Rienso. Another Pharmaceutical drug withdrawn as it caused serious hypersensitivity reactions

Another pharmacetical drug, Rienzo (Ferumoxytol), has been quietly withdrawn from the market. Have you heard about it? No?

Well, the withdrawal was quietly announced in MIMS, which describes itself as "one of the most up-to-date prescribing references for healthcare professionals", in an email published on 18th March 2015, and on its website on 16th March 2015 where the event was described as follows:

          "The intravenous iron preparation Rienso (ferumoxytol) has been withdrawn for commercial reasons. Launched in 2012, it was licensed for the treatment of iron deficiency anaemia in patients with chronic kidney disease".

That's it! And we should perhaps note that the withdrawal was done "for commercial reasons". So nothing wrong with that, then.

Except, of course, the reason for the withdrawal was not quite as benign as that! 

In another MIMS article, published in September 2014, the reason for the 'withdrawal' for 'commercial reasons' may become a little clearer.

           "Takeda has issued a letter to healthcare professionals about the risk of serious hypersensitivity reactions associated with the use of its injectable colloidal iron-carbohydrate complex, ferumoxytol (Rienso)".

So the European Medicines Agency (EMA) and the British drug regulator, MHRA, provided restrictive prescribing information for Rienzo "to mitigate the risk of serious hypersensitive reactions". It was 'contraindicated in patients with any history of drug allergy". The drug had to be "administered by trained staff in an environment where resuscitation facilities are available", and patients receiving the drug were to be monitored for hypersensitivity reactions, "including blood pressure and pulse rate, during and for at least 30 minutes after completion of the infusion". And even after this, patients were to be advised to seek urgent medical attention if they start to feel unwell

Less than two years earlier, MIMS had heralded the new drug, and its safety and efficacy in clinical drug trials!

          "The safety and efficacy of intravenous ferumoxytol were assessed in three open-label studies involving 837 patients with CKD and iron-deficiency anaemia".

It proceeded to outline and reference the studies.  The article went on to describe how 'well tolerated' the drug was, as demonstrated by three further RCTs (Randomised Controlled Tests).

Clearly 'evidence-based medicine' at its very best!

Yet this is a common tale. The conventional medical establishment heralds a new drug as being safe and effective. Then it is discovered the drug is neither safe or effective. Then, if there is no profit to be made in marketing the drug, it is quietly withdrawn "for commercial reasons".

And as far as Rienso is concerned, this all happened all in less than 3 years.

Perhaps my skeptic friends, who spend their time upholding the value of RCTs, who demand this evidence for homeopathy and other alternative medical therapies, who champion the benefits of 'evidence-based-medicine' would like to comment on this post. I would be interested to hear their views on the value of drug testing and drug regulation, and the safety of marketing drugs like this for patients.

Unfortunately, I don't think they will have anything to say!

Homeopathy - the real Evidence Based Medicine

What is the best form of medicine? 
What sort of medicine would you prefer?

* A therapy, such as homeopathy, based on simple principles or laws, that gives patients' safe remedies, and bases its practice, and develops its practice, on observing the outcomes of those remedies with patients?

* Or a drug-based medical system, that tests its drugs for effectiveness and safety on the basis of 'Randomised Controlled Tests', or RCTs, which are then regularly withdrawn after being given to millions of patients and found to be ineffective, dangerous, or both?

When you consider how often, and how regularly Conventional Medicine (ConMed) gets it wrong about the safety and efficacy of their drugs, and gives patients drugs that either don't work, or cause further disease and even death, it is quite amazing (see, for example, this website that lists many of the banned and withdrawn pharmaceutical drugs).

So there is, of course, only one sensible answer. Patients, first and foremost, want to be safe. They don't want to take drugs that not only fail not make them better, but actually cause further disease. They just want to be better!

One of the latest admissions of error concerns Hypertension, and 'high-blood-pressure'. It has emerged that 25% of people diagnosed with this condition don't actually have it!

But patients with hypertension are still given ConMed drugs - usually Statins. Most people know only what they have been told about Statin drugs - they are very effective - and entirely safe. But of course, they aren't! They are now associated with the following disease-inducing-effects (DIEs) - even though some conventional doctors are still telling us they are 'entirely safe'.

* Diabetes
* Serious skin infections
* Prostate Cancer
* Serious structural muscle damage (that can cause death)
* Certain cognitive problems.

Statin drugs, and Conventional Medicine generally, is a bad deal for patients. It tells us that HPB is bad for you (even this can be seriously questioned). It devises a test for HBP and then discovers it is getting it wrong with at least 25% of patients. Then it provides people who are probably not sick drugs that can make them very sick!

And Conventional Medicine then claims that it is entirely based on 'evidence'!

Well, in fairness, I suppose it is. It is just that the evidence of RCTs are not reliable. In fact, they have proven to be so unreliable they rarely tell us about the dangers of drugs until millions have taken them, and suffered their DIEs.

In stark contrast, homeopaths can give patients remedies knowing they will do no harm - the basic principle of the Hippocratic Oath that all doctors subscribe to. And if the remedy matches the symptoms of disease it is treating, they will treat the illness successfully.

How do we know what the patient's symptoms are? Simple! We ask them!

How do we know the symptom-picture of remedies? Simple! We test, or prove the remedies on people (knowing already that the process of potentizing remedies makes them entirely safe), and we observe the outcomes with patients. All this evidence has been put together over the last 200+ years - and is contained within the Homeopathic Materia Medica, and the Homeopathic Repertories.

The skill of the homeopath is to learn the complex and complicated techniques of 

matching the symptoms of both patient and remedy.

So where do RCTs enter this picture. Well, they don't! Homeopathy does not need RCTs to examine, or re-examine, what homeopaths have been doing for centuries. Why should we make use of a technique that has proven to be worthless when applied to ConMed drugs? ConMed, and Big Pharma drug companies have been using them for decades to confirm that drugs are safe and effective when, in fact, they have eventually been proven to be ineffective and dangerous. Statins have yet to be banned, or heavily restricted, like so many others. But it will come, as with all the others.

So drug-based conventional medicine is not 'evidence-based' medicine - because the so-called evidence that supports it has proven itself to be totally unreliable.

The real 'evidence-based' medicine is homeopathy. We  know our remedies. We know what they do. Patients routinely benefit from homeopathy, and do so in complete safety. But the real evidence comes from out patients - people who were ill, and get better after homeopathic treatment.

Medical Research mostly flawed

Dr John Ioannidis, who Natural News describe as the foremost expert in assessing the credibility of medical research, has stated that up to 90% of published medical information is either misleading, exaggerated, or quite often just wrong!

Well you only need to look at the fact that generations of pharmaceutical drugs to know that medical science has been, and continues to get it wrong. The evidence base for conventional medicine is just about non-existent! His paper shows that that

               "... both theoretically and empirically that 80% of non-randomized studies (the most common type), 25% of the "gold-standard" randomized trials, and nearly 10 percent of the "platinum-standard" large randomized trials were incorrectly executed.

He found that even 49 of the most highly regarded and cited research papers published in the past 13 years, 41% had later been disproved, and 24% hadn't been retested! Even studies that had overturned the original findings were ignored, with scientists more likely to refer to the original, inaccurate study.

What did be think the reason for this has been?

               "Economics appears to be an underlying cause of the research inaccuracies. A successful scientific career depends upon your research being funded and published. This intellectual conflict of interest motivates scientists to pursue and produce results that will be funded. Scientific journals are naturally biased towards publishing new, exciting research; they rely upon a vetted peer review process that is frequently commandeered by scientists in pursuit of career advancement. Worst of all are drug studies, funded by pharmaceutical companies and commonly corrupted by a much stronger financial conflict of interest.

The Natural News article cites several drugs that have been marketed under these circumstances, including Vioxx, Zelnorm, and Baycol, all removed from the market for safety concerns, and anti-depressants such as Prozac, Zoloft, and Paxil which are now known to be no more effective than placebos.

So much for 'evidence based medicine'. There is increasing confirmation coming to light that conventional medicine is a sham, and money-making concern that has little or nothing to do with our health.

Original article

http://www.naturalnews.com/031121_medical_research_fraud.html#ixzz1CFKaeFL6

Electro-Convulsive Therapy - and 'Evidence Based Medicine'

"Don't use homeopathy, there is no evidence" the homeopathy denialists tell us. Well, not only is this nonsense - there is plenty of evidence, empirical (patients getting better) and nearly 500 RCTs. 

Yet the implication of this criticism of homeopathy is that conventional medical treatments are based on good scientific evidence.

Electro-convulsive therapy (ECT) has been used by conventional medicine to 'treat' mental health patients since the 1950's, and apparently it still goes on. What evidence is there for this the safety and effectiveness of this treatment, which has been practiced now for over 70 years. 

None whatsoever

          "Despite ongoing controversy, there has never been a large-scale, prospective study of the cognitive effects of electroconvulsive therapy"                  Dr Harold Sackeim, et al, 2007

This is a quotation from an article by the Alliance of Human Research Protection, who have reported on the first trials, which were conducted by Dr Sackeim, and reported in Neuropsychopharmacology (32:244-254. 2007), 'Cognitive Effects of Electroconvulsive Therapy in Community Setting'. It states that:
               “This study provides the first evidence in a large, prospective sample that the adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings.”

The study confirmed that ECT can induce long-term memory loss, and other cognitive problems, especially in women (the majority of people subjected to this treatment are women).

So, no evidence for it being effective; but plenty of evidence that it can cause harm. It seems that this is the norm for conventional medicine.

The full Alliance for Human Research Protection article on this barbaric treatment can be found at

http://www.ahrp.org/cms/content/view/759/9/

Postscript
March 2019
So does conventional medicine still make use of this awful treatment? Or is electroshock treatment an abandoned medical brutality from the past? 

This Natural News article says that nearly 23,000 patients were 'brain shocked in the UK from 2015-16. So it goes on, regardless of safety, regardless of its lack of effectiveness, regardless of any medical science to support its use.

How spin takes the science out of medicine

Conventional Medicine prides itself on being an "evidence-based" science. Yet most studies on which doctors rely have been created by marketing companies, who are working for Big Pharma.

So says the Magazine 'What doctors don't tell you', usually shortened to WDDTY, is excellent for doing just that - it tells you what you GP does not usually, or willingly tell you. This particular piece can be found at WDDTY Vol 21 No 8. Page 7-8, and examines why it is that for decades we have been led to believe in conventional medicine, and its ability to cure disease.

          "Around 90,000 so-called 'scientific' drug trials, published over the past 10 years in journals, have  been nothing more than public relations (PR) dressed up as research".


WDDTY calls this a scam, that makes a mockery of the idea that conventional medicine is 'scientific', and describes principally the activities of the drug company, Wyeth. Wyeth is being sued by 14,000 women who developed breast cancer after taking its HRT drug, Prempro. They have been forced to reveal 'secret' documents that have shown just how 'scientific' ConMed is.

Yet, as the report says, the Wyeth documents are "but the tip of the iceberg of a practice carried out by most drug companies".

I have written about this before, in The Failure of Conventional Medicine, or more specifically at Medical Science. The failure to protect, where the use of 'cheque-book science', 'ghost' writing, and much more, is described in some detail.

The fact is that ConMed drugs are no more than a confidence trick, a massive deception on patients who are not told the truth, but Government, the NHS, our doctors, and the mainstream media. The dangerous failure of a succession of pharmaceutical drugs, over the last 50-60 years in particular, demonstrates they have no 'evidence base' whatsoever.

The evidence that patients look for is that treatment is effective, and safe. Medical Science has proven itself to be totally ineffective in safeguarding our health; indeed, it has contributed to our ill-health. It is outcomes that are important:

I am ill; I am treated; I get better

It is homeopathy, and other natural CAM therapies, that have provided patients with good outcomes - and this is why so many people are turning to medical therapies that have such an evidence base.