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    More: Spiffy, hand sanitizer, antipsychotics, 1st amendment, panels, free speech, cancers, sleep disorders, U.S. Supreme Court  
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5855 clicks; posted to Main » on 07 Dec 2012 at 9:44 PM (3 years ago)   |   Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2012-12-07 11:20:48 PM  

Amos Quito: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.


I'll see your Sulfonamide, and raise you a Thalidomide (or any one of DOZENS of FDA approved "safe and effective" products that have killed, maimed, and CONTINUE to kill and maim Americans in their tens (hundreds?) of thousands annually.

Show me an "herbal supplement" that compares to the hell raised by NSAIDS or even PPI's, and I'll show you a product that was yanked from the market.


Ya, Ephedra... you're arguing which of the deadly dumbass things is deadlier. It's like you two are having a hemlock v. cyanide argument. You're both right, in that there are clearly bad things on the other side... but also both in quite possibly the dumbest pissing war I've witnessed on fark, and that's really saying something.
 
2012-12-07 11:21:09 PM  

Amos Quito: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.


I'll see your Sulfonamide, and raise you a Thalidomide (or any one of DOZENS of FDA approved "safe and effective" products that have killed, maimed, and CONTINUE to kill and maim Americans in their tens (hundreds?) of thousands annually.

Show me an "herbal supplement" that compares to the hell raised by NSAIDS or even PPI's, and I'll show you a product that was yanked from the market.


You idiot, you need to read up on thalidomide and FDA, AND WHY THERE WERENT ANY THALIDOMIDE PRESCRIPTIONS to pregnant women in U. S.

This ruling may not protect pharma companies from civil judgments for off label promotions, and SCOTUS may get involved.

Free speech should be jealously guarded and patients sgould be protected.
 
2012-12-07 11:21:36 PM  

BoxOfBees: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.
What happens when AltMed Shills get friends in congress.

I agree that it's good to help people get medicine that will supposedly help them, but consider:

1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.

the Elixir of Sulfonamide case is interesting

so is the recent fungal meningitis outbreak. Some companies will engage in unsafe practices even when strict regulations are (supposedly) enforced.

I generally advocate for across-the-board legalization of all drugs. Keeping people in the dark and nanny-stating them out of harm's way is not a fool-proof system. Knowledge is power. I don't take any drugs, and I have rarely taken even prescription medication in the past, so I really have nothing to gain except that I want to encourage my fellow citizens to be responsible and free.


I I agree that knowledge is power, and we should empower consumers to know about the medicines they purchase. The problems comes when there is so much information that is untrue that it is difficult for a lay person to distinguish between what is factual and helpful and what is not.

When it comes to meds, the Internet can be a horrible place to get info.

/got my first tablet. Typing on these things accurately can be difficult.
 
2012-12-07 11:22:33 PM  

BoxOfBees: 1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.


Number three is terrifying. You do realize that there are a LOT of drugs in common use that if not closely monitored, can kill you or quickly become toxic, right? In addition, one that comes to mind immediately is antibiotics. We have a huge problem right now because people stockpile antibiotics for one condition, and take them for another weeks or months afterword. Not only do they promote antibiotic resistance for the conditions they don't finish their course because "they feel better", they take drugs which can cause real harm, or promote antibiotic resistance for other conditions that they are ineffective for, or they take them for viral illnesses.

There's a reason why Paramedics (In the last 5 years.), RNs, Nurse Practicioners and PAs, and MD/DOs go to school to learn how to use the drugs they use like that.

BoxOfBees: so is the recent fungal meningitis outbreak. Some companies will engage in unsafe practices even when strict regulations are (supposedly) enforced.


The Fungal Meningitis outbreak is actually a case where lax regulation standards contributed to it. If you have a few hours, set down and read the issues and preceding timeline of events that lead up to it, namely the issues with pseudo-manufacturing compounding pharmacies. They exploit legal loopholes to do what they do, when the laws that allow them to operate never intended for them to be manufacturing the medicines they were using.
 
2012-12-07 11:26:25 PM  

Animatronik: This ruling may not protect pharma companies from civil judgments for off label promotions, and SCOTUS may get involved.

Free speech should be jealously guarded and patients sgould be protected.


As I understand the law, the Pharma companies are actually NOT allowed to promote and market medicines for off-label uses unless they have been proven and officially approved to be used as such by the FDA.
 
2012-12-07 11:30:55 PM  

BronyMedic: BoxOfBees: 1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.

Number three is terrifying. You do realize that there are a LOT of drugs in common use that if not closely monitored, can kill you or quickly become toxic, right? In addition, one that comes to mind immediately is antibiotics.


My first thought was Tylenol. There are a lot of opioid drugs that combine with acetaminophen to make a stronger pain relieving effect. If a person combines those with Tylenol, they could easily go into liver failure and die a painful death within weeks. The therapeutic index is only around 4 (which means that you only need 4x the recommended dose before you reach toxic level), which is absolutely horrible for a drug. I am one of those who believes that if Tylenol were brought to market today, the FDA would have denied it. But it was grandfathered in instead.
 
2012-12-07 11:33:01 PM  

mgshamster: My first thought was Tylenol. There are a lot of opioid drugs that combine with acetaminophen to make a stronger pain relieving effect. If a person combines those with Tylenol, they could easily go into liver failure and die a painful death within weeks. The therapeutic index is only around 4 (which means that you only need 4x the recommended dose before you reach toxic level), which is absolutely horrible for a drug. I am one of those who believes that if Tylenol were brought to market today, the FDA would have denied it. But it was grandfathered in instead.


PediProfen comes to mind, too. Every pediatric patient I've ever seen on dialysis was on it because they got it when they were dehydrated, or less than six months old.
 
2012-12-07 11:34:45 PM  

BronyMedic: Of course, homeopathy is 100% safe. Because it doesn't do anything, period.


If it causes someone to avoid medical treatment for a dangerous disease or condition, then I wouldn't call it safe.
 
2012-12-07 11:36:38 PM  

cyberspacedout: If it causes someone to avoid medical treatment for a dangerous disease or condition, then I wouldn't call it safe.


True, true.

BronyMedic and Miss have to use Walgreens for our insurance. Every Walgreens I've ever been in has the "Homeopathic Medicine" shelf right in front of the Pharmacy check-out window. I asked one of the PharmDs one day why they push that stuff. Her reply was that they know it's useless, but they're not allowed by Walgreens to take it down, or to talk people out of buying it.

Apparantly Walgreens make a lot of money on Placebos.
 
2012-12-07 11:39:25 PM  

BronyMedic: cyberspacedout: If it causes someone to avoid medical treatment for a dangerous disease or condition, then I wouldn't call it safe.

True, true.

BronyMedic and Miss have to use Walgreens for our insurance. Every Walgreens I've ever been in has the "Homeopathic Medicine" shelf right in front of the Pharmacy check-out window. I asked one of the PharmDs one day why they push that stuff. Her reply was that they know it's useless, but they're not allowed by Walgreens to take it down, or to talk people out of buying it.

Apparantly Walgreens make a lot of money on Placebos.


Yes they do. I've asked a pharmacist about it (she worked at Walgreens), and she told me it's because the product is very lucrative. It's cheap to make, and they can mark it up a lot.
 
2012-12-07 11:42:37 PM  

mgshamster: Yes they do. I've asked a pharmacist about it (she worked at Walgreens), and she told me it's because the product is very lucrative. It's cheap to make, and they can mark it up a lot.


For anyone who's wondering what we're bantering about, Homeopathic Medicine is the principle that diluting something makes it more powerful the more you dilute it, and that "like can cure like"

Dilution are measured in (number of dilutions)C. For example, a common preparation of Homeopathic medicine for the flu is diluted to 200C. To have one molecule of the original substance in that compound, you'd have to have 10320 Universes to find one.
 
2012-12-07 11:44:43 PM  

firefly212: Amos Quito: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.


I'll see your Sulfonamide, and raise you a Thalidomide (or any one of DOZENS of FDA approved "safe and effective" products that have killed, maimed, and CONTINUE to kill and maim Americans in their tens (hundreds?) of thousands annually.

Show me an "herbal supplement" that compares to the hell raised by NSAIDS or even PPI's, and I'll show you a product that was yanked from the market.

Ya, Ephedra... you're arguing which of the deadly dumbass things is deadlier. It's like you two are having a hemlock v. cyanide argument. You're both right, in that there are clearly bad things on the other side... but also both in quite possibly the dumbest pissing war I've witnessed on fark, and that's really saying something.



How many deaths were POSITIVELY linked to Ephedra - an herbal product that was BANNED?

Compare that to Proton Pump Inhibitors:

"
May 26, 2009 -- An estimated 33,000 deaths a year from hospital-acquired pneumonia may result from the practice of routinely prescribing proton pump inhibitors and other acid-suppressing drugs during hospitalization to patients who don't need them.

Use of acid-reducing drugs was associated with a 30% increased risk for developing pneumonia in a newly reported study.
"

Have PPI's been banned?

No? Why?

Yeah, those "herbs" are sure scary.
 
2012-12-07 11:49:40 PM  
Hey, now we can save a bundle by scrapping the FDA!

/Off to harvest some nightshade.
//It's great for insomnia.
 
2012-12-08 12:00:47 AM  
"The government clearly prosecuted Caronia for his words - for his speech," the majority wrote in the 2-to-1 decision. It concluded that "the government cannot prosecute pharmaceutical manufacturers and their representatives" under the Food, Drug and Cosmetic Act for speech promoting off-label drug uses.

"Off-label" usage is not the same thing as making up uses for a drug out of whole cloth and claiming your snake oil will cure brain tumors and retardation. I've been using off-label meds for years, since the process for approving psychotropic medications is very slow--as it should be. I certainly wouldn't want pharmaceutical companies to ban off-label usage completely; but I don't want to see their reps allowed to run around claiming whatever they want to, either.

It sounds like either this was a paid-for decision...or, just as likely, some judges didn't bother to understand what "off-label" really meant before they ruled. Either way, it better get overturned.


This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.
 
2012-12-08 12:16:42 AM  

Amos Quito: How many deaths were POSITIVELY linked to Ephedra - an herbal product that was BANNED?

Compare that to Proton Pump Inhibitors:


Ephedra was banned because it was being marketed as an herbal supplement for weight loss, not a medicine with demonstrated clinical use. Not because it was approved as effective for a medication. In reality, they had made attempts to ban its sale for years because they knew it was being marketed to people with BP and heart conditions, but they couldn't do anything about it due to the DSHEA.

Amos Quito: Compare that to Proton Pump Inhibitors:

"
May 26, 2009 -- An estimated 33,000 deaths a year from hospital-acquired pneumonia may result from the practice of routinely prescribing proton pump inhibitors and other acid-suppressing drugs during hospitalization to patients who don't need them.

Use of acid-reducing drugs was associated with a 30% increased risk for developing pneumonia in a newly reported study."

Have PPI's been banned?

No? Why?

Yeah, those "herbs" are sure scary.


False comparison. PPIs actually have clinical uses they are demonstrated safe and effective for. You said it yourself in your link: "Patients who DID NOT need it." In addition, your article is trying to state, in one way you word it, that PPIs caused pneumonia in hospitalized patients. In the actual article, it states that it was associated with a 30% increase in the risk factor for developing nosocomial pneumonia in patients it was not needed for. PPIs do not cause pneumonia. Viruses and bacteria, and aspirated gastric contents do.

Read that again, nice and slow. You are arguing a drug should be banned because it was being used improperly, and clinical practice has changed because of research demonstrating that. Not because a drug is dangerous.

As I said before, this is one area where clinical practice has changed as a DIRECT RESULT of the studies you link vilifying an effective drug that was in reality being improperly used on the notion that ulcers in clinically stressed patients were being caused by acid erosion of the gastic lining, and it would reduce the damage in the event someone aspirated. PPIs are still used in the ICU for patients who need them - namely people who have esophageal erosion, bleeding ulcers, or varicees and reflux.

And yes. Herbs are scary when you think they are being marketed to patients as effective, when in reality most of them do nothing at the concentrations they are being ingested at, and in other cases, can react with medication being taken for a particular condition.

And they're especially scary when you have people slimy enough to push them as a cure or treatment for a condition which there ARE effective treatments for, and they encourage people to eskew for their "natural" remedy instead.
 
2012-12-08 12:19:10 AM  
Does hand sanitizer kill that virus that can transmit cervical cancer?

Bing
 
2012-12-08 12:35:59 AM  
Farked up!
 
2012-12-08 12:42:11 AM  
BronyMedic, you beat me to it.

Also, am I the only person in here who was grinding their teeth when when they extrapolated that "33,000" number from different sets of statistical analyses and carelessly tried to pass if off as a legitimate estimate?
 
2012-12-08 12:45:21 AM  

Zugswang: BronyMedic, you beat me to it.

Also, am I the only person in here who was grinding their teeth when when they extrapolated that "33,000" number from different sets of statistical analyses and carelessly tried to pass if off as a legitimate estimate?


I facepalmed when he tried to claim that PPIs caused 33,000 cases of fatal pneumonia, and then said they should be banned because of that.

Kind of like the hundreds of thousands of people who supposedly die as a direct result of drug and surgical errors in the United States, yet don't even rank in the top ten despite killing more people than Cancer, Heart Disease, Stroke, and COPD, right? (Not discounting that drug and surgical errors DO cause an unacceptable amount of death and disability in the United States, but it's not the number one killer of people.)
 
2012-12-08 12:50:32 AM  

modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.


I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.

Which sucks. Drug reps always had the best pens and swag.
 
2012-12-08 01:02:47 AM  

JonPace: It's ultimately up to your Dr to prescribe it, and your right to find a be Dr


I think you've found plenty of a be Drs, and you need to stop it and go to bed.
 
2012-12-08 01:36:54 AM  

BronyMedic: modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.

I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.

Which sucks. Drug reps always had the best pens and swag.


The swag is gone, but they are still allowed to push for off label uses. : ( It is a sad thing that I learned a little too late in the game.

With regard to mr. ephedra is safe because I don't believe the death statistics related to it, but PPIs are made of evil and death because people can still catch pneumonia while on it, he's the reason I've been cranky the last few weeks. That is to say him and people like him. In a growing number of threads, there's this wacky belief that "my ignorance is equal in validity to your science" from young earthers to tectonic plate denyers to the Christ Scientist now at the head of the House Committee for science, to anti-vaxxers to when people were calling Rachel Maddow unqualified to speak to President Obama on the topic of how to present/merchandise his tax package (she is a Rhodes Scholar with a PhD in Politics from Oxford)... there's this weird belief out there that seems more and more pervasive every day that people can simply make shiat up, and that's as good as the people on the other side having an actual, oberservable-reality-based argument. It frustrates me beyond belief, I haven't the foggiest clue how to engage people who have consciously chosen to disengage from the reality that is observable because it does not line up with their beliefs.

The shiat of it is, I've been on the receiving end of a total shaftjob that cost me parts of my nervous system so Pfizer shareholders could get a fraction of a penny more... I'm not at all sympathetic to the drug companies... but to pretend that the pharmaceutical market is more dangerous than that of unregulated drugs, or that somehow natural=safe (someone say heroin?) just doesn't jive with reality. I know, firsthand, the devastation and feelings of personal violation that having drug company reps pushing misinformation on neurologists causes, and I'm really worried that this judgement will pave the way for more Neurontin-like shenanigans... but instead of a reasoned discussion of that, we just get kooks with the brains of Pam Anderson drawing good people like you into a rather irrelevant argument to the end that we can't really have a discussion about how broken the current system already was, or how this greenlight could adversely affect patient care with doctors, nurses, and emtps unwittingly getting passed bad info, bogus research (biased by omission of unfavorable results), and inaccurate information regarding off-label uses.

This is one of the few areas of medicine where I feel personally qualified to speak to the topic (normally I stick to the political and economic sides of healthcare)... I know every thread gets the trollolols, but I kinda had hope for this one.
 
2012-12-08 02:35:29 AM  

firefly212: BronyMedic: modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.

I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.

Which sucks. Drug reps always had the best pens and swag.

The swag is gone, but they are still allowed to push for off label uses. : ( It is a sad thing that I learned a little too late in the game.

With regard to mr. ephedra is safe because I don't believe the death statistics related to it, but PPIs are made of evil and death because people can still catch pneumonia while on it, he's the reason I've been cranky the last few weeks. That is to say him and people like him. In a growing number of threads, there's this wacky belief that "my ignorance is equal in validity to your science" from young earthers to tectonic plate denyers to the Christ Scientist now at the head of the House Committee for science, to anti-vaxxers to when people were calling Rachel Maddow unqualified to speak to President Obama on the topic of how to present/merchandise his tax package (she is a Rhodes Scholar with a PhD in Politics from Oxford)... there's this weird belief out there that seems more and more pervasive every day that people can simply make shiat up, and that's as good as the people on the other side having an actual, oberservable-reality-based argument. It frustrates me beyond belief, I haven't the foggiest clue how to engage people who have consciously chosen to disengage from the reality ...


If you think this is bad, you need to see him in any politics thread regarding or even mentioning Israel, or any Zimmerman thread. This Alt Med derp is not even close to what he's capable of. It's Crank Magnetism - that is to say anyone holding irrational beliefs are predisposed to holding other ones.
 
2012-12-08 02:50:19 AM  

BronyMedic: mgshamster: AliceBToklasLives: Meh, caveat emptor.

/why do we have the FDA anyway? It's restraint of trade.
//I don't need nanny government to run drug trials I can damn well perform myself.

Because neither you nor I (a trained toxicologist with a higher education) nor anyone else is able to tell exactly what is in that medicinal bottle (or pill or whatever) you're being sold without equipment that cost hundreds of thousand of dollars to purchase and years of training to operate and analyze.

You do realize you're a personal hero of mine on FARK for this stuff, right?


For responding to sarcasm sincerely?
 
2012-12-08 02:57:22 AM  

BronyMedic: modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.

I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.


Once upon a time, drug reps weren't allowed to push meds for off-label use. It wasn't merely illegal, it cost Pfizer a farking fortune. That changed this week, when the court farked everything up. I'm with Derek Lowe on this issue; the court decision opened up a horrific can of worms, this needs to go to the Supreme Court, but until the Supremes rule, believe it or not, it's legal. (It can and should still be a firing offense for the salesweasels, even if that means less swag for you. Keeping it as a firing offense until this farkup gets settled is a good hedge against risk for both the pharma industry and for patients whose doctors have stopped paying attention.)

Real world example: I'm kinda heavily weighted in a stock with a drug that's been approved for one indication, and for which it's completed a Phase 3 study that demonstrates pretty damn good results for a similar indication that's an order of magnitude wider than their presently approved label. I'm hoping doctors choose to prescribe it off-label, not just because I stand to indirectly bank some coin off it, but because I think approval for the expanded indication really is justified by the PIII data out there, and because they're doing further studies to see if the stuff does more than just change biomarkers that are merely associated with improved outcomes, but if it actually improves outcomes. I'm convinced on the biomarkers because the results are out, but I haven't a farking clue if the improved biomarkers will turn out to be causally connected to better outcomes - nopony knows if it'll turn out to be the real deal or a multibillion-dollar facehoof of statistically-insignificant proportions.

The problem is, the call on whether or not the indication is justified by the PIII data isn't my call to make. That should be the doctor's call. And the doctor needs guidance, just in case that PIII study was bogus and somehow slipped through the peer review process. If an academic farks up in peer review, his friends laugh at him for a few months, then forget about it because everybody's got tenure. If the FDA farks up in peer review, people with very cushy government jobs have to answer to angry congressmen. The FDA's a lot more likely to err on the side of caution than the scientific community. So who makes the call? An arbiter that's even harder-assed than the peer review system, and that's the FDA. As an investor, I hate that it takes the better part of 12-18 months to go from PIII completion to drug approval, but that's the nature of the beast.

Back to my little investment. If, unprompted by salesweasels, doctors read the published PIII results and start prescribing this thing off-label for people at the closer-to-indicated end of the range of the desirable wider indication a year early, I'll swallow my ethical pride and wallow in a pit of money. But I could have done that without the Supremes' ruling, because doctors are smart people and should be able to read through the salesweasel BS, and that's especially true now that there's no longer any swag involved. If the company crosses the line and tries to market it for the expanded indication before the FDA actually expands the indication, it doesn't matter if it's legal or not, fark 'em, I'm selling. (If a salesweasel, rather than the evidence as vetted both by peer review and the FDA, is enough to convince my doctor of the merits of a treatment option, I'll also be changing doctors!)

As of right now, it's not only legal to market an approved drug for an indication for which you have solid PIII data (but neither FDA approval, nor even an NDA filing) as it is to market the same drug to cure dandruff, baldness, and terminal acne. A salesweasel can tell you Viagra cures cancer, or that Herceptin cures restless leg syndrome. That's so feathering derped I don't even...

tl;dr: this is a bad ruling for the industry. If it stands, patients, physicians, and investors alike are in for a real doozie, and I really hope the Supremes shoot it down in flames.
 
2012-12-08 03:02:51 AM  
BronyMedic
I really like your perspective on things such as this.

/dad was an fda inspector in the early 60 in the Bay area. His notes on inspections that he did
would make anyone ill if they knew what used to be the norm for food, much less medicine processing/manufacture
 
2012-12-08 03:12:35 AM  

firefly212: BronyMedic: modelcitizen: This is done every day in every state by drug reps. I've been to the conferences (aka free fancy dinner to listen to their pitch). It's the doctors call and their responsibility to make the correct one. If they think it might have substantial off label use, they should do the research and make their decision accordingly. Sadly, this happens very rarely in reality.

I didn't think that drug reps were allowed by federal law to push medicines for off-label uses they were not FDA approved for. I know in our system, no one is allowed to get any swag or free meals when a drug rep or medical rep comes to give a class or talk, and it's a terminatable offense for doing so.

Which sucks. Drug reps always had the best pens and swag.

The swag is gone, but they are still allowed to push for off label uses. : ( It is a sad thing that I learned a little too late in the game.

With regard to mr. ephedra is safe because I don't believe the death statistics related to it, but PPIs are made of evil and death because people can still catch pneumonia while on it, he's the reason I've been cranky the last few weeks. That is to say him and people like him. In a growing number of threads, there's this wacky belief that "my ignorance is equal in validity to your science" from young earthers to tectonic plate denyers to the Christ Scientist now at the head of the House Committee for science, to anti-vaxxers to when people were calling Rachel Maddow unqualified to speak to President Obama on the topic of how to present/merchandise his tax package (she is a Rhodes Scholar with a PhD in Politics from Oxford)... there's this weird belief out there that seems more and more pervasive every day that people can simply make shiat up, and that's as good as the people on the other side having an actual, oberservable-reality-based argument. It frustrates me beyond belief, I haven't the foggiest clue how to engage people who have consciously chosen to disengage from the reality ...


Well, let's try our best to have a substantive discussion.

I read this article, and the sad thing is, this contortion of the first amendment isn't a unique argument. If you recall, this is an almost carbon copy of the argument that was put forth by credit ratings agencies when they claimed that they were not liable for the now definitively wrong credit ratings they assigned to different groups and organizations, because it was their "independent opinion". Never mind the fact that their "opinion" was widely recognized and advertised by these agencies as being based off of rigorous expert analysis of a company assessing its economic health and creditworthiness. (There must be some hidden bunker where business law attorneys go to torture the English language until it says what they want it to, like some kind of linguistic S-21.)

But the difference is, the claims to drug indications are about as close as an absolute fact as you can realistically get. Claims for which we can provide direct, verifiable, repeatable evidence. It's why I hold out hope that this appeals court ruling will be overturned. If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless. Hell, you have to file a supplemental NDA if you change how the drug gets made. It's incredibly disappointing to think that short-sighted people who have no appreciation of history are attempting to reverse 80+ years of legal framework in the interests of making a short-term profit at the expense of everyone else, and it's happening in the two most important spheres of citizens' lives: medicine and finance.
 
2012-12-08 04:07:52 AM  

alienated:
/dad was an fda inspector


Zugswang: It's incredibly disappointing to think that short-sighted people who have no appreciation of history are attempting to reverse 80+ years of legal framework in the interests of making a short-term profit at the expense of everyone else, and it's happening in the two most important spheres of citizens' lives: medicine and finance.


This and this.

Investor-wise, the months between the study's completion and the study's publication, the months between publication and NDA (or sNDA) filing, the fact that even an sNDA takes six months... it's frustrating as all hell, but it beats the alternative. A CRL can be fixed with a few hundred million and a few years of science. A drug who's risks are found to have outweighed its benefits after approval is more than just a political embarassment for the FDA; it's gotta be a personal nightmare for everybody on the committee that voted for approval.

Whether you keep score in dollars earned or lives saved, sometimes you win, sometimes you lose. Sometimes balancing patient safety and drug efficacy is an art, but the science has to come first. At no time have I ever felt the FDA has taken any approach other than the one that says the science comes first. The FDA is not your friend, the FDA is not your enemy. They're just the referee in a very difficult game, and they're just doing their job. It's not supposed to be easy.

/and apparently, it's why none of us who've taken even a passing glance at the industry can ever sleep...
 
2012-12-08 04:43:20 AM  

Zugswang: If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless.


While I agree with you in general, I think you've missed one big complication: about 90% of pediatric drugs are used off-label because they have never been tested in children. To get approved for use in a new population (children) I think they'd have to do complete safety tests, not just simple efficacy tests.
 
2012-12-08 09:55:13 AM  

BoxOfBees: BronyMedic: Amos Quito: On the contrary, the FDA is a safeguard of oligarchic monopoly.

You don't study history much, do you?

Pure food and Drug act of 1906, i.e. what the world was BEFORE pharmaceuticals were regulated.
What happens when the Government has no teeth to enforce prescription drug standards, i.e. the Elixir of Sulfonamide disaster.
What happens when AltMed Shills get friends in congress.

I agree that it's good to help people get medicine that will supposedly help them, but consider:

1. Information is widely available. The Internet. Libraries. Books. Magazines. Informative T-shirts.
2. Physicians can help people come to decisions about medications. Sometimes.
3. Not everyone has a physician or pharmacist, so some people, in order to save money, might just take x random drug and hope it cures them. This sounds like a travesty, but considering the number of people self-medicating with various opioids and some other drugs, the pendulum won't swing very far in terms of real consequences.

the Elixir of Sulfonamide case is interesting

so is the recent fungal meningitis outbreak. Some companies will engage in unsafe practices even when strict regulations are (supposedly) enforced.

I generally advocate for across-the-board legalization of all drugs. Keeping people in the dark and nanny-stating them out of harm's way is not a fool-proof system. Knowledge is power. I don't take any drugs, and I have rarely taken even prescription medication in the past, so I really have nothing to gain except that I want to encourage my fellow citizens to be responsible and free.


You are powerless.
 
2012-12-08 10:15:11 AM  

LiquidSky: Zugswang: If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless.

While I agree with you in general, I think you've missed one big complication: about 90% of pediatric drugs are used off-label because they have never been tested in children. To get approved for use in a new population (children) I think they'd have to do complete safety tests, not just simple efficacy tests.


Well, just as a caveat, that is only true in certain cases where the course of the disease or the effect of the drug differs significantly from adults to children. In instances where this isn't the case, additional data can be supplemented, for example, via pharmacokinetic studies, and waivers can be granted in these instances, though it's a different process from getting waivers for drugs that treat terminal illnesses or disease states with small populations.

However, I don't know how significant this is. I don't have a lot of pediatrics experience, so I couldn't tell you roughly how many drugs differ significantly enough that they'd have to do additional safety tests before they would be approved in peds. (I don't suppose anyone could shed any light on this? Because now my curiosity has been piqued.)
 
2012-12-08 11:06:50 AM  

LordOfThePings: BronyMedic: mgshamster: AliceBToklasLives: Meh, caveat emptor.

/why do we have the FDA anyway? It's restraint of trade.
//I don't need nanny government to run drug trials I can damn well perform myself.

Because neither you nor I (a trained toxicologist with a higher education) nor anyone else is able to tell exactly what is in that medicinal bottle (or pill or whatever) you're being sold without equipment that cost hundreds of thousand of dollars to purchase and years of training to operate and analyze.

You do realize you're a personal hero of mine on FARK for this stuff, right?

For responding to sarcasm sincerely?


At first, I didn't think it was sarcasm. I've met a lot of people who actually believe what you said, including members of my own family. At one point in my life, every person with whom I associated (family, friends, colleagues, even girlfriend) believed in things like that (and also a varying mix of creationism, Obama = next dictator, anti-vaccine, organic = healthy and safer and better for environment and better for you in all ways, and more). It was tough being the one person who everyone thought was wrong (while at the same time claiming they were proud of me for getting a college degree).

It wasn't until your second post that I realized you were just being snarky. But considering the things Amos has posted here, would you be surprised if someone took you seriously?

/Now I have mostly different friends, and a new SO (married now), but still the same family.
//I mostly keep quiet and don't talk about reality around extended family.
 
2012-12-08 01:21:25 PM  
static.crushable.com
 
2012-12-08 02:09:46 PM  

mgshamster: It wasn't until your second post that I realized you were just being snarky.


That wasn't my post.

The tip-off was "drug trials I can damn well perform myself." Though maybe in your line of work, that's something you hear every day.
 
2012-12-08 02:26:05 PM  

LordOfThePings: mgshamster: It wasn't until your second post that I realized you were just being snarky.

That wasn't my post.

The tip-off was "drug trials I can damn well perform myself." Though maybe in your line of work, that's something you hear every day.


D'oh! You're right. Sorry.

But yeah, I do hear something similar to that fairly often. It's not that the people I talk to think they can legitimately do true drug trials, like toxicity testing and clinical trials (mostly because they don't know what a true drug trial is), but they do think they they can simply try different drugs themselves and determine which works the best for them - and that should be good enough. Specifically, I hear it a lot with homeopathy enthusiasts, usually to the tune of, "Just try it out for yourself, and you'll see how well it works." I've even heard it from people who push very dangerous alt-med "remedies," such as the guy who sells bleach for consumption and/or suppositories as a way to cure autism. Published on his own website is the phrase (paraphrased from memory), "Brave parents know how well MMS works; are you brave enough to try it on your autistic child?"
 
2012-12-08 03:04:50 PM  

mgshamster: D'oh! You're right. Sorry.


No worries; I was being snarky.

mgshamster: the guy who sells bleach for consumption and/or suppositories as a way to cure autism. Published on his own website is the phrase (paraphrased from memory), "Brave parents know how well MMS works; are you brave enough to try it on your autistic child?"


Ugh.
 
2012-12-08 05:39:05 PM  

LordOfThePings: For responding to sarcasm sincerely?


Not sure if you care, but...

BronyMedic and I have been in a multitude of threads over the years combating the anti-science folk. It's kind of nice to receive recognition from someone I respect for the posts I've made on Fark. Because I'm not a particularly snarky person, I tend to be ignored around these parts, but I figure that people like factual information, so I post mostly for the lurkers. Some of the threads I've saved because I like the comments and want to keep them for future use (which have come in handy from time to time). This thread (specifically the linked post) was one I was particularly proud of (ignore the typos).
 
2012-12-08 08:01:03 PM  

mgshamster: LordOfThePings: For responding to sarcasm sincerely?

Not sure if you care, but...

BronyMedic and I have been in a multitude of threads over the years combating the anti-science folk. It's kind of nice to receive recognition from someone I respect for the posts I've made on Fark. Because I'm not a particularly snarky person, I tend to be ignored around these parts, but I figure that people like factual information, so I post mostly for the lurkers. Some of the threads I've saved because I like the comments and want to keep them for future use (which have come in handy from time to time). This thread (specifically the linked post) was one I was particularly proud of (ignore the typos).


I know it sounds silly, and I am one that is INCREDIBLY snarky and sarcastic, but you made my night by saying this. While I come off as condescending at times, it's really not intentional for me to do so unless someone's being an unmitigated ass. "Alternative medicine" irks me on a personal level, because a good person I highly admired, and who was very influential in my early career was diagnosed with Stage I Pancreatic Cancer - when it was still in a treatable stage. He got scared and despirate, and got suckered into using the "Gearson Therapy", and only stopped when it had metastasized to his intestines.

Thank you for that. While there ARE practices that science-based medicine does deserve to be called out on, that in no way validates alternative medicine, or the shameful practices they engage in on preying on false hope and despirate people.
 
2012-12-09 08:19:11 AM  

Zugswang: LiquidSky: Zugswang: If you have a drug already on the market and you find another indication for that drug, filing a supplemental new drug application is not such an overwhelming onus, in terms of time or economics, that you wouldn't just wait for its approval before telling health care professionals and customers (and I say customers, because that's the relationship pharmaceutical companies have with the people we refer to as "patients") that drug x is indicated for use y. The data is there, it just has to be assembled and sent. And before anyone jumps in about how arduous the drug approval process is in this country (which is true, and for good reason), the process by which an already available drug gets approved for additional uses is comparatively painless.

While I agree with you in general, I think you've missed one big complication: about 90% of pediatric drugs are used off-label because they have never been tested in children. To get approved for use in a new population (children) I think they'd have to do complete safety tests, not just simple efficacy tests.

Well, just as a caveat, that is only true in certain cases where the course of the disease or the effect of the drug differs significantly from adults to children. In instances where this isn't the case, additional data can be supplemented, for example, via pharmacokinetic studies, and waivers can be granted in these instances, though it's a different process from getting waivers for drugs that treat terminal illnesses or disease states with small populations.

However, I don't know how significant this is. I don't have a lot of pediatrics experience, so I couldn't tell you roughly how many drugs differ significantly enough that they'd have to do additional safety tests before they would be approved in peds. (I don't suppose anyone could shed any light on this? Because now my curiosity has been piqued.)


My background is psych/genetics so I'm definitely not an expert. I ran across the "90% of paeds drugs are off-label" factoid when I googled to see how off-label meds were marketed here (in Oz). The 90% is an Aussie figure, but I'd bet the US figure is similar - there'd be no reason to get approval for kids in one country but not the other (FDA and the Aussie equivalent have info-sharing agreements, and use similar standards).

I went looking for what drugs might have a different effect in kids, and was quite suprised. I already knew there were questions about anti-depressants increasing suicide risk in children/teens. Other than that, I thought it'd just be the ones that affect hormones/thyroid/pituitary, but there seems to be a wide range of issues:

Aspirin: Reye's syndrome is possibly a child-specific complication of aspirin therapy ... thus over 16/over-19 warning labels in the UK/US. Link

This FDA link had a bunch of examples, including:
Chloramphenicol (antibiotic): killed several infants in the 50's before doctors realised their immature liver couldn't break it down.
Pepcid (famotidine) (anti-reflux med). Patients up to 3 months of age require a lower dose because their ability to get rid of the drug is less than that of older children and adults.
Midazolam hydrochloride (sedative): higher risk of serious and life-threatening adverse events for children with congenital heart disease and pulmonary hypertension.
Neurontin (gabapentin) (adjunctive therapy in the treatment of partial seizures). Neuropsychiatric adverse events identified in 3- to 12-year-olds.
Ultane (sevoflurane) volatile liquid for inhalation (general anaesthetic): rare reports of seizures in paediatric patients.

And I thought this article was pretty good. Link Basically just a history of the some of the big adverse drug reactions in paeds patients, but touches on the mechanisms, which was interesting.
 
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