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Steven Gray is an independent specialist in sales
and marketing health care compliance, was historically the UK Compliance
Officer for AstraZeneca and has worked for a number of other pharmaceutical
companies
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In January and February this year, readers of The Pharmaceutical
Journal reacted angrily to an educational insert distributed
within the same wrapper as The Journal. Entitled ‘The
new NICE guidance on the use of statins in practice — Considerations
for implementation’,
the insert (cover picture, right) was included with the 20 January issue.
The
NICE guidance referred to in the insert had been published the same
month (“Statins for the prevention of cardiovascular events”;
Health Technology Appraisal 94).
Readers complained that the insert was, in effect, disguised promotion
for AstraZeneca’s statin, Crestor (rosuvastatin). The insert was
subsequently the focus of a complaint to the Medicines and Healthcare
products Regulatory Agency and, last week, the Prescription Medicines
Code of Practice Authority, that enforces the the Association of the
British Pharmaceutical Industry’s code of practice, published the
results of its own
investigations.
The MHRA ruled that there had been no breach of medicines advertising
legislation; the PMCPA found that AstraZeneca’s actions had brought
the industry into disrepute. So, with hindsight, was the PJ right to
publish the insert? Did the authors act appropriately in writing it?
And should AstraZeneca be castigated for its actions in this episode?
Clearly, mistakes were made, but was there really any deliberate intent
to mislead? The risk now is that any material that has sponsorship from
a pharmaceutical company is treated with suspicion and that sponsorship
from the industry is shunned.
It is therefore worth moving past the inevitable
headline reactions and investigating some of the detail of the investigations — particularly
those of the PMCPA because they transparently publish the representations
of all parties involved in their investigations.
In March 2007, the MHRA published the results of its investigation and
ruled that the insert was not a breach of the medicines advertising Regulations
because, in its opinion, editorial control rested with the two authors
and the insert was therefore not considered to be an advertisement. The
MHRA noted, however, that it was aware of the ongoing PMCPA investigation.
Additionally,
the MHRA declared publicly that it had subsequently provided advice to
The Pharmaceutical Journal, and to the authors, on the need
to include relevant declarations of interest and also to bear in mind
the need for relevant safety precautions when medicines are discussed.
The PMCPA investigation was not published until the end of August; the
PMCPA found that AstraZeneca breached seven clauses of the ABPI Code
of Practice as a result of this insert, including “failing to maintain
high standards” and “bringing the industry into disrepute”.
The PMCPA investigated the complaints in five letters published in The
Journal about the insert. The key aspect the PMCPA had to consider was
the degree of AstraZeneca’s involvement. If AstraZeneca was deemed
to have been influential in the placing of the insert or its content,
then the insert was subject to the full weight of the code. If not, then
the content would be deemed to be entirely appropriate because it is
perfectly acceptable under the code for companies to provide financial
sponsorship to support the development of independent educational material.
There are several key factors that determine whether material is independent
and merely “sponsored” by a pharmaceutical company or whether
the material is “promotional” in nature. These factors include:
• The existence (or lack) of a formal agreement between the authors and
the company stating that the arrangement is one of arm’s-length
support.
• Whether the company initiated the project or responded to a request
for help
• Whether the company or the third party selects the authors
• Whether the company supplies any content and under what circumstances
• Whether the company is able to influence the content in anything other
than a correction of factual inaccuracies
• How the authors receive payment (it is difficult to claim an arm’s-length
agreement if a company pays the authors
directly)
• Payment of any kind by the company for the placing of the document;
this effectively makes it an advertisement and therefore promotional
• Having the final say about whether the material is published certainly
implies the company has a promotional interest in it.
In this case, AstraZeneca’s own evidence confirmed that none of
the required conditions were actually met. They commissioned the insert,
they paid the authors, they paid The Journal to distribute it, they reviewed
the document and they provided information for inclusion (albeit at the
request of the authors). Taken together, the circumstances were such
that it became impossible for AstraZeneca to argue that the insert was
independently produced as far as the Code of Practice was concerned.
This case has resulted in one of the highest number of upheld complaints
ever recorded for a single item, 27 in all:
• Three breaches of Clause 2 (for bringing the industry into disrepute)
• Five breaches of Clause 9.1 (for not maintaining high standards)
• Five breaches of Clause 10.1 (for conducting disguised promotion)
• One breach of Clause 7.10 (for failing to encourage the rationale use
of a medicine)
• Three breaches of Clause 4.1 (for not including prescribing information
in the insert)
• Eight breaches of Clauses 7.2 (for making various misleading claims)
• Two breaches of Clause 7.4 (for making claims that were not capable
of substantiation).
Some readers might be puzzled that the same breaches were not consistently
applied to all five complaints. This is because of the way the code is
applied. Essentially, each complaint is considered individually on the
alleged breaches raised by that complainant. Therefore if the complainant
does not list a particular allegation it is not considered for that specific
case.
So, three of the complainants raised issues relating to patient
safety and the apparent advocating of the 40mg dose of Crestor without
reflecting the need for specialist supervision and regular monitoring
of patients treated with that dose. This, combined with the encouragement
to follow guidelines that were contrary to national policy was stated
as the main reason for ruling breaches of Clause 2 in those three complaints.
Because
the other two complainants did not raise those points the PMCPA did not
find enough evidence in those complaints to rule that AstraZeneca
brought the industry into disrepute.
A number of the breaches related to the use of the Joint British Societies
guidelines. The NICE guidance had declined to comment on treatment targets,
however the authors of the insert chose to draw practical conclusions
arising from the NICE guidelines in the context of cholesterol targets.
Unfortunately,
in the few months between the document being written and it being published,
the Department of Health’s cardiovascular tsar
(Professor Roger Boyle) issued national policy targets, which were different
from the JBS targets quoted in the article. While the code recognises,
and allows for, publishing delays, it was decided that AstraZeneca would
have had sufficient time to withdraw the document before publication
once the targets were announced.
Some readers might also be confused about why AstraZeneca appealed the
original decisions of the PMCPA. Clearly Astra- Zeneca would not have
welcomed the rulings on Clause 2 and Clause 9.1 in particular and, given
the reasoning of the PMCPA that the insert was not independent, it was
always likely that AstraZeneca would lose any appeal. Regardless of AstraZeneca’s
actual reasons, there may be a firm constitutional rationale to the decision.
There is an important element of the ABPI constitution that effectively
means that if a company does not appeal a breach of the code, any subsequent
complaints about the same matter can be considered again — and
can be ruled in breach again. Effectively, without an appeal, if 1,000
pharmacists decided to complain independently in a year’s time
about this insert, AstraZeneca could have been ruled in breach another
1,000 times.
It is also worth pausing to note that all of the breaches
ruled arose from a single (albeit fundamental) error on the part of AstraZeneca.
The company failed to recognise its involvement in the insert was enough
to turn it from being arm’s-length sponsorship to one where the
document was deemed to be promotional. There has never been any suggestion
that AstraZeneca intended to mislead or to risk patient safety in any
way.
Nor should we think negatively of the authors; they were commissioned
to write an educational insert and they delivered a thoughtful and challenging
document, which in the absence of pharmaceutical sponsorship would possibly
have been received very differently.
It is also inappropriate to cast any blame on The Journal; while
there was a vocal response when the insert was first released, the PJ
acted
in good faith and should not be expected to know the detail of the Code
of Practice which governs the pharmaceutical industry — that is
a matter for pharmaceutical companies and the PMCPA.
Company involvement
was, after all, declared prominently on the front cover of the insert.
The PJ has a remit to deliver challenging and useful content,
and it should be complimented for transparently publishing the initial
criticism
and the outcome of the complaints.
It is important to ensure that in the response to this incident, health
care professionals do not risk losing the valuable (and valued) support
of the industry. In general, the attitude of the industry towards compliance
is not a negative one; since the current code was published at the beginning
of 2006, pharmaceutical companies have “self reported” breaches
on at least nine occasions.
The rulings by the PMCPA were no less forgiving
for the fact that the case was raised by self-admission. In any event,
the rulings of the PMCPA concerning the statins insert certainly underline
that while pharmaceutical marketing may be
controversial, it is effectively policed.
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