Regulation

Margaret McCartney

Is making booze more expensive the way to cut binge drinking, abuse of alcohol – and even cut deaths caused by it? The evidence is mounting that this is an efficient way to improve health.

And is does seem illogical, from a health perspective, that soft drinks are not much cheaper than alcohol either in supermarkets or bars. The Lancet publishes a very interesting modelling study - Estimated effect of alcohol pricing policies on health and health economic outcomes in England: an epidemiological model – demonstrating that increasing the price of alcohol could be a feasible and useful public health tool.

If it can be done, then should it? How far should governmental control go? I suppose the government already has substantial influence on tax already: what I’d like to see is more evidence it could work here in the UK.

Margaret McCartney

I am the first to accept that modern medicine is not always good: lots of it is still unproven, or weakly proven, and in general use: and it has taken a very long time for doctors to realise that good intentions are not enough.

One has to have evidence of benefit and knowledge of harms: and to inform the patient of these and the uncertainties connected with treatment.

But – this only applies, it seems, if you are a regulated doctor. If you are dealing in unproven medicine, and your intentions are good, then it doesn’t really seem to matter whether your treatments work, or even if they give you cancer or renal failure.

This report on the judgement from the UK Old Bailey on a practitioner of Chinese medicine – Chinese herbal pills destroyed UK woman’s health – quotes the judge as saying “Although the MHRA did their best to try and make sure everybody knew about the dangers and about the regulations, it is not a foolproof system and I am certainly not blaming you for the fact you didn’t know about these regulations”.

This seems really rather a mystery of logic to me. If I set up a shop selling erratically behaving electrical goods which had a habit of giving the odd fatal electric shock, would I not be in some way responsible for my actions?

Margaret McCartney

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has a difficult job, given that it is meant to license all medications to ensure the public are using properly tested medications safely. But it is doing a difficult job increasingly badly.

Over the last few years it has made a number of decisions which seem neither fact-based nor helpful. One of these, in 2006, was the decision to allow manufacturers of homeopathic preparations to make health claims about their products, in spite of a lack of evidence. This seemed a rather dangerous precedent. We need strong evidence and information about medicines, and the MHRA should be upholding rigorous standards.

Then we have the move to make antibiotics for eye infections, themselves of questionable value, available from pharmacists without a doctors’ prescription. And now we have another: the decision to approve the purchase of tamsulosin, or Flomax, from a pharmacist, again without the need for a prescription.

The MHRA say that obtaining the drug, which is used to treat prostatic enlargement, will “encourage men to play a more active role in their healthcare”. I find this argument utterly patronising. I fail to see how going along to a pharmacist, who will do a questionnaire, supply two weeks worth of the drug, and then, after a further meeting, four weeks more, followed then by instructions to see a GP, improves anything at all.

The thing about benign prostatic hypertrophy is that it needs to be diagnosed. That means a discussion, an examination, and, possibly, referral for further tests. NICE are due to bring out guidelines next year: but here are some guidelines from the European Association of Urology, and the NHS Centre for Reviews and Dissemination, who say much the same.

The MHRA say that the questionnaire pharmacists will use has been “developed and validated by Boehringer Ingelheim” (the manufacturers of Flomax.) They also say that they have reduced the time a man can have the prescription for, without seeing a doctor, from 10 to six weeks after consultation. I find both these decisions questionable, and the petition for pharmacy-only prescribing from Boehringer is, I think, inconsistent. They point out that NHS guidance says cases of prostate cancer are no more frequent in men with mild prostate enlargement than the general population. But they ignore guidance saying that all men should have a rectal exam in making a diagnosis. For that is the key – diagnosis.

The move does not, in reality, improve access to healthcare. Nor is there any evidence that men will take more of a role in their healthcare because of this scheme. Instead, people may have to pay more money, make more visits to healthcare professionals, and have their disorder treated outwith the usual and recommended way to a diagnosis. If this is an advance for healthcare, I think it is a very sorry one.

Margaret McCartney

The UK Home Secretary, Alan Johnson, fired Professor Alan Nutt – former chief drugs advisor – at the end of last week after he criticised the government for reclassifying cannabis for political, rather than science-based reasons. This sacking is a disaster.

Prof Nutt’s government post was unpaid and, by the sounds of things, demanding of time and energy. You can read about some of his university work and research: biography and research interests of proff Nutt. His approach is rooted in evidence. He clearly saw his job as making sure the government understood and were updated, on what is known about the harms of illegal drugs.

Prof Nutt was accused of “lobbying for change in policy” about the classification of cannabis. He felt that there was no evidence to make cannabis a class B drug, and should have been made class C. But the government disagreed and discharged him of his duties.

Prof Nutt’s sacking is a disaster because it implies, firstly, that debate is unhealthy. If you look in any medical journal, or attend any lecture at a conference, you will find people noisily going on about what the degrees of certainty are and what isn’t known.  This is good: this is what can cause progress.

Second, it means that independent experts may only be appointed in future if it is felt they will keep quiet where there is disagreement between evidence and politicians, or will only interpret evidence to suit political masters.

Ultimately, this leads to a loss of confidence in the “independent” evidence government is exposed to. And lastly, it is a disaster for science. There will be incidences where government does not wish to take up the advice of experts for various reasons, and sometimes this might be warranted.

But that gulf should be visible to us, the electorate, as a means to judge our elected representatives. This debacle, frankly, does not do the Labour government any favours.

Margaret McCartney

So, just because something is statistically significant, doesn’t mean it’s clinically significant

And just because it’s clinically significant, doesn’t mean you should be doing it.

And here is why. In this illuminating article from the New England Journal of Medicine - Lost in Transmission – FDA Drug Information That Never Reaches Clinicians - Lisa Schwartz and Steven Woloshin illustrate how the distillation of evidence that goes into the package inserts of drugs is not always clear or complete.

Andrew Jack

The US Food & Drug Administration has recruited one of its own long-standing critics, hiring Peter Lurie from the watchdog Public Citizen as a policy adviser. That suggests a more enlightened approach from the regulator under Margaret Hamburg, the new commissioner named by President Barack Obama.But what is good for goverment is bad for independent scrutiny. Earlier this year, the agency hired Sidney Wolfe, another vocal critic from Public Citizen, which must now be reeling from the departures. Who will be left to provide commentary and outside analysis?

It all tastes less of poacher turned gamekeeper than of gamekeeper poaches critics.

Health and science blog




This blog, part of the FT's health series, is a forum for readers interested in the science, policy, management, technology, business and delivery of healthcare.

This blog is no longer active but it remains open as an archive.
Follow on twitter

About our regular bloggers

Margaret McCartney is a Glasgow-based GP and FT Weekend columnist. She started writing for the Life and Arts section in 2005 and moved to the magazine in 2008. She also has her own blog: www.margaretmccartney.com/blog

Clive Cookson has been a science journalist for the whole of his working life. He joined the FT in 1987. Clive, the FT's science editor, picks out the research that everyone should know about. He also discusses key policy issues, from R&D funding to science education.

Andrew Jack is pharmaceuticals correspondent, covering the industry and public health issues. He has been a journalist with the FT for 19 years, based in London, Paris and Moscow

The Health blog: a guide

Comment: To comment, please register with FT.com, which you can do for free here. Please also read our comments policy here.
Contact: You can write to Ursula Milton, the blog's editor, using this email format: firstname.surname@ft.com
Time: UK time is shown on posts.
Follow: Links to the blog's Twitter and RSS feeds are at the top of the page. You can also read the Health blog on your mobile device, by going to www.ft.com/healthblog
FT blogs: See the full range of the FT's blogs here.