The news of Lilly and Zyprexa (olanzapine) seemed to dominate the news last week and I felt it was a big enough story that I wanted to see how it developed and have a chance to read multiple reports before commenting on the story. What follows are the various stories and Lilly’s response and my comments on them.
Eli Lilly Said to Play Down Risk of Top Pill - New York Times
This NY Times article talks about the problem of significant weight gain in patients on the drug. The quotes below show that early on there were some concerns but that these were minimized and played down by Lilly sales reps.
Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.
“From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives,” said Dr. James Phelps, a psychiatrist in Corvallis, Or. ‘Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company.”
Again, it is very difficult to PROVE cause and effect. Merck has taken the same approach in the Vioxx cases and this is a common strategy for drug makers when their drugs have problems. The weight gain is fairly easy to prove but does that lead to diabetes I think is the key question. While their maybe a lot of evidence SUGGESTING being overweight contributes to the odds of developing diabetes doesn’t necessarily cause it. I don’t think this negates the need to be safe and consider the down sided when developing drugs. Too often though, it is felt that since a drug is approved they need to do everything to defend the company or the product. I’ll have more to say on this aspect later in this post.
While the weight gain and the associated health problems are bad, if it controlled otherwise difficult cases of schizophrenia then the risk-benefit profile might still be worthwhile. However, the problem is the the drug appears to have been heavily promoted for off-label use. The following NY Time article talked about this.
Drug Files Show Maker Promoted Unapproved Use - New York Times
Off-label use is another of those controversial issues with regard to prescriptions drugs. I personally think the idea is okay but that many times it is taken advantage off. Many doctors rely on the information provided to them by the drug sales reps. Unfortunately, it has been shown that this system can be distorted and while the FDA may be able review the marketing documentation, they can’t regulate what these sales reps actually tell the doctor in their face to face contacts.
The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved.
I really think this is an area ripe for review. I personally would like to see this aspect of the system reformed and that may be occurring indirectly. Pfizer has greatly cut their sales force and other pharma companies are likely to follow suit. However this still doesn’t address the interaction itself. Maybe what is needed is an easy system for doctors to be able to access information from the FDA regarding the adverse events reported to the FDA. Doctors are already overworked in many cases and this system would need to be easily accessed and should also be available to consumers.
Lilly released a statement basically saying that a lot of this was taken out of context and represented only a small fractions of the documents available.
Eli Lilly and Company Statement Regarding Today’s New York Times Article
This too is a common strategy but in this case I think what has been seen is pretty damaging. If you look at other cases, sometimes companies try to bury the bad in a deluge of other information. Finding the nuggets contained therein then becomes a truly Herculean effort.
Too many times, pharma companies come out swinging which I feel just reinforces the view of the public that they are not concerned about patient safety and are primarily concerned about their profits. J. Scott Armstrong, a professor at the Wharton Business School at the University of Pennsylvania has studies this sort of situation in regard to Panalba an Upjohn drug that had problems back in the 1960’s and was finally removed in 1970.
The NY Times also had an editorial on this.
Playing Down the Risks of a Drug - New York Times (editorial)
Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials.
While it may be legal it may not be moral. It is impossible to regulate what drug reps tell doctors. Even though the actual material is legal what is said or conved may be entirely different. Current think is that it is easier to get approval for a serious condition and then expand usage by “encouraging” off-label use. My understanding is that drug reps can leave “literature” on other uses for their drugs but can not “promote” for that.
Lilly also came out fighting by demanding the some documents where obtained illegally and should be returned to the court.
Court Orders Lawyer to Return Documents About an Eli Lilly Drug - New York Times
There were also other letters to the editor concerning Zyprexa.
Eli Lilly and the Dangers of a Drug (5 Letters) - New York Times
The problem is that no one wants to acknowledge the downside of their drugs. This is why labeling can be such a clash between the drug companies and the FDA. The labeling for drugs must be negotiated and I think this is a prime area where the FDA needs more authority. I’d like to see the FDA have the ability to add certain wording to labels based on strong scientific evidence regardless of the companies position.
Drug companies will say there is no proof of a given drug causing a certain problem but in many cases, this concern may have been brought up in internal meetings. However, it may be decided NOT to gather data that could be potentially damaging. I personally have sat in on meetings where it was decided NOT to do certain trials or look at certain aspects of drug because it might uncover potential problems. I have always argued strongly that in the long run it is best to have all the pertinent data but usually upper management and marketing come down that there is a large potential downside and no upside so these proposed studies are not done. It is the old head in the sand strategy; they would rather not know. Ignorance is truly bliss for them although I don’t think that can be maintained as a long term strategy.
An example of this is not comparing drugs to know which are most efficacious in which patients. This is something that needs to be done and could greatly benefit patients, but drug companies many times do not want to know the answer! They are afraid their product isn’t as good as some older less expensive drugs. While there have been some studies comparing various drugs these are far too few since it isn’t in the companies best interest. This is where the government could play a positive role in my opinion.
I think there is a need for adverse events reported not only to drug companies but directly to a reformed drug safety dept within the FDA. There also need strong authority to deal with such issues and the penalties should be strong enough to discourage this abuse. Drug companies have shown in several cases they can not be relied upon to provide un-biased information and many doctors are losing faith in drug reps.
There are always risks with drugs, something that I think is overlooked by many, including doctors and patients. Recently the FDA is wanting stronger worded language on pain relievers on the possibility of complication even with acetomenophen.
Many of these cases are the result of trying to protect something AT ALL costs! J. Scott Armstrong studies on the Panalba incident and some role playing he designed definitely shines
light on how these sorts of decisions are made.
The Panalba Case (pdf)
The Panalba Role Playing Case was designed to get participants to examine their behavior in a situation where their role can lead them to act in a socially irresponsible manner. A description of the case is provided along with instructions to the administrator. Much research has been done on this case, allowing subjects to compare their behavior with that of previous subjects.
Case of the Detrimental Drug: Implications of the Stakeholder Theory of Directorship
I highly recommend both of these as they give insight into why drug companies make their decisions and that it comes down to protecting their own corporation (they have a vested interest) rather than concentrating on patient safety.
Other Resources from J. Scott Armstrong
• Corporate Boards Should Represent a Broader Community of Interests
• Social Irresponsibility in Management
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Email Ed Vawter
Related Posts:
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