Case Summary
A complainant, who described him/herself as a concerned UK health professional, alleged that two Ecalta (anidulafungin) leavepieces (refs ECA359 and PP-ERA-GBR-0169) which he/she had found online, contained out of date prescribing information. The complainant provided links which referred to the Pfizerpro website and pdf copies of the leavepieces as well as a screenshot of his/her Google search results. Both leavepieces promoted Ecalta for the treatment of invasive candidiasis in adults.
The complainant noted that the first leavepiece (ref ECA359) appeared to have been prepared in 2016 and the prescribing information updated in 2014. There had since been eight updates to the prescribing information and although some of those were minor, the complainant stated that the volume of updates, as well as the lack of an update of the prescribing information in 6 years, was not in keeping with high standards. It was likely that the item had not been recertified since 2016.
The complainant stated that there was no check to ensure someone was not a member of the public. The information displayed on Google itself was bad enough and was apparently promoting to the general public, but that the general public could also download out of date promotional materials was worse.
The detailed response from Pfizer is given below.
The Panel noted from the screenshot provided by the complainant that his/her Google search for ‘Echinocandin’ (the class of medicine to which anidulafungin belonged), appeared to have provided links to the two Ecalta leavepieces.
The Panel noted that, according to Pfizer, the two leavepieces were withdrawn from use in April 2017 and October 2017 respectively, as part of prescribing information updates and had not been available on the Pfizerpro website since; the files were ‘unpublished’ on the Pfizerpro platform meaning that they could no longer be viewed or downloaded from the Pfizerpro website. Since receiving the complaint, Pfizer had learnt that whilst ‘unpublishing’ removed the files from view, it did not delete the pdf files from the folders sitting behind the Pfizerpro website. The URLs for the files could still be accessed by Google and direct links to the files returned in the complainant’s Google search for ‘Echinocandin’. The Panel noted Pfizer’s submission that the health professional self-validation pop-up was not enabled on the URLs for the pdf files as it did not know that Google could directly access them.
The Panel noted that since receiving the complaint, Pfizer had deleted the pdf files for the two leavepieces from behind the Pfizerpro website to ensure that they could not be viewed by Google. The company had also set the status of all embedded pdf files on the Pfizerpro website to ‘private’ which meant that a full login/registration step was required before the files could be accessed; this hid the files from Google ensuring that direct links to the files and associated descriptions would not be returned in any future Google searches for related terms.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it noted that the two leavepieces had been withdrawn and unpublished from the Pfizerpro website in 2017. The pdf files, however, still sat behind the Pfizerpro website and, in that regard, it seemed reasonable to consider that the leavepieces were on an internal company page rather than one which was intended for an external audience including the public. The Panel noted Pfizer’s submission that website analytics showed that the first time either of the files had been accessed since they were first published in 2016 and 2017 respectively, was on 12 August 2020 when each file had had a single visit from outside the Pfizer virtual private network; Pfizer believed that was the PMCPA downloading the leavepieces as part of the preparation of this case. Pfizer could not explain how the complainant had accessed the leavepieces prior to the submission of his/her complaint on 11 August 2020 without its analytics being able to detect that the files had been accessed. Nor could the company see any evidence that the files had ever been accessed by anyone, health professional or member of the public, prior to those dates.
In the Panel’s view, it was unfortunate that, despite being withdrawn in 2017 and so unpublished and thus unable to be viewed or downloaded from the Pfizerpro website, the two leavepieces, which now contained out of date prescribing information could still be accessed online in August 2020. The Panel considered that the complainant’s submission that there was no check to ensure that he/she was not a member of the public suggested that when he/she had accessed the leavepieces he/she was not on the live Pfizerpro website. It seemed reasonable in this case to consider the leavepieces as material on an internal company site. On balance, the Panel decided that the two leavepieces, which Pfizer had removed from its website but which had unintentionally, and unknown to Pfizer, remained directly accessible by Google, did not amount to promotion of Ecalta to the public. No breach of the Code was ruled.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that promotional material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company. Given its comments and ruling above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breaches of the Code were ruled including of Clause 2.
CASE AUTH/3369/8/20 NO BREACH OF THE CODE
COMPLAINANT v PFIZER
Access to data behind a website
A complainant, who described him/herself as a concerned UK health professional, alleged that two Ecalta (anidulafungin) leavepieces (refs ECA359 and PP-ERA-GBR-0169) which he/she had found online, contained out of date prescribing information. The complainant provided links which referred to the Pfizerpro website and pdf copies of the leavepieces as well as a screenshot of his/her Google search results. Both leavepieces promoted Ecalta for the treatment of invasive candidiasis in adults.
The complainant noted that the first leavepiece (ref ECA359) appeared to have been prepared in 2016 and the prescribing information updated in 2014. There had since been eight updates to the prescribing information and although some of those were minor, the complainant stated that the volume of updates, as well as the lack of an update of the prescribing information in 6 years, was not in keeping with high standards. It was likely that the item had not been recertified since 2016.
The complainant stated that there was no check to ensure someone was not a member of the public. The information displayed on Google itself was bad enough and was apparently promoting to the general public, but that the general public could also download out of date promotional materials was worse.
The detailed response from Pfizer is given below.
The Panel noted from the screenshot provided by the complainant that his/her Google search for ‘Echinocandin’ (the class of medicine to which anidulafungin belonged), appeared to have provided links to the two Ecalta leavepieces.
The Panel noted that, according to Pfizer, the two leavepieces were withdrawn from use in April 2017 and October 2017 respectively, as part of prescribing information updates and had not been available on the Pfizerpro website since; the files were ‘unpublished’ on the Pfizerpro platform meaning that they could no longer be viewed or downloaded from the Pfizerpro website. Since receiving the complaint, Pfizer had learnt that whilst ‘unpublishing’ removed the files from view, it did not delete the pdf files from the folders sitting behind the Pfizerpro website. The URLs for the files could still be accessed by Google and direct links to the files returned in the complainant’s Google search for ‘Echinocandin’. The Panel noted Pfizer’s submission that the health professional self-validation pop-up was not enabled on the URLs for the pdf files as it did not know that Google could directly access them.
The Panel noted that since receiving the complaint, Pfizer had deleted the pdf files for the two leavepieces from behind the Pfizerpro website to ensure that they could not be viewed by Google. The company had also set the status of all embedded pdf files on the Pfizerpro website to ‘private’ which meant that a full login/registration step was required before the files could be accessed; this hid the files from Google ensuring that direct links to the files and associated descriptions would not be returned in any future Google searches for related terms.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it noted that the two leavepieces had been withdrawn and unpublished from the Pfizerpro website in 2017. The pdf files, however, still sat behind the Pfizerpro website and, in that regard, it seemed reasonable to consider that the leavepieces were on an internal company page rather than one which was intended for an external audience including the public. The Panel noted Pfizer’s submission that website analytics showed that the first time either of the files had been accessed since they were first published in 2016 and 2017 respectively, was on 12 August 2020 when each file had had a single visit from outside the Pfizer virtual private network; Pfizer believed that was the PMCPA downloading the leavepieces as part of the preparation of this case. Pfizer could not explain how the complainant had accessed the leavepieces prior to the submission of his/her complaint on 11 August 2020 without its analytics being able to detect that the files had been accessed. Nor could the company see any evidence that the files had ever been accessed by anyone, health professional or member of the public, prior to those dates.
In the Panel’s view, it was unfortunate that, despite being withdrawn in 2017 and so unpublished and thus unable to be viewed or downloaded from the Pfizerpro website, the two leavepieces, which now contained out of date prescribing information could still be accessed online in August 2020. The Panel considered that the complainant’s submission that there was no check to ensure that he/she was not a member of the public suggested that when he/she had accessed the leavepieces he/she was not on the live Pfizerpro website. It seemed reasonable in this case to consider the leavepieces as material on an internal company site. On balance, the Panel decided that the two leavepieces, which Pfizer had removed from its website but which had unintentionally, and unknown to Pfizer, remained directly accessible by Google, did not amount to promotion of Ecalta to the public. No breach of the Code was ruled.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that promotional material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company. Given its comments and ruling above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breaches of the Code were ruled including of Clause 2.
A complainant, who described him/herself as a concerned UK health professional, complained about two Ecalta (anidulafungin) leavepieces (refs ECA359 and PP-ERA-GBR-0169) which he/she had found online (links and pdf copies were provided as well as a screenshot of his/her Google search results). Both leavepieces promoted Ecalta for the treatment of invasive candidiasis in adults.
COMPLAINT
The complainant stated that he/she had found the first leavepiece (ref ECA359) at the specific link provided which included reference to the Pfizerpro website as well as in the list of items on Google when searching for the class of medicine ‘Echinocandin’ and stated that it appeared to have been prepared in 2016 and the prescribing information updated in 2014. The complainant stated that there had since been eight updates to the prescribing information and although some of those updates were minor, the sheer volume of updates, as well as the lack of an update of the prescribing information in 6 years, was hardly in keeping with high standards. The complainant considered it likely that the item had not been recertified since 2016.
The complainant provided a list of items he/she had found when searching for the ‘Echinocandin’ class of medicine on Google and noted that the second leavepiece (PP-ERA-GBR-0169) also appeared which also had out of date prescribing information.
The complainant stated that there was no check to ensure someone was not a member of the public. The information displayed on Google itself was bad enough and was apparently promoting to the general public, but that the general public could also download out of date promotional materials was worse.
When writing to Pfizer, the Authority asked it to consider the requirements of Clauses 2, 9.1 and 26.1 of the Code.
RESPONSE
Pfizer noted that the complainant had identified two Ecalta pdf information leaflets; certified copies of the materials and details of the signatories were provided for both.
The Ecalta leavepiece (ref ECA359) was certified on 13 January 2016 as a hard copy leavepiece and a downloadable pdf to be hosted on the Pfizerpro website. The Ecalta Digital Differentiation leavepiece (ref PP-ERA-GBR-0169) was certified on 24 May 2017 as a digital item for use by representatives and downloadable pdf to be hosted on the Pfizerpro website. When in use on the website and accessed via that route, the leavepieces sat behind the Pfizer health professional self-validation pop-up and no further registration steps were required to access them. The Ecalta leavepiece was withdrawn from use in April 2017 and the Ecalta Digital Differentiation leavepiece was withdrawn from use in October 2017, in both instances as part of prescribing information updates and neither had been available on the Pfizerpro website since.
Pfizer explained that when the two leavepieces were withdrawn, the files were ‘unpublished’ on the Pfizerpro platform meaning that they could no longer be viewed or downloaded from the Pfizerpro website pages. The company did not believe that the complainant or any other health professional had been able to navigate to these items via the Pfizerpro website since their withdrawal.
Since receiving the complaint, Pfizer had learnt that whilst the unpublishing process removed the files from view on the Pfizerpro website pages, it did not actually delete the pdf files from the folders sitting behind the Pfizerpro website. The URL for those files could still be accessed by Google and direct links to the files returned in the complainant’s Google search for ‘Echinocandin’. Pfizer was previously unaware that these files could be accessed directly by Google.
Pfizer explained that its health professional self-validation pop-up was associated with the URL for each of the Pfizerpro webpages so that internet users navigating to any of the Pfizerpro webpages would be presented with the Pfizer health professional self-validation pop-up before being able to access the website content. Pfizer stated that as it did not know that Google could directly access pdf files that were [not] intended for viewing through the Pfizerpro website, the Pfizer health professional pop-up was not enabled on the URLs for those files and so the complainant was not presented with the health professional self-validation pop-up when he/she accessed the leavepieces directly from the folders sitting behind the website.
Pfizer stated that since receiving the complaint and identifying that the unpublished files were still in existence and visible to Google, it had run internet traffic reports for both files. The first time that it could see that anyone had accessed either file, since they were first published in 2016 and 2017 respectively, was on 12 August 2020. Each file had a single visit on the 12 August 2020 from outside the Pfizer virtual private network, which it believed was the PMCPA downloading the pieces as part of the preparation of this case. The company could see no evidence that the files had ever been accessed by anyone, health professional or member of the public, prior to those dates. A copy of the internet traffic analytics was provided. Pfizer stated that it was thus unable to explain how the complainant had accessed the leavepieces prior to the submission of his/her complaint on 11 August 2020 without its analytics being able to detect that the files had been accessed.
Pfizer explained that it certified metadata to support each of the webpages on Pfizerpro. This was designed to help ensure that the descriptions of the website pages returned in a Google search were appropriate and did not promote a medicine to the public. Provision of such metadata, however, did not guarantee that Google would use those descriptions in its search results and there was still the potential that Google would create its own description for a Pfizerpro webpage. Given that Pfizer did not know that the leavepieces were visible to Google, it had not taken any steps to influence the description of the items presented in Google search results.
In terms of corrective action, Pfizer stated that since receiving the complaint, it had deleted the pdf files for the two leavepieces from the folders sitting behind the Pfizerpro website to ensure that they could not be viewed by Google. The company had set the status of all embedded pdf files presented on the Pfizerpro website to ‘private’ which meant that a full login/registration step was required before the files could be accessed. The requirement for login/registration hid the files from Google ensuring that direct links to the files and associated descriptions would not be returned in any future Google searches for related terms.
In conclusion, Pfizer stated that it took all identified required actions to withdraw the leavepieces from the Pfizerpro website in 2017 when updates to the materials were required. Analytics indicated that apart from one visit on 12 August 2020, assumed to be the PMCPA case preparation manager, neither items had been accessed by a member of the public.
It was possible that a member of the public searching for the specialist term ‘Echinocandin’ might have been presented with the same search results as the complainant. However, given that Pfizer was not aware that the leavepieces were visible to Google, it had not influenced the description of the items presented in a Google search result, the description was generated by Google itself. Pfizer, therefore, did not consider that it had promoted a prescription only medicine to the general public.
Pfizer stated that it took all reasonable actions to manage the removal of the leavepieces from the Pfizerpro website in 2017. On receipt of this complaint, it took swift action to ensure that the leavepieces, already removed from the website, could not still be found in a Google search. Pfizer submitted that it had maintained high standards at all times and had not brought discredit upon the industry and it denied breaches of Clauses 26.1, 9.1 and 2 of the Code.
PANEL RULING
The Panel noted from the screenshot provided by the complainant that his/her Google search for ‘Echinocandin’ appeared to have provided links to the two Ecalta leavepieces (refs ECA359 and PP-ERA-GBR-0169) which appeared as the seventh and eighth listing of the returned Google search; each listing was entitled ‘Ecalta it is not just another Echinocandin’.
The Panel noted that, according to Pfizer, the two leavepieces were withdrawn from use in April 2017 and October 2017, respectively, as part of prescribing information updates and had not been available on the Pfizerpro website since; the files were ‘unpublished’ on the Pfizerpro platform meaning that they could no longer be viewed or downloaded from the Pfizerpro website. Since receiving the complaint, Pfizer had learnt that whilst the unpublishing process removed the files from view on the Pfizerpro website pages, it did not actually delete the pdf files from the folders sitting behind the Pfizerpro website. The URLs for the files could still be accessed by Google and direct links to the files returned in the complainant’s Google search for ‘Echinocandin’. The Panel noted Pfizer’s submission that the health professional self-validation pop-up was not enabled on the URLs for the pdf files as it did not know that Google could directly access them.
The Panel noted that since receiving the complaint, Pfizer had deleted the pdf files for the two leavepieces from the folders sitting behind the Pfizerpro website to ensure that they could not be viewed by Google. The company had also set the status of all embedded pdf files presented on the Pfizerpro website to ‘private’ which meant that a full login/registration step was required before the files could be accessed; this hid the files from Google ensuring that direct links to the files and associated descriptions would not be returned in any future Google searches for related terms.
Although the Panel was concerned that material that did not appear to meet the requirements of the Code could be accessed, it noted that the two leavepieces had been withdrawn and unpublished from the Pfizerpro website in 2017. The pdf files, however, still sat behind the Pfizerpro website and, in that regard, it seemed reasonable to consider that the leavepieces were on an internal company page rather than one which was intended for an external audience including the public. The Panel noted Pfizer’s submission that website analytics showed that the first time either of these files had been accessed since they were first published in 2016 and 2017 respectively, was on 12 August 2020 when each file had had a single visit from outside the Pfizer virtual private network; Pfizer believed that was the PMCPA downloading the leavepieces as part of the preparation of this case. Pfizer was unable to explain how the complainant had accessed the leavepieces prior to the submission of his/her complaint on 11 August 2020 without its analytics being able to detect that the files had been accessed. Nor could the company see any evidence that the files had ever been accessed by anyone, health professional or member of the public, prior to those dates.
In the Panel’s view, it was unfortunate that, despite being withdrawn in 2017 and so unpublished and thus unable to be viewed or downloaded from the Pfizerpro website, the two leavepieces, which now contained out of date prescribing information were still available to access via a Google search in August 2020 when the complaint was received. The Panel considered that the complainant’s submission that there was no check to ensure that he/she was not a member of the public suggested that when he/she had accessed the leavepieces he/she was not on the live Pfizerpro website. It seemed reasonable in this case to consider the leavepieces as material on an internal company site. On balance, the Panel decided that the two leavepieces, which Pfizer had removed from its website but which had unintentionally, and unknown to Pfizer, remained directly accessible by Google, did not amount to promotion of Ecalta to the public. No breach of Clause 26.1 was ruled.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that promotional material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company. Although concerned that the two leavepieces could still be found via a Google search, given its comments and ruling above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of Clause 9.1 was ruled. The Panel also ruled no breach of Clause 2.
Complaint received 11 August 2020
Case completed 29 March 2021
