Pharmaceutical industry

I may not have seen a pharmaceutical rep for over five years, but still the branded pens they gift to medics continue to infiltrate my house and my handbag. I conciously throw out the drug company pens I find, but they just seep back in: every time I lose my own plain biro, there is another pen somewhere near, in a ravishing colour or with streamlined design, beckoning to take its place.

The reasons why I don’t like seeing drug reps are several. But mainly they come down to this: time is precious, and unbiased appraisals of evidence are better delivered elsewhere. Reps are there to sell, and fair evidence should not need ‘sold’.

But this may not be quite enough. An interesting paper in the Archives of Internal Medicine has examined the effect of exposing medical students exposure to brand logos on equipment – stickers on clipboards or branded notepaper – prior to being asked about the implicit attitudes towards these drugs. The students who had been exposed to the promotional material held higher implicit values for the promoted drug compared with the control group.

There are obvious limitations to this study - it is a single study performed with one cohort of students, and it does not necessarily mean that prescribing is going to vary with the presence of promotional gifts. Yet we don’t know that it doesn’t. Here is a report in Pharmaceutical Field magazine calling on reps to find those ‘rare but lovely creatures’ – GPs who see reps daily. We now have the internet and excellent sources of information. I do not think that pharmaceutical sales reps are needed, or advantageous to patient care. 

A couple of other potential harms bother me. First, pharmaceutical reps are usually highly qualified and very able individuals. They are utterly wasted in being drug reps.  And second, do people seeing their doctor feel any differently for the presence of branded goods in the consulting room?

Or perhaps not so much a makeover, but a radical shift in how drug research is decided upon, performed and reported. The suggestions come from Sir Iain Chalmers, who is editor of the James Lind Library in Oxford, and Silvio Garattini, director of the Mario Negri Institute for Pharmacological Research in Milan. Writing in the British Medical Journal, they say that their proposals would not only benefit patients but also industry, which is not winning any prizes for popularity at present.

They are:

1) Patients to be involved in shaping the research agenda – in other words, making sure research questions have resonance in real life and real-world situations

2) Legal requirements for research to be published, including trial protocols, by all (mandatory publication of trial data has had legal backing in the US since late 2007; no such protection for patients currently exists in the UK)

3) Independent evaluation of drugs. As the paper says: “The monopoly that the drugs industry has in evaluating its own products, and the secrecy surrounding this process, leads to biased evidence that is currently only rarely questioned by independent studies.”

4) A requirement to demonstrate “added value” for all new drugs – is this drug better than the current best drug treatment, or does it benefit in addition to it, and is it better than non-drug treatments? Too often, trials are done comparing a new treatment to placebo where there is a known intervention which is better than placebo. This means that uncertainty about how to use it best persists.

The authors say that these would help improve public confidence in pharma, would improve returns from investment in R&D, but could also improve efficiency in other ways. For example: “Tim Mant, a director of a major contract research organisation, has acknowledged how frustrating it is to be commissioned to organise a clinical trial that he knows is going up a scientific blind ally because he has been there previously with another company but cannot divulge information that is commercially confidential.”

I hope that people in the pharmaceutical industry take notice: I would genuinely love to write about the improvements that are being made.

I’ve been reading a brave book that I wanted to like but I don’t. It is called Drug Truths: Dispelling the Myths about Pharma R&D. The author is John L LaMattina, who is the retired president of Pfizer Global Research and Development.

The pharmaceutical industry has had a bad press over the past couple of years, and nothing would have given me greater joy to report that all was now good; that there was no more overselling of drugs and no more inappropriate advertising. But instead, I am seriously worried by this book. It seems to imply that there was no such overselling in the first place and that industry has always behaved well.

For example, let me quote a piece about disease mongering. “The view that the pharmaceutical industry sits around dreaming up new diseases and then convinces people that their minor ailment urgently needs drug treatment is absurd. First of all, a company cannot simply declare a new disease and market a drug to treat it. A disease must be recognised by global regulatory agencies who set up criteria that a drug must meet in order to have even the most remote chance to be approved. Second, payers must believe that the condition is serious enough to warrant reimbursement of the cost of the drug to treat it. Third, physicians must believe the disease is serious enough to be willing to prescribe a drug to their patients to treat it. And finally, patients must be concerned enough about their pain or discomfort to be willing to seek treatment in the first place.”

From a perspective of unfiltered primary care, I think I’m in a reasonable position to comment. Why do patients go to their doctor? All kinds of reasons. The ecology of what goes on in the consulting room is dependent on numerous external influences; advertising – or let us call it “disease awareness”, where people are encouraged via “educational campaigns” to see their doctor if they have symptoms of various diseases or disorders, is one. Expectation of medication is introduced with ease. One example is the “awareness campaign” a couple of years ago encouraging men to attend their doctors if they had erectile dysfunction. On the value of seeing one’s doctor, I could not disagree. However, ED can have a variety of causes, from the psychological to vascular disease. Medication can be useful, however it may not be appropriate, and further tests may be needed. But by creating expectation of medication, the process of proper medical care is short circuited. LaMattina has not considered that some physicians will simply give in to the expectation and pressure to prescribe. Similarly, LaMattina describes irritable bowel syndrome (IBS) as another disorder where the pharmaceutical industry cannot be accused of disease mongering: “This is clearly not a disease invented by a pharmaceutical sales executive.” What he fails to do is to appreciate the spectrum in the disorder. Like depression, anxiety, and pain, there will be some people who are entirely or heavily disabled by their symptoms. And then there will be others who have minor symptoms, who are only occasionally bothered by them, who may find that taking medication is more hassle than not, or who have other non-pharmacological ways of dealing with their symptoms. But ”disease awareness” advertising threatens to make these people “patients” with all the problems that this delivers.

Similarly, with cholesterol, LaMattina says, of a particular senario, “…should you take a statin? Given that statin use lowers your risk of a heart attack by as much as 35 per cent, the answer should be a resounding ‘yes’! This type of treatment is not disease mongering – it is preventative medicine.” But actually, it’s not just disease mongering but also scaremongering. It is almost impossible to make a realistic decision about risk based on relative risk alone. What you need to know is your absolute risk – there is no point knowing what per cent you can reduce your risk by until you know what your risk was to start with.

Now, if the pharmaceutical industry were able to say: actually, we won’t get involved with “awareness campaigns” anymore because the best health information is independent health information,  I would be happier. If there was an acknowledgement that funding patient groups was fraught with difficulty, I might be sympathetic. The recent report from the Royal College of Physicians on Physicans and the Pharmaceutical Industry . makes it clear that the pharmaceutical industry wants to rehabilitate itself. There are some things all are agreed on  – industry shouldn’t be offering “gifts” to doctors, and doctors shouldn’t be accepting them. But the RCP report argues for “co-operation” between doctors and pharmaceutical firms especially with regard to research. I think this is premature and potentially dangerous. Pharmaceutical companies simply do have a different agenda to doctors. Any relationship has to be under constant and open scrutiny; and I am not sure that there has been a proper appreciation of the past problems such that they have disappeared and will cause us no problems in the future.

Thank you to a correspondent for the link to this promotional website offering workers suffering from colds all manner of unnecessary things. There are suggested out-of-office email messages (“I’m taking a BENYLIN® day or two and will reply to your email as soon as I’ve recovered!”) , recommendations for DVDs (all fairly rubbish, in my opinion) for frittering away your time until feeling better, and scripts of what to say to your boss when letting him or her know you won’t be in.

The ingredients of Benylin Max Strength Capsules are:

Paracetamol (available on its own, at a much cheaper price)

Caffeine (available from your teapot/cafetiere, where it is supplied along with warm, tasty hydration)

Phenylephrine (a decongestant; but you might be interested to read this abstract from a 2007 US systematic review of its effects; it concludes: “There is insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant.” )

In other words, I think we should still call them “sick days”.

“GlaxoSmithKline is to make public the level of advisory fees it offers to doctors and medical academics, and will strictly cap the payments they can receive in the US to $150,000 (£88,000) a year each. Andrew Witty, chief executive of the UK-based pharmaceutical company, said he was introducing tougher new rules to impose a cap “without exception” on such payments and promised to publish the amounts.”

I’m catching up with my reading. Andrew Jack interviewed Andrew Witty, the chief exec of GSK, in the FT a week or two ago. That’s the first paragraph of a very interesting piece. 

Now, publishing the amounts GSK pay doctors is very good, but, er, 88K a year? For a couple of lectures and lending one’s name to a bit of ghost-writing? GSK, please save your cash and don’t pay any doctors not wholly employed by you for any advisory anythings. Last year the kickbacks received by orthopaedic surgeons – some up to $1m worth – in the US were revealed after a federal investigation showed just how closely doctors and the orthopaedic industry were “working”.  There is still cash being thrown at doctors in the UK. I am tired of throwing out all the invitations I get to hearing the latest on cardiac risk factors/obesity management/urinary incontience over dinner at very nice restaurants courtesy of pharmaceutical reps.

Would you want the advice of a doctor who has just been eating canapes courtesy of the latest anti-inflammatory rep? Would you take the recommendation for your type of hip replacements from someone who has just spent a few five star days giving “consultancy” to the manufacturers?

I hope not. Medicine is difficult enough without having one’s judgment impaired by biased interpretations of the evidence. There is lots of dialogue to be had between doctors and both the pharmaceutical and medical device industries. But this should be done without personal gain. 

That should be obvious. Professionals should not be technicians who can be puppeteered at the whim of the sponsor; they should be acting for the best interests of those they serve with 20/20 clarity. That’s surely the bare minimum we should expect as patients, from doctors?

Every time I have written about this I have had emails from doctors who tell me that I am a fool. You can have nice dinners and lux conference stays and still be a pro, they say, I can’t be bought! But of course you can. Anyone can. The point of being a professional is surely that you choose not to be.

I was in central Glasgow last week. On my rainy travails down Buchanan Street, I came across a tent pitched just beside the statue of Donald Dewar. Beside that was a mat on the ground with pictures of hot coals on it, that invited people to try and experience the trial of “chronic pain”. The smiling ladies giving out leaflets were wearing t-shirts saying “Still in pain? Take Control”. The leaflets asked “Are you still suffering?” and offered “Help on discussing neuropathic pain with your doctor”.

Here are some quotes from the leaflet

“When will I feel better? … The ‘right treatment’ for you may mean speaking with your doctor to identify other treatments that may provide greater, long-term, pain relief or fewer side effects. Your doctor may have to prescribe more than one treatment before they find the one that is right for you and this may take time.”

Margaret McCartney’s Blog

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A forum on healthcare policy and professional issues, by Glasgow-based GP and FT Weekend columnist Margaret McCartney.

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