Diabetic Shenanigans

08 June 2017

I do my best writing in the bath. This morning I wrote a letter in my head to the CEO of Eli Lilly, whom I blame for the fact that my left eye is packing up (thanks to a drug I took for a decade, which has given me diabetes. Diabetes causes blindness, amongst other things) and a witty but scathing account of my experience with the diabetic nurse at my surgery. Usually I've forgotten my brilliant compositions by the time I've dried and dressed, but I will write to the Big Chief at Eli Lilly. It’ll  be deleted by whoever combs his email for communications from disgruntled patients, but what else can I do? The drug, olanzapine, brand name Zyprexa, was widely prescribed to people like me who’d a bad reaction to every antidepressant they took. I was given it as a ‘mood stabiliser’ even though it’s simply an antipsychotic, and antipsychotics are just major tranquillisers. ‘Mood stabiliser’ is a marketing term, and insofar as olanzapine knocks you into a drooling coma it could be said to stabilise you. It was never licensed for use in depression, but there are many thousands like me, who were given it 'off label' nonetheless. Antipsychotics have their uses: sometimes people need calming down, and a bit of space between themselves and tormenting thoughts and feelings. What they don’t need is to be left on the stuff for years – decades – because they don’t you much good in the long term. In fact, long term, they wreak terrible damage to almost every part of your body.

Olanzapine/Zyprexa has two spectacularly egregious effects, which started, probably, from the first benign-looking small pill I tossed down in 2001. It screws the appetite control mechanism, so at first I couldn’t stop eating, like someone in the throes of acute bulimia, only I missed out the bit where you tickle the back of your throat and regurgitate the week’s worth of food you’ve just consumed in an hour. I piled on a staggering amount of weight, in a staggeringly short time. It also, probably via a different mechanism, buggers your blood lipids and, fatally, your blood sugars. Only no-one checks. No one takes a baseline reading, then looks, regularly, to see what’s happening to your metabolic systems. Or they didn’t, back in 2000 when I started taking it. In 2008 GPs got paid a bonus to track down people with high blood sugar, and there was a sudden burst of fiscal interest in combing through their patient list for potential diabetics. I was borderline, but diabetes is nasty, and I was very compliant – the NHS’s term for patients who dutifully and uncomplainingly do what they’re told. So I trekked off to see the diabetic nurse (the work had been internally outsourced to a nurse). Listened to bullshit dietary advice (no fats, lots of carbs), took the statins, had the annual eye check and generally behaved myself. 

When I stopped taking olanzapine a few years later (another story) https://rxisk.org/olanzapine-withdrawal-sallys-story/ my blood sugar dropped back,  immediately, to normal. I didn't do a thing - no medication, extreme dieting or much (any) exercise. Problem was, no one, but no one accepted that olanzapine had caused the malfunctioning blood sugars. Not one damn person. I refused to classify myself as a diabetic. So when they went wrong again recently, I was exceedingly pissed off and not at all compliant. I had a go at taking metformin, an old, tried and well-tested medication, which does work, but it gave me such terrible diarrhoea I had to give up. 

Some people knew that olanzapine screws your blood sugar, lipid levels and turns you into a Michelin woman. Eli Lilly, who made the drug,  knew from the outset: warning signals sounded when the drug was still in development, back in the 1990s. But hey, pharmaceuticals are a business and you don’t willingly draw attention to the fact that your potential golden egg, blockbuster drug can, and probably will, give patients a chronic, disabling and life-limiting disease. In fact you bury the information. And when the evidence gets too obvious to hide, you develop a battle plan that goes something like this:

1. Diabetes is a symptom of schizophrenia anyway (forgetting the fact that just as many people were taking it for severe depression).

2. Olanzapine/Zyprexa doesn’t cause any more weight gain, or diabetes, than the other antipsychotics made by competitors.

3. Oh well, actually it does, so much so that even psychiatrists have started to complain. Doctors must ensure they encourage patients to watch what they eat and take plenty of exercise. Lifestyle interventions. Over to you, patients.

4. None of this really matters anyway in the long run, because Eli Lilly is a main player in the diabetic meds market, so  everyone who develops diabetes as a result of olanzapine/Zyprexa will end up on a Lilly drug. What’s not to like?

I know all this because I’ve followed the olanzapine/diabetes story with a certain amount of personal interest. There’s a fair amount of solid evidence, not least the fact that Eli Lilly was forced to put it as a side effect on the patient information leaflet, and eventually to issue a ‘black box’ warning (the red alert for a potentially fatal side effect). The most startling thing I found, the one that made me stop and weep, were the ‘crib’ sheets issued to sales reps in 2000. Viva Zyprexa was a US marketing drive and the bullet-point instructions about how to avoid mentioning the link to diabetes at all costs are ..not very nice. 

I know too that Eli Lilly funds most, if not all,  ‘continuing professional education’ for GPs and nurses on diabetes. And that they are huge sponsors for the main UK charity, Diabetes UK.  But I got another shock recently: I can’t stomach metformin, so took a look at the alternatives. It’s a red-hot, expanding market, so competition is fierce.  Eli Lilly and a German company, Boehringher Ingelheim formed an (unholy) Alliance to sell a new diabetes med; Jardiance. It lowers glucose levels just fine - but with gruesomely unpleasant side effects. No one knows how it works (what's new) but a great deal hangs on whether it reduces the risk of heart attacks and stroke - a critical risk for diabetics. A big trial suggests it might, and the Alliance lost no time broadcasting the possibility. They did this by sending out what looked uncannily like a 'Dear Doctor' letter: the term for a mass mailing, alerting docs and nurses to important new safety info. It was simply a piece of promotion. They were reported to the Association of the British Pharmaceutical Industry for breaching their Code of Practice (by a disgruntled competitor). It's a self-regulatory body, so lacks the punch of a proper  telling-off but nonetheless, the Alliance, and Eli Lilly got their knuckles seriously rapped this year. http://www.pmcpa.org.uk/cases/Pages/2825.aspx

'The Panel considered that the prominence given within the letter to the cardiovascular outcome data from the EMPA-REG study promoted Jardiance for cardiovascular risk reduction for which it was not licensed.  The results of the study went beyond the SPC statement that Jardiance did not increase cardiovascular risk.  The results were not presented in the context of the safety profile for Jardiance.  The statement on page 2 that Jardiance was not indicated for cardiovascular risk reduction was insufficient to mitigate the otherwise misleading and primary impression given by page 1 and the reference to outcomes data.  In the Panel’s view, the material was preparing the market for an anticipated licence extension.  A breach of the Code was ruled which was upheld on appeal. The Panel noted the allegation that the letter resembled a ‘Dear Doctor’ letter and was therefore disguised promotion.  A breach of Clause 2, a sign of particular censure, was ruled and upheld on appeal. It appeared that the Alliance had decided to put commercial gain before compliance.  This was totally unacceptable. ' 

Same old tricks, 30 years on. And no, I won't be taking Jardiance.