Mormons!
Wednesday, June 30, 2010
PharmaTimes | Industry News | World News | German cabinet backs negotiated drug prices
PharmaTimes | German cabinet backs negotiated drug prices
German Chancellor Angela Merkel’s Cabinet has approved legislation that will require pharmaceutical manufacturers and health insurers to negotiate the prices of new drugs based on cost-effectiveness criteria, it was announced yesterday.
The bill - which would however also allow drugmakers to set a price unilaterally if agreement with the insurers had not been reached after 15 months - still needs to be approved by the lower house of parliament, the Bundestag, which earlier this month gave its backing to proposals to increase rebates paid to manufacturers on patented drugs but also set curbs on their prices.
The two measures, which form part of the 80 billion-euro budget cuts announced by Chancellor Merkel’s ruling Christian Democrat (CDU) party earlier this month, could take effect from next January and are plan to run to 2013. Together, they could produce savings of as much as 1.7 billion euros next year, according to officials speaking yesterday.
The 5.3% rise in pharmaceutical spending last year by the public health insurers - which cover over 70% of Germany’s 82 million population – was entirely due to the 8.9% increase in the prices of patented medicines, according to government spokesmen, who point out that the prices of generics, on the other hand, declined 2% last year.
The public health insurers’ deficit for 2011 could be as high as 15 billion euros, it is forecast.
Drugmakers have always been free to set their own prices in Germany and, as a result, prescription drug prices there are usually the highest out of a group of 10 European nations, together with Ireland and Belgium, according to a recent study.
German Chancellor Angela Merkel’s Cabinet has approved legislation that will require pharmaceutical manufacturers and health insurers to negotiate the prices of new drugs based on cost-effectiveness criteria, it was announced yesterday.
The bill - which would however also allow drugmakers to set a price unilaterally if agreement with the insurers had not been reached after 15 months - still needs to be approved by the lower house of parliament, the Bundestag, which earlier this month gave its backing to proposals to increase rebates paid to manufacturers on patented drugs but also set curbs on their prices.
The two measures, which form part of the 80 billion-euro budget cuts announced by Chancellor Merkel’s ruling Christian Democrat (CDU) party earlier this month, could take effect from next January and are plan to run to 2013. Together, they could produce savings of as much as 1.7 billion euros next year, according to officials speaking yesterday.
The 5.3% rise in pharmaceutical spending last year by the public health insurers - which cover over 70% of Germany’s 82 million population – was entirely due to the 8.9% increase in the prices of patented medicines, according to government spokesmen, who point out that the prices of generics, on the other hand, declined 2% last year.
The public health insurers’ deficit for 2011 could be as high as 15 billion euros, it is forecast.
Drugmakers have always been free to set their own prices in Germany and, as a result, prescription drug prices there are usually the highest out of a group of 10 European nations, together with Ireland and Belgium, according to a recent study.
Tuesday, June 29, 2010
Supreme Court rejects Pfizer appeal in lawsuits over experiments on Nigerian children - Courant.com
Supreme Court rejects Pfizer appeal in lawsuits over experiments on Nigerian children - Courant.com
The Supreme Court is staying out of a dispute between Nigerian families and Pfizer, Inc., over the drug maker's use of a new antibiotic Trovan on children during a deadly outbreak of meningitis in the mid-1990s.
The justices on Tuesday rejected the pharmaceutical giant's appeal of a court ruling that allowed the lawsuits filed by the Nigerians in U.S. courts to go forward. The families allege that Pfizer violated international law against involuntary medical experimentation when it tested the drug, Trovan. The company failed to get the informed consent of the children or their parents, or to tell them that the drug had not been approved for use in children, the lawsuits say.
The Supreme Court is staying out of a dispute between Nigerian families and Pfizer, Inc., over the drug maker's use of a new antibiotic Trovan on children during a deadly outbreak of meningitis in the mid-1990s.
The justices on Tuesday rejected the pharmaceutical giant's appeal of a court ruling that allowed the lawsuits filed by the Nigerians in U.S. courts to go forward. The families allege that Pfizer violated international law against involuntary medical experimentation when it tested the drug, Trovan. The company failed to get the informed consent of the children or their parents, or to tell them that the drug had not been approved for use in children, the lawsuits say.
Cholesterol drugs for the healthy still debatable - Yahoo! Finance
Cholesterol drugs for the healthy still debatable - Yahoo! Finance
An analysis published Monday questions research that led federal regulators to allow the statin drug Crestor wider use for prevention.
An analysis published Monday questions research that led federal regulators to allow the statin drug Crestor wider use for prevention.
The new analysis, appearing in Monday's Archives of Internal Medicine, raises those questions again. A second paper in the same journal finds no justification from the earlier results for using a test for CRP to make treatment decisions. And a third paper, an analysis of 11 published studies including the 2008 study, finds no evidence that statins help high-risk people without heart disease live longer.
"Why take a medicine that hasn't been shown to make you feel better or live longer? Yet that's what millions of Americans are doing," said Archives of Internal Medicine editor Dr. Rita Redberg, a cardiologist at University of California San Francisco.
Why Avandia Will Change The Drug Industry « The Science Business
via blogs.forbes.com
David Graham's study, if confirmed in another data set, could offer the FDA another lawyerly exit. Both Avandia and Actos cause heart failure, a weakening of the heart muscle, but in Graham's study Avandia was worse. That could give the FDA a reason to restrict its use or remove it from the market without ever admitting a mistake in its handling of the heart attack data.
JAMA study: Diabetes drug Avandia can increase risk of stroke, heart disease - OrlandoSentinel.com
JAMA study: Diabetes drug Avandia can increase risk of stroke, heart disease - OrlandoSentinel.com
In a study of nearly a quarter million Type 2 diabetics on two diabetes drugs, the risk of heart failure was 25 percent greater on Avandia than the competitor drug, Actos, and the risk of stroke was 27 percent greater. The study comes two weeks before an expert panel from the Food and Drug Administration convenes to decide whether to keep the drug on the market.
In a study of nearly a quarter million Type 2 diabetics on two diabetes drugs, the risk of heart failure was 25 percent greater on Avandia than the competitor drug, Actos, and the risk of stroke was 27 percent greater. The study comes two weeks before an expert panel from the Food and Drug Administration convenes to decide whether to keep the drug on the market.
Monday, June 28, 2010
Fosamax- Merck hit with $8M verdict | greenbaypressgazette.com | Green Bay Press Gazette
Drugmaker Merck & Co. hit with $8M verdict | Green Bay Press Gazette
The U.S. District Court jury in New York awarded that amount in compensatory damages to Shirley Boles, 72, of Fort Walton, Fla., who alleged Merck's Fosamax destroyed her jawbone near her ears, causing serious pain and disability.
The U.S. District Court jury in New York awarded that amount in compensatory damages to Shirley Boles, 72, of Fort Walton, Fla., who alleged Merck's Fosamax destroyed her jawbone near her ears, causing serious pain and disability.
Shire braced for US study into heart risks of attention deficit drug | Business | The Guardian
Shire braced for US study into heart risks of attention deficit drug | Business | The Guardian
Pharmaceutical group Shire is braced for a report from US regulators on the safety of drugs used to treat attention-deficit hyperactivity disorder (ADHD) which could affect almost a third of its annual sales of $3bn (£1.9bn).
Findings from the study by the food and drug administration and US department of health into ADHD medicines that use stimulants such as amphetamines are due in early August. The study was launched in 2007 amid concern about the potential for increased risk of heart attack, stroke or other cardiovascular problems when the drugs are used by children and adults.
The new drugs don't work for big pharma, report shows | Business | The Guardian
The new drugs don't work for big pharma, report shows | Business | The Guardian
There is fresh evidence of the dwindling pipeline of new drugs from the pharmaceuticals industry in research today showing just 7% of sales come from medicines launched in the past five years.
The report by CMR International, owned by Thomson Reuters, shows that the bulk of sales at the world's leading pharmaceuticals is derived from an ageing portfolio of drugs, while the number of medicines failing during late-stage testing is sharply on the rise.
The problem is the "patent cliff" – after a few years products come off patent and generic drugmakers are allowed to produce cheaper versions.
Saturday, June 26, 2010
Friday, June 25, 2010
Amylin Cuts 60 Jobs (AMLN)
Amylin Cuts 60 Jobs (AMLN)
San Diego-based Amylin Pharmaceuticals (Nasdaq: AMLN) has cut 60 jobs, or about 4 percent of its workforce, according to a recent story in the Union-Tribune.
San Diego-based Amylin Pharmaceuticals (Nasdaq: AMLN) has cut 60 jobs, or about 4 percent of its workforce, according to a recent story in the Union-Tribune.
PharmaTimes | Council of Europe Assembly slams WHO, pharma over pandemic
PharmaTimes | Industry News | World News | Council of Europe Assembly slams WHO, pharma over pandemic
The Council of Europe Parliamentary Assembly has backed a highly-critical report on the handling of the H1N1flu pandemic, and called on the pharmaceutical industry to revise its rules on how it cooperates with the public sector.
In a debate which adopted the Assembly Health Committee’s report on the pandemic, published on June 4, the parliamentarians condemned the “waste of large sums of public money and unjustified scares and fears about the health risks faced by the European public” which had resulted from the way the pandemic had been handled by the World Health Organization (WHO), European Union (EU) health agencies and national governments. There was “overwhelming evidence that the seriousness of the pandemic was vastly overrated by WHO,” resulting in a distortion of public health priorities, they added.
They supported the findings of the report – produced by Health Committee rapporteur and UK Labour Member of Parliament Paul Flynn – that there were “grave shortcomings” in the transparency of decision-making about the outbreak, generating concerns about the influence of the pharmaceutical industry on decisions taken. Plummeting confidence in such advice could prove “disastrous” in the case of a severe future pandemic, they warned.
The Council of Europe Parliamentary Assembly has backed a highly-critical report on the handling of the H1N1flu pandemic, and called on the pharmaceutical industry to revise its rules on how it cooperates with the public sector.
In a debate which adopted the Assembly Health Committee’s report on the pandemic, published on June 4, the parliamentarians condemned the “waste of large sums of public money and unjustified scares and fears about the health risks faced by the European public” which had resulted from the way the pandemic had been handled by the World Health Organization (WHO), European Union (EU) health agencies and national governments. There was “overwhelming evidence that the seriousness of the pandemic was vastly overrated by WHO,” resulting in a distortion of public health priorities, they added.
They supported the findings of the report – produced by Health Committee rapporteur and UK Labour Member of Parliament Paul Flynn – that there were “grave shortcomings” in the transparency of decision-making about the outbreak, generating concerns about the influence of the pharmaceutical industry on decisions taken. Plummeting confidence in such advice could prove “disastrous” in the case of a severe future pandemic, they warned.
Thursday, June 24, 2010
Mexico fines pharmaceutical firms for price fixing
Mexico fines pharmaceutical firms for price fixing
Eli Lilly y Compania-Mexico, Laboratorios Cryopharma, Probiomed and Laboratorios Pisa conspired between 2003 and 2006 to ensure a lack of competitive bidding for contracts to sell insulin, an essential medicine in the treatment of diabetes.
For their part, Pisa, Fresenius Kabi Mexico and Baxter engaged in anti-competitive collusion in their bidding for contracts to sell injectable saline solutions from 2003 to 2006.
Eli Lilly y Compania-Mexico, Laboratorios Cryopharma, Probiomed and Laboratorios Pisa conspired between 2003 and 2006 to ensure a lack of competitive bidding for contracts to sell insulin, an essential medicine in the treatment of diabetes.
For their part, Pisa, Fresenius Kabi Mexico and Baxter engaged in anti-competitive collusion in their bidding for contracts to sell injectable saline solutions from 2003 to 2006.
FT.com - Drug groups to limit medicine ‘sampling’
FT.com / Brussels / Business regulation - Drug groups to limit medicine ‘sampling’
Member companies will pledge to limit “sampling” or giving free medicines to doctors to four packets per doctor, and for no longer than two years after the launch of a new drug.
The practice – widespread in the US, where a recent estimated suggested companies provided $3bn at market priced of samples each year – has been criticised for distorting prescribing away from the most clinically appropriate or affordable treatments.
It has been particularly important in the past in the US where so many patients have to pay for their own treatment, but has also comes under scrutiny in Europe where most medicines are paid for by governments or insurers as a form of marketing.
The new “four by two” sampling ceiling agreed by the trade body would restrict such gifts, leaving just enough to give doctors a chance to see and try new treatments.
LOLPharma contd. ...
Nissen on patient enrollment in TIDE: "500 patients in 14 months. To get 16,000 patients will take another 448 months."
FDA Oversight of Foreign Drug Trials Lacking, Report Says
FDA Oversight of Foreign Drug Trials Lacking, Report Says
According to the report, during fiscal year 2008, only about one percent of all foreign drug sites were tested by the FDA, said the AP, noting that the report was issued yesterday by the Inspector General for the Department of Health and Human Services (HHS). It seemed, according to the report, that in many cases, the agency did not know about so-called early-stage trials taking place in foreign countries such as South America and Central America, said the AP.
According to the report, during fiscal year 2008, only about one percent of all foreign drug sites were tested by the FDA, said the AP, noting that the report was issued yesterday by the Inspector General for the Department of Health and Human Services (HHS). It seemed, according to the report, that in many cases, the agency did not know about so-called early-stage trials taking place in foreign countries such as South America and Central America, said the AP.
Diabetes - Novo Nordisk out, Lilly in at Walmart
Walmart, Lilly Team Up to Provide Human Insulin to People With Diabetes - Yahoo! Finance
Beginning in mid-September, Lilly's Humulin® brand of insulin will be available in Walmart pharmacies across the U.S. under the dual-branded name Humulin® ReliOn®, including 10 mL vials of Humulin® R U-100, Humulin® N, and Humulin® 70/30 formulations.
Beginning in mid-September, Lilly's Humulin® brand of insulin will be available in Walmart pharmacies across the U.S. under the dual-branded name Humulin® ReliOn®, including 10 mL vials of Humulin® R U-100, Humulin® N, and Humulin® 70/30 formulations.
Ouch!! Pfizer Suspends Osteoarthritis Trials of Pain Drug After FDA Request - WSJ.com
Pfizer Suspends Osteoarthritis Trials of Pain Drug After FDA Request - WSJ.com
Pfizer Inc. said it would suspend osteoarthritis trials of its pain drug tanezumab after a "small number" of reports that patients' ailments worsened to the point of needing joint replacement.
Pfizer Inc. said it would suspend osteoarthritis trials of its pain drug tanezumab after a "small number" of reports that patients' ailments worsened to the point of needing joint replacement.
NICE rejects Glaxo, Genmab leukaemia drug | Reuters
NICE rejects Glaxo, Genmab leukaemia drug | Reuters
The National Institute for Health and Clinical Excellence (NICE) said on Thursday it could not recommend the drug for reimbursement on the National Health Service (NHS) because evidence did not yet show how well it compared with standard treatment.
"This uncertainty, combined with the additional cost of ofatumumab (Arzerra) compared to currently available treatment, meant the committee could not recommend the drug as an efficient use of NHS resources," NICE Chief Executive Andrew Dillon said.
It marks Glaxo's third rebuff from NICE this month, following previous rejections of its cancer drug Tyverb and platelet-boosting drug Revolade.
Wednesday, June 23, 2010
Law.com - AstraZeneca Settlement Expected to Yield High Payouts to Consumers
Law.com - AstraZeneca Settlement Expected to Yield High Payouts to Consumers
The theory of the multidistrict litigation is that pharmaceutical companies inflated published average wholesale prices, which are used by the government and other third-party payers to set drug company reimbursement rates. The companies are also alleged to have offered secret discounts to physicians, thus enabling the physicians to reap higher reimbursements, and the drug companies to maintain or increase market share.
The theory of the multidistrict litigation is that pharmaceutical companies inflated published average wholesale prices, which are used by the government and other third-party payers to set drug company reimbursement rates. The companies are also alleged to have offered secret discounts to physicians, thus enabling the physicians to reap higher reimbursements, and the drug companies to maintain or increase market share.
PharmaTimes | Industry News | World News | GSK signs OTC cold sore pact with Medivir, expands Prosensa deal
PharmaTimes | Industry News | World News | GSK signs OTC cold sore pact with Medivir, expands Prosensa deal
Xerclear (acyclovir/hydrocortisone) is the first and only topical herpes labialis treatment clinically proven to help prevent cold sore lesions appearing, the firms said. The combo was granted marketing approval in 14 European countries in October 2009 and based on strong clinical data, Xerclear was given “a unique label, which differentiates it from other topical cold sore products currently on the market,” GSK says.
The treatment, previously known as Lipsovir, will be distributed as part of GSK’s over-the-counter Zovirax (acyclovir) franchise in multiple markets, including Europe, Russia, Japan, India, Australia and New Zealand but not North and South America, China, South Korea and Israel. The drugs giant will pay up to 3 million euros in upfront and pre-launch milestones and up to double-digit royalties.
Xerclear (acyclovir/hydrocortisone) is the first and only topical herpes labialis treatment clinically proven to help prevent cold sore lesions appearing, the firms said. The combo was granted marketing approval in 14 European countries in October 2009 and based on strong clinical data, Xerclear was given “a unique label, which differentiates it from other topical cold sore products currently on the market,” GSK says.
The treatment, previously known as Lipsovir, will be distributed as part of GSK’s over-the-counter Zovirax (acyclovir) franchise in multiple markets, including Europe, Russia, Japan, India, Australia and New Zealand but not North and South America, China, South Korea and Israel. The drugs giant will pay up to 3 million euros in upfront and pre-launch milestones and up to double-digit royalties.
Novo Nordisk withdraw insulin Mixtard 30 - Diabetes UK
Novo Nordisk withdraw insulin Mixtard 30 - Diabetes UK
“We are very disappointed about this withdrawal as it is not in the best interests of people with diabetes. We think this is wrong and asked Novo Nordisk to reconsider their decision, considering the 90,000 or so people currently using Mixtard 30, but they argued they are committed to withdrawing all older types of human insulin over time.
“We then asked for a longer withdrawal period to ensure a properly co-ordinated response to this, but that proposal was also turned down.”
Paxil Litigation Over Birth Defects Shifts to Settlement
Drugmaker GlaxoSmithKline has agreed to settle almost 200 cases in which plaintiffs allege the use of the antidepressant Paxil caused birth defects.
Only one case in Philadelphia's mass tort Paxil program has gone to trial.
GSK has settled every other case scheduled for trial in the eight months since a Philadelphia jury awarded a $2.5 million plaintiffs verdict in the first Philadelphia Paxil test case to go to trial.
GSK started to appeal that plaintiffs verdict from October. The jury awarded only compensatory damages and no punitive damages. But GSK then decided to settle Kilker v. SmithKline Beecham Corp. d/b/a GlaxoSmithKline along with another 190 cases, according to an order signed by Philadelphia Common Pleas Judge Sandra Mazer Moss last week.
The cases have settled for confidential amounts, said Jamie Sheller of the Sheller firm and local plaintiffs liaison counsel for the Paxil pregnancy mass tort program. GSK confirmed the settlements but said in a spokeswoman's statement that the terms of the settlements are confidential.
Sheller estimates that up to another 100 cases, including cases that have not yet been filed, have settled. The litigation is two-thirds over, Moss and Sheller said.
The Kilker case was viewed by the plaintiffs mass torts bar as a leading indicator of the strength of more than 600 similar cases.
"When you're dealing with children with birth defects that's a concern for any company," Sheller said. "GSK gave it their all at that trial. ... Despite that, the plaintiffs were successful in the case and that set a tone for their analysis. Even though they mounted an excellent and strong defense they weren't able to overcome the plaintiffs' position."
The next cases in the litigation are scheduled for trial in the fall.
GSK spokeswoman Sarah Alspach said in an e-mail statement that GSK has agreed to settle some cases involving the use of Paxil during pregnancy "despite its litigation defenses, in order to avoid the costs, burdens and uncertainties of ongoing litigation."
Moss, the coordinating judge of Philadelphia's mass tort program, the Complex Litigation Center, said the philosophy of GSK "is to try and settle what they can and to settle in groups."
Moss also said the Paxil litigation has been resolving successfully in the last few months because of the cooperation between the plaintiffs and the defense bars and because GSK has not taken a stance that they're "not offering a penny."
"I think there is a great deal of cooperation between the plaintiffs and defendants," Moss said. "They actually work well together. There is not a lot of animosity."
Moss has been meeting monthly with the Paxil plaintiffs lawyers and the Paxil defense team, Sheller said.
Michael T. Scott, a defense attorney with Reed Smith's life sciences health industry group, said that settling a case is not an admission that the company did anything wrong and does not mean that all cases are going to settle. Scott said his firm represents GSK in some matters, but not in cases involving Paxil.
Tom Kline, a plaintiffs attorney with Kline & Specter, said that it appears that the Kilker trial was a "cathartic event" that influenced the course of the litigation.
Pharmaceutical companies have "economic and reputational incentives" to turn away from litigation, Kline said.
Pharmaceutical companies think in terms of billions of dollars, Kline said, and settling cases en masse doesn't break their bottom line and must be weighed against the impact on their reputation with the public -- including the federal Food and Drug Administration and health care professionals -- with every case that goes to trial, Kline said.
Moss said a mediator paid for by the defendants and the plaintiffs also was very helpful in settling the cases.
More of the cases that are settling involve cardiac defects, but there are other minor plaintiffs alleging defects because of their mothers' use of Paxil, Sheller said.
Because the cases involve minors, Orphans' Court approval is necessary, Moss said.
Moss said because the cases involve many out-of-state plaintiffs, she is working with Judge Joseph D. O'Keefe, administrative judge of Orphans' Court, on how to handle settlements for out-of-state minor plaintiffs.
Moss said it is contemplated that out-of-state minor plaintiffs can have approval for their settlements given by the state court jurisdictions in which the plaintiffs live. However, cases will come back to Philadelphia Orphans' Court if there is any reason that approval by judges in other states doesn't happen, Moss said.
O'Keefe said last week the Orphans' Court has not yet started to receive any Paxil cases.
Despite settling many of the Paxil cases, GSK continues to argue it acted appropriately regarding the drug.
"GSK believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use and in updating pregnancy information in the medicine's label as new information became available," Alspach said.
In post-trial motions seeking judgment notwithstanding the verdict or a new trial in Kilker, GSK said that 65 percent of all birth defects have no known cause and less than 1 percent of all birth defects are attributable to a mother's exposure to medication during pregnancy.
Plaintiff Lyam Kilker has three congenital defects in his heart: a defect between the upper two chambers of his heart, a defect between the lower two chambers of his heart and a defect that has left a hole in the wall of his heart that separates the two pumping chambers of the heart as well as preventing the heart's aorta from forming a complete "tube," according to court papers.
The last of Kilker's heart defects, called an interrupted aortic arch, is a defect that GSK argued has not been found in research to be associated with the use of Paxil by pregnant mothers and the cause of this type of heart defect is generally considered to be unknown.
"There is no established -- or even speculative -- link between Paxil and interrupted aortic arch," GSK said in its post-trial motions.
Sheller said last fall that GSK thought it could win on Kilker's more rare defect, which is why they took Kilker to trial and settled other cases.
Prior to Kilker, three other bellwether cases settled for confidential amounts.
Joseph O'Neil of Philadelphia's Lavin O'Neil Ricci Cedrone & DiSipio is the local defense liaison counsel for the Paxil pregnancy program.
The main plaintiffs firms include Clark Burnett Love & Lee in Houston, the Tracey Law Firm in Houston and Robinson Calcagnie & Robinson in Newport Beach, Calif., Sheller said.
via law.com
Wanted - Drug Reps for a UK TV documentary
"Are you:
* Confident?
* A self-starter?
* Used to taking orders?
* Used to repeating the company line?
* Perhaps feeling you are pushing a doctor into taking on a sub-standard drug?
If so, please email me in confidence at Pharma10@hotmail.co.uk as I'm working on a major tv documentary that will cover a key current story in the drugs industry. I'm interested in hearing from drug company representatives about the pressure to make sales and the methods used to recruit key opinion leaders and counter adverse publicity".
Tuesday, June 22, 2010
AstraZeneca's $103M Drug Pricing Settlement Is Merely Tip of the Over-Charging Iceberg | BNET Pharma Blog | BNET
But if you put it all together, it becomes clear that AZ spent years overcharging Medicare, Medicaid and private insurance coverage providers for its drugs, contributing significantly to the increased cost of healthcare in the U.S. The extra money AZ milked from the system was certainly much larger than the $103 million it agreed to pay late last week.
Do the math!!
Biovail and Valeant Agree to $3.2 Billion Merger - NYTimes.com
Two drug makers with sometimes stormy pasts, Biovail and Valeant Pharmaceuticals International, said Monday that they had agreed to merge in a $3.2 billion deal. The merger will create a big Canadian-American player in the world of specialty pharmaceutical companies.
via nytimes.com
Pfizer pulls leukemia drug from U.S. market - Yahoo! News
Drugmaker Pfizer Inc is pulling a decade-old leukemia medicine off the U.S. market after a study found a higher death rate and no benefit for patients.
Mylotarg won approval under an abbreviated process to help bring treatments for serious diseases to patients more quickly. Medicines cleared in that way must pass follow-up tests to confirm they work.
The Food and Drug Administration said on Monday it asked Pfizer to withdraw the drug after a recent clinical trial raised new concerns about the product's safety and the drug "failed to demonstrate clinical benefit to patients enrolled in trials."
via news.yahoo.com
Liam Grant: 'Ireland's Erin Brockovich' and a €1m battle with the drugs industry - Health, News - Belfasttelegraph.co.uk
His story has parallels with that of Erin Brockovich, whose David-and-Goliath battle against a US energy company became the subject of a Hollywood film. But unlike the American legal clerk, Liam Grant is taking on a giant pharmaceutical company.
In 1996, Mr Grant's 19-year-old son, also called Liam, was prescribed Roaccutane, an acne drug. Formerly cheerful and outgoing, he soon became withdrawn and reclusive. Four months after he started taking the drug, he was found hanging from a tree outside Dublin. A jury delivered a verdict of suicide.
Mr Grant has spent more than €1m (£835,000) of his own money pursuing the drug's manufacturer, the Swiss company Roche, and the regulators whom he holds responsible for his son's death. Roche denies it is to blame for any deaths or severe mental health problems.
He has now won a crucial ruling from the European Ombudsman, Nikiforos Diamandouros, that the European Medicines Agency (EMA) should release details of all adverse reactions to the medicines it licenses. It is required to respond by 31 July. If it complies, patients will for the first time have access to Europe-wide details of suspected adverse reactions to all medicines licensed by the EU's drug safety body.
A forensic accountant from Dublin, Mr Grant was supported by his wife, Loyola, and their three surviving children in investigating Roaccutane. When he could not persuade the company to carry out the studies he thought necessary, he funded them himself.
In 2004, he sued Roche in the Irish courts. The company responded by offering to pay him the maximum compensation under Irish law for the death of his son – about €30,000 – as well as his costs and special damages. When he refused, Roche appealed to the Irish Supreme Court to compel him to accept. In 2008, the Court threw out the appeal and ruled that his case could go ahead.
"I did this out of utter anger," Mr Grant said. "Roaccutane was licensed for the treatment of acne in 1982. Soon there were studies showing patients got depression within weeks of starting on it. When I started investigating, I was looking at 20 to 30 published studies linking the drug to depression, psychosis and suicide. Why wasn't Roche carrying out studies?
"I met with the Committee on Safety of Medicines in the UK and the Food and Drug Administration in the US. I argued that if they can give a company a licence they should be able to say, you must do these studies. They responded that they had no power to compel companies to carry out studies."
A scientist hired by Mr Grant to investigate Roaccutane found that despite the number of studies suggesting a link with depression and suicide, at the time only a handful of countries required that the drug carry warnings to this effect. Warnings were subsequently added in all countries. The drug has triggered about 5,000 personal injury claims.
Mr Grant, 61, said his professional career had helped him to keep focused on his campaign. His wife, Loyola, died in 2007. "I am not giving up now. I have spent the last 30 years as a forensic accountant investigating some of the biggest frauds in the country and preparing reports for the courts. That has allowed me to avoid getting involved emotionally and keep objective. It hasn't dominated my life," he said.
It would be "wonderful", he added, if the EMA granted public access to its documents on suspected adverse reactions. "Hopefully, it will be a one stop shop so people can go to a single source for the information. At the moment, some countries give the information and some don't, some collect it in one way and some in another."
The EMA had argued that circulating all the data it collects about adverse reactions to drugs could prove "misleading" or "unreliable" because many suspected cases turn out not to be linked with the drug in question.
But the ombudsman disagreed, saying the EMA should include warnings with the data to reduce the risk of misinterpretation. It added that the regulator had failed to provide Mr Grant valid and adequate grounds for its refusal to make the information available. "This constitutes an instance of maladministration," Mr Diamandouros said.
The EMA said it had launched an initiative to improve the transparency of its processes, due for implementation by the end of the year. A draft policy proposes that the general public should have access to "spontaneous reports for all types of medicines".
Roche said: "Since 1982, over 15 million patients have been treated with Roaccutane. Although there have been very rare reports of suicides and suicidal ideation in patients with acne being treated with the medicine, the fact is that severe acne can cause some sufferers to become depressed and can also affect their mood and self esteem.
"Although there is no proven causal link between Roaccutane and suicide, we stress through our patient information leaflet provided with every pack that patients must tell their doctors if they notice any change in mood or behaviour and give examples of the types of changes they should look out for."
Monday, June 21, 2010
Dr. Larry Dossey: Creating Disease: Big Pharma and Disease Mongering
You may think there is enough disease in the world already, and that no one would want to add to the diseases that we humans must deal with. But there is a powerful industry in our society that is working overtime to invent illnesses and to convince us we are suffering from them.
This effort is known as "disease mongering," a term introduced by health-science writer Lynn Payer in her 1992 book Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. Payer defined disease mongering as "trying to convince essentially well people that they are sick, or slightly sick people that they are very ill." This strategy has also been called "the corporate construction of disease" by Ray Moynihan, Iona Heath and David Henry in the British Medical Journal. "There's a lot of money to be made from telling healthy people they're sick," they say. "Pharmaceutical companies are actively involved in sponsoring the definition of diseases and promoting them to both prescribers and consumers."
Disease mongering got rolling in 1879 with the invention of Listerine, which was originally considered a surgical antiseptic. It was named for the famous English surgeon Joseph Lister, who performed the first antiseptic surgical procedure. Soon, however, Listerine's inventors, Dr. Joseph Lawrence and Jordan W. Lambert, were selling it in concentrated form as a floor cleaner and as a treatment for gonorrhea. In 1895 they began to market it to dentists for oral care, and in 1914 it became the first over-the-counter mouthwash marketed in the United States. By the 1920s, the Lambert Pharmacal Company, Listerine's maker, was confident they had found a cure; now all they needed was a disease. So they made one up: "halitosis." Before that time, halitosis was an obscure medical term that almost no one had heard of. Advertisers began to promote Listerine as a cure for this condition, which, they said, could blight anyone's chances of succeeding in romance, marriage and work. Soon, people all over America were suffering from halitosis.
The trick was to inflate a common, everyday condition to the level of pathology, which, if not attended to, could blight one's prospects for personal happiness and success. The ads the Listerine marketers crafted were mini-soap operas, in which people risked social shame and failure unless they used the product.
The Listerine marketers refined the marketing techniques that were pioneered by the patent-medicine makers of the 19th century. Novelist Henry James was so vexed by these hucksters he called them "nostrum-mongers." His brother, Harvard psychologist William James, who is considered the father of American psychology, was also exasperated by them, saying that "the authors of these advertisements should be treated as public enemies and have no mercy shown."
Payer identified several disease-mongering tactics. Among them:
• Taking a normal function and implying that there's something wrong with it and that it should be treated
• Describing suffering that isn't necessarily there
• Defining as large a proportion of the population as possible as suffering from the "disease"
• Defining a condition as a deficiency disease or as a disease of hormonal imbalance
• Recruiting doctors to spin the message
• Using statistics selectively to exaggerate the benefits of treatment
• Promoting the treatment as risk free
• Taking a common symptom that could mean anything and making it sound as if it is a sign of a serious disease
Healthcare watchdogs are now blowing the whistle on the major pharmaceutical companies who are engaged in this activity, and they have identified several "illnesses" as current examples of disease mongering. They are not saying these conditions don't exist -- they are indeed problematic for some people -- but that their incidence and relevance is wildly exaggerated in the pursuit of corporate profits. Among these "illnesses" are erectile dysfunction, female sexual dysfunction, bipolar disorder, attention deficit hyperactivity disorder (ADHD), restless legs syndrome, osteoporosis, social shyness (also called social anxiety disorder and social phobia), irritable bowel syndrome and balding.
Why should we be concerned about disease mongering? There is a huge psychological burden in thinking of ourselves as diseased when we are not. Beyond the psychological cost, there are financial costs, both personal and social. Treating these "illnesses" with pharmaceuticals is not cheap. Moreover, no tax-funded healthcare system can sustain the cost of drug treatment for all the risks for which the drug companies would like to treat the population.
Reversing disease mongering won't be easy. There is a near-limitless amount of money to be made from marketing pharmaceutical remedies for diseases that exist mainly in the imagination, and there are powerful economic, political, and professional interests who desperately want this process to continue.
The way forward may be in immunizing ourselves psychologically against the messages from Big Pharma that invade our lives on every hand. We have to learn to stop being suckers.
How? Heath believes our fear of suffering and death make us susceptible to disease mongering. Today, because the comforts of religion are no longer real for many people, death seems more final, resulting in a panicky rush to use anything that offers better health and increased longevity. So it may be that the best way to resist disease mongering is not to beat our heads against the fortress of Big Pharma, but to develop the psychological and spiritual maturity that makes us resistant to their efforts to instill fear and dread in our lives.
It's been said that one of the main ways we humans differ from other creatures is in our desire to take a pill. The pharmaceutical companies know that. Yet our health is determined mainly not by the pills we choose to swallow, but how we choose to live our lives -- the ways we eat, exercise, work, play, love and relate to others. Realizing that, we can outsmart the efforts of the disease mongerers to pathologize every moment of our existence.
~ Larry Dossey, MD
References:
L. Dossey. Listerine's long shadow: disease mongering and the selling of sickness. Explore. September 2006; 2(5): 379-385.
R. Moynihan, I. Heath I, D. Henry. Selling sickness: the pharmaceutical industry and disease mongering. British Medical Journal. 2002;324:886-891. Available at: http://bmj.bmjjournals.com/cgi/content/full/324/7342/886.
L. Payer. Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. New York, NY: Wiley & Sons; 1992.
Listerine. Wikipedia. Available at: http://en.wikipedia.org/wiki/Listerine.
Special Collection on Disease Mongering. Public Library of Science (PloS Medicine). http://www.ploscollections.org/article/browseIssue.action?issue=info%3Adoi%2F10.1371%2Fissue.pcol.v07.i02.
What Allergan doesn't want to you know about Botox | The Orange County Register
via ocregister.com
Dr. Sharla Helton, of Oklahoma City, won a $15 million lawsuit against Allergan over the side effects of Botox, which she says left her in constant pain and partially paralyzed. A jury agreed that Allergan had failed to disclose potential side effects. The company is appealing.
Sunday, June 20, 2010
A turning point for "pay for delay"?
The U.S. government’s decade-long fight to limit drugmakers’ ability to keep generic medicines off the market may reach “a turning point” soon, Federal Trade Commission Chairman Jonathan Leibowitz said.
The FTC is counting on a review by an appeals court to break a deadlock over agreements made by brand-name drugmakers that it says delay the introduction of lower-priced generic medicines. The focus is on the 2nd U.S. Circuit Court of Appeals in New York, which may decide by August whether to review a deal between Bayer AG andTeva Pharmaceutical Industries Ltd.’s Barr unit on when a generic version of the antibiotic Cipro can go on the market.
The Cipro case “signals a renewed concern about these pay-for-delay deals, and hopefully it will mark a turning point towards a legal rule that prohibits brand pharmaceutical companies from paying off their generic competitors to sit it out,” Leibowitz, 52, said in an interview. The review could bring the issue of agreements before the Supreme Court.
The fight pits drugmakers against the FTC, the Justice Department, pharmacies such as CVS Caremark Corp. and President Barack Obama, who cited the greater availability of generic drugs as a way to reduce health-care costs. There also is an effort in Congress to restrict the settlements.
Saturday, June 19, 2010
AstraZeneca settles drug price suit for $103M - BusinessWeek
via businessweek.com
AstraZeneca PLC on Friday agreed to pay $103 million to settle lawsuits that allege it inflated the price of its cancer drug Zoladex and its child asthma medication Pulmicort.
The lawsuits alleged that the British drug maker inflated the average wholesale price of the drugs, a benchmark rate used to determine how much the drugs cost for consumers, health plans and government programs.
Friday, June 18, 2010
Sanofi Aventis - Lantus: cancer risk question
Sanofi-Aventis SA fell the most in a year in Paris trading on renewed concern that the French drugmaker’s Lantus diabetes treatment may be linked to an increased risk of cancer.
Sanofi dropped 2.91 euros, or 5.7 percent, to 48.20 euros at 11:40 a.m. The stock slid as much as 8.1 percent, the biggest intraday drop since June 26, 2009.
A study published this week in the journal Diabetes Care linked insulin glargine, as Lantus also is known, to an increased risk of cancer, according to a note today from Hobart Capital Markets, a London brokerage. Sanofi in the past has said the drug is safe and it’s doing additional studies.
In the study, researchers compared the health records of 1,340 people with diabetes who developed cancer to a group of patients matched for age, sex and weight to see if they could tease out any differences that may have contributed to tumor development. During the six-year review, people diagnosed with cancer had taken significantly higher daily doses of Lantus, according to the report in Diabetes Care. No association between new cancer and other forms of insulin were found.
Source
Sanofi dropped 2.91 euros, or 5.7 percent, to 48.20 euros at 11:40 a.m. The stock slid as much as 8.1 percent, the biggest intraday drop since June 26, 2009.
A study published this week in the journal Diabetes Care linked insulin glargine, as Lantus also is known, to an increased risk of cancer, according to a note today from Hobart Capital Markets, a London brokerage. Sanofi in the past has said the drug is safe and it’s doing additional studies.
In the study, researchers compared the health records of 1,340 people with diabetes who developed cancer to a group of patients matched for age, sex and weight to see if they could tease out any differences that may have contributed to tumor development. During the six-year review, people diagnosed with cancer had taken significantly higher daily doses of Lantus, according to the report in Diabetes Care. No association between new cancer and other forms of insulin were found.
Source
Cardiovascular system examination on YouTube
The Clinical Skills Online (CSO) is a project aimed at providing online videos demonstrating core clinical skills common to a wide range of medical and health-based courses.
This project has been funded by the Higher Education Academy Subject Centre for Medicine, Dentistry and Veterinary Medicine.
Who is it for?
These videos are freely available to anyone using them for educational, personal and non-commercial purposes only. (Please read both the site disclaimer and the creative commons license for more information).
http://rs67.rapidshare.com/files/146..._deviation.wmv
http://rapidshare.com/files/146895817/percussion.wmv
http://rapidshare.com/files/14689587..._expansion.wmv
http://rapidshare.com/files/146895875/phlebotomy.wmv
http://rapidshare.com/files/146895959/respiratory.wmv
http://rapidshare.com/files/14689597...ation-male.wmv
http://rapidshare.com/files/146895978/abdominal.wmv
http://rapidshare.com/files/14689598...ous_access.wmv
http://rapidshare.com/files/14689600..._blood_gas.wmv
http://rapidshare.com/files/146896017/cvs.wmv
http://rapidshare.com/files/146896029/thyroid.wmv
http://rapidshare.com/files/14689609...ion-female.wmv
Plus : http://www.youtube.com/user/PACESresources#p/u
Pharma prices in Europe - who wins?
Prescription drug prices in the UK, Norway and Sweden are the lowest among a group of 10 European nations, while the most expensive are in Ireland, Belgium and – usually – Germany, according to a new report.
Out of the 10 countries constituting the reference price “basket” for prescription drug prices in Norway – which also include Austria, Denmark, Finland and the Netherlands – the UK is usually the cheapest country, apart for those generic drugs which are subject to reference pricing in Norway, in which case it will of course be the cheapest market, says the study, which was conducted for the Norwegian Pharmacy Association (Apotekforeningen) by the country’s Institute for Research in Economics and Business Administration (SNF).
The study examines prices across Europe during the first half of 2009, using data from IMH Health.
Overall, retail prices of prescription drugs are about 17% less expensive in the UK than in Norway, but wholesale prices in Norway are the lowest of the 10-nation group, with UK prices being the second-cheapest, according to the researchers. Pharmacy-level prices of patented prescription drugs in the UK are on average 19.8% cheaper than Norway, while those in Sweden are 6.9% more expensive and Belgium has the highest prices of the group, averaging 68.4% more than Norway. Generic drugs which are subject to reference pricing are the cheapest by far in Norway of the 10 nations, with prices in Sweden, the second-cheapest country, averaging 13% more than in Norway.
Pharmacy margins among the 10-nation group are the highest in Ireland, where they are 25 percentage points higher than in Norway, says the study; the average margin in Norway is approximately 18% while in Ireland it is around 43%. Finland, the Netherlands and Germany also have relatively high margins, as do Austria and the UK albeit to a lesser extent, while those in Sweden, Denmark and Belgium are not significantly different from Norway. Pharmacy margins in the UK are lower than in Norway for products without generic competition, while the opposite applies for those with generic competition, it adds.
Looking at pricing developments during 2007- 9, the researchers note that while most of the 10 countries experienced price reductions during the period, those in Norway were “fairly strong” compared with the reference countries. Norway’s low prices and margins are due its strict regulation of prices and margins in the patented sector, combined with incentives creating competition in the reference-priced generic segment (trinnpris). “These factors are also likely to explain why Norway is one of the cheapest countries in Western Europe when it comes to prescription drugs,” they add.
Commenting on the report’s findings, analysts at IHS Global Insight forecast that drug price levels are likely to widely fluctuate in the short-to-medium term, given that several countries among Norway’s basket of reference countries now implementing major cost-containment measures. For example, Finland’s introduction of reference pricing for generics in April 2009 is likely to put serious downward pressure on prices of off-patent products, not only in that market but also in Norway.
Also Germany - whose system currently tends to encourage high pricing of branded medicines - is in the process of overhauling its drug pricing scheme, with the aim of requiring makers of patented drugs to negotiate prices, and with an interim three-year freeze on pharmaceutical prices expected to take effect from August 1, if Parliament agrees to the drug package presented by the coalition government. If it does so, these measure are likely to reduce the prices of patented drugs in Germany significantly and this will, inevitably, lead to a Europe-wide decrease in prices, since Germany is a reference for many member states, says IHS Global Insight.
By Lynne Taylor
http://www.pharmatimes.com/WorldNews/article.aspx?id=18046&src=EWorldNews
Out of the 10 countries constituting the reference price “basket” for prescription drug prices in Norway – which also include Austria, Denmark, Finland and the Netherlands – the UK is usually the cheapest country, apart for those generic drugs which are subject to reference pricing in Norway, in which case it will of course be the cheapest market, says the study, which was conducted for the Norwegian Pharmacy Association (Apotekforeningen) by the country’s Institute for Research in Economics and Business Administration (SNF).
The study examines prices across Europe during the first half of 2009, using data from IMH Health.
Overall, retail prices of prescription drugs are about 17% less expensive in the UK than in Norway, but wholesale prices in Norway are the lowest of the 10-nation group, with UK prices being the second-cheapest, according to the researchers. Pharmacy-level prices of patented prescription drugs in the UK are on average 19.8% cheaper than Norway, while those in Sweden are 6.9% more expensive and Belgium has the highest prices of the group, averaging 68.4% more than Norway. Generic drugs which are subject to reference pricing are the cheapest by far in Norway of the 10 nations, with prices in Sweden, the second-cheapest country, averaging 13% more than in Norway.
Pharmacy margins among the 10-nation group are the highest in Ireland, where they are 25 percentage points higher than in Norway, says the study; the average margin in Norway is approximately 18% while in Ireland it is around 43%. Finland, the Netherlands and Germany also have relatively high margins, as do Austria and the UK albeit to a lesser extent, while those in Sweden, Denmark and Belgium are not significantly different from Norway. Pharmacy margins in the UK are lower than in Norway for products without generic competition, while the opposite applies for those with generic competition, it adds.
Looking at pricing developments during 2007- 9, the researchers note that while most of the 10 countries experienced price reductions during the period, those in Norway were “fairly strong” compared with the reference countries. Norway’s low prices and margins are due its strict regulation of prices and margins in the patented sector, combined with incentives creating competition in the reference-priced generic segment (trinnpris). “These factors are also likely to explain why Norway is one of the cheapest countries in Western Europe when it comes to prescription drugs,” they add.
Commenting on the report’s findings, analysts at IHS Global Insight forecast that drug price levels are likely to widely fluctuate in the short-to-medium term, given that several countries among Norway’s basket of reference countries now implementing major cost-containment measures. For example, Finland’s introduction of reference pricing for generics in April 2009 is likely to put serious downward pressure on prices of off-patent products, not only in that market but also in Norway.
Also Germany - whose system currently tends to encourage high pricing of branded medicines - is in the process of overhauling its drug pricing scheme, with the aim of requiring makers of patented drugs to negotiate prices, and with an interim three-year freeze on pharmaceutical prices expected to take effect from August 1, if Parliament agrees to the drug package presented by the coalition government. If it does so, these measure are likely to reduce the prices of patented drugs in Germany significantly and this will, inevitably, lead to a Europe-wide decrease in prices, since Germany is a reference for many member states, says IHS Global Insight.
By Lynne Taylor
http://www.pharmatimes.com/WorldNews/article.aspx?id=18046&src=EWorldNews
FDA Warns Drug Makers On Misleading Promotional Efforts
2nd UPDATE: FDA Warns Drug Makers On Misleading Promotional Efforts
The U.S. Food and Drug Administration sent letters to several companies requesting that they stop distributing misleading promotional materials for their drugs.
The letters were sent in recent weeks to Eisai Co. Ltd. (4523.TO, ESALY), Auxilium Pharmaceuticals Inc. (AUXL), Cumberland Pharmaceuticals Inc. (CPIX) and Dainippon Sumitomo Pharma Co.'s (4506.TO) Sepracor unit, and posted on the 
The FDA said a 60-second television advertisement for Sepracor's Lunesta sleep aid makes "unsubstantiated superiority claims" in violation of federal law. A voice-over in the ad says viewers who have trouble sleeping even after taking a sleep aid should ask their doctors about switching to Lunesta because Lunesta is "different." The ad says Lunesta "keys into receptors that support sleep."
The FDA said this language misleadingly implies that Lunesta is clinically superior to other insomnia medications, and that Lunesta might work where others fail. The agency says it isn't aware of any evidence to support these claims. Also, the agency said the claim about how Lunesta works is misleading because there's still some uncertainty about the drug's mechanism of action.
The FDA requested that Sepracor stop distributing promotional materials such as the ad cited.
"Female Viagra" a Flop, Says FDA Panel - CBS News
"Female Viagra" a Flop, Says FDA Panel - CBS News
The wait for a pill to prop up women's sagging sex drives might be longer than expected.
An FDA panel weighing whether to green-light flibanserin, the so called "female Viagra," say the drug failed to boost women's libidos in recent studies.
What's more, many women who took the once-a-day drug experienced significant side effects, including depression, fatigue, and fainting.
The wait for a pill to prop up women's sagging sex drives might be longer than expected.
An FDA panel weighing whether to green-light flibanserin, the so called "female Viagra," say the drug failed to boost women's libidos in recent studies.
What's more, many women who took the once-a-day drug experienced significant side effects, including depression, fatigue, and fainting.
Thursday, June 17, 2010
Sanofi to Further Cut Costs, Reduce Sales Force, Contamine Says - Bloomberg.com
Sanofi to Further Cut Costs, Reduce Sales Force, Contamine Says - Bloomberg.com
Sanofi-Aventis SA, France’s biggest drugmaker, plans further expense reductions in areas such as marketing to offset lower revenue that’s resulting from health- care reforms in Europe.
Sanofi-Aventis SA, France’s biggest drugmaker, plans further expense reductions in areas such as marketing to offset lower revenue that’s resulting from health- care reforms in Europe.
“The way to cope with that is to continue to cut costs,” Chief Financial Officer Jerome Contamine said at a conference yesterday in Los Angeles organized by Goldman, Sachs & Co. “We are restructuring. We are changing our marketing model. We are merging sales forces, we are reducing sales forces, having a multiproduct sales force. We will continue to do that.”
BI Plays Up Sexual Disorder, With a Pill in Waiting - NYTimes.com
BI Plays Up Sexual Disorder, With a Pill in Waiting - NYTimes.com
In the last month, Boehringer Ingelheim has been trying to lay the consumer groundwork with a promotional campaign about women’s low libido, including a Web site, a Twitter feed, a Discovery Channel documentary and a publicity tour by Lisa Rinna, a soap opera star and former Playboy model, who describes herself as someone who has suffered from a disorder that Boehringer refers to as a form of “female sexual dysfunction.”
“This is really a classic case of disease branding,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school who researches drug marketing and has studied the campaign. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”
In the last month, Boehringer Ingelheim has been trying to lay the consumer groundwork with a promotional campaign about women’s low libido, including a Web site, a Twitter feed, a Discovery Channel documentary and a publicity tour by Lisa Rinna, a soap opera star and former Playboy model, who describes herself as someone who has suffered from a disorder that Boehringer refers to as a form of “female sexual dysfunction.”
“This is really a classic case of disease branding,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school who researches drug marketing and has studied the campaign. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”
Big Pharma's stalled R&D machine - By BEN HIRSCHLER and KATE KELLAND, Reuters
LONDON - At just 28, Duncan Casey has already been from the university science bench to the world of Big Pharma research and back again. Now working in an Imperial College lab tucked behind London’s famous Science Museum, he has no illusions about the prospects for researchers in the pharmaceutical industry.
“The unit I used to work in — GlaxoSmithKline’s place in Harlow — has been closed down now,” says Casey, dressed in signature protective goggles and white coat as he works on synthetic chemistry. “It used to be a job for life. Now it’s a job until the next restructuring.”
Across the western world, Big Pharma is cutting back on the number of scientists it employs in its labs and the money it spends on research and development. The hunt for new drugs continues, but the men and women in white coats — traditionally viewed as the lifeblood of the industry — are not as untouchable as they once were.
It’s a similar story at GlaxoSmithKline’s research laboratories in Verona, where lunchtime conversations can be decidedly gloomy. Glaxo is axing the Italian facility, shedding 500 jobs as part of a programme of cuts designed to improve returns on R&D. Many scientists feel stranded or wonder why they entered the profession at all.
“It’s a sad but true fact that science really doesn’t pay any more,” says one young researcher who would not give her name for fear of jeopardising her future prospects in the industry. “The lunchtime discussion today was about what we’d go back and study if we were 18 again and choosing university courses. There were only a few of us who said they’d still go for a science degree.”
Across the Atlantic in Cambridge, Mass., Adrian Ivinson, director of Harvard’s NeuroDiscovery Center, is reminded of the shifts underway in the industry every time he looks out of his window. Over the road, the “gorgeous, state of the art labs””no longer house Merck & Co Inc’s neuroscience team. “They only built it a few years ago and had this wonderful neuro group in there,” Ivinson says. “Now they’re gone.”
The magnitude of the changes is hard to ignore.
U.S. drug giants Pfizer Inc and Merck have slashed thousands of jobs since acquiring smaller rival firms last year. British-Swedish firm AstraZeneca has plans to close its research labs at Charnwood in central England by the end of 2011, with the loss of up to 1,200 jobs; its Swedish research unit in Lund will also shut. In Japan, Astellas Pharma Inc has announced plans to limit its research expenditure.
NEW PRODUCTS, NEW MARKETS
One factor forcing Big Pharma to rethink its business model is the huge number of patents that are set to expire over the next five years. As patents run out on blockbuster prescription tablets like Pfizer’s $12 billion-a-year cholesterol medicine Lipitor and AstraZeneca’s $5 billion heartburn pill Nexium, cut-price generics are sure to rush in and slash margins. Between now and 2015 products with sales of more than $142 billion will face copycat competition, according to IMS Health, the leading global supplier of prescription drug data. It is the biggest “cliff””of patent expiries in the history of the pharmaceuticals industry.
Add in tougher regulatory hurdles and a brutal squeeze on healthcare budgets as cash-strapped governments push austerity programmes and it’s little wonder that drug companies are cutting back and shifting focus.
The strategy so far has been to buy promising new drugs from outside developers and boost investment in the relative safety of non-prescription consumer products. Big drugmakers are also moving into new markets — with Asia at the top of everybody’s list. It all adds up to a redesign of the multinational pharmaceutical company. In the 21st century, says Isaly, Big Pharma will primarily be a distribution business.
HORLICKS HELPS CEO SLEEP AT NIGHT
A peek inside the bag of free goodies handed out to shareholders at Glaxo’s annual meeting in London gives an idea of one direction the industry is headed. Aquafresh toothpaste, Corsodyl mouthwash, Breathe Right nasal strips and Lucozade energy drink are not exactly at the cutting edge of bioscience, yet they are all products that now enjoy top billing under Glaxo’s youthful Chief Executive Andrew Witty.
Under Witty, who has been in the top job for two years, over-the-counter remedies, oral care and health drinks have become a key pillar of Glaxo’s drive to reduce reliance on traditional prescription pharmaceuticals. As if to emphasise that fact, the one new hire highlighted by the CEO in his address to the meeting was Emma Walmsley — an executive poached from French cosmetics group L’Oreal SA and heir apparent to run Glaxo’s reinvigorated consumer healthcare business.
Glaxo may be working on groundbreaking treatments for cancer, but one of Witty’s favourite products is Horlicks, a malted milk powder best known in Britain as a bedtime drink for the elderly. Horlicks is a huge seller in the key emerging market of India. The brand clocked up 146 million pounds ($214 million) in Indian sales in 2009, bagging an enormous 48 percent of the hot drinks market there.
For industry veterans like Andy Smith, who worked at what was then SmithKline Beecham in the 1990s and is now a healthcare fund manager at Axa Framlington, the change is profound. “When I worked for consumer healthcare we were always the poor relation, which is actually why I moved to the pharmaceuticals division,” he says. “Senior management always used to complain about the mixed P/E (price-to-earnings) multiple of having a consumer healthcare business and a pharmaceutical business and the fact that the analysts didn’t understand it — but now they are really appreciating it.”
It’s not hard to see why. Ten years ago, the pharmaceutical sector was trading at 30 times expected earnings. Today, most Big Pharma shares have a forward P/E of under 10, while consumer products companies like Procter & Gamble Co fetch around 15 times forecast earnings.
But diversity doesn’t just mean selling a wider range of products. Big western drugmakers are also expanding into emerging markets such as China, which is set to overtake Germany as the world’s third biggest drugs market next year, according to IMS. The fast-expanding middle classes in China and elsewhere are demanding drugs that they couldn’t afford a few years ago. Overall sales growth in emerging markets is expected to be three times that of developed markets in the next five years.
In China, western companies have linked up with local players and research institutes. Some firms are even cosying up to old enemies in the Indian generics sector, following new legislation that has improved patent protection in that country.
But multinational drugmakers know they have to do more than sell toothpaste and expand into Asia. They need more and better drugs to sell — and they need them fast.
REVERSE ALCHEMY
The problem is, Big Pharma doesn’t have nearly enough new drugs in the pipeline to replace all those it is about to lose. Since 1950 — virtually the dawn of the modern era of medicine — a total of 1,256 new drugs have been approved by the U.S. Food and Drug Administration (FDA). But the industry today produces roughly the same number of new medicines that it did 60 years ago.
Ten years ago there was a lot of hope that process-led research systems would industrialise the hunt for new drugs. But that optimism may have been misplaced. A spike in drug approvals in the mid-1990s, it turns out, was not the result of any fundamental improvement in productivity but largely down to the FDA clearing a backlog of applications after the introduction of a new system under which companies paid “user fees””to help speed the process.
Despite pouring billions into research — more than $65 billion last year in the U.S. alone — the number of new drugs launched annually has fallen 44 percent since 1997, according to CMR International, a Thomson Reuters subsidiary.
Big Pharma has also struggled over the past decade to produce the kind of big new hits that make the bulk of its money. As with other industries dominated by blockbusters — think Hollywood movies or oil and gas exploration — it’s not easy to pick winners years in advance. Even after a drug gets approval, commercial success can be a hit-and-miss affair, as evidenced by lacklustre sales of recent arrivals such as the keenly anticipated blood-thinner Effient from Eli Lilly and Co and Daiichi Sankyo Inc.
“Once you take into account all the drugs that have fallen by the wayside, the returns have been pretty bad,” says Peter Fellner, a veteran with three decades experience in both pharmaceuticals and biotechnology. “It is a reverse alchemy calculation where you are taking a very large amount of gold and quite rapidly transmuting it into lead.”
Few people understand the current change better than Fellner. After working for Swiss drugs giant Roche Holding AG in the 1980s, he headed up Britain’s flagship biotech company Celltech. Now the quietly spoken management veteran chairs a clutch of small drug development and medical technology companies.
The move to cut R&D, he says, is one of the most profound changes in the industry in decades. Some firms are pulling back from problematic areas like depression, where proving the value of new medicines in clinical trials is fiendishly difficult. Lack of progress in this field is a prime reason behind Glaxo’s decision to cut research in Verona. Other firms are cutting back in areas that used to be their bread and butter. Pfizer, for instance, is trimming research into cardiovascular drugs and AstraZeneca is ending discovery in psychiatric medicine.
Instead of pouring money into R&D themselves, drugmakers are turning to smaller firms, outsourcing routine research functions and even buying in smart blue-sky discovery work.
Some scientists fear that shift will strip drug companies of the creative talent that has driven the industry for decades. But it is good news for contract research organisations (CROs) like U.S.-based firms Covance Inc and Charles River Laboratories International Inc, which saw their shares soar — at least until late 2008, when the recession and the scale of the structural problems facing the pharmaceuticals industry forced many smaller drugmakers to abandon certain areas of research altogether. Despite the setback, big CROs expect to expand in the long-term and are investing heavily in drug discovery services.
BRAIN SHIFT
They’re also happy to pick up Big Pharma’s leftovers. Glaxo, for example, is negotiating to sell its Verona site to a U.S.-based CRO called Aptuit. Parexel International Corp, which is based in Boston and conducts clinical trials for drugmakers around the world, is busy hiring hundreds of new staff — many of them refugees from Big Pharma. “It’s a brain shift,” says Parexel’s chief executive and founder Josef von Rickenbach. “The rate of outsourcing has continued to tick up pretty much every year across all clinical trial activities.”
How far can it go? Does it make sense for big drugmakers to simply throw in the towel on early-stage research and instead buy in promising products from smaller operators in the biotech sector? “In the current phase of the cycle, I think you will see companies come close to it,” says Fellner.
The short-term commercial case is compelling. Morgan Stanley analysts calculate that $1 invested by a big drugmaker in a product licensed from outside researchers will, on average, deliver three times as much value as the same dollar invested in in-house research. Some of today’s top drugs started life in outside labs, including AstraZeneca’s cholesterol fighter Crestor and Bristol-Myers Squibb Co’s schizophrenia drug Abilify.
While the immediate reasons for exiting some areas of R&D may be clear, though, the long-term implications are harder to know. There are obvious practical considerations. For one thing, pharmaceutical companies will need to make sure they retain enough internal know-how that they can continue to properly assess new drug prospects pitched to them by outside firms.
There are also significant reputational issues. Drug companies have long promoted the idea that they pursue new drugs for the good of humanity; it’s an argument Big Pharma regularly uses to justify the huge profits it makes. High returns, the industry argues, can be ploughed back into research on the next medical breakthrough. If Big Pharma is not doing the research itself, will the big margins be harder to defend?
Glaxo’s Witty says it’s all about balance. “We’d like to have a decent western, white pill business but I don’t want any part of the group to be overwhelmingly important. I want a balanced organisation,” he told Reuters. “I’d feel very comfortable if in a few years’ time ... we had a quarter of the business in that traditional pharmaceutical space, a big chunk of business in vaccines, a big chunk in consumer products and a big chunk in emerging markets, with new large molecules (biotech drugs) also coming through.”
A BIOTECH FUTURE — PERHAPS
There’s also a question of control. One hunting ground in the new-look world of Big Pharma is biotechnology. Biotech start-ups contribute an increasing share of the experimental compounds entering the development pipeline. Biotech’s “large molecule””protein drugs, made using genetic engineering, have proven superior at fighting complex diseases like cancer to many conventional “small molecule””chemical drugs.
By 2014, the world’s two top-selling prescription drugs won’t be tablets sold in blister packs but needle-based biotech treatments — Avastin for cancer, sold by Roche, and Humira for rheumatoid arthritis, from Abbott Laboratories — according to consensus forecasts compiled by Thomson Reuters.
But while biotech is attracting increased interest from large pharmaceutical firms, the sector is struggling with its own problems. Early funding is hard to come by and there’s growing scepticism from investors because of the huge risks involved in researching something that might never pay off. “Theoretically, this should all be good news for biotech because it means that Big Pharma is looking round more intensively for good pipeline opportunities,” says Sijmen de Vries, chief executive of Dutch biotech firm Pharming Group NV. “The reality is different. Financially, much of biotech is in a bad state of health because of the extremely unhealthy situation that exists at the moment with regards to investing in things that have even remotely the word ‘risk’ associated with them.”
De Vries, a straight-talking Dutchman who trained as a doctor before working at Novartis AG and SmithKline Beecham, knows all about risk. His company lies at one of the extreme edges of biotechnology and is pinning its hopes on a drug derived from the milk of genetically modified rabbits. The company hopes the milk can help a small group of patients with a rare genetic disorder, hereditary angioedema, which causes acute and painful swelling of the body’s soft tissues. European regulators could announce their verdict on the drug this month. If the drug is approved, the company should thrive. If it’s rejected, Pharming will struggle. Such binary events are typical in biotech.
All that puts biotech firms into something of a financial Catch-22. As Big Pharma cuts its R&D, it is looking to small independent companies such as biotech start-ups to fill the gap. But without financial backers to help develop new drugs through those early stages, those smaller firms struggle to survive. “Pharma companies are very good at certain things but the thinking-outside-the-box, early-stage stuff is generally better done in biotech than in pharmaceutical companies because pharmaceutical companies tend to be more conservative,” says Steve Jackson, professor of biology at the University of Cambridge. “The problem with that model is that venture capital funding is becoming more difficult to come by for biotech companies ... so that is another threat to the pharmaceutical companies’ pipelines. I’m not sure how many new biotech companies are going to be springing up over the next five years or so.”
Jackson has first-hand experience at how tough it is to shepherd a drug through those first few years. In the 1990s, he developed a cancer drug that prevents certain DNA repair proteins from working. That led to the creation of biotech company KuDOS in 1997. Finance was tough, but persistence and a winning idea eventually secured him three rounds of venture capital funding and, in 2005, the company’s sale to AstraZeneca. Today, he is looking to start another biotech business but finding times much harder. Ironically, while his original cancer drug is continuing to show promise in clinical trials, the KuDOS facility in Cambridge is now one of those facing closure as a result of the AstraZeneca cuts.
ONE LAST REFUGE
Back at Imperial College, Nick Brooks, a scientist working on membrane biophysics, scrutinises a computer screen showing the results of X-ray diffraction. For now, academia remains a refuge from change.
“Certainly, at the moment, the prospect of getting your job taken away is a lot less severe here than it is in the pharmaceutical industry,” he says.
He wonders how far the drug industry can change before it loses its science core — and its way. “I can’t help but feel that the idea of a pharmaceutical company having good researchers in-house to be able to take part in the whole process from conception of a drug through to marketing must be a benefit,” he says, before turning back to his work.
(Additional reporting by Julie Steenhuysen in Chicago and Bill Berkrot in New York; Editing by Simon Robinson and Sara Ledwith)
http://cnews.canoe.ca/CNEWS/World/2010/06/16/14417751.html?cid=rssnewslast24hours
“The unit I used to work in — GlaxoSmithKline’s place in Harlow — has been closed down now,” says Casey, dressed in signature protective goggles and white coat as he works on synthetic chemistry. “It used to be a job for life. Now it’s a job until the next restructuring.”
Across the western world, Big Pharma is cutting back on the number of scientists it employs in its labs and the money it spends on research and development. The hunt for new drugs continues, but the men and women in white coats — traditionally viewed as the lifeblood of the industry — are not as untouchable as they once were.
It’s a similar story at GlaxoSmithKline’s research laboratories in Verona, where lunchtime conversations can be decidedly gloomy. Glaxo is axing the Italian facility, shedding 500 jobs as part of a programme of cuts designed to improve returns on R&D. Many scientists feel stranded or wonder why they entered the profession at all.
“It’s a sad but true fact that science really doesn’t pay any more,” says one young researcher who would not give her name for fear of jeopardising her future prospects in the industry. “The lunchtime discussion today was about what we’d go back and study if we were 18 again and choosing university courses. There were only a few of us who said they’d still go for a science degree.”
Across the Atlantic in Cambridge, Mass., Adrian Ivinson, director of Harvard’s NeuroDiscovery Center, is reminded of the shifts underway in the industry every time he looks out of his window. Over the road, the “gorgeous, state of the art labs””no longer house Merck & Co Inc’s neuroscience team. “They only built it a few years ago and had this wonderful neuro group in there,” Ivinson says. “Now they’re gone.”
The magnitude of the changes is hard to ignore.
U.S. drug giants Pfizer Inc and Merck have slashed thousands of jobs since acquiring smaller rival firms last year. British-Swedish firm AstraZeneca has plans to close its research labs at Charnwood in central England by the end of 2011, with the loss of up to 1,200 jobs; its Swedish research unit in Lund will also shut. In Japan, Astellas Pharma Inc has announced plans to limit its research expenditure.
Sam Isaly, managing partner at OrbiMed Advisors — with some $5 billion under management it is one of the world’s largest healthcare investment firms — expects employment in the 14 Big Pharma companies across the United States, Europe and Japan to fall around 20 percent between 2009 and 2015. That means some 200,000 jobs will disappear across the drugs business — not only in research but also in sales and back office functions. “The management of these companies have to deliver to their shareholders, so they are downsizing or making acquisitions or diversifying,” says Isaly.
NEW PRODUCTS, NEW MARKETS
One factor forcing Big Pharma to rethink its business model is the huge number of patents that are set to expire over the next five years. As patents run out on blockbuster prescription tablets like Pfizer’s $12 billion-a-year cholesterol medicine Lipitor and AstraZeneca’s $5 billion heartburn pill Nexium, cut-price generics are sure to rush in and slash margins. Between now and 2015 products with sales of more than $142 billion will face copycat competition, according to IMS Health, the leading global supplier of prescription drug data. It is the biggest “cliff””of patent expiries in the history of the pharmaceuticals industry.
Add in tougher regulatory hurdles and a brutal squeeze on healthcare budgets as cash-strapped governments push austerity programmes and it’s little wonder that drug companies are cutting back and shifting focus.
The strategy so far has been to buy promising new drugs from outside developers and boost investment in the relative safety of non-prescription consumer products. Big drugmakers are also moving into new markets — with Asia at the top of everybody’s list. It all adds up to a redesign of the multinational pharmaceutical company. In the 21st century, says Isaly, Big Pharma will primarily be a distribution business.
HORLICKS HELPS CEO SLEEP AT NIGHT
A peek inside the bag of free goodies handed out to shareholders at Glaxo’s annual meeting in London gives an idea of one direction the industry is headed. Aquafresh toothpaste, Corsodyl mouthwash, Breathe Right nasal strips and Lucozade energy drink are not exactly at the cutting edge of bioscience, yet they are all products that now enjoy top billing under Glaxo’s youthful Chief Executive Andrew Witty.
Under Witty, who has been in the top job for two years, over-the-counter remedies, oral care and health drinks have become a key pillar of Glaxo’s drive to reduce reliance on traditional prescription pharmaceuticals. As if to emphasise that fact, the one new hire highlighted by the CEO in his address to the meeting was Emma Walmsley — an executive poached from French cosmetics group L’Oreal SA and heir apparent to run Glaxo’s reinvigorated consumer healthcare business.
Glaxo may be working on groundbreaking treatments for cancer, but one of Witty’s favourite products is Horlicks, a malted milk powder best known in Britain as a bedtime drink for the elderly. Horlicks is a huge seller in the key emerging market of India. The brand clocked up 146 million pounds ($214 million) in Indian sales in 2009, bagging an enormous 48 percent of the hot drinks market there.
For industry veterans like Andy Smith, who worked at what was then SmithKline Beecham in the 1990s and is now a healthcare fund manager at Axa Framlington, the change is profound. “When I worked for consumer healthcare we were always the poor relation, which is actually why I moved to the pharmaceuticals division,” he says. “Senior management always used to complain about the mixed P/E (price-to-earnings) multiple of having a consumer healthcare business and a pharmaceutical business and the fact that the analysts didn’t understand it — but now they are really appreciating it.”
It’s not hard to see why. Ten years ago, the pharmaceutical sector was trading at 30 times expected earnings. Today, most Big Pharma shares have a forward P/E of under 10, while consumer products companies like Procter & Gamble Co fetch around 15 times forecast earnings.
But diversity doesn’t just mean selling a wider range of products. Big western drugmakers are also expanding into emerging markets such as China, which is set to overtake Germany as the world’s third biggest drugs market next year, according to IMS. The fast-expanding middle classes in China and elsewhere are demanding drugs that they couldn’t afford a few years ago. Overall sales growth in emerging markets is expected to be three times that of developed markets in the next five years.
In China, western companies have linked up with local players and research institutes. Some firms are even cosying up to old enemies in the Indian generics sector, following new legislation that has improved patent protection in that country.
But multinational drugmakers know they have to do more than sell toothpaste and expand into Asia. They need more and better drugs to sell — and they need them fast.
REVERSE ALCHEMY
The problem is, Big Pharma doesn’t have nearly enough new drugs in the pipeline to replace all those it is about to lose. Since 1950 — virtually the dawn of the modern era of medicine — a total of 1,256 new drugs have been approved by the U.S. Food and Drug Administration (FDA). But the industry today produces roughly the same number of new medicines that it did 60 years ago.
Ten years ago there was a lot of hope that process-led research systems would industrialise the hunt for new drugs. But that optimism may have been misplaced. A spike in drug approvals in the mid-1990s, it turns out, was not the result of any fundamental improvement in productivity but largely down to the FDA clearing a backlog of applications after the introduction of a new system under which companies paid “user fees””to help speed the process.
Despite pouring billions into research — more than $65 billion last year in the U.S. alone — the number of new drugs launched annually has fallen 44 percent since 1997, according to CMR International, a Thomson Reuters subsidiary.
Big Pharma has also struggled over the past decade to produce the kind of big new hits that make the bulk of its money. As with other industries dominated by blockbusters — think Hollywood movies or oil and gas exploration — it’s not easy to pick winners years in advance. Even after a drug gets approval, commercial success can be a hit-and-miss affair, as evidenced by lacklustre sales of recent arrivals such as the keenly anticipated blood-thinner Effient from Eli Lilly and Co and Daiichi Sankyo Inc.
“Once you take into account all the drugs that have fallen by the wayside, the returns have been pretty bad,” says Peter Fellner, a veteran with three decades experience in both pharmaceuticals and biotechnology. “It is a reverse alchemy calculation where you are taking a very large amount of gold and quite rapidly transmuting it into lead.”
Few people understand the current change better than Fellner. After working for Swiss drugs giant Roche Holding AG in the 1980s, he headed up Britain’s flagship biotech company Celltech. Now the quietly spoken management veteran chairs a clutch of small drug development and medical technology companies.
The move to cut R&D, he says, is one of the most profound changes in the industry in decades. Some firms are pulling back from problematic areas like depression, where proving the value of new medicines in clinical trials is fiendishly difficult. Lack of progress in this field is a prime reason behind Glaxo’s decision to cut research in Verona. Other firms are cutting back in areas that used to be their bread and butter. Pfizer, for instance, is trimming research into cardiovascular drugs and AstraZeneca is ending discovery in psychiatric medicine.
Instead of pouring money into R&D themselves, drugmakers are turning to smaller firms, outsourcing routine research functions and even buying in smart blue-sky discovery work.
Some scientists fear that shift will strip drug companies of the creative talent that has driven the industry for decades. But it is good news for contract research organisations (CROs) like U.S.-based firms Covance Inc and Charles River Laboratories International Inc, which saw their shares soar — at least until late 2008, when the recession and the scale of the structural problems facing the pharmaceuticals industry forced many smaller drugmakers to abandon certain areas of research altogether. Despite the setback, big CROs expect to expand in the long-term and are investing heavily in drug discovery services.
BRAIN SHIFT
They’re also happy to pick up Big Pharma’s leftovers. Glaxo, for example, is negotiating to sell its Verona site to a U.S.-based CRO called Aptuit. Parexel International Corp, which is based in Boston and conducts clinical trials for drugmakers around the world, is busy hiring hundreds of new staff — many of them refugees from Big Pharma. “It’s a brain shift,” says Parexel’s chief executive and founder Josef von Rickenbach. “The rate of outsourcing has continued to tick up pretty much every year across all clinical trial activities.”
How far can it go? Does it make sense for big drugmakers to simply throw in the towel on early-stage research and instead buy in promising products from smaller operators in the biotech sector? “In the current phase of the cycle, I think you will see companies come close to it,” says Fellner.
The short-term commercial case is compelling. Morgan Stanley analysts calculate that $1 invested by a big drugmaker in a product licensed from outside researchers will, on average, deliver three times as much value as the same dollar invested in in-house research. Some of today’s top drugs started life in outside labs, including AstraZeneca’s cholesterol fighter Crestor and Bristol-Myers Squibb Co’s schizophrenia drug Abilify.
While the immediate reasons for exiting some areas of R&D may be clear, though, the long-term implications are harder to know. There are obvious practical considerations. For one thing, pharmaceutical companies will need to make sure they retain enough internal know-how that they can continue to properly assess new drug prospects pitched to them by outside firms.
There are also significant reputational issues. Drug companies have long promoted the idea that they pursue new drugs for the good of humanity; it’s an argument Big Pharma regularly uses to justify the huge profits it makes. High returns, the industry argues, can be ploughed back into research on the next medical breakthrough. If Big Pharma is not doing the research itself, will the big margins be harder to defend?
Glaxo’s Witty says it’s all about balance. “We’d like to have a decent western, white pill business but I don’t want any part of the group to be overwhelmingly important. I want a balanced organisation,” he told Reuters. “I’d feel very comfortable if in a few years’ time ... we had a quarter of the business in that traditional pharmaceutical space, a big chunk of business in vaccines, a big chunk in consumer products and a big chunk in emerging markets, with new large molecules (biotech drugs) also coming through.”
A BIOTECH FUTURE — PERHAPS
There’s also a question of control. One hunting ground in the new-look world of Big Pharma is biotechnology. Biotech start-ups contribute an increasing share of the experimental compounds entering the development pipeline. Biotech’s “large molecule””protein drugs, made using genetic engineering, have proven superior at fighting complex diseases like cancer to many conventional “small molecule””chemical drugs.
By 2014, the world’s two top-selling prescription drugs won’t be tablets sold in blister packs but needle-based biotech treatments — Avastin for cancer, sold by Roche, and Humira for rheumatoid arthritis, from Abbott Laboratories — according to consensus forecasts compiled by Thomson Reuters.
But while biotech is attracting increased interest from large pharmaceutical firms, the sector is struggling with its own problems. Early funding is hard to come by and there’s growing scepticism from investors because of the huge risks involved in researching something that might never pay off. “Theoretically, this should all be good news for biotech because it means that Big Pharma is looking round more intensively for good pipeline opportunities,” says Sijmen de Vries, chief executive of Dutch biotech firm Pharming Group NV. “The reality is different. Financially, much of biotech is in a bad state of health because of the extremely unhealthy situation that exists at the moment with regards to investing in things that have even remotely the word ‘risk’ associated with them.”
De Vries, a straight-talking Dutchman who trained as a doctor before working at Novartis AG and SmithKline Beecham, knows all about risk. His company lies at one of the extreme edges of biotechnology and is pinning its hopes on a drug derived from the milk of genetically modified rabbits. The company hopes the milk can help a small group of patients with a rare genetic disorder, hereditary angioedema, which causes acute and painful swelling of the body’s soft tissues. European regulators could announce their verdict on the drug this month. If the drug is approved, the company should thrive. If it’s rejected, Pharming will struggle. Such binary events are typical in biotech.
All that puts biotech firms into something of a financial Catch-22. As Big Pharma cuts its R&D, it is looking to small independent companies such as biotech start-ups to fill the gap. But without financial backers to help develop new drugs through those early stages, those smaller firms struggle to survive. “Pharma companies are very good at certain things but the thinking-outside-the-box, early-stage stuff is generally better done in biotech than in pharmaceutical companies because pharmaceutical companies tend to be more conservative,” says Steve Jackson, professor of biology at the University of Cambridge. “The problem with that model is that venture capital funding is becoming more difficult to come by for biotech companies ... so that is another threat to the pharmaceutical companies’ pipelines. I’m not sure how many new biotech companies are going to be springing up over the next five years or so.”
Jackson has first-hand experience at how tough it is to shepherd a drug through those first few years. In the 1990s, he developed a cancer drug that prevents certain DNA repair proteins from working. That led to the creation of biotech company KuDOS in 1997. Finance was tough, but persistence and a winning idea eventually secured him three rounds of venture capital funding and, in 2005, the company’s sale to AstraZeneca. Today, he is looking to start another biotech business but finding times much harder. Ironically, while his original cancer drug is continuing to show promise in clinical trials, the KuDOS facility in Cambridge is now one of those facing closure as a result of the AstraZeneca cuts.
ONE LAST REFUGE
Back at Imperial College, Nick Brooks, a scientist working on membrane biophysics, scrutinises a computer screen showing the results of X-ray diffraction. For now, academia remains a refuge from change.
“Certainly, at the moment, the prospect of getting your job taken away is a lot less severe here than it is in the pharmaceutical industry,” he says.
He wonders how far the drug industry can change before it loses its science core — and its way. “I can’t help but feel that the idea of a pharmaceutical company having good researchers in-house to be able to take part in the whole process from conception of a drug through to marketing must be a benefit,” he says, before turning back to his work.
(Additional reporting by Julie Steenhuysen in Chicago and Bill Berkrot in New York; Editing by Simon Robinson and Sara Ledwith)
http://cnews.canoe.ca/CNEWS/World/2010/06/16/14417751.html?cid=rssnewslast24hours
Wednesday, June 16, 2010
Boehringer Sex Pill May Not Aid Women, FDA Staff Say (Update1) - Bloomberg.com
Boehringer Sex Pill May Not Aid Women, FDA Staff Say (Update1) - Bloomberg.com
The drug flibanserin “failed to demonstrate a statistically significant improvement” in sexual desire, Food and Drug Administration staff said in a review released today. It was also linked to appendicitis, depression and loss of consciousness. Side effects led about 15 percent of women to stop treatment with the drug, the review said.
The drug flibanserin “failed to demonstrate a statistically significant improvement” in sexual desire, Food and Drug Administration staff said in a review released today. It was also linked to appendicitis, depression and loss of consciousness. Side effects led about 15 percent of women to stop treatment with the drug, the review said.
Drug firms banished from medical talks - JSOnline
Drug firms banished from medical talks - JSOnline
There's a good way to figure out when a drug company plans to introduce a new product.
When pharmaceutical company scientists show up at medical meetings to give talks about diseases that most people never have heard of - disorders such as female sexual dysfunction or cardio metabolic syndrome - it is likely that a new drug is coming, said James Stein, a cardiologist at the University of Wisconsin School of Medicine and Public Health.
But such talks, which Stein and others say can be used to create a buzz for new drugs, may be coming to an end.
The ongoing controversy over drug industry influence in continuing medical education has taken a sharp twist: Pharmaceutical industry employees will not be allowed to make medical education presentations later this year at the one of the largest medical meetings in the world, the American Heart Association's annual Scientific Sessions.
The policy was set by a national organization that accredits the heart association's continuing medical education programs as well as the programs of other medical organizations. It applies to the medical meetings of all those groups.
The development, which has fired up the medical community, came up last week at a National Institutes of Health meeting in Bethesda, Md. There it was learned that the heart association would not be allowed to let drug industry employees make educational presentations for doctors at its upcoming annual meeting.
Adriane Fugh-Berman, a critic of industry funding of medical education, said the policy is a reasonable move that should be applied to doctors who work as speakers and consultants for drug companies as well as employees.
"I don't think industry employees should be giving CME," said Fugh-Berman, a physician and associate professor of physiology and biophysics at Georgetown University.
She said they should not be in the position of evaluating potential therapies when they have a financial stake in such matters. Beyond that, it is human nature for a researcher to put a positive spin on information about a drug the researcher has studied.
"It's not impugning the integrity of anyone who works for industry," she said. "There are good scientists who work for industry. It's about evaluating the science."
On June 25, Georgetown University and the organization PharmedOut, which Fugh-Berman heads, will hold a daylong conference on whether the drug industry should fund continuing medical education.
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