When Prozac first came out, Lilly(?) made claims that sexual side effects occurred in, I believe, 2% of the testing pool. They may have upgraded it since, but sure as not to the near 100% rate I have experienced among my fellow depressed compadres. Now I can dig on observer error and all, but…C’mon! Do the drug companies
Believe their test are representative and are just plain wrong
Are they’re threshold scales completely out of whack
Do they intentionally downgrade side effects for benefit of sales.
And before you vote this one, please think. Is this just observer error on a grand scale?
How many prozac-taking, depressed compadres do you have? What is their age distribution? What other medications do they take and what sort of psychotherapy do they partake in (if any?) It takes, at the very least, a thousand random individuals to get good sample data. Consider that most of your friends are probably similar to you (age/health-wise) and chalk it up to being a kowinkidink.
Most pre-marketing clinical trials are designed to test and prove that a drug is effective. Side effects are monitored for but it makes a big difference whether the companies actively seek them out or merely monitor. So, if participants in the study are explicitly asked, “is your tongue turning green” they’ll get a different frequency of responses than if they depended on the patients to volunteer their side effects, and even to identify them as side effects in the first place.
Critically, most pre-marketing studies are done in controlled conditions which are very much unlike the real world. In real life, the side effect profile is often different (people are on other medicines, and have other illnesses). This is why post-marketing surveillance is so critical to detect side effects. Indeed, there are seldom enough patients enroled in pre-marketing studies to have a good chance of detecting the less common side effects. So, for example if the actual likelihood of a particular side effect is one in a hundred, but only two hundred people were studied, there’d be a good chance that the side effect did not appear, just by random chance. Post-marketing studies, with their huge numbers, tend to avoid this.
This is especially crtitical for rare and serious side effects. If the actual chance of side effect X is one in a thousand, you need to study three thousand patients to have a 95 percent chance of picking it up (I think).
Friedo,
I would say i know roughly 50 people personally who are taking, or who have taken prozac or similar SSRI. Every single person said it dramatically affected their sex drive. Now, I’m no t-tester, but even given your cogent remark about my friends and i probably being similar psychographically, that is still far too many in that pool to be chance. BTW if you look at forums on depression (FUN! I know) most people will tell you it drastically affects sex drive.
There is also a psychoogical effect. I mean, if someone is prescribed Prozac and they read that it has potential sexual side effects then there is a chance they either a) start to have the side effects because of the medication; b) give themselves the side effects by convincing themselves they have them; c) don’t even really have the side effect but just imagine they do; or d) have the side effect but unrelated to the medication.
I used to work for a small pharmaceutical firm. I was at the very bottom of the org chart, a mere underpaid clerical drudge but I noticed some things. I’ve also participated in a few clinical trails. Please don’t imagine what I’m about to describe is universal.
When you participate in a “human clinical trial” sometimes you get a little booklet and you write down how you are feeling every day. Everything in those little booklets had to be taken very, very seriously. One person wrote in their book that her car was stolen. We had to report to the FDA that in a statistically insignificant number of patients, the drug caused your car to be stolen. I’m not kidding.
Some doctors are good and tell their patients to write down only things they think are related to the drug. Some doctors don’t tell their patients anything, and they write everything or nothing as their fancy takes them. There are some ailments people are willing to talk about. Have you ever noticed that just about ever drug’s #1 side effect is headache? I’m guessing that people are willing to mention a headache, but are not willing to talk about a severely declined sex drive.
I don’t know whether to advocate for more and more through testing, or brush it off as a small price to pay for not having a serious depression get out of control.
“I would say i know roughly 50 people personally who are taking, or who have taken prozac or similar SSRI. Every single person said it dramatically affected their sex drive.”
Am I missing something here? One of the major symptoms of depression is diminished libido. If you are depressed and you take Prozac and it works, then your libido will increase. This is not called a side effect. This is called effective treatment.
Entirely true, and very frustrating. Anything that happens to a Clinical Trial Participant is to be recorded and reported. One is never sure what may or may not be an adverse event. The patient’s car was stolen… Why was the patient’s car stolen? Was it because they had a nice car? Or was it because they left the keys in the ignition due to a lack of attention caused by the trial medication? What if the patient gets hit by a truck while crossing the street? Same story: Maybe it was just bad luck, or maybe the patient was hit by the truck because of some bizarre side effect reduced his ability to hear it coming, or impaired his judgement, or reduced his peripheral vision… You get the point.
It’s really hard to get Investigators (physicians administering the trial) to understand this, and as noted by TDG, some don’t properly inform the participants, nor collect all necessary data. Informed Consent is a critical item in Good Clinical Practice (for an example of why it’s so important, note what happened at Johns Hopkins University recently!), and investigators that fail to follow GCP are a threat to their patients and the public. Unfortuantely, it’s hard to weed out the marginal cases. The obvious ones are noted and discontinued immediately, but the subtle ones, the ones who fail to report seemingly inconsequential information, are a b!tch to locate. The FDA keeps a list of poor performing investigators, and if your clinical trial uses an investigator from the black-list, you’d best be prepaired to explain why, as they dig into your trial submission with a microscope!
I have a medical condition that has caused me to need quite a lot of perscription medication. I have been amused to find that sometimes the potential side effects of a particular medication are the same as the symptoms that the medication is supposed to be treating!
The prozac sexual side effect underestimate was widely regarded as a big embarrassing snafu in the clinical trial system. The accepted number now is that around 50% of patients on SSRIs will have a loss of sexual function. (I don’t think the FDA has revised the official numbers, tho.) Researchers who looked at what went wrong generally came to the conclusion that the problem was patients’ reluctance to spontaneously mention sexual problems. Also, depressed patients are much less likely to notice a loss in sexual performance until they are much better, and clinical trials looking for side effects are usually relatively short.
It’s okay if people are overreporting unrelated symptoms, because theoretically patients on placebo should report a comparable number of unrelated symptoms. So if people on a drug have a statistically significant difference a given effect only then would it be something that becomes an “official” side effect of the drug. (One person having their car stolen couldn’t possibly be statistically significant).
I agree the lack post-marketing surveillance for drug side effects is the biggest failure of the system. I also think clinical trials for safety and side effects should include long-term (one year+) studies for any drug that will be approved for long-term use.
Sorry Yeah, but it ain’t always that simple. I was definitely depressed, but functioning okay sexually.
I took Prozac and within a week I couldnt get an erection. I still wanted to have sex, but I couldn’t even masturbate. I found this VERY weird. I mean I don’t want to share too much information, but it was like a dear friend whose presence brought me daily joy suddenly vanished. And boy, did I miss that friend. And so did my friends!
All the odd effects of psychogenic (izzat right?) medications are frequently dismissed as trivial by people who don’t have to take them and who think they never will have to take them. But they are NOT trivial. They can be very unsettling and have the ability to significantly mar the effectiveness of the medication.
I hope you never have to earn this knowledge through experience dear Yeah
