FDA gives advice to drug companies on how to present drug risks

Legalize it!

Boo, subscription article!

Pair-o-Dice: FDA gives advice to drug companies on how to present drug risks

Legalize it!

Die in a fire!

This thread may cause anal seepage.

"The FDA said the omission or minimization ..."

... of what? What happens next?! AAAGH THE SUSPENSE, the article cuts off in mid-sentence.

/rude

Lucidz: Pair-o-Dice: FDA gives advice to drug companies on how to present drug risks

Legalize it!

Die in from side-effects of a fire!

/fixed for insurance purposes

How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

Speaking of those side effects.... did you notice some of the more serious ones? Or the ones that defeat the purpose of taking the stupid drug?

Like may cause death, blindness, suicide!!! WTF, side effect is you want to kill yourself? I guess they don't want repeat customers.

Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

Freaking retarded.

manimal2878: How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

100% THIS. I never understood the need for 5 minute commercials for drugs that have to be prescribed. I call the Caduet ad 'the commercial show' because it's so friggin' long.

I think my favorite side effect that I've seen for a drug is "fatal events may occur". WTF??

StarshipPooper: Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

That's code for 'This drug doesn't exactly 'work'...'

manimal2878: How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

Agreed. Why can't they just admit the decision to allow prescription drug ads was a bust and re-ban them? Oh yeah, I forgot, big pharma money can make or break any politician.

Personally I like the sleep aid that makes you more outgoing... or suicidal.

/Fark.com may cause losing long periods of time, decreased productivity, or loss of keyboard. Do not operate heavy machinery while on Fark.

Lucidz: Pair-o-Dice: FDA gives advice to drug companies on how to present drug risks

Legalize it!

Die in a fire!

So...smoke it?

P.I. Staker: StarshipPooper: Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

That's code for 'This drug doesn't exactly 'work'...'

That's not really code.

I love the ad for some new anti-allergy spray that has the cartoon field officer mustering his troops. Right after the litany of side effects the officer exclaims "Mission accomplished!"

It's as if they succeeded in giving you the side effects! Whoever edited that spot should lose his job for sure.

The kicker is the drug companies don't pay for those stupid ass commercials, we do. They write them off as R&D, which the government pays for from the tax "revenue".

manimal2878: Drug companies shouldn't be advertising for stuff that requires a prescription.

Most countries prohibit direct-to-consumer advertising for prescription meds. We suffer tremendously from restless leg syndrome. :)

Interesting factoid: In 2005 Americans spent an average of 16 hours watching televised drug advertisements - far more time than they spent with family doctors. (source)

StarshipPooper: Speaking of those side effects.... did you notice some of the more serious ones? Or the ones that defeat the purpose of taking the stupid drug?

Like may cause death, blindness, suicide!!! WTF, side effect is you want to kill yourself? I guess they don't want repeat customers.

Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

Freaking retarded.

I love the ones that say "If you're allergic to xxxx, don't take it".
Well duh.

as long as the advertisement shows people being active and having fun while they present the risks, i'm okay with it. there's nothing like hearing about the possibility of explosive diarrhea and migraines while they show some beautiful person kayaking or rock climbing.

I remember a certain incontinence drug that listed "anal leakage" as a side effect.

The ones that get to me are the ads for d!ck pills. You can't watch a sporting event without being bombarded by these (insert derogatory statement here).

/one of the main reasons for a DVR
//when we (GASP) watch live TV and a commercial starts, both my 5 yr old and 3 yr old say "Skip it, Daddy!"

Ask your doctor if Marijuana is right for you.

Anal Leakage..

I think I have some of her DVD's..she is quite the little minx

You know what else is ? Posting links to subscription only sites.

manimal2878: How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

Agreed. add to that a legal requirement for docs to fully and completely divulge the side effects to patients, and problem solved.

Everything is fine here folks. Move along and just keep believing that you have the best health care in the world.

I find that calling anal leakage an involuntary colon release safety mechanism sounds better.

StarshipPooper: Speaking of those side effects.... did you notice some of the more serious ones? Or the ones that defeat the purpose of taking the stupid drug?

Like may cause death, blindness, suicide!!! WTF, side effect is you want to kill yourself? I guess they don't want repeat customers.

Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

Freaking retarded.

Those are my favorite. One of the asthma drugs that my doctor is always pushing increases your risk of dying from an asthma attack. I think I'll take my chances and not pay to take a pill that might help me die quicker.

manimal2878: How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

Why not? So long as they actually tell you what the disease is that it treats, I don't really see what the harm is. Brings in a positive return, assumably, so it's helping keep prices low(er than they could be). Good for me as a consumer, anyhow.

P.I. Staker: StarshipPooper: Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

That's code for 'This drug doesn't exactly 'work'...'

Um, no. If you fiddle with a specific system, when it backfires it's usually gonna be that system going haywire. So if you're treating your blood pressure with a chemical that targets the blood pressure regulatory system, then if your body overcompensates it's gonna result in blood pressure going up instead of down.

Most drugs work this way, opposite effect is... well, I wouldn't say common, but frequent enough to be worth mentioning. Just like some people get hyper when they drink or chill out big time after a couple cups of coffee. Doesn't mean the drug doesn't work.

What's interesting is that most people seem to think that the FDA actually tests these drugs. They don't. They don't have the resources. The drug companies do their own testing and then present the results to the FDA. Or not. It's tough to decide if a drug is safe if all you have to go by is the results of tests done by people who have no stake in showing if anything is wrong with the drug. Not to mention that the FDA's primary concern is efficacy anyway.

My fave ad has a "doctor" reeling off this list of cataclysmic side effects while the prospective drug-taker looks worried. Then the "doctor" says chances of permanent genital loss or whatever is rare, and the "patient's" face relaxes into bliss.

tzzhc4: I remember a certain incontinence drug that listed "anal leakage" as a side effect.

I also remember a brand of low fat potato chips advertising that same side effect. Olestra anyone?

anyone know what brand or company that had the commercial immitating a pharmaceutical add a couple years back that said "may cause head ache, fever, and/or your offspring may be born with the head of a golden retriever"?

it had been plaguing me for years and it was freakin hilarious

comedy gold

Dear FARK,
Don't greenlight links that go to an article that isn't finished yet.
Love,
FARK

StarshipPooper: Speaking of those side effects.... did you notice some of the more serious ones? Or the ones that defeat the purpose of taking the stupid drug?

Like may cause death, blindness, suicide!!! WTF, side effect is you want to kill yourself? I guess they don't want repeat customers.

Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

Freaking retarded.

I think my personal favorite is the asthma medication that increases your chances of dying from an asthma attack.

This drug may cause sudden bouts of uncontrolled masturbation.

DEFAULT TEXT: Olestra


mmmm anal leakage AND loose stool

Incredulous: StarshipPooper: The kicker is the drug companies don't pay for those stupid ass commercials, we do. They write them off as R&D, which the government pays for from the tax "revenue".


Here's a small hint, Starry ---- There's no such thing as a business that loses money. A business that loses money goes out of business. Every cent of every expenditure by a business must be recouped from its customers.

And here is the crux of our ills. Our "healthcare" is a business. Just another product with which to create and fill our perceived needs.

Billy Ligue: DEFAULT TEXT: Olestra


mmmm anal leakage AND loose stool

Homer: Hey, Apu, you got any of those potato chips that give you diarrhea? I need to do a little spring cleaning.

Apu: They are in the safety cabinet. I'll get the key.

StarshipPooper: Speaking of those side effects.... did you notice some of the more serious ones? Or the ones that defeat the purpose of taking the stupid drug?

Like may cause death, blindness, suicide!!! WTF, side effect is you want to kill yourself? I guess they don't want repeat customers.

Allergy drug that ends up causing you to have other allergies.
High blood pressure drugs that ... gues what? May cause you to have higher blood pressure, etc.

Freaking retarded.

I like how it covers their ass if they just say, "[whatever drug] is not for everyone." Great caveat! If you go insane and kill a couple of people, well, hey! We told you it wasn't for everyone!

My high school buddy suffered from rheumatoid arthritis. She was prescribed a drug to help with it, which she took for only two years. One of the side effects listed was "blood disorders" and when she asked her doctor about, he said 'not to worry'. Eight years later she found out the hard way that by "blood disorders" what they REALLY meant was "leukemia" and that's what killed her. There was no doubt in the mind of her cancer specialists that the arthritis drug caused the disease. "We see it all the time," they said - in fact, that's the first question they asked her after she was diagnosed: "Did you ever take [wish I could remember the name of the drug] for arthritis?" She was only 48 when she died; left 3 kids behind and I never figured out how come drug companies can get away with shiat like this.

/and the arthritis drug didn't do squat for her arthritis, either.
//sure made the drug companies rich, though
///same drug company that makes crappy arthritis medicine ALSO makes ineffective leukemia meds

TriviaQueen: My high school buddy suffered from rheumatoid arthritis. She was prescribed a drug to help with it, which she took for only two years. One of the side effects listed was "blood disorders" and when she asked her doctor about, he said 'not to worry'. Eight years later she found out the hard way that by "blood disorders" what they REALLY meant was "leukemia" and that's what killed her. There was no doubt in the mind of her cancer specialists that the arthritis drug caused the disease. "We see it all the time," they said - in fact, that's the first question they asked her after she was diagnosed: "Did you ever take [wish I could remember the name of the drug] for arthritis?" She was only 48 when she died; left 3 kids behind and I never figured out how come drug companies can get away with shiat like this.


I would guess the drug was one of the relatively new "biologics". Humira, Enbrel, or Remicade.

Lotsa accusations being floated about in here... let's go through some of them...

1. The kicker is the drug companies don't pay for those stupid ass commercials, we do. They write them off as R&D, which the government pays for from the tax "revenue".

Citation, please? I agree they shouldn't be advertising, but it's not like Pfizer can deny they've spent millions of dollars this year on ads for Viagra. Worst case scenario is that they funnel some of the R&D money into ad money (which is doubtful because R&D money is what they need right now - the number of new big money drugs in the pipeline is declining and a lot of the big money drugs are approaching generic status...)

2. What's interesting is that most people seem to think that the FDA actually tests these drugs. They don't. They don't have the resources.

I'm honestly not sure about that first sentence - could be true, could be false. The other two are basically 100% accurate though (at best, the FDA will run through analytical tests for the composition of the drug to assure the purity is as reported. At BEST.)

3. The drug companies do their own testing and then present the results to the FDA. Or not.

Not always, and not usually actually. Most (though not all) companies farm their nonclinical/clinical testing out to companies that specialize in those areas. Maintaining those FDA certifications is a real biatch. This is a good thing, though - the companies doing the testing only have an interest in keeping their certification status. They DO NOT want to falsify data, because if they get caught they'll never do any studies again. These studies usually run in the hundreds of thousands to millions of dollars. That's A LOT of money to risk for a product you don't actually own and hold no financial stake in.

As for not submitting studies - possible, but VERY unlikely. If you, as a drug company, plan on submitting data to the FDA, you need to write up your testing protocols and plans BEFORE you start running the study, and you HAVE to submit the results to the FDA (because they KNOW you did the study, you told them about it beforehand). Now you *could* run a bunch of studies WITHOUT telling the FDA, and then weed out the ones that show poor results beforehand, but that would cost millions of dollars. Without any guarantee that it would work. I suspect any company that actually did this would go broke sooner rather than later. Remember, most drugs DON'T survive the application process. A lot of them don't even make it to human testing.

4. It's tough to decide if a drug is safe if all you have to go by is the results of tests done by people who have no stake in showing if anything is wrong with the drug.

They're called "lawsuits". Drug companies have a vested interest in avoiding them. See "Vioxx". They've got a big stake in not getting sued. Further they'd be 100% liable if they falsified data, and vulnerable to lawsuits from ANYBODY that took the drug. That's potentially a billion dollar loss right there. Not to mention that nobody would trust another drug from that company ever again.

5. Not to mention that the FDA's primary concern is efficacy anyway.

This is 100% untrue. The primary concern is always safety (though, balanced against the target of the drug therapy - a cancer drug can have a wider range of adverse effects than an allergy drug, because cancer is lethal and allergies aren't.) All nonclinical (ie animal) testing is done to show that the adverse effects in animals aren't worse than the target disease/condition. Then you move on to safety testing in humans, where you demonstrate that healthy humans don't show any unexpected adverse effects. Only THEN do you move onto efficacy studies and dosing, and even then, if the efficacy wasn't as expected they may decide that the adverse effects outweigh the drug benefits.


Well, that's all I've got for now...

Ooh, more stuff...

6. Why not? So long as they actually tell you what the disease is that it treats, I don't really see what the harm is. Brings in a positive return, assumably, so it's helping keep prices low(er than they could be). Good for me as a consumer, anyhow.

The problem is that their incentive is to convince people they've got diseases and market drugs towards annoying but ultimately harmless conditions. "Does your legs itch every now and then? Did you know it might be (insert scary sounding latin term that translates to itchy legs here)? Talk to your doctor now!!!" It's about manufacturing conditions now and convincing people to get a drug for it. That's a bad thing, because it diverts money from real illnesses.

Jim_Callahan: manimal2878: How about NO!

Drug companies shouldn't be advertising for stuff that requires a prescription.

Why not? So long as they actually tell you what the disease is that it treats, I don't really see what the harm is. Brings in a positive return, assumably, so it's helping keep prices low(er than they could be). Good for me as a consumer, anyhow.

It's not so much that they are allowed to advertize it's how they do it. They list off a bunch of symptoms that everyone feels at one time or another, and then tell you that you have to ask your doctor about the drug. People start diagnosing themselves instead of going to a doctor for a checkup and having him decide what medication is best. One of the people in this relationship has been to medical school, the other has not.

Also, as long as a company holds the exclusive patent, they have no reason to keep prices down. Advertising just makes them more money.

I think my personal favorite is the asthma medication that increases your chances of dying from an asthma attack.

I always thought that was funny, but now I take it... I'm not dead yeubhyyugh

/Not really dead
//Did really headbutt the keyboard

I'm in healthcare advertising so I'm getting a kick...
/really