Sunday, July 23, 2006

Be careful what you say about off label prescribing

Do you speak at continuing medical education conferences on drug therapy? Do you ever mention off label use? Be concerned. You may wind up in handcuffs. That’s what happened to Dr. Peter Gleason, a Maryland psychiatrist whose career has been destroyed in an episode characterized by the New York Times as illustrative of the “murky” relationship between drug companies and physicians who help promote their medications. Dr. Gleason frequently spoke about off label use of the Jazz Pharmaceuticals product Xyrem, a drug approved for narcolepsy. Although the extent of Dr. Gleason’s promotional activities are concerning this may be a case of over zealous prosecution. Dr. Gleason stated that he was arrested and charged only after he refused to cooperate with the prosecutor’s investigation of the company. Moreover, according to independent legal experts interviewed by the Times, Gleason’s activities were not clearly illegal. Rather, prosecutors were concerned merely that Dr. Gleason “went too far.”

Off label use of drugs is legitimate. The mention of off label drug prescribing is commonplace at drug company supported CME events. This prosecution sets a dangerous precedent. There are no clear legal constraints regarding such activities, and this could happen to any speaker at drug company supported educational events.

10 comments:

Daniel Haszard said...

I took zyprexa starting in 1996 the year the FDA approved it, which was ineffective for my condition and gave me diabetes.

Zyprexa is the product name for Olanzapine,it is Lilly's top selling drug.It was approved by the FDA in 1996 ,an 'atypical' antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.Zyprexa has been linked to causing diabetes and pancreatitis.

Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly's $14.6 billion revenue last year.

Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta?

Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place!

I was prescribed Zyprexa from 1996 until 2000.
In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.

All the psychiatrist I've interviewed and the information on line presents zyprexa as a worse offender than the other Atypicals such as seroquel.My doctor has stopped prescribing zyprexa altogether.

The PDR classifies zyprexa as 'severe' for causing weight gain and diabetes and seroquel as 'moderate'.

Of course the 50 year old Thorazine didn't cause diabetes and is many times cheaper but it could cause tardive dyskinesia.

Where Eli Lilly's negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it.

Lilly's incentive not to readily disclose is they had billion$ coming in from state medicaid scripts.
----
Daniel Haszard http://www.zyprexa-victims.com

Anonymous said...

"Off label prescribing is legitimate" Hmmm. Isn't Dr. RW a big champion of evidence based medicine? Yet, off label prescribing is, by definition, prescription to treat conditions for which there is NO EVIDENCE that such prescription works.

Oh well, I suppose Dr. RW just flushes down the toilet her principles wheneever a fellow doctor is held accountable. Typical.

R. W. Donnell said...

Anonymous,
You said "Yet, off label prescribing is, by definition, prescription to treat conditions for which there is NO EVIDENCE that such prescription works."

Wrong.

Off label prescribing is prescription for any use not approved by the government. That doesn't equate to evidence of drug effectiveness. Your confidence in government approval appears to be misplaced. Since when has government approval of drugs kept pace with science?

Please consider these examples of off label drug uses which are backed up by substantial evidence:

Metformin for polycystic ovary syndrome; tricyclic antidepressants and anticonvulsants for neuropathic pain; Viagra for pulmonary hypertension; caspofungin for invasive candida infections.

Anonymous said...

Wrong, Mr. R.W.! The "label" constitutes FDA's approval that the drug is 1. effective for treating its intended disease and 2. safe. "Off-label" prescription is for diseases for which effectiveness has NOT been shown to the FDA.

Now, evidence may develop later that a particular drug is effective at treating other diseases--as you so pedantically point out. However, off-label presecription typically lacks such evidence.

Given the limited knowledge of most doctors in matters pharmacological, I find this frightening. That a champion of evidence based medicine should be blithely OK with it demonstrates how doctors are always more interested in preserving the professional perrogatives than intellectual honesty.

Alice said...

RW - Thanks for posting about this story.

Anonymous - What's your authority for decrying Dr. RW's knowledge of off-label prescriptions? It's well known among doctors that the FDA is slow to recognize and approve all possible uses of a drug which has already been approved as safe (and since when do you really trust either the FDA or the drug companies to give you accurate information about safety?).

R. W. Donnell said...

Anonymous,
At the risk of being pedantic once again: in the four examples I gave, the evidence for effectiveness has been there a long time, and still no action by the FDA. If my examples are faulty, please educate me with specific reference to the examples.

Also, note that I did not defend Dr. Gleason's promotions in by blog post. Although they were not clearly illegal (or deserving of prosecution in my opinion) I expressed my concerns about how he went about it.

Anonymous said...

Mr. RW:

And, at the risk of being pedantic, it is still the case that most off label prescription is not evidence based, and none of it is evidence based to the satisfaction of the FDA.

THe problem with off-label prescription is that doctors pretend their experience gives them knowledge that they, in fact, do not have. (Example of doctors overweening pretension: In RW's opinion, Gleeson did nothing illegal--uhh, what law school did you go to) We can't trust these bizarre megalomaniacs to make difficult epidemiological decisions for which most of them lack adequate expertise.

R. W. Donnell said...

Anonymous,
FDA labeling doesn't set the only evidentiary standard for drug therapy. If it did, evidence based medicine would be easy---all one would need would be the PDR, which contains all the FDA approved labeling. We wouldn't have to mess with Pub Med, Up to Date and all the other resources. We wouldn't have to *search* for the best evidence.

Maybe we can meet half way on this: Some off label prescribing is evidence based while some clearly is not. Some *on label* prescribing is evidence based while some is not.

Concerning the legality of Dr. Gleason's actions, I based my statement on the opinions of the independent legal experts cited by the Times, any expertise of my own.

Christina said...

Thank you all for your comments. If any one would be interested in contributing their thoughts or help to Dr. Gleason's defense, please send an email to me:

ckate (at) umd.edu

C. said...

A Forum for Discussion:


http://gleasondiscussion.blogspot.com/