We work with a lot of people who have suffered serious, sometimes life-threatening injuries after taking medication or having a medical procedure that they thought was safe. Two questions we hear most often are—Why would my doctor recommended an unsafe drug or procedure? And how is it possible that this unsafe drug or procedure got on the market in the first place?Sometimes the answer to these very reasonable questions is the publication bias of clinical trials.
Clinical trials are part of the research and testing that’s done to ensure a drug or procedure is safe. Volunteers raise their hands to be test subjects to evaluate the drug’s safety and side effects. Researchers then (ideally) conduct a fair study, record the results, submit them to the Food and Drug Administration (FDA) for approval, and publish the findings in medical journals. But it doesn’t always go that smoothly…
Publication bias essentially refers to an organization or company choosing to publish only the positive results of a clinical trial—the results that show a drug is likely safe and effective for its intended use. This makes it less likely that the public (you and your doctor) will see the negative findings—the ones that show that the drug is maybe not as effective or has serious or even fatal side effects. Although the FDA does see the results of all clinical trials, not all of the data is made public.
See, it is possible (even likely) that your doctor did not know that he prescribed a medication that was unsafe, or recommended a procedure that could cause you serious harm. Perhaps if the manufacturer published the findings of their clinical trials, your doctor would be better informed about the best options for your treatment.
Studies show that the impact of big pharma funded trials is severe. For example, one study found that pharma-funded studies report positive results of the drug being tested 78% of the cases, while independent bodies report positive results of a drug in 48% of cases. It is unlikely that industry-funded trials just happen to get positive results that much more than independent scientific bodies. What is more likely is that pharmaceutical companies are choosing to only publish the positive results of their studies so that they can benefit from selling their products.Cherry-picking results in this way can lead to major losses and even death. By only showing the medical community the positive outcomes of testing and neglecting to share the negative outcomes, many patients are at risk of experiencing the kind of dangerous effects that lie in the hidden trial results.
Under the US Food and Drug Amendments Act, all clinical drug trials submitted to the FDA must be made public on ClinicalTrials.gov within one year of trial completion. Although, there are very few details (if any) of the experiment or the findings of the trial listed on the site. In order to get that information, the medical community refers to medical publications. But a study done by PLOS medicine found that only half of those studies are actually published, giving the medical community a dismal understanding about the effectiveness of the drug.
