Outdated HRT website breaches Code
pharmafile | September 22, 2010 | News story | Medical Communications | ABPI, Code of Practice, PMCPA, Pfizer, Wyeth
A website which contained outdated information about the risk of using hormone replacement therapy has been found in breach of the UK pharma industry Code of Practice.
The case has been reviewed by the industry self-regulatory body the PMCPA, after a clinical pharmacist complained about the information being out of date.
The site was originally run by Wyeth (acquired by Pfizer in 2009) and included claims that oestrogen only HRT was protective against breast cancer – whereas more recent data suggests that HRT in fact raises the risk of breast cancer.
The complainant alleged that Wyeth had misrepresented the data and the website needed to be updated. The website was taken down as soon as Pfizer became aware of the issue.
The material in question had been certified in April 2008 by Wyeth, and was drawn from the Women’s Heath Initiative (WHI) Study published in 2004. However a more recent European study showed a small but significant increase in the risk of developing breast cancer.
The Drug Safety Update of September 2007 issued by the MHRA and the Commission on Human Medicines reported the background incidence of breast cancer per 1,000 women in Europe aged 50-59 and 60-69 years.
It noted that use of oestrogen-only HRT for 5 or 10 years was associated with an increased risk (two additional cases in women aged 50-59 who took oestrogen-only HRT for five years and up to nine additional cases in the 60-69 year old group who took oestrogen-only HRT for 10 years).
The PMCPA Panel concluded that it was unacceptable to refer only to 2004 US data, and to not include 2007 European data on a UK website that was certified in 2008.
It stated that it was “extremely important that information given to patients about the long-term risks of therapy was fair, factual and not misleading”.
It ruled that the website was not based on up-to-date evidence, and that the data shown had not been presented in a balanced way, as it exaggerated the differences in background incidence of breast cancer and the incidence in the oestrogen-only HRT groups.
Breaches of the Code’s clauses 7.2 and 22.2 were ruled as acknowledged by Pfizer.
The Code also requires companies to maintain ‘high standards’ in their conduct, and the Panel ruled that the company had not done this, resulting in a breach of clause 9.1 of the Code.
The full details of the case are published in the August 2010 review and can be found online here.
Andrew McConaghie
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