Pharmaceuticals

Margaret McCartney

Magical powers are always being squeezed from fruit. The latest is derived from the pomegranate, which is said to tackle drug-resistant infections such as MRSA.

This claim, by a team from the University of Kingston in Surrey, tells me two things. First, media reporting doesn’t always recognise the discrepancy between laboratory experiments and real life ones. If something works in the lab – Kingston reports “moderate” effects – there’s no certainty that it will work in practice. Second, the prospect of a cure for one superbug has obscured the fact that others are still at large.

MRSA is not the only resistant bacteria causing problems. There are Klebsiella pneumonia, Pseudomonas aeruginosa, Acinetobacter baumanni, and that’s just the start of a very long list. MRSA used to be sensitive to vancomycin, an antibacterial – but now there are strains showing resistance. And of course there is clostridium difficle, caused when antibiotic use destabilises the balance of bacteria in the gut.

Continue reading “The war on superbugs”

Margaret McCartney

New year in my house, never mind consulting room, is usually heralded by a succession of sneezes and snuffles. I always feel rather mean advising little more than patience and paracetamol. But while viral colds can be miserable, there’s simply not much one can do.

Some doctors I know recommend vitamin C on the basis that it feels good to have something to offer and it is unlikely to do any harm. We all know that denying the body vitamin C leads to scurvy, but we also need it to heal wounds, to act as an antioxidant – protecting against harmful free radicals – and to support immunity, as well as helping to absorb iron. Is it asking too much for it to help stave off colds as well?

Perhaps the benefit – as far as colds are concerned – from taking extra vitamin C is indeed because of the placebo effect. Most vitamin C tablets are effervescent, invigorating and reassuringly large. And there’s always the chance that people might go for the real thing, such as an orange, to keep up their vitamin C levels.

Continue reading “C is for colds”

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

Those of us who prefer Cochrane reviews for our evidence, and who know that the majority of pharmaceutical companies do not publish all of their research, will not be surprised by this publication in the BMJ today: Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. The lead author is Dr Tom Jefferson, who we’ve interviewed for the blog. Here’s the conclusion, about the impact of neuraminidase inhibitors oseltamivir and zanamivir :

” Neuraminidase inhibitors have modest effectiveness against the symptoms of influenza in otherwise healthy adults. The drugs are effective postexposure against laboratory confirmed influenza, but this is a small component of influenza-like illness, so for this outcome neuraminidase inhibitors are not effective. Neuraminidase inhibitors might be regarded as optional for reducing the symptoms of seasonal influenza. Paucity of good data has undermined previous findings for oseltamivir’s prevention of complications from influenza. Independent randomised trials to resolve these uncertainties are needed.”

Margaret McCartney

Thank goodness for the small but awfully potent Drugs and Therapeutics Bulletin (DTB). On its front page this month, it notes that new warnings about side effects of statins have still to be included in the patient information leaflets about them. These side effects include sexual dysfunction, memory loss and depression.

In February 2008, they say, the Medicines and Healthcare products Regulatory Agency  (MHRA) decided, following a review of clinical trials, reports of adverse drug reactions, and publications, they were to update the leaflet ” to reflect a number of different side effects as class effects of all statins”.

Andrew Jack

Sometime companies dabbling with branding just try too hard. GlaxoSmithKline and Pfizer announced a joint venture for all their HIV products last April, but only this week launched it – and announced the name: ViiV Healthcare.

The idea? It contains bits of the words Virus and HIV, sounds like life in French (the mother tongue of its new chief executive) and it’s a palindrome – handily reflecting its two corporate shareholders (though Pfizer only holds 15 per cent).

It may not roll off the tongue, but at least its creation reflects the new spirit of austerity. It was dreamed up in-house, with no expensive brand consultant brought in. It’s at least no worse than many such costly offerings.

Now all the company has to do is deliver new drugs.

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

How the pleasure of youth quickly turns to the pain of old age. It looks as though Amgen has now completed its transition away from a fast-growing and spritely West Coast biotech business to a global pharma giant.Before, it stressed its focus to breakthrough new drugs. But at the European Health Forum in Gastein this week, it has sponsored a session on “discovering new indications for approved medicines” – the sort of “lifecycle management” that is distinctly “old pharma” not “new biotech”.

Read the FT Healthcare & the Recovery special report published Septenber 30, 2009

Andrew Jack

Shareholders may have been more concerned about shifts in strategy, governments about new approaches to pricing, and patients to any shift in the development of its experimental medicines, but GlaxoSmithKline’s own employees had something else on their mind when Andrew Witty took over as chief executive last year, according to a recent feel-good internal corporate blog: Orange Day at Camp Smile-A Mile 

Mr Witty, who is British, did away with “JP Days”, named after his French predecessor Jean-Pierre Garnier, who had allowed staff an extra day off work at the end of each year for a job well done. But instead of total abolition, he de-personalised them, creating an annual “Orange Day”. The new deal? In a sign of a more mid-Atlantic attitude to working hours and corporate loyalty, he allowed staff an extra day off – in order to volunteer in their communities.

Margaret McCartney

I’ve been kindly pointed toward an interview held a couple of days ago on BBC World Service: Pfizer agrees record fraud fine. John Kopchinski, a Gulf War veteran, was a sales rep for Pfizer who was fired by them after he claimed that one drug, Bextra, was being mis-sold. Pfizer agrees to plead guilty in painkiller case

There were 3,000 reps being asked to do work that was “blatantly illegal” including recommending the drug for acute pain, which it wasn’t licensed for, and at higher doses than what it had been approved for.

The reps were paid fifty dollars for each surgical protocol – proof of prescribing – obtained, despite the fact that this drug wasn’t licensed for use in this setting. It took over 6 years for Kopchinski to expose this, as he has recently done, via the US False Claims Act. Pfizer have to pay $2.3bn in civil and criminal penalties: Kopchinski himself will be awarded over $50m million.

He sounds a very admirable, and brave man. Five other reps were also involved in the lawsuit. This means, though, that approximately 2,994 reps did nothing about what they were hearing about Bextra.

Do we need a similar False Claims Act in the UK?

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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

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