May 20, 2010 at 7:55 pm (Big Pharma, Business, Woo) (Allergan, Astellas, Big Pharma, Botox, Botulinum Toxin, Mycamine, Pharmaceutical, PMCPA, Prescription Medicines Code of Practice Authority, Roche and Chugai)
From time to time, I have referred to instances of the promoters of Alternative Medicine falling foul of regulators (for example the ASA). I thought it time to take a look at pharmaceutical slapdowns.
Here, you can find completed cases on the website of the Prescription Medicines Code of Practice Authority (hat-tip Jo Brodie).
Many of the available examples seem fairly trivial or banal – for example this, regarding Roche and Chugai: “…the inside pages of the supplement were not sufficiently dissimilar to the standard editorial text of the journal and so in that regard their nature was disguised“. [PDF of full case report.]
Then there’s Astellas, who conducted a Mycamine (micafungin) advisory board:
The complainant noted that he was invited to a series of advisory boards […] The complainant had no particular issue with the agenda on the day but got the feeling that he was being promoted to, more than having his advice sought. [PDF of full case report.]
In the Panel’s view the overall arrangements for the advisory boards showed that they had, at least in part been held for a promotional purpose and to develop brand advocates / opinion leaders rather than solely for gathering expert advice and opinion. Thus the Panel ruled that the overall arrangements for the advisory boards were disguised promotion in breach of the Code. The payment of a fee to attend a promotional event was unacceptable and in effect an inducement to prescribe, administer or recommend a medicine. A breach of the Code was ruled.
Allergan, meanwhile, were originally found to have produced and distributed a marketing study the content and distribution of which “were such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry” – although on appeal the company were found by the Appeal Board not to have breached the relevant clause of the Code of Practice. [Allergan PDF.]
What did Allergan do that was so bad? They produced a survey that consisted of two pages of 22 questions and sub-questions:
Nine questions, ie all but one, on page 2 related to the use of botulinum toxin injections. Six of the questions specifically referred to the use of botulinum toxin injections for the treatment of primary headache or migraine.
The accompanying letter from the agency described the survey as a marketing study on the management of primary headache and migraine conditions […] carried out on behalf of a pharmaceutical company which had a specific interest in individual clinicians’ treatment practice in this therapy area. The letter further stated that as this was a marketing study as opposed to a market research study participants would be identifiable to the company commissioning the research. A cheque for £35 was included.
The identity of the commissioning pharmaceutical company was not clear from the documentation. The agency confirmed that it was Allergan. Allergan marketed Botox (botulinum toxin). Botox was not licensed for the treatment of primary headache or migraine.
The Panel considered that the survey promoted Botox in a manner which was inconsistent with the particulars listed in its summary of product characteristics (SPC). A breach of the Code was ruled, which was upheld on appeal by Allergan.
The Panel considered that the material at issue promoted botulinum toxins in the guise of a survey. In that regard the promotional activity was disguised and the Panel ruled a breach of the Code, which was upheld on appeal by Allergan.
The Panel considered that given the survey was not a market research activity but promotional and solicited an interest in unlicensed indications the attached cheque for £35 was wholly inappropriate. […] However the Appeal Board considered that the payment of £35 was not in itself an inducement to prescribe Botox. Thus no breach of the Code was ruled.
The company involved were considered to have made an inappropriate payment, but this inappropriate payment was eventually ruled (on appeal) not to have breached the Code of Practice. Allergan had also disguised marketing activity as a survey – and this breach was upheld by the Appeal Board.
In two of the examples I used to illustrate Big Pharma naughtiness, payments made by companies were questioned – and in one of the cases it was ruled that the payment was in breach of the code.
In each of the three examples I have provided, companies have been charged with disguising promotional activity.
While quacks are catching the eye with their outrageous claims, pharmaceutical companies are quietly pushing marketing dressed up as surveys, editorial text, or advisory boards.
It is a little ironic that quacks squawk about sceptics not blogging about Big Pharma when it might well be the case that one of the reasons for the apparent focus on alternative medicine at the expense of Big Pharma is the tendency of quacks to make outrageous claims. If they weren’t quite so outrageous, then perhaps fewer bloggers would be distracted by them.
I could blog about decisions of the PMCPA more often – there’s probably enough material to do a monthly round-up. However, I suspect that very few people would be interested in reading such a round-up.
The grotesque claims of homeopaths with fantasies of curing Aids with their magic sugar pills or the quacks claiming to “reverse autism” by using aura patches will likely get more attention from sceptical bloggers than a pharma company involved in marketing activity disguised as a survey.
Be honest – what would you rather read? The above blog post or something that features MP3 healing and homeopathic hair transmission? Good vibrations indeed…