Big Pharma, Bad Medicine

(Photo credit: Mike Licht, NotionsCapital.com)

Given the importance of rigorous, verifiable research in the practice of modern medicine, it seems a natural assumption that the doctors who treat us base their actions and recommendations on solid, irrefutable evidence. Evidence-based medicine, is, after all, the mantra that we as patients hear over and over again, especially when it comes to our inquiries into the implementation of alternative therapies that fall outside of the medical mainstream. More often than not we are told that there is simply no evidence for the effectiveness of this or that alternative therapy, and that rather than waste our time and energy on unproven and possibly dangerous unconventional remedies, we should stick to the tried-and-true, which almost always come in the form of pharmaceutical products produced by one of the giant multinational pharmaceutical firms, known collectively as “Big Pharma”.

The logic behind such thinking isn’t necessarily faulty. Untold millions of dollars are spent developing drugs and putting them through laborious clinical trials, the result of which is the evidence upon which “evidence-based medicine” thrives. Absent the data produced by this research model, the practice of medicine would be largely reduced to educated guesswork, based solely on the experiences and impressions of individual medical practitioners, which by definition would be limited in scope and might easily be skewed by subliminal prejudices and statistical aberrations physicians could encounter during the course of their careers. Relying instead on evidence amassed through years of rigid research encompassing thousands of patient hours makes deciding which medicine to prescribe or procedure to recommend an exercise in logic and intellectual reasoning, the cornerstones of all disciplines of modern science.

This all makes perfect sense, and indeed this very reasoning has fueled the rapid advances seen in many fields of medicine over the last half-century. However, if the evidence which is the foundation of evidence-based medicine becomes unreliable, or downright misleading, the entire edifice that is modern medicine stands in danger of collapse. To an extent that is almost incomprehensible, this is the very environment in which patients and physicians now find themselves operating, as the research published in scholarly journals and presented at medical symposiums appears to be increasingly biased in favor of the drugs being researched, to the point that physicians are now basing their treatment decisions on woefully incomplete data sets and trial results that conveniently leave out the negative while emphasizing the positive.

As is documented by British psychiatrist Dr. Ben Goldacre in his book “”Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients”, which was recently excerpted at Salon.com (click here), the trial evidence upon which doctors base their most important decisions is often misleading at best, and outright dishonest at worst. As more and more medical research is funded by the drug companies themselves, rather than by independent concerns such as foundations or government agencies, the results of that research appear to be becoming less and less reliable. Dr. Goldacre cites studies which show that research funded by pharmaceutical companies is far more likely to favor the drug being tested than studies funded by independent organizations.

One such study, conducted in 2007, looked at every published study investigating the effectiveness of statin drugs, which are commonly prescribed to lower cholesterol. The studies either compared an individual drug to another kind of treatment, or to a competing statin drug. In all, 192 studies were surveyed, and researchers found that pharmaceutical company funded studies were 20 times more likely to give results favoring the test drug than similar trials funded by independent concerns. Other studies looking at different bodies of research found discrepancies that weren’t quite so dramatic, but invariably found that industry funded studies were far more favorable to the drug being researched.

The reasons for this bias are many. Trial results can be manipulated by testing a drug against another drug given at a sub optimal dosage. Patient populations can be manipulated, so that only patients most likely to get better are used in the research. The researchers themselves, even those conducting studies that are properly designed, may be subconsciously biased by the knowledge that their paycheck is being funded by the pharmaceutical company whose drug is being tested. Whatever the reasons, the evidence appears to be irrefutable: the trial results upon which doctors base their treatment decisions are very often biased in favor of the treatment being tested.

To make matters worse – much worse – drug companies routinely fail to report negative research outcomes, never allowing them to see the light of day. The companies conduct many studies on a single drug, and only publish those studies whose findings are positive for the drug in question. Dr. Goldacre writes about a situation in which he did the very best he could as a doctor, only to later find that he had been misled by the very act of doing his due diligence. In deciding on an antidepressant drug on which to put a patient for whom other drugs had proven ineffective, Dr. Goldacre read every published study he could find on a new drug he was considering, which all showed it to be better than placebo, and as good if not better than competing antidepressant drugs. Later, Dr. Goldacre learned that, though he had read all of the available studies, he’d only received a tiny glimpse into the true research record of the drug he was investigating, Reboxetine.

Some time after Goldacre prescribed Reboxetine for his patient, researchers did a comprehensive survey of all the trials that had ever been conducted on the drug, including those that had not been submitted for publication in academic journals by the drug company, collecting their data through numerous requests to manufacturers and regulating agencies. They found that seven studies had compared Reboxetine to placebo. Of those seven studies, only one found the drug had a positive result, the other six found Reboxetine to be no better than a dummy sugar pill. Only the positive study was published for review by physicians. The six failed studies were never submitted for publication. Trials comparing the drug to competing drugs showed a similar pattern. Three trials, totaling 507 patients, found Reboxetine to be more effective than a rival drug. However, other trials, which used data derived from 1657 patients, found that Reboxetine treated patients fared worse than those on other drugs. These findings were again left unpublished, shielded from the view of the physicians.

Tragically, this situation is typical of the industry. The fact that pharmaceutical companies can fund their own studies and decide to only publish positive data is unfathomable. Would we let, say, automobile manufacturers conduct their own safety tests, and without question accept their claims that the cars they make are the safest in the land? Of course not, yet this same practice has been allowed to flourish in an industry upon which the health of the world has come to rely. The situation is outrageous, but is so endemic that remedies are difficult to come by.

The British Medical Journal, a highly respected academic journal better known these days as BMJ, has, as of January of this year, announced that it will only publish studies that allow access to patient data from all of the studies conducted on the drug in question. The editors of the BMJ lay out their case for this action in a hard-hitting editorial published last October (click here). If only other academic journals would follow suit. The pharmaceutical giant GlaxoSmithKline announced in October 2012 that it will open up all research data for investigation by physicians and scientists (click here). While this is an admirable step, it comes only after GlaxoSmithKline was forced to pay $3 billion to the Federal Drug Administration to settle three charges of fraud levied against it (click here), one of which included holding back data and making unsupported claims regarding its diabetes drug Avandia.

Another of the charges in the GlaxoSmithKline settlement was that the pharmaceutical giant used inappropriate tactics to influence physicians to prescribe their drugs, tactics which included paying large speaking fees to doctors and providing them free access to high-priced entertainment. Couple the reality that pharmaceutical companies have been allowed to bury negative trial data with the fact that these companies routinely use their huge sales forces to court practicing physicians with offers of all-expenses-paid trips to “educational symposiums” in exotic locales, free gifts and lunches, and sponsored lectures, and we have what some cases amounts to a completely rigged system.

As circumstances currently stand, physicians find themselves faced with a situation in which they can’t trust the research published in academic journals (often their only resource for such vital information), and many find themselves subject to conflicting influences offered by pharmaceutical companies, the success of whose products lies completely in the hands of these same physicians. The end result can only be that patients in general, who trust their very lives to doctors, can only wonder about the motivation and correctness of the treatment decisions made on their behalf. For MS patients, whose drugs can cost tens of thousands of dollars a year and some of which carry potentially deadly side effects, the gravity of these questions is only multiplied.

It’s a situation that truly boggles the mind.

The below video is a presentation given by Dr. Ben Goldacre on some of these very same issues. It's really a must watch…
 

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Bits and Pieces: Pharmaceutical Follies Edition

Oh, those pharmaceutical companies, always generating such tremendous tidings of joy and overwhelming warm and fuzzy feelings in the hearts of their adoring public. They’ve cured almost every disease that has ever plagued mankind, urged doctors to only prescribe their products when absolutely necessary, kept the price of medicine low enough so that even the most unfortunate can afford their wares, and have conducted their beneficent and altruistic research in a transparent, above the board manner that engenders absolute trust in all of their findings. How lucky we are to…

Whoops! Sorry, I started writing the above paragraph during a brief visit to an alternate universe, one much more to my liking, in which vintage Godzilla movies keep winning Oscars decades after they were made, bacon is a health food, blithering idiots are scorned rather than given their own reality TV shows, and I’m fluent in 10 languages, drive a mint condition 1956 Ford Thunderbird, and am a world-class triathlete. But, since I appear to have suddenly shifted back to this reality, I guess I’ll have to change the tenor of this blog post. Bummer.

I haven’t done a “Bits and Pieces” post in a while, because, well, it’s my blog and I’ll scribble what I want to. There’s been lots of stuff happening in the world of MS, and in the world in general, so in order to limit this post to a length not exceeding War and Peace, I’ll judiciously pick just which bits and pieces of info to highlight. Not that I’ve ever been willy-nilly about picking bits and pieces in previous posts, but I needed an excuse to use the expression willy-nilly, due to an obligation made in an alternate universe. We all must do our part to keep the cosmos in order, you know…

So, presented for your review are the following tidbits of mostly MS related news items, most of them having to do with pharmaceutical companies and their products, with a liberal dose of my take on things thrown in. Bon appétit…

♦ A study which throws into question the efficacy of the interferon drugs (Rebif, Avonex, and Betaseron) to alter the course of MS disease progression (click here) has caused quite a bit of hubbub on numerous Internet MS related forums, blogs, websites, and Facebook pages, and rightfully so. This retrospective study looked at three groups of MS patients, and tracked the course of their disease over a ten-year period. One group was comprised of patients who were treated with the interferon drugs, another of MS patients that were left untreated, and a third was comprised of patients from before the days that the interferon drugs were first made available (they arrived on the scene in the mid-1990s). The study found that patients treated with interferon were no less likely than untreated patients to experience disease progression leading to significant disability.

However, another study, which received much less play in the Internet MS universe, came to the exact opposite conclusion, finding that the interferon drugs do significantly reduce the risk of progression for multiple sclerosis patients across the board (click here).

So what’s going on here? Obviously, it’s hard to say, but, as this article points out (click here), the study that found the interferons ineffective had some possible methodological flaws. One might assume that the population of patients in the untreated group was left untreated because their disease was generally less severe and aggressive than those who were in the treated group, which would invalidate a direct comparison between these two patient populations. If this were the case, the study’s findings would actually show the interferons were effective, because they kept patients with more severe disease from progressing more quickly than those with less severe disease.

Whatever the case, the situation remains as clear as mud. The interferon drugs are much disparaged among many MS patients, because they obviously do not cure MS, cost a fortune, have very unpleasant side effects, don’t work at all for many who try them, and, to top it off, are injectables, and nobody relishes the idea of giving themselves a shot several times a week. What does seem clear, though, is that, at the very least, these drugs do offer some patients relief from debilitating relapses, even if they don’t ultimately alter the course of their disease. Many patients report a severe curtailing of their relapse rates once on the interferon drugs, which amounts to a significant uptick in their quality of life. This benefit cannot be discounted, even if interferons ultimately do prove to be worthless in stopping disease progression, which of course would be disappointing. I’m not one to defend the pharmaceutical companies, but the interferons were never approved under the auspices of stopping disease progression; rather, their approval was based on their ability to reduce relapse rates and the amount of enhancing lesions as seen on MRIs. It was hoped that these two effects would translate into a lessening of disease progression, but that was always just an assumption, a point never tested in clinical trials.

An interesting window into the opinions of patients about this issue is the comments that appear after a piece Julie Stachowiak wrote about the negative study in her always excellent Ask.com MS column (click here). I expected to see a fusillade of outrage voiced by the commenters, but surprisingly, a preponderance of the comments are from patients who say they’ve benefited from the interferons and intent to stay on them because of their increased quality of life. I guess the bottom line is that, drugs or no drugs, MS sucks, and will continue to suck for the foreseeable future. Actually, that’s pretty much the bottom line about everything related to MS…

♦ Here’s an example of a pharmaceutical company snatching victory from the jaws of defeat. The FDA recently warned about seizures associated with the MS drug Ampyra (click here), made by Acorda pharmaceuticals, which is supposed to improve the ability to walk in some MS patients. Much to the chagrin of investors, this warning caused a marked decrease in Acorda’s stock price. Ampyra is given in 10 mg doses, and the FDA asked Acorda to conduct trials to see if a 5 mg dose would be as effective as a 10 mg dose while cutting the risk of seizures.

The results of this follow-up study showed that both the 5 mg and 10 mg doses of Ampyra failed to demonstrate any efficacy in regards to increased walking ability (click here). Acorda claims that this is because the methodology used in this study was different than that of the original studies. Regardless, Ampyra remains on the market in 10 mg doses, since it was previously approved by the FDA based on prior clinical study results. In a happy twist for the drug company and its investors, even though the drug failed the follow-up study, the fact that the 5 mg dose was ineffective means that Acorda retains its long-term patent rights on the 10 mg dose, whereas if the 5 mg dose have been effective copycat drugs could have been manufactured and placed on the market as soon as 2017 (click here). Acorda’s stock price rose on this news, so all is well in investor land, despite the fact that the drug can cause seizures and may be largely ineffective. So, bad news for MS patients, good news for those making money through the marketing of a drug whose efficacy is highly suspect. Talk about alternate universes…

♦ In a case that didn’t work out quite as well for the drug company, Genzyme submitted the drug Lemtrada (formally known as Campath) to the FDA, fully expecting an approval. The company was so confident that the drug would be approved that they started pulling Campath, which had been marketed for years as a treatment for leukemia, off the shelves to keep it from being used off label to treat MS. This was done so that Genzyme could hike the price of the renamed drug to fully take advantage of the more lucrative multiple sclerosis market (click here). After all, MS patients need to take their drugs for years on end, but victims of leukemia either go into remission or die, limiting their necessity to consume drugs. But, ha ha on Genzyme, the FDA turned around and requested that the company resubmit their application (click here), asking the company to change the presentation of the data so the agency can “better navigate the application”, whatever that means. The FDA didn’t order any additional trials of studies to be run.

While it feels good to see a case of corporate greed smacked back, even if only a little, Lemtrada is an interesting MS drug. It is a powerful immunosuppressant, but has been shown in studies to actually decrease the amount of disability seen in patients, even five years after they stopped taking it (click here). This is a result previously unseen with any other MS drug, and may be due to the fact that Lemtrada is such a strong immunosuppressant that it forces the body to rebuild its immune system. This is a similar mechanism to some autologous stem cell treatments, in which a patient’s immune system is completely wiped out with very potent chemotherapy drugs, and then “rebooted” through the use of an infusion of bone marrow stem cells. The effectiveness of the drug does come at a price, though, as 30% of those taking it develop autoimmune thyroid disease, and a smaller percentage develop a serious blood disorder. Unlike Tysabri, though, for some reason the risk of serious infection seems to be quite low, despite the powerful immunosuppressive characteristics of Lemtrada. For patients willing to take the risk, Lemtrada, if and when it is eventually approved, may be the most effective MS drug available. Of course, it only works for RRMS patients; those with SPMS or PPMS are, as usual, left to flap in the breeze…

Having said all that, it sure would be nice if researchers would concentrate their efforts on finding ways to combat MS that don’t tinker with the immensely complex human immune system, since this approach clearly leaves patients open to potentially lethal side effects while doing nothing to actually cure the disease. Perhaps trying to figure out why the immune system goes bonkers in MS patients would be a good place to start…

♦ Just to bolster your confidence that science is aggressively attacking some of the most important issues facing mankind, a cure for baldness appears to be closer than ever (click here). Apparently, Vitamin D holds the key, and researchers around the world are scrambling to finally solve the horrendously tragic and heartbreaking epidemic of typical male pattern baldness, which has brought frustration and shame to men longing to be hairy since time immemorial. Just think about how much time and money is being spent chasing this cherished dream, and how many brilliant minds are dedicated to it. Forget about cancer, heart disease, ALS, and even MS – rejoice, for soon baldness may be cured! I know that I, for one, even with my head full of thick, voluminous hair, will celebrate mightily when the cure for baldness is finally announced. I’ll sit in my wheelchair and feebly raise a pathetically weakened fist as high in the air as my ever more afflicted muscles will allow, reveling in the knowledge that some perfectly healthy bald men will soon be able to proudly make appointments at barbershops and hair salons the world over. It’s all about priorities, people, and mine are definitely in order.

♦ This little bit of news is funny and sad at the same time. Seems an MS suffering grandfather in Scotland forgot he was married and wed his girlfriend, getting into all kinds of trouble due to the fact that he is now a bigamist (click here). The 50-year-old claims he thought his first wife had signed divorce papers, but he apparently forgot that she hadn’t.

In all fairness to the gent, he’d been separated from his first wife for several years, and MS does cause cognitive and memory issues in many who suffer from it. Furthermore, his second wife left him a few months after they were married, and the stress ensuing from this whole mess triggered a relapse, leaving him using two crutches. I’ve had women leave me emotionally crippled before, but this guy really got the short end of the stick. Or, in his case, sticks. In related news, a new study found that ginkgo biloba, an herbal remedy purported to improve cognitive function, had no effect on the cognitive abilities of MS patients (click here).

♦ If you’re in need of a little inspiration, this (click here) infographic about the Paralympics can provide plenty of it. Recently completed in London, this international sporting event for disabled athletes embodies the best of the human spirit. Though the bodies of participating athletes may not fit the standard definition of perfect, their hearts certainly defy definition.

I’ll leave you with the following video, in which a noted brain researcher recounts her experiences during and after suffering a stroke. These experiences provided her with startling and fascinating insights into not only the workings of the human brain, but of the universe and our place in it as well. I have an endless fascination for the mysterious place where science gently kisses spirituality, and this talk navigates that enigmatic realm as well as any I’ve ever heard. It’s 20 minutes long, but I guarantee it’s time well spent, and will provide you fodder for much contemplation…

Related articles

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Greed Trumps Common Sense Once Again, Courtesy Big Pharma

Image by Images_of_Money via Flickr

The mix of money and medicine often makes for a strange brew. Far too often, conflicts arise between what is best for the patient and what is best for the bottom line. Over the last several decades, treating chronic illness has mushroomed into a worldwide multibillion dollar industry. To the megacorporations reaping these profits, patients are seen first as consumers, rather than sick individuals needing to be healed. This truth is often camouflaged with warm and fuzzy programs designed for patient outreach and education, but CEOs of publicly traded medical corporations, as mandated by law, are beholden to their shareholders, not to the patients consuming their company's products, a mission which is sometimes at odds with what should be the goal of all involved in the healing professions: the curing of illness and the alleviation of suffering.

We see this unfortunate circumstance play out time and time again in the world of multiple sclerosis. Since Big Pharma finances the vast majority of medical research done in the USA, promising therapies with little profit-making potential are left to wither on the vine. Thus, medical research increasingly involves only therapies that stand to attain blockbuster status. We therefore have very little scientifically reliable data on the effectiveness of Low Dose Naltrexone, dietary supplements, acupuncture, naturopathic remedies, and other largely benign practices and substances. Alternative theories about the disease, such as CCSVI, are met with a fusillade of negativity instead of intellectual curiosity, as might be expected in the case of a disease as intractable as multiple sclerosis.

One of the oddest examples of the profit motive trumping common sense involves the drug Rituxan (click here), a compound first formulated to battle B cell non-Hodgkin's lymphoma, for which it was approved by the FDA in 1997. Rituxan was the first monoclonal antibody used to fight cancer, and proved to be both safe and effective in that role. The compound works by destroying B cells, one of the major components of the human immune system. Therefore, in addition to its lymphoma fighting abilities, Rituxan is a powerful immunosuppressant. Due to these immunosuppressive properties, the drug was tried with varying degrees of success on a number of autoimmune diseases, and has been approved for use in patients suffering from rheumatoid arthritis.

Several years ago, clinical trials were started testing Rituxan's efficacy in fighting multiple sclerosis. These trials included not only RRMS patients, as is typical of MS trials, but also PPMS patients, a population for which there are no approved therapies. Phase 1 and 2 trials showed the drug to be extremely effective, dramatically reducing the amount of enhancing lesions seen on patient MRIs, and cutting by half the number of relapses experienced by RRMS trial subjects (click here). The trial results were at least equal to those seen with the drug Tysabri, which to date had been the most effective MS drug on the market. Rituxan had the added advantage of having a long history of use, which showed it to have a much lower incidence than Tysabri in expexposing patients on the therapy to to the possibility of developing PML , a sometimes fatal brain infection. Trials for PPMS were not as successful, although analysis of the data did seem to indicate that a subgroup of PPMS patients did appear to benefit from Rituxan therapy (click here).

So, it would seem that all systems were "go", and that Rituxan would be quickly shepherded into phase 3 multiple sclerosis trials, the final step needed before FDA approval to go to market, right? Well, this is where things go a little bonkers. It turns out that Rituxan's patent is due to expire in 2015, meaning that the company that makes it, Genentech, will no longer have exclusive rights to the drug, and generic versions of it could come on the market, esseessentially stripping Rituxan of its profit-making potential. Because of the complexity involved in making monoclonal antibodies, it was at first thought that the production of generics would be too costly to be seriously considered, but other companies, sensing opportunity, did indeed step into the arena (click here). Given this situation, despite the great promise shown in the earlier trials, Genentech pulled the plug on further MS Rituxan trials. Nevermind that Rituxan appeared to be safe and effective in alleviating some of the suffering caused by a dread disease, there was no money to be made from it, so any further development hit a brick wall.

Instead, Genentech did some tinkering with the production methods used to make the drug, and came up with a compound called Ocrelizumab (click here), another monoclonal antibody that destroys B cells, which was quickly put into clinical trials for rheumatoid arthritis, lupus, multiple sclerosis, and hematological cancers. By developing this new compound, so similar to Rituxan, Genentech was insured of maintaining exclusive rights to the drug for several decades, with no threat to the tremendous profits a drug equally as effective as Rituxan could generate. Ah, but the best laid plans of man sometimes go awry, and things didn't work out quite the way Genentech intended.

In 2010, Genentech was forced to suspend Ocrelizumab trials in rheumatoid arthritis and lupus due to deaths resulting from opportunistic infections attacking trial participants (click here). Of course, this was a tremendous blow to Genentech's wily plan to circumvent Rituxan's patent issues (click here), and a serious kick in the bottom line. But, alas, all was not lost, as trials continued testing Ocrelizumab's use in multiple sclerosis. Recently released phase 2 clinical trial results have shown Ocrelizumab to be highly effective in reducing enhancing lesions and relapses in RRMS patients (click here), and Genentech is now in the process of recruiting patients for phase 3 trials for both RRMS and PPMS (click here, here, and here). Apparently, the perception is that tolerance for risk is higher in the MS population than it is among lupus or RA patients, so it's full speed ahead, torpedoes be damned.

Rituxan is currently still on the market, often used off label for the treatment of MS, and has proven to be very effective in relieving some of the suffering of RRMS patients. Unfortunately, since it is not FDA approved for use in MS, many insurance companies refuse to pay for it, as it is an extremely expensive therapy (over $40,000 per year). Once the generics do hit the market in several years, the price of the drug should plummet. Should Ocrelizumab pass its phase 3 trials for MS, and be approved by the FDA, rest assured that Genentech's marketing machine will use every trick in the book to get this newer, less proven, and possibly more dangerous drug given preferential treatment over its low-rent cousin.

Of course, neither of these drugs does one whit to cure MS, but why try to cure something when treating it is so immensely profitable? Rituxan has proven to be quite effective and relatively safe (the PML rate is in the range of 1 in 100,000) when used to treat MS, and the fact that it will never even be given the chance to get FDA approval as an MS therapy simply because its power to generate millions of dollars in profits will soon disappear is nothing short of a travesty, further compounded by the emergence of Ocrelizumab, whose sole reason for existence is to sop up the profits that will be lost when Rituxan goes off patent. Might not the money used to develop and test Ocrelizumab, a figure undoubtedly in the millions of dollars, have been better spent on research that might further our knowledge of how to combat MS, rather than simply finding a way to mimic the actions of an already existing drug in a form conveniently different enough to be patentable (and, apparently, more dangerous)?

Unlike some other MS advocates, who label all of the available mainstream disease modifying drugs nothing more than snake oil, I recognize their value in improving the quality of life of many of the patients taking them. Certainly, even if they do nothing to halt the progression of the disease, dramatically reducing the amount of relapses suffered by RRMS patients has great value, and I know of many patients whose lives have been tremendously improved through the use of today's DMDs. What I can't stomach, though, is the blatant profiteering practiced by the big pharmaceutical companies, as is so clearly illustrated in the Rituxan/Ocrelizumab saga. People's lives are at stake, but I suppose in the world of big money modern medicine that concern pales in comparison with the chase for the almighty dollar.

I say shame on all involved…

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Related articles

• New drug shows promise against multiple sclerosis (eurekalert.org)
• New Multiple Sclerosis Therapy Promising In Early Trial (nlm.nih.gov)
• Ph2 Roche study delivers promising long-term ocrelizumab data on MS (fiercebiotech.com)

Bits and Pieces: End of Summer Edition

Image by Claudio.Ar via Flickr

Well, here's another collection of various items of interest (well, at least of my interest), most of which have something to do with MS, and none of which have anything to do with the end of summer. Just thought I'd note that the seasons have changed once again, and we are now officially in autumn, my favorite time of year.

Time just whizzes by, doesn't it? I've noticed that the older you get, the faster time seems to pass, so much so that it becomes increasingly difficult to get your arms around the quickly passing days, and events unfold at breakneck speed. Remember when the two-month summer vacation from grade school seemed like an eternity, filled with innumerable dramas and intricate subplots? Now two months seem to pass in the time it takes me to let out a good yawn.

Just goes to show how subjective is our existence. I suppose this ever increasing sense that time is speeding up has something to do with the fact that as we get older, each increment of time becomes a lesser part of our lives. For example, a two-day-old infant experiences a single day as 1/2 their lives, whereas, at 48 years old, a single day represents 1/17520 of my existence. All the more reason to try to make the most of your remaining time on earth, and here I've gone and completely wasted about a minute of your precious, ever dwindling allotment of life. Please forgive me.

With that, my latest collection of flotsam and jetsam…

♦ Researchers have discovered that the brains of MS patients show a marked deficiency in substances known as Neuro-Steroids (click here). Neuro-Steroids help build brain cells and maintain their function, thus increasing their levels in patients deficient in them might not only stop MS in its tracks, but also actually repair some of the damage that the disease does to the central nervous system. Better still, drugs designed to increase the level of Neuro-Steroids are already being trialed for use in combating epilepsy and depression, meaning that, if successful, Neuro-Steroid drugs could be on the market much quicker than a newly discovered compound that has yet to hit the trial pipeline. Of course, this research is still in its early stages, but it does seem quite promising.

♦ In other drug-related news, researchers have figured out a way to deliver drugs across the blood brain barrier, an obstacle that has inhibited the treatment of many central nervous system diseases throughout the history of medicine (click here). The blood brain barrier functions to keep the brain and spinal cord out of harm’s way by carefully selecting just what substances can cross from the bloodstream into the CNS, much like the doorman at an exclusive nightclub picks and chooses amongst the riffraff clamoring to get in, only allowing entry to the anointed few deemed worthy of such a privilege, a practice that made me want to vomit even back in the glory days when I was "fortunate" enough to be one of those deemed worthy. Anyway, researchers have now figured out a way to open a temporary window in the blood brain barrier, potentially paving the way for a new level of efficiency in treatments designed specifically for central nervous system disorders.

♦ Researchers in Japan have discovered a high-tech method of analyzing cerebral spinal fluid (CSF), allowing for the differentiation between MS and other neurologic diseases (click here). This could be hugely important, as currently there is no test specific for MS, making it a diagnosis by exclusion. In other words, doctors diagnose MS primarily by eliminating other possible causes of a patient's symptoms and diagnostic test results, a process which results in a fairly wide margin of error and a misdiagnosis rate of about 5%-10% . That's right, for every 10 people reading these words, there's a good chance that one of you has been misdiagnosed. So put that in your pipe and smoke it.

♦ A bit of bad news, as simvastatin (otherwise known as Zocor) has been found to be ineffective as a treatment for MS (click here). Four or five years ago there was much buzz about the statin drugs (commonly used to treat high cholesterol) possibly being of use in the treatment of MS, potentially as an add-on to be used in addition to other therapies, but recent research results have been disappointing.

♦ In CCSVI related news, the Buffalo Neuroimaging Analysis Center (BNAC) published a comprehensive overview of all of the CCSVI research that has been done to date. The BNAC Patient Advisory Council, of which I am part, put together an easy-to-read digest distilled from the much longer piece, written specifically with patient education in mind (click here). It's done in a question-and-answer format, and should provide a nice overview of the current state of CCSVI knowledge.

♦ The Canadian province of Saskatchewan this week announced that it will be sending MS patients to Albany, New York to participate in a CCSVI treatment clinical trial (click here). Although CCSVI research is not moving along as fast as many of us wish it would, in actuality the pace of research is quickening and gaining momentum, and hopefully we will soon start to reap the benefits of that research.There is still far more about CCSVI that we don't know than we do, and getting those questions answered, dither pro or con, in the quickest possible fashion is in the best interests of all, regardless of their stance on the hypothesis.

♦ For those interested in a comprehensive and extremely well researched and well-written account of the history of the CCSVI hypothesis and the science behind it, a terrific resource is the book "CCSVI As the Cause of Multiple Sclerosis" (click here), written by Marie Rhodes, a nurse and MS patient who was at the forefront of the CCSVI movement when it was in its early infancy. The book offers a wealth of knowledge, and is even available in a Kindle version.

♦ The Multiple Sclerosis Association of America (MSAA), a terrific organization that does much to aid MS patients, is offering a couple of interesting programs that caught my eye. The first is a webinar series designed to instruct patients on taking care of their financial well-being (click here), an incredibly important topic given the fact that so many of us are either already on disability or are contemplating a potentially financially treacherous future out of the workplace. The first webinar, "Being Money Smart", is scheduled for October 6, so sign up now!

The second program is the MSAA's Annual Art Showcase, which is now accepting submissions (click here). This year's theme is "Change", and artists are encouraged to interpret this theme as creatively and broadly as they wish. The showcase is limited to two dimensional art, and doesn't include photography (boo!).

♦ For those interested in the alternative treatment Low Dose Naltrexone (LDN), Julie Stachowiak, who writes About.com's invaluable weekly column on MS, has been keeping a diary of her recent foray into the world of LDN (click here). Naltrexone is an old drug that is used to treat various addictions, but in very low doses it has been purported to alleviate the symptoms of MS and a variety of other diseases. Anecdotal accounts seem very encouraging, with many patients reporting significant improvements while taking LDN. I tried LDN early on in my MS adventures, but found it didn't do anything for me. Of course, I'm not the best example to go by, since my diagnosis is quite uncertain (click here).

Unfortunately, because Naltrexone is an off patent drug it's cheap and there's not much money to be made from it, so very few if any scientifically valid clinical trials have been done to test its efficacy on MS patients. Just another of the many travesties visited upon chronically ill patients worldwide by a medical research system driven more by the quest for profit than by the desire to alleviate the misery of millions. Harrumph.

♦ Researchers in Scotland have found that marriage between cousins is not to blame for the high rate of MS found in that region (click here). Scotland has one of the highest rates of MS in the world, approximately 1 in 500, and the islands in which the study was conducted, Orkney and Shetland, have rates higher still. Far be it for me to cast judgment, so all I'll say to those contemplating marrying a close relative is that you can put any fears about your future children being predisposed to developing MS to rest. As for fears about extra limbs, or eyeballs in the middle of their foreheads, well, that's another story…

♦ In a sad bit of news, a lion suffering from Multiple Sclerosis like symptoms in Brazil died this past July (click here). Apparently, the plight of Ariel the lion touched the hearts of many, and his story was chronicled on his own website and Facebook page. Since I believe in a just universe, I'd like to think that Ariel is now in lion heaven, where he is using his fully functional claws, paws, and powerful legs to viciously maul and tear to pieces all of the naughty wildebeests and zebras who were sent to wildebeest and zebra hell. For everything, there is a season…

As Porky the Pig might say, th-th-th-that's all folks…

Latest MS Drug News; Much of It Bad…

Image by mtsofan via Flickr

There’s been a spate of news in the last two weeks regarding existing and proposed MS drugs, much of it on the negative side. Several drugs have been rejected by the European regulatory agencies, and another has seen the specter of its deadly side effects continue to rise.

Although much maligned by the MS activist community, many of the drugs prescribed for MS have in fact improved the quality of life for many of the patients taking them. Although exorbitantly expensive, not targeted at the root cause of the disease (which remains unknown), and of help to only a portion of the MS population, the approved drugs have been shown to reduce the rate of relapses in some RRMS patients, though there is much question over whether they actually slow the insidious progression of the disease.

The injectable CRAB drugs (Copaxone, Rebif, Avonex, and Betaseron) have been demonstrated in clinical trials to significantly reduce relapse rates in about one third of patients taking them. Copaxone has a relatively mild side effect profile, but the other three compounds, all forms of beta interferon, often make those taking them suffer flulike symptoms for a day or two after dosing. For the patients in whom they work, though, a significant drop in relapse rates can substantially lessen the impact of the disease on their lives. Unfortunately, after over a decade of use, it's still not clear whether or not these drugs have any influence on the progression of disability. A recent report out of Great Britain challenged the notion that the CRAB drugs positively impact progression (click here), but other studies (click here, here, and here) seem to support the claim that these drugs do at least something to slow progression.

A newer generation of MS drugs, including Tysabri, Rituxan, and the recently approved (by the FDA) Gylenia offer a marked uptick in efficacy in both the reduction in relapse rates and MS symptoms, as well as the proportion of the patient population for whom they are beneficial . Unfortunately, along with this increased efficacy comes an increased severity in their potential side effects, which can include deadly brain infections and cancer. These drugs, too, do nothing to address the underlying cause of MS, and work by profoundly altering the workings of the very complex and little understood human immune system, the consequences of which, over the long-term, have yet to be seen. Still, the sometimes dramatic improvements experienced by some patients taking these drugs have led many to be extremely reticent to give them up. In the case of Tysabri, I personally know several patients who, after several years on the drug, have tested positive for the virus that causes PML, a ghastly brain infection, but still refuse to come off Tysabri because of the positive impact it has had on their lives.

Unlike some other MS voices on the Internet, I'm unwilling to label the current crop of MS drugs "snake oil", simply because of the positive influence they do have on the lives of many patients. Certainly, they do nothing to cure the disease, and I do doubt their ability to significantly impact the progression of MS, but I know of enough patients whose lives have remained relatively productive in large part due to these medications that I can't help recognize their value. The actual financial cost of these drugs is mind-boggling, with the price of the newly approved Gylenia (the first oral medication approved for MS) coming in at almost $50,000 per year, and I abhor the fact that MS has been turned into the goose that continues to lay the golden egg for many pharmaceutical companies, but the apparent positive effect of these compounds shouldn't be ignored. Before the introduction of the CRAB drugs, MS was known among physicians as a "diagnose and adios" disease, one with very little that could be done to combat it. The advent of these drugs, no matter how flawed they are, has at least put some arrows in the quiver of those trying to fight MS.

Unfortunately, all of the drugs currently approved for MS have only been shown to work on patients suffering from the relapsing remitting form of the disease; those of us suffering from the progressive forms remain shut out from any even nominally effective treatment. Very few drugs have even been trialed for use on progressive MS patients, but recently at least some attention has been turned to the plight of those suffering from SPMS and PPMS (click here).

Okay, enough of my bloviating about the current state of MS drugs. Here's a rundown of the latest news regarding MS pharmaceuticals. The fact that many of the articles linked to come from financial websites speaks volumes as to the sad state of affairs regarding MS as Big Business:

• Biogen, the makers of Tysabri, released its monthly report on the rate of PML (a devastating brain infection) in patients taking the drug (click here). When first starting Tysabri therapy, patients in the United States are enrolled in what's called the TOUCH program, designed to carefully track them for signs of the infection. The risk of PML infection as a result of Tysabri therapy has long been touted as 1000:1. The statistics released earlier this month show that the infection rate for patients taking Tysabri for less than two years falls well within that figure, but starts to rise dramatically once patients surpass the 24 month mark. The incidence of PML in long-term therapy is now stated at 2.13 per 1000, and the trend suggests that the longer patients are on Tysabri, the higher their risk of infection. After first being introduced in 2005, Tysabri was quickly withdrawn from the market when the threat of PML became known. It was reintroduced in the second half of 2006; therefore, the majority of patients taking it have yet to reach the "danger zone". As I stated previously, many patients are loathe to stop Tysabri after experiencing sometimes dramatic relief from their MS symptoms while on the drug. As the PML count increases, many patients now on Tysabri will have to grapple with some very difficult decisions.
• The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended against the approval of the oral drug Fampyra (click here), which in North America is called Ampyra. Ampyra, approved by the FDA in 2010, is the only drug thus far approved strictly for the symptomatic relief of MS. The compound increases walking speed in approximately 1/3 of the patients who take it. Some patients on Ampyra also report an overall increase in muscle strength. In recommending against the drug, the CHMP said that it "was not convinced that Fampyra’s small effect on the walking speed was a meaningful benefit for patients. The effect on speed could not be linked to meaningful improvements such as better coordination, balance or stamina or increased range of action. The Committee was of the view that the medicine’s uncertain benefits did not outweigh its side effects which included pain, dizziness, paraesthesia (unusual sensations like pins and needles) and problems with balance, as well as symptoms similar to those of multiple sclerosis that could impair the patient’s ability to walk. The Committee also noted the lack of adequate long-term data on the medicine’s benefits and safety as well as data on some groups of patients, such as the elderly and patients with epilepsy or heart problems. The CHMP concluded that the benefits of Fampyra did not outweigh its risks and recommended that it be refused marketing authorisation."
• The CHMP also recommended against the approval of the experimental oral MS medication Cladribine (click here), marketed by the giant drug company Merck. Cladribine has been used in IV form as an anticancer agent since the mid-1990s, with known possible severe side effects. Reformulated in an oral form and named Movectro, the drug went through a full trial regimen for use in RRMS patients, and was shown to reduce the rate of MS relapses and possibly impede the speed of disease progression. In deciding against the drug, the CHMP had concerns about the medicine’s safety. "An increased number of patients with cancer were observed in trials with Movectro, which may indicate an increased risk of cancer over time and with increasing doses. The Committee also noted that the benefits and the most appropriate dosage for treatment had not been fully established in patients who were expected to use the medicine. Therefore, at that point in time, the CHMP was of the opinion that the benefits of Movectro did not outweigh its risks and recommended that it be refused marketing authorisation." The drug will be up for FDA approval later this year, and it will be interesting to see if the FDA follows their European cousins’ decision.
• The CHMP recommended for the approval of the oral MS drug Gylenia, formally known as Fingolimod or FTY 720 (click here). This drug has already won approval from the FDA, and should be hitting the market sometime in the first half of this year. Gylenia is a powerful drug that greatly alters the workings of the human immune system. The compound traps the immune system's T cells in the lymphatic system, thereby keeping them out of not only the central nervous system, but the rest of the body as well. As one neurologist told me, "Tysabri keeps the cops out of a certain neighborhood, but Gylenia keeps them locked in the police station". While many patients relish the thought of giving up their injections or monthly infusions for the simplicity and pain-free action of taking a daily oral tablet, the mechanism of this drug should give pause. Though it has not yet reached the market, it is believed that neurologists will initially be quite careful in prescribing the drug. Interestingly, Gylenia is being tested as a possible neuroprotective agent, so the drug may have a double-barreled effect. It would be wonderful if science could isolate Gylenia's neuroprotective properties and develop a compound that shields nerve cells from the MS disease process, but that development seems far off in the future.

As an MS patient, I find it incredibly frustrating that millions upon millions of dollars are being spent researching, developing, and marketing pharmaceutical compounds that do absolutely nothing to actually cure the disease, but in effect turn patients into indentured servants of Big Pharma. Unfortunately, our medical research model has evolved into a highly dysfunctional beast, one which all too often ignores real patient benefit in favor of the possibility of huge financial gain. The aberrant immune reaction seen in MS is essentially a symptom of an as yet undiscovered disease cause. If even a fraction of the research dollars spent by Big Pharma on drugs designed to suppress or modulate the immune system were instead spent on finding this unknown cause, we might actually be on the road to a cure for this damned disease.

One can only hope that the beliefs of the most fervent CCSVI advocates hold forth, and vascular abnormalities do prove to be a vitally important part of the MS disease process. At the very least, may investigations into CCSVI finally wrench the focus of MS research away from the concept of autoimmunity and onto a model of MS as disease in which an immune system gone awry signifies greater ills still hidden, and at long last brings those hidden ills to light.

Can I get an Amen?

Some Very Bad News for CCSVI Advocates… Followed by Some Very Good News…

Image via Wikipedia

But first, a little shameless self-promotion. Next Tuesday, September 7, at 8 PM EST, I will be interviewed live on the Internet as part of a nine week series entitled "MS Voices". I was very flattered to be asked to participate by the host of the series, Karen Gordon (The Self-Healing Coach), as some very impressive names are in the interview lineup, including Scott Johnson (founder of the Myelin Repair Foundation, one of my favorite MS nonprofits), Ashton Embry (founder of Direct-MS, a nonprofit MS advocacy organization), and Stuart Schlossman (founder of MS Views and News, an invaluable resource of MS info with worldwide reach), among a bevy of other very notable people in the MS universe. Truly, I'm delighted to have been included in this group, and I only hope I can hold my own amongst such an all-star lineup. Please register for the live netcast, and tune in next Tuesday night, if only to hear whether or not I make a complete ass of myself (click here to register).

Okay, on with the show…

On Thursday, August 26, the Canadian Institutes of Health Research (CIHR), in collaboration with the MS Society of Canada, convened a meeting of medical experts to determine whether or not the Canadian federal government should fund treatment trials of the CCSVI Liberation Procedure. Thus far, the MS societies of the US and Canada have divided $2.4 million worth of research funding up between seven CCSVI research projects, none of them directly testing the efficacy of The Liberation Procedure, the catheter venogram technique used to open up the blocked veins of patients found to have the venous abnormalities and resultant disruption in blood flow that have come to be called CCSVI.

Treatment trials of the procedure would clearly be the quickest and most effective way of determining the efficacy of the technique, and by doing so, the merits of the entire CCSVI hypothesis. To date, thousands of patients (estimates range from 1000 to 3000) have undergone the Liberation Procedure, many of them spending many thousands of dollars and traveling thousands of miles to foreign clinics for a chance at relieving their debilitating MS symptoms and the insidious progression of the disease, as very few doctors in the US (and none in Canada) are doing the procedure. Anecdotal evidence suggests that, for a sizable proportion of patients, the Liberation Procedure does seem to offer benefit, sometimes to a dramatic degree.

During the procedure, balloons or stents are used to open the blockages in patients' jugular and azygous veins, blood vessels that drain the central nervous system. While there is some acknowledged risk in the use of stents, and some complications have arisen due to their implementation, when balloon venoplasty is used alone it has proven to be a remarkably safe, minimally invasive procedure. Patients usually undergo the procedure with little or no sedation, and many leave the hospital only hours after the procedure is finished. Admittedly, the technique is not without its faults, as many patients see the blockages in their veins return some weeks or months after undergoing "liberation", a problem referred to as restenosis.

Earlier this week, the CIHR announced its verdict regarding treatment trials of the Liberation Procedure: "There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed Liberation Procedure" (click here for announcement). The decision outraged many MS patients and CCSVI activists, this writer included. The CIHR released a 10 page document outlining the evidence presented and the reasoning behind its decision (click here for document).

I find it absoutely unconscionable that the simplest and most direct method of testing the CCSVI hypothesis has been continuously blocked, in large part by individuals and organizations entrenched in and enriched by the standard narrative that MS is an autoimmune disease that is strictly neurologic in nature. The autoimmune theory has held sway for over 20 years now, and has yielded, after countless research man-hours and billions upon billions of dollars spent, a handful of drugs that either modulate or suppress the human immune system. These drugs have been demonstrated to reduce MS relapses and the amount of lesions shown in MRI imaging in some, but by no means all, of the MS patients taking them. Ranging from obscenely to hideously expensive, the available MS drugs do absolutely nothing to address the underlying cause of the disease, and the continued emphasis on autoimmunity has effectively stopped most research seeking to find that cause.

One of the primary reasons cited for not approving immediate trials on the Liberation Procedure were alleged safety concerns for the patients involved. This reasoning is almost laughable. As I alluded to above, when confined to balloon venoplasty, we have thus far seen no major complications, and very few minor ones. These same experts so concerned with patient safety routinely prescribe drugs to those under their care that carry potential side effects the stuff of which nightmares are made.

The CCSVI hypothesis offers a radical departure from standard MS dogma. It is so "outside the box" that many neurologists seem to shun it reflexively, unable to even entertain the idea that MS might actually be of vascular origin, often treating proponents of the idea with derision and barely disguised mockery. A turf war has ensued, pitting neurologists against interventional radiologists (the specialists who perform the Liberation Procedure); tragically, it is the patients that are caught in no man's land, desperately seeking a cure, and finally finding a reasonable explanation of their disease that allows them, at long last, some hope.

On pages 9 and 10 of the document put out by the CIHR (click here) is a list of all of the experts who participated in making the decision to not fund treatment trials. A little googling should easily turn up e-mail addresses and phone numbers for most if not all of these experts. I'm not usually one to advocate open insurrection, but in this particular case I believe that these people should hear from the human beings their decision has impacted, which includes literally every single MS patient in the world, each of whom stand to benefit if CCSVI proves to play a part in the MS puzzle. I urge people to contact these luminaries, and in very polite, rational, but no uncertain terms let them know the misery that comes with waking up each day with MS, and the potentially calamitous effect their decision to delay CCSVI treatment trials has had on them and their loved ones.

Let me be absolutely clear, I am not promoting the harassment of these individuals. Contact with them should under no circumstances be in the form of epithet filled irrational harangues, but rather in personal stories of desperation, disability, and hopelessness. I am calling for advocacy, not agitation. I cannot stress this point enough. Expressing unfocused anger, resentment, and hostility will only make these folks dig their heels in harder, and will set back efforts to bring CCSVI into the mainstream. I am also very specifically pleading against the demonization of the staffers of the MS Societies, who work diligently to assist in the daily battles against the MS scourge that patients must endure. The staffers of these societies have nothing to do with the decisions made by the scientific panels and board members of these organizations. They are conscientious and well meaning, and it's not their fault that those above them seem to have their heads firmly implanted up their own backsides on the issue of CCSVI. So please, direct your frustrations at those responsible, a list of which is thoughtfully provided in the back of the CIHR document, not at those good souls who staff the MS societies.

Okay, enough with the bad news, here's some terrific news. A large-scale treatment trial of the Liberation Procedure has been approved here in the US. Dr. Manish Mehta, working out of Albany, New York, has been given approval to begin a 600 patient trial, scheduled to start in August 2010 and finish in September 2011 (click here for details). The trial will split patients into two groups, one which will get the liberation treatment, and the other a "sham" procedure. Comparing the progress of two groups will reveal whether or not the Liberation Procedure does in fact improve the condition of MS patients, and the degree to which the placebo effect is in play. Following just days on the heels of the discouraging news out of Canada, this approval seems almost heaven sent. The buzz in the CCSVI world is that a second approval is pending, with perhaps even more to come after that.

Of course, these trial approvals do not prove the CCSVI hypothesis, but at long last we will be on the road to discovering, sooner rather than later, using accepted, objective scientific standards, whether or not the Liberation Procedure actually provides relief from MS symptoms. These treatment studies will not answer the vast galaxy of issues swirling around CCSVI, but they will address the single most important question that patients suffering from the son of a bitch we call MS want answered: Does the opening of blockages in the veins that drain the central nervous system improve the physical well-being of Multiple Sclerosis patients?

We wait with bated breath for the answer…

Pieces and Bits

I'm getting tired of titling posts "Bits and Pieces", so I cleverly changed things up this time around. Don't be too rattled, though, what follows is still a collection of MS related items that I thought you might find useful and/or interesting...

Image by hitthatswitch via Flickr

• How effective are the CRAB (Copaxone, Rebif, Avonex, and Betaseron) drugs at slowing down the progression of disability in MS patients? Not very, according to some recently published studies. A paper analyzing these results has been making the rounds of the Internet forums for the past week (click here for paper), and the conclusion is that these widely prescribed and very expensive drugs do practically nothing to halt disability progression in the Multiple Sclerosis. The paper does a wonderful job at analyzing this very disappointing data, but I have to respectfully disagree with several of the conclusions it draws from this information. Written by Ashton Embry, who administers the excellent alternative MS site "Direct-MS" (click here) which contains very good information on the role of nutrition in the battle against MS, the paper draws the conclusion that the CRAB drugs are no better than snake oil in treating MS. While the new data suggests that these drugs don't stop the inexorable march of disability in MS patients, the drugs have been shown in clinical studies to cut down on the number of relapses and enhancing lesions (as seen in MRIs) experienced by the MS patients taking them. When these drugs were first approved, the assumption was that a reduction in relapse rate and lesion load would translate into a significant delay in disease progression. While it is a crushing disappointment that the CRABs most likely do not slow progression, to say they are worthless overstates things a bit. The fact is, they do reduce relapse rates for some taking them, which does improve the quality of life for patients with Relapsing Remitting Multiple Sclerosis. Although an improvement in quality of life might be less than what was hoped for, it is still of considerable benefit to those afflicted with the disease. Certainly, the drugs have been overhyped, and overpriced, but patients who had been experiencing four or five relapses a year before being put on one of the CRABs, and only one or two after, would argue that their taking the drug has not been without value.

  The fact that research is now showing the CRAB drugs to be of limited, if any, value in halting or even delaying disease progression points to the abject failure of putting MS into a box marked "autoimmune". Countless millions of dollars have been spent developing and marketing these drugs, and billions upon billions of dollars have been made selling them to the captive audience that is the Multiple Sclerosis patient population. The CRAB drugs have been a tremendous boon both to pharmaceutical companies and to the practices of MS specialists, but this latest data highlights the fact that they are only sophisticated mechanisms for symptom management, and that the years spent searching for compounds to better tinker with the human immune system have taken the eye of medical research off of its rightful target, which should have been the search for the root cause of the autoimmune reaction. The concept of autoimmunity has managed to turn MS into a multibillion dollar a year industry, and yes, the drugs that have been developed with that concept in mind have been of some relief to some MS patients. One can only imagine, though, that if the same time, money, and energy had been put into searching for that which causes our immune systems to go awry, we'd be much farther along in our quest for a cure to the scourge that we call MS.

  Let me state unequivocally that I am a CCSVI advocate who believes that the hypothesis should be researched as vigorously and as quickly as possible. The recent data regarding the ineffectiveness of the CRAB drugs in combating disease progression makes CCSVI research all the more imperative, and should fuel the clamor of MS patients worldwide to have their voices heard. We need treatment studies, and we need them now. If such studies should by chance disprove the CCSVI hypothesis, then so be it. At least the effort will have been expended in a noble effort to free MS patients from their disease, rather than consign them to a lifetime of indentured servitude to drugs of only marginal effectiveness.

• MS is a notoriously hard disease to diagnose, the diagnostic process being one of exclusion, meaning that other possible conditions must be ruled out before a firm diagnosis of MS can be established. My own diagnosis has been seriously called into question, and there is disagreement between the doctors who have examined me at the National Institutes of Health and my personal neurologist over just what it is that is slowly crippling me. I've been questioning my diagnosis almost from the day I received it; my symptoms and disease course just didn't seem to match what I'd read about Primary Progressive Multiple Sclerosis and the experiences of others suffering from the disease. Studies have shown that between 5% -15% of those diagnosed with Multiple Sclerosis have been misdiagnosed, and are actually suffering from some other illness. Here's a paper (click here) that details the conditions that can be mistaken for MS, and includes a list of 100 such diseases. It's easy to make yourself crazy with information such as this (and believe me, I speak from experience), so be careful not to let this create doubt where there should be none, but if you have serious questions regarding your diagnosis, this paper is an invaluable resource. Knowledge is power, but be sure to wield it wisely.

• Multiple Sclerosis Dreams (click here for website) is a new organization designed to bring hope and excitement to patients living with MS. Similar to the Make a Wish Foundation, MS Dreams is a nonprofit organization that will be granting the dreams and wishes of desperate and needy MS sufferers of any age. Such dreams might include sending them on the vacation a lifetime, meeting someone they've found inspirational, or supplying them with much-needed treatments or devices. The organization will be in the running for a "Pepsi Refresh" grant of $25,000, which you can help them achieve by voting for MS dreams once the internet polls open on August 1. Although a new organization, its organizers seem extremely sincere and devoted, and I wish them the best of luck in launching their endeavor. So, please visit their website, and vote early and vote often...

• Researchers at UCLA have found a possible physiological cause for the depression often suffered by MS patients (click here for info). As if dealing with MS and its associated crap isn't depressing enough, it now appears that the disease causes atrophy of the hippocampus, a region of the brain closely associated with depression. MRIs have revealed that MS causes gray matter atrophy in general, so I suppose findings like this shouldn't be all that unexpected. A more momentous finding would be identifying what causes such atrophy, and may I suggest that decreased blood flow through the brain, such as might be seen in a vascular condition like, say, CCSVI, might be a pretty good candidate.

  Of course, zombies also have an appetite for gray matter, but I don't think I've ever seen a paper linking zombies with depression or MS. As a matter of fact, a good zombie movie often cheers me up, so I'm willing to go on record right here and right now stating that zombies do not cause MS. Then again, no zombie flick I've ever seen really identifies exactly what causes zombie-ism, so I guess it can’t be ruled out that MS causes zombies. So be careful during your next visit to the neurologist's office, you never know when one of your fellow patients may try to take a bite out of you.

Well, not the most uplifting collection of information I've ever presented, so let me leave you all with cheerfully healing thoughts of puppy dogs, rainbows, pretty ponies, and...

zombies zombies zombies. It's fun to say "zombie". (Don't forget, I dictate these posts using voice recognition software...)

Don't Believe Everything That You Read

Unless you read it here, of course...

As somebody who keeps a close eye on MS related news, literally each and every day I come across news articles and press releases touting some amazing new medical breakthrough or groundbreaking drug therapy that promises to smite the MS beast. These bits of news are quickly gobbled up by the various Internet MS message boards, and generate all kinds of excited chatter in the virtual MS world.

The e-mail inboxes of MS patients are often filled with notes sent by well-meaning family members and friends, breathlessly announcing these findings. Now, there's nothing wrong with hope and optimism, as we'd be doomed without them, but it's important that patients learn to keep things in perspective, if only just to keep from suffering repeated disappointments.

The truth of the matter is that most of the breakthroughs generating these headlines amount to far less than meets the eye. Just today, there is news about a group of scientists who have identified two genes that seem to be vital in determining the severity of MS. Reading a little bit deeper, though, reveals that this discovery was made on mice, and the genes in question are mouse genes. I like mice as much as the next guy (as long as they stay the hell out of my house), but the simple fact is that MICE DON'T GET MS.

Scientists induce mice to get diseases that kind of resemble MS (most often, an allergic reaction called EAE), and then test all kinds of things on these mice to see if they'll affect the phony MS that the mice have been given. Quite often, the drugs and therapies being tested prove to have a dramatic effect on the mouse MS imposter. So often, in fact, that I've come to believe that staring intently at a stricken mouse, or talking lovingly to it, will cure it of this MS pretender (note to self: get some mice, make them gimpy, apply for MS research grant, tell mice that you love them, schedule press conference). Unfortunately, the same benefits rarely carry over to humans, because, as I mentioned before, MICE DON'T GET MS.

Another flavor of MS news item that often creates a frenzy are early-stage drug trial results, typically released by the pharmaceutical company developing the drug in question. In order to meet FDA approval, experimental drugs must go through a three stage trial process. Each of these phases are usually double blinded, placebo-controlled trials, in which one group of patients is given the actual test drug, and the other a placebo. The trial process generally takes about 8 to 10 years.

Very often, the results of successful early Phase 1 or Phase 2 trials are loudly announced to the world, setting off a wave of excitement among MS patients starving for optimistic news. Tellingly, these announcements are usually found in the financial or business pages of newspapers or Internet news sites. Why is that, you might ask? The answer is simple, but somewhat disheartening. The primary motivation behind the release of such results is not to give MS patients hope that they can hang their hats on, but rather to pump up stock prices (in the case of the big public pharmaceutical companies) or generate investor cash (in the case of smaller, startup firms). Very early in my MS career, my neurologist, Dr. Big Brain, warned me to not take any of these reports too seriously, as the primary motivation behind them is financial.

One must never forget that the pharmaceutical business is a mega-industry in this country, and that the fortunes, both literally and figuratively, of pharmaceutical company executives rise and fall with the stock prices of the companies they run. In fact, as public companies, the big pharmaceutical companies are mandated to place the interests of their stockholders before the interests of the patients taking the drugs they produce. These companies must generate ever-increasing profits, or risk the calamity of falling stock prices.

There have been recent revelations of pharmaceutical companies burying unfavorable trial results data, and sometimes even misrepresenting such data (in other words, lying about it). Even when data is not actually misrepresented, the methods used to statistically analyze it can influence the favorability of the data one way or another. Naturally, drug companies choose to analyze the data in the fashion most favorable to the outcomes they desire, but very often, this does not result in the most accurate assessment of a drug's effectiveness and/or risk to patients. Unfortunately, the reported results of these giant shell games often toy with the emotions of desperately ill patients hungering for a little good news.

All in all, it's best to take much of the news generated about MS with several grains of salt. Between mice that don't get MS, and the financial wheelings and dealings of the pharmaceutical industry, much of the information out there just isn't very reliable. Don't get me wrong, I believe that there are great strides being made in battling the disease, but if even one quarter of the positive news reported about MS were true, the illness would have been cured years ago...

More MS on the Internet

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Since my last entry updated a post I made several months ago, I figured I'd keep the trend going by updating yet another post I made several months back, which was titled "MS on the Internet". That post was made up of a list of Multiple Sclerosis related websites that I find useful, and it received a good response from WK readers.

Since then, I've come across several additional websites that I think are of value. Most of these sites aren't devoted strictly to Multiple Sclerosis, but offer a wealth of information on neurology and general healthcare, in addition to having sections specific to MS...

Can you tell I spend way too much time on the web?

TheBrainMatters.org-This website is run by the American Academy of Neurology, and covers a wide range of neurologic disorders, including a section devoted to Multiple Sclerosis. It also has a "Find a Neurologist" tool, which users might find very helpful.

The Neurology Patient Pages-This site contains summaries of research studies from the journal Neurology, prepared especially for patients. Although not all of the studies are pertinent to Multiple Sclerosis, the summaries are a rich resource for information on all neurologic disorders.

Wellsphere-A general wellness information site, with lots of good material on nutrition and alternative and complementary therapies. The site hosts some educational and user-friendly patient communities, and has even named Wheelchair Kamikaze as one of their "Top Health Bloggers".

Patients Like Me-This is a unique website, which allows patients to set up their own profiles, and track the progression of their disease and the treatments that they undergo. Covering a wide range of conditions and diseases, this site allows users to "compare notes" with other patients who share similar experiences. The site also hosts some active patient forums.

The National Institute of Neurologic Disorders and Stroke-This is the official website of the NINDS, which is the arm of the National Institutes of Health responsible for all government-funded neurologic research. The site is a treasure trove of information on all neurological disorders, as well as info on clinical trials and patient resources.

ClinicalTrials.gov-A comprehensive registry of all federally and privately financed clinical trials conducted in the United States and worldwide. The listings include inclusion criteria as well as contact information for all of the trials. If you're interested in getting involved in a clinical trial, this is the place to look. The registry is easily searchable by disease and location.

MedlinePlus-A terrific site that includes information on the latest medical news, drugs and supplements, a medical dictionary, a medical encyclopedia, and a directory of physicians and hospitals.

NeurologyChannel.com-Run by physicians, the site offers a wide range of information and services, including a patient forum, and a section devoted to patient stories.

The Health Care Blog-An great site for commentary on healthcare issues and policy. Makes for some very interesting reading.