By Dr. Mercola
Exposure and concerns over medical research fraud is on the rise, and for good reason. Publication bias — the practice of selectively publishing trial results that serve an agenda — represents a “systematic flaw of the scientific basis of medicine,” Ben Goldacre says in his TED Talk above.
Indeed this issue is a very serious one, and I agree with Goldacre’s assertion that it is “a cancer at the core of evidence-based medicine.” It undermines and negates everything modern medicine prides itself in.
In recent years, we’ve discovered that fraud can occur anywhere. Even at the best institutions.
Even if a drug or treatment is “scientifically proven,” the examples highlighted by Goldacre make it crystal clear that this simply is not a guarantee of safety or effectiveness.
Likewise, if an alternative treatment has not been published in a medical journal, it similarly does not mean it is unsafe or ineffective. There's much to be said for the ancient tried-and-true remedies, even if they've not been rigorously studied by a modern researcher.
What Gets Published, and What Doesn’t?
I am a firm believer in the scientific method, provided it's applied appropriately. And that's the key issue here. In order to qualify in the first place, the research must be unbiased, unprejudiced and free from any significant conflicts of interest. Sadly, this is simply not the case with most of modern medicine — especially notwhen it comes to drug research. It is clearly the exception and not the rule.
In the talk above, and in two recent articles published in Salon1 and The New York Times,2 Goldacre offers a number of examples of publication bias, which is pervasive across all fields of medicine. Both articles are excellent, and I recommend reading both of them if you have the time, along with his 13-minute long talk above. Bias can take a few different forms, such as:
The Industry Doesn’t Pay for Negative Results
Scientific fraud and/or the misuse of science to further a preconceived commercial agenda is so rampant today that it can be quite tricky to determine what's what. One key factor you'd be wise to consider is who paid for the study?
It's well-established that the source of funding can significantly skew research results, as those who pay generally want the research to be of benefit to them, one way or another. Truly independent research that is not funded or executed by any person or group with a financial stake or interest in the results is, generally speaking, the most trustworthy. Although sometimes you may have to do some sleuthing to determine whether the research might have hidden ties or agendas.
In the New York Times, Goldacre writes:
“There is one last study I’d like to tell you about. It turns out that this pattern of industry-funded trials being vastly more likely to give positive results persists even when you move away from published academic papers and look instead at trial reports from academic conferences, where data often appears for the first time...
When Negative Results Go 'Missing in Action'
Publication bias is profoundly serious, because the end result is that people frequently will die if they are making choices on inaccurate information and recommendations. Research does not exist in a vacuum. Published studies are used by doctors and health agencies as the basis for making recommendations and writing prescriptions. When they’re given a radically skewed picture of the facts, how can they make sound recommendations?
According to Goldacre, negative results missing in action cuts to the core of publication bias. When negative results are suppressed, people die. Sometimes in very large numbers.
In 1980, a study was done on a heart arrhythmia drug called lorcainaide. It included 100 people. Half of them received the drug; the other a placebo. Among those who received the drug, 10 died, compared to just one death in the placebo group. The trial was stopped and the drug was abandoned. The results of the study were never published. Over the next decade, other pharmaceutical companies created and marketed similar drugs to treat arrhythmia in heart attack patients. An estimated 100,000 people died before the deaths were finally traced back to the drugs. This case is now used as a perfect example of the price of publication bias, as the publication of those negative results could have provided an early warning.
Currently, the science behind the flu drug Tamiflu is also M.I.A., which should concern every citizen in every country that recommends it and stockpiles it in anticipation of a flu pandemic. Remarkably, eight of the 10 studies on Tamiflu have never been released for review, despite years of effort.
The Cochrane Collaboration conducts and publishes analyses of the scientific evidence supporting the use of various drugs and vaccines. They are considered the "gold standard" of independent scientific reviews, so when they issue a report, you're well advised to pay heed because it's free of conflict of interests and therefore very objective. I've previously discussed a number of their reviews on flu vaccines that have shed light on the sheer lack of scientific data supporting the claim that flu vaccines are a safe and effective means of preventing seasonal influenza.
Last year, Cochrane decided to update previous reviews that might have a bearing on influenza management, which includes Tamiflu. The previous assessment of Tamiflu was done in 2009. At the time, the group was unable to get Roche, the manufacturer of Tamiflu, to release eight of the 10 clinical trials involving the drug. The review therefore concluded that:
"Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza. Independent randomized trials to resolve these uncertainties are needed."
Years later and faced with continued stonewalling, Cochrane in collaboration with the British Medical Journal decided to take the issue to the public. The BMJ Open Data Campaign5 was recently created in an effort to force transparency as Roche continues to refuse to release the data from eight out of 10 clinical trials on Tamiflu. The campaign site contains links to Cochrane's correspondence with not just Roche, but also with the CDC and WHO — all of whom appear to be complicit in this scheme to massively promote a drug without scientific support for doing so.
The Depressing Research on Antidepressants
The antidepressant Reboxetine is another example of how negative results jeopardize the health of patients. Goldacre had a patient who found no relief from other antidepressants, so after doing his research, he put the patient on Reboxetine. However, they’d both been sorely misled.
As it turns out, while seven studies had been completed on the drug, only ONE was published — the one showing a favorable result. Six studies showing negative results were never published, and were therefore not taken into consideration when Goldacre suggested the drug to his patient. Three trials comparing Reboxetine against other antidepressants had also been published, in which the drug was found to be as just as good as the others. However, three times as many patients’-worth of data was collected, but never published, showing that Reboxetine was worse than other antidepressants, and that patients suffered more debilitating side effects on it.
“I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them and I discussed them with the patient. We made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill, and worse, it does more harm than good. As a doctor, I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished...
Publication bias has been well studied — over 100 of them have been done. And they all testify to the fact that publication bias is very real, and very serious. For example, researchers looked at all trials submitted to the FDA during the approval process of 12 different antidepressants. They found 38 positive results, and 36 negative ones. That’s just about 50/50 going either way. But guess how many of these studies could be found in the published medical literature after the drugs were approved? Thirty-seven of the positive studies were published, and only THREE of those with negative findings. This is a staggering difference, and this publication bias is no doubt having a profoundly negative impact on patients.
Fake Fixes Frequently Fatal
So, is anything being done to remedy this pervasive, ongoing problem? In the New York Times, Goldacre writes:
“The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day. But in 2012, the British Medical Journal published the first open audit of the process, which found that four out of five trials covered by the legislation had ignored the reporting requirements. Amazingly, no fine has yet been levied.
Real Fixes are What is Needed
The last point is an important one. In order for modern medicine to be “science-based” we have to go far enough back to include ALL the research for ALL the treatments that are currently IN USE. Otherwise, we’re operating on quicksand. As Goldacre states in his TED talk:
“I don’t know what world it is in which we’re only practicing medicine based on trials completed in the past two years.”
Fixing the problem and returning science-based medicine is easy though. According to Goldacre, we must:
Take Control of Your Health
It's important to understand that our current medical system has been masterfully orchestrated by the drug companies to create a system that gives the perception of science when really it is a heavily manipulated process designed to convince and deceive you to use expensive and potentially toxic drugs that benefit the drug companies more than they benefit your health. Across the board, drugmakers do an excellent job of publicizing the findings they want you to know, while keeping studies that don’t support their product hidden from you and the medical community.
It's important to realize that all research is NOT published. And it should come as no surprise that drug studies funded by a pharmaceutical company that reaches a negative conclusion will rarely ever see the light of day...
What this means is that even if you scour the medical literature to determine what the consensus is on any given medical topic, what you'll find is an overwhelming preponderance of data in favor of the drug approach that in no way, shape or form reflects the reality of the scientific investigation that went into that specific drug. With so much data missing in action, what does the claim “scientifically proven” really amount to? It certainly cannot be construed as a guarantee of safety or effectiveness...
I recommend using all the resources available to you, including your own common sense and reason, true experts' advice and experiences of others, to determine what medical treatment or advice will be best for you in any given situation.
Sources and References
1 Salon January 27, 2013
2 New York Times February 1, 2013
3 Nature March 28, 2012; 483(7391):531-3
4 Journal of Medical Ethics 2011; 37: 249-253
5 BMJ Open Data Campaign
6 Salon January 27, 2013