Adverse Events Need A Human Touch

One of the most dramatic moments in the annals of adverse events was when in 2008 Audrey Bahrick, a psychologist linked to the U of Iowa, contacted her senator, Senator Chuck Grassley, telling him about Post SSRI Sexual Dysfunction (PSSD) and asking him to alert FDA to the problem in the hope that something could be done to ensure not too many people were affected.  He did as she asked.

The Full Correspondence is here.  I’ve cited the outcome again and again. Steven Masson for FDA replied – his bottom line was:

It is not possible for FDA in any individual case to determine if the discontinued SSRI, the underlying disorder, or some other unknown factor is responsible for causing sexual dysfunction.

I’ve made the point again and again that the primary reason why FDA cannot determine if the discontinued SSRI, the underlying disorder, or some other factor is responsible for causing PSSD in any person suffering with PSSD is because they do not have the names of individuals whom they can interview nor anyone who can interview the named sufferers – See The Black Hole of Modernity.

If a doctor working for FDA or a company interviewed the woman who first reported her PSSD to me in the late 1990s and heard her say she had been off Citalopram for 3 months and could take a hard-bristled brush and rub it up and down her genitals and feel nothing, given that SSRIs do this to many people when on them and there is no other medical explanation for this, it would have been instantly clear that PSSD should be included in the drug label.

In 2018 when filing a Petition with FDA to get PSSD recognized, we offered them the names and contact details of over 80 people who had reported the problem to RxISK and were willing to be contacted and over 30 doctors who had written letters saying they could not see any cause for this disorder other than the SSRI. FDA declined our offer.

Eight years later we are still waiting for a response.  We had word several years ago that FDA had all but decided to reject the petition. But something stayed their hand.  What none of us knew until two weeks ago was the Modern Act was taking shape – was this a factor in the stay of execution?  Perhaps.  See The Black Hole of Modernity.

I was somewhat discombobulated a while ago to hear MHRA claim they followed up some adverse event reports. But that was okay. I rarely believe anything coming from MHRA.  I was a lot more discombobulated to hear FDA had been following PSSD sufferers up in early 2025 – although this seemed to grind to a halt.

What might have been going on became clear two weeks ago (by accident) and is informative. Several of those apparently ‘interviewed’ were approached rather than interviewed if by interviewed you mean listening to and engaging with the person and the issue. None have described the contact as pleasant, informative or open-ended.

The questions you see below are the questions several people agree were what they were asked. One person in a rush asked for the questions to be emailed.  This point is important not because it confirms the accuracy of the questions but because it confirms their invariance.

Dr C. I presume

They all report being contacted by a Dr C – someone who, while having their name, did not give his name.  He began as follows.

I am a psychiatric pharmacist and safety evaluator at the Food and Drug Administration (FDA) in the Division of Pharmacovigilance. I review postmarketing adverse event reports associated with SSRIs. We received your report in which you described …. I would appreciate if you could answer the following questions:

Sexual history:

• How frequently do you engage in masturbation?
• Do your sexual problems persist during masturbation, or only during partnered intercourse?

Symptoms:

• You mentioned in your report that the symptoms of sexual dysfunction emerged “almost immediately.” What was the pattern in which the symptoms emerged? E.g., did all the symptoms begin at once, or did you notice some symptoms first before others? Did symptoms emerge at the same severity?
• Had you ever experienced any symptoms of sexual dysfunction prior to taking X
• Were there any significant life events occurring during or around the time when you first noticed these symptoms?
• How would you describe your mental health in the period after you stopped taking X?
• Do you have trouble getting in the mood for sexual activity (libido)
• Do you have difficulty achieving an erection/vaginal lubrication for sexual activity?
• Do you have difficulty maintaining an erection/ vaginal lubrication during sexual activity?
• Do you experience discomfort/pain during sexual activity?
• Do you experience headaches during sexual activity?
• Where is the genital numbness located? For example, is it strictly genital – if so which part – or does it involve any other areas on your body?
• Are the area(s) insensitive to pressure? That is, unable to feel anything by touch.
• Are the area(s) insensitive to temperature? That is, unable to feel any change in temperature, like warmth or cold.
• Are the area(s) insensitive to pain? That is, unable to detect painful stimulation, like a pinch or poke.
• Are the area(s) accompanied by any type of pain? For example, electric shock or tingling pains.
• Did you experience any other side effects when you took X?  .
• How have your symptoms changed over time? E.g., have they worsened, improved, stayed about the same, or waxed and waned
• How have these symptoms impacted your intimate relationship(s)?

Medical history:

• What is your height?
• What physical health problems have you been diagnosed with in the past? For example, high blood pressure, high cholesterol, diabetes, damage to the spine.  .
• What mental health problems have you been diagnosed with in the past? For example, depression, bipolar disorder, borderline personality disorder, anxiety.
• Do you currently or have you ever engaged in self-injurious behavior? Do you currently or have you ever had thoughts of suicide?
• What surgical procedures have you experienced in the past?
• What sexual problems have you been diagnosed with by a licensed medical professional in the past?
• What treatment have you received for sexual problems? For example, use of medications, psychotherapy, or other techniques.
• How much alcohol do you consume in a month?
• Have you ever smoked tobacco? If so, how much and for how long
• Have you ever used or currently use any other recreational drugs? For example, marijuana/cannabis, opiates, amphetamines, cocaine.
• Does your doctor attribute your current sexual problems to X?
• What urological or gynecological examinations have you received? (That is, procedures or tests performed by specialist in urinary and reproductive health problems.).
• Do you experience any difficulty walking or standing?
• Do you have a history of any events in your life that you would call traumatic?
• Do you have a history of sexual trauma, occurring during childhood or adulthood?
• What prescription medications do you currently take? Include all forms of medications, including pills, creams/ointments, injections, etc.
• What over the counter medications do you currently take? For example, acetaminophen (Tylenol) as needed for pain.
• What herbal or supplement medications do you currently take? For example, multivitamins.

PHQ‐2 and GAD‐2

Over the last 2 weeks, how often have you been bothered by the following problems?

• Little interest or pleasure in doing things: Not at all, Several Days, More than half the days, or Nearly every day?
• Feeling down, depressed, or hopeless: Not at all, Several Days, More than half the days, or Nearly every day?
• Feeling nervous, anxious or on edge: Not at all, Several Days, More than half the days, or Nearly every day?
• Not being able to stop or control worrying: Not at all, Several Days, More than half the days, or Nearly every day?

Feel free to include any additional information or records that you think would be helpful. Thank you for your time and for submitting your report to the FDA.

Dr. C.

Safety Evaluator, Division of Pharmacovigilance-I
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Dr C.

Dr C. is Joseph Cusimano, PharmD, BCPP.  The link in his name gives you his photograph and a non-interview in which he claims

“As a safety evaluator, I’m like a public health detective,” he said. “I search for undiscovered adverse reactions to FDA-approved drugs in my area of expertise. I review adverse event reports and medical literature to identify new safety signals, build case series with affected patients, and recommend regulatory action when needed.”

PSSD – Undiscovered?

His area of Expertise?  He is not being given a chance to exercise Expertise.  He is given a rigid formula that looks pretty well designed to throw up a load of details that make it impossible for Joe or a committee of Joes to ever decide we can say for sure that stopping SSRIs is linked to enduring sexual dysfunction.

There is no opening for Joe to be asked – what do you make of being able to rub a hard bristled brush up and down your genitals and feel nothing?

There is no opening for Joe to be asked – why do you not believe me? Along with the Black Hole of Modernity follow up questions.

The following point might seem petty – but this petty point is something FDA and Industry trade on. Joe doesn’t have standing here.  He is a PharmD. Not a medical doctor.

Judges routinely throw out expert reports on drug effects written by clinical psychologists or other professionals, who are well qualified when they see a patient in therapy fall asleep before them to offer a view they may be over-sedated.

The semi-legal thinking here is that offering views like this would be an illegal practice of medicine.  Putting it slightly differently – this is the professional correlate of lived experience expertise. If you don’t have the experience born of having to take a risk on living or dying (someone else living or dying) on the basis of your judgement calls, your views about things are not much better than day-dreams.  This professional lived experience, not that of anyone who has PSSD, is what counts.

Judges are looking after themselves here – they think their experience of having to make decisions in court (with consequences for other people) trumps everything else.

Doctors end up thinking they are good people – because they have witnessed so much suffering – the suffering of others!

Apologies to Joe if he feels put out by or badly treated by these points.  They allow me, however, to recombobulate. I was strictly speaking right to say FDA or MHRA or EMA do not have any doctors able to interview patients and make decisions.

Why wouldn’t FDA have doctors able to do this?  You have to realise FDA, EMA, MHRA etc are bureaucracies. There is no way, this side of Doomsday, bureaucrats are going to take a chance on letting a doctor on her own interview a patient and decide the only way to explain what’s happening is the drug has caused it. End of Story.  Industry know this all too well.

The crowd that should but don’t know it have been steadily morally compromised (like a slowly boiled lobster) because they don’t know it, and who don’t realize the power they have to change things – are doctors.   See Narcissistic Doctor Disorder.