GlaxoSmithKline, one of the Big Five global pharmaceutical companies, this week gave the world an overdue Christmas present. Glaxo will stop paying doctors to promote its drugs and will no longer pay its sales representatives on the basis of the number of prescriptions written by those practitioners.
But before we say thanks – and ask Glaxo’s peers to follow its lead – we need to ask: is this tinsel or transparency?
Pharmaceuticals are big business. We like to believe that drug development and marketing “just happens”, but drug companies vigorously seek to influence government policy at home and abroad.
We have seen this in lobbying about free trade agreements, which typically privilege the interests of overseas drug companies over Australian consumers and taxpayers. The taxpayer is important because we subsidise prescription medications through the Pharmaceutical Benefit Scheme.
The secret Trans Pacific Partnership Agreement, for example, has rightly been condemned for threatening to increase the price Australians pay for pharmaceuticals.
Drug companies also influence medical practitioners and medical practices. One way is through pharmaceutical payola: practitioners get financial incentives for prescribing a particular company’s medications.
Some lucky practitioners, managers and partners have been getting presents in the form of free trips to professional conferences or, more egregiously, to educational opportunities at plush overseas resorts. There’s nothing like a week of golf in Hawaii interspersed with promo about drug x or drug y.
Given the money at stake, leading companies have gone further. They’ve influenced perceptions of their products through ghostwriting research papers in professional publications and through consulting arrangements for gatekeepers or “opinion leaders”.
Some companies simply haven’t reported problems with medications. And some have actively promoted products for unapproved uses, potentially with a tangible risk of serious injury or death. Dementia patients, for example, were at increased risk of stroke after being prescribed Johnson & Johnson medications that were only approved for the treatment of schizophrenia.
The Australian Competition & Consumer Commission (ACCC), informed by industry critics, has slowly started to address the lack of pharmaceutical transparency in Australia. In signing off on the industry self-regulatory scheme, it encouraged Medicines Australia – representing major non-generic drug companies – to move towards greater transparency about payments. Medicines Australia has agreed to aggregate disclosure but resisted transparency about benefits to individuals.
Regrettably, there is still no requirement for disclosure at the researcher or practitioner level and no expectation that gift-giving stop altogether.
Action by the ACCC followed news that the US government has imposed billion-dollar penalties on leading drug companies over a range of marketing abuses. Johnson & Johnson, for example, paid US$2.2 billion. The US Justice Department stated that a Johnson & Johnson arm knew patients taking Risperdal had an increased risk of developing diabetes but nonetheless promoted the drug as “uncompromised by safety concerns (does not cause diabetes)”.
Glaxo paid US$3 billion after the government found it unlawfully promoted Paxil for treating depression in young patients even though the drug was unapproved for paediatric use. Glaxo’s Wellbutrin was promoted for weight loss, treatment of sexual dysfunction, substance addictions and ADHD despite legally only being prescribed for severe depression.
Glaxo, along with its peers, concurrently indicated it would behave as a good citizen. Leading drug companies acknowledged that there had been misbehaviour, in some instances direct illegality. Their excuses? Some claimed over-zealous agents were primarily responsible, that such behaviour was standard practice across the industry and had been tacitly accepted by a range of regulators, or that market realities meant that they were at the mercy of practitioners.
The new Glaxo move to stop paying doctors for speaking engagements or to attend conferences and abolish sales targets for drug reps will come into effect in Australia and other nations during the next two years. We can expect Glaxo’s peers to follow. That emulation will reflect marketing – no-one wants to be left behind. It’s also a way of pre-empting government regulation.
But we still need to question the gift-wrapping. Glaxo’s announcement coincides with investigation in China of what would conventionally be described as bribes (claims doctors were paid handsomely for conferences that did not take place).
It also anticipates disclosure under the Physician Payments Sunshine Act, as part of Obama’s controversial health plan.
But Glaxo has not revealed how much it has been paying to individual researchers, reviewers, ghost writers and practitioners. And it will continue to make “unsolicited, independent educational grants” to doctors.
A truly beneficial Christmas present – one with more substance than tinsel – would be a commitment by drug companies to publicly reveal where the money is going on such “grants”, “consultancies” and ghostwriting. Public health specialists advocate disaggregated disclosure – and it is possible.
Next Christmas let’s see how much is going to individuals. If there is nothing wrong with the payment, there is nothing to hide and everyone can enjoy the festivities.