Note: This article has become a tome but will tell you all the informed consent information about the current medications for MS - you should read it all, before making your decisions.
Also, late breaking news: A study called "PROMiSe" was reported on at the 2004 ACTRIMS convention. The results of this double blind study on Copaxon "confused" researchers, reported the MS magazine for April 2004.That's because those treated with the drug, REAL MS patients, showed NO DIFFERENCE in disease process OR exacerbations from those in the group treated with placebo. Not surprising at all. And as far as interferon - it never really was that effective for EAE which they decided was NOT MS anyway.
A new study showed that a smoker (cigarettes) has a 50 percent greater chance of coming down with MS! So if you smoke NOW, STOP!
by Sue Widemark
Some history or how we got from there to here
How they test the medications (mostly NOT on MS patients!)
Two double blind studies and analysis
Sales in MS medications are in the billions of bucks
Reality of MS, how it progresses and what treatment is
If you don't want to take the medications here are some other medical treatments (less fun than the meds!)
Yes, the ABC and other drugs DO have side effects!
A few years ago, the MS Society publications were simple printed magazines with no color photos. Local MS societies had mimeographed publications.
Today, the MS Society puts out expensive professional magazines with color pictures at both the National and local levels.
What could have made the difference?
Paging through the publications gives us a clue - in prominence are three and four page ads from the pharmaceutical companies producing drugs for MS i.e. Avonex, Betaseron, Copaxon, Novantrone and Rebif.
Avonex, Rebif and Betaseron are a form of Interferon, a chemical which is found naturally in the body. Copaxon is composed of fragments of a synthetic myelin which is thought to decoy anti bodies which might attack real myelin. (the sheathing of the nerve cells which is affected in MS). Novantrone is a cancer chemotherapy drug which kills many cells including some of the affected immune cells as well as many healthy cells.
Because Copaxon (which might make the most sense) is less effective than the interferon drugs, it is less popular. And to take cancer drugs for MS seems the height of insanity. Cancer drugs ALL kill healthy cells as well as sick cells and thus can cause injury in major organs, particularly the kidneys and those organs which are quickly making new cells all the time. Currently, some in the medical field are feeling that chemotherapy may not even be appropriate for all cases of cancer.
The interferon drugs, Avonex, Rebif and Betaserone represent a second generation approach. They are all formulated to target anti-bodies which are thought to be specifically attacking the myelin tissue in MS. Generally, they are thought to not cause a significant immune challenge in MS patients. No guarantees on that one of course.
The idea of taking interferon and/or immune system suppressants for Multiple Sclerosis (MS) is not a new idea - it was around in the 1980's when a popular type of research used rats with an induced type of myelin destroying disease called EAE. Interferon sometimes worked to slow the progression of this disease in some rats.
When Sylvia Lawry, the founder of MS Society was actively involved, the MS society took a careful view on medications and suggested a healthy program of good nutrition, stopping smoking, no booze and "some sitting, some standing and some resting". (Note: since Nutrasweet, the sweetener found in many diet foods can cause MS like symptoms, stopping consuming diet pop and other artificially sweetened foods should be the first thing an MS patient does.)
Over the years the MS society has changed its views on medications in general (and gotten quite a bit of funding from the Pharmaceuticals producing those medications). The Society approves of the medications although does not actively advocate them, at least not directly. They do give seminars financed by the manufacturers of the current medications for MS, from time to time which really can be quite enlightening.
A recent seminar I attended by Dr Michael Powers of BNI (Barrows Neurological Institute) offered quite a bit of information about what these drugs CAN do and what they don't do. I found out that they still don't promise much to patients on these drugs except that they are thought to reduce the number of acute attacks of MS (called 'exacerbations') but interestingly enough, the drugs have NOT been observed to slow long term disability.
The effectiveness of the medications is purely judged on the number of white patches in the brain which show up on an MRI - if less white patches appear after a few months of treatment, the drug is considered to be working well. Some physicians don't bother giving MRIs after the first couple if the patient appears to be feeling reasonably well. Also, Dr Powers pointed out that the number of white patches on the brain can vary from day to day. Additionally, it has been well known since 1972 that the number of white patches on the brain do not necessarily predict the clinical presentation (amount of disability seen in the patient).
There have not
been many double blind studies on the drugs... here are a couple reported on in
a conference by one of the researchers, involved in most of the
studies cited, Dr Jonathan Carter, MD,
researcher and director of the MS Clinic at Mayo Clinic in Phoenix, AZ:
(It should be noted that the following studies were done on patients thought to
be coming down with MS - rather than those diagnosed with MS. About 50
percent of the cohort never came down with MS).
Dr Powers noted that they were not currently, doing double blind studies on these medications because they had already been observed to be "disease modifying" and thus they could not, ethically deny half the cohort, the help thought to be offered from the drug. This turns out to be an excuse for not doing double blind studies on many drugs and what this basically means for the patient/consumer is that experimentation goes on until such time that they can connect dots WITHOUT double blind studies. A rather "hit or miss" approach, it seems and a process which sometimes takes as long as 40 years, often leaving a path of injured patients in its wake.
What no one has made much of is that the sale of the medications yield a rather hefty profit for those pharmaceutical companies who manufacture the drugs. For example, I found this on the Nastech.com site. Nastech is apparently the pharmaceutical company which manufactures all the interferon-beta drugs marketed by Biotech (Avonex), Berlex (Betaserone) and Ares-Serono (Rebif):
Interferon Beta- Relapsing forms of Multiple Sclerosis
Interferon beta is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS). It is a protein of relatively high molecular weight (approximately 19-24kD) and is currently administered by injection only. Interferon beta is marketed worldwide by Biogen, Inc., Berlex Laboratories, Inc., and Ares-Serono. Total sales exceed $1.1 billion annually. <<<<<<
Did I read that right? Over ONE BILLION dollars in sales each year?
In 1972, the Symposium on MS in UCLA presented two cases. One case was a lady who was walking and had a slight limp as her only symptom. When she was killed in an auto accident, her brain was autopsied and to their surprise, pathologists found vast areas of MS lesions and de-myelinated tissue! Another case, the opposite, was bedridden - when her brain was autopsied, only a couple of MS lesions were found. The consensus (which has not changed since Dr Carter mentioned it later on in his talk) is that the number of lesions in the brain does not predict the disability caused by MS!
So, in plain language, it may not mean much to you, the patient as to how you feel or how much disability you have, if a medication you are injecting once a week. intra-muscularly or every other day, sub-cutaneously, 'reduces the white patches' in your brain!
Does this bear out in studies on patients who have been diagnosed of remitting and relapsing MS, the common 'textbook' variety? In fact, although interestingly enough, there have not been many studies of this type, one study showed that the ABC drugs had no effect on the progression of MS and/or disability in diagnosed patients!
The North American Secondary Progressive MS study on 939 patients with relapsing and remitting MS using Betaseron as the drug with half the patients, showed that Betaseron had no effect on the progression and disability of MS!
A Canadian Study on "Rebif" (a drug similar to Avonex now being sold in the United States) on 618 patients with relapsing and remitting MS also showed that the drug had no effect on progression of disability in MS!
Did these drugs have any effect on Brain Atrophy (Brain Parenchymal Fraction - BCF)? According to Dr Carter, basically not really. Six - eight years after one study, about 35 percent of those on Avonex had "significantly progressed" in the course of the disease and a study of patients on Betaseron suggested that BCF was irreversible.
So what is medicine offering you if you don't wish to inject expensive drugs which can cost as much as $10,000 bucks a year?
Baylor Institute in Texas has a new treatment they are testing in which they remove all the T-cells (white cells) in your blood, inactivate them and return them to your blood stream. Nothing has been said about how well you fight disease with inactivated T-cells. Any guesses? No bets!
Baylor, by the way, made itself famous as the initiator of the Medrol studies in the 1970's. Thousands of MS patients were given medrol I.V. as a partial replacement of spinal cord fluid. This treatment showed immediate improvement of symptoms (any treatment with steroids will do that) but a goodly percentage of the patients came down with Tuberculosis soon after being treated. More importantly, patients who had received Medrol showed a much greater rate of progression and disability 2 years after treatment, than those not so treated. Needless to say, Baylor dropped the treatment a couple of years later. The Medrol treatment was, by the way, done in Mexico after Baylor discontinued it and foolish MS patients paid big bucks to go down to Mexico and receive the treatment. Telling them they might get much worse in two years didn't seem to make much difference in their decisions. Do we tend to be short sighted when it comes to our health?
Other 'treatments' medicine offers us involve using dangerous cancer drugs. These drugs totally shut down the immune system and can cause major injury to many organs including the kidneys and the heart. If a person has cancer and is in danger of dying, I can see where the use of these toxic drugs might be appropriate. But, it would seem inappropriate to use such drugs on people with MS about whom the Merck Manual comments "Lifespan is probably of normal length"!
(By the way, years ago, treating an attack with no drugs was given as an option but now, all MSers having attacks are given I.V. Steroids, despite the rather clear evidence that even a short term of steroids might cause MS progression and disability to be greater.)
Money has always been a problem for the MS Society which tries to service patients as well as finance long term research. If studies show some type of improvement in MS using the drugs, what can be the harm of helping acquaint people with what's available and also, obtaining large sums of money to be used to further help people? Patients are happy, thinking they are doing something to treat MS (and the placebo effect in MS patients is high - about 85 percent so even if the drugs are not helping, if they are not harming the patients, the patients through the placebo effect might be helping themselves!). Pharmaceuticals are making all kinds of money and the MS society receives financing from the pharmaceuticals to help patients. It's the old 'ends justify the means' outlook.
But no one has really looked at the long term side effects, or the possible connection these drugs might have to autoimmune disease. Also, unless the drugs are causing an 85 percent improvement in the MS disease process, it means they might be counterproductive.... that is if the placebo effect is 85 percent in MS, then a drug which does NOTHING chemically, should effect at least that much improvement or the drug might be causing some injury to the patient. Often in modern medicine, few people ask this type of question.
Today's MS society released a press statement recently, lamenting that of 350,000 people with MS in the United States, ONLY 70,000 were taking the "ABC" drugs.
So why aren't more people taking these drugs? For some, it's the expense. For others, they really didn't notice any difference in their symptoms and perhaps had less faith that the promise that they might have less symptoms in years to come, would materialize. Since the drugs are basically protein based, they must be injected in order to avoid the GI tract mistaking them for food. Some folks aren't all that keen on taking shots that often.
Because (interferon) can modify immune response, consideration must be given to the possibility that it could interfere with useful immune function. For example, treatment might in theory, interfere with the recognition of foreign antigens in a way that could undermine the body's defense against infections and inner surveillance.
Some patients get cold symptoms, stuffy nose etc after each shot particularly of the Interferon medications (betaserone, avonex and rebif) which abate after a few hours or a day at the most.
Injection sites can get sore and swollen
and the MS society offers some tips to reduce the soreness:
Hold a bag of frozen vegetables on the injection site before and after the shot to numb it and minimize swelling.
Schedule the shot near bedtime, taking over-the-counter analgesics a few hours before to counter flu-like symptoms.
Tuck a vial under your arm a few minutes to warm it before injecting.
As a kid, I took the "Pasteur" treatment - that's because silly Sue stuck her finger into a hamster cage and the small animal did what any smart animal would... mistook my finger for food and nipped me. Then, the next day the teacher promptly lost the hamster. The Pasteur treatment (against rabies) was then, 14 I.M. shots to the general torso. They did switch around the sites. But by the 10th day, I was breaking out in large welts. Not pretty. "Sore injection sites" can be so, not fun!
What a deal for the drug companies - they don't even have to offer immediate effects. Their promises are vague and far in the future and meanwhile, they sell lots of drugs at big bucks.
MSers have traditionally been a population whose desperate feelings about the disorder have made them sitting ducks for just about any crazy medical treatment which came along. But years ago, the MS society would protect the patients from these. Now, no one protects them.
The Society wins (more bucks from the pharmaceuticals), the Pharmaceutical Companies win.
The only loser seems the MS patients who by possibly challenging their immune system for questionable results may not live long enough to see the fulfillment of the vague promises by those they once trusted.
Conference given by Dr Michael Powers, MD BNI (Barrows
Neurological Institute, Phoenix AZ) Aug 9, 2003
Conference given by Dr Jonathan Carter, MD, researcher and head of the MS Clinic in Mayo, Phoenix, June 2000
Merck Manual - 1994, 1996, 1998
1972 Symposium on MS at UCLA
Reuters Health Service
(other references available upon request)