Wednesday, 8 June 2016

Alcohol dependence drug - the 'science' that supports it!

Nalmefene, trade name Selincro, and originally known as Nalmetrene (one drug, three names!), is an 'opioid antagonist' used for alcohol dependence. It was developed in the 1970's, so it has been known about now for over 40 years. It has been used in the USA for over 20 years. The drug was, of course, scientifically tested, and approved and licensed by drug regulators throughout the world, as being both safe and effective. In Britain it is a drug approved and recommended by NICE, the National Institute for Clinical Excellence (note the name).

Nalmefene's known and accepted side effects include nausea, dizziness, insomnia, and headache, although these are largely dismissed by the conventional medical establishment as being 'mild' or 'moderate' or 'of short duration". Well, that's all right then! Is it?

The problem is that the drug, known for over 40 years, and prescribed for most of that time, has now been found to be ineffective. The doctor's magazine, Pulse, reported this on 8th June 2016

          'The researchers from the University of Stirling found that nalmefene had not been tested in an NHS setting, concluding that its relevance to UK primary care ‘is unknown’, with other weaknesses in the evidence arising from primary outcomes not being specified fully prior to the start of trials and a lack of trials comparing nalmefene to existing treatments such as naltrexone.

          "In the analysed trials, the team also found that more participants taking nalmefene dropped out of trials than those taking a placebo due to experiencing more common adverse reactions including nausea, insomnia, fatigue and vomiting.


The Stirling team concluded that whilst ‘proponents for nalmefene argue that it should be used widely and proactively for public health benefit;, ...uncertainties about efficacy, effectiveness and cost-effectiveness of nalmefene inhibit appraisal of the possibility of such benefits.’

Of course, the drug company disagrees with this assessment. Well, they would, wouldn't they!  So Pulse continues.

          "The study, published in Addiction, searched for all published research papers relating to using nalmefene for alcohol consumption problems and found six published studies to analyse, three of which had been sponsored by Lundbeck, the pharmaceutical company who produce nalmefene under the brand name Selincro.

Well, so half the papers were 'sponsored' by the drug company. No issue there then for conventional medicine, as most drug research is bought and paid for by the drug companies that will profit from its use!

          "These three papers were used by the NICE appraisal committee to assess whether nalmefene could be recommended for treatment of alcohol-dependent patients...... NICE currently recommends that nalmefene can be given as an option for reducing alcohol consumption for alcohol-dependent patients who have a high-drinking risk level without physical withdrawal symptoms or in alcohol-dependent patients who do not require immediate detoxification.

So NICE agreed with the 'science' supporting the drug, and recommends it for patients. Professor Carole Longson, from NICE, is then quoted as follows:

          ‘Our appraisal process for nalmefene thoroughly interrogated the evidence base and, as is the standard with all our appraisals, we engaged with and took into account submissions from a multitude of stakeholders. When presented with the evidence, including the analysis of the clinical studies, the independent committee concluded that there was sufficient evidence to recommend nalmefene in specific circumstances.’

Then, a spokesman for the drug company is allowed to comment, and is quoted as follows:

          "We are surprised by the conclusions of [the study] and strongly disagree. Robust scientific data is the reason for nalmefene being the first and only drug approved for the indication “reduction in alcohol consumption for alcohol dependent patients” and nalmefene has demonstrated a positive efficacy/safety profile for dependent drinkers. ‘Moreover, nalmefene was assessed by NICE and the SMC, who both concluded that nalmefene is a cost-effective treatment for alcohol-dependent patients and should be available for prescription in the NHS in England, Wales and Scotland.’

So, medical science appears to speak without any clear agreement. So is this really science that underpins pharmaceutical drugs? Can patients be assured, with an certainty, that what they are told about a drug is true? Some 'medical scientists', from the drug company, and NICE, appears to think so. But the 'scientists' from Stirling would appear to disagree, and as far as I am aware, they have no financial interest in the drug. Yet their science, it would seem, is summarily dismissed. It is not going to be looked into further.

So does medical science really provide patients with guarantees about the safety and effectiveness of pharmaceutical drugs - and not just this one, all of them? With a drug that causes mild and short term side effects, taking an ineffective pharmaceutical drug is one thing. But what about drugs with more serious side effects? Is 'medical science' more certain about these drugs? But wait, what is this? A list of side effects published in Drug.com about Nalmefene.

          "Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast, slow, or irregular heartbeat; fever; flushing; heart rhythm changes; seizures; severe or persistent headache or dizziness; shortness of breath; sudden chest pain.

Does the drug company, NICE , and Pulse know about these side effects? Do these side effects change the balance, and make taking an 'ineffective' drug less acceptable?

Probably not. The history of pharmaceutical drugs indicate that they have to do far more harm to patients before they are seriously challenged within the conventional medical establishment. The safety and ineffectiveness of a drug rarely becomes an issue until it begins to cause serious damage to patients, over a long period of time, to the point when the damage can no longer be denied.

Conventional medical science, based as it is on RCT's (Randomised Controlled Tests), is a farce. It always has been a farce. RCT's can prove whatever they want to prove, or more accurately, they can prove anything those who pay for the trials want them to prove. Then, and for many years after, RCT evidence is written on tablets of stone, it becomes law, not to be challenged or questioned, despite any new evidence that emerges.

This drug is good for patients. No, the drug is bad for patients.
Breast feeding is good for babies. No, breast feeding is not good for babies.
And so on, ad nauseam, the gold standard of science!

And the nonsense does go on! It has always gone on. So what should patients look for in medical treatment?
  • First, they should look for a therapy that does not, and cannot cause harm.
  • Second, they should find out whether that therapy has been used to treat a particular condition, illness or disease.
  • Third, they should discover search the outcomes of that treatment.
Take homeopathy for instance. Even our critics admit that it cannot do harm, indeed, they attack us for this very reason! It can treat any condition, illness or disease through its symptoms, and has done for over 220 years. And there are millions of patients who can testify that they have been treated homeopathically, both safely and effectively.

And most important of all, homeopathy does not depend upon the kind of 'medical science' that leads to such disagreement, uncertainty and disarray.