Key Topic 1: Encourage Rational Prescribing – Overstated Efficacy
Care must be taken not to state or imply that a medicine is more efficacious than it actually is, or that it has effects that have not been demonstrated.
Remember this can happen through artwork as well as written statements.
For example would you approve the following ‘before and after’ artwork for an acne treatment?
This may be acceptable if the vast majority of patients achieved this result with the treatment. However if this was not a typical response to treatment it could not be used, even with the caveat ‘individual response may vary’ as it would be deemed an over statement of efficacy.
Consider this example
A complaint was made in Australia about a leavepiece by Pfizer about its product Celebrex (celecoxib) – used to treat the pain of osteoarthritis.
The leave piece included the heading “How can you stop the increasing burden of osteoarthritis?” with graphics of human figures showing the percentages of comorbidities in patients with osteoarthritis. The conditions listed as co-morbidities were depression, sleeping disorders, neuropathic pain and musculoskeletal pain.
The complainant alleged that the cover graphic implied that arthritic burden caused other conditions, depression, sleep disorders, and not that these conditions were merely associated with osteoarthritis.
Which of the following do you agree with?
- Such imagery could imply that celebrex has an effect on the co-morbidities listed the Committee deemed this to be the case
- The complainant is correct that this implies that osteoarthritis causes the co-morbidities the Committee agreed
- These associated co-morbidities constitute ‘common medical knowledge’ and therefore do not need substantiation
- The title is specific to osteoarthritis so this claim is substantiated it was deemed that the claim referred to co-morbidities as well as osteoarthritis per se
- It is obvious that treating osteoarthritic pain would have a positive impact on these comorbidities so the claim can be substantiated the Appeals Committee noted that general practitioners would be aware that chronic pain may impact the presentation of many of the comorbidities, and that it is intuitive that treating the pain associated with osteoarthritis may assist in the treatment of the co-morbidities, but this was not proven.
Ruling
The Committee agreed that Pfizer had overstated the efficacy of Celebrex and this was upheld on Appeal –Pfizer had to pay a fine of $85,000.
