Thursday, November 8, 2012

Bits and Pieces: Batten Down The Hatches Edition

The clouds were amazing this afternoon during ...
First, thanks to everybody who inquired about my well-being after Superstorm Sandy hit the New York-New Jersey area. Luckily, I live in the uptown section of Manhattan, which was relatively unaffected by the storm. The folks downtown had it harder, as much of that area flooded and there were extended power outages and lots of property damage from the overflowing waters. As I’m sure most of you have seen on the TV news, some other areas had it much worse. Parts of Queens and Staten Island look like war zones, as does much of the New Jersey shore. The damage done to these areas was in some cases absolutely catastrophic, and those who live in them face months or years of rebuilding and trying to regain some sense of normalcy. My heart and thoughts go out to them.

The worst my area saw was some downed trees, which by comparison is barely worth mentioning. Subway service was disrupted throughout the five boroughs of New York City, as, for the first time in history, the New York City subway system was extensively flooded. City officials are still not sure when subway service will get back to normal. Although this has created hardships for millions of New Yorkers, Karen and I were not affected. Due to my disabilities, I haven’t been on the subways in years, as they have some serious accessibility issues. Karen is lucky enough to be able to walk to work; her rigorous commute is a walk through Central Park.

All in all, we got lucky. We live on the 18th floor of our building, and if we lost power for a significant amount of time, I’m not quite sure how I would get out of the building. I guess the police or firemen would have to carry me down the 18 flights, an exercise I’m sure none of us would enjoy. Particularly since I’m quite positive I wouldn’t be able to refrain from reeling off a string of pathetic attempts of humor, which might tempt my heroic first responders to “accidentally” drop me down some stairs. Note to self: in the event of an emergency, refrain from making wisecracks until you are on terra firma, lest you wind up being dropped on your head.

So, that’s the scoop on Superstorm Sandy from my perspective. Kind of scary that Sandy is called Superstorm Sandy, but I guess the combination of a hurricane and a nor’easter deserves a new moniker. We are experiencing another nor’easter as I write this, which will only exacerbate problems for all those folks seriously affected by Sandy. I blame it all on Ernest Borgnine, pretty much because I neurotically feel the need to have somebody to blame for everything. BTW, I’m quite certain my disease was caused by Ethel Merman.

Okay, enough with the preliminaries, here’s my monthly (or so) collection of MS related news items and informational tidbits. If you don’t like them, or find them boring, blame it on Zsa Zsa Gabor.

♦ CCSVI is always a hot topic, and although interest in the issue seems to have lost a little bit of its initial ferocious intensity, there were some interesting and newsworthy CCSVI developments over the last several weeks. After much outcry by the patient population of Canada, the Canadian government has finally given the go-ahead to a national CCSVI clinical trial (click here). While this is a positive development, like the entire CCSVI theory itself, these trials are not without their controversies, ranging from the size and scope of the trial to the makeup of the principals who will be conducting it, as is made clear in this article by Anne Kingston, a Canadian journalist who has been doing terrific reporting on all things CCSVI for several years now (click here).

Doctor Robert Zivadinov, who heads up the BNAC (Buffalo Neuroimaging Analysis Center) CCSVI research project, recently testified before the Canadian Senate on his research findings and their potential impact on not only MS but other neurologic diseases as well. The video of his testimony is must watch material for anybody interested in the current state of CCSVI research. Though the testimony runs almost 45 minutes, it’s time well spent and viewing it is highly recommended:

Zivadinov at the Senate meeting by dm_509535f98f233

Here in the states, CCSVI has finally hit the national media, in an article published in the widely read New York Times Sunday Magazine section (click here). It’s incredible that this far into the game CCSVI has been barely mentioned in the US news media, but this article is at least a good start. It very likely won’t make either ardent proponents or opponents of CCSVI particularly happy, which probably means it’s a pretty fair accounting of the topic. One can only hope that this article will spark some interest in the issue in the wider American newsgathering community, since the CCSVI saga has all the hallmarks of a juicy medical news item, namely a huge amount of patient advocacy, infighting between practitioners of different medical specialties, and a desperate patient population dealing with a potentially gruesome disease. The fact that the story has received almost no coverage at all in the US is truly mystifying.

♦ There have been several interesting developments on the MS drug front. The latest clinical trials show that the drug Lemtrada (formally known as Campath) is significantly more effective in stopping disease activity than the currently available treatments (click here). Lemtrada is a very powerful drug, initially developed to treat leukemia and lymphoma. A powerful immunosuppressant, Lemtrada basically takes down a patient’s entire immune system, forcing the body to “reboot” and rebuild a new one, an action that appears to have extremely beneficial effects on MS disease activity, in some cases even reversing a patient’s level of disability. The drug is given intravenously, every day for five days, and then, approximately one year later, another three doses over three days. Trials have found that the drug appears to remain effective as long as five years after being administered.

All of this sounds great on first blush, but Lemtrada can have some very serious side effects. About one in five patients taking the drug develop autoimmune thyroid disease, and a smaller but significant number can develop a potentially life-threatening (but treatable) blood disorder. As with all available MS therapies, the drug does not appear to be effective on patients suffering from progressive disease.

Lemtrada has also recently been at the eye of yet another example of outrageous behavior by pharmaceutical companies (click here). When it appeared that the drug was about to be approved by the FDA, the makers of the drug, Genzyme and Sanofi, started pulling Campath off the shelves to facilitate a huge increase in the price of the stuff, up to the levels being charged for other MS “blockbuster” treatments. Yes, the drug companies are going to dramatically hike the price of a drug that has been widely available for the treatment of cancer since 2001 simply because it’s approaching approval for use in a disease whose treatments are noted for their obscenely high prices. Some might call this sound business practice, but to me it sounds like simple old-fashioned price gouging. Shame on them.

The experimental oral MS drug BG 12 has also been shown to be quite effective in late stage trials, and was submitted to the FDA for approval (click here). Since the trials had shown the drug to have a very good safety profile, it was a surprise when the FDA extended its review process on BG 12 (click here). I was wondering what might have prompted that action when I came across this article (click here), which tells of a drug called Reata, which was being tested for use against kidney disease and shares the same molecular target as BG 12. Reata had its clinical trials abruptly halted because of serious side effects and even mortality among test subjects. Although the two drugs do share a common molecular target, they work in very different ways, so BG 12 quite likely won’t suffer the same fate as Reata, but better safe than sorry. Although the reason for the FDA’s extension in reviewing BG 12 has not been made public, I can only imagine that the problems with Reata might be the cause.

♦ has put together a list of 18 of the best MS blogs, and lo and behold, Wheelchair Kamikaze was chosen as part of the group. A big thanks to Healthline, and congratulations to the other blogs chosen (click here). Be sure to check out some of the other blogs on the list, they are all quite excellent, and each has a unique take on life with the disease. has also put together a collection of the best iPhone and android MS apps, so get ready to do some downloading (click here).

♦ This paradigm shifting, earthshaking study, entitled "Social and Economic Burdens of Walking and Mobility Problems in Multiple Sclerosis", reveals that walking and mobility problems cause significant problems for MS patients (click here)!!! Contrary to what severely delusional and/or heavily sedated people might think, patients with more severe walking and mobility problems (or WMPs, as the researchers like to call them) require more caregiver support, visit a greater variety of doctors, and require more non-disease modifying drugs than patients who have less problems walking. Can you fracking believe it? The researchers also found that work productivity was impacted by the severity of a patient’s walking and mobility problems. Wow! Freaking gimps, letting a little problem like not being able to walk get in the way of their ability to work! Upon further study, the researchers even found a more subtle link: levels of work productivity decreased when levels of walking and mobility problems increased. Again, who would’ve thunk it? As somebody becomes more crippled, their ability to work also becomes more crippled? Like, you mean, there’s a direct relationship? Holy Rollators!

Let me save future researchers some time, and provide these insights gleaned from my own life experiences: the ability of people with progressive retinal diseases to negotiate obstacle courses decreases dramatically when they go completely blind, patients with flatulence problems can really stink up the joint after eating several bowls of baked beans, and patients who die of cancer require a tremendous amount of medical attention until they expire, at which point they mysteriously stop being a drain on medical resources. Astounding conclusions, I know, but I take much pride in my keen analytical mind and powers of perception.

♦ Regular readers of this blog know that I have a thing for pointing out the deficiencies of our medical research process, and that many of my gripes are based on the fact that the vast majority of medical research is conducted by for-profit pharmaceutical companies, whose reason for existence is not to produce the best drugs possible, but the most profitable. Yes, sometimes these two endpoints come together to the benefit of all, but they can often be at odds, to the detriment of patients. The following video, part of the incredibly wonderful TEDtalk series, brings to light one particularly egregious aspect of how medical research is currently conducted. It’s quite common, it seems, for pharmaceutical companies to simply withhold inconclusive or negative drug studies, while publishing positive studies on the very same drug. This, of course, can lead to disasters in which drugs get approved but then are found, after hitting the general market, to have horrendous side effects. There are numerous instances of this occurring, and this video provides some of the reasons why:

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  1. You absolutely deserve the recognition for having a great MS blog. I like how yours was listed first amongst the blogs I associate with having a single person responsible for publishing. Being right behind the National Multiple Sclerosis Society and ahead of the rest is impressive. The order may or may not be intended to have meaning, but I was always told the positions intended to garner the most interest in any presentation shroud be at the beginning and end. Clearly, your blog is meant to be amongst the very first they want to use to give the list credibility, and it does.

    I'm also glad to see the video about the non publication of negative trial results get more press. I thought it was an excellent video when my sister-in-law, a family practice MD, sent it to me. I tried to talk about it on the Kojo Nnamdi show on our local NPR, with experts from government and watch group. Dr. Robert Temple, the Deputy Director for Clinical Science, at the US Food and Drug administration said the results of all trials have to be published at (an interesting site to search for MS trials and results)

    Thank you for the time and effort you put into your blog. It's a huge asset for all of us with MS.

    1. Thanks for the kind words. I think my blogs position in the list of MS blogs was totally random, but I'm not complaining.

      Apparently, some trials do not get posted to clinical In any event, there have been enough scandals to prove that the pharmaceutical companies do withhold negative information and findings regarding their products. Along with a whole host of other nefarious activities. But, hey, it's business…

  2. Regarding the pricing of lemtrada by sanofi - it would be naive to assume that pharmaceutical companies are solely driven by treating illness and not to generate a profit. Their survival is dependent on this. That said, the pricing of the drug has to take into the cost of R&D. If price gouging is suspected watch dog groups should bring this our attention.

    1. Certainly, the R&D of Lemtrada was completed years ago, when the drug was first developed for use in treating various cancers. Granted, the clinical trials required to get it approved for MS certainly cost money, but not enough to warrant the four or five times increase in price that Sanofi is expected to slap on Campath, oops, I mean Lemtrada…

      The watchdog group called "the press" did bring it to our attention. Although it's often forgotten in the culture wars, one of the jobs of a healthy news media is to bring such situations the light…

  3. So good to hear you weathered the storm. Thought of you a lot while I watched CNN. Thanks for including the Canadian Senate footage.
    The drugs are getting scarier. I'm meeting with my MS doctor next week to talk about stopping Copaxone. They have already tried to talk me into Gilenya. The side effects are worse than the symptoms I currently have.
    Thanks for everything you do Marc. You deserve the accolades.
    Take care,

    1. Not being a physician, I can't give medical advice. Suffice it to say that there may be better choices than Gilenya…

      The choice of whether to go drug or no drug is intensely personal. While I know patients who do very well "no drug", I do know others who have taken that route only to be slammed hard by the disease later on. Of course, I can say the same thing for people to take the "drug" route, too. The situation is as clear as mud…

  4. I blame Ethel Merman for my MS too!!!!!!!!


  5. And then we wonder why medicine prices are so darn high. Pharmaceutical companies should really be ashamed of what they're doing; they're leaving a lot of lives wither away for the sake of profit.

  6. "...not to produce the best drugs possible, but the most profitable" - this has always been the problem of companies; everything is done for the sake of money, and not for the purpose they stand for. Pharmaceutical companies create medicines for profit; not because of their concern for the people's health. Just like how food businesses distribute food for profit and not because they want to distribute proper nutrition.

  7. I think it will be near to impossible to see a drug company that's totally not into earning a profit out of their products (the big ones at least, maybe the small-scale makers aren't really like that). It's probably the main reason why they contract primary care providers, solo practitioners, and everybody else to try their drugs; every other reason is secondary (though not necessarily out of the question).