The safety of our children is a sacred obligation we strive to preserve. Anything or anyone that harms them becomes the object of our distrust and potential wrath. I want to raise the possibility that psychiatry, for all its accomplished … Full Article →
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.
There’s an interesting February 11, 2014, article on Peter Breggin’s website: $1.5 Million Award in Child Tardive Dyskinesia Malpractice. Apparently the individual in Dr. Breggin’s paper was diagnosed with autism as a child and was prescribed SSRI’s before the age of seven. The SSRI’s caused some deterioration in the child’s behavior and mental condition, to combat which his first psychiatrist prescribed Risperdal (risperidone). Subsequently a second psychiatrist added Zyprexa (olanzapine) to the cocktail. Both Risperdal and Zyprexa are neuroleptics (euphemistically known in psychiatric circles as antipsychotics), and are known to cause tardive dyskinesia. Full Article →
A Hong Kong study links short “Duration of Untreated Psychosis” (DUP) to better long-term outcome. The authors propose that factors linked to long DUP may be implicated in poor recovery, and so may provide targets for intervention. Other than specifying that enrollees had taken antipsychotics for a week or less (1/2 being medication naive), treatment modality in this study was unspecified.
Recently, I have been the target of much wooing by my local Sunovion rep. I think he leaves messages for me almost weekly and he sends me missives – glossy brochures and reprints from major psychiatric journal. What is the subject of this attention? The drug – lurasidone (Latuda). Full Article →
Connecticut continues to block public access to information on homicide investigations, according to the Connecticut News Times, an effort that began with concerns over the shooting in Sandy Hook by Adam Lanza in December of 2012. Such disclosure would “cause a lot of people to stop taking their medications,” said CT Assistant Attorney General Patrick B. Kwanashie, speaking at a Freedom of Information Act hearing called by Ablechild last year.
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 →
An important study was headlined on MIA this week. The study examined the effectiveness of cognitive behavioral therapy (CBT) to treat the symptoms of people labeled with a diagnosis of schizophrenia and related conditions who had elected to not take neuroleptic drugs. Full Article →
In “the first randomised trial of cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs”, researchers from the U.K. found cognitive therapy without medication was both safe and effective in reducing symptoms.” “Additionally, cognitive therapy significantly improved personal and social functioning and some dimensions of delusional beliefs (cognitive) and voice hearing (cognitive and physical).” The study appears today in The Lancet, with a commentary calling the study “ground-breaking evidence” for an alternative.
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.”
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 →
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.”
Two pieces of research have been published over the last two years that should prompt a major reorientation of the treatment of schizophrenia and psychosis, and a fundamental reappraisal of the use of antipsychotic drugs in general. Put together, these studies suggest that the standard approach to treating serious mental health problems may cause more harm than good. Long-term treatment with antipsychotic drugs has adverse effects on the brain, and may impair rather than improve chances of recovery for some. Many people ask me how the psychiatric profession has responded to this data. Surely, they think, it must have stimulated a major debate within the profession, and some critical reflection about why it took so long to recognise these worrying effects? Sadly, this does not appear to be happening. Full Article →
I received the following question from a reader regarding the controversial CAFÉ – Comparisons of Atypicals in First Episode of Psychosis – study. (This was the study in which Dan Markingson committed suicide.) “It appears that there was no head-to-head with a control group taking a placebo pill. Nor was there a control group featuring ‘old’ types of ‘antipsychotic’. If that was the case then it is very poor study . . . what on earth can you hope to show from the data?” I started to write a response, but the subject is complex, and my response became the following article. Full Article →
Attorneys representing about 300 lawsuits alleging that Risperdal causes enlargement of breast tissue in men have asked a Pennsylvania judge to unseal relevant clinical studies data. Johnson & Johnson had previously argued that there was no reason to unseal the documents as they were generated for researchers and regulators and not for the general public.
Responding to a letter signed by 175 scholars asking for an inquiry into the death of Dan Markingson at the University of Minnesota, the Faculty Senate voted to investigate clinical research at the university. But the university president says the Markingson case will not be part of the investigation. What is he trying to hide? Full Article →
Before the early 1990’s the use of antipsychotic medications was largely reserved for adults with severe psychotic disorders; unpleasant involuntary movement disorders (extrapyramidal side-effects) and cardiovascular risks appear to have largely limited their use outside these disorders. The introduction and intense marketing of what seemed to be better tolerated and safer (now proven not to be), second generation atypical antipsychotics (AAPs) such as risperidone, olanzapine, quetiapine, ziprasidone and aripiprazole from the mid 1990’s led to a rapid expansion of antipsychotic medication use for a wide variety of unlicensed conditions and in more diverse clinical populations. Full Article →
Consumer Reports writes that the number of children prescribed antipsychotics has tripled over the last 10 to 15 years, despite a lack of evidence that the drugs are either effective or safe for either approved or unapproved (“off-label”) uses, such as behavioral problems. “What’s not known about the long-term effects is very troubling,” said an assistant professor at Tufts University School of Medicine. “The younger you go, the more you can affect the developing brain.”
Counsel for ex rel Watson v. King-Vassel - Psychrights’latest effort to show that prescribing medication for children that is not supported by scientific evidence constitutes fraud when submitted for Medicaid reimbursement – has chosen to settle the case rather than proceed. This decision came in light of the judge’s indication that he was planning to issue rulings that would prevent the case from prevailing. and that he would impose sanctions if counsel chose to go forward with the case.
LAW360 reports that a Pennsylvania federal judge has dismissed a lawsuit over a movement disorder attributed to Bristol-Myers’ drug Abilify. The judge held that drug makers are not required to provide detailed instructions to physicians about monitoring adverse reactions.
Thirty years ago, the prescription of neuroleptic drugs to children under 14 years of age was almost unheard of. It was rare in adolescents, and even in adults was largely confined to individuals who had been given the label schizophrenic or bipolar. By 1993 about a quarter of 1% of the national childhood population were receiving antipsychotic prescriptions during office visits. The percentage for adolescents was about three quarters of 1%. By 2009, these figures had increased to 1.83% and 3.76% respectively. The devastating effects of these neurotoxic drugs are well known, and it is natural to wonder what forces might be driving this trend. Full Article →
Law 360 reports that Johnson & Johnson asked a Pennsylvania judge to keep a series of clinical studies related to the drug Risperdal under seal, saying that the plaintiffs were improperly seeking to publicly release them.