Communicating the risks of pharmaceuticals has never been easy. Say too much and no-one wants to take your drug; say too little and politicians, competitors and soon, the entire social media, will fill in the gaps for you.
Of course, in an ideal world, the regulators should be the only ones sifting through the evidence since that is what they are trained and paid to do. But if the story of Avandia, GlaxoSmithKline’s anti-diabetic drug, tells us anything it is that the verdict of expert advisory committees counts for little once the mere sniff of a safety scandal has got out.
In 2006, just before safety concerns about Avandia were made public, the drug dominated the diabetes market with sales of more than $3 billion, according to EvaluatePharma. In 2007, an advisory committee voted by 22 to one to allow the drug to remain on the market with appropriate warnings. But certain studies showing it raised the risk of a heart attack gained in currency and by 2008, its sales were less than half those of 2006. Other studies did not show this risk but these were not so avidly discussed.
Earlier this month, another FDA advisory committee again ruled in favour of Avandia remaining on the market, albeit with a reduced majority and new warnings. But this considered opinion is unlikely to make doctors rush for their prescription pads. Even if they did, their type-2 diabetic patients are also looking at their options.
Takeda, meanwhile, which makes Actos, Avandia’s main rival, is laughing all the way to the bank. Sales of the drug have risen from $2.8 billion in 2006 to $3.8 billion in 2008, according to EvaluatePharma. Not only has the company benefited from politicians such as Rosa De Lauro, a Democrat from the House of Representatives, screaming that “Avandia is dangerous and should be pulled from the market.” But it has also been gifted a copyline for a direct-to-consumer ad campaign most agencies would die for. The day after the FDA decision, Takeda started running ads that are scheduled to appear in 154 publications over the next few weeks saying: “Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke.”
In the light of such adverse publicity it is hard to see how Avandia can possibly recover. Indeed, all that can be said in favour of the FDA vote is that it should reduce what GSK can expect to pay in lawsuits.
The lesson to be drawn from the Avandia story is that companies should take every step to be seen to be upfront and clean when communicating the risks and benefits of prescription drugs. This has always been the case but it is especially true now that Big Business — be it Big Banking, Big Oil or Big Pharma — is under such intense public scrutiny and when the world has become so much more transparent. Politicians, as we also see from the BP environmental disaster, can score easy points by attacking Big Business. Patients, hearing attacks on Big Pharma drugs, pick up only on the risks, amplifying them further on social media sites. Competitors, meanwhile, can hardly believe their luck, and will understandably exploit the situation to the hilt.
The result should be a compelling argument for Risk Evaluation & Mitigation Strategies, otherwise known as REMS, whereby regulators effectively put more onus on companies for a full appraisal of the risks associated with their drugs. Whether such strategies will work remains to be seen; the truth is that everyone, patients as well as companies, wants drugs presented in the best possible light — until, of course, something goes wrong.