New drugs may not be as effective as claimed

Professor George Jelinek, Founder of Overcoming Multiple Sclerosis, and Head of the Neuroepidemiology Unit of the Melbourne School of Population and Global Health, has previously published about the concerning influence of the pharmaceutical industry on modern medical research and practice. In the light of just published research from bioethicists and physicians in the US, he has now added his voice to calls for greater transparency by industry in marketing new medications.

Dr Jennifer Miller from the New York University School of Medicine headed this new study examining records available around the process of licensing by the US Food and Drug Administration (FDA) of a range of new medications in 2012, including the new disease-modifying drug for multiple sclerosis, teriflunomide (trade name Aubagio).

In this first-of-its-kind study, the authors examined a range of data sources including data from Drugs@FDA, ClinicalTrials.gov (a repository of registered clinical trials), MEDLINE-indexed journals and drug company communications. The FDA approved 15 major new drugs in 2012, produced by 10 large pharmaceutical companies.

These 15 new therapies were evaluated by 318 separate clinical trials. Yet, by drug, only about half (57%) of these trials were registered with the usual clinical trial registries, and only one in five study results were reported.

This is an important issue, as good modern research practice relies on researchers registering their trials before they undertake them, and reporting their results, so that if they produce a negative result, the research community will take that into account in assessing the benefits or otherwise of the therapy, rather than just considering the trials that showed a positive benefit.

The Sanofi-produced MS drug Aubagio was an interesting case in point, with only one in six of all studies on the drug actually being published, by far the lowest of any of the 15 drugs studied.

This selective publishing can mean that studies that did not show any benefit were not published, artificially inflating the apparent benefit of the drug in those studies that were chosen to be published. The authors argued for continuing the practice of ranking new drugs according to how transparently the results of their clinical trials were reported.

For people looking at taking one of the newer drugs on the market, this study suggests some pause for reflection, as these drugs may not be as effective as claimed in the medical literature.