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AUTH/2517/6/12 - Anonymous v ProStrakan

Case number:AUTH/2517/6/12
Case ref:Anonymous v ProStrakan
Description:Promotion of Adcal D3 Caplet
No breach:No breaches Clauses 2, 7.2, 7.4, 9.1, 15.2, 18.1 and 18.4
Breach:Breach Clause 15.9
Appeal:No appeal
Status:Breach ruled, case report pending
Review:Published in the November 2012 Review
Received:19/06/2012
Completed:05/09/2012
Case Summary:

An anonymous, non-contactable complainant who signed his/her complaint ‘An aggrieved Surgery’ complained about certain practices by ProStrakan and its representatives in relation to Adcal-D3 Caplet (calcium carbonate and colecalciferol).

The complainant recently saw a sales representative and manager who had promoted the latest addition to the Adcal range, Adcal-D3 Caplet.

The complainant noted that the same information was used to promote other products in the range. The representative and manager assured the complainant that the data in the detail aid and leavepieces were relevant to Adcal-D3 Caplet and the product was included in the clinical trials cited. This was alleged to be misleading as the studies were almost a decade old and Adcal-D3 Caplet could not be included as it was not a year old.

The complainant stated that his/her surgery had used ProStrakan’s switch programme to swap patients from other calcium supplements to Adcal- D3 Caplet based on misleading data in the material. However the complainant and his/her colleagues considered that they had compromised their patients by unwittingly believing the data and the ‘carrot’ that was dangled in the form of a switch programme. The surgery would review those patients that had been inconvenienced by the switching of medication.

The detailed response from ProStrakan is given below.

The Panel noted ProStrakan’s submission that the claims made for Adcal-D3 Caplet were based on Chapuy et al and Tang et al. Neither included any of the Adcal range of products. However, the results of Chapuy et al were detailed in Section 5.1, Pharmacodynamic properties, of the Adcal-D3 Caplet summary of product characteristics (SPC). The 18 month efficacy data to support the UK marketing authorization application for Adcal-D3 Caplet were derived from Chapuy et al.

The Panel noted that page 3 of the detail aid was entitled ‘The NEW Adcal-D3 Caplet – offering your patients an effective dose of calcium and vitamin D3’. The page gave the results of Chapuy et al in relation to the use of 1200mg elemental calcium and 800IU vitamin D3 daily in significantly reducing hip fractures and non-vertebral fractures vs placebo over 18 months. Page 4 of the detail aid had the same title and noted that a meta-analysis (Tang et al) concluded that daily doses of at least 1200mg calcium and 800IU vitamin D3 had been shown to achieve a better therapeutic effect than lower doses. Similar information appeared in the leavepiece. ThePanel noted that the adult and elderly daily dose of Adcal-D3 Caplet (two tablets twice a day) delivered a total daily dose of 3000mg of calcium carbonate (equivalent to 1200mg of calcium) and 800IU of colecalciferol (equivalent to 20mcg vitamin D3).

The Panel considered that the detail aid and leavepiece were clear that the efficacy data included was for 1200mg calcium and 800IU vitamin D3 daily rather than specifically for Adcal-D3 Caplet. They were not misleading in that regard. The Panel noted that the marketing authorization for Adcal-D3 Caplet was granted on the basis of established use including Chapuy et al data. The Panel considered that in principle Chapuy et al and Tang et al could substantiate claims for Adcal-D3 Caplet and, on this narrow ground, such claims were not misleading. No breaches of the Code were ruled.

The Panel noted that the complainant bore the burden of establishing his/her case on the balance of probabilities. The Panel noted that ProStrakan had denied the allegations but it was unable to identify those concerned and respond in detail to the allegations. The Panel noted that it was difficult in cases involving discussions between representatives and a health professional to know exactly what had transpired. A judgement had to be made on the available evidence. The Panel did not consider that the complainant had shown that, on the balance of probabilities, the representative and his/her manager had failed to maintain a high standard of ethical conduct in relation to claims about the product. No breaches of the Code were ruled.

The Panel noted its rulings above about the representatives but nonetheless was concerned about the briefing material. Whilst it was made clear in the detail aid briefing document that Adcal-D3 was not included in Tang et al no such caveat was applied to Chapuy et al. The Panel considered that it was particularly important to give clear instructions to representatives about this matter. The failure to make any relevant comment in relation to Chapuy et al followed by unequivocal statements that Adcal-D3 was not used in Tang et al was misleading by omission. The specific briefings on the two studies had not provided the representatives with a clear message in this regard. Consequently the briefing material was likely to lead to a breach of the Code and a breach was ruled. This did not amount to a failure to maintain high standards and no breach, including Clause 2, was ruled.

The Panel noted ProStrakan’s submission that it did not offer a switch service but that it did support a therapy review service for patients who might be at risk of osteoporosis. The Panel noted that the Code permitted therapy reviews, providing they enhancedpatient care, or benefited the NHS whilst maintaining patient care.

The Panel noted that the sales force briefing for the review service stated that the service was offered an aid to improve patient care with respect to the provision of appropriate calcium and vitamin D supplementation. The service comprised of a review conducted within GP practices, which aimed to identify patients who might have calcium and/or vitamin D deficiency and therefore might be at risk of developing osteoporosis.

The briefing stated that the review would focus on patients: receiving bisphosphonates to assess the need for adjunctive calcium/vitamin D therapy; with a Read code of osteoporosis who were not receiving necessary treatment; with a prior fragility fracture and those who were elderly, housebound or institutionalised. The service might also include, requested, a review of patients in line with an enhanced service for osteoporosis.

The service was open to any GP practice which was computerised and was not to be linked in any way promotional activity or be carried out in such a way as to be an inducement to prescribe, supply, administer, recommend or buy any medicine. Representatives were instructed that if they had included a product detail in a call then the service should only be discussed in brief and another call arranged to discuss it in detail. If a doctor had volunteered that he wished to switch any patients a ProStrakan product then the service could not offered as this would be seen as facilitating a switch programme. The briefing provided detailed steps the representative to undertake once a practice had agreed to the service and the protocol was signed. The representative introduced the pharmacist carrying out the review to the practice but then the representative was to leave and have no further interaction with the pharmacist. There could be promotional activity in the location on the day of therapy review or for three days before or after.

The Panel noted that, without details of the surgery, ProStrakan was unable to respond in detail to allegations about the offer and implementation of the service at the surgery in question. The Panel further noted that the complainant had produced evidence in relation to the allegation that the service provided by ProStrakan was a switch service and/ that it was offered as such. The Panel did not consider that the calcium and vitamin D therapy review service was a switch service as alleged nor was it offered as such. The service was not an inducement to prescribe, supply, administer, recommend, buy or sell a medicine and no breach was ruled including Clause 2.