Tuesday, March 31, 2009
Pfizer - Rezulin: a mere $750 million
Pfizer has resolved all but three of 35,000 claims over its withdrawn diabetes drug Rezulin for a total of about $750 million, 21 percent less than what it set aside for the cases, people familiar with the litigation said.
Pfizer, which is acquiring rival Wyeth for almost $64 billion, paid about $500 million to settle Rezulin cases consolidated in federal court in New York, according to court filings. The company also paid as much as $250 million to resolve state-court suits, two people familiar with the cases said. In 2004, it set aside $955 million to end Rezulin cases.
More at Bloomberg
Pfizer, which is acquiring rival Wyeth for almost $64 billion, paid about $500 million to settle Rezulin cases consolidated in federal court in New York, according to court filings. The company also paid as much as $250 million to resolve state-court suits, two people familiar with the cases said. In 2004, it set aside $955 million to end Rezulin cases.
More at Bloomberg
Cardinal cuts
Cardinal Health Inc. said Tuesday its clinical and medical products unit will eliminate 1,300 jobs, with most of the cuts made over the next six months, as hospitals cut back on equipment purchases.
Cardinal plans to spin the unit off later this year under the name CareFusion Corp. Cardinal said the business will lay off 800 people and eliminate 500 more jobs through attrition. The region most affected by the job cuts is southern California, with 200 jobs in San Diego being eliminated.
Washington Times
Cardinal plans to spin the unit off later this year under the name CareFusion Corp. Cardinal said the business will lay off 800 people and eliminate 500 more jobs through attrition. The region most affected by the job cuts is southern California, with 200 jobs in San Diego being eliminated.
Washington Times
Eric Pickles MP gets feedback
"My appearance (on Question Time) was not a complete success, shall we say. After the programme, I phoned Mrs Pickles for her verdict and she said it was 'mixed'. 'You looked a bit slimmer after your diet. But on the other hand..you were crap'," Pickles revealed.
Merck - Vioxx: silencing critics - "We may need to seek them out and destroy them where they live,"
AN international drug company made a hit list of doctors who had to be "neutralised" or discredited because they criticised the anti-arthritis drug the pharmaceutical giant produced.
Staff at US company Merck &Co emailed each other about the list of doctors - mainly researchers and academics - who had been negative about the drug Vioxx or Merck and a recommended course of action.
The email, which came out in the Federal Court in Melbourne yesterday as part of a class action against the drug company, included the words "neutralise", "neutralised" or "discredit" against some of the doctors' names.
It is also alleged the company used intimidation tactics against critical researchers, including dropping hints it would stop funding to institutions and claims it interfered with academic appointments.
"We may need to seek them out and destroy them where they live," a Merck employee wrote, according to an email excerpt read to the court by Julian Burnside QC, acting for the plaintiff.
Merck & Co and its Australian subsidiary, Merck, Sharpe and Dohme, are being sued for compensation by more than 1000 Australians, who claim they suffered heart attacks or strokes as a result of Vioxx.
The Australian
Staff at US company Merck &Co emailed each other about the list of doctors - mainly researchers and academics - who had been negative about the drug Vioxx or Merck and a recommended course of action.
The email, which came out in the Federal Court in Melbourne yesterday as part of a class action against the drug company, included the words "neutralise", "neutralised" or "discredit" against some of the doctors' names.
It is also alleged the company used intimidation tactics against critical researchers, including dropping hints it would stop funding to institutions and claims it interfered with academic appointments.
"We may need to seek them out and destroy them where they live," a Merck employee wrote, according to an email excerpt read to the court by Julian Burnside QC, acting for the plaintiff.
Merck & Co and its Australian subsidiary, Merck, Sharpe and Dohme, are being sued for compensation by more than 1000 Australians, who claim they suffered heart attacks or strokes as a result of Vioxx.
The Australian
Monday, March 30, 2009
Pharmalyzer: Are you prescribing under the influence?
Go here to find out!
PharmedOut's new 3 credit, interactive CME module helps prescribers assess their susceptibility to pharma influence.
PharmedOut's new 3 credit, interactive CME module helps prescribers assess their susceptibility to pharma influence.
Statins for clots
No, not like "Windows for Dummies!"
Matt Robinson writes:
The New England Journal of Medicine has published the results of a randomised controlled study that aimed to quantify any benefits of rosuvastatin in the prevention of venous thromboembolism (VTE). The results have been reported in the general media (BBC).
The study recruited 17,802 participants with a low-density lipoprotein (LDL) cholesterol below 3.4 mmol/L and a high-sensitivity C-reactive protein (hs-CRP) levels of 2.0mg/L or above. Participants were randomly assigned to treatment with rosuvastatin 20mg daily or placebo. Median follow up was approximately 2 years. The primary outcome was symptomatic venous thromboembolism or pulmonary embolism.
During the study the primary outcome occurred in 34 patients taking rosuvastatin and 60 patients taking placebo. This represents a 43% relative risk reduction (Hazard ratio 0.57, 95% Confidence interval 0.37 to 0.86; P=0.007) from a baseline risk of 0.32 events per 100 patient-years based on the placebo arm risk.
44 instances of the primary outcome were classified as ‘provoked‘ because they were associated with cancer or recent trauma, hospital admission or surgery. The risk reduction was similar in both the ‘provoked’ and ‘unprovoked’ subgroups. There was a increased tendency to pulmonary embolism in the rosuvastatin group but this was not statistically significant.
Although these findings are interesting, further research is required to quantify potential benefits in patients at higher risk of venous thromboembolism. In addition, hs-CRP tests are currently not widely available and the clinical significance of hs-CRP results lacks consensus.
Statins should not be routinely used with the exclusive aim of preventing VTE. Efficacy and safety has not been demonstrated in individuals at high risk.
Matt Robinson writes:
The New England Journal of Medicine has published the results of a randomised controlled study that aimed to quantify any benefits of rosuvastatin in the prevention of venous thromboembolism (VTE). The results have been reported in the general media (BBC).
The study recruited 17,802 participants with a low-density lipoprotein (LDL) cholesterol below 3.4 mmol/L and a high-sensitivity C-reactive protein (hs-CRP) levels of 2.0mg/L or above. Participants were randomly assigned to treatment with rosuvastatin 20mg daily or placebo. Median follow up was approximately 2 years. The primary outcome was symptomatic venous thromboembolism or pulmonary embolism.
During the study the primary outcome occurred in 34 patients taking rosuvastatin and 60 patients taking placebo. This represents a 43% relative risk reduction (Hazard ratio 0.57, 95% Confidence interval 0.37 to 0.86; P=0.007) from a baseline risk of 0.32 events per 100 patient-years based on the placebo arm risk.
44 instances of the primary outcome were classified as ‘provoked‘ because they were associated with cancer or recent trauma, hospital admission or surgery. The risk reduction was similar in both the ‘provoked’ and ‘unprovoked’ subgroups. There was a increased tendency to pulmonary embolism in the rosuvastatin group but this was not statistically significant.
Although these findings are interesting, further research is required to quantify potential benefits in patients at higher risk of venous thromboembolism. In addition, hs-CRP tests are currently not widely available and the clinical significance of hs-CRP results lacks consensus.
Statins should not be routinely used with the exclusive aim of preventing VTE. Efficacy and safety has not been demonstrated in individuals at high risk.
Sunday, March 29, 2009
Harvard's Psych Crew subpoena
Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
Saturday, March 28, 2009
Friday, March 27, 2009
Pharma Giles writes.......
At a recent computer expo (COMDEX), Bill Gates reportedly compared the computer industry to the auto industry and stated: “If GM had kept up with technology like the computer industry has, we would all be driving $25 cars that got 1,000 miles to the gallon.”
In response to Bill's comments, General Motors apparently issued a press release stating:
“If GM had developed technology like Microsoft, we would all be driving cars with the following characteristics:
1. For no reason whatsoever, your car would crash. Twice a day.
2. Every time they repainted the lines in the road, you would have to buy a new car.
3. Occasionally your car would die on the freeway for no reason. You would have to pull to the side of the road, close all of the windows, shut off the car, restart it, and reopen the windows before you could continue. For some reason you would simply accept this. When all else failed, you would be expected to call 'customer service' in a foreign country and be instructed in a foreign language as to how to fix your car yourself.
4. Occasionally, executing a manoeuvre such as a left turn would cause your car to shut down and refuse to restart, in which case you would have to reinstall the engine.
5. Macintosh would make a car that was powered by the sun, was reliable, five times as fast and twice as easy to drive - but would run on only five percent of the roads.
6. The oil, water temperature, and alternator warning lights would all be replaced by a single 'This Car Has Performed An Illegal Operation’ warning light.
7. The airbag system would ask 'Are you sure?' before deploying.
8. Occasionally, for no reason whatsoever, your car would lock you out and refuse to let you in until you simultaneously lifted the door handle, turned the key and grabbed hold of the radio antenna.
9. Every time a new car was introduced, car buyers would have to learn how to drive all over again because none of the controls would operate in the same manner as the old car.
10. You'd have to press the 'Start' button to turn the engine off.”
Fair comment, don’t you think?
In response to Bill's comments, General Motors apparently issued a press release stating:
“If GM had developed technology like Microsoft, we would all be driving cars with the following characteristics:
1. For no reason whatsoever, your car would crash. Twice a day.
2. Every time they repainted the lines in the road, you would have to buy a new car.
3. Occasionally your car would die on the freeway for no reason. You would have to pull to the side of the road, close all of the windows, shut off the car, restart it, and reopen the windows before you could continue. For some reason you would simply accept this. When all else failed, you would be expected to call 'customer service' in a foreign country and be instructed in a foreign language as to how to fix your car yourself.
4. Occasionally, executing a manoeuvre such as a left turn would cause your car to shut down and refuse to restart, in which case you would have to reinstall the engine.
5. Macintosh would make a car that was powered by the sun, was reliable, five times as fast and twice as easy to drive - but would run on only five percent of the roads.
6. The oil, water temperature, and alternator warning lights would all be replaced by a single 'This Car Has Performed An Illegal Operation’ warning light.
7. The airbag system would ask 'Are you sure?' before deploying.
8. Occasionally, for no reason whatsoever, your car would lock you out and refuse to let you in until you simultaneously lifted the door handle, turned the key and grabbed hold of the radio antenna.
9. Every time a new car was introduced, car buyers would have to learn how to drive all over again because none of the controls would operate in the same manner as the old car.
10. You'd have to press the 'Start' button to turn the engine off.”
Fair comment, don’t you think?
Surprise! - pharma outsourcing downturn
There was a sharp slowdown in pharmaceutical outsourcing in the last six months which "really caught a lot of people by surprise", according to Jim Miller of outsourcing consultancy PharmSource, in his annual review of the sector at the Interphex show in New York.
More
More
Dr Joseph Biederman's new clothes
Dr. Joseph Biederman, chief of the Massachusetts General Pediatric Psychopharmacology Clinic, is already under investigation by Harvard University and the National Institutes of Health for failing to report income received from drug companies. Now, in newly released court documents, Biederman appears to be promising drugmaker Johnson & Johnson in advance that his studies on the antipsychotic drug risperidone will prove the drug to be effective when used on preschool age children.
Biederman's status at Harvard and his research have arguably made him, until recently, America's most powerful doctor in child psychiatry. Biederman has strongly pushed treating children's mental illnesses with powerful antipsychotic medicines. Diagnoses like ADHD and pediatric bipolar disorder, along with psychiatric drug use in American children, have soared in the last 15 years. No other country medicates children as frequently.
Reports from court actions, along with an ongoing investigation of conflict of interest charges led by Sen. Chuck Grassley, R-Iowa, threaten to topple Biederman from his heretofore untouchable Olympian heights. Biederman has cried foul.
He says the drug company dollars (declared and undeclared) have not influenced him or his research. He had agreed temporarily to sever most of his financial ties with the drug industry pending the outcome of the ongoing inquiry.
He claims his science and publications are pure, supported by a peer-review system that is supposed to verify accuracy and authenticity. Finally, he challenges as office gossip reports of his legendary anger and intolerance of those who disagree or don't support his proposals.
In a contentious exchange with a deposing lawyer, he also indicated he ranks just below God in the Harvard faculty hierarchy or firmament.
Biederman's situation is emblematic of a very compromised medical research and academic community that has become dependent on industry money for its existence.
Virtually all researchers say they are not influenced by drug company money. Doctors rarely out-and-out lie about their research, but spin influences how a study is set up, its statistical analysis and interpretation. Research on drug studies repeatedly shows that drug trial results are tilted toward a positive description of the drug's effects when the research is funded by a drug company rather than the government or an independent agency.
Big Pharma money is most powerful when promoting Biederman's research and point of view over competing models. Drug companies copy and mail his important papers on psychiatric drugs to every American physician working with children. A member of the Biederman team is at every important meeting on children's psychiatric issues and medical education. Their presence, and often the conference, itself, are supported by drug industry dollars.
Only when children die or side effects are severe - as in the FDA hearings on children and antidepressants in 2004, and in the recent publicity over obesity and diabetes caused by the bipolar drugs - do opposing viewpoints get the country's eyes and ears.
Biederman's conflict of interest problems have exposed his strong pro-drug views to the public for scrutiny. Until now, fear of the Biederman team has operated quietly on the small club of child psychiatric researchers.
Only when 2-year-olds started taking three psychiatric drugs simultaneously under a Biederman protocol for bipolar disorder did the emperor's clothes become so invisible as to begin the naming of names.
Business ethics, whose main concerns are profit and legal operation, collide with medical ethics, which are directed to the patient's benefit, when academic research is dependent on industry money. We must formulate and enforce a new set of rules to restore doctors' credibility.
The federal government has recently promised funds to compare existing drugs with newer, more expensive competitors. This is a welcome shift of emphasis away from previous drug-company-sponsored studies that only had to prove that their drug, short term, was better than a placebo. In the meantime, Biederman's personal travails tragically inform us about a crisis in academic medicine that must be resolved.
Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF.
Biederman's status at Harvard and his research have arguably made him, until recently, America's most powerful doctor in child psychiatry. Biederman has strongly pushed treating children's mental illnesses with powerful antipsychotic medicines. Diagnoses like ADHD and pediatric bipolar disorder, along with psychiatric drug use in American children, have soared in the last 15 years. No other country medicates children as frequently.
Reports from court actions, along with an ongoing investigation of conflict of interest charges led by Sen. Chuck Grassley, R-Iowa, threaten to topple Biederman from his heretofore untouchable Olympian heights. Biederman has cried foul.
He says the drug company dollars (declared and undeclared) have not influenced him or his research. He had agreed temporarily to sever most of his financial ties with the drug industry pending the outcome of the ongoing inquiry.
He claims his science and publications are pure, supported by a peer-review system that is supposed to verify accuracy and authenticity. Finally, he challenges as office gossip reports of his legendary anger and intolerance of those who disagree or don't support his proposals.
In a contentious exchange with a deposing lawyer, he also indicated he ranks just below God in the Harvard faculty hierarchy or firmament.
Biederman's situation is emblematic of a very compromised medical research and academic community that has become dependent on industry money for its existence.
Virtually all researchers say they are not influenced by drug company money. Doctors rarely out-and-out lie about their research, but spin influences how a study is set up, its statistical analysis and interpretation. Research on drug studies repeatedly shows that drug trial results are tilted toward a positive description of the drug's effects when the research is funded by a drug company rather than the government or an independent agency.
Big Pharma money is most powerful when promoting Biederman's research and point of view over competing models. Drug companies copy and mail his important papers on psychiatric drugs to every American physician working with children. A member of the Biederman team is at every important meeting on children's psychiatric issues and medical education. Their presence, and often the conference, itself, are supported by drug industry dollars.
Only when children die or side effects are severe - as in the FDA hearings on children and antidepressants in 2004, and in the recent publicity over obesity and diabetes caused by the bipolar drugs - do opposing viewpoints get the country's eyes and ears.
Biederman's conflict of interest problems have exposed his strong pro-drug views to the public for scrutiny. Until now, fear of the Biederman team has operated quietly on the small club of child psychiatric researchers.
Only when 2-year-olds started taking three psychiatric drugs simultaneously under a Biederman protocol for bipolar disorder did the emperor's clothes become so invisible as to begin the naming of names.
Business ethics, whose main concerns are profit and legal operation, collide with medical ethics, which are directed to the patient's benefit, when academic research is dependent on industry money. We must formulate and enforce a new set of rules to restore doctors' credibility.
The federal government has recently promised funds to compare existing drugs with newer, more expensive competitors. This is a welcome shift of emphasis away from previous drug-company-sponsored studies that only had to prove that their drug, short term, was better than a placebo. In the meantime, Biederman's personal travails tragically inform us about a crisis in academic medicine that must be resolved.
Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF.
BMS - Plavix: $2.1 million settlement with FTC
Back stories here
Bristol-Myers Squibb Co. agreed to pay $2.1 million to settle a U.S. Federal Trade Commission lawsuit filed today over statements it made about a failed 2006 agreement involving the blood-thinner Plavix.
The FTC, in a complaint in federal court in Washington, accused the New York-based drugmaker of concealing material information about the agreement and violating a 2003 consent order it reached with the agency in another case that limited its ability to sign settlements in patent suits.
More at Bloomberg
Bristol-Myers Squibb Co. agreed to pay $2.1 million to settle a U.S. Federal Trade Commission lawsuit filed today over statements it made about a failed 2006 agreement involving the blood-thinner Plavix.
The FTC, in a complaint in federal court in Washington, accused the New York-based drugmaker of concealing material information about the agreement and violating a 2003 consent order it reached with the agency in another case that limited its ability to sign settlements in patent suits.
More at Bloomberg
Slumdog Clinical Trials - now the FDA steps in (with a little help from Congress)
The Food and Drug Administration Wednesday defended its ongoing efforts to improve clinical trial oversight and protect patients at a time when a growing number of companies are studying new drugs and devices outside the United States.
The FDA, which first announced actions in 2006 to keep up with global clinical trials, said it would require monitoring groups called institutional review boards to register with the government starting in September to better track the trials.
It also said that it issued new standards for data collected from certain studies conducted in other countries by drug and device manufacturers.
"We wanted to make sure that the studies... would ensure the protection of human subjects and also that quality of data," Joanne Less, who oversees the FDA's Good Clinical Practice Program, said in an interview. The program helps develop standards and guidelines.
A congressional hearing is due to be held on Thursday into whether the United States and such review board firms, or IRBs, are doing enough to ensure patient safety.
Before they can win U.S. approval, drug and device manufacturers must conduct human trials for experimental products after completing lab and animal tests. They hire IRB companies to monitor the process.
Some lawmakers are concerned that the review process is not regulated enough, and they have raised questions about IRBs' oversight, since such companies are hired by manufacturers doing the research.
On Thursday, a House Energy and Commerce panel will hear from FDA's Less and others on the issue and release a report from congressional investigators. A representative for the panel declined to comment.
The FDA said it had implemented new requirements and was working on voluntary guidelines for companies and IRBs to follow. While manufacturers do not have to adhere to them, guidelines could help them collect strong enough data to submit a product to the FDA for approval as well as to keep patients safe, Less said.
The FDA detailed its efforts in a report released on its website here. In the report, the FDA said its actions included shifting more resources to inspect ongoing studies.
Still, while FDA bears "the ultimate responsibility," companies, scientific investigators, and review boards must also ensure patients are kept as safe as possible, Less said.
"Everyone has a role, and everyone needs to perform because if they don't (human) subjects could be put at risk. The idea behind the system is that it's a system of checks and balances... it's not just one person's responsibility," she said.
The sting!
The head of one review board that earlier this month said it had been the target of what it called a "sting" operation by congressional investigators is also expected to testify.
Coast Independent Review Board had been asked to review a clinical trial that it earlier said was set up by the House panel using false credentials and data. Representatives for President and CEO Dan Dueber declined to comment Wednesday.
Its clients include AstraZeneca Plc, Eli Lilly and Co, GlaxoSmithKline Plc and Pfizer Inc, among others, according to the company's website.
More
The FDA, which first announced actions in 2006 to keep up with global clinical trials, said it would require monitoring groups called institutional review boards to register with the government starting in September to better track the trials.
It also said that it issued new standards for data collected from certain studies conducted in other countries by drug and device manufacturers.
"We wanted to make sure that the studies... would ensure the protection of human subjects and also that quality of data," Joanne Less, who oversees the FDA's Good Clinical Practice Program, said in an interview. The program helps develop standards and guidelines.
A congressional hearing is due to be held on Thursday into whether the United States and such review board firms, or IRBs, are doing enough to ensure patient safety.
Before they can win U.S. approval, drug and device manufacturers must conduct human trials for experimental products after completing lab and animal tests. They hire IRB companies to monitor the process.
Some lawmakers are concerned that the review process is not regulated enough, and they have raised questions about IRBs' oversight, since such companies are hired by manufacturers doing the research.
On Thursday, a House Energy and Commerce panel will hear from FDA's Less and others on the issue and release a report from congressional investigators. A representative for the panel declined to comment.
The FDA said it had implemented new requirements and was working on voluntary guidelines for companies and IRBs to follow. While manufacturers do not have to adhere to them, guidelines could help them collect strong enough data to submit a product to the FDA for approval as well as to keep patients safe, Less said.
The FDA detailed its efforts in a report released on its website here. In the report, the FDA said its actions included shifting more resources to inspect ongoing studies.
Still, while FDA bears "the ultimate responsibility," companies, scientific investigators, and review boards must also ensure patients are kept as safe as possible, Less said.
"Everyone has a role, and everyone needs to perform because if they don't (human) subjects could be put at risk. The idea behind the system is that it's a system of checks and balances... it's not just one person's responsibility," she said.
The sting!
The head of one review board that earlier this month said it had been the target of what it called a "sting" operation by congressional investigators is also expected to testify.
Coast Independent Review Board had been asked to review a clinical trial that it earlier said was set up by the House panel using false credentials and data. Representatives for President and CEO Dan Dueber declined to comment Wednesday.
Its clients include AstraZeneca Plc, Eli Lilly and Co, GlaxoSmithKline Plc and Pfizer Inc, among others, according to the company's website.
More
Thursday, March 26, 2009
Psych! APA cleans house
The American Psychiatric Association's board of trustees has voted to phase out industry-supported symposia and industry-supplied meals at its annual meetings. The group, which says that it's following the growing transparency trend, says that Pharma's involvement in its activities has "invited a concern" that doctors may be biased in favor of the sponsoring company's treatments.
More at FiercePharma
More at FiercePharma
Diabetes drugs - April Fool!
Two new diabetes drugs face tough appraisals from U.S. experts next week, promising a volatile ride for shares in Novo Nordisk, AstraZeneca and Bristol-Myers Squibb.
Investors are nervous about prospects for Novo's Victoza, or liraglutide, and AstraZeneca and Bristol's Onglyza, or saxagliptin, both of which could face safety issues that delay their approval in the key U.S. market.
Worries have been heightened since March 6, when Takeda Pharmaceutical said the U.S. Food and Drug Administration (FDA) needed more data to review its new diabetes drug alogliptin, sending the Japanese group's stock tumbling.
More
Investors are nervous about prospects for Novo's Victoza, or liraglutide, and AstraZeneca and Bristol's Onglyza, or saxagliptin, both of which could face safety issues that delay their approval in the key U.S. market.
Worries have been heightened since March 6, when Takeda Pharmaceutical said the U.S. Food and Drug Administration (FDA) needed more data to review its new diabetes drug alogliptin, sending the Japanese group's stock tumbling.
More
GSK's "Research Triangle" layoffs - anyone know how many?
No, not the Bermuda Triangle.
An undisclosed number of employees at GlaxoSmithKline's customer response center in Research Triangle Park lost their jobs Wednesday. The layoffs were part of cuts the British drug maker announced in November.
GSK, which has its U.S. headquarters and more than 5,000 employees in the Triangle, plans to eliminate 1,000 jobs companywide by the end of April. The cuts are part of a restructuring program that started more than a year ago.
More
An undisclosed number of employees at GlaxoSmithKline's customer response center in Research Triangle Park lost their jobs Wednesday. The layoffs were part of cuts the British drug maker announced in November.
GSK, which has its U.S. headquarters and more than 5,000 employees in the Triangle, plans to eliminate 1,000 jobs companywide by the end of April. The cuts are part of a restructuring program that started more than a year ago.
More
Wednesday, March 25, 2009
AstraZeneca - Seroquel: the bearded one speaks
Last week's discussions around here about the merits (and demerits) of pharma-industry research seem to be coming at what's either a really good or a really bad time. Take a look at this Washington Post article on the handling of clinical data at AstraZeneca (AZN).
These details have come up during a large array of lawsuits over Seroquel (quetiapine). And if they're as represented in this article, it doesn't make AZ's marketing folks look very good, and (by extension) the rest of the industry's. We shouldn't be doing this sort of thing, on general principle. But if that's not enough, and it probably isn't, here's a more practical concern: does it take much imagination or vision to think that, with all kinds of health care reform ideas in the air, this sort of behavior might just make Congress want to reform our industry really good and hard?
These details have come up during a large array of lawsuits over Seroquel (quetiapine). And if they're as represented in this article, it doesn't make AZ's marketing folks look very good, and (by extension) the rest of the industry's. We shouldn't be doing this sort of thing, on general principle. But if that's not enough, and it probably isn't, here's a more practical concern: does it take much imagination or vision to think that, with all kinds of health care reform ideas in the air, this sort of behavior might just make Congress want to reform our industry really good and hard?
GSK promises to come clean on trials
GlaxoSmithKline, the UK-based pharmaceuticals group previously accused of concealing sensitive information on its medicines, has pledged to make public the findings and details of all clinical trials within 18 months of their completion.
In its latest corporate social responsibility report, the company says it will post on its clinical study register all research on new drugs.
FT
In its latest corporate social responsibility report, the company says it will post on its clinical study register all research on new drugs.
FT
Tuesday, March 24, 2009
Grassley vs FDA's Torti - "shaddap you face gate"
Back story here.
Sen. Charles Grassley, R-Iowa, wants the acting commissioner of the Food and Drug Administration to send an email to agency employees reminding them of their right to provide information to Congress without fear of retaliation or reprisal.
Grassley is concerned that a memo sent two weeks ago by acting FDA commissioner Frank Torti outlining prohibitions on disclosure of commercial information "goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress," according to a letter sent Tuesday to Torti.
"If the memo sent last week was intended to have a chilling effect on FDA employees who want to speak up about problems, then that memo is contrary to the President's call for open and transparent government, and the Acting Commissioner needs to set the record straight," Grassley said in a statement.
Silencing whistle blowers is illegal, Grassley added. Grassley is senior member of the Senate Finance Committee, which oversees the FDA.
Torti said in a March 13 email to FDA employees that disclosing commercial information "can result in disciplinary sanctions and/or individual criminal liability." He also said releasing interagency documents with protected information was also covered, including emails, letters and memorandums.
FDA said, in response to press inquiries at the time, that the memo was simply a reminder to staff that they need to be mindful of confidential information.
Grassley said he appreciates Torti's concerns, noted in the email to employees, about protecting confidential information from unauthorized disclosures. The timing of the memo, however, raises questions amid recent incidents that have shown "failures in FDA's regulatory mission."
Grassley cited recent news reports suggesting political influences may have guided some FDA decision making.
Source
Sen. Charles Grassley, R-Iowa, wants the acting commissioner of the Food and Drug Administration to send an email to agency employees reminding them of their right to provide information to Congress without fear of retaliation or reprisal.
Grassley is concerned that a memo sent two weeks ago by acting FDA commissioner Frank Torti outlining prohibitions on disclosure of commercial information "goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress," according to a letter sent Tuesday to Torti.
"If the memo sent last week was intended to have a chilling effect on FDA employees who want to speak up about problems, then that memo is contrary to the President's call for open and transparent government, and the Acting Commissioner needs to set the record straight," Grassley said in a statement.
Silencing whistle blowers is illegal, Grassley added. Grassley is senior member of the Senate Finance Committee, which oversees the FDA.
Torti said in a March 13 email to FDA employees that disclosing commercial information "can result in disciplinary sanctions and/or individual criminal liability." He also said releasing interagency documents with protected information was also covered, including emails, letters and memorandums.
FDA said, in response to press inquiries at the time, that the memo was simply a reminder to staff that they need to be mindful of confidential information.
Grassley said he appreciates Torti's concerns, noted in the email to employees, about protecting confidential information from unauthorized disclosures. The timing of the memo, however, raises questions amid recent incidents that have shown "failures in FDA's regulatory mission."
Grassley cited recent news reports suggesting political influences may have guided some FDA decision making.
Source
AstraZeneca - Seroquel: investor investigation
An investigation on behalf of current investors in AstraZeneca PLC (NYSE: AZN) over possible Securities Laws violations was announced. If you are a current investor in AstraZeneca PLC (NYSE: AZN) and/or hold AstraZeneca PLC (NYSE: AZN) since 2005, you should contact the Shareholders Foundation, Inc. immediately!
Email: Mail@ShareholdersFoundation.com
or Call us TODAY!
Phone: +1-(858)-779-1554
According to the investigation by a law firm on February 26, 2009, AstraZeneca PLC agreed to unseal documents related to its multi-billion-dollar antipsychotic drug Seroquel concerning lawsuits pending in a U.S. federal court brought by thousands of plaintiff’s alleging to be harmed by Seroquel. On February 27, 2009, the Wall Street Journal reported in an article entitled “AstraZeneca Papers Raise Seroquel Issues” as follows:
“A document dated February 12, 1997, describes internal company deliberations over how to report “Study 15,” a study comparing Seroquel to Haldol, an older-generation psychiatric drug. In the document, an AstraZeneca employee named Richard Lawrence writes to his team that one of his colleagues had done a great “smoke and mirrors job,” and another suggested an approach that “should minimize [sic] (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.”
Also on February 26, 2009, so the investigation, AstraZeneca PLC received a “Complete Response Letter” from the U.S. Food and Drug Administration requesting additional information for AstraZeneca PLC’s supplemental New Drug Application for SEROQUEL XR, an extended release formulation of Seroquel.On February 28, 2009, the Wall Street Journal further reported in an article entitled “AstraZeneca Drug’s Effectiveness Questioned” as follows:
“In some of its marketing material for the drug, AstraZeneca says that Seroquel works as well as – and sometimes better than – some other antipsychotics.
However, a newly unveiled analysis from 2000 of a dozen studies AstraZeneca conducted to test Seroquel’s efficacy indicates that the drug was less effective than a half-century old generic medicine called haloperidol. Seroquel proved only more effective than a placebo, according to the analysis, which emerged Friday among the hundreds of pages of unsealed documents”.
The Wall Street Journal article further observed that the previously undisclosed data suggesting that Seroquel may not be as effective as some of its competitors could affect sales of AstraZeneca’s second-biggest selling drug. Moreover, according to the article, AstraZeneca doctors had debated how to handle the efficacy findings:
“In a March 23, 2000, email, John Tumas, the publications manager for Seroquel, wrote to other AstraZeneca employees that “the data don’t look good.” He added that the company’s own analysis supported the view “that we are less effective than haloperidol and our competitors.”
On February 27, 2008, the trading day after the above noted disclosures, AstraZeneca securities declined approximately 5% on heavier than usual volume, so the investigation.
According to the investigation this case may affect purchasers of securities as early as February 2005. If you are a current investor in AstraZeneca PLC (NYSE: AZN) and/or hold AstraZeneca PLC (NYSE: AZN) since 2005, you should contact the Shareholders Foundation, Inc. immediately!
Email: Mail@ShareholdersFoundation.com
or Call us TODAY!Phone: +1-(858)-779-1554
Shareholders Foundation, Inc.
Trevor Allen
3111 Camino Del Rio North
- Suite 423 -
92108 San Diego
Tel:+1-(858)-779-1554
Fax:+1-(858)-605-5739
mail@shareholdersfoundation.com
http://www.shareholdersfoundation.com/
Source
Email: Mail@ShareholdersFoundation.com
or Call us TODAY!
Phone: +1-(858)-779-1554
According to the investigation by a law firm on February 26, 2009, AstraZeneca PLC agreed to unseal documents related to its multi-billion-dollar antipsychotic drug Seroquel concerning lawsuits pending in a U.S. federal court brought by thousands of plaintiff’s alleging to be harmed by Seroquel. On February 27, 2009, the Wall Street Journal reported in an article entitled “AstraZeneca Papers Raise Seroquel Issues” as follows:
“A document dated February 12, 1997, describes internal company deliberations over how to report “Study 15,” a study comparing Seroquel to Haldol, an older-generation psychiatric drug. In the document, an AstraZeneca employee named Richard Lawrence writes to his team that one of his colleagues had done a great “smoke and mirrors job,” and another suggested an approach that “should minimize [sic] (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study.”
Also on February 26, 2009, so the investigation, AstraZeneca PLC received a “Complete Response Letter” from the U.S. Food and Drug Administration requesting additional information for AstraZeneca PLC’s supplemental New Drug Application for SEROQUEL XR, an extended release formulation of Seroquel.On February 28, 2009, the Wall Street Journal further reported in an article entitled “AstraZeneca Drug’s Effectiveness Questioned” as follows:
“In some of its marketing material for the drug, AstraZeneca says that Seroquel works as well as – and sometimes better than – some other antipsychotics.
However, a newly unveiled analysis from 2000 of a dozen studies AstraZeneca conducted to test Seroquel’s efficacy indicates that the drug was less effective than a half-century old generic medicine called haloperidol. Seroquel proved only more effective than a placebo, according to the analysis, which emerged Friday among the hundreds of pages of unsealed documents”.
The Wall Street Journal article further observed that the previously undisclosed data suggesting that Seroquel may not be as effective as some of its competitors could affect sales of AstraZeneca’s second-biggest selling drug. Moreover, according to the article, AstraZeneca doctors had debated how to handle the efficacy findings:
“In a March 23, 2000, email, John Tumas, the publications manager for Seroquel, wrote to other AstraZeneca employees that “the data don’t look good.” He added that the company’s own analysis supported the view “that we are less effective than haloperidol and our competitors.”
On February 27, 2008, the trading day after the above noted disclosures, AstraZeneca securities declined approximately 5% on heavier than usual volume, so the investigation.
According to the investigation this case may affect purchasers of securities as early as February 2005. If you are a current investor in AstraZeneca PLC (NYSE: AZN) and/or hold AstraZeneca PLC (NYSE: AZN) since 2005, you should contact the Shareholders Foundation, Inc. immediately!
Email: Mail@ShareholdersFoundation.com
or Call us TODAY!Phone: +1-(858)-779-1554
Shareholders Foundation, Inc.
Trevor Allen
3111 Camino Del Rio North
- Suite 423 -
92108 San Diego
Tel:+1-(858)-779-1554
Fax:+1-(858)-605-5739
mail@shareholdersfoundation.com
http://www.shareholdersfoundation.com/
Source
FTalphaville - who's buying who?
Predictable really.
After the recent flurry of big deals in the pharmaceutical sector - think Pfizer’s $68bn bid for Wyeth, Roche’s $47bn offer for the chunk of Genentech it did not already own and Merck’s $41bn takeover of Schering-Plough - it was only a matter of time before the rumour mill started to whirl into action.
And how. First there is talk that GlaxoSmithKline is lining up a bid for Allergan, the botox specialist listed on the NYSE which has a market value pf over $13bn, and then there is speculation that Baxter is eyeing Stryker, another medical devices company.
More from the FT
After the recent flurry of big deals in the pharmaceutical sector - think Pfizer’s $68bn bid for Wyeth, Roche’s $47bn offer for the chunk of Genentech it did not already own and Merck’s $41bn takeover of Schering-Plough - it was only a matter of time before the rumour mill started to whirl into action.
And how. First there is talk that GlaxoSmithKline is lining up a bid for Allergan, the botox specialist listed on the NYSE which has a market value pf over $13bn, and then there is speculation that Baxter is eyeing Stryker, another medical devices company.
More from the FT
For sale - Nycomed
Switzerland’s Nycomed has reportedly asked Goldman Sachs to explore a possible sale of the company which could bring in as much as 10 billion euros.
The Wall Street Journal, citing people familiar with the situation, said that the privately-held, Zurich-headquartered firm is looking for potential buyers. It is also considering an initial public offering, according to the newspaper.
Nycomed is not commenting on the story and neither is Nordic Capital, which has a 41% stake in the firm. What is certain is that Nycomed is looking to get a commercial partner in the USA for Daxas (roflumilast) for chronic obstructive pulmonary disease, which is expected to be filed on both sides of the Atlantic soon.Aside from Daxas and continuing strong sales of the gastrointestinal drug Protonix (pantoprazole) outside the USA, the attraction of Nycomed lies in its strong prersence in the emerging markets.
Last month, chief executive Hakan Bjorklund noted that the company is doing particularly well in Russia and Latin America, a situation which is likely to prompt interest from some big pharma players who are looking outside the traditional markets of the USA and Europe for future growth.
In 2008, Nycomed posted a 1.2% decline in profits to 1.20 billion euros, while turnover slipped 4.3% to 3.35 billion euros due to at-risk launches of generic Protonix in the USA, where the drug was sold by Wyeth.
By Kevin Grogan
PharmaTimes
The Wall Street Journal, citing people familiar with the situation, said that the privately-held, Zurich-headquartered firm is looking for potential buyers. It is also considering an initial public offering, according to the newspaper.
Nycomed is not commenting on the story and neither is Nordic Capital, which has a 41% stake in the firm. What is certain is that Nycomed is looking to get a commercial partner in the USA for Daxas (roflumilast) for chronic obstructive pulmonary disease, which is expected to be filed on both sides of the Atlantic soon.Aside from Daxas and continuing strong sales of the gastrointestinal drug Protonix (pantoprazole) outside the USA, the attraction of Nycomed lies in its strong prersence in the emerging markets.
Last month, chief executive Hakan Bjorklund noted that the company is doing particularly well in Russia and Latin America, a situation which is likely to prompt interest from some big pharma players who are looking outside the traditional markets of the USA and Europe for future growth.
In 2008, Nycomed posted a 1.2% decline in profits to 1.20 billion euros, while turnover slipped 4.3% to 3.35 billion euros due to at-risk launches of generic Protonix in the USA, where the drug was sold by Wyeth.
By Kevin Grogan
PharmaTimes
Who's worse - AIG bonus execs or Seroquel marketeers?
"AstraZeneca's failure to disclose what they knew about Seroquel is a public health issue so there is a lot more at stake than just dollars and cents. As the Post article says, AstraZeneca officials "explicitly discussed misleading physicians. So if I'm picking out bad guys, the people who made the call to hide Seroquel Study 15 from doctors and patients rank well ahead of the AIG bonus guys, our current villains of the month. "
Source
Source
Monday, March 23, 2009
Merck - Vioxx: "a target"
Merck said Monday it received a letter from federal prosecutors notifying the company it is "a target" of a grand jury investigation involving the painkiller Vioxx, which Merck pulled from the market in 2004.
Merck has previously disclosed the investigation, which the company said has been ongoing since 2004. Monday's update said the company received a letter from the U.S. Attorney's Office in Massachusetts stating the company was a target.
More
Merck has previously disclosed the investigation, which the company said has been ongoing since 2004. Monday's update said the company received a letter from the U.S. Attorney's Office in Massachusetts stating the company was a target.
More
Letter from a somebody
ACADEMIC FREEDOM AND CONTROVERSY OVER THE PUBLICATION OF FACTUALLY CORRECT, PUBLICLY AVAILABLE INFORMATION
Jonathan Leo, Ph.D.
Over the past several years, I have written about the potential impact of conflicts-of-Interest in medicine (COI). I have also watched how the mainstream media reports the results of medical research with great interest. As a neuroanatomist, I was particularly interested in a recent study published in the Journal of the American Medical Association (JAMA), which reported that the prescription of escitalopram lowered the rate of depression in patients who had recently suffered a stroke. I co-authored a letter to JAMA with Dr. Jeffrey Lacasse of Arizona State University, in which we pointed out the problem of selective reporting within the study: Problem-solving psychotherapy was statistically equivalent to escitalopram, but this was never mentioned. In the mass media, the principal investigator recommended that all stroke victims should be prescribed antidepressants without mentioning that problem-solving therapy was statistically equivalent.
In the process of reading this body of research, my co-author and I noticed a problem with the COI disclosures in this positive trial of escitalopram published in JAMA. The principal investigator on the project, Dr. Robert Robinson, had not declared that he had previously received funding from Forest Laboratories, the makers of escitalopram. The financial relationship with Forest Laboratories was well-documented and easily discoverable via a Google search, as evidenced by Dr. Robinson's previous self-disclosures in varied sources such as here, here, here, here, and here.
I urge my students to carefully consider COI when they read an article as such conflicts can be important in how one interprets research. I do not consider myself a whistleblower, but I do think that the full story behind clinical trials should be transparent so that patients and doctors can make informed decisions. This instance of unreported COI in a gold-standard study published in JAMA seemed like a perfect case study of problematic COI issues. First, I informed JAMA of what we had found. We then co-authored a commentary describing this saga and the potential implications, linking together the unreported COI, selective reporting in JAMA, and in the mass media. We submitted it to the British Medical Journal (BMJ), who agreed to publish it as a Rapid Response on their website.
Months later, before publishing the BMJ letter, I called JAMA editorial staff twice to talk about the upcoming piece, and I also sent an email. Given the topic of the letter, I wanted to give JAMA an opportunity to correct any factual errors. No one from JAMA responded to my phone calls or email. The letter underwent legal review at BMJ and was approved for publication. We then published what we thought of as a fairly unremarkable letter primarily of interest to researchers who study COI.
The immediate, aggressive response from JAMA has been well documented. Threatening phone calls, personal attacks, and emails were accompanied by demands that we retract the entire BMJ letter.
Our letter was published without any negative commentary regarding JAMA itself, and included the following statement: ≥We are fully aware that JAMA is concerned about conflicts of interest and has taken a leading role in promoting policies to benefit the medical community. We are pleased to report that we learned at the end of business on Thursday (3/5/09) that the JAMA Editorial Staff has looked into this matter and will be discussing it in the forthcoming March 11 issue.≤ Our letter did not attack JAMA and, if anything, presents the facts of the matter flatly.
JAMA continued to ask that the entire piece be retracted. We were stunned by the continued, heated reaction from JAMA, and were concerned that we might have inadvertently made an error of fact in our letter. I made the following offer repeatedly: Please tell me what we have written that is factually incorrect, and if we have made a mistake or misinterpretation, we will retract the entire piece and issue a public apology. No factual errors were ever pointed out. I remain confused as to why JAMA felt they could demand that we retract an accurate letter.
Phone calls were followed by a scathing JAMA editorial which pinpoints my actions as the cause of the problem- with no mention of the culpability of the researchers who failed to disclose their COI, or the fact that the undisclosed COI was unearthed by a 5-minute Google search.
JAMA now insists that it was inappropriate to disclose the COI while they were conducting an investigation. This is curious, for several reasons. First, their investigation was complete by the time our letter was published. Second, the undisclosed COI information contained in the article is publicly available on the Internet (again, here, here, here, here, and here). JAMA has never clarified how the re-publication of publicly available information after the fact could interfere with a completed investigation. This investigation, which took five months, resulted in a short correction published in JAMA, along with a letter from the authors apologizing for their lapse of memory resulting in undisclosed COI. JAMA has claimed that the result of their investigation was more comprehensive than our BMJ piece. I only ask that readers actually compare the material published in JAMA with that published in BMJ. The material published in JAMA does not include any analysis of the context or potential implications. I believe our BMJ letter presents a more complete (and troubling) story.
Importantly, I am under the impression that JAMA objected not to the timing of the publication of the letter, but to us publishing the letter at all. In their most recent editorial, JAMA seems to assert that they have some right to control the publication of publicly available information outside their own medical journal. I do not believe they have any such right. It would seem to be an infringement of academic freedom to threaten academics who analyze publicly stored information. This information was available to anyone with access to the Internet. The view that JAMA should control such information is anachronistic at best. At worse, it is a reflection of a scientifically and ethically inappropriate effort to suppress the free exchange of information, which is at the heart of productive scientific discourse.
The implications of the JAMA's reaction to our letter are significant. For instance, the pharmaceutical industry is often criticized for their impact on evidence-based medicine. In the past, I have criticized direct-to-consumer advertising of psychiatric medications, which is not helpful to Big Pharma. However, I have never been telephoned or threatened by representatives from Big Pharma. In contrast to my experience with JAMA, any exchanges have been civil and appropriate.
The claim that JAMA can control the flow of information in the public record should be considered by bioethicists and other academics who study the process of medical research and publication. In my opinion, this claim has shifted this issue markedly. What began as a short (and potentially obscure) letter about undisclosed COI has now led to questions about the limits of institutional authority in the medical publishing industry, the extent of academic freedom, and even the role of the First Amendment.
Competing Interests: None.
Acknowledgement: Jeffrey R. Lacasse, Ph.D., provided editorial assistance in the preparation of this letter.
Back story here
Jonathan Leo, Ph.D.
Over the past several years, I have written about the potential impact of conflicts-of-Interest in medicine (COI). I have also watched how the mainstream media reports the results of medical research with great interest. As a neuroanatomist, I was particularly interested in a recent study published in the Journal of the American Medical Association (JAMA), which reported that the prescription of escitalopram lowered the rate of depression in patients who had recently suffered a stroke. I co-authored a letter to JAMA with Dr. Jeffrey Lacasse of Arizona State University, in which we pointed out the problem of selective reporting within the study: Problem-solving psychotherapy was statistically equivalent to escitalopram, but this was never mentioned. In the mass media, the principal investigator recommended that all stroke victims should be prescribed antidepressants without mentioning that problem-solving therapy was statistically equivalent.
In the process of reading this body of research, my co-author and I noticed a problem with the COI disclosures in this positive trial of escitalopram published in JAMA. The principal investigator on the project, Dr. Robert Robinson, had not declared that he had previously received funding from Forest Laboratories, the makers of escitalopram. The financial relationship with Forest Laboratories was well-documented and easily discoverable via a Google search, as evidenced by Dr. Robinson's previous self-disclosures in varied sources such as here, here, here, here, and here.
I urge my students to carefully consider COI when they read an article as such conflicts can be important in how one interprets research. I do not consider myself a whistleblower, but I do think that the full story behind clinical trials should be transparent so that patients and doctors can make informed decisions. This instance of unreported COI in a gold-standard study published in JAMA seemed like a perfect case study of problematic COI issues. First, I informed JAMA of what we had found. We then co-authored a commentary describing this saga and the potential implications, linking together the unreported COI, selective reporting in JAMA, and in the mass media. We submitted it to the British Medical Journal (BMJ), who agreed to publish it as a Rapid Response on their website.
Months later, before publishing the BMJ letter, I called JAMA editorial staff twice to talk about the upcoming piece, and I also sent an email. Given the topic of the letter, I wanted to give JAMA an opportunity to correct any factual errors. No one from JAMA responded to my phone calls or email. The letter underwent legal review at BMJ and was approved for publication. We then published what we thought of as a fairly unremarkable letter primarily of interest to researchers who study COI.
The immediate, aggressive response from JAMA has been well documented. Threatening phone calls, personal attacks, and emails were accompanied by demands that we retract the entire BMJ letter.
Our letter was published without any negative commentary regarding JAMA itself, and included the following statement: ≥We are fully aware that JAMA is concerned about conflicts of interest and has taken a leading role in promoting policies to benefit the medical community. We are pleased to report that we learned at the end of business on Thursday (3/5/09) that the JAMA Editorial Staff has looked into this matter and will be discussing it in the forthcoming March 11 issue.≤ Our letter did not attack JAMA and, if anything, presents the facts of the matter flatly.
JAMA continued to ask that the entire piece be retracted. We were stunned by the continued, heated reaction from JAMA, and were concerned that we might have inadvertently made an error of fact in our letter. I made the following offer repeatedly: Please tell me what we have written that is factually incorrect, and if we have made a mistake or misinterpretation, we will retract the entire piece and issue a public apology. No factual errors were ever pointed out. I remain confused as to why JAMA felt they could demand that we retract an accurate letter.
Phone calls were followed by a scathing JAMA editorial which pinpoints my actions as the cause of the problem- with no mention of the culpability of the researchers who failed to disclose their COI, or the fact that the undisclosed COI was unearthed by a 5-minute Google search.
JAMA now insists that it was inappropriate to disclose the COI while they were conducting an investigation. This is curious, for several reasons. First, their investigation was complete by the time our letter was published. Second, the undisclosed COI information contained in the article is publicly available on the Internet (again, here, here, here, here, and here). JAMA has never clarified how the re-publication of publicly available information after the fact could interfere with a completed investigation. This investigation, which took five months, resulted in a short correction published in JAMA, along with a letter from the authors apologizing for their lapse of memory resulting in undisclosed COI. JAMA has claimed that the result of their investigation was more comprehensive than our BMJ piece. I only ask that readers actually compare the material published in JAMA with that published in BMJ. The material published in JAMA does not include any analysis of the context or potential implications. I believe our BMJ letter presents a more complete (and troubling) story.
Importantly, I am under the impression that JAMA objected not to the timing of the publication of the letter, but to us publishing the letter at all. In their most recent editorial, JAMA seems to assert that they have some right to control the publication of publicly available information outside their own medical journal. I do not believe they have any such right. It would seem to be an infringement of academic freedom to threaten academics who analyze publicly stored information. This information was available to anyone with access to the Internet. The view that JAMA should control such information is anachronistic at best. At worse, it is a reflection of a scientifically and ethically inappropriate effort to suppress the free exchange of information, which is at the heart of productive scientific discourse.
The implications of the JAMA's reaction to our letter are significant. For instance, the pharmaceutical industry is often criticized for their impact on evidence-based medicine. In the past, I have criticized direct-to-consumer advertising of psychiatric medications, which is not helpful to Big Pharma. However, I have never been telephoned or threatened by representatives from Big Pharma. In contrast to my experience with JAMA, any exchanges have been civil and appropriate.
The claim that JAMA can control the flow of information in the public record should be considered by bioethicists and other academics who study the process of medical research and publication. In my opinion, this claim has shifted this issue markedly. What began as a short (and potentially obscure) letter about undisclosed COI has now led to questions about the limits of institutional authority in the medical publishing industry, the extent of academic freedom, and even the role of the First Amendment.
Competing Interests: None.
Acknowledgement: Jeffrey R. Lacasse, Ph.D., provided editorial assistance in the preparation of this letter.
Back story here
A quote for AstraZeneca's Seroquel Commercial Strategist Richard Lawrence
Lawyers spend a great deal of their time shoveling smoke.
Oliver Wendell Holmes Jr.
US jurist (1841 - 1935)
Story , LOL
Oliver Wendell Holmes Jr.
US jurist (1841 - 1935)
Story , LOL
BMS withdraw Ixempra application from EMEA
Ixempra (ixabepilone) was expected to be used to treat locally advanced or metastatic breast cancer after failure of previous cytotoxic chemotherapy treatments. It was to be used in combination with capecitabine.
The application for the marketing authorisation for Ixempra was submitted to the Agency on 24 September 2007. On 20 November 2008, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
The company stated in its official letter that the withdrawal of application for Ixempra was based on the fact that the information provided in the re-examination procedure did not provide the Committee with sufficient evidence to change the benefit-risk balance.
The application for the marketing authorisation for Ixempra was submitted to the Agency on 24 September 2007. On 20 November 2008, the Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.
The company stated in its official letter that the withdrawal of application for Ixempra was based on the fact that the information provided in the re-examination procedure did not provide the Committee with sufficient evidence to change the benefit-risk balance.
US drug reps cut by a quarter by 2012
At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates' U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.
More
More
Slumdog Clinical Trials contd. - the case of Wyeth's Prevnar
Supervisory shortcomings, rather than problems with a vaccine itself, led to the death of a baby girl in India last fall during a Wyeth clinical trial, according to an official investigation by India's top drug regulator.
The findings by the Drugs Controller General of India are likely to add to concerns about how well Western pharmaceutical companies oversee human testing of potential new medicines in developing countries.
More at WSJ
Sunday, March 22, 2009
AstraZeneca - let's not forget what happened in 2003
AstraZeneca Pharmaceuticals LP (“AstraZeneca”), a major pharmaceutical manufacturer headquartered in Wilmington, Delaware, today pleaded guilty in federal district court in Wilmington, Delaware to a healthcare crime and agreed to pay $355,000,000 to resolve criminal charges and civil liabilities in connection with its drug pricing and marketing practices with regard to Zoladex, a drug sold by AstraZeneca Pharmaceuticals LP and used primarily for the treatment of prostate cancer.
Link
Link
Saturday, March 21, 2009
New jobs for laid off drug reps contd. - job fair in Rhode Island
"I need more managers, I need more competent staff, and I need more attractive waitresses to go along with the ones I have right now," said co-owner Tom Tsoumas.
More info at HuffPo
More info at HuffPo
Duplicity - the trailer
Duplicity, has two giant pharmaceutical companies locked in a struggle so intense that they employ vast numbers of secret agents to discover the other's secrets. Julia Roberts plays Claire Stenwick, formerly CIA, now an undercover operative, secretly working for Burkett & Randle while serving as a security expert for that company's bitter rival, Omnikrom. Clive Owen is Ray Koval, formerly of MI6, and her contact.
Insider's view: Not as exciting as real life!
New jobs for laid off drug reps - the Carla Stokes story
Carla Stokes worked in pharmaceutical sales for eight years, five of them in Nashville. As a regional sales manager, she was able to travel throughout the Southeast. Everything, even the company car, was provided for her.
But then her company was bought out, and her position eliminated.
So the Green Hills resident took some time to travel and figure out what she really wanted to do. And it turned out her travels would lead her to her next endeavor.
Friday, March 20, 2009
AstraZeneca - Seroquel: Now Dr. Daniel Carlat chips in
"Because of these documents, Astra Zeneca’s credibility is officially out the window. They should not be allowed to be involved in any medical education event. They should be banned from hiring promotional speakers and from supporting CME.
AstraZeneca has lied to the medical community once too often. "
The Carlat Psychiatry Blog
AstraZeneca has lied to the medical community once too often. "
The Carlat Psychiatry Blog
MeReC Monthly/Extra - read all about it!
The UK's MeReC Monthly No 12: http://www.npc.co.uk/ebt/merec/cns/schiz/merec_monthly_no12.html
· Antipsychotics increase mortality in patients with Alzheimer’s disease
· Further evidence to support individualised antipsychotic drug treatment for schizophrenia
· Antiepileptic product information to be updated
· All non-analgesics similarly effective for neuropathic pain
Past editions:
http://www.npc.co.uk/MeReC_Monthly/monthly2008index.htm
Plus, MeReC Extra No 38: http://www.npc.co.uk/ebt/merec/cardio/diabetes2/resources/merec_extra_no38.pdf
· Don’t miss out on news you want to hear
· Insignificant benefits for intensive glucose control in type 2 diabetes
· Dual antihypertensive therapy in patients at high risk of CV disease
· What’s new from the National Prescribing Centre?
Update ; Links now working, hopefully
· Antipsychotics increase mortality in patients with Alzheimer’s disease
· Further evidence to support individualised antipsychotic drug treatment for schizophrenia
· Antiepileptic product information to be updated
· All non-analgesics similarly effective for neuropathic pain
Past editions:
http://www.npc.co.uk/MeReC_Monthly/monthly2008index.htm
Plus, MeReC Extra No 38: http://www.npc.co.uk/ebt/merec/cardio/diabetes2/resources/merec_extra_no38.pdf
· Don’t miss out on news you want to hear
· Insignificant benefits for intensive glucose control in type 2 diabetes
· Dual antihypertensive therapy in patients at high risk of CV disease
· What’s new from the National Prescribing Centre?
Update ; Links now working, hopefully
J&J - Risperdal - Biederman's God Delusion
In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.“What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.
If only computers did have a "smite" button!
Who might buy Stiefel?
Stiefel Laboratories Inc., a closely held pharmaceutical maker, is considering selling itself in a deal that could be worth several billion dollars, according to people familiar with the matter.
The potential sale has drawn interest from a number of major drug companies, including Johnson & Johnson, Novartis and GlaxoSmithKline, these people said.
WSJ
The potential sale has drawn interest from a number of major drug companies, including Johnson & Johnson, Novartis and GlaxoSmithKline, these people said.
WSJ
Thursday, March 19, 2009
Pharma Giles writes .......
Pussy for Pills – the true story so unbelievable they said it could never be made into a movie. Coming to a cinema near you.
The story so far…
Florida. September. Wayne looked out of the window of his luxury hotel penthouse suite and let his gaze wander across the distant sun-drenched beach to the sunlit horizon.
He smiled.
Life was good, and a $200,000 salary plus expense account to match went a long way towards keeping it that way. Sure, being a top gun medical director for AstraZeneca was demanding. Very demanding. But there were plenty of rewards.
Wayne turned that thought over in his mind and laughed quietly to himself. He turned his eyes from the rolling, golden curves of the sand dunes and back to the rolling, golden curves of Redacted, who was pacing back and forth in the room behind him.
Make that physically demanding, he thought.
“Just tell me what you want, Wayne,” she said, worrying a blood-red finger nail. “Tell me what you really want.”
Time to get back to work, Wayne realised. He shivered.
“Honey, what I’d really like is for you to turn the air-con down,” Wayne replied. “It’s freezing in here.”
Redacted’s flimsy, figure-hugging dress revealed a couple of tell-tale signs, signs of either the artificially cool apartment breeze or her aura of barely-suppressed excitement. Wayne suspected they were due to the latter.
“Wayne, you just don’t understand,” she sighed. “Industrial espionage isn’t my scene. I’m just a silly little clinical researcher at silly little Parexel. What possible use am I to a high-flyer at AZ like you?”
Wayne stood up sharply and took three short, quick strides across to where Redacted was standing. He seized her long, copper-coloured hair and pulled her tight to him.
“Stop it! You’re hurting me,” she squealed. Then… “Don’t stop….”
He kissed her savagely, crushing her mouth to his lips, and felt her tremble with hot, needy desire.
“You’ve got something I want,” he purred. “Times, dates, results. You know. And in return, I’ve got something you want…”
He felt her hand reach feverishly for his belt.
“No, not that,” he laughed. “Not yet, anyway…”
She smiled. “Did you bring them?”
“They’re in the drawer, by the bed. The small blue bottle.”
Redacted smiled and turned away into the bedroom. Wayne heard her open the drawer and take out the vial holding the three precious Vicodin tablets. Her reward for being such a good girl, he reflected.
Yes, such a good girl. Just like all of the others.
Wayne thought back to the early days. AZ had always been one long party. He remembered the corporate excesses of his old US CEO, good ol’ Lars. Now there was a guy who really knew who to party.
He smiled at the memory. Even back then, Wayne had acquired a reputation as a Don Juan amongst medical researchers. Love ‘em, lay ‘em, leave ‘em. Back then of course, such behaviour was perfectly acceptable, even encouraged and certainly greatly admired, even by the ladies.
His abilities in that sphere of research operations had not gone unnoticed by senior management, either.
“Zere iz nozzing wrong viz using your greasy pole to help climb ze greasy pole,” Lars himself had once joked to him.
Great days, great days. All different now, of course. Political correctness had forced out Lars long ago. And most of the characters like him.
“Not the anything has really changed,” Wayne’s former marketing colleague Mike Zubillaga had once said to him. “You can still pull the same old stunts to get results. The only thing is that now, if you get caught, your management will cut you off at the knees. They feel they have to pretend that they don’t know what really goes on. If it’s all going well, then fine, but if Joe Public finds out what you’re up to, then it’s goodbye. No way will an executive take a bullet in support of guys like us, these days.”
And boy, did Zube ever find that out the hard way, reflected Wayne…
“What are you thinking about, Wayne?” cooed Redacted, interrupting his reverie.
She was standing in the bedroom doorway, wearing a translucent white cotton hotel bathrobe. Her long, tanned legs carried her to his side.
“About us,” replied Wayne, truthfully.
And about the e-mails and the rumours. Seroquel had always been a product with a deep, dark secret, one that threatened bring down the whole AZ empire. Everyone who was anyone at AZ knew that, but now the smoke was blowing away and the mirrors were tarnishing. And the execs were looking for people to blame…
“Do you love me?” asked Redacted.
Wayne slid his hand inside her bathrobe. “Of course I do,” he smiled.
And it was true. He loved all of his ladies. Every one of them.
Her bathrobe slid to the floor. Redacted shivered with excitement as Wayne pressed his lips to her (continued next post…)
Well, it could have been like that. Check out Jim Edwards at BNET for the full, hilariously sleazy story from the real world…
The story so far…
Florida. September. Wayne looked out of the window of his luxury hotel penthouse suite and let his gaze wander across the distant sun-drenched beach to the sunlit horizon.
He smiled.
Life was good, and a $200,000 salary plus expense account to match went a long way towards keeping it that way. Sure, being a top gun medical director for AstraZeneca was demanding. Very demanding. But there were plenty of rewards.
Wayne turned that thought over in his mind and laughed quietly to himself. He turned his eyes from the rolling, golden curves of the sand dunes and back to the rolling, golden curves of Redacted, who was pacing back and forth in the room behind him.
Make that physically demanding, he thought.
“Just tell me what you want, Wayne,” she said, worrying a blood-red finger nail. “Tell me what you really want.”
Time to get back to work, Wayne realised. He shivered.
“Honey, what I’d really like is for you to turn the air-con down,” Wayne replied. “It’s freezing in here.”
Redacted’s flimsy, figure-hugging dress revealed a couple of tell-tale signs, signs of either the artificially cool apartment breeze or her aura of barely-suppressed excitement. Wayne suspected they were due to the latter.
“Wayne, you just don’t understand,” she sighed. “Industrial espionage isn’t my scene. I’m just a silly little clinical researcher at silly little Parexel. What possible use am I to a high-flyer at AZ like you?”
Wayne stood up sharply and took three short, quick strides across to where Redacted was standing. He seized her long, copper-coloured hair and pulled her tight to him.
“Stop it! You’re hurting me,” she squealed. Then… “Don’t stop….”
He kissed her savagely, crushing her mouth to his lips, and felt her tremble with hot, needy desire.
“You’ve got something I want,” he purred. “Times, dates, results. You know. And in return, I’ve got something you want…”
He felt her hand reach feverishly for his belt.
“No, not that,” he laughed. “Not yet, anyway…”
She smiled. “Did you bring them?”
“They’re in the drawer, by the bed. The small blue bottle.”
Redacted smiled and turned away into the bedroom. Wayne heard her open the drawer and take out the vial holding the three precious Vicodin tablets. Her reward for being such a good girl, he reflected.
Yes, such a good girl. Just like all of the others.
Wayne thought back to the early days. AZ had always been one long party. He remembered the corporate excesses of his old US CEO, good ol’ Lars. Now there was a guy who really knew who to party.
He smiled at the memory. Even back then, Wayne had acquired a reputation as a Don Juan amongst medical researchers. Love ‘em, lay ‘em, leave ‘em. Back then of course, such behaviour was perfectly acceptable, even encouraged and certainly greatly admired, even by the ladies.
His abilities in that sphere of research operations had not gone unnoticed by senior management, either.
“Zere iz nozzing wrong viz using your greasy pole to help climb ze greasy pole,” Lars himself had once joked to him.
Great days, great days. All different now, of course. Political correctness had forced out Lars long ago. And most of the characters like him.
“Not the anything has really changed,” Wayne’s former marketing colleague Mike Zubillaga had once said to him. “You can still pull the same old stunts to get results. The only thing is that now, if you get caught, your management will cut you off at the knees. They feel they have to pretend that they don’t know what really goes on. If it’s all going well, then fine, but if Joe Public finds out what you’re up to, then it’s goodbye. No way will an executive take a bullet in support of guys like us, these days.”
And boy, did Zube ever find that out the hard way, reflected Wayne…
“What are you thinking about, Wayne?” cooed Redacted, interrupting his reverie.
She was standing in the bedroom doorway, wearing a translucent white cotton hotel bathrobe. Her long, tanned legs carried her to his side.
“About us,” replied Wayne, truthfully.
And about the e-mails and the rumours. Seroquel had always been a product with a deep, dark secret, one that threatened bring down the whole AZ empire. Everyone who was anyone at AZ knew that, but now the smoke was blowing away and the mirrors were tarnishing. And the execs were looking for people to blame…
“Do you love me?” asked Redacted.
Wayne slid his hand inside her bathrobe. “Of course I do,” he smiled.
And it was true. He loved all of his ladies. Every one of them.
Her bathrobe slid to the floor. Redacted shivered with excitement as Wayne pressed his lips to her (continued next post…)
Well, it could have been like that. Check out Jim Edwards at BNET for the full, hilariously sleazy story from the real world…
Pfizer - anyone know Tommy Farina?
A former district sales manager for Pfizer was convicted on March 16, 2009, in federal court of obstruction of justice.
Thomas Farina, 42, of Fairport, NY, was found guilty following a five day trial in Boston.
Prosecutors said evidence presented during the trial proved that in the summer of 2004, Farina caused a sales representative under his direction to alter documents and backdate the alterations on his computer to delete the evidence of the promotion of a drug for uses and dosages for which it was not indicated or approved for promotion by the U.S. Food and Drug Administration.
The evidence demonstrated that Farina instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.
Sentencing has been scheduled for June 11. Farina faces up to 20 years imprisonment, to be followed by three years of supervised release and a $ 250,000 fine.
Prosecutors said Pfizer Inc disclosed this conduct to the federal government and fully cooperated in the investigation and prosecution of the case.
Source
Thomas Farina, 42, of Fairport, NY, was found guilty following a five day trial in Boston.
Prosecutors said evidence presented during the trial proved that in the summer of 2004, Farina caused a sales representative under his direction to alter documents and backdate the alterations on his computer to delete the evidence of the promotion of a drug for uses and dosages for which it was not indicated or approved for promotion by the U.S. Food and Drug Administration.
The evidence demonstrated that Farina instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.
Sentencing has been scheduled for June 11. Farina faces up to 20 years imprisonment, to be followed by three years of supervised release and a $ 250,000 fine.
Prosecutors said Pfizer Inc disclosed this conduct to the federal government and fully cooperated in the investigation and prosecution of the case.
Source
AstraZeneca - Seroquel: Dr S Charles Schulz and study 15
"These two things, they don't go together," said Glen Spielmans, an assistant professor of psychology at Metropolitan State University, who has reviewed the documents. "Either the (company) analysis was wrong or Schulz's presentation was wrong."
No relation to Charles M Schulz?
SanofiAventis - Multaq: an accident waiting to happen?
Sanofi-Aventis won a U.S. panel's support on Wednesday for its most important near-term product, a heart drug that was rejected three years ago amid concerns about patient deaths.
A panel of outside experts voted 10-3 to recommend approval of experimental drug Multaq for patients with an irregular heartbeat called atrial fibrillation but said use should be limited.
The drug should not be prescribed to patients with severe heart failure and Sanofi should not be allowed to claim the medicine reduces the risk of death, panel members said.
More at Reuters
Insider's view: Those who forget history ........
A panel of outside experts voted 10-3 to recommend approval of experimental drug Multaq for patients with an irregular heartbeat called atrial fibrillation but said use should be limited.
The drug should not be prescribed to patients with severe heart failure and Sanofi should not be allowed to claim the medicine reduces the risk of death, panel members said.
More at Reuters
Insider's view: Those who forget history ........
The tort lawyers should watch this one.
Wednesday, March 18, 2009
Evergreening - at last the EPO wises up
The rate of patent applications refused in Europe has risen to an all time high, as authorities target "evergreening" of intellectual property.
In 2008 the number of applications grew 3.6%, largely due to companies seeking to marginally 'update' and extend existing patents to hold off competition.
But the number refused crept up to more than 50%, compared with 49.5% in 2007, as a result of the European Patent Office (EPO) demanding better quality and relevance on applications put in.
President of the EPO Alison Brimelow says quality in the process must be maintained.
"The strict application of patentability criteria by our patent examiners has led to more refusals to grant a patent. These are important steps to ensure the relevance of the patents entering the innovation process."
The EPO received 146,600 applications last year compared with 141,400 in 2007. Companies attempt to continuously extend patents by seeking a new patent that "updates" the first one before its expiry, known as "evergreening".
The debate about evergreening is particularly current for the pharmaceutical industry, as the European Competition Commission is currently investigating alleged anti-competitive measures around patents.
More
In 2008 the number of applications grew 3.6%, largely due to companies seeking to marginally 'update' and extend existing patents to hold off competition.
But the number refused crept up to more than 50%, compared with 49.5% in 2007, as a result of the European Patent Office (EPO) demanding better quality and relevance on applications put in.
President of the EPO Alison Brimelow says quality in the process must be maintained.
"The strict application of patentability criteria by our patent examiners has led to more refusals to grant a patent. These are important steps to ensure the relevance of the patents entering the innovation process."
The EPO received 146,600 applications last year compared with 141,400 in 2007. Companies attempt to continuously extend patents by seeking a new patent that "updates" the first one before its expiry, known as "evergreening".
The debate about evergreening is particularly current for the pharmaceutical industry, as the European Competition Commission is currently investigating alleged anti-competitive measures around patents.
More
Tuesday, March 17, 2009
Clot Wars contd. - FDA's concerns over Xarelto
Johnson & Johnson and Bayer’s new pill to prevent blood clots after hip or knee surgery may cause excess bleeding in “significantly more patients” than the standard drug, Sanofi-Aventis’ Lovenox, U.S. regulators said.
Risks for liver injury and other damage were less clear in studies of the experimental drug, rivaroxaban, which Bayer and J&J plan to market as Xarelto, according to a review by Food and Drug Administration staff posted today on the agency’s Web site. A panel of FDA advisers will consider the findings when they meet March 19 to recommend whether the tablets can be sold in the U.S.
Xarelto would be the U.S.’s first new oral anticoagulant, used to prevent blood clots in the veins, since warfarin was approved in 1954.
The Chemistry of Hell
The following is an actual question given on a University of Washington chemistry mid term
The answer by one student was so 'profound' that the professor shared it with colleagues, via the Internet, which is, of course, why we now have the pleasure of enjoying it as well :
Bonus Question: Is Hell exothermic (gives off heat) or endothermic (absorbs heat)?
Most of the students wrote proofs of their beliefs using Boyle's Law (gas cools when it expands and heats when it is compressed) or some variant.
One student, however, wrote the following:
First, we need to know how the mass of Hell is changing in time. So we need to know the rate at which souls are moving into Hell and the rate at which they are leaving. I think that we can safely assume that once a soul gets to Hell, it will not leave. Therefore, no souls are leaving. As for how many souls are entering Hell, let's look at the different religions that exist in the world today.
Most of these religions state that if you are not a member of their religion, you will go to Hell. Since there is more than one of these religions and since people do not belong to more than one religion, we can project that all souls go to Hell. With birth and death rates as they are, we can expect the number of souls in Hell to increase exponentially. Now, we look at the rate of change of the volume in Hell because Boyle's Law states that in order for the temperature and pressure in Hell to stay the same, the volume of Hell has to expand proportionately as souls are added.
This gives two possibilities:
1. If Hell is expanding at a slower rate than the rate at which souls enter Hell, then the temperature and pressure in Hell will increase until all Hell breaks loose.
2. If Hell is expanding at a rate faster than the increase of souls in Hell,then the temperature and pressure will drop until Hell freezes over.
So which is it?
If we accept the postulate given to me by Teresa during my Freshman year that, 'It will be a cold day in Hell before I sleep with you,' and take into account the fact that I slept with her last night, then number two must be true, and thus I am sure that Hell is exothermic and has already frozen over. The corollary of this theory is that since Hell has frozen over, it follows that it is not accepting any more souls and is therefore, extinct......leaving only Heaven, thereby proving the existence of a divine being which explains why, last night, Teresa kept shouting 'Oh my God.'
The answer by one student was so 'profound' that the professor shared it with colleagues, via the Internet, which is, of course, why we now have the pleasure of enjoying it as well :
Bonus Question: Is Hell exothermic (gives off heat) or endothermic (absorbs heat)?
Most of the students wrote proofs of their beliefs using Boyle's Law (gas cools when it expands and heats when it is compressed) or some variant.
One student, however, wrote the following:
First, we need to know how the mass of Hell is changing in time. So we need to know the rate at which souls are moving into Hell and the rate at which they are leaving. I think that we can safely assume that once a soul gets to Hell, it will not leave. Therefore, no souls are leaving. As for how many souls are entering Hell, let's look at the different religions that exist in the world today.
Most of these religions state that if you are not a member of their religion, you will go to Hell. Since there is more than one of these religions and since people do not belong to more than one religion, we can project that all souls go to Hell. With birth and death rates as they are, we can expect the number of souls in Hell to increase exponentially. Now, we look at the rate of change of the volume in Hell because Boyle's Law states that in order for the temperature and pressure in Hell to stay the same, the volume of Hell has to expand proportionately as souls are added.
This gives two possibilities:
1. If Hell is expanding at a slower rate than the rate at which souls enter Hell, then the temperature and pressure in Hell will increase until all Hell breaks loose.
2. If Hell is expanding at a rate faster than the increase of souls in Hell,then the temperature and pressure will drop until Hell freezes over.
So which is it?
If we accept the postulate given to me by Teresa during my Freshman year that, 'It will be a cold day in Hell before I sleep with you,' and take into account the fact that I slept with her last night, then number two must be true, and thus I am sure that Hell is exothermic and has already frozen over. The corollary of this theory is that since Hell has frozen over, it follows that it is not accepting any more souls and is therefore, extinct......leaving only Heaven, thereby proving the existence of a divine being which explains why, last night, Teresa kept shouting 'Oh my God.'
Monday, March 16, 2009
Mega-Mergers: FAIL
In summary, the current wave of mega-mergers does not solve but rather exacerbates the deeper problems of the pharmaceutical industry. Despite the industry's appetite, its emptying product supply will never be filled without a reliable research-and-development engine. Radical restructuring, not merger mania, is the need of our time.
More on the new Hamburg Sharfstein FDA
US President Barack Obama has named long-time industry critic Dr Joshua Sharfstein as principal deputy commissioner at the Food and Drug Administration (FDA). His choice to lead the agency is former New York City Health Commissioner Dr Margaret Hamburg.
Announcing Dr Hamburg's appointment on March 14, Pres Obama said that, in New York, she had “brought a new life to a demoralized agency, leading an internationally-recognized initiative that cut the tuberculosis rate by nearly half.” She will bring to her new role at the FDA “not only a reputation for integrity but a record of achievement in making Americans safer and more secure,” he added.
Dr “Peggy” Hamburg has not been generally touted as a front-runner for the top FDA post, left vacant in January by the resignation of Dr Andrew von Eschenbach. Her other previous posts include Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services, Assistant Director of the National Institute of Allergy and Infectious Diseases and founding Vice President of the Nuclear Threat Initiative’s Biological Program.
Her appointment has to be confirmed by the Senate but Pres Obama’s choice for her principal deputy does not. A pediatrician and health commissioner for the city of Baltimore, Dr Sharfstein conducted an assessment of the FDA for the Obama transitional team, but hit the headlines in 2007 with his attempts to get the marketing of over-the-counter (OTC) cough and cold medicines to children banned. He is “recognised as a national leader” for these efforts, said Pres Obama, adding: “and he’s designed an award-winning programme to ensure that Americans with disabilities had access to prescription drugs.”
Dr Sharfstein had been widely regarded as joint front-runner, with Cleveland cardiologist and fellow industry critic Dr Steve Nissen, to take over from Dr von Eschenbach, but neither doctor would have been the choice of industry. And responding to the appointments at the weekend, the Pharmaceutical Research and Manufacturers of America (PhRMA) praised Dr Hamburg’s managerial skills, but made no comment on Dr Sharfstein.
However, Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), said he “brings exceptional knowledge of what it takes to ensure the safety and efficacy of the medicines that Americans rely on to improve their health. His commitment to protecting the public health is stellar." Dr Hamburg is “an excellent choice” for FDA Commissioner, Ms Jaeger went on, adding: “now more than ever, FDA needs a strong, smart manager and Dr Hamburg answers that call.”
Dr Sharfstein’s current boss, Baltimore mayor Sheila Dixon, has called him “a superstar within my administration,” while House Energy and Commerce Committee chairman Henry Waxman, welcoming both nominees as “a team that has strong public health credentials and demonstrated management abilities,” added: “I have known Dr Sharfstein for almost 10 years. He is exceptionally intelligent, energetic, and has a deep understanding of public health. He will be a real asset to this Administration.”
By Lynne Taylor
PharmaTimes
Announcing Dr Hamburg's appointment on March 14, Pres Obama said that, in New York, she had “brought a new life to a demoralized agency, leading an internationally-recognized initiative that cut the tuberculosis rate by nearly half.” She will bring to her new role at the FDA “not only a reputation for integrity but a record of achievement in making Americans safer and more secure,” he added.
Dr “Peggy” Hamburg has not been generally touted as a front-runner for the top FDA post, left vacant in January by the resignation of Dr Andrew von Eschenbach. Her other previous posts include Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services, Assistant Director of the National Institute of Allergy and Infectious Diseases and founding Vice President of the Nuclear Threat Initiative’s Biological Program.
Her appointment has to be confirmed by the Senate but Pres Obama’s choice for her principal deputy does not. A pediatrician and health commissioner for the city of Baltimore, Dr Sharfstein conducted an assessment of the FDA for the Obama transitional team, but hit the headlines in 2007 with his attempts to get the marketing of over-the-counter (OTC) cough and cold medicines to children banned. He is “recognised as a national leader” for these efforts, said Pres Obama, adding: “and he’s designed an award-winning programme to ensure that Americans with disabilities had access to prescription drugs.”
Dr Sharfstein had been widely regarded as joint front-runner, with Cleveland cardiologist and fellow industry critic Dr Steve Nissen, to take over from Dr von Eschenbach, but neither doctor would have been the choice of industry. And responding to the appointments at the weekend, the Pharmaceutical Research and Manufacturers of America (PhRMA) praised Dr Hamburg’s managerial skills, but made no comment on Dr Sharfstein.
However, Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), said he “brings exceptional knowledge of what it takes to ensure the safety and efficacy of the medicines that Americans rely on to improve their health. His commitment to protecting the public health is stellar." Dr Hamburg is “an excellent choice” for FDA Commissioner, Ms Jaeger went on, adding: “now more than ever, FDA needs a strong, smart manager and Dr Hamburg answers that call.”
Dr Sharfstein’s current boss, Baltimore mayor Sheila Dixon, has called him “a superstar within my administration,” while House Energy and Commerce Committee chairman Henry Waxman, welcoming both nominees as “a team that has strong public health credentials and demonstrated management abilities,” added: “I have known Dr Sharfstein for almost 10 years. He is exceptionally intelligent, energetic, and has a deep understanding of public health. He will be a real asset to this Administration.”
By Lynne Taylor
PharmaTimes
Some new (to me) blogs
Taxpayers Against Fraud Education Fund is a nonprofit, public interest organization dedicated to combating fraud against the Federal Government through the promotion and use of the Federal False Claims Act and its qui tam provisions.
http://www.taf.org/
Joint Effort - a personal look at US healthcare, with a single payer accent
http://jointeffort.wordpress.com/
The primary purpose of the Labor Campaign for Single-Payer Health Care is to increase grassroots labor support for H.R. 676 as an essential element in winning the support of Congress to enact the National Health Care Act "Medicare for All" as the public policy of this country because we believe that health care is a human right.
http://www.laborforsinglepayer.org/
Physicians for a National Health Program is a non-profit research and education organization of 16,000 physicians, medical students and health professionals who support single-payer national health insurance.
http://www.pnhp.org/
http://www.taf.org/
Joint Effort - a personal look at US healthcare, with a single payer accent
http://jointeffort.wordpress.com/
The primary purpose of the Labor Campaign for Single-Payer Health Care is to increase grassroots labor support for H.R. 676 as an essential element in winning the support of Congress to enact the National Health Care Act "Medicare for All" as the public policy of this country because we believe that health care is a human right.
http://www.laborforsinglepayer.org/
Physicians for a National Health Program is a non-profit research and education organization of 16,000 physicians, medical students and health professionals who support single-payer national health insurance.
http://www.pnhp.org/
What's a quadrillion?
Counting one dollar per second, it would take 32 million years to count to one quadrillion dollars.
How big is the derivatives bubble?
$1.144 quadrillion!
How big is the derivatives bubble?
$1.144 quadrillion!
Sunday, March 15, 2009
AstraZeneca - Seroquel: good news (for their lawyers)
AstraZeneca has already racked up more than $500 million in legal defense costs, according to the company's most recent annual report. The company carries product liability insurance to cover such costs, but it expects legal fees to exceed its insurance coverage
Saturday, March 14, 2009
Pharma Giles writes ......
Stick Out Your Can, It's The Garbageman…
Paris-based pharmaceutical giant Sanawful-Avastmess has a new CFO, starting next week: Jerbil Contaminatedland, a former exec at French waste management company Vileoliar Environment, will move into the finance office as of March 16. His charge, according to a statement from CEO Klaus Volebotherer, is to be "deeply involved in the simplification of our operational structures to adapt our group to future challenges, by firing half of our R&D staff."
“We’ve decided that most of our research is rubbish,” said Vilebastard, “and so it makes sense to hire a CFO with extensive experience of getting rid of large quantities of expensive trash. Let the fly-tipping commence…”
Tales from the parallel universe of reality can be found here and here…
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