By Dr. Mercola
When your physician writes you a prescription, you probably assume that it has been scientifically proven to be both effective and safe.
This is the basis upon which the modern medical paradigm revolves... break this revered tenet and the entire system comes crashing down.
Well, let me tell you, the walls are already crumbling; the system is nearing collapse, as all is not what it seems on the medical forefront as it pertains to science.
You see, those little blue pills, or red ones, or white ones or whatever color or shape they may be, may very well have been the subject of a multi-million-dollar, double-blind, placebo-controlled study. Perhaps even multiple studies.
But that means very little when it comes to protecting your health, as the system is set up so that drugs can virtually never fail.
Science is Regularly "Tweaked" in Favor of the Drugs – NOT Your Health
In an extract from his book Bad Pharma, Ben Goldacre highlights how drugs enter the market and are promoted as effective by pharmaceutical companies and doctors, even when trials have shown then to be ineffective and, often, unsafe.
He first used the example of reboxetine, an antidepressant. He had read the trial data, which suggested the drug was better than a placebo and as good as other antidepressants on the market. But that was because he had reviewed the one study that had been published in an academic trial.
There were six others as well, but none of the data had been published. Why? Because they all showed that reboxetine was no better than a placebo. Other unpublished data on the drug showed it was less effective than other drugs on the market, while posing a greater risk of side effects. No right-minded physician would prescribe this drug to a patient if he or she saw the whole picture. But the whole picture very rarely gets seen.
"Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us.
...Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects."
Regulators See Most Trial Data – But Even That Doesn't Translate to a Safe Drug Market
Regulators are given access to most trial data from drug companies from early on in the drug's development. Trial data is often shared only behind closed doors with the regulators, who then make a decision about the drug's future. Conflict of interest, intimidation and fraud have all played a role in why various drugs have made it past regulators even when the data showed clear evidence of harm.
One of the most glaring was Avandia, which was on the market for years before a study by cardiologist professor Steve Nissen came out in 2007 showing a 43 percent increase in the risk of heart problems among patients taking the drug. This study was based on data that regulators had access to for years, and, in fact, the drug's maker, GlaxoSmithKline (GSK), had also conducted studies using this data in 2005 and 2006 – but conveniently didn't publish them until 2008.
"Nissen used the rosiglitazone (Avandia) data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines," Goldacre wrote.
Industry-Funded Studies Far More Likely to Have Positive Results
Overall, meta-analyses looking into whether industry funding is associated with positive results shows that an industry-funded study is about four times as likely to yield favorable results. One study even found that every trial they reviewed favored the drug of the study's sponsor.1
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.
The fact is, there are many ways to turn an otherwise negative study positive:
- Design bias or rigging the study to have more favorable results from the start, such as by comparing the drug to something you know doesn't work as well, such as a placebo or another drug at the wrong dose
- Choosing study participants who are more likely to benefit from the treatment
- Stopping the trial early if results look good (even if they would take a turn for the worse in a few more months or years)
- Hiding, or simply not publishing, negative results; in fact, researchers of industry-funded studies often sign gag orders that forbid them from publishing, discussing or analyzing data without permission of the funder
"Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell.
Will this drug kill patients? Is there any evidence that it's dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence," Goldacre continued.
Drug Companies are Not Always Legally Obligated to Disclose Serious Side Effects
Drugs are oftentimes prescribed for so-called "off label uses," uses for which the drug hasn't been specifically approved, but which physicians can (legally) prescribe them for nonetheless. In order for the drug to become "official" for a certain off-label use, they must conduct additional safety studies to be submitted for approval.
But if serious side effects come up during those studies, the company is not legally obligated to notify anyone – even if the drug is being used extensively for that purpose.
For instance, GSK conducted trials of its antidepressant drug paroxetine (Paxil) on children between 1994 and 2002. The studies not only showed no benefit, but also suggested it may increase their risk of suicidal tendencies. But GSK made no mention of the findings, even though tens of thousands of children were receiving the drug off-label, until 2003 (and even then they mentioned it in passing at a meeting discussing another issue, Goldacre reported).
Time and time again, we're seeing that the drug industry is not concerned about protecting and bettering human health as they would have you believe, but rather is devoted to protecting their bottom line. The pharmaceutical industry as a whole has become the poster-child for fraud, deception, and manipulation of science for profit. Nearly 20 percent of the top 100 Corporate Criminals listed for the 1990s were in fact drug companies!
The Scientific "Well" Has Been Poisoned …
Getting back to my original point... when your physician prescribes you a medication, even if he or she has reviewed the relevant published data, there is virtually no way to know whether that drug is truly safe or effective. The well from which that data has been drawn has been "poisoned" so that it's nearly impossible to decipher what is real and what is a fabrication. Goldacre continued:
"Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us."
Since it is very well established that most prescribed drugs do absolutely nothing to treat the cause of disease, it would be prudent to exercise the precautionary principle when evaluating ANY drug claim, as it will more than likely be seriously flawed, biased, or worse... And, of course, I always advise taking control of your health, which you can easily do by reviewing my comprehensive nutritional plan that summarizes my thirty years of clinical experience and treating 25,000 patients. I put this together so you can stay well and avoid falling into the dangerous, deceitful traps discussed in this article.