For marketing an off label use of Zyprexa, Lilly has agreed to to pay 1,42 billion .
The medication has FDA approval for treatment of schizophrenia and bipolar disease but it is alleged that Lilly vigorously promoted its use to control agitation in the demented elderly as well as in children with certain behavior disorders.A number of physicians, academic and otherwise, took part in various of these promotional activities.One promotional campaign was cutely named "Viva Zyprexa".
In 2007,sales for Zyprexa reached 4.8 billion with total Lilly drug sales of 18.6 billion.
As interns, we carried around black bags that were given to us on graduation from medical school.Lilly gave out those bags and they came with our names on the bag and I think a reflex hammer and tuning fork inside.Big pharma was known as the "ethical drug industry" back then.How the adjective became part of their designation I don't know. It seemed similar to the House Ways and Means Committee always being referred to as the Powerful Ways and Means.The later adjective still applies, not so much for the former one.
I have written about the Zyprexa saga before and in that blog quoted Dr. Patricia Illingworth:
"some commonly accepted principles of business ethics are fundamentally incompatible with medical ethics"
I believe that is true but what ethics precept could Lilly have possibly adhered to in regard to the Zyprexa promotional activities.
Showing posts sorted by relevance for query zyprexa. Sort by date Show all posts
Showing posts sorted by relevance for query zyprexa. Sort by date Show all posts
Thursday, January 15, 2009
Monday, December 18, 2006
More accusations of big pharma behaving very badly
The ethics of business is not the same as the ethics of medicine but if recent accusations against Lilly are true you might conclude that in regard to some businesses the word does not even apply. I have quoted Dr. Patricia Illingworth before:
...some commonly accepted principles of business ethics are fundamentally incompatible with traditional medical ethics...,
These practices include spinning and playing down the negative aspects of your product and intentionally misleading customers and maybe that is why we have laws against deceptive trade practices.
Reuters today published an article saying that the NY Times web site describes Lilly's activities promoting off label use of Zyprexa (olanzapine) and acting to play down Zyprexa's known side effects of significant weight gain and increased risk of diabetes. They are accused of a stealth campaign to promote the drug's use in dementia. Olanzapine has FDA approval for use only in Bipolar disease and schizophrenia.
NY Times writes about internal Lilly documents that suggest Zyprexa be promoted to primary care docs for use in dementia noting that psychiatrists are the physicians who mainly treat schizophrenia and bipolar disorder and primary docs do not feel confident is managing those conditions but they do manage many elderly patients with varying degrees of dementia.
Evidence is presented that indicates sales reps did in fact promote the drug for the off label use with the result of a significant increase in sales and were given monetary incentives for those activities. The promotional program was known as "Viva Zyprexa". A representative for Lilly denies claims of promoting the drug use for non approved indications and is quoted as stating that a Zyprexa-diabetes link has not been proven.
...some commonly accepted principles of business ethics are fundamentally incompatible with traditional medical ethics...,
These practices include spinning and playing down the negative aspects of your product and intentionally misleading customers and maybe that is why we have laws against deceptive trade practices.
Reuters today published an article saying that the NY Times web site describes Lilly's activities promoting off label use of Zyprexa (olanzapine) and acting to play down Zyprexa's known side effects of significant weight gain and increased risk of diabetes. They are accused of a stealth campaign to promote the drug's use in dementia. Olanzapine has FDA approval for use only in Bipolar disease and schizophrenia.
NY Times writes about internal Lilly documents that suggest Zyprexa be promoted to primary care docs for use in dementia noting that psychiatrists are the physicians who mainly treat schizophrenia and bipolar disorder and primary docs do not feel confident is managing those conditions but they do manage many elderly patients with varying degrees of dementia.
Evidence is presented that indicates sales reps did in fact promote the drug for the off label use with the result of a significant increase in sales and were given monetary incentives for those activities. The promotional program was known as "Viva Zyprexa". A representative for Lilly denies claims of promoting the drug use for non approved indications and is quoted as stating that a Zyprexa-diabetes link has not been proven.
Wednesday, October 11, 2006
More bad news regarding second generation antipsychotics.
The October 12, 2006 issue of The New England Journal of Medicine published an article regarding the use of the second generation antipsychotic drugs (SGAs) in the management of aggression and agitation and psychotic behavior in dementia. These drugs are widely used for this application although it is not approved (by the FDA) for that use and in fact there is a "black box" warning regarding increased risk of death in older patients with dementia.
Three drugs were compared with placebo in 421 patients in a multi center study; 1) olanzapine (Zyprexa), 2) risperidone (Risperdal) and 3)quetipine (Seroquel).
This trial differed from the typical efficacy-safety RCT done by drug companies as it looked at a "real clinical life" end point of time of discontinuing the medication because of any reason. The other primary outcome was the number of patients who had a minimal improvement a clinical behavior scale.
The authors concluded that the three drugs were more effective than placebo but the incidence of side effects limited their use. As seems to be more and more the case in clinical trials, there are so many comparisons made and often with rather arcane statistical tools it is difficult to know what to conclude. For example, Zyprexa was significantly better than placebo with the "Cox model" but not when compared with placebo with the "Hockberg adjustment" for multiple comparisons.Apparently this adjustment is an alternative to the Bonferroni technique to decrease the number of "false positives" when multiple comparisons are made. But how do you decide which technique to use-in this case the resultant answers seems 180 degrees apart.
Although the headline news- sound bites about this article may claim these drugs were useless, that characterization seems too simple.They can help control the symptoms of interest but often have to be discontinued because of side effects . Even the authors seems a bit ambivalent in their comments about the results;
"...our findings suggest that there is no large clinical benefit of treatment with atypical antipsychotic medications as compared with placebo."
They also say:
"Although the atypical antipsychotic drugs were more effective than placebo, adverse effects limited their overall effectiveness."
My take on all of this is these drugs may help a bit in the control of agitation and aggression in dementia patients but in a significant number of patients side effects lead to their discontinuation. Certaintly the exuberant enthusiasm driven in no small measure by drug company hype is waning. These drugs are not nearly as good as the efforts to promote them suggested. It would have been interesting and perhaps instructive for Haldol to have been included in the drugs that were compared in this study as for years it has been the stand by drug in difficult situations with dementia patients with aggressive behavior.
Three drugs were compared with placebo in 421 patients in a multi center study; 1) olanzapine (Zyprexa), 2) risperidone (Risperdal) and 3)quetipine (Seroquel).
This trial differed from the typical efficacy-safety RCT done by drug companies as it looked at a "real clinical life" end point of time of discontinuing the medication because of any reason. The other primary outcome was the number of patients who had a minimal improvement a clinical behavior scale.
The authors concluded that the three drugs were more effective than placebo but the incidence of side effects limited their use. As seems to be more and more the case in clinical trials, there are so many comparisons made and often with rather arcane statistical tools it is difficult to know what to conclude. For example, Zyprexa was significantly better than placebo with the "Cox model" but not when compared with placebo with the "Hockberg adjustment" for multiple comparisons.Apparently this adjustment is an alternative to the Bonferroni technique to decrease the number of "false positives" when multiple comparisons are made. But how do you decide which technique to use-in this case the resultant answers seems 180 degrees apart.
Although the headline news- sound bites about this article may claim these drugs were useless, that characterization seems too simple.They can help control the symptoms of interest but often have to be discontinued because of side effects . Even the authors seems a bit ambivalent in their comments about the results;
"...our findings suggest that there is no large clinical benefit of treatment with atypical antipsychotic medications as compared with placebo."
They also say:
"Although the atypical antipsychotic drugs were more effective than placebo, adverse effects limited their overall effectiveness."
My take on all of this is these drugs may help a bit in the control of agitation and aggression in dementia patients but in a significant number of patients side effects lead to their discontinuation. Certaintly the exuberant enthusiasm driven in no small measure by drug company hype is waning. These drugs are not nearly as good as the efforts to promote them suggested. It would have been interesting and perhaps instructive for Haldol to have been included in the drugs that were compared in this study as for years it has been the stand by drug in difficult situations with dementia patients with aggressive behavior.
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