Is the failure of health regulation damaging our well-being? by Dr
Crises affecting the NHS are in the news every week. Staff shortages and bed-blocking; increasing demand from patients with chronic conditions; the worst A&E waiting times for a decade. This is despite the government investing £700m in emergency care over the past few months.
But perhaps it’s not all about money or, rather, it’s about spending whatever money we have wisely. For once in healthcare, there is a lesson to be learned from the US, where it is estimated that a third of all healthcare brings no benefit to patients.
We should be very wary of a similar situation arising in the UK. Towards the end of last year, the UK Academy of Medical Royal Colleges reported that at least £2bn was being wasted on unnecessary tests and treatment. Up to a quarter of hospital admissions among the elderly are due to dangerous drug interactions. How did we reach this point? Is it the cumulative result of a combination of perceptions, including biased funding of research and reporting in medical journals and conflicts of interest. Have these resulted in misinformed doctors and patients and a culture of “more is better”, creating a recipe for an inefficient health service?
One would hope the National Institute of Health and Care Excellence (Nice) would protect the population from these excesses. It was set up to “provide independent and evidence-based guidance on the most effective ways to prevent, diagnose and treat disease and ill health reducing inequalities and variation”. But is it doing its job properly – is Nice fit for purpose?
Recent guidance, lowering the threshold for the prescription of statins to patients with a 10-20% risk of developing cardiovascular disease in a 10-year period, has generated much controversy, with many experts questioning the sense of mass-medicating healthy people.
In a letter to Jeremy Hunt, the secretary of state for health, prominent signatories, including the president of the Royal College of Physicians, Sir Richard Thompson and former chair of the Council of the Royal College of General Practitioners, Clare Gerada, raised major concerns over the impartiality of the guideline development group on statins, with eight of the 12 members declaring financial ties to companies manufacturing statins and related drugs. There is no suggestion that the panel acted in any improper way. However, when confidence in an organisation such as Nice is imperative, it is essential there should be no perceptions of conflicts of interest. The systems for selection of panellists, the scrutiny of evidence and the methodology and openness of the consultation need to be beyond reproach.
The letter to Hunt also raised concern that the data driving Nice guidance in matters such as statins comes almost entirely from studies funded by pharmaceutical companies. Furthermore, the raw data is not available for review by independent researchers.
Another example: last April, independent scientists of the Cochrane Collaboration concluded that Britain wasted more than £500m on the influenza drug Tamiflu. After gaining access to withheld clinical trials data, the body found Tamiflu was no better than paracetamol in relieving flu symptoms and had potentially serious side effects including kidney problems and psychiatric disturbance. Nice was criticised for failing to call for the full data to be released by the pharmaceutical company manufacturing the drug before giving its hasty approval.
Towards the end of last year, Nice issued guidance expanding the offer of bariatric surgery to up to a million more people. The move has been described by obesity researcher Zoe Harcombe as “useful as putting a plaster on a severed artery”. This expensive surgery would put even more strain on the NHS and provide further distraction from addressing the causes of obesity. Harcombe discovered that six out of 14 members on the panel issuing the guidelines were deliverers, or recipients, of bariatric surgery.
But perhaps the gravest concern is actual political interference. Could ideology be behind Nice’s perceived perpetuation of an increasingly over-medicalised patient population? Insiders recently expressed concerns to the investigations editor of the BMJ, Deborah Cohen, that there was ministerial encouragement on Nice committees to be more favourable to the drug and device industries. 71 coalition MPs have been linked to health firms set to profit from opening up more of the market within the NHS. Failure to regulate the banks was responsible for the biggest crash in half a century and failure to regulate the drug and device industries is causing unfathomable damage to our health at great cost.
Yet, increasingly, doctors are refusing to allow transparency and objectivity to be trumped by eminence and vested interests. A survey in Pulse, a publication for GPs, in October revealed that two-thirds of GPs were rejecting Nice advice to offer statins to those at low risk. Such an unprecedented revolt would be less likely in the US where despite 84% of doctors expressing concerns about industry influence over clinical guidelines, fear of malpractice suits drives many to adhere to them
And is there another scandal on the horizon? The stroke drug Alteplase was approved by Nice, yet now the Medical and Health Regulatory Agency is considering its withdrawal due to potential “misinterpretation” of data. This follows independent analysis that suggests any potential benefits may be considerably outweighed by the risk of fatal brain haemorrhage.
It was therefore welcome news that a few weeks ago the BMJ, one of the most respected medical journals in the world, announced that it would no longer publish any editorials or clinical education articles from experts with financial ties to industry. Nice must take this opportunity to strengthen its inadequate system in managing conflicts and ensure complete transparency in its methodology behind clinical guidelines. If Nice is being further compromised by pressure from a misguided industry-friendly government, then loud protests are essential to defend an NHS struggling with rising demand and a vast funding deficit, putting patient care at risk.
JP van Besouw, the president of the Royal College of Anaesthetists, said to me last week: “We want doctors for patients, not doctors for doctors.” Encouraging scientists to concentrate on research that matters to patients, not their careers or the advance of drug companies, would be a good start.
Aseem Malhotra is a cardiologist and consultant clinical associate to the Academy of Royal Medical Colleges