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The Controlled Clinical Trial: An Analysis

by Harris L. Coulter, Ph.D.

In THE CONTROLLED CLINICAL TRIAL: AN ANALYSIS, Harris Coulter, author of DIVIDED LEGACY: A HISTORY OF THE SCHISM IN MEDICAL THOUGHT and DPT: A SHOT IN THE DARK, critically examines the usefulness of randomised clinical trials. His thorough research, based almost exclusively on medical literature, reveals why the "controlled clinical trial" (CCT) cannot guarantee drug safety and efficacy.

Coulter argues that while allopaths talk pompously about this so-called "gold standard" of medicine, no controlled clinical trial matching the textbook definition has ever been performed. "Because the theoretical requirements are unrealistic and unscientific. How can you test a drug on 12 or 100 or 1,000 identical or 'homogenous' people all with the same thing wrong with them? Allopaths can't even find five homogenous patients. You'll always find things that are different between people, because we are all chemically, physically, structurally, and emotionally unique. The CCT can never tell a doctor how a given patient will react to a given drug at any given time. The findings from the so-called controlled clinical trial are useless in one-on-one doctor patient interactions."

THE CONTROLLED CLINICAL TRIAL not only investigates the science behind the CCT, but also delves into its history and politics. According to Coulter, the CCT has become popular primarily for political reasons. "It's used as a stick to beat alternative medicine with for failing to perform these trials. Since these trials are very expensive it costs about $200 million today to get a new drug on the market the controlled clinical trial is really an instrument for limiting competition in medicine, and for raising the costs of medicines to the public."

He asserts that monopolistic objectives are not the only built-in fraud feature of the CCT. Fraud in safety testing of drugs is a strong likelihood. The clinical investigator is paid enormous sums of money by the very manufacturer of the drug, and financial temptation to perform dishonest trials is strong. It's a very lucrative business - many of them receive more than $1 million annually from their testing programs. Coulter dedicates a chapter of the book to demonstrate the extent of fraudulent drug testing. "Frightful examples of dishonesty, fraud, negligence, and other kinds of wrongdoing in clinical trials have been staple fare for readers of the [US] daily press since the 1970s, when Congressional committees and subcommittees renewed their interest in the topic." One typical example cited is that in the United States in 1976 the General Accounting Office found that trials of a drug designed to prevent rejection of kidney transplants had led to 85 deaths in the 650 patients participating, and not one of these deaths was reported to the Food and Drug Administration.

Senator Edward Kennedy, conducting a Hearing of the Senate Health Subcommittee, noted that if only 10% of the data from ongoing clinical trials is defective, the problem is enormous. "When you consider the potential cumulative effect of faulty animal data coupled with faulty human data, you have the elements of a regulatory nightmare."

While Coulter doesn't dismiss the CCT outright - saying that if it's properly conducted it may have some role - he offers an alternative that helps overcome the problem of biological and physiological differences among patients.

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Corporate Crime in the Pharmaceutical Industry

by Dr John Braithwaite

The sordid behaviour of today's pharmaceutical corporations has been further demonstrated by Dr John Braithwaite, now a Trade Practices Commissioner, in his devastating exposé, CORPORATE CRIME IN THE PHARMACEUTICAL INDUSTRY (1984).

International bribery and corruption, fraud in the testing of drugs, criminal negligence in the unsafe manufacture of drugs - the pharmaceutical industry has a worse record of law-breaking than any other industry. Describing many examples of corporate crime, which shows the depth and seriousness of the crime problem in the pharmaceutical industry, Dr Braithwaite's revealing study is based on extensive international research, including interviews of 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala.

The book shows how pharmaceutical multinationals defy the intent of laws regulating safety of drugs by bribery, false advertising, fraud in the safety testing of drugs, unsafe manufacturing processes, smuggling and international law evasion strategies. At the time of researching the subject, Braithwaite was a Research Criminologist at the Australian Institute of Criminology and a Fulbright Fellow affiliated to the University of California, Irvine and the United Nations Center on Transnational Corporations.

"Data fabrication is so widespread", says Dr Braithwaite, "that it is called 'making' in the Japanese pharmaceutical industry, 'graphiting' or 'dry labelling' in the United States." He further states:

"Pharmaceutical companies face great temptations to mislead health authorities about the safety of their products. It is a make or break industry - many companies get virtually all their profits from just two or three therapeutic winners. Most of the data that the Australian Drug Evaluation Committee relies upon in deciding questions of safety and efficacy is data from other countries, particularly the US. Inquiries into scientific fraud in the US have shown there is a substantial problem of fraud in safety testing of drugs in the US, just as has been documented in Japan."

The book reports that between 1977 and 1980 the United States Food and Drug Administration have discovered 62 doctors who had submitted manipulated or downright falsified clinical data. A study conducted by the FDA has revealed that one in five doctors investigated, who carry out field research of new drugs, had invented the data they sent to the drug companies, and pocketed the fees. Citing case examples, Dr Braithwaite states: "The problem is that most fraud in clinical trials is unlikely to even be detected. Most cases which do come to public attention only do so because of extraordinary carelessness by the criminal physician..."

According to Dr Judith Jones, Director of the Division of Drug Experience at the FDA, if the data obtained by a clinician proves unsatisfactory towards the drug being investigated, it is quite in order for the company to continue trials elsewhere until satisfactory results and testimonials are achieved. Unfavourable results are very rarely published and clinicians are pressured into keeping quiet about such data.

It is very easy for the drug company to arrange appropriate clinical trials by approaching a sympathetic clinician to produce the desired results that would assist the intended application of the drug. The incentive for clinical investigators to fabricate data is enormous. As much as $1000 per subject is paid by American companies, which enables some doctors to earn up to $1 million a year from drug research, and investigating clinicians know all too well that if they don't produce the desired data, the loss of future work is inevitable.

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Poisonous Prescriptions

by Dr Lisa Landymore-Lim

"Given that a poison is ANY substance that when introduced into or absorbed by the body injures health or destroys life, most of today's pharmaceutical preparations, because of their harmful effects, may be labelled poisonous."

The above opening to POISONOUS PRESCRIPTIONS (1994) gives the gist of the author's view on allopathic drugs. A view that could not be easily dismissed by health authorities, as Dr Landymore-Lim, a British scientist, is well qualified by their own standards. She graduated in 1983 from the School of Chemistry and Molecular Sciences, University of Sussex, England, with a First Class Honours degree in Chemistry by Thesis. In 1984 she was awarded a study scholarship by the Swedish Institute, and has worked briefly for the Medical Research Council at the National Institute for Medical Research, London, and at the Dunn Nutrition Unit, Cambridge. Concerned about preventing disease, Landymore-Lim is now an independent consultant and investigator, focusing on the harmful effects of pharmaceutical drugs and other chemicals.

POISONOUS PRESCRIPTIONS, which evolved from the author's clinical research conducted in the UK, provides readers with an insight into the poisonous nature of pharmaceutical drugs. The book includes information on a number of commonly used drugs in the United Kingdom and other industrialised countries, paying particular attention to those that are routinely pushed onto babies and young children.

Among the numerous other adverse reactions that are inherently linked to all drugs, Landymore-Lim's investigations have found that diabetes and asthma can result from exposure to antibiotics and other commonly used pharmaceutical drugs. To support her assertions she provides ample evidence from hospital records and her own studies and she explains clearly and simply the complex mechanisms behind the diabetes and asthma-causing properties of chemicals. In dispelling the authorities' widely held misconception that diabetes is largely a genetic disorder Landymore-Lim provides statistics and graphs showing how the incidence of diabetes in industrialised countries has dramatically increased in the last 40 years, coinciding with the rapid rise in the use of drugs during that time period.

No doubt that if Dr Landymore-Lim's information breaks through the Media censorship it will send shock waves through the medical profession. We support her efforts and urge you to assist her group's on-going research. The Prevention of Diseases & Disability (PODD) would like to hear from anyone in Australia who has suffered from any serious drug-related condition to be included on a register.

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Vaccination: 100 Years of Orthodox Research Shows that Vaccines Represent a Medical Assault on the Immune System

by Viera Scheibner Ph.D.

This book (published 1993) is a concise summary of the results of orthodox medical research into vaccines and their effects. It aims to inform medical professionals, parents and the general public about short and long-term dangerous side-effects, including brain damage and death, of vaccines; of the ineffectiveness of vaccines in preventing infectious diseases, as shown by epidemics in fully vaccinated populations; and the causal link between DPT and polio vaccines and cot death.

Dr Viera Scheibner, retired Principal Research Scientist for the NSW Government with a doctorate in Natural Sciences, has published 3 books and some 90 scientific papers in refereed scientific journals in Australia and overseas during her distinguished career.

She and her husband, Leif Karlsson, an electronic engineer specialising in patient monitoring systems, developed Cotwatch, a true breathing monitor for babies. Vaccination proved to be the most prominent stressful event to sound the alarm. A microprocessor version of Cotwatch recording babies' breathing patterns presented the effect of vaccination clearly on the computer print-outs and the link between vaccine injections and cot death became painfully obvious.

Following this finding, Dr Scheibner studied some 30,000 pages of medical papers dealing with vaccination. She found no evidence that vaccines are safe or effective. Vaccines are highly noxious. They contain formaldehyde, aluminium phosphate, thiomersal (mercury compound), foreign proteins (antigens) and contaminating animal proteins and viruses from the tissues used as growth medium to culture the viral and bacterial components of vaccines. None of these substances should ever be injected into human beings. They erode the immune system and alter the immunological response to diseases.

The appearance of many new, autoimmune diseases like asthma, affecting alarming numbers of children, childhood leukaemia, and cancer, the enormous upsurge in the incidence of cerebral palsy and infantile convulsions seen in children of vaccination age and not before, should all be taken as serious warnings. Infectious diseases contracted at the appropriate age and allowed to run their course are beneficial because they serve to prime and mature the child's immune system.

The overwhelming evidence from the numerous human clinical and epidemiological studies cited by Dr Scheibner demonstrates beyond any doubt the dangers and ineffectiveness of vaccinations and her book is a most valuable contribution towards exposing the myth of vaccinations.

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The Cot Death Cover-Up?

by Dr Jim Sprott

THE COT DEATH COVER-UP? is the culmination of over fifteen years of cot death research by the author, a highly respected consulting chemist and forensic scientist from New Zealand.

In 1986 Sprott arrived at the conclusion that babies were succumbing to cot death because of inadvertent gaseous poisoning by an extremely toxic nerve gas generated by microbiological action on something within the baby's cot, but he wasn't able to identify the gas. Then in 1989 consulting scientist Barry Richardson, working independently in Britain came to the same conclusion and in addition identified the offending gases. It was not long before the two teamed-up to work on what they describe as the "Richardson Hypothesis".

According to Sprott the three identified gases that were generated from mattresses on which babies died of SIDS are "phosphine, arsine and stibine, all extremely toxic 'nerve gases'. They are produced by the action of the otherwise harmless fungus Scopulariopsis brevicaulis on substances containing phosphorus, arsenic and antimony. These elements are often present in cot and other mattresses." These odourless but intensely poisonous gases, with toxicities about 100 times as great as hydrogen cyanide (prussic acid), act upon the baby's nervous system to inhibit breathing and heart function.

The problem, in fact, has been first identified as far back as the 1880's when the mystery of thousands of unexpected child deaths throughout Western Europe and the UK was solved by Italian chemist Gosio. He had discovered that deaths were due to a toxic gas, arsine and/or alkyl homologues generated by the micro-organism Scopulariopsis brevicaulis (then known as Penicillium brevicaules). It acted upon copper arsenate, used in green pigments in wallpaper, and arsenious oxide, used as a preservative in wallpaper glue.

THE COT DEATH COVER-UP? contains ample evidence supporting Sprott and Richardson's findings. Among the many graphs it contains one that demonstrates the rapid drop in cot deaths in Britain in 1986-1994. The graph, based on official statistics, shows that when the findings were first made public in mid-1989 the SIDS rate started to fall immediately, dropping 35 per cent by the time the official "Back to Sleep" campaign was launched in December 1991. In the period 1989-1994, Britain saw a staggering 70 per cent reduction in the SIDS rate.

Despite these remarkable results, Sprott and Richardson were fiercely opposed by their respective country's health authorities and official SIDS groups. Their struggle for official recognition of their findings is reminiscent to that of other independent SIDS researchers such as Dr Archie Kalokerinos and Dr Glen Dettman, who had proved that severe depletion of a child's vitamin C level, precipitated by various insults including childhood vaccinations, could predispose it to SIDS.

The author says that the book is not aimed at academics (although its first-class material should suffice their snobbery), but is aimed at parents - parents who have to suffer the consequences of a system that puts them and their babies last in the "war" against this human tragedy known as SIDS.

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