A Patient Speaks Out about Cells=Drugs

By Chris Centeno, MD /

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cells=drugs

I get e-mails from patients with serious and chronic diseases all the time. They often ask me to use stem cells to treat their illness. Since we only treat orthopedic conditions, I can’t help other than to refer them to someone who I think is doing credible work. This one was so well written and so spot on with regard to the cells= drugs debate, I thought I needed to share it [I’ve deleted a few words to protect her identity]. Her editorial is even more relevant now due to a new study that by coincidence happened to be published while I was getting permission to use her e-mail. This study showed that the new MS drugs (which are heralded at scientific conferences as the best thing since sliced bread), actually couldn’t beat “no drugs” for stopping the progression of MS towards disability! Looking at the graph above shows that 5 years ago, these top 5 drugs earned revenues of more than 7 billion USD. A study last year calculated that the cost to the average MS patient’s insurer is about 30K a year and that these drugs all have very marginal benefits. As a result, when you calculate the amount of money it takes to produce one year of perfect quality of life for an MS patient-the real drug costs are 1-2 million USD per year of quality living!

From the above reference:

“And the gains in health from the drugs were small. A person taking Avonex for 10 years would gain the equivalent of two extra months of perfect health and those taking Copaxone would gain one month. Those taking Beteaseron would have six years free of relapses, compared to five years free of relapses for those not taking any of the drugs.”

Now back to the perspective of an RN with MS. In particular, when you see these numbers versus the lack of benefits, is it any wonder big pharma can’t let your stem cells be used as body parts?  They first have to figure out how to commercialize these cells as drugs costing at least as much as these lifetime MS therapies. In that world, a simple procedure using your own stem cells to treat your MS that should cost 15-20K if performed by your doctor transplanting your cells, will have to cost at least 100-200K to recoup the existing drug fees that will evaporate. If you think that there’s no way pharma would ever have the audacity to suggest that a single dose of a cellular therapy should cost 100K, think again. Provenge, a cellular therapy for prostate cancer that’s already on the market currently runs 93K a dose!

“I am an RN and I have MS. 

The therapies available for MS are abysmal–truly. The long term research shows they aren’t really beating natural history by much (if anything) and the cost analysis done at BNAC recently put it at 800,000 USD for one quality adjusted year. Author’s conclusion? lower the price of the drugs–Really?? what universe are they from?!!! 

In spite of this, neuros universally think these drugs work great and tell patients the marketing talking-points they’ve grown so familiar with. It goes like this “We just don’t see patients like we used to, people do great for years at a time! These drugs have made a huge difference and the next generation is going to be really good!” 

Never mind the immuno suppression is so strong we have black box warnings and a mortality rate. Truth is the patients that did well for years before the age of drugs had no reason to BE in the neuro office–so yeah the drugs make a visible difference because the office is full of patients that are in natural history’s documented “good years” having their liver function and heart function checked for drug side effects. In the old days such patients had no reason to be in the office at all; consequently neurologists are right–the office IS full of healthy and still functional MS patients! 

Unfortunately this sort of mass hypnosis of an entire branch of medicine by the pharmaceutical companies has been very successful at creating advocates of the standards in spite of poor drug performance. They are all become watchdogs and staunch skeptics when any other ideas come along that might help MS patients, like stem cells. 

I’ve been waiting since Scientific American had a special issue on immune cells in about 93 which showed mice with strokes given labelled stem cells showed the stroke area full of labelled nerves and better functional recovery. I never imagined it’d be so long. 

The decades drag by and I am so disabled now I wonder what the point is of waiting–there’s so little left to save I estimate that within a decade I will need full time care. This is with the best possible care and excellent MRI evidence of response to drug (no inflammation or lesions)–and I jogged several times a week when I got the MS drugs. There are no treatments left for me to try and there are hundreds of thousands like me. 

What are we supposed to do: stand at the sidelines of this scientific debate cheering because we are treated “scientifically” while we drop like flies??? No. I don’t thank FDA for this. 

I find myself so frustrated with this debate I can hardly stand it. I see from the stem cell forum group that most members seem to be sponsored by these companies which are aiming for an off the shelf solution to the problem–the good old Merck version of stem cells instead of our own cells in a one-one therapy grown from [our] tissue… 

It seems to me these people advocate an abundance of caution about cell therapies and direct to patient approaches like…. This comes along with hyperbolic foaming at the mouth about safety when I cynically wonder if that isn’t all about “gee, my product is only stage II, this whole stem cell revolution can’t take off yet…I want my product to be the front of the pack with the biggest pile of evidence before it takes off so we are the ones getting the patients” 

Do you think I misread? Am I missing the wider issues and safety? I can’t help but think we give stem cell rescue in cancer therapy all the time and have done so for years –is it REALLY that different to expand the cells? I am obviously a nurse not a lab rat so I am ignorant and I know it. 

But I have lost the battle for a decent quality of life and I am beginning to think it may be another decade before this is really here. Do you see this as a political fight between well funded people developing an off the shelf product and tiny clinics that would destroy that “captive market” by letting people make their own? 

I guess my question to you is this [I have taken out the names of the drugs on purpose]

If an MS drug is like this xxxx with heart damage 20% of the time, leukemia 1/135 and only possibly slows progression (does not stop MS)…… 

and if another yyyy causes PML 11/1,000 (so far) and a death rate of 30% of those affected….and does not stop MS 

and if zzzz causes hashimoto’s 30% of the time and has an undetermined luekemia risk (it’s newer but severely suppressive)…. 

Can you see any way MSC’s expanded and re administered would really be worse than that? (assuming here good lab practices just like any blood product)”

This patient has it about right. Most of the cells=drugs debate is about protecting the price of a widget, not about protecting patients.

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Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
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