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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, 17 April 2026

Big Pharma is allowed to sell patients harmful drugs, doctors are allowed to prescribe them, even when known to be dangerous to our health.

Drug Regulation does not work! When it discovers a harmful drug it does little/nothing. It is failing to address its primary purpose - to safeguard patients from harm

This is Medscape’s headline. “FDA Issues Alert on Liver Injuries Linked to Vasculitis Drug, Following Withdrawal Request”.

The FDA is the USA’s Drug Regulator, but its decisions are widely influential with drug regulators around the world. So its decisions affect all of us. It issued an alert about liver injury, including fatal cases, that have been linked to avacopan (Tavneos), a drug used for a rare autoimmune disease “that the agency had already asked to be voluntarily removed from the market”

Dangerous enough, you might think, for it to be withdrawn by the drug company, and/or banned by the regulator?

The Medscape article went on to say that on 31st March 2026 the FDA issued a public notice outlining their serious concerns about post-marketing cases of drug-induced liver injury that have been associated with avacopan. However, this seems to have carried little weight with Amgen, the drug’s manufacturer, who

          “..announced in January that it intended to continue to market this drug even though the FDA requested a voluntary withdrawal of avacopan. Separately, European regulators in January announced a safety review of the drug.

The article goes on to state that the problem about this drug had been known for over 5 years.

          “In 2021, FDA staff expressed deep concern about liver risk even while approving avacopan for a serious and sometimes fatal autoimmune condition, severe active antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The FDA required a special safety study focused on liver risk as part of this approval.

So, 5 years on, what does the drug regulator do to fulfil its main function - to protect patients from a drug that causes patient harm, and is known to cause fatalities?

          “In the new alert, the FDA recommends that patients talk to their healthcare professional about safety risks associated with avacopan and to discuss whether to continue therapy or switch to alternative treatments” especially if “they develop any signs or symptoms of liver injury, including nausea, vomiting, unusual itching, light-colored stools, yellowing of skin or eyes, dark urine, swelling in the stomach or abdomen, or pain in the right upper abdomen. The FDA also advised clinicians who have patients taking avacopan to conduct liver panel testing every 2 weeks in the first month of treatment, monthly for the next 5 months, and thereafter as clinically indicated”.

The FDA continues to state that avacopan should be discontinued promptly, and alternative treatments considered, in certain circumstances.

So there is a difference of opinion. The company is clearly confident that avacopan is both “effective and safe”, based, it says, on “robust clinical data and real-world evidence demonstrating the effectiveness and favorable benefit-risk profile”. And it is committed to continue marketing the drug.

However, the FDA says it has identified 76 cases of drug-induced liver injury “with reasonable evidence of a causal association with avacopan use … that comes from reviews of postmarketing data, medical literature, and the FDA Adverse Event Reporting System ... Of these 76 cases, 74 reported a serious outcome, including 54 hospitalizations and eight deaths”.

These clinical outcomes might be considered adequate grounds for taking more robust protective action for patients in addition to “discussing” the issues with a doctor. But no. One comment outlined in the Medscape article states that:

          “The FDA’s Drug Safety Communication about avacopan highlighting the eight fatal cases of drug-induced liver injury is important, but insufficient”.

So, a drug that causes 8 deaths is not sufficient reason to withdraw, or ban it. How many more drugs are drug regulators approving, drug companies selling, and doctors prescribing, that are causing this level of patient harm?

Even Medscape raises this question. It asks why, if the FDA has requested the drug be voluntarily withdrawn from the US market, the agency not making this request publicly, and pushing back against the company for not having already withdrawn the drug? Why does the prescribing information for avacopan not include a boxed warning for the risk of fatal liver disease?

These are urgent questions for the FDA to answer. Yet the FDA has failed to do so, and so confirms that no pharmaceutical drug should be considered “safe and effective”, that drug regulators are failing to act decisively to protect patients, that doctors will therefore continue to prescribe harmful drugs to patients.

Avacopan is a small drug. But it represents a good example of how conventional medicine now treats the issue of patient safety. It demonstrates a medical system that is prepared to “discuss” how many patients it is allowed to kill, how much chronic disease it is allowed to cause, before any robust action is taken to protect us. It shows h

ow patient safety takes second place to pharmaceutical profits.

I would suggest that the only sensible solution for everyone is to develop a healthy mistrust, and to studiously avoid a medical system that is clearly failing to protect us.

Tuesday, 8 November 2016

Homeopathy. Placebo? Or lethal medical therapy?

Have you heard and seen the arguments about homeopathy? They have been going on now for over 220 years, and during the last two decades, as conventional medicine struggles, and homeopathy expands, they have been getting ever more strident.

  • Homeopathy is not effective because its remedies have no active ingredient.
  • Homeopathy works because of the placebo effect, that is, they get better because they believe that the remedies will make them better.
  • Homeopathy is quackery, because all patient receive is a sugar pill.
Yet now the USA drug regulator, the Food and Drug Administration (FDA) has recently stated that one homeopathic treatment has caused 10 deaths! So some rethinking is necessary! How is it that sugar pills, remedies with no active ingredient, that work only through the placebo effect, have been found to kill people.

First, what did the FDA say? The FDA made a new release on 30th September 2016 entitled "FDA warns against the use of homeopathic teething tablets and gels". In this it warned consumers that homeopathic teething tabled and gels "may pose a risk to infant and children". The FDA had released an earlier statement 6 years earlier, on 23rd October 2010, which stated:

               "Hyland's Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps."

The mainstream news media took up the story, and it has been running there ever since. It has now crossed the Atlantic ocean. The Mail Online, for instance, published an article called "Panic over homeopathic teething tablets after TEN children are killed". So this story has become 'a panic', and not just ten children are killed but TEN!

Now, before going any further, the FDA regulates all issues regarding food and drugs in the USA, especially the approval and regulation of pharmaceutical drugs and vaccines. And a conservative estimate is that these pharmaceutical drugs and vaccines kill about 250,000 people in the USA every year. There seems to be some disparity here.
  • The FDA has recommended consumers to stop using these homeopathic products; but at the same time it is content to allow conventional doctors to prescribe and consumers to continue using pharmaceutical drugs and vaccines, even though they are known to cause harm and death. Some of these pharmaceutical drugs, known to be dangerous particularly for children, are used for teething (as we will see below).
  • The FDA states that they have not evaluated or approved homeopathic teething agents or gels "for safety or efficacy", and that "they are not aware of any proven health benefits of the products". They have, of course, evaluated pharmaceutical drugs and vaccines for safety and efficacy, including many known to be harmful, and including those recommended for teething children (as we will see below).
  • The FDA said that they had been "analysing adverse events reported to the agency regarding homeopathic teething tablets and gels...since 2010" which, if they have caused 10 deaths and 400 cases of seizures and other reactions seems rather an long time. The FDA goes on to say that consumers "should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels". Again, if a homeopathic preparation is really causing these kinds of side effects, why did the FDA not act in 2010? Perhaps the answer is that the FDA is aware of the harm caused by pharmaceutical drugs and vaccines, although in their case, they are usually initially involved in denials, and taking action sometimes take them several decades!
  • The FDA also urged health care professionals and consumers to report adverse events. This is understandable. Adverse drug reactions should be routinely reported, but it is well known that as far as pharmaceutical drugs and vaccines are concerned only about 10% (a very conserative estimate) are reported in the USA, and throughout the world.

So the response of the FDA to this homeopathic remedy seems to be rather more pro-active than their response to conventional drugs and vaccines. If the FDA, and other drug regulators, took similar action again pharmaceutical products that were thought to have caused 10 (TEN!) deaths, and caused the kind of side effects listed, how many of them would still be available to us? Few, if any!

Yet this is not the main issue. The question is, can something dismissed as 'placebo' actually do this?How is it possible for homeopathy to come under attack in this way when for the past 220 years it has been attacked for being ineffective? The answer is 'No' for anyone who has an interest in honesty. Our critics have been right. The substances used in homeopathy to produce remedies are highly diluted, to the point where chemistry tells us there is no active ingredient left. Yes, the Hyland product is made from Belladonna, which is highly poisonous. But the Belladonna has been diluted so much there is none left. So there is no possibility that the teething product would have caused death, or even the side effects mentioned.

If anyone is in doubt, read this article, in which homeopathy is dismissed as a "200 year scam" very much in the traditional fashion. It is written by a typical homeopathy denialist, using typical anti-homeopathy rhetoric. And when you have read how homeopathy is dismissed, consider how homeopathy remedies can cause these dangers they are now accused of!

So can homeopathy honestly be attacked from both sides? The answer is, of course, 'Yes'. What homeopathy faces is a large, grossly wealthy, invasively influential and hugely powerful medical establishment. Moreover, it is an establishment that is under severe pressure. There are many kinds of chronic disease that have been, and continue to increase in epidemic proportions. And the pharmaceutical industry has no answer, all its drugs and vaccines are failing, for three main reasons.
  • They do not work, and there is an increasing realisation amongst the general public, and with doctors, that they do not work.
  • They are causing serious side effects, disease and death, and their disease inducing properties are leading directly to increasing levels of ill health.
  • There are no new drugs coming through to replace those that have had to be withdrawn, or are known to be ineffective.
And whilst the conventional medical establishment is slowly beginning to realise that it is failing, that it has no answer to the spiralling health demands of a population that is becoming sicker and sicker, they witness homeopathy, and other traditional therapies, increasing in popularity.

The FDA is a part of this conventional medical establishment, as are all the national drug regulation agencies! They are staffed by pharmaceutical place-men. Their main concerns are the concerns of the pharmaceutical industry first and foremost. Patient health, and protection from dangerous drugs and vaccines are very much secondary considerations. So yes, the FDA can attack homeopathy in any way it wants. 

The problem has been that the placebo argument is not a strong one. It has to ignore the millions of sick people who have been successfully treated by homeopath throughout the world, all with their placebo sugar pills! It must be galling for them. They must feel entirely hopeless.

And yes, the mainstream media can also attack homeopathy from both sides, if they, too, are part of the conventional medical establishment. In order to survive financially the mainstream media need pharmaceutical advertising. So they are prepared to attack homeopathy in any way their paymasters tell them! So, the Mail Online can 'panic' about a homeopathic remedy that had 'allegedly' caused 10 deaths, but fail to report that pharmaceutical drugs that kill thousands.

So, the homeopathic profession requires two explanations. The first concerns how a placebo, a sugar pill could possibly have killed 10 (TEN) people. The second is to examine the conventional approach to teething, and to examine how safe and effective this approach is. After all, in the FDA news release a spokeswoman informed us that "teething can be managed without prescription or over-the-counter remedies"! To do so, I have had to look at the NHS Choices website for guidance. When my children were teething I recall receiving little or no help or support from conventional medicine, but fortunately I was just becoming aware of homeopathy at the time, and used the remedy Chamamilla, very successfully, and very safely!

NHS Choices first recommend teething rings. These "may ease their discomfort and distract them from any pain". Yes, many people use these, and they are just a little more useful than useless!

The next suggestion is teething gels. I remember using Bonjela, so I decided to see how safe this was. The patient information leaflet (PIL) says that it contains a painkiller, so immediately this raises concern, and sure enough there are several 'cautions' mentioned. 
  • "This is a medicine; Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist.
  • Seek advice before using if you are breast feeding, pregnant, planning to become pregnant, or suffer from allergies.
  • Keep all medicines out of the reach of children.
  • Unsuitable for children under 2 months.
Then the PIL states that it can cause allergies, skin problems, fatigue, and that if these "became serious" to consult with your doctor.

The next suggestion made by NHS Choices is to give the child paracetamol and ibuprofen, contained in 'sugar free painkilling medicine' which contains "a small dose" of each. This brings the FDA's response to the homeopathic product into perspective.
  • Paracetamol (or acetamorphen) has become a major cause of liver failure, even if taken for just a few days, in small doses.
  • Paracetamol is known to cause over 100 deaths in the USA each year.
  • In 2007, the Lancet reported that the FDA were so concerned about paracetamol that it was considering restricting the drug's availability
  • Likewise, Ibuprofen is known to cause a wide variety of serious side effects. At the end of this process it is known to increase the risk of heart and circulation problems, and the longer it is used, the greater the risk of side effects become.
So the FDA is able to attack a homeopathic preparation because of the alleged side effects, and recommended that customers stop buying it. At the same time, conventional medicine continues to recommend painkilling drugs known to have the most serious side effects. It is double standards. It is powerful vested interests defending their trade. It is a medical profession that has little interest in patient safety.

Perhaps the last word on this subject should be left to Hylands, and its defence of its homeopathic teething products? It can be found by clicking here. It is a very cautious, measured response. So let me make a somewhat bolder statement!

Homeopathic remedies, even when based on poisonous and toxic substances, are entirely safe, because of the process of dilution through which they pass during manufacture. It is this process of dilution, which homeopaths call potentization, that makes all homeopathic remedies entirely safe for all patients, including young children.


Wednesday, 12 August 2015

Are NSAID painkillers killing us? Are we to be warned?

The history of painkillers have demonstrated three important things about pharmaceutical drugs. The first is that they are important element in the credibility of conventional medicine. The second is that many millions of people take them routinely and regularly on the basis that they are (at least relatively) safe. The third is that painkilling drugs are a profitable product for the drug companies.

It is the second element, the safety of these painkilling drugs that is the issue. I have written about the dangers of NSAID painkillers regularly, this article putting together information about the harm they do to patients, mainly information that has been known for decades.

Other websites have done the same on a regular basis. In 2011, Agora Health's 'Daily Health' bulletin outlined how widely used non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen and fenoprofen were, and that they increased our risk of a second heart attack by as much as 45%. More recently Agora Health have said this.

"These popular painkillers have also been associated with a 66 % chance of developing dementia, and a 57% chance of developing Alzheimer's disease. Last year (2014) another study found using NSAID pain relievers increase your risk of atrial fibrillation, a potentially deadly heart rhythm, by a whopping 84%. 

Yet despite the increasing evidence against these painkillers, which has built up over the years, patients have not been informed. Instead there has been a deafening silence from the conventional medical establishment, seemingly content to maintain their credibility with the public against the growing evidence of harm they were causing, and to maintain their profitability regardless of the damage they must have known it was doing to patients.

Now, the American Food and Drug Administration (FDA) finally admitted that the evidence against NSAIDs is too overwhelming to ignore, and is now demanding that these painkillers carry a label warning about their heart attack and stroke risks. (But presumably, no mention of the risk of dementia). Moreover, the idea that you had to take lots of painkillers, over a long period before suffering the dreadful, disease-inducing consequences has been laid to rest. The FDA has admitted, at last, the NSAID painkillers increase the risk of heart disease and stroke from the very first dose.

  • Remember, NSAID drugs, like Paracetamol and Ibuprofen, are readily available, over-the-counter drugs, that can be purchased without prescription, and without any medical oversight.
  • Remember that these same NSAID drugs will still be available in the USA, but with a warning on the label.
  • Remember that these same painkilling drugs will still be available in India, Britain, and the rest of Europe, Australia, Canada, and elsewhere, even without a warning label.

And listen. Can you hear anything from our mainstream media about this? Is the BBC, our 'public services broadcaster' informing us? No! The deafening silence continues.

Instead, listen to Agora Health, who tell us that after years of ignoring adverse reports about NSAID painkillers that the FDA finally agreed to look again at the science behind these drugs, and what they discovered.

  • NSAID drugs can increase your risk of heart failure
  • Our chance of having a heart attack or stroke increases quickly from the first time we take them
  • But the longer we take them, and the higher the dose, the greater the danger becomes
  • Even occasional users have an increased risk of heart attack or stroke, even people with healthy hearts
  • And patients given NSAID's following a first heart attack were more likely to die within a year compared to those who did not take them

The conventional medical establishment must be the last industry that runs its industry on the basis that safety is secondary, that harm has to be proven, beyond all reasonable doubt, before any action is taken to protect the public. There is a pattern that seems to fit all conventional pharmaceutical drugs, including not just painkillers, but Statins, Anti-depressants, Beta Blockers, Anti-biotics - the list is endless!

     * Unsafe drugs come on to the market.
          * People take them, with doctors telling us that they are safe.
               * Only then, as we get ill, do serious side effects become clear.
                    * The reported dangers, (heart disease, dementia), are ignored, often for decades.
                         * Increasing numbers of people, usually many millions, are harmed by the drug.
                              * Drug Regulators do nothing, for as long as they can.
                                  * Warnings may then be placed on the drug labels, that few people read.
                                      * But the Media remains quiet, the public largely uninformed.
                                 
AND THE DRUGS, HOWEVER DANGEROUS THEY MIGHT BE, CONTINUE TO BE SOLD, READILY AVAILABLE FOR ANY UNSUSPECTING PERSON TO TAKE.

AND THE PUBLIC REMAIN LARGELY UNINFORMED, CONTINUING TO BELIEVE THAT THE DRUGS THEY BUY ARE 'SAFE', JUST AS THEY WERE TOLD, MANY YEARS EARLIER.

What other industry is, or would be allowed to carry on in this way? And why is it that the conventional health industry is allowed to continue to do so?

Thursday, 16 July 2015

Drug Regulation. Pharmaceutical drugs that have killed people, and caused disease, have all been approved.

Pharmaceutical drug regulation system has failed patients

Every pharmaceutical drug and vaccine that has been found to cause disease, and are known to have killed people, have passed through the regulatory process designed to protect patients!

So this poster is not a joke - it is real.

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The drug regulatory system should ensure all the following:

  • drug companies have thoroughly researched the drug
  • drug companies have thoroughly test the drug, to prove that it works, and if safe for patients to take.
  • Drug regulators, in every country, thoroughly review the evidence prior to approving and giving a licence to any particular drug.
So it must be self evidently true that all the drugs and vaccines that have caused side effects, adverse reactions, disease and death - and most conventional drugs and vaccines do all these things - have "slipped through the net".

Actually, there is no realistic net. The drug regulators in every country, including the FDA in the USA, and the MHRA in Britain, is dominated by Big Pharma place-men who see their role as safeguarding pharmaceutical profits rather than protecting patients.

Most conventional pharmaceutical drugs and vaccines harm patients. Most of them actually cause disease. Many of them are known to kill patients.

What should we learn from this? There can be no assumption that any drug or vaccine approved by drug regulators can be trusted not to harm us.

Thursday, 8 January 2015

Big Pharma's snout at the feeding trough!

Some Big Pharma drug companies are annoyed, and are threatening to take the British government to court. The problem? They may be denied access to a large pot of NHS money.

The government set up the 'Cancer Drugs Fund in 2010, one of its first acts following their election, to provide extra funding for medicines that were considered 'too expensive', and 'poor value for money' by NICE, and so could not be prescribed within the NHS. £200 million was set aside. This has risen to £280 million. And apparently the fund is already overspent by £30 million this year.

Does that sound generous? Well, apparently not generous enough for the Big Pharma companies. Two drug companies are threatening to take the government to court because their drugs are being 're-assessed'. Their feeding frenzy at the NHS feeding trough is being threatened!

Just how arrogant is this? Public money is being spent on ludicrously expensive drugs, and the drug companies object to a decision that seeks to ensure that taxpayer's money is being spent appropriately! They must assume they have some kind of 'right' to the money being spent on their drugs. And that our government has not responsibility to make decisions that are detrimental to their profitability.

Of course, that is not the way they put it, or how our meek mainstream media is describing it. The government is denying patients access to 'life-saving' drugs (according to the BBC), or, if you prefer the 'Mail Online',

"Thousands of women with advanced breast cancer are set to be denied ‘last chance’ medication that can give them extra months, if not years, with their loved ones".

Although the Media is sufficiently honest to point out the costs of these drugs, up to £90,000 per year per patient, little or nothing was said about the safety of effectiveness of the six drugs, Eribulin, Avastin, Kadcyla, Afinitor, Tyverb and Perjeta. So let's consider just one of these, Avastin, and consider it's history.

Avastin was approved in February 2004 by the FDA, the US drug regulator. Within 5 months, however, it discovered that the new 'wonder drug' could cause stroke, heart attacks, angina, and double the risk of a fatal blood clot. Apparently, even when it was approved, Avastin was known to  cause fatal stomach perforations and congestive heart failure. The situation only got worse, though.


So, it would seem that what is being 'denied' to 'thousands of women with advanced breast cancer' is a 'life saving' drug that is exorbitantly expensive, dangerous to our health, and useless too!

Does that sound like a good deal? Well, it is good enough for the drug companies. And apparently it is good enough for our mainstream media, including the BBC, who continue to refuse to tell us the truth about conventional drugs and vaccines.

I suppose we are just expected to believe the passive and unquestioning promotion of pharmaceutical drugs, take it when they are given to us regardless of their affects on our health, and pay exorbitantly for the privilege!

Anyone want to stop jumping to Big Pharma's tune?

Friday, 6 September 2013

The Menopause and Homeopathy

The Menopause is not a disease, it is a natural life-transition, but it is a condition that many women suffer from quite seriously. It can produce irregular, heavy or painful periods, and problems such as host flushes, night sweats, insomnia, mood swings, concentration and memory problems, vaginal dryness, fatigue, depression, headaches, heart palpitations, loss of libido, weight gain - and much else.

Conventional medical treatment had, prior to 2007, been with Hormone Replacement Therapy drugs (HRT). Doctors had always told women how safe and effective this treatment was, but in 2002, the Women's Health Initiative began 'the largest and best designed federal studies of HRT'. These were stopped in 2007 when it was discovered that HRT significantly increased the risk of dying from cervical cancer, breast cancer, heart attacks, strokes, and blood clots. There were also increase risk of dementia.


Were these findings a devastating or terminal blow for HRT? It would appear not! The NHS Choices website, even now, states that the main treatment for the Menopause "if the symptoms are severe" is non-other than HRT!

So the main treatment used for Menopausal symptoms within the NHS is a drug that has been found to have deadly consequences!

In fairness, NHS Choices also describes some other treatments, but these raise other serious issues for the health of women. One is the drug Tibolone - described as a synthetic steroid hormone drug that “acts in the same way” as HRT - which given HRT's record is not really re-assuring! 

However, it should be noted with some trepidation that Tibolone is a treatment that the FDA (the USA drug regulator) has refused to approve. 

However, in the UK (according to NHS Choices) it is a safe treatment, and “carries some small risks, including a small increased risk of breast cancer, cancer of the womb, and stroke”. Is that okay then? Does that re-assure you that this drug is safe? Why is it that a drug used in one country can be considered dangerous whilst the same drug in another country is safe, and only carries 'small risks'?

Clonidine is another drug used for the menopause, although apparently it was originally designed to treat high blood pressure “but has been found to reduce hot flushes and night sweats in some menopausal women”. However, as NHS Choices continues:

    “Clonidine can cause unpleasant side effects including dry mouth, drowsiness, depression, constipation and fluid retention”.

I remain uncertain why the side-effects of Clonidine are described as ‘unpleasant’ whilst those for Tibolone are considered to be just ‘small risks’.

I discovered this when I was preparing an article on my website, "Why Homeopathy?". I started my research believing that the use of HRT had been practically terminated, and was surprised to find that it was still the main treatment in use for the menopause by the Conventional Medical Establishment.

So, how much safer, and more effective is homeopathic treatment? Well it could hardly be more dangerous - and, of course, like all homeopathic treatment, it is very safe. And homeopathy has a number of key remedies that are known to treat menopausal symptoms successfully, and have been doing so for over 200 years. 

What is more, these remedies relate to the woman's individual experience of the menopause. Homeopathy does not treat women, or the menopause, as a single condition, with a single 'off-the-shelf' remedy for all. Homeopaths are trained to discover the symptoms experienced by the individual, and then to find a remedy that best matches those symptoms.


It has to be the better option!


Tuesday, 30 July 2013

Darvon, Darvocet, Co-Proxamol: history of a banned painkiller

Pharmaceutical drugs come and go. They come initially heralded as wonder drugs, magic bullets. They go as unsafe, dangerous, or even lethal. It is a pattern that has been repeated decade after decade for the last 100 years. (See 'Banned, withdrawn, dangerous Big Pharma drugs').

Darvon, or Darvocet, or Co-Proxamol (Big Pharma drugs are called different names in different countries) is such a drug. The main ingredient of the drug is propoxyphene, and the drug may be masquerading under other names - it is the way the drugs industry obfuscates and misleads us so we never quite know what we are taking! The drug was introduced in the 1950's, and had a long history of safety fears. But obviously, it is in Big Pharma's best interests to keep drugs on the market for as long as possible, and this is what they have done.

The problem is that the drug caused heart problems. The public interest group, 'Public Citizen' called for the drug to be banned in 1978. It again called for a ban in 2006. It was eventually banned in the UK in 2006. But as dangerous as the drug might have been here, it continued to be sold elsewhere, throughout the world. The European Drugs Agency banned the drug in Europe in 2009. But it was still sold in the USA, and other parts of the world.

Eventually it was banned by the FDA in the USA on 19 November 2010. But even then, there was prevarication. Drugs are not banned without a fight! Following the Public Citizen petitioning to ban the drug in 2006, it took three years for an 'expert advisory committee' to vote, narrowly, to ban the drug. But that was not the end of the matter. The FDA overruled the committee's decision, and asked the drug company to investigate the affect of the drug on the heart. Only when this report was received was the drug banned!

When banning the drug the FDA said that it puts patients at risk of abnormal, and even fatal heart rhythm abnormalities. Yet the drug has been marketed as a painkiller for over 50 years before ANY action was taken, even though the evidence of its dangers had been known for most of that time. So, for over 50 years, patients were given a drug that could have given them serious heart disease.

It has been estimated that 10 million people in the US took the drug. But the advice from FDA had a further sting in the tale. Patients must not stop taking the drug - because there was a danger of 'serious withdrawal symptoms'. So they had to continue taking the drug, which caused heart disease; or they had to suffer severe withdrawal symptoms.

As usual, patients did not receive a good deal from the Big Pharma drugs industry!

And little timely, or effective protection from the statutory drug regulatory bodies!

Indeed, Public Citizen castigated the FDA for waiting for so long to protect the public. They said the because of FDA negligence at least 1,000 to 2,000 people in the USA died from using these drugs - just during the period between the ban in the UK and the ban in the USA.

Yet, in another sense, all this is routine stuff. The drugs industry introduces a drug, after testing and regulatory controls are undertaken. It is given to patients. Reports of 'side-effects' or 'adverse reactions' are received, and ignored by the regulators. Patients suffer by contracting new, usually more serious diseases. Many patients die. And only then, when faced with an untenable situation, do the drug regulators act.

There is no fail safe mechanism in the world of pharmaceutical drugs. Drugs are considered safe until such time that they prove, overwhelmingly, that they are not. It has been the same with drugs-past, drugs-now, and drugs-future. These drugs have little to do with health, and plenty to do with the drugs business, and making money.


Tuesday, 30 October 2012

FDA Warning. Statins now linked to Memory Loss


This blog, on Statin drugs, is based on a Health Services Institute newsletter, dated 29th October 2012.  Visit the HSI Website, and subscribe to receive their regular newsletter.

Our regular readers will remember that, o a few years ago, I told you about Dr. Duane Graveline, a former NASA astronaut. Soon after starting Lipitor, Dr. Graveline experienced two bouts of total global amnesia (TGA). That's when all memory vanishes for several minutes to several hours. 

I was reminded of Dr. Graveline's terrible ordeal when I read this comment from one of our readers, called Kevin: 

          "Modern day super-statins are exceedingly powerful. My fear is that the doses are much too high and that dosage regimens have been developed for ease of prescribing. I also find that the side effects of these drugs correlate with the dosage. For years doctors tried to get me to take 40mg of simvastatin instead of a daily mini-aspirin and I said: 'Thanks, but no thanks.' 

          "I can no longer take aspirin and with very great reluctance, I have agreed to start with simvastatin. I insisted on 10mg tablets which I cut in half so the effective dose is 5mg. I have been guided here by the tremendous work of Dr Duane Graveline, who is a former USAF Flight Surgeon, NASA Astronaut and Family Doctor. I strongly recommend his books Lipitor: thief of memory and The Statin Damage Crisis." 

Thief of memory 

After Dr. Graveline's episodes of 'vanishing' memory he launched his own investigation of statin-related TGA. He found hundreds of people who shared their experiences of memory loss while using statins. 

In fact Dr. John Briffa, contributing editor to The Cholesterol Truth, said that when he deals with ageing patients who complain about memory loss, one of the first things he asks them is whether they are taking cholesterol-lowering statins or not. 

To further support the effects that statins can have on brain function, research into 171 individuals who complained of statin-related brain symptoms found that 90 per cent of people who stopped statins experienced an improvement in their symptoms… This tells me that there must be a link between statins and deteriorating brain function. 

In his own research Dr. Graveline discovered that certain brain cells produce their own cholesterol. Neurons need this cholesterol to function properly. When something impairs cholesterol production, it can compromise thought processes. 

The result… TGA, and just about everything in between. Including depression. 

A few years ago, The Wall St. Journal ran an article about memory loss linked with statin use. Many readers posted comments about cognition problems and TGA. One reader suffered a crippling depression while taking statins. But her symptoms disappeared when she quit. From that point, it was an easy decision. She said that risk of a heart attack "would be preferable to life on statins." 

Given that statin benefits are wildly exaggerated, that's what I call clear thinking. 

Now, after nearly 10 years the American Food and Drug Administration (FDA) has finally caught up and has recently noted in a Consumer Update that memory loss, forgetfulness, and confusion "span all statin products and all age groups." 

We are yet to see if this so-called consumer update will carry any further weight.


Some additional thoughts on this article.
The FDA may have caught up - but have our doctors, the NHS, as they seem intent on continuing to prescribe Statin drugs, regardless of the evidence that they are causing serious DIEs. Indeed, I am no certain that all doctors have stopped telling us that these awful drugs are 'entirely safe'.

And what exactly is 'memory loss'. At the extreme end of the spectrum, memory loss equals Dementia. Can the FDA, or Big Pharma, or the NHS, tell us that 'memory loss' ends with a little bit of forgetfulness? Can they be certain Statin drugs are not implicated in the epidemic of dementia that we have been experiencing over recent decades.

Of course they can't; it is best that all of us started to say 'No thanks' to Statin drugs!

Thursday, 25 November 2010

Children, coughs and colds, and ConMed drugs

I hope no-one believes their children are safe from Conventional Medical drugs. In the USA, in 2007, the drug manufacturers agreed to withdraw from the market certain 'over-the-counter' drugs for coughs and colds for children under two years of age - because (in the words of the FDA they caused "serious and potentially life-threatening side-effects". Have a look at this article.

http://www.NaturalNews.com/030496_cough_medicines_children.html

And whilst doing so, ask yourselves these questions.

1. If these drugs, sold without doctor prescription, are dangerous to children under two years old, are they really safe for children aged 3, or 4, or 5? Or for adults, for that matter!
2. If the drug company accepted they were unsafe (they did so by withdrawing them) why did they continue to sell them to patients in other parts of the world? Are they only unsafe in the USA? Are we in the UK protected in some way?
3. Why have people in the UK not been told about this in our mainstream media? Why do the NHS not tell us? Why do doctors not tell us? The silence in deafening.
4. If "emergency rooms have seen 50% less visits from injured or killed babies and toddlers" in the USA have babies and toddlers in the UK continued to appear in our hospitals?
5. If our drug regulator, the MHRA have said these drugs were not safe, why are they allowing them to be sold? Why have they not been withdrawn, as in the USA?

So in one short article we see the problem, and the dangers we face from the NHS-ConMed Establishment. They simply don't tell us the truth. They don't act to protect us. And they don't do so even when they know there is a serious problem. And the UK media are equally quiet.

This is why I say that it is best to avoid all ConMed drugs, and seek safer medical therapies. It seems to be the case that Big Pharma is too big to control; and to corrupt to act in the best interests of patients - even when those patients are babies and children.

Tuesday, 2 November 2010

Meridia (Reductil). Another dangerous drug.

So, you are overweight, and the GP gives you a drug. That drug increases your risk of heart disease and stroke. Is that a good deal?

http://articles.mercola.com/sites/articles/archive/2010/10/30/drug-meridia-yanked-from-market.aspx

So another pharmaceutical drug hits the buffers. Meridia (known as Reductil in the UK, I believe), presumably tested to the satisfaction of the FDA (and the MHRA) to be effective and safe, it has been given to 8 million patients throughout the world; and 13 years have elapsed before 'medical science' eventually decided that it wasn't safe because it caused a 16% increase in heart attacks and stroke.

So the ConMed farce goes on. The drug Reductil has been withdrawn in the USA' and was banned in Europe in January 2010. No doubt the drug will continue to be sold anywhere the drug companies can make a profit on it, at the expense of patients.

And do we hear about it from the government, the NHS, or the mainstream media? Do a web search! The usual silence remains. Drug company profits must not be affected. And to hell with the patient!

Friday, 24 September 2010

Avandia is banned

At last, Avandia has been banned in Europe. This drug has demonstrated everything that is wrong with conventional medicine. It was introduced in 1999 and hailed as a major advance in the treatment of diabetes. It has been an enormously successful drug - financially. But disastrous for many patients who were eagerly persuaded to take it.

The drug never cured anyone with diabetes. It was never intended to do so. Like most pharmaceutical drugs it merely suppressed the symptoms, whilst ignoring the underlying causes of the disease.

It is unknown how many people it has killed, but it was found to increase the chance of heart attack by 43%. Few would have known about the dangers of the drug, because they would not have been told. It is now known that the FDA knew about the dangers since 2003 - 7 years ago. And they have still not banned it in the USA.

The European Medicines Agency has now banned the drug in Europe, about 11 years too late for many patients! It is the usual story. A drug, that progressed through all its 'scientific' testing, and was announced to be safe and effective by the conventional medical establishment. 


This is the 'evidence base', the science, upon which all pharmaceutical drugs are supposed to be based. It is a lie, a charade, a profit-driven deception on patients, to which the drug companies, the government, the NHS, and all those who prescribe the drug, are party.


This is not the first, nor will it be the last drug to be banned. Pharmaceutical drugs that are being prescribed by our doctors today will come to the same predictable, almost inevitable end.

For further information see 
Banned, withdrawn, restricted drugs
Avandia