Something strange is happening, and it’s only happening in America. Fake drugs used in clinical trials, known as placebos, appear to be getting more and more effective, which is making it harder for real drugs to pass the trials designed to see if they work or not. These odd findings were the result of a new analysis in the journal Pain, which looked at medical studies going back to 1990.
Placebos are used as controls in pharmaceutical research to give researchers something to compare to the results of the drugs under study. After studying the outcomes of 84 clinical trials of drugs performed all over the globe from 1990 to 2013 researchers from McGill University announced that people who are taking placebos in studies today report more pain relief than those who took them in studies 25 years ago. Over that period, the pain relief experienced by patients in the placebo group improved steadily, reaching an average 30% decrease in pain levels by 2013. Comparable increases in placebo response have earlier been witnessed in clinical trials of antidepressants and antipsychotic drugs.
Trying to Explain the Results
Interestingly enough the McGill analysis found the increase in placebo responses occurred only in trials led solely in the U.S., this geographic separation wasn’t part of the studies around antidepressants and antipsychotics. Trials led in Europe or Asia displayed no changes in placebo responses. One difference between the US and Europe and Asia? The US allows drug companies to advertise directly to consumers, (New Zealand is the only other country that allows direct advertising).
The scientists are postulating that part of the explanation may be that people today have higher hopes about drugs, based on the increased exposure to information about clinical trials and drug research in media and the pharmaceutical marketing. Based on that type of information people expect to feel better when they’re participating in an expensive drug study.
Another factor could be that clinical drug trials have been growing in number and length over the last twenty years. In the U.S., but not elsewhere, trials are becoming longer (from an average of four-weeks long in 1990 to 12 weeks in 2013) and larger (from an average of fewer than 50 patients in 1990 to an average of more than 700 patients in 2013).
Researchers also observe that larger US trials hire contract research organizations that can afford to bring on nurses who devote attention to the trial patients, offering a very different experience for patients.
Higher failure rate for Pharmaceutical trials
These things are uniting to create an increasingly high failure rate for clinical trials of drugs designed to control chronic pain caused by nerve damage. As the assessment of the performance of placebos is increasing, it’s making it harder for manufacturers to show that their drugs outperform placebos at a high enough rate to get their drugs approved. Apparently in the last ten years more than 90% of potential drugs for treatment of neuropathic and cancer pain have failed at advanced phases of clinical trials.
“Data from the study that larger and longer trials are associated with larger placebo responses,” says the researcher from McGill. “This, in turn, has a propensity to result in the failure of those trials—it then makes it more difficult for pharmaceutical companies to verify that the drug being tested is more effective than treatment with a placebo.”
Potential Solutions for Drug Companies
One suggestion was that drug companies looking to raise their success rate may need to change the way they conduct clinical trials, making them shorter and smaller. Another remedy might be when setting up trials they compare new drugs against their greatest competitors as an alternative to using a placebo. A third is that drug companies need to come up with better, more effective, drugs.
The research also suggests it is also worth investigating the elements that are generating the powerful placebo response in the U.S. trials, and then working to incorporate those elements (such as the relationship between patient and nurse) into patient care.
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Lindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.