Key Topic 3: Working with patients and the public
As well as being non promotional, there are three other very specific requirements for information and materials aimed at the general public. These are:
- They should not encourage a member of the public to ask their health professional to prescribe a particular medicine
- They should not raise unfounded hopes about response to treatment
- They should not cause undue alarm
Some of the materials you are most likely to see will be disease awareness campaigns and patient support programmes.
Disease Awareness Campaigns (DACs) provide information, promote awareness or educate the public about health, diseases and their management. In some cases they may help the public recognise symptoms and highlight useful sources of advice.
The primary purpose of a DAC must be to increase awareness and knowledge of a disease. It should not be to promote or raise awareness of a particular treatment.
Generally patient support programmes provide information, services or items. Examples of different types of patient support include:
- Information about the disease
- Information about the AstraZeneca treatment
- Various items to assist with the management of the treatment (for example glucose testing sticks for insulin patients)
- Literature
- Websites
- Medicine delivered to the patient’s home
- Treatment being delivered in the patient’s home
- Alert service to remind patients to take medicine
- Organised interactions with other patients
Consider these examples:
Promotional?
In Australia Pfizer issued a number of ‘Community Service Announcements’ (CSAs) in general media publications about their product Lipitor (atorvastatin). The announcements were sent out at a time when a number of generic versions of atorvastatin had been launched in Australia. Pfizer said that it had received an ‘unprecedented number of calls from consumers’ regarding the availability of Lipitor. Of these calls, 25% of patients had presented a prescription for Lipitor to a pharmacist and were given false information including that the product was no longer available or had been discontinued.
The title of the announcements was: “A message to the more than 1 million patients prescribed Lipitor”.
Pfizer took the view that that its primary responsibility in releasing in the CSAs was to address the misinformation and to allow patients to make a proper, informed treatment choice.
Which of the following do you agree with?
- These announcements constitute promotion of Lipitor to the public
- The intent of the communication appears to be to encourage patients on Lipitor to request that they are continued on Lipitor
- This is a response to misinformation about a product and is therefore not promotional
- The title of the communication contains a promotional claim
Ruling
This was the subject of a complaint to the Australian Code Authority by a doctor who alleged that it was advertising of Lipitor to the public. The Committee agreed that that the announcements were advertisements. Most of the Committee felt that the communication was intended to encourage patients to ask to continue being treated with the Lipitor brand rather than another brand of atorvastatin.
The Committee agreed that Pfizer had a right to correct the misinformation being communicated about its product, but any communication to the general public should not have included a promotional claim.
Pfizer had to pay a fine of $50,000
Unfounded hopes?
In the UK Bayer placed an advert in ‘The Economist’ (a weekly newspaper). It was headed ‘Fighting Multiple Sclerosis’ followed by the Bayer corporate logo which included the phrase ‘Science For A Better Life’, followed by ‘Providing Hope’.
The advertisement stated that in the fight against multiple sclerosis Bayer had brought to market the first therapy with long-term efficacy in significantly reducing the frequency of periods of exacerbation. It also stated that the company was continuing to investigate new therapies to give patients the most precious gift possible: a life full of hope for the future. Bayer marketed the product Betaferon in the UK.
Bayer stated that ‘The Economist’ was targeted at individuals with an interest in finance and politics, not the general public per se. The advertisement was to show Bayer as an ethical company committed to scientific research and the provision of high quality healthcare.
Which of the following do you agree with?
- This is a corporate advertisement and is therefore acceptable
- This raises unfounded hopes about treatment for MS
- As this newspaper is for those interested in finance and politics, this advert is acceptable
- This advert effectively advertises Betaferon to the public
- This cannot be advertising to the public as no product is specifically named
Ruling
The Panel did not accept that this was just ‘corporate advertising’ as a specific therapy area was mentioned. They stated that the advert also referred to Bayer Schering’s treatment for MS (although not specifically named) and included clinical claims for the product.
Furthermore the advertisement also hinted that something else would become available and this would give patients ‘a life full of hope for the future’. The Panel felt that this raised unfounded hopes of successful treatment given that MS was an incurable disease.
Bayer were found to have breached the regulations by advertising to the general public and raising unfounded hopes of successful treatment.
Undue alarm
Take a look at the following statements made on a website with public access by Boehringer Ingelheim:
“Australia is facing an epidemic of stroke” in people with atrial fibrillation and “this decision could be a matter of life or death for many thousands of elderly Australians with atrial fibrillation”
The decision being referred to was the Australian Government’s deferral of the listing of a particular product to prevent stroke in people who have atrial fibrillation. The primary purpose of the website was to encourage healthcare professionals and members of the general public to petition the Government to reverse its decision to defer the listing.
Would you approve this for dissemination to the general public?
The Committee considered that the language in the website was highly emotive and inflammatory and would create alarm and concern in members of the public.
Patient support items
In the UK Merck Serono complained about a soft toy, water bottle and backpack offered as patient support items by Sandoz in relation to its product Omnitrope (somatropin). The product was used to treat growth hormone deficiency in children (daily injections).
In defence of each item Sandoz stated:
The backpack aids adherence by allowing the patient to store and transport their growth hormone and supporting items from one destination to another, including repeat visits, ensuring that they have all the items they need to perform each injection on a daily basis regardless of their location.
The soft toy was designed to comfort and reduce the fear associated with daily injections and thus aimed to limit intentional non- adherence.
The water bottle supported the ‘Water in School is Cool’ Campaign that was appointed by the Department of Health to research and develop the Food in Schools Water Provision guidance. Sandoz therefore considered that the availability of the water bottle for patients being treated with Omnitrope gave patients the ability to keep hydrated throughout the day and ultimately supported their general health
Before checking the ruling – think about which of these, if any, you would think was approvable for use as a patient support item (Hint: consider relevance to the treatment of GH deficiency)
Ruling
The Panel viewed the backpack and water bottle as unacceptable as they were not directly related to the treatment of the patient’s condition. In fact the product needed to be stored at 2-8 degrees Celcius and so the backpack was not suitable for its transportation.
