‘Scientific Evidence’ v ‘Real World Effectiveness’
It is increasingly recognized that conclusions drawn from classical clinical trials are not always a useful aid for decision-making – assessing the value of a drug or technology requires an understanding of its impact on current management in a practical, real-life setting or real world evidence.
The key question about any scientific data should always be ‘how does it translate into real world effectiveness?’.
But some people in the scientific community like to attack our successful non-medical therapy with the throw away statement ‘Do you have any independent, peer reviewed scientific evidence? They say this as though it’s ‘the’ most important aspect, when in reality it’s not or that it is easy to obtain and everyone should have it but with no regard to the fact that this type of ‘evidence’ costs millions of pounds to obtain. The simple answer is ‘no, as all our evidence is REAL not fabricate’. This is due to the fact that:
‘Most published scientific evidence is not credible as no one knows which parts of the study were ‘real’ and which parts were simply ‘made up or falsified’.
Top British universities found producing ‘fake research’
Hundreds of allegations of “fake research” conducted at some of the UK’s top universities were reported between 2011 and 2016, figures show.
The Radio 4 program ‘Everything we know is wrong‘ documented this scientific misconduct. Every day the newspapers carry stories of new scientific findings. There are 15 million scientists worldwide all trying to get their research published. But a disturbing fact appears if you look closely: as time goes by, many scientific findings seem to become less true than we thought. It’s called the “decline effect” – and some findings even dwindle away to zero.
Some in the scientific community always try to argue this fact with the thoroughly ‘unproven and unscientific’ statement ‘it’s just a few bad scientists’ but the real questions is ‘how many are there?’ Is it just one or two, or one or two thousand? The answer is, no one knows for sure so the statement is meaningless (unscientific) but there shouldn’t be any for the scientific system to be ‘credible and reliable’ as claimed.
But what the ‘independent evidence does prove’ is, the scientific model is not the gold standard as claimed, it is broken and beyond repair due to widespread ‘scientific fraud and misconduct’ which is ‘systematic and endemic’ and certainly not a ‘few rogue scientists’ as always claimed.
Interestingly, not one of these people will take the Addiction Challenge to prove which method of treating addiction is ‘the best with the best patient outcomes’.
The UK operates an allopathic healthcare model which is recommends drugs above other better treatments. Drug companies have been rocked by a series of revelations that have undermined their claims of an evidence based system, as one expert said ‘in reality, the only evidence one can really trust is genuine client evidence, the same type of evidence the pharma industry rely on under the yellow card scheme’.
Widespread Fraud & Misconduct
False positives: fraud and misconduct are threatening scientific research. High-profile cases and modern technology are putting scientific deceit under the microscope. A scientist carrying out research on an experimental drugs has become the first person in Britain to be jailed for falsifying results over a six-year period between 2003 and 2009.
But now unproven and untested medicines will be fast-tracked so they can be tested on critically ill patients
Drug companies are deliberately withholding the results of adverse clinical trials – putting patients at risk, an MP warned. Dr Sarah Wollaston, a Tory backbencher, said ‘pharmaceutical companies were burying bad news about the effectiveness and side effects of their medicines’. At least one million people a year in Britain are admitted to hospital for treatment after severe adverse reactions (ADR) to prescription medicines. That’s almost 20,000 people a week admitted to hospital because their medication is not safe.
Drug side effects are now a leading cause of death, disability, and illness. Experts estimate that only 1–10% of “serious” adverse events (those causing hospitalization, disability, or death) are ever reported. Not to mention the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s concentration, functioning, judgment, and ability to care.
Drug companies must publish all data – good and bad. Patients have a right to expect independent drug trials free from influence by manufacturers.
But now, pharmaceutical companies could be forced to publish secret research into how drugs are created under new European laws, potentially revealing information about dangerous and unknown side-effects.
There is also the tendency to ‘spin‘, in conjunction with other well-known biases such as publication bias, selective reporting of outcomes, and lack of external validity, may be responsible for an important gap between the public perception of the beneficial effect and the real effect of the treatment studied.
For example: The benefits of the annual flu jab have been ‘over-hyped’, scientists claim. The US researchers say ministers in Britain as well as America are ‘wasting taxpayers’ money’ on the jab.
While Tamiflu has been approved by regulators worldwide and stockpiled by many governments in case of a global outbreak, there is criticism among researchers who say there is little evidence that it works. They have been lobbying the firm since 2009 to pressure it to make public data on clinical trials and some have called for a boycott of the company’s products.
Some clinical trials for breast cancer treatments are being “spun” by scientists anxious to show them in a positive light, according to a new report.
Retracted Scientific Papers due to Fraud & Misconduct
Nearly three-quarters of the retracted drug studies were attributed to scientific misconduct ‘which includes data falsification or fabrication, questionable veracity, unethical author conduct, or plagiarism’. Big Pharma criminality no longer a conspiracy theory: Bribery, fraud, price fixing now a matter of public record.
Retraction Watch highlight this problem in more detail. A study suggesting global warming is exaggerated was rejected for publication in respected journal because it was ‘less than helpful’ to the climate cause, claims professor.
The whole scientific process is a sham or a charade as most medical evidence is either ‘wrong, fraudulent or falsified’. From randomized controlled trials to meta-analysis to peer review the whole scientific process is a ‘sum of flawed parts’ dressed up as science but it’s a charade’. As one leading critic said ‘most medical scientific data or clinical evidence isn’t worth the paper it’s written on.
Deeply flawed research into cancer wonder drug accepted by science journals ‘despite obvious errors’
For example: According to two Merck scientists who filed a False Claims Act complaint in 2010 — a complaint which has just now been unsealed — vaccine manufacturer Merck knowingly falsified its mumps vaccine test data, spiked blood samples with animal antibodies, sold a vaccine that actually promoted mumps and measles outbreaks, and ripped off governments and consumers who bought the vaccine thinking it was “95% effective.”
While a leading British medical journal is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug can actually stop the influenza virus.
A shocking 88 percent of 53 “landmark” studies on cancer that have been published in reputable journals over the years cannot be reproduced, according to the review, which means that their conclusions are patently false. ‘These are the studies the pharmaceutical industry relies on to identify new targets for drug development,” said Begley about the false studies. “But if you’re going to place a $1 million or $2 million or $5 million bet on an observation, you need to be sure it’s true. As we tried to reproduce these papers we became convinced you can’t take anything at face value.” Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid’.
A leading Professor of Clinical Research Design and Analysis says “I cannot help wonder why many people shrug their shoulders when they learn of scientific misconduct and why many scientists don’t care that they deceive their readers repeatedly and betray the confidence society has bestowed on them, whether for a political gain, for fame, for money, for getting research funding or for any other reason. People may keep on being dishonest, may get away with it and may publish in the same journals time and again, to the hurrahs of like-minded people who are often editors of the same journals”.
A research group from McMaster University in Canada, found most papers in medical journals do not reach basic scientific standards. They determined 28 basic criteria that should be met in scientific papers and then examined 4000 papers. The criteria covered issues like study design, quality of data, statistical references, and documentation. They found that only one per cent of the papers met all the criteria.
Publish or Perish
Pressure on scientists to publish or perish has led to a situation where any paper, however bad, can now be printed in a journal that claims to be peer-reviewed. In addition, doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned. Four former executives at Pfizer Inc, the world’s largest drug company — Henry McKinnell, John LaMattina, Karen Katen, Joseph Feczko – as well as Gail Cawkwell, Pfizer’s current Vice President of Medical Affairs, will all face trial for allegedly concealing the unfavorable results of drug trials involving Celebrex and Bextra.
Missing data from clinical trials could and is endangering patients. The British Medical Journal has raised concern that some test results go unreported and are deliberately hidden, enabling pharmaceutical firms to make unfounded claims. This practice has been going on for years in the medical industry. 1. Decide on the desired outcome. 2. Find any evidence that supports 1 above. 3. Hide any evidence that contradicts 1 above. Announce your “findings” as being conclusive.
The US Food and Drug Administration (FDA) has announced that drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval.
‘This means the once bench-mark claims of ‘evidence based medicine’, ‘clinical trialed’ or ‘scientifically proven’ and other such claims are completely misleading as no one knows which parts of the study were ‘real’ and which parts were simply ‘made up or falsified’ as this type of research fraud can take years to discover.
For example: GlaxoSmithKline (GSK) paid $3bn (£1.9bn) in the largest healthcare fraud settlement in US history. The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA). The company admitted a multi-year criminal scheme to hide unhelpful scientific evidence, manipulate articles in medical journals and lavish gifts on sympathetic doctors.
Typical Drug Testing Scenario
A drug is tested in highly artificial conditions, participants are selected from a narrowly specified age range (i.e.30 to 35) with certain symptoms and any hard to treat or server cases excluded from the trial. This cheery picked group are then split into two groups, half receiving the drug and the other half receiving the placebo. The drug only has to show its is marginally better (5%) than doing nothing (placebo) to gain FDA approval after which it is then sold to the whole population as a successful ‘evidence based’ treatment for that general condition. Therefore trials may have internal validity but extremely low external validity when used by the general public, it’s a’ charade’, said one leading critic.
People believe the drugs are effective and safe because they have all been properly tested in clinical trials. But this is a dangerous delusion. Healthy people are being harmed by the trend to ‘overdiagnose’ conditions that will never cause serious symptoms and ‘vested interests’ are also to blame say medical experts.
The pharmaceutical industry is in crisis because companies are rewarded for developing new drugs that have few clinical advantages over existing ones, experts say. They pointed to independent reviews that found between 85 and 90 per cent of all new drugs developed over the past 50 years have provided few benefits and considerable harms.
One of the world’s biggest drug companies is at the centre of an urgent investigation after failing to disclose reports that 15,000 people died while taking its medicines. Swiss pharmaceutical giant Roche failed to pass on a further 65,000 reports of suspected side effects that were recorded by patients.
Drugs such as Prozac were hailed in the early Nineties as wonder pills that would banish depressive blues for good. But in the past five years, growing scientific evidence has shown these drugs work for only a minority of people.
Widespread Research Fraud
Research fraud is so common place it’s almost the norm. Fraud is a particularly serious in science, whose whole purpose is supposed to be the pursuit of truth or knowledge. In the biomedical sciences in particular, a distressingly common pattern of misconduct seemed to be emerging. ‘The health care industry has been monopolised by health fraud’.
Doctor John Ioannidis has based his career on exposing the lies and untrustworthy nature of medical research, and it has made him one of the most celebrated medical scientists in the world. Indeed, Ioannidis worries that the medical research system is so broken that it cannot ever be fixed.
No Legal Credibility
Because of ‘research fraud, simply making it up or getting it wrong’, the legal profession is giving less weight so-called scientific data as ‘credible evidence’ because it is not ‘agreed’ there is always conflicting opinion about alleged scientific data, it is not a gold standard as claimed, it’s a charade.
Peer Review – A Non Validated ‘Charade’
Dr. Horrobin, a brilliant researcher, questioned whether there was “Something Rotten at the Core of Science?” in a 2001 issue of Trends in Pharmacological Sciences . Commenting on an analysis of the medical journal peer review system and a U.S. Supreme Court decision which questioned the authority of peer review, Dr. Horrobin concluded that, “Far from filtering out junk science, peer review [paid review] may be blocking the flow of innovation and corrupting public support of science’ and ‘that peer review might sometimes be flawed, and that therefore this criterion was not unequivocal evidence of validity or otherwise. A recent analysis of peer review adds to this controversy by identifying an alarming lack of correlation between reviewers’ recommendations’.
The U.S. Supreme Court has ruled peer review is ‘flawed’ and is therefore not ‘the sacred pillar of the scientific edifice’.
Peer review has no validated experimental base, and if it consistently refuses open scrutiny, it is not surprising that the public is increasingly skeptical about the agenda and the conclusions of science.
Largely because of this antagonism to openness and evaluation, there is a great lack of good evidence either way concerning the objectivity and validity of peer review. What evidence there is does not give confidence but is open to many criticisms. Now, Peter Rothwell and Christopher Martyn have thrown a bombshell. Their conclusions are measured and cautious, but there is little doubt that they have provided solid evidence of something truly rotten at the core of science.
Forget the reviewers. Just flip a coin.
Rothwell and Martyn performed a detailed evaluation of the reviews of papers submitted to two neuroscience journals. Each journal normally sent papers out to two reviewers. Reviews of abstracts and oral presentations sent to two neuroscience meetings were also evaluated. One meeting sent its abstracts to 16 reviewers and the other to 14 reviewers, which provides a good opportunity for statistical evaluation. Rothwell and Martyn analyzed the correlations among reviewers’ recommendations by analysis of variance. Their report should be read in full; however, the conclusions are alarmingly clear. For one journal, the relationships among the reviewers’ opinions were no better than that obtained by chance. For the other journal, the relationship was only fractionally better. For the meeting abstracts, the content of the abstract accounted for only about 10 to 20 percent of the variance in opinion of referees, and other factors accounted for 80 to 90 percent of the variance.
They concluded that none of the reviewers seemed to agree on anything! Horrobin lamented that, ‘The core system by which the scientific community allots prestige (in terms of oral presentations at major meetings and publication in major journals) and funding is a non validated charade whose processes generate results little better than does chance. Given the fact that most reviewers are likely to be mainstream and broadly supportive of the existing organization of the scientific enterprise, it would not be surprising if the likelihood of support for truly innovative research was considerably less than that provided by chance’.
Horrobin noted that scientists often become angry because the public rejects the results of the scientific process. However, the Rothwell and Martyn report indicates that the public may be on the right track and is waiting for science to do more than just state its superiority but actually put itself to objective evaluation. Dr. Horrobin found that in the midst of the rejection of science by the public there is also the fact that pharmaceutical research is failing. The annual number of new chemical entities submitted for approval is steadily declining. Horrobin concluded that drug companies are merging because of failure; it is not a measure of success.
Prof Joachim Boldt
Medical journals and the peer review process were dealt another huge blow in November 2010 by the fake research of Prof Joachim Boldt. He faked over 90 papers all ‘peer reviewed’ by two or three reviewers (usually experts in the field) and by learned members of 16 different journal’s editorial board. They are meant to accept the paper outright or they recommend changes, either minor or substantial. They can also reject it outright if they think it’s rubbish. So what happened in the case of these 90+ papers? Critics said ‘even the peer review process is a sham, these journals need to be investigated too’.
‘Some journals only require the corresponding author (i.e. the author submitting the manuscript) to electronically sign for all authors by ticking a checkbox on a webpage. Often, the journals don’t even inform you of the fact and it’s only by chance that you find you are listed as an author. Frankly, that beggars belief, given the vital importance of publication in legitimising and validating scientific papers. The problem is most of this junk science is funded by pharmaceutical companies. One can see that the good professor’s studies showing how wonderful these drugs were, seem to have been directly proportional to the financial support he received from the drug companies’.
Furthermore, many critics of allopathic medicine were not surprised by the recent disclosures and widespread practice of ghost medicine meaning that most studies in the medical literature are marketing dressed up as research. For as many as 90,000 published drug trials, a drug company hired a PR firm—a ‘medical education and communication company’ (MECC)—to carry out its clinical trials, engaged a ‘ghost’ to write an article with a positive spin, enlisted a prominent academic to put his name to the paper he’s had nothing to do with—and then succeeded in getting it published in a peer-reviewed journal. And for all those people who ignorantly claim that modern pharmaceutical science is based on “scientific evidence,” just give them these three words: Dr Scott Reuben.
Making It Up
It’s being called the largest research fraud in medical history. Dr Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals. Dr. Reuben [and many others] has made a career out of faking studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.
Not forgetting the scandal regading Prof Joachim Boldt who is at the centre of a criminal investigation amid allegations that he may have forged up to 90 crucial studies [which were all peer reviewed] over the last 10 years. He has been stripped of his professorship and sacked from a German hospital following allegations about his research into drugs known as colloids.
Invalid Drug Trials
A new study in Science Translational Medicine has cast doubt over the scientific validity of nearly all randomized, double-blind placebo controlled studies involving pharmaceuticals used on human beings. It turns out that many pharmaceuticals only work because people expect them to, they are just placebo’s, (Glaxo chief admits: Our 90% of drugs do not work on most patients) not because they have any “real” chemical effect on the body. When test subjects were told that they were not receiving painkiller medications — even though they were — the medication proved to be completely worthless.
Critics say ‘most drugs are engineered to look successful, misrepresented to the licensing authorities and then miss-sold to the public’.
The World Health Organization (WHO) issued a fact sheet [Dec 09 No:335] warning about the corruption and unethical practices that are endemic to every step of the pharmaceuticals business. The medicine chain refers to each step involved in getting drugs into the hands of patients, including drug creation, regulation, management and consumption. According to WHO data, unethical practices such as bribery, falsification of evidence, and mismanagement of conflicts of interest are “common throughout the medicine chain.” Click here to see more.
Regulators are “protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data”, according to researchers in articles published by the BMJ while the ‘widespread selective reporting of research data results means we don’t know the true benefits and harms of prescribed drugs’.
In addition there are undisclosed payments to health advisory groups who are supposed to be independent but often advocate for research and the approval of new drugs on top of promoting public awareness.
Flawed & Manipulated Studies
Highly respected scientists toss out data all the time. They pretty much have to. Douglas Altman, who directs the Centre for Statistics in Medicine in Oxford , examined more than 100 drug studies, comparing raw data and published results. He found that in most studies some data was left out – and more often than not it didn’t fit the conclusions and might raise difficult questions.
In an anonymous survey of 3,200 medical researchers in the journal Nature, a third confessed to at least one fraudulent act or ‘massaging’ research results. In a similar survey, half the research workers said they knew of studies that involved fraud. The proportion that are caught is minuscule. What motivates such surprising levels of dishonesty?
The answer is simple: researchers need to keep on publishing impressive findings in scientific journals in order to keep their professional careers alive, and some seem unable to come up with them through honest work. The ultimate form of data cleansing is throwing away a whole study’s worth of information by not submitting it for publication because the results aren’t the ones hoped for. Often, these ‘lost’ negative results are from studies funded by drug companies – if you are trying to get a medicine onto the market, you don’t want to publish research that makes it look bad, so they only submit the favorable data.
Critics say ‘there isn’t a day goes by without some sort of study being published in the manipulated media claiming one thing or another. The problem is ALL these studies are compromised by cherry picking the data to support the hypothesis or by loading the study with certain types of people. A year or so later another study appears which contradicts the finding of the first and so the cycle continues resulting in conflicting medical advice. This is how the system works and how researchers stay employed. Don’t believe any studies in the media as they are ALL compromised, they are meaningless when you dig a little deeper’.
A good example of manipulating data and meaningless studies is a new salt study which found that low-salt diets increase the risk of death from heart attacks and strokes and do not prevent high blood pressure but ALL studies manipulate their data to support the findings they want, Dr. Peter Briss, a medical director at the centers, said that the study was small; that its subjects were relatively young, with an average age of 40 at the start; and that with few cardiovascular events, it was hard to draw conclusions. And the study, Dr. Briss and others say, flies in the face of a body of evidence indicating that higher sodium consumption can increase the risk of cardiovascular disease.
Most studies are compromised and therefore meaningless but they are portrayed by the scientific community and medical profession as the gold standard however they are just a massive fraud.
Wrong or Fraudulent Studies
Dr John Ioannidis, a doctor and medical research analyst, has looked at hundreds of scientific/clinical studies and discovered that ‘two in every three conclusions published in medical journals are later found to be wrong or fraudulent.
For example: Hailed as the biggest breakthrough in genomics in a decade, the project explained how swathes of DNA once thought to have no purpose and labelled as ‘junk DNA’, actually form a complex “control panel” for our genes.
Marketing Bad Machine
In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It the former editor of the New England Journal of Medicine contends that the industry has become a marketing machine that produces few innovative drugs and is dependent on monopoly rights and public-sponsored research. The majority of the new products the industry puts out, says Angell, are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.”
Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo [see placebo fraud] they can get the regulatory green light. Angell attacks major pharmaceutical industry — whose top ten companies make more in profits than the rest of the Fortune 500 combined — for using “free market” rhetoric while opposing competition at all costs’. A new study estimates that 85 per cent of new drugs offer few if any new benefits while having the potential to cause serious harm due to toxicity or misuse.
As a result pharmaceutical companies are in trouble and generally rely on patentable drugs which they can sell at high prices without having to fear competition as long as the patent holds good. That means, their research – by necessity – has to go further and further away from using natural molecules, those the human body has been exposed to and has learned to live with for millennia.
Instead of searching for better ways to deliver nutrients that help our bodies cope with stress and illness, the pharmaceutical world must look for synthetics, which are patentable but which, more often than not, end up disturbing homeostasis, in an effort to suppress this or that symptom. The real causes of illness are almost never addressed.
As a result, there isn’t s single clinical trial or study that will stand up to independent scrutiny as they all suffer from the same flaws and fraud, such as ‘intimidating scientists, buying scientific endorsements, buying medical influence, cherry picking data to support the hypothesis while ignoring data which contradicts the hypothesis, ghostwriting studies for academic researchers, suppressing studies that may show that a drug could be dangerous, selecting favorable data to publish, showing results that favor one product over another and simply ‘making it up’.
Some studies are simply a rehash of old data, critics said ‘this illustrates the ‘pharmaceutical process’ of marketing drugs with little benefit based upon data supplied by trials funded by the company and written up by employees or person funded by the company, clearly bias and not independent’.
Most experts agree, ‘90% of all drugs trials are engineered for success, the drugs are then misrepresented to the licensing authorities and then miss-sold to the public’.
Example: The evidence for statins can also be made to seem more favourable that it really is. One technique used by drug companies is ‘simply to not say very much about negative findings’, says Dr Shah Ebrahim, senior author of the latest review.
Speaking the Truth = Hate Campaigns
Two Australian doctors identified Helicobacter as a cause of some ulcers. This could be treated by a low cost antibiotic method. This then undermined the market for the drug companies’ palliative continuous treatments to suppress symptoms. The two doctors were subject to a “concensus” hate campaign for some considerable time until their work was properly recognised (incidentally these bacteria were initially sighted back in 1876). There is still considerable resistance to extending their work further because that could further undermine the sales of palliative antacid remedies.
‘Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.” Sir Richard Sykes. House of Commons Health Committee -The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05.
Dr Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them. “The vast majority of drugs – more than 90 per cent – only work in 30 or 50 per cent of the people,” Dr Roses said. “I wouldn’t say that most drugs don’t work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don’t work in everybody.” This goes against a marketing culture within the industry that has relied on selling as many drugs as possible to the widest number of patients.
No Comparative Effectiveness Data
In fact, huge red flags are being raised about how drugs are tested and approved in two new studies, including one just published in the May 4th issue of the Journal of the American Medical Association. A case in point: it turns out that only about half of the new prescription medications pushed onto the market over the last decade had the proper data together for the U.S. Food and Drug Administration – yet the FDA approved them anyhow. The information in question is known specifically as comparative effectiveness data . And it is – or should be – a very big deal when it comes to deciding whether a drug should be approved and sold to the public.
In addition placebo fraud has exposed the foundations of drug based medicine as most [90%] of the thousands of clinical trials over the last five decades must now be completely thrown out as utterly ‘non-scientific’ or ‘evidence based’ rendering the studies ‘scientifically invalid’ and their drugs as ‘unproven’.
Placebo fraud is extremely important because the FDA is most interested as to whether or not the drug is more effective than a placebo. Even if it is only 5% more effective than a placebo, then it can be approved and claim to be ‘scientifically proven’ and/or ‘evidence based’. As there are no rules on what a placebo can be, the pills could have contained an ingredient that adversely affects a patient to make the drug look better in trials and perform ‘better than a placebo’. As most trials never even bother to described the ingredients of their placebo pills to hide any wrong doing, this brings into question the credibility and scientific validity of any clinical trials involving placebos for the last 50 years, rendering the all the studies scientifically invalid.
Clinical Trials on Healthy People vs. Mass Vaccination Campaigns: Tomljenovic and Shaw clearly state the obvious in their abstract by stating that vaccines represent ‘a special category of drugs generally given to healthy individuals and therefore a small level of risk for adverse reactions is acceptable.’
Merck’s clinical trials were flawed because they used an aluminum adjuvant as a ‘placebo’ and only used saline as a comparative for minor, non-serious adverse reactions. With serious adverse reactions, they pooled the results from the saline group and the aluminum ‘placebo’ group. By doing this, they concealed the true rate of serious reactions.
Just a Placebo
Placebos in drug trials are getting more effective and drug makers are desperate to know why. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time. It turns out drug companies are finding it harder to find people who aren’t influenced by all their claims and advertising.
The scientific community also like to attack any non-pharmaceutical treatment on the basis that any positive benefits derived from the therapy can only be achieved through the ‘placebo effect’ rather than by any positive benefits of the therapy or its efficacy, they are of course wrong as the placebo effect applies more to pharmaceutical drugs than it does to complementary treatments.
But now nearly all doctors have given their patients placebos, a study has found. Researchers say 97 per cent admitted giving ‘impure’ placebos – those which have medicinal value but are unproven in the illness they are given for – at least once and impure placebos were considered acceptable by 84 per cent of doctors. Which means the rules for ‘evidence based medicine’ are no longer valid as an excuse to block CAM therapies.
Real World Evidence – Not Scientific
The days of relying on falsified clinical data are over, ‘value-based pricing and risk-sharing agreements will provide hard data on efficacy, the only thing that really matters is how these treatments perform in the real world’.
As one expert said ‘it seems the only evidence you can really trust is genuine ‘anecdotal evidence’. The pharmaceutical industry eventually rely on anecdotal evidence to assess the side-effects of their medications under the Yellow Card Scheme, this seems to be the only credible source of reliable data in the whole process’.
In the legal system, anecdotal evidence is considered the ‘best form of evidence’, now imagine a document that everyone knew had been ‘specially falsified’ with only favorable data and any unfavorable data had been deleted, not only that the document had been prepared with an overly positive spin and then presented by a prominent academic who had nothing to do with it other than putting his name to it, how much weight would the Court allow this document? None as it is meaningless.
However, in the scientific community this is exactly how ‘scientific/clinical evidence’ is prepared, in the legal system it would not even be considered as credible ‘evidence’, yet in the scientific community they consider this type of evidence to be the gold standard!.
How to Compile Scientific Evidence
Do you have any scientific evidence? – So what you want me to do is: test the treatment against something that makes the control group feel worse, employ someone to write up the data (ignoring any negative effects or results) with a positive spin, then pay a top academic to put their name to it even though they have had nothing to with it and then present that information as though it had been complied with the highest ethical standards and you will accept it? – ‘Yes’.
There are two types of evidence:
The main question concerning any scientific evidence should always be ‘What is the real world evidence of the scientific evidence? How does it translate into reality?
Example: The outcome of the ‘scientifically proven’ treatments for drug addiction and dependency was just 4.3% in 2009 however the real world evidence was 0% as the numbers leaving treatment ‘drug free’ are disputed as the terms ‘treatment complete’ or ‘treatment complete, drug free’ are not clinical terms/definitions, critics say ‘it does not mean the person is actually drug free – the terms essentially just record entry into and exit from the NDTMS reporting framework and have no clinical value at all, they are intentionally misleading’.
Medical Fraud – Senate Enquiry
For the past 4 years, the staff of the Senate Committee on Finance (Committee) has been examining allegations of ‘orangised medicine’ that pharmaceutical companies attempt to manipulate science to improve the marketability of drugs, potentially at the expense of public safety. These allegations include intimidating scientists, buying scientific endorsements, buying medical influence, ghostwriting studies for academic researchers, suppressing studies that may show that a drug could be dangerous, and selecting data to publish results that favor one product over another.
They said, ‘the actions and deceptions of the pharmaceutical industry, their executives and scientists are considered the norm and constitute their ‘industry standard’. This includes but is not limited to intimidation of unwilling scientists, deception of regulating bodies, falsification and suppression of evidence. Getting caught is a calculated risk. This is reflected in the fact that the pharmaceutical industry has paid fines and penalties of some $7billion between 2004 and 2009 in the U.S. alone. Glaxo alone set aside £2.3 billion ($3.5 billion) in one year for “legal and other disputes” as of the end of March 2010, to resolve a majority of lawsuits alleging the company’s Avandia diabetes drug can cause heart attacks and strokes.
‘It takes approximately 10 years for any serious side-effects of a drug to be accepted as a probable cause, in that time the drug can earn hundreds of billions of dollars, when it comes to settling any damages, they are only likely to be between $1billion to $2billion, so there are huge incentives to hide any damaging data’ said one expert.
GlaxoSmithKline has agreed to pay a £1.6bn charge to cover settlements and legal actions relating to its diabetes pill Avandia and antidepressant Paxil. Gbola Amusa, an analyst at UBS in London said ‘this is exceptionally good news given the market has discounted $6 billion liability’, for Avandia litigation. ‘We had outlined an absolute worst-case scenario where $500,000 per case would have to be paid’ however they agreed to settle about 10,000 suits for an average of at least $46,000 apiece or just $460 million in total.
Another analyst said, ‘the pharmaceutical industry make Wall St look like the good guys. Goldman Sachs faces U.S. criminal investigation into $1bn mortgage securities fraud which brought the world economy down, it gives you some idea of the scale of the pharmaceutical problem and how much money is involved, some of these guys pay over $1bn a year just in fines, which sounds a lot but it’s nothing in terms of their $750 billion market’.
When it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, the FBI considered Pfizer was too big to nail. But it paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected. It also paid a billion dollars more to settle a batch of civil suits — although it denied wrongdoing — on allegations that it illegally promoted 12 other drugs. In all, Pfizer lost the equivalent of three months’ profit.
But after years of overseeing similar cases against other major drug companies, even Mike Loucks, the federal prosecutor, isn’t sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large. ‘I worry that the money is so great,” he said, that dealing with the Department of Justice may be ‘just of a cost of doing business’.
Numerous U.S. states have or are in the process of filing lawsuits against drug companies alleging that drug companies had abused the Medicaid system and 24 other states have all been involved in lawsuits against Big Pharma as well. Even the federal government has sued drug companies for reimbursement fraud, the lawsuit alleges that drug companies were marking up costs as high as 6000 percent above actual costs.
An open letter from 20 consultants and a patient group published on bmj.com, calls on the Prime Minister to take action over a legal loophole that allows drug companies to make massive profits by re-licensing existing treatments for rare or orphan diseases. Examples quoted are a drug to treat two rare muscle diseases costs £800 to £1,000 per patient per year but costs the NHS £40,000 to £70,000 per patient per year a 50-fold to 70-fold increase and oral ibuprofen for analgesia that costs £0.08 per gram but is later resold to the NHS for £6,575 per gram.
In the U.K. the health secretary has decided to change the way the government pays for its medication, it will now be based on the value they deliver he said ‘we need a much closer link between the price the NHS pays and the value that a new medicine delivers’ rather than pricing being based on falsified clinical data. ‘The data and claims from clinical trials are meaningless, what really counts is the experience of using these drugs and how they actually perform in the real world’ said one expert.
Why is scientific or clinical data so important to demystify? Because it is always used to block non-pharmaceutical treatments from gaining wider recognition and/or availability on the NHS.
The field of modern medicine has been largely reduced to nothing more than a type of reactionary, drug-input system where only synthetic chemicals that induce a specific and narrowly-measurable response are considered scientifically valid but ‘ultimately the NHS’s legitimacy comes from making decisions based on a combination of patients’ needs, budgetary considerations and real-world evidence’.
The Department of Health
Ex-Health Secretary Andrew Lansley said ‘‘We believe in patients being able to make informed choices about their treatments, and in a clinician being able to make informed choices about their treatments. The local NHS and clinicians, rather than Whitehall, are best placed to make decisions on what treatment is appropriate for their patients – including complementary or alternative treatments such as homeopathy – and provide accordingly for those treatments’.
Health Secretary Andrew Lansley said ‘the NHS will now be judged on patients’ feedback on care’ and not scientific data as it is now.
As the NHS will now be judge on ‘real world evidence’, critics say ‘the demand for scientific evidence is much over-stated and over-rated – in fact, all the evidence proves the ‘evidence based’ treatments for addiction and dependency do not work while treatments that do work are blocked by those with ‘vested interests’ by using the out-dated argument ‘they are not scientifically proven’.
This argument is wrong on many levels, the most obvious being the current system (to prolong the problem and safeguard jobs) has ‘not been scientifically proven’ either and ‘scientific medical evidence’ from drug trials is the least credible evidence. Also 30 per cent of hospital admissions require surgery but only 2 per cent of medical research funding goes into testing whether surgical procedures have a scientific grounding so the ‘clinical data’ and ‘scientific evidence’ arguments are merely smoke screens to stop alternative treatments from gaining any recognition, in fact most medical procedures (80% to 90%) have not been ‘clinically trialed’ and/or are not ‘evidence based’ either.
NHS – Patient Feedback
The government is now moving towards ‘real world evidence’ as a true reflection of treatment outcomes and care. No other treatment center in the UK has more or more comprehensive client feedback than us, making us the UK’s No 1 choice for treatment help to stop smoking, stop drinking or stop using drugs.
Critics say, ‘most medical scientific evidence isn’t worth the paper it’s written on, the next time you hear someone say it’s ‘scientifically proven’ or it’s not ‘scientifically proven’, you will know this argument is complete nonsense. What counts is how these treatments perform in the real world’. After all ‘EBM is not restricted to randomised trials and metaanalyses. It involves tracking down the best external evidence with which to answer our clinical questions’. What Evidence in Evidence-Based Medicine by John Worrall
However all that changed in 2014 when changes for evidence based medicine ‘lobbied for by the pharmaceutical industry as too many drugs were failing in trials so as to by-passes that stage and put patients at risk of untested and unproven drugs. The argument for evidence based medicine is well and truly dead’.