Paroxetine, Panorama and user reporting of
ADRs: Consumer intelligence matters in
clinical practice and post-marketing drug surveillance
http://www.socialaudit.org.uk/IJRSM-161-169.pdf
Charles Medawar a,∗, Andrew Herxheimer b, Andrew Bell c and Shelley Jofre c
a Social Audit Ltd., London, UK bDIPEx Project, Department of Primary Health Care, University of Oxford, Oxford, UKc British Broadcasting Corporation (BBC), London, UK
1. Introduction
An estimated 4.4m people recently watched “Secrets of Seroxat” (Panorama, BBC-TV), a 50-minute
programme about paroxetine, an SSRI antidepressant for which UK general practitioners wrote an estimated 4.7m prescriptions in 2001.
2. Methods
Printouts of the 1,374 Panorama emails (less duplicates) were closely read, and categorized as positive
(234 reports [17%] rated from very positive to “worth taking – just”), negative (647 [48%], rated from
not worth taking to severely disabling), and uncertain (469 [35%], giving no or insufficient evidence
of paroxetine use).
Wednesday, 31 March 2010
Saturday, 27 March 2010
Genetic test could match mentally ill patients with the best drug
Genetic test could match mentally ill patients with the best drug
The new test will assess whether 26 psychiatric drugs ? including Prozac ? are likely to work or cause side-effects
http://www.timesonline.co.uk/tol/life_and_style/health/mental_health/article7078157.ece
Mark Henderson, Science Editor 1 Comment
Recommend? (3) A genetic test that predicts how patients with mental illnesses such as depression and schizophrenia will respond to drugs is to be offered to British doctors, in a step towards a new era of personalised medicine.
The £1,000 procedure, which is already used in several US hospitals, uses individuals’ DNA to assess whether 26 psychiatric drugs — including Prozac and Seroxat — are likely to work or cause side-effects.
It promises to bring significant improvements to the care of patients with psychiatric conditions, at least a third of whom do not currently benefit from the first drug they are prescribed because they cannot tolerate it or it has no effect.
The development highlights the growing potential of genetics to tailor treatment according to patients’ DNA profiles. This practice, known as pharmacogenetics or pharmacogenomics, is expected to transform many branches of medicine over the next decade, helping doctors to select the therapy that works best for a particular patient.
The psychiatric DNA test, known as GeneSightRx, is offered by the US company AssureRx, which plans to introduce it in Europe by the end of the year.
It is intended for patients who have already proved difficult to treat but could eventually be used by GPs before they prescribe anti-depressants. British experts agreed that such tests could have significant benefits, but cautioned that while the science behind GeneSightRx is sound, there is little evidence yet that it improves patient outcomes.
Peter McGuffin, Professor of Psychiatric Genetics at the Institute of Psychiatry in London, said: “There’s a lot of promise here, and in the long run pharmacogenomics will work, but it’s complex.
“We need evidence that these tests provide an advantage over practice as usual, and in my view that hasn’t been done yet. There is sound science underlying this, but the practicalities have not been looked at in nearly enough detail.”
Donald Singer, Professor of Clincial Pharmacology and Therapeutics at the University of Warwick, said: “At the sharp end of psychiatry, when people are having suicidal thoughts, you really have to get the drug right at the beginning, and a test like this could be very helpful.
“The technology is there, but clinical evidence is the stumbling block: we need to investigate the human element of how it is used and whether it affects patient outcomes.”
Pharmacogenomic tests are founded on the understanding that variations in DNA alter the way that individuals respond to medicines.
Some genes influence the speed with which drugs are metabolised: too fast and a patient may get no benefit, too slow and levels can build up to cause side-effects. Other genes affect the biological receptors on which drugs are designed to work, so that some peoplelack the ability to respond.
GeneSightRx uses a cheek swab to collect DNA, after which five genes are analysed. These are CYP2D6, CYP2C19 and CYP1A2, which affect metabolism, and SLC6A4 and 5HTR2A, which affect serotonin, the brain-signalling chemical on which many psychiatric drugs work. The test was developed by scientists at the Mayo Clinic in Minnesota and Cincinnati Children’s Hospital in Ohio, and is in standard use at both hospitals.
It sorts antipsychotics and antidepressants into three colour-coded groups. A green code indicates drugs that should be safe to use normally, yellow denotes drugs that should be used “with caution”, and red highlights greater risks.
Jim Burns, President of AssureRx, said: “It’s a tool to guide doctors to a medication that might be a better choice for that patient, or to make a dosage adjustment. It is mostly about identifying patients at risk for extreme side-effects: if you cannot tolerate a drug, it will not be useful.”
Caroline Wright, head of science at the PHG Foundation, a genetics think-tank, said the results would be important.“The question is whether such tests improve clinical practice. We don’t yet know whether this actually helps doctors to find the best drug, or whether it’s easier just to try out several different treatments.”
Majorie Wallace, chief executive of the mental health charity SANE, said: “It would be marvellous if there were a way of identifying those people who responded well to certain psychotropic drugs while avoiding giving particular drugs to those for whom it may not be effective or cause distressing side-effects.”
Tailored for a better fit
Warfarin Two genes, CYP2C9 and VKORC1, affect response to the blood-thinning drug given to heart attack and stroke patients. DNA tests can be used to adjust dosage to ensure patients benefit while avoiding potentially fatal bleeding
Abacavir About 6 per cent of people have a gene that makes them hypersensitive to this HIV drug. DNA screening is now recommended before use
Codeine About 10 per cent of Caucasian people have a version of the CYP2D6 gene that means they cannot process the painkiller, and thus derive no benefit
Statins The SLC01B1 gene influences risk of muscle damage while on the cholesterol-lowering drugs. Scientists are investigating whether genetic factors affect which statin is most likely to work
Cancer drugs About 1 in 300 people lacks the gene to metabolise the leukaemia drug 6-mercaptopurine, and thus risk fatal side-effects. Cancer drugs such as Herceptin and Iressa are also tailored to target particular genetic mutations in tumours
Source: Francis Collins, The Language of Life; Times database
The new test will assess whether 26 psychiatric drugs ? including Prozac ? are likely to work or cause side-effects
http://www.timesonline.co.uk/tol/life_and_style/health/mental_health/article7078157.ece
Mark Henderson, Science Editor 1 Comment
Recommend? (3) A genetic test that predicts how patients with mental illnesses such as depression and schizophrenia will respond to drugs is to be offered to British doctors, in a step towards a new era of personalised medicine.
The £1,000 procedure, which is already used in several US hospitals, uses individuals’ DNA to assess whether 26 psychiatric drugs — including Prozac and Seroxat — are likely to work or cause side-effects.
It promises to bring significant improvements to the care of patients with psychiatric conditions, at least a third of whom do not currently benefit from the first drug they are prescribed because they cannot tolerate it or it has no effect.
The development highlights the growing potential of genetics to tailor treatment according to patients’ DNA profiles. This practice, known as pharmacogenetics or pharmacogenomics, is expected to transform many branches of medicine over the next decade, helping doctors to select the therapy that works best for a particular patient.
The psychiatric DNA test, known as GeneSightRx, is offered by the US company AssureRx, which plans to introduce it in Europe by the end of the year.
It is intended for patients who have already proved difficult to treat but could eventually be used by GPs before they prescribe anti-depressants. British experts agreed that such tests could have significant benefits, but cautioned that while the science behind GeneSightRx is sound, there is little evidence yet that it improves patient outcomes.
Peter McGuffin, Professor of Psychiatric Genetics at the Institute of Psychiatry in London, said: “There’s a lot of promise here, and in the long run pharmacogenomics will work, but it’s complex.
“We need evidence that these tests provide an advantage over practice as usual, and in my view that hasn’t been done yet. There is sound science underlying this, but the practicalities have not been looked at in nearly enough detail.”
Donald Singer, Professor of Clincial Pharmacology and Therapeutics at the University of Warwick, said: “At the sharp end of psychiatry, when people are having suicidal thoughts, you really have to get the drug right at the beginning, and a test like this could be very helpful.
“The technology is there, but clinical evidence is the stumbling block: we need to investigate the human element of how it is used and whether it affects patient outcomes.”
Pharmacogenomic tests are founded on the understanding that variations in DNA alter the way that individuals respond to medicines.
Some genes influence the speed with which drugs are metabolised: too fast and a patient may get no benefit, too slow and levels can build up to cause side-effects. Other genes affect the biological receptors on which drugs are designed to work, so that some peoplelack the ability to respond.
GeneSightRx uses a cheek swab to collect DNA, after which five genes are analysed. These are CYP2D6, CYP2C19 and CYP1A2, which affect metabolism, and SLC6A4 and 5HTR2A, which affect serotonin, the brain-signalling chemical on which many psychiatric drugs work. The test was developed by scientists at the Mayo Clinic in Minnesota and Cincinnati Children’s Hospital in Ohio, and is in standard use at both hospitals.
It sorts antipsychotics and antidepressants into three colour-coded groups. A green code indicates drugs that should be safe to use normally, yellow denotes drugs that should be used “with caution”, and red highlights greater risks.
Jim Burns, President of AssureRx, said: “It’s a tool to guide doctors to a medication that might be a better choice for that patient, or to make a dosage adjustment. It is mostly about identifying patients at risk for extreme side-effects: if you cannot tolerate a drug, it will not be useful.”
Caroline Wright, head of science at the PHG Foundation, a genetics think-tank, said the results would be important.“The question is whether such tests improve clinical practice. We don’t yet know whether this actually helps doctors to find the best drug, or whether it’s easier just to try out several different treatments.”
Majorie Wallace, chief executive of the mental health charity SANE, said: “It would be marvellous if there were a way of identifying those people who responded well to certain psychotropic drugs while avoiding giving particular drugs to those for whom it may not be effective or cause distressing side-effects.”
Tailored for a better fit
Warfarin Two genes, CYP2C9 and VKORC1, affect response to the blood-thinning drug given to heart attack and stroke patients. DNA tests can be used to adjust dosage to ensure patients benefit while avoiding potentially fatal bleeding
Abacavir About 6 per cent of people have a gene that makes them hypersensitive to this HIV drug. DNA screening is now recommended before use
Codeine About 10 per cent of Caucasian people have a version of the CYP2D6 gene that means they cannot process the painkiller, and thus derive no benefit
Statins The SLC01B1 gene influences risk of muscle damage while on the cholesterol-lowering drugs. Scientists are investigating whether genetic factors affect which statin is most likely to work
Cancer drugs About 1 in 300 people lacks the gene to metabolise the leukaemia drug 6-mercaptopurine, and thus risk fatal side-effects. Cancer drugs such as Herceptin and Iressa are also tailored to target particular genetic mutations in tumours
Source: Francis Collins, The Language of Life; Times database
Friday, 26 March 2010
GP guidelines recomend suicide check within 9 months of antidep script
The study of 33,483 patients from 88 practices, who had evidence of depression in their notes, found 96 per cent were on antidepressants despite having no recorded episode of depression in the previous two years. There was also evidence GPs were ignoring local guidelines recommending referral and a suicide risk check within nine months of a first depressive episode or antidepressant script.
GPs risk legal action over poor depression notes
03 Aug 03
GPs are failing to keep adequate notes to show they manage patients on antidepressants appropriately.
The findings of a major study prompted a warning from medicolegal experts that GPs could be hauled before the GMC and face legal claims for failing to document their monitoring of patients.
The study of 33,483 patients from 88 practices, who had evidence of depression in their notes, found 96 per cent were on antidepressants despite having no recorded episode of depression in the previous two years. There was also evidence GPs were ignoring local guidelines recommending referral and a suicide risk check within nine months of a first depressive episode or antidepressant script.
Only 10 per cent of 1,391 patients with a recorded episode were referred and 2 per cent had suicide risk recorded, according to results presented to the Society for Academic Primary Care annual conference last month.
Research leader Keith Prescott, educational facilitator in general practice at Queen Mary University of London, said depression's episodic nature made it 'crucial' GPs recorded each episode and reviewed patients.
Lawyers preparing a class action over Seroxat warned in June that any GP appearing to prescribe inappropriately could be vulnerable to legal action.
Dr Stephanie Bown, head of medical services at the Medical Protection Society, said failure to document patient monitoring or what led to an antidepressant script would make it harder for GPs to defend their actions.
'If it's shown you have been irresponsible by continuing to prescribe without showing that patient had been reviewed, you could face a clinical negligence claim and you could find yourself up before the GMC.'
Dr Arnold Zermansky, author of Government guidelines on medication review, said GPs' fears over withdrawing drugs from 'quiet, satisfied patients' and the extra work involved in review could explain why so many with no recent depressive episode were on antidepressants.
The new contract awards 23 quality points for 15-monthly reviews of patients with severe long-term mental health problems
GPs risk legal action over poor depression notes
03 Aug 03
GPs are failing to keep adequate notes to show they manage patients on antidepressants appropriately.
The findings of a major study prompted a warning from medicolegal experts that GPs could be hauled before the GMC and face legal claims for failing to document their monitoring of patients.
The study of 33,483 patients from 88 practices, who had evidence of depression in their notes, found 96 per cent were on antidepressants despite having no recorded episode of depression in the previous two years. There was also evidence GPs were ignoring local guidelines recommending referral and a suicide risk check within nine months of a first depressive episode or antidepressant script.
Only 10 per cent of 1,391 patients with a recorded episode were referred and 2 per cent had suicide risk recorded, according to results presented to the Society for Academic Primary Care annual conference last month.
Research leader Keith Prescott, educational facilitator in general practice at Queen Mary University of London, said depression's episodic nature made it 'crucial' GPs recorded each episode and reviewed patients.
Lawyers preparing a class action over Seroxat warned in June that any GP appearing to prescribe inappropriately could be vulnerable to legal action.
Dr Stephanie Bown, head of medical services at the Medical Protection Society, said failure to document patient monitoring or what led to an antidepressant script would make it harder for GPs to defend their actions.
'If it's shown you have been irresponsible by continuing to prescribe without showing that patient had been reviewed, you could face a clinical negligence claim and you could find yourself up before the GMC.'
Dr Arnold Zermansky, author of Government guidelines on medication review, said GPs' fears over withdrawing drugs from 'quiet, satisfied patients' and the extra work involved in review could explain why so many with no recent depressive episode were on antidepressants.
The new contract awards 23 quality points for 15-monthly reviews of patients with severe long-term mental health problems
Thursday, 25 March 2010
Fiddaman's Dilemma - A blast from the past, this day 10 years ago.
25 Mar 2000
I have been involved with a dispute with my employer's over a disability
issue. Basically, they have put me on a Long Term Absence Register and will
not allow me back to work, not medically retire me or will not let me apply
for voluntary redundancy! They have postponed no less then 4 Industrial
Tribunals and WILL NOT come to an out of court settlement with my legal
advisor. They are a very high profile company who are almost never out of
the news. Would it be advisable for me to go to the press with my story? And
what would the going rate be for such a story bearing in mind that they are
hardly ever out of the news?
http://groups.google.co.uk/group/uk.media.newspapers/browse_thread/thread/d7e6574c676e3a72/5ada06079451c2f6?hl=en&pli=1
--
Bob
Birmingham. UK
ballbreaker...@netscapeonline.co.uk
Sunday, 21 March 2010
How AstraZeneca Is Turning the Tide in Its Legal War Over Antipsychotic Drugs | BNET Pharma Blog | BNET
How AstraZeneca Is Turning the Tide in Its Legal War Over Antipsychotic Drugs BNET Pharma Blog BNET: "How AstraZeneca Is Turning the Tide in Its Legal War Over Antipsychotic Drugs"
AstraZeneca (AZN)’s victory in the first Seroquel lawsuit to go to trial will leave many baffled: How could a company that promoted the antipsychotic drug as better than a generic when it wasn’t; that promoted the drug as “weight neutral” when executives knew it led to weight gain; and that hired staffers who traded sex for study write-ups, possibly be winning the legal war?
The answer can be found in history. America may be a litigious nation, famous for its jackpot hot coffee payouts, but the legal nitty gritty is often far less profitable for plaintiffs than most people think. AZ knew this from the start, and has seemingly relied on it for its so-far successful strategy.
Going in to these cases — there are 10,399 of them — AZ had the benefit of Merck (MRK)’s experience with the painkiller Vioxx. Those cases were far more serious than Seroquel — people died — and at one point Wall Street analysts thought Merck might have to pay $50 billion in costs to plaintiffs. It ended up settling the whole shebang for a tenth of that: Just $4.5 billion.
Merck had advance warning of which way the wind would blow before that settlement came, even though it lost the first case that went to trial. Merck won the appeal of that case. Here’s an old press release summing up the state of the Vioxx litigation before the settlement.
Of the 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck.
AZ will have to sit through several more trials and rounds of appeals before it knows what percentage of these cases is likely to succeed. That hasn’t been cheap. Settlements with the government, plus the company’s own legal fees for defending cases, have topped $1.1 billion. But it may just be that AZ has been right all along: There’s no “there” there, at least legally.
AstraZeneca (AZN)’s victory in the first Seroquel lawsuit to go to trial will leave many baffled: How could a company that promoted the antipsychotic drug as better than a generic when it wasn’t; that promoted the drug as “weight neutral” when executives knew it led to weight gain; and that hired staffers who traded sex for study write-ups, possibly be winning the legal war?
The answer can be found in history. America may be a litigious nation, famous for its jackpot hot coffee payouts, but the legal nitty gritty is often far less profitable for plaintiffs than most people think. AZ knew this from the start, and has seemingly relied on it for its so-far successful strategy.
Going in to these cases — there are 10,399 of them — AZ had the benefit of Merck (MRK)’s experience with the painkiller Vioxx. Those cases were far more serious than Seroquel — people died — and at one point Wall Street analysts thought Merck might have to pay $50 billion in costs to plaintiffs. It ended up settling the whole shebang for a tenth of that: Just $4.5 billion.
Merck had advance warning of which way the wind would blow before that settlement came, even though it lost the first case that went to trial. Merck won the appeal of that case. Here’s an old press release summing up the state of the Vioxx litigation before the settlement.
Of the 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck.
AZ will have to sit through several more trials and rounds of appeals before it knows what percentage of these cases is likely to succeed. That hasn’t been cheap. Settlements with the government, plus the company’s own legal fees for defending cases, have topped $1.1 billion. But it may just be that AZ has been right all along: There’s no “there” there, at least legally.
Court says thimerosal did not cause autism
The Associated Press: Court says thimerosal did not cause autism: "Court says thimerosal did not cause autism"
By RANDOLPH E. SCHMID (AP) – Mar 12, 2010
WASHINGTON — The vaccine additive thimerosal is not to blame for autism, a special federal court ruled Friday in a long-running battle by parents convinced there is a connection.
While expressing sympathy for the parents involved in the emotionally charged cases, the court concluded they had failed to show a connection between the mercury-containing preservative and autism.
"Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration," special master George Hastings Jr. wrote.
But, he added, Congress designed the victim compensation program only for families whose injuries or deaths can be shown to be linked to a vaccine and that has not been done in this case.
The ruling came in the so-called vaccine court, a special branch of the U.S. Court of Federal Claims established to handle claims of injury from vaccines. It can be appealed in federal court.
The parents presented expert witnesses who argued mercury can have a variety of effects on the brain, but the ruling said none of them offered opinions on the cause of autism in the three specific cases argued. They testified that mercury can affect a number of biological processes, including abnormal metabolism in children.
Special master Denise K. Vowell noted that in order to succeed in their action, the parents would have to show "the exquisitely small amounts of mercury" that reach the brain from vaccines can produce devastating effects that far larger amounts ... from other sources do not. The ruling said the parents were arguing that the effects from mercury in vaccines differ from mercury's known effects on the brain. Vowell concluded that the parents had failed to establish that their child's condition was caused or aggravated by mercury from vaccines.
Friday's decision that autism is not caused by thimerosal alone follows a parallel ruling in 2009 that autism is not caused by the combination of vaccines with thimerosal and other vaccines.
The cases had been divided into three theories about a vaccine-autism relationship for the court to consider. The 2009 ruling rejected a theory that thimerasol can cause autism when combined with the measles-mumps-rubella vaccine. After that, a theory that certain vaccines alone cause autism was dropped. Friday's decision covers the last of the three theories, that thimerosal-containing vaccines alone can cause autism.
The ruling doesn't necessarily mean an end to the dispute, however, with appeals to other courts available.
The new ruling was welcomed by Dr. Paul Offit of Children's Hospital of Philadelphia, who said the autism theory had "already had its day in science court and failed to hold up."
But the controversy has cast a pall over vaccines, causing some parents to avoid them, he noted, "it's very hard to unscare people after you have scared them."
On the other side of the issue, a group backing the parents' theory charged that the vaccine court was more interested in government policy than protecting children.
"The deck is stacked against families in vaccine court. Government attorneys defend a government program, using government-funded science, before government judges," Rebecca Estepp, of the Coalition for Vaccine Safety said in a statement.
SafeMinds, another group supporting the parents, expressed disappointment at the new ruling.
"The denial of reasonable compensation to families was based on inadequate vaccine safety science and poorly designed and highly controversial epidemiology," the goup said.
The advocacy group Autism Speaks said "the proven benefits of vaccinating a child to protect them against serious diseases far outweigh the hypothesized risk that vaccinations might cause autism. Thus, we strongly encourage parents to vaccinate their children to protect them from serious childhood diseases."
However, while research has found no overall connection between autism and vaccines, the group said it would back research to determine if some individuals might be at increased risk because of genetic or medical conditions.
Meanwhile, in reaction to the concerns of parents, thimerosal has been removed from most vaccines in the United States.
In Friday's action the court ruled in three different cases, each concluding that the preservative has no connection to autism.
The trio of rulings can offer reassurance to parents scared about vaccinating their babies because of a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.
The U.S. Court of Claims is different from many other courts: The families involved didn't have to prove the inoculations definitely caused the complex neurological disorder, just that they probably did.
More than 5,500 claims have been filed by families seeking compensation through the government's Vaccine Injury Compensation Program, and the rulings dealt with test cases to settle which if any claims had merit.
Autism is best known for impairing a child's ability to communicate and interact. Recent data suggest a 10-fold increase in autism rates over the past decade, although it's unclear how much of the surge reflects better diagnosis.
Worry about a vaccine link first arose in 1998 when a British physician, Dr. Andrew Wakefield, published a medical journal article linking a particular type of autism and bowel disease to the measles vaccine. The study was later discredited.
Copyright © 2010 The Associated Press. All rights reserved.
By RANDOLPH E. SCHMID (AP) – Mar 12, 2010
WASHINGTON — The vaccine additive thimerosal is not to blame for autism, a special federal court ruled Friday in a long-running battle by parents convinced there is a connection.
While expressing sympathy for the parents involved in the emotionally charged cases, the court concluded they had failed to show a connection between the mercury-containing preservative and autism.
"Such families must cope every day with tremendous challenges in caring for their autistic children, and all are deserving of sympathy and admiration," special master George Hastings Jr. wrote.
But, he added, Congress designed the victim compensation program only for families whose injuries or deaths can be shown to be linked to a vaccine and that has not been done in this case.
The ruling came in the so-called vaccine court, a special branch of the U.S. Court of Federal Claims established to handle claims of injury from vaccines. It can be appealed in federal court.
The parents presented expert witnesses who argued mercury can have a variety of effects on the brain, but the ruling said none of them offered opinions on the cause of autism in the three specific cases argued. They testified that mercury can affect a number of biological processes, including abnormal metabolism in children.
Special master Denise K. Vowell noted that in order to succeed in their action, the parents would have to show "the exquisitely small amounts of mercury" that reach the brain from vaccines can produce devastating effects that far larger amounts ... from other sources do not. The ruling said the parents were arguing that the effects from mercury in vaccines differ from mercury's known effects on the brain. Vowell concluded that the parents had failed to establish that their child's condition was caused or aggravated by mercury from vaccines.
Friday's decision that autism is not caused by thimerosal alone follows a parallel ruling in 2009 that autism is not caused by the combination of vaccines with thimerosal and other vaccines.
The cases had been divided into three theories about a vaccine-autism relationship for the court to consider. The 2009 ruling rejected a theory that thimerasol can cause autism when combined with the measles-mumps-rubella vaccine. After that, a theory that certain vaccines alone cause autism was dropped. Friday's decision covers the last of the three theories, that thimerosal-containing vaccines alone can cause autism.
The ruling doesn't necessarily mean an end to the dispute, however, with appeals to other courts available.
The new ruling was welcomed by Dr. Paul Offit of Children's Hospital of Philadelphia, who said the autism theory had "already had its day in science court and failed to hold up."
But the controversy has cast a pall over vaccines, causing some parents to avoid them, he noted, "it's very hard to unscare people after you have scared them."
On the other side of the issue, a group backing the parents' theory charged that the vaccine court was more interested in government policy than protecting children.
"The deck is stacked against families in vaccine court. Government attorneys defend a government program, using government-funded science, before government judges," Rebecca Estepp, of the Coalition for Vaccine Safety said in a statement.
SafeMinds, another group supporting the parents, expressed disappointment at the new ruling.
"The denial of reasonable compensation to families was based on inadequate vaccine safety science and poorly designed and highly controversial epidemiology," the goup said.
The advocacy group Autism Speaks said "the proven benefits of vaccinating a child to protect them against serious diseases far outweigh the hypothesized risk that vaccinations might cause autism. Thus, we strongly encourage parents to vaccinate their children to protect them from serious childhood diseases."
However, while research has found no overall connection between autism and vaccines, the group said it would back research to determine if some individuals might be at increased risk because of genetic or medical conditions.
Meanwhile, in reaction to the concerns of parents, thimerosal has been removed from most vaccines in the United States.
In Friday's action the court ruled in three different cases, each concluding that the preservative has no connection to autism.
The trio of rulings can offer reassurance to parents scared about vaccinating their babies because of a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise.
The U.S. Court of Claims is different from many other courts: The families involved didn't have to prove the inoculations definitely caused the complex neurological disorder, just that they probably did.
More than 5,500 claims have been filed by families seeking compensation through the government's Vaccine Injury Compensation Program, and the rulings dealt with test cases to settle which if any claims had merit.
Autism is best known for impairing a child's ability to communicate and interact. Recent data suggest a 10-fold increase in autism rates over the past decade, although it's unclear how much of the surge reflects better diagnosis.
Worry about a vaccine link first arose in 1998 when a British physician, Dr. Andrew Wakefield, published a medical journal article linking a particular type of autism and bowel disease to the measles vaccine. The study was later discredited.
Copyright © 2010 The Associated Press. All rights reserved.
Saturday, 20 March 2010
VIOXX - 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck
Merck Wins Appeal of First VIOXX® Case to go to Trial
Merck Also Wins Appeals of Major Aspects of New Jersey Cases
WHITEHOUSE STATION, N.J., May 29, 2008 - Merck & Co., Inc. said today that it is gratified that a Texas appeals court overturned the August 2005 verdict of a state court jury in Brazoria County and rendered a judgment in favor of Merck in the VIOXX product liability case Ernst v. Merck. It was the first VIOXX case to go to trial after the Company voluntarily removed the medicine from the market.
Merck also said today that a New Jersey appellate division has overturned the punitive damage and consumer fraud awards in the 2006 verdict in a two-plaintiff VIOXX trial involving Thomas Cona and John McDarby.
"We are gratified that the Texas appeals court correctly found that VIOXX did not cause Mr. Ernst's death and reversed the previous decision for the plaintiff in the first VIOXX case to go to trial. In addition, the New Jersey court correctly reversed the awards of punitive damage and consumer fraud. Today's decisions overturn almost $40 million of damages and attorneys fees previously awarded to plaintiffs at trial," said Bruce Kuhlik, executive vice president and general counsel of Merck & Co., Inc. "We intend to seek further review of the portion of the award that remains standing after the New Jersey decision. We continue to believe Merck acted responsibly."
Ernst Decision
The Texas Fourteenth Court of Appeals found that VIOXX did not cause the death of Mr. Ernst, reversed the jury's verdict and rendered a judgment in favor of Merck.
Chief Justice Adele Hedges, writing for a unanimous panel, said in the ruling, "we find no evidence that Ernst suffered a thrombotic cardiovascular event, i.e., a myocardial infarction triggered by a blood clot. Accordingly, appellee failed to show that ingestion of VIOXX caused her husband's death."
The jury's original verdict on Aug. 19, 2005 included $24,450,000 in compensatory damages and $229,000,000 in punitive damages for a total of $253,425,000 against Merck. On June 23, 2006, based on relevant Texas law which limits the amount of punitive damages, the punitive damage verdict of $229,000,000 was reduced to $1,650,000.
Cona/McDarby Decision
In the Cona and McDarby cases, the New Jersey Appellate Division, an intermediate appellate court, overturned the punitive damage award as well as the consumer fraud award, and let stand the compensatory damages for personal injury to Mr. McDarby. In reversing the consumer fraud verdict, the court also rejected the attorneys fees granted to the plaintiffs' attorneys.
As a result, the court overturned more than $13 million in damages and attorneys fees.
In the trial, which resulted in a partial victory for Merck, the Company presented evidence that both of the heart attacks were caused, not by VIOXX, but by the pre-existing medical conditions of the two men. While the jury found that VIOXX did not cause Mr. Cona's heart attack, it found in favor of Mr. McDarby, awarding him both compensatory and punitive damages.
The jury awarded both men the out of pocket costs associated with their purchases of VIOXX under the consumer fraud statute. Today's decision overturns that award as well.
Status of Litigation
Merck has won the large majority of cases that have gone to trial and thousands of lawsuits have been dismissed. Of the 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck.
Merck has entered into an agreement to resolve state and federal myocardial infarction and ischemic stroke claims filed or tolled by Nov. 9, 2007. The settlement program is progressing in a satisfactory manner. Because of the large number of enrollments received so far, Merck is confident that the number of verified enrollments will exceed the thresholds that will obligate the Company to pay $4.85 billion into a resolution fund.
During the Ernst trial, which led to a verdict on Aug. 19, 2005, Merck was represented by Gerry Lowry of Fulbright & Jaworski, L.L.P. of Houston and David C. Kiernan of Williams & Connolly, L.L.P. of Washington D.C. Merck's appellate counsel are Katherine D. Mackillop of Fulbright & Jaworski L.L.P. in Houston and Charles C. Lifland of O'Melveny & Myers LLP in Los Angeles.
Merck's appellate counsel in the Cona and McDarby cases are Douglas S. Eakeley of Lowenstein, Sandler LLP and Charles C. Lifland of O'Melveny & Myers LLP in Los Angeles.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
http://www.merck.com/newsroom/news-release-archive/corporate/2008_0529a.html
Merck Also Wins Appeals of Major Aspects of New Jersey Cases
WHITEHOUSE STATION, N.J., May 29, 2008 - Merck & Co., Inc. said today that it is gratified that a Texas appeals court overturned the August 2005 verdict of a state court jury in Brazoria County and rendered a judgment in favor of Merck in the VIOXX product liability case Ernst v. Merck. It was the first VIOXX case to go to trial after the Company voluntarily removed the medicine from the market.
Merck also said today that a New Jersey appellate division has overturned the punitive damage and consumer fraud awards in the 2006 verdict in a two-plaintiff VIOXX trial involving Thomas Cona and John McDarby.
"We are gratified that the Texas appeals court correctly found that VIOXX did not cause Mr. Ernst's death and reversed the previous decision for the plaintiff in the first VIOXX case to go to trial. In addition, the New Jersey court correctly reversed the awards of punitive damage and consumer fraud. Today's decisions overturn almost $40 million of damages and attorneys fees previously awarded to plaintiffs at trial," said Bruce Kuhlik, executive vice president and general counsel of Merck & Co., Inc. "We intend to seek further review of the portion of the award that remains standing after the New Jersey decision. We continue to believe Merck acted responsibly."
Ernst Decision
The Texas Fourteenth Court of Appeals found that VIOXX did not cause the death of Mr. Ernst, reversed the jury's verdict and rendered a judgment in favor of Merck.
Chief Justice Adele Hedges, writing for a unanimous panel, said in the ruling, "we find no evidence that Ernst suffered a thrombotic cardiovascular event, i.e., a myocardial infarction triggered by a blood clot. Accordingly, appellee failed to show that ingestion of VIOXX caused her husband's death."
The jury's original verdict on Aug. 19, 2005 included $24,450,000 in compensatory damages and $229,000,000 in punitive damages for a total of $253,425,000 against Merck. On June 23, 2006, based on relevant Texas law which limits the amount of punitive damages, the punitive damage verdict of $229,000,000 was reduced to $1,650,000.
Cona/McDarby Decision
In the Cona and McDarby cases, the New Jersey Appellate Division, an intermediate appellate court, overturned the punitive damage award as well as the consumer fraud award, and let stand the compensatory damages for personal injury to Mr. McDarby. In reversing the consumer fraud verdict, the court also rejected the attorneys fees granted to the plaintiffs' attorneys.
As a result, the court overturned more than $13 million in damages and attorneys fees.
In the trial, which resulted in a partial victory for Merck, the Company presented evidence that both of the heart attacks were caused, not by VIOXX, but by the pre-existing medical conditions of the two men. While the jury found that VIOXX did not cause Mr. Cona's heart attack, it found in favor of Mr. McDarby, awarding him both compensatory and punitive damages.
The jury awarded both men the out of pocket costs associated with their purchases of VIOXX under the consumer fraud statute. Today's decision overturns that award as well.
Status of Litigation
Merck has won the large majority of cases that have gone to trial and thousands of lawsuits have been dismissed. Of the 18 plaintiffs whose cases went to trial, only three have outstanding product liability judgments against Merck.
Merck has entered into an agreement to resolve state and federal myocardial infarction and ischemic stroke claims filed or tolled by Nov. 9, 2007. The settlement program is progressing in a satisfactory manner. Because of the large number of enrollments received so far, Merck is confident that the number of verified enrollments will exceed the thresholds that will obligate the Company to pay $4.85 billion into a resolution fund.
During the Ernst trial, which led to a verdict on Aug. 19, 2005, Merck was represented by Gerry Lowry of Fulbright & Jaworski, L.L.P. of Houston and David C. Kiernan of Williams & Connolly, L.L.P. of Washington D.C. Merck's appellate counsel are Katherine D. Mackillop of Fulbright & Jaworski L.L.P. in Houston and Charles C. Lifland of O'Melveny & Myers LLP in Los Angeles.
Merck's appellate counsel in the Cona and McDarby cases are Douglas S. Eakeley of Lowenstein, Sandler LLP and Charles C. Lifland of O'Melveny & Myers LLP in Los Angeles.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
http://www.merck.com/newsroom/news-release-archive/corporate/2008_0529a.html
Parents of suicidal children get 15% to 40% of Seroxat prescription cost
After attorneys' fees and the costs of administering the settlement are deducted from the $40 million, the balance will be distributed to Class members who qualify and submit a claim as described below. The Class member's submission must certify, as provided in the claim form, that the member is seeking only the member's actual out-of-pocket and unreimbursed cost, based on the amount paid by the Class member, exclusive of any co-payments, deductibles, or other amounts not paid by the member to determine your actual costs for Paxil® prescribed for persons under the age of 18, between January 1, 1998 and December 31, 2004. If the records show a diagnosis of Major Depressive Disorder, the claim amount is calculated at 40% of the actual costs. Otherwise, the claim amount will be 15% of the actual costs.
http://www.pediatricpaxiltppsettlement.com/faq.htm
http://www.pediatricpaxiltppsettlement.com/faq.htm
Seroxat settlement sought $600 million - got $40 million fromm GSK
GSK has entered into a proposed settlement with the Plaintiffs and has agreed to pay $40 million to settle the claims set forth in Plaintiffs' lawsuits as follows:
After attorneys' fees and the costs of administering the settlement are deducted from the $40 million, the balance will be distributed to Class members who qualify and submit a claim as described below. The Class member's submission must certify, as provided in the claim form, that the member is seeking only the member's actual out-of-pocket and unreimbursed cost, based on the amount paid by the Class member, exclusive of any co-payments, deductibles, or other amounts not paid by the member to determine your actual costs for Paxil® prescribed for persons under the age of 18, between January 1, 1998 and December 31, 2004. If the records show a diagnosis of Major Depressive Disorder, the claim amount is calculated at 40% of the actual costs. Otherwise, the claim amount will be 15% of the actual costs.
http://www.pediatricpaxiltppsettlement.com/faq.htm
After attorneys' fees and the costs of administering the settlement are deducted from the $40 million, the balance will be distributed to Class members who qualify and submit a claim as described below. The Class member's submission must certify, as provided in the claim form, that the member is seeking only the member's actual out-of-pocket and unreimbursed cost, based on the amount paid by the Class member, exclusive of any co-payments, deductibles, or other amounts not paid by the member to determine your actual costs for Paxil® prescribed for persons under the age of 18, between January 1, 1998 and December 31, 2004. If the records show a diagnosis of Major Depressive Disorder, the claim amount is calculated at 40% of the actual costs. Otherwise, the claim amount will be 15% of the actual costs.
http://www.pediatricpaxiltppsettlement.com/faq.htm
Pediatric Paxil Third-Party Payor Settlement
Pediatric Paxil Third-Party Payor Settlement: "Pediatric Paxil Third-Party Payor Settlement"
http://www.pediatricpaxiltppsettlement.com/faq.htm
extract -
7. What does the settlement provide?
GSK has entered into a proposed settlement with the Plaintiffs and has agreed to pay $40 million to settle the claims set forth in Plaintiffs' lawsuits as follows:
After attorneys' fees and the costs of administering the settlement are deducted from the $40 million, the balance will be distributed to Class members who qualify and submit a claim as described below. The Class member's submission must certify, as provided in the claim form, that the member is seeking only the member's actual out-of-pocket and unreimbursed cost, based on the amount paid by the Class member, exclusive of any co-payments, deductibles, or other amounts not paid by the member to determine your actual costs for Paxil® prescribed for persons under the age of 18, between January 1, 1998 and December 31, 2004. If the records show a diagnosis of Major Depressive Disorder, the claim amount is calculated at 40% of the actual costs. Otherwise, the claim amount will be 15% of the actual costs.
If the total amount of qualified claims exceeds the available funds, claims will be reduced pro rata. If there is money left over after all claims are paid, the balance up to one million dollars will be donated to a charity involved with childrens' mental health issues. Any remainder of funds, after the charitable donation, shall be allocated to increase the amount payable to class members who have submitted qualifying claims, on a pro rata basis based upon the total pediatric Paxil expenditures during the class period that remain uncompensated after the initial claims process, without regard to diagnoses of the presence or absence of diagnostic information in any Class Member’s claims form.
http://www.pediatricpaxiltppsettlement.com/faq.htm
extract -
7. What does the settlement provide?
GSK has entered into a proposed settlement with the Plaintiffs and has agreed to pay $40 million to settle the claims set forth in Plaintiffs' lawsuits as follows:
After attorneys' fees and the costs of administering the settlement are deducted from the $40 million, the balance will be distributed to Class members who qualify and submit a claim as described below. The Class member's submission must certify, as provided in the claim form, that the member is seeking only the member's actual out-of-pocket and unreimbursed cost, based on the amount paid by the Class member, exclusive of any co-payments, deductibles, or other amounts not paid by the member to determine your actual costs for Paxil® prescribed for persons under the age of 18, between January 1, 1998 and December 31, 2004. If the records show a diagnosis of Major Depressive Disorder, the claim amount is calculated at 40% of the actual costs. Otherwise, the claim amount will be 15% of the actual costs.
If the total amount of qualified claims exceeds the available funds, claims will be reduced pro rata. If there is money left over after all claims are paid, the balance up to one million dollars will be donated to a charity involved with childrens' mental health issues. Any remainder of funds, after the charitable donation, shall be allocated to increase the amount payable to class members who have submitted qualifying claims, on a pro rata basis based upon the total pediatric Paxil expenditures during the class period that remain uncompensated after the initial claims process, without regard to diagnoses of the presence or absence of diagnostic information in any Class Member’s claims form.
American lawyers seek $600 million on childrens Seroxat refund - but did they get it?
The drug was not officially sanctioned by US regulator the food and drug administration for use in under-18s. But doctors were allowed to use their own judgment, based on information letters sent by GSK. The lawsuit claims some of these letters omitted the negative information about the drug.
The class action lawsuit was filed in a Minnesota district court last month and is a federal case. The lead plaintiff, Nancy Gerdts, bought the drug for her 12-year-old son in August 2002 and is attempting to get her money back.
Because the law firm is still targeting the thousands of people who bought the drug, the amount the class action is seeking to recover is not yet known. Mr Dahlberg said he estimated the claim could be worth as much as $600m.
Class action lawsuits relating to drugs have been increasingly common in the US, particularly those involving serotonin reuptake inhibitors, which include Prozac and Seroxat
http://www.guardian.co.uk/business/2004/sep/06/medicineandhealth.mentalhealth
The class action lawsuit was filed in a Minnesota district court last month and is a federal case. The lead plaintiff, Nancy Gerdts, bought the drug for her 12-year-old son in August 2002 and is attempting to get her money back.
Because the law firm is still targeting the thousands of people who bought the drug, the amount the class action is seeking to recover is not yet known. Mr Dahlberg said he estimated the claim could be worth as much as $600m.
Class action lawsuits relating to drugs have been increasingly common in the US, particularly those involving serotonin reuptake inhibitors, which include Prozac and Seroxat
http://www.guardian.co.uk/business/2004/sep/06/medicineandhealth.mentalhealth
American parents sue GSK over Seroxat - seeking prescription cost refund
American parents sue GSK over Seroxat
Heather Tomlinson The Guardian, Monday 6 September 2004 09.15 BST Article history
A lawsuit has been filed against GlaxoSmithKline in the United States seeking refunds for children and adolescents given the antidepressant, Seroxat, following claims that the firm suppressed data showing the drug did not work and increased suicidal tendencies in young people.
The class action suit follows an inquiry by New York state attorney general Eliot Spitzer that made similar accusations.
Last month GSK settled with Mr Spitzer for $2.5m (£1.4m), without admitting liability.
The amount surprised the industry because Mr Spitzer had originally said he wanted to recover all the money GSK had made from selling Seroxat - named Paxil in the US - which analysts have estimated at about £200m.
http://www.guardian.co.uk/business/2004/sep/06/medicineandhealth.mentalhealth
Heather Tomlinson The Guardian, Monday 6 September 2004 09.15 BST Article history
A lawsuit has been filed against GlaxoSmithKline in the United States seeking refunds for children and adolescents given the antidepressant, Seroxat, following claims that the firm suppressed data showing the drug did not work and increased suicidal tendencies in young people.
The class action suit follows an inquiry by New York state attorney general Eliot Spitzer that made similar accusations.
Last month GSK settled with Mr Spitzer for $2.5m (£1.4m), without admitting liability.
The amount surprised the industry because Mr Spitzer had originally said he wanted to recover all the money GSK had made from selling Seroxat - named Paxil in the US - which analysts have estimated at about £200m.
http://www.guardian.co.uk/business/2004/sep/06/medicineandhealth.mentalhealth
Friday, 19 March 2010
Seroxat USER group expert witness was paid consultant to GSK
http://bjp.rcpsych.org/cgi/reprint/180/6/547.pdf
Prof Healy is a paid consultant for GSK, Pfizer & a number of other pharmaceutical companies
Correspondence
by D Healy - 2002 - Related articles
http://bjp.rcpsych.org/cgi/reprint/180/6/547.pdf
PPH Diet Drug Wrongful Death Trial Settles for $10 million - source BNET
.The first diet drug wrongful death trial involving primary pulmonary hypertension (PPH) ended Jan. 27 with a reported $10 million settlement by American Home Products Corp. (AHP) (Thomas F. Linnen, et al. v. A.H. Robins Co. Inc., et al., No. 97-2307, Mass. Super., Middlesex Co.).
http://findarticles.com/p/articles/mi_pwwi/is_20050229/ai_mark13005453/?tag=content;col1
Besides being the first wrongful death PPH case to go to trial, the case of Mary J. Linnen is noteworthy because she used fen-phen for only 24 days, because jurors were allowed to asked written questions of witnesses, because it was disclosed that AHP indemnified the prescribing doctor and because AHP's general counsel personally intervened six days into the plaintiff's case and negotiated a settlement.
Linen's parents, Thomas F. and Mary J., sued AHP subsidiaries A.H. Robins and Wyeth-Ayerst Laboratories Inc., phentermine manufacturer Fisons Corp., prescribing physician Dr. Abby Landzberg, Walgreens pharmacy and pharmacist Robert Blake. They say that Linnen, 30, wanted to lose 30 pounds for her upcoming wedding and Landzberg prescribed fen-phen in April 1996. Linnen stood 5-foot-5-inches tall and weighed 185 pounds and was reported to be in excellent health when she began taking the drugs.
Eleven days after starting the regimen, Linnen began experiencing heart palpitations and shortness of breath and the drugs were discontinued on Landzberg's orders.
Linnen was later diagnosed with PPH and died in February 1997 of the disease.
Fisons was dismissed last month after Judge Raymond Brassard of the Massachusetts Superior Court for Middlesex County disqualified plaintiff phentermine experts Drs. Paul Wellman and Alan Woolf. Walgreen settled before trial.
The AHP subsidiaries and Landzberg remained the only defendants when testimony began Jan. 18.
http://findarticles.com/p/articles/mi_pwwi/is_20050229/ai_mark13005453/?tag=content;col1
Besides being the first wrongful death PPH case to go to trial, the case of Mary J. Linnen is noteworthy because she used fen-phen for only 24 days, because jurors were allowed to asked written questions of witnesses, because it was disclosed that AHP indemnified the prescribing doctor and because AHP's general counsel personally intervened six days into the plaintiff's case and negotiated a settlement.
Linen's parents, Thomas F. and Mary J., sued AHP subsidiaries A.H. Robins and Wyeth-Ayerst Laboratories Inc., phentermine manufacturer Fisons Corp., prescribing physician Dr. Abby Landzberg, Walgreens pharmacy and pharmacist Robert Blake. They say that Linnen, 30, wanted to lose 30 pounds for her upcoming wedding and Landzberg prescribed fen-phen in April 1996. Linnen stood 5-foot-5-inches tall and weighed 185 pounds and was reported to be in excellent health when she began taking the drugs.
Eleven days after starting the regimen, Linnen began experiencing heart palpitations and shortness of breath and the drugs were discontinued on Landzberg's orders.
Linnen was later diagnosed with PPH and died in February 1997 of the disease.
Fisons was dismissed last month after Judge Raymond Brassard of the Massachusetts Superior Court for Middlesex County disqualified plaintiff phentermine experts Drs. Paul Wellman and Alan Woolf. Walgreen settled before trial.
The AHP subsidiaries and Landzberg remained the only defendants when testimony began Jan. 18.
Thursday, 18 March 2010
Scientology award to Fiddaman's publisher Chipmunka's Jason Pegler
http://www.pr-inside.com/three-human-rights-awards-presented-by-r105271.htm
Saturday, 13 March 2010
AZ falls foul of ABPI Code of Practice with Seroquel ad
AZ falls foul of ABPI Code of Practice with Seroquel ad
http://www.pharmatimes.com/UKNews/article.aspx?id=17534
10 March 2010
A preliminary ruling by the Prescription Medicines Code of Practice Authority says AstraZeneca broke advertising rules by failing to accurately reflect the side-effects of its antipsychotic Seroquel.
The policing arm of the Association of the British Pharmaceutical Industry has allegedly found the Anglo-Swiss drugmaker to be in breach of the Code on three counts, with claims made in an ad – published in the British Journal of Psychiatry in 2004 - that Seroquel (quetiapine) has a favourable weight profile compared with rival drugs, according to media reports.
Because weight gain is in fact a fairly common side effect of Seroquel, the PMCPA ruled that the company’s ad was misleading and had breached ethical code requirements that marketing information should be “accurate and fair, and be capable of substantiation”, according to the Financial Times.
A spokeswoman for the PMCPA could not divulge any details regarding the ruling, as, she stressed, the information is only intended for full disclosure when a final decision is reached, and should not have been made public at this point.
However, she was able to confirm to PharmaTimes UK News that the PMCPA received three separate complaints regarding AZ’s promotion of Seroquel in January – one from a healthcare professional, one from a journalist and one from a member of the public – and that letters regarding the initial ruling on these cases had been sent out on Monday, allowing the claimants and AZ until the end of the week to lodge any appeals.
In defence, AZ is arguing that the intended audience for the advert would have understood that the information was in fact claiming that while Seroquel did result in weight gain, its profile was still favourable to other antipsychotics on the market at that time. "The intended audience for the advertisement was UK healthcare professionals, including UK specialist psychiatrists who we believe would have understood the statement in the broader context of the debate around weight gain and atypical antipsychotics in UK" the company said in an emailed statement to PharmaTimes.
Furthermore, AZ said it has long worked with regulatory authorities “to ensure that the safety profile of Seroquel is reflected appropriately in the label so that doctors can weigh the risks and benefits of medicines when making treatment decisions”, and that when Seroquel was first cleared for use in the UK, “the label alerted physicians that ‘weight gain’ had been observed”.
Misleading claims?
However, earlier this year a former employee of AZ has told the BBC he was pressured by the firm’s marketeers to approve claims that Seroquel was not linked with weight gain, despite evidence to the contrary.
John Blenkinsopp, the company's former UK medical manager, told the BBC Radio 4’s File on 4 programme that, while clinical studies at the time Seroquel’s launch “showed patients developed significant weight gain, significant both statistically and clinically”, the company’s marketing team “came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain”.
Launched in 1997 for the treatment of schizophrenia and later bipolar disorder, Seroquel quickly became one of the world’s top 10 selling drugs and, with annual sales of around $4.45 billion a year, AZ’s second-biggest earner.
News of the ruling will likely come as a bitter blow to the firm, which is currently battling thousands of lawsuits in the US alleging that it withheld information and failed to adequately warn patients of Seroquel’s side effects such as significant weight gain and an increased risk of diabetes.
A spokesperson for AZ could not comment on the ruling but told PharmaTimes UK News that the company was still examining the PMCPA's decision in detail, before deciding on whether or not to lodge an appeal.
By Selina McKee
http://www.pharmatimes.com/UKNews/article.aspx?id=17534
10 March 2010
A preliminary ruling by the Prescription Medicines Code of Practice Authority says AstraZeneca broke advertising rules by failing to accurately reflect the side-effects of its antipsychotic Seroquel.
The policing arm of the Association of the British Pharmaceutical Industry has allegedly found the Anglo-Swiss drugmaker to be in breach of the Code on three counts, with claims made in an ad – published in the British Journal of Psychiatry in 2004 - that Seroquel (quetiapine) has a favourable weight profile compared with rival drugs, according to media reports.
Because weight gain is in fact a fairly common side effect of Seroquel, the PMCPA ruled that the company’s ad was misleading and had breached ethical code requirements that marketing information should be “accurate and fair, and be capable of substantiation”, according to the Financial Times.
A spokeswoman for the PMCPA could not divulge any details regarding the ruling, as, she stressed, the information is only intended for full disclosure when a final decision is reached, and should not have been made public at this point.
However, she was able to confirm to PharmaTimes UK News that the PMCPA received three separate complaints regarding AZ’s promotion of Seroquel in January – one from a healthcare professional, one from a journalist and one from a member of the public – and that letters regarding the initial ruling on these cases had been sent out on Monday, allowing the claimants and AZ until the end of the week to lodge any appeals.
In defence, AZ is arguing that the intended audience for the advert would have understood that the information was in fact claiming that while Seroquel did result in weight gain, its profile was still favourable to other antipsychotics on the market at that time. "The intended audience for the advertisement was UK healthcare professionals, including UK specialist psychiatrists who we believe would have understood the statement in the broader context of the debate around weight gain and atypical antipsychotics in UK" the company said in an emailed statement to PharmaTimes.
Furthermore, AZ said it has long worked with regulatory authorities “to ensure that the safety profile of Seroquel is reflected appropriately in the label so that doctors can weigh the risks and benefits of medicines when making treatment decisions”, and that when Seroquel was first cleared for use in the UK, “the label alerted physicians that ‘weight gain’ had been observed”.
Misleading claims?
However, earlier this year a former employee of AZ has told the BBC he was pressured by the firm’s marketeers to approve claims that Seroquel was not linked with weight gain, despite evidence to the contrary.
John Blenkinsopp, the company's former UK medical manager, told the BBC Radio 4’s File on 4 programme that, while clinical studies at the time Seroquel’s launch “showed patients developed significant weight gain, significant both statistically and clinically”, the company’s marketing team “came at me with a number of potential claims all of which were trying to intimate that Seroquel was not associated with weight gain”.
Launched in 1997 for the treatment of schizophrenia and later bipolar disorder, Seroquel quickly became one of the world’s top 10 selling drugs and, with annual sales of around $4.45 billion a year, AZ’s second-biggest earner.
News of the ruling will likely come as a bitter blow to the firm, which is currently battling thousands of lawsuits in the US alleging that it withheld information and failed to adequately warn patients of Seroquel’s side effects such as significant weight gain and an increased risk of diabetes.
A spokesperson for AZ could not comment on the ruling but told PharmaTimes UK News that the company was still examining the PMCPA's decision in detail, before deciding on whether or not to lodge an appeal.
By Selina McKee
Seroxat "has made me a danger" - Bob Fiddaman states in letter to Sunday Mercury
Letter: Drug has made me a danger
Sunday Mercury (Birmingham, England), June 27, 2004
I READ with great interest the story of Faye Elliot from Gloucestershire regarding her plight with the antidepressant Seroxat. I, like Faye, am part of the Online Seroxat Support Group and have had horrendous side-effects from this so-called 'wonder drug'.
Fortunately, I am now Seroxat-free, coming off the drug 'cold turkey' over four months ago. This was my fourth attempt to come off after being prescribed them by my GP over six years ago.
During those six years, I made one suicide attempt, separated from my wife and three children and lost my job. The effects have had a devastating effect on my life.
Seroxat has changed me as a person -I no longer wish to be in social situations because I fear for the safety of whoever says the wrong thing to me.
A lot of my anger is vented toward the company that manufacture the drug, Glaxo SmithKlein (GSK), for their lies and deceit on the general public.
This anti-depressant should be banned immediately whilst there is a public inquiry.
The frustration and anger inside me grow each day, particularly recently as there have been many stories regarding people's struggles with this demon drug.
I do not blame the GPs or psychiatrists -they have been kept as much in the dark as the patients. Something needs to be done and it needs to be seen to be done with immediate effect otherwise there will be more stories of suicide or homicidal tendencies.
I hope one day that the powers-that-be at GSK and the Medicines and Healthcare products Regulatory Agency (MHRA), a board set up to grant licences to pharmaceu-tical companies, are force-fed this drug for a six-week period -then taken off it. Let's see them suffer the electric-like zaps through the body, the profuse sweating, the bouts of insomnia, the bouts of parasomnia, the rage and fury. Let them lose their wife and kids, their job, their friends, their sanity.
I applaud the Sunday Mercury for shedding light on this matter.
The Online Seroxat Support Group can be contacted via fiddaman64@blueyonder.co.uk
BOB FIDDAMAN Quinton Birmingham
http://findarticles.com/p/news-articles/sunday-mercury-birmingham-england/mi_7995/is_2004_June_27/letter-drug-danger/ai_n37255173/
Sunday Mercury (Birmingham, England), June 27, 2004
I READ with great interest the story of Faye Elliot from Gloucestershire regarding her plight with the antidepressant Seroxat. I, like Faye, am part of the Online Seroxat Support Group and have had horrendous side-effects from this so-called 'wonder drug'.
Fortunately, I am now Seroxat-free, coming off the drug 'cold turkey' over four months ago. This was my fourth attempt to come off after being prescribed them by my GP over six years ago.
During those six years, I made one suicide attempt, separated from my wife and three children and lost my job. The effects have had a devastating effect on my life.
Seroxat has changed me as a person -I no longer wish to be in social situations because I fear for the safety of whoever says the wrong thing to me.
A lot of my anger is vented toward the company that manufacture the drug, Glaxo SmithKlein (GSK), for their lies and deceit on the general public.
This anti-depressant should be banned immediately whilst there is a public inquiry.
The frustration and anger inside me grow each day, particularly recently as there have been many stories regarding people's struggles with this demon drug.
I do not blame the GPs or psychiatrists -they have been kept as much in the dark as the patients. Something needs to be done and it needs to be seen to be done with immediate effect otherwise there will be more stories of suicide or homicidal tendencies.
I hope one day that the powers-that-be at GSK and the Medicines and Healthcare products Regulatory Agency (MHRA), a board set up to grant licences to pharmaceu-tical companies, are force-fed this drug for a six-week period -then taken off it. Let's see them suffer the electric-like zaps through the body, the profuse sweating, the bouts of insomnia, the bouts of parasomnia, the rage and fury. Let them lose their wife and kids, their job, their friends, their sanity.
I applaud the Sunday Mercury for shedding light on this matter.
The Online Seroxat Support Group can be contacted via fiddaman64@blueyonder.co.uk
BOB FIDDAMAN Quinton Birmingham
http://findarticles.com/p/news-articles/sunday-mercury-birmingham-england/mi_7995/is_2004_June_27/letter-drug-danger/ai_n37255173/
Friday, 12 March 2010
Seroxat & Prozac birth defects rate similar - MHRA
The agency said it had looked at the evidence from a number of studies of fluoxetine, the active ingredient in Prozac, and concluded that it could double the background rate of congenital heart defects.
http://bobfiddaman.blogspot.com/2010/03/pregnant-women-warned-over-prozac-risk.html
About one in 100 babies are typically born with a problem such as a heart murmur, hole in the heart or other problem with the organ’s structure or rhythm.
But the MHRA estimates this rate increases to almost two in 100 pregnancies among women prescribed fluoxetine, which is a similar rate to another common antidepressant, Seroxat (paroxetine).
The drugs are part of a group known as selective serotonin reuptake inhibitors (SSRIs), which are not recommended to be taken during pregnancy because of the risk of withdrawal symptoms in the developing baby.
http://bobfiddaman.blogspot.com/2010/03/pregnant-women-warned-over-prozac-risk.html
About one in 100 babies are typically born with a problem such as a heart murmur, hole in the heart or other problem with the organ’s structure or rhythm.
But the MHRA estimates this rate increases to almost two in 100 pregnancies among women prescribed fluoxetine, which is a similar rate to another common antidepressant, Seroxat (paroxetine).
The drugs are part of a group known as selective serotonin reuptake inhibitors (SSRIs), which are not recommended to be taken during pregnancy because of the risk of withdrawal symptoms in the developing baby.
Pregnant women warned over Prozac risk to foetus - Times Online
Pregnant women warned over Prozac risk to foetus - Times Online: "Pregnant women warned over Prozac risk to foetus"
Pregnant women who take Prozac, the antidepressant, are twice as likely to give birth to babies with a congenital heart problem, the medicines regulator has warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) said there was a “possible small risk” of congenital heart defects if women were given the drug in early pregnancy.
The agency said it had looked at the evidence from a number of studies of fluoxetine, the active ingredient in Prozac, and concluded that it could double the background rate of congenital heart defects.
About one in 100 babies are typically born with a problem such as a heart murmur, hole in the heart or other problem with the organ’s structure or rhythm.
But the MHRA estimates this rate increases to almost two in 100 pregnancies among women prescribed fluoxetine, which is a similar rate to another common antidepressant, Seroxat (paroxetine).
The drugs are part of a group known as selective serotonin reuptake inhibitors (SSRIs), which are not recommended to be taken during pregnancy because of the risk of withdrawal symptoms in the developing baby.
But it is estimated that 2.3 per cent of pregnant women each year are prescribed SSRIs when the benefits are considered to outweigh the risks.
Studies suggest that up to one in five mothers-to-be suffer from depression at some point during pregnancy, which if left untreated can cause low birth weight and premature birth.
The MHRA said that a class effect with SSRIs on heart formation in utero “could not be excluded” and recommended GPs were mindful of this when prescribing the drugs.
The agency said: “When prescribing fluoxetine to treat depression during pregnancy, prescribers should be aware that there may be a small increased risk of congenital cardiac defects in infants exposed in early pregnancy, similar to that seen with paroxetine.”
Letter: Drug has made me a danger
http://findarticles.com/p/news-articles/sunday-mercury-birmingham-england/mi_7995/is_2004_June_27/letter-drug-danger/ai_n37255173/
read on -
Pregnant women who take Prozac, the antidepressant, are twice as likely to give birth to babies with a congenital heart problem, the medicines regulator has warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) said there was a “possible small risk” of congenital heart defects if women were given the drug in early pregnancy.
The agency said it had looked at the evidence from a number of studies of fluoxetine, the active ingredient in Prozac, and concluded that it could double the background rate of congenital heart defects.
About one in 100 babies are typically born with a problem such as a heart murmur, hole in the heart or other problem with the organ’s structure or rhythm.
But the MHRA estimates this rate increases to almost two in 100 pregnancies among women prescribed fluoxetine, which is a similar rate to another common antidepressant, Seroxat (paroxetine).
The drugs are part of a group known as selective serotonin reuptake inhibitors (SSRIs), which are not recommended to be taken during pregnancy because of the risk of withdrawal symptoms in the developing baby.
But it is estimated that 2.3 per cent of pregnant women each year are prescribed SSRIs when the benefits are considered to outweigh the risks.
Studies suggest that up to one in five mothers-to-be suffer from depression at some point during pregnancy, which if left untreated can cause low birth weight and premature birth.
The MHRA said that a class effect with SSRIs on heart formation in utero “could not be excluded” and recommended GPs were mindful of this when prescribing the drugs.
The agency said: “When prescribing fluoxetine to treat depression during pregnancy, prescribers should be aware that there may be a small increased risk of congenital cardiac defects in infants exposed in early pregnancy, similar to that seen with paroxetine.”
Letter: Drug has made me a danger
http://findarticles.com/p/news-articles/sunday-mercury-birmingham-england/mi_7995/is_2004_June_27/letter-drug-danger/ai_n37255173/
read on -
Thursday, 11 March 2010
Seroxat USERS collaborate with MHRA Expert Working Group
10.3 The Group was informed that the Seroxat Users Group, which is a UK patient support group, has been in correspondence with the MHRA and its predecessor the Medicines Control Agency expressing its concerns about the safety of paroxetine. The MHRA had informed the Seroxat Users Group of its willingness to consider any reports of suspected adverse drug reactions submitted by members of the Seroxat User Group. In recent correspondence the Seroxat Users Group has expressed an interest in meeting with the Expert Group in order to contribute to its work.
10.4 The Expert Group commented that the views of the Seroxat User Group would provide a valuable contribution to the ongoing review. It was agreed that the Seroxat
Users Group should be given the opportunity to make a presentation to the Group should they wish. However, they might prefer a less formal meeting between representatives of the Expert Group and members of the MHRA to discuss their concerns. It was agreed that it would be helpful if the Seroxat Users Group provided a written representation which could then be considered by the Group.
http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003485.pdf
10.4 The Expert Group commented that the views of the Seroxat User Group would provide a valuable contribution to the ongoing review. It was agreed that the Seroxat
Users Group should be given the opportunity to make a presentation to the Group should they wish. However, they might prefer a less formal meeting between representatives of the Expert Group and members of the MHRA to discuss their concerns. It was agreed that it would be helpful if the Seroxat Users Group provided a written representation which could then be considered by the Group.
http://www.mhra.gov.uk/home/groups/pl-p/documents/committeedocument/con003485.pdf
Sunday, 7 March 2010
Seroxat Sock Puppet Mark Harvey tells GSK don't accept liability just change the P.I.L.
http://groups.yahoo.com/group/uksurvivors/message/12365
http://www.hjfs.co.uk/images/partners/Mark%20Harvey.jpg
The chemistry of happiness , located @
http://www.seroxatusergroup.org.uk/media_interest.htm
Harvey is not the sort of hot-headed litigator we may be familiar
with from the movies; he does not distrust Big Medicine per se.
~~~~and he has a moderate suggestion 'If [GSK] were sensible, they
would sit down and go, "We don't accept any legal liability but we
recognise that we could improve the information that we give to the
patient and the doctor."'
The chemistry of happiness , also located @
http://society.guardian.co.uk/mentalhealth/story/0,8150,707016,00.htm
http://www.hjfs.co.uk/images/partners/Mark%20Harvey.jpg
The chemistry of happiness , located @
http://www.seroxatusergroup.org.uk/media_interest.htm
Harvey is not the sort of hot-headed litigator we may be familiar
with from the movies; he does not distrust Big Medicine per se.
~~~~and he has a moderate suggestion 'If [GSK] were sensible, they
would sit down and go, "We don't accept any legal liability but we
recognise that we could improve the information that we give to the
patient and the doctor."'
The chemistry of happiness , also located @
http://society.guardian.co.uk/mentalhealth/story/0,8150,707016,00.htm
Wednesday, 3 March 2010
BBC checking out Seroxat's Shelley Jofre yet again !
IP Address 132.185.240.124
ISP BRITISH BROADCASTING CORPORATION
Domain BBC.CO.UK
City LONDON
Region ENGLAND
Country UNITED KINGDOM
Returning Visits 4
Date Time WebPage
March 03, 2010 9:09:47 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: Shelley Jofre who failed expectant mothers everywhere, she knew there was a problem with all SSRI, but only researched Seroxat to meet the requirements Seroxat lawyer Mark Harvey
http://bobfiddaman.blogspot.com/2010/01/shelley-jofre-who-failed-expectant.html
http://www.google.co.uk/search?q=shelley%20jofre&hl=en&sa=N&tab=bw
March 03, 2010 9:09:04 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint
http://bobfiddaman.blogspot.com/2010/02/uksurvivors-message-shelley-jofre.html
http://blogsearch.google.co.uk/blogsearch?q=shelley%20jofre&hl=en&tab=nb
February 26, 2010 8:48:34 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint
http://bobfiddaman.blogspot.com/2010/02/uksurvivors-message-shelley-jofre.html
http://www.google.co.uk/search?tbo=1&tbs=blg%3A1&q=shelley%20jofre&hl=en&ie=UTF- 8&tab=nb
ISP BRITISH BROADCASTING CORPORATION
Domain BBC.CO.UK
City LONDON
Region ENGLAND
Country UNITED KINGDOM
Returning Visits 4
Date Time WebPage
March 03, 2010 9:09:47 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: Shelley Jofre who failed expectant mothers everywhere, she knew there was a problem with all SSRI, but only researched Seroxat to meet the requirements Seroxat lawyer Mark Harvey
http://bobfiddaman.blogspot.com/2010/01/shelley-jofre-who-failed-expectant.html
http://www.google.co.uk/search?q=shelley%20jofre&hl=en&sa=N&tab=bw
March 03, 2010 9:09:04 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint
http://bobfiddaman.blogspot.com/2010/02/uksurvivors-message-shelley-jofre.html
http://blogsearch.google.co.uk/blogsearch?q=shelley%20jofre&hl=en&tab=nb
February 26, 2010 8:48:34 PM SEROXAT SUFFERERS - STAND UP AND BE COUNTED: uksurvivors : Message: Shelley Jofre Panorama programme removed after complaint
http://bobfiddaman.blogspot.com/2010/02/uksurvivors-message-shelley-jofre.html
http://www.google.co.uk/search?tbo=1&tbs=blg%3A1&q=shelley%20jofre&hl=en&ie=UTF- 8&tab=nb
Monday, 1 March 2010
Spitzer only wanted a trial data web site - not Paxil sales restriction
extract from - http://bostonreview.net/BR35.2/spitzer.php
When we sued Glaxo, they thought we wanted money. But we only wanted them to change the way they acted. We asked them to create a Web site for the clinical testing data so that doctors and journals could make informed judgments. They agreed. The settlement became part of a longer process, a move toward substantially more disclosure when it comes to drugs and testing data.
From Glaxo’s perspective, the more data they withheld, the better it was for them. They could persuade more people to use Paxil. So, again: only government can ensure integrity, transparency, and fair dealing.
When we sued Glaxo, they thought we wanted money. But we only wanted them to change the way they acted. We asked them to create a Web site for the clinical testing data so that doctors and journals could make informed judgments. They agreed. The settlement became part of a longer process, a move toward substantially more disclosure when it comes to drugs and testing data.
From Glaxo’s perspective, the more data they withheld, the better it was for them. They could persuade more people to use Paxil. So, again: only government can ensure integrity, transparency, and fair dealing.
NOT for Spitzer to decide if Paxil was good/bad for teenagers - the case was about disclosure of information
extract from - http://bostonreview.net/BR35.2/spitzer.php
Here’s another story. We brought a case against GlaxoSmithKline, which was at the time marketing Paxil—an anti-depressant—as effective for teenagers. It had been approved for other purposes, but this was off-label marketing. We found that a significant number of the clinical tests they had done proved something directly at odds with their claims. It was not for me as attorney general to determine whether this drug was bad or good for teenagers, but to insist on full disclosure of critically relevant information so that doctors and journals could make that determination.
When we sued Glaxo, they thought we wanted money. But we only wanted them to change the way they acted. We asked them to create a Web site for the clinical testing data so that doctors and journals could make informed judgments. They agreed. The settlement became part of a longer process, a move toward substantially more disclosure when it comes to drugs and testing data.
From Glaxo’s perspective, the more data they withheld, the better it was for them. They could persuade more people to use Paxil. So, again: only government can ensure integrity, transparency, and fair dealing.
Here’s another story. We brought a case against GlaxoSmithKline, which was at the time marketing Paxil—an anti-depressant—as effective for teenagers. It had been approved for other purposes, but this was off-label marketing. We found that a significant number of the clinical tests they had done proved something directly at odds with their claims. It was not for me as attorney general to determine whether this drug was bad or good for teenagers, but to insist on full disclosure of critically relevant information so that doctors and journals could make that determination.
When we sued Glaxo, they thought we wanted money. But we only wanted them to change the way they acted. We asked them to create a Web site for the clinical testing data so that doctors and journals could make informed judgments. They agreed. The settlement became part of a longer process, a move toward substantially more disclosure when it comes to drugs and testing data.
From Glaxo’s perspective, the more data they withheld, the better it was for them. They could persuade more people to use Paxil. So, again: only government can ensure integrity, transparency, and fair dealing.
Eliot Spitzer: The Rules - Government’s proper role in the market
Boston Review — Eliot Spitzer: The Rules
Eliot Spitzer
Every day we read the headlines, feel the tensions, observe the consequences of the recent failures of market and government. Having a serious conversation about how to remedy these failures lies at the heart of current American politics. And that conversation should address three distinct questions:
• What are the parameters of government intervention in the marketplace? What rules should we use in deciding when the government should act, and when it should let the market take its course?
read on -
http://bostonreview.net/BR35.2/spitzer.php
Eliot Spitzer
Every day we read the headlines, feel the tensions, observe the consequences of the recent failures of market and government. Having a serious conversation about how to remedy these failures lies at the heart of current American politics. And that conversation should address three distinct questions:
• What are the parameters of government intervention in the marketplace? What rules should we use in deciding when the government should act, and when it should let the market take its course?
read on -
http://bostonreview.net/BR35.2/spitzer.php
An Overdose at 15 - Traci Johnson / Tylenol (paracetamol)?
An Overdose at 15
Johnson seemed like a good candidate for the duloxetine trial. At 5-foot-4 and 130 pounds, she was physically fit and, by all accounts, reliable and upbeat.
But during her interview, she told screeners that when she was 15, she had landed in the emergency room after overdosing on Tylenol pills and had to have her stomach cleared, according to a psychiatrist studying duloxetine who has read a report on Johnson's case. The doctor spoke on condition of anonymity because the information was considered confidential
http://66.102.9.132/search?q=cache:XZTbVB6fKjAJ:articles.latimes.com/2004/apr/02/science/sci-humantest2+%22A+Godsend,+Till+a+Life+Unravels%22&cd=1&hl=en&ct=clnk
Johnson seemed like a good candidate for the duloxetine trial. At 5-foot-4 and 130 pounds, she was physically fit and, by all accounts, reliable and upbeat.
But during her interview, she told screeners that when she was 15, she had landed in the emergency room after overdosing on Tylenol pills and had to have her stomach cleared, according to a psychiatrist studying duloxetine who has read a report on Johnson's case. The doctor spoke on condition of anonymity because the information was considered confidential
http://66.102.9.132/search?q=cache:XZTbVB6fKjAJ:articles.latimes.com/2004/apr/02/science/sci-humantest2+%22A+Godsend,+Till+a+Life+Unravels%22&cd=1&hl=en&ct=clnk
A Godsend, Till a Life Unravels - Los Angeles Times
A Godsend, Till a Life Unravels - Los Angeles Times: "A Godsend, Till a Life Unravels"
Traci Johnson joined a clinical trial of an antidepressant to pay for college. The devout woman ended up taking her own life.
THE NATION
COLUMN ONEApril 02, 2004
Alan Zarembo and Benedict Carey , Times Staff WritersINDIANAPOLIS — Traci Johnson believed it was God's plan for her to leave home to attend a tiny Bible college here -- and she prayed every day for the Lord to provide for her tuition.
Then an unusual opportunity presented itself.
read on - http://articles.latimes.com/2004/apr/02/science/sci-humantest2
Traci Johnson joined a clinical trial of an antidepressant to pay for college. The devout woman ended up taking her own life.
THE NATION
COLUMN ONEApril 02, 2004
Alan Zarembo and Benedict Carey , Times Staff WritersINDIANAPOLIS — Traci Johnson believed it was God's plan for her to leave home to attend a tiny Bible college here -- and she prayed every day for the Lord to provide for her tuition.
Then an unusual opportunity presented itself.
read on - http://articles.latimes.com/2004/apr/02/science/sci-humantest2
justAna: People close to Trace Johnson left three comments anonymously
justAna: People close to Trace Johnson left three comments anonymously
I received three comments of someone or more than one person that claims they mourn Traci's death and was very close to her. These are the comments:
melissa said...
I just wanted to comment here, that I too remember dearest Tracy. I was all too close to her this very night that she passed and my prayers continue for her family that survived her passing. Now 6 years later and my heart still bleeds a bit as we pass by this season of life again and mourn her loss.
With Love,
-Someone who was Called to the scene of passing-
February 14, 2010 6:25 PM
This one at this post and:
AnnaJ said...
I knew Traci. What a loss! We still carry the pain and sadness of her absence from our lives.
February 27, 2010 3:16 PM
Anonymous said...
Thank you for honoring Traci. She is sorely missed. We knew Traci. She was a part of our lives. The sheer devistation has not healed even after 7 years. We are still suffering from the absence of this wonderful person in our lives.
February 27, 2010 3:23 PM
these at my other blog here.
Thank you for leaving these messages but I will never understand why people who are close to Traci Johnson says nothing, keep in silence and don't fight for justice to what was done to this 19 years-old healthy girl who was murdered at Eli-Lilly's facilities after taking Cymbalta and having as side effect drug-induced suicidal ideation. She hanged herself but keep in mind that she was not testing Cymbalta as an antidepressant but as a medicine for urinary incontinence and that she has never had any kind of mental disease since it was one of the requirements to be a volunteer in that clinical trial. Eli-Lilly wanted healthy people for this clinical trial and Traci Johnson was accepted after being examined and classified as not having any kind of mental disease. We are talking about a girl who just volunteered to a clinical trial because her father was jobless and she was going to be paid $ 150 a day.
I don't understand why these people are commenting anonymously and since I started bloging I asked many people if they knew about Traci Johnson's parents, relatives or friends.
If you keep on silent and don't fight for justice like Sara Carlin's parents and others I have to admit that I have to believe in those who claim that Elli Lilly has payed the family to keep silent.
Unacceptable.
I received three comments of someone or more than one person that claims they mourn Traci's death and was very close to her. These are the comments:
melissa said...
I just wanted to comment here, that I too remember dearest Tracy. I was all too close to her this very night that she passed and my prayers continue for her family that survived her passing. Now 6 years later and my heart still bleeds a bit as we pass by this season of life again and mourn her loss.
With Love,
-Someone who was Called to the scene of passing-
February 14, 2010 6:25 PM
This one at this post and:
AnnaJ said...
I knew Traci. What a loss! We still carry the pain and sadness of her absence from our lives.
February 27, 2010 3:16 PM
Anonymous said...
Thank you for honoring Traci. She is sorely missed. We knew Traci. She was a part of our lives. The sheer devistation has not healed even after 7 years. We are still suffering from the absence of this wonderful person in our lives.
February 27, 2010 3:23 PM
these at my other blog here.
Thank you for leaving these messages but I will never understand why people who are close to Traci Johnson says nothing, keep in silence and don't fight for justice to what was done to this 19 years-old healthy girl who was murdered at Eli-Lilly's facilities after taking Cymbalta and having as side effect drug-induced suicidal ideation. She hanged herself but keep in mind that she was not testing Cymbalta as an antidepressant but as a medicine for urinary incontinence and that she has never had any kind of mental disease since it was one of the requirements to be a volunteer in that clinical trial. Eli-Lilly wanted healthy people for this clinical trial and Traci Johnson was accepted after being examined and classified as not having any kind of mental disease. We are talking about a girl who just volunteered to a clinical trial because her father was jobless and she was going to be paid $ 150 a day.
I don't understand why these people are commenting anonymously and since I started bloging I asked many people if they knew about Traci Johnson's parents, relatives or friends.
If you keep on silent and don't fight for justice like Sara Carlin's parents and others I have to admit that I have to believe in those who claim that Elli Lilly has payed the family to keep silent.
Unacceptable.
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