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Analysis of Antidepressant Paxil Finds Data on Teen Risk Was Held Back

110 points by pmcpinto 11y ago

digikata 11y ago
So why isn't there some sort of post-approval monitoring system for drugs? With aircraft and cars we have enough data captured that problems can be identified and traced.
- cma 11y ago
  There is, post market monitoring.
  - digikata 11y ago
    So why didn't data from the monitoring suggest a study was needed much earlier?
joesmo 11y ago
What? A drug company hiding the fact that its drugs don't work from the scientists assigned to oversee it to make billions of dollars? Why never would I have thought this possible! Seems like for this segment of the market, they could have saved billions by releasing a placebo with better effects. Amazing!
refurb 11y ago
For all the condemnation of GSK, it appears that the "harm coding" changed from the original trial because the FDA changed the system they used. And was a major driver for why the AEs were captured in this study and not others. The other thing to keep in mind is that if this was a pivotal trial study, the FDA had the complete data set yet failed to recognize the increase in suicidal ideation as well.
- MichaelGG 11y ago
  The FDA really seems to have a bad rep. See, for instance, Ranbaxy: http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/ They were faking results and running terrible QC, to the point of shipping glass in pills. The FDA was very slow to fine them, and then only closed specific sites. It's obvious this company was rotten to the core, and is now part of Sun Pharma. FDA's done a bit more since then, but they should have issued a full ban and then started to whitelist things bit by bit. Local health inspectors come down harder. It creates other effects, too. By looking bad in some cases, people stop trusting the FDA. They then decide that things like sucralose are harmful "because you can't trust the FDA", and instead consume large amounts of sugar (it's natural!).
linkydinkandyou 11y ago
I take SSRIs (Lexapro). I find them helpful. But I think they may be safer in a mature, experienced, rational person which, unfortunately, doesn't reflect the reality of a lot of depressed people. I understand what the drug does and react and modify my behavior accordingly.
deleted 11y ago
[deleted]
jgalt212 11y ago
What blows my mind about these clinical trials is that the truth is always going to come out if the drug goes to market. And for big pharma, that's the goal--get the drug to market (and the largest market possible). While you can hide bad results when n is small. i.e. just re-run the trial with another or smaller n. However, when n gets large as the drug comes to market, there is nowhere to hide. The negative effects will become obvious and compelling as the sample size grows. How do they think they can hide this?
pessimizer 11y ago
Drug Patents Give Companies Like GlaxoSmithKline Incentive to Lie Published: 15 July 2010 "A NYT editorial ( http://www.nytimes.com/2010/07/15/opinion/15thu1.html?ref=opinion http://www.nytimes.com/2010/07/15/opinion/15thu1.html?ref=op... ) commented on evidence that the drug maker GlaxoSmithKline had concealed negative research findings on its diabetes drug Avandia: "'The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly. The company must be watched like a hawk as additional trials that it sponsors go forward.' "Arghhhhhhhhhhhhhhhh! Doesn't the NYT believe in the profit motive and incentives? The patent system, by granting monopolies that raise prices several thousand percent above the cost of production, gives drug companies an enormous incentive to conceal negative research findings. As long as these perverse incentives exist, then we have to watch every drug company like a hawk. "Maybe some wacko socialists think that drug companies will act for the public good and willingly forego vast profits, but those who believe on markets and economics know that drug companies will try to get away with anything they can get away with. One day maybe an iota of original thought will be allowed into public policy debates on the patent system, but we haven't gotten there yet." http://www.cepr.net/blogs/beat-the-press/drug-patents-give-companies-like-glaxosmithkline-incentive-to-lie http://www.cepr.net/blogs/beat-the-press/drug-patents-give-c... ----- Pharmaceutical Company Invented Diseases, One of the Incentives Provided by Patent Monopolies http://www.cepr.net/blogs/beat-the-press/pharmaceutical-company-invented-diseases-one-of-the-incentives-provided-by-patent-monopolies http://www.cepr.net/blogs/beat-the-press/pharmaceutical-comp... Tufts Economist Documents Inefficiency of Patent System for Financing Drug Research http://www.cepr.net/blogs/beat-the-press/tufts-economist-documents-inefficiency-of-patent-system-for-financing-drug-research http://www.cepr.net/blogs/beat-the-press/tufts-economist-doc... ----- Patent Monopolies and the Costs of Mismarketing Drugs April 2015, Ravi Katari and Dean Baker Abstract: "Patent monopolies have long been used as a mechanism for financing innovation and research. The logic is that the government awards a monopoly on a product or process for a limited period of time in order to reward innovation. However, in addition to providing incentives for innovation and research, patent monopolies also provide incentives for a wide-range of rent-seeking behaviors, many of which can have major social costs. This paper attempts to calculate one category of these costs for prescription drugs. It produces estimates of the costs associated with mismarketing drugs. The estimates are based on assessments of the costs in the form of increased morbidity and mortality associated with five prominent cases of mismarketing over the last two decades." http://www.cepr.net/publications/reports/patent-monopolies-and-the-costs-of-mismarketing-drugs http://www.cepr.net/publications/reports/patent-monopolies-a...
circuit_breaker 11y ago
This affected me. It's immoral and should be illegal
buffoon 11y ago
My wife was nearly a victim of this particular drug in the late 1990s. They have no idea how much shit they caused people by withholding this information. Several years of people's lives destroyed. I doubt they will acknowledge it or even apologise let alone offer compensation. When I say they, I don't mean the faceless corporation or brand, but the individuals who made this decision, ran the initial trials and pushed it to start with.
- kaffeemitsahne 11y ago
  "They have no idea how much shit they caused people by withholding this information." They do.
- phkahler 11y ago
  >> When I say they, I don't mean the faceless corporation or brand, but the individuals who made this decision... Hopefully they're scared shitless right now because of the talk around the GM recall case. Politicians are throwing around the idea of criminal charges because they didn't disclose safety problems soon enough. My first thought was "what about pharma?" Not sure what I think of the idea, but some folks in pharma are certain to be following that case.
  - seiji 11y ago
    Medical problems are difficult to class action because they are so distributed and so private. Earlier this year a doctor killed a family member of mine by telling her, across multiple visits in the same week, her swollen ankle was a sprain and to just rest. It was actually a blood clot due to being overweight and on birth control pills. The day after her last visit, she threw a PE and died alone on her couch. Another doctor told another family member his chest pains were end-stage cancer and he would die within a month. A second opinion showed it was mesothelioma treatable by state-of-the-art radiotherapy delivered by only one lab in the country. He's still alive two years later. I've probably got another half dozen stories just from immediate relatives about doctors seemingly doing random or nonsensical things instead of driving proper diagnoses and/or treatments forward. Doctors are in general awful unless you can afford to buy an entire private "council of doctors" to consult and berate each other into actually getting shit done.
acveilleux 11y ago
I use to work in pharma research (at the data acquisition and analysis side, blinded from treatment) and the fact that pharmas are able to start clinical trials and then shut them down without reporting result is a problem. The folks who make those decision usually have access to unblinded data and in the least objectionable case they do it due to lack of efficacy but you never know. Maybe they found a side-effect and would rather it not be looked at in the context of what the drug is approved for. There's easily the recovery of a billion dollar of R&D costs at stake.
- throwaway98031 11y ago
  > pharmas are able to start clinical trials and then shut them down without reporting result is a problem. As you've worked in the industry, I'm curious: What do you think could remedy this situation? Forcing all registered clinical trials to release all of their data seems like the obvious solution. We still need the ability to shut down clinical trials if unexpected side effects such as increased suicide rates appear, but allowing companies to keep the results private is obviously problematic.
  - andreyf 11y ago
    One option: https://en.wikipedia.org/wiki/Contract_research_organization https://en.wikipedia.org/wiki/Contract_research_organization
    - acveilleux 11y ago
      How is that a solution? I worked for a CRO and contractually, all we did belonged to the client, including all publishing rights on all results.
      - andreyf 11y ago
        Sorry for not expounding, that was indeed a bit opaque. I don't have first hand experience with the industry and so would appreciate any corrections to my understanding of it. When research is done via contract between two companies, it can be more effectively regulated to prevent hiding or discarding of results. I imagine there are already laws in place saying a company can't hide research results like this and CROs make compliance more likely because they do not benefit from hiding bad results as pharmaceutical manufacturers do. I don't think publication rights are the important bit here, but compliance with rules about disclosure to the FDA.
marincounty 11y ago
Now let's find out if this anti-depressant really helps anyone, or is it just another terrible drug with horrid side effects? If it doesn't help better than placebo; take it off the market? Let's throw out all those lousy studies that were done in the 90's and later? Let's start fresh--study these antidepressants, and get rid of them(adolescents, adults alike) if they really don't help anyone besides doctors, and drug companies finances? Yes, I know it's tough when you have a suicidal person in your office, and all you have in your arsenal is dubious drugs--marketed by ruthless companies? I don't what a caring practitioner should do. I really hope Psychiatry/Psychology makes some breakthroughs? I do know drug companies have pretty much stopped all research in new anti-depressants. Why--they were caught with their pants down, lying, hiding bad studies, and fooling doctors and patients alike with their Slick claims. (If you happen to be depressed, I can guarantee it gets better as you age, or with time. Hang in there. Don't let our rediculious, narcissistic society get the better of you. The problems you have in your youth--just might look a lot less serious as you get older? Yes--talk is cheap, but I have no reason to lie. I have no agenda. I don't want your money. I'm just a dude who's been through the system, and didn't like what I saw, or ingested. If you are really on the verge of doing something drastic; go straight to,the emergency room. There's one procedure that actually has a high cure rate--if you are really that desperate? I am obviously not a doctor, nor would ever want to be one.)
- witty_username 11y ago
  > (If you happen to be depressed, I can guarantee it gets better as you age, or with time. Hang in there. Not always, people can be depressed for long periods.
  - astazangasta 11y ago
    Get a good therapist. They work.
- throwaway98031 11y ago
  > Now let's find out if this anti-depressant really helps anyone, or is it just another terrible drug with horrid side effects? If it doesn't help better than placebo; take it off the market? The claim that SSRIs are no better than placebo is increasingly popular on the internet and among some researchers eager to make headlines, but the claim is not backed by the data. At best, it represents a misunderstanding of how the studies work, what they're showing, and how surprisingly effective placebo is in cases of mild depression. Scott Alexander has already done a great job debunking these claims: http://slatestarcodex.com/2014/07/07/ssris-much-more-than-you-wanted-to-know/ http://slatestarcodex.com/2014/07/07/ssris-much-more-than-yo... > I do know drug companies have pretty much stopped all research in new anti-depressants. Why--they were caught with their pants down, lying, hiding bad studies, and fooling doctors and patients alike with their Slick claims. This incident is deplorable and highlights a huge problem in our clinical trials process that needs to be addressed, but your extrapolations here not only don't make sense but they are flat-out incorrect. There is quite a huge amount of research on new antidepressants. In the past few years alone we've added Vilazodone and Vortioxetine to our arsenal, both of which are primarily SSRIs but have some additional properties that might reduce the side effects due to requiring lower doses. We also have Levomilnacipran which is the first SNRI that favors norepinephrine over serotonin, which can be very helpful in some patients. There are many interesting compounds in the pipeline as well, from rapid-acting compounds for addressing suicidal patients (ketamine infusion, esketamine nasal spray, GABA-A5 antagonists) to completely novel antidepressant compounds: opiod-modulating drugs like ALKS-5461 which have been very impressive in clinical trials, NMDA and sigma-1 antagonists, mGluR5 antagonists, NR2B antagonists, some very impressive BDNF modulators, anti-glucocorticoid strategies, and so on. Contrary to your claims that "ruthless drug companies" have stopped all research, this is the most exciting time for anti-depressant research we've ever seen.
nickysielicki 11y ago
Why are you ending every sentence with a question mark? It makes you sound unsure?
- dang 11y ago
  We detached this subthread from https://news.ycombinator.com/item?id=10239014 https://news.ycombinator.com/item?id=10239014 and marked it off topic.
- xlm1717 11y ago
  I've been noticing that as a nasty habit picking up steam on HN. It's usually the commenter talking down to a previous commenter.
  - DanBC 11y ago
    marincounty just uses a lot of question marks. Your nasty attack is incorrect, and you should probably apologise.
    - function_seven 11y ago
      I'm sorry, but one can't "just use a lot of question marks" without completely destroying whatever meaning they're trying to get across. I don't give a rat's ass if someone confuses "their" with "there", or "it's" with "its". The meaning is entirely left intact. But ending every single sentence with a question mark is very confusing to the reader. I still have no idea if marincounty is agreeing with the parent, calling them out on those statements, or something in between.
      - DanBC 11y ago
        It helps if you read it in an Australian accent?
        function_seven 11y ago
        Haha, maybe? I'll give it a try? Yeah, it kinda does!?
cryoshon 11y ago
Of course the data was held back, it would hurt sales. This is extremely typical of psychiatric drugs. Typically we only find these things out after the drug has been on the market for a number of years, with predictable (had we known!) consequences. Pharmas need to be held accountable for this bad behavior and all clinical trial results (including negative results) need to be 100% transparent. I am going to be blunt: this would massively hurt their bottom line. Because accountability would hurt the pharmas bottom line, it will be like pulling teeth to get any kind of legislation to fix this problem-- they love to buy politicians specifically because it protects them in times like these where they have done wrong. We need to stop allowing "because money" to be a valid reason for allowing people to get hurt. Psychiatric drugs are huge cash cows and are very frequently (see numerous meta-analyses) only dubiously or narrowly effective. They're a stopgap for a missing mental healthcare system, and allowed a lot of leeway because of this.
CaptainZapp 11y ago
I think this series of articles : http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/chapter-1.html http://highline.huffingtonpost.com/miracleindustry/americas-... is relevant in this context.
cs2818 11y ago
Wow, I was prescribed Paxil as a teenager for a year or so. Glad the only side effect I experienced was weight gain.
- peterwwillis 11y ago
  I remember being on it too. But i'm not sure if my problems in school were related to this drug, or the many other drugs I was put on in the course of trying to discover a "cure" for being a lonely sad teenager. (They never ended up finding a 'fix' for me, and by 18 I was an adult and could finally refuse the medication)
xlm1717 11y ago
I've been seeing this pop up on all the major news outlets and science websites, but still have not seen one mention of the side effect that may be behind both increased risk of suicide and increased risk of violent behavior: akathisia. Akathisia is a side effect of antidepressants that causes an intense inner restlessness and inability to sit still. This can cause agonizing pain and terrible anxiety, and people can resort to extreme behaviors to relieve their symptoms, often becoming violent. This has been known for a while now. If you look at the references on the Wikipedia page for akathisia, you find one paper linking antidepressant-induced akathisia to violence from 2006: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1564177/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1564177/ Quoting from that paper on akathisia: “Increased tenseness, restlessness, insomnia and a feeling of being very uncomfortable”. “On the first day of treatment he reacted with marked anxiety and weepiness, on the second day felt so terrible with such marked panic at night that the medication was cancelled”. “The first few doses frequently made them anxious and apprehensive. They reported increased feelings of strangeness, verbalised by statements such as ‘I don't feel myself’ or ‘I'm afraid of some of the unusual impulses I have'’. "Events such as these in clinical trials of antidepressants have commonly been coded under headings such as agitation, emotional lability, and hyperkinesis (overactivity), and only rarely to akathisia." The good thing is that you can treat akathisia with common medicines already used to treat anxiety, such as benzodiazepines. The bad thing is that since information on side effects has been suppressed, patients are not likely to know what is happening to them and how to treat it, won't get the help they need, and run the risk of hurting themselves or others.
- existencebox 11y ago
  What concerns me as much as the initial side effects is your last paragraph, and the sentiment surrounding it. Benzos have been known to have some additional significant neurological consequences in the long term, and have always felt to me like a rather large sledgehammer for the problems they often treat. As such, "your behavior-modifying drugs give you a side effect so we'll shove more powerful drugs in your face" was an attitude that I've seen multiple times and NEVER to good effect. (I'll be very candid that I was part of the "you have ADHD so we'll treat you with pills" generation, at a much younger age, but will leave it at that it didn't end as planned.) I hope I'm not a total tin foil hatter by looking askew at this trend, but being married to a neurologist and the son of a behaviorist, I'm VERY aware of how little we understand what we're doing when we muck around up there.
mzs 11y ago
Depression runs in my family. Please be considerate in your replies here to me. I think in US every available antidepressant has that 'suicidal thoughts' warning right at the top of the list yet antidepressants have been a very valuable tool for our family for young and old alike. I do not believe that any causation has been determined for currently commonly prescribed medications. This is Reuters article reprinted at sciam does not show that at least. What GSK did hiding studies is reprehensible of course. Vulnerable families were hurt. The positive is the increased scrutiny now thanks to that. My beliefs on the matter: Antidepressants are one tool, about 20% of dealing with the level of depression in my family. Sometimes the chemicals in our brains are just so out of whack no amount of therapy gets to us. For an adult like me, I have had enough experiences (bad relationships, financial strain, health issues, legal problems, work stress, and so on) in my life to more easily put them in healthy context to what happens three years out say. I also remember how when I was younger that was impossible cause I lacked that experience. This is reflected by the rest of my family. What I believe happens is the following: People with depression are already more likely to have thoughts of hurting themselves. There are some young people that will use manipulation to get what they want that also suffer from depression. 'You take away the only thing I like and I will hurt myself,' where that thing is not a healthy coping mechanism. So that thing gets taken away and the kid gets a psych-eval. The social worker evaluating everything decides this is a case of manipulation and the child is at an appropriate level of care. The problem is that some children have used manipulation but really do end-up hurting themselves after this since the other coping mechanisms they have in place at the time either get ignored or are insufficient. Now my ire does not rest solely with GSK here. When I said the licensed state social worker evaluates everything, aspects come into that which should not for medical reasons but do for societal ones. One of those things have been what other options are available. People have been denied needed care based on there not being room in the programs (because of underfunding essentially), there not even being the appropriate program (for example intensive outpatient again often because of underfunding), or what insurance will pay. Thankfully that has not effected my nuclear family too much, but has affected others in my wider family that are unfortunate to live in other places or have worse insurance. That said, even to this day there are limits to mental health in my insurance program. Thankfully they are not not as onerous as they were in the past, but it does cause us stress to navigate it and not go over what is permitted. The other thing is that simply you need a good team to work with you, a doctor and a therapist. There are those with mental health illnesses that are unlucky to not have good choices there. There are too many practitioners that are simply overworked and can't really offer the attention that is needed for proper care. They have known about this 'suicidal thoughts' danger, but they also see the benefits which nothing else offers. So they get into a routine of using one system for everyone as much as possible. But then because of time and insurance reasons there is not enough attention to tune it then as time goes on together with therapy. For example our insurance will only pay for a parent to consult with a therapist once a week for a child even in intensive outpatient care. So you have to find one willing to do that over the phone more often and not get paid for it essentially. Well that was rambling, sorry, but somewhat therapeutic for me currently, thank you.
throwaway98031 11y ago
This is an egregious violation on many levels. It highlights a massive gap in the clinical trials process (companies can stop trials without reporting negative results) that really should be addressed. I think everyone (outside of drug companies) can agree on that much. I would like to say a few words on SSRIs (the class of drugs that Paxil is in) and their risks in general, because articles like these tend to cultivate strongly negative feelings toward SSRIs due to the deplorable drug company actions mentioned in this article. I don't blame people for mistrusting the drug companies after reading something like this. I also feel that SSRIs are prescribed too quickly and with too little extra guidance from doctors, although that trend is changing a bit as doctors become more educated. But my biggest concern is that we're starting to see many people with severe depression who refuse to take SSRIs because they don't trust the drug companies and they've come to believe that their severe depression is still better than the side effects or risks of an SSRI, which couldn't be farther from the truth. The bottom line is that SSRIs, while far from perfect, are still one of the most effective first-line treatments for severe depression that we have, and they do it with a side effect profile that is head-and-shoulders above previous generation anti-depressants. Perhaps the biggest problem with SSRI treatment is the delayed onset of action. Unlike short-term rewarding drugs such as stimulants or opioids that may boost one's mood in the short term but quickly develop tolerance, SSRIs work through long-term adaptive changes. These changes are numerous, from increased BDNF and hippocampal growth to HPA axis normalization and restoration of brain connectivity back to a state that more closely matches that of non-depressed patients. However, the problem is that all of this happens as downstream effects of an alteration in how serotonin moves through the brain, which is very disruptive in the short-term while the brain adapts to the changes. SSRI stands for selective serotonin reuptake inhibitor, which means that it inhibits the ability of serotonin-releasing neurons to take serotonin back up from the synapse after they release it. This doesn't "raise serotonin levels" as many describe it (unfortunately perhaps due to some awful SSRI marketing in the 90s and 00s) but rather alters the dynamics of how serotonin-based circuits operate. Serotonin will now spend more time in the synaptic cleft, activating post-synatpic serotonin receptors and synaptic transmission becomes a bit more smoothed out as the transmission takes longer to terminate via MAO deactivation of the serotonin or via uptake from the ~20% of uninhibited serotonin transporters. Over time (4-8 weeks on average) the post-synaptic receptors adjust to the "new normal" levels of serotonin that they see in the synaptic space. This adjustment might even be key to some of the therapeutic effects of SSRIs, as some serotonin circuits may be too active in depressed or anxious patients, but the chronic SSRI administration quiets those receptors down, somewhat counter-intuitively. The big problem here is that until those receptors compensate, the patient may actually feel worse in the short-term. (Note that some patients actually feel substantially better during this phase, so please don't take this as a given). In the worst-case, depression or anxiety are actually worsened temporarily, combined with an increased energy due to the SSRI's activating effects. At the extreme worst-case scenario, this can lead to suicidal ideation, and for whatever reason this is more common in teenagers. I wrote all of this out because the HN crowd tends to want to know how things work behind the scenes or under the hood when making decisions for themselves. My goal is not to suggest that everyone who experiences depression should be on SSRIs, because I actually feel that medication is probably best reserved as a first-line treatment for moderate to severe depression. Instead, my goal is to keep everyone informed such that they can work with their doctor to find the best treatment for themselves without unnecessarily fearing SSRIs due to these deplorable actions of drug companies a few years ago. If you're feeling depressed, work with your doctor to find a solution. If you question your doctor's decision, see someone else. But it's important to explore all options if depression is taking a toll on your life, and if you choose to go the SSRI route then be aware that therapeutic effects are 4-8 weeks out, at least, and talk to your doctor right away if you're concerned.
pella 11y ago
-> http://www.alltrials.net/ http://www.alltrials.net/ and this topic: http://www.alltrials.net/news/new-research-on-old-data/ http://www.alltrials.net/news/new-research-on-old-data/ - BMJ Editorials: "Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research" : http://www.bmj.com/content/351/bmj.h4601 http://www.bmj.com/content/351/bmj.h4601 - BMJ "No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility" http://www.bmj.com/content/351/bmj.h4629 http://www.bmj.com/content/351/bmj.h4629
- mzs 11y ago
  That last link in particular as a very good read for me, thank you for sharing.
DanBC 11y ago
This study is more interesting. young people on certain anti-depressants are at higher risk of violence. We don't know which way causality runs. We don't see the effect in older people. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001875#abstract2 http://journals.plos.org/plosmedicine/article?id=10.1371/jou... > These findings show an association between SSRIs and violent crime that varies by age group. They cannot, however, prove that taking SSRIs actually causes an increase in violent crime among young people because the analytical approach used does not fully account for time-varying risk factors such as symptom severity or alcohol misuse that might affect an individual’s risk of committing a violent crime (residual confounding). In addition, some people who committed a violent crime might have subsequently taken SSRIs to cope with the anxiety and stress of arrest (reverse causation). The lack of a significant association between SSRIs and violent crime among most people taking SSRIs is reassuring; the association between violent crimes and SSRIs among individuals younger than 25 years is worrying. However, this finding needs confirming in studies with other designs undertaken in other settings. If confirmed, warnings about the increased risk of violent behavior among young people when being treated with SSRIs might be needed. But, note the researchers, it might be inappropriate to restrict the use of SSRIs in this age group because increases in adverse outcomes associated with poorly treated depression, such as suicide, might outweigh the public health benefit accruing from decreases in violence.
- throwaway98031 11y ago
  The study is interesting and worth following up on, but the biggest takeaway from your post is your statement that: > We don't know which way causality runs. The study found a correlation, not a causation, and even the authors suggest that reverse causation is actually a very possible explanation. Note that the study was performed in Sweden, where they do a much better job of rehabilitating offenders than we do in the USA. So good, in fact, that the reoffending rates in Sweden are half of other European countries. Sweden is actually closing prisons lately because their prison population is dropping so much. I can't find any direct evidence to back this up, but it's not a stretch to think that young violent offenders in Sweden are much more likely than the general population to end up receiving psychiatric treatment, and thus are more likely to be prescribed SSRIs than the general population. As such, I wouldn't read too much in that study.

110 points by pmcpinto 11y ago

So why isn't there some sort of post-approval monitoring system for drugs? With aircraft and cars we have enough data captured that problems can be identified and traced.

cma 11y ago
There is, post market monitoring.
- digikata 11y ago
  So why didn't data from the monitoring suggest a study was needed much earlier?

joesmo 11y ago

What? A drug company hiding the fact that its drugs don't work from the scientists assigned to oversee it to make billions of dollars? Why never would I have thought this possible! Seems like for this segment of the market, they could have saved billions by releasing a placebo with better effects. Amazing!

refurb 11y ago

For all the condemnation of GSK, it appears that the "harm coding" changed from the original trial because the FDA changed the system they used. And was a major driver for why the AEs were captured in this study and not others. The other thing to keep in mind is that if this was a pivotal trial study, the FDA had the complete data set yet failed to recognize the increase in suicidal ideation as well.

MichaelGG 11y ago
The FDA really seems to have a bad rep. See, for instance, Ranbaxy: http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/ They were faking results and running terrible QC, to the point of shipping glass in pills. The FDA was very slow to fine them, and then only closed specific sites. It's obvious this company was rotten to the core, and is now part of Sun Pharma. FDA's done a bit more since then, but they should have issued a full ban and then started to whitelist things bit by bit. Local health inspectors come down harder. It creates other effects, too. By looking bad in some cases, people stop trusting the FDA. They then decide that things like sucralose are harmful "because you can't trust the FDA", and instead consume large amounts of sugar (it's natural!).

linkydinkandyou 11y ago

I take SSRIs (Lexapro). I find them helpful. But I think they may be safer in a mature, experienced, rational person which, unfortunately, doesn't reflect the reality of a lot of depressed people. I understand what the drug does and react and modify my behavior accordingly.

deleted 11y ago

[deleted]

jgalt212 11y ago

What blows my mind about these clinical trials is that the truth is always going to come out if the drug goes to market. And for big pharma, that's the goal--get the drug to market (and the largest market possible). While you can hide bad results when n is small. i.e. just re-run the trial with another or smaller n. However, when n gets large as the drug comes to market, there is nowhere to hide. The negative effects will become obvious and compelling as the sample size grows. How do they think they can hide this?

pessimizer 11y ago

Drug Patents Give Companies Like GlaxoSmithKline Incentive to Lie Published: 15 July 2010 "A NYT editorial ( http://www.nytimes.com/2010/07/15/opinion/15thu1.html?ref=opinion http://www.nytimes.com/2010/07/15/opinion/15thu1.html?ref=op... ) commented on evidence that the drug maker GlaxoSmithKline had concealed negative research findings on its diabetes drug Avandia: "'The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly. The company must be watched like a hawk as additional trials that it sponsors go forward.' "Arghhhhhhhhhhhhhhhh! Doesn't the NYT believe in the profit motive and incentives? The patent system, by granting monopolies that raise prices several thousand percent above the cost of production, gives drug companies an enormous incentive to conceal negative research findings. As long as these perverse incentives exist, then we have to watch every drug company like a hawk. "Maybe some wacko socialists think that drug companies will act for the public good and willingly forego vast profits, but those who believe on markets and economics know that drug companies will try to get away with anything they can get away with. One day maybe an iota of original thought will be allowed into public policy debates on the patent system, but we haven't gotten there yet." http://www.cepr.net/blogs/beat-the-press/drug-patents-give-companies-like-glaxosmithkline-incentive-to-lie http://www.cepr.net/blogs/beat-the-press/drug-patents-give-c... ----- Pharmaceutical Company Invented Diseases, One of the Incentives Provided by Patent Monopolies http://www.cepr.net/blogs/beat-the-press/pharmaceutical-company-invented-diseases-one-of-the-incentives-provided-by-patent-monopolies http://www.cepr.net/blogs/beat-the-press/pharmaceutical-comp... Tufts Economist Documents Inefficiency of Patent System for Financing Drug Research http://www.cepr.net/blogs/beat-the-press/tufts-economist-documents-inefficiency-of-patent-system-for-financing-drug-research http://www.cepr.net/blogs/beat-the-press/tufts-economist-doc... ----- Patent Monopolies and the Costs of Mismarketing Drugs April 2015, Ravi Katari and Dean Baker Abstract: "Patent monopolies have long been used as a mechanism for financing innovation and research. The logic is that the government awards a monopoly on a product or process for a limited period of time in order to reward innovation. However, in addition to providing incentives for innovation and research, patent monopolies also provide incentives for a wide-range of rent-seeking behaviors, many of which can have major social costs. This paper attempts to calculate one category of these costs for prescription drugs. It produces estimates of the costs associated with mismarketing drugs. The estimates are based on assessments of the costs in the form of increased morbidity and mortality associated with five prominent cases of mismarketing over the last two decades." http://www.cepr.net/publications/reports/patent-monopolies-and-the-costs-of-mismarketing-drugs http://www.cepr.net/publications/reports/patent-monopolies-a...

circuit_breaker 11y ago

This affected me. It's immoral and should be illegal

buffoon 11y ago

My wife was nearly a victim of this particular drug in the late 1990s. They have no idea how much shit they caused people by withholding this information. Several years of people's lives destroyed. I doubt they will acknowledge it or even apologise let alone offer compensation. When I say they, I don't mean the faceless corporation or brand, but the individuals who made this decision, ran the initial trials and pushed it to start with.

kaffeemitsahne 11y ago
"They have no idea how much shit they caused people by withholding this information." They do.
phkahler 11y ago
>> When I say they, I don't mean the faceless corporation or brand, but the individuals who made this decision... Hopefully they're scared shitless right now because of the talk around the GM recall case. Politicians are throwing around the idea of criminal charges because they didn't disclose safety problems soon enough. My first thought was "what about pharma?" Not sure what I think of the idea, but some folks in pharma are certain to be following that case.
- seiji 11y ago
  Medical problems are difficult to class action because they are so distributed and so private. Earlier this year a doctor killed a family member of mine by telling her, across multiple visits in the same week, her swollen ankle was a sprain and to just rest. It was actually a blood clot due to being overweight and on birth control pills. The day after her last visit, she threw a PE and died alone on her couch. Another doctor told another family member his chest pains were end-stage cancer and he would die within a month. A second opinion showed it was mesothelioma treatable by state-of-the-art radiotherapy delivered by only one lab in the country. He's still alive two years later. I've probably got another half dozen stories just from immediate relatives about doctors seemingly doing random or nonsensical things instead of driving proper diagnoses and/or treatments forward. Doctors are in general awful unless you can afford to buy an entire private "council of doctors" to consult and berate each other into actually getting shit done.

acveilleux 11y ago

I use to work in pharma research (at the data acquisition and analysis side, blinded from treatment) and the fact that pharmas are able to start clinical trials and then shut them down without reporting result is a problem. The folks who make those decision usually have access to unblinded data and in the least objectionable case they do it due to lack of efficacy but you never know. Maybe they found a side-effect and would rather it not be looked at in the context of what the drug is approved for. There's easily the recovery of a billion dollar of R&D costs at stake.

throwaway98031 11y ago
> pharmas are able to start clinical trials and then shut them down without reporting result is a problem. As you've worked in the industry, I'm curious: What do you think could remedy this situation? Forcing all registered clinical trials to release all of their data seems like the obvious solution. We still need the ability to shut down clinical trials if unexpected side effects such as increased suicide rates appear, but allowing companies to keep the results private is obviously problematic.
- andreyf 11y ago
  One option: https://en.wikipedia.org/wiki/Contract_research_organization https://en.wikipedia.org/wiki/Contract_research_organization
  - acveilleux 11y ago
    How is that a solution? I worked for a CRO and contractually, all we did belonged to the client, including all publishing rights on all results.
    - andreyf 11y ago
      Sorry for not expounding, that was indeed a bit opaque. I don't have first hand experience with the industry and so would appreciate any corrections to my understanding of it. When research is done via contract between two companies, it can be more effectively regulated to prevent hiding or discarding of results. I imagine there are already laws in place saying a company can't hide research results like this and CROs make compliance more likely because they do not benefit from hiding bad results as pharmaceutical manufacturers do. I don't think publication rights are the important bit here, but compliance with rules about disclosure to the FDA.

marincounty 11y ago

Now let's find out if this anti-depressant really helps anyone, or is it just another terrible drug with horrid side effects? If it doesn't help better than placebo; take it off the market? Let's throw out all those lousy studies that were done in the 90's and later? Let's start fresh--study these antidepressants, and get rid of them(adolescents, adults alike) if they really don't help anyone besides doctors, and drug companies finances? Yes, I know it's tough when you have a suicidal person in your office, and all you have in your arsenal is dubious drugs--marketed by ruthless companies? I don't what a caring practitioner should do. I really hope Psychiatry/Psychology makes some breakthroughs? I do know drug companies have pretty much stopped all research in new anti-depressants. Why--they were caught with their pants down, lying, hiding bad studies, and fooling doctors and patients alike with their Slick claims. (If you happen to be depressed, I can guarantee it gets better as you age, or with time. Hang in there. Don't let our rediculious, narcissistic society get the better of you. The problems you have in your youth--just might look a lot less serious as you get older? Yes--talk is cheap, but I have no reason to lie. I have no agenda. I don't want your money. I'm just a dude who's been through the system, and didn't like what I saw, or ingested. If you are really on the verge of doing something drastic; go straight to,the emergency room. There's one procedure that actually has a high cure rate--if you are really that desperate? I am obviously not a doctor, nor would ever want to be one.)

witty_username 11y ago
> (If you happen to be depressed, I can guarantee it gets better as you age, or with time. Hang in there. Not always, people can be depressed for long periods.
- astazangasta 11y ago
  Get a good therapist. They work.
throwaway98031 11y ago
> Now let's find out if this anti-depressant really helps anyone, or is it just another terrible drug with horrid side effects? If it doesn't help better than placebo; take it off the market? The claim that SSRIs are no better than placebo is increasingly popular on the internet and among some researchers eager to make headlines, but the claim is not backed by the data. At best, it represents a misunderstanding of how the studies work, what they're showing, and how surprisingly effective placebo is in cases of mild depression. Scott Alexander has already done a great job debunking these claims: http://slatestarcodex.com/2014/07/07/ssris-much-more-than-you-wanted-to-know/ http://slatestarcodex.com/2014/07/07/ssris-much-more-than-yo... > I do know drug companies have pretty much stopped all research in new anti-depressants. Why--they were caught with their pants down, lying, hiding bad studies, and fooling doctors and patients alike with their Slick claims. This incident is deplorable and highlights a huge problem in our clinical trials process that needs to be addressed, but your extrapolations here not only don't make sense but they are flat-out incorrect. There is quite a huge amount of research on new antidepressants. In the past few years alone we've added Vilazodone and Vortioxetine to our arsenal, both of which are primarily SSRIs but have some additional properties that might reduce the side effects due to requiring lower doses. We also have Levomilnacipran which is the first SNRI that favors norepinephrine over serotonin, which can be very helpful in some patients. There are many interesting compounds in the pipeline as well, from rapid-acting compounds for addressing suicidal patients (ketamine infusion, esketamine nasal spray, GABA-A5 antagonists) to completely novel antidepressant compounds: opiod-modulating drugs like ALKS-5461 which have been very impressive in clinical trials, NMDA and sigma-1 antagonists, mGluR5 antagonists, NR2B antagonists, some very impressive BDNF modulators, anti-glucocorticoid strategies, and so on. Contrary to your claims that "ruthless drug companies" have stopped all research, this is the most exciting time for anti-depressant research we've ever seen.

nickysielicki 11y ago

Why are you ending every sentence with a question mark? It makes you sound unsure?

dang 11y ago
We detached this subthread from https://news.ycombinator.com/item?id=10239014 https://news.ycombinator.com/item?id=10239014 and marked it off topic.
xlm1717 11y ago
I've been noticing that as a nasty habit picking up steam on HN. It's usually the commenter talking down to a previous commenter.
- DanBC 11y ago
  marincounty just uses a lot of question marks. Your nasty attack is incorrect, and you should probably apologise.
  - function_seven 11y ago
    I'm sorry, but one can't "just use a lot of question marks" without completely destroying whatever meaning they're trying to get across. I don't give a rat's ass if someone confuses "their" with "there", or "it's" with "its". The meaning is entirely left intact. But ending every single sentence with a question mark is very confusing to the reader. I still have no idea if marincounty is agreeing with the parent, calling them out on those statements, or something in between.
    - DanBC 11y ago
      It helps if you read it in an Australian accent?
      - function_seven 11y ago
        Haha, maybe? I'll give it a try? Yeah, it kinda does!?

cryoshon 11y ago

Of course the data was held back, it would hurt sales. This is extremely typical of psychiatric drugs. Typically we only find these things out after the drug has been on the market for a number of years, with predictable (had we known!) consequences. Pharmas need to be held accountable for this bad behavior and all clinical trial results (including negative results) need to be 100% transparent. I am going to be blunt: this would massively hurt their bottom line. Because accountability would hurt the pharmas bottom line, it will be like pulling teeth to get any kind of legislation to fix this problem-- they love to buy politicians specifically because it protects them in times like these where they have done wrong. We need to stop allowing "because money" to be a valid reason for allowing people to get hurt. Psychiatric drugs are huge cash cows and are very frequently (see numerous meta-analyses) only dubiously or narrowly effective. They're a stopgap for a missing mental healthcare system, and allowed a lot of leeway because of this.

CaptainZapp 11y ago

I think this series of articles : http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/chapter-1.html http://highline.huffingtonpost.com/miracleindustry/americas-... is relevant in this context.

cs2818 11y ago

Wow, I was prescribed Paxil as a teenager for a year or so. Glad the only side effect I experienced was weight gain.

peterwwillis 11y ago
I remember being on it too. But i'm not sure if my problems in school were related to this drug, or the many other drugs I was put on in the course of trying to discover a "cure" for being a lonely sad teenager. (They never ended up finding a 'fix' for me, and by 18 I was an adult and could finally refuse the medication)

xlm1717 11y ago

I've been seeing this pop up on all the major news outlets and science websites, but still have not seen one mention of the side effect that may be behind both increased risk of suicide and increased risk of violent behavior: akathisia. Akathisia is a side effect of antidepressants that causes an intense inner restlessness and inability to sit still. This can cause agonizing pain and terrible anxiety, and people can resort to extreme behaviors to relieve their symptoms, often becoming violent. This has been known for a while now. If you look at the references on the Wikipedia page for akathisia, you find one paper linking antidepressant-induced akathisia to violence from 2006: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1564177/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1564177/ Quoting from that paper on akathisia: “Increased tenseness, restlessness, insomnia and a feeling of being very uncomfortable”. “On the first day of treatment he reacted with marked anxiety and weepiness, on the second day felt so terrible with such marked panic at night that the medication was cancelled”. “The first few doses frequently made them anxious and apprehensive. They reported increased feelings of strangeness, verbalised by statements such as ‘I don't feel myself’ or ‘I'm afraid of some of the unusual impulses I have'’. "Events such as these in clinical trials of antidepressants have commonly been coded under headings such as agitation, emotional lability, and hyperkinesis (overactivity), and only rarely to akathisia." The good thing is that you can treat akathisia with common medicines already used to treat anxiety, such as benzodiazepines. The bad thing is that since information on side effects has been suppressed, patients are not likely to know what is happening to them and how to treat it, won't get the help they need, and run the risk of hurting themselves or others.

existencebox 11y ago
What concerns me as much as the initial side effects is your last paragraph, and the sentiment surrounding it. Benzos have been known to have some additional significant neurological consequences in the long term, and have always felt to me like a rather large sledgehammer for the problems they often treat. As such, "your behavior-modifying drugs give you a side effect so we'll shove more powerful drugs in your face" was an attitude that I've seen multiple times and NEVER to good effect. (I'll be very candid that I was part of the "you have ADHD so we'll treat you with pills" generation, at a much younger age, but will leave it at that it didn't end as planned.) I hope I'm not a total tin foil hatter by looking askew at this trend, but being married to a neurologist and the son of a behaviorist, I'm VERY aware of how little we understand what we're doing when we muck around up there.

mzs 11y ago

Depression runs in my family. Please be considerate in your replies here to me. I think in US every available antidepressant has that 'suicidal thoughts' warning right at the top of the list yet antidepressants have been a very valuable tool for our family for young and old alike. I do not believe that any causation has been determined for currently commonly prescribed medications. This is Reuters article reprinted at sciam does not show that at least. What GSK did hiding studies is reprehensible of course. Vulnerable families were hurt. The positive is the increased scrutiny now thanks to that. My beliefs on the matter: Antidepressants are one tool, about 20% of dealing with the level of depression in my family. Sometimes the chemicals in our brains are just so out of whack no amount of therapy gets to us. For an adult like me, I have had enough experiences (bad relationships, financial strain, health issues, legal problems, work stress, and so on) in my life to more easily put them in healthy context to what happens three years out say. I also remember how when I was younger that was impossible cause I lacked that experience. This is reflected by the rest of my family. What I believe happens is the following: People with depression are already more likely to have thoughts of hurting themselves. There are some young people that will use manipulation to get what they want that also suffer from depression. 'You take away the only thing I like and I will hurt myself,' where that thing is not a healthy coping mechanism. So that thing gets taken away and the kid gets a psych-eval. The social worker evaluating everything decides this is a case of manipulation and the child is at an appropriate level of care. The problem is that some children have used manipulation but really do end-up hurting themselves after this since the other coping mechanisms they have in place at the time either get ignored or are insufficient. Now my ire does not rest solely with GSK here. When I said the licensed state social worker evaluates everything, aspects come into that which should not for medical reasons but do for societal ones. One of those things have been what other options are available. People have been denied needed care based on there not being room in the programs (because of underfunding essentially), there not even being the appropriate program (for example intensive outpatient again often because of underfunding), or what insurance will pay. Thankfully that has not effected my nuclear family too much, but has affected others in my wider family that are unfortunate to live in other places or have worse insurance. That said, even to this day there are limits to mental health in my insurance program. Thankfully they are not not as onerous as they were in the past, but it does cause us stress to navigate it and not go over what is permitted. The other thing is that simply you need a good team to work with you, a doctor and a therapist. There are those with mental health illnesses that are unlucky to not have good choices there. There are too many practitioners that are simply overworked and can't really offer the attention that is needed for proper care. They have known about this 'suicidal thoughts' danger, but they also see the benefits which nothing else offers. So they get into a routine of using one system for everyone as much as possible. But then because of time and insurance reasons there is not enough attention to tune it then as time goes on together with therapy. For example our insurance will only pay for a parent to consult with a therapist once a week for a child even in intensive outpatient care. So you have to find one willing to do that over the phone more often and not get paid for it essentially. Well that was rambling, sorry, but somewhat therapeutic for me currently, thank you.

throwaway98031 11y ago

This is an egregious violation on many levels. It highlights a massive gap in the clinical trials process (companies can stop trials without reporting negative results) that really should be addressed. I think everyone (outside of drug companies) can agree on that much. I would like to say a few words on SSRIs (the class of drugs that Paxil is in) and their risks in general, because articles like these tend to cultivate strongly negative feelings toward SSRIs due to the deplorable drug company actions mentioned in this article. I don't blame people for mistrusting the drug companies after reading something like this. I also feel that SSRIs are prescribed too quickly and with too little extra guidance from doctors, although that trend is changing a bit as doctors become more educated. But my biggest concern is that we're starting to see many people with severe depression who refuse to take SSRIs because they don't trust the drug companies and they've come to believe that their severe depression is still better than the side effects or risks of an SSRI, which couldn't be farther from the truth. The bottom line is that SSRIs, while far from perfect, are still one of the most effective first-line treatments for severe depression that we have, and they do it with a side effect profile that is head-and-shoulders above previous generation anti-depressants. Perhaps the biggest problem with SSRI treatment is the delayed onset of action. Unlike short-term rewarding drugs such as stimulants or opioids that may boost one's mood in the short term but quickly develop tolerance, SSRIs work through long-term adaptive changes. These changes are numerous, from increased BDNF and hippocampal growth to HPA axis normalization and restoration of brain connectivity back to a state that more closely matches that of non-depressed patients. However, the problem is that all of this happens as downstream effects of an alteration in how serotonin moves through the brain, which is very disruptive in the short-term while the brain adapts to the changes. SSRI stands for selective serotonin reuptake inhibitor, which means that it inhibits the ability of serotonin-releasing neurons to take serotonin back up from the synapse after they release it. This doesn't "raise serotonin levels" as many describe it (unfortunately perhaps due to some awful SSRI marketing in the 90s and 00s) but rather alters the dynamics of how serotonin-based circuits operate. Serotonin will now spend more time in the synaptic cleft, activating post-synatpic serotonin receptors and synaptic transmission becomes a bit more smoothed out as the transmission takes longer to terminate via MAO deactivation of the serotonin or via uptake from the ~20% of uninhibited serotonin transporters. Over time (4-8 weeks on average) the post-synaptic receptors adjust to the "new normal" levels of serotonin that they see in the synaptic space. This adjustment might even be key to some of the therapeutic effects of SSRIs, as some serotonin circuits may be too active in depressed or anxious patients, but the chronic SSRI administration quiets those receptors down, somewhat counter-intuitively. The big problem here is that until those receptors compensate, the patient may actually feel worse in the short-term. (Note that some patients actually feel substantially better during this phase, so please don't take this as a given). In the worst-case, depression or anxiety are actually worsened temporarily, combined with an increased energy due to the SSRI's activating effects. At the extreme worst-case scenario, this can lead to suicidal ideation, and for whatever reason this is more common in teenagers. I wrote all of this out because the HN crowd tends to want to know how things work behind the scenes or under the hood when making decisions for themselves. My goal is not to suggest that everyone who experiences depression should be on SSRIs, because I actually feel that medication is probably best reserved as a first-line treatment for moderate to severe depression. Instead, my goal is to keep everyone informed such that they can work with their doctor to find the best treatment for themselves without unnecessarily fearing SSRIs due to these deplorable actions of drug companies a few years ago. If you're feeling depressed, work with your doctor to find a solution. If you question your doctor's decision, see someone else. But it's important to explore all options if depression is taking a toll on your life, and if you choose to go the SSRI route then be aware that therapeutic effects are 4-8 weeks out, at least, and talk to your doctor right away if you're concerned.

pella 11y ago

-> http://www.alltrials.net/ http://www.alltrials.net/ and this topic: http://www.alltrials.net/news/new-research-on-old-data/ http://www.alltrials.net/news/new-research-on-old-data/ - BMJ Editorials: "Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research" : http://www.bmj.com/content/351/bmj.h4601 http://www.bmj.com/content/351/bmj.h4601 - BMJ "No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility" http://www.bmj.com/content/351/bmj.h4629 http://www.bmj.com/content/351/bmj.h4629

mzs 11y ago
That last link in particular as a very good read for me, thank you for sharing.

DanBC 11y ago

This study is more interesting. young people on certain anti-depressants are at higher risk of violence. We don't know which way causality runs. We don't see the effect in older people. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001875#abstract2 http://journals.plos.org/plosmedicine/article?id=10.1371/jou... > These findings show an association between SSRIs and violent crime that varies by age group. They cannot, however, prove that taking SSRIs actually causes an increase in violent crime among young people because the analytical approach used does not fully account for time-varying risk factors such as symptom severity or alcohol misuse that might affect an individual’s risk of committing a violent crime (residual confounding). In addition, some people who committed a violent crime might have subsequently taken SSRIs to cope with the anxiety and stress of arrest (reverse causation). The lack of a significant association between SSRIs and violent crime among most people taking SSRIs is reassuring; the association between violent crimes and SSRIs among individuals younger than 25 years is worrying. However, this finding needs confirming in studies with other designs undertaken in other settings. If confirmed, warnings about the increased risk of violent behavior among young people when being treated with SSRIs might be needed. But, note the researchers, it might be inappropriate to restrict the use of SSRIs in this age group because increases in adverse outcomes associated with poorly treated depression, such as suicide, might outweigh the public health benefit accruing from decreases in violence.

throwaway98031 11y ago
The study is interesting and worth following up on, but the biggest takeaway from your post is your statement that: > We don't know which way causality runs. The study found a correlation, not a causation, and even the authors suggest that reverse causation is actually a very possible explanation. Note that the study was performed in Sweden, where they do a much better job of rehabilitating offenders than we do in the USA. So good, in fact, that the reoffending rates in Sweden are half of other European countries. Sweden is actually closing prisons lately because their prison population is dropping so much. I can't find any direct evidence to back this up, but it's not a stretch to think that young violent offenders in Sweden are much more likely than the general population to end up receiving psychiatric treatment, and thus are more likely to be prescribed SSRIs than the general population. As such, I wouldn't read too much in that study.