I was listening to Pandora where I was presented with a commercial for a treatment for UC or Chron’s with death being a potential side effect. I don’t know anyone with those issues that I’m aware of so here I am. Even the common side effects are bad enough that I suspect the diseases are pretty damn bad. So you have my sincerest sympathy if you have one of those. Or any chronic condition for that matter.
I presume the chances of PML are minuscule for it to get FDA approval, but my risk averseness is prettty much pegged when death is an option.
ETA:
dammit. copy/paste broke on me. progressive multifocal leukoencephalopathy is the potential side effect.
The drug you probably heard the ad for was Tysabri (natalizumab) and because the risk is real, it’s only used when nothing else works. It was actually withdrawn from the market for a while because of that potential side effect.
Someone needs to consider all the associated risks when they are looking at treatment options, and as I understand it, any side effect found during drug trials must be made known to the public, hence the long list of issues noted when you read the fine print about a particular medication.
While the reading of that list during a TV ad can be tiresome to watch, it’s about reducing the chances of someone who is thinking about taking a drug, and who didn’t see or read the fine print, getting an unexpected surprise. Multi-focal leukoencephalopathy may have only occurred a couple of times during the many trials the drug had to go through to get FDA approval, but the drug company is still required to list it.
Last year I was on an FDA committee where we weighed whether to withhold a new treatment option from approval because of an extremely serious side effect. We decided to allow the treatment to be approved since for some children there was no other option available.
If you have it bad and are flaring up, it’s difficult to travel anywhere, even to work. Going to the beach or a concert or on a road trip are basically out. And, if your condition stays bad, you’re at much greater risk of colon cancer. If that’s caught early, it can be treated, usually by cutting out the colon, leaving you with a colostomy bag.
A lot of those biologics have really scary side effects, and some of them are for seemingly very minor conditions (Are your elbows dry? Take this, a twice monthly shot. Side effects include extra limb growth, blindness, and spontaneous combustion). Uncontrolled UC and Crohn’s are not minor conditions.
Ulcerative colitis and Crohn’s disease together are known as inflammatory bowel disease (IBD). IBD can be a very debilitating and often life-threatening disease. A few decades back I had a patient in his mid twenties who had failed all treatments available & who had it so bad he opted for total colectomy and a permanent colostomy. Afterwards he felt his life had been improved 1000% by the procedure. I’m sure he’d had jumped at the chance to try natalizumab, had it and other monoclonal antibody treatments been available then.
My wife has IBD. Fortunately it’s been responsive to less risky meds, but she nearly died from it when she came down with norovirus at the same time she was having a mild flare of the IBD.
On a side note, IBD and IBS (irritable bowel syndrome) are not the same things. The latter can be an extremely annoying, misery-causing, life-disrupting condition but it generally is not a threat to health or life.
A huge number of drugs can cause deaths, so you have to look at costs vs benefits for each drug compared to other drugs which treat a particular illness. For example are any pain relievers 100% safe? Acetaminophen and aspirin probably cause a few hundreds deaths a year while the opiates cause many thousands.
My mother’s BFF’s husband (both are deceased now) had a colectomy and permanent colostomy from the time he was 17 years old, in the late 1940s, until his death around 2000. I don’t know what disease he may have had, but it must have been horrible because, I mean, really, being 17 is the pits anyway, and then, you’re going to be living…THIS WAY? And he did, for the next >50 years. He got a college degree, got married, and had three kids, and lived an otherwise normal life. He was also one of those people who would go talk to people who were facing this surgery, and let them know that yes, it’s hard to live with, but doesn’t everyone have something?
I’ve followed a YouTuber known as Let’s Talk IBD who had a colostomy installed when she was in high school, and finally had a colectomy about 5 years ago, in her late 20s. She’s a non-practicing RN who is PREGNANT and very happy about it, and talking about all the changes she’s had to make to her routine because of her constantly-changing belly shape. She had been taking Humira and went off it when she started trying to conceive, and hasn’t really seen much difference in her condition, so maybe it’s gone into remission.
I don’t mean it to minimize psoriasis, rather that’s another disease with a ton of advertising for biologics. More that IBD can kill you and not just be a chronic condition.
Living with untreated or active IBD is incredibly unpleasant. Imagine going from feeling fine to needing to go to the bathroom so badly it is impossible to hold, in a matter of minutes. 30 seconds might be all the warning you get between the first urge and when things are coming out, ready or not.
Repeat that a dozen times per day.
On good days you feel mostly fine between episodes, but on bad days you are cramping and hurting all the time.
On confusing days you have the urge to go continuously, but usually it is a false alarm. Of course mix in some real emergencies, so you can’t just ignore the false alarms.
Anyway, taking extreme measures, such as a colonostomy or risky drugs, looks real good.
Now, the need for effective treatment is not an endorsement of drug advertising.
I couldn’t agree more, but doctors are human, and they aren’t going to know or remember all of the possible side effects of a particular drug. Listing them on TV, and including them in a written ad, increases the chances someone is going to read or hear about possible side effects. It certainly can’t hurt to do it.
I would assume that it has to be a really rare side effect for the drug to be licensed - too rare to be picked up in clinical studies. My guess is that it was noted in post-authorization monitoring. (That is to say, adverse events reported from the field once the drug goes on sale. A marketed drug usually has much more exposure than is possible in clinical trials, so this is where the rare side effects are identified.)
Yeah, I had ulcerative colitis. I was immunosupressed for five years - and I was one of the lucky ones (!). Mercaptopurine - which I was on - has some pretty horrible side effects, but my view was that I had no option (see descriptions of the symptoms above). In a coincidence so bizarre that I will blame nobody for simply disbelieving it, during the period I was being treated I was also professionally involved in safety monitoring of mercaptopurine, and thus gifted specialist information which, if I had the choice, I would have preferred not to know about. It led to some interesting conversations with my doctor.
j
ETA - in remission for more than 10 years now. My five years of immunosupression finished shortly before COVID hit.
Progressive Multifocal Leukoencephalopathy (PML) occurred in three patients who received TYSABRIin clinical trials [see Warnings and Precautions (5.1)]. Two cases of PML were observed in the 1869 patients with multiple sclerosis who were treated for a median of 120 weeks. These two patients had received TYSABRI in addition to interferon beta-1a [see Warnings and Precautions (5.1)]. The third case occurred after eight doses in one of the 1043 patients with Crohn’s disease who were evaluated for PML. In the postmarketing setting, additional cases of PML have been reported in TYSABRI-treated multiple sclerosis and Crohn’s disease patients who were not receiving concomitant immunomodulatory therapy.
[so: ~0.10%] [NB: I couldn’t math (!)]
Advise the patient that TYSABRI is only available through a restricted program called the TOUCH® Prescribing Program {…}