Enjoy.
Friday, August 31, 2007
Quote of the week
"Exubera was not our finest day," acknowledged Pfizer's vice chairman, David Shedlarz, during a recent conference call with analysts. "We made a lot of mistakes with what is a profoundly important therapeutic."
Source
Source
Thursday, August 30, 2007
Abbott - Wiki or wicked?
Patients not Patents, Inc.
1712 Eye Street,
NW Suite 915,
Washington, DC 20006
www.PatientsNotPatents.org
Phone -- 202.277.6213 Fax – 202.223.5318
jeff@patientsnotpatents.org
PRESS RELEASECONTACT: Jeffrey Light Phone: 202-277-6213
FOR IMMEDIATE RELEASE
ABBOTT LABORATORIES DELETES SAFETY CONCERNS FROM WEB
Washington, D.C., August 29, 2007 – Newly available data show that employees of Abbott Laboratories have been altering entries to Wikipedia, the popular online encyclopedia, to eliminate information questioning the safety of its top-selling drugs.
In July of 2007, a computer at Abbott Laboratories’ Chicago office was used to delete a reference to a Mayo Clinic study that revealed that patients taking the arthritis drug Humira faced triple the risk of developing certain kinds of cancers and twice the risk of developing serious infections. The study was published in the Journal of the American Medical Association in 2006.
The same computer was used to remove articles describing public interest groups’ attempt to have Abbott’s weight-loss drug Meridia banned after the drug was found to increase the risk of heart attack and stroke in some patients.
The site’s editors restored the deleted information, but Abbott’s activities illustrate drug companies’ eagerness to suppress safety concerns, said Jeffrey Light, Executive Director of the Washington, D.C.-based advocacy group Patients not Patents. “The argument that drug companies can be trusted to provide adequate safety information on their own products has been used by the pharmaceutical industry to fight against government regulation of consumer advertising. Clearly such trust is misplaced. As Abbott’s actions have demonstrated, drug companies will attempt to hide unfavorable safety information when they think nobody is watching.”
The changes are part of over one thousand edits made from computers at Abbott’s offices. The data was obtained from WikiScanner, an independent site that allows users to look up anonymous changes to Wikipedia articles.
1712 Eye Street,
NW Suite 915,
Washington, DC 20006
www.PatientsNotPatents.org
Phone -- 202.277.6213 Fax – 202.223.5318
jeff@patientsnotpatents.org
PRESS RELEASECONTACT: Jeffrey Light Phone: 202-277-6213
FOR IMMEDIATE RELEASE
ABBOTT LABORATORIES DELETES SAFETY CONCERNS FROM WEB
Washington, D.C., August 29, 2007 – Newly available data show that employees of Abbott Laboratories have been altering entries to Wikipedia, the popular online encyclopedia, to eliminate information questioning the safety of its top-selling drugs.
In July of 2007, a computer at Abbott Laboratories’ Chicago office was used to delete a reference to a Mayo Clinic study that revealed that patients taking the arthritis drug Humira faced triple the risk of developing certain kinds of cancers and twice the risk of developing serious infections. The study was published in the Journal of the American Medical Association in 2006.
The same computer was used to remove articles describing public interest groups’ attempt to have Abbott’s weight-loss drug Meridia banned after the drug was found to increase the risk of heart attack and stroke in some patients.
The site’s editors restored the deleted information, but Abbott’s activities illustrate drug companies’ eagerness to suppress safety concerns, said Jeffrey Light, Executive Director of the Washington, D.C.-based advocacy group Patients not Patents. “The argument that drug companies can be trusted to provide adequate safety information on their own products has been used by the pharmaceutical industry to fight against government regulation of consumer advertising. Clearly such trust is misplaced. As Abbott’s actions have demonstrated, drug companies will attempt to hide unfavorable safety information when they think nobody is watching.”
The changes are part of over one thousand edits made from computers at Abbott’s offices. The data was obtained from WikiScanner, an independent site that allows users to look up anonymous changes to Wikipedia articles.
Pfizer - Exubera: another blow for the bong
Poor Pfizer. Industry insiders fear a planned marketing push for Exubera, fast becoming the US giant’s highest-profile disappointment, will be in vain.
Analysts were forecasting blockbuster annual sales of $2bn (£1.01bn, E1.49bn) for the insulin spray. It delivered just $4m in the second quarter of 2007 – the first time Pfizer disclosed sales of the product.
In July, Pfizer launched a massive television and print ad campaign in the US to jump-start sales. Reducing the number of inhalers produced is a clear indication management are unsure their next campaign will have much impact on sales.
The cutbacks are spelt out in a report filed with the US Securities and Exchange Commission by West Pharmaceutical Services, the American drug technology firm that makes about 60% of the device.
It said: “We expect Pfizer’s high inventory levels and slower-than-expected demand will affect our fourth-quarter 2007 and full-year 2008 sales levels. In coordination with our customer, Nektar, we have reduced production to one shift per day at our dedicated facility beginning in the third quarter of 2007.”
More at The Business
Analysts were forecasting blockbuster annual sales of $2bn (£1.01bn, E1.49bn) for the insulin spray. It delivered just $4m in the second quarter of 2007 – the first time Pfizer disclosed sales of the product.
In July, Pfizer launched a massive television and print ad campaign in the US to jump-start sales. Reducing the number of inhalers produced is a clear indication management are unsure their next campaign will have much impact on sales.
The cutbacks are spelt out in a report filed with the US Securities and Exchange Commission by West Pharmaceutical Services, the American drug technology firm that makes about 60% of the device.
It said: “We expect Pfizer’s high inventory levels and slower-than-expected demand will affect our fourth-quarter 2007 and full-year 2008 sales levels. In coordination with our customer, Nektar, we have reduced production to one shift per day at our dedicated facility beginning in the third quarter of 2007.”
More at The Business
Sexist Sanofi?
Four female sales representatives have sued pharmaceutical group Sanofi-Aventis for sexual discrimination in a $300m class action lawsuit.
In a suit filed with a US District Court in New York, the women allege that they were barred from promotion opportunities, received lower pay rises than their male colleagues and were subjected to sexually abusive working environments.
Three women were added as plaintiffs in Wednesday's complaint, which follows an original suit filed in March.
The suit seeks class action status, with potentially larger implications for the 8,000 US sales personnel of the French drug maker.
Marc Greene, a spokesman for Sanofi-Aventis, the third-largest pharmaceutical company in the world, said that the company was confident that "the suit lacks merit, and that all of our employees are treated fairly and in compliance with all applicable federal and state laws".
This month, a US federal judge gave the green light to another class-action discrimination suit, this time against Novartis, the Swiss pharmaceuticals group. In the $100m lawsuit, 19 female sales workers alleged they were discriminated against in payment and promotions.
Plaintiff Karen Bellifemine, who worked for Sanofi-Aventis for more than 12 years, alleges that the company "does not discipline managers or other employees when they discriminate against female employees or create a sexually charged and inhospitable workplace for women".
Ms Bellifemine said sexually explicit language was used in e-mails and during "happy hours", and that she was twice denied promotions that were given to male colleagues.
More
In a suit filed with a US District Court in New York, the women allege that they were barred from promotion opportunities, received lower pay rises than their male colleagues and were subjected to sexually abusive working environments.
Three women were added as plaintiffs in Wednesday's complaint, which follows an original suit filed in March.
The suit seeks class action status, with potentially larger implications for the 8,000 US sales personnel of the French drug maker.
Marc Greene, a spokesman for Sanofi-Aventis, the third-largest pharmaceutical company in the world, said that the company was confident that "the suit lacks merit, and that all of our employees are treated fairly and in compliance with all applicable federal and state laws".
This month, a US federal judge gave the green light to another class-action discrimination suit, this time against Novartis, the Swiss pharmaceuticals group. In the $100m lawsuit, 19 female sales workers alleged they were discriminated against in payment and promotions.
Plaintiff Karen Bellifemine, who worked for Sanofi-Aventis for more than 12 years, alleges that the company "does not discipline managers or other employees when they discriminate against female employees or create a sexually charged and inhospitable workplace for women".
Ms Bellifemine said sexually explicit language was used in e-mails and during "happy hours", and that she was twice denied promotions that were given to male colleagues.
More
Wednesday, August 29, 2007
Bad boys, bad boys
Watcha gonna do when they come for you!
In most industries, word of an investigative subpoena or a regulatory inquiry can send share prices tumbling. In the pharmaceutical industry, it is more likely to generate a shrug or even a yawn.
Almost every major drugs company that does business in the US is facing at least a couple of federal and state investigations into their sales, pricing or distribution practices.
Several, including Schering-Plough and Purdue Frederick, have recently pleaded guilty to corporate criminal charges and paid hundreds of millions of dollars in fines. Bristol-Myers Squibb recently completed a two-year probation period that put a government monitor in its boardroom.
Is it any wonder that Pfizer and Merck recently promoted lawyers to the roles of chief executive and global number two respectively?
More at the FT
In most industries, word of an investigative subpoena or a regulatory inquiry can send share prices tumbling. In the pharmaceutical industry, it is more likely to generate a shrug or even a yawn.
Almost every major drugs company that does business in the US is facing at least a couple of federal and state investigations into their sales, pricing or distribution practices.
Several, including Schering-Plough and Purdue Frederick, have recently pleaded guilty to corporate criminal charges and paid hundreds of millions of dollars in fines. Bristol-Myers Squibb recently completed a two-year probation period that put a government monitor in its boardroom.
Is it any wonder that Pfizer and Merck recently promoted lawyers to the roles of chief executive and global number two respectively?
More at the FT
Icahn buys stake in Biogen
Carl C. Icahn, the billionaire investor who has battled executives at Motorola, Time Warner, and other iconic corporations, now appears to have Biogen Idec in his crosshairs.
Mr. Icahn, who recently bought a 1 percent stake in the Cambridge, Mass. biotech company, won federal approval Friday to take a bigger stake, sending shares to a two-year-high Monday on talk Biogen Idec could become a takeover target.
More at NYT
Mr. Icahn, who recently bought a 1 percent stake in the Cambridge, Mass. biotech company, won federal approval Friday to take a bigger stake, sending shares to a two-year-high Monday on talk Biogen Idec could become a takeover target.
More at NYT
Pfizer - Provera: settlement in Reno
Pfizer unit agreed to settle three women's claims that its hormone-replacement drug Provera caused their breast cancer, leaving only the Madison-based drugmaker Wyeth to face the women in a trial in less than three weeks.
Pfizer's Pharmacia & Upjohn unit agreed to pay an undisclosed amount to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester to resolve accusations that the company didn't adequately warn them about Provera's breast cancer risk. Pfizer, the world's largest drugmaker, markets Provera to help women deal with symptoms of menopause.
''The settlement is in no way an admission by Pharmacia that Provera contributed to breast cancer in any of the three women involved this case," Pfizer spokeswoman Bryant Haskins said today in an interview.
The accord means the women won't press their Provera claims against the Pfizer unit when the case goes to trial Sept. 10 in state court in Reno, Nevada. Rowatt, Scofield and Forrester also are suing Wyeth over its menopause medicines.
Wyeth faces more than 5,000 product-liability suits over its hormone-replacement drugs Premarin and Prempro. A 2002 study found women taking the drugs to deal with hot flashes and other menopausal symptoms had an increased rate of breast cancer.
More
Pfizer's Pharmacia & Upjohn unit agreed to pay an undisclosed amount to Arlene Rowatt, Jeraldine Scofield and Pamela Forrester to resolve accusations that the company didn't adequately warn them about Provera's breast cancer risk. Pfizer, the world's largest drugmaker, markets Provera to help women deal with symptoms of menopause.
''The settlement is in no way an admission by Pharmacia that Provera contributed to breast cancer in any of the three women involved this case," Pfizer spokeswoman Bryant Haskins said today in an interview.
The accord means the women won't press their Provera claims against the Pfizer unit when the case goes to trial Sept. 10 in state court in Reno, Nevada. Rowatt, Scofield and Forrester also are suing Wyeth over its menopause medicines.
Wyeth faces more than 5,000 product-liability suits over its hormone-replacement drugs Premarin and Prempro. A 2002 study found women taking the drugs to deal with hot flashes and other menopausal symptoms had an increased rate of breast cancer.
More
Tuesday, August 28, 2007
Lundbeck - more on that boardroom kerfuffle
As Lundbeck faces up to patent expirations and a bare pipeline, it appears that there have been a few problems at management level as well given the news that the Danish firm’s chairman has stepped down earlier than expected.
The group issued a statement saying that Flemming Lindelov has decided to resign his duties as chairman and leave Lundbeck’s supervisory board “in order to restore some calm around the company”.
He was expected to leave at the annual general meeting next April but has left early, to be succeeded by Per Wold-Olsen.
The call to restore calm comes after newspapers in Denmark reported that Mr Lindelov had said that chief executive Claus Braestrup would leave his post when his contract expires in the spring of 2009. This came as news to Mr Braestrup who was reported as saying he had no plans to step down, and this led to a quick response from Mr Lindelov who claimed that the media had misunderstood his remarks.
Mr Lindelov’s departure led to a slight rise in Lundbeck’s share price and analysts believe that the appointment of Mr Wold-Olsen now means that management can unite in guiding the firm through this tricky period. The company remains exposed to the weak US dollar and looming patent expiries starting in 2012 of the blockbuster Lexapro (escitalopram), sold in the USA by licensee Forest Laboratories, and Lundbeck's own Cipralex brand of the antidepressant.
The company also recently announced disappointing Phase III data for the new stroke drug desmoteplase, which came a couple of months after Lundbeck and partner Merck & Co said that data from Phase III studies suggested that the clinical profile for gaboxadol in insomnia did not support further development. Last month, Mr Braestrup acknowledged that the firm was in a crisis of sorts and needs to find a replacement for Lexapro/Cipralex and fast.
Source: PharmaTimes
The group issued a statement saying that Flemming Lindelov has decided to resign his duties as chairman and leave Lundbeck’s supervisory board “in order to restore some calm around the company”.
He was expected to leave at the annual general meeting next April but has left early, to be succeeded by Per Wold-Olsen.
The call to restore calm comes after newspapers in Denmark reported that Mr Lindelov had said that chief executive Claus Braestrup would leave his post when his contract expires in the spring of 2009. This came as news to Mr Braestrup who was reported as saying he had no plans to step down, and this led to a quick response from Mr Lindelov who claimed that the media had misunderstood his remarks.
Mr Lindelov’s departure led to a slight rise in Lundbeck’s share price and analysts believe that the appointment of Mr Wold-Olsen now means that management can unite in guiding the firm through this tricky period. The company remains exposed to the weak US dollar and looming patent expiries starting in 2012 of the blockbuster Lexapro (escitalopram), sold in the USA by licensee Forest Laboratories, and Lundbeck's own Cipralex brand of the antidepressant.
The company also recently announced disappointing Phase III data for the new stroke drug desmoteplase, which came a couple of months after Lundbeck and partner Merck & Co said that data from Phase III studies suggested that the clinical profile for gaboxadol in insomnia did not support further development. Last month, Mr Braestrup acknowledged that the firm was in a crisis of sorts and needs to find a replacement for Lexapro/Cipralex and fast.
Source: PharmaTimes
Pharmageddon?
Britain is in the grip of a prescription drug-taking epidemic, with unprecedented numbers of medicines being handed out by GPs, costing billions of pounds and stretching already tight NHS resources to breaking point.
Prescription drug use has increased by 27 per cent in the past the five years and the NHS drug bill topped £10bn in 2006. GPs prescribed 918 million medicines last year compared with 721 million five years ago, according to figures obtained by The Independent on Sunday.
More
Prescription drug use has increased by 27 per cent in the past the five years and the NHS drug bill topped £10bn in 2006. GPs prescribed 918 million medicines last year compared with 721 million five years ago, according to figures obtained by The Independent on Sunday.
More
Monday, August 27, 2007
Pfizer's new CFO and his "rhythm of numbers"
Pfizer Inc. named Frank D'Amelio, an executive at French communications company Alcatel-Lucent, to be the pharmaceutical giant's next chief financial officer, starting next month.Mr. D'Amelio, 49 years old, is known among Wall Street analysts for his ability to dig into the details of a company's financial position. One of his favorite phrases is "the rhythm of the numbers," according to a note from Lehman Brothers pharmaceuticals analyst Anthony Butler.
Mr. D'Amelio was also a key figure in restructurings that reduced Lucent's staff to 30,000 from 136,000, Mr. Butler noted.
Lundbeck - sounds like a hell of a board meeting
Danish pharmaceutical company H. Lundbeck said Chairman Flemming Lindeløv resigned and withdrew from the board Friday "to restore some calm around the company."
WSJ
WSJ
AstraZeneca and MedImmune - less is more
Even as MedImmune Inc. officials promise hundreds of new hires within the year, new owner AstraZeneca has identified $245 million in redundant annual expenses between the two companies.
At an Aug. 9 regional technology gathering, David Mott, MedImmune's president and CEO and an AstraZeneca senior executive, said the companies are in the final stages of deciding how to combine; a process that will map out the geography of the redundant spending.
At an Aug. 9 regional technology gathering, David Mott, MedImmune's president and CEO and an AstraZeneca senior executive, said the companies are in the final stages of deciding how to combine; a process that will map out the geography of the redundant spending.
London-based AstraZeneca, which bought MedImmune in June, has said it wants the redundancies eliminated by 2010.
Source
Source
Sunday, August 26, 2007
Are NICE too, er, nice?
Cost-effectiveness watchdog NICE, often criticised for rejecting pricey new drugs, may actually be too generous in approving medicines for use in the National Health Service, experts said on Friday.
"The uncomfortable truth is that NICE's threshold has no basis in either theory or evidence," John Appleby, chief economist at the King's Fund think tank, and colleagues at City University in London wrote in the BMJ.
"The uncomfortable truth is that NICE's threshold has no basis in either theory or evidence," John Appleby, chief economist at the King's Fund think tank, and colleagues at City University in London wrote in the BMJ.
Friday, August 24, 2007
Bad news - good news
First the bad news.
UK cost-effectiveness body the National Institute for Health and Clinical Excellence has firmly closed the door on Eli Lilly’s Alimta for non-small cell lung cancer.
NICE published its draft verdict on the use of Alimta (pemextred) and Roche’s Tarceva (erlotinib) for locally advanced or metastatic NSCLC last year, concluding that there is no evidence the drugs are more cost-effective than the older treatment docetaxel.
Yesterday, the Institute published its final guidance rejecting Alimta, after an appeal by Lilly failed to overturn the recommendations, following suit of the Scottish Medicines Consortium, which issued a red light for the therapy in February.
“The independent Appraisal Committee was not persuaded that the evidence presented provided a robust demonstration of the clinical and cost effectiveness of pemetrexed compared with either docetaxel or best supportive care and therefore concluded that the drug is not an effective use of NHS resources,” explained Andrew Dillon, NICE’s chief executive.
Lilly said it was “extremely disappointed” with the decision, given that “additional costs related to the provision of Alimta for the treatment of non-small-cell lung cancer, and the associated reduction in incidence of life threatening toxicities, are around £500 per month for three or four months."
Last month, Lilly celebrated success after getting the Institute to overturn an earlier decision rejecting Alimta for patients with mesothelioma, a cancer associated with asbestos exposure and mostly affecting the lungs.
NICE’s review of the available evidence last year failed to demonstrate that the drug was better than other, cheaper therapies on the market. But explaining the u-turn at the time, Dr Gillian Leng, implementation director and executive lead for the guidance, said that during the subsequent consultation a number of significant factors came to light, “which, taken together, have enabled the independent appraisal committee to recommend pemetrexed disodium as a treatment option for the majority of people with MPM.”
Now for the good news.
There was better news for Elan and partner Biogen Idec after NICE issued guidance recommending Tysabri (natalizumab) for the treatment of multiple sclerosis.
The Institute released its final appraisal document recommending the drug last month, opening up a period of consultation for any objections to its guidance, but has now given full consent for doctors to prescribe the treatment on the NHS.
The decision is especially sweet for Elan and Biogen given the rocky road Tysabri has travelled to market. Shortly after being launched in the USA, the drug was quickly pulled back off the shelves in February 2005 after being linked to a rare brain infection and a small number of fatalities. But following a safety review by US regulators, the monoclonal antibody was licensed across Europe in June last year, and placed on NICE’s fast-track programme for approvals in August.
Source: PharmaTimes
UK cost-effectiveness body the National Institute for Health and Clinical Excellence has firmly closed the door on Eli Lilly’s Alimta for non-small cell lung cancer.
NICE published its draft verdict on the use of Alimta (pemextred) and Roche’s Tarceva (erlotinib) for locally advanced or metastatic NSCLC last year, concluding that there is no evidence the drugs are more cost-effective than the older treatment docetaxel.
Yesterday, the Institute published its final guidance rejecting Alimta, after an appeal by Lilly failed to overturn the recommendations, following suit of the Scottish Medicines Consortium, which issued a red light for the therapy in February.
“The independent Appraisal Committee was not persuaded that the evidence presented provided a robust demonstration of the clinical and cost effectiveness of pemetrexed compared with either docetaxel or best supportive care and therefore concluded that the drug is not an effective use of NHS resources,” explained Andrew Dillon, NICE’s chief executive.
Lilly said it was “extremely disappointed” with the decision, given that “additional costs related to the provision of Alimta for the treatment of non-small-cell lung cancer, and the associated reduction in incidence of life threatening toxicities, are around £500 per month for three or four months."
Last month, Lilly celebrated success after getting the Institute to overturn an earlier decision rejecting Alimta for patients with mesothelioma, a cancer associated with asbestos exposure and mostly affecting the lungs.
NICE’s review of the available evidence last year failed to demonstrate that the drug was better than other, cheaper therapies on the market. But explaining the u-turn at the time, Dr Gillian Leng, implementation director and executive lead for the guidance, said that during the subsequent consultation a number of significant factors came to light, “which, taken together, have enabled the independent appraisal committee to recommend pemetrexed disodium as a treatment option for the majority of people with MPM.”
Now for the good news.
There was better news for Elan and partner Biogen Idec after NICE issued guidance recommending Tysabri (natalizumab) for the treatment of multiple sclerosis.
The Institute released its final appraisal document recommending the drug last month, opening up a period of consultation for any objections to its guidance, but has now given full consent for doctors to prescribe the treatment on the NHS.
The decision is especially sweet for Elan and Biogen given the rocky road Tysabri has travelled to market. Shortly after being launched in the USA, the drug was quickly pulled back off the shelves in February 2005 after being linked to a rare brain infection and a small number of fatalities. But following a safety review by US regulators, the monoclonal antibody was licensed across Europe in June last year, and placed on NICE’s fast-track programme for approvals in August.
Source: PharmaTimes
Thursday, August 23, 2007
Bacn - it's not quite spam
Bacn is a new problem now plaguing our email inboxes.
Putting it simply, Bacn is email you receive that isn’t spam… And isn’t personal mail. It’s the middle class of email. It’s notifications of a new post to your Facebook wall or a new follower on Twitter. It’s the Google alert for your name and the newsletter from your favorite company.
Pfizer and Wyeth - a $90 billion deal?
Beset by cost-cutting, layoffs, and high-profile drug failures, what’s a big pharma to do?
How about spend $90 billion to take out a competitor?
That’s what a Credit Suisse drug industry analyst recommends for Pfizer, the troubled, top-heavy drug giant in the midst of a drastic restructuring from its executive suite to its far-flung labs and sales offices. In a report released Monday Credit Suisse’s Catherine Arnold wrote that Wyeth is ripe, and Pfizer should do the plucking.
Wyeth’s stock is down $16.64, or 27 percent, from a late-June high of $62.20 after a series of pipeline setbacks. Even with its shares in decline, Wyeth has a market capitalization of more than $60 billion and has produced $21 billion in revenues the past 12 months.
Ms. Arnold saw a $69 per share takeout price for Wyeth, which would push the total outlay into the $90 billion range. But why Pfizer? The main reason is that Pfizer could pick up Wyeth’s biologics business. Pfizer doesn’t have one and biotech drugs have become some of industry’s most lucrative offerings.
NYT
How about spend $90 billion to take out a competitor?
That’s what a Credit Suisse drug industry analyst recommends for Pfizer, the troubled, top-heavy drug giant in the midst of a drastic restructuring from its executive suite to its far-flung labs and sales offices. In a report released Monday Credit Suisse’s Catherine Arnold wrote that Wyeth is ripe, and Pfizer should do the plucking.
Wyeth’s stock is down $16.64, or 27 percent, from a late-June high of $62.20 after a series of pipeline setbacks. Even with its shares in decline, Wyeth has a market capitalization of more than $60 billion and has produced $21 billion in revenues the past 12 months.
Ms. Arnold saw a $69 per share takeout price for Wyeth, which would push the total outlay into the $90 billion range. But why Pfizer? The main reason is that Pfizer could pick up Wyeth’s biologics business. Pfizer doesn’t have one and biotech drugs have become some of industry’s most lucrative offerings.
NYT
Wednesday, August 22, 2007
Quote of the day
“The criminal conduct involved in the marketing of OxyContin has been one of the most tragic examples in recent memory of a company favoring the bottom line over the health of our nation’s citizens.”
US Senate Judiciary Committee chairman Senator Patrick Leahy
Is linking a "crime"?
From The Register:
A mental health doctor is headed for a showdown with the General Medical Council (GMC) in the High Court because she is accused of breaking confidentiality by posting a link on her blog.
Dr Rita Pal's link led to an American site called Furious Seasons, which had published a PDF of the minutes of a July 2006 fitness to practice hearing of the British Psychological Society (BPS).
The hearing concerned Lisa Blakemore-Brown, a psychologist who has been involved in several high profile child health controversies. Her work included highlighting the controversy over Munchausen's Syndrome by Proxy, a disputed theory that was used to obtain several wrongful child murder convictions.
The hearing garnered attention from bloggers who highlighted the BPS's use of testimony from a psychiatrist who , according to the minutes, had not actually examined Blakemore-Brown.
Dr Pal was forced out of her locum job at Worcestershire NHS Trust in early May after managers got wind that she was being investigated by the GMC over the link. The GMC is the statutary body responsible for regulating doctors in the UK.
Dr Pal is part of a team which produces NHS Exposed, a campaigning website that aims to "obtain justice and fair treatment for those abused by the NHS".
After featuring the Blakemore-Brown case on NHS Exposed, she was notified by the GMC that it had received complaints and would investigate two of them under its own fitness to practice procedures. She stands accused of breaking the GMC's confidentiality rules.
Lisa Blakemore-Brown has said that she had not been aware that the minutes were going to be published online, but had no objections once they were.
The BPS first accused Blakemore-Brown in January of breaching its confidentiality rules, which she said was "laughable". She added: "I'm absolutely staggered they [the GMC] should drag Rita into it, especially because all she did was put a link up; she wasn't the first to publish it."
Rita Pal's lawyers have now applied to the High Court for a judicial review to have the case against her dismissed before any GMC hearing.
Dr Pal told The Reg: "It's bizarre. I linked to a document which was already public."
Another UK doctor's blog, Scientific Misconduct, also posted a link to the hearing minutes, but its operator, Dr Aubrey Blumsohn has had no contact from the GMC.
He said, on his site: "I wrote to them asking for clarification of their complaint against Dr Pal, clarification as to the relevance of the matter to their remit, and what offense they regard her to have committed under GMC rules so that I could properly accuse myself. I received acknowledgement but no reply."
A secondary accusation of falsely using the job title "psychiatrist" is also disputed by Dr Pal's lawyers.
Worcestershire NHS confirmed that Dr Pal left after it became aware of the GMC's investigation, but refused to comment further, citing confidentiality.
The GMC said it does not comment on ongoing investigations.
Hat tip: Philip at http://www.furiousseasons.com/
A mental health doctor is headed for a showdown with the General Medical Council (GMC) in the High Court because she is accused of breaking confidentiality by posting a link on her blog.
Dr Rita Pal's link led to an American site called Furious Seasons, which had published a PDF of the minutes of a July 2006 fitness to practice hearing of the British Psychological Society (BPS).
The hearing concerned Lisa Blakemore-Brown, a psychologist who has been involved in several high profile child health controversies. Her work included highlighting the controversy over Munchausen's Syndrome by Proxy, a disputed theory that was used to obtain several wrongful child murder convictions.
The hearing garnered attention from bloggers who highlighted the BPS's use of testimony from a psychiatrist who , according to the minutes, had not actually examined Blakemore-Brown.
Dr Pal was forced out of her locum job at Worcestershire NHS Trust in early May after managers got wind that she was being investigated by the GMC over the link. The GMC is the statutary body responsible for regulating doctors in the UK.
Dr Pal is part of a team which produces NHS Exposed, a campaigning website that aims to "obtain justice and fair treatment for those abused by the NHS".
After featuring the Blakemore-Brown case on NHS Exposed, she was notified by the GMC that it had received complaints and would investigate two of them under its own fitness to practice procedures. She stands accused of breaking the GMC's confidentiality rules.
Lisa Blakemore-Brown has said that she had not been aware that the minutes were going to be published online, but had no objections once they were.
The BPS first accused Blakemore-Brown in January of breaching its confidentiality rules, which she said was "laughable". She added: "I'm absolutely staggered they [the GMC] should drag Rita into it, especially because all she did was put a link up; she wasn't the first to publish it."
Rita Pal's lawyers have now applied to the High Court for a judicial review to have the case against her dismissed before any GMC hearing.
Dr Pal told The Reg: "It's bizarre. I linked to a document which was already public."
Another UK doctor's blog, Scientific Misconduct, also posted a link to the hearing minutes, but its operator, Dr Aubrey Blumsohn has had no contact from the GMC.
He said, on his site: "I wrote to them asking for clarification of their complaint against Dr Pal, clarification as to the relevance of the matter to their remit, and what offense they regard her to have committed under GMC rules so that I could properly accuse myself. I received acknowledgement but no reply."
A secondary accusation of falsely using the job title "psychiatrist" is also disputed by Dr Pal's lawyers.
Worcestershire NHS confirmed that Dr Pal left after it became aware of the GMC's investigation, but refused to comment further, citing confidentiality.
The GMC said it does not comment on ongoing investigations.
Hat tip: Philip at http://www.furiousseasons.com/
Healthy Skepticism's Dr Peter Mansfield - now booking for world tour 2008
Dr Peter Mansfield OAM BMBS is an Australian GP and Director of the excellent organisation Healthy Skepticism, an international non-profit organisation for health professionals and everyone with an interest in improving health. Their main aim is to improve health by reducing harm from misleading drug promotion.
Peter is also a Lecturer, Discipline of General Practice, at the University of Adelaide.
Peter will be giving a seminar in Cologne, Germany on a Monday between 21 April and 26 May 2008 inclusive for IQWiG (The Institute for Quality and Efficiency in Health Care).
Peter is also a Lecturer, Discipline of General Practice, at the University of Adelaide.
Peter will be giving a seminar in Cologne, Germany on a Monday between 21 April and 26 May 2008 inclusive for IQWiG (The Institute for Quality and Efficiency in Health Care).
When asked about his talks he told PharmaGossip:
Many doctors believe that to suggest that they are influenced by drug promotion is to insult their professionalism, integrity, intelligence and education. In the 1840s doctors felt similarly insulted by the suggestion that they should wash their hands before delivering babies especially after doing autopsies of women who had died of childbed fever.
Those doctors were intelligent and well intentioned but did not understand the risk of invisible microbes. Nowadays the existence of invisible microbes is well accepted so the idea that we should wash our hands is not regarded as a personal insult.
We are now going through a similar paradigm shift towards understanding the risk of invisible unintended bias from exposure to industry influence techniques.
Just as professionalism, integrity, intelligence and education provide little protection against invisible microbes they also provide little protection from invisible bias.
To help understand this lack of protection please consider the example of a space shuttle commander. Space shuttle commanders are the elite of elite pilots. They are highly intelligent and very well trained. However, space shuttle commanders have to trust the experts in mission control to tell them if all systems are go for launch or not. They do not have the time to get out of the cockpit and check all the systems themselves. Nor do they have all the specific skills required. If mission control is wrong then they will be misled and they and their crews will die.
Intelligence and education do not protect people from being misled when they trust a source of information that happens to be wrong. Intelligence and education give us the ability to see through some promotional techniques some of the time. However, we rarely have the time and specific skills required to see through them all.
Cologne marks the "first gig" of a potential world tour - which could cover Europe and North America in April, May or June.
If you would like to invite Peter to speak please get in touch with him at: peter.mansfield@adelaide.edu.au
Tuesday, August 21, 2007
The stiletto run
On Saturday, 100 girls from all over Germany took part in a 100 meter run at the Berlin Wittenberg Platz square, wearing very unique high performance shoes. Competitors were obliged to wear spike heeled shoes at least 2.7 inches high with heels not wider than .6 inches in diameter.
What has this to do with pharma, you ask?
Nothing, is my reply - but it's my blog!
Show me the money! - US MD's incentivised to Rx generics
Once wooed by pharmaceutical giants with lavish gifts as a push to increase sales of their new drugs, doctors now are getting cash incentives from health insurance companies when they switch patients to cheaper generic medications.
The money is usually tied to how often doctors follow other measures to improve patients' health and cut costs, such as making sure patients get flu shots, immunizations and regular screenings for mammograms and colon cancer, or even having flexible office hours that help make doctors more accessible to patients.
Insurers' motivation for the incentives is simple: To cut costs. Generic drugs are much cheaper than brand-name medications. For example, some brand name cholesterol-lowering drugs cost more than $100 for a month's supply, while the cost for generics is under $10.
There are benefits to consumers, too, because generic drugs tend to come with cheaper co-pays.
A recent Blue Care Network program paid 2,400 Michigan doctors $2 million for switching patients to generic cholesterol-lowering drugs from brand-name drugs like Lipitor and Crestor. The insurer said it saved nearly $5 million. And the HMO expects members who switched will save a total of $1 million from lower co-payments this year.
Dr. Steven Bernstein, a University of Michigan professor of internal medicine, doesn't see the harm in paying physicians for generic switches, so long as the doctor takes the patient's health into account first.
"The more affordable that we can make medications for patients, the better off they could be," said Bernstein, who also is director of outcomes management for the U-M's faculty group practice.
Bernstein and his colleagues say insurers have been giving doctors financial incentives for years, and they're widely accepted within the industry because they generally reflect good clinical care.
More
The money is usually tied to how often doctors follow other measures to improve patients' health and cut costs, such as making sure patients get flu shots, immunizations and regular screenings for mammograms and colon cancer, or even having flexible office hours that help make doctors more accessible to patients.
Insurers' motivation for the incentives is simple: To cut costs. Generic drugs are much cheaper than brand-name medications. For example, some brand name cholesterol-lowering drugs cost more than $100 for a month's supply, while the cost for generics is under $10.
There are benefits to consumers, too, because generic drugs tend to come with cheaper co-pays.
A recent Blue Care Network program paid 2,400 Michigan doctors $2 million for switching patients to generic cholesterol-lowering drugs from brand-name drugs like Lipitor and Crestor. The insurer said it saved nearly $5 million. And the HMO expects members who switched will save a total of $1 million from lower co-payments this year.
Dr. Steven Bernstein, a University of Michigan professor of internal medicine, doesn't see the harm in paying physicians for generic switches, so long as the doctor takes the patient's health into account first.
"The more affordable that we can make medications for patients, the better off they could be," said Bernstein, who also is director of outcomes management for the U-M's faculty group practice.
Bernstein and his colleagues say insurers have been giving doctors financial incentives for years, and they're widely accepted within the industry because they generally reflect good clinical care.
More
MD's vs pharmacists - let battle commence
Watch out pharmacy - here comes MD's response to "doc in a box"!
Three out of four Americans would have their prescription filled in their doctor's office instead of a pharmacy if given the choice, a new study finds, suggesting physicians are missing an opportunity to improve patient satisfaction and enhance revenue by not dispensing medicine in their office.
The nationwide research, conducted by Opinion Research Corporation on behalf of Purkinje, a healthcare technology and services company, examined consumer attitudes of an FDA-approved service known as in-office medication or point-of-care dispensing. The practice involves distributing pre-packaged medications directly to patients at the point-of-care, saving them a trip to the pharmacy and allowing them to immediately begin their treatment.
Overall preference for office-based medication dispensing appears to be driven by the prospect of saving time and improving quality of care. A majority of respondents (84%) said such a service would be more convenient, and 62% said it would help them better manage their health.
Other highlights:
Households with children (83%) and respondents age 25-44 (82%) were most likely to have their prescriptions filled in a physician's office if given the choice. There were no apparent attitude differences according to household income or geographic location.
Respondents with an annual household income of less than $25,000 (77%) and those age 25-34 (72%) were most likely to agree that in-office medication dispensing would help them better manage their own health.
In general, there were no attitude differences according to the gender, household income, level of education or geographic location of respondents.
"Thousands of progressive medical and dental offices around the nation are adding medication dispensing as a way to heighten the patient experience and create a new source of revenue," said Tom Doerr, M.D., chief medical officer for Purkinje and a practicing physician.
"Patients like the comfort of having their prescription filled in the privacy of their physician's office, and the convenience of starting their treatment right away."
More
Three out of four Americans would have their prescription filled in their doctor's office instead of a pharmacy if given the choice, a new study finds, suggesting physicians are missing an opportunity to improve patient satisfaction and enhance revenue by not dispensing medicine in their office.
The nationwide research, conducted by Opinion Research Corporation on behalf of Purkinje, a healthcare technology and services company, examined consumer attitudes of an FDA-approved service known as in-office medication or point-of-care dispensing. The practice involves distributing pre-packaged medications directly to patients at the point-of-care, saving them a trip to the pharmacy and allowing them to immediately begin their treatment.
Overall preference for office-based medication dispensing appears to be driven by the prospect of saving time and improving quality of care. A majority of respondents (84%) said such a service would be more convenient, and 62% said it would help them better manage their health.
Other highlights:
Households with children (83%) and respondents age 25-44 (82%) were most likely to have their prescriptions filled in a physician's office if given the choice. There were no apparent attitude differences according to household income or geographic location.
Respondents with an annual household income of less than $25,000 (77%) and those age 25-34 (72%) were most likely to agree that in-office medication dispensing would help them better manage their own health.
In general, there were no attitude differences according to the gender, household income, level of education or geographic location of respondents.
"Thousands of progressive medical and dental offices around the nation are adding medication dispensing as a way to heighten the patient experience and create a new source of revenue," said Tom Doerr, M.D., chief medical officer for Purkinje and a practicing physician.
"Patients like the comfort of having their prescription filled in the privacy of their physician's office, and the convenience of starting their treatment right away."
More
Monday, August 20, 2007
US feels the pain
Retail sales of five leading painkillers nearly doubled over the last eight years, reflecting a surge in use by patients nationwide who are living in a world of pain, according to a new Associated Press analysis of federal drug prescription data.
The analysis reveals that oxycodone usage is migrating out of Appalachia to areas such as Columbus, Ohio, and Fort Lauderdale, Fla., and significant numbers of codeine users living in many suburban neighborhoods around the country.
The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005, according to Drug Enforcement Administration figures.
More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during 2005.
More
The analysis reveals that oxycodone usage is migrating out of Appalachia to areas such as Columbus, Ohio, and Fort Lauderdale, Fla., and significant numbers of codeine users living in many suburban neighborhoods around the country.
The amount of five major painkillers sold at retail establishments rose 90 percent between 1997 and 2005, according to Drug Enforcement Administration figures.
More than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during 2005.
More
Bayer - Trasylol: to err is human
Bayer has revealed the findings of an independent lawyer’s investigation into the company’s failure to disclose data about the risks of Trasylol, used to reduce blood loss during heart surgery, which concludes that no cover-up was involved.
In October last year, Bayer acknowledged that it failed to keep the US Food and Drug Administration informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol (aprotinin).
Preliminary findings from this new observational study of patients from a hospital database reported that use of the drug may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
A month earlier, the panel had concluded that Bayer's Trasylol was safe and effective when used to prevent blood loss in patients undergoing coronary artery bypass grafting (CABG). But after seeing the new data, the FDA issued a warning that Trasylol should only be used only “where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.”
Bayer said at the time that it "mistakenly did not inform the [FDA] about a retrospective study commissioned by the company to analyse the effects of aprotinin, aminocaproic acid and tranexamic acid in patients undergoing CABG surgery."
The aforementioned investigation was started by Fred Fielding but he was appointed chief White House counsel so William Taylor of Zuckerman Spaeder took over.
He has completed his report and says that the failure to supply the FDA with risk data for Trasylol “was not motivated by any intent to conceal the existence of the study but was regrettable human error". Bayer had said that the data was not shared immediately with the agency by two senior staff (since suspended) because it was preliminary in nature and Mr Taylor echoed this view.
He said “these two individuals did not immediately disclose this information, because they had significant questions about the study's methodology and analyses," noting that no other Bayer employees or any of the external consultants who supported the firm at the panel meeting knew that the preliminary report had been received.
Bayer added that it has undertaken “a thorough analysis” of all of the company’s drug safety and monitoring procedures and based on “Mr Taylor’s report, and lessons learned from this experience, we have strengthened a variety of already strong structures and rigorous processes”. In particular, the firm said it has made changes in the responsibilities of its protocol review committee, “a unit whose structured processes play a critical role in ensuring that the mistakes and omissions that occurred” are not repeated.
The drug was once predicted to be able to reach peak annual sales of more than 500 million euros but revenues in the second quarter fell 18.4% (though no sales figure was given), hurt by the FDA's insistence on a new label last year which highlights the possible risk of kidney damage associated with taking the drug, a claim disputed by Bayer.
Source: PharmaTimes
In October last year, Bayer acknowledged that it failed to keep the US Food and Drug Administration informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol (aprotinin).
Preliminary findings from this new observational study of patients from a hospital database reported that use of the drug may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
A month earlier, the panel had concluded that Bayer's Trasylol was safe and effective when used to prevent blood loss in patients undergoing coronary artery bypass grafting (CABG). But after seeing the new data, the FDA issued a warning that Trasylol should only be used only “where the clinical benefit of reduced blood loss is essential to medical management of the patient and outweighs the potential risks.”
Bayer said at the time that it "mistakenly did not inform the [FDA] about a retrospective study commissioned by the company to analyse the effects of aprotinin, aminocaproic acid and tranexamic acid in patients undergoing CABG surgery."
The aforementioned investigation was started by Fred Fielding but he was appointed chief White House counsel so William Taylor of Zuckerman Spaeder took over.
He has completed his report and says that the failure to supply the FDA with risk data for Trasylol “was not motivated by any intent to conceal the existence of the study but was regrettable human error". Bayer had said that the data was not shared immediately with the agency by two senior staff (since suspended) because it was preliminary in nature and Mr Taylor echoed this view.
He said “these two individuals did not immediately disclose this information, because they had significant questions about the study's methodology and analyses," noting that no other Bayer employees or any of the external consultants who supported the firm at the panel meeting knew that the preliminary report had been received.
Bayer added that it has undertaken “a thorough analysis” of all of the company’s drug safety and monitoring procedures and based on “Mr Taylor’s report, and lessons learned from this experience, we have strengthened a variety of already strong structures and rigorous processes”. In particular, the firm said it has made changes in the responsibilities of its protocol review committee, “a unit whose structured processes play a critical role in ensuring that the mistakes and omissions that occurred” are not repeated.
The drug was once predicted to be able to reach peak annual sales of more than 500 million euros but revenues in the second quarter fell 18.4% (though no sales figure was given), hurt by the FDA's insistence on a new label last year which highlights the possible risk of kidney damage associated with taking the drug, a claim disputed by Bayer.
Source: PharmaTimes
PhRMA - spend, spend. spend
The U.S. drug industry lobby group, the Pharmaceutical Research and Manufacturers of America (PhRMA), spent $10.7 million in the first six months of 2007 lobbying the U.S. government. (In the preceding six-month period, PhRMA spent $8.8 million).
Associated Press reports that in PhRMA'S latest lobbying report, required under the Lobbying Disclosure Act of 1995, the group states that it had lobbied Congress, the U.S. Food and Drug Administration and the Department of Health and Human Services and other agencies on "issues related to Medicare, patent reform, international trade and drug fees, importation and safety".
Billy Tauzin, (pic) a former Louisiana Republican member of the House of Representatives turned PhRMA chief executive, is one of the group's registered lobbyists.
Source
Associated Press reports that in PhRMA'S latest lobbying report, required under the Lobbying Disclosure Act of 1995, the group states that it had lobbied Congress, the U.S. Food and Drug Administration and the Department of Health and Human Services and other agencies on "issues related to Medicare, patent reform, international trade and drug fees, importation and safety".
Billy Tauzin, (pic) a former Louisiana Republican member of the House of Representatives turned PhRMA chief executive, is one of the group's registered lobbyists.
Source
Lilly goes east
Hutchison China Meditech, the China-based pharmaceutical company, said its unit Hutchison MediPharma has agreed a research collaboration with US pharmaceutical company Eli Lilly to co-develop oncology and anti-inflammatory medicines.
Hutchison said it will receive milestone payments of $20-29 million, depending on the clinical candidate, along with an upfront fee, annual research and development support costs and also potential royalties.
Under the terms of the agreement, Hutchison will take responsibility for initial research and development, while Eli Lilly will offer technological advice and clinical trial expertise as the project advances.
The research will be carried out in China to 'expedite the drug discovery process and reduce overall costs', Hutchison said.
Forbes
Hutchison said it will receive milestone payments of $20-29 million, depending on the clinical candidate, along with an upfront fee, annual research and development support costs and also potential royalties.
Under the terms of the agreement, Hutchison will take responsibility for initial research and development, while Eli Lilly will offer technological advice and clinical trial expertise as the project advances.
The research will be carried out in China to 'expedite the drug discovery process and reduce overall costs', Hutchison said.
Forbes
Sunday, August 19, 2007
Saturday, August 18, 2007
Novartis - Reclast: this is my once a year day!
Swiss drugmaker Novartis said on Friday it had won U.S. approval to sell the first once-a-year treatment for the bone-thinning disease osteoporosis.
The drug, Reclast, is administered annually in a 15-minute infusion for women with post-menopausal osteoporosis.
It will compete with osteoporosis pills that are taken daily, weekly or monthly.
More
The drug, Reclast, is administered annually in a 15-minute infusion for women with post-menopausal osteoporosis.
It will compete with osteoporosis pills that are taken daily, weekly or monthly.
More
Merck - Cozaar: coincidental cut
Merck Sharp & Dohme has cut the price of Cozaar by up to a third in the UK, but denied the move was related to the OFT report on drug pricing.
The blockbuster hypertension treatment has been on the market for more than 10 years and is one of the most widely prescribed angiotensin II receptor blockers (ARB) in the UK.
ARBs were among a number of drug classes identified in the Office of Fair Trading's report on the PPRS earlier this year as being priced significantly out of line with patient benefits.
MSD announced the price cut shortly after the government responded to the OFT report - saying it would overhaul the current drug pricing system - but the company said the timing was purely coincidental.
Hmmmmmm!
More at Pharmafocus
The blockbuster hypertension treatment has been on the market for more than 10 years and is one of the most widely prescribed angiotensin II receptor blockers (ARB) in the UK.
ARBs were among a number of drug classes identified in the Office of Fair Trading's report on the PPRS earlier this year as being priced significantly out of line with patient benefits.
MSD announced the price cut shortly after the government responded to the OFT report - saying it would overhaul the current drug pricing system - but the company said the timing was purely coincidental.
Hmmmmmm!
More at Pharmafocus
Friday, August 17, 2007
Drug Eluting Stents - an end to the "epidemic of madness"?
Back story here.
Drug-oozing heart stents became the fastest-selling medical device in modern history -- and a cash cow for Johnson & Johnson and Boston Scientific Corp. -- because of the device's ability to prevent scar tissue from forming new blockages after artery-clearing surgery.
But safety questions about the stents have triggered steep sales declines and job cuts for the makers, and are expected to shrink the U.S. market by one-third this year -- a $1 billion drop just four years after the tiny gizmos were introduced.
J&J is cutting nearly 5,000 jobs due in part to a stent decline after studies questioned the devices' safety and effectiveness in preventing heart attacks and bypass surgery. Boston Scientific is preparing its own cuts after its stock hit a five-year low and its credit rating sank below junk-bond status.
But wait...........
More at BusinessWeek
Drug-oozing heart stents became the fastest-selling medical device in modern history -- and a cash cow for Johnson & Johnson and Boston Scientific Corp. -- because of the device's ability to prevent scar tissue from forming new blockages after artery-clearing surgery.
But safety questions about the stents have triggered steep sales declines and job cuts for the makers, and are expected to shrink the U.S. market by one-third this year -- a $1 billion drop just four years after the tiny gizmos were introduced.
J&J is cutting nearly 5,000 jobs due in part to a stent decline after studies questioned the devices' safety and effectiveness in preventing heart attacks and bypass surgery. Boston Scientific is preparing its own cuts after its stock hit a five-year low and its credit rating sank below junk-bond status.
But wait...........
More at BusinessWeek
DTC - an advertising tsunami
An eyebrow-raising report from the NEJM reveals that spending growth in direct-to-consumer advertising by US drug companies has entered exponential mode. The report reviews the decade since controversial new federal regulations permitted drug companies to advertise prescription medications on TV.
Although in 1997 there was widespread opposition to the decision - reached after relentless lobbying by the TV and pharma industries - few could have realised the magnitude of the ad tsunami that would be unleashed.
Ten years on, DTC spending on such ads grows at a faster rate than overall ad spending by the industry. Growth in DTC activity over the ten year period has averaged 14% per year and will this year hit $4.2 billion (€3.12bn; £2.11bn).
More
Although in 1997 there was widespread opposition to the decision - reached after relentless lobbying by the TV and pharma industries - few could have realised the magnitude of the ad tsunami that would be unleashed.
Ten years on, DTC spending on such ads grows at a faster rate than overall ad spending by the industry. Growth in DTC activity over the ten year period has averaged 14% per year and will this year hit $4.2 billion (€3.12bn; £2.11bn).
More
Thursday, August 16, 2007
GSK - Avorn on Avandia
The (FDA) agency is now addressing yet another follow-on drug as the glitazone story evolves. In 1997, the first entry in this class of antidiabetic agents, troglitazone (Rezulin, Parke-Davis), was observed to cause fulminant hepatic necrosis, sometimes fatal. Regulatory authorities throughout the world quickly concluded that the product had an indefensible risk–benefit ratio, and it was withdrawn from the market, often within just a few months of approval.
Yet the FDA and its advisory committee were swayed by the arguments of the manufacturer and kept it in use in the United States for 2 years after it had been made unavailable in nearly every other country.4
Now, a decade later, troglitazone's younger sibling, rosiglitazone (Avandia, GlaxoSmithKline), has been implicated in raising the risks of congestive heart failure and myocardial infarction, without impressive evidence of a countervailing advantage in clinical outcomes.
An advisory committee meeting on July 30, 2007, did not fuel hopes for a new era of data-driven reform.
The committee voted, 20 to 3, that rosiglitazone increases cardiac ischemic risk in type 2 diabetes but then recommended, by a 22-to-1 vote, that the drug remain in use. The decision was more suggestive of Rezulin redux (and of Redux) than it was of resolve. Although Avandia has been prescribed widely since 1999, several participants noted that neither the manufacturer nor the FDA had carried out enough safety studies to permit a clear conclusion.
Source
Yet the FDA and its advisory committee were swayed by the arguments of the manufacturer and kept it in use in the United States for 2 years after it had been made unavailable in nearly every other country.4
Now, a decade later, troglitazone's younger sibling, rosiglitazone (Avandia, GlaxoSmithKline), has been implicated in raising the risks of congestive heart failure and myocardial infarction, without impressive evidence of a countervailing advantage in clinical outcomes.
An advisory committee meeting on July 30, 2007, did not fuel hopes for a new era of data-driven reform.
The committee voted, 20 to 3, that rosiglitazone increases cardiac ischemic risk in type 2 diabetes but then recommended, by a 22-to-1 vote, that the drug remain in use. The decision was more suggestive of Rezulin redux (and of Redux) than it was of resolve. Although Avandia has been prescribed widely since 1999, several participants noted that neither the manufacturer nor the FDA had carried out enough safety studies to permit a clear conclusion.
Source
Wednesday, August 15, 2007
Amgen - yep, now they are a Big Pharma!
The biotechnology giant Amgen announced the first layoffs in its heretofore charmed history today in reaction to sliding sales of the anemia drugs that account for nearly half its revenue.
The company said it would cut its work force by 2,200 to 2,600 people, or about 12 to 14 percent. It also said that it would cut its planned capital expenses by $1.9 billion over two years, close certain production operations and prune its research and development operations.
In total, the moves would save $1.0 billion to $1.3 billion next year, it said.
More at NYT
The company said it would cut its work force by 2,200 to 2,600 people, or about 12 to 14 percent. It also said that it would cut its planned capital expenses by $1.9 billion over two years, close certain production operations and prune its research and development operations.
In total, the moves would save $1.0 billion to $1.3 billion next year, it said.
More at NYT
Thought for the day
Every age has its little compensations:
Youth has innocence. Adulthood has power. Age has wisdom.
Youth has innocence. Adulthood has power. Age has wisdom.
Big Pharma - the musical
On Pharma came up with the idea.
Prescriptionforchange.com did the video.
Sounds like a great idea.
Maybe Michael Moore might be interested in being a Broadway angel!
The biotech feeding frenzy continues
Icagen has entered into a collaboration and licensing agreement with Pfizer for potential treatments for pain and related disorders and announced an equity investment of up to $15 million by Pfizer.
The companies will develop and commercialize compounds that target three specific sodium ion channels, which are important in the generation of electrical signals in nerve fibers that mediate the initiation, transmission and sensation of pain, Icagen said.
More
The companies will develop and commercialize compounds that target three specific sodium ion channels, which are important in the generation of electrical signals in nerve fibers that mediate the initiation, transmission and sensation of pain, Icagen said.
More
Bayer - money well spent?
German drug maker Bayer AG spent more than $2 million in the first half of 2007 to lobby the federal government, according to a Congress disclosure form.
The company lobbied on numerous issues, including patent reform, energy and environmental legislation, drug safety measures, international trade and others, according to the form posted online Friday by the Senate's public records office.
Source
The company lobbied on numerous issues, including patent reform, energy and environmental legislation, drug safety measures, international trade and others, according to the form posted online Friday by the Senate's public records office.
Source
Tuesday, August 14, 2007
Amgen is now a real Big Pharma
Amgen has received a boost from an analyst’s upgrade and report which claims that the US biotechnology firm’s profits will increase so long as it responds to its recent problems concerning its anaemia drugs by restructuring.
The rumour mill has been awash with stories that Amgen is on the verge of announcing major job cuts, a position it may have been forced into by the attacks from all sides against Aranesp (darbopoietin alfa) and Epogen (epoetin alfa). The effect of label changes, concerns over the safety of erythropoietin stimulating agents and changes in reimbursement have all taken their toil on the firm’s share price.
Amgen’s management, in a filing to the US Securities and Exchange Commission last Friday, said that “as a result of these challenges, we have commenced a global review of the company's business plans to identify opportunities to improve our cost structure in response to any resulting declines in revenues".
The firm added it will “refocus spending on critical R&D and operational priorities and seek greater efficiencies in how we conduct our business”.Amgen has said nothing more specific but some changes would appear to be afoot and Geoffrey Porges at Bernstein Research thinks that a swift restructuring will help greatly. He upgraded the stock to ‘outperform’ from ‘market perform,’ and raised his price target to $69 per share from $65, while predicting that the company will announce a plan before September 11, when it is due to discuss the safety of its drugs Aranesp and Epogen with the US Food and Drug Administration.
The Center for Medicare and Medicaid Services’ plan to set new guidelines for ESAs will drastically cut reimbursements and prescriptions of anaemia drugs and Mr Porges noted that "Amgen will likely lose at least 40% of their US Aranesp revenue by 2008 with even greater downside possible for both Aranesp and Epogen if upcoming reimbursement and regulatory decisions go against them".
However if Amgen cuts costs, continues to buy back stock and improves its tax rate, the analyst argued, it could increase its earnings per share by 10%-12% each year from 2008 to 2011 and achieve savings of $250 million to $1 billion between now and 2010. This can be achieved even if it does not develop any other significant drug candidates, Mr Porges concluded.
Source: PharmaTimes
The rumour mill has been awash with stories that Amgen is on the verge of announcing major job cuts, a position it may have been forced into by the attacks from all sides against Aranesp (darbopoietin alfa) and Epogen (epoetin alfa). The effect of label changes, concerns over the safety of erythropoietin stimulating agents and changes in reimbursement have all taken their toil on the firm’s share price.
Amgen’s management, in a filing to the US Securities and Exchange Commission last Friday, said that “as a result of these challenges, we have commenced a global review of the company's business plans to identify opportunities to improve our cost structure in response to any resulting declines in revenues".
The firm added it will “refocus spending on critical R&D and operational priorities and seek greater efficiencies in how we conduct our business”.Amgen has said nothing more specific but some changes would appear to be afoot and Geoffrey Porges at Bernstein Research thinks that a swift restructuring will help greatly. He upgraded the stock to ‘outperform’ from ‘market perform,’ and raised his price target to $69 per share from $65, while predicting that the company will announce a plan before September 11, when it is due to discuss the safety of its drugs Aranesp and Epogen with the US Food and Drug Administration.
The Center for Medicare and Medicaid Services’ plan to set new guidelines for ESAs will drastically cut reimbursements and prescriptions of anaemia drugs and Mr Porges noted that "Amgen will likely lose at least 40% of their US Aranesp revenue by 2008 with even greater downside possible for both Aranesp and Epogen if upcoming reimbursement and regulatory decisions go against them".
However if Amgen cuts costs, continues to buy back stock and improves its tax rate, the analyst argued, it could increase its earnings per share by 10%-12% each year from 2008 to 2011 and achieve savings of $250 million to $1 billion between now and 2010. This can be achieved even if it does not develop any other significant drug candidates, Mr Porges concluded.
Source: PharmaTimes
Women in film
Mary Pickford, Lillian Gish, Gloria Swanson, Marlene Dietrich, Norma Shearer, Ruth Chatterton, Jean Harlow, Katharine Hepburn, Carole Lombard, Bette Davis, Greta Garbo, Barbara Stanwyck, Vivien Leigh, Greer Garson, Hedy Lamarr, Rita Hayworth, Gene Tierney, Olivia de Havilland, Ingrid Bergman, Joan Crawford, Ginger Rogers, Loretta Young, Deborah Kerr, Judy Garland, Anne Baxter, Lauren Bacall, Susan Hayward, Ava Gardner, Marilyn Monroe, Grace Kelly, Lana Turner, Elizabeth Taylor, Kim Novak, Audrey Hepburn, Dorothy Dandridge, Shirley MacLaine, Natalie Wood, Rita Moreno, Janet Leigh, Brigitte Bardot, Sophia Loren, Ann Margret, Julie Andrews, Raquel Welch, Tuesday Weld, Jane Fonda, Julie Christie, Faye Dunaway, Catherine Deneuve, Jacqueline Bisset, Candice Bergen, Isabella Rossellini, Diane Keaton, Goldie Hawn, Meryl Streep, Susan Sarandon, Jessica Lange, Michelle Pfeiffer, Sigourney Weaver, Kathleen Turner, Holly Hunter, Jodie Foster, Angela Bassett, Demi Moore, Sharon Stone, Meg Ryan, Julia Roberts, Salma Hayek, Sandra Bullock, Julianne Moore, Diane Lane, Nicole Kidman, Catherine Zeta-Jones, Angelina Jolie, Charlize Theron, Reese Witherspoon, Halle Berry.
Hat tip: http://www.myspace.com/eggman913
Wyeth - bifeprunox: no effect
Belgium’s Solvay and partner Wyeth’s hopes of launching bifeprunox, their investigational compound for schizophrenia, next year in the USA have been scuppered by US regulators.
The companies have received an action letter from the US Food and Drug Administration which rejects their New Drug Application for bifeprunox, an atypical antipsychotic reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The agency stated that bifeprunox demonstrated effectiveness in the long-term maintenance study, and indicated that a second study could be sufficient to support a maintenance claim for the compound, but has concluded that “efficacy data, when compared to reference drugs, were not sufficient for approval”.
The FDA also requested further information regarding the human metabolism of bifeprunox, and information “regarding a complex case of a patient who died while participating in one of the trials”.
Laurence Downey, chief executive of Solvay’s US operations, said the firms will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible, while Wyeth’s chief medical officer Gary Stiles claimed that the drug “offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy”.
He added that “we continue to support the development of the compound and the approach," and the firms are looking to speak to the agency shortly to discuss the design of this additional study.
The FDA’s rejection is a major blow to both firms but did not come as a great surprise.
The bad news about bifeprunox comes less than a month after the FDA requested additional clinical trial data for Pristiq (desvenlafaxine), the follow-up to its blockbuster depression drug Effexor (venlafaxine), that could push back the launch of that drug by a year or more. The delays to Pristiq and now bifeprunox spell serious problems for Wyeth as they were expected to buffer declining sales of the $3.5 billion-a-year Effexor when it comes off patent in 2010.
Source: PharmaTimes
The companies have received an action letter from the US Food and Drug Administration which rejects their New Drug Application for bifeprunox, an atypical antipsychotic reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The agency stated that bifeprunox demonstrated effectiveness in the long-term maintenance study, and indicated that a second study could be sufficient to support a maintenance claim for the compound, but has concluded that “efficacy data, when compared to reference drugs, were not sufficient for approval”.
The FDA also requested further information regarding the human metabolism of bifeprunox, and information “regarding a complex case of a patient who died while participating in one of the trials”.
Laurence Downey, chief executive of Solvay’s US operations, said the firms will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible, while Wyeth’s chief medical officer Gary Stiles claimed that the drug “offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy”.
He added that “we continue to support the development of the compound and the approach," and the firms are looking to speak to the agency shortly to discuss the design of this additional study.
The FDA’s rejection is a major blow to both firms but did not come as a great surprise.
The bad news about bifeprunox comes less than a month after the FDA requested additional clinical trial data for Pristiq (desvenlafaxine), the follow-up to its blockbuster depression drug Effexor (venlafaxine), that could push back the launch of that drug by a year or more. The delays to Pristiq and now bifeprunox spell serious problems for Wyeth as they were expected to buffer declining sales of the $3.5 billion-a-year Effexor when it comes off patent in 2010.
Source: PharmaTimes
Monday, August 13, 2007
Roche sell off
Roche Holding AG and Actavis Group HF, an Iceland-based generics company, have signed agreements for the sale of three of Roche's pharmaceutical products to Actavis for an undisclosed sum.
The Basel-based drug maker said that product rights -- with some territorial exceptions -- for cardiovascular drugs Bezalip and Rapilysin and dermatology product Neotigason are being transferred to Actavis.
More
The Basel-based drug maker said that product rights -- with some territorial exceptions -- for cardiovascular drugs Bezalip and Rapilysin and dermatology product Neotigason are being transferred to Actavis.
More
Sunday, August 12, 2007
Saturday, August 11, 2007
Jeremy Laurance writes
One issue has remained taboo in the two-year battle between campaigners and the UK's National Institute for Clinical Excellence (Nice) over Alzheimer's drugs: how the drug companies set their prices.
While anger and scorn have been heaped on the Government's medicines watchdog for its inhumanity in denying the drugs to sufferers of a dreadful disease, the drug companies who make and market the drugs have escaped almost without criticism.
Yet there is a simple move they could make to win Nice's support for their treatments: reduce the cost of the drugs. Not a single response from patients' organisations and pressure groups to yesterday's High Court decision criticised the companies for failing to adjust what they charge in the light of the drugs' limited effectiveness. This is not surprising. Most of the organisations firing off angry press releases yesterday via PR companies are funded by the drug manufacturers.
The drugs are widely quoted as costing "only" £2.50 a day. But this ignores the fact they only work in some people -estimates range from 15 to 50 per cent. Their effect in the mild stages is also "very, very limited", Professor Michael Rawlins, chairman of Nice, said yesterday.
The problem of the affordability of drugs is set to get much worse. Nice is under fire for restricting access to a drug, Lucentis, to treat macular degeneration, the commonest cause of blindness, on the ground that, at £9,000 a year, it is not cost effective. But some primary care trusts have taken matters into their own hands by authorising doctors to use an equally effective alternative, Avastin, which is available at a fraction of the price but not licensed for ophthalmic use.
Waiting in the pipeline are a host of new cancer drugs costing up to £100,000 a patient which will impose new burdens on the NHS. Herceptin, the breast cancer drug, which costs around £20,000 a patient, is already forcing NHS trusts to find savings elsewhere to pay for it.
The NHS budget is not a bottomless purse. Decisions have to be made how to spend the available cash to get the best results. The Government announced last week that it is to review the Pharmaceutical Price Regulation Scheme, its drug pricing agreement with the industry, in order to get better value for money.
Only if that review delivers a cut in prices will the NHS be able to buy more treatments.
Source
While anger and scorn have been heaped on the Government's medicines watchdog for its inhumanity in denying the drugs to sufferers of a dreadful disease, the drug companies who make and market the drugs have escaped almost without criticism.
Yet there is a simple move they could make to win Nice's support for their treatments: reduce the cost of the drugs. Not a single response from patients' organisations and pressure groups to yesterday's High Court decision criticised the companies for failing to adjust what they charge in the light of the drugs' limited effectiveness. This is not surprising. Most of the organisations firing off angry press releases yesterday via PR companies are funded by the drug manufacturers.
The drugs are widely quoted as costing "only" £2.50 a day. But this ignores the fact they only work in some people -estimates range from 15 to 50 per cent. Their effect in the mild stages is also "very, very limited", Professor Michael Rawlins, chairman of Nice, said yesterday.
The problem of the affordability of drugs is set to get much worse. Nice is under fire for restricting access to a drug, Lucentis, to treat macular degeneration, the commonest cause of blindness, on the ground that, at £9,000 a year, it is not cost effective. But some primary care trusts have taken matters into their own hands by authorising doctors to use an equally effective alternative, Avastin, which is available at a fraction of the price but not licensed for ophthalmic use.
Waiting in the pipeline are a host of new cancer drugs costing up to £100,000 a patient which will impose new burdens on the NHS. Herceptin, the breast cancer drug, which costs around £20,000 a patient, is already forcing NHS trusts to find savings elsewhere to pay for it.
The NHS budget is not a bottomless purse. Decisions have to be made how to spend the available cash to get the best results. The Government announced last week that it is to review the Pharmaceutical Price Regulation Scheme, its drug pricing agreement with the industry, in order to get better value for money.
Only if that review delivers a cut in prices will the NHS be able to buy more treatments.
Source
Novartis - Prexige: the liver is evil - it must be punished!
Australia's medicines Regulator, the Therapeutic Goods Administration (TGA) has cancelled the registration of the osteoarthritis drug, lumiracoxib because of serious liver side effects associated with the use of the drug.
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).
Lumiracoxib was first approved in Australia in July 2004 but has only recently become widely used since being listed on the Pharmaceutical Benefits Scheme (PBS) in 2006. According to the TGA's Principal Medical Adviser, Dr Rohan Hammett, as of 10th August 2007 the TGA had received 8 reports of serious liver adverse reactions to the drug, including two deaths and two liver transplants.
"The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug," Dr Hammett said.
"The TGA has taken this advice to cancel the registration of Lumiracoxib in order to prevent further cases of severe liver damage. "It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the Lumiracoxib immediately and to discuss alternative treatments with their doctor," Dr Hammett said.
Approximately 60 000 people take Lumiracoxib in Australia which is typically prescribed for: symptomatic relief in the treatment of osteoarthritis, relief of acute pain, including post-operative pain and pain related to dental procedures and relief of pain due to primary dysmenorrhoea.
Further information can be obtained by contacting the TGA Info Line on 1800 004 599 (8.30 am-8.30 pm seven days a week), or Novartis Pharmaceuticals on 1800 671 203
Media contact: Kay McNiece, TGA Media Adviser, 0412 132 585
Hat tip: Benedict.
Lumiracoxib, marketed by Novartis Pharmaceuticals under the brand name of Prexige, is a Cox 2 inhibitor belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS).
Lumiracoxib was first approved in Australia in July 2004 but has only recently become widely used since being listed on the Pharmaceutical Benefits Scheme (PBS) in 2006. According to the TGA's Principal Medical Adviser, Dr Rohan Hammett, as of 10th August 2007 the TGA had received 8 reports of serious liver adverse reactions to the drug, including two deaths and two liver transplants.
"The TGA and its expert advisory committee, the Adverse Drug Reactions Advisory Committee (ADRAC), have urgently investigated these reports. ADRAC has today recommended the cancellation of the registration of Lumiracoxib due to the severity of the reported side effects associated with this drug," Dr Hammett said.
"The TGA has taken this advice to cancel the registration of Lumiracoxib in order to prevent further cases of severe liver damage. "It seems that the longer people are on the medicine, the greater the chance of liver injury. The TGA is, therefore, advising people to stop taking the Lumiracoxib immediately and to discuss alternative treatments with their doctor," Dr Hammett said.
Approximately 60 000 people take Lumiracoxib in Australia which is typically prescribed for: symptomatic relief in the treatment of osteoarthritis, relief of acute pain, including post-operative pain and pain related to dental procedures and relief of pain due to primary dysmenorrhoea.
Further information can be obtained by contacting the TGA Info Line on 1800 004 599 (8.30 am-8.30 pm seven days a week), or Novartis Pharmaceuticals on 1800 671 203
Media contact: Kay McNiece, TGA Media Adviser, 0412 132 585
Hat tip: Benedict.
Friday, August 10, 2007
Pfizer/Eisai - Aricept: NICE judgement
In the first ever judicial review case brought against the National Institute for Clinical Excellence (NICE), Mrs Justice Linda Dobbs ruled that the Government's drugs watchdog was correct to state that the drugs are only cost-effective when prescribed in later stages of the disease.
The case was brought by Eisai, the Japanese pharmaceutical firm, and Pfizer, which distributes the drugs in Britain, and backed by the Alzheimer's Society charity, which said that treating people at an earlier stage could slow their mental degeneration.
They had accused NICE of acting "irrationally and unlawfully" in recommending that the drugs should not be funded on the NHS for people with early-stage symptoms. They also argued that Nice's decision was "procedurally flawed".
Although the case was defeated on five out of six counts, the campaigners were successful on one count - that tests to assess Alzheimer's were "discriminatory" against people who speak English as a second language or those with learning disabilities.
However, the key claim of the campaigners - that patients should be given NHS Alzheimer's treatment at an earlier stage in the illness - was defeated.
More at TimesOnLine
The case was brought by Eisai, the Japanese pharmaceutical firm, and Pfizer, which distributes the drugs in Britain, and backed by the Alzheimer's Society charity, which said that treating people at an earlier stage could slow their mental degeneration.
They had accused NICE of acting "irrationally and unlawfully" in recommending that the drugs should not be funded on the NHS for people with early-stage symptoms. They also argued that Nice's decision was "procedurally flawed".
Although the case was defeated on five out of six counts, the campaigners were successful on one count - that tests to assess Alzheimer's were "discriminatory" against people who speak English as a second language or those with learning disabilities.
However, the key claim of the campaigners - that patients should be given NHS Alzheimer's treatment at an earlier stage in the illness - was defeated.
More at TimesOnLine
GSK - Avandia: more bad news
A majority of healthcare professionals responding to an online survey conducted by MedPage Today (http://www.MedPageToday.com) stated that they will not prescribe rosiglitazone (Avandia) for their patients with type 2 diabetes, and one in four believe that the drug should be pulled off the market.
More
More
Things that make you go "Hmmm!" contd.
Blackstone's record breaking $21.7bn Blackstone Capital Partners V fund has agreed to make a $500m minority investment in pharmaceutical company Stiefel Laboratories.
The investment will be accomplished pursuant to the issuance by Stiefel Laboratories of a new class of preferred stock to Blackstone.
Current shareholders will not sell any shares as part of the transaction. The Stiefel family will retain control of Stiefel Laboratories and continue to hold a majority share ownership. Stiefel Laboratories considered a number of private equity firms as partners, the company said in a statement.
Chinh Chu, senior managing director of Blackstone, said, 'Stiefel Laboratories has a robust and diversified product portfolio across the entire field of dermatology, with numerous pipeline products and international expansion opportunities.'
Source
The investment will be accomplished pursuant to the issuance by Stiefel Laboratories of a new class of preferred stock to Blackstone.
Current shareholders will not sell any shares as part of the transaction. The Stiefel family will retain control of Stiefel Laboratories and continue to hold a majority share ownership. Stiefel Laboratories considered a number of private equity firms as partners, the company said in a statement.
Chinh Chu, senior managing director of Blackstone, said, 'Stiefel Laboratories has a robust and diversified product portfolio across the entire field of dermatology, with numerous pipeline products and international expansion opportunities.'
Source
AstraZeneca - Nexium: don't panic - yet!
The American drug regulator said yesterday it would be reviewing the safety of two AstraZeneca treatments after studies raised fears they could increase the risk of heart attacks. The drugs, for stomach ulcers, are Prilosec and Nexium - its top seller with sales of $5bn (£2.5bn) a year.
AstraZeneca shares plummeted 87p, or 3.5%, on the news to £24.30, wiping £1.3bn off the value of the company. It comes shortly after a similar scare over GlaxoSmithKline's diabetes drug Avandia.
The US Food and Drug Administration and Health Canada said AstraZeneca had submitted data in May from two studies of patients with severe GERD, where stomach acid gets into the windpipe and erodes it. The studies sought to compare the effects of the two drugs to surgery.
The regulator said yesterday those results had "raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the drugs".
The regulator added, however, that additional data since May suggested there was no link to heart problems: it said its preliminary conclusion was that "collectively, these data do not suggest an increased risk of heart problems". But it said it would complete a safety review within three months.
Alastair Forbes, professor of gastroenterology at University College London, said Prilosec, which has been around since 1989, and Nexium, launched in 2001, had been used in vast amounts.
He said: "This is the FDA trying to be responsible and not to sound guilty that they might have known or suspected something. What they are doing here is being very cautious."
Thursday, August 09, 2007
GSK - Advair: take my breath away
GlaxoSmithKline has been left stunned by a decision by US regulators to issue a ‘not approvable’ letter the highest dose of its asthma inhaler Advair Diskus for the treatment of chronic obstructive pulmonary disease.
In issuing the letter, the US Food and Drug Administration questioned how a 500/50 microgram dose of Advair/Seretide (fluticasone and salmeterol) compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK said it will be meeting with the agency to discuss this request in more detail and determine next steps, including discussion of data the firm has recently generated on the reduction of exacerbations with the Advair 250/50 strength.
Katharine Knobil, vice president of respiratory clinical development for COPD at GSK said that “we are very surprised and disappointed by this FDA decision” particularly given the outcome of the agency’s advisory committee meeting in May. The latter voted unanimously (11 to 0) that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations in patients with COPD, the fourth leading cause of death in the USA.
Ms Knobil added that “we believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.” Given the comments made by the advisory committee in May, that way forward may require a head-to-head comparison of the highest dose and the 250/50 dose of Advair, which GSK has not put before the agency. Instead, the firm submitted data from three clinical trials to the FDA in support of the new indication for Advair, including the landmark 6,100-patient TORCH study which showed a 2.6% improvement in survival over three years among patients receiving Advair compared to placebo.
Some observers believe that the not ‘approvable letter’ is a sign that the FDA is taking an ever-more cautious line when it comes to giving the green light to drugs but whatever the reason, a new approval would have helped GSK add to its already impressive sales of Advair which reached £871 million in the second quarter. More cash in the coffers would have been particularly welcome at a time when the firm is suffering from sliding sales of the diabetes drug Avandia (rosiglitazone), as prescribers pull back following a meta-analysis that alleged increased risk of cardiovascular disease.
Source: PharmaTimes
In issuing the letter, the US Food and Drug Administration questioned how a 500/50 microgram dose of Advair/Seretide (fluticasone and salmeterol) compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK said it will be meeting with the agency to discuss this request in more detail and determine next steps, including discussion of data the firm has recently generated on the reduction of exacerbations with the Advair 250/50 strength.
Katharine Knobil, vice president of respiratory clinical development for COPD at GSK said that “we are very surprised and disappointed by this FDA decision” particularly given the outcome of the agency’s advisory committee meeting in May. The latter voted unanimously (11 to 0) that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations in patients with COPD, the fourth leading cause of death in the USA.
Ms Knobil added that “we believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.” Given the comments made by the advisory committee in May, that way forward may require a head-to-head comparison of the highest dose and the 250/50 dose of Advair, which GSK has not put before the agency. Instead, the firm submitted data from three clinical trials to the FDA in support of the new indication for Advair, including the landmark 6,100-patient TORCH study which showed a 2.6% improvement in survival over three years among patients receiving Advair compared to placebo.
Some observers believe that the not ‘approvable letter’ is a sign that the FDA is taking an ever-more cautious line when it comes to giving the green light to drugs but whatever the reason, a new approval would have helped GSK add to its already impressive sales of Advair which reached £871 million in the second quarter. More cash in the coffers would have been particularly welcome at a time when the firm is suffering from sliding sales of the diabetes drug Avandia (rosiglitazone), as prescribers pull back following a meta-analysis that alleged increased risk of cardiovascular disease.
Source: PharmaTimes
Wednesday, August 08, 2007
Putting the B in diabetes - could it B this simple?
A lack of vitamin B has been linked to vascular disease in diabetes sufferers, groundbreaking research shows.University of Warwick researchers found found for the first time that diabetics - both type one and two sufferers - have a massive three quarters less thiamine (vitamin B1) in their blood than healthy people.
And in what could be a major finding for treatment of diabetes-related vascular conditions, the experts found the shortage was linked to damage to the kidneys, retina and nerves in the arms and legs - common in diabetics.Boffins said diabetics were getting enough vitamin B1 in their diet, but trials are being carried out to see whether a supplement pill lowers the risk of those conditions - with experts predicting it could lead to as much as a 40 per cent decrease. And the study was the first to ever make the finding, after all previous reports had missed the shortage and assumed normal levels of vitamin B1 in diabetics.
Lead researcher Prof. Paul Thornalley said a vitamin B supplement pill could be taken by all diabetics and would work alongside conventional glucose controls and bring separate benefits.
He said: "This is a particularly important study because thiamine has been found to prevent vascular problems in previous research."
"We found that virtually all of the diabetics with an enzyme showing higher chances of vascular disease had less than normal thiamine levels."The idea - once clinical trials are carried out - would be that this supplement would be immediately available for all diabetics - it would be very easy to make.
"The important thing is also that the benefits work independent of glucose control normally used to reduce risks of vascular disease."Around 40 per cent of diabetics still develop vascular disease despite using glucose control - a thiamine supplement might reduce the number.
"You might expect increased levels of thiamine to reduce the risk of vascular disease in diabetics by 30 or 40 per cent." The study - published in diabetes journal Diabetologia - compared 26 type 1 and 48 type 2 diabetics with 20 healthy patients.It found thiamine concentration in blood plasma was decreased 76 per cent in type 1 sufferers and 75 per cent in type 2 patients.
They then found there was a direct link between low thiamine levels and the presence of a "marker" - a protein already known to point to increased risk of microvascular and macrovascular complications.The presence of the marker is linked to problems in cells that line the body's whole circulatory system and an increased risk of inflammation in the artery walls.
Prof. Thornalley said: "In virtually all the diabetics with this marker we found lowered levels of thiamine."
The boffins said the dearth of vitamin B in diabetes sufferers' blood plasma was not down to them not eating enough foods containing it like.Instead it was caused by an increased rate in removal of thiamine from the blood into urine. Up to 15 times more thiamine is passed in urine by diabetics.
Professor Thornalley said: "People are getting their recommended levels in their diet."This is caused by the fact that in healthy people when the blood passes through the kidneys thiamine has to be reabsorbed back into the blood.
"But diabetics are failing to reabsorb it back into the blood in the kidneys. The rate of excretion of thiamine increased to up to 15 fold in diabetic patients."The recommended diet intake of vitamin B1 is around 1 milligram, but we are talking about a supplement of around 100 mg."While this study focused on the actual thiamine levels in the blood plasma, past research focused on the activity of an enzyme called transketolase in diabetics- leading scientists to wrongly assume thiamine levels were also normal.
In fact the normal enzyme activity was due to increased amounts of two proteins - THTR-1 and RFC-1 - that help move thiamine into red blood cells.The increased levels were actually a direct response to a deficiency of thiamine in the body, the research found.
Source
And in what could be a major finding for treatment of diabetes-related vascular conditions, the experts found the shortage was linked to damage to the kidneys, retina and nerves in the arms and legs - common in diabetics.Boffins said diabetics were getting enough vitamin B1 in their diet, but trials are being carried out to see whether a supplement pill lowers the risk of those conditions - with experts predicting it could lead to as much as a 40 per cent decrease. And the study was the first to ever make the finding, after all previous reports had missed the shortage and assumed normal levels of vitamin B1 in diabetics.
Lead researcher Prof. Paul Thornalley said a vitamin B supplement pill could be taken by all diabetics and would work alongside conventional glucose controls and bring separate benefits.
He said: "This is a particularly important study because thiamine has been found to prevent vascular problems in previous research."
"We found that virtually all of the diabetics with an enzyme showing higher chances of vascular disease had less than normal thiamine levels."The idea - once clinical trials are carried out - would be that this supplement would be immediately available for all diabetics - it would be very easy to make.
"The important thing is also that the benefits work independent of glucose control normally used to reduce risks of vascular disease."Around 40 per cent of diabetics still develop vascular disease despite using glucose control - a thiamine supplement might reduce the number.
"You might expect increased levels of thiamine to reduce the risk of vascular disease in diabetics by 30 or 40 per cent." The study - published in diabetes journal Diabetologia - compared 26 type 1 and 48 type 2 diabetics with 20 healthy patients.It found thiamine concentration in blood plasma was decreased 76 per cent in type 1 sufferers and 75 per cent in type 2 patients.
They then found there was a direct link between low thiamine levels and the presence of a "marker" - a protein already known to point to increased risk of microvascular and macrovascular complications.The presence of the marker is linked to problems in cells that line the body's whole circulatory system and an increased risk of inflammation in the artery walls.
Prof. Thornalley said: "In virtually all the diabetics with this marker we found lowered levels of thiamine."
The boffins said the dearth of vitamin B in diabetes sufferers' blood plasma was not down to them not eating enough foods containing it like.Instead it was caused by an increased rate in removal of thiamine from the blood into urine. Up to 15 times more thiamine is passed in urine by diabetics.
Professor Thornalley said: "People are getting their recommended levels in their diet."This is caused by the fact that in healthy people when the blood passes through the kidneys thiamine has to be reabsorbed back into the blood.
"But diabetics are failing to reabsorb it back into the blood in the kidneys. The rate of excretion of thiamine increased to up to 15 fold in diabetic patients."The recommended diet intake of vitamin B1 is around 1 milligram, but we are talking about a supplement of around 100 mg."While this study focused on the actual thiamine levels in the blood plasma, past research focused on the activity of an enzyme called transketolase in diabetics- leading scientists to wrongly assume thiamine levels were also normal.
In fact the normal enzyme activity was due to increased amounts of two proteins - THTR-1 and RFC-1 - that help move thiamine into red blood cells.The increased levels were actually a direct response to a deficiency of thiamine in the body, the research found.
Source
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