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Do statistically insignificant outcomes in multiple sclerosis treatment study deserve a news release?

Treating at the Earliest Sign of MS May Offer Long-Term Benefit

Our Review Summary

multiple sclerosis tabletThis release summarizes a study that followed 11-year treatment outcomes of two groups of patients with early symptoms of multiple sclerosis (MS). All of the patients had experienced a first episode suggestive of MS, called clinically isolated syndrome (CIS), and a  magnetic resonance imaging (MRI) scan suggesting MS. Up to 85 percent of people with CIS go on to develop MS.

The two patient groups were randomized to either receive interferon beta-1 by injection immediately or receive a placebo for two years. After two years, the placebo group could receive their treatment of choice.

The patients who received the drug immediately appeared to have fewer relapses over the 11 years of study, according to the lead author, but no advantages were observed in other patient outcomes such as overall disability and MRI scans. The release would have been stronger if it provided more context for judging the reduced number of relapses, especially in light of the two groups showing no difference in disability. The release also omitted mention of significant potential conflicts of interest, the high annual cost of interferon beta-1 and the drug’s side effects.

 

Why This Matters

Society faces tough questions because of the high prices of drugs that target the immune system, such as interferon beta-1b for multiple sclerosis. This news release suggests drug therapy should begin sooner for patients without including any of the controversy on cost playing out in the United States and Europe. Last year authors of a different research study, also published in Neurology, called the rise in MS drug prices “alarming” and wrote it was also puzzling, since some of the drugs are not new.

“Why the costs of MS DMTs [disease modifying therapies] in the United States have risen so dramatically is uncertain. However, the simplest explanation is that pharmaceutical companies raise prices of new and old MS DMTs in the United States to increase profits and our health care system puts no limits on these increases,’ they wrote.

Why is cost so important to mention? This drug study, in particular, has significant potential conflicts of interest, discussed below under the Funding Sources & Conflict of Interest Disclosure criteria.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release does not mention cost. A year’s treatment of one form of interferon beta costs about $60,000, according to this article which suggests prices are rising much faster than inflation. Another concern is that some insurers are no longer covering some forms of interferon beta-A, For example, GoodRX.com says that some insurers are no longer covering Avonex, a top selling form of interferon, starting in 2016.

Another article from the United Kingdom, however, argued that this kind of drug can be cost-effective over 20 years by reducing the disability of the patients.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release includes many numbers but does not include the statistically insignificant primary outcome results.

The final result that researchers indicated they were measuring was the percentage of patients who had relapses at 11 years, which was much closer between the two patient groups than the other (secondary) results that they presented in greater depths.

The final results: Those patients without definite MS at 11 years was 76/167 (45%) in the early treatment group and 43/111 (39%) in the delayed treatment group. This result is not statistically significant, a result that was not mentioned in the results section of the paper and represented only a 16% relative rate reduction and 6% absolute rate reduction.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

What are the risks of treating early vs. the benefit? This release does not mention any potential harms of treatment. There are significant side effects reported to therapy with interferon beta-1b, including depression and thoughts of suicide, according to the National Library of Medicine. No harms were mentioned in the study. We also wonder — if patients routinely receive a therapy before official diagnosis — whether that risks treating people for a condition they do not eventually develop.

The published study states that about 85% of people who encounter a single episode of demyelination (often an  early sign of MS) go on to develop MS. Doesn’t that mean 15% never get the disorder at all? Taking injections for a disorder you don’t have seems like potential risk. In the paper, the authors mention but do not quantify the adverse effects and only say that they are consistent with those previously reported. This seems an inadequate description since some patients used the drug for two years longer than others.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

We rate this as borderline satisfactory. The release does a good job of explaining the double-blind randomized controlled study carried out on a beginning group of more than 400 patients. And to its credit, the release notes one limitation of the study: “participants and researchers learned after the fifth-year tests which participants received the drug and which received the placebo and that after the placebo-control phase of the study, all of the participants received treatment, so there was no untreated control group after that point.”

But as noted under the Benefits criteria, the release would have been improved with a discussion of the primary outcome results.

Does the news release commit disease-mongering?

Satisfactory

There was no disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release states that this research was supported by the drug manufacturer Bayer HealthCare Pharmaceuticals but did not spell out that Bayer markets interferon beta-1b under the brand name Betaseron. Nor does the release note that many of the researchers involved with the study have numerous financial ties to Bayer including stock, royalties, consulting, speaking, honoraria, travel and salaried employment.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The study was addressing whether early therapy was better than later therapy, so the release should not be held to the standard of comparing interferon to other drugs. However, it’s worth noting here that the number of drugs for treating MS have nearly doubled to 20 over the past three years.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The drug is widely available and the news release gives that impression as well.

Does the news release establish the true novelty of the approach?

Satisfactory

The release explains that this particular study is adding to evidence and is not particularly novel.

“Our study adds to the evidence supporting treatment at the earliest sign of the disease and indicates that early treatment has a long-lasting effect on disease activity,” a researcher says in the release.

However, another novelty of the study is starting treatment after one event and not waiting for any further events. This could lead to a much larger market for the drug. It could be concerning since some patients only have a few recurrences in their lifetime.

Total Score: 6 of 10 Satisfactory

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