The Journal of Law, Medicine and Ethics looks at institutional corruption in the pharmaceutical industry; “An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or mis-represent evidence about new drugs; distort the medi-cal literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After deﬁning institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of beneﬁts.” (more…)
Around the world, drug regulatory agencies spend billions of dollars engaged in activities which purport to ensure the safety, efficacy and quality of legal drugs. If the goal of regulation is to protect public health and safety, there can be no argument that it has failed. Safe drugs are not associated with annual rises in mortality and morbidity, effective drugs are not associated with increased prevalence of the conditions they are designed to treat and with greater chronicity of those conditions, quality drugs are not discovered to be contaminated with solvents months after their manufacture and release to the market. Effective regulation does not see companies repeatedly breaching standards and shrugging off sanctions. Full Article →
Saying that the Arkansas supreme court had departed from 170 years of precedent by deciding in favor of Johnson & Johnson on grounds not raised in any of the case filings, Arkansas Attorney General Dustin McDaniel is asking the court to reconsider its decision to toss out a $1.2 billion judgment over the marketing of the antipsychotic Risperdal. Discuss →
I began reading the book History Beyond Trauma by Françoise Davoine and Jean-Max Gaudillière during a turbulent time in my life — when deaths, losses, and uncertainties continually piled up. Despite my best efforts to remain optimistic and push forward with life as planned, traumatic stress was threatening to be more than a subject I researched or a condition I treated. At times I felt I was only a narrow step out of its grasp. At first I didn’t speak of this, as if by not voicing my fears I would somehow outpace them. Full Article →
The European Parliament voted on Wednesday to ensure open reporting of European clinical trials, even when negative. The new laws, expected to take effect in 2016, will require results of all new clinical trials to be published within a year of the trial ending. Discuss →
HR 3717, authored by Congressman Tim Murphy, has been introduced in response to mounting concerns about the treatment of persons with mental health challenges. It is universally recognized that improvements are needed in the mental health system. Unfortunately, HR 3717 will have serious unintended consequences. Full Article →
The House Subcommittee on Health will hold a hearing tomorrow (Thursday, April 3, 2014) on the “Helping Families in Mental Health Crisis Act,” also known as the “Murphy Bill” after its sponsor, Rep. Tim Murphy of Pennsylvania. The hearing will be in room 2322 of the Rayburn House Office Building at 10:30 a.m. Discuss →
Harvard Law professor (emeritus) Alan Dershowitz will represent Justina Pelletier in her family’s fight to regain custody from the state of Massachusetts and Boston Children’s Hospital. “When you hear about a case like this you scratch your head and you say ‘something else must be going on,’ said Dershowitz, who will work with the family’s current legal team on a pro bono basis to address the “broader Constitutional Issues.” Discuss →
Leaders of medical schools and hospitals receive much more compensation from pharmaceutical companies than the doctors who have previously been scrutinized for drug company ties, according to a study released today by the Journal of the American Medical Association. 40% of the world’s largest drug companies had at least on board member who also served in leadership at a U.S. academic medical center, according to the study, with average annual compensation of $313,000. Discuss →
The Sunday Times of London reports on Peter Gotzsche’s efforts to obtain pharmaceutical licensing data before the Medicines and Healthcare Products Regulatory Agency (MHRA) routinely destroys the information 15 years after licensing. Ben Goldacre, co-founder of AllTrials, said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded.”
Research published this week in JAMA Internal Medicine finds that about half of American adults believe in at least one medical conspiracy theory. ”Science in general – medicine in particular – is complicated and cognitively challenging because you have to carry around a lot of uncertainty,” said the lead author. ”To talk about epidemiology and probability theories is difficult to understand as opposed to ‘if you put this substance in your body, it’s going to be bad . . . Scientific thinking is not a very intuitive way to see the world. For people who don’t have a lot of education, it’s relatively easy to reject the scientific way of thinking about things.”
Forest Labs has been hit with a new lawsuit in Massachusetts, over misleading marketing of its antidepressant drugs Celexa and Lexapro to adolescents, even as it agreed to pay up to $10.4 million to settle accusations of misleading Missouri parents into buying the drugs for children though the drugs were only approved for adults.
1BoringOldMan picks up where he left off two years ago – critiquing Robert Gibbons’ misuse of statistical analysis to claim that antidepressants were both safe and effective in adolescents – to critique the use of the tools of clinical neuroscience to substantiate the theory that “mental illness” is biologically based. “One could actually see a living brain – even watch it do things. Very exciting. But within a few short years, the fantasies and hypotheses generated by this technology blossomed and were joined by those associated with the new drugs . . . They’re touted as pointers to conclusions not yet remotely reachable, conclusions that have only been dreamed.”
GlaxoSmithKline, which previously announced it would suspend the practice of paying outside doctors to promote drugs, has announced that it will instead hire doctors to “educate” their peers about its drugs, though they will not be able to answer questions about treating specific patients. Because they will be Glaxo employees, the company will not have to report payments to the doctors.
A report released today by Express Scripts, the nation’s largest prescription drug manager, offers “the most current and comprehensive analysis of ADHD medication use” among privately insured Americans, finding that from 2008 to 2012 the number who use medication for ADHD rose 36% to 4.8 million. “Most surprisingly, we saw the greatest increase in use during the five-year study period was among adults, with the largest gains seen in women ages 26 to 34, climbing 85%.”
Teva Pharmaceuticals has agreed to pay $27 million to settle federal and state accusation of false claims regarding the antipsychotic Clozapine, and payments made to an Illinois physician to under a “consulting contract.” “Pharmaceutical companies must not be allowed to improperly influence physicians’ decisions in prescribing medication for their patients,” said the U.S. Attorney for the Northern District of Illinois.
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 →