Biologics linked to 34,000 deaths

This article was published last year, but I just found it last night after Googling "Humira and congestive heart failure" since my GI just ordered an Echo test to rule that out. I'm sure I don't have it, but it still freaked me out. And this article freaked me out as well. I know many of us don't really have many options other than biologics though, so what do you do.

https://www.jsonline.com/story/news/investigations/2019/05/30/arthritis-psoriasis-drugs-darker-aspect-34-000-reports-deaths/1206103001/

I know, sorry to be a downer. I debated even posting it and maybe I shouldn't have.

I try not to lol at stuff like that. Or eve read through the lists of possible side effects. Because I know that I’m easily influenced into worrying and subtly influenced into over- magnification of symptoms and side effects.

I mean look at it this way — what are the statistics for how many people die in car crashes every year? But we still drive or ride in cars. Statistics will drive you crazy and sometimes we’re just better off not knowing right? This disease if left untreated can kill us too.

I'm glad you posted it, I've been thinking about biologics this morning and wondering what treatment was like even 50 years ago, they didn't have all these drugs, did they just do nothing? I am thinking about it because the longer it gets from my last infusion of Entyvio the better I feel. I spent a year and a half with horribly debilitating body pain, like have the flu all the time. When I told doctors about it they diagnosed me (without any tests I might add) with everything from fibro to depression, and gave me all sorts of prescriptions. If I'd taken any of them I'd likely be a totally drugged out zombie at this point. I am supposed to be switching to Stelara but wondering if I'd actually be better off without it. My symptoms are consistently mild to moderate. If I am continuing to see the GI and get annual colonoscopies then I think the risk profile of no meds may be less than than with yet another biologic. I have reacted badly to every single drug and I am kind of feeling maybe that is not the answer for me.

“Linked to“ is doing a lot of work in that Clickbait headline. How many of those had other serious medical conditions that could have caused their actual deaths?

Then they go on to explain the 34,000 “linked to” deaths were since 2004 which comes to about 2,000 deaths a year that it is “linked to”

One of the leading causes of deaths is medical errors and that is 250,000+ deaths A YEAR. Which comes out to 4,000,000 deaths since 2004.

Biologicals are VERY safe medications when properly used.

poopydoop said...
Here is a paper published in 1956, the title is
EXPERIENCES WITH PREFRONTAL LOBOTOMY FOR INTRACTABLE ULCERATIVE COLITIS
https://jamanetwork.com/journals/jama/article-abstract/304807

At least 3 out of 5 went into remission. The other two died. One ate too much and had a bowel obstruction and the other one had a colectomy regardless and died of an infection. WOW

iPoop said...


Regarding the 1st article, immunosuppression whether through thiopurines or biologics does increase our risk of serious infections. It is unfortunate the article does lack odds of such events. It's roughly 40 per 10,000 treated patients (or 0.4%) having serious infections as a result of these meds, whereas 99.6% do not have any issues with those infections.

Define serious infections? The Flu? It’s a common but serious infection that killed 61,000 and infected 45,000,000 Americans in the 2017-2018 flu season. I’ll grant that Sepsis was caused by Remicade but the likelihood of that happening is remote (until you get it yourself) but these medications do much more good than they do harm and the headline for this article is recklessly irresponsible.

By the way, before I started Humira I asked my GI about the fungal infection risk that the lady died from - it was listed on the possible side-effects paperwork. He said that I was his only patient who ever asked him about it (probably in 2012). Patients need to take responsibility and make better and more informed decisions.

sevodreams said...
I wonder if entyvio is safer since it’s gut specific?

I wondered that, too.

IamCurious: Aww, thank you! I agree with you in feeling like the risks are downplayed at times. I'm taking biologics now but I'm still very worried about them, and I had a terrible experience on Imuran, Remicade only worked for 9 weeks, and Humira hasn't worked at all, so I'm not a huge fan so far. I'll probably try another one, but I still like to research a lot and know what I'm getting myself into.

Andrina said...

poopydoop said...
Here is a paper published in 1956, the title is
EXPERIENCES WITH PREFRONTAL LOBOTOMY FOR INTRACTABLE ULCERATIVE COLITIS
https://jamanetwork.com/journals/jama/article-abstract/304807

At least 3 out of 5 went into remission. The other two died. One ate too much and had a bowel obstruction and the other one had a colectomy regardless and died of an infection. WOW

That's crazy that was only about 60 years ago!

(Why is IAC constantly permitted to denigrate the terrific Mods we have here? )

Biologics have been a game changer in the treatment of IBD. Some people don't respond, and a small few have adverse events.

ks1905 said...
“Linked to“ is doing a lot of work in that Clickbait headline. How many of those had other serious medical conditions that could have caused their actual deaths?

Then they go on to explain the 34,000 “linked to” deaths were since 2004 which comes to about 2,000 deaths a year that it is “linked to”

One of the leading causes of deaths is medical errors and that is 250,000+ deaths A YEAR. Which comes out to 4,000,000 deaths since 2004.

Biologicals are VERY safe medications when properly used.

As a former journalist myself, I found the reporting in this article to be solid and I found the headline to be accurate and not "clickbait." This is a widely-respected newspaper, not some online blog or other such garbage. I wouldn't have shared it if I didn't think it was solid reporting.

Your math's a tad off since the article was written in 2019. I don't think they are counting the flu as a serious infection, but I haven't had a chance to really dig into it. And yes, medical errors account for a huge number of deaths each year. I don't really see your point. That doesn't mean biologics can't also be unsafe, even if there are fewer deaths than from medical errors. I've never heard of people dying from mesalamines, but you aren't comparing those. I wonder how many people commenting on this post actually read the entire article.

I see where you're coming from. The article wasn't about the benefits (though it did mention more than helping elbow skin...). The drug companies shove the benefits down our throats as it is.

This is basically the lede, several paragraphs in (the gist of the article):

"The drugs are effective in treating rheumatoid arthritis, psoriasis and other autoimmune disorders. They often lead to significant improvement in symptoms, even remission.

But there is a darker aspect to the drugs that is less known to the public: They leave patients more susceptible to a growing number of infections and other serious side effects."


And more than the 34,000 deaths, there were over a million "adverse events." If you don't think any of this matters, that's fine, but it seems significant to me. Maybe I'm not right, I haven't done extensive research into biologics, but I do know taking a medication that hasn't been around all that long with a bold black warning about causing lymphoma and leukemia and serious infections scares me.


"More than 1 million “adverse events” were reported in people using the drugs during that time, including nearly 500,000 that were deemed serious, the investigation found.

The FDA defines an adverse event as any undesirable experience associated with a medical product. To be considered serious, the situation must involve death, disability, hospitalization, permanent damage or a life-threatening issue. The FDA’s database, though, does not verify any cause-and-effect relationship between the drug and what happened.

While the drugs make up only a small slice of the $450 billion-plus prescription drug industry — they were on pace for about $45 billion last year — they have an outsized effect.

Among all prescription drugs over the last 15 years, the biologics Humira and Enbrel are the most-cited in the FDA’s database, the Journal Sentinel review found.

Humira was linked to 169,000 reported serious adverse events and 13,000 reports of deaths, followed by Enbrel with 135,000 serious events and 8,000 deaths. Yet neither is among the top 20 prescribed medications in America, according to IQVIA data.

“Those numbers are important,” said Steven Woloshin, a professor of medicine at Dartmouth Geisel School of Medicine. “It certainly is a signal that can’t be ignored.”

Remicade, the drug Tschannen was taking, had 98,000 reports of serious adverse events, including 6,000 reports of deaths, the analysis found."


Edit to add this from the article: "The most recent numbers, based on a 2005 Government Accountability Office report, estimate the system captures 10% or less of all adverse events."

Perhaps the more important thing to consider is why are most of the treatments for U.C. just band-aids? Instead of getting to the cause of the inflammation, biologics just inhibit your immune system, which of course leaves you susceptible to infections and cancer.
It's pretty obvious that the reason most research focuses on biologics is because of the obscene profits they can bring. Meanwhile the search for a cure languishes.