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April 16, 2024 Big Chemical Toxic Exposures Views

Toxic Exposures

‘Very Bad Idea’: Harvard M.D. Wants to Let Pharmacies Hand Out Antidepressants Without a Prescription

Encouraging people to diagnose their own depression and buy medication without a prescription — medication linked to suicide and sexual dysfunction in some people and difficult to stop taking — is a very bad idea.

magnifying glass over pills with word "depression" on top

In a recent STAT article, Dr. Roy Perlis, a professor of psychiatry at Harvard Medical School, argued that antidepressants, known as selective serotonin reuptake inhibitors (SSRIs), should be made available at U.S. pharmacies without a prescription.

Perlis called on the drug manufacturers to “engage with the FDA [U.S. Food and Drug Administration] and invest the necessary resources” to make it possible because SSRIs have “repeatedly been shown to be safe and effective for treating major depression and anxiety disorders.”

It comes off the back of a recent FDA ruling that allows the purchase of the oral contraceptive Opill (norgestrel) over-the-counter, without a prescription at drug stores, convenience stores and grocery stores, as well as online.

Perlis, who treats patients at Massachusetts General Hospital, failed to declare his ties to the pharmaceutical industry in the article, sparking anger among academics online.

While his concerns about patients’ limited access to doctors and treatment services are valid, doing “everything possible” to make antidepressants more easily available is not the answer.

Antidepressants are among the most prescribed treatments in the world. In fact, many experts have argued they are over-prescribed.

In February, the journal Pediatrics published new research that revealed monthly antidepressant prescriptions to adolescents and young adults jumped more than 66% between January 2016 and December 2022.

And following pandemic lockdowns in March 2020, prescriptions rose 63% faster due to soaring rates of depression, anxiety, trauma and suicidality — so limited access to antidepressants is not the problem.

Perlis acknowledges that antidepressants can increase the risk of suicide in people under the age of 25, but he also claims there’s “clear evidence” that the risk of suicidality is reduced in older people.

However, SSRI-induced suicidality is not limited to young people. In 2007 the FDA updated the black box label on SSRI packaging, warning doctors to monitor suicidality in patients of all ages after commencing the medications:

“All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.”

Large trials are rare in the field of antidepressant research. Most of them have been industry-funded and the few that exist are short-term, typically 4-6 weeks, and inadequate for assessing suicidality and clinically meaningful outcomes.

In some instances, when researchers have gained access to regulatory documents, they’ve found that vital data on suicides were excluded from the journal publications.

In the two major Prozac trials in children, for example, Gøtzsche and Healy analyzed clinical study reports and found the authors made numerous data errors, including omitting two suicide attempts from the journal publication. The journal editors have refused to retract or correct the studies.

Perlis also says there is a low potential for misuse and abuse of antidepressants, but he overlooks the fact that SSRIs can lead to dependency. People often experience “discontinuation syndrome” upon ceasing SSRIs because they are habit-forming and can cause abstinence symptoms.

In fact, about half of people on SSRIs have difficulty stopping them, and in rare cases, their withdrawal symptoms can lead to suicide, violence and homicide — some patients report that withdrawal is worse than their original depression.

Many doctors still mistake the symptoms of antidepressant withdrawal for a relapse of depression, which conceals the scale of the problem.

Fortunately, SSRI withdrawal is being taken more seriously by the establishment following the recent publication of the “Maudsley Deprescribing Guidelines,” which provides guidance to healthcare practitioners on how to stop these medications safely in patients.

If SSRIs become available without a prescription, who will counsel patients about tapering off their medications? Cutting out doctors from the patient: doctor relationships will only harm patients and deny them the ability to obtain informed consent about their therapy.

Another significant problem is that few patients — and doctors for that matter — are aware that SSRIs have the potential to cause severe, sometimes irreversible, sexual dysfunction that persists even after discontinuing the medication.

The condition, called Post-SSRI Sexual Dysfunction (PSSD), has been described by sufferers as “chemical castration.” The problem is under-recognized and largely under-reported, but drug regulators are starting to pay attention.

In June 2019, the European Medicines Agency updated the “Special Warnings and Precautions” section on the package insert label to warn that sexual dysfunction can persist even after treatment stops.

And in 2021, Health Canada also did a review of the evidence and “found rare cases of long-lasting sexual symptoms persisting after stopping SSRI or SNRI treatment” and updated the product label for Canadians.

Perlis says that people with depression may be uncomfortable talking about their symptoms, or simply unable to schedule and keep appointments because of work or family obligations.

But cognitive behavioral therapy has been shown to reduce repeated self-harm and repeated suicide attempts, unlike SSRIs. Sure, taking a pill is easy, but dealing with the short and long-term harms of SSRIs may ultimately be worse.

Perlis says people should be able to access antidepressants without prescription because they’re capable of “self-diagnosing” their own depression, in the same way many over-the-counter products are used to treat symptoms when people diagnose their own conditions.

“Think yeast infections, acid reflux, or respiratory infections,” explained Perlis.

But this is misguided because it undermines the role of the doctor-patient relationship.

Not only will it lead to the medicalization of negative emotions, but clinical depression requires careful assessment by a doctor to exclude other serious conditions.

Self-diagnosis means that one might assume they have depression and completely miss an underlying medical syndrome — for example, low mood and anxiety, which can manifest in other conditions like hypertension, thyroid disorders or heart disease.

Missing a diagnosis can be harmful, even fatal.

I’m not a medical doctor and I don’t give medical advice, but I am a medical researcher and I have spent the last decade reading the literature on antidepressants.

Encouraging people to diagnose their own depression and buy medication without a prescription — medication which has an unfavorable benefit: harm profile in most people and is difficult to stop taking — is a very bad idea.

Originally published on Maryanne Demasi’s Substack page.

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