On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
Showing posts with label Zyprexa. Show all posts
Showing posts with label Zyprexa. Show all posts
Sunday, June 14, 2009
Sunday, April 12, 2009
Atypical antipsychotics: too hard a sell?
Use of drugs such as Abilify, Seroquel and Zyprexa for treatment-resistant depression is gaining ground. Some see an 'unmet need' for medication. Others worry about side effects.
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
Thursday, January 15, 2009
Lilly to Pay Biggest Fine Ever to End Zyprexa Probe (Update7)
Eli Lilly & Co. will plead guilty to a charge of promoting its antipsychotic drug Zyprexa for unapproved uses and pay $1.42 billion, including the largest criminal fine ever imposed by the U.S. on an individual company.
The company admitted its marketing of Zyprexa was illegal in a civil and criminal settlement announced jointly today in a statement by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will also submit to U.S. monitoring against future lawbreaking.
Lilly resolved federal and state probes into how it marketed the drug and will make its guilty plea in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis- based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act.
“Eli Lilly completely ignored the law” and made “hundred of millions of dollars” from its illegal promotion of Zyprexa, Magid said at a press conference in Philadelphia today. “We’re holding a company responsible for putting thousands and thousands of patients at risk.”
READ MORE @ BLOOMBERG
The company admitted its marketing of Zyprexa was illegal in a civil and criminal settlement announced jointly today in a statement by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will also submit to U.S. monitoring against future lawbreaking.
Lilly resolved federal and state probes into how it marketed the drug and will make its guilty plea in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis- based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act.
“Eli Lilly completely ignored the law” and made “hundred of millions of dollars” from its illegal promotion of Zyprexa, Magid said at a press conference in Philadelphia today. “We’re holding a company responsible for putting thousands and thousands of patients at risk.”
READ MORE @ BLOOMBERG
Monday, October 27, 2008
Zyprexa and Seroquel Side Effects May Increase Heart Disease Risk
New research suggests that Zyprexa and Seroquel may increase the risk of heart disease when compared to other antipyschotic medications.
Eli Lilly’s Zyprexa (olanzapine) and AstraZeneca’s Seroquel (quetiapine fumarate) are both blockbuster medications which are part of a class of drugs known as “atypical” antipsychotics. They are commonly used to treat symptoms of schizophrenia, but have also been widely used for other conditions like bipolar disorder, dementia, autism and obsessive-compulsive disorders.
Both drugs have previously been linked to a number of serious side effects, including severe weight gain, diabetes and pancreatitis. However, a new study published in the October 2008 issue of the journal Schizophrenia Research raises the potential for concerns about a small increased risk of coronary heart disease associated with the drugs.
read more @ AboutLawsuits.com
Eli Lilly’s Zyprexa (olanzapine) and AstraZeneca’s Seroquel (quetiapine fumarate) are both blockbuster medications which are part of a class of drugs known as “atypical” antipsychotics. They are commonly used to treat symptoms of schizophrenia, but have also been widely used for other conditions like bipolar disorder, dementia, autism and obsessive-compulsive disorders.
Both drugs have previously been linked to a number of serious side effects, including severe weight gain, diabetes and pancreatitis. However, a new study published in the October 2008 issue of the journal Schizophrenia Research raises the potential for concerns about a small increased risk of coronary heart disease associated with the drugs.
read more @ AboutLawsuits.com
Friday, October 24, 2008
Lilly Will Take $1.42 Billion Charge in Zyprexa Probe (Update1)
Eli Lilly & Co. said it is having ``advanced discussions'' to settle investigations by U.S. and state authorities over marketing the antipsychotic Zyprexa and will take a $1.42 billion charge in the third quarter.
The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.
Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.
``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.
READ MORE @ BLOOMBERG
The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.
Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.
``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.
READ MORE @ BLOOMBERG
Monday, September 8, 2008
Judge OKs Zyprexa Class Action, Unseals Documents
A federal judge has granted class action status to a Zyprexa lawsuit that claimed Eli Lilly hid the drug’s serious side effects. The decision by Judge Jack B. Weinstein of Federal District Court in Brooklyn also unseals confidential documents relating to the antipsychotic medication. Eli Lily
The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.
The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.
READ MORE @ NEWS INFERNO
The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.
The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.
READ MORE @ NEWS INFERNO
Wednesday, July 30, 2008
Lilly May Need Stronger U.S. Warning on Zyprexa Label (Update4)
Eli Lilly & Co.'s current label warning on health risks linked to its antipsychotic Zyprexa may not be strong enough, according to court documents.
Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It also says Zyprexa is more ``associated'' with higher blood- sugar levels -- a risk factor for diabetes -- than similar medications.
The warning, approved by the U.S. Food and Drug Administration, may need to be adjusted to link Zyprexa more directly to higher blood sugar and diabetes, according to a letter to the Indianapolis-based drugmaker from the agency. The document was produced for a lawsuit by the state of Alaska claiming the company withheld information on risks of Zyprexa, Lilly's top-selling drug with sales of $4.76 billion last year.
``We anticipate that additional labeling changes will be necessary when we have reviewed the results of the additional analyses that we have requested,'' FDA administrator Tom Laughren wrote to Lilly in an Aug. 28 letter.
READ MORE @ BLOOMBERG
Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It also says Zyprexa is more ``associated'' with higher blood- sugar levels -- a risk factor for diabetes -- than similar medications.
The warning, approved by the U.S. Food and Drug Administration, may need to be adjusted to link Zyprexa more directly to higher blood sugar and diabetes, according to a letter to the Indianapolis-based drugmaker from the agency. The document was produced for a lawsuit by the state of Alaska claiming the company withheld information on risks of Zyprexa, Lilly's top-selling drug with sales of $4.76 billion last year.
``We anticipate that additional labeling changes will be necessary when we have reviewed the results of the additional analyses that we have requested,'' FDA administrator Tom Laughren wrote to Lilly in an Aug. 28 letter.
READ MORE @ BLOOMBERG
Friday, March 14, 2008
Lilly E-Mail Discussed Off-Label Drug Use
John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote e-mail in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators.
Dr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.
The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.
Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. In his e-mail message, Dr. Lechleiter discusses the use of Zyprexa by children and teenagers.
READ MORE @ NY TIMES
Dr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors.
The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes.
Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. In his e-mail message, Dr. Lechleiter discusses the use of Zyprexa by children and teenagers.
READ MORE @ NY TIMES
Saturday, March 8, 2008
A Chilly Court: Alaska Attacks Lilly Over Zyprexa
This is the Zyprexa trial we’re talking about. The state, you may recall, sued Lilly in 2006, alleging the drugmaker failed to warn of weight gain and diabetes caused by Zyprexa, and wants Lilly to cover treatment costs of Medicaid patients who suffered serious health problems.
The civil suit is being closely watched by state and federal prosecutors investigating the drugmaker, because this is the first lawsuit filed by a state against Lilly to make it to trial. The outcome - and even the evidence - could, therefore, influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general. An unfavorable verdict could also prompt other states to file lawsuits, although eight others already have done so. (By the way, if you want to read the controversial Zyprexa documents, visit Furious Seasons).
For its part, Lilly argues the state has two irreconcilable positions - at the same time Alaska is suing the drugmaker, the state continues to seek court orders to force mental patients to take the very drug it says is harmful. These are the slides Lilly’s lawyers used in court.
READ MORE @ PHARMALOT
The civil suit is being closely watched by state and federal prosecutors investigating the drugmaker, because this is the first lawsuit filed by a state against Lilly to make it to trial. The outcome - and even the evidence - could, therefore, influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general. An unfavorable verdict could also prompt other states to file lawsuits, although eight others already have done so. (By the way, if you want to read the controversial Zyprexa documents, visit Furious Seasons).
For its part, Lilly argues the state has two irreconcilable positions - at the same time Alaska is suing the drugmaker, the state continues to seek court orders to force mental patients to take the very drug it says is harmful. These are the slides Lilly’s lawyers used in court.
READ MORE @ PHARMALOT
Thursday, February 7, 2008
Lilly's Monthly Zyprexa Causes Sleepiness, FDA Says (Update3)
Eli Lilly & Co's once-a-month version of its top-selling antipsychotic medicine Zyprexa, while effective, has risks that include excessive sleepiness, U.S. regulators said.
People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience ``profound sedation,'' staff of the Food and Drug Administration said in documents posted today on the agency's Web site. The sleepiness is a ``serious safety concern'' because of its severity and ``relatively high'' incidence, the FDA said.
An FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year, accounting for about a quarter of Indianapolis-based Lilly's revenue. The drugmaker is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.
``There's a huge demand,'' said Jeffrey Lieberman, the chairman of psychiatry at Columbia University in New York in a telephone interview. ``Even though this is a long-acting form of an existing drug, it's a significant event for the simple reason that the biggest trouble with treating people with antipsychotics is adherence to treatment.''
READ MORE @ BLOOMBERG
People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience ``profound sedation,'' staff of the Food and Drug Administration said in documents posted today on the agency's Web site. The sleepiness is a ``serious safety concern'' because of its severity and ``relatively high'' incidence, the FDA said.
An FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year, accounting for about a quarter of Indianapolis-based Lilly's revenue. The drugmaker is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.
``There's a huge demand,'' said Jeffrey Lieberman, the chairman of psychiatry at Columbia University in New York in a telephone interview. ``Even though this is a long-acting form of an existing drug, it's a significant event for the simple reason that the biggest trouble with treating people with antipsychotics is adherence to treatment.''
READ MORE @ BLOOMBERG
Sunday, December 30, 2007
Lilly’s Zypreza, Pfizer’s Geodon could see reimbursement restrictions next year
Psychiatric drugs like Eli Lilly’s Zyprexa could be next on the list for reimbursement restrictions based on comparative effectiveness data, experts in the field told Pharmawire.
The move would also spell trouble for AstraZeneca’s Seroquel and Pfizer’s Geodon, two commonly prescribed and costly antipsychotics. Cost pressures will be felt most acutely starting in June, when the patent expires on Johnson & Johnson’s competing product Risperdal.
Public and private payers have been fueling the growing interest in compiling data that allows them to compare different drugs within the same therapeutic category. The information then helps shape reimbursement programs - like step therapy, where patients are required to try a cheaper drug before a more expensive one will be covered.
Tanisha Carino, a director at research firm Avalere Health and former policy analyst at the Centers for Medicare and Medicaid Services, noted that mental health is a prime target for using comparative effectiveness data to make coverage decisions.
The National Institute of Mental Health is already sponsoring the large-scale Clinical Antipsychotics Trials of Intervention Effectiveness (also known as CATIE), which have shown that older, less expensive drugs can be as effective as newer ones. The data is rife with cost effectiveness comparisons.
READ MORE @ FINANCIAL TIMES
The move would also spell trouble for AstraZeneca’s Seroquel and Pfizer’s Geodon, two commonly prescribed and costly antipsychotics. Cost pressures will be felt most acutely starting in June, when the patent expires on Johnson & Johnson’s competing product Risperdal.
Public and private payers have been fueling the growing interest in compiling data that allows them to compare different drugs within the same therapeutic category. The information then helps shape reimbursement programs - like step therapy, where patients are required to try a cheaper drug before a more expensive one will be covered.
Tanisha Carino, a director at research firm Avalere Health and former policy analyst at the Centers for Medicare and Medicaid Services, noted that mental health is a prime target for using comparative effectiveness data to make coverage decisions.
The National Institute of Mental Health is already sponsoring the large-scale Clinical Antipsychotics Trials of Intervention Effectiveness (also known as CATIE), which have shown that older, less expensive drugs can be as effective as newer ones. The data is rife with cost effectiveness comparisons.
READ MORE @ FINANCIAL TIMES
Friday, October 5, 2007
Lilly Adds Label Warnings for Mental Illness Drug
Eli Lilly today added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing the drug’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.
For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.
Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.
READ MORE @ NY TIMES
For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.
Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.
READ MORE @ NY TIMES
Sunday, September 30, 2007
Zyprexa may get OK for teen use - Senior regulator overrules peers on drug's benefits for adolescents
Eli Lilly and Co.'s best-selling schizophrenia drug Zyprexa is poised to get U.S. approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.
READ MORE @ Indianapolis Star
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.
READ MORE @ Indianapolis Star
Thursday, September 13, 2007
The endocrine effects of the psychiatric drug Zyprexa are extremely dangerous, says Swedish Professor in Psychiatry
Speaking out about the harmful effects of the psychiatric drug Zyprexa, the Swedish Professor in Psychiatry, Rolf Adolfsson, said: “There is nothing worse than seeing a young person 17-18 years with a weight gain of 40-50 kg, and no one does anything! What is Swedish psychiatry doing?”
The psychiatrist spoke out in Swedish national television, in a program covering the illegal marketing of Zyprexa and the harmful effects of the new so called atypical neuroleptics. Zyprexa is the 6th most sold drug in Sweden, all categories.
Despite the fact that nine States in the US are suing the manufacturer of Zyprexa, Eli Lilly, and despite the fact that almost 30.000 persons have been awarded 1.2 billion dollars due to the injuries caused by Zyprexa, there has been a complete silence about this affair in Sweden.
Until now.
The Professor, who according to the program has been investigating harmful effects of drugs for the last 7 years, further said: “I’ve seen so many complications, and I have met so many patients – that I completely choke. Are we so damned gullible, and it must be – there is only one thing – marketing.”
READ MORE @ TRANSWORLDNEWS
The psychiatrist spoke out in Swedish national television, in a program covering the illegal marketing of Zyprexa and the harmful effects of the new so called atypical neuroleptics. Zyprexa is the 6th most sold drug in Sweden, all categories.
Despite the fact that nine States in the US are suing the manufacturer of Zyprexa, Eli Lilly, and despite the fact that almost 30.000 persons have been awarded 1.2 billion dollars due to the injuries caused by Zyprexa, there has been a complete silence about this affair in Sweden.
Until now.
The Professor, who according to the program has been investigating harmful effects of drugs for the last 7 years, further said: “I’ve seen so many complications, and I have met so many patients – that I completely choke. Are we so damned gullible, and it must be – there is only one thing – marketing.”
READ MORE @ TRANSWORLDNEWS
Friday, July 6, 2007
Lilly May Face More Zyprexa Lawsuits After FDA Letter (Update2)
Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators.
The U.S. Food and Drug Administration told Lilly in March it would delay the approval of Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac.
The FDA's request, in a letter to Lilly obtained by Bloomberg, may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.
READ MORE @ BLOOMBERG
The U.S. Food and Drug Administration told Lilly in March it would delay the approval of Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac.
The FDA's request, in a letter to Lilly obtained by Bloomberg, may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.
READ MORE @ BLOOMBERG
Thursday, June 28, 2007
Approval of J&J's Antipsychotic Delayed for Teens
U.S. regulators delayed a request by Johnson & Johnson to expand use of its top-selling Risperdal to include schizophrenia and bipolar disorder in adolescents.
The FDA didn't request new studies on the treatment in a letter to the company, J&J said in a statement today. J&J said it would work with the agency to complete prescribing information on the drug, which is already approved for use in children with autism and adults with schizophrenia and bipolar disorder.
Use of antipsychotic drugs for younger patients has risen sharply in recent years, prompting concern among some doctors and parents about side effects including weight gain and diabetes. Risperdal, which generated $4.2 billion last year, is the second such drug delayed by U.S. regulators for teen use. Eli Lilly's Zyprexa was held up in April.
READ MORE @ REUTERS NEWS
The FDA didn't request new studies on the treatment in a letter to the company, J&J said in a statement today. J&J said it would work with the agency to complete prescribing information on the drug, which is already approved for use in children with autism and adults with schizophrenia and bipolar disorder.
Use of antipsychotic drugs for younger patients has risen sharply in recent years, prompting concern among some doctors and parents about side effects including weight gain and diabetes. Risperdal, which generated $4.2 billion last year, is the second such drug delayed by U.S. regulators for teen use. Eli Lilly's Zyprexa was held up in April.
READ MORE @ REUTERS NEWS
Saturday, June 16, 2007
Eli Lilly: Drug ads influencing patients
Eli Lilly, which has faced thousands of lawsuits over its anti-psychotic Zyprexa, says lawyers' ads about the drug are prompting some patients to stop taking mental illness medications when they shouldn't.
The advertising blitz "presents yet another barrier for patients who suffer from severe mental illness" and increases the risks that people will not get the care they need, said Carole Puls, a spokeswoman for the Indianapolis-based drug maker.
Lilly released the results of a company-funded survey that asked 402 psychiatrists who treat patients with bipolar disorder or schizophrenia to complete an online questionnaire. More than half of the participating psychiatrists said they believed their patients who stopped medication or reduced the dosage did so after seeing lawyers' advertisements about anti-psychotic drugs.
READ MORE @ AP
Eli Lilly: Lawyers' Ads Are Hurting Patients - Law.com
The advertising blitz "presents yet another barrier for patients who suffer from severe mental illness" and increases the risks that people will not get the care they need, said Carole Puls, a spokeswoman for the Indianapolis-based drug maker.
Lilly released the results of a company-funded survey that asked 402 psychiatrists who treat patients with bipolar disorder or schizophrenia to complete an online questionnaire. More than half of the participating psychiatrists said they believed their patients who stopped medication or reduced the dosage did so after seeing lawyers' advertisements about anti-psychotic drugs.
READ MORE @ AP
Eli Lilly: Lawyers' Ads Are Hurting Patients - Law.com
Monday, June 11, 2007
Big Headache for Big Pharma
For pharmaceutical giant Eli Lilly, death and injury are just a cost of doing business. When Zyprexa, Lilly’s drug to treat schizophrenia and bipolar disorder, hit the marketplace in 1996, it was hailed as an “atypical” – a “safe, gentle psychotropic,” more effective than older drugs like Thorazine and Trilafon, without the dangerous side effects. Sales skyrocketed. The hype soon gave way to reality, as Lilly faced waves of lawsuits by patients suffering from diabetes, massive weight gain, pancreatitis and cardiac problems. Lilly responded with the cozy arrangement that worked with Prozac, another blockbuster plagued with problems: quietly settle suits out of court, with proceedings sealed and secret under a gag order. Anything embarrassing – or illegal – that Lilly is doing behind closed doors would remain hidden from public view.By - Will Hall co-founder of the Freedom Center, and a member of the Icarus Project.
READ MORE @ Adbusters
Thursday, May 3, 2007
Puzzle of antipsychotic drug weight gain solved
Researchers said on Monday they have pinpointed the reason some drugs used to treat mental illnesses like schizophrenia cause patients to gain a lot of weight, raising hope for developing drugs without this side effect.
Antipsychotic medications such as Zyprexa, made by Eli Lilly and Co., increase the activity of an enzyme called AMPK in cells in the part of the brain that regulates eating behavior, according to research in mice led by scientists at Johns Hopkins University in Baltimore.
READ MORE @ Reuters
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