Healthwise
Patients have a right to expect independent drug trials free from influence by manufacturers
6:58AM BST 16 Jun 2014
13 Comments
Determining whether a drug works isn’t as straightforward as you might think. There are multiple confounding factors, things that might skew a result or bias the outcome of a trial. I’m no anti-pharmaceutical-company evangelical, but it’s still not surprising that the trials they publish tend to be complimentary of their products. This makes evaluating the efficacy of medicines very difficult.
Independent trials are costly and time-consuming, and there aren’t a lot of people willing to fund them, so doctors must apply a critical eye when appraising the research available. In the past few months, one group of drugs has dominated this debate more than any other: statins.
Last year, a study published in the British Medical Journal suggested that 20 per cent of people taking the pills suffer debilitating side-effects, a figure subsequently retracted by the authors after the study was published. This was followed by a study claiming that, in fact, the drugs were entirely free from side-effects, a conclusion reached by an overview of previously published research.
But there was a problem. The authors acknowledged that they relied on data taken from trial publications. Variation in the way each of the trials defined or monitored side-effects varied, so it wasn’t always easy to compare like with like. There was also concern that, especially in drug trials funded by pharmaceutical companies, people who dropped out of a trial because of severe side-effects were not included in the final data. If anything, the study showed the limit of conducting analysis of drug trials when you only have partial data.
We’re left with a lot of confusion, and a lack of evidence, when trying to make a decision on who should be offered statins based on a cost-benefit analysis of side-effects versus health benefits. This is the background to the proposal by the National Institute for Health and Care Excellence (Nice) to recommend that the threshold on who is offered the drugs be lowered.
In February, Nice announced plans to cut the “risk threshold” for statins in half, which would result in the vast majority of men aged over 50 and most women over 60 being advised to take the medication. Last week, as this newspaper reported, a group of nine leading doctors, including Sir Richard Thompson, the president of the Royal College of Physicians, and Prof Clare Gerada, former chair of the Royal College of General Practitioners, wrote to Nice and Jeremy Hunt, the Health Secretary, raising concerns about the impartiality of the panel that made the recommendations. They noted that eight of the 12 members who produced the guidelines had “direct financial ties” to firms that manufacture statins.
Prof Mark Baker, a senior Nice official, described the concerns as “completely unjustified” and said that none of the panel members stood to gain financially from the guidance. This rather misses the point, I think. The panel members cannot be impartial if they have links with the manufacturers. Drug companies spend vast amounts of money each year on advertising, marketing and attempting to foster links with doctors, scientists and opinion leaders precisely because they know that this will mean they are more likely to view products favourably.
In recent years there have been limitations placed on drugs companies: they are no longer allowed to take doctors on lavish holidays or out for expensive meals. In fact, they are no longer allowed even to give out a pen with a drug’s name on it. But what do these regulations matter when companies can access people who sit on a national board that makes decisions about prescribing to millions of people?
Two things need to happen: firstly, drug companies must be compelled to publish all their trials data, good and bad, so that their drugs can be independently assessed. Without all the data, we only get part of the picture. Secondly, people who sit on Nice panels with responsibility for producing guidelines must be free from association with the pharmaceutical companies whose drugs they are assessing. We cannot allow their decisions to swayed, however subtly, by manufacturers. This is the only way that we will be able to decide objectively upon which drugs to dish out, and to whom.
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Farrah Fawcett campaigned against ignorance before her death
One cancer continues to buck the trend
In recent years, scientific and clinical advances have greatly improved the survival rates for many cancers. Deaths from one cancer, however, have quadrupled in Britain since the Seventies, according to new figures from Cancer Research UK. While anal cancer remains relatively rare, with 1,200 people diagnosed every year, it is responsible for around six deaths every week. The rise is shocking given the overall improvement in managing cancer in general.
The actress Farrah Fawcett campaigned tirelessly to raise awareness of this cancer before she died from it in 2009. Yet there is still tremendous ignorance. Few people, for example, know that there is a vaccine that can reduce the risk of contracting it.
It is estimated that 90 per cent of anal cancer is linked with human papillomavirus (HPV), a group of viruses also linked to cervical cancer. The introduction of the HPV vaccine for girls is expected to help, but what about for boys? In 2011, 113 men and 186 women made up the 299 deaths from anal cancer that year. The Joint Committee on Vaccination and Immunisation is considering whether to extend the vaccine to boys. I don’t see why there is even any debate.
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Sorry might be hard for some doctors – but not this one
According to new guidelines issued last week by the General Medical Council, doctors should apologise to patients more. I completely agree. It’s always baffled me why sorry is sometimes the hardest word.
I’m a great fan of apologising. I’m the kind of person who apologises for everything, even when it is not my fault. Someone bumps into me? I apologise. Someone stands on my foot? Sorry!
A few weeks ago, my secretary pointed out that, when writing to patients who had failed to come to their outpatients appointments, I began my letters with: “I was sorry that you didn’t attend…” “Why are you apologising to them for the fact they didn’t turn up?” she asked. “Oh, sorry,” I replied.
Max Pemberton’s latest book, 'The Doctor Will See You Now’ is published by Hodder. To order a copy, call Telegraph Books on 0844 871 1515
