By Dr. Mercola
The gold standard for modern medicine is the double-blind, placebo-controlled and randomized trial. But there are serious problems with many published studies, unknown to most, but acknowledged by researchers.
The modern medical paradigm revolves around two words: scientifically proven. It is this phrase that public health agencies, physicians and researchers use to promote their products.
Scientists can easily set up a study that shows a drug is effective for a very limited period of time. Unfortunately, the process of scientific study and research has been masterfully orchestrated to create the perception of science while being heavily manipulated.
I believe the scientific method works when it's applied appropriately and executed in an unbiased and unprejudiced manner. However, this has not been the case with many studies. Publication bias, or the practice of selectively publishing results that serve an agenda, is a serious flaw that affects your health care.
Physicians make recommendations for medications and lifestyle choices based on the results of studies published in major medical journals. Unknowingly, they may be offering advice based on biased research that won't stand the test of time, such as the 60,000 people who died taking Vioxx.
Vioxx was approved by the U.S. Food and Drug Administration (FDA) after the safety and efficacy of the medication was "scientifically proven" for the treatment of rheumatoid arthritis. The number of deaths that may be attributed to Vioxx may even be grossly underestimated.1,2
'Sense About Science' Defends the Big Guys
As mistrust of the scientific community continues to rise, a self-appointed organization stepped up to the plate to anoint themselves as purveyors of truth and guardians of solid science.
Sense About Science began their quest in 2001 as a charity-based organization led by Dick Taverne, to "advocate and support public interest in sound science, and to encourage scientists to participate in public discussion,"3 and "expose bogus science."4
While their published undertaking appears well-meaning, actual activities reveal another agenda. The London and U.S. based offices present themselves as a trustworthy intermediary who claims to champion transparency.
In a recent op-ed, director Tracey Brown downplayed concerns about industry funded studies, suggesting the question is asked by people with an ax to grind.5
It may be that Sense About Science has its own ax to grind as their founder, director of the American-based group, and associated organizations all appear to have their own affiliations with large industries, including tobacco, food, communications and pharmaceutical companies.6
In the same year that Taverne argued in Britain's House of Lords that solar activity triggers 80 percent of global warming,7 British Petroleum contributed £15,000 to the organization, even though the theory of solar activity and global warming had been discredited two years previously.8
Asbestos and E-Cigarettes Only 2 of Many Chemicals Championed by Sense About Science
Considering the background of the organization, their backing of large industry-supported studies should come as no surprise. Most people would urge caution with chemicals having no long-term safety history. However, Sense About Science appears to have the opposite view.
In other words, unless there are studies to demonstrate a negative effect on health, then health officials should not urge regulation. E-cigarettes are just one of the products promoted by the tobacco industry which Sense About Science believes should remain untouched by regulators.
The rapidly rising popularity of e-cigarettes is concerning,9 as nicotine has demonstrated poor health outcomes10 and the more than 7,000 flavoring chemicals have not demonstrated safety when inhaled.11 Sense About Science challenged research demonstrating the effects of nicotine, dismissively stating:
"The same effect is generated by watching a thriller or a football match or sitting an exam."
The organization also promotes anti-regulation on asbestos, long proven a human carcinogen.12,13 Using the "toxicity depends on dose" rule, John Hoskins, Ph.D., toxicologist for Sense About Science, writes:14
"Away from the high doses of occupational exposure a whole host of unwanted chemicals finds their way into our bodies. Most leave quickly but some stay: asbestos and silica in our lungs, dioxins in our blood. Do they matter? No!"
Hoskins' resume reveals his relationship with the Chrysotile Institute, which mines a variety of asbestos. This was not disclosed in an article he co-authored disputing claims that chrysotile causes a rare cancer. When those ties were exposed, the journal issued an error report to disclose his conflict of interest.15
Health Care Decisions Seriously Skewed as Negative Studies Often Remain Unpublished
Publication bias affects every field of medicine and positive findings are twice as likely to be published as negative findings, according to Ben Goldacre in his TEDmed talk in the video above.
Not knowing the true or full effects of the treatments and medicines prescribed can have serious health ramifications for vast numbers of people.
While Sense About Science defends research published by large industries, much of the research conveying negative results remain unpublished once the study has been concluded. In fact, nearly half of the clinical trials by drug companies have not come to light in the past decade.16
To bring this information to the public, Sense About Science, participating with other groups, launched a new online tool17 created and published by AllTrials.18 The percentage of research results that go unpublished or unreported is now easily found.
For instance, since 2006 the Alliance for Clinical Trials in Oncology initiated 160 trials and published 31, meaning the results of 80.6 percent of their trials were never published.
Two drug companies hold first and last place with Shire, a biotech which published all of their results since 2006 when the tool started tracking results, and Ranbaxy Laboratories Limited, which didn't publish any of the trials they completed.19
Far from being an academic exercise in who completes their homework, the lack of published results impacts your health care and the prescriptions your physician chooses. Amid claims of unsafe drugs, litigation revealed some drug trial results were never released or published.20
The effort of AllTrials and trial litigation prompted some researchers to sift through research determining the safety of antidepressant drug Paxil when GlaxoSmithKline newly released the research results. What they found was evidence that contradicted the company's claims the drug was safe for teens.21
Interpretation of Scientific Research Can Be a Complicated Affair
The Paxil safety review is just one example of how companies can manipulate sales and the marketplace.22 Former editor-in-chief of the New England Journal of Medicine (NEJM), Dr. Marcia Angell, believes the record may also be distorted by what is not said as much as what is published. She commented:23
"Any reputable journal is at the mercy of what is submitted to it and must choose from whatever comes over the transom. Many studies never see the light of day because their findings are negative. There is a heavy bias toward positive studies, and this negative bias is a real problem. A company may conduct 1,000 trials; if two are positive, they get FDA approval and are published. The other 998 never see the light of day."
The research that is published may also not reflect enough of the results for a reader to draw an accurate conclusion. When the experimental group is smaller or the research measures smaller differences between the experimental and control groups, when there is a greater flexibility in the definition, outcome and design of the study or when there is financial interests or prejudice in the researcher, the results may not be accurate.24
In his evaluation of the accuracy of research, lead author Dr. John Ioannidis enters into a lengthy appraisal of the development, bias and criteria used in current scientific research that has guided physician decisions regarding medication, surgery and other treatment modalities. What he found was disheartening.
Biomedical Research Conclusions May Be Exaggerated or Flat-Out Wrong
Ioannidis (pronounced yo-NEE-dees) is one of the world experts on the accuracy of medical research. He and his team have demonstrated that many of the studies published today are inaccurate, exaggerated or just plain wrong in their conclusions. He believes that researchers have an obsession with winning funding that has ultimately weakened the reliability of the research. He says:25
"At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded. There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded."
Ioannidis developed a model that predicted 80 percent of non-randomized studies, 25 percent of randomized trials and 10 percent of large randomized trials eventually turn out to be wrong. The reason for this staggering rate of scientific failure goes back to the fact that if a researcher is sufficiently convinced or incentivized to show a certain outcome, they can — provided there's even a little wiggle room in how the evidence is assembled.26
His article published in PLoS Medicine spelled out his belief that researchers were chasing findings that could advance their careers and manipulating data analysis to achieve their results. Doug Altman, is a medical statistician and researcher at the University of Oxford who directs the Centre for Statistics in Medicine. He commented:
"You can question some of the details of John's calculations, but it's hard to argue that the essential ideas aren't absolutely correct."
This is a viewpoint that appears to be held by, or at least is a concern of, many of his peers. As noted by The Atlantic in 2010, Ioannidis' paper on the subject was at that time the most downloaded in the journal's history."27
Peer Review Process May Not Be Valuable to Study Conclusions
Although the peer review process may be valued by scientists and science journalists, some researchers have admitted that process may be biased, erroneous and even fraudulent as well. The goal is to have research reviewed by peers in the same field to attest to the validity and accuracy of the study. However, in a 2006 editorial, science journal Nature stated:28
"Scientists understand that peer review per se provides only a minimal assurance of quality, and that the public conception of peer review as a stamp of authentication is far from the truth."
The editor went on to make recommendations to improve the currently flawed and sometimes dishonest system of reviewing research for publication. The process may pressure researchers to build on previous findings instead of working on new ideas. Publication in a prestigious journal is key to academic advancement and garnering limited funding for grants and jobs.29
Ioannidis assessed 49 of the more highly regarded findings in medicine over the previous 13 years. These were papers that were widely cited in research and appeared in professional journals. These particular papers also led to treatments such as post-menopausal hormone-replacement, and using coronary stents and low-dose aspirin to prevent heart attacks.
With these 49 articles, Ioannidis determined that 45 claimed to uncover effective interventions, 34 of those claims had been retested and 14 were convincingly determined to be wrong or exaggerated. In essence, nearly one-third of what the medical community believed was the best research was actually wrong. If nearly one-third of all primary research is untrustworthy, and many researchers are only building on previous findings, that percentage may be drastically higher.
Ioannidis believes these problems with medical research could be solved if people stopped expecting science to be right all the time. Science and medicine are practiced and are akin to an art form. Science is the systematic organization of a body of knowledge, and not a mathematical certainty.
It requires being wrong, with mistakes openly discussed and evaluated, to move knowledge forward. When research is disguised as success to forward a career, then all of humanity suffers. Until careers are not contingent on producing "correct" research, then scientists will likely opt to continue to deliver results that further their lifetime contribution and do not jeopardize their potential future career.