Off-label

On Monday, the US Supreme Court declined to hear Johnson and Johnson’s final appeal, forcing the company to pay $124 million for the deceptive marketing of the antipsychotic Risperdal. In 2011, South Carolina ordered the company to pay $327 million for pursuing “profits-at-all-costs” in its efforts to persuade doctors to prescribe their drug, but the fine was lowered to $136 million last year. The company had hoped to argue that the remaining penalties constituted an “excessive fine” and was supported by PhRMA, the Washington Legal Foundation, the Cato Institute and the Chamber of Commerce.

“Do they make people less aggressive? Yes, sometimes they do. Will they sedate people? Absolutely. Will they make kids easier to manage? They will,” Robert Whitaker tells Liz Spikol for Philadelphia Magazine. “But I know of no study that shows that medicating these kids long-term will help them grow up and thrive. The developing brain is a very delicate thing. The narrative is that these side effects are mild, and that’s just not true, and that the benefits are well-established, and so often they’re not.”

Martha Rosenberg calls the reanalysis of Paxil and Study 329 “a victory for safety activists, medical reporters, the public and freedom of the press.” But, she warns, “many pro-pill doctors continue to fight evidence of Paxil’s suicide risks and similar SSRIs.”

On his website, Dr. Nardo details the hidden risks and bad science behind the growing practice of using atypical antipsychotics to augment antidepressant treatment for severe depression. The story of Atypical Antipsychotic Augmentation of Treatment Resistant Depression is a “prime example” “to illustrate how commercial interests have invaded medical practice.” “Besides the obvious dangers of the Metabolic Syndrome and Tardive Dyskinesia, these drugs don’t really do what they’re advertised to do – make the antidepressants work a lot better.”

Stimulant medications like Ritalin and Adderall, often prescribed to treat children diagnosed with ADHD, are known to cause hallucinations and psychotic symptoms. Until recently these adverse effects were considered to be rare. A new study to be published in the January issue of Pediatrics challenges this belief, however, and finds that many more children may be experiencing psychotic symptoms as a result of these drugs than previously acknowledged.

"To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other...

“In 2014, the number of people who died from drug overdoses in the United States reached 47,055 — an all-time high, according to a disturbing report published Friday by the Centers for Disease Control and Prevention (CDC),” but “the effort to get physicians to curb their prescribing of these drugs may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.”

Recent meta-analyses of antidepressant clinical trials have revealed that up to 82% of the effects associated with the drugs may be attributed to placebo and non-medication factors. A new study examined the attitudes of psychiatrists toward these non-pharmacologic factors and found a large discrepancy between their beliefs and the empirical evidence.

“A new study is giving insight into how long-term care patients in the province are progressing — or, in some cases, worsening — over time. It found those living in central Newfoundland are more likely to be given antipsychotic drugs they don't need.”

A former pharma executive has broken ranks with the industry in a new book by reporting how multiple psychiatrists, schools, and his desperate hopes pressed him to allow higher and higher doses of antipsychotic medications. The result: his 15-year-old son's death from Seroquel.

“Some autistic adults have spent much of their lives with the wrong diagnosis, consigned to psychiatric institutions or drugged for disorders they never had,” Jessica Wright writes in The Atlantic.

“While evidence of abuse of the disabled has piled up for decades, one for-profit company has used its deep pockets and influence to bully weak regulators and evade accountability.”

Yesterday, the FDA approved Pfizer's “QuilliChew ER” chewable methylphenidate for ADHD in children as young as six. “CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.”

The New York Times reports that a growing number of infants and toddlers are being prescribed dangerous psychiatric drugs. “Almost 20,000 prescriptions for risperidone (commonly known as Risperdal), quetiapine (Seroquel) and other antipsychotic medications were written in 2014 for children 2 and younger, a 50 percent jump from 13,000 just one year before.”

The Wall Street Journal highlights a new study that found that off-label medications represent about 12% of drug prescriptions and are resulting in negative...

Eugene Raikhel reveals ads from 1966 where Ritalin, now prescribed largely for ADHD, was marketed as a “kind of mind antidepressant for housewives.”  “I...

US news coverage has primarily framed the opioid drug abuse epidemic as a criminal justice issue rather than a public health problem, according to new research published ahead of print in the Journal of Psychiatric Services. The media’s framing of the epidemic may increase stigma against those who develop a dependency on prescription drugs and distract political attention from public-health oriented solutions, such as increased access to substance abuse recovery treatments.

Martha Rosenberg highlights how the popular antipsychotic Seroquel is a perfect example of how direct-to-consumer advertising made billion dollar blockbuster drugs possible before side-effects...

Dr. Max Pemberton “The Mind Doctor” weighs in on the Cochrane review which questioned the evidence for Ritalin for ADHD. He writes: “History is...

For the North Carolina Law Review, Katie Rose Guest Pryal writes, that “ a psychiatric diagnosis, or involuntary civil commitment to a psychiatric ward—which is...

Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory”. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue.

In 2004, the FDA added a black-box warning to SSRI antidepressants on the increased risk of suicide among children taking these drugs. A new study suggests that this warning has increased the proportion of children who begin an antidepressant on a low dose, but the majority are still receiving higher than recommended doses.

Acknowledging that current depression treatments are failing many people, researchers from Michigan State and MIT have developed a new model for understanding how multiple psychological, biological, social and environmental factors contribute to depression.

Today on Radio Times, U.S. Representative Tim Murphy (R-PA), Mark Salzer, professor and chair of the Department of Rehabilitation Sciences at Temple University, and Leah...

The authors of a large scale well-conducted systematic review of methylphenidate, also known as Ritalin, conclude that there is a lack of quality evidence for the drug’s effectiveness. Their research also revealed that Ritalin can cause sleep problems and decreased appetite in children.