Many thanks Ivar for this posting.
Another recent celebrated case that you might be aware of is the HRT prescribing
issue.
Have you read this recent article:
The Haunting of Medical Journals: How Ghostwriting Sold HRT
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000335
The article in PLoS reveals that approximately 1500 documents put forward in the
HRT litigation provided unprecedented insights into how pharmaceutical companies
promote drugs, including the use of vendors to produce ghostwritten manuscripts
and place them into medical journals.
The author of this article concludes (taken directly from source):
* Dozens of ghostwritten reviews and commentaries published in medical journals
and supplements were used to promote unproven benefits and downplay harms of
menopausal hormone therapy (HT), and to cast raloxifene and other competing
therapies in a negative light.
* Specifically, the pharmaceutical company Wyeth used ghostwritten articles to
mitigate the perceived risks of breast cancer associated with HT, to defend the
unsupported cardiovascular benefits of HT, and to promote off-label, unproven
uses of HT such as the prevention of dementia, Parkinson's disease, vision
problems, and wrinkles.
* Given the growing evidence that ghostwriting has been used to promote HT and
other highly promoted drugs, the medical profession must take steps to ensure
that prescribers renounce participation in ghostwriting, and to ensure that
unscrupulous relationships between industry and academia are avoided rather than
courted.
Yet another very important case that all of us who are enthusiasts for
off-license prescribing should be aware of, is that of Ezetimibe.
According to the ENHANCE trial, the results of which were published a full two
years after it finished, and then only because the US Congress
actually threatened to subpoena the pharmaceutical company MSD who were
deliberately withholding and refusing to release the unfavourable trial results,
Ezetimibe is essentially a worthless drug.
The FDA is now investigating and re-evaluating the drug:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070779.htm
Following on from this, on 15th July 2009, Merck and Schering Plough struck a
$5.4 million deal with 35 US State Attorneys General to resolve an investigation
into the companies' lengthy delay in releasing negative results from the ENHANCE
trial, which showed that Ezetimibe combined with cholesterol-lowering
Simvastatin was no better than Simvastatin alone. As I mentioned earlier, the
trial was completed in May 2006, but the results were not announced until
January 2008.
During the lengthy delay, the companies engaged in aggressive direct-to-consumer
(DTC) marketing of their two Ezetimibe products, Zetia and Vytorin, spending
$200 million on DTC marketing in 2007 alone, according to a study
(http://content.nejm.org/cgi/content/abstract/358/17/1819) published last year
in the New England Journal of Medicine.
The settlement extends the terms that Merck agreed to in 2008 in its settlement
with the states over its marketing of Rofecoxib (Vioxx) to marketing of
Ezetimibe.
According to a press release
(http://www.ag.state.il.us/pressroom/2009_07/20090715.html) issued by the
Illinois Attorney General, the settlement requires the companies to:
* Obtain pre-approval from the FDA for all DTC television advertisements, and
comply with FDA suggestions to modify the advertising
* Register clinical trials and post their results
* Refrain from ghostwriting articles for medical journals
* Reduce conflicts of interest for members of data safety monitoring boards
* Comply with detailed rules prohibiting the deceptive use of clinical trials
The company was found guilty by the US Attorneys General on all the above counts
in relation to Ezetimibe.
The settlement resolves only a small portion of the litigation and governmental
investigations the companies face over their flawed handling of the ENHANCE
trial.
Regards,
Ash
Dr Ash Paul
Medical Director
NHS Bedfordshire
21 Kimbolton Road
Bedford
MK40 2AW
Tel no: 01234897224
Email: [log in to unmask]
________________________________
From: Ivar Aursnes <[log in to unmask]>
To: [log in to unmask]
Sent: Mon, 27 December, 2010 20:10:35
Subject: Lack of evidence
Dear all,
MEDICINE WITH LACK OF EVIDENCE BASE
I and collaborators have found that the antidepressant drug citalopram is
ineffective when one takes the recommended dose of 20 mg per day.
Moreover, at least in Denmark this dose was marketed even before it had
been tested in trials.
Our paper is perhaps located in an awkward place:
http://www.webmedcentral.com/article_view/1207
- so far read by very few people after a month with free access on the
Internet.
A reviewer asks the authors what to do about it? We only intended to point
to some facts and believe that license holders and regulatory agencies
ought to draw their conclusions, alternatively contradict us.
Ivar Aursnes
Department of Pharmacology
University of Oslo
