Case Summary
A clinical pharmacist complained that a website produced and sponsored by Wyeth, contained out dated information about the risks of hormone replacement therapy (HRT). In particular the data presented on the website indicated that oestrogenonly HRT was protective against breast cancer vs an increased risk presented in the more recent data contained in the BNF.
The complainant alleged that Wyeth had misrepresented the data and the website needed updating.
Wyeth had recently merged with Pfizer and so the matter was taken up with that company.
The detailed response from Pfizer is given below.
The Panel noted that the Wyeth website had been shut down as soon as Pfizer became aware of its content. The material at issue, provided by Pfizer, had been certified in April 2008 by Wyeth. The section of the website referring to breast cancer risk for oestrogen-only HRT in patients aged 50-59 and 60-69 was provided. The data was taken from the Women's Heath Initiative (WHI) Study (2004).
The data for each age group was presented as the number of women in a group of 1,000 who had never taken HRT who were at risk of breast cancer followed by another page showing how many would be as risk if all 1,000 women used oestrogen-only HRT for 5 years. The 50-59 age group background data was shown as a grid of 1,000 tiny figures of women with 21 figures highlighted and a very prominent '21' superimposed over the grid ie in a group of 1,000 women aged 50-59 who had never taken HRT, 21 would be at risk of developing breast cancer. Readers were asked how many would be at risk if they all used oestrogen-only HRT. The next screen ie the equivalent grid for 1,000 women aged 50-59 who had taken oestrogen-only HRT for five years had 15 tiny figures highlighted but had a very prominent '-6' superimposed over the grid. Less prominently, above the grid it was stated that 'If you were all using oestrogen-only HRT, then 15 of you would be at risk'. The prominent numbers shown on the equivalent grids for women aged 60-69 were '24' on the background grid and '-6' on the oestrogenonly HRT grid. The data had been taken from the WHI Study (2004) which assessed the affects of the most commonly used HRT in the US. The study authors had stated that the possible reduction in breast cancer risk required further investigation.
The Drug Safety Update of September 2007 (issued by the MHRA and the Commission on Human Medicines) reported the background incidence ofbreast cancer per 1,000 women in Europe aged 50-59 and 60-69 and noted that use of oestrogen-only HRT for 5 or 10 years was associated with an increased risk (2 additional cases in women aged 50-59 who took oestrogen-only HRT for 5 years and up to 9 additional cases in the 60-69 year old group who took oestrogen-only HRT for 10 years). It was further noted that European studies had generally identified higher breast cancer risk than US studies which might be due to differences in the prevalence of obesity. It was stated in the Drug Safety Update that the risk of breast cancer was increased in women who took HRT for several years; combined HRT was associated with the highest risk with a lower risk associated with oestrogen-only HRT. It was noted that some studies had not shown an increased risk with oestrogen-only HRT. The Drug Safety Update did not state or imply that oestrogen-only HRT might decrease the risk of breast cancer.
The Panel considered 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 was extremely important that information given to patients about the long-term risks of therapy was fair, factual and not misleading. The website at issue claimed that there was less of a risk of developing breast cancer with the use of oestrogen-only HRT whereas other data reported either no difference in the risk or additional risk.
The Panel considered that the website was not based on an up-to-date evaluation of all the evidence. The use of very prominent minus numbers over the oestrogen-only HRT grids meant that the data that had been used was not presented in a balanced way; it exaggerated the differences in background incidence of breast cancer and the incidence in the oestrogen-only HRT groups. Breaches of the Code were ruled as acknowledged by Pfizer.
The Panel considered that high standards had not been maintained. A further breach of the Code was ruled
CASE AUTH/2305/3/10 CLINICAL PHARMACIST v PFIZER
Menopause patient website
A clinical pharmacist complained that a website produced and sponsored by Wyeth, contained out dated information about the risks of hormone replacement therapy (HRT). In particular the data presented on the website indicated that oestrogen only HRT was protective against breast cancer vs an increased risk presented in the more recent data contained in the BNF.
The complainant alleged that Wyeth had misrepresented the data and the website needed updating.
Wyeth had recently merged with Pfizer and so the matter was taken up with that company.
The detailed response from Pfizer is given below.
The Panel noted that the Wyeth website had been shut down as soon as Pfizer became aware of its content. The material at issue, provided by Pfizer, had been certified in April 2008 by Wyeth. The section of the website referring to breast cancer risk for oestrogen-only HRT in patients aged 50-59 and 60-69 was provided. The data was taken from the Women’s Health Initiative (WHI) Study (2004).
The data for each age group was presented as the number of women in a group of 1,000 who had never taken HRT who were at risk of breast cancer followed by another page showing how many would be as risk if all 1,000 women used oestrogen-only HRT for 5 years. The 50-59 age group background data was shown as a grid of 1,000 tiny figures of women with 21 figures highlighted and a very prominent ‘21’ superimposed over the grid ie in a group of 1,000 women aged 50-59 who had never taken HRT, 21 would be at risk of developing breast cancer. Readers were asked how many would be at risk if they all used oestrogen-only HRT. The next screen ie the equivalent grid for 1,000 women aged 50-59 who had taken oestrogen-only HRT for five years had 15 tiny figures highlighted but had a very prominent ‘-6’ superimposed over the grid. Less prominently, above the grid it was stated that ‘If you were all using oestrogen-only HRT, then 15 of you would be at risk’. The prominent numbers shown on the equivalent grids for women aged 60-69 were ‘24’ on the background grid and ‘-6’ on the oestrogenonly HRT grid. The data had been taken from the WHI Study (2004) which assessed the affects of the most commonly used HRT in the US. The study authors had stated that the possible reduction in breast cancer risk required further investigation.
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 and noted that use of oestrogen-only HRT for 5 or 10 years was associated with an increased risk (2 additional cases in women aged 50-59 who took oestrogen-only HRT for 5 years and up to 9 additional cases in the 60-69 year old group who took oestrogen-only HRT for 10 years). It was further noted that European studies had generally identified higher breast cancer risk than US studies which might be due to differences in the prevalence of obesity. It was stated in the Drug Safety Update that the risk of breast cancer was increased in women who took HRT for several years; combined HRT was associated with the highest risk with a lower risk associated with oestrogen-only HRT. It was noted that some studies had not shown an increased risk with oestrogen-only HRT. The Drug Safety Update did not state or imply that oestrogen-only HRT might decrease the risk of breast cancer.
The Panel considered 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 was extremely important that information given to patients about the long-term risks of therapy was fair, factual and not misleading. The website at issue claimed that there was less of a risk of developing breast cancer with the use of oestrogen-only HRT whereas other data reported either no difference in the risk or additional risk.
The Panel considered that the website was not based on an up-to-date evaluation of all the evidence. The use of very prominent minus numbers over the oestrogen-only HRT grids meant that the data that had been used was not presented in a balanced way; it exaggerated the differences in background incidence of breast cancer and the incidence in the oestrogen-only HRT groups. Breaches of the Code were ruled as acknowledged by Pfizer.
The Panel considered that high standards had not been maintained. A further breach of the Code was ruled.
A clinical pharmacist complained about a website produced and sponsored by Wyeth, www.menopausefacts.co.uk. Wyeth had recently merged with Pfizer Limited and so the matter was taken up with that company.
COMPLAINT
The complainant noted that the website at issue informed patients about the risks and benefits of hormone replacement therapy (HRT). References to the Women's Health Initiative (WHI) Study and data from the Medicines and Healthcare products Regulatory Agency (MHRA)/Committee on the Safety of Medicines (CSM) dated from 2004 had both been superseded by the data in the Drug Safety Update of September 2007 as summarised in the British National Formulary (BNF), 58.
The data presented on the website therefore indicated that oestrogen-only HRT was protective against breast cancer vs an increased risk presented in the more recent data contained in the BNF.
The complainant alleged that Wyeth had misrepresented the data and the website needed to be updated.
When writing to Pfizer, the Authority asked it to consider the requirements of Clauses 7.2, 9.1 and 22.2 of the Code.
RESPONSE
Pfizer submitted that on its merger with Wyeth it had acquired a number of existing Wyeth projects of which the website at issue was one, it had now been shut down.
Pfizer acknowledged that before its closure some of the content required updating with regard to current UK clinical and regulatory opinion on HRT and the risk of breast cancer. The company thus accepted that there could potentially have been breaches of Clauses 7.2 and 22.2 of the Code. The website was closed down as soon as Pfizer became aware of the situation.
Pfizer considered it harsh to judge that it had not maintained high standards. Whilst it acknowledged that the balance of UK clinical opinion might now be that there was a small increased risk associated with the use of oestrogen-only HRT, there was no international consensus on the matter (2010 position statement of the North American Menopause Society). Indeed, even within the UK there were conflicting data and opinions (Roberts 2007). Therefore, bearing in mind the fluent nature of the clinical debate and that Pfizer had closed down the site as soon as it knew of its content, the company did not consider a ruling of a breach of Clause 9.1 was warranted.
In response to a request for further information Pfizer explained that in the WHI Study, women in the oestrogen-only arm demonstrated no increased risk of breast cancer after an average of 7.1 years of use, with six fewer cases of invasive breast cancer per 10,000 women per year of oestrogen-only use. This was not statistically significant, however the risk of breast cancer was statistically significantly reduced in three subgroups (50-59, 60-69 and 7079yrs) upon post-hoc analysis where fewer breast cancers with localised disease were diagnosed in the oestrogen-only group compared with the placebo group (Hazard ratio, 0.69; 95%CI, 0.51-0.95).
The most recent Drug Safety Update, September 2007 stated that the risk of breast cancer was increased in women who took HRT for several years. It also mentioned that the risk of breast cancer was lower for those treated with oestrogen only HRT than with combined HRT. The update further noted that some studies had not shown an increased breast cancer risk for oestrogen-only HRT and that the decision to prescribe HRT should be based on a thorough evaluation of the potential benefits and the potential risks of treatment.
Given that the website was discontinued as soon as Pfizer became aware of its content, which it acknowledged necessitated updating prior to its closure, as well as the differing clinical expert opinion and conflicting body of evidence requiring further research, Pfizer believed that high standards had been met and therefore a ruling of a breach of Clause 9.1 was not warranted.
PANEL RULING
The Panel noted that the Wyeth website had been shut down as soon as Pfizer became aware of its content. The material at issue, provided by Pfizer, had been certified in April 2008 by Wyeth. The section of the website referring to breast cancer risk for oestrogen-only HRT in patients aged 50-59 and 60-69 was provided. The data was taken from the WHI Study (2004).
The data for each age group was presented as the number of women in a group of 1,000 who had never taken HRT who were at risk of breast cancer followed by another page showing how many would be at risk if all 1,000 women used oestrogen only HRT for 5 years. The 50-59 age group background data was shown as a grid of 1,000 tiny figures of women with 21 figures highlighted and a very prominent ‘21’ superimposed over the grid ie in a group of 1,000 women aged 50-59 who had never taken HRT, 21 would be at risk of developing breast cancer. Readers were asked how many would be at risk if they all used oestrogen-only HRT. The next screen ie the equivalent grid for 1,000 women aged 50-59 who had taken oestrogen-only HRT for five years had 15 tiny figures highlighted but had a very prominent ‘-6’ superimposed over the grid. Less prominently, above the grid it was stated that ‘If you were all using oestrogen-only HRT, then 15 of you would be at risk’. The prominent numbers shown on the equivalent grids for women aged 60-69 were ‘24’ on the background grid and ‘-6’ on the oestrogen-only HRT grid. The data had been taken from the WHI Study (2004) which assessed the effects of the most commonly used HRT in the US. The study authors had stated that the possible reduction in breast cancer risk required further investigation.
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 5059 and 60-69 and noted that use of oestrogen-only HRT for 5 or 10 years was associated with an increased risk (2 additional cases in women aged 50-59 who took oestrogen-only HRT for 5 years and up to 9 additional cases in the 60-69 year old group who took oestrogen-only HRT for 10 years). It was further noted that European studies had generally identified higher breast cancer risk than US studies which might be due to differences in the prevalence of obesity. It was stated in the Drug Safety Update that the risk of breast cancer was increased in women who took HRT for several years; combined HRT was associated with the highest risk with a lower risk associated with oestrogen-only HRT. It was noted that some studies had not shown an increased risk with oestrogen-only HRT. The Drug Safety Update did not state or imply that oestrogen-only HRT might decrease the risk of breast cancer.
The Panel considered 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 was extremely important that information given to patients about the long-term risks of therapy was fair, factual and not misleading. The website at issue claimed that there was less of a risk of developing breast cancer with the use of oestrogen-only HRT whereas other data reported either no difference in the risk or additional risk.
The Panel considered that the website was not based on an up-to-date evaluation of all the evidence. The use of very prominent minus numbers over the oestrogen-only HRT grids meant that the data that had been used was not presented in a balanced way; it exaggerated the differences in background incidence of breast cancer and the incidence in the oestrogen-only HRT groups. Breaches of Clauses 7.2 and 22.2 were ruled as acknowledged by Pfizer.
The Panel considered that high standards had not been maintained. A breach of Clause 9.1 was ruled.
Complaint received 26 March 2010
Case completed 19 May 2010
