Open Medicine EU

ZYPREXA OFF-LABEL

Prescribing “off-label” means prescribing a medicine for a use for which it is not authorised. Pharmaceutical companies may not promote off-label use of their medicines, for good reason. There is not the same tested scientific base for off-label use as there is for authorised use.

Qualified doctors may prescribe off-label, on the basis of their own professional judgement or experience – the wisdom of doing so is a matter for them. Companies can make a lot of money from off-label use of their medicines. There is an obvious temptation here that is not always resisted.

One such case was Zyprexa, an anti-psychotic from Eli Lily, and in the same class of atypical anti-psychotics as Seroquel, the subject of my first post. In 2009, Eli Lily pleaded guilty to having promoted Zyprexa for off-label use between 1999 and 2001. Many other related cases, including patient class actions and cases taken by individual US states have been settled.

I’ve been looking at many of the documents released in these cases. Zyprexa was indicated (authorised) at the time in cases of Schizophrenia and Bi-Polar 1 Disorder.

In 2000, the company launched a campaign, called Viva Zyprexa, to market Zyprexa to primary care physicians (PCPs), such as GPs and front line doctors in hospitals. Market research indicated that many PCPs were not comfortable in dealing with schizophrenia and Bi-Polar 1 and preferred to refer patients to psychiatrists. The Viva Zyprexia campaign, which had its own company song (lyrics only, can anyone guess the tune? ) sought to redefine “how primary care physicians treat mood thought and behavioural disturbances” by establishing Zyprexa as a “safe proven solution for mood thought and behavioural disorders”. It seems to me that we are a long way here from schizophrenia and bi-polar.

Similar problems can be seen in other documents associated with the campaign. A pre-campaign strategy document referred to framing the discussion “around symptoms and behaviour rather than indications”. I don’t know what actually happened in the field but promoting a medicine on the basis of symptoms and not diagnosis is not just unscientific; it is truly dangerous.

A briefing document from around the same time declared that it was not intended to promote for non-approved indications “but rather to illustrate potential symptom and behaviour profiles for which Zyprexa represented a much-needed solution”.

Hmm.

Eight months into the campaign, an implementation guidance document contained three (modified) patient profiles that could be used in promotion. Bi-polar was mentioned for one of the patient profiles, but the key aim was to establish Zyprexa as a broad spectrum “safe proven solution for mood thought and behavioural disorders”.

In the guilty plea the company acknowledged to having, between September 1999 and March 31, 2001, “promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia”. There was no admission or finding that the campaign strategy might have facilitated other off-label uses.

Later work, including work published by the company itself, indicated a significant risk of mortality among elderly patients treated with Zyprexa

As to the dates, the government contended that the off-label promotion continued past March 2001 but the company did not accept that. In the plea agreement the government agreed in effect not to take the matter further.

Among the documents I did find one complaint alleging promotion of off-label use in August 2001. From handwritten notes it seems that the company intended to contact the doctor concerned but I found no other references to this complaint in the documents that I have seen.

A Sales Force Guide from 2002 seemed to be different in tone and much more limited in scope than the material from the Viva Zyprexa campaign. If readers have any views on this document I will be glad to hear from them.

Tech Note: The link to the “Viva Zyprexa” campaign document above is slow The document is on a google.docs site because of formatting problems.

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Comments

  1. Hi Jim,
    just followed you from today’s IT article on Pharma, and wanted to say it’s great to see someone else exercised and articulate on this issue. We’ve sometimes tried to bring some understanding of Pharma’s promotion techniques to other doctors. I’ll keep in touch with the blog, well done.

  2. Zyprexa legacy

    The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease.
    The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.
    One in 145 adults died in clinical trials of those taking the antipsychotic drugs Zyprexa.
    I took Zyprexa prescribed *off label* for PTSD , for 4 years got diabetes classic case.

    Daniel Haszard Zyprexa victim activist

  3. Thanks Peadar,

    I’d be glad to hear of specific cases you may come across of how science is conducted or presented in a commercial context
    Best wishes.
    Jim

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