blogs created to prevent or detect a crime http://www.opsi.gov.uk/acts/acts1997/ukpga_19970040_en_1
Tuesday, 7 February 2012
** FIDDAMAN blog Exclusive - Scientologist Jan Eastgate, has been charged with perverting the course of justice
http://www.abc.net.au/news/2012-02-07/top-scientologist-charged-with-perverting-justice/3816954?section=nsw
Last year, Ms Eastgate was charged with perverting the course of justice in relation to allegations that she coached an 11-year-old girl to lie to police and community services about the sexual abuse she suffered at the hands of her Scientologist stepfather.
The allegations were raised publicly for the first time on Lateline in 2010.
Today, she was charged with another offence relating to perverting the course of justice.
Ms Eastgate is the international president of the Citizens Commission on Human Rights, an organisation founded by the Church of Scientology. She was awarded the Church's Freedom Medal for promoting human rights in 1988.
Jan Eastgate is due to appear at a committal hearing at Sydney's Downing Centre on May 15. She has yet to enter a plea
GlaxoSmithKline GSK ** Exclusive FIDDAMAN blog reveals profits up sharply
UK drugmaker GlaxoSmithKline has reported pre-tax profits of £1.9bn during the three months to the end of December 2011, up from a £193m loss during the same period in 2010.
For the whole year, the firm reported pre-tax profit of £8.2bn, up from £4.5bn in 2010.
http://www.bbc.co.uk/news/business-16913816
The results were boosted by rising sales in Japan and emerging markets but this was offset by a 4% fall in Europe.
The firm also said it was continuing with its effort to cut costs.
Glaxo - which makes medicines such as Wellbutrin, Zovirax, Ventolin and Advair - has been undergoing a major restructuring over the past three years to try to save money and improve efficiency.
The headline profit figures do not include the costs of restructuring. Taking those into account, Glaxo made £1.7bn from October to December and £7.6bn throughout the whole of 2011.
Analyst reaction has been cautiously positive.
"While the results were superficially slightly disappointing, Q4's underlying picture is positive and reinforces our view that GSK's structural recovery is on track, with the stock likely just beginning a multi-year re-rating," said Emmanuel Papadakis, pharmaceutical analyst at Collins Stewart.
"2012's performance is likely to be buoyed by growing generalist appeal and positive R&D newsflow."
European dip
Chief executive Andrew Witty said sales in Europe had dipped because of poor economic conditions and Glaxo's overall sales were shifting away from "white pills in western markets".
"Pricing pressure in Europe adversely impacted underlying growth in the region by approximately 5 percentage points (approximately £320m) during 2011," said Mr Witty.
"We anticipate a similar impact in 2012. I will acknowledge here the resilience of our European management team in what is a very challenging environment."
Sales in Glaxo's flu vaccine also fell compared with 2010 when it was used against both regular flu and the outbreak of swine flu.
Drug development
The firm announced that it expects to complete development of a new lung drug called Relovair in mid-2012 to treat chronic obstructive pulmonary disease (COPD) and asthma. The new drug would replace its former best-selling lung treatment, Advair.
Relovair is one of a number of new drugs that the company expects to introduce in 2012.
The firm highlighted 15 drugs and vaccines that were in the late stages of development last year, and Mr Witty said that nine of them had finished clinical trials, three were ready to file with regulators and one had already been filed.
Glaxo hopes that the new pipeline of drugs will go some way to avoiding the loss of revenue that occurs when drugs go out of patent and face competition from cheaper generic versions.
"All this comes with increasing signs that we can replenish our pipeline on an ongoing basis," Mr Witty said.
Rival drugs firm AstraZeneca recently announced that profits for the three months to the end of December had fallen to $2.05bn, down from $2.28bn the year before, citing competition from generic drugs as one reason for the drop.
AstraZeneca also announced a further 7,300 job cuts over the next two years as part of a new restructuring programme
For the whole year, the firm reported pre-tax profit of £8.2bn, up from £4.5bn in 2010.
http://www.bbc.co.uk/news/business-16913816
The results were boosted by rising sales in Japan and emerging markets but this was offset by a 4% fall in Europe.
The firm also said it was continuing with its effort to cut costs.
Glaxo - which makes medicines such as Wellbutrin, Zovirax, Ventolin and Advair - has been undergoing a major restructuring over the past three years to try to save money and improve efficiency.
The headline profit figures do not include the costs of restructuring. Taking those into account, Glaxo made £1.7bn from October to December and £7.6bn throughout the whole of 2011.
Analyst reaction has been cautiously positive.
"While the results were superficially slightly disappointing, Q4's underlying picture is positive and reinforces our view that GSK's structural recovery is on track, with the stock likely just beginning a multi-year re-rating," said Emmanuel Papadakis, pharmaceutical analyst at Collins Stewart.
"2012's performance is likely to be buoyed by growing generalist appeal and positive R&D newsflow."
European dip
Chief executive Andrew Witty said sales in Europe had dipped because of poor economic conditions and Glaxo's overall sales were shifting away from "white pills in western markets".
"Pricing pressure in Europe adversely impacted underlying growth in the region by approximately 5 percentage points (approximately £320m) during 2011," said Mr Witty.
"We anticipate a similar impact in 2012. I will acknowledge here the resilience of our European management team in what is a very challenging environment."
Sales in Glaxo's flu vaccine also fell compared with 2010 when it was used against both regular flu and the outbreak of swine flu.
Drug development
The firm announced that it expects to complete development of a new lung drug called Relovair in mid-2012 to treat chronic obstructive pulmonary disease (COPD) and asthma. The new drug would replace its former best-selling lung treatment, Advair.
Relovair is one of a number of new drugs that the company expects to introduce in 2012.
The firm highlighted 15 drugs and vaccines that were in the late stages of development last year, and Mr Witty said that nine of them had finished clinical trials, three were ready to file with regulators and one had already been filed.
Glaxo hopes that the new pipeline of drugs will go some way to avoiding the loss of revenue that occurs when drugs go out of patent and face competition from cheaper generic versions.
"All this comes with increasing signs that we can replenish our pipeline on an ongoing basis," Mr Witty said.
Rival drugs firm AstraZeneca recently announced that profits for the three months to the end of December had fallen to $2.05bn, down from $2.28bn the year before, citing competition from generic drugs as one reason for the drop.
AstraZeneca also announced a further 7,300 job cuts over the next two years as part of a new restructuring programme
PAXIL / Seroxat - "litigation tourism" flood Philadelphia's courts - a new home for FIDDAMAN?
http://www.legalnewsline.com/spotlight/235133-study-shows-plaintiff-bias-in-philly-courts
Study shows plaintiff bias in Philly courts
BY MICHAEL P. TREMOGLIE
Wright
PHILADELPHIA (Legal Newsline) - For years defendants in tort cases have said that Philadelphia's courts are biased, but little in the way of empirical data was available to substantiate the claims.
But, a new study - by Professor Joshua D. Wright for the International Center of Law and Economics (ICLE), Portland, Ore. - indicates that the accusations of structural biases in favor of plaintiffs are justified.
Wright is a law professor at George Mason University School of Law School in Arlington, Va.
The study, originally published in October 2011, has updated information as of February 2012 that confirms its original hypothesis that Philadelphia courts are biased towards plaintiffs.
Initially, the study attempted to answer whether the Philadelphia courts engaged in "litigation tourism," a practice of plaintiffs' attorneys from out-of-state locales suing in courts that have advantageous rules and procedures for defendants.
The study considered all the civil courts in Philadelphia including the Complex Litigation Center (CLC). It determined that Philadelphia is a plaintiff friendly place.
"This preliminary analysis (of a sample of approximately 20% of the Philadelphia Complex Litigation Center's active cases) strongly supports the conclusion that Philadelphia courts demonstrate a meaningful preference for plaintiffs by providing a unique combination of advantages for plaintiffs aimed at coaxing 'business' from other courts outside of Philadelphia and the state," the ICLE study states.
It lists the following as preliminary evidence to back up its claims:
- More than two-thirds of the cases in the sample were brought by plaintiffs located out-of-state and without any apparent connection to Pennsylvania or Philadelphia.
- Of those cases where injury or home address could be determined, fewer than one in seven was brought by plaintiffs residing in Philadelphia.
- The most substantial case types where the plaintiffs were overwhelmingly out-of-state were: hormone therapy, denture adhesive cream, and Paxil birth defect cases.
- Although most or all of the companies involved in these cases do business in Philadelphia and a few have some sort of administrative offices here, the vast majority of defendants do not have their principal place of business in Philadelphia or even in Pennsylvania.
According to the study, Philadelphia employs several "plaintiff-friendly procedural devices, including a more lenient standard for expert testimony and, until recently, a broad application of joint and several liability, where multiple contributors to a tort harm could be held responsible for the entire injury - no matter how small their relative fault. Philadelphia courts compound these with permissive procedural rules including a 'reverse bifurcation' trial, where damages from a purported wrong are calculated prior to establishing liability - as opposed to the normally bifurcated trial, where a plaintiff must establish liability before proving damages."
Last month, however, the CLC temporarily suspended the practice of reverse bifurcation, announcing it would take trials straight through during a study period.
The ICLE monograph continued, "The Philadelphia Complex Litigation Center (CLC) perhaps distinguishes Philadelphia from other Pennsylvania courts; ...hears mass-tort cases and has openly stated its desire to lure 'business away from other courts.' The American Tort Reform Association has labeled Philadelphia courts as a 'judicial hellhole,' amongst the most plaintiff-friendly and lawsuit-inviting jurisdictions in the nation."'
ICLE analyzed litigation trends and outcomes in Philadelphia in relation to the rest of Pennsylvania and the United States. It said that the CLC, which specializes in mass torts and other potentially large-verdict cases, is the main cog that turns the wheel of Philadelphia's litigation environment.
The CLC deals with product liability cases such as asbestos and pharmaceutical litigation. It also attracts class actions where many plaintiffs have little or no connection to Philadelphia.
The procedures adopted by the CLC appear to have successfully increased litigation, bringing in more clients and more work for Pennsylvania lawyers, though likely at significant cost to Pennsylvania consumers and businesses alike, the study states.
The ICLE study also asserted that Philadelphia courts: a) have a larger docket than expected; b) Philadelphia plaintiffs are less likely to settle than other non-Philadelphia Pennsylvania plaintiffs; and c) Philadelphia plaintiffs are disproportionately likely to prefer jury trials.
According to the ICLE, these findings are consistent with a conclusion that Philadelphia courts demonstrate a marked and meaningful preference for plaintiffs, "consistent with both the CLC's intention" of inviting "business" from other courts. It also comments that Philadelphia's courts are a plaintiff-friendly venue.
Philadelphia juries also render unusually high numbers of large damage awards, says the ICLE study, with verdicts routinely exceeding $1 million.
Out-of-state plaintiffs' lawyers prefer the CLC due to its quick and relatively rigid trial dates that outpace the federal Eastern District of Pennsylvania and Multi-District Litigation counterparts; the Philadelphia courts in turn strictly enforce a procedural rule requiring out-of-state attorneys to retain local counsel in prosecuting suits.
While the CLC's caseload declined from more than 15,000 cases in 2004 to just under 3,000 in 2008, Judge Sandra Mazer-Moss replaced Judge Allan Tereshko as coordinating judge of the CLC in 2009 and a new era began. Mass-tort cases in the CLC began anew with hormone replacement therapy suits against several pharmaceutical companies.
ICLE maintains that the implication of its study is that the Philadelphia courts - and the CLC in particular - attract a substantial share of plaintiffs to file cases in the jurisdiction even when neither the plaintiff nor the alleged injury has a connection to Philadelphia or, in many cases, even the state of Pennsylvania. This has been confirmed by data recently added in February 2012 that indicated a fraction of plaintiffs with cases pending at the CLC have no discernible or relevant connection to Philadelphia or to Pennsylvania.
"Using case inventories obtained from the CLC ...we were able to identify the Plaintiff's home address in 1,355 cases," the study says.
"We identified electronically filed complaints in 638 cases and were able to identify the Plaintiff's location of injury in 369 cases. ...Of the 1,357 cases ...67.2% were out-of-state without any apparent connection to Pennsylvania or Philadelphia. Only 13.3% lived in or alleged injury in Philadelphia. The case types which provided the most out-of-state plaintiffs were overwhelmingly Hormone Therapy, Denture Adhesive Cream, and Paxil Birth Defect."
When the report considered only the plaintiffs' home addresses, similar results were yielded. Only 6.1% had Philadelphia home addresses, whereas 72.8 percent reside out of state.
Regarding those cases where evidence of the location of the plaintiff's injury was available electronically, 35.8% of the plaintiffs alleged injury occurred in Philadelphia and only 33.1% alleged injury occurred in another Pennsylvania county.
Nearly all were asbestos cases with 123 plaintiffs reporting exposure in Philadelphia and 119 more plaintiffs reporting exposure in another Pennsylvania city. If they are excluded, only 16% of plaintiffs allege injury in Philadelphia and 12% in another Pennsylvania city.
ICLE claimed that it did not systematically analyze the defendants' locations. It said it appeared that the majority named in major cases in the CLC do not have corporate headquarters in Philadelphia (or Pennsylvania).
For the hormone therapy, asbestos, denture adhesive, and Paxil birth defect cases, which was more than 95% of their sample, the main and largest defendants were Wyeth/Pfizer, GlaxoSmithKline/SmithKline Beecham, Barr Pharmaceuticals/Teva Pharmaceuticals, Goodyear Tires, and Ford Motor Co.
Wyeth has a pharmaceutical division headquarters in Collegeville, Pa. But it is owned now by Pfizer which has a New York City headquarters. Glaxo's U.S. corporate headquarters is in Philadelphia.
Barr Laboratories is a fully owned subsidiary of Teva Pharmaceutical which is headquartered in Montvale, N.J. Goodyear Tires is located in Akron, Ohio, and Ford is located in Dearborn, Mich.
The asbestos complaints would often list every location the plaintiff had ever worked as a location of possible exposure. Often, the complaints would identify a possible source of exposure by location only if it was Philadelphia or another Pennsylvania city. Given the corporate locations, ICLE states it is unlikely that venue was moved to Philadelphia in most or any of the cases at the defendants' behest.
Tort attorney Max Kennerly, of Philadelphia's Beasley firm, has a different take of the ICLE study. He said that the research is erroneous.
"Philadelphia is the home to so many asbestos cases for two reasons," Kennerly said. "First, the Philadelphia Navy Shipyard employed over 40,000 workers during WWII, and so was the primary location where these plaintiffs were exposed to asbestos."
He noted that the study does not mention the role of the Philadelphia Navy Shipyard in asbestos litigation and excludes asbestos in tabulating "plaintiff injury location."
He also said that "more than a decade ago the federal MDL judicial panel created the largest asbestos MDL in the federal courts in Philadelphia. Philadelphia state courts are thus often the most convenient forum for many asbestos defendants because they have already coordinated their defense teams to handle the federal cases in Philadelphia.
"Ninety-five percent of the report's numbers come from hormone therapy, denture adhesive, and Paxil cases, cases which allege negligence by Wyeth and GlaxoSmithKline, both of which have their pharmaceutical divisions headquartered in the area," he said.
"If these companies didn't have their 'nerve center' in Pennsylvania, they would have removed the cases to federal court under the Supreme Court's Hertz Corp. v. Friend opinion."
He maintains that "generally, it doesn't make sense to focus on the plaintiff's home for the consolidation of mass torts cases because mass torts victims are spread out all over the country.
"The whole point of consolidation is to avoid overburdening courts across the country with cases that involve common issues...When we as a society consider how mass torts cases should be resolved, one important issue is the efficiency of the court systems involved, and few dispute that Philadelphia is one of the most efficient court systems in the country."
A 2004 study performed by the National Center for State Courts (NCSC) did indeed praise Philadelphia's courts for efficiency. However, that study was commissioned by the First Judicial District of Pennsylvania - which is the Philadelphia courts.
According to NCSC, this efficiency is responsible for the migration of cases to Philadelphia. It is not because of plaintiff bias, but because the cases will be disposed of quickly, the NCSC study states.
The NCSC study essentially was a commentary of the speed with which cases are processed in Philadelphia, not a discernment of any trends in verdicts or bias in procedures..
"...the Civil Section has undertaken an impressive effort to eliminate its case backlog and improve the flow of cases. This effort has met with considerable success in reducing the size of its pending civil inventory and the age of cases at disposition."
A third source, the Department of Justice's Bureau of Justice Statistics (BJS), seems to sustain what the ICLE study says. This was a survey of tort bench and jury trials for 2005.
According to the study, Philadelphia had 539 trials of all torts in 2005. Plaintiffs (308) were the winners in 57.5% of those trials.
At 308 plaintiff victories, the city was ranked number one among the 75 most populous counties.
Of the 75 most populous counties surveyed by BJS, Philadelphia had the second highest number of civil trials in state courts with litigants seeking punitive damages (608) and the second highest number of plaintiff winners (357).
Cases in which the plaintiff claimed medical malpractice were most often disposed of by juries (99%). This was followed by asbestos litigation (95%).
http://www.legalnewsline.com/spotlight/235133-study-shows-plaintiff-bias-in-philly-courts
Study shows plaintiff bias in Philly courts
BY MICHAEL P. TREMOGLIE
Wright
PHILADELPHIA (Legal Newsline) - For years defendants in tort cases have said that Philadelphia's courts are biased, but little in the way of empirical data was available to substantiate the claims.
But, a new study - by Professor Joshua D. Wright for the International Center of Law and Economics (ICLE), Portland, Ore. - indicates that the accusations of structural biases in favor of plaintiffs are justified.
Wright is a law professor at George Mason University School of Law School in Arlington, Va.
The study, originally published in October 2011, has updated information as of February 2012 that confirms its original hypothesis that Philadelphia courts are biased towards plaintiffs.
Initially, the study attempted to answer whether the Philadelphia courts engaged in "litigation tourism," a practice of plaintiffs' attorneys from out-of-state locales suing in courts that have advantageous rules and procedures for defendants.
The study considered all the civil courts in Philadelphia including the Complex Litigation Center (CLC). It determined that Philadelphia is a plaintiff friendly place.
"This preliminary analysis (of a sample of approximately 20% of the Philadelphia Complex Litigation Center's active cases) strongly supports the conclusion that Philadelphia courts demonstrate a meaningful preference for plaintiffs by providing a unique combination of advantages for plaintiffs aimed at coaxing 'business' from other courts outside of Philadelphia and the state," the ICLE study states.
It lists the following as preliminary evidence to back up its claims:
- More than two-thirds of the cases in the sample were brought by plaintiffs located out-of-state and without any apparent connection to Pennsylvania or Philadelphia.
- Of those cases where injury or home address could be determined, fewer than one in seven was brought by plaintiffs residing in Philadelphia.
- The most substantial case types where the plaintiffs were overwhelmingly out-of-state were: hormone therapy, denture adhesive cream, and Paxil birth defect cases.
- Although most or all of the companies involved in these cases do business in Philadelphia and a few have some sort of administrative offices here, the vast majority of defendants do not have their principal place of business in Philadelphia or even in Pennsylvania.
According to the study, Philadelphia employs several "plaintiff-friendly procedural devices, including a more lenient standard for expert testimony and, until recently, a broad application of joint and several liability, where multiple contributors to a tort harm could be held responsible for the entire injury - no matter how small their relative fault. Philadelphia courts compound these with permissive procedural rules including a 'reverse bifurcation' trial, where damages from a purported wrong are calculated prior to establishing liability - as opposed to the normally bifurcated trial, where a plaintiff must establish liability before proving damages."
Last month, however, the CLC temporarily suspended the practice of reverse bifurcation, announcing it would take trials straight through during a study period.
The ICLE monograph continued, "The Philadelphia Complex Litigation Center (CLC) perhaps distinguishes Philadelphia from other Pennsylvania courts; ...hears mass-tort cases and has openly stated its desire to lure 'business away from other courts.' The American Tort Reform Association has labeled Philadelphia courts as a 'judicial hellhole,' amongst the most plaintiff-friendly and lawsuit-inviting jurisdictions in the nation."'
ICLE analyzed litigation trends and outcomes in Philadelphia in relation to the rest of Pennsylvania and the United States. It said that the CLC, which specializes in mass torts and other potentially large-verdict cases, is the main cog that turns the wheel of Philadelphia's litigation environment.
The CLC deals with product liability cases such as asbestos and pharmaceutical litigation. It also attracts class actions where many plaintiffs have little or no connection to Philadelphia.
The procedures adopted by the CLC appear to have successfully increased litigation, bringing in more clients and more work for Pennsylvania lawyers, though likely at significant cost to Pennsylvania consumers and businesses alike, the study states.
The ICLE study also asserted that Philadelphia courts: a) have a larger docket than expected; b) Philadelphia plaintiffs are less likely to settle than other non-Philadelphia Pennsylvania plaintiffs; and c) Philadelphia plaintiffs are disproportionately likely to prefer jury trials.
According to the ICLE, these findings are consistent with a conclusion that Philadelphia courts demonstrate a marked and meaningful preference for plaintiffs, "consistent with both the CLC's intention" of inviting "business" from other courts. It also comments that Philadelphia's courts are a plaintiff-friendly venue.
Philadelphia juries also render unusually high numbers of large damage awards, says the ICLE study, with verdicts routinely exceeding $1 million.
Out-of-state plaintiffs' lawyers prefer the CLC due to its quick and relatively rigid trial dates that outpace the federal Eastern District of Pennsylvania and Multi-District Litigation counterparts; the Philadelphia courts in turn strictly enforce a procedural rule requiring out-of-state attorneys to retain local counsel in prosecuting suits.
While the CLC's caseload declined from more than 15,000 cases in 2004 to just under 3,000 in 2008, Judge Sandra Mazer-Moss replaced Judge Allan Tereshko as coordinating judge of the CLC in 2009 and a new era began. Mass-tort cases in the CLC began anew with hormone replacement therapy suits against several pharmaceutical companies.
ICLE maintains that the implication of its study is that the Philadelphia courts - and the CLC in particular - attract a substantial share of plaintiffs to file cases in the jurisdiction even when neither the plaintiff nor the alleged injury has a connection to Philadelphia or, in many cases, even the state of Pennsylvania. This has been confirmed by data recently added in February 2012 that indicated a fraction of plaintiffs with cases pending at the CLC have no discernible or relevant connection to Philadelphia or to Pennsylvania.
"Using case inventories obtained from the CLC ...we were able to identify the Plaintiff's home address in 1,355 cases," the study says.
"We identified electronically filed complaints in 638 cases and were able to identify the Plaintiff's location of injury in 369 cases. ...Of the 1,357 cases ...67.2% were out-of-state without any apparent connection to Pennsylvania or Philadelphia. Only 13.3% lived in or alleged injury in Philadelphia. The case types which provided the most out-of-state plaintiffs were overwhelmingly Hormone Therapy, Denture Adhesive Cream, and Paxil Birth Defect."
When the report considered only the plaintiffs' home addresses, similar results were yielded. Only 6.1% had Philadelphia home addresses, whereas 72.8 percent reside out of state.
Regarding those cases where evidence of the location of the plaintiff's injury was available electronically, 35.8% of the plaintiffs alleged injury occurred in Philadelphia and only 33.1% alleged injury occurred in another Pennsylvania county.
Nearly all were asbestos cases with 123 plaintiffs reporting exposure in Philadelphia and 119 more plaintiffs reporting exposure in another Pennsylvania city. If they are excluded, only 16% of plaintiffs allege injury in Philadelphia and 12% in another Pennsylvania city.
ICLE claimed that it did not systematically analyze the defendants' locations. It said it appeared that the majority named in major cases in the CLC do not have corporate headquarters in Philadelphia (or Pennsylvania).
For the hormone therapy, asbestos, denture adhesive, and Paxil birth defect cases, which was more than 95% of their sample, the main and largest defendants were Wyeth/Pfizer, GlaxoSmithKline/SmithKline Beecham, Barr Pharmaceuticals/Teva Pharmaceuticals, Goodyear Tires, and Ford Motor Co.
Wyeth has a pharmaceutical division headquarters in Collegeville, Pa. But it is owned now by Pfizer which has a New York City headquarters. Glaxo's U.S. corporate headquarters is in Philadelphia.
Barr Laboratories is a fully owned subsidiary of Teva Pharmaceutical which is headquartered in Montvale, N.J. Goodyear Tires is located in Akron, Ohio, and Ford is located in Dearborn, Mich.
The asbestos complaints would often list every location the plaintiff had ever worked as a location of possible exposure. Often, the complaints would identify a possible source of exposure by location only if it was Philadelphia or another Pennsylvania city. Given the corporate locations, ICLE states it is unlikely that venue was moved to Philadelphia in most or any of the cases at the defendants' behest.
Tort attorney Max Kennerly, of Philadelphia's Beasley firm, has a different take of the ICLE study. He said that the research is erroneous.
"Philadelphia is the home to so many asbestos cases for two reasons," Kennerly said. "First, the Philadelphia Navy Shipyard employed over 40,000 workers during WWII, and so was the primary location where these plaintiffs were exposed to asbestos."
He noted that the study does not mention the role of the Philadelphia Navy Shipyard in asbestos litigation and excludes asbestos in tabulating "plaintiff injury location."
He also said that "more than a decade ago the federal MDL judicial panel created the largest asbestos MDL in the federal courts in Philadelphia. Philadelphia state courts are thus often the most convenient forum for many asbestos defendants because they have already coordinated their defense teams to handle the federal cases in Philadelphia.
"Ninety-five percent of the report's numbers come from hormone therapy, denture adhesive, and Paxil cases, cases which allege negligence by Wyeth and GlaxoSmithKline, both of which have their pharmaceutical divisions headquartered in the area," he said.
"If these companies didn't have their 'nerve center' in Pennsylvania, they would have removed the cases to federal court under the Supreme Court's Hertz Corp. v. Friend opinion."
He maintains that "generally, it doesn't make sense to focus on the plaintiff's home for the consolidation of mass torts cases because mass torts victims are spread out all over the country.
"The whole point of consolidation is to avoid overburdening courts across the country with cases that involve common issues...When we as a society consider how mass torts cases should be resolved, one important issue is the efficiency of the court systems involved, and few dispute that Philadelphia is one of the most efficient court systems in the country."
A 2004 study performed by the National Center for State Courts (NCSC) did indeed praise Philadelphia's courts for efficiency. However, that study was commissioned by the First Judicial District of Pennsylvania - which is the Philadelphia courts.
According to NCSC, this efficiency is responsible for the migration of cases to Philadelphia. It is not because of plaintiff bias, but because the cases will be disposed of quickly, the NCSC study states.
The NCSC study essentially was a commentary of the speed with which cases are processed in Philadelphia, not a discernment of any trends in verdicts or bias in procedures..
"...the Civil Section has undertaken an impressive effort to eliminate its case backlog and improve the flow of cases. This effort has met with considerable success in reducing the size of its pending civil inventory and the age of cases at disposition."
A third source, the Department of Justice's Bureau of Justice Statistics (BJS), seems to sustain what the ICLE study says. This was a survey of tort bench and jury trials for 2005.
According to the study, Philadelphia had 539 trials of all torts in 2005. Plaintiffs (308) were the winners in 57.5% of those trials.
At 308 plaintiff victories, the city was ranked number one among the 75 most populous counties.
Of the 75 most populous counties surveyed by BJS, Philadelphia had the second highest number of civil trials in state courts with litigants seeking punitive damages (608) and the second highest number of plaintiff winners (357).
Cases in which the plaintiff claimed medical malpractice were most often disposed of by juries (99%). This was followed by asbestos litigation (95%).
http://www.legalnewsline.com/spotlight/235133-study-shows-plaintiff-bias-in-philly-courts
Antidepressant-suicide link in youths absent in new analysis - FIDDAMAN blog ** Exclusive
Antidepressant-suicide link in youths absent in new analysis
February 6, 2012 http://medicalxpress.com/news/2012-02-antidepressant-suicide-link-youths-absent-analysis.html
February 6, 2012 http://medicalxpress.com/news/2012-02-antidepressant-suicide-link-youths-absent-analysis.html
Monday, 6 February 2012
Benefit cuts are fuelling abuse of disabled people ....** Exclusive FIDDAMAN counterpoint blog
The government's focus on alleged fraud and overclaiming to justify cuts in disability benefits has caused an increase in resentment and abuse directed at disabled people, as they find themselves being labelled as scroungers, six of the country's biggest disability groups have warned
http://www.guardian.co.uk/society/2012/feb/05/benefit-cuts-fuelling-abuse-disabled-people?newsfeed=true
http://www.guardian.co.uk/society/2012/feb/05/benefit-cuts-fuelling-abuse-disabled-people?newsfeed=true
Sunday, 5 February 2012
Saturday, 4 February 2012
Seroxat PAXIL 329 University will not support Keller retraction - FIDDAMAN ** Exclusive counterpoint blog
The University will not support an effort to retract a controversial study co-authored by Professor of Psychiatry and Human Behavior Martin Keller, wrote Edward Wing, dean of medicine and biological sciences, in a recent letter to the global nonprofit Healthy Skepticism.
http://www.browndailyherald.com/u-will-not-support-keller-retraction-1.2694739
The study — commonly referred to as Study 329 — identified the drug Paxil as an effective combatant of adolescent depression. Since its publication in 2001, the study has raised concerns due to findings that link Paxil to higher rates of suicidal tendencies.
Citing claims that Keller's study intentionally misrepresented the effectiveness of Paxil by suppressing data, Healthy Skepticism asked the University to write to the Journal of the American Academy of Child and Adolescent Psychiatry and request a retraction of the findings, The Herald reported in November.
Jon Jureidini, a co-author of the Healthy Skepticism letters and a professor at the University of Adelaide in Australia, received Wing's most recent reply on Monday. In an email to The Herald, Jureidini wrote that Healthy Skepticism would not be discouraged by the University's response, though he added he was unsure how the group would proceed.
"One hopes that universities are leaders in moral and scientific integrity, but how can they expect students to acquire such values when their behavior directly contradicts their stated policies?" wrote Healthy Skepticism co-author Leemon McHenry in an email to The Herald. McHenry is also a researcher, lecturer and part-time professor at California State University in Northridge.
Wing declined to comment, citing confidentiality reasons.
In its initial letter to the University last October, Healthy Skepticism expressed concerns that the study's continued citation is misleading doctors and harming adolescents. The letter accused Paxil's parent company GlaxoSmithKline of ghostwriting the study and alleged that the study's authors withheld data connecting Paxil usage to suicidal tendencies to protect GlaxoSmithKline's profits.
The allegations have their roots in several ethical examinations of Study 329, including an investigation by the Senate Finance Committee, a documentary by the BBC, a 2008 book and several journal articles.
Keller acknowledged in a 2006 deposition that he had received tens of thousands of dollars from GlaxoSmithKline and its affiliates over the years, The Herald reported in 2008.
Wing first responded to Healthy Skepticism's letter in November. "The University takes seriously any questions about the soundness of faculty-conducted research," Wing wrote in the letter. "I would caution you not to confuse the University's policy of confidentiality with inactivity."
Healthy Skepticism replied in December, reiterating its call for an open letter requesting retraction and asking for a date by which the University would complete its internal review of the charges against Keller. Wing's most recent reply did not include an estimated date.
Keller, who stepped down as chair of the psychiatry department in 2009 but remains a professor, did not respond to multiple requests for comment
http://www.browndailyherald.com/u-will-not-support-keller-retraction-1.2694739
The study — commonly referred to as Study 329 — identified the drug Paxil as an effective combatant of adolescent depression. Since its publication in 2001, the study has raised concerns due to findings that link Paxil to higher rates of suicidal tendencies.
Citing claims that Keller's study intentionally misrepresented the effectiveness of Paxil by suppressing data, Healthy Skepticism asked the University to write to the Journal of the American Academy of Child and Adolescent Psychiatry and request a retraction of the findings, The Herald reported in November.
Jon Jureidini, a co-author of the Healthy Skepticism letters and a professor at the University of Adelaide in Australia, received Wing's most recent reply on Monday. In an email to The Herald, Jureidini wrote that Healthy Skepticism would not be discouraged by the University's response, though he added he was unsure how the group would proceed.
"One hopes that universities are leaders in moral and scientific integrity, but how can they expect students to acquire such values when their behavior directly contradicts their stated policies?" wrote Healthy Skepticism co-author Leemon McHenry in an email to The Herald. McHenry is also a researcher, lecturer and part-time professor at California State University in Northridge.
Wing declined to comment, citing confidentiality reasons.
In its initial letter to the University last October, Healthy Skepticism expressed concerns that the study's continued citation is misleading doctors and harming adolescents. The letter accused Paxil's parent company GlaxoSmithKline of ghostwriting the study and alleged that the study's authors withheld data connecting Paxil usage to suicidal tendencies to protect GlaxoSmithKline's profits.
The allegations have their roots in several ethical examinations of Study 329, including an investigation by the Senate Finance Committee, a documentary by the BBC, a 2008 book and several journal articles.
Keller acknowledged in a 2006 deposition that he had received tens of thousands of dollars from GlaxoSmithKline and its affiliates over the years, The Herald reported in 2008.
Wing first responded to Healthy Skepticism's letter in November. "The University takes seriously any questions about the soundness of faculty-conducted research," Wing wrote in the letter. "I would caution you not to confuse the University's policy of confidentiality with inactivity."
Healthy Skepticism replied in December, reiterating its call for an open letter requesting retraction and asking for a date by which the University would complete its internal review of the charges against Keller. Wing's most recent reply did not include an estimated date.
Keller, who stepped down as chair of the psychiatry department in 2009 but remains a professor, did not respond to multiple requests for comment
SCIENTOLOGY, convicted of FRAUD in France, loses court appeal - FIDDAMAN blog
Court upholds Scientology fraud ruling in France
RUADHÁN MAC CORMAIC in Paris
http://www.irishtimes.com/newspaper/world/2012/0203/1224311175786.html
A FRENCH appeals court has upheld fraud charges and a €600,000 fine against the Church of Scientology for cajoling followers into paying large sums for bogus personality tests and cures.
Rejecting the church’s appeal against a 2009 ruling, the court said two French branches of the US-based organisation were guilty of “organised fraud” and gave four of its leaders suspended jail sentences of up to two years.
A French parliamentary committee described Scientology in 1995 as a “dangerous cult”, not a religion, and individual Scientologists had been prosecuted before, but this case marked the first time the organisation as a whole was convicted.
There had been expectations the French courts might ban the group, but legislation passed just before the original trial in May 2009 ruled that out.
The latest ruling found Scientology’s “celebrity centre” and its bookshop in Paris had taken advantage of vulnerable individuals in the 1990s. A personality test offered to followers had “no scientific value” and expensive treatments recommended on foot of negative results were purely a source of revenue.
The five plaintiffs in the case had accused the group of persuading them to spend tens of thousands of euro on the personality tests, vitamin cures, sauna sessions and “purification packs”.
“This is very good news for those who fight against cults and it is a serious defeat for the Church of Scientology,” said Olivier Morice, a lawyer for the plaintiffs.
Mr Morice said that while Scientology could still operate in France, the court’s ruling went to the heart of its activities and opened the door to a ban or dissolution as a possible outcome in other pending lawsuits.
Prosecutors had originally hoped the 2009 trial would lead to a ban in France. However, a change in French law that was approved shortly before a verdict briefly made it impossible to ban or dissolve a group convicted of fraud.
The law has since been changed back, but a ban on the group or its dissolution cannot be enforced retroactively.
Commenting yesterday, the church called the ruling “illegal” and said it would seek to have it overturned through a final appeal to the Cour de Cassation, France’s highest court, which can assess whether the law was applied correctly but not re-examine evidence.
“The church wishes that the fairness of justice, such as protected by our constitution, becomes a reality once again for all the citizens of our country, scientologists included,” a statement said.
The accused and their lawyers were not in court for yesterday’s verdict, but a few dozen scientologists protested outside the court with signs that read “I have the right to my religion”. In 1997 and 1999, French courts convicted Scientology members of fraud, while a court fined the church for violating privacy laws in 2002.
Founded in 1954 by science fiction writer L Ron Hubbard, the church bases its beliefs on the study of his 1950 book, Dianetics: The Modern Science of Mental Health
RUADHÁN MAC CORMAIC in Paris
http://www.irishtimes.com/newspaper/world/2012/0203/1224311175786.html
A FRENCH appeals court has upheld fraud charges and a €600,000 fine against the Church of Scientology for cajoling followers into paying large sums for bogus personality tests and cures.
Rejecting the church’s appeal against a 2009 ruling, the court said two French branches of the US-based organisation were guilty of “organised fraud” and gave four of its leaders suspended jail sentences of up to two years.
A French parliamentary committee described Scientology in 1995 as a “dangerous cult”, not a religion, and individual Scientologists had been prosecuted before, but this case marked the first time the organisation as a whole was convicted.
There had been expectations the French courts might ban the group, but legislation passed just before the original trial in May 2009 ruled that out.
The latest ruling found Scientology’s “celebrity centre” and its bookshop in Paris had taken advantage of vulnerable individuals in the 1990s. A personality test offered to followers had “no scientific value” and expensive treatments recommended on foot of negative results were purely a source of revenue.
The five plaintiffs in the case had accused the group of persuading them to spend tens of thousands of euro on the personality tests, vitamin cures, sauna sessions and “purification packs”.
“This is very good news for those who fight against cults and it is a serious defeat for the Church of Scientology,” said Olivier Morice, a lawyer for the plaintiffs.
Mr Morice said that while Scientology could still operate in France, the court’s ruling went to the heart of its activities and opened the door to a ban or dissolution as a possible outcome in other pending lawsuits.
Prosecutors had originally hoped the 2009 trial would lead to a ban in France. However, a change in French law that was approved shortly before a verdict briefly made it impossible to ban or dissolve a group convicted of fraud.
The law has since been changed back, but a ban on the group or its dissolution cannot be enforced retroactively.
Commenting yesterday, the church called the ruling “illegal” and said it would seek to have it overturned through a final appeal to the Cour de Cassation, France’s highest court, which can assess whether the law was applied correctly but not re-examine evidence.
“The church wishes that the fairness of justice, such as protected by our constitution, becomes a reality once again for all the citizens of our country, scientologists included,” a statement said.
The accused and their lawyers were not in court for yesterday’s verdict, but a few dozen scientologists protested outside the court with signs that read “I have the right to my religion”. In 1997 and 1999, French courts convicted Scientology members of fraud, while a court fined the church for violating privacy laws in 2002.
Founded in 1954 by science fiction writer L Ron Hubbard, the church bases its beliefs on the study of his 1950 book, Dianetics: The Modern Science of Mental Health
Friday, 3 February 2012
Children exposed to anaesthetic early in life 'have double risk of ADHD' - FIDDAMAN blog
Toddlers exposed to anaesthesia are more likely to develop attention-deficit/hyperactivity disorder (ADHD), a study has found.
Children who were given two or more doses of anaesthetic before they turned three years old had more than double the incidence of ADHD than children who had no exposure, the Mayo Clinic research found.
Dr David Warner, a pediatric anaesthsiologist and investigator on the observational study, decided to investigate the effects of anaesthesia when basic science studies began to suggest it causes changes in the brains of young animals.
'Those studies piqued our interest,' Dr. Warner says. 'We were sceptical that the findings in animals would correlate with kids, but it appears that it does.'
The study used results of an existing epidemiological study that looked at educational records of children born between 1976 and 1982 in Rochester, Minnesota, and determined those who developed some form of learning disability or ADHD.
Among 341 cases of ADHD in those younger than 19, researchers traced medical records in the Rochester Epidemiology Project, a decades-long database of all patient care in Olmsted County, Minnesota, looking for exposure to anaesthesia and surgery before they were three years old.
Children who had no exposure to anaesthesia and surgery had ADHD at a rate of 7.3 per cent. The rate after a single exposure was approximately the same.
For children who had two or more exposures to anaesthesia and surgery, the rate of ADHD was 17.9 per cent
For children who had two or more exposures to anaesthesia and surgery, the rate of ADHD was 17.9 per cent - even after researchers adjusted for other factors, including gestational age, sex and birth weight.
The results of the study, however, do not definitively mean that anaesthesia causes ADHD.
'This is an observational study,' D Warner says.
'A wide range of other factors might be responsible for the higher frequency of ADHD in children with multiple exposures.
'The findings certainly do suggest that further investigation into this area is warranted, and investigators at Mayo Clinic and elsewhere are actively pursuing these studies.
Read more: http://www.dailymail.co.uk/health/article-2096022/Children-exposed-anaesthetic-early-life-double-risk-ADHD.html#ixzz1lMMZsJsm
Children who were given two or more doses of anaesthetic before they turned three years old had more than double the incidence of ADHD than children who had no exposure, the Mayo Clinic research found.
Dr David Warner, a pediatric anaesthsiologist and investigator on the observational study, decided to investigate the effects of anaesthesia when basic science studies began to suggest it causes changes in the brains of young animals.
'Those studies piqued our interest,' Dr. Warner says. 'We were sceptical that the findings in animals would correlate with kids, but it appears that it does.'
The study used results of an existing epidemiological study that looked at educational records of children born between 1976 and 1982 in Rochester, Minnesota, and determined those who developed some form of learning disability or ADHD.
Among 341 cases of ADHD in those younger than 19, researchers traced medical records in the Rochester Epidemiology Project, a decades-long database of all patient care in Olmsted County, Minnesota, looking for exposure to anaesthesia and surgery before they were three years old.
Children who had no exposure to anaesthesia and surgery had ADHD at a rate of 7.3 per cent. The rate after a single exposure was approximately the same.
For children who had two or more exposures to anaesthesia and surgery, the rate of ADHD was 17.9 per cent
For children who had two or more exposures to anaesthesia and surgery, the rate of ADHD was 17.9 per cent - even after researchers adjusted for other factors, including gestational age, sex and birth weight.
The results of the study, however, do not definitively mean that anaesthesia causes ADHD.
'This is an observational study,' D Warner says.
'A wide range of other factors might be responsible for the higher frequency of ADHD in children with multiple exposures.
'The findings certainly do suggest that further investigation into this area is warranted, and investigators at Mayo Clinic and elsewhere are actively pursuing these studies.
Read more: http://www.dailymail.co.uk/health/article-2096022/Children-exposed-anaesthetic-early-life-double-risk-ADHD.html#ixzz1lMMZsJsm
SEROXAT - Abnormal Brain Structure Implicated in Stimulant Drug Addiction - FIDDAMAN counterpoint blog
Science 3 February 2012:
Vol. 335 no. 6068 pp. 601-604
DOI: 10.1126/science.1214463
•Report http://www.sciencemag.org/content/335/6068/601.abstract
Abnormal Brain Structure Implicated in Stimulant Drug Addiction
Karen D. Ersche1,*, P. Simon Jones1, Guy B. Williams1,2, Abigail J Turton1, Trevor W. Robbins1, Edward T. Bullmore1,3,4
+ Author Affiliations
1Behavioural and Clinical Neuroscience Institute and Department of Experimental Psychology and Department of Psychiatry, University of Cambridge, Cambridge, CB2 3EB and CB2 0SZ, UK.
2Wolfson Brain Imaging Centre, Department of Clinical Neurosciences, University of Cambridge, Cambridge CB2 0QQ, UK.
3Clinical Unit Cambridge, GlaxoSmithKline, Addenbrooke’s Centre for Clinical Investigations, Cambridge CB2 2GG, UK.
4Cambridgeshire and Peterborough Foundation, National Health Service Trust, Cambridge CB21 5EF, UK.
↵*To whom correspondence should be addressed. E-mail: ke220@cam.ac.uk
Abstract
Addiction to drugs is a major contemporary public health issue, characterized by maladaptive behavior to obtain and consume an increasing amount of drugs at the expense of the individual’s health and social and personal life. We discovered abnormalities in fronto-striatal brain systems implicated in self-control in both stimulant-dependent individuals and their biological siblings who have no history of chronic drug abuse; these findings support the idea of an underlying neurocognitive endophenotype for stimulant drug addiction.
Received for publication 26 September 2011.
Accepted for publication 29 November 2011.
Vol. 335 no. 6068 pp. 601-604
DOI: 10.1126/science.1214463
•Report http://www.sciencemag.org/content/335/6068/601.abstract
Abnormal Brain Structure Implicated in Stimulant Drug Addiction
Karen D. Ersche1,*, P. Simon Jones1, Guy B. Williams1,2, Abigail J Turton1, Trevor W. Robbins1, Edward T. Bullmore1,3,4
+ Author Affiliations
1Behavioural and Clinical Neuroscience Institute and Department of Experimental Psychology and Department of Psychiatry, University of Cambridge, Cambridge, CB2 3EB and CB2 0SZ, UK.
2Wolfson Brain Imaging Centre, Department of Clinical Neurosciences, University of Cambridge, Cambridge CB2 0QQ, UK.
3Clinical Unit Cambridge, GlaxoSmithKline, Addenbrooke’s Centre for Clinical Investigations, Cambridge CB2 2GG, UK.
4Cambridgeshire and Peterborough Foundation, National Health Service Trust, Cambridge CB21 5EF, UK.
↵*To whom correspondence should be addressed. E-mail: ke220@cam.ac.uk
Abstract
Addiction to drugs is a major contemporary public health issue, characterized by maladaptive behavior to obtain and consume an increasing amount of drugs at the expense of the individual’s health and social and personal life. We discovered abnormalities in fronto-striatal brain systems implicated in self-control in both stimulant-dependent individuals and their biological siblings who have no history of chronic drug abuse; these findings support the idea of an underlying neurocognitive endophenotype for stimulant drug addiction.
Received for publication 26 September 2011.
Accepted for publication 29 November 2011.
Tuesday, 31 January 2012
Experts want suicide risk warning on ADHD drug - Focalin, see FIDDAMAN counterpoint blog
GAITHERSBURG, Maryland (Reuters) - Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S. pediatric health advisers said on Monday.
http://www.reuters.com/article/2012/01/30/us-fda-adhd-idUSTRE80T1WI20120130
Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older.
The FDA often follows the advice of its committees, although it is not required to.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.
"The suicidal ideation seems to be pretty serious," said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children's Hospital.
But the FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.
"I'm somewhat puzzled by the focus of suicidal ideation," said Tom Laughren, head of the FDA's psychiatric products division, in response to the panel's recommendation.
"These drugs are very widely used. And what you're seeing here are a handful of reports that are difficult to interpret with regard to causality," he said.
The number of children diagnosed with attention deficit hyperactivity disorder (ADHD) has skyrocketed in recent years, with the condition now affecting 3 to 5 percent of kids globally.
Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school. There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication.
In the United States, some 2.7 million people have prescriptions for ADHD drugs including Novartis' Ritalin, Johnson & Johnson's Concerta, Shire's Adderall and Vyvanse and Eli Lilly's Strattera.
Some patient advocates say doctors and parents may be too quick to diagnose kids with the condition, and the drugs may cause side effects that can damage children's health.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011.
The label for Focalin already warns patients that they may have new psychotic or manic symptoms after taking the drug, but does not mention suicidal thoughts.
Out of other ADHD drugs, only Strattera's label mentions thoughts of suicide as a side effect, as part of a restrictive "black box" warning.
The FDA monitors reports of side effects from medicines after they've been approved in order to discover potential safety problems. For drugs that are used by children, the agency must hold regular advisory meetings to review their safety.
The advisory committee and FDA reviewers also recommended a change to Focalin's label to reflect the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
Novartis said it is will make any necessary changes to Focalin's label after discussing them with the FDA.
"Novartis is committed to patient safety and will continue to work closely with the FDA as the agency completes its review," said Brandi Robinson, spokeswoman for the company.
(Reporting by Anna Yukhananov; Editing by Richard Chang)
http://www.reuters.com/article/2012/01/30/us-fda-adhd-idUSTRE80T1WI20120130
Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk. The drug is approved for children aged 6 or older.
The FDA often follows the advice of its committees, although it is not required to.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine. The link for the remaining cases was less clear.
"The suicidal ideation seems to be pretty serious," said Dr. Sheldon Kaplan, panel member and chief of infectious diseases at Texas Children's Hospital.
But the FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.
"I'm somewhat puzzled by the focus of suicidal ideation," said Tom Laughren, head of the FDA's psychiatric products division, in response to the panel's recommendation.
"These drugs are very widely used. And what you're seeing here are a handful of reports that are difficult to interpret with regard to causality," he said.
The number of children diagnosed with attention deficit hyperactivity disorder (ADHD) has skyrocketed in recent years, with the condition now affecting 3 to 5 percent of kids globally.
Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school. There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication.
In the United States, some 2.7 million people have prescriptions for ADHD drugs including Novartis' Ritalin, Johnson & Johnson's Concerta, Shire's Adderall and Vyvanse and Eli Lilly's Strattera.
Some patient advocates say doctors and parents may be too quick to diagnose kids with the condition, and the drugs may cause side effects that can damage children's health.
The FDA said about 1.8 million children received prescriptions for Focalin or its generic versions from May 2005 to July 2011.
The label for Focalin already warns patients that they may have new psychotic or manic symptoms after taking the drug, but does not mention suicidal thoughts.
Out of other ADHD drugs, only Strattera's label mentions thoughts of suicide as a side effect, as part of a restrictive "black box" warning.
The FDA monitors reports of side effects from medicines after they've been approved in order to discover potential safety problems. For drugs that are used by children, the agency must hold regular advisory meetings to review their safety.
The advisory committee and FDA reviewers also recommended a change to Focalin's label to reflect the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.
Novartis said it is will make any necessary changes to Focalin's label after discussing them with the FDA.
"Novartis is committed to patient safety and will continue to work closely with the FDA as the agency completes its review," said Brandi Robinson, spokeswoman for the company.
(Reporting by Anna Yukhananov; Editing by Richard Chang)
Sunday, 29 January 2012
Fiddaman goes for a career change, could it be Pharmacokinetics Assessor - MHRA?
Recently added vacanciesPurpose of role:
The Licensing Division is responsible for the quality, safety and efficacy evaluation of all applications for medicinal products to be authorised for the UK through national and EU Community procedures. To reflect the importance of pharmacokinetic data in the evaluation of clinical safety and efficacy and the increasing use of pharmacometrics in drug development we have a new post for a pharmacokineticist in the Division to integrate knowledge of pharmacokinetics into the assessment of safety and efficacy.
Key responsibilities:
Your scientific and professional expertise in pharmacokinetics will be vital in this challenging role, as you will work alongside clinical pharmacologists, clinicians and biostatisticians to evaluate the efficacy and clinical safety of a range of products including the latest new drugs, generic drugs and clinical trial products. You will provide advice on pharmacokinetic issues to colleagues within the Division and will review pharmacokinetic aspects of clinical trial data, preparing reports and recommendations which are highly influential in bringing new medicines to the market. You will need to interact with colleagues in other European regulatory agencies, the European Medicines Agency and to present your considerations to UK and European multi-disciplinary advisory committees. You will also be involved in the development of new regulatory guidelines and the provision of scientific advice on drug development programmes.
read more - http://www.mhra.gov.uk/Aboutus/Workingforus/Currentjobvacancies/CON140825
Mr. Fiddaman goes for a career change. Time for something new.
Mr. Fiddaman goes for a career change. Time for something new.
Saturday, 28 January 2012
about Gary Null, host to Evil Lin Pringle - poisoned by his own quack vitamin potions
http://en.wikipedia.org/wiki/Gary_Null
Null owns Gary Null & Associates, a company which markets dietary supplements, as well as a health-food store in New York City.[15] In 2010, Null claimed that he was sickened and nearly killed by his own dietary supplements.[1][3][2] He filed suit against a contractor involved in producing the supplement, "Gary Null's Ultimate Power Meal", claiming that the supplement contained 1,000 times the labeled dose of Vitamin D and that it had led to the hospitalizations of 6 consumers poisoned by excessive doses of the vitamin.[1] Null reportedly suffered severe pain and kidney damage from "Gary Null's Ultimate Power Meal", but continued consuming the supplement in the belief that it would relieve his symptoms.[1]
The New York Post noted that Null's near-death experience with his own supplement brand was "not exactly a ringing endorsement."[1] The Los Angeles Times wrote that Null's experience "should give pause to anyone lured by the extravagant claims of many supplements makers", and noted that it was common for dietary supplements to contain doses "wildly different than those indicated on their label" as a result of weak regulation.[3] Null's attorney cast the alleged vitamin poisoning as an isolated incident, saying: "We don't want anything to affect the physical well-being of anyone or the reputation of the company."[2]
Null owns Gary Null & Associates, a company which markets dietary supplements, as well as a health-food store in New York City.[15] In 2010, Null claimed that he was sickened and nearly killed by his own dietary supplements.[1][3][2] He filed suit against a contractor involved in producing the supplement, "Gary Null's Ultimate Power Meal", claiming that the supplement contained 1,000 times the labeled dose of Vitamin D and that it had led to the hospitalizations of 6 consumers poisoned by excessive doses of the vitamin.[1] Null reportedly suffered severe pain and kidney damage from "Gary Null's Ultimate Power Meal", but continued consuming the supplement in the belief that it would relieve his symptoms.[1]
The New York Post noted that Null's near-death experience with his own supplement brand was "not exactly a ringing endorsement."[1] The Los Angeles Times wrote that Null's experience "should give pause to anyone lured by the extravagant claims of many supplements makers", and noted that it was common for dietary supplements to contain doses "wildly different than those indicated on their label" as a result of weak regulation.[3] Null's attorney cast the alleged vitamin poisoning as an isolated incident, saying: "We don't want anything to affect the physical well-being of anyone or the reputation of the company."[2]
Fiddaman girl Evelyn Pringle guest on Gary Null show podcast - listen from 49 min in
http://thegarynullshow.podbean.com/2012/01/20/the-gary-null-show-01-20-12/
Guest Evelyn Pringle is an award-winning investigative journalist focused on exposing corruption in government and in American corporations. Over the past 8 years, she has written numerous exposes on the psycho-pharmaceutical complex with a focus on the government and drug-maker cartel that has a mission to over-medicate children. In 2009 she aided Senator Grassley's office in compiling data on TeenScreen and the pharmaceutical front organizations pushing for the drugging of US children
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