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Introduction

In this article we will explore what the various regulatory agencies do to protect our interests and our health acting as intermediaries between the general public and the pharmaceutical industry. In Europe, the european wide regulatory agency is the EMA (European Medicines Agency), in the US the FDA (Food and Drug Administration), in the UK the MHRA (Medicines and Healthcare Products Regulatory Agency).  

I think there is enough dirt around the internet that exposes the conflict of interest within the regulatory agencies, because how can they possibly have a purely disinterested regulatory authority like the FDA that receives a lot of its funding from the pharmaceutical industry.  Similarly, how can you have disinterested congressman who are receiving funds from pharmaceutical lobbyists?

The lawsuits that are slapped on pharmaceutical companies is all part of doing business and the revolving door which is like the a star trek transporter exchanging executive personnel between the regulatory bodies and the pharmaceutical companies..one day an executive is working in a high position in a drug company, and the next day they are working for the regulatory agency and in some cases within days, positions are exchanged like pieces on a chessboard.  This exchange of personnel occurred when Obama elected some of the wall street insiders who orchestrated the financial meltdown in the first place to be part of his administration to advise on financial controls and regulation…WHAT?  

Another example of the lunatics taking over the asylum.  

Clearly, something is amiss when you read the next chapter on Grim statistics, either the Pharmaceutical companies are concealing adverse drug trial information or the regulator is approving drugs without insisting on greater proof of safety and efficacy of the drug being asked of them to approve.  If this two way process was working the following statistics would read quite differently.


Grim Statistics

Pharmaceutical drugs are the third leading cause of death after heart disease and cancer. In the US alone around 100,000 deaths are attributed to prescription drugs, while an additional 100,000 die because of medical errors. In total there are around 784,000 annual deaths from conventional medicine mistakes and taking prescription medication. The American medical association in their journal, state that 290 people in the US are killed by prescription drugs every day.  The EU chalks up 200,000 deaths/year due to prescription drugs.  I suspect these numbers are actually much higher, since the actual death rate is 2.6 million/year, and only 200,000 are attributable to medical mistakes and prescription drugs.  A pathologist pronouncing a cause of death is never going to say death by adverse affects from a drug even if it was the cause, how would he know anyway, he/she would simply say for example ‘ Cause of Death Pulmonary aneurysm’.  According to Peter Gotzsche from his book ‘Deadly medicines and Organized crime’ he estimates inferior drugs used to treat hypertension cause around 40,000 deaths, Antiarrhythmic drugs cause around 50,000 deaths/year in the US.  In 2004, the drug  Rofecoxib that has now been recalled, was a NSAID used to treat osteoarthritis, acute pain and dysmenorrhea (menstrual cramps)  likely caused 140,000 death worldwide due to thrombosis.  By the same year Celecoxib another NSAID likely caused 75,000 deaths worldwide because of thrombosis. By 2007 Olanzapine (antipsychotic drug to treat schizophrenia and bipolar disorder) had taken around 200,000 lives worldwide.


The mission statement of the Regulatory Agencies

The FDA

The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation (they want to make sure you get your fair share of radiation for your cancer treatment). FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The MHRA

The primary aim of the MHRA is to safeguard public health; this is achieved through the compliance of those involved in the development, manufacture, placing on the market and distribution of medicines and medical devices.

The EMA

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

You will notice that all three mission statements refer to public health protection.


The official drug approval process of the FDA

American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER).

The center’s best-known job is to evaluate new drugs before they can be sold. CDER’s evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

No Accountability

The FDA website contains a slew of information on adverse reactions from drugs (CDER section)and in some cases that just cannot be anticipated, as I have said before we are all individuals, and some react differently to drugs than others, however the habit of physicians to prescribe multiple drugs simultaneously propels the patient into uncharted waters and expose the patient to completely unpredictable and potentially disastrous outcomes. Most physicians have no idea of the mechanism of action of one drug let alone the potentiation effect of taking multiple drugs. The variables and the number of biological pathways that are affected by it are innumerable.  

As Dr  Barbara Starfield associated with the John Hopkins schools of health said in 2009 “ the fact that more and more unsafe drugs are being approved for use which many people attribute to the fact that the pharmaceutical industry is required to pay the FDA for new drug reviews.  This puts the FDA into an untenable position of working for the industry its regulating”.  Dr Starfield also commented “ the state of US healthcare is an indictment of the different bodies involved such as insurance companies, speciality and disease oriented medical academia, the pharmaceutical and device industries who all contributes heavily to re-election campaigns for the members of congress, and we have no government that is free of influence of vested interests”.  Having said that, if prescription drugs the FDA is certifying as safe is killing 100,000 people /years the FDA must be made accountable, no matter what extenuating circumstances exist. In effect the justice department is giving everyone a free pass to medically kill 225,000 people/year, the FDA for 100,000 and medical errors attributed to the other 125,000.

Illegal street drugs only kill 10,000 people /year but the perpetrators have to hide in the shadows and are hunted down and incarcerated for drug peddling

The Vietnam war lasted 20 years (1955-1975) and some 200,000 US soldiers lost their lives which = 10,000/year ( let us not forget the the 2 million civilians on both sides and 1.1 million north Vietnamese and 250,000 south Vietnamese also lost their lives)

In the immortal lyrics from Marvin Gaye’s most beautiful song ‘Whats going on’ ;

Mother, mother

There’s too many of you crying

Brother, brother, brother

There’s far too many of you dying

You know we’ve got to find a way

To bring some lovin’ here today,

What’s the problem with Alternatives

By now, if you are not convinced that food should always be thy medicine by now then you should go back and re read my articles..lol.  For some inexplicable reason regulatory agencies dismiss this, I can’t believe that all regulatory employees are that ignorant..no I believe that many are diet/medicine advocates but they are afraid of losing their jobs or worse if they speak out?  The general public are not so stupid and ask themselves ‘how many people die from healthy food..eh..0’, OK then “how many people die from prescription drugs​”..eh..106,000/year in the US alone..so what do you choose?

“Are you kidding..I choose life!”


Famous Alternative Practitioners – Dr Max Gerson

Dr Max Gerson who even as a small boy growing up in Eastern Germany in the 1880s realised that soil had a profound affect on food and the dwelling organisms there. Gerson suffered from migraine headaches when he was at medical school and after a 2 year elimination diet settling with fruits/vegetables no fat,salt,alcohol or spices he managed to eliminate it. Dr Ferdinand Sauerbruch the famous lung specialist in 1924 established a 450 patient clinical trial for patients suffering from skin tuberculosis using Gerson’s ‘Migraine’ dietary regime resulted in a 99% recovery rate. Gerson was acquainted with Albert Schweitzer and he cured his wife of lung tuberculosis, and cured Albert’s type II diabetes.

In 1933, he fled the Nazi tyranny and arrived in New York only to subject himself to the tyranny of the anti-alternative medicine police. Gerson’s dietary therapy consisted of a low salt, low fat, high carbohydrate, supplemental vitamins and minerals, organic fruit, vegetable juices and and a liver detox using coffee enemas (I read on Wikipedia who claim that coffee enemas “can cause colitis (inflammation of the bowel), fluid and electrolyte imbalances, and in some cases septicemia”  and that Gerson’s diet “has been blamed for the deaths of patients who substituted it for standard medical care’)..Now you see how the media can spin the truth and some poor wretch will read that and believe it..yeah..yeah..as the Great Dr Good would say “ look at the data..where is the evidence”. Maybe the wiki writers should research the work of the famous cardiologist Sodi Pallares who used a similar dietary regime  or read the NCBI article ‘Homage to Doctor Demetrio Sodi Pallares in his 60 years of professional activities’. It is some regret that by just 4 votes in the Pepper Commission of 1946 Gerson was stripped of his medical license influenced by organized medicine’s powerful lobbyists who wanted nothing to do with an alternative to chemotherapy, radiation and surgery.


Digging up the past – The History of Pharmaceutical interests

It was the Flexner report published in 1910 and driven by the Carnegie family that sounded the death knoll for alternative medicine which included  osteopathic medicine, chiropractic medicine, electrotherapy, eclectic medicine, naturopathy and homeopathy. Abraham Flexner was recruited to investigate the quality of the 161 medical schools that existed in 1910 ultimately destroying the credibility and funding of the schools reducing it to 81 drug based institutions.

Unless medicine had some scientific evidence associated with it, he wasn’t interested, and any treatment that did not involve vaccines and drugs was just quackery.  So the many naturopath hospitals were forced to close because Carnegie and the flexner report made sure that they were no longer funded, although osteopathic medicine survived by aligning themselves with Flexner’s recommendations in terms of evidence based science.  The Rockefeller family used their tremendous fortune to donate considerable funds to universities and medical schools that were drug based.  

In 1939 a drug trust alliance was established between Rockefeller and the German chemical company IG Farben (yes the manufactures of the killer gas Zyklon B used in the concentration camps and is now the aspirin maker Bayer). This alliance included General Mills, Kellogg, Nestle, Bristol Myers Squibb, Procter and Gamble, Roche and Hoechst (now Sanofi-Aventis).  The Rockefeller foundation in tandem with JP Morgan Chase own half of the pharmaceutical interests in the US. Notice there are processed food companies among the alliance..did nestle produce pharmaceutical medicines before making chocolate..or did general mills own pharmacists before ‘Red Lobster’ ?..what a fine web we weave!


Quack Busting

When P. Joseph Lisa’s book ‘The Assault on Medical Freedom’ was published in 1994 the world learnt of secret files that were kept in the AMA’s Chicago department of Investigation that had collected information to expose ‘mental health quackery’, but as he discovered, the documents were not evidence to expose quackery but an organized propaganda campaign to discredit alternative medicine and foreign drugs. It was proposed that the  birth of the AMA in 1847 launched an organized push for a “totalitarian medical pharmaceutical police state”. Funded by the drug industry, a single, medical monopoly was established using the insurance industry, the U.S. Department of Justice, the Federal Trade Commission (FTC), the Internal Revenue Service (IRC), the U.S. Postal Service and other state and federal agencies.  Part of the AMA’s anti quackery campaign even shut down the Sears catalog of home remedies..was nothing safe. By 1964 the AMA’S committee on quackery created the Coordinating Conference on Health Information (CCHI) whose members included:

  • The American Cancer Society (ACS),
  • The American Pharmaceutical Association,
  • The Arthritis Foundation,
  • The Council of Better Business Bureaus,
  • The National Health Council,
  • The Food and Drug Administration,
  • The Federal Trade Commission (FTC),
  • The U.S. Postal Service,
  • The Office of Consumer Affairs,
  • The U.S. and State Attorney Generals’ Office
  • The Internal Revenue Service.

Some of the CCHI’s tactics were to send fictitious letters to chiropractic schools to try and catch them out making curative claims which would be turned over to the US postal service to be used as evidence of false and misleading advertising.  This commission also managed to get a chapter on a chiropractic career deleted from the department of labor’s ‘Health careers guidebook’. It then engineered a falsification of a study which was funded by the American Medical Association (AMA) being carried out by Stanford Research Institute to make the results appear negative, achieved by the AMA themselves.

Eventually a lawsuit to be heard on behalf (lawsuit was originally filed in 1976) of 4 chiropractors accused the AMA, four of its officials and 10 other medical groups (including the American College of Surgeons and the American College of Radiology) of conspiring to prevent chiropractors from practicing in the US, labeling all chiropractors ‘Unscientific cultists’.  The chiropractors prevailed leaving the defendants ( the AMA ) basically saying ‘ we don’t think there was ever a boycott or a conspiracy’….It wasn’t us Guv…we love chiropractery..we’ve been fitted up..lol..The fact that the chiropractic profession had to endure this BS harassment for 11 years is unconscionable.

Doyle Taylor the elected secretary of the original Committee on Quackery wrote a memo in late 1974 when the CCHI was disbanded to charge the committee to compile a list of items. goals, objectives and operating procedures to be passed on to the next underground anti quackery group which happened to be the National and regional councils against health fraud whose leaders were The California council against health fraud and the Lehigh Valley committee against health fraud in Pennsylvania ( the shadow CCHI).  The offspring of these two entities became The National Council Against Health Fraud ( NCAHF) run by none other than Stephen Barrett the retired psychiatrist and founder of the website ‘Quackwatch…I’m so thankful that we have this guardian angel protecting us from this evil menace ‘Alternative Medicine’  This non for profit “who shall we call?” QUACKBUSTERS came crashing down in 2003 when they went after Botanical Laboratories and lost the court case after which the 3 judge panel summed up the case:

Conclusion – Appellant (NCAHF) believes that no one should be allowed to market homeopathic remedies. Congress has decided otherwise, and officially recognizes the Homeopathic Pharmacopoeia.  Appellants broad brush approach of sweeping all homeopathic remedies into a single bag marked ‘Undesirable’ simply does not work in the courts, where each claimed instance of unfair advertising and unfair business practice must be closely scrutinized.  Appellant failed to present any admissible evidence in this case that respondents are guilty of false advertising and unfair business practices with respect to any of their products.

According to Consumer advocate Tim Bolen the NCAHF is operating out of a cardboard box in the back room of a removal salon with very little money to pay the defendant’s court fees that were estimated to be around $500,000.  So Barrett should stay retired..go and do something useful like gardening,,can’t do much harm there unless you want to sue the organisms that live in the earth for false health claims.

The US postal service was instructed to keep an eye on Clinics, manufacturers and physicians using chiropractic, acupuncture, homeopathy and naturopathy practices, and the use of vitamin therapy, alternative cancer and arthritis treatments. By 1984, the next part of the quack busting plan was to make sure that vitamins and minerals and chiropractic were not covered by insurance, and this organization made sure that all insurance companies were informed of any questionable practices that the insurance companies should deny claim for. This then opened the door for the pharmaceutical companies to produce synthetic vitamin supplements.  Wow..Apart from the president’s administrative office they had just about everybody on their side. Now I understand the term ‘Medical Mafia’.  But this assembly of an extreme power base is indicative of protecting a healthcare system that is ineffective and they know it, but suppressing any competition is tantamount to a dictatorship..OMG..and you want to visit a doctor or should I say Reichsführer.


Conclusion

I hope this article has enlightened you, it certainly was for me when I researched the material.  To create such a powerful clandestine group to protect their medical monopoly is stuff of conspiracy, and although I like Alex Jones I always believed him to be too radical in his views, but now I think he is onto something, based on what I have discovered.  In next article we will speak more on the activities of the regulators and the drug companies to discover more analogies of the ‘Spanish Inquisition’.

Ximinez: Now, old woman — you are accused of heresy on three counts — heresy by thought, heresy by word, heresy by deed, and heresy by action — *four* counts. Do you confess?

Old Lady: I don’t understand what I’m accused of.

Ximinez: Ha! Then we’ll make you understand! Biggles! Fetch…THE CUSHIONS!

(JARRING CHORD)

(Biggles holds out two ordinary modern household cushions)

Biggles: Here they are, lord.

Ximinez: Now, old lady — you have one last chance. Confess the heinous sin of heresy, reject the works of the ungodly — *two* last chances. And you shall be free — *three* last chances. You have three last chances, the nature of which I have divulged in my previous utterance.

Old Lady: I don’t know what you’re talking about.

Ximinez: Right! If that’s the way you want it — Cardinal! Poke her with the soft cushions!

(Biggles carries out this rather pathetic torture)

Ximinez: Confess! Confess! Confess!

Biggles: It doesn’t seem to be hurting her, lord.

Ximinez: Have you got all the stuffing up one end?

Biggles: Yes, lord.

Ximinez : (angrily hurling away the cushions)Hm! She is made of harder stuff! Cardinal Fang! Fetch…THE COMFY CHAIR!

(JARRING CHORD)

(Zoom into Fang’s horrified face)

Fang: (terrified) The…Comfy Chair?

(Biggles pushes in a comfy chair — a really plush one)

Ximinez: So you think you are strong because you can survive the soft cushions. Well, we shall see. Biggles! Put her in the Comfy Chair!

(They roughly push her into the Comfy Chair)

Ximinez: (with a cruel leer) Now — you will stay in the Comfy Chair until lunch time, with only a cup of coffee at eleven. (aside, to Biggles) Is that really all it is?

Quote from the sketch ‘Spanish Inquisition’ Monty Python


References/Acknowledgments:

 

  1. Racketeering in Medicine Book James Carter 1992
  2. Bad Pharma Book 2012 Ben Goldacre
  3. American Medical Association Source watch
  4.  Flexner Report, Gerson Wikipedia
  5.  Deadly Medicines and Organized crime Book Peter Gotzsche 2013
  6.  FDA, MHRA,EMA official websites
  7. US Judge finds medical group conspired against chiropractic New York Times    1987
  8.  For Quackbusters: NCAHF -Its all over but the shouting Tim Bolen July 2003
  9. Spanish inquisition Monty python website

 

 

 

Author: Eric Malouin

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