Date: 5/27/2009
KRISTIN M. HALL
Associated Press Writer
FORT CAMPBELL, Ky. (AP) — Regular duties are suspended for three days at Fort Campbell, which leads the Army in suicides this year, so commanders can identify and help soldiers who are struggling with the stress of war and most at risk for killing themselves.
The post began a stand down on Wednesday so soldiers can focus on suicide prevention training in the wake of 11 confirmed suicides by Fort Campbell soldiers this year. More deaths are being investigated as possible suicides.
“This is not a place where Fort Campbell and the 101st Airborne Division want to be,” said Brig. Gen. Stephen Townsend. “We don’t want to lead the Army in this statistic.”
From January to March, the installation on the Kentucky-Tennessee line averaged one suicide per week, Townsend said. After an Army-wide suicide prevention campaign in started in March, there were no suicides for six weeks, he said.
“But last week we had two. Two in a week,” Townsend said.
In a series of addresses this week, Townsend will speak to each of the approximately 25,000 soldiers assigned to the division. He told more than 4,000 soldiers Wednesday morning that the suicides must stop.
“Someone here has had thoughts or is having thoughts about hurting themselves,” Townsend said. “Or you know someone who is.”
Army leaders have been developing new guidance for commanders to help installations like Fort Campbell deal with rising suicide rates. Across the Army, suicides from January through March rose to a reported 56 — 22 confirmed and 34 still being investigated and pending confirmation.
The Army has said that soldier suicides reached the highest rate on record in 2008. Officials said the deaths in 2008 would amount to a rate of 20.2 per 100,000 soldiers, which is higher than the civilian rate, when adjusted to reflect the Army’s younger and male-heavy demographics.
Frequent deployments by the division since 2001 have contributed to the stress suffered by soldiers at Fort Campbell, said Col. Ken Brown, the head of chaplains on the installation.
The three 101st Airborne combat brigades have gone through at least three tours in Iraq. The 3rd Brigade also served seven months in Afghanistan, early in the war, and the 4th Brigade has just returned from a 15-month tour in Afghanistan.
“We’ve been at war at this installation for seven years,” Brown said. “I think that has a cumulative effect across the force.”
Fort Campbell leaders have asked soldiers on the post to look out for each other and paired them up through a “battle buddy” system. Unit leaders are also reviewing and updating lists of soldiers who may be a risk for suicide and are reminding them they can seek help from resources such as a chaplain or a hospital.
But Army officials say many soldiers are afraid that seeking help for mental health issues will hurt their career or make them appear weak to their fellow soldiers. Townsend urged soldiers to speak up.
“You wouldn’t hesitate to seek medical attention for a physical wound or injury,” Townsend said. “Don’t hesitate to seek medical attention for a psychological injury.”
Copyright 2009 The Associated Press.
AstraZeneca e-mails show debate on Seroquel risks
Date: 5/20/2009 4:01 PM
LINDA A. JOHNSON
AP Business Writer
TRENTON, N.J. (AP) — Marketing executives at British drugmaker AstraZeneca PLC for years blocked efforts by company scientists to raise concerns antipsychotic drug Seroquel caused weight gain and other problems, saying that would harm sales, plaintiff lawyers say.
They say their claim is backed by internal documents released Wednesday as part of ongoing lawsuits against the company brought by patients alleging they were harmed by the blockbuster drug for schizophrenia and bipolar disorder.
Some of the internal e-mails and other documents, released late Tuesday to The Associated Press, show efforts to keep public information about Seroquel positive amid a spirited debate between the company’s scientists and its marketing executives.
Ed Blizzard, a Houston attorney whose firm is helping to represent about 6,000 Seroquel plaintiffs, said data showing Seroquel was “not very effective” and had serious side effects “was either spun or skewed or outright concealed.”
AstraZeneca spokesman Tony Jewell said that since the drug was approved in late 1997, the label or detailed package insert has stated that diabetes, high blood sugar and weight gain have been observed in patients in clinical studies.
He noted that the U.S. Food and Drug Administration in the past several years has approved Seroquel as safe for new uses — bipolar mania, then bipolar depression and then an extended-release version.
Other internal e-mails and planning documents suggest the company pondered uses for which Seroquel was not approved by the Food and Drug Administration, including in dementia patients, though none of the documents indicate the company actually marketed the drug for those uses.
Doctors are allowed to prescribe drugs for unapproved uses, but drugmakers can’t promote them for those uses.
A strategic plan dated 2000 suggested a “key success factor” would be to “broaden Seroquel use on and off label,” specifically targeting educational programs “to share off label data.”
Jewell said in an e-mailed statement that the documents do not recommend “inappropriate promotion” of the drug and refer to intentions to seek approval for additional indications. The statement also points out physicians often prescribe atypical antipsychotics like Seroquel off-label.
Blizzard challenged that in a conference call. “The only way they can broaden its use off-label is by marketing it to physicians,” he said.
Seroquel was AstraZeneca’s No. 2 drug in sales last year, with revenue of $4.5 billion.
Blizzard said U.S. District Judge Anne C. Conway in Orlando, Fla., who has been coordinating pretrial details of nearly 6,000 federal Seroquel lawsuits, recently ordered them returned to the federal courts where they were filed.
First, she is settling issues such as which of the many documents plaintiff lawyers obtained through pretrial discovery should be available for use in those trials and open to the public. AstraZeneca has claimed its documents are confidential but agreed to release hundreds in February and 400 more Wednesday.
In a chain of e-mails in one document, a scientistific safety committee in June 2000 recommended removing “limited” before the words “weight gain” in the list of Seroquel side effects, because many patients gained significant weight.
Marketing staff suggested trying other explanations, such as whether patients took other drugs that could be blamed. One marketing executive, Medical Affairs Manager Richard Owen, then wrote that such a change “is potentially damaging to Seroquel.”
The change in the drug’s label was finally made in 2002. That was after Barry Arnold, the vice president for clinical drug safety, complained repeatedly to the physician in charge of Seroquel drug safety about “Commercial (executives) having such an influence.”
Yet soon after the label change, AstraZeneca trademarked the term “weight-neutral” as a slogan for Seroquel, Blizzard noted. He said data showed about one-quarter of patients taking Seroquel increased their weight by more than 7 percent.
Later in 2002, Simon Hagger, global brand manager for Seroquel, e-mailed nearly 20 marketing staffers to say “we are under clear instruction from the highest level within AstraZeneca at this time not to discuss details surrounding trial 41,” outside the company. That patient study, concluded that year, found elevated levels of blood sugar.
AstraZeneca has been trying to get Seroquel approved in the U.S. for treating patients with depression and anxiety disorder, a group that includes more than 20 million people.
In April, a panel of FDA scientific advisers said Seroquel’s side effects, including weight gain, high blood sugar and potential heart problems, were too troubling to make it a first choice against depression or anxiety. On a split vote, the panel said Seroquel could be used as an added therapy for patients taking other medicines but not getting relief from depression. The FDA has yet to issue a final ruling.
“Going back almost 20 years, AstraZeneca has conducted 118 studies on the safety and efficacy of Seroquel,” company spokesman Jewell said.
AstraZeneca faces roughly 15,000 lawsuits over Seroquel, about 60 percent of them in state courts.
AstraZeneca’s U.S.-traded shares rose 75 cents to $41.05 Wednesday morning.
Copyright 2009 The Associated Press.
LINDA A. JOHNSON
AP Business Writer
TRENTON, N.J. (AP) — Marketing executives at British drugmaker AstraZeneca PLC for years blocked efforts by company scientists to raise concerns antipsychotic drug Seroquel caused weight gain and other problems, saying that would harm sales, plaintiff lawyers say.
They say their claim is backed by internal documents released Wednesday as part of ongoing lawsuits against the company brought by patients alleging they were harmed by the blockbuster drug for schizophrenia and bipolar disorder.
Some of the internal e-mails and other documents, released late Tuesday to The Associated Press, show efforts to keep public information about Seroquel positive amid a spirited debate between the company’s scientists and its marketing executives.
Ed Blizzard, a Houston attorney whose firm is helping to represent about 6,000 Seroquel plaintiffs, said data showing Seroquel was “not very effective” and had serious side effects “was either spun or skewed or outright concealed.”
AstraZeneca spokesman Tony Jewell said that since the drug was approved in late 1997, the label or detailed package insert has stated that diabetes, high blood sugar and weight gain have been observed in patients in clinical studies.
He noted that the U.S. Food and Drug Administration in the past several years has approved Seroquel as safe for new uses — bipolar mania, then bipolar depression and then an extended-release version.
Other internal e-mails and planning documents suggest the company pondered uses for which Seroquel was not approved by the Food and Drug Administration, including in dementia patients, though none of the documents indicate the company actually marketed the drug for those uses.
Doctors are allowed to prescribe drugs for unapproved uses, but drugmakers can’t promote them for those uses.
A strategic plan dated 2000 suggested a “key success factor” would be to “broaden Seroquel use on and off label,” specifically targeting educational programs “to share off label data.”
Jewell said in an e-mailed statement that the documents do not recommend “inappropriate promotion” of the drug and refer to intentions to seek approval for additional indications. The statement also points out physicians often prescribe atypical antipsychotics like Seroquel off-label.
Blizzard challenged that in a conference call. “The only way they can broaden its use off-label is by marketing it to physicians,” he said.
Seroquel was AstraZeneca’s No. 2 drug in sales last year, with revenue of $4.5 billion.
Blizzard said U.S. District Judge Anne C. Conway in Orlando, Fla., who has been coordinating pretrial details of nearly 6,000 federal Seroquel lawsuits, recently ordered them returned to the federal courts where they were filed.
First, she is settling issues such as which of the many documents plaintiff lawyers obtained through pretrial discovery should be available for use in those trials and open to the public. AstraZeneca has claimed its documents are confidential but agreed to release hundreds in February and 400 more Wednesday.
In a chain of e-mails in one document, a scientistific safety committee in June 2000 recommended removing “limited” before the words “weight gain” in the list of Seroquel side effects, because many patients gained significant weight.
Marketing staff suggested trying other explanations, such as whether patients took other drugs that could be blamed. One marketing executive, Medical Affairs Manager Richard Owen, then wrote that such a change “is potentially damaging to Seroquel.”
The change in the drug’s label was finally made in 2002. That was after Barry Arnold, the vice president for clinical drug safety, complained repeatedly to the physician in charge of Seroquel drug safety about “Commercial (executives) having such an influence.”
Yet soon after the label change, AstraZeneca trademarked the term “weight-neutral” as a slogan for Seroquel, Blizzard noted. He said data showed about one-quarter of patients taking Seroquel increased their weight by more than 7 percent.
Later in 2002, Simon Hagger, global brand manager for Seroquel, e-mailed nearly 20 marketing staffers to say “we are under clear instruction from the highest level within AstraZeneca at this time not to discuss details surrounding trial 41,” outside the company. That patient study, concluded that year, found elevated levels of blood sugar.
AstraZeneca has been trying to get Seroquel approved in the U.S. for treating patients with depression and anxiety disorder, a group that includes more than 20 million people.
In April, a panel of FDA scientific advisers said Seroquel’s side effects, including weight gain, high blood sugar and potential heart problems, were too troubling to make it a first choice against depression or anxiety. On a split vote, the panel said Seroquel could be used as an added therapy for patients taking other medicines but not getting relief from depression. The FDA has yet to issue a final ruling.
“Going back almost 20 years, AstraZeneca has conducted 118 studies on the safety and efficacy of Seroquel,” company spokesman Jewell said.
AstraZeneca faces roughly 15,000 lawsuits over Seroquel, about 60 percent of them in state courts.
AstraZeneca’s U.S.-traded shares rose 75 cents to $41.05 Wednesday morning.
Copyright 2009 The Associated Press.
FDA backs drug that treats diabetes via the brain
Date: 5/6/2009 1:08 PM
LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) — People with Type 2 diabetes may soon get a very different treatment approach: A drug that helps control blood sugar via the brain — an idea sparked, surprisingly, by the metabolism of migrating birds.
The Food and Drug Administration approved Cycloset, maker VeroScience Inc. announced Wednesday. It’s a new version of an old drug called bromocriptine, used in higher doses to treat Parkinson’s disease and a few other conditions. But unlike its older parent, Cycloset is formulated to require a low, quick-acting dose taken just in the morning — no other time of day.
That timing provides a bump of activity in a brain chemical that seems to reset a body clock that in turn helps control metabolism in Type 2 diabetes, said VeroScience’s Anthony Cincotta, who led the drug’s development.
Company studies suggest that one morning dose helped lower the usual post-meal blood sugar rise at breakfast, lunch and dinner. Over six months, 35 percent of Cycloset users reached recommended average blood sugar levels, compared with 10 percent of diabetics given a dummy drug, Cincotta said.
Cycloset is the first drug to win FDA approval under new guidelines that require better evidence that diabetes treatments are heart-safe. Diabetics are at increased risk of heart disease. In a yearlong safety study involving 3,000 diabetics, those given Cycloset had 42 percent fewer heart attacks and other cardiovascular complications than those given a dummy drug.
Where do the birds come in? Years ago, Louisiana State University researchers were studying how migrating birds arrived at their destinations without being emaciated. They develop seasonal insulin resistance, the very condition that in people leads to Type 2 diabetes.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway.
The researchers discovered a biological clock — in the brain’s hypothalamus — that controlled when the metabolism change kicked in for the birds, and also in hibernating mammals. Different concentrations of certain brain chemicals, including dopamine, at different times of day dictated whether the bird metabolized like a fall bird or a summer bird, said Cincotta.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway in sensitivity to insulin, although Cycloset apparently did not affect weight.
Bromocriptine mimics dopamine: “We’re regulating the regulator,” Cincotta said.
Side effects include nausea and dizziness, sometimes because of blood pressure dips upon standing. Nursing women shouldn’t use it. Bromocriptine inhibits lactation, and although no link is proven, there have been reports of strokes in postpartum women using higher doses. The FDA said it also should be used cautiously with people taking blood pressuring-lowering medication.
It’s uncertain how soon sales can begin, or the drug’s cost: VeroScience, of Tiverton, R.I., is in negotiations with larger drug companies to find a distributor.
Copyright 2009 The Associated Press.
LAURAN NEERGAARD
AP Medical Writer
WASHINGTON (AP) — People with Type 2 diabetes may soon get a very different treatment approach: A drug that helps control blood sugar via the brain — an idea sparked, surprisingly, by the metabolism of migrating birds.
The Food and Drug Administration approved Cycloset, maker VeroScience Inc. announced Wednesday. It’s a new version of an old drug called bromocriptine, used in higher doses to treat Parkinson’s disease and a few other conditions. But unlike its older parent, Cycloset is formulated to require a low, quick-acting dose taken just in the morning — no other time of day.
That timing provides a bump of activity in a brain chemical that seems to reset a body clock that in turn helps control metabolism in Type 2 diabetes, said VeroScience’s Anthony Cincotta, who led the drug’s development.
Company studies suggest that one morning dose helped lower the usual post-meal blood sugar rise at breakfast, lunch and dinner. Over six months, 35 percent of Cycloset users reached recommended average blood sugar levels, compared with 10 percent of diabetics given a dummy drug, Cincotta said.
Cycloset is the first drug to win FDA approval under new guidelines that require better evidence that diabetes treatments are heart-safe. Diabetics are at increased risk of heart disease. In a yearlong safety study involving 3,000 diabetics, those given Cycloset had 42 percent fewer heart attacks and other cardiovascular complications than those given a dummy drug.
Where do the birds come in? Years ago, Louisiana State University researchers were studying how migrating birds arrived at their destinations without being emaciated. They develop seasonal insulin resistance, the very condition that in people leads to Type 2 diabetes.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway.
The researchers discovered a biological clock — in the brain’s hypothalamus — that controlled when the metabolism change kicked in for the birds, and also in hibernating mammals. Different concentrations of certain brain chemicals, including dopamine, at different times of day dictated whether the bird metabolized like a fall bird or a summer bird, said Cincotta.
People don’t have those seasonal variations but the theory is the dopamine plays a role anyway in sensitivity to insulin, although Cycloset apparently did not affect weight.
Bromocriptine mimics dopamine: “We’re regulating the regulator,” Cincotta said.
Side effects include nausea and dizziness, sometimes because of blood pressure dips upon standing. Nursing women shouldn’t use it. Bromocriptine inhibits lactation, and although no link is proven, there have been reports of strokes in postpartum women using higher doses. The FDA said it also should be used cautiously with people taking blood pressuring-lowering medication.
It’s uncertain how soon sales can begin, or the drug’s cost: VeroScience, of Tiverton, R.I., is in negotiations with larger drug companies to find a distributor.
Copyright 2009 The Associated Press.