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.

 

Big Pharma announces new drugs. We await to hear about their side effects, and how patients will be harmed by them

MIMS, first published in 1959, claims that it is an "essential prescribing and clinical reference for general practice", and so it is, probably. It is published quarterly, and print copies are sent free of charge to all UK-based GPs. What they claim to be their top 10 stories for 2017 make interesting reading. Here are some of them.

Quinine for muscle cramps linked to increased mortality.
This announces that long-term use of quinine for nocturnal leg cramps, something that doctors have prescribed for many years, has now been found to increase the risk of mortality. The British study was published in the medical journal, JAMA. It is yet another pharmaceutical drug that has been found to be deadly to patients, but as usual, only after many patients have died in order to prove it!

The authors of the study concluded that "the benefits of quinine in reducing cramps should be balanced against the risks" and owing to the poor benefit-to-risk ratio, both NICE and the drug regulator MHRA now (belatedly) advise that quinine should not be considered as a routine treatment for nocturnal leg cramps. However, this does NOT constitute a ban! It can still be considered when self-care measures fail, and cramps cause regular disruption of sleep.

Adjust gabapentin dose to avoid respiratory depression, MHRA advises
Gabapentin, perhaps better known as Neurontin, is a drug used for epilepsy, neuropathic pain, hot flashes, and restless legs syndrome. For many years it has been associated with a rare risk of severe respiratory depression when prescribed with or without concomitant opioids. (Many drug side effects are described as 'rare' to reassure patients and to encourage them to take the drug. But remember, only 1% to 10% of adverse drug reactions are ever notified).

Now the MHRA has issued a drug safety update - which means they were not aware of all the adverse drug effects before, but the damage done to patients is now sufficiently clear to have to come clean!

                "Prescribers should consider whether the dose of gabapentin needs to be adjusted in patients at higher risk of respiratory depression, including patients with compromised respiratory function, those with respiratory or neurological disease or renal impairment, patients taking other CNS depressants and elderly people."

The game of Russian Roulette, played with our health at stake, clearly continues within the conventional medical establishment!

First triple combination inhaler launched for COPD
The other top 10 stories are apparently considered to be good news! Trimbow has been approved as 'maintenance treatment' in adults with moderate to severe COPD "who are not adequately treated by the combination of an inhaled corticosteroid and a long-acting beta2-agonist". It says that as COPD patients deteriorate in time treatment needs to be progressively increased, and patients may have to take several drugs through two or three different inhalers. Trimbow simplifies treatment by providing just one inhaler, and a 'measured' dose.

Nothing about safety, of course. But inhalers are steroid drugs, with serious known side effects. Trimbow apparently enables patients to risk the side effects more efficiently. As as COPD patients 'deteriorate in time' it would appear that they are not entirely effective either!

Liraglutide provides new weight loss option for overweight and obese adults
MIMS tells us that Liraglutide, an anti diabetic drug, is now available as Saxenda - for weight management in obese patients and overweight patients with one or more associated comorbidities. What it does not tell us is that this 'top 10' story concerns a drug that already has a length list of side effects, some of them extremely serious, as detailed in this Drugs.com webpage. MIMS mentions a few of these, but it would appear that any 'new' branding of an old drug constitutes good news for the conventional medical establishment!

Baricitinib: oral rheumatoid arthritis treatment in new drug class
Baricitinib, or Alumiant, is now available to doctors for the treatment of moderate-to-severe active rheumatoid arthritis. More good news! The drug is apparently a 'Janus kinase inhibitor'. No, I don't know either - so let MIMS explain.

               "There are four known Janus kinase (JAK) enzymes. Baricitinib is a reversible inhibitor of JAK1 and JAK2, which are widely expressed and mediate signalling of multiple cytokines implicated in the pathogenesis of RA, including interleukin-6, granulocyte-macrophage colony-stimulating factor and interferons."

Perhaps it is sufficient to say that Baricitinib is another drug that seems to prevent our bodies working normally! So it is a drug that will cause side effects. MIMS does its best to explain what these are.

               "The most frequent adverse events seen with baricitinib during trials were increases in LDL-cholesterol, upper respiratory tract infections and nausea. The risks and benefits of treatment should be carefully considered before initiating therapy in patients with active, chronic or recurrent infections. Lipids should be assessed 12 weeks after starting treatment."

However, as this is a new drug, and if history repeats itself, the full side effects will not be known until patients are prescribed the drug, suffer them, report them, and conventional medicine takes action. This might take several years, during which time lots of patients will suffer!

Tofacitinib: new type of rheumatoid arthritis treatment launches
So, yet more 'good news' for sufferers of rheumatoid arthritis! MIMS says that Tofacitinib, or Xeljanz is a new oral treatment option for patients with moderate to severe active rheumatoid arthritis. It says that it belongs to a new class of therapies called Janus kinase (JAK) inhibitors. I feel that we have heard this before, quite recently! So its a new drug, and the good news is that doctors can now use it. So what about side effects? At least, the side effects currently known after just 3 months of clinical trials?
               "The most common serious adverse reactions to tofacitinib are serious infections, including pneumonia, cellulitis and herpes zoster."

The drug is also known to cause headache, respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension. Nothing too serious there, then. No wonder the drug regulator approved them! And I am sure that doctors will, right now, be treating their arthritis patients in the hope that they won't contract any of these conditions, or indeed any of the other adverse drug effects not yet known to conventional medicine.

So it must have been an exciting 'good news' year for MIMS, with these warnings about the new side effects of old drugs, and the new drugs with unknown side effects!. Perhaps what this really demonstrates is more 'good news' - that there is absolutely no 'good news' coming out of conventional medicine at the moment.

Sick people need to understand that conventional medicine has little to offer patients. There are no good new drugs coming through the pipeline, and plenty of bad new about old, failing drugs. Time for everyone to check out alternative medicine before conventional medicine fails completely.

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.