How Many Teens Killed Themselves Because They Didn't Take Antidepressants?
A year and a half ago, the U.S. Food and Drug Administration, citing concerns about possibly increased adolescent suicides from using antidepressant medications, ordered drugmakers to put a black box warning on them. This is the government's strongest safety warning. As the AP reported, "The agency's action comes at a time when it faces withering criticism for not acting sooner on antidepressants." In fact, as webMD reported, the FDA found that the studies did not clearly establish a link between the use of these drugs and a higher risk of suicidal thoughts or actions, but they do not rule it out. Nevertheless, timid bureaucrats were stampeded by panicky politicians and a confused public--it always better regulate and say you're sorry later.
Now, according to a press release from the Harvard Mental Health Letter:
While the use of antidepressants increased in the 1990s, the suicide rate among adolescents declined--coincidentally or not--by 31%. And recent autopsy studies have shown that adolescents who commit suicide, even when they have a prescription for an antidepressant, are usually not taking the drug at the time of death. A consensus seems to be emerging that the risk of suicide in children and adolescents taking antidepressants may have been exaggerated.
Of course, if parents and physicians are refusing to let their depressed teenagers take the drugs, that may well have bad consequences too. But never mind that.
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There's a simpler reason for the link between suicide and antidepressants--who takes antidepressants? Depressed people. Who commits suicide? Depressed people.
Blame antidepressants? Or admit they're less than 100% effective?
But America is uncertainty-averse.
I generally have no problem with medication; you have the right to take whatever you want.
But for me, personally, I still don't like the idea of toying with my own brain chemistry (with a few notable exceptions, ahem...)
may have been exaggerated
Scaremongerers? In this country? I don't believe it.
"Of course, if parents and physicians are refusing to let their depressed teenagers take the drugs..."
And do we have any evidence that such a thing is happening?
There seems to be a very small minority of patients who have a really bad reaction to this class of antidepressants. So they put a label on the box telling patients and doctors to keep an eye out.
If we're asserting that patients can make their own decisions about medications without hurting themselves, wouldn't it follow that they can read a warning label without hurting themselves?
If we're asserting that patients can make their own decisions about medications without hurting themselves, wouldn't it follow that they can read a warning label without hurting themselves?
It is a sloppy HnR habit to treat a labelling requirement as a prohibition. Really they are opposite things, at least if the labelling requirement requires info that customers perceive as relevant (cf, Pro Libertate's joke warnings on Preskool Math thd).
If I were the tort jury, I would be a lot less sympathetic to the survivor's of a teen suicide if they were warned ahead of time. If I were the tort judge, the case probably wouldn't even make it to the jury because of the labelling.
Some advocates just don't understand what their client's best interests really are.
Good god, Joe, it's too early in the fuckin' morning for that tortured brand of psuedo-logic!
"And do we have any evidence that such a thing is happening?"
Which is why he used the words "if" and "then" (well, pretty much).
"If we're asserting that patients can make their own decisions about medications without hurting themselves, wouldn't it follow that they can read a warning label without hurting themselves?"
However, given that the FDA and its warning label regime has ultimately established itself as the authority on drug safety...it seems very odd to me that you cannot (or refuse to) understand that, if the FDA grossly exaggerates the hazards of a drug that may be able to help people, and this results in the judgment of some patients (or their caretakers) being incorrectly skewed, then some actual harm may come from it?
What if one person died from a life-safing heart drug. That person was well-connected. Politicians, the media, and the populace push for a harsh warning to be placed on the bottle. Because of this warning, many people are scared off---even though the warning is mostly unfounded. As a result, people die who could have been safed if the FDA hadn't put such a harsh label warning on the med. Is this still okay?
Yes, Joe, folks are still free to make their own decisions---but when the self-appointed authority on something is in error, then that authority should receive the blame.
Dave:
"It is a sloppy HnR habit to treat a labelling requirement as a prohibition. Really they are opposite things, at least if the labelling requirement requires info that customers perceive as relevant"
See my above post to joe. Nobody said anything about a prohibition---but when the authority on med safety fucks up, then it's perfectly acceptable (not "sloppy") to criticize said authority---especially when their screw-up was due to political pressure.
Well, it's also a sloppy HnR habit to accuse participants generally of sloppy habits. I'm all for product safety disclosure, but it doesn't follow that the state should or must require such disclosure. As for tort liability, the question invariably goes to whether the information provided sufficed for purposes of informed consent and / or assumption of risk. A judge would be properly worried about being reversed if he dismissed a case thus precluding the jury's ability to make a finding in that regard.
Yet another lack-of-facts-reality-or-sound-judgement situation...right up there with the follies of Repressed Memory Syndrome, Multiple Personality Disorder and the McMartin Preschool prosecution.
Sad how the combination of ignorance and sensationalism continue to drive public mores.
Good god, Joe, it's too early in the fuckin' morning for that tortured brand of psuedo-logic!
It's also too early in the morning to start beating up on joe...or anyone else for that matter.
Go drink some coffee and take a Paxil.
One of my relatives attempted suicide last month. In response, I did a lot of fact-based research on suicide, using peer-reviewed journals and sources such as the CDC. What I found was that a lot of what people assume they know about suicide is false.
First off, not everyone who commits suicide is depressed. This may be hard to fathom, but depression isn't the first or even the second leading predictor of suicide. The first predictor is isolation and the second is alcohol and drug abuse...
This is really stunning, but most depressed people do not attempt suicide and most people who attempt suicide are not depressed.
Second, the term "chemical imbalance" really doesn't mean anything. There is no clinical test available which will allow a doctor to diagnose depression or suicidal tendency by looking at "brain chemistry". They only know you're depressed by asking you and observing behavior. Depression is not, at least not yet, a disease which can be identified through lab testing - it is merely a description of a certain pattern of behavior.
Third, drugs are not the most effective means of preventing suicide or curing depression. The most effective intervention is "cognitive-behavior therapy" in conjunction with short-term prescription drug use. The second most effective intervention is cognitive-behavior therapy alone. The drugs, by themselves, don't really work very effectively at all.
Fourth, as joe stated, a very small minority of patients have a psycotic reaction to this class of drugs. To withhold this information from the public would be criminal.
on med safety fucks up
That is a pretty harsh assessment of what is going on here. Like global warming, drug side effects can be difficult to suss out. Sometimes things that look like side effects aren't. Sometimes side effects that have been unperceived become perceived. Clinical science may not be as hard as law, but it is still hard.
This particular Reasonwriter now understands that he lives in a greenhouse. He can ease off on the stone throwing. Seems like a problem that is getting worked out rationally and with reasonable dispatch.
To respond to DAR: Tell you what -- you go and make a private safety organization for drugs. Something like the UL, but for drugs. If your private organization establishes a track record of warning patients about drug risks more accurately than the FDA does, presumably because it is not corrupt like gov't, then, and only then, I will join in the quest to disband the FDA. Ball is in your court, Ridgely. Get to! You show us how good you can do and the people will come.
The second most effective intervention is cognitive-behavior therapy alone.
In the beginning, anti-depressants almost excusively were prescribed by psychiatrists as part of larger therapy they oversaw as part of treatment. Now they're prescribed by family practice physicians and referred to counselors.
Unfortunately, most folks just take the drugs and avoid the "stigma"(or hassle) of therapy. Presribing doctors don't follow up. No one is cured.
BTW...as an aside, do you think the makers of anti-depressant want you to know that? Probably not.
...go and make a private safety organization for drugs. Something like the UL, but for drugs.
I think one already exists. I heard about http://www.consumerlab.com on NPR earlier this week. It's new without much track record yet but the concept seems much like what you're going for.
Well... my wife works for Merck so it's not like I'm anti-drug company or anything. From what she has told me, the scientists at these companies are generally complete idealists who only want to cure disease. The same actually goes for the company leadership. The CEO and CFO are already so rich that they are primarily motivated by helping people. The problems all come from the Marketing and Sales groups. Basically, thes salesmen (usually women, actually) are complete scumbags. Their aim is to turn every cure into a maintenance plan.
So, instead of having a depressed person take their drug for six months while getting the therapy they need, their ideal situation is to get people to take these drugs for the rest of thier lives in order to maintain a low-level depression.
seems much like what you're going for.
It is more what DAR is going for. I am skeptical that a private organization is up to this particular challenge. We'll see though. I hope they have a paypal button so DAR can put more behind this effort than mere words.
Evan,
IF the FDA grossly exaggerates the risk of a drug, that would be bad for patients. I don't see any reason to conclude that that has happened in this case. Hence my question about there being any evidence.
The argument seems to be, becasue there's a warning label, the FDA must be grossly exaggerating the risk of the drug. I don't see any reason to suspect that such a thing is happening.
Oh, wait, except that Ron Bailey has told us it is. And when has he ever steered his readers wrong on scientific questions relating to public policy that effects big business?
Oh, wait, except that Ron Bailey has told us it is. And when has he ever steered his readers wrong on scientific questions
joe, please report to the thread on human enhancement.
I trust and love the FDA, and they would never tell me the wrong thing. Because, of course, it's a happy, shiny, benevolent government agency who would never think of lying to poor little citizen me. Mmm, Koolaid.
I trust and love the FDA...(a) benevolent government agency who would never think of lying to poor little citizen me.
They've been so honest about RU486/Morning After pills these days. And about allowing anyone to label their products as "organic."
"The argument seems to be, becasue there's a warning label, the FDA must be grossly exaggerating the risk of the drug. I don't see any reason to suspect that such a thing is happening."
No, Joe, the argument is: The black box warning label that the FDA was pressured into including on this drug has been shown, according to the evidence cited above, to not have any strong connection to suicide. Furthermore, as the WebMD report above shows, the FDA had scant evidence at the time they originally decided to require the warning, which means that not only were they proven to be erroneous, but their original decision was not made without this information.
Since the reason for including the "block box" warning was a supposed connection to suicides, and this connection has been pretty much debunked (and was flimsy to begin with), I don't see why you have "no reason" to suspect that they're exaggerating the correlation. Indeed, you have a very good reason.
"Oh, wait, except that Ron Bailey has told us it is. And when has he ever steered his readers wrong on scientific questions relating to public policy that effects big business?"
Um, Joe, no offense, but you're just a big old asshole sometimes.
Mmm, Koolaid.
MMM, doing something beside bitching:
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Many people who undergo chemotherapy subsequently die of cancer. Seems pretty clear to me that chemotherapy causes cancer.
Many people who undergo chemotherapy subsequently die of cancer. Seems pretty clear to me that chemotherapy causes cancer.
Or maybe it is death itself that causes chemotherapy. Just because we remember things from the past and not the future does not mean that time is moving in the direction we all think it is.
If we're asserting that patients can make their own decisions about medications without hurting themselves, wouldn't it follow that they can read a warning label without hurting themselves?
If the warning label were completely honest, that would be true. But the warning label (according to the article) is an alert "linking the drugs to increased suicidal thoughts and behavior among children and teens taking them." All Bailey is pointing out with the link to Harvard mental Health Letter is that the warning apparently disregards the greater risk that NOT taking the drug as prescribed, another kind of self-medication, may be even more dangerous. This is akin to telling someone to look one way before crossing the street.
As an aside, I get very concerned about the idea of "closely monitoring" mental health patients of this type. There seem to be two common and extremely opposite environments that lead to depression in children (and later, adults). One is emotional neglect, basically the parent(s) ignoring the child. The other is the parent(s) closely monitoring the child to the point of distrust and paralysis. It seems to me a child prescribed this medication but refusing to take it is in some way asserting a chance to make a decision for himself, even though decision-making is a skill the parent(s) kept from developing. At this point, suggesting a patient be closely monitored doesn't really mean anything.
Dave W.,
I am doing something: preparing to retreat from society when people finally realize that there's no turning back.
Or plan B, keeping my nose out of issues I don't fully understand by making jokes. I freely admit to my mild ignorance, hence my return to Academia.
The FDA bowing to external pressures at the expense of solid research is a real problem. As madpad points out, there are a lot of groups out there who are trying to work the FDA. The FDA, like any drug safety evaluator, public or private, needs to base its decisions solely on the science and not on public pressure to be effective.
Side-effect warning do have a chilling effect that harms outcomes when they're not accurate. One of the first questions I ask the doctor about a prescription drug I'm being prescribed are what are the side effects and their frequencies. This warning would be likely to deter usage for adolescents who do have major depression but without suicidal thoughts - the warning labels won't throw off a competent psychiatrist, but general practioners and patient's and their guardians may get the wrong impression.
Personally, I think that antidepressants generally should only be perscribed by a psychiatrist after personally evaluating the patient, since they are very powerful drugs and misdiagnosis of bipolar disorder as depression, where antidepressants will make manic episodes much worse unless paired with a mood stabilzer like lithium.
Taktix,
None of that should prevent u from sending money to the private alternative to the FDA. U can do it all! A 3 year subscription saves u 26%! That's just good bizness.
Because of this warning, many people are scared off---even though the warning is mostly unfounded. As a result, people die who could have been safed if the FDA hadn't put such a harsh label warning on the med. Is this still okay?
Yes, Joe, folks are still free to make their own decisions---but when the self-appointed authority on something is in error, then that authority should receive the blame.
True. One point being missed in the discussion abotu regulatory agneyc responsiblity for the consequences of their labeling requirements is that teens don't have the same type of power adults have to take a drug that benefits them.
Take your scenario, throw a depressed teen with a concerned, or overreactive, parent who decides for the teen that drug is too dangerous, even if it's been working for the teen until now.
There are many parents who would deny their kid the drug rather than face others who would blame them for letting their kid take it if the kid later committed suicide, and yet others who would blame them for taking their kid off the drug if their kid later committed suicide. Kind of a no-win, if you're concerned with others' scorn and blame.
Perhaps we should treat these teens like we would adults, and allow them to decide the course of their treatment given all the available evidence.
Evan,
You are grossly overstating the evidence (and in a manner that supports your political position). Psychotic reactions to antidepressants have been shown to be real, just rare, in those studies you cite. When make a cost/benefit decision, you take into account both the likelihood and severity of an outcome.
Russ 2000, "This is akin to telling someone to look one way before crossing the street." I disagree. By the time a doctor is prescribing the drug, or a patient is having it prescribed to him, they already know about depression and its risks. Everyone is already looking the other way before crossing the street.
Dave W --
Pretty strong overreaction to "but it doesn't follow that the state should or must require such disclosure."
Of course, your challenge is absurd precisely because the FDA controls not only the testing process but the legal availability of those drugs. Eliminate the latter and the rest of it -- the private UL or Consumer Reports services could at least then be tested.
But you wouldn't be willing to run that risk, would you?
Of course, your challenge is absurd precisely because the FDA controls not only the testing process but the legal availability of those drugs.
There are plenty of drugs available for purchase and testing. It is easier to test a drug after it is legal anyway because it becomes much easier to get test subjects. THey should start by testing the ones where they think the FDA warning is either to severe or too cavalier. Then consumerlabs will show the world that a private FDA is the best FDA of all. And, you, DAR, will have helped make it all possible with the seed capital of your 3 year subscription.
Hint: the ccv number is the 3 digits at the end of the long number in the vicinity of the signature block on the reverse side of your VISA card. You may need that in addition to your cc# when ordering.
Do it today!
"Or maybe it is death itself that causes chemotherapy. Just because we remember things from the past and not the future does not mean that time is moving in the direction we all think it is."
You believe this, yet they actually let you into a court room?
Jesus.
I dunno, joe. When I cross a one-way street, I still look both ways.
Dave W.:
Please at least try to know what you're talking about before posting. ConsumerLab.com tests nutrional suplements, which explicitly fall outside of the FDA's safety and efficacy testing for drugs and typically contain a little warning saying the FDA hasn't evaluated them. Since these aren't evaluated by the FDA, unsurprisingly, a private company has got into the business of doing so. If you do use a lot of nutritional supplements, it may be a good idea to suscribe, just like you may want to check out the relevant Consumer Reports tests before making a major purchase, but this doesn't overlap with the FDA's drug regulation regime.
I note my question was not answered.
But you wouldn't be willing to run that risk, would you?
It is not that I am or am not willing to take the risk -- this is just a timing issue. You build up the alternative real good first and show it to be superior. At that point, I will buy in, too. Not earlier because I want to see this scheme work before I tear down the existing protections. There is absolutely nothing stopping Consumerlabs except the fact that you haven't sent in your money yet. The sooner you enable them, the sooner they will win me over to your approach. Simple, really. (They have gift subscriptions too, hint, hint.)
ConsumerLab.com tests nutrional suplements. . . Consumer Reports tests before making a major purchase, but this doesn't overlap with the FDA's drug regulation regime.
Not now because they don't have enough funds. It costs money to build a private FDA just like it takes money to build a private lighthouse. Sometimes the lighthouse has to start modest before making one of those big lighthouses like they have in the Simpsons episode where the hot pants ship crashes.
Don't let this initial period of modesty discourage you MattXIV because you hold the key to the future. A bright future with a real beacon on a hill of a private FDA. This long journey starts with just your small subscription, an the payments of everybody else dissatisfied with the FDA we got now. I know you don't need the dumb newsletter -- you need a private FDA -- and ConsumerLabs is the most promising start -- a very promising start indeed.
If you are nervous about paying over the Internet with a cc (and what libertarian isn't) then you can send a check -- a check as big as your dreams for the future of your kids n grandkids!
Do it today.
Not earlier because I want to see this scheme work before I tear down the existing protections.
Short version: no.
Dave W.:
To get into more detail, although I suspect it's futile with you...
There are already efficacy trials conducted outside of the FDA process by drug companies and others. This information is actively used by physicians in a practice known as "off-label" prescribing, where a drug is prescribed for a condition which it has not been evaluated for efficacy for that particular condition by the FDA. This is an accepted part of medical practice. Sometimes FDA approval for these additional uses will also be obtained if it doesn't require too much additional work.
Before the drug gets to that point, the FDA has to approve the drug as safe and effective for at least one condition. Until it reaches that point, the drug cannot be prescribed. The problem with this is that the FDA has a "one-size-fits-all" outlook on safety and efficacy and bans drugs that do not fit it. Having an alternate organization do the safety evaluation as well is futile as long as the FDA prohibits proscribing drugs that don't meet it's requirements, since if you get a positive for safety while the FDA gets a negative, you can't use the drug anyway and when someone else finds evidence that a drug isn't safe, the FDA tends to pick up on it quickly. The FDA does not actually fund the trials - the drug companies do. What the FDA does is set the requirements for the trials it will accept and analyze the results. The actual body of drug efficacy and safety research goes far beyond the range of FDA-required trials. The real question is whether the FDA should have the authority to ban prescribing or mandate labels based on its evaluation of that body of knowledge.
Consumerlabs does content assays of nutritional supplements. What they do is closer to generating the nutrional labels on food, but they do it for ingredients and products that the normal labels don't apply to. I doubt they have the right personel or resources for evaluating, let alone doing, drug trials.
Gosh, it is almost like that lighthouse will never get built. I wonder if they have a name for this sort of problem.
Dave W.:
At first I though maybe you hadn't read the site you linked to in detail. Then I though you just didn't know how drug research is actually done. Now I think you have a psychological condition where you can only derive sexual satisfaction from making unpersuasive arguments - I'm think I'm going to start calling that problem Dave W. Syndrome.
here's a hint:
http://en.wikipedia.org/wiki/Public_good
Man, that was satisfying. I'm beat. I feel like I could drink a raw egg!
Wow - Dave W. might be as dumb as joe! I didn't think it was possible...
I wish. joe has a knack for saying things that I either didn't know or didn't think of.
I'm totally Artiste. Yeah, I do see some of you as Capitalista sometimes.
~30 years ago the AMA published a book of its own drug evaluations. That was probably in response to slow FDA action on their own evaluation of pre-1962 drugs for efficacy.
Consumer Reports did publish Brecher's compendium on ilicit & illicit drugs around the same time.
The USP is a private drug standards formulating organiz'n.
Dave W -
I think they have a name that explains the reason for the "never built the lighthouse" metaphor - it's called a government monopoly - not a public good.
Not to mention the fact that the whole notion of the lighthouse as a public good only government could or would provide is wrong as a matter of historical fact. See "The Lighthouse in Economics." Journal of Law and Economics 17, no. 2 (October 1974): 357-76.
Are you saying that Coase's article destroys the entire notion of a public good, or are you saying that the lighthouse is not truly a public good despite the fact that it is often used (as I am doing here) as a pedagogical example?