The competition for ‘world’s worst company’ has just become fiercer – and the wider implications are unsettling for users of pharmaceutical-based healthcare. But the pharmaceutical model of healthcare, vaccines and all, may soon change forever.
In the grand All-Fat Cat Corporate Race-to-the-Bottom Sweepstakes for Worst Company in the World, Monsanto has been way ahead for some time. But who’s this making a late run on the outside? Why, it’s UK pharmaceutical giant GlaxoSmithKline, surging forward on the news of a record US$3 billion fine for defrauding the USA healthcare system.
GSK received its whopping fine for so-called ‘off-label promotion’ of three of its drugs: antidepressant and smoking cessation drug Wellbutrin (bupropion, sold as Zyban in the European Union [EU]); antidepressant Paxil (paroxetine, known as Seroxat in the EU); and diabetes drug Avandia (rosiglitazone). Avandia is no stranger to controversy, having been withdrawn from the EU market for increasing the risk of heart conditions.
In short, off-label promoting amounts to an enormous chemical experiment on the population. Drugs are approved only for the very specific therapeutic indications for which the clinical trials process has shown them to be clinically useful. The law forbids manufacturers from promoting their drugs ‘off label’ for conditions outside those indications. However, in recognition of their years of training and clinical experience, medical doctors are legally given an exemption in European and USA law to prescribe as they wish – so-called ‘off-label prescribing’. Never ones to miss out on a commercial opportunity, or to worry overmuch about ethics or the law, off-label promotion to doctors by pharma companies is an everyday practice. Big Pharma sweetens the deals with agreeable Caribbean holidays, spa days and hunting trips for the docs, and has been found to twist clinical trial results in medical journals to throw a favourable light on the off-label use it’s promoting. Enormous profits ensue.
The loser, as always, is the long-suffering public. Most people implicitly trust their doctor to judiciously prescribe the most effective drug for their condition, based on the most gold-plated of rigorous scientific testing. In fact, there may be a reasonable chance that their drug never went anywhere near a relevant clinical trial. At a stroke, off-label promotion and prescribing turns pharmaceutical-based healthcare from something (supposedly) evidence-based into a lottery, where doctors are influenced by – at best – expert clinical evidence or – at worst – drug company largesse when they reach for the prescription pad. Patient safety doesn’t even get a look-in.
One reason why off-label promotion is so important to Big Pharma is that it’s run out of ideas: the research and development pipeline has run dry. Instead, companies like GSK are now trying to bully their way into the lucrative natural products arena and are investing in emerging markets.
Another favoured tactic of Big Pharma is to rely on its friends in the medicines regulators. GSK may soon be able to offset its huge fine if the USA Food and Drug Administration (FDA) agrees to the company’s request to ban the marketing of dietary supplements as treatments for obesity. According to GSK, the World Health Organization and pretty much all the major health authorities, obesity has become a disease, and as a disease, it may only be legally treated with licensed drugs.
Of course, vaccines are Big Pharma’s other big money spinner, and the current headlong rush to vaccinate is at least partly caused by pressure on governments from anxious pharmaceutical companies. This vital plank of the Big Pharma model may be about to disintegrate, however, with news of an Italian court ruling that the combined measles, mumps and rubella (MMR) vaccine caused a child’s autism. The makers of MMR? Why, our old friends GSK. US$3 billion will be loose change compared with their liabilities if the MMR vaccine becomes widely acknowledged as a cause of autism.
Vaccination as a concept will also come under unprecedented scrutiny as a result. What will happen if Dr Andrew Wakefield is vindicated, following on from his colleague Prof John Walker-Smith, who recently won an appeal against professional misconduct? This followed the research, originally published in the Lancet journal in 1998, that has kept Wakefield in the cross-hairs of the vaccine industry, media and the medical establishment for some 14 years.
Whatever happens, it’s clear that Big Pharma as we know it is about to undergo drastic change, along with the current model of pharmaceutical-based healthcare. We await developments with eager interest.
Updated: 4 Jul 2012
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