News Roundup: Exelon Skin Patch, Antidepressant Warning, and Ethics Questions

Several news stories in the world of mental health drew our attention last week; here’s a roundup of a few…

Skin Patch for Alzheimer’s Disease

From Novartis, news of the Exelon transdermal patch for delivering rivastigmine for the treatment of Alzheimer’s:

An international study of the first transdermal patch for patients with Alzheimer’s — a degenerative brain disease estimated to affect more than 15 million people worldwide — has shown that it may provide a promising new treatment approach1.

The six-month IDEAL trial of 1,195 patients with Alzheimer’s disease showed that the Exelon Patch provided benefits across a range of symptoms and the target dose was well tolerated. Results were presented today at the 10th International Conference on Alzheimer’s Disease and Related Disorders (ICAD), presented by the Alzheimer’s Association in Madrid, Spain.

Patients receiving Exelon Patch (rivastigmine transdermal patch) had significant improvements in memory and were better able to maintain everyday activities than those receiving placebo. They could also complete a concentration task up to 20 seconds faster compared to those taking placebo, and physicians considered Exelon Patch patients to have done better overall.

FDA Warns on Antidepressant Drugs with Migraine Drugs

From the FDA (and widely reported elsewhere, such as in the New York Times), news of a public health advisor concerning the use of certain anti-depressants together with migraine headache drugs called triptans:

The FDA has important new safety information about taking triptans (drugs used to treat migraine headaches) together with certain types of antidepressant medicines. The antidepressant medicines of concern are selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). Names of the triptans, SSRIs and SNRIs are provided below.

A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much serotonin, a chemical found in the nervous system. Serotonin syndrome symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea. Serotonin syndrome may be more likely to occur when starting or increasing the dose of a triptan, SSRI or SNRI.

The FDA has determined that serotonin syndrome occurs with combined use of triptans and a SSRI or SNRI through reports describing serotonin syndrome in people taking these medications together. Each of these types of medicine increases serotonin levels on its own, as well.

Patients who are taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medications.

Please see the original FDA advisory for the full list of drugs.

Ethics Questions Hang Over Major Studies

And from the Wall Street Journal, questions are raised about the ethics of practices at two prominent medical journals:

Charles Nemeroff, one of the nation’s most prominent psychiatrists, edits the journal Neuropsychopharmacology, which this month favorably reviewed a controversial new treatment for depression.

But yesterday, the journal said it plans to publish a correction because it failed to cite the ties of the article’s eight academic authors to the company that makes the treatment, including the article’s lead author: Dr. Nemeroff.

The journal’s nondisclosure of the financial ties of its own editor as well as those of the other authors highlights the failure of many respected medical journals to identify relationships between academic researchers and medical companies that may…

The article highlights a study about vagus nerve stimulation for depression (VNS) at the journal Neuropsychopharmacology, and another at the Journal of the American Medical Association on pregnancy and the use of antidepressant drugs.

From the Wall Street Journal’s comments about the JAMA article:

Last week, the Journal of the American Medical Association published a correction indicating that seven authors of a February paper on depression during pregnancy failed to reveal they were paid by the makers of antidepressants. It was the third such incident at JAMA this year.

“If journals are going to have ethical standards and if those ethical standards are going to mean anything, there has to be sanctions associated with them,” says Sheldon Krimsky, a Tufts University professor who has studied conflict-of-interest policies of medical journals. Most policies require authors to report financial ties, but don’t include any punishment if they fail to do so.

And concerning the Neuropsychopharmacology article:

Of the nine authors of the review, eight are academic researchers who serve as consultants to the company, according to Ronnie Wilkins, executive director of the American College of Neuropsychopharmacology, which publishes Neuropsychopharmacology. The ninth author is an employee of Cyberonics, which was reported in the review article.

It turns out the study’s lead author — Nemeroff — is in fact the editor of the journal itself!