It is worth wading through some slow moving stuff at the start of this post to get to the juicy bits.
Drugs do things. Company marketing divides these things into the one good thing the company wants you to focus on – good for a company bottom-line and the ninety-nine other “side effects” that we are doing our best to minimize.
This issue came up in the recent Dolin case in Chicago. Its comparatively unusual for an SSRI like Paxil- Seroxat to produce an overall benefit in nervous states beyond what you can get from placebo, but in most cases it will emotionally numb to some extent and in pretty well all cases as the Court heard it will cause some genital numbness. But the label for Paxil and other SSRIs mentions nothing about either emotional or genital numbness.
There is no mention in some cases because investigators in clinical trials were told not to ask questions about certain issues – like sexual issues or non-issues on SSRIs. Aside from that, clinical trialists are hypnotized to focus on what the company wants them to focus on and to miss anything else that might be happening.
The unfortunate thing about this is that the best way to discover new drugs is to get those who are taking them to report back just exactly what the drug did for them. Sometimes they will notice an effect because its something they wanted done – in which case bing you have a new drug for something that people really need that can be got on the market because its already there or just about there.
This is how we got Viagra. People in clinical trials of a drug for angina cleared their throats and said you know what…..
This is still the best way to find new drugs. In blocking efforts to report “side effects” or take them seriously, drug companies not only jeopardize our lives and safety, they also hit their own bottom line.
The culture companies have created means that even on RxISK we slip into talking about adverse effects and side effects. This implicitly accepts company claims about the primary effects. But more importantly it does nothing to help people on treatment notice unexpected or surprising helpful effects.
I know a lot about unexpected effects but recently someone who opened my eyes to a very surprising effect. Checking with others who know a lot about unexpected effects, none of them had heard about this surprise either, which was reassuring but added to the surprise.
The person I was chatting with had been diagnosed with benign prostatic hypertrophy – BPH – something that is supposedly very common in men of a certain age – and not so common in young women. Its a pain to live with.
Thirty years ago BPH was something every doctor had to take into account when prescribing antidepressants. The tricyclic antidepressants have anticholinergic effects and it was this we were told and all textbooks said and still say that could tip an older man with BPH into urinary retention.
I never fully bought the BPH story. Much more anticholinergic drugs like procyclidine and benztropine didn’t cause urinary retention. There was too much of a sense that companies wanted to pin all the good things an antidepressant might do on their catecholamine reuptake inhibiting effects and all the bad things on their anticholinergic actions. But the patients I met said far from causing problems strong anticholinergics were euphoriants – sufficient to support a market in them, unlike anything else in mental health.
And then a colleague in her mid-twenties told me the catecholamine reuptake inhibitor, nortriptyline, she was on caused her urinary retention.
Twenty years later we got duloxetine – Cymbalta – as a bladder stabilizer. At least we did in Europe. FDA blocked the license in the USA because women with bladder instability seemed to be committing suicide when they were put on it. The dual effects in duloxetine were catecholamine reuptake inhibition for bladder stabilization and serotonin reuptake inhibition for suicide and nightmares and other effects.
Many of the drugs now used for BPH have the opposite effect on catecholamine systems to nortriptyline and duloxetine. The idea is to increase urinary flow. The market leader is called Flomax. A terrible drug my colleague said as have several other people.
He then tried finasteride but didn’t like it either.
Finally he got Cialis online and bingo everything was vastly better. Turns out within four years of Viagra coming on the market people were reporting the same thing when using it. Lilly went ahead and did trials with Cialis to prove it was helpful but they don’t market it for this purpose and almost no-one seems to know about it.
All sorts of people are now trying to work out what’s going on. There is talk of a neurotransmitter pathway that was new to me – an l-cysteine/hydrogen sulfide pathway. And there is also talk of LUTS – lower urinary tract symptoms. In other words, an enlarged prostate may be irrelevant. In older age, men can get bladder instability or overactivity. Chances are anyone who has it will also have BPH but the BPH may be irrelevant – women get LUTS too.
What is needed is some doing and on the basis of what happens we can try to explain what’s going on. My colleague couldn’t get his doctor to prescribe Cialis for him. I would happily have done so but he now has a regular supply from an online source. Its worth trying to get one of these drugs. They are relatively harmless compared to Flomax and Finasteride. And doctors can prescribe them, even though no company markets them for this purpose.
We also need a culture that believes what people report. This vignette popped up when I was trying to tell my colleague that the problem today is that no-one really listens to people who take drugs anymore. He didn’t seem to realize it was men like him taking Viagra who made this discovery – not Lilly when they did a clinical trial of Cialis.
We need more research. We need some of you to find out what might be going on in terms of other actions Viagra and Cialis and related drugs have – on hydrogen sulfide or pixie dust or whatever the latest neurotransmitter is.
But we also need people to find out what these drugs do by taking them and reporting back. The bedrock of everything that’s in the books and in any doctor’s head is what you notice when you take a drug. The books and patient information leaflets are close to worthless compared with you and any friends you may have on the same drug or your hairdresser – a great untapped source of observations about the effects of drugs that aren’t in the textbooks.
Women with bladder instability may have more to contribute than anyone else. Does Cialis or Viagra help you with LUTs? There is a lot of talk about interstitial cystitis these days but this might all need to be revised if some women with LUTs find they are helped by sildenafil, vardenafil or one of the other phosphodiesterase inhibitors.