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|FDA Warns Pfizer Over Geodon Study|
|The U.S. Food and Drug Administration (FDA) issued a warning to drug maker Pfizer Inc over a number of “failures” that resulted in overdoses in no less than 13 children, said Reuters. The overdoses occurred during Pfizer’s clinical trial of <"http://www.yourlawyer.com/topics/overview/Geodon">Geodon, an antipsychotic medication; the letter was made public yesterday.
We’ve been following the issue of psychotropic drugs and pediatric patients for some time, especially regarding efficacy and safety. Last June we wrote that an FDA vote was scheduled for three psychotropic medications and their safety and efficacy for children with specific conditions, including Geodon. At that time, the Wall Street Journal reported that the agency said the medications effectively treat some psychiatric disorders in pediatric patients, but come with serious risks, including sedation and weight gain.
Earlier this month, the FDA issued a warning letter to Pfizer saying it “failed to ensure proper monitoring" of the trial, said Reuters, noting that some children experienced “tremors, restless legs, and other complications.” Pfizer, the world’s largest drug maker, is looking to market Geodon to pediatric bipolar disorder patients, added Reuters.
Many experts are concerned that psychotropic medications, which are generally prescribed in the adult population for the treatment of depression, schizophrenia, and bipolar disorder, might not work in the same way when taken in children and teens, whose brains are still developing, said Reuters.
Reuters previously reported that drug reviewers recommended regulators conduct additional studies into the effects of these drugs on children. According to FDA staff, said Reuters previously, an emerging health insurance claim study revealed that children treated with psychotropic medications “were much more likely to experience an adverse metabolic effect than adults, and the likelihood was directly correlated with age.” Such effects include “abnormal weight gain, diabetes, and increases in cholesterol and blood pressure,” said Reuters.
The FDA letter said that Pfizer did not appropriately monitor the study and, "as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner," and said its letter came after repeated violations about which Pfizer was notified in 2005, quoted Reuters.
Meanwhile, we also recently reported that doctors and hospitals were paid a whopping $35 million by Pfizer in the second half of last year. According to The Wall Street Journal, the payments to about 4,500 hospitals and doctors, were for the research and promotion of Pfizer drugs. Reuters explained that Geodon was first approved in 2001 for adults with schizophrenia and has since been cleared for the treatment of bipolar disorder in adults.
Pfizer’s new disclosure effort comes just months after the drug maker struck an agreement with the U.S. Department of Justice to pay $2.3 billion to settle claims arising from the illegal marketing of some drugs, including Geodon. Among the charges covered by the settlement were allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe this, as well as other, drugs.
|Pfizer Geodon Whistleblower Represented by Parker Waichman Alonso LLP|
|A whistleblower who was involved in last week's record breaking $2.3 billion Pfizer settlement was represented by the Great Neck, NY law firm of Parker Waichman Alonso LLP. The whistleblower lawsuit alleged that Pfizer illegally promoted the off-label use of the antipsychotic medication <"http://www.yourlawyer.com/topics/overview/Geodon">Geodon.
"We are proud of our client and the other relators who stepped forward to expose Pfizer's wrongdoing, and helped to make this settlement possible," said David Krangle, an attorney with Parker Waichman Alonso LLP. "We are also proud that our firm was able to play a part in obtaining justice for American taxpayers."
The Parker Waichman Alonso lawsuit was one of nine settled by the U.S. Department of Justice that charged Pfizer illegally marketed Geodon, as well as the pain killer Bextra; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs.
As we reported last week, the $2.3 billion settlement is the largest healthcare fraud settlement in the history of the U.S. Department of Justice. The Geodon portion of the settlement was $301 million.
Under the terms of the settlement, Pfizer subsidiary Pharmacia & Upjohn Company Inc. has also agreed to plead guilty to a felony violation that it illegally promoted the off-label use of Bextra. Pharmacia & Upjohn will pay $1.3 billion toward the total settlement.
Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter, the Justice Department said.
Whistleblower lawsuits are filed under the False Claims Act, a federal law that empowers people to file lawsuits against federal contractors claiming fraud against the government. Successful whistleblowers can receive a portion of the damages recovered. According to the Department of Justice, the whistleblowers involved in last week's Pfizer settlement will receive $102 million of the federal fines.
|FDA Panel Backs Seroquel, Zyprexa and Geodon for Kids, But Cites Risks|
A U.S. Food and Drug Administration’s (FDA) advisory panel voted to recommend approval of three popular psychotropic medications—atypical antipsychotics— for children with specific conditions. The vote concerned AstraZeneca PLC’s <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel Incendiary video , Eli Lilly and Company’s Zyprexa, and Pfizer Inc.’s Geodon .
According to the agency’s advisory panel, the three drugs have been deemed safe and effective for pediatric patients—children and teens—who have been diagnosed with schizophrenia or bipolar disorder, Reuters reported. However while the panel did recommend approval of the broader use for Seroquel, Zyprexa, and Geodon, it did warn about the drugs’ long-term effects in children, said Reuters. All three drugs are approved for use in adults and, like any other medication, can be used off-label if the prescribing physician feels the medication is warranted, in this case, to children, Reuters pointed out. An expanded approval by the FDA 48 Angels download would enable the industry to market the drugs for kids.
The final approval decision rests with the FDA itself. The agency usually follows recommendations of advisory panels, though it is not required to do so.
Colour Me Kubrick: A True...ish Story movie Seroquel, Zyprexa, and Geodon have long been prescribed off-label to the younger demographic for schizophrenia and bi-polar diagnoses and many of these younger patients have connections to child welfare and juvenile justice systems, said Youth Today last week. For example, approximately 14 percent of children in foster care are prescribed some psychotropic medication, reported Youth Today citing a 2006 policy paper written by the Institute for Juvenile Research at the University of Illinois at Chicago. This figure will likely increase as the practice of prescribing atypical antipsychotics to children becomes a more greatly accepted practice, now that approval to do so has been granted.
But, the drugs are not without problems. For instance, this January, a study published in The New England Journal of Medicine found that patients taking Seroquel and other atypical antipsychotics were likelier to suffer sudden cardiac death than patients taking older antipsychotics. This April, an FDA advisory panel cited the risk of Seroquel and sudden cardiac death when it recommended the drug not be approved as a first line treatment for depression. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the drug’s diabetes risk.
In addition to blood sugar risks, there are concerns Geodon might increase the risk of a specific, potentially fatal heart-rhythm irregularity. Additional side effects include: Feeling unusually tired; nausea; constipation; dizziness; restlessness; diarrhea; rash; cough; runny nose; and abnormal muscle movements, including tremor, shuffling, and uncontrollable movements.
Some panel members expressed concern, said Reuters, that short-term research did not adequately reveal the effects of these medications on children over time. "I'm concerned about the lack of true long-term studies" especially in younger patients "who will have a long lifetime, hopefully," said Ruth Day, a researcher at Duke University, quoted Reuters. Some agency advisors were unclear why the FDA accepted the three medications in children for what would likely be a lifetime of treatment when studies only looked at this demographic for between three and six weeks, reported Reuters, noting that effect of these drugs on the developing brain remains unknown.
Also of concern was the likelihood of drug misuse and prescribing practices for other conditions—attention deficit disorder (ADD) or hyperactivity, to name two—Reuters pointed out, as well as treatment to much younger children. "Soon we'll be seeing four-, five- and six-year-olds being treated. It's a slippery slope ... I just get worried about where this is going," said Kenneth Towbin an agency panelist and head of the National Institute of Mental Health's child psychiatry mood disorders program, quoted Reuters.Pirates of the Caribbean: Dead Man's Chest rip
|FDA Panel to Vote on Seroquel, Zyprexa and Geodon for Kids|
A vote is scheduled for next week regarding three psychotropic medications and their safety and efficacy for children with specific conditions. Youth Today reports that although the U.S. Food and Drug Administration (FDA) does not need committee approval for pharmaceutical company applications, the agency’s Psychopharmacologic Drugs Advisory Committee will be voting on <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa, <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel
, and <"http://www.yourlawyer.com/topics/overview/Geodon">Geodon.
The Nine Lives of Fritz the Cat release While it is widely known that physicians have been prescribing Zyprexa, Seroquel, and Geodon to pediatric patients for some time, what might not be known is that many of those younger patients have connections to child welfare and juvenile justice systems, said Youth Today. For example, approximately 14 percent of children in foster care are prescribed some psychotropic medication, reported Youth Today citing a 2006 policy paper written by the Institute for Juvenile Research at the University of Illinois at Chicago.
The issue is rife with controversy because not only is the FDA not required to obtain approvals of this sort, many critics feel that there are too many so-called “troubled” children prescribed psychotropic medications, pointed out Youth Today.Shortbus download
According to David Cohen, a psychotherapist and professor at Florida International University, "When an advisory committee is convened, it usually means the evidence is not so clear," quoted Youth Today, which added that these types of committee rulings are sought in cases when "other issues need to be considered, or the consequences are so weighty," said Cohen.Sharpe's Company dvd
For instance, in the case of Eli Lilly’s Zyprexa, prescribed "for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the acute treatment of schizophrenia in adolescents," quoted Youth Today, there have been huge financial settlements linked to illegal marketing as well as significant adverse effects. Lilly agreed to pay the government $1.4 billion to settle criminal and civil cases, noted Youth Today. Zyprexa is known to cause significant weigh gain; diabetes, hyperglycemia, and other blood sugar disorders; lowering of good, or HDL, cholesterol levels; and cardiac issues.
AstroZeneca’s Seroquel is, quoted Youth Today, prescribed "for the acute treatment of schizophrenia in adolescents from 13 to 17 years of age, and the acute treatment of bipolar mania in children from 10 to 12 years of age and adolescents from 13 to 17 years of age." This January, a study published in The New England Journal of Medicine found that patients taking Seroquel and other atypical antipsychotics were more likely to suffer sudden cardiac death than patients taking older antipsychotic drugs. This April, an FDA advisory panel cited the risk of Seroquel sudden cardiac death when it recommended the drug not be approved as a first line treatment for depression. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk.Slumdog Millionaire trailer
Pfizer’s Geodon is prescribed "for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages from 10 to 17 years of age." In addition to blood sugar risks, there are concerns Geodon might increase the possibility of a specific, potentially fatal heart-rhythm irregularity. Additional side effects include: Feeling unusually tired; nausea; constipation; dizziness; restlessness; diarrhea; rash; cough; runny nose; and abnormal muscle movements, including tremor, shuffling, and uncontrollable movements.