Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Doctors or Drug Pushers
- Susan O Mayaki, O. A Adebajo (6 February 2007)
-
Anti psychotic drugs in the UK
- Jerome Burne (7 February 2007)
-
A Personal Perspective on the Zyprexa Documents
- Stefan P Kruszewski (11 March 2007)
|
|
|||
|
Susan O Mayaki, SHO Birmingham and Solihull Mental Health NHS Trust, O. A Adebajo
Send response to journal:
|
This story raises a number of questions for doctors in general. First and foremost, how do we negotiate our roles in the complex health economy and socio-cultural milieu in which we, our professional institutions and our patients live? The pragmatic clinician has to strike a careful balance between being bowled over by promotional literature, skilfully compiled by professional marketers and adroitly sold by pharmaceutical representatives and the active encouragement of our professional regulators and employers to be aware of new trends in treatments. Furthermore, we live in an age of increased availability of health- related information and very often, new treatments are heralded in the press and internet forums long before detailed critical appraisal has become available. Our patients, and their relatives, receive this information and sometimes attend clinics armed with questions and hopes as a result of this biased and unselective information. It must be emphasised that there is no free lunch in pharmacotherapy and the rational use of drugs is a continuous exercise in risk-benefit analysis. We must involve our patients in this process and use our critical appraisal skills to tilt the balance towards those forms of treatment that achieve a satisfactory risk-benefit ratio at all times. The dictum ‘above all, do no harm’, must not be turned into a mantra for ‘when in doubt do nothing’. Competing interests: None declared |
|||
|
|
|||
|
Jerome Burne, Medical Journalist Freelance
Send response to journal:
|
What intrigues me is the way that stories about Eli Lilly being investigated for improper marketing of olanzapine in the States are written about as if they have no implications for the UK at all. Olanzapine is the most widely prescribed antipsychotic in the UK, has it been improperly marketed here? According to replies I have had from the MHRA (Medicines and Healthcare products Regulatory Agency) it has no investigation into this underway nor have they been given any evidence of it. Promoting off-label use is certainly outlawed in the UK; isn't it odd that companies behave improperly in the USA but not in the UK? It's not as if the drug is not widely used off-label in the UK. As part of an investigation I carried out for the Daily Mail into the use of antipsychotics on dementia patients - published this week - I calculated that they are prescribed off-label to around 200,000 patients with dementia using figures obtained from the MHRA and from others given in response to parliamentary questions. This is despite the fact that there is a specific MHRA warning that two of the most comnonly used ones - olanzapine and risperidone - should not be given to dementia patients because they increase the risk of stroke. What's more, a recent randomized double blind etc study on the use of antipsychotics on the elderly - including olanzapine - published in the NEJM (Schneider L Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525- 38.) found that these drugs were no better than a placebo. Now it could be that many prescribers believe that at least atypical antipsychotics such as olanzapine are less damaging to patients than the older antipsychotics but recent major studies conducted by the American Institutes of Health and the Veterans administration (details in Rosenheck R Outcomes, Costs, and Policy Caution ARCH GEN PSYCHIATRY/VOL 63, OCT 2006) found that there was no difference in effectiveness or in side effects. A large UK study had similar findings (Jones P Randomized Controlled Trial of the Effect on Quality of Life of Second- vs First- Generation Antipsychotic Drugs in Schizophrenia Arch Gen Psychiatry. 2006;63:1079- 1087) According to Owen Dyer's story, the American Agency for Healthcare Research and Quality found that "atypical antipsychotics such as olanzapine are often prescribed for unapproved conditions such as depression, dementia, and geriatric aggression despite serious side effects and little evidence of efficacy." Presumably this is cause for concern in the States, I'm puzzled as to why 200,000 people getting a class of drug that is neither safe nor effective is not considered a problem in the UK. Jerome Burne Competing interests: None declared |
|||
|
|
|||
|
Stefan P Kruszewski, Neuropsychiatrist, addictionologist Harrisburg, Pennsylvania USA
Send response to journal:
|
On February 13, 2007, Judge Jack Weinstein from the U.S. Federal District Court in Brooklyn, New York, castigated Dr. David Egilman, Attorney Jim Gottstein, and New York Times reporter, Alex Berenson – the players who publicly sought to disclose selected internal Eli Lilly documents about Zyprexa. Those individuals, such as me, who had been named in the injunction despite never viewing the documents, are no longer enjoined. Judge Weinstein’s 78-page ruling was guided primarily by procedures of law and the need to maintain the cloistered nature of what had previously been ruled Lilly’s proprietary protected documents. From the Philadelphia firm of Pepper Hamilton and the New York firm of McCarter & English, lawyers working on behalf of Lilly argued in a pre-judicial summary that “vulnerable patients taking lifesaving medications should be guided by their doctors and not by selective leaking of documents…” (1) An additional Lilly argument, that patients should not be subjected to treatment based upon incomplete or selectively-released data, might be an unwelcome two-edged sword for the company. Lilly reaffirms the doctor- patient relationship and the value of medicines carefully prescribed and consumed. That is incontrovertible and reassuring. However, the sword’s other edge eviscerates a separate Lilly argument. On the one hand, Lilly wants to curtail selective release of documents so that physicians and patients can reliably make decisions about their product. By their own admission, however, the company selectively chooses what information is provided about that product to regulatory bodies (FDA, MHRA), and subsequently to physicians. Therefore, by virtue of Lilly’s forceful argument discouraging selective release by Egilman, Gottstein, and the New York Times, should not Lilly be held to the same standard of accountability that it demands of others for its proprietary database? To avoid being hypocritical, Lilly should take the opportunity to release every clinical scientific document about Zyprexa. Will they? The answer to that question is probably the same as the likelihood that the men in the US and UK will abandon their interests in football and rugby, respectively, in favor of opera and ballet. The point for every psychiatric specialist and primary care physician who prescribes olanzapine, or any other medication, is the same. We physicians cannot assume to have or to provide expertise in the effects, effectiveness and adverse events of prescription medications if our fund of information is compromised by selectively-released or cherry-picked data. Since Lilly agrees with this premise in their report to the U.S. Federal Court, let’s ask them to put all of the clinical data where their mouth says it should be---in the hands of physician-scientists who require it to make life-changing decisions. (1) Page 17 of Eli Lilly and Company’s Reply Memorandum in Support of its Motion to Modify and Extend the Court’s January 3, 2007 Temporary Mandatory Injunction. Competing interests: Dr. Kruszewski works with certain US state governments and Federal regulatory agencies to examine issues pertaining to the science that underscores certain neuropsychiatric devices and pharmaceuticals |
|||