One of the real problems with drug company sponsored research in multiple sclerosis (MS) is that the clinical trials are done in a somewhat artificial setting, with participants in the trials carefully chosen, with many possible participants excluded because of concurrent illnesses, other medications, or other reasons.
This can make it difficult to know whether we can generalize the results from these highly selected trial participants to people with MS in the real world.
Further, the fact that almost all the studies on the medications are funded by the pharmaceutical industry reduces confidence in the robustness and objectivity of results, as the companies aim to highlight the most positive aspects of their data.
Trial results which seem to support the benefits of medications enable medications to be licensed for use and the companies supporting the research, drug development and marketing will make a profit for their shareholders on their investment in the drugs.
Many authorities therefore argue that once the industry sponsored trials of the drugs that enable them to be brought to market are completed, it is important to undertake independent observational research examining how the drugs perform in the real world setting of ordinary people with MS, who potentially have other medical conditions and take other medications.
The main outcome that is measured in many of these trials is relapse rate. While this is an important outcome, we would argue that disability, and change in type of MS, e.g. progressing from benign MS to relapse remitting, or to progressive secondary MS, is a more important outcome for many people who live with MS.
Our HOLISM research group has now undertaken one of the few studies that looks at relapse rate, disability and quality of life in a real world setting, and the results have just been published in the international neurology journal Neurological Research.
Overall we studied 2,276 PwMS from 56 different countries around the world. Around half were taking a disease-modifying drug (DMD), mostly Copaxone or one of the interferons.
Overall, people taking one of the DMDs did not have a better quality of life than those not taking a medication; in fact, in several domains, their quality of life was worse.
Interestingly, when comparing the four most commonly used DMDs, only Copaxone users had a better quality of life than people not taking a DMD; those taking Tysabri, Gilenya or one of the interferons had worse quality of life.
We also looked closely at PwMS who were taking low dose naltrexone (LDN), a drug not licensed as a DMD in MS, but used by many PwMS, because of the widespread interest in the potential of this inexpensive medication by the MS community.
Despite widely being felt by people taking the drug to result in improvement, our data showed a similar pattern to the DMDs, that is a worse quality of life for those taking LDN than for those not taking a medication. It is important to point out here that as the HOLISM data only shows a snapshot in time, we cannot infer causality.
That is, we cannot say whether those who have worse quality of life are more likely to be prescribed and be taking medication, or whether those who are taking medication have worse quality of life as a result.
Those taking a DMD also did not demonstrate a lower relapse rate than those not taking a DMD, although for those who had taken a DMD for longer than 12 months, there was a 24% reduction in relapse rate, similar to the sort of level of relapse rate reduction seen in clinical trials, but with no difference in disability compared to those not taking a DMD.
One concerning aspect of the data was that PwMS taking five or more medicines, over the counter or herbal preparations for various symptoms had dramatically worse quality of life than those taking fewer of these.
Overall, our data shows that the medications commonly used for MS are associated with slightly worse quality of life, except for Copaxone.
The next phase of the HOLISM study, which is currently underway, will provide further evidence about the associations of medications with quality of life, disability, and relapse rate and change in type of MS over time.
That is the next step in showing whether or not medications cause changes in these important outcomes. The other approaches that have been investigated in our other publications from the same group of PwMS world-wide showed strong associations of better quality of life with diet, exercise, meditation, and omega 3 supplementation, along with better physical health.
People with a diagnosis of MS need to carefully consider the evidence about the medications commonly used in MS when evaluating their treatment options.
Professor George Jelinek, lead author of the study, said: “Our HOLISM study data strongly support a preventive medicine approach to managing MS, with comprehensive attention to modifying lifestyle risk factors. A drug-only approach to managing MS is not good medicine.”
However, in the spirit of doing ‘whatever it takes’ to get well after a diagnosis of MS, many PwMS will choose to take a DMD in addition to a preventive medicine approach; the HOLISM study data support the OMS view that this is an individual decision.
Similarly, for PwMS who opt to take one of the DMDs, the evidence about quality of life differences between the medications should be borne in mind when choosing which one to take.
► Jelinek GA, Hadgkiss EJ, Weiland TJ, Pereira N, Marck CH, van der Meer DM. Medication use in a large international sample of people with multiple sclerosis: associations with quality of life, relapse rate and disability. Neurol Res 2015 Apr 23:1743132815Y0000000036 View pdf