Friday, March 15, 2013

Dr Aseem Malhotra writes

Big Pharma Harms Patients for Profit but Doctors Must Also Share the Blame

Earlier this week, the government's chief medical officer Professor Dame Sally Davis created headlines by announcing that the threat to our health posed by antibiotic resistance was on a level comparable to global terrorism. She suggested greater government collaboration to financially incentivise Big Pharma to produce newer, more effective antibiotics. But can we trust the pharmaceutical industry to deliver? Unfortunately their recent track record suggests we cannot.

Cardiologists around the world are only recently coming to terms with the fact that an intra-aortic balloon pump, a device that for decades we have been implanting in the sickest patients who have suffered a heart attack has recently been proven to have no objective benefit in reducing the risk of death.

This is following the publication of a randomised controlled trial (the most robust type of study into the benefits of a treatment) in the New England Journal of Medicine. The findings were discussed at an educational conference I attended in late December. A renowned academic presented a slide with a graph showing how the introduction of a new technology is enthusiastically embraced by the profession, often fuelled by the company manufacturing and successfully promoting the benefits of its product. Its implementation increases reaching a peak over a period of time after which enthusiasm wanes once more robust studies, usually independent of industry influence, question its benefits.

The speaker pointed out that as clinical utilisation declines a point is reached where the treatment achieves the "you wouldn't use it on your dog" status. It is then replaced by a newer technology which promises to be an improvement on the previous one and the cycle continues. Unfortunately not a single person in the audience questioned the area under the curve. What about the cost to the thousands of patients? Many would have undoubtedly suffered serious complications such as stroke, kidney failure and even limb amputation. And this doesn't even include the valuable time of the doctors and nurses who for years have been implanting and managing the device for up to several days in the hospital ward under a belief that it was of benefit.

In economic terms the average purchasing cost of the machine that works the pump is approx. £40,000, (a specialist cardiac hospital will have 1-2 of these) and the individual pumps come at around £800 per patient. With approximately 140,000 patients a year worldwide receiving this technology; the overall costs add up to a staggering amount. I would like to believe that such wastage is a rare occurrence in health care but unfortunately this is just the tip of the iceberg.

Last week the British Medical Journal launched a campaign entitled 'Too Much Medicine' in an effort to tackle what now poses one of the greatest threats to human health in the developed world; over diagnosis, and the harms and waste from unnecessary tests and treatments. It's former editor Richard Smith, director of United Health Group's chronic disease initiative recently blogged that only 11% of 3,000 health interventions have good evidence to support them, with 80% of new drugs copies of old ones and 153 million euros a day being lost through corruption in health systems.

In his book Bad Pharma, Ben Goldacre has eloquently drawn attention to how drug companies mislead doctors and harm patients, and is rightly calling for the industry to publish all their trial data. But many of the corporate crimes committed by the pharmaceutical industry wouldn't happen if an influential minority of doctors weren't complicit or wilfully blind to these misdemeanours. Leading clinicians often compromise medical ethics and integrity by lending their name to ghost written articles published in academic journals that may support the approved use of a drug for unlicensed conditions, either for financial gain or greater kudos amongst peers. Peter Gotzsche, director of the Nordic Cochrane centre says " the consequences of these crimes are huge, including the unnecessary deaths of thousands of people and many billions in losses for our national economies every year."

Big Pharma also tries to influence and exaggerate its importance in medical education. Last month the Lancet withdrew its support from a document stating how health care professionals could collaborate with the drug industry. The editor Richard Horton said the action was initiated as a result of information given by University College London medical student Tom Yates, who is active in Conflict Free, a campaign calling for medical education to be freed of industry involvement.

Yates revealed that the document contained false claims including that the industry "plays a valid and important role in the provision of medical education" and that "medical representatives can be a useful resource for healthcare professionals." He told me that he wants universities to dedicate more resources into conducting research so we can be more confident that scientific objectivity is not distorted by vested interests.

He is also calling for all who provide medical education to openly declare whether they have received funding from or have links to the industry. This would certainly be a step in the right direction but this doesn't necessarily mitigate the potential harm that can still be done to patients and the public. A study revealed that any source who discloses a conflict of interest will feel morally licenced to exaggerate his or her advice more emphatically making the conflicted individual appear more, rather than less credible.

I was very disturbed to read a publication in the New England Journal of Medicine entitled 'Myths, Presumptions and Facts about Obesity'. Some of the key messages of the paper included that there was no evidence that snacking contributed to obesity and that tablets may be the solution to our expanding waist lines. The declarations of conflicts of interests at the end of the paper were more than half a page long, with authors receiving funding from McDonalds, Coca-Cola, Kraft foods and several pharmaceutical companies including Astra Zenica, and Merck.

Marion Nestle, New York University professor of nutrition and food studies said "it raises many questions about what the purpose of this paper is and whether it's aimed at promoting drugs, meal replacement products and bariatric surgery as solutions. The big issues in weight loss is how you change the food environment in order for people to make healthy choices, such as limits on soda sizes and marketing of junk food to children." In my view this not only undermines public health but the authors, many with doctorates also do a disservice to the qualification PhD.

Professor Rory Collins of Oxford deserves to be congratulated in his research in relation to statins, but I do not support his recent calls for everyone to over the age of 50 to take the cholesterol lowering drug. Referring to industry data he states that only 1% who take the pill suffer a serious adverse consequence. But in reality the number suffering from side effects such as muscle pain, or memory problems, that significantly interfere with quality of life is significantly higher. Although there is good evidence in risk reduction for patients with known heart disease, this benefit does not appear translate into an otherwise healthy population. Furthermore, there are serious concerns that statins increase the likelihood of developing type 2 diabetes.

It would be much better for doctors to advocate lifestyle modification. A rigorous study published last month revealed that a Mediterranean diet reduced the risk of heart attack, stroke or death by 30% over a five year period in a high risk population in comparison with a 'low fat' diet. Clinical epidemiologist Professor Simon Capewell told me "this study provides further strong causal scientific evidence that nutrition based primary prevention interventions can be both powerful and rapid."

The medical profession should pay more attention to the risks of poly-pharmacy. Up to a quarter of all hospital admissions in the elderly are due to dangerous medication interactions. But influential academics on guideline boards, often with financial ties to the industry are able to encourage a culture of greater prescribing. It's time to take a breath and reflect on the direction we wish our future health care to be shaped. I believe I speak for the overwhelming majority of doctors in the NHS when I say I went into medicine to practice evidence based, not corporate-influenced medicine. To paraphrase the late Allesandro Liberati founder of the Italian Cochrane centre, "encouraging researchers to concentrate on research that matters to patients, not to their careers or drug companies" would be a good start.

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