Lawsuit Claims J&J Hid Drug Studies Showing Risperdal Causes Diabetes to Protect Billions in Sales

Johnson & Johnson hid studies showing its Risperdal anti-psychotic drug caused diabetes to protect billions of dollars in sales, a lawyer said in the first personal-injury claim over the medication to go to trial. Researchers at J&J’s Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators probing links between the disease and anti-psychotic medicines, Fletch Trammell, a lawyer for a former Risperdal user, told a New Jersey jury today in opening statements. “The evidence will show Janssen buried studies for a competitive advantage,” Trammell told jurors in state court in New Brunswick, New Jersey. J&J, the world’s second-largest health-products maker, is based in the city. The trial of Gary Skala’s claims that his 14 years’ worth of Risperdal use caused his diabetes began two weeks after J&J agreed to pay $158 million to settle Texas officials’ claims that it fraudulently marketed the drug. More »

The New York Times on Psychiatric Disorders, “Not Diseases, but Categories of Suffering”

YOU’VE got to feel sorry for the American Psychiatric Association, at least for a moment. Its members proposed a change to the definition of autism in the fifth edition of their Diagnostic and Statistical Manual of Mental Disorders, one that would eliminate the separate category of Asperger syndrome in 2013. And the next thing they knew, a prominent psychiatrist was quoted in a front-page article in this paper saying the result would be fewer diagnoses, which would mean fewer troubled children eligible for services like special education and disability payments. Then, just a few days later, another front-pager featured a pair of equally prominent experts explaining their smackdown of the A.P.A.’s proposal to eliminate the “bereavement exclusion” — the two months granted the grieving before their mourning can be classified as “major” depression. This time, the problem was that the move would raise the numbers of people with the diagnosis, increasing health care costs and the use of already pervasive mind-altering drugs, as well as pathologizing a normal life experience. Fewer patients, more patients: the A.P.A. just can’t win. Someone is always mad at it for its diagnostic manual. More »

Latest list of mental disorders leaves a bad taste in one’s mouth

It has come to my attention that I am mentally ill. I always knew I was neurotic - who isn't? - but it still comes as something of a surprise to learn that I am suffering from an actual mental illness. Others, perhaps, will not be surprised in the least. The particular mental illness that afflicts me was added only recently to the so-called Bible of psychiatry, otherwise known as the Diagnostic and Statistical Manual of Mental Disorders. This is the big reference book that officially catalogues all the mental illnesses recognized by modern psychiatry. The latest edition is nearly 1,000 pages. You would have to be almost pathologically normal to find nothing in there that applies to you. More »

American Psychiatric Association’s Push to Broaden Definitions of Mental Disorders Sparks Revolt

A panel appointed by the American Psychiatric Association is proposing changes to the industry's guide for mental illnesses, which determines how patients are diagnosed and treated, and whether insurers pay for care. The new edition of the Diagnostic and Statistical Manual of Mental Disorders is scheduled to be published next year. "Everyday disappointments, sufferings and eccentricities are being redefined as psychiatric disorders, and that could lead to medication treatment," said Frances, a professor emeritus at Duke University who lives in San Diego, California. "This is expanding the boundaries of psychiatry." More »

Grassley & Senate Watchdog Target Doctors Prescribing Mass Amounts of Dangerous Drugs

An influential U.S. senator is grilling officials in nearly three-dozen states, demanding to know how they are cracking down on physicians who prescribe massive amounts of potentially dangerous prescription drugs. Iowa Republican Charles Grassley sent letters to 34 states Monday asking what steps they had taken to investigate doctors whose prescribing of antipsychotics, anti-anxiety drugs and painkillers to Medicaid patients far exceeds that of their peers. More »

Whistleblower says antipsychotic drug maker subverted science & induced others to betray patients

Johnson & Johnson said on Thursday it will pay $158 million to settle a Texas lawsuit accusing the drugmaker of improperly marketing its Risperdal anti-psychotic drug to state residents on the Medicaid health program for the poor. The settlement fully resolves all Risperdal-related claims in Texas, the company said. The agreement is specific to the state of Texas and does not involve other ongoing state or federal Risperdal litigation. More »

U.S. to Force Drug Firms to Report Money Paid to Doctors

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported. The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul. “The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said. More »

J&J Paid Texas Official to Speak Around the U.S., Jury Told

Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said. Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin. Texas is suing J&J, saying the company fraudulently promoted Risperdal and overbilled Medicaid by at least $579 million. More »

4 Creepy Ways Big Pharma Peddles its Drugs

It's no secret that advertising works. Big Pharma wouldn't spend over $4 billion a year on direct-to-consumer advertising if it didn't mean massive profits. What is more unknown is why drug ads that sow hypochondria, raise health fears and "sell" diseases are often the most common--and effective--even when the drugs themselves are of questionable safety. The nation's fourth most frequent drug ads in 2009 for were Cymbalta, making Eli Lilly $3.1 billion in one year, despite the antidepressant's links to liver problems and suicide. Pfizer spent $157 million advertising Lyrica for fibromyalgia in 2009, despite the seizure pill's links to life-threatening allergic reactions. The same year, it spent $107 million advertising the antidepressant Pristiq, even though it also had links to liver problems. More »

Texas AG suit over the drug Risperdal goes to trial Monday

A routine inquiry a decade ago by an investigator for the Pennsylvania inspector general exposed a pattern in which pharmaceutical companies showered trips, meals and other perks on state officials in positions to influence which drugs would be used to treat patients under Medicaid. The efforts appeared to have been particularly successful in Texas, which has one of the largest Medicaid populations. In 2004, Allen Jones, a whistle-blower who worked with the Pennsylvania inspector general, filed suit alleging that pharmaceutical giant Johnson & Johnson improperly marketed its antipsychotic drug Risperdal for unapproved uses while funneling money to members of a state panel charged with recommending drug treatments for those in state health programs. More »

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