The dangers of generic drugs…

“Patches Rhode believes her son, Brandon, died in agony from a lethal injection in a Georgia prison because the UK-sourced anaesthetic, sodium thiopental, appeared not to have been effective,” says today’s Guardian.

The Guardian – other papers too, for all I know – has been getting its knickers in a twist about low-grade sodium thiopental for some time now, while overlooking one major, and far more important fact – what’s happening with sodium thiopental is just the tip of the iceberg; such laxity in manufacture and quality control is common through the entire generic drugs industry.

I take 16 different drugs daily, and all but two are generic, and I know from experience that the quality of generic drugs varies widely, from ineffective to overdose and everywhere in between. And when it comes to inhalers, the metering of the doses is widely variable and the valve mechanisms prone to failure.

The problem, I believe, is the utterly inadequate licensing system operated by the Medicines and Healthcare Products Regulatory Agency (MHRA), who appear to be happy to grant licenses to any bugger at all, as long as they get a fee. The sodium thiopental in question, for example, was supplied – quite legally – by a company called Dream Pharma, which operates out of the back room of a goddamned driving school! Who the hell would grant a license to such a half-arsed operation, sight unseen? The MHRA, that’s who.

As the Guardian also says:-

“The British Association of Pharmaceutical Wholesalers (BAPW) will warn this week that the Dream Pharma case highlights serious inadequacies in the licensing regime operated by the government’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Tony Garlick, the BPAW’s technical director, claimed the association had a vested, financial interest in granting licences and was therefore unable to enforce correct handling of drugs according to medical guidelines. “The MHRA is self-financing,” he said. “The more licences they grant, the more money they receive. They are granting too many licences to these small operators. They are not being inspected for three years and someone can do quite a lot of damage in that time. You don’t need to be a qualified pharmacist to be a licensed wholesaler.” ”

Is it me, but shouldn’t inspections take place before the granting of a license, not three bloody years later? And shouldn’t the drugs being supplied be analysed to ensure they’re of suitable quality? Otherwise, what the hell is the MHRA for? It just appears to be a self-perpetuating organism, living off fees and issuing licenses in a closed loop, while not actually doing anything useful at all.

And it seriously pisses me off that their shortcomings are only being mentioned in the light of a convicted killer not being anaesthetised adequately as he was executed – what about those of us being inadequately or excessively medicated by effectively uncontrolled generic drugs here in Britain? Don’t we matter, then?

The MHRA, of course, were singularly unhelpful when I contacted them about a batch of  Omeprazole** that was so toxic it caused violent, uncontrollable, diarrhoea, suggesting that as long as the specified drug was present, any old crap can be included along with it.

**Typing Omeprazole in the Search box will bring up the thread.

I currently have two batches of that drug in which, instead of the capsules containing the usual sustained-release granules of the drug, they actually contain – a tablet!

Now, Omeprazole does come in tablet form, but not in the form that’s in the capsules. No point in contacting the MHRA, of course – they don’t give a shit.  The drug does seem to be effective, though, but whether or not the tablets actually contain Omeprazole or some other PPI I really have no idea.

I would have liked to have sent this post to the appropriate editor at the Guardian (as well as publishing it here), but for reasons best known to themselves, they don’t give an email address. Ah well…

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