So For All You Heavy Drinkers That May Be Addicted And Want To Quit…? Get Yourself Some Topamax!

October 10, 2007 in Bipolar Disorder, Facts About Patient Anonymous, Health, Medicine, Meds, Migraines, Neat Neuro Stuff, Patient Advocacy, Seizures, You Decide

Oh.My.God. I just about had a Simple Partial Seizure when I read this, for which I do take this med (among other things…)

I don’t even know where to start. It must be my week (or a few days?) to get hit with a Big Pharma blast as yes (of course?) they were involved in this. Not to mention some rather overzealous researchers? Or ill informed ones? Granted, I am not a scientist, nor a M.D., nor a statistician…nor…nor…nor…

However.

Take a look at this article: Pill Helps Alcoholics Taper Off Drinking. Now, I usually link to msn.com as I think their links stay live but I’m not sure. I haven’t gone back and checked them from older posts and no one has told me that they ended up in error or you need to pay for subscriber services, archives or anything. Nonetheless, forgive me AP for drawing attention to some highlights. That maybe a naughty in the reproduction department but I did link to the original which is fine. And no one is making money from me so sue me for the “parts” I reproduce. I’m just a wee mental case blogger with an opinion. Not many people read me anyway?

But I really need to talk about this.

First off in this very tiny blurb about Topamax/Topiramate and it being used as a treatment for alcoholism, they refer to it as a “migraine med.” Okay, perhaps I am being picky but Topamax is primarily used to treat seizures. It is an Anticonvulsant.  For migraines, it is used in prophylaxis. It is not the same as an abortive. So skipping ahead, when people read this, will they say in the same vein with preventing alcoholism, “Gee, doc’…my migraines are killing me. Can I pop some Topamax when they get bad?” Then the doctors, neuros etc… have a bloody flip out as they can’t deal with uneducated patients asking for crap they know nothing about. Think of all the adverts you see on television now for this drug and that drug…

“Talk to your doctor if this is the right drug for you!” Again…thank you Big Pharma. I have read posts on doctors’ blogs who absolutely hate these ads!

Alright, time for some excerpts for those of you who have not clicked on the above link. And I will apologize here. This is going to be a long post.

Now, before I get into the AP stuff, there is a link there that will take you to the study published in JAMA (The Journal of the American Medical Association.) At the moment, the study is free to read but it will probably disappear in a week. Yes. If you are not a subscriber, you will have to wait six months to read it! And again, that is if the link on msn.com survives! So you’ll just have to take my amateurish word re: the JAMA stuff.

Okay, let’s have some fun! From the AP blurb on msn.com:

Experts said the drug is likely to appeal to heavy drinkers who would rather seek help from their own doctors, rather than enter a rehab clinic to dry out.

No fucking kidding! Rehab’s a drag! Let’s just pop a pill–even if it doesn’t work!

Addiction specialists not involved in the study said the findings are promising, although side effects such as trouble concentrating, tingling and itching caused about one in five people to drop out of the study.

I’ll tackle this when I get to JAMA. But I had the first two with Topamax and they went away with time. I still have trouble concentrating but that’s more to do with the ADD.

The study, published in Wednesday’s Journal of the American Medical Association, was funded by the maker of the drug, Johnson & Johnson Inc.’s Ortho-McNeil Neurologics. The researchers also reported financial ties to the company. Ortho-McNeil reviewed the manuscript, but did not change the results or interpretation, the researchers reported.

Well, good bloody god, I hope not!

“You can come in drinking a bottle of scotch a day and get treatment without detox,” said Dr. Bankole Johnson of the University of Virginia, who led the study, which was conducted at 17 U.S. sites from 2004-2006.

Bankole’s so positive you know. Despite that fact, I think he might have been just about the only one not mentioned on the Financial Disclosure of the JAMA study? However he was involved in The Lancet’s prior dalliance with this where the JAMA study got their “magic number” (as I call it) dosage of Topamax for this engagement. Again, why the hell people dropped out?

The study didn’t follow the drinkers long-term, so it’s unclear how many relapsed after they stopped taking the pill.

This is actually accurate reporting. The JAMA study states this. So, erm…who the hell knows? Addiction is addiction. Or, having problems with drinking, is simply that. People fall off the wagon all the time! How do you know if your study works if you don’t track your outcomes over time? Especially with something as tenuous as this?

But there were lasting effects for Tom Wolfe, 44, a carpenter from Earlysville, Va., who said he has been sober for two years thanks to Topamax. After years of heavy drinking, he took part in an earlier Topamax study. He felt “a little lightheaded” at first until he got used to the drug. Alcohol lost its enjoyment, strengthening his resolve to quit.

“It’s been a miracle to me,” Wolfe said. “It got the monkey off my back.”

Ah, nothing like a good testimonial to drive it home, right kids?

The drug works by inhibiting dopamine, the brain’s “feel-good” neurotransmitters that are involved in all addictions, said Stephen Dewey, a neuroscientist the Brookhaven National Laboratory, who was not involved in the study but does similar research.

It’s a new approach, he said, that “clearly did work on a very small subset in the population.”

Okay, Dewey. Were you misquoted here? Fair enough it does theoretically inhibit dopamine but lets not forget about GABA and glutamate? They are also possible neurotransmitters that are involved? It’s not just about knocking out pleasure seeking. Remember, this is primarily an Anticonvulsant and dopamine is not necessarily thought to be involved in causing seizures. Otherwise, we could throw people with epilepsy and seizure disorders on a bunch of Antipsychotics! Granted they generally hit the D2 receptors…theoretically.  Regardless…there is more to Topamax than dopamine.

As a matter of fact, if I may go on my typical little speech about Topamax, it is a Temporal Lobe drug. It hits your Temporal Lobe hard. That is why it is considered “hit or miss” for people with Bipolar. For seizures, it’s a little more interesting as they seem to know a bit more about them–possibly. Dependent upon what type of seizures you may be having, a better Anticonvulsant might work for you (i.e. there are usually preferred ones for absence seizures etc… or at least ones to try first.) And, you may even get lucky with a physiological issue during an MRI scan (well, usually that may not be so “lucky…”) or something might be caught on an EEG to help you along. For migraine prophylaxis, who the hell knows as even less is understood about them!

As for Dewey’s latter statement, broad and sweeping and of no relevance, thank you.

Willenbring, who wrote an accompanying editorial, predicts that a future pill, although probably not Topamax, will do for alcohol dependence what Prozac did for depression: Remove the stigma.

Prozac changed the nature of depression treatment 20 years ago by allowing patients to see their family doctors for help, Willenbring said. An effective drug with few side effects could do the same for alcoholism treatment, he said.

Oh.My.God (Part II) Who the hell is this guy?! Just exactly what did Prozac do to remove the stigma of Depression or mental illness? When has any drug done that? A lot of times, when uninformed people hear you’re on meds they can get totally freaked out! And when Prozac came out, it was one of the most overprescribed drugs on the market! And an “effective drug with few side effects.” Ohhhh…I’d like to see just one pharmaceutical company produce one of those–for anything!

And yes, here’s his finest moment:

“This is a huge market,” Willenbring said. “We’re approaching a Prozac moment.”

Ironically, on msn.com this was somehow posted under the url of http://news.moneycentral.msn.com.(etc…) That’s just too hilarious. Or not.

Okay, this is kind of weird:

But Topamax has big obstacles. With the drug maker’s patent expiring next year, there won’t be any big push to advertise it for alcoholism, Willenbring said.

Maybe I’m not up on my FDA patents but the Canadian patent expired a while ago and I have to take the generic due to my drug plan’s stipulations. Ah well…at this point, I’m too tired to bother looking it up and you still have to deal with me going through the JAMA article!

On Tuesday, Dr. Sidney Wolfe, director of Public Citizen’s health research group, sent a protest letter to the U.S. Food and Drug Administration questioning the promotion of Topamax for alcoholics by researchers funded by Ortho-McNeil.

“This is a very bad message to send out,” Wolfe said.

Well, Hallelujah! At least someone’s paying attention besides wee PA!

Are you all still with me or falling asleep yet? Alright, I’ll try to keep the JAMA stuff brief.

Alright, so JAMA at least touched upon a bit of the glutamate stuff so that’s decent. And again, they proposed the study as a hypothesis (hello?) so it wasn’t so ridiculously posed as the media spun it.

Okay, they ran the dosage up to 300mg of Topamax (my “magic number,” right?) According to the JAMA study (from what I can gather from a notation) this was derived from a 2003 study that was published in The Lancet. Recall, happy Bankole Johnson? He was in on that one.

Now if you can jump on the JAMA study before it disappears and look at the titration schedule, well ‘geez, it’s no wonder some of the people went a little loopy and started bolting before it was completed! I mean, wow, they were titrating everyone 25mg every week! What happened to the rule of a slow and steady titration! When I looked a the chart I was just…

*PA shakes head*

I’m trying to recall my titration and if it was that fast and I don’t think it was. I’m pretty sure I went up 25mg every two weeks? Or maybe I didn’t. Maybe I did initially do 25mg a week with Dr. Asshole my ex-GP and then slowed it down? Either way…woo! I was pretty out there. And I’m on 200mg now. Good enough for me doing triple duty: Bipolar, Seizures and Migraines (although I ended up needing an adjunct for seizures–well, for Bipolar too.) Regardless, everyone is different but that is my point. Slap, bang! Let’s just ramp everyone up to 300mg!

Understood, I get that you need to have some sort of gauge in your study but also, when I looked at the table as well to show the adverse effects of Topamax participants vs. placebo…interesting variance in some cases? Certainly more than what you might see on something more generic like rxlist.com? Wasn’t anyone paying attention to prior research? At least they admitted in their limitations that their titration rates were too high. Well, duh.

Other limitations that they excluded were a significantly(?) large population of people that might have addiction problems? Yes, indeed…they called their population “…relatively healthier and more homogenous…” Okay, so how do the rest of the sickos and those with comorbidities work out? Not so well?

And yes…no follow up, period. But they were quite happy with their study results nonetheless and concluded as such:

Our finding in this study that topiramate is a safe and consistently efficacious medication for treating alcohol dependence is scientifically and clinically important. Alcoholism ranks third and fifth on the US and global burdens of disease, respectively. Discovering pharmacological agents such as topiramate that improve drinking outcomes can make a major contribution to global health. Because topiramate pharmacotherapy can be paired with a brief intervention deliverable by nonspecialist health practitioners, a next step would be to examine its efficacy in community practice settings.

Please…please…no.