This news release from the University of California San Francisco (UCSF) describes a trial using the antihistamine drug clemastine fumarate to see if it regenerated nerves in patients with chronic multiple sclerosis (MS). Approved by FDA in 1977 for allergies, the generic form of this drug has been available over the counter since 1993.
The study found that the drug improved results on a test of function in a nerve pathway in the visual system, which is usually damaged in MS. These test results indicated that myelin had been repaired, a first for MS treatment. This is encouraging, although no effect on actual symptoms was shown in this small, short-term trial.
UCSF’s release does a thorough job explaining the disease mechanism of MS, especially in clarifying how nerve degeneration through the progressive damage of myelin leads to symptoms like loss of vision and coordination problems. The release also gives a thorough, clear description of the study design, including an easy-to-understand illustration of what a “crossover” trial is.
Costs are not discussed in this news release, but it’s a hot topic in the MS community, since current drug therapies amount to tens of thousands of dollars per year. Clemastine as a generic, “older” drug would provide a much welcome cheaper alternative.
Overall, we feel this release was well written and informative, leaving readers with a good sense of what was uncovered in this study and why the findings are important.
MS is an autoimmune neurodegenerative condition affecting almost 2.5 million people around the world. It is potentially disabling depending on its severity, as some people may lose their ability to walk.
Many drugs are already out on the market, the latest disease modifying therapy being ocrelizumab (Ocrevus). The only FDA-approved drug for primary progressive MS, Ocrevus is expensive with a list price of $65,000 a year, but this figure may be lower depending on patients’ insurance policies. Despite the steep price tag, this is still about 20 percent lower than the current market average for an MS treatment like Rebif, another MS disease modifying therapy.
If future studies show clemastine fumarate demonstrates clinical benefits for patients through repair of damaged myelin, it would be a much cheaper alternative, costing only about $400 per year.
Clemastine fumarate, also known by its brand name Tavist, is an antihistamine that can currently be bought over the counter. According to GoodRx.com, 60 tablets of 2.68mg Clemastine go for $33.33. If patients take the clinical trial’s dose of 2 tablets per day, this supply should last 30 days.
Since costs are not discussed in this news release, we give it a Not Satisfactory rating here.
The news release doesn’t cite any figures to support its benefits claims. It only states that neural signals from the eyes to the brain were “significantly accelerated over baselines measurements.”
The study authors report that clemastine reduced the delay by 1.7 ms/eye in the treatment group compared to the placebo group.
We caution against using the word “significant” when describing benefits data due to its ambiguity. “Significant” in a scientific context usually refers to a result being “statistically significant,” which means the result is probably not attributable to chance.
It’s important to recognize the distinction between significance on a lab test (a surrogate outcome) and something patients actually care about–a clinical improvement in a symptom. In this study they measured visual acuity, for example, and found no difference between the groups. Perhaps in a longer trial they would find a difference, but this should be made clear. A lot more work needs to be done to see if this drug will be truly useful.
Since benefits data are not given quantitatively, we rate this one Not Satisfactory.
Most common side effects associated with clemastine include transient drowsiness, sedation, dizziness and disturbed coordination. Other adverse effects include rash, low blood pressure, vomiting, difficulty urinating and wheezing.
Participants did not experience serious adverse effects during the trial, according to the published journal article (page 5). Some patients experienced fatigue, which resulted in a patient modifying his/her dose, and a small number of patients showed increased levels of triglycerides, a type of fat found in blood.
Since harms are not addressed in the news release, we rate it Not Satisfactory.
The news release does an excellent job laying out the basics of the trial, providing an easy-to-understand, thorough description of the study design. This five-month phase II trial enrolled 50 patients with relapsing, long-standing MS, whose histories also revealed deficits in neural transmission. One group was given clemastine for 90 days, while the other took a corn starch placebo. Then the groups were switched for the next 60 days, with the first group taking placebo with the other undergoing clemastine drug therapy.
Researchers measured how quickly it took for visual signals to travel from patients’ eyes to the back of their brains. While there was improvement in speed of transmission, how would that translate to improved outcomes for patients? What should have been made more clear was that no clinical benefits were seen that improved patients’ day-to-day lives.
The news release does address the inability to observe the regeneration of myelin using magnetic resonance imaging (also called MRI) scans. Researchers chalked this up to the inadequate imaging methods currently in place.
We rate this Satisfactory.
There is no disease mongering in this news release. It gives readers a primer on what myelin is and how its progressive degeneration leads to MS. One clever clarification was to point out the differences between myelin and rubber insulation around wires.
We rate this one Satisfactory.
The news release mentions that work was funded by the Rachleff Family.
However, five out of 18 authors, including the first author, had multiple competing interests, mostly in the form of personal and consulting fees from the world’s largest pharmaceutical companies according to the original journal report. Those conflicts should have been mentioned in the news release.
As there is no cure for MS, treatment focuses on slowing its progression, managing its symptoms and speeding up recovery after attacks.
The release does note that current drugs work on the immune system, but there’s more that could be said. To treat MS attacks, patients are given corticosteroids or plasma exchanges, in which their blood cells are mixed with a protein solution and put back into their bodies.
Different drugs, such as beta interferons, are prescribed to delay MS progression and to alleviate symptoms. Patients may also undergo physical therapy and be given muscle relaxants to reduce muscle stiffness.
The news release doesn’t mention any of these therapies, which is why we give it a Not Satisfactory rating here.
The news release reports that clemastine was first approved by the US FDA in 1977 for allergies and that its generic form has been available over the counter since 1993.
We rate this Satisfactory.
The news release does a good job explaining what exactly is new in this study. This is the first time to the best of their knowledge, according to the principal investigator, that a drug therapy can reverse nerve damage. Participants had been living with MS for years, but their nerves showed “strong” evidence of repair, the first author added.
However, this is not the first time an older, generic drug showed it could restore nerve function. There have been previous reports that high doses of the immune-suppressing drug cyclophosphamide could also slow MS progression and bring back neurological function lost to the disease.
Although this background could have been provided, we feel the news release does a Satisfactory job here.
The headline (“Allergy drug improves function in patients with chronic injury from multiple sclerosis”) may be misleading to some readers since improving function in the usual sense implies a clinical benefit and that is clearly not the case here.The study did not report on improvements in loss of coordination or balance and other common symptoms of the disease.
The very specialized laboratory test used to measure the speed of visual transmission did show an improvement in a surrogate for the disease, but not as claimed in another sentence as “restores nervous system function in patients.”
Aside from that, the news release avoids unjustifiable, sensational language and, instead, continually warns readers that this drug is “not a cure.”
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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