Furosemide is good for filling the patient’s bladder, but the patient probably did not call for help filling his/her bladder.

- Rogue Medic

Can we trust drug companies to provide accurate information about their products? Part I

 

A friend sent the following email in response to what I wrote about the Circuit Court panel’s ruling allowing drug company representatives to discuss/promote off-label use of their drugs.[1] This is going to be in several parts, because there are many factors to consider. We probably agree on almost all of them, but we disagree on the right way to handle them.
 

This ruling on off-label promotion is actually potentially harmful to rational marketing and promotion of drugs, and many of us see it as a really bad ruling.

 

Everything is potentially harmful. What we need are better regulations. Not less. Not more. Better.

If this encourages fraud, that helps the drug companies and the tort lawyers, not patients.

This should stimulate some important discussion of how we learn about drugs (and medical devices).

Does this ruling make fraud more legal?
 

This has nothing to do with the discussion of off-label uses in other forums. It has to to with making sure that drug representatives, with huge financial interest in the sale of their drug, both personal and institutional, cannot just make $#!+ up to sell their drug.

 

Does this permit anyone to make false claims?

No.

Does this permit anyone to make misleading claims?

That is going to be the difficult part to prevent.

What is misleading?
 

Epinephrine (Adrenaline) is promoted in many misleading ways for cardiac arrest, even though the people recommending the use of epinephrine are not making any money off of epinephrine and do not appear to be trying to deceive. There is no evidence of better outcomes with epinephrine.[2]

Epinephrine has been shown to get more pulses back, but a lot more patients die in the hospital, or on the way to the hospital.

Is a few hours, or days, intubated and in a coma, with no awareness of anything, but discharged to the morgue, a good outcome?

I do not know of any evidence demonstrating any appropriate use of epinephrine in cardiac arrest.
 

Kayexalate is just as routine for hyperkalemia as epinephrine is for cardiac arrest. As with epinephrine, there is no valid evidence of improved outcomes with Kayexalate.[3] When I mentioned that Kayexalate does not work (at one of the top university hospitals in the world), I was told – We’ve seen it work.

We don’t need drug companies to deceive us. We lie to ourselves, when we say – We’ve seen it work.
 

Much of the same can be said for alternative medicine. Some of the pushers of alternative medicine believe their hocus pokus works. Valid evidence to support their claims does not exist. Therefore the FDA (Food and Drug Administration) does not permit alternative medicine pushers to make medical claims because they are not medicines.

Joe Mercola is perhaps the biggest alternative medicine pusher, who has repeatedly violated the law, but continues to be allowed to sell his snake oil.[4],[5],[6]

Maybe he believes in the nonsense he is making millions of dollars selling to the unsuspecting public.

If he has fooled himself, does that make his products in any way beneficial or make them any less dangerous?

Of course not.

He cannot peddle his snake oil as medicine. He has to use the Quack Miranda Warning –
 

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”[7]

 

This is the Required to Stay Out Of Jail warning used by frauds to convince a jury that their claims should not be taken seriously by any intelligent individual.

But scam artists convince us to ignore our intelligence and to trust them.
 


 

A lot of people still fall for these scams. Maybe they believe Dr. Mercola when he claims that there is some grand conspiracy by doctors, governments, and drug companies to silence him. Bernie Madoff probably made the same claims about his scams.[8]

The reasoning appears to be that there are examples of fraud by the drug companies, therefore anything else must be better. Choosing the complete fraud of alternative medicine over the occasional fraud of drug companies is a mistake.

Yes, the drug companies do a lot of bad things, but the way to stop that is to expose the misbehavior, not to prevent the drug companies from discussing off-label use of their drugs.

These laws are weak.

These laws prevent only some people (drug representatives) from providing this information.

These laws assume that doctors do not get their information from anywhere else.

Yes, there are plenty of gullible doctors, who will blindly accept what the drug representatives tell them.

I do not see these laws making the gullible doctors less gullible, or less dangerous.

We don’t need drug companies to deceive us. We lie to ourselves, when we say – We’ve seen it work.

The problem is that too many of us do not understand how to tell the difference between dangerous wishful thinking and medicine that really works.

To be continued in Part II.

Footnotes:

[1] Advertising unapproved uses of drugs is free speech, which is what the FDA has been trying to say
Rogue Medic
Wed, 5 Dec 2012
Article

[2] What is Evidence-Based Medicine?
Rogue Medic
Tue, 06 Nov 2012
Article

[3] Bonus – Is Kayexalate Useless?
by EMCRIT
March 22, 2011
Podcast page

[4] FDA Warning Letter to Dr. Mercola
February 16, 2005
Ref. No. CL-04-HFS-810-134
FDA
Warning letter download in PDF format from FDA

Plain text version of this warning letter at Casewatch.org

[5] FDA Warning Letter to Dr. Mercola
September 21, 2006
CHI-7-06
FDA
Warning letter in plain text from FDA

Plain text version of this warning letter at Casewatch.org

[6] FDA Warning Letter to Dr. Mercola
March 22, 2011
Meditherm Inc. 3/22/11
FDA
Warning letter in plain text from FDA

Plain text version of this warning letter at Casewatch.org

[7] Quack Miranda Warning
PalMD
White Coat Underground
Article

[8] Bernard Madoff
Wikipedia
Article

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