Case Summary
A pharmacist member of a cancer services network complained about a 'Dear Doctor' letter sent by Eli Lilly and Company which referred to Alimta (pemetrexed) continuation maintenance now being listed with funding available from the National Cancer Drugs Fund for patients with non-squamous non small cell lung cancer (NS NSCL).
The complainant drew attention to the second part of the letter that 'The Paramount trial demonstrated that Alimta continuation maintenance treatment plus best supportive care (BSC) versus placebo plus BSC immediately following induction with Alimta/ cisplatin for advanced NS NSCLC showed a median overall survival of 16.9 months with a manageable side effect profile'.
The complainant alleged a breach of the Code as the letter, by not referring to the survival of the placebo group, implied that pemetrexed added 16.9 months survival advantage. The claim of 16.9 months was from induction rather than the 13.9 months that was quoted in the summary of product characteristics (SPC) which was from the start of maintenance treatment.
The detailed response from Lilly is given below.
The Panel noted that the Paramount study showed a survival benefit for pemetrexed maintenance therapy vs placebo (median overall survival 16.9 months vs 14 months respectively) from the start of induction treatment. The 'Dear Doctor' letter, however, only referred to the pemetrexed results and did not give the results for the placebo group. In that regard the Panel did not consider that the letter was sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of pemetrexed. The letter was misleading in that regard and a breach was ruled.
The Panel further noted that the letter referred to the 'median overall survival of 16.9 months' demonstrated with pemetrexed but only the phrase 'overall survival of 16.9 months' was emboldened; the preceding 'median' was in normal typeface. The Panel considered that the emphasis on 'overall survival of 16.9 months' was such that the letter was misleading and not capable of substantiation. Further breaches were ruled.
In the Panel's view, it was likely that some readers would assume that 'immediately following induction' with Alimta/cisplatin as used in the letter, was the same as 'Following Alimta plus cisplatin induction' as used in the SPC. This was not so. The Panel considered that the letter was not entirely clear from which time point the 16.9 months survival had been measured and a breach was ruled.
CASE AUTH/2595/4/13 PHARMACIST v LILLY
Promotion of Alimta
A pharmacist member of a cancer services network complained about a ‘Dear Doctor’ letter sent by Eli Lilly and Company which referred to Alimta (pemetrexed) continuation maintenance now being listed with funding available from the National Cancer Drugs Fund for patients with non-squamous non small cell lung cancer (NS NSCL).
The complainant drew attention to the second part of the letter that ‘The Paramount trial demonstrated that Alimta continuation maintenance treatment plus best supportive care (BSC) versus placebo plus BSC immediately following induction with Alimta/ cisplatin for advanced NS NSCLC showed a median overall survival of 16.9 months with a manageable side effect profile’.
The complainant alleged a breach of the Code as the letter, by not referring to the survival of the placebo group, implied that pemetrexed added 16.9 months survival advantage. The claim of 16.9 months was from induction rather than the 13.9 months that was quoted in the summary of product characteristics (SPC) which was from the start of maintenance treatment.
The detailed response from Lilly is given below.
The Panel noted that the Paramount study showed a survival benefit for pemetrexed maintenance therapy vs placebo (median overall survival 16.9 months vs 14 months respectively) from the start of induction treatment. The ‘Dear Doctor’ letter, however, only referred to the pemetrexed results and did not give the results for the placebo group. In that regard the Panel did not consider that the letter was sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of pemetrexed. The letter was misleading in that regard and a breach was ruled.
The Panel further noted that the letter referred to the ‘median overall survival of 16.9 months’ demonstrated with pemetrexed but only the phrase ‘overall survival of 16.9 months’ was emboldened; the preceding ‘median’ was in normal typeface. The Panel considered that the emphasis on ‘overall survival of 16.9 months’ was such that the letter was misleading and not capable of substantiation. Further breaches were ruled.
In the Panel’s view, it was likely that some readers would assume that ‘immediately following induction’ with Alimta/cisplatin as used in the letter, was the same as ‘Following Alimta plus cisplatin induction’ as used in the SPC. This was not so. The Panel considered that the letter was not entirely clear from which time point the 16.9 months survival had been measured and a breach was ruled.
A pharmacist member of a cancer services network complained about a ‘Dear Doctor’ letter (ref UKALM00536a) from Eli Lilly and Company Limited. The letter referred to Alimta (pemetrexed) continuation maintenance now being listed with funding available from the National Cancer Drugs Fund for patients in England with non-squamous non small cell lung cancer (NS NSCL).
COMPLAINT
The complainant drew attention to the second part of the letter that:
‘The Paramount trial demonstrated that Alimta continuation maintenance treatment plus best supportive care (BSC) versus placebo plus BSC immediately following induction with Alimta/ cisplatin for advanced NS NSCLC showed a median overall survival of 16.9 months with a manageable side effect profile.’
The complainant alleged that the above was in breach of Clause 7 of the Code as it implied that pemetrexed added 16.9 months survival advantage, as it did not refer to the survival of the placebo group.
The claim of 16.9 months was from induction rather than the 13.9 months that was quoted in the summary of product characteristics (SPC) which was from the start of maintenance treatment.
When writing to Lilly, the Authority asked it to respond in relation to Clauses 7.2 and 7.4.
RESPONSE
Lilly stated that the PARAMOUNT registration trial assessed the superiority of pemetrexed as continuation maintenance treatment compared with placebo after induction treatment with pemetrexed and cisplatin for patients with advanced non-squamous non small cell lung cancer.
Eligible patients (n=939) received 4 cycles of induction treatment with pemetrexed and cisplatin. Patients who showed clinical response were then randomised to receive either pemetrexed plus best supportive care (BSC) maintenance treatment (n=359) or placebo plus BSC (n=180). The median overall survival (mOS) from randomisation (start of continuation maintenance) was 13.9 months for patients in the pemetrexed arm, compared with 11 months for the placebo group (p=0.0195, unadjusted HR=0.78, 95%CI:0.64-0.96). For patients who received both induction and maintenance, the mOS from the start of induction treatment was 16.9 months for pemetrexed vs 14 months for placebo (P=0.0191, HR=0.78, 95% CI:0.64-0.96). The values for mOS from induction included both non-randomised and randomised components.
The ‘Dear Doctor’ letter at issue referred to 16.9 months as the ‘median overall survival’ for patients participating in PARAMOUNT.
Further, the letter was primarily intended to notify health professionals that pemetrexed as a continuation maintenance treatment option for patients with advanced NS NSCLC could be funded through the National Cancer Drugs Fund. There was no intention to mislead health professionals about the PARAMOUNT data. However, Lilly agreed that additional data points as published in the study report and SPC should have been included for completeness. Accordingly, Lilly withdrew the letter with immediate effect on 18 April, the day it received notice of the complaint. The letter had been replaced with a new version containing additional data points.
With regard to the complainant’s view that the claim of 16.9 months was from induction rather than the 13.9 months that was quoted in the SPC which was from the start of the maintenance treatment, Lilly noted that both the figures relating to mOS could be found in Section 5.1 of the SPC. This claim could therefore be substantiated and Lilly denied a breach of Clause 7.4.
PANEL RULING
The Panel noted that the Paramount study showed a survival benefit for pemetrexed maintenance therapy vs placebo (median overall survival 16.9 months vs 14 months respectively) from the start of induction treatment. The ‘Dear Doctor’ letter, however, only referred to the pemetrexed results and did not give the results for the placebo group. In that regard the Panel did not consider that the letter was sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of pemetrexed. The Panel considered that the letter was misleading in that regard and a breach of Clause 7.2 was ruled.
The Panel further noted that the ‘Dear Doctor’ letter referred to the ‘median overall survival of 16.9 months’ demonstrated with pemetrexed but only the phrase ‘overall survival of 16.9 months’ was emboldened; the preceding ‘median’ was in normal typeface. The Panel considered that the emphasis on ‘overall survival of 16.9 months’ was such that the letter was misleading in that regard and a further breach of Clause 7.2 was ruled. The Panel considered that the selective emboldening of ‘overall survival of 16.9 months’ resulted in a claim which could not be substantiated. A breach of Clause 7.4 was ruled.
The Panel noted that the ‘Dear Doctor’ letter referred to median overall survival ‘immediately following induction’ with Alimta/cisplatin. Section 5.1 of the Alimta SPC referred to median overall survival ‘Following Alimta plus cisplatin induction’ (13.9 months) and median overall survival ‘from the start of Alimta plus cisplatin first-line induction’ (16.9 months). In the Panel’s view, it was likely that some readers would assume that ‘immediately following induction’ as used in the ‘Dear Doctor’ letter, was the same as ‘Following Alimta plus cisplatin induction’ as used in the SPC. This was not so. The Panel considered that the letter was not entirely clear from which time point the 16.9 months survival had been measured. The letter was misleading in that regard and a breach of Clause 7.2 was ruled.
Complaint received 17 April 2013
Case completed 17 May 2013
