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pellicle

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Interesting

https://www.fairwarning.org/2019/11/whats-in-a-name-ghost-writing-in-medical-literature/

...The paper was about the risks of warfarin, a generic anti-clotting drug, for people also taking herbal supplements. AstraZeneca was developing a rival drug that would supposedly be safer for supplement users. A positive article could give the new drug a promotional lift. Fugh-Berman was considered an expert on drug-supplement interactions, so her byline would carry some weight. But long concerned about overprescribing in medicine, she turned out to be the wrong person to ask.
 

Astro

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Disturbing Influence. I hope that the major journals are actively looking for this bias before agreeing to publish any article.
 

tom in MO

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From an Wikipedia web page (I think) a few years ago, below are some of the major fines and thus proven fraud for pharmaceutical companies. This covers just the first 10 or so years of the 21st century.


FDA Fines
CompanyFineProblemYearProducts
GlaxoSmithKline$3 billion ($1B criminal, $2B civil)Criminal: Off-label promotion, failure to disclose safety data.
Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program
2012Avandia, Wellbutrin,
Paxil, Advair,
Lamictal, Zofran,
Imitrex, Lotronex,
Flovent, Valtrex;
Pfizer[2]$2.3 billion ($1.3B crimimal, $1B civil)Off-label promotion/kickbacks2009Bextra/Geodon/
Zyvox/Lyrica
Abbott Laboratories[$1.5 billionOff-label promotion2012Depakote
Eli Lilly$1.4 billionOff-label promotion2009Zyprexa
TAP Pharmaceutical Products[$875 millionMedicare fraud/kickbacks2001Lupron
Amgen$762 millionOff-label promotion/kickbacks2012Aranesp
Serono$704 millionOff-label promotion/
kickbacks/monopoly practices
2005Serostim
Merck$650 millionMedicare fraud/kickbacks2008Zocor/Vioxx/Pepsid
Purdue Pharma$601 millionOff-label promotion2007Oxycontin
Allergan$600 millionOff-label promotion2010Botox
AstraZeneca$520 millionOff-label promotion/kickbacks2010Seroquel
Bristol-Myers Squibb$515 millionOff-label promotion/
kickbacks/Medicare fraud
2007Abilify/Serzone
Schering-Plough$435 millionOff-label promotion/
kickbacks/Medicare fraud
2006Temodar/ Intron A/K-Dur/
Claritin RediTabs
Pfizer$430 millionOff-label promotion2004Neurontin
Cephalon$425 millionOff-label promotion2008Actiq/Gabitril/Provigil
Novartis$423 millionOff-label promotion/kickbacks2010Trileptal
Schering-Plough$345 millionMedicare fraud/kickbacks2004Claritin
 

Warrick

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spinning science to sell drugs scum

Wonder how much slips thru the cracks..
I guess theyve gotten sneaky at it
 

Protimenow

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There's quite a bit of off label stuff going on. I wasn't aware that drug companies that provide this information can get into trouble for promoting off label uses. I wonder how effective off label uses can become common knowledge - or, at least, knowledge - when this information can't be shared with doctors. Rogaine (Minoxidil) was originally presecribed as a heart medication (and probably still is) - and hair growth was a common side effect. Somehow, the off label use of it for hair growth became known - and productized.

Similarly, finasteride - used in 5 mg doses for prostate issues - was seen to help with hair growth in male patients (very few females have prostates that need it....), and the 1 mg dose became propecia. Still only available by prescription, but this 'off label' use became a regularly prescribe medication for hair loss.

I just wonder about how much off label information will result in a fine -- or if it's just okay for doctor-to-doctor word of mouth, but criminal conduct if drug companies report it to physicians.
 

tom in MO

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In the US, doctor's are allowed to prescribe drugs "off-label". Pharmaceutical companies are not allowed to market "off-label." They must run a clinical trial (two phases) to prove the drug works for the new use and those results must be deemed acceptable by the FDA. If a pharmaceutical company markets a drug "off-label" they are no better than a 19th century quack selling elixirs out of a "medicine wagon" and moving on to the next town before they are tarred and feathered.

Anytime a doctor prescribes you a drug for an off-label application, they are basically betting that their personal rationalization of the drug's action and/or anecdotal evidence is strong enough to prove efficacy, but there is no empirical (factual) science behind that medical decision.
 

Protimenow

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In the US, doctor's are allowed to prescribe drugs "off-label". Pharmaceutical companies are not allowed to market "off-label." They must run a clinical trial (two phases) to prove the drug works for the new use and those results must be deemed acceptable by the FDA. If a pharmaceutical company markets a drug "off-label" they are no better than a 19th century quack selling elixirs out of a "medicine wagon" and moving on to the next town before they are tarred and feathered.

Anytime a doctor prescribes you a drug for an off-label application, they are basically betting that their personal rationalization of the drug's action and/or anecdotal evidence is strong enough to prove efficacy, but there is no empirical (factual) science behind that medical decision.
No better than a 19th century quack? Really?

If a pharmaceutical company is running two phase trials for what may be considered an 'off label' use for its medication, and the FDA approves it, are the doctors who learned of the drug's other benefits STILL no better than a 19th century quack?

In my earlier post, I noted a number of medications that were developed for one use, and side effects or other effects were discovered that made them useful for what were originally 'off label' uses.

Doctors who prescribe medications of off label indications may have strong evidence that supports the use - perhaps medical journals that report the off label uses of the drug, or information shared by other doctors who have learned of other uses and have had success in patients who received the off label medications.

It's not fair - and rather foolish to brand any physician who prescribes an off label medication as 'no better than a 19th century quack' or a foolish risk taker who is prescribing for an off label use that may have otherwise been well documented.

Look at aspirin -- it's for pain relief. Right? So why do people take it at the first signs of a stroke? Why are many of us taking baby doses on the assumption that it will be of value in heart patients? Aren't these 'off label' uses? Is taking two aspirin at the first sign of a stroke - a well documented first step that may help to reduce the damage caused by a stroke - and probably not an indication for prescribing it - an off label use? Should those who take it be considered risk takers?

I don't have a problem with off label prescriptions if the medication's 'off label' effects are well documented. Why do you?
 

Astro

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In order for a drug to become FDA approved (TGA approved in Australia; MHRA in the UK) for a particular medical use, it takes resources to push it through the government processes. Only pharmaceutical companies with a new ‘shinny’ drug bother. This means that an older drug may be used all over the World “off-label” for a use that is considered standard treatment in the literature. There is no money in old drugs. There is no incentive for a pharmaceutical company to waste money and resources with the government processes (which have to be repeated for every country). Hence, off-label use is an accepted part of clinicians’ work. If you were a clinician and the literature says that the patient you are treating would benefit from an off-label use of a drug, wouldn’t you do it?

Every time a clinician uses a drug whether on-label or off-label, it must be justified. It must be considered reasonable treatment. Prescribing warfarin for knee arthritis would be unacceptable - the medical field would line up to condemn you (sorry if you were planning to make money from selling black-label warfarin for knee arthritis!).
 

Protimenow

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Hey, Astro - do you mean 'shiny.' Perhaps it's spelled differently in Australia? Or are you an orthopedic surgeon who is more familiar with shins than you are with shine?

Thanks for clarifying the role of off-label in medical practice. Clearly, doctors who use medications off-label are NOT equivalent to 19th Century quacks; clearly, if they use prevailing literature that describes off-label uses, they aren't dangerous risk takers.
 

Astro

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Hey, Astro - do you mean 'shiny.' Perhaps it's spelled differently in Australia? Or are you an orthopedic surgeon who is more familiar with shins than you are with shine?

Thanks for clarifying the role of off-label in medical practice. Clearly, doctors who use medications off-label are NOT equivalent to 19th Century quacks; clearly, if they use prevailing literature that describes off-label uses, they aren't dangerous risk takers.
Yes, I meant ‘shiny’. The on-label system is an important protection from drug companies pushing untested drugs on the population. Unfortunately, it doesn’t work well for older drugs. A new drug can’t be available unless approved. I think that I under sold the value of the FDA, TGA, MHRA, etc. They are definitely important.
 

Protimenow

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No. I don't think you undersold any of those agencies. New drugs are approved for specific conditions. The testing is done for certain conditions. It's extremely valuable that these agencies require great rigor in proving the effectiveness and safety, interactions, counterindications, etc. of drugs or devices that they ultimately grant or deny approval.

However, off-label (there, I've hyphenated it) is also an interesting outgrowth of this. It may initially be somewhat by accident, or through observance of unexpected side effects (such as hair growth or erections) that off label uses are discovered - and through journals and word of mouth (or whatever) that these uses are discovered and their possible effectiveness shared between physicians and others. If the initial drug isn't approved for a specific purpose (or purposes), the drug wouldn't be put into initial use. Off-label uses may occur almost by accident. If the drug manufacturers learn about the off-label uses, and somehow promote them, this, I think, is how they get into trouble.

I certainly didn't want to diminish the importance of the regulatory agencies that you listed.
 
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tom in MO

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Protime you can't have it both ways, mistrust doctors on one hand and then believing them to be golden girls when prescribing drugs for off-label uses. Doctors are not pharmacological scientists.

I'll give you an example right out of the current news. There is a $2 billion industry prescribing testosterone to rich men. The majority of this money is spent on conditions that have been proven not to be effected by testosterone therapy and/or not really diseases unless you call old age a disease. https://www.medscape.com/viewarticle/920447?src=wnl_edit_tpal&uac=267029AZ&impID=2160057&faf=1

Some of my work is on a project where new uses of some of the oldest drugs on the market are being investigated in legal clinical trials conducted in a variety of places around the world. Money for this type of investigation comes from a variety of sources.
 

Protimenow

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I'm not looking to have it both ways -- not all doctors prescribing off-label are doing so as a result of good data that describes effective off-label use. But I wouldn't label ALL doctors to prescribe off-label drugs as quacks.

Doctors who prescribe off-label medications (like those you mentioned, who prescribe testosterone with little evidence that it does as it's supposed to, and with no information about side-effects) are irresponsible. Those with good data about the off-label uses should be considered to be acting responsibly, with well documented effectiveness and awareness of negative consequences.

Plus--the doctors I mistrust are mistrusted for reasons other than off-label prescribing. (And when did I say that I mistrust doctors? My basic issue is with the labs.)

Doctors who prescribe off-label aren't necessarily 'golden girls' -- the ones who research journals and other sources, and are reasonably certain that off-label uses of certain medications can be useful or curative for various conditions shouldn't necessarily be faulted for doing so.

The situation isn't as black and white as you've made it sound.
 

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