaying Vioxx's heart risks.
In earlier court cases -- and as late as Wednesday in Houston -- Reicin testified that Merck provided prompt and truthful details about Vioxx heart risks. A Merck spokeswoman said yesterday that the company declined to comment further.
Staffers working for Lanier are scouring Reicin's past testimony to determine whether it supports a perjury investigation.
Lanier said juries were unlikely to be asked to interpret scientific subtleties that interest physicians -- like the relative risk of suffering a heart attack while taking Vioxx increasing from 4.25 times to 5 times because of the more complete cardiovascular safety data.
''What a jury is going to get is A, Merck fudged on the details," Lanier said. ''B, the fudge was in their favor. C, it was on purpose. D, Merck lied about fudging, or at least covered it up. And E, the most prestigious medical journal in the United States of America has called their hand on it and said this is unethical and wrong."
Insiders view: This will be a true battle royal! Better than Matlock and Perry Mason all rolled into one!
Source: Boston Globe
Saturday, December 10, 2005
Topol toppled?
Less than a week after his videotaped lambasting of Merck was played in a Houston federal courthouse, Dr. Eric Topol, a prominent cardiologist, has lost his title as chief academic officer of the Cleveland Clinic's medical college.
Topol said Friday that he believed his demotion may be related to his testimony in that case, the third Vioxx lawsuit to reach trial. Topol has questioned Vioxx's safety for several years and said in his testimony, played in court last Saturday that he believed Merck had acted irresponsibly and committed scientific misconduct when it promoted Vioxx.
"The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified," Topol said Friday. "No wonder nobody stands up to the industry."
Topol will remain the chief of cardiology at the clinic, a prestigious nonprofit health system with almost $4 billion in annual revenue, and the loss of his title as chief academic officer does not affect his salary. But he will lose his position on the clinic's governing board. His job change was first reported Friday by The Cleveland Plain Dealer.
Topol did not offer specific evidence to back his allegation. Eileen Sheil, a spokeswoman for the clinic, said that Topol was not being punished for his Vioxx testimony. Topol lost his title as part of a broader administrative reorganization, Sheil said.
"The organization made the decision that that position was no longer needed," she said.
Insider says: Look how Dr Topol was described in the most recent Merck Vioxx trial!
Mercks' lawyer Phillip Beck depicted Topol as self-important and "the kind of guy who doesn't like to be contradicted and has an ax to grind."
That would be Insiders' definition of most, if not all, academic cardiologists!
However, Dr Topol has shown courage in speaking out. Insider salutes him and urges him to continue to dig for the whole truth about Vioxx.
http://framehosting.dowjonesnews.com/sample/samplestory.asp?StoryID=2005120821180000&Take=1
http://www.chron.com/disp/story.mpl/business/3515643.html
Topol said Friday that he believed his demotion may be related to his testimony in that case, the third Vioxx lawsuit to reach trial. Topol has questioned Vioxx's safety for several years and said in his testimony, played in court last Saturday that he believed Merck had acted irresponsibly and committed scientific misconduct when it promoted Vioxx.
"The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified," Topol said Friday. "No wonder nobody stands up to the industry."
Topol will remain the chief of cardiology at the clinic, a prestigious nonprofit health system with almost $4 billion in annual revenue, and the loss of his title as chief academic officer does not affect his salary. But he will lose his position on the clinic's governing board. His job change was first reported Friday by The Cleveland Plain Dealer.
Topol did not offer specific evidence to back his allegation. Eileen Sheil, a spokeswoman for the clinic, said that Topol was not being punished for his Vioxx testimony. Topol lost his title as part of a broader administrative reorganization, Sheil said.
"The organization made the decision that that position was no longer needed," she said.
Insider says: Look how Dr Topol was described in the most recent Merck Vioxx trial!
Mercks' lawyer Phillip Beck depicted Topol as self-important and "the kind of guy who doesn't like to be contradicted and has an ax to grind."
That would be Insiders' definition of most, if not all, academic cardiologists!
However, Dr Topol has shown courage in speaking out. Insider salutes him and urges him to continue to dig for the whole truth about Vioxx.
http://framehosting.dowjonesnews.com/sample/samplestory.asp?StoryID=2005120821180000&Take=1
http://www.chron.com/disp/story.mpl/business/3515643.html
Friday, December 09, 2005
Thursday, December 08, 2005
Merck - Uh oh, here comes trouble
Merck shares went south today on news that a study published in 2000 in The New England Journal of Medicine excluded data that might have linked the drug to an increase in heart attacks.
As first reported on Forbes.com, editors at the world's top medical journal found by examining a computer diskette that relevant data about Vioxx's risk to the heart compared with an older pain drug, naproxen, were deleted two days before the paper was initially submitted.
Insiders view: Hmm! That's the trouble with technology sometimes. It can leave ghosts in the machine!
Here's the NEJM piece:
NEJM
Here is the NJ Star Ledgers take:
Star Ledger
AZ - CytoFab - Is this a good buy?
Protherics PLC surged more than 50% on Thursday after AstraZeneca PLC agreed to pay up to $338 million for the rights to a drug to treat a potentially lethal blood infection.
Protherics said it's won a late-stage licensing deal with AstraZeneca ( AZN) valued at as much of £195 million to license its anti-sepsis product CytoFab, which is being prepared for a Phase III trial.
Insider is looking into CytoFab. But this looks like a great deal for Protherics. The question is will it also be a good deal for AZ? Cheshire-based Protherics reckon CytoFab could help around three million people worldwide to fight sepsis, a dangerous reaction to bacteria in the bloodstream.
AZ have a base in Cheshire as well. Now isn't that a convenient and handy coincidence!
Insider reserves his judgement, for the moment.
Protherics said it's won a late-stage licensing deal with AstraZeneca ( AZN) valued at as much of £195 million to license its anti-sepsis product CytoFab, which is being prepared for a Phase III trial.
Insider is looking into CytoFab. But this looks like a great deal for Protherics. The question is will it also be a good deal for AZ? Cheshire-based Protherics reckon CytoFab could help around three million people worldwide to fight sepsis, a dangerous reaction to bacteria in the bloodstream.
AZ have a base in Cheshire as well. Now isn't that a convenient and handy coincidence!
Insider reserves his judgement, for the moment.
Wednesday, December 07, 2005
CafePharma - What's the story?
CafePharma seems to be blocking the word "PharmaGossip" on their bulletin boards.
Try it for youself:
Go to http://www.cafepharma.com and type in "pharmagossip" and see what happens......all that comes up is **********.
Is this censorship, Insider asks?
It's flattering in a way, that a little blog has caused this action. But who got CP to do this? If you know anything feel free to share with Insider : pharmagossip@hotmail.co.uk
Try it for youself:
Go to http://www.cafepharma.com and type in "pharmagossip" and see what happens......all that comes up is **********.
Is this censorship, Insider asks?
It's flattering in a way, that a little blog has caused this action. But who got CP to do this? If you know anything feel free to share with Insider : pharmagossip@hotmail.co.uk
AstraZeneca - Getting on by getting out!
Quitting your job just because you're unhappy with it.
Say what? In this day and age?
There are times a career coach can help, so says Janet Steinwedel, director of leadership coaching at AstraZeneca.
A few questions to consider:
- Do you want your work and life to be less complicated?
- Do you want or need to accelerate results at work?
- Is there a gap in your knowledge, skills or confidence?
- Are you being asked to tackle a massive project, without enough time or resources?
- Is your work and life out of balance?
- Is there a new manager or leader in your company?
- Do you need more organization and ability to self-manage?
Form an orderly line to speak with Janet, please!
http://www.startribune.com/stories/535/5767061.html
Say what? In this day and age?
There are times a career coach can help, so says Janet Steinwedel, director of leadership coaching at AstraZeneca.
A few questions to consider:
- Do you want your work and life to be less complicated?
- Do you want or need to accelerate results at work?
- Is there a gap in your knowledge, skills or confidence?
- Are you being asked to tackle a massive project, without enough time or resources?
- Is your work and life out of balance?
- Is there a new manager or leader in your company?
- Do you need more organization and ability to self-manage?
Form an orderly line to speak with Janet, please!
http://www.startribune.com/stories/535/5767061.html
Tuesday, December 06, 2005
Conference freebies - contributions welcome
Big Pharma sponsored conferences are usually awash with gifts from the munificent firms. These freebies range from pens bearing company logos to copious food and drink.
The Second European Influenza Conference, which took place in Malta recently, was no exception. But companies are clearly casting about for novel ways to impress. Points for unintended (we hope) hilarity go to the firm that handed out bath oil beads - packaged in very sharp, pointy little plastic pyramids and thoughtfully placed on the seats of a darkened lecture hall. We are not aware of any serious injuries, though there were some near misses.
But top marks go to the company that offered delegates a free sample of its product - a flu vaccination, provided by a friendly Maltese doctor in the corporate hospitality suite. Uptake appeared to be good, even though the jab obviously does not protect against the bird flu that preoccupied the meeting.
Insider recalls a branded "smoke hood" giveaway a number of years back.
LOL
So, just as the plane is crashing and burning the MDs put on their hood and think "I must prescribe more Panexa"!
Source: New Scientist, hat tip: Brad at http://robothink.blogspot.com/
The Second European Influenza Conference, which took place in Malta recently, was no exception. But companies are clearly casting about for novel ways to impress. Points for unintended (we hope) hilarity go to the firm that handed out bath oil beads - packaged in very sharp, pointy little plastic pyramids and thoughtfully placed on the seats of a darkened lecture hall. We are not aware of any serious injuries, though there were some near misses.
But top marks go to the company that offered delegates a free sample of its product - a flu vaccination, provided by a friendly Maltese doctor in the corporate hospitality suite. Uptake appeared to be good, even though the jab obviously does not protect against the bird flu that preoccupied the meeting.
Insider recalls a branded "smoke hood" giveaway a number of years back.
LOL
So, just as the plane is crashing and burning the MDs put on their hood and think "I must prescribe more Panexa"!
Source: New Scientist, hat tip: Brad at http://robothink.blogspot.com/
WHO suspects fraudulent adverse event reporting - The XYZ puzzle
Take a look at page 19 of this WHO report:
http://www.who-umc.org/graphics/6899.pdf
"In July last year the UMC received a regular batch of ADR reports fromone of our European national centres. What was particular about this submission was the covering letter that stated "Please note that several of the attached reports refer to DRUG X, which is a generic product containing SUBSTANCE Y. We suppose that the reports may originate from the marketing strategy of the main competitor, the marketing authorization holder of the original product DRUG Z. We do not have any proof of our suspicions, but there are several hints for this".
Anyone any ideas what X Y and Z are? A nice Christmas present awaits.......
Hat tip: Anon
http://www.who-umc.org/graphics/6899.pdf
"In July last year the UMC received a regular batch of ADR reports fromone of our European national centres. What was particular about this submission was the covering letter that stated "Please note that several of the attached reports refer to DRUG X, which is a generic product containing SUBSTANCE Y. We suppose that the reports may originate from the marketing strategy of the main competitor, the marketing authorization holder of the original product DRUG Z. We do not have any proof of our suspicions, but there are several hints for this".
Anyone any ideas what X Y and Z are? A nice Christmas present awaits.......
Hat tip: Anon
Naked News - Michelle Pantoliano
Michelle Pantoliano, age 30, joined Naked News in January 2002. Michelle's solid reporting background, versatility and communication skills, along with her innate beauty, made her a natural to join the program.
Michelle's hilarious Locker Talk segment can be seen each weekend on Naked News. Some have referred to it as the rantings of a madwoman, but we say no one else will make you laugh like Michelle.
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