MS BLOG: Sort Anecdotal Claims, Real Science Before Research Treatments
Can we all agree that research studies are important and they are necessary to prove whether a concept works or it doesn’t? Even from the biggest failures, we can learn more.
We can also all agree that research has to be done via properly conducted studies to be accepted as valid, right?
And foremost, I know we certainly agree that the people who are participating as subjects in trials must be taken care of and assured that their participation will cause no harm.
Based on my brief list, I want to share my thoughts –
Without research studies, we make no advances in treatment. Without research studies we don’t stand a chance of finding a cure for MS. Research is only possible if people are willing to help and become research participants. There are lots of studies that can’t find enough people to engage with and ultimately we all are hurt by that. If you can, join a research study and help.
Research studies have to follow certain rules and protocols to produce valid data. The work of a researcher must be reproducible — in other words, others should be able to do the same work and get the same results. The requirement for being true research means it shares the truth in the findings.
Protection of the human subject is the most important thing, and here in the US everyone has that protection under the Common Rule, which helps shape the ethical treatment guidelines of anyone willing to put themselves into a research study. Before researchers can do things with humans, they must demonstrate that their ideas are safe — and usually this involves studies with mice if you are talking about MS research.
These really are three simple points commonly accepted by everyone, and yet in the world of multiple sclerosis (MS), they continue to be ones that people are willing to overlook when they are desperate for a cure.
All of this common knowledge can easily get chucked out the window when you have a chronic disease and are facing declining health with no options that meet these three points. So what do we do? We are tempted to toss all three of these guiding tenants out and forge ahead trying whatever the latest treatment suggestion might be —damn the studies, the evidence, and even the patient safety.
The MS community seems to be particularly susceptible to this thinking. It just takes a few anecdotal tales of people getting cures (or at least major relief), to send our members seeking access to unproven ideas and opening their checkbooks, or even taking out hefty loans to finance treatment.
There was this rush for treatment using CCSVI liberation therapy a few short years ago — Chronic Cerebrospinal Venous Insufficiency was based on the idea that a lack of blood flow to the brain caused MS. Even though there were no clinical trials, no evidence that could be reproduced, and no oversight for the protection of patients, people rushed to get the liberation treatment done because they heard other people had success and were ‘cured’ of their MS. The rush usually involved going to a foreign country and paying thousands of dollars to have the experimental procedure. Unfortunately, the CCSVI procedure did cause harm to some and even death for a few people, and it diverted millions of critical research dollars from other MS studies to quiet the crowd that demanded CCSVI be studied. There are still believers, but they are getting fewer and quieter. Now most people affected by MS understand the studies showed there is no evidence CCSVI is linked to multiple sclerosis[i].
Now that you know where I come from with the need for scientific studies, reproducible evidence and subject protection, you might also understand why I hesitate in endorsing the recent demand for quick access to hematopoietic stem cell therapy (HCST). I support the concept that HCST might unlock the cure for MS – I have said since my diagnosis in 2008 that stem cell therapy will unlock this disease — but I can’t ignore that we don’t have the oversight and evidence from more than a few studies. I read too many cases of people traveling to foreign countries, and even a few unauthorized places in the US, undergoing stem cell replacement and then coming home excited that they are cured, only to have the reality and past symptoms of their MS slowly return.
We only hear the enthusiastic words of those people who believe that HCST worked for them in the short term, and we rarely hear the words of disappointment from the majority for whom it has failed.
There are stem cell therapy clinical trials now being reported that 1) are qualified research studies 2) are seeking results that are reproducible and 3) protect the humans who are involved as test subjects. For now, the studies that meet these criteria are having a fairly high success rate of stopping disease progression, which is very encouraging — this is from both the HALTS[ii] trial in the US and an even higher rate in a similar trial in Canada[iii]. None of the researchers with these two studies claim to have found a ‘cure’ for MS.
Notably though, the Canadian trial had one death out of 24 people — which is an unacceptable mortality rate — and the US trial had a success rate of just under 80%. Having stem cell replacement therapy involves rebooting the immune system by essentially depleting every bit of it through harsh chemotherapy drugs, and then reintroducing the person’s own stem cells back into their body. It is not a procedure to be undertaken without understanding the full range of risks and it should not be available just because a person has enough money to travel and cover the costs.
The next time you read about personal stem cell therapy success stories, I hope you will stop and question if the person’s experience took place via a valid research study, and not just because they had the funds to cover costs. Ask if their results are reproducible with additional people; and if the person faced unnecessary and unprotected risk. A followup with the person six months and a year later to find out if they are still benefiting from their treatment would be very useful and informative. It’s important to know the entire story when we read the anecdotal stories. Part of knowing involves understanding the basics of good research.
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