"The Cost Of Doing Business"
October 1, 2015 11:57 AM   Subscribe

 
"redesign to withstand the next decade."
a.k.a. burying the lede deeper than the graves at Hart Island.
If you found it totally TLDR, it's about how Risperdol, the drug intended to replace the off-patent Haldol as a revenue source, went very wrong, over-prescribed and unsafe for many. Like much of HuffPo, there are boobies, but in this case, on a little boy.
posted by oneswellfoop at 12:12 PM on October 1, 2015 [9 favorites]


Argh, my usual goto when websites try to distract me from reading their article is to turn off javascript (I'm looking at you, Guardian). In this instance no javascript means reading a blank page.
posted by Dmenet at 12:25 PM on October 1, 2015 [6 favorites]


But the world in which Johnson & Johnson thrives today seems to have corroded the credo.

This is a really weird way to phrase this; Johnson & Johnson aren't responsible, it's the modern world! It corroded the credo like the credo was an old iron fishing boat sitting in the harbor for a long time and the modern world was the briny deep just eating away at the noble and valiant credo corroding it until it was no longer seaworthy. This does not appear to me to be great writing.
posted by Mrs. Pterodactyl at 12:28 PM on October 1, 2015 [4 favorites]


Ads for many of these [high-margin medical devices and still higher-margin prescription drugs] dominate our television screens and magazine pages.

"Our screens and pages" means for those in the United States and New Zealand. Everywhere else, there is no Direct-to-Consumer advertising for medical stuff, it's the less lucrative marketing to doctors (NPR, Oct. 2009 - Selling Sickness: How Drug Ads Changed Health Care).
posted by filthy light thief at 12:31 PM on October 1, 2015


Assumed this was going to be about Edward Snowden above the fold.
posted by Going To Maine at 12:31 PM on October 1, 2015


Evil. Absolute, horrifying evil.

J&J: How about if we prescribe it for children?
FDA: No.
[J&J urges doctors to prescribe it for children]
J&J: Hey, how about we prescribe it for the elderly?
FDA: No.
[J&J urges doctors to prescribe it for the elderly]
J&J: What if we just ruin untold lives? Can we do that? It would really help our shareholders.
FDA: This drug is appropriate in an incredibly tiny percentage of cases. Stop handing it out like candy.
[J&J hands it out like candy.]
posted by a fiendish thingy at 12:42 PM on October 1, 2015 [4 favorites]


Oh god. I had to stop reading once it became obvious what this was about. I was briefly prescribed Risperdal as a kid off-label for severe social anxiety, and it fucked. my. shit. up. I gained a massive amount of weight, which, as it turns out, does not alleviate adolescent anxiety in any way, the sedative effects made my already lackluster and withdrawn performance at school even worse, and it had lasting metabolic effects that it took until my late 20s and a punishing exercise regimen to start to shake off.

A few years back, I checked out the psychiatrist who'd written the prescription with an online tool (I wish I remembered which one) showing the marketing $ various drug manufacturers had spent on a per-doctor basis, and big surprise, he was on the take to an astonishing degree (though apparently within the ethically proscribed limit for the profession). I literally didn't know that safer anti-anxiety drugs existed until I was 27 and had already more or less dropped out of life.

Long story short, this is why I'll never be a libertarian. Johnson & Johnson should be regulated to within an inch of its corporate life with a big spiked bat.
posted by Merzbau at 12:55 PM on October 1, 2015 [30 favorites]


The opening up of television drug advertising direct to consumers is probably one of the ten worst governance decisions of my lifetime, IMNSHO. I happen to be a leftie of the free speech bent such that I think Citizens United was probably the right decision, even if I dislike the upshot. But I cannot see a way that advertising prescription drugs straight to people who cannot make the independent decision to buy them is a good thing. Maybe we'd have coped with it if our health care system wasn't such a fuster cluck, but as it is it sure made up a component of the perfect storm of garbage that is our skyrocketing health insurance costs.
posted by phearlez at 1:03 PM on October 1, 2015 [3 favorites]


This is a really weird way to phrase this; Johnson & Johnson aren't responsible, it's the modern world!

The article couldn't be any clearer that Johnson & Johnson is responsible. However, it's also about how the entire pharmaceutical industry is getting away with a lot of the same stuff, and how there's never any meaningful punishment, and how Wall Street investors acknowledge that the companies they invest in are doing horrible evil things and they're totally fine with it as long as it's accounted for so it doesn't hurt the bottom line much. ("Oh, they've already reserved for [the settlement they'll have to pay for doing something illegal and immoral].")

That the people at Johnson & Johnson (or, apparently, every other big pharmaceutical company) would callously disregard the law while intentionally harming people and specifically targeting children and the elderly is unconscionable, and every person who participated in these programs should be punished severely. However, they won't be, and also the fact that there's no punishment is immune to change because of the interplay between big money and government. The article wants both the horrific evil of J&J and the horrific evil of those who allow and bolster and refuse to punish their actions to be clear.
posted by IAmUnaware at 1:17 PM on October 1, 2015 [1 favorite]


I maintain medical records for long term care and skilled nursing facilities for a living. Ninety percent or so of the residents I do records for are above retirement age. If I add or remove Risperdal to or from a resident's chart only a dozen times a day, that's a remarkably slow day. I'm talking currently. So while the article seems to be phrasing everything in the past tense, J&J didn't get away with this. They are getting away with this currently.
posted by Caduceus at 1:32 PM on October 1, 2015 [5 favorites]


Caduceus, now that Risperdal is generic, it's not just J&J getting away with it (unless you SNF is buying the brand name product, which would be weird, but not unprecedented).
posted by Hactar at 2:37 PM on October 1, 2015


Yes, it's still happening. I was prescribed Risperdal as a kid for a short period too; it would've been around the time period Brill wrote about. In my opinion it was a form of child abuse. We're giving this stuff to foster kids for behavior problems. Also child abuse. It's prescribed to control elderly people in nursing homes, despite the drug having a black box warning indicating increased risk of death in exactly that population. In 2015, after all the evidence and all the lawsuits, any physician who still prescribes the stuff on a regular basis or lets drug representatives from the major antipsychotic makers into their offices no longer merits the title "doctor".

A few months ago I wrote a very angry letter to the quack who prescribed it. No word back. I also looked her up in the open payments database, and as of 2014, she was still accepting lunches from drug reps to hawk their poisons. The drug they'd promoted most? Invega Sustenna. Invega, for those who don't know, is Janssen's brand name for paliperidone — it's the primary active metabolite of risperidone (Risperdal). The new drug appears to be functionally equivalent to the old one except that a new compound means a new patent-protected monopoly. And the Sustenna part? They got approval for a monthly injectable form, which means an even longer period of patent protection. So I expect 10-15 years from now we'll be hearing how they did it again with a slightly different compound. The entire market for psychiatric pharmaceuticals is a goddamn criminal enterprise.
posted by Wemmick at 2:42 PM on October 1, 2015 [3 favorites]


"Beginning in 1995, Janssen executives focused on a quick-win priority: make Risperdal the new drug of choice at state-run Medicaid programs that provide healthcare for the poor, including children in state-run mental health facilities and the elderly in state-run nursing homes. Promoting the drug quietly to institutions, rather than broadly to thousands of individual doctors, was more efficient—and less likely to arouse the suspicions of the FDA."

Simply evil.
posted by lookoutbelow at 3:27 PM on October 1, 2015 [1 favorite]


I apologize, because this is long and rambling (because nuanced positive reviews are almost always harder than negative ones), and because my profile is new enough that I feel I run the risk of being dismissed as a Big Pharma shrill. And I'll flat-out confess to not RTFA, because I got tired of rolling my eyes.

I was also proscribed Risperdal as a child in the 1990s. It was, arguably, one of the best things that's ever happened to me.

I still remember, a week or so after starting on Risperdal, sitting at home reading and realizing with a start that I wasn't just bored. I was lonely. It was weird and novel and honestly fucked me up beyond belief for years.

Apart from that, it's hard for me to describe the effects. I started on it literally over half a lifetime ago, and -- this far out -- it's difficult to distinguish the effects of being on the drug from the effects of going through adolescence. (Ditto for some of the side effects. Exhaustion? I feel like being a teenager is being in a state of sleep deprivation. I totally lactated, though. Not much, but a little. I'm female, but it was still weird.)

What I can point to are the effects of going off of Risperdal.

Pretty close to a decade after I started taking the drug, I started to develop extrapyramidal symptoms. I switched from Risperdal to another class of drug entirely, with another set of side effects that sounds horrific to outsiders. I lost all the weight I'd gained on the atypicals and then some. The EPS abated. I still occasionally get an muscle twitch when I'm tired, and my teeth sometimes chatter even when I'm not really cold. I suspect both are permanent.

And yet -- going off Risperdal was like having a selective stroke. I lost the ability to pick up on the social cues I'd started to recognize unconsciously. (I wasn't even aware I'd gained half of them until I went off of it.) I stopped being able to look people in the eye when I spoke. I started to not be able to catch myself when I rambled. I stopped feeling lonely. I started to get overstimulated way more easily. I lost the ability to be angry without feeling rage. (I used to be able to get into online debates. Now, I have to walk away from the screen.)

I've recovered most of those skills, or at least learned to mitigate them. I've taught myself to equate boredom with loneliness. (I'm enough of an extrovert that I'm usually right.) I've learned to catch myself when I go on tangents, at least sometimes. I've returned to reading facial expressions and body language consciously.

I still can't look people in the eye.

And maybe some people might not mind these things. Who needs to look someone in the eye? Who cares what other people think about me? Who cares about being normal? Even on the atypicals, the amount of cognitive effort I put into social interactions was huge.

On the other hand, though, I'm an extrovert, and I'm female. If I need to learn social skills to fit in (and because I'm female, I have to learn twice as many as a man on the spectrum and practice them twice as well), I learn social skills, even if that means I spend my weekends memorizing Emily Post. Being able to pass as neurotypical - even if a somewhat odd one - opens tons of doors, and - at least for me - the trade-off is worth it.

So, yeah. I'm sure that Johnson & Johnson did some illegal stuff with the drug. (There's nuances the article missed, of course. A *ton* of drugs are used for off-label purposes, but that's another story.) I'm sure that there are tons of people it hurt.

That said, if there's anything this article has reminded me to do, it's to track down whoever headed the team that developed Risperdal and send them a thank-you note. Because, like I said, they literally changed my life.
posted by steady-state strawberry at 4:51 PM on October 1, 2015 [3 favorites]


In 2015, after all the evidence and all the lawsuits, any physician who still prescribes the stuff on a regular basis or lets drug representatives from the major antipsychotic makers into their offices no longer merits the title "doctor".

I'm not a medical professional and by no means up on the very latest research but as far as I can tell the severity of side effects of risperdone is not that much an outlier among antipsychotics. But, as with a number of the "atypical"/second-generation antipsychotics it turns out not to improve much on the first generation. J&J is accused of minimizing the extent to which it is not an improvement - hyperprolactinemia in particular is a significant side effect of several first generation drugs but only of risperdone among the second generation - and of pushing all sorts of uses of its supposedly kinder, gentler drug.
posted by atoxyl at 6:00 PM on October 1, 2015


I am still working my way through all the articles. (They could have benefited from tighter editing - I love me some litigation minutiae and whistle-blower tales, but this sprawls.) I don't think the article is saying that Risperdal is completely without merit and doesn't help patients. Clearly, it does. But should pharmaceutical companies push the off-label prescriptions for the most vulnerable patients who can't advocate for themselves? Medicine is not my field, so as a layperson when I think of off-label use I assume it's an outlier case - the patient has tried other, tested treatments without success and the prescribing doctor has thoroughly reviewed the published studies. Sort of like - the doctor's privilege to find a solution for the patient. I don't think most people want off-label usage to be an end run by J&J, Merck, Lilly, etc, on the FDA saying, "Wow, no, your data is not showing what you want it to show and there's too great a risk of harm to patients."
posted by stowaway at 10:47 PM on October 1, 2015


So, yeah. I'm sure that Johnson & Johnson did some illegal stuff with the drug. (There's nuances the article missed, of course. A *ton* of drugs are used for off-label purposes, but that's another story.) I'm sure that there are tons of people it hurt.

steady-state strawberry, I'm thrilled that the medication was so positive for you. You are one of the people it was made for. The improvements you experienced in your quality of life were real, and tangible, and they were the result of the drug being used in its proper application. No one here is saying that the drug should not exist, or that it did not work when properly prescribed.

I didn't mention it above, but my brother was prescribed Risperdal for a short period, and our family is still feeling the aftershocks. He gained weight which added to the horribly bullying he experienced at school (another reason I have no patience with metafilter's "calories in calories out!!!" crew). He developed incredibly severe OCD (a symptom he had never exhibited before) which mostly took the form of constant, unstoppable, trichotillomania. In the years since, subsequent doctors have expressed horror that he was ever prescribed this medication, because its effects are so incredibly destructive when it is prescribed off-label.

Prescribing off-label often ranges from mostly harmless to very useful. I take an anti-anxiety medication that began its life as an antihistamine. Dudes who enjoy Viagra are delighted at the accidental effects of what was originally a blood pressure medication.

I am genuinely happy Risperdal made your life better, but your conclusion that the illegal actions taken by J&J to make sure it made millions of lives worse so that they could make a profit is a pretty blithe dismissal of the actual content of the article. I mean, thank goodness for chemotherapy, when it is prescribed to people who have cancer. But it is just poison when it is prescribed to anyone else, which is why that oncologist who decided to make a profit by treating patients without cancer with aggressive chemo regimes has been accused of actual crimes. J&J basically did a similar thing, for a long time, and they are continuing to reap profits from it.
posted by a fiendish thingy at 6:03 AM on October 2, 2015 [4 favorites]


I didn't mention it above, but my brother was prescribed Risperdal for a short period, and our family is still feeling the aftershocks.

This sounds terrible and I am so, so sorry your family is going through this and I hope it gets better and easier for all of you.
posted by Mrs. Pterodactyl at 6:27 AM on October 2, 2015


The improvements you experienced in your quality of life were real, and tangible, and they were the result of the drug being used in its proper application. No one here is saying that the drug should not exist, or that it did not work when properly prescribed.

Well it sounds like they were prescribed it off-label (for ASD?) which is why it's a counterpoint to some of the ideas in the article. An anecdote of success does not, of course, excuse J&J's aggressive sales tactics or manipulation of information.
posted by atoxyl at 12:32 PM on October 2, 2015


Yes, it was prescribed off-label for ASD.

And I'll readily admit that my experience is an anecdote. I admitted that earlier. But so are all the other experiences that have been reported here -- as are all the other experiences reported in the article. Narrative is usually full of anecdotal evidence. I'm not excusing J&J's aggressive sales tactics, but I am objecting to the portrayal of Risperdal (and, specifically, its off-label usage for ASDs) as the horrific treatment TFA seems to want it to be.
posted by steady-state strawberry at 12:39 PM on October 17, 2015


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