A featured article in the British Medical Journal relates the perspective of FDA investigator Thomas Marciniak, who says “Drug companies have turned into marketing machines. They’ve kind of lost sight of the fact that they’re actually doing something which involves your health . . . You’ve got to take away the key components of the trials from drug companies.” 1 boring Old Man reflects further on the implications for psych drugs.
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.
A Pennsylvania Superior Court has affirmed a lower court’s ruling that GlaxoSmithKline is not responsible for the congenital heart defect that lead Joanne Thomas to abort her child in 2001. Thomas did not learn until studying for her nursing boards in 2007 that Paxil has been associated with such defects. The judge ruled, however, that Thomas could not produce “clear, precise, and convincing evidence” that GSK had concealed the peril. “Because Thomas never alleged any affirmative misrepresentations directed specifically at her,” the court said, “We conclude the trial court properly determined that the fraudulent concealment doctrine did not apply, and that GSK was entitled to summary judgment as a matter of law.”
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.
A century ago Freud and Jung made us aware of the biases underpinning what patients say. Not everything should be accepted at face value. In particular claims of abuse may not be based on reality. We needed experts – analysts – they claimed, to tease out what is real from what is not. The Catholic Church was once intensely hostile to Freud, but when it came to child abuse adopting a Freudian approach was very convenient. But while Freud essentially denied that real abuse was taking place and got away with it in his life-time, the Catholic Church has learnt to its cost that many claims of abuse are real. 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.
The widow of Darwin Stout – who murdered their son and took his own life while taking the nicotine-cessation drug Chantix – has filed suit in Eugene, Oregon against the dentist who prescribed the drug and the hospital that discharged him. According the FDA documents, 544 suicides and 1,869 attempted suicides have been connected to Chantix in the past five years.
Dinesh Bhugra, MD., who next year will become the first openly gay president of the World Psychiatric Association, has told the Guardian newspaper in the U.K. that psychiatry, as it rethinks its conceptions of mental illness, should focus on social functioning rather than symptom reduction as a primary goal of treatment. He also calls for psychiatry to apologize for its past treatment of lesbian, gay, and bisexual people, and, more generally, to women. ”There is no doubt psychiatry hasn’t covered itself in glory. I think we ought to be apologizing for all of the areas, not just one bit – like the treatment of women. I remember seeing a patient admitted to a psychiatric hospital when she was 16 because she got pregnant outside marriage. She died there in her 80s.”
The mental health care of young people has increased more rapidly than that of adults, and has coincided with increased psychotropic medication use, according to an analysis of survey data in JAMA Psychiatry. The majority of mental health care is provided by non-psychiatrist physicians. The researchers conclude that while this trend represents new opportunities to help children and teens, it also “poses risks related to adverse medication effects, delivery of non-evidence-based care and poorly coordinated services.”
In Belgium, patients with mental health problems mostly receive drug treatment despite the emphasis in international guidelines on the importance of psychological approaches. Currently one in ten Belgians takes antidepressants. That makes Belgium the European leader when it comes to antidepressant prescriptions and costs our country 300 million euros annually. This has been a glaring concern for our Minister of Health. From January 1, 2016, all psychologists and psychotherapists in Belgium will need to register in an official list. This should slash the number of unqualified therapists and help more Belgians stay off antidepressants. Full Article →
Justina Pelletier, a 15-year-old Connecticut teenager who had been diagnosed with mitochondrial disease, remains trapped in Boston Children’s Hospital 9 months after a team of doctors changed her diagnosis to “somatoform disorder”, and caused her to be removed from her parents’ custody. The parents, accused of “overmedicalizing” their child, were removed from the hospital by security. “I am dismayed . . . This represents the most severe and intrusive intervention a patient can undergo,” said a former member of the girl’s medical team, “for a clinical hunch.”
Following Johnson & Johnson’s record $2.2 billion settlement for criminal marketing — including $1.4 billion related to its marketing of Risperdal, making it one of the largest fraud settlements involving a single drug — two academics who contributed to an article that helped sell the drug are expressing concerns about their participation. The paper included an error that cut young boys’ projected risk of developing breasts by half.
Facing a sexual abuse lawsuit, the archdiocese of St Paul and Minneapolis made a big deal of putting an independent panel in place to investigate. They put the Reverend Reginald Whitt in charge of appointing the panel and receiving its reports on behalf of the archdiocese. Rev. Whitt told priests and deacons that the task force may review specific files to determine whether the policies of the archdiocese concerning clergy sexual misconduct were properly followed. But, he wrote, “Access to these files will be within my control, and limited only to what is necessary for the task force.” This sounds terribly like the approach Sir Andrew Witty is attempting to put in place for GSK, AbbVie and the rest of the branded pharmaceutical industry vis-a-vis abuses, including child abuse committed in their name. They are asserting their right to spin their version of what it is you put in your body even though this clashes fundamentally with your right to know what you are putting in your body. Full Article →
E. Fuller Torrey has a new book. While I was not thrilled to support the Treatment Advocacy Center, I was curious as to what he had to say. Where Torrey has clarity, I contend there is much that we still do not understand. I worry that a perspective that suggests the answers are clear cuts us off from inquiry into alternate approaches. Full Article →
“My studies in this area lead me to a very uncomfortable conclusion: Our citizens would be far better off if we removed all the psychotropic drugs from the market, as doctors are unable to handle them. It is inescapable that their availability creates more harm than good.”
- Peter Gøtzsche, MD; Co-founder of the Cochrane Collaboration
Sources for Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Health Care:
A Philadelphia jury yesterday ordered Johnson & Johnson subsidiary Janssen to pay $11 million to the parents of a five-year-old boy for failure to warn doctors of potential birth defects associated with its epilepsy drug Topamax. “Janssen knew about Topamax’s serious risk of causing birth defects years before these mothers were prescribed the drug, but did not advise physicians of those risks,” said the family’s lawyers in a press release. The case is the second of about 134 pending in Philadelphia.
In recent months the English pharmaceutical company GlaxoSmithKline (GSK) has assiduously portrayed itself as an advocate of transparency, and in support of access to clinical trial data. Well, in support of “Responsible Access.” “Responsible” here essentially means that a researcher commits to the primacy of RCTs and statistical significance over an analysis of adverse events. It would not, for example, be responsible to claim that an SSRI causes suicide, a statin muscle damage or cognitive failure, or hypoglycemics cause hypoglycemia unless a trial has shown this to happen to a Statistically Significant extent – and they never do. Full Article →
At least 250 lawsuits involving Johnson & Johnson’s improper marketing of Risperdal are pending in Pennsylvania’s Philadelphia Court of Common Pleas, according to information provided by a law firm involved in the litigation. The firm, which represents individuals who may have developed gynecomastia (male breast growth) as a result of the drug, alleges that the unapproved use of Risperdal to treat ADHD is also on the rise.
The Los Angeles Times business section explores how it is possible that “so many scientists looking for cures to diseases have been building on ideas that aren’t even true.” Noting that only a small fraction of research findings are ever validated, and many if not most are found to be flawed when carefully reviewed, a Berkeley researcher adds “The journals want the papers that make the sexiest claims . . . And scientists believe that the way you succeed is having splashy papers in Science or Nature — it’s not bad for them if a paper turns out to be wrong, if it’s gotten a lot of attention.”
The Obama administration will announce today, according to the New York Times, regulations that will require insurers to offer care for mental health issues as if they are “just like physical illnesses.” The requirements are seen as critical to reducing gun violence by making treatment more available to those with mental illness.
The whistleblowers who helped to build the case for prosecuting Johnson & Johnson for illegal marketing of Risperdal will take home nearly $168 million of the $2.2 billion the company will pay. Judith Doetterl stayed undercover for nine years while the case played out. ”Here’s a 34-year-old woman with a tremendous job, putting her career on the line and wearing a wire, all in order to do the right thing,” said Doetterl’s lawyer.
Following Johnson & Johnson’s $2.2 billion settlement for off-label marketing and kickbacks related to its antipsychotic Risperdal, Pennsylvania legislators Brandon Neuman and Tony DeLuca are renewing their push for a Pennsylvania version of the False Claims Act. Whistleblowers in three states will collect $167.7 million under the federal False Claims Act, they say, while Pennsylvania remains the largest state in the union without such a law. “Pennsylvanians lose as much as $200 million a year through Medicare and Medicaid fraud and abuse,” according to Neuman, “Our Pennsylvania False Claims Act legislation … would go a long way toward deterring this dishonesty.”
Johnson & Johnson and its subsidiaries will pay more than $2.2 billion – one of the largest health-care fraud settlements in history – to settle criminal and civil liabilities arising from marketing of Risperdal and its injectable version, Invega, for uses not approved by the FDA. J&J admitted to inappropriate promotion of Risperdal to treat elderly, non-schizophrenic patients for symptoms such as anxiety, agitation, depression, hostility and confusion. ”The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder.