Before we take a new drug, or give a prescribed drug to a loved one, we usually read the pill bottle to make sure this is the proper medication for our problem. In addition, we refer to the folded information pamphlet that accompanies our pill bottle, to review the trials and tests performed in the creation of this drug, as well as reading about any and all side effects.
But what would you do, and how much apprehensive would you feel, if I were to tell you that you might as well throw the pamphlet away, unpeel the pill instructions from the pill bottle, and disregard any information in regards to that pill?
That is the predicament we have found ourselves in, thanks to “publication bias,” which is where negative results are left unpublished, so they cause no drawbacks in rolling out this pill to the masses.
There has been lots of well-documented evidence that prove publication bias, depending on who is conducting these trials. When comparing industry-funded trials to government-funded trials, the results are jaw-dropping. This “research about research” has led to an alarming and very dangerous situation, and as we are learning more about this very scary, yet very real problem, we sit, dumbfounded, not knowing who to blame or how to fix the problem.
It is easier to conceptualize if some examples and statistics are given, so let us take a moment to detail a few instances of publication bias in action, looking at two factors: whether the trial results were positive, and whether they were funded by the industry.
In 2006, researchers examined every single trial conducted in four separate academic journals over a four-year period, focusing only on psychiatric drugs. Of the 542 total trial outcomes, 78% (or 422.76) yielded favorable outcomes for industry-sponsored trials, whereas independently-funded trials only yielded positive results in 48% (or 216.8).
In 2007, researchers followed this same method for statin’s, which are a class of drug used to lower cholesterol levels, essentially reducing the risk of heart attack. Of the 192 statin trials conducted, they discovered that industry-funded trials were 20 times more likely to favor the test drug, which compared statins against another, or against a different kind of treatment.
This publication bias does not appear to be slowing down anytime soon, either. In 2010, three Harvard and Toronto researchers compared all the trials of five major drug classes, such as antidepressants and ulcer drugs. 85% of the 500+ trials (425+) of the industry-funded studies were positive, compared to a measly 50% (250) of the government-funded trials. These two numbers are too far apart to be acceptable, and it is solely because of publication bias.
The problem isn’t that these drugs companies are lying. They are simply presenting the trial results that benefit their company, choosing not to show the detrimental results to the public.
In an attempt to prevent these industry-funded trials from using publication bias, researchers came up with the systematic review process, which is where they take a scientific approach, and publish every result, whether it is beneficial or detrimental.
Studies using this systematic review process in 2007 showed that over a four-year period, 18 of the 20 published reports were more likely to report positive results in industry-sponsored trials.
Now that we have the information laid out in front of us, we should be asking, “why? Why is it that industry-sponsored trials almost always yield a positive result?” And the answer is a combination of factors. Sometimes, trials are flawed by design, and until we test them out, we are unsure that they will fail. The companies conducting these studies can intentionally sift through potential patients, looking for patients that are naturally better candidates for the drug being tested. Although this isn’t lying, it is intentionally skewing the results in their favor. They can compare the drug with a placebo sugar pill that does nothing, or compare the drug to a drug they know is worse, or at an inadequate dosage. They can review the results in real-time, as the studies are being done, so that they can abandon the trial if they benefit the researcher.
This problem may have reached the dreaded cliché, “past the point of no return.” But what does this mean? The medical field has used this publication bias for such a long period of time that we cannot simply just vow to wake up tomorrow and make a permanent change in the right direction. Doctors, practicing medicine and dedicating their time to helping their patients get better, are innocently making informed decisions on what they believe to be the best possible treatment, but they are relying on the very falsified, fixed, and skewed trial results we have been discussing in detail.
Still not convinced? Let’s discuss a few drugs in detail, and demonstrate the magnitude of the problem.
Reboxetine is an antidepressant drug used to treat depression, anxiety, panic disorder, and ADD/ADHD. At one point, it went head-to-head in leading competitor studies, and was better than any placebo, approved for use in the United Kingdom by the Medicines and Healthcare products Regulation Agency (MHRA). On its surface, it seemed as though it were an effective and safe drug, prescribed worldwide by the millions each year.
But, in 2005, a group of researchers gathered all the trials ever conducted on Reboxetine, and crunched the numbers. Seven trials compared Reboxetine against the placebo, and only one trial in 254 patients yielded a positive result, published in an academic journal for doctors and researchers to read. Six more trials were conducted in almost 10 times the number of patients, and they all showed that Reboxetine was essentially the equivalent of a placebo sugar pill; yet none of these studies were published.
Doctors prescribing Reboxetine only had the one positive study to analyze in their determination of the drug’s effectiveness. There’s no question that in the instant the other six studies were published, the doctors would have had second thoughts.
Studies comparing Reboxetine to competing drugs yielded the same result: 507 patients in three studies showed Reboxetine was just as good as the other drugs, and, of course, all three studies were published. Yet 1,657 patients’ data was never published, and sure enough, this unpublished data proved that Reboxetine did worse than the other drugs on the market.
The same pattern was true of Reboxetine’s side effects, too. Patients who took Reboxetine were more likely to develop side effects, more likely to drop out of the experiment, and more likely to discontinue use, when there were safer, more effective drugs to be taken instead.
As we mentioned previously, the problem isn’t only that the companies and researchers conducting these trials are using publication bias in their favor; it is also the fact that the doctors are relying on half truths, and prescribing medications (with their best intentions) that are harmful to the patient.
The only thing a doctor can do when analyzing the possible drug treatments for a patient is to rely on evidence, research, and testing done by third parties before these drugs are given the “okay” to prescribe. But if all of the data is not released and published, we will never get anywhere in solving this problem. If I am trying to convince you of something, and I present you with half of the evidence, evidence which you are unknowledgeable about, I can successfully hide the other half of the evidence from you, the half that would prevent you from believing me.
So why are these drug companies getting away with this? Shouldn’t they have a conscience? Don’t they have any morals or an ethical code? Simply put, the answer is that it is because they can get away with it. They are not breaking any laws in doing so, and they are continually growing financially by the sale and market of these drugs.
But legal or not, these drug companies should not be allowed to get away with this. They aren’t just skewing numbers and helping sales; they are affecting the livelihood of real-life people; people who trust that these companies are producing drugs that do exactly what they say they do. Whether information about a drug could potentially lead to the patient choosing a different brand, or even an entirely different treatment method, the patient should have the right to weigh all the information and make an informed decision with their doctor.
This is a subject matter that is quite alarming, and many of us may not have even been aware of how serious this problem is. We’re curious as to your thoughts on this story. How has this story affected you and your loved ones? Are you indifferent? Will you try and do your own research and see more statistics from other drugs?
Feel free to comment on this blogpost, or contact a Gacovino Lake attorney at 1-800-246-HURT (4878)for more information.