July 11, 2008

Politics In The Suicide Black Box Decision For Bipolar, Epilepsy Meds

As some of you know, yesterday the FDA's psychopharmacology advisory committee declined to approve the FDA's recommendation that a black box warning be added to 11 anti-seizure drugs used to treat bipolar disorder and epilepsy. I've not seen a lot of press on the decision yet, so the committee's reasoning is not clear to me, but you can glean a bit from this early piece by the Dow Jones News Service:

"Panel members raised concerns about the unintended consequences of adding a black-box warnings to epilepsy [drugs], saying such a move would make doctors wary of prescribing the drugs.

"Panel member Sean Hennessy, a doctor, said he thinks there should be an additional warning on epilepsy drug labels, but added the FDA's analysis shows suicidal risks are 'modest.'

"'To me (the data) says there ought to be a warning, but given what we know about the effects on prescribing, I don't know if they rise to the level of a black box,' Hennessy said.

"GlaxoSmithKline Plc's (GSK) Jack Modell, vice president of clinical development, said his company believes additional warnings should be included on the label. An FDA analysis showed that Glaxo's epilepsy drug Lamictal had a higher increased risk of suicidal behavior and suicidal thoughts than other drugs."

Basically what went down is the committee ended up voting to approve warning language for suicide risks--I've not seen the language--but felt that a black box was going too far and that adding a black box would dilute the meaning of other black boxes because the level of risk of suicide wasn't high enough. I'm curious if Hennessy and his colleagues have in mind a number of suicides that would justify a black box because they clearly don't get that one suicide is one suicide too many.

What's more, I'm confused as to what effect on prescribing Hennessy means because I don't see any data to support the notion that anti-depressant use or atypical antipsychotic use has decreased as a result of the black boxes added to those drugs in 2004. In fact, prescriptions for both classes of drugs are now higher than in 2004. So what the hell were they thinking? And wouldn't warning language say the same thing as a black box warning sans the bordered box? I find these kind of political semantics discouraging.

Suicide is suicide and if it can be connected to the use of a drug, then the public and doctors should be warned and the appropriate method is via a black box. Anyway, it'll be interesting to see how the lone consumer representative on the panel voted.

One side note: it's interesting to me that most of the press coverage in advance of the committee hearing acted as if the anti-seizure drugs "epilepsy drugs." I hate to nitpick my colleagues in the press, but at least 50 percent, if not more, of the sales of these drugs are for their use in treating bipolar disorder.

Posted by Philip Dawdy at July 11, 2008 12:03 AM
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This is alarming, and so are the withdrawal symptoms re: Lamictal. This drug (my opinion)gives a temporary high, that could/can last as long as the user needs it.

*speaking from experience.

Wow: good for the drug industry, so glad they have it all together.

Posted by: Stephany at July 10, 2008 10:30 PM

just as i thought: here's a member of the committee who thinks that doing a black box warning would scare patients off their meds. typical bullshit. maybe if we could count on docs to be up to date on this type of information, there would be no need to have the info highlighted so prominently. from bloomberg:

"'Are we doing this in the best interest of the patients?' asked panel member Rochelle Caplan, a psychiatry professor at the University of California at Los Angeles. 'If we have good drugs and we have drugs that are working, you need to be very careful about scaring the patients.'"

fortunately, the fda isn't bound to follow the committee's recommendation, so we'll see what happens here.

Posted by: Philip Dawdy at July 11, 2008 10:25 AM

Shouldn't a patient be scared off of a medication that will make his or her death more likely? What if this was pot they were talking about? Now another bind for those of us labeled as smi, if we take the meds, were' crazy because taking a drug that will make it more likely you'll commit suicide is suicidal, and if we don't take the drugs we're crazy because, uh, help me out, I can't think of a sane reason to take drug that will make your death more likely. And there are some who wonder why all of those mental patients are anxious and angry.

Posted by: Sally at July 11, 2008 11:11 AM

Honestly it's so patronizing of doctors, professionals and regulatory authorities to decide what they think is in the best interest of patients and to decide for the patients what level of fear is appropriate to impart regarding a given side effect. I think as much information as possible should be prominently and clearly displayed, not obfuscated in the PDR or some wordy insert in miniscule print and technical language. People need to be forewarned that suicidal thinking and behavior is a distinct possibility and what exactly that is likely to look like. The powers that be managed to keep this out of a black box because, unlike antidepressants, they were able to demonstrate efficacy, at least in seizures. So fine -- that deserves to be on the label too and let the patient decide and be properly prepared. Just like mood disorders, there are alternatives in the form of diet and neurofeedback that can help in the regulation of seizures and patients need to be motivated to pay attention to these so, if they still have to use medications, it can be at the lowest possible dose.

Posted by: Sara at July 11, 2008 03:16 PM

that scare tactic is complete bullshit. let's just ignore suicidal ideation and actions as a result of these meds. fucking hell, i witnessed the same reaction in my daughter on depakote as luvox, impramine, zoloft and prozac.

fine. let them turn their backs for 4 more years until it finally ends up on a black box warning.

i wonder how many ppl will be dead by then.

Posted by: Stephany at July 11, 2008 05:00 PM

Epilepsy is a serious condition and one rife with it's own universe of discrimination, misdiagnoses and misunderstanding. It's possible that the risk of death from a grand mal seizure might be greater than the risk of death from suicide caused by the drugs, however, it's also true that there are lots of anti-seizure meds that are not on the list, plenty of options, cheaper, more effective options for epileptics still available with no risk of suicide.

Posted by: Sally at July 11, 2008 06:05 PM

well yeah Sally, but when these drugs are given to kids and adults for bipolar disorder, it's a whole new ball game. my dog has grand mal seizures and is on Phenobarb, which reduced/stopped the seizures and caused him to go berserk instead.

Posted by: Stephany at July 12, 2008 03:30 AM

Yes, I know folks are on the drugs for bipolar and as you know largely because of the increased suicide risk that supposedly bipolar folks face off meds - so they prescribe drugs that cause suicide! You're much better at articulating the outrage and understanding the biochemistry. I shudder to think that had I ever filled the prescriptions I was given for trileptal (sp), I would have had an increased chance of suicide at a very hard, sad time in my life, and then I left the hospital with a 10,000 bill and a prescription for almost 800.00 worth of drugs a month and the record of a pre-existing condition that would make health insurance, among other things impossible, not to mention the zyprexa which would have worked wonders on my congenital heart problems and chunkiness I'm sure. Ironically, it's not having any way to pay for the drugs that probably saved my life.

And I realize that compared to most my experience is so mild that it seems like nothing. The carnage is horrific.

I've worked with epileptics who are for all intents and purposes legally forced to take anti-seizure meds so I feel for these folks too.

Posted by: Sally at July 12, 2008 12:56 PM

When my daughter was prescribed lamictal for bipolar depression, she was suicidal but the doc, a member of the Glaxo Lamictal "Group" made no mention of any danger from the drug. The danger started immediately, followed a hormonal cycle, and we lived through our most scary suicidal times on this crap until she tapered down in a hospital.

I wonder whose arms were twisted to tac the bipolar depression use onto the epilepsy use in these drugs and what clinical trials there actually are. And I, too, am so insulted at the doctors who used the old Zyprexa excuse - "Don't scare them or, God forbid, they might stop taking the drug."

Posted by: sorrowful at July 13, 2008 07:53 AM

Interesting this about these drugs? same as SSRI's or antipsychotics....not one class has long-term efficacy stats that prove they actually help, in all reality they have stats that show more adverse effects, that good results. The scare tactic is a pharma PR fueled agenda, not an agenda to promote healthy human beings. Honest to God, show me empty psych wards, show me psychiatrists without full schedules, show me people who haven't trialed 3-20 medications and are still suffering.

It's all about drug industry profit!

Posted by: Stephany at July 13, 2008 01:05 PM

I read this posting and have to offer this to objective readers and those who have other medical issues who have been affected by black box warnings:

I'm sorry I cannot state the specific drug that was recalled for treating inflammatory bowel syndrome about 4 to 6 years ago, but what I gleemed from the experience was this:
A new drug comes out, that gets oversold as a first line indication and too many docs write for it like pez, and when mortality issues arise, albeit not a large percentage, it gets pulled from the market and not available to anyone. The reality turns out to be the drug has an indication as a second or third line intervention, but because human nature is one of a pendulum mentality, we go from overuse to no use, thus depriving responsible physicians and patients from accessing a treatment modality that could have a legitimate impact for a sizeable population in the end.

So, bringing it back to here, if the goal of some zealots is to see all psychiatric drugs, or ones with psychiatric impacts, be removed from the market, sounds like the agenda doesn't serve the overall population if the healthy agenda is to mark such a medication as a later choice in the treatment process. I've seen antiseizure meds do wonders for a good number of patients; the trick is slow titration and get to a lowest endpoint dose to minimize side effects while maximizing the positive endpoint.

It is fascinating to see this drug class (antisz meds) help certain types of psychiatric patients. I would agree they are not a first line indication for some diagnoses, but in the end, what is the goal of a black box warning: to minimize use to a point where the FDA can almost guarantee little to no consequences, so they look good.

From the perspective of the adage--least to most invasive--a lot of psychiatric drugs should be viewed this way. So maybe therapy has a place early on in the treatment process that has been shoved, if not buried, to the bottom of treatment interventions for almost purely financial reasons when it comes to insurance reimbursement.

Think about that a bit, folks. Maybe if doctors get back to the right standard of care, we'll see less toxic issues 'cause less meds are being prescribed.

Pay attention to who advocates for what, and then look behind the scenes. Innocent, responsible people have no one behind them; the others, well, just look for the shields and distractions.

Just my opinion.

Posted by: therapyfirst at July 13, 2008 01:14 PM

Yes, TF I am biased, no doubt about it. When I've witnessed my daughter trial nearly 20 drugs and end up without a mind as a 20 year old, hoping to God Clozaril doesn't kill her--and after spending hundreds of hours in 4 psych wards over the last 3 years, getting to know hundreds of patients (having a larger experience than most psych's I've met over the years) being inside of psych wards, I can safely say that I've seen a handful, like maybe 3 patients out of HUNDREDS be helped by these drugs.

This is a personal experience story not an attack on the psych profession.

I have an extensive insider background, and it's one that I cannot EVER ingore.

Posted by: Stephany at July 13, 2008 02:00 PM

PS this is why I am a mental health advocate, and I also would like to toss this out as a disclaimer: I never tell people NOT to take these meds. I advocate for people who do not have a voice in this system, and frankly that means all consumers.

Imagine navigating these waters as a parent-who learned the ropes to take a doctor to court and prevent a child from institutionalization and winning. I am not an attorney, I just see what is wrong and fix it.

Being strapped to a gurney being injected with Haldol is forced treatment and silencing of patients and most of the time I witnessed it, it was women.

Sorry for the rant everyone, I'm repeating myself.

Posted by: Stephany at July 13, 2008 02:05 PM

This is not an article about banning these drugs. I'm not sure why anyone would get the idea it was, still, when we look at the purported criteria for making a drug illegal, drugs like marijuana and heroin are illegal supposedly because they make insanity more likely, and what are these drugs doing? When someone commits suicide, the ripple effect harms society.

Correct me if I'm wrong, but I believe the black box warning only effects 11 anti seizure drugs, and also that all anti seizure drugs are major tranquilizers. For people who "need" another drug in this class, there are safer alternatives.

With bipolar, the warning is especially necessary, because this condition is over diagnosed, and then these folks are in my area prescribed trilepta as a first resort, then when they get worse, it's attributed to the bipolar getting worse and the dosage is increased, the dosage of drugs that cause the symptoms the meds are supposedly trying to prevent. It's like giving an cancer patient a drug that causes cancer.


Posted by: Sally at July 14, 2008 04:21 AM
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