Pregabalin has killed at least 131 patients in the last two years in the UK alone. But Britain's drug regulator states it will take no action. So who is protecting us?

The Conventional Medical Establishment (CME) routinely prescribes dangerous drugs to its patients. They cause illness, disease, and death - but little or nothing is ever done to protect us from them.

Pregabalin is an anti-epileptic or anti-convulsant drug which has recently returned to my attention in two Pulse articles. The first article, published on 20th August 2021, was entitled "Northern Ireland GP's told to stop initiating pregablin for neuropathic pain amid deaths rise".

        "According to the Northern Ireland Statistics and Research Agency, there were 77 drug-related deaths involving pregabalin in 2019 - appearing in 40% of all drug-related deaths recorded that year - rising from 54 in 2018."

A routine report? Surely, this was the CME doing what it should be always do, something most people assume it usual does - to protect patients from pharmaceutical drugs that cause them harm.

The second article, published on 27th September 2021, was entitled "MHRA (the UK's drug regulator) has no plans to curb pregabalin prescribing by GP's".

    "The drug was removed from the country’s formulary as the preferred option for the treatment of neuropathic pain but GPs will still be able to prescribe pregabalin where they deem it to be ‘clinically appropriate’. Now the MHRA has confirmed to Pulse that it has no plans to limit prescribing of gabapentinoids, including pregabalin and gabapentin."

So this was the CME doing what it normally does: very little, or nothing at all, to protect patients from pharmaceutical drugs, even though the CME admits that the drug killed 77 patients last year, and 54 patients the year before.

This is not a unique situation. It has happened to all pharmaceutical drugs over the years, dangerous, but banned only after years, sometimes decades, of patient harm. This is why we cannot, and should not, ever be assured that the drugs doctors prescribe today are safe.

I have written about Pregabalin before. In April 2020 I wrote an article that reported a similar situation,  "Health, Safety & Pharmaceutical Drugs. Pregabalin/Lyrica causes death each and every year - but doctors can continue prescribing it! So this is not a new problem that the CME does not know about!

Further back, in June 1917, I wrote "The NHS, Pfizer and Lyrica. Corporate Profit and Patient Harm", in which I described pregabalin (or Lyrica as it was then known) as "a nasty little drug, with lots of nasty side effects", including infection, ataxia, blurred vision, constipation, diplopia, dizziness, drowsiness, fatigue, headache, peripheral edema, tremor, weight gain, visual field loss, accidental injury, xerostomia, abnormal gait, abnormality in thinking, amnesia, arthralgia, asthenia, cognitive dysfunction, confusion (dementia), edema, neuropathy, sinusitis, speech disturbance, vertigo, visual disturbance, myasthenia, and amblyopia.  

At this time, death was not listed amongst its "side effects". Nor is it still! Note that "death" is still not listed as a "side effect" on the Drugs.com website, a website that is supposed to provide doctors and patients with a complete list of side effects for every pharmaceutical drug.

The simple moral we can take from this simple tale is simply this.....

• ANY PATIENT WHO AGREES TO TAKE A DOCTOR-PRESCRIBED DRUG SHOULD NOT ASSUME THAT THE DRUG WILL BE SAFE, THAT IT WILL NOT CAUSE THEM HARM!

• NONE OF US CAN BE ASSURED THAT OUR DOCTORS ARE SUPPORTED BY A STRUCTURE THAT PROTECTS PATIENTS FROM HARMFUL PHARMACEUTICAL DRUGS AND VACCINES!
  

So we all need to be aware of how the CME operates, and avoid all of them.

 

Health, Safety & Pharmaceutical Drugs. Pregabalin/Lyrica causes death each and every year - but doctors can continue prescribing it!

What sphere of human activity can human lives be lost on a regular basis but NOTHING is done to prevent it happening in the future?

• Perhaps a factory where workers die regularly every year?
• Or a domestic product that kills people regularly every year?
• Is there anywhere else?

In fact there is only one area of life where this is being allowed to happen

CONVENTIONAL MEDICINE & PHARMACEUTICAL DRUGS

The drug Pregabalin can be used to amply demonstrates this!

Pregabalin, or Lyrica, or Gabapentin (the multiplicity of names is just to confuse patients) are drugs used to treat epilepsy, neuropathic pain associated with the brain, fibromyalgia and generalised anxiety disorder. It was first approved for medical used in 2004 in the USA, and they have been used in the UK for over twenty years. Initially it was presented to us as a new 'wonder drug', often described as 'the new valium' (a much older 'wonder' drug). Both are now known killers. Yesterday, as we will see, it became a 'class C drug' in Britain.

The side effects of pregabalin have been known for as long as the drug has been prescribed to patients. Unfortunately, patients have not been told about them. I went to the NHS website today (the day after the announcement about pregabalin becoming a class C drug) to see what the conventional medical establishment were telling patients about this drug.

               "The side effects of pregabalin are usually mild and go away by themselves. The most common ones are feeling sleepy, dizziness and headaches."

In 2016 there were 111 recorded deaths in the UK caused by Pregabalin. Even Pfizer, the drug company that manufactures Lyrica, the original brand name, said at that time

               "Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of pregabalin misuse, abuse or dependence."

This need for 'caution' has arisen, apparently, as the drug produces feelings of euphoria, relaxation and calmness, and over the years there has been a growing 'illicit' market in the drug. So doctors have been told that they can continue to prescribe these killer drugs, but they are expected to be careful that patients are not selling them on for recreational use!

So delay and prevarication is rife. This precautionary advice to doctors has been around at least since 2014 - but clearly the advice has done little good as doctors have continued to prescribe them in increasing amounts. Data provided by NHS Digital shows that prescriptions for pregabalin have risen more than 11-fold in the last decade, from 476,102 prescriptions in 2006 to 5,547,560 in 2016!

So patients are not told about the killer side effects, and doctors do not appear to mind prescribing drugs that are known to kill their patients. Presumably conventional medicine has nothing safer to offer to its patients!

Talk about making pregabalin a 'class C drug' has been mooted since at least 2017. See my blog on this subject published in 2017. This would make it illegal to possess the drug without a doctor's prescription. So yet more delay and prevarication - it was only in April 2019 that Pregabalin was actually 'reclassified' - apparently because in 2017, in Northern Ireland (alone), it caused 33 deaths, compared to only (sic) 8 deaths the previous year! 

So the drug has become a growing threat not just to human health, but to human life. And it is allowed to continue doing so by the conventional medical establishment.

And the threat is not just that pregabalin kills patients. The Drugs.com website tells us that "commonly reported" side effects of pregabalin include infection, ataxia, blurred vision, constipation, diplopia, dizziness, drowsiness, fatigue, headache, peripheral oedema, tremor, weight gain, visual field loss, accidental injury, and xerostomia, plus abnormal gait, abnormality in thinking, amnesia, arthralgia, asthenia, cognitive dysfunction, confusion, oedema, neuropathy, sinusitis, speech disturbance, vertigo, visual disturbance, myasthenia, amblyopia, increased appetite, and twitching. But this is only a summary. For a more comprehensive list of adverse effects known to be caused by pregabalin go to the Drugs.com website.

However, there is another health warning to be made here! This website is owned by pharmaceutical interests, and it should be noted that 'death' is not one of the 'side effects' mentioned! So more delay, more prevarication, more hiding of evidence that conventional medicine causes serious harm to patients, and can even kill them without patients being told!

And through all this doctors can continue to prescribe this drug to their patients - just so long as they are certain we are not going to use them for 'recreational purposes', or sell them on for recreational use!

• Where else in society would this be allowed to happen?
• What has happened to the principle - "First, do no harm"?
• Where is the 'precautionary principle' in conventional medicine?
• Does Health and Safety play any role in the practice of conventional medicine?
• Is the concept of 'informed consent' completely unknown to our doctors?

And this is just one of the drugs they regularly prescribe for their patients!

Another Pharmaceutical Drug to be 'Controlled': Gabapentinoids / Lyrica / Neurontin

The business of the pharmaceutical companies is to come up with new drugs that purportedly are capable of treating illness.They do research, they test, they present drugs to the drug regulatory system, which approve them as both safe and effective, and then doctors give them to patients.

The history of new pharmaceutical drugs is that they never prove to be as safe or as effective as the claims initially made for them. The conventional medical establishment, aided and abetted by the mainstream media, then hides this information from patients for as long as possible, but as evidence accumulates, their lack of effectiveness, and the serious and often lethal harm they can cause, can no longer be censored. Drugs are then banned, withdrawn, or in this most recent case, 'controlled'.

The latest pharmaceutical drug to be 'controlled' in Britain are Gabapentinoids, perhaps better known as gabapentin and pregabalin, or by its trade names, Lyrica and Neurontin. This follows a number of studies about the 'side effects' they cause, and a sudden rise in the number of deaths related to it.

If you have not heard this news, don't be surprised! It is not the kind of news that drug companies, conventional doctors, or indeed our mainstream news media are likely to tell us. So here is an outline of what has happened, taken from the GP e-magazine, Pulse.

               "Home Office minister Sarah Newton told Pulse that the Government had accepted recommendations from advisers to make them a class C drug, subject to a consultation. It comes after official figures revealed there were 111 deaths related to pregabalin in 2016 and 59 related to gabapentin, compared with four and eight respectively in 2012."

I notice that the Home Office minister has not told us! And I do wonder, from this statement, why the 4 and 8 deaths in 2012 were considered acceptable, whilst the 111 and 59 deaths were considered unacceptable. Each of these patients are equally dead! And their death was caused by a pharmaceutical drugs! Pulse then asks whether Gabapentinoids is going to be "the new diazepam" before continuing with the story.

               "The Advisory Council on the Misuse of Drugs (ACMD) wrote to the Home Office in January 2016 calling for the drugs to be controlled, warning that ‘pregabalin and gabapentin present a risk of addiction and a potential for illegal diversion and medicinal misuse’."

January 2016 is now 20 months ago. Why does it take so long before the medical establishment moves to protect patients from pharmaceutical drugs that are known to be harmful? Pulse then goes on to provide information about a number of recent studies (not reported in the media of course) that have recommended that GP's refrain from prescribing the drugs.

               "An Addiction paper in May this year, from University of Bristol researchers, suggested GPs consider alternatives to pregabalin and gabapentin after finding the recent substantial increase in prescriptions to be closely correlated with a rise in the number of deaths associated with gabapentinoids in England and Wales, with a 5% increase in deaths per 100,000 increase in prescriptions."

               "A Cochrane Review from June this year concluded that gabapentin ‘can provide good levels of pain relief to some people with postherpetic neuralgia and peripheral diabetic neuropathy’, but added: ‘Evidence for other types of neuropathic pain is very limited… Over half of those treated with gabapentin will not have worthwhile pain relief but may experience adverse events."

So the drug will now be 'controlled', not, you should notice, withdrawn or banned, so it can still be prescribed to patients! This is because the drug, in addition to being unsafe and ineffective, is also addictive. It is commonly misused, and is know to create dependency. One study, according to Pulse, from the University of Kentucky in the USA, found that misuse of gabapentin was at a "staggering" 40 to 65% among patients with prescriptions. Pulse also quotes Dr Steve Brinksman, clinical director of the drug and alcohol treatment professionals group SMMP as saying that the drug has "psychotropic effects, which means patients are likely to continue taking them even if they are not proving effective. They probably do have a withdrawal effect – though that has not been proven conclusively yet."

It always astounds me that whilst in every other walk of life the 'precautionary' principle applies. But it conventional medicine harm has to be proven 'conclusively' before any action is taken to protect patients. Yet, in most of the Pulse articles that I read I always find that the comments made by doctors tell us much more about what is going on within conventional medicine. Following this article, some GP's are seem to be neither surprised or saddened by the situation.

               "Good. They are dirty drugs and I'm glad their risk combined with limited therapeutic efficacy is being highlighted. "

               "Long overdue; minimal therapeutic value, often prescribed beyond both evidence and licence, widely abused."

Yet conventional doctors have been prepared to prescribe these drugs to patients for over 20 years! And will no doubt continue to do so. Other doctors seem resigned, cynical, or in despair.

              " Oh well. Back to amitriptyline then. It has so many side effects no one could possibly abuse it could they? Some individuals will abuse anything including imodium and cyclizine. According to the new NICE guidelines on back pain all that we can offer patients is our commiserations - x-rays and analgesia are off the table. Someone is going to get sued at some point for failing to x-ray what later turns out to be metastatic disease, multiple myeloma or osteoporotic collapse!"

Other doctors realise, and bemoan the fact, that they have no effective drugs to treat pain.

               "Soon we won't be allowed to prescribe any painkillers. *sigh."

               "Better tell the pain clinics then."

               "I know we can give people with chronic pain colouring books and teach them to be resilient."

               "Can’t use NSAIDs, opioids, or gabapentinoids. I do agree they should be a controlled drug. But what I am supposed to use when paracetamol is leaving my patients in pain?"

               "Some patients will have to live with pain, doctors are not gods."

No, indeed, doctors are not Gods, although they have been presented as such for a long time now! Worse, on their own admission, they have no effective medical treatment to offer their patients. It is little wonder that morale within the NHS is at such a low ebb. As I have said, many times, on this blog is that the crisis in the NHS has nothing to do with lack of resources, nothing to do with poor management, but everything to do with the failure of conventional medicine, controlled and dominated as it is by the pharmaceutical companies. Moreover, there are more serious questions now need to be addressed.

• When will doctors, the NHS, and the media tell their patients about the ineffectiveness, the dangers, and addictiveness of these, and other drugs they are using?

• When will it be acknowledged that conventional medicine has no effective treatment for most of the chronic diseases?

• When will patients be told, openly, honestly, and transparently, about the side effects of the pharmaceutical drugs and vaccines they are given by doctors, and that these side effects actually cause serious chronic disease, and death.

Without these questions being answered, patients will continue to be unable to make informed choices about their medical treatment.

The NHS, Pfizer and Lyrica. Corporate Profit and Patient Harm

Conventional medicine treats neuropathic pain with a drug called pregabalin, conditions such as fibromyalgia, shingles, diabetic nerve problems, spinal cord injury, and many others. It is an anticonvulsant and neuropathic pain agent - and a dispute over patenting rights with drug companies has cost the English NHS, and the British taxpayer, an estimated additional £54 million.

Pregabalin is a nasty little drug, with lots of nasty side effects. The Drugs.com website lists these, and they include infection, ataxia, blurred vision, constipation, diplopia, dizziness, drowsiness, fatigue, headache, peripheral edema, tremor, weight gain, visual field loss, accidental injury, xerostomia, abnormal gait, abnormality in thinking, amnesia, arthralgia, asthenia, cognitive dysfunction, confusion (dementia), edema, neuropathy, sinusitis, speech disturbance, vertigo, visual disturbance, myasthenia, amblyopia, and so on.

Yet the harm it is known to cause patients has not been the issue, as usual. The problem has been money and profits - as usual! From July 2014 to March 2015 most prescriptions for pregabalin were for the 'generic' (the cheaper but identical) versions of the drug. However, the manufacturers of the branded (the expensive) version, Pfizer and Warner-Lambert, did not like this. When their UK patent for Lyrica expired in July 2014 they claimed they still held a ‘second medical use’ patent for when it is prescribed for 'neuropathic pain'. So they took the matter to court. An interim judgment found in favour of Pfizer, so in March 2015 NHS England backed down and issued guidance forcing doctors to switch thousands of patients’ prescriptions for generic pregabalin back to Lyrica.

In September 2015 the High Court threw out Pfizer's patent claim as 'invalid', and the Judge stated that Pfizer had made ‘groundless threats’ to pharmacists about dispensing the generic drug. They, too, backed down, and the GP magazine Pulse says that "some pharmacies even triggered a significant event alert every time a GP prescribed so as not to fall foul of Pfizer’s ‘threats’."

So now, after two years, and an appeal, the English NHS is directing doctors to switch thousands of patients back to generic pregabalin. Well, all is fair in love (the love affair between the NHS and drug companies) and war (the battle for profit)!

Pulse analysed the cost of this decision, estimating that prescribing Lyrica instead of generic pregabalin had cost the NHS an extra £54m between February and September 2015 - less than a year! It stated a BMA spokesman, Dr Andrew Green, told them that patients had lost out.

               "Pfizer, by threatening legal action against pharmacists and doctors if they prescribed generically, have boosted their profits and denied patients effective treatments that otherwise could have been provided with that money."

Financially, this is certainly true. The NHS has been screwed by Pfizer, but by now it should be used to this, pharmaceutical companies have been screwing the NHS for nearly 70 years! Green added,

               "They now have a moral duty to pay that money back to the NHS."

Maybe. But there seems precious little 'moral duty' around within the NHS, and certainly not within the pharmaceutical industry! They are both locked together in a medical monopoly, together with most patients who depend on the NHS, and therefore depend on pharmaceutical drugs and vaccines.

What nobody has been spared, or even discussed, during all this time, have been the dangerous side effects of taking this awful drug.

Postscript 24 January 2018
The doctor's e-magazine Pulse reported that official figures show that pregabalin-related deaths rose from 4 to 111 between 2012 and 2016, and gabapentin-related deaths went from 8 to 59 within the same period. There has apparently been discussions about how to control this nasty little pharmaceutical drug.

As a result proposals were made to restrict pregabalin and gabapentin, but according to Pulse these restrictions were labelled as ‘onerous’ and unjustified by the BMA. Too bad, doctors seem to be okay about prescribing dangerous drugs that can kill us; but taking precautions to protect us is a little too onerous!

Well, that at least demonstrate something about the priorities of the conventional medical establishment!