Posts Tagged ‘weight gain’
Wednesday, July 7th, 2010
BNET
By Jim Edwards
July 7, 2010
AstraZeneca (AZN) says it has lost a crucial internal document that would explain how an ad for its antipsychotic Seroquel misleadingly claimed there was “no weight gain” with the drug and described its “favorable weight profile.” But the company admits it kept the six-year-old envelope that once allegedly contained the ad’s approval certificate, according to a ruling by the U.K.’s Prescription Medicines Code of Practice Authority.
The drug industry watchdog also alleges AZ’s Seroquel management team “pressured and manipulated” executives around them in order to make sure negative data on Seroquel was buried. The PMCPA ruled that AZ had breached its code of practice, which requires companies to operate in “a professional, ethical and transparent” manner.
If there’s a lesson here for managers, it’s this: Simply winning the legal war isn’t good enough. Consumers — and your own employees, as the Seroquel case shows — expect companies to go above and beyond. (AZ has mostly won the litigation filed against it which alleges the company failed to warn patients that Seroquel causes weight gain and diabetes. It settled with the Department of Justice for $520 million.)
Many of the allegations in the PMCPA case are familiar, but what’s new is the source: One of the complainants was an unnamed male former AZ executive, employed at the company from 1992 to 2001, who from 1995 to 2000 was responsible for the medical aspects of the U.K. launch and subsequent marketing of Seroquel.*
In terms of the ad, the BBC reported in January that AZ had published a misleading ad in the British Journal of Psychiatry in April 2004. The PMCPA asked AZ to produce all the documentation behind the ad. Here’s its characterization of AZ’s response:
… for a product that had been marketed for more than 12 years in the UK, the company did not believe that it could reasonably investigate and respond to such a broad request in relation to specific clauses of the code.
The Code requires companies keep relevant documents for three years, AZ argued, and the ad itself was at least five years old, thus, “AstraZeneca had been unable to produce the certificate approving the advertisement from its archive.” But:
The Appeal Board noted from the AstraZeneca representatives at the appeal that although the job bag for the advertisement at issue still existed, it did not contain the relevant certificate.
How unfortunate!
More seriously, the PMCPA appeared to take seriously the ex-employee’s allegation that AZ buried or manipulated data on Seroquel long after the company became aware of weight-gain effects on its patients. The executive alleged that in 1997 he was told by a colleague…
Read entire article here: http://industry.bnet.com/pharma/10008835/the-dog-ate-astrazenecas-homework-evidence-on-misleading-drug-ad-dissappears-from-companys-files/
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Tags: $520 million, advertisement, antipsychotic, approval certificate, AstraZeneca, AZN, buried data, code of practice, Department of Justice, diabetes, drug company, drug industry, illegal marketing of drugs, internal document, litigation, misleading advertising, PMCPA, Seroquel, U.K.’s Prescription Medicines Code of Practice Authority, weight gain
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Thursday, June 17th, 2010
Natural News
By David Gutierrez
June 17, 2010
Drug giant AstraZeneca attempted to obscure the connection between one of its blockbuster drugs and diabetes risk for years after it knew of the problem, according to documents recently unsealed as part of lawsuits against the company.
More than 15,000 patients have sought damages from the company, alleging that they were harmed by side effects from its atypical antipsychotic Seroquel. According to the plaintiffs, AstraZeneca deliberately hid information linking the drug to an increased risk of weight gain and diabetes. The lawsuits have been consolidated into a single case for the purpose of pre-trial proceedings.
The recently unsealed documents include notes from a meeting between salesperson Nancy White and a doctor in July 2006, during which the doctor said that his patients were expressing concern about Seroquel’s links to diabetes. White reported telling the doctor that “there has been no causative effect” proven between the drug and the disease.
Yet in November 2002, AstraZeneca had issued a warning to doctors in Japan that due to dozens of reports linking Seroquel to diabetes, “causality with the drug could not be ruled out.” The company cautioned doctors not to prescribe the drugs to diabetics and to encourage all Seroquel patients to monitor their blood sugar. Just over a year later, the company issued a similar warning to doctors in the United States.
Read entire article: http://www.naturalnews.com/029012_AstraZeneca_diabetes_drug.html
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Tags: antipsychotic, AstraZeneca, blood sugar, damages, Dan Carlat, diabetes, disease, drug company, hid information, increased risk, Japan, lawsuit, patients, plaintiffs, psychiatric drug, Seroquel, trial, weight gain
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Thursday, June 10th, 2010
The MetroWest Daily News
By Jacob Azerrad
June 10, 2010
In 2001, Harry Markopolos repeatedly warned the authorities about Bernie Madoff. No one listened. Only a serious downturn in the economy led to Madoff’s downfall. It’s not a Ponzi scheme, but once again, no one is listening and the red flags are everywhere. This time the victims are our very young, innocent children in the millions. Today, children as young as 2, are being prescribed powerful anti-psychotic medications. Side effects include tics, drooling, and incessant eating. Some children have gained up to 100 pounds and often progress to becoming diabetic.
Virtually nothing is known about the long-term impact of these medications. And no one seems to care. Certainly not the drug companies pushing these drugs, nor the doctors who have been coerced by the pharmaceutical industry and panicking parents alike into prescribing them. The increase in the use of anti-psychotics is directly tied to the rising incidence of one particular diagnosis, bipolar disorder. Experts estimate that the number of kids with this diagnosis is now more than one million and rising, making it more common than autism and diabetes combined. To treat it, doctors are administering medications that have yet to be approved for children. Mothers are legally medicating their two-year-olds with Risperdal to quiet their tantrums, Trileptal to stabilize their moods, and Clonidine to help them sleep.
This is not the old story about ADD or ADHD and the use of Ritalin or other approved drugs in use since the 1970′s. This is not about helping the child who fidgets and can’t concentrate in their elementary school classroom. This is about tens of thousands of energetic, outgoing, healthy, and normal 3- and 4-year-olds who just won’t sit still in Mommy and Me. It is those children who have now been diagnosed with a new and controversial diagnosis – Childhood Bipolar Disorder.
On Sept. 4, 2007, The New York Times stated that studies in the 1970s and 80s concluded bipolar disorder was rare in children, but between 1994 to 2003, there was an astounding 40-fold increase in the number of children diagnosed with bipolar disorder.
In a 2007 “60 Minutes” episode, Katie Couric focused on the short life of 4-year-old Rebecca Riley of Hull. Diagnosed with bipolar disorder at age 28 months, she was dead one year later from an overdose of a psychotropic drug cocktail. At one point, Couric asks Rebecca’s mother, who had been charged with her daughter’s murder, if she thought her child’s behavior might have been normal. That in fact, maybe little Rebecca was just exhibiting Terrible Two’s behavior.
On Nov. 19, 2008, the New York Times reported that 31 children who were diagnosed with Childhood Bipolar Disorder and given the drug Risperdal for tantrums died, and 1,176 suffered serious side effects.
Read entire article: http://www.metrowestdailynews.com/opinion/x1602634540/Azerrad-Drugging-pre-school-children-A-crime-against-childhood
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Tags: 3-year-olds, 4-year-olds, 40-fold increase in the number of children diagnosed with bipolar disorder, ADD, ADHD, anti-psychotics, antipsychotic drugs, bipolar disorder, child drugging, childhood, children, classroom, clonidine, crime, death, diabetes, diabetic, diagnosed, died, drooling, Drug companies, elementary school, energetic, fidgets, healthy, incessant eating, medications, mothers, normal, outgoing, pharmaceutical industry, Rebecca Riley, Risperdal, Ritalin, serious side effects, side effects, tantrums, tics, Trileptal, two-year-olds, weight gain
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Monday, April 26th, 2010
New York Magazine
By Jennifer Senior
April 25, 2010
Two Jews may, as the saying goes, have three opinions, but that appears to be a fairly modest ratio when compared with psychiatrists. It was inevitable that revisions to the Diagnostic and Statistical Manual of Mental Disorders would invite controversy—it’s the classic reference work for mental-health professionals, and a convenient field guide to understanding crazy exes for the rest of us—but even the American Psychiatric Association, which first appointed the work groups to update the text two years ago, couldn’t have predicted the squabbles now under way. Dr. Allen Frances, the man who chaired the task force that created the current edition (the DSM-IV), has today emerged as the most trenchant, and relentless, critic of the proposed revisions to the upcoming edition (the DSM-5; among the changes is a transition to Arabic numerals). Last Tuesday was the final day those revisions were open to public comment. “And hopefully,” Frances says, “most of them will drop out.”
Basically, Frances believes that the first draft of the DSM-5 is too promiscuous with its labels, both by loosening diagnostic criteria and by introducing a host of new and, to his mind, problematic maladies—like Binge Eating Disorder (more or less defined as gorging on massive amounts at least once a week for three months). By the estimate of one DSM-5 task-force member, Frances says, this disorder already afflicts 6 percent of the population. “And that,” he notes, “is before drug companies start marketing something for it.”
As Frances pointed out in a recent Los Angeles Times editorial, such taxonomic adjustments only seem to further shrink “the ever-shrinking domain of the normal.” Take another DSM-5 proposed addition: Temper Dysregulation Disorder With Dysphoria. Frances fears this may be deployed for kids who have typical temper problems. Or Major Depressive Episode: As it’s redefined, it could now be used to describe someone who’s spent two weeks grieving over a lost spouse, he contends. But the worst offender, in Frances’s view, is Psychosis Risk Syndrome, which attempts to identify and treat youngsters before they become psychotic. In his view, there isn’t any evidence that early intervention with medication helps, while there’s plenty to suggest that many teens could be misidentified. “And that I saw as a public-health danger,” he says, “because there are real drawbacks to being on antipsychotics.” Like weight gain and diabetes. “Those children are also disproportionately on Medicaid,” he adds.
Read entire article: http://nymag.com/news/intelligencer/65632/
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Tags: Allen Frances, American Psychiatric Association, antipsychotics, APA, Binge Eating Disorder, diabetes, Diagnostic and Statistical Manual of mental disorders, Drug companies, dsm, DSM-5, DSM-IV, Major Depressive Episode, Marketing, Medicaid, psychiatric drugs, psychiatrist, Psychosis Risk Syndrome, Temper Dysregulation Disorder With Dysphoria, weight gain
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Friday, January 29th, 2010
BBC News
January 26, 2010
The marketing team sued over a drug’s alleged side effects tried to suppress key data, an ex-employee has claimed.
Seroquel’s former UK medical adviser told the BBC he was pressured to approve promotional material which said weight gain was not an issue.
Maker AstraZeneca, which faces fresh legal action next month, said it took concerns about its conduct seriously.
In the same programme, the British Medical Journal editor urged that the medicine licensing system be reviewed.
Dr Fiona Godlee said industry should no longer provide the evaluations of its own drugs which the licensing body considered.
‘Job threat’
Thousands of patients are suing AstraZeneca in US courts, claiming the anti-psychotic drug Seroquel caused weight gain and diabetes.
The patients allege Seroquel, its second biggest selling drug worth $4.5bn (£2.7bn) a year, was marketed without adequate warning about possible side effects such as massive weight gain and the development of diabetes. However, this is denied by the company.
Read entire article: http://news.bbc.co.uk/2/hi/health/8478924.stm
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Tags: AstraZeneca, Seroquel, side effects, weight gain
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Monday, January 4th, 2010
Ed Silverman
Portfolio.com
January 4, 2010
If elderly people with dementia are so vulnerable to the risks posed by antipsychotics, why are so many nursing-home residents regularly prescribed the medications?
The answer can be found in a controversy with its roots in aggressive marketing and lackadaisical supervision. Known in the medical community as atypical antipsychotics, this group of drugs was originally approved by the Food and Drug Administration to treat adults suffering from schizophrenia. They go by snazzy names such as Zyprexa, Geodon, Abilify, and Seroquel. Later, regulators allowed doctors to prescribe them for treating bipolar disorder. Over the past decade, the pills have become a veritable goldmine; in 2008 alone, sales in the U.S. reached $14.6 billion.
But critics say those big sales are actually due, in part, to an epidemic of off-label marketing, which is promoting a drug for unapproved uses, although doctors are free to write a prescription regardless. And so drugmakers encouraged doctors to prescribe these meds for children before the FDA sanctioned their use for youngsters. This was particularly troubling, given that the drugs can cause diabetes and weight gain, side effects that prompted thousands of lawsuits claiming that drugmakers tried to hide evidence of these problems.
Read entire article: http://www.portfolio.com/industry-news/health-care/2010/01/04/drugging-kids-for-profit/
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Tags: Abilify, anti-psychotic, antipsychotic, diabetes, FDA, Foos and Drug Administration, Geodon, off-label marketing, Seroquel, weight gain, Zyprexa
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Wednesday, December 9th, 2009
Jennifer Corbett Dooren
The Wall Street Journal
December 8, 2009
WASHINGTON (Dow Jones)–A top Food and Drug Administration official said Tuesday the agency is considering strengthening the labels of antipsychotic drugs to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults.
Thomas Laughren, the director of FDA’s division of psychiatric products, said the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose, which can cause diabetes and blood cholesterol levels which can lead to cardiovascular problems over time.
While the labels of the drugs already discuss weight gain and its associated problems, Laughren said the agency is considering putting all the information in the warnings section, which would amount to a strengthening of the warning.
Laughren made his comments Tuesday at a pediatric advisory committee meeting which was reviewing the safety of several drugs used in children, including antipsychotics.
Laughren said the labels for AstraZeneca PLC’s (AZN) Seroquel and Eli Lilly & Co.’s (LLY) Zyprexa were already changed last week when the agency approved the products for use in younger patients and, in Seroquel’s case, when it was approved as an add-on treatment for major depression. However, he said all of the drug labels in the class could change as the FDA continues its “comprehensive” review.
The drugs are used to treat a variety of mental illnesses, including bipolar disorder, schizophrenia and depression that doesn’t respond to other types of medication.
A study published last month in the Journal of the American Medical Association found the drugs caused children and adolescents to gain an average of 19 pounds in 11 weeks of treatment. The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.
In advance of the pediatric panel meeting, FDA staff recommended the agency should conduct an additional review of antipsychotic drugs to look at the impact of weight gain in children. Several studies have shown children and adolescents gain weight at a faster rate than adults.
Other drugs in the class include Risperdal, made by a unit of Johnson & Johnson (JNJ); Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co.; and Pfizer Inc.’s (PFE) Geodon. Antipsychotics were the top-selling drug class in the U.S. last year, with $14.6 billion in sales, ahead of the $14.5 billion in sales of cholesterol drugs, according to IMS Health.
See article: http://online.wsj.com/article/BT-CO-20091208-714877.html
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Tags: Abilify, antipsychotic, diabetes, FDA, Food and Drug Administration, Seroquel, weight gain, Zyprexa
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Friday, December 4th, 2009
AttorneyAtLaw.com
December 4, 2009
The use of powerful antipsychotic drugs like Seroquel and Zyprexa in children should be further studied to determine the risks of metabolic disorders and other serious health complications, Food and Drug Administration staffers say in a new report.
FDA drug reviewers said medical researchers have found a direct link between the use of so-called atypical antipsychotics in younger children and weight gain, high cholesterol, and increased blood pressure, according to a Reuters news report.
Seroquel, Zyprexa and similar antipsychotic drugs are not approved for use in children, but an estimated two million American children are given the drugs by doctors each year to treat a variety of psychiatric disorders. An FDA advisory panel recently recommended approving their use in kids.
The research findings should prompt further FDA evaluation to determine the extent of the risks and possibly take action to limit the use of Zyprexa, Seroquel, and similar drugs in younger age groups, staff in the FDA’s division of pharmacovigilance wrote in an October 14 memo, according to Reuters.
Read entire article: http://www.attorneyatlaw.com/2009/12/fda-staff-urges-more-review-of-seroquel-and-zyprexa-use-in-kids/
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Tags: Abilify, antipsychotics, FDA, Food and Drug Administration, high cholesterol, increased blood pressure, Risperdal, Seroquel, weight gain, Zyprexa
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Friday, November 13th, 2009
Christina Jewett, ProPublica
SamRoe, Chicago Tribune
November 11, 2009
Executives inside pharmaceutical giant AstraZeneca faced a high-stakes dilemma.
On one hand, Chicago psychiatrist Dr. Michael Reinstein was bringing the company a small fortune in sales and was conducting research that made one of its most promising drugs look spectacular.
On the other, some worried that his research findings might be too good to be true.
As Reinstein grew irritated with what he perceived as the company’s slights, a top executive outlined the scenario in an e-mail to colleagues.
“If he is in fact worth half a billion dollars to (AstraZeneca),” the company’s U.S. sales chief wrote in 2001, “we need to put him in a different category.” To avoid scaring Reinstein away, he said, the firm should answer “his every query and satisfy any of his quirky behaviors.”
Putting aside its concerns, AstraZeneca would continue its relationship with Reinstein, paying him $490,000 over a decade to travel the nation promoting its best-selling antipsychotic drug, Seroquel. In return, Reinstein provided the company a vast customer base: thousands of mentally ill residents in Chicago-area nursing homes.
Read entire article: http://www.chicagotribune.com/health/chi-drugs-seroquel-reinsteinnov11,0,6067737.story
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Tags: anti-psychotic, antipsychotic, AstraZeneca, diabetes, Dr. Michael Reinstein, nursing homes, Seroquel, weight gain
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Thursday, November 12th, 2009
Geoff Leisik
Deseret News
November 11, 2009
Pharmaceutical giant Eli Lilly and Co. has agreed to pay $24 million to settle a lawsuit filed by the Utah Attorney General’s Office.
Attorney General Mark Shurtleff sued the company after a nearly four-year investigation revealed that Lilly concealed its knowledge of significant weight gain and obesity associated with the anti-psychotic medication Zyprexa. Investigators also showed that Lilly’s sales representatives illegally promoted the drug for uses not approved by the U.S. Food and Drug Administration.
“We’re not just asking them for money. We want their bad conduct to stop,” Shurtleff said Wednesday while announcing the settlement.
“As part of the settlement agreement, there are corporate integrity responsibilities and remedial provisions that will continue to be monitored by the court to stop (Lilly’s) harmful behavior.”
Zyprexa is approved for the treatment of schizophrenia and certain types of bipolar disorder in adults. But authorities say that in 1999, Lilly’s marketing arm that focuses on doctors who treat the elderly began encouraging physicians to prescribe the drug for dementia, Alzheimer’s disease, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. Lilly also trained its sales teams to avoid discussions with health-care professionals about the weight gain side effect, investigators said.
Read entire article: http://www.deseretnews.com/article/705343716/Firm-to-pay-Utah-24M-in-settlement.html
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Tags: anti-psychotic, antipsychotic, Eli Lilly, Medicaid, obesity, off-label prescribing, settlement, Utah Attorney General, weight gain, Zyprexa
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