Thursday, March 27, 2008

You Would Think Someone Would Notice A Suicide Or Two During Testing


I know this is a gossip blog, but it is also my blog, and so I can do pretty much whatever the hell I want. I had just finished the story about the NY subway worker who has a rags to riches screenwriting story and you can read about that here.

After reading that story I had a smile on my face, and was genuinely happy for the guy, and then another story caught my eye. Apparently the FDA is investigating the drug Singulair which is made by Merck to treat "stuffy noses, sneezing, and other allergy symptoms as well as asthma."

Why is the FDA investigating? Well it seems when you have a stuff nose and take Singulair, one of the side effects is that you get suicidal thoughts. WTF? Look I get allergies sometimes, but I would much rather just be f**king miserable for a few weeks, rather than take some pill which will only work for a few hours on the allergy, but might leave me dead before it wears off.

How did someone not discover this before the drug was approved? Did they test the drug in a mental hospital and so no one noticed if the suicide rate went up while it was being tested? Someone must have noticed somewhere. After the drug hit the markets, and after Merck became aware they were probably going to get their asses sued on a fairly regular basis, they added this list of side effects to the label: risk of tremors, depression, anxiousness and suicidal behavior.

I can hear the television commercial now. A really kind female voice is talking in the background while a couple are enjoying a hike through the forest. "Although side effects are rare, they may include rashes, red skin, tremors, depression, anxiousness, or a desire to kill yourself. Notify your doctor if any of these occur. Of course should you kill yourself before you can get an appointment with your doctor, then at least you won't be suffering from allergies."

The FDA is also reviewing Accolate and Zyflo, but has not determined if they make you want to kill yourself or not. I thought the idea was that they were supposed to do all this reviewing and testing BEFORE people started taking it.

34 comments:

Kat said...

You know, I am really sickened by the state of things with regard to pharmaceutical companies. Sure, there are so many drugs out there which benefit us at times when we need them, but the fact that others seem to come with so many side-effects makes me really angry.

My sister attempted suicide some years ago and thankfully, she survived it. Just recently I heard that Accutane, an acne medication, has been linked to suicide and depression, and sure enough, she'd been taking it then.

I am thinking all the holistic health practitioners out there are the ones who have it right. We need to stop with all the chemicals and get back to basics.

If you have allergies, get a kleenex. Better than a gun!

YahMoBThere said...

EL wrote:
"I know this is a gossip blog, but it is also my blog, and so I can do pretty much whatever the hell I want."


Haha....think that will keep the complainers from complaining???

The pharmaceutical industry is corrupt. They've got Washington in their hip pocket and they do whatever they like. They don't pull a drug until they have something to replace it with because they don't want to lose money. They falsify test results and lie to the public as well as to the FDA. They also re-brand drugs, so if they find out that the side effect of a drug being taken for headaches stops arthritis pain, for example, they rebrand it with another name and market it as a new drug. In fact, they rebrand first generation drugs long after they've been out of commission just to get more profits w/o having to do any research. Very little profit goes toward research - they just keep reinventing the same wheel.

By the way, Singulair isn't the only drug that causes thoughts of suicide - there's Accutane which is taken for acne and many teens have killed themselves, including a politicians child and even HE cannot get the damn junk off the market. It's frightening how much power they have. You think Thank You for Smoking was bad - I hope someone comes out with a documentary or movie about big pharma. Their execs are no better than those in the tobacco industry - and I hope they all burn in hell.

Sorry - this is a hot button for me, can you tell?

ablake said...

There is another somewhat innocous drug that is being quietly recalled as well, for the same reason. Not sure (I'll look it up) but it's pretty much one of those 'wtf...suicidal?'

Seems the FDA needs to be a bit more stringent before they approve things for multi billion dollar companies.

Then again, therein probably lies the reason why they don't.

surfer said...

Paxil is another one of those drugs. There were quite a number of teenagers who took their life while being on this drug. Got quite a bit of publicity too.

jax said...

one more reason i love being in Canada, they test test test and retest just for giggles.

no offense to my american peeps but TS is right it is corrupt as f*ck.

ps can anyone tell me why in gods name the most common profession of reality stars are Pharmecutical Reps?? I swaer there are at least 2 in every Bachelor etc.

califblondy said...

ps can anyone tell me why in gods name the most common profession of reality stars are Pharmecutical Reps?? I swaer there are at least 2 in every Bachelor etc.

Jax, reading through the posts, I was going to write the same thing. How many pharmecutical reps can there be? I've always throught it has to be another term for "unemployed." You're right, they do seem to turn up on the Bachelor. Hmmm, I wonder why? I know it takes drugs to watch the show, maybe it takes more than the free-flowing alcohol to be a contestant?

Anonymous said...

Lately FDA has approve some medication that now are coming out to be dangerous for some other reason. I keep saying why did they not find these before they were sold to the public. Shouldn't someone start investing the FDA as to why they aren't doing their job. Is money that important that they don't give a damn about the people?

YahMoBThere said...

Califblondy, pharmaceutical companies hire young, reps that look like models. They pay them BIG BIG BUCKS to sell their wares to busy doctors, and it works. A good pharmaceutical rep for a big company can earn over $200K without batting an eye.

Jax, I try to follow the U.K. when it comes to drugs. Anything they've black boxed, I pretty much stay away from, because they react quicker than the U.S. does, too.

Ask A Hooker said...

Heh if the image of a pharmaceutical rep is anything like that of Heather Locklear playing one on Scrubs, then the reason the Bachelor has so many of them, is because they're all bimbos :) I imagine it doesn't hurt for a pharmaceutical rep to be super hot!

r said...

Chantix, the antismoking drug causes suicide as well if it is stopped suddenly. Google it.

oka said...

Fat, brunette mom of two, pharma rep here.

80% of pharma reps are madison avenue talking heads that deliver samples.

20% of pharma reps, care about patients, so they work with doctors, nurses and advocacy groups to keep patients educated about their disease, as well as provide the information needed to recieve free, or reduced price drug through many pharma companies. Check out Partnership for Prescription Assistance.

I work with neurologists and psychs because my products treat Bipolar Disorder, Epilepsy, and Parkinson's Disease.

My sister took her life a year ago today. She didn't want to take her meds for bipolar because they made her fat.

Sometimes it's better to have a side effect on a drug than no drug at all.

Anonymous said...

Ok, I'm going to defend the bastards because I'm one of them.

I work in psychiatric clinical research on the site level (where research subjects are seen). Our cost of seeing 1 patient is (depending on the length of a trial) is $6000-12000 usually. It usually costs us about $2500-5000 to find just one person who qualifies and wants to be in the study. Multiply that by 3000 for the course of all the patients that need to be seen before it's even sent to the FDA. Now, that's just my time.

On pharma's time, I usually deal with 4-8 people who have already spent a good 6-12 months on this, and have at least 3-6 months after I'm done seeing subjects. Toss in the chemists who develop these drugs and the cost of making them and shipping them out to the sites.

I'm not saying that there isn't some fat that could be trimmed (FedEx/UPS/DHL makes a mint of these guys for all the crap that gets overnighted that could be emailed/faxed).

And then triple it again, because for every drug that is approved, there are 3-5 that didn't get approved. That's a LOT of money.

TS is right about the lobbyists and rebranding. I take a little bit of offense to falsifying results, but only because we don't falsify at our site, but we have heard of other sites that do.

And do you know how side effects are determined? We ask subjects if there is anything that they notice that's different. If they don't tell us and it doesn't show up on labs/ekg/assessments, it doesn't get reported. And then the doc at the site determines how likely it is to be related to drug. And then it gets sent to pharma, who then compiles everything. That is why you typically see side effects added well after something is on the market is because once it's in use in the general population, you get all sorts of interactions and people with other health issues going on that interact.

Mother Campfire said...

Also - there is a suit against the makers of Chantix, the anti-smoking drugs because it leads the users to suicide. Something about changing dopamine levels so that the smokers can't have pleasure while smoking. Ends up it effects your pleasure sensors for everything and you end up killing yourself. Yay.

Cancer doesn't sound so bad.

YahMoBThere said...

Oka, I'm so sorry about your loss. How devastating that must be.

DN, don't take offense, I know there are plenty of honest reps out there, but Oka's 20% doesn't seem unreasonable to me, and as you say - you know others ARE falsifying results.

And speaking of side effects, it's only been within the past 20 years or so that women were even included in testing of drugs. Prior to that it was only men.

Yeah, I could post all day long about this. I've read plenty and it's really one of my hot buttons.

r said...

And if they didn't flood the doctor's offices and hospitals with useless crap like branded logo clipboards, pens, stress relief balls, that might cut some costs too.

Anonymous said...

Don't know if this is a stupid question but is their a website that will give more information on a medicated drug besides the side effect you read on the label?

YahMoBThere said...

YES Rebecca, and how about flooding the doctors offices with LUNCHES every day? I have two doctor friends. One refuses the lunches and the other takes them. They just have to sit through a little 15 minute talk about drugs specific to that drug reps company and then they get their free lunch.

Guess who pays for those lunches? There's a reason the mark up on drugs is ridiculously high, and it has nothing to do with research dollars.

YahMoBThere said...

Great question, Sylvia. Try just googling the name of the drug + side effects and also check out www.drugs.com. It's a start.

jax said...

i read that too TS,something about it being against the law to test on child baring age women.
scary all the results we thought were fool proof weren't even tested on young fertile women.

"Breast cancer, party of thousands!"

OKA- i am so sorry for your sister.

surfer said...

oka, i'm so sorry about your sister.

What a nice change of pace, to see smart dialogue, rather than the usual nit-picking. Very interesting comments from oka and dn (others too!).

ajurk said...

I took rozerem (sleeping pill, commercial with the bever and ab lincoln). i took it for two nights, on the third day, i wanted to kill myself. i had never had a suicidal thought EVER before this. i thought that i was worthless and did not deserve to live and would have driven myself off of the side of the road if it wasnt for a friend calling me while i was driving home that night. i went home and read about rozerem and i did find that it can cause suicidal thoughts, but to keep taking it and the thoughts would go away. i choose insomnia over feeling like that.

the unfortunate part of this is a lot of people experience different side effects. if i react to a medication, it usually falls under the most rare side effects category. but i also take adderall and it always me to read and drive without killing people because i have zero attention span. my co-workers abuse adderall and they tell me its like coke but without feeling like crap the next day. if only i felt that when i take it...

The Dude Abides said...

Every drug goes through a number of stages in its development. Preclinical (test tube and animal testing; Phase 1 (small # of human subjects, safety test only); Phase 2 (50 to 300 humans, usually varying dose ranges, safety and efficacy testing); Phase 3 (several hundred to 10,000 patients, has experimental arm compared to control arm, sometimes control arm is placebo, other times control arm is an already FDA-approved treatment). Fatal or serious side effects often don't get caught at the Phase 3 stage because not enough patients have been tested. Sometimes these side effects only occur in 1/20,000 people. That's just the way it is.

Anonymous said...

Thanks Twisted!

Sydney in Wonderland said...

I have bad side effects to a lot of medications. Allegra paralyzed me from the waist down while giving me scream-and-tear-worthy back pain. Hydrocodone made me want to kill myself. Like others, it had never crossed my mind before that. I've never been on most prescription medications, but I can recommend numerous vitamins and minerals that help with anything from depression to problems losing weight.

I'm a little afraid to take things that are prescribed to me, to the point where I refused any pain medication when I broke my foot (in four places, ouch!) two months ago. Legitimate fear.

Majik said...

I also work in Clinical Research (shout out, DN~!), but I'm in Oncology--breast and colorectal cancers. You could say I'm up to my neck in tits and ass all day....lmao.

I love my job, but I often think that there is faaaaaar too much involvement from the drug companies--reps are at the Centre I am at least twice a week. Every pen, every tie clip, ever pad of paper the docs use has some company's name shamelessly emblazoned all over it. They pay for us to travel wherever we need to in order to hear more propaganda (one woman in our department just got back from two weeks in Geneva, all expense paid), they feed us, they bribe us any and every way they can.

It's disheartening, especially if you're in it for the altruism instead of the money. But that's the same for any profession nowadays--yay capitalism...*retch*

dbfreak said...

Speaking of rare side effects, I got meningitis from taking prescription Naproxen, which is an anti-inflammatory and has the same active ingredient as over the counter Alleve does. That sucked and was not listed as a side effect.

Unknown said...

what a nice on-topic non drama discussion! I'd heard about the paxil and chantix which kinda made sense (tho tragic)because both were mood-related drugs addiction/depression) but isn't it rare for something as common as an antihistamine to have such a severe sideeffect?

Pendragon said...

Hi. Long time lurker..first time poster. I just had to mention one of my 'favorite' horrifying Rx commercials. It is for a nasal spray (can't remember which one) and at the end, you see a line that basically reads as 'we don't know how this works, it just does.'
Hmm...we don't know how it works but take it anyway? I don't know what toilet bowl cleaner would do to me either...

YahMoBThere said...

Welcome Pendragon. MY favorite is for some drug that has a long list of side effects, including lymphoma. As a survivor of lymphoma, I have to say I hope people aren't ignoring that and taking the drug anyway. There are probably other drug options and I'd rather play russian roulette with some other side effect than that.

Sydney in Wonderland said...

dbfreak -- Naproxen, really? That scares the crap out of me, given that I have to occasionally grumble and take it. Every doctor I've seen refuses to vaccinate me for meningitis because I have dormant viral mononucleosis. I was out of commission for about 7 months when I was 17 thanks to it, and it's decided to never go away.

The more I learn, the scarier it is.

Ayesha said...

Uh oh. Don't get me started on this...

1. Many drugs have reported side effects that are worse than what you're taking it to cure. Nail fungus drug has some whopper side effects. Why not paint your toenails with tea tree oil?

2. I know LOTS of people who started taking one drug. Then the drug gave them side effects, so the doc presecribed a drug to alleviate THAT side effect. Ad nauseum. Especially older people who are less prone to question "authority".

Every single person I know who has started taking a prescription for something winds up with more symptoms and more drugs. They never get any healthier. I stay away from prescription drugs. Haven't put anything stronger than Advil in my body, ever.

dbfreak said...

Hey Alpine Summer - yes, really : (
However, the form of meningitis I had was not the most serious form (bacterial). It is called aseptic and is caused by very odd things including a certain class of drugs and Naproxen is in that small class of drugs. It looks and feels like viral but is not contagious either. So could have been worse! I had not ever taken prescription Naproxen and got meningitis the first time I did. From the research I did at the time, people like me will most likely get meningitis every time they take the drug that caused it the first time, so if you've taken it within the last couple of years without getting meningitis I definitely wouldn't worry about it. I have to admit that it's mostly a helpful medicine to most people who take it. As one of my friends said, I am a member of the 2% clug : )

dbfreak said...

And that would be club, not clug.

Jessy Jane said...

The richest people on the planet own all the stocks in the pharmaseutical industry. including the president. that's why everyone is medicated, and insane about it. and that's also why there is so much anti marijuana propaganda. it's a joke. restless leg syndrome? what the hell...

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