You’ve got to hand it to Sanofi-Aventis.
At the same time as the Vioxx case before the Federal Court is producing an alarming string of stories about the hazards of overly close ties between doctors and pharma (as an example, see this story in the Oz and this one in The Age), Sanofi-Aventis has enticed a prominent medical research institute into a bed that is likely to prove most uncomfortable.
The 1 May issue of Australian Doctor has just landed on my desk, confirming this story in today’s Oz.
Page 13 carries a Sanofi-Aventis ad for its blood thinning medicine clopidogrel (brand name Plavix) that also boasts the logo of the Baker IDI Heart & Diabetes Institute.
Readers are told: “When you write a Plavix script, Baker IDI & Diabetes Institute benefits too. For every Plavix script dispensed through retail pharmacy in 2009, sanofi-aventis will donate 25c to support their medical research and preventative health programs.”
The deal has already raised $100,681 for the Baker, according to the advertisement.
It’s a clever campaign. While everyone loves to receive a gift, most people feel even better about giving one. Rather than wooing doctors with the usual range of prezzies – nice meals, trips to somewhere exotic, crappy pens etc – this campaign is turning them into gift-givers.
This may be clever but it’s also extremely dubious. Is it suggesting that considerations other than what is best for the patient before them might influence doctors’ prescribing choices? Perish the thought.
And here’s a few other questions:
• Will all of the Institute’s researchers be declaring this tie in their future conflict of interest statements?
• Will they declare this conflict when making any public pronouncements – in the media, in journals, at conferences, in committee meetings – about any conditions or areas of research where Sanofi-Aventis may have an interest, especially in relation to this drug?
• Will the public’s confidence in the Institute and its scientific integrity be dented?
One of the lessons to have emerged so far from the Vioxx case is the naivity – or perhaps in some cases wilful ignorance – with which many doctors have entered into relationships with pharmaceutical companies.
The companies use these relationships to their marketing advantage; while there may be some gains for the individual doctors involved in terms of access to research funding and so on, they also risk suffering damage to their reputations and perceived independence.
This may also be the lesson for the Baker; the deal may bring them in some extra dollars, but at what cost?
I have no problems with a drug company donating money to research institutes and publicising their philanthropy.
I also have no problems with the research institution accepting and acknowledging such support so long as all the details of the arrangement are transparent.
But I do have a problem with a drug company making their financial support to a research institute dependent upon doctors writing a script for a company product.
I have a greater problem with a research institute going along with this arrangement and allowing their logo to placed on such advertisements.
Section 7.1.2 of the current (15th Edition) of Medicines Australia’s (MA) Code of Conduct says, “No sponsorship should be conditional upon any obligation to prescribe a particular product. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a healthcare professional’s prescribing or dispensing practices”.
While “sponsorship” is undefined in the MA Code, in my opinion this arrangement between Sanofi-Aventis and the Baker Institute that provides the Institute with 25 cents for each prescription of Plavix certainly interferes with the independence of a prescribing doctor. It is thus is a potential breach of Section 7.1.2 of the MA Code.
In the future, this arrangement is also likely to impact on the cost of drugs to patients. Currently, clopidogrel is jointly patented and marketed in Australia by Sanofi-Aventis as Plavix and by Bristol-Meyers Squibb as Iscover. The products of both companies are available on the PBS for the same price ($80.49 for 28, 75 mg tablets). Plavix had worldwide sales last year of $7.3 billion, making it the world’s second-largest-selling drug.
Generic clopidogrel has been produced by several pharmaceutical companies and in India is available at about 1/30th the price of the originator. Sanofi-Aventis and Bristol-Myers Squibb won a patent battle on clopidogrel in the US in 2007 and in Australia in 2008 after Apotex started selling a generic version of the drug. The courts ruled that Apotex could not sell their generic clopidogrel until the patent had expired (2011 in the US and 2013 in Europe).
This arrangement between Sanofi-Aventis and the Baker Institute is therefore likely to encourage the continued prescription of Plavix after the patent has expired. This will almost certainly result in an increased cost of this drug to patients due to the price premium Sanofi-Aventis is likely to charge over and above the cost of the generic product.
In conclusion, as well a breaching Section 7.1.2 of the MA Code I argue that this arrangement also breaches Section 10.8 of the Code; “activities engaged in by companies with healthcare professionals that bring discredit upon, or reduce confidence in the pharmaceutical industry”.
Sanofi will be smacked hard for that one hopefully. Nothing (other than peer reviewed data) should be used to directly encourage increased prescriptions of a product.
Baker Institute has also messed up big time – but will they be disciplined? They aren’t technically part of the MA.