Monthly Archives: July 2016

Tecfidera TV ad gets yanked

Have you seen the TV ad for Tecfidera?  The one that shows a woman being able to do all sorts of active things because she’s on the drug, which has reduced the frequency of her Multiple Sclerosis exacerbations?

I was surprised when I saw it on my screen one day.  Frankly, I didn’t think there was enough of an audience of potential Tecfidera users to justify the cost of this kind of an ad campaign.  I guess I was right.

According to the web site www.mmm-online.com, that ad campaign failed to boost Tecfidera’s sales.  The ad has been pulled and Biogen has said it probably won’t be getting back into TV advertising anytime soon.

Lousy sales might not have been the only reason for dropping that ad.  There was also a strong push-back from some MS patients.  One, in particular, was once a “patient consultant” for Biogen, the manufacturer of Tecifidera. She wrote a blog post slamming the ad.  It began: “What on earth are you thinking with  your recent drug campaign?”  The blog continues: “You show everyone  that if we take this blue pill once a day we can do anything.  I am the first one to be encouraging,  but your ad takes it beyond that. Even people with ‘normal’ health will not hike, swim and go to the fair in one day and still look so good; someone with MS would be out of the day before they hit noon.”

A quick search of YouTube turned up an even more personal comment, in a video posted by a young woman named Heather.   “Tecfidera,” she tells the camera, “is not going to make anyone jump out of their MS suit and become Michael Phelps.”

By the way, about a week ago Biogen CEO George Scangos, who shepherded the launch of Tecfidera, announced that he’s leaving the company.

What do you think?  Is it a good idea to use TV to advertise MS drugs?

(BTW, I’m really excited about a weekly MS column that I’m now writing for www.multiplesclerosisnews.com.  Some of those columns will be repeated here, some won’t.  Please check it out).

Biogen

MS drug maker getting new top guy

If you have Multiple Sclerosis the chances are good that you’ve used, or will use, a drug made by Biogen.  The biophamaceutical company makes Avonex, Tysabri, Tecfidera, Fampya, Plegridy and Zinbryta to treat MS.  I’ve used two of them myself and participated in the double-blind study for Avonex, way back when.

Now, Biogen’s Chief Executive Officer, George Scangos, has announced that he’s leaving.  What will that mean to those of us who depend upon companies, such as Biogen, to continue to produce new, and hopefully better, MS drugs?

It’s been a roller coaster ride for Biogen over the six years that Scangos has been at its helm.  Financially, the company had a strong second quarter this year.  But sales, overall, have slowed.  The Wall Street Journal reports that “sales of its biggest drug, Tecfidera, continued to cool in its latest quarter….Revenue from Avonex, Biogen’s No. 2 treatment, slipped from a year earlier.” Last month Opicinumab, an experimental MS drug for which Biogen had high hopes, failed to improve the health of patients in a midstage study.

The Boston Globe quotes biotech analyst Eric Schmidt as saying “George is leaving the company in good health, but this company, which wants to be a leader in treatments for neurodegenerative diseases, has a lot of wood to chop to strengthen the pipeline.”  Does this mean less focus on MS drugs and more on drugs to treat other neurodegenerative diseases, such as Alzheimer’s and spinal muscular atrophy?  Says Bloomberg biotech columnist Max Nisen: “Scangos deserves credit for building the world’s leading MS drug franchise. But his follow-through has been less exciting. Instead of spending $5 billion on something that might shift Biogen’s narrative of slowing growth and excessive risk, investors are getting a buyback. Scangos’s successor will need to be more creative.”

From the viewpoint of this MS patient, a patient who’s been helped by medicines that Biogen has developed, let’s hope that “more creative” doesn’t mean less attention to the needs of those of us with this lousy disease.

 

 

 

Whole body cryotherapy for multiple sclerosis?

Whole body cryotherapy is one of the latest “treatments” claiming to help multiple sclerosis patients.

Those who sell WBC machines and who operate WBC “spas” claim that it can also help a range of other ailments, from asthma to rheumatoid arthritis.  They say it can improve blood circulation, increase metabolism, improve recovery and soreness after workouts and relieve joint and body pain. That’s a lot of problems, and the Food and Drug Administration warns users: it has no evidence that whole body cryotherapy treats, or helps, anything!  And the FDA has recently sent out a specific reminder that this “treatment” isn’t FDA-approved.

“Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved WBC devices as safe and effective to treat medical conditions,” says Dr. Aron Yustein, of the FDA’s Center for Devices and Radiological Health. “That is not the case.”

Cryotherapy uses techniques that can be as simple as using an ice pack to cool a part of your body.  You might have used it to ease your aching back.  Whole body cryotherapy is like cryotherapy on steroids.  It applies super-cold vapors, as cold as minus 300 degrees, over your whole body.  A person might stand in a can-like enclosure, with his or her head outside the can, while being exposed to those super-cold temperatures for two to four minutes.  Or, a group might be exposed while in a room.  Sometimes liquid nitrogen is used to generate the cold vapors.  Sometimes it’s just cold air.

FDA says the risks outweigh any benefits

What actually happens physiologically to your body when it’s super-cooled; to things like your blood pressure, heart rate and metabolism?

“We simply don’t know,” says the FDA’s Dr. Anna Ghambaryan.  But, Dr. Ghambaryan warns, while the healing benefits are unconfirmed the potential risks are apparent.  “Potential hazards include asphyxiation, especially when liquid nitrogen is used for cooling,” says Dr. Ghambaryan. Nitrogen vapors in a closed room lower the amount of oxygen in the room.  That can result in hypoxia, or oxygen deficiency, and that can end up with someone become unconscious.  Other risks include frostbite, burns and eye injury from the extreme temperatures.

If you decide to try whole body cryotherapy to treat your multiple sclerosis the FDA wants you make sure you know that it hasn’t cleared or approved any of these WBC devices for treatment of any medical conditions.

The FDA is also concerned that patients who opt for WBC treatment—especially in place of treatment options with established safety and effectiveness—may experience a lack of improvement or a worsening of their medical conditions.

If you still want to try it, or if you’re already using it, the FDA suggests that you, at least, talk about it with your doctor.

Therapeutic riding: a winner for M.S.

A few years ago I got back in the saddle again.

At age 63, more than 30 years after being diagnosed with multiple sclerosis and about 50 years since I’d last ridden a horse, I found my feet in the stirrups, butt in the saddle and riding a gentle, friendly horse that was led around the ring at the Great and Small therapeutic riding center in Boyds, MD outside Washington, DC.

Laurie Dove, a fabulous instructor who is certified in equine therapy by the Professional Association of Therapeutic Horsemanship (PATH), gave me a boost onto the horse after he was led into the slot of a boarding “platform,” sort of like a subway train slides into a station at the platform.  She then led my horse around the ring as I tried my best to keep my balance and remember what little I could from when I rode as a kid.

Laurie assessed my riding skills, and my physical needs, and then she began to work me through activities that would help my balance, leg strength and core muscles.  This included stretching to place rings over posts, guiding the horse using leg pressure and, on a trail outside, riding up and down hills and over rough surfaces.

After just 3 or 4 thirty minute sessions my balance, and my leg and core strength, improved enough for me to try riding without using the stirrups.  At first, I could only do it for only about 30 seconds.  Later, I was good for several minutes.  After about 9 months of weekly sessions the horse and I were trotting and I was riding on my own…no leader line being held by Laurie anymore!  Therapeutic riding was really therapeutic…not to mention being an amazing stress reliever.  There’s no doubt in my mind that it improved my mobility. And it was fun!

I’m fairly mobile, so therapeutic riding might not be the right thing for someone whose disability is more severe than mine.  However, hippotherapy might be.  Hippotherapy is very similar to therapeutic riding but the riding instructor is a physical or occupational therapist.  There was a great article about hippotherapy recently in the New York Times.

When I retired I moved three hours away from the Great and Small stables and, unfortunately, the distance made it impossible to continue riding there.   It’s been a couple of years now since I’ve ridden but I’m hoping that I can find a way to get back in the saddle again, soon.

 

 

 

When should you start using a DMT?

A friend of mine was diagnosed with Multiple Sclerosis about fifteen years ago.  She’s been very stable since her DX without being on any disease modifying drugs.

But, we’ve both wondered if she should be proactive and start using using Avonex, Betaseron, Copaxone, Tysabri or another of the many disease modifying therapies that are available today.  So far, her neurologist has suggested that my friend hold off.

I’ve lived with MS since 1980 and I was in the original Phase-III study of Avonex back in 1996.  After several years on Avonex I moved to Tysabri and then to Aubagio.  So, I’ve been doing these drugs a long time. Over those years I’ve asked myself a lot, “was starting down the DMT road the right thing to do when I did it?”  I really can’t say. My MRIs show the plaque in my brain has been stable, yet my disability has certainly increased over the past twenty years, or so.  Would my Multiple Sclerosis have worsened more had I not been using those drugs?  Who knows?

Translate that uncertainty to my friend’s situation. When is the right time for her to begin a DMT?  Today?  After a serious exacerbation?  Should she have started years ago or does she have years to go before she takes that plunge?  There’s an interesting article about this in the June 23rd issue of Neurology Today.  It reports on a debate on this question that occurred at the annual meeting of the American Academy of Neurology last April.  As the introduction to the article says, “the answers were almost as vexing as an individual’s disease course.”  It’s a very interesting read.