Subsidiaries of Johnson & Johnson have agreed to pay $5.9 million to settle Montana’s lawsuit over the company’s fraudulent marketing of Risperdal. According to the lawsuit, J&J and its subsidiaries knew that the drug could cause weight gain, diabetes, and vascular complications, but hid the risks. After approval by the FDA for adult schizophrenia and bipolar disorder in adults, the companies promoted the drug for various conditions in both adults and children.
The FDA has released a new checklist meant to clarify the ways a pharmaceutical manufacturer may use scientific and medical literature to promote products. The checklist constitute a revision of 2009 guidelines that were criticized for restricting companies’ ability to “promote the public health.” The new guidelines call for an emphasis on science, not promotion, and also recommends that literature not be funded – either in whole or in part – or distributed by a company.
Lawyers for Johnson & Johnson took the stand in Arkansas today, a final effort at convincing the Arkansas Supreme Court to overturn a jury’s award of $1.2 billion for off-label marketing of Risperdal. J&J plans to argue that the award is excessive, and that the company was exercising its right to free speech in promoting the drug. The attorneys general of 35 states have filed a brief urging the court to uphold the verdict.
A study in JAMA Psychiatry finds that inpatient admissions for behavioral health disorders significantly declined following the 2006 expansion of health insurance coverage in Massachusetts, contrary to expectations. ”This signifies much lower out of pocket burden for young adults with a behavioral health crisis, as well as less uncompensated care burdening hospitals,” the researchers write.
A Chicago jury awarded $1.5 million to an autistic child who developed irreversible and disabling tardive dyskinesia and tardive akathisia while treated with Risperdal, followed by Zyprexa. The boy had been diagnosed with autism as a child and started on SSRI antidepressants by the age of seven, which according to expert witness Peter Breggin caused his mental condition and behavior to deteriorate.
My last blog raised issues about the involvement of Shire Pharmaceuticals in lobbying for the inclusion of mandatory screening of children for ADHD in a bill before the UK parliament. It questioned the involvement of key opinion leaders including MEP … Full Article →
A study from Lisa Cosgrove at Harvard’s Safra Center for Ethics of potential conflicts of interest among DSM-5 committee members, investigators of new DSM-5 diagnoses, and drug companies finds that neither increased transparency (e.g., registration on ClinicalTrials.gov) or mandatory disclosure were sufficient to prevent the appearance of bias in either the DSM revision process or in clinical decisions about treatment of DSM disorders.
A memorandum submitted on the Children And Families Bill by the UK ADHD Partnership (UKAP) recommended that regulations issued to accompany the Children and Families Bill should include a requirement that “all children who receive two fixed term exclusions from school are screened for ADHD and, if appropriate, an assessment process for ADHD initiated.” The UKAP certainly appears to be a group the UK parliament should trust and, on the face of it, there is no reason that parliament should not adopt their recommendation. Except that the UKAP appears to be a front group for pharmaceutical company Shire, who manufacture the ADHD drug marketed as Vyvanase in the US and Elvanse in the UK. Full Article →
Delegates attending the International Congress of the Royal College of Psychiatrists at London’s Barbican Centre in June this year will almost certainly not hear about the results of the seven-year outcome of the Dutch First Episode (FE) study widely discussed on Mad in America in recent months. Full Article →
In 2004, a patient was given an experimental antipsychotic called bifeprunox and died of hepatorenal failure nine days later. But the sponsor apparently did not investigate the death for three years. In late 2007 the sponsor issued a safety alert and suspended all bifeprunox studies. This is where things get interesting. Full Article →
Harlan Krumholz, director of Yale University’s Open Data Access Project (YODA), writes in the New York Times about YODA’s agreement to oversee release of Johnson & Johnson’s clinical trial data. User of the data will sign “an agreement that restricts them to their proposed research question. Most important, they must agree to share whatever they find. And we exclude applicants who seek data for commercial or legal purposes. Our intent is not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to overall scientific knowledge.”
Yale University has agreed to screen access – with Johnson & Johnson’s input – to detailed clinical trial data on the pharmaceutical giant’s products. Outside academic researchers interested in conducting safety, efficacy and other studies will have access to the “entire trove of clinical trial data assets and they have given us complete authority and jurisdiction over all decisions regarding data access,” according to Dr. Harlan Krumholz, the project’s head.
Schizophrenia Bulletin follows the movement change to the name and concept of “Schizophrenia”, revealing that Japan has taken the lead. Japan, to remove the stigma, social and professional consequences, notions of dangerousness and lack of hope that the old name and model conveyed, was the first country to update and revise the schizophrenia concept by embracing the name “Integration Disorder”, and the stress vulnerability model, along with evidence that people “recover and lead a normal life.”
A Louisiana appeals court has thrown out a $257 million verdict which held Johnson & Johnson liable for deceptive practices in marketing its antipsychotic Risperdal by downplaying its links to diabetes, and claiming it was safer than competing antipsychotics. The justices ruled that Louisiana could not produce evidence showing that J&J’s “misleading statements” actually resulted in doctors prescribing Risperdal even though competing drugs were “equally safe and less expensive.”
A study in the Journal of the American Medical Association finds that, although “many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood,” in reality the quality of evidence for new drugs’ safety and efficacy varies widely, with about a third of new drugs winning approval on the basis of a single clinical trial. “Not all FDA approvals are created equally,” explained the study’s lead author.
The Pennsylvania Supreme Court has ruled that pharmaceutical companies can be held liable for negligent design and marketing of drugs, agreeing with the family of a deceased woman that a drug’s manufacturer “owed a duty . . . not to introduce onto the market a drug that was unreasonably dangerous for any person to use” and dismissing a summary judgment in favor of Wyeth, the manufacturer of Redux. Wyeth had argued that pharmas are responsible for “impurities or deficient warnings” only, and that the roles of doctors and the FDA relieves the manufacturer of responsibility.
In 1972, prisoners at Holmesburg Prison in Philadelphia were paid $3 to have their eyes held open with clamps and hooks while Johnson & Johnson’s baby shampoo was dropped into them. In 2011, mothers of newborns were arrested when their babies tested positive for exposure to cannabis, a false result caused by the use of Johnson & Johnson’s Head-to-Toe Foaming Baby Wash. Young men have undergone mastectomies to remove breasts grown as a result of Johnson & Johnson antipsychotics, which were used as a result of Johnson & Johnson’s criminal promotion of its drugs for off-label purposes. And now, Johnson & Johnson has announced the removal of carcinogenic chemicals from their No More Tears baby shampoo. Full Article →
Jim Gottstein’s talk on the Role of Litigation in a Strategic Approach to Mental Health System Change at the annual rights conference of the National Association of Rights Protection and Advocacy (NARPA), September 27, 2013 in Hartford, Connecticut.
Consumer Reports affirms that, though the use of antipsychotic drugs to treat conditions not approved by the Food and Drug Administration has increased significantly in the last decade, “our analysis shows that there is only limited research about the effectiveness and safety of antipsychotics drugs when used for these conditions, and that it’s unclear whether any potential benefit outweighs the risk of experiencing side effects.”
The custody of Justina Pelletier, a Connecticut 15-year-old whose odyssey of diagnosis with “Somatoform Disorder” has trapped her in Boston Children’s Hospital since last February, will be decided by a Boston judge tomorrow. (Video)
Last week, Rep. Tim Murphy (PA) introduced the Helping Families in Mental Health Crisis Act of 2013 to Congress and almost simultaneously mental health and disability rights advocates voiced their opposition to the proposed legislation with a statement from the Bazelon Center for Mental Health Law. The bill, as many people who follow what’s happening in mental health law know, calls for the enactment of assisted (involuntary) outpatient commitment laws at the Federal level and is purportedly crafted to ensure the safety of those deemed “severely mentally ill” by giving families, courts and mental health providers increased authority to commit individuals to outpatient treatment. Full Article →
In a first for a major drug company, GlaxoSmithKline, the British pharma that was fined $3 billion for illegal marketing of Paxil and Wellbutrin, has said that by 2016 it will no longer pay doctors to promote its drugs and will stop tying sales representatives’ compensation to the number of prescriptions doctors write. GSK will also stop providing doctors with financial support to attend conferences.
A New Zealand judge has upheld the appeal of a sexual abuse survivor against a decision that sexual abuse cannot cause schizophrenia. The judge noted research by John Read and Richard Bentall, and a previous UK judge’s similar decision, in overturning the lower court’s decision that there was no causal link between early trauma and schizophrenia.