This is Marie.
I recently wrote a note about Treating autoimmunity early
This week has shown the release of work by Helen Tremlett of University of British Columbia's Therapeutics Initiative. The therapeutics initiative can be thought of as a kind of "consumers reports" for drugs. They evalaute claims and studies done by industry without any money or input from that industry.
Dr Tremlett's study says that interferon drugs do not slow progressive losses in function even though they reduce relapses. They evalauted this by looking at the records of thousands of people seen in MS clinics in Canada. They compared people treated with interferon with those who qualified for treatment but chose no treatment. What made this especially interesting is they also compared to people from former decades who would have qualified for treatment but didn't get the drug because it was not out yet. This gave two comparator groups, a current one and a historical one.
They found no significant difference between groups when looking at the percentage that progressed to an EDSS 6 (needing a cane or brace for walking). In all groups a similar percentage progressed to the EDSS 6 within 15 years from diagnosis.
Here are a couple other papers suggesting interferon makes little difference to progressive disease.
Risk Sharing Scheme
Interferon in SPMS
Years of Interferon
What is interesting is that the Tremlett paper explains why some research seems to support the idea that interferons make a big difference in progression for MS patients. She talks about what went wrong in these other studies here.
"Previous postmarketing studies have suggested a positive association between interferon beta and MS disability outcomes.4-10,30 However, conducting adequately controlled longitudinal observational studies is challenging, and many such studies have faced methodological issues. One of the larger studies to date, from 2 Italian centers,10 was susceptible to immortal time bias13,15 because of differing baselines for the treated and untreated cohorts. The use of a propensity score method in that study10 could not address immortal time bias. An independent reanalysis found no apparent beneficial association with interferon beta treatment once this bias was considered."
Wow! A second researcher actually did the bias correction on a published study and suddenly the study conclusion was flipped on its head showing no benefit.
This demonstrates that HOW the researcher applies statistical analysis makes all the difference to the conclusion. By excluding some people's data or jiggering the groups (such as that I called out in my previous note) it is possible to make something that is ineffective look better than it is.
Dr Tremlett's study went out of its way to look at how bias influenced other papers in this area and to make sure their fresh analysis was free from these mistakes.
The problem for MS patients living with the disease today that it has taken far too many years before we have started to get more objective findings from people like Dr Tremlett. We've been dependent on commercially supported studies and resulting marketing for our information until recently. While it's completely understandable that a company with investors, CEO's and product lines to maintain must present their product in the best light it isn't right that people who need help managing something like MS lack accurate information.
Perhaps some patients would have chosen to suffer through relapses with just steroids and avoid the "flu-like reaction" of daily or weekly injection if they'd known that at 15 years there'd be no difference in disability level... But they didn't have that information.
Perhaps people would have preferred not to spend countless dollars on co-pays for a drug that is near 40k a year (depending on health plan) over those 15 years if they'd have known progression would be the same.
Did anyone lose their health insurance coverage because their drugs were too expensive? Would that money have been better spent on a scooter? Or a bioness walking aid? Or physical therapy?
The questions related to this are not academic--these are real people with real lives, not numbers on a statistical analysis.
The question is how do we gain balance back in this system?
I'd suggest that we as patients are the balancing factor. We're the ones with skin in the game and the ones whose lives are at stake. We have a right to demand that commercial interests do not dominate the conversation and suppress other ideas.
The scientific truth is that we still do not understand the basic cause of MS. Until we reallly understand the steps that lead to a lesion in an MS brain, any treatment we try is based on someone's theory, including the CCSVI model.
Thankfully the CCSVI theory is now being investigated and its findings are triggering a whole lot of other research as well...We need to know how freeing blood flow can contribute to better outcomes in MS. All we have to do is support it.
Have you given to the Alliance or the Hubbard Foundation or the Funicello fund recently? If all 20,000 of us committed $5 every month for a year we'd raise a 1.2 million dollars for CCSVI research....THIS YEAR!
These volunteer organizations run on pennies, and the volunteers all contribute time and resources on a regular basis to keep it going. We can all be part of the solution; $5 goes a long way when we all do it.
In May I ordered a large bunch of books at author's discount and Joan bought 38 at cost for "thank you gifts" for the Alliance out of her own pocket. If you give $100 to the Alliance you can have one of these books as a thank you for your tax deductible gift. All you have to do is CLICK HERE make a $100 donation and write your name and address in the paypal comment box. Joan will personally send you a book! How awesome is that?
And if you don't have your CCSVI book yet and simply want to buy one 10% of that money goes to research too. The book is an invaluable reference...you could be looking up how the immune system works in MS or reading about angioplasty right now if you had one...
You can even order a cute Annette Funicello movie like Beach Blanket Bingo and create some funds for research!
There are lots of ways to participate.
Remember the Newfoundland study where the province followed 30 patients who paid for their own CCSVI treatment abroad and compared them to 10 untreated people? That study cost $400,000.
We cannot fight this flood of commercial influence without money for studies of our own designed by vascular doctors to evaluate CCSVI in a fair way. The Hubbards did a brilliant study that showed positive results on BOLD MRI after angioplasty. BOLD is objective and not placebo prone. It showed treatment produced a very positive effect on perfusion....Unfortunately they could only afford to do 10 patients.
We can make a difference. Please consider this and accept my heartfelt thanks for your time and thoughtfulness.
Marie
