AUTH/3191/4/19 - Anonymous v Amgen

Sponsored therapy review services

  • Received
    30 April 2019
  • Case number
    AUTH/3191/4/19
  • Applicable Code year
    2016
  • Completed
    14 October 2020
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    Appeal by complainants

Case Summary

An anonymous contactable group, which described itself as consisting of GPs, NHS leaders, pharmacists, NHS patients and current staff from a named third party providing therapy review services, complained about a number of therapy review services provided by that third party on behalf of a number of pharmaceutical companies, including Amgen Limited. The service sponsored by Amgen was related to bone health.

Amgen marketed Prolia (denosumab) for the treatment of, inter alia, osteoporosis in post-menopausal women and in men at increased risk of fractures.

The complainants stated that a therapy review service sponsored by a pharmaceutical company would, in the majority of cases, lead to an increase in prescribing of that pharmaceutical company’s medicines; a fact widely known and accepted within the healthcare industry. It also followed that a therapy review service programme which did not demonstrate an increase in prescribing of the product of the sponsoring company would not lead to ongoing financial investment from the sponsoring company.

In order to remain profitable, the named third party service provider had to retain pharmaceutical companies as clients by providing them with a ‘return on investment’ when it delivered therapy review services. It did this by coaching its pharmacists on what it called ‘client value’ which was a guise for ‘return on investment’. The complainant stated that the named third party service provider had historically done this verbally, being careful not to put anything in writing. Like most untoward activities however the truth was eventually exposed.

There was now written proof that the named service provider linked its therapy review services to the products of the sponsoring pharmaceutical company. This was commercial bias.

The complainants stated that their complaint was based on an internal email sent by a very senior employee at the named third party service provider to the entire clinical team dated 14 August 2018. The complainants alleged that within the email there were several links made between pharmaceutical company product and therapy review service which was totally unacceptable and represented clear breaches of the Code.

The complainants stated that regardless of whether some of the services referred to were currently ‘live’ or not, the confidence and integrity of the pharmaceutical companies involved, along with the Code had already been breached by the sending of the email.

The complainants referred to a number of companies and used the example of linking some named products to some named companies as implying that other therapy reviews listed where no product was mentioned had a clear and obvious link to client product/therapy priorities. There was a number of cross referrals within the letter of complaint.

The email read as follows with regard to the involvement of Amgen:

‘4 of our 5 regions are currently recruiting Amgen reviews in a handful of CCGs [clinical commissioning groups], but I am pleased to say that Amgen will be releasing some additional CCGs in which we can recruit within the next week or so – more to follow from [name] on this.’

Another extract from the email (final paragraph), provided to Amgen was as follows:

‘As the business evolves a constant challenge will be to transition and integrate client product/therapy priorities into our internal resource and schedules. The addition of new clients such as [three named companies – not Amgen] also add in the additional challenge of new clinical training. Whilst not every aspect will run exactly to plan the list above illustrates clearly that our reputation as the UK service provider of choice continues to grow and that our objectives of expansion and diversification are on track.’

The complainants noted the wording of the final paragraph of the email and submitted that it was not Code compliant for an ‘independent’ clinical service provider to email its pharmacists about integrating client product/therapy priorities into its internal resources and schedules. The complainants alleged that this was an attempt to influence the pharmacists and set the expectation for client product where there should be no link at all. The wording implied that the therapy reviews named in the email had a clear and obvious link to ‘client product/therapy priorities’.

As the therapy reviews from Amgen was referred to within the email a breach of Clause 2 was alleged.

By operating in this way, the sponsored therapy review services were misleading, deceptive and unlawful. The services were not transparent to either those who used them or to patients who had their notes accessed and medicines altered without their consent or knowledge of this bias.

The complainants stated that the matter was being reported to the NHS Counter Fraud Authority. The activities would soon be highlighted in the pharmaceutical and mainstream media as it was in the public interest. The public needed to know that GPs were being misled into signing up to ‘independent’ reviews and that patients had had their treatments changed by the named third party service provider which had a hidden agenda to provide a return on investment to the pharmaceutical companies which paid its wages in order for it to make a profit as a business. The NHS and the public needed protecting from this.

The detailed response from Amgen is given below.

The Panel noted that before considering each individual case, there were general points relevant to the therapy review services and the email in question which, in its view, were relevant to all of the cases and these are given below. Each individual case would be considered on its own merits.

In the Panel’s view, the overall impression of the email was such that in the view of the author the therapy services carried out by the third party service provider were inextricably linked to the products of the sponsoring companies. It was extremely concerning that in places the email linked the service to particular products or only offered the service in practices where the formulary did not preclude the company’s product. This and the reminder regarding developing the business including the phrase ‘integrate client product/therapy priorities’ could link company products to a therapy review service. Even where a particular product was not mentioned by name it was extremely likely that the company’s product would be linked to the relevant therapy review, as understandably many of the recipients might see integrating client product/therapy priorities as increased prescribing of the company’s medicines. The important consideration for the Panel was the effect and influence of the email in question in relation to all the other arrangements for each therapy review.

The Panel noted its comments with regard to the impression of the entire email but noted that the email did not refer to a specific Amgen medicine nor link the Amgen therapy review service to a specific medicine.

The Panel noted Amgen’s submission that the aim of the osteoporosis therapy review service was to assist the key long-term goals of osteoporosis management and to support GP practices in the review and implementation of NICE Clinical Guideline 146, which offered best practice advice on the assessment of fragility fracture risk in adults, in order to reduce the risk of fracture complications and disease progression. A further aim was to support GP practices to optimise the care of patients at risk of fragility fractures associated with osteoporosis via medicinal and non-medicinal interventions according to practice defined treatment pathways and current best practice guidelines in defined cohorts of patients. According to the brief to the named third party provider pharmacists, the service was available to practices for which a need had been identified for a review of patients with a confirmed diagnosis of osteoporosis or those at high risk of fragility fractures. Amgen submitted that its representatives were not involved in offering the service. The service was offered to practices by the third party provider staff, for example when working within practices on different projects, when asked if they had any services available that could optimise the care of patients with bone health issues. Additionally, there were several Academic Health Science Networks, CCGs and other NHS regional organisations that encouraged practices to participate in the service. The clinical protocol required practices to complete two options of preferred first line bone sparing agents and two options of the practice preferred second line bone sparing agent with restrictions for each.

The Panel noted the documents provided by Amgen regarding the arrangements as set out below.

The Panel noted that according to Amgen and its documentation each clinical assessment might result in a proposed intervention such as (but not limited to) an invitation for a practice review, a change in dose, preparation or treatment, cessation of treatment or referral to a secondary care osteoporosis clinic. Amgen submitted that the third party service provider pharmacists would only implement the therapeutic review services and would not recommend a specific pharmaceutical product, write prescriptions or recommend or take any action that did not comply with the approved and signed protocol from the GP. The service was not offered on the condition that any Amgen products would be prescribed and therapy choice arising from the patient review process remained the choice and sole decision of the lead GP.

The Panel noted that Amgen did not appear to provide any product information to the third party service provider pharmacists. Pharmacists involved received internal training on the osteoporosis therapy review service overseen by national and regional lead pharmacists. According to the briefing document, all third party service provider pharmacists involved in the delivery of the therapy review would have received appropriate training and would have a thorough working knowledge of the relevant guidelines and key principles of the management of osteoporosis. Amgen submitted that the staff from the third party undertook regular field visits to ensure company procedures and agreed protocols were adhered to at all times.

The Panel noted the dashboard of anonymised, aggregated service-related data provided by Amgen. The dashboard contained baseline data, including analysis of current bone sparing agent prescribing across aggregated practices by medicine and included data regarding denosumab. An analysis following pharmacist led review was included in the dashboard but made no reference to any specific medicine.

Whilst the Panel had concerns including about how the email portrayed the named third party therapy services and its effect on its pharmacists and other staff, it, nonetheless, noted that the complainant bore the burden of proof. On the balance of probabilities, it was not unreasonable that some, if not all, of the named third party service provider pharmacists would associate the Amgen therapy review with Amgen’s products particularly based on the email at issue; denosumab was referred to within the clinical protocol in that treatments, such as denosumab and teriparatide should not be stopped without a specialist review to consider alternative follow-on therapy. However, taking all the circumstances into account, including the Panel’s view that Amgen’s written arrangements for the review did not appear to constitute a switch to Amgen’s medicine, the Panel did not consider that the complainant had established, on the balance of probabilities, that the email demonstrated that the arrangements for the osteoporosis therapy review supported by Amgen were such that they failed to meet the requirements for medical and educational goods and services in the Code. Nor had the complainants provided evidence that the therapy review constituted disguised promotion. The Panel therefore ruled no breaches of the Code.

In the Panel’s view, Amgen had been let down by its third party. The Panel had serious concerns about the impression given by the entire email. However, it did not consider that, in the particular circumstances of this case, the complainants had provided evidence to show that Amgen had failed to maintain high standards and no breach of the Code was ruled. This ruling was upheld following an appeal from the complainant.

Given its rulings of no breach of the Code, the Panel consequently ruled that there was no breach of Clause 2.