Case Summary
An anonymous, non-contactable complainant, who appeared to be a clinician, complained that a booklet, 'Life We're working on it' produced by Celgene, promoted Abraxane (protein bound paclitaxel) to the public. Abraxane was indicated for the treatment of various cancers including in combination with gemcitabine for first line treatment of adult patients with metastatic adenocarinoma of the pancreas.
The 24 page booklet referred to Celgene's activities to discover and deliver innovative therapies for cancer and immune inflammatory diseases. The inside front cover and introduction referred to '... help many more people live longer, happier, healthier lives'. Rare disease therapy areas the company was working on and the company's clinical trial programme were outlined.
The complainant stated that he/she was compelled to complain following a very difficult consultation with a patient and a family member who had the booklet. The complainant noted the information about the availability of Celgene's medicine for pancreatic cancer and that it was the 'first therapy with clinical benefits for pancreatic cancer'. This was false. Abraxane was for advanced disease only. The references cited in support of the claim, 'the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years', clearly referred to Abraxane and contained links to articles about the medicine.
The complainant submitted that it was wholly unacceptable for a pharmaceutical company to create such booklets with information about specific medicines so easily accessible to members of the public and those who were not medically qualified. The complainant stated that there were references to other medicines, as well as mentions of all other diseases in which Celgene had a vested interest. The complainant was dismayed that a pharmaceutical company found it acceptable to advertise in booklets that could be accessed by the public.
The complainant hoped that his/her complaint would help to ensure that pharmaceutical companies would begin to take their responsibility to the public more seriously; they needed to understand that compromising patients and their wellbeing was not acceptable.
The detailed response from Celgene is given below.
The Panel noted that Celgene described the booklet as a corporate brochure. The booklet discussed therapy areas where the company had a commercial interest. Whilst it did not name Abraxane, in the Panel's view, Abraxane was, contrary to Celgene's assertion and together with the first phosphodiesterase-4 inhibitor, indirectly identified. The Panel noted that the booklet discussed Celgene's interactions with clinicians and patients within the context of its clinical heritage and ongoing medical innovation. In the Panel's view, the booklet primarily sought to raise the company's corporate profile with a particular emphasis on cancer, inflammation and immunology and the company's ethos in relation to innovation, access, commitment and investment.
The Panel noted that, according to Celgene, the target audience was broad and included internal staff, external stakeholders, the public and parliamentarians. It was distributed to Celgene employees including copies to be shared with potential employees. In addition, copies were on display at an industry round table discussion which was not attended by members of the public. The complainant was concerned that the brochure had been obtained by his/her patient or carer. The Panel noted that it was not possible to contact the complainant to ascertain how and when the booklet had been received by his/her patient/carer. In this regard, the Panel noted that the date of the complaint was the same date the booklet was made available to the public for a limited time at a New Scientist Live event. In the particular circumstances of this case, and irrespective of the content of the booklet, there was insufficient evidence that Celgene had distributed the booklet to, or otherwise made it available to, the complainant's patient or carer as alleged on or before the date of the complaint and thus the Panel ruled no breach of the Code on this narrow point.
The Panel noted that the complainant also made a broader allegation about the principle of companies producing such booklets with information about specific medicines and stated that they should not be so easily accessible to members of the public and those who were not medically qualified. The complainant referred to advertising in the booklet. On this point, the Panel considered that the availability of the booklet at the New Scientist conference was relevant. Notwithstanding that the complainant was non-contactable, the Panel noted Celgene's submission that it accepted the booklet had ultimately been received by a patient and it was certified for such. In the Panel's view, the complaint was not about the provision of the booklet to employees, parliamentarians and such like (who might be considered members of the public) but rather to those individuals who would not normally interact professionally with a pharmaceutical company and, solely for the purposes of this point of the complaint, it interpreted members of the public as referred to by the complainant accordingly. Whilst the job bag summary described the booklet as having undergone promotional certification, it was also described as a corporate brochure for both internal and external use. Whilst it was not unacceptable to have a broad audience, the company must ensure that such material was genuinely suitable for each component of the audience in relation to the requirements of the Code. For instance, material suitable for staff might not be suitable for the broader general public including individual patients. The Panel noted the references to pancreatic cancer patients, the first phosphodiesterase-4-inhibitor for the treatment of plaque psoriasis and rare disease areas that the company was working on, within the 'Passion for Discovery' section. The Panel considered that context was important and, in this regard, noted that page 9 began by referring to future proofing medical innovation and that the first therapy with clinical benefits for pancreatic cancer patients in 20 years was a result of Celgene's bold approach to innovation. The top of the page described Celgene as a leader in the field of rare diseases. In the Panel's view, there was an implication that Celgene's products were cutting edge and a significant advance on products currently available. The Panel noted its comments above about the target audience which included members of the public. On balance, within the overall context of the booklet, the Panel did not consider that page 9 promoted specific prescription only medicines to the public. No breach was ruled. In the Panel's view the material was such that patients might be encouraged to ask their doctors to prescribe specific medicines contrary to the requirements of the Code and a breach was ruled.
In the Panel's view, the material was misleading; it implied that the clinical benefits would potentially be seen in all patients and that was not so, Abraxane was only licensed for use in combination in patients with advanced disease. The Panel ruled a breach on this point.
Noting its rulings above, the Panel ruled a breach as high standards had not been maintained. Overall, the Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 and ruled no breach of that Clause.
AUTH/2983/10/17 Anonymous non-contactable v Celgene
Promotion of Abraxane to the Public
An anonymous, non-contactable complainant, who appeared to be a clinician, complained that a booklet, 'Life We're working on it' produced by Celgene, promoted Abraxane (protein bound paclitaxel) to the public. Abraxane was indicated for the treatment of various cancers including in combination with gemcitabine for first line treatment of adult patients with metastatic adenocarinoma of the pancreas.
The 24 page booklet referred to Celgene's activities to discover and deliver innovative therapies for cancer and immune inflammatory diseases. The inside front cover and introduction referred to '... help many more people live longer, happier, healthier lives'. Rare disease therapy areas the company was working on and the company's clinical trial programme were outlined.
The complainant stated that he/she was compelled to complain following a very difficult consultation with a patient and a family member who had the booklet. The complainant noted the information about the availability of Celgene's medicine for pancreatic cancer and that it was the 'first therapy with clinical benefits for pancreatic cancer'. This was false. Abraxane was for advanced disease only. The references cited in support of the claim, 'the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years', clearly referred to Abraxane and contained links to articles about the medicine.
The complainant submitted that it was wholly unacceptable for a pharmaceutical company to create such booklets with information about specific medicines so easily accessible to members of the public and those who were not medically qualified. The complainant stated that there were references to other medicines, as well as mentions of all other diseases in which Celgene had a vested interest. The complainant was dismayed that a pharmaceutical company found it acceptable to advertise in booklets that could be accessed by the public.
The complainant hoped that his/her complaint would help to ensure that pharmaceutical companies would begin to take their responsibility to the public more seriously; they needed to understand that compromising patients and their wellbeing was not acceptable.
The detailed response from Celgene is given below.
The Panel noted that Celgene described the booklet as a corporate brochure. The booklet discussed therapy areas where the company had a commercial interest. Whilst it did not name Abraxane, in the Panel's view, Abraxane was, contrary to Celgene's assertion and together with the first phosphodiesterase-4 inhibitor, indirectly identified. The Panel noted that the booklet discussed Celgene's interactions with clinicians and patients within the context of its clinical heritage and ongoing medical innovation. In the Panel's view, the booklet primarily sought to raise the company's corporate profile with a particular emphasis on cancer, inflammation and immunology and the company's ethos in relation to innovation, access, commitment and investment.
The Panel noted that, according to Celgene, the target audience was broad and included internal staff, external stakeholders, the public and parliamentarians. It was distributed to Celgene employees including copies to be shared with potential employees. In addition, copies were on display at an industry round table discussion which was not attended by members of the public. The complainant was concerned that the brochure had been obtained by his/her patient or carer. The Panel noted that it was not possible to contact the complainant to ascertain how and when the booklet had been received by his/her patient/carer. In this regard, the Panel noted that the date of the complaint was the same date the booklet was made available to the public for a limited time at a New Scientist Live event. In the particular circumstances of this case, and irrespective of the content of the booklet, there was insufficient evidence that Celgene had distributed the booklet to, or otherwise made it available to, the complainant's patient or carer as alleged on or before the date of the complaint and thus the Panel ruled no breach of the Code on this narrow point.
The Panel noted that the complainant also made a broader allegation about the principle of companies producing such booklets with information about specific medicines and stated that they should not be so easily accessible to members of the public and those who were not medically qualified. The complainant referred to advertising in the booklet. On this point, the Panel considered that the availability of the booklet at the New Scientist conference was relevant. Notwithstanding that the complainant was non-contactable, the Panel noted Celgene's submission that it accepted the booklet had ultimately been received by a patient and it was certified for such. In the Panel's view, the complaint was not about the provision of the booklet to employees, parliamentarians and such like (who might be considered members of the public) but rather to those individuals who would not normally interact professionally with a pharmaceutical company and, solely for the purposes of this point of the complaint, it interpreted members of the public as referred to by the complainant accordingly. Whilst the job bag summary described the booklet as having undergone promotional certification, it was also described as a corporate brochure for both internal and external use. Whilst it was not unacceptable to have a broad audience, the company must ensure that such material was genuinely suitable for each component of the audience in relation to the requirements of the Code. For instance, material suitable for staff might not be suitable for the broader general public including individual patients. The Panel noted the references to pancreatic cancer patients, the first phosphodiesterase-4-inhibitor for the treatment of plaque psoriasis and rare disease areas that the company was working on, within the 'Passion for Discovery' section. The Panel considered that context was important and, in this regard, noted that page 9 began by referring to future proofing medical innovation and that the first therapy with clinical benefits for pancreatic cancer patients in 20 years was a result of Celgene's bold approach to innovation. The top of the page described Celgene as a leader in the field of rare diseases. In the Panel's view, there was an implication that Celgene's products were cutting edge and a significant advance on products currently available. The Panel noted its comments above about the target audience which included members of the public. On balance, within the overall context of the booklet, the Panel did not consider that page 9 promoted specific prescription only medicines to the public. No breach was ruled. In the Panel's view the material was such that patients might be encouraged to ask their doctors to prescribe specific medicines contrary to the requirements of the Code and a breach was ruled.
In the Panel's view, the material was misleading; it implied that the clinical benefits would potentially be seen in all patients and that was not so, Abraxane was only licensed for use in combination in patients with advanced disease. The Panel ruled a breach on this point.
Noting its rulings above, the Panel ruled a breach as high standards had not been maintained. Overall, the Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 and ruled no breach of that Clause.
An anonymous, non-contactable complainant, who appeared to be a clinician, complained that a booklet, ‘Life We’re working on it’ (ref UK-CELG160202), produced by Celgene Limited, promoted Abraxane (protein bound paclitaxel) to the public. Abraxane was indicated for the treatment of various cancers including in combination with gemcitabine for first line treatment of adult patients with metastatic adenocarinoma of the pancreas.
The 24 page booklet referred to Celgene’s activities to discover and deliver innovative therapies for cancer and immune inflammatory diseases. The inside front cover and introduction referred to ‘... help many more people live longer, happier, healthier lives’. Rare disease therapy areas the company was working on and the company’s clinical trial programme were outlined. Page 9 referred to ‘the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years’, referenced to the Abraxane summary of product characteristics (SPC) and a study by Al-Hajeli et al (2016).
COMPLAINT
The complainant stated that he/she was compelled to complain following a very difficult consultation with a patient. As a clinician, his/her duty of care was always to his/her patients.
The complaint stated that the booklet in question was brought in by one of his/her patients and a family member during a recent consultation. The complainant noted the pages entitled ‘A passion for discovery’ and in particular information about the availability of the Celgene’s medicine for pancreatic cancer and that it was the ‘first therapy with clinical benefits for pancreatic cancer’. This was false. The medicine at issue, Abraxane, was for advanced disease only, furthermore it was removed from the Cancer Drugs Fund some years ago. Cited in support of the claim, ‘the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years’, references 6 and 7 were listed at the back of the book and clearly referred to Abraxane and contained links to articles about the medicine.
The complainant submitted that it was wholly unacceptable for a pharmaceutical company to create such booklets with information about specific medicines so easily accessible to members of the public and those who were not medically qualified. The complainant stated that he/she had gone through this booklet and had seen references to other medicines, as well as mentions of all other diseases in which Celgene had a vested interest. The complainant was dismayed that a pharmaceutical company found it acceptable to advertise in booklets that could be accessed by the public.
The complainant hoped that his/her complaint would help to ensure that pharmaceutical companies would begin to take their responsibility to the public more seriously; they needed to understand that compromising patients and their wellbeing was not acceptable.
Although no comment was made by the complainant, the copy of the booklet which he/she provided also underlined the following:
‘We were also proud to contribute to the advancement of immune disorder therapies with the first phosphodiesterase-4 inhibitor approved for the treatment of plaque psoriasis.’
and:
‘Rare disease therapy areas we are currently working with include Behçets disease, relapsed and refractory multiple myeloma and hepatocellular carcinoma.’
When writing to Celgene, the Authority asked it to consider the requirements of Clauses 2, 9.1 and 26.
RESPONSE
Celgene submitted that it was committed to operating according to the highest standards outlined in the Code in order to ensure that the healthcare industry fulfilled its commitment to patients and health professionals. Therefore, it was very concerned to receive this complaint and it immediately conducted an internal review and gathered information to address and respond to the allegations.
Celgene stated that corporate brochures were widely used by the industry. Celgene used its brochures as a vehicle to introduce the company, its culture, therapeutic focus, innovation and commitment to research and patients. The brochures were not designed or used to promote any medicines. The brochure at issue was prepared as part of the 10th anniversary of the company in the UK and Ireland; it was designed to enhance the reputation of the company and it described, in general terms, the mission and purpose of the company and its commitment to research.
Celgene stated that its 24 page brochure contained information about its activities in discovering and developing innovative therapies for cancer and immune inflammatory disease. The brochure, as a whole, had to be considered rather than one page of the text in order to objectively consider its apparent purpose. It included the following page headings:
- Putting patients first
- Improving the lives of patients worldwide
- A passion for discovery
- Cancer
- Inflammation & immunology
- Further innovation
- The virtuous cycle of innovation
- Corporate social responsibility
- References.
The brochure was produced and job bagged by the corporate affairs department to be approved for certification under the Code, with a target audience of internal staff, external stakeholders, the public and parliamentarians. The intended first use was 7 November 2016. Celgene provided a copy of the job bag summary.
Celgene reiterated that its brochure had no promotional intent. There was no reference to branded medicines in the body of the brochure, and there was no statement that could properly be viewed as encouraging members of the public to request treatment with a specific medicine because of the claim made about it. The brochure was not prepared with the intent to promote any products marketed by the company, but rather to describe the company’s commitment to research and its focus on cancer, inflammation and immunology in general. While the brochure did not refer to medicines in the body of the text, in the references section (page 21 of the brochure) there was a reference to certain research in respect to products for which Celgene held the marketing authorization, including Abraxane. These were included to demonstrate that claims about Celgene’s commitment to research were factual and balanced.
In line with the supplementary information to Clause 26.2, the brochure was intended to be used as ‘nonpromotional information about prescription only medicines to the public’ which ‘includes information provided by means of posters distributed for display in surgery waiting rooms etc and reference information made available by companies on their websites or otherwise as a resource for members of the public’.
Celgene understood that corporate brochures, as public relations tools, were therefore deemed acceptable under Clause 26.2. Clause 26 also stated that companies should consider including references to other credible sources of information about a medicine: ‘Pharmaceutical companies are not obliged to provide reference information but it is considered good practice to provide as a minimum the regulatory information comprising the summary of product characteristics (SPC), the package leaflet (PIL) and the public assessment report (PAR) (UK or European) where such a document exists’.
The brochure at issue had no promotional intent and the only reference to Abraxane was in the reference section where the SPC was referenced in line with the guidance in Clause 26.2.
Celgene explained that Abraxane was indicated for the treatment of metastatic breast cancer in adults who had failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy was not indicated. Abraxane, in combination with gemcitabine, was also indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. Abraxane, in combination with carboplatin, was indicated for the first-line treatment of non-small cell lung cancer in adults who were not candidates for potentially curative surgery and/or radiation therapy.
The EU marketing authorization for Abraxane was first granted by the European Medicines Agency in January 2008 for metastatic breast cancer patients and thereafter, the additional indications were approved. A copy of the current SPC was provided.
Celgene noted, however, that it did not currently support promotional activities for Abraxane. In 2016, it disbanded its Abraxane sales team but continued to provide the required scientific support for the medicine. Celgene reiterated that there was no promotional intent in the brochure.
Celgene noted that the complainant alleged that the claim ‘first therapy with clinical benefits for pancreatic cancer’ was false. Celgene considered that the claim had been taken out of context. The statement in the brochure was presented in the context of highlighting Celgene’s ‘bold approach to innovation’, which led to the development of ‘the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years’ (emphasis added). When Abraxane was approved, data from Cancer Research UK demonstrated that, unlike the majority of cancers, five and ten-year survival for pancreatic cancer had not shown much improvement since the early 1970s. In men and women, five-year age standardised net survival for pancreatic cancer had not increased significantly between 1971-1972 and 2010-2011 in England and Wales.
Celgene submitted that there had only been two therapies licensed for the treatment of pancreatic cancer in the past 20 years. The first, Tarceva (erlotinib), showed a mean improvement in overall survival of 0.4 months (12 days).
Abraxane was the second therapy licensed in this 20 year period and was the first to provide a meaningful benefit – a 1.8 month increase in median overall survival. As such, Celgene submitted that the claim ‘the first therapy with clinical benefits for pancreatic cancer patients in almost 20 years’ (emphasis added) was fair and balanced and could be substantiated.
Celgene noted that nothing was stated in the brochure about the stage of disease that Abraxane treated or the types of patients for which the medicine was suitable. In fact, the product was only mentioned in the reference cited in support of the claim on page 8 to explain the context in which the claim was made.
Celgene noted the complainant’s statement that Abraxane was removed from the Cancer Drug Fund (CDF) some years ago. The brochure did not mention the availability of Abraxane, whether within the CDF or otherwise within the NHS. Socio-economic variations across the UK were not addressed and could not be deduced from the current content of the brochure. Celgene should not be the addressee for a complaint about socio-economic variations in the UK. Abraxane was available across the UK since EMA approval. CDF fund was continuously supported in some parts of the UK, while in others access was temporarily limited. Since 7 August 2017 patients had been able to once again be treated with Abraxane through the CDF. Celgene considered that this reflected the importance that payors placed on treatments in this very difficult to treat area and Celgene was proud to strive to make medicines available for those conditions with very significant unmet need.
The complainant had also challenged the statement ‘we are also proud to contribute to the advancement of immune disorder therapies with the first phosphodiesterase-4 inhibitor approved for the treatment of plaque psoriasis’. This was factually correct. Celgene believed that the claim was focused on science and on the innovative mode of action which was phosphodiesterase-4 inhibition. Similarly, it was correct that Celgene was currently working on Behçet’s disease, relapsed and refractory multiple myeloma and hepatocellular carcinoma. Celgene submitted that this spoke to its innovative approach to drug development. There were no product claims made and the only mention of a product was in the reference section.
Celgene submitted that it was unclear as to how the content of the brochure, or the claims highlighted by the complainant, could compromise patient safety and wellbeing as alleged.
Celgene stated that 2016 represented a very important milestone for the company as it celebrated its 10th year of UK and Ireland operations. The Celgene brochure was electronically certified on 25 November 2016.
Celgene submitted that its investigation showed that the final hard copy of the brochure was not signed off.
Hard copies of the brochure were distributed internally to Celgene employees, including its field force, on 25 and 29 November 2016 as part of the 10- year anniversary celebration communication.
Celgene stated that it had looked closely into the distribution of the brochure externally before 28 September, the date of the letter from the complainant, and it found the following:
- 5 copies were provided to a human resources employee at Celgene who wanted them to share with potential candidates and recruiters for the purpose of introducing them to Celgene. As that employee had since left Celgene, the company did not know whether those copies were further distributed.
- On 22 September 2017, at an Institute of Public Policy Research event entitled ‘Mind the Gap: The Health and Care Funding Crisis’ which was a roundtable discussion about the gap in funding for social and health care in the UK, attended by UK policy makers and other health care, government and industry leaders.
No members of the public attended that event. The general manager participated as a panel speaker at the event. Five copies of the corporate brochure were on display but all five copies were subsequently returned after the meeting.
The brochure had not been proactively distributed to patients or the public before 28 September 2017. Celgene could not explain how this patient received this brochure which, at this time, had only been distributed internally (bar a small number displayed, but not taken, at the IPPR event). It would welcome further information if that were available.
Celgene set out for the Authority’s information, and in the interests of disclosure, additional information that it had been able to identify about the brochure. However, these events could not have influenced the complaint, given they occurred after the complaint was made. On 28 September, outside the scope of this complaint, at the New Scientist Live Exhibition event in London where Celgene sponsored a stand entitled ‘This is Axiom’, copies of the brochure were inadvertently made available to attendees between 10am and 12:30pm. Participants included members of the general public. On arriving at the stand, a final medical signatory who was responsible for review and approval for all materials used at the event, removed the brochure because it had not been specifically reviewed for use at the exhibition. On 9 October 2017, Celgene formally initiated a withdrawal process to remove the brochure from use due to lack of final certification. Celgene noted that these events were initiated before the company was notified of this complaint. Celgene provided a copy of the withdrawal form which was sent electronically to all employees in the UK and Ireland.
Relevant provisions of the 2016 Code of Practice
Celgene did not prepare the brochure with the intent to promote specific products. The document was created to describe the company’s mission, its culture, its therapeutic focus, its innovation and its commitment to research and to patients. The information was factually correct and accurate and Celgene understood that, under the Code, reference to the SPC was considered to be best practice. However, following the New Scientist Live Exhibition in London, the final signatory noticed the brochure had not been certified for use at the event and the withdrawal process was later initiated before Celgene was notified of this complaint. Celgene further noted that in response to a PMCPA audit in connection with a separate matter in October 2016, it had made significant updates to its internal processes, added compliance resources and trainings. While the company regretted the failure of the final certification, this did not affect the nature of the material itself, which was the focus of the complaint. Celgene submitted that the brochure did not bring discredit upon, or reduce confidence in, the industry.
Celgene stated that its compliance program included policies, standard operating procedures and electronic tools for the review and approval of materials. Celgene had reviewed and updated those policies, processes and systems and invested additional compliance resources in 2017. While certain aspects of the approval of this brochure were not in line with Celgene’s procedures, the noncompliant brochure was identified and withdrawn quickly. Celgene thus submitted that high standards had been maintained and in fact Celgene’s procedures were already being strengthened as a result of the recommendations from the audit.
The brochure contained information about Celgene’s activities in discovering and developing innovative therapies for cancer and immune inflammatory disease for the wellbeing and benefit of patients. The brochure provided non-promotional information about prescription only medicines, disease areas and clinical trials. Celgene submitted that the information in the brochure was accurate and could be substantiated and that the content of the brochure did not compromise patient safety. Celgene did not actively distribute the brochure to patients, although it accepted that it was ultimately received by a patient without final certification. The only mention of the name of Abraxane, or any other prescription medicine in the brochure, was in the references section (page 21 of the brochure) in line with the guidance in the supplementary information in the Code and accurately cited the information about the company’s research and development that was included in the body of the text. Based on these facts, Celgene submitted that the brochure did not advertise prescription only medicines to the public; it did not constitute direct to consumer advertising and the information in the brochure was factual and presented in a balanced way. Furthermore, Celgene did not believe, and certainly did not intend, that the information in the brochure would raise unfounded hopes of successful treatment or mislead with respect to the safety of the prescription only medicines and therefore the company denied a breach of Clauses 26.1 and 26.2. The brochure had now been withdrawn from use because of the lack of final certification, but a breach of Clause 26.1 and 26.2 was denied.
PANEL RULING
The Panel noted that the complainant was anonymous and non-contactable. The Constitution and Procedure for the Prescription Medicines Code of Practice Authority stated that anonymous complaints would be accepted but that, like all other complaints, the complainant had the burden of proving his/ her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The complainant could not be contacted for more information.
Clause 26.1 prohibited the promotion of prescription only medicines to the public and Clause 26.2 required that information about prescription only medicines, which is made available to the public directly or indirectly, must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product. The relevant supplementary information referred to the provision of non promotional information about prescription only medicines, inter alia, by dissemination of such information via public relation activities. The section headed ‘Information to Current or Prospective Employees’ stated that information about pharmaceutical companies, provided to current or prospective employees, might relate to both existing medicines or those not yet marketed. Such information should be presented in a balanced way.
The Panel noted that Celgene described the booklet as a corporate brochure. The Panel considered that corporate brochures were, of course, a legitimate activity. Such brochures that fell within the scope of the Code had to comply with it. The booklet discussed therapy areas where the company had a commercial interest. Whilst it did not name Abraxane, in the Panel’s view, Abraxane was, contrary to Celgene’s assertion and together with the first phosphodiesterase-4 inhibitor, indirectly identified. The Panel noted that the booklet discussed Celgene’s interactions with clinicians and patients within the context of its clinical heritage and ongoing medical innovation. In the Panel’s view, the booklet primarily sought to raise the company’s corporate profile with a particular emphasis on cancer, inflammation and immunology and the company’s ethos in relation to innovation, access, commitment and investment.
As noted above, the Panel considered that, in principle, corporate brochures were a legitimate activity but considered that when assessing their acceptability under the Code, much would depend on, inter alia, the intended audience. The Panel noted that, according to Celgene, the target audience was broad and included internal staff, external stakeholders, the public and parliamentarians. In practice, and prior to the date of the complaint, the brochure was distributed internally to Celgene employees including 5 copies to a human resource employee to be shared with potential employees. In addition, 5 copies were on display at an industry round table discussion which was not attended by members of the public. The complainant was concerned that the brochure had been obtained by his/her patient or carer. The Panel noted the status of the complainant set out above. It was not possible to contact him/her to ascertain how and when the booklet had been received by his/her patient/carer. In this regard, the Panel noted that the complaint was dated 28 September, the same date the booklet was made available to the public for a limited time at the New Scientist Live event. In the particular circumstances of this case, and irrespective of the content of the booklet, there was insufficient evidence that Celgene had distributed the booklet to, or otherwise made it available to, the complainant’s patient or carer as alleged on or before the date of the complaint and thus the Panel ruled no breach of Clauses 26.1 and 26.2 on this narrow point.
The Panel noted that the complainant also made a broader allegation about the principle of companies producing such booklets with information about specific medicines and stated that they should not be so easily accessible to members of the public and those who were not medically qualified. The complainant referred to advertising in the booklet. On this point, the Panel considered that the availability of the booklet at the New Scientist conference was relevant. Notwithstanding that the complainant was non-contactable, the Panel noted Celgene’s submission that it accepted the booklet had ultimately been received by a patient and it was certified for such. The Panel noted the requirements of Clause 26 and the permissible activities described in the relevant supplementary information set out above and the booklet’s broad intended audience. In the Panel’s view, the complaint was not about the provision of the booklet to employees, parliamentarians and such like (who might be considered members of the public) but rather to those individuals who would not normally interact professionally with a pharmaceutical company and, solely for the purposes of this point of the complaint, it interpreted members of the public as referred to by the complainant accordingly. Whilst the Zinc job bag summary described the booklet as having undergone promotional certification, it was also described as a corporate brochure for both internal and external use. Whilst it was not unacceptable to have a broad audience for such material, the company must ensure that the material was genuinely suitable for each component of the audience in relation to the requirements of the Code. For instance, material suitable for internal staff might not be suitable for the broader general public including individual patients. The Panel noted the references to pancreatic cancer patients, the first phosphodiesterase-4- inhibitor for the treatment of plaque psoriasis and rare disease areas that the company was working on, on page 9 of the booklet within the ‘Passion for Discovery’ section. The Panel considered that context was important and, in this regard, noted that the page began by referring to future proofing medical innovation and that the first therapy with clinical benefits for pancreatic cancer patients in 20 years was a result of Celgene’s bold approach to innovation. The top of the page described Celgene as a leader in the field of rare diseases. In the Panel’s view, there was an implication that Celgene’s products were cutting edge and a significant advance on products currently available. The Panel noted its comments above about the target audience which included members of the public. On balance, within the overall context of the booklet, the Panel did not consider that page 9 promoted specific prescription only medicines to the public. No breach of Clause 26.1 was ruled. In relation to members of the public as described above, and particularly individual patients, in the Panel’s view the material was such that patients might be encouraged to ask their doctors to prescribe specific medicines contrary to the requirements of Clause 26.2. The Panel considered that sufficient information had been given for products to be identified. A breach of Clause 26.2 was ruled.
Clause 26.2 required relevant materials to be factual and presented in a balanced way and the relevant supplementary information stated that the requirements of, inter alia, Clause 7.2 also applied to information to the public. The Panel noted the complainant also alleged that Abraxane was for advanced disease only. In this regard, the Panel noted that it was licensed for use in combination with gemcitabine for first line treatment of adult patients with metastatic pancreatic cancer. The page in question referred to ‘clinical benefits for pancreatic cancer patients’. In the Panel’s view, the material was misleading; it implied that the clinical benefits would potentially be seen in all patients and that was not so, it was only licensed for use in combination in patients with advanced disease. The Panel ruled a breach of Clause 26.2 on this point.
Noting its rulings above, the Panel considered that high standards had not been maintained. A breach of Clause 9.1 was ruled. Overall, the Panel did not consider that the circumstances warranted a ruling of a breach of Clause 2 and ruled no breach of that Clause.
Complaint received 6 October 2017
Case completed 19 January 2017
