Pharmaceutical Industry Carlat Reports

Research Update

From The Carlat Psychiatry Report, Esketamine

REVIEW OF: Filipcic I et al, J Psychiatr Res 2019;114:113–119 TYPE OF STUDY: Randomized single-blind controlled trial Seven transcranial magnetic stimulation (TMS) devices are FDA approved for depression, but only one—the Brainsway—is distinctly different from the others. Brainsway uses a patented H1 coil that penetrates deeper into the cortex t

Expert Q&A

What’s Wrong With Generics?

From The Carlat Psychiatry Report, Problems with Generics

Topics: Generics | Pharmaceutical Industry

TCPR: What’s wrong with generic drugs?Ms. Eban: That’s the question that got me started. In 2008, I got a phone call from Joe Graedon, the pharmacologist who hosts the NPR program The People’s Pharmacy. He was getting complaints from listeners who were saying that their generic drugs were either causing troubling side effects or weren’t effectiv

Clinical Update

Nuedexta in Agitated Dementia

From The Carlat Psychiatry Report, Inflammation and Depression

Treating agitation in dementia is no easy task. Behavioral interventions are first line, but they are difficult to implement and often insufficient. Psychotropics show modest benefits, but they are prone to causing adverse events. Benzodiazepines can precipitate falls, disinhibition, and confusion. Antipsychotics have a black box warning about an increa

Ask The Editor

Is Paxil the Best SSRI for Anxiety?

From The Carlat Psychiatry Report, How to Talk about Medication

Dear Dr. Aiken: Your review of Paxil’s risks in the May issue failed to mention a benefit that’s unique to this drug. Isn’t it the best SSRI for anxiety? Dr. Aiken: Paroxetine’s (Paxil’s) reputation as the anti-anxiety SSRI got off to a running start. It was first launched for panic disorder in 1996, two years before its approval for depres

News of Note

Concerta: Brand vs Generic

From The Carlat Child Psychiatry Report, Autism in Children and Adolescents

Topics: Child Psychiatry | News of Note | Pharmaceutical Industry | Psychopharmacology

In November 2016, the FDA announced that it was requiring two companies to withdraw their generic versions of Concerta (OROS methylphenidate) because of efficacy concerns. Such actions are quite unusual, and when they occur, they tend to shake doctors’ confidence in the generic drug system—which branded drug companies are often eager to encourage. B

From The Carlat Psychiatry Report,

From The Carlat Psychiatry Report,

As a clinical psychologist with a specialty in chronic pain management, I am often referred patients with both chronic pain and psychiatric issues. Many of these patients see a psychiatrist and a therapist, and are taking with both psychotropic and pain medications. The referral is often made because there is a sense that psychological issues are compli

From The Carlat Psychiatry Report,

Topics: Pharmaceutical Industry | Practice Tools and Tips | Psychopharmacology Tips | Women's Issues in Psychiatry

We’ve been hearing for some time now about the FDA’s plans to revise the long-standing categories A, B, C, D, and X designations for risk of using medications in pregnancy. The new rule (referred to as PLLR for Pregnancy and Lactation Labeling Rule) was proposed in 2008, finalized in 2014, and implementation began during the summer of 2015.

Article

What’s New with the FDA Labeling for Pregnancy and Lactation?

From The Carlat Psychiatry Report, Medication in Pregnancy

Topics: Pharmaceutical Industry | Practice Tools and Tips | Psychopharmacology Tips | Women's Issues in Psychiatry

We’ve been hearing for some time now about the FDA’s plans to revise the long-standing categories A, B, C, D, and X designations for risk of using medications in pregnancy. The new rule (referred to as PLLR for Pregnancy and Lactation Labeling Rule) was proposed in 2008, finalized in 2014, and implementation began during the summer of 2015. What

Expert Q&A

How to Evaluate and Treat Mood Disorders in Pregnancy

From The Carlat Psychiatry Report, Medication in Pregnancy

Topics: Mood Stabilizers | Pharmaceutical Industry | Practice Tools and Tips | Psychopharmacology Tips | Women's Issues in Psychiatry

Article

The GeneSight Genetic Test: A Review of the Evidence

From The Carlat Psychiatry Report, Biomarkers in Psychiatry

Topics: Diagnostic Testing | Genetics and Psychiatry | Pharmaceutical Industry | Practice Tools and Tips

Assurex Health recently sent me an email inviting me to dine at Legal Seafood to learn about “Clinical Applications of Psychiatric Pharmacogenetics.” I didn’t go, but increasingly I am hearing from colleagues about their experiences at these dinner programs: “What do you think about this GeneSight test? The data looked pretty impressive at this

News of Note

FDA Notice: Be Wary of Some Generic Versions of Concerta

From The Carlat Child Psychiatry Report, ADHD

Topics: ADHD | News of Note | Pharmaceutical Industry

News of Note

New Schizophrenia Drug Fails Two Phase III Trials

From The Carlat Psychiatry Report, Women’s Psychiatry

Topics: News of Note | Pharmaceutical Industry

News of Note

J&J Starts Sharing Clinical Trial Information

From The Carlat Psychiatry Report, Women’s Psychiatry

Topics: News of Note | Pharmaceutical Industry

News of Note

Controversy Surrounds FDA Approval of New Opioid Drug

From The Carlat Addiction Treatment Report, Change Management in Addiction Treatment

Topics: Addiction | News of Note | Pharmaceutical Industry

News of Note

Welcome to the Future: Drug Testing with a Fingerprint

From The Carlat Addiction Treatment Report, Change Management in Addiction Treatment

Topics: Addiction | News of Note | Pharmaceutical Industry

News of Note

Johnson & Johnson Settles $2.2 Billion Pharma Fraud Case

From The Carlat Psychiatry Report, Military Psychiatry

Topics: News of Note | Pharmaceutical Industry

Article

Clinical Trials: Show Us the Data

From The Carlat Psychiatry Report, Depression

Topics: Laboratory Testing in Psychiatry | Pharmaceutical Industry

“It is no longer possible to pretend that a report of a clinical trial in a medical journal is enough to allow full independent scrutiny ….” Fiona Godlee, Editor, British Medical Journal (BMJ) Too often our literature presents an oversimplified picture driven by some agenda, usually commercial. We prescribers, or, more accurately, “research c

Article

A Boatload of New Data on Stimulants and Cardiac Events

From The Carlat Psychiatry Report, ADHD

Topics: ADHD | Pharmaceutical Industry

In 2006, an FDA panel recommended all manufacturers of stimulants to add a “black box” warning about an increased risk of “serious cardiovascular events.” Ultimately, the FDA did not require the warning, and instead recommended that manufacturers of stimulant medications add label warnings regarding the risk of sudden death in patients with know

Article

Hot Topics in Pharmaceutical Industry Ethics

From The Carlat Psychiatry Report, Ethics in Psychiatry

Topics: Pharmaceutical Industry

The ethical practices of the pharmaceutical industry have recently come under scrutiny as never before. Here is a quick rundown of the main issues involved and what reforms have taken place, or may soon take place. Industry-funded ghostwriting Background. Industry-funded ghostwriting refers to the practice whereby drug companies pay medical writer