February 15, 2012
By Ethan A. Huff
“Isn’t Johnson & Johnson supposed to be one of the most trusted companies in the world? Apparently not.” –KTRN
For the first time, an individual user of the Johnson & Johnson (J&J) antipsychotic drug Risperdal is suing the pharmaceutical giant for allegedly committing fraud and lying about the safety of the drug. According to reports, Fletch Trammell, lawyer for the individual filing the suit, told a New Jersey jury that J&J knew as early as 1999 that Risperdal caused diabetes, but lied about it to the public in order to protect billions of dollars in sales.
Risperdal has been the subject of numerous lawsuits recently, including several filed by individual U.S. states that say they were defrauded by J&J’s illegal marketing of Risperdal, which includes marketing it for off-label purposes, and pushing doctors and health officials to promote the drug in place of less-expensive, safer alternatives.
But now an individual who says the drug caused him to rapidly gain weight and develop diabetes is making the same claims. Based on much of the same evidence used in the state lawsuits, Trammell says Janssen Pharmaceuticals, the division of J&J that manufactures Risperdal, engaged in an illegal coverup of data showing that Risperdal was more dangerous than one of its main competitors, Eli Lilly & Co.’s Zyprexa drug.
“He went to them for help and they gave him diabetes,” said Trammell of J&J concerning his client. This client, who reportedly did not have diabetes at the time and was not overweight, had begun taking Risperdal in 1996 after attempting to commit suicide. But not long after, the plaintiff reportedly gained a lot of weight very quickly, and by 2002 had developed full-blown diabetes.
November 23, 2011
The New York Times
By BENEDICT CAREY
“As if being in a foster home isn’t bad enough, they are now pumping the kids full of drugs they don’t need.” –KTRN
Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, a new study suggests.
The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs include Risperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms.
“The kids in foster care may come from bad homes, but they do not have the sort of complex medical issues that those in the disabled population do,” said Susan dosReis, an associate professor in the University of Maryland School of Pharmacy and the lead author.
The implication, Dr. dosReis and other experts said: Doctors are treating foster children’s behavioral problems with the same powerful drugs given to people with schizophrenia and severe bipolar disorder. “We simply don’t have evidence to support this kind of use, especially in young children,” Dr. dosReis said.
In recent years, doctors and policy makers have grown concerned about high rates of overall psychiatric drug use in the foster care system, the government-financed program that provides temporary living arrangements for 400,000 to 500,000 children and adolescents. Previous studies have found that children in foster care receive psychiatric medications at about twice the rate among children outside the system.
The new study focused on one of the most powerful classes of drugs, antipsychotics. It found that about 2 percent of foster children took at least one such drug, even though schizophrenia and bipolar disorder, for which the drugs are approved, are extremely rare in young children.
“It’s a significant and important finding, and it should prompt states to improve the quality of care in this area,” said Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University who did not contribute to the research.
In the study, mental health researchers analyzed 2003 Medicaid records of 637,924 minors from an unidentified mid-Atlantic state who were either in foster care, getting disability benefits for a diagnosis like severe autism or bipolar disorder, or in a program called Temporary Assistance for Needy Families. All of these programs draw on Medicaid financing. The investigators found that 16,969, or about 3 percent of the total, had received at least one prescription for an antipsychotic drug.
May 11th, 2011
The Huffington Post
The growing use of a popular drug in the long-term treatment of bipolar disorder is based largely on a single, flawed clinical trial that may be steering doctors and patients away from drugs with a more established track record, a new review published this week in the journal PLoS Medicine suggests.
The drug, Abilify (aripiprazole), was initially used to treat schizophrenia and acute episodes of mania, the better-than-good feeling that characterizes bipolar disorder. In 2005, the Food and Drug Administration (FDA) also approved it for long-term use in bipolar patients whose moods have stabilized (known as “maintenance” therapy).
Since then Abilify sales have more than doubled, according to market research cited in the review. And a 2008 survey of doctors found that it had become the first-choice drug for bipolar maintenance therapy among 23 percent of psychiatrists and 16 percent of primary care physicians.
The medical research does not appear to justify the widespread use of Abilify for maintenance therapy, says psychiatrist Alexander C. Tsai, M.D., one of the lead authors of the review and a visiting researcher at Harvard University. “We failed to find sufficient data to support its use.”
Tsai emphasizes that individuals taking Abilify for bipolar disorder should not abruptly stop the medication. “It may actually be working for some people,” he says. “But it’s certainly worth talking to your doctor about how it’s working for you.”
After noticing that a growing number of patients seemed to be asking for Abilify by name, Tsai and his colleagues performed an in-depth search of double-blind, randomized controlled trials–both published and unpublished–on the use of Abilify for the long-term treatment of bipolar disorder. Studies of that design are considered the gold standard of medical research.
Their search turned up just one clinical trial, data from which was used in two published studies. The trial was funded jointly by Otsuka Pharmaceutical Co., the Japanese company that developed Abilify, and Bristol-Myers Squibb, which markets the drug in the U.S.
That trial had several important limitations, according to Tsai and his coauthors. For one, they say, it may have been too short to judge the drug’s true effectiveness in preventing mood swings over the long term. The first phase of the trial lasted for 26 weeks, and less than one-fifth of the participants went on to complete the 48-week follow-up phase.
What’s more, the study population was limited to people whose mood had already stabilized on Abilify during the preliminary phase of the trial, and the placebo group therefore consisted of patients who were abruptly switched from Abilify to placebo. The potentially harmful effects of rapid drug withdrawal may have made the placebo group appear artificially prone to relapse–the key finding that made Abilify appear beneficial, Tsai and his colleagues say.
Psychiatrists have continued to refer to the results of the trial despite these weaknesses, Tsai says. “Frankly, I think it’s an embarrassment to the profession that [Abilify] has been accepted so uncritically for this indication.”
Gregory E. Simon, M.D., a psychiatrist at Group Health Research Institute, in Seattle, says that the perceived flaws noted in the review are not so clear-cut. “The methods of studying long-term effectiveness are complex, and experts disagree regarding the best ways to study this question,” he says.
Alternatives within the same class of drugs, known as atypical antipsychotics, include Seroquel (quetiapine) and Zyprexa (olanzapine). Older drugs, such as lithium, also remain in popular use.
Evidence for the long-term effectiveness of lithium is far stronger than that for newer medications, including Abilify, Simon says. For that reason, lithium remains his first-line treatment for maintenance therapy in bipolar disorder, despite the potentially dangerous side effects associated with too-high doses.
The increased use of Abilify for maintenance therapy may be leading to higher treatment costs for consumers, Tsai says. Abilify runs upwards of $600 for a month’s supply and is not yet available in a generic form. “But our main concern,” he adds, “is that patients are getting diverted from more effective treatments.”
Sonia Choi, the director of public affairs for Bristol-Myers Squibb, said in a statement that the company has conducted five long-term studies of Abilify in the maintenance of bipolar disorder, some of which were presented at medical conferences rather than published in peer-reviewed journals. (Dr. Tsai and his colleagues restricted their analysis to peer-reviewed randomized controlled trials.)
Bristol-Myers Squibb and Otsuka are committed to making data from those studies available to physicians, Choi said. “We are confident in the Abilify clinical development program and will continue to make available information about the efficacy and safety of Abilify from our studies in this and other indicated uses.”
Sandy Walsh, an FDA spokesperson, said the agency will review the new study.
November 18th, 2010
By: Jonathan Benson
Taking antidepressant drugs like Risperdal (risperidone) and Seroquel (quetiapine fumarate) could cause you to gain a lot of weight very quickly, according to a recent report in CNN. Atypical antipsychotic drugs are responsible for causing voracious hunger episodes in roughly 30 percent of patients who take them, which can lead to some seriously rapid weight gain.
Earlier in the year, the U.S. Food and Drug Administration (FDA) began an investigation into antipsychotic drugs and their link to weight gain. The announcement came shortly after the agency approved two popular antipsychotic drugs for children between the ages of 13 and 17.
The drugs — which include the aforementioned as well as Zyprexa (olanzapine), Abilify (aripiprazole), and Geodon (ziprasidone) — appear to trigger enzymes that induce appetite. In one case, a young girl taking risperidone gained 5.5 pounds, or 14 percent of her body weight, within one year. And a 19-year-old college student on the same drug as well as other anti-anxiety medications gained 25 pounds in just six months.
A 2007 study conducted by researchers from Johns Hopkins University and the University of Vermont found that both Zyprexa and Clozaril (clozapine) increased appetite levels by 400 percent. And earlier this year, a study published in the journal Obesity found that men who took Zyprexa for a mere two weeks increased their eating consumption by an average of 18 percent.
Experts are urging the public to be cautious about the use of such antipsychotic drugs. Not only do they induce appetite and subsequent weight gain, but they can also lead to high blood pressure, elevated blood-sugar levels, heart disease, and diabetes.
October 18th, 2010
By: David Gutierrez
Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”
“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.
Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.
Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.
In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.
Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.
Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.
Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.
Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.
April 1, 2010
By: Meg Tirrell
Sales of prescription drugs in the U.S. rose 5.1 percent last year, a rebound from 2008, led by demand for antidepressants and cancer medicines.
Higher sales of antidepressants including Eli Lilly & Co.’s Cymbalta and tumor-fighting therapies such as Roche Holding AG’s Avastin helped bolster pharmaceutical revenue to $300.3 billion, research firm IMS Health Inc. said in a statement.
Drug sales recovered from 2008, when growth of 1.8 percent was the most sluggish in at least 47 years, caused by patients cutting expenses during the recession, IMS said. The rising popularity of cheaper generic versions of medicines still kept growth slower than in 2006, when sales increased 8 percent.
“In 2009, demand for pharmaceuticals proved stronger than in the prior two years, yet remained at historically low levels,” Murray Aitken, a senior vice president at IMS, said in the statement. “The greater availability of generic options, growing differentials in co-pays between brands and generics, and efforts by patients, insurers and employers to encourage appropriate use of lower-cost alternatives were all factors.”
Sales of antidepressants rose 3 percent to $9.9 billion, Norwalk, Connecticut-based IMS said. That made them the fourth- largest class of medicines by sales, up from fifth in 2008. Revenue from targeted cancer therapies increased 9 percent, led by demand for Roche’s Avastin, Herceptin and Rituxan, which is co-marketed with Biogen Idec Inc. They were the sixth-largest class of therapies.
Antipsychotics, such as Lilly’s Zyprexa and Bristol-Myers Squibb Co.’s Abilify, remained the top-selling class of medicines, with 2009 sales of $14.6 billion, the same as 2008, IMS said.
Cholesterol regulators, including Pfizer Inc.’s Lipitor, were the biggest therapy class by prescription volume. Prescriptions grew 5 percent to 212 million in 2009, while sales fell 10 percent to $13.1 billion. That reflected the shift toward lower-cost generic versions, IMS said.
Generic products now make up 75 percent of all prescriptions dispensed in the U.S., up from 57 percent in 2004, IMS said. Last year, the number of generic prescriptions dispensed rose 5.9 percent, while branded drugs fell 7.6 percent.
March 17, 2010
As much as $75 million in popular Eli Lilly & Co <LLY.N> prescription medicines such as Prozac were stolen during a raging storm from a Connecticut warehouse over the weekend, police said on Tuesday.
Burglars broke into the Lilly warehouse either late Saturday or early Sunday in the town of Enfield, Connecticut, as violent rain and winds lashed the Eastern seaboard, Enfield Lt. Steven Kaselouskas said.
“You certainly don’t see a $50 million to $75 million burglary many times in your career,” he said. “This was a well-planned event.”
The thieves disabled a burglar alarm in the building and carted away dozens of pallets loaded with Lilly antidepressants Prozac and Cymbalta, anti-psychotic Zyprexa and other company medicines, according to published reports.
A warehouse employee saw the hole in the roof on Sunday afternoon and notified police. Police did not receive notice of an alarm going off, said Kaselouskas.
Kaselouskas speculated the drugs could be headed for the black market and possibly overseas, where there is demand for medicines made in the United States because of their deemed safety.
Lilly officials could not immediately be reached for comment and did not issue a release about the theft.
But a Lilly spokesman said in a published report the loss may not have a material financial impact for the company and has not disrupted supply of medicines to the east coast.
January 06, 2010
The Food and Drug Administration has canceled a meeting to review Eli Lilly & Co.’s antidepressant Cymbalta for a new use against chronic pain.
The agency said in a statement Tuesday that the Jan. 28 meeting was canceled “to allow time for the FDA to review new information,” about the proposed use.
Lilly shares fell 82 cents, or 2.3 percent, to $35 in afternoon trading.
Calls placed to Lilly Tuesday were not immediately returned. The company is based in Indianapolis.
Lilly withdrew an application in November 2008 after FDA reviewers questioned the methodology and dosing in some of the company’s trials.
The company submitted a new application last summer that included a study of Cymbalta for chronic pain caused by osteoarthritis, along with new data from a study of lower back pain.
Cymbalta is already approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia.
The drug is Lilly’s second-best selling product, behind the anti-psychotic Zyprexa. Cymbalta generated $2.24 billion in sales through the first three quarters of 2009.
Lilly faces the loss of patents protecting several of its top selling drugs in the next few years. The patent protecting Zyprexa, which generated more than $4 billion in 2008, expires in 2011. Cymbalta’s patent expires in 2013.
December 14, 2009
By Mike Adams
Popular antipsychotic drugs are under fire for causing severe side effects such as hyperglycemia, hyperlipidemia, and weight gain. Researchers discussed the issue in Biological Psychiatry, noting that the mentally ill who take such drugs are already at an increased risk for developing heart disease problems including diabetes and hypertension.
Jonathan Meyer and his study team took data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and used it to evaluate the effect of antipsychotic drugs on systemic inflammation. Every drug tested, particularly Zyprexa and Seroquel, markedly increased inflammation levels which are implicated in causing all sorts of other disorders.
Elevated levels of C-reactive proteins in particular were noted as a common side effect of taking antipsychotic drugs. High levels of these proteins are implicated in bringing about illnesses like heart disease and stroke.
Cardiovascular problems have long plagued the mentally ill. There is a much higher death rate from cardiovascular disease among the mentally ill population than there is among the general population. With current research indicating that serious inflammation also occurs from the same drugs, all indications seem to point directly to antipsychotic drugs as the culprit in unleashing a myriad of health problems.
Study doctors believe that the findings will encourage medical professionals to more closely examine the effects of these drugs in their patients. They also hope that as new information comes to light about the consequences of commonly-prescribed medications such as antipsychotic drugs, doctors will be more cautious in evaluating when and if to prescribe them.
Comments by Mike Adams, the Health Ranger
According to the pharmaceutical companies, there’s no need to be concerned about the side effects caused by psychiatric drugs. Why? Because they have other drugs to treat all those side effects, too!
In fact, there’s nothing wrong with one drug that can’t be treated with another drug.
Seriously: This is the mindset of modern medicine: Pump people full of drugs, chasing side effects with one chemical after another until people either die or run out of insurance coverage, at which point none of it really matters anymore.
From a Big Pharma marketing perspective, the best thing about pharmaceuticals is precisely the fact that they have side effects that create long-term repeat business. And psychiatric drugs, it turns out, are particularly good at bringing patients back to the hospital with yet more serious health problems.
November 2, 2009
By David Gutierrez
A pharmacy benefits manager (PMB) for drug store chain CVS entered a secret agreement with pharmaceutical giant Eli Lilly to promote the company’s antipsychotic Zyprexa to doctors, according to internal documents revealed as part of an insurance industry lawsuit against the drug maker.
Advance PCS, a unit of CVS, agreed to send unsolicited mail to doctors promoting Zyprexa, even though it was under contract at the time to represent health insurers by gaining the most favorable possible drug prices from Lilly.
“The problem is that PBMs are negotiating these hidden deals while at the same time telling employers that they represent them at the negotiating table,” said former PBM executive Gerry Purcell. “These documents will add fuel to the perception that the companies and the PBMs are in cahoots with each other.”
“This is the kind of stuff the drug companies and the PBMs hate to see get out.”
Lilly is being sued for illegally marketing Zyprexa for unapproved uses, especially for dementia, and for concealing its side effects of diabetes and dangerous weight gain. Unsealed documents have also revealed that the company hired ghostwriters to author favorable studies on the drug. The insurance companies allege that they drastically overpaid due to these practices.
Zyprexa costs significantly more than the generic antipsychotic haloperidol, by $3,000 to $9,000 per year.
According to the unsealed documents, Advance PCS offered in 2004 to send doctors letters about Zyprexa based on “the most recent … data” on their prescribing habits — in other words, selectively target doctors who were treating people with mental illness. Another PBM, Express Scripts, also sent out the letters.
“There’s no question that these folks are all in bed together,” said Richard Beck of the Texas Pharmacy Business Council. “They make these deals and never disclose them. It’s the clearest example of a conflict of interest I can think of.”