All I Want for Christmas Is a Cure for This Damned Disease!

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I had a slight meltdown while serving as a semi-official MS patient advocate last week. Please let me explain…

I was invited to take part in a conference call organized by a significant multiple sclerosis consortium. The group is planning an MS conference which will take place over several days, with one of the days devoted to patients and patient education. My purpose on the call, along with several other patient advocates, was to help decide which seminar topics would be most interesting and useful for patient attendees of the planned meetings. In advance of the call I was supplied with a list of potential subjects and was told to be ready to choose which I thought should be included as part of the conference program.

As I perused the list, which included items such as "2018 MS Drug Pipeline" and "Mindfulness and MS", I found myself surprised and then increasingly angered by one glaring omission: there was no mention at all about the search for a potential cure for MS. This annoyed me to no end. After all, shouldn’t one of the primary goals of every MS Association, researcher, and neurologist be figuring out how to put themselves out of business by curing this damned disease? I thought it quite telling (and nauseating) that the planners of this MS conference hadn’t thought enough of this subject to even include it as part of the equation.

Despite assurances to myself that I would remain calm during the conference call, once it came my turn to speak I just couldn’t help myself. What began with my evenly pointing out that the prospect of a cure had somehow been overlooked quickly devolved into a sputtering, barely coherent chastisement of the entire MS medical establishment. Let’s not forget, the field of MS neurology was not so long ago considered a medical backwater, but has since been transformed into one of the biggest cash cows in all of modern medicine, all on the backs of outrageously expensive pharmaceutical products that may curtail disease activity but do absolutely nothing at all to cure MS.

Is this really where the MS status quo now resides? A place where we must accept that disease management is the best we’re going to get? Where patients struck with a hideous illness should be content or even grateful that the modern medical divinities have graced some of them with the ability to keep their potentially crippling malady in check for who knows how long? Where the torrents of cash generated by insanely priced drugs have so corrupted the MS establishment from top to bottom that the prospect of a cure seems unfit for conversation in polite company – why, for fear of spooking the goose that lays perpetual golden eggs? And what about those of us with progressive disease, who now have a whopping total of one approved drug that might, just might, slow the insidious decline of a subset of us by a less than dazzling 20%-25%? I readily admit that the disease modifying drugs currently available do dramatically improve the quality of life for many of the patients taking them– they also carry with them long lists of frightening and sometimes fatal side effects – but they do nothing at all towards stomping out MS. Forgive me for not genuflecting at the feet of the MS gods. How about this? Come up with a drug that cures my creeping paralysis and I’ll genuflect my ass off.

Some of the other patients on the conference call responded to my little tirade by saying that they’d given up hope for a cure in their lifetime. Though I do understand the frustration that lies at the root of this sentiment, to that I respectfully say “bullcrap”! Each of the top-selling MS drugs generates profits measured in billions of dollars per year; you’d think that some of that money might be spent looking for the cause of and then cure for multiple sclerosis. Instead, we have pharmaceutical companies devoting more money to marketing than to research (click here), and the funds that are spent on research are almost exclusively directed towards finding newer and better ways of manipulating the human immune system. NEWSFLASH TO MS RESEARCHERS: the aberrant immune response seen in MS patients is not the cause of the disease, it’s a symptom of some much deeper ill. Though the following analogy may be a bit of a stretch, treating MS by suppressing the immune system is like treating a broken leg with painkillers. It may make the patient feel better, but it doesn’t do a damned thing towards fixing the underlying problem.

At this point, you might rightfully ask, so, Mr. Smarty-Pants, if you’re so clever and smug and full of yourself, where would you suggest we start this quest for an MS cure? Well, I’m glad you asked. Even though I’m not a physician or researcher, I think I have a few good ideas. Here are just some of them:

• We’ve known for years that the Epstein-Barr virus is somehow implicated in the MS disease process. In fact, there seems to be such a close relationship between EBV and MS that some researchers have gone so far as to state that if a person doesn’t have EBV, they don’t have MS (click here). Certainly, EBV alone doesn’t cause MS, but in conjunction with specific genetic predispositions, it may just be the fire starter. We now have the ability to map patients’ genomes, so shouldn’t there be at least a few researchers laser-focused on understanding the interaction between EBV and patient genetic profiles in an attempt to get to the guts of the problem? At the very least, a comprehensive database of the genetics of MS patients should be started posthaste so that gene variants and epigenetic changes can be detected and identified.

• It’s been observed that HIV patients taking powerful antiretroviral drugs seem to develop MS in far lesser numbers than the general population (click here) and that HIV patients who already have MS often see their disease go into nearly complete remission once starting these drugs (click here). Again, why isn’t this a subject for intense scrutiny? Especially since one of the most commonly used anti-HIV drugs, AZT, has been shown to have anti-EBV properties (click here)? Please note, there was one trial of an anti-HIV drug, Raltegravir, on MS patients. This trial failed, but Raltegravir does not effect EBV.

• HSCT, the form of stem cell therapy that first eradicates an MS patient’s immune system with strong chemotherapy drugs and then reboots it via stem cell transplant has been shown to put properly selected multiple sclerosis patients into long-term remission (click here). Shouldn’t these patients be carefully tracked and tested to see just why this treatment can be so incredibly effective? Is it simply that their reconstituted immune systems are no longer autoreactive, or might there be some other reason? Does HSCT not only put MS into remission but actually cure it, with those patients who see a resumption in disease activity somehow developing MS anew after coming into contact with some environmental trigger? The fact is that Epstein-Barr virus, when dormant, resides in immune system B cells which are wiped out during the chemotherapy-induced eradication of patient’s immune systems at the start of the HSCT process. This means HSCT rids the body of EBV. Does this allow the genetic triggers of the disease to then reset, putting a halt to the autoimmune process? A shot in the dark, maybe, but one worth examining…
  
  
• Researchers at Harvard are currently studying the use of a century-old tuberculosis vaccine, called the BCG vaccine, to treat patients with type I diabetes, an autoimmune disease. They are reporting remarkable success, completely reversing the disease in some patients (click here). Apparently, the BCG vaccine works on both the immune system and on the genetic level, and thus could theoretically be of use not only in type I diabetes but across a broad spectrum of so-called autoimmune diseases. In fact, before the introduction of the MS disease-modifying drugs, there was promising research into the use of BCG to treat MS (click here), which seems to have been abandoned once money started rolling in from the first MS drugs. Why devote research monies to a 100-year-old vaccine that costs relative pennies when gazillions of dollars can be generated developing a never-ending stream of boutique drugs that profoundly alter the workings of the human immune system, the long-term ramifications of which are entirely unknown? As Deep Throat told Woodward and Bernstein, follow the money…

Okay, in the parlance of corporate speak, I’ve just spitballed a few ideas on which MS researchers devoted to finding a cure for the disease might focus their considerable brainpower. Of course, many of these ideas don’t have near-term blockbuster profit potential, so in the upside down world of pharmaceutical company driven medical research, they likely won’t get much attention. I’ve said it before, and I’ll say it again – capitalism is a wonderful system for creating wealth, but the marriage of capitalism and medicine is proving to be an unholy one. As long as profits take precedence over patients, as is currently the case, cures for any diseases will be rare beasts indeed.

MS organizations should never lose sight of the fact that their prime directive should be hastening their own demise by contributing to the effort to find a cure for the disease. The current status quo must not stand, and patients should not stand for it. I for one will not shut up about this topic, no matter how nuts it may make me seem to those less inclined to histrionics. If MS patients themselves don’t demand better, we will never get better, both figuratively and literally.

Oh, yeah, Happy Holidays!

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Since it is the season of giving, please allow me to recommend two MS nonprofits that are very worthy of your and your families’ and friends’ donations. I’m not suggesting the National Multiple Sclerosis Society, as, quite frankly, they have a vast contribution generating machine that sucks up lots of the cash that might be better directed at smaller MS organizations. Given the topic of this essay, I’m recommending two groups that are striving to find a cure for multiple sclerosis.

The first is the Tisch Multiple Sclerosis Research Center of New York (click here), which is currently in the process of building the largest stem cell laboratory devoted strictly to stem cells for MS, and will soon be starting the only FDA approved phase 2 stem cell trial on PwMS. In addition, the Tisch Center is involved in a wide range of groundbreaking research, from identifying MS biomarkers to understanding the root cause or causes of the disease, without an understanding of which there can be no cure.

My second pick is the Accelerated Cure Project (click here). The ACP is currently focused on the iConquerMS project, a crowdsourced database of information supplied by MS patients that will give researchers worldwide the opportunity to detect patterns and trends in the MS population that very well could provide the clues needed to come up with a cure for the disease. In addition to donating to the ACP, if you’re not already a participant in the iConquerMS project, I urge you to visit their website (click here) and start participating by answering some quick surveys. This is a patient-driven research effort and gives you a chance to join in the search for a cure.

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Finally, here’s a little Christmas present to my dear readers. The following clips are from the exquisite but little-known 1995 film “Smoke”, one of my faves.. Despite the fact that there are no explosions or car crashes, this one of my favorite scenes in all of filmdom, just one friend telling another a compelling Christmas story. Is the story true or made up, and does it matter? The scene features a masterful performance by the great Harvey Keitel playing opposite William Hurt, and touches on just about everything that makes Christmas and human beings such endlessly fascinating subjects.

Please watch both clips to get the full effect (I recommend viewing full-screen), as I couldn’t find a single clip that encompasses the entire sequence. As an added bonus, the sequence finale features one of my favorite Tom Waits songs, Innocent When You Dream. If you’re interested in watching Smoke in its entirety, it’s available for streaming on Amazon (click here). Enjoy!

Happy No-Thanksgiving!

Well, this year I’m in no mood for Thanksgiving. Quite frankly, the state of my life, health, and the world in general has me feeling grumpier than a starving vegan in a steakhouse. Between being increasingly decimated by a progressively crippling disease, forced to witness a nation and a planet gone mad and suffering through the worst fantasy football season I’ve had in over a decade, I find myself more inclined this year to say “no thanks” than “thanks.” So, I’ve decided to invent my own little holiday: No-Thanksgiving, a day when one can feel free to share their disdain and disgust with freedom and pride.

No-Thanksgiving coincides precisely with Thanksgiving, so those who find themselves forced this Thursday to sit around a table of people gushing with gratitude while feeling only varying shades of repulsion are hereby granted license to let loose with a bile laced torrent of grievances when it comes your turn to speak. You’ll feel a whole lot better, and you can tell the others at the table – as they look at you horrified in slack-jawed bewilderment – to pull up their big boy pants and just carve the freaking bird. And then you must swallow some air and unceremoniously burp out a hearty “Happy No-Thanksgiving!”. A burped “Happy No-Thanksgiving” is the only mandatory ritual required of those celebrating this new holiday.

So, what am I especially not thankful for this year? Oh, let the litany begin…

I am aghast at the list of famous and powerful men who have proved to be harassers and sexual abusers of women, a register that seems to grow daily like an ignored melanoma. Granted, some of the grievances committed are worse than others – in my mind, there is a world of difference between cupping someone’s butt and sexually touching a 14-year-old – but none can be considered acceptable behavior. These ongoing revelations have led me to ponder questions I never imagined I’d formulate, such as how much satisfaction can there be in forcing somebody to watch you masturbate? Back when I was healthy and single, the thrill of finding a new partner lay largely in the fact that she actually liked me. When introduced to a beautiful woman I never once had the slightest urge to corner her in a private space with the intent of forcing her to watch me pull out my Wee Willie Banjo and start strumming a tune. Definitely not my idea of making beautiful music together. The fact that women subjected to such spectacle didn’t immediately projectile vomit on the men in question is testament to the strength of the female gender. A pox on all of these degenerates, along with an especially nauseated “no thank you.”

I am horror-struck at the destructive power of my disease, which knows no bounds and defies any attempts to arrest it. This thing is Godzilla, and my life is Tokyo. It doesn’t help that during the last few months I’ve been hit with a series of flu bugs and other viruses, which are to multiple sclerosis as fine hooch is to a recovering alcoholic clinging to the edge of the wagon. The frightening thing about my getting sick with any kind of bug is that the resulting physical carnage always proves to be a preview of things to come in the not-too-distant future of my disease’s relentless progression. I’ve often surprised myself and others with my stoicism in the face of hurricane MS, but I must admit there have been moments these last few months that have left me scared shitless. Not being able to get myself in or out of bed, control my bladder, or summon up the strength to push a fork through a piece of broccoli are not exactly harbingers of a rosy future. Note to my doctors or any other doctors who happen to be out there: help! And to my disease: an emphatic no thank you!

I am driven to distraction – literally, I can’t sleep – over the abominable tax plan being rammed down the throats of the American people by Congress. I’ve always tried to keep politics off of these pages, but not speaking out against the abhorrent is the worst kind of cowardice. And these tax proposals, as currently constituted, are most certainly abhorrent. Putting aside the fact that they are yet another attempt at supply-side economics, a theory which has never, ever proven successful whenever it’s been implemented – “But, but, Reagan!” I can hear some sputtering, conveniently forgetting that President Reagan raised taxes 11 times after he initially cut them (click here) – what is really unsettling me is the fact that by all objective estimates the current tax proposals will increase the federal deficit by between $1 trillion and $2 trillion (click here, here, and here). This very likely will trigger mandatory cuts to Medicare (click here), and I fear will eventually be used as an excuse for yet another misguided push to privatize Social Security, Medicare, and Medicaid. The combined effects of these changes would leave millions of the most vulnerable Americans – the elderly, chronically ill, and disabled – without the social safety net they so desperately need. There is no doubt that the US is in need of tax reform, and getting through the process will always be as pleasant as a national root canal, but the hyper-partisan tax proposals now on the table should be anathema to all reasonable Americans. So, with all the strength I can muster, I shout “no thanks” to the current version of tax reform. If you agree, call your Representatives and Senators at (202) 224-3121.

I am a horribly disillusioned by modern medicine as it is currently practiced, rife with conflicts of interest and cynical calculations that put profits over people. Due to the explosive growth in the cost and profitability of pharmaceutical drugs, it seems the goal of modern medicine has become treating rather than curing, a model which is great for Big Pharma but sucks elephants for those of us saddled with horrible diseases. The eye-popping amounts of money generated by drugs that treat but don’t cure have insidiously transformed the landscape of medicine from top to bottom. The medical journals, increasingly reliant on Big Pharma monies for their survival, predominantly publish studies favorable to pharmaceutical company interests. These studies are usually conducted by researchers who are on the payroll of the companies whose drugs they are studying. The doctors reading these published studies are in turn very often paid handsomely in the form of shady speaking and consulting fees by the very pharmaceutical companies whose products they prescribe. In any other industry people would go to jail for this kind of crap, but in medicine, where they can perhaps do the most harm, these practices are now considered business as usual. For an insightful article on just how pernicious these shenanigans can be, (click here). So, come this Thursday’s No-Thanksgiving I will include the entire medical establishment high on my list of no thank you’s…

I’ll end my list here due to time constraints, though in my current state of disgruntlement I could easily extend it ad infinitum. No-Thanksgiving day will soon be upon us, and it wouldn’t make much sense to publish this article once the day has passed. I’d ask all who wish to join me in celebrating this new holiday to refrain from throwing a drumstick at your idiot uncle and instead help to grow the popularity of No-Thanksgiving day by providing a list of your own candidates for “no thank you’s” in the comments section of this essay. Come on, give voice to all of your pent-up grievances, grudges, and gripes so that all of your fellow MS curmudgeons can revel in your misanthropic meanderings!

To all my wonderful Wheelchair Kamikaze readers, I wish you a tremendously Happy No-Thanksgiving! And a Happy Thanksgiving to the more well-adjusted among us…

Outrageous! Doctors Earn Luxury Goods by Answering Pharma Funded Surveys

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National MS Society Decision Makers Take Big Bucks from Big Pharma

As I detailed in two recent Wheelchair Kamikaze essays, the American National Multiple Sclerosis Society has repeatedly rejected grant proposals to help fund the only FDA approved human MS stem cell trial currently being conducted in the US, which is now underway at the Tisch Multiple Sclerosis Research Center of New York (click here and here). These two previous posts resulted in a flood of email and phone calls to the powers that be at the NMSS (thank you, dear readers), who responded by saying that the Society makes decisions regarding which research projects to fund based on the recommendations of committees populated by a wide range of internationally renowned experts. This got me thinking, just who are these experts and what elements might go into their decision-making process? Inspired by a comment left by WK reader Jennifer Ziegler, I decided to do some digging.

One of the provisions of the ever controversial Affordable Care Act (otherwise known as Obamacare) is the creation of a website that allows the general public to search a database of pharmaceutical company payments to physicians, called the Open Payments Data website (click here). For those who may be blissfully unaware – and as outrageous as it may seem to those who are aware – it’s common practice in this country for pharmaceutical companies to line the pockets of the physicians who prescribe their products by way of cash payments given out largely as consulting and speaking fees. Mind you, for the most part these payments are perfectly legal, but it does make one wonder just how objective even the most well-meaning physician can be when making decisions that involve choosing between the products of the drug manufacturers whose money they accept versus those of their benefactor's competitors. This ethical quagmire is often described quite politely as a potential “conflict of interest”.

The NMSS helpfully provides lists of the “Scientific Peer Reviewers” who advise the Society on decisions regarding which research projects are worthy of support (click here). Plugging the names of these peer reviewers into the Open Payments Data website reveals what I think is some enlightening information. First, though, please let me illustrate just how much money the pharmaceutical companies that sell MS drugs pay to physicians in efforts to promote their wares. On a drug by drug basis, the following list details the amount of money that made its way from pharmaceutical company coffers into the pockets of MS doctors in the five months spanning August-December 2013. Naturally, the list excludes drugs that have been approved since 2013. I gleaned this info from the Pro Publica website (click here), which provides detailed numbers derived from the database compiled by Open Payments Data:

· Aubagio $3.4M

· Avonex $775.8K

· Betaseron $510.8K

· Copaxone $4M

· Gilenya $682.2K

· Rebif $856.6K

· Tecfidera $2.2M

· Tysabri $1.4M

· TOTAL $13,825,400

Your eyes are not deceiving you, the pharmaceutical companies paid MS doctors who prescribe their drugs $13,825,400 during the last five months of 2013 alone. Again, this is all publicly disclosed data, and such payments are perfectly legal. Call me crazy, but I can think of only one non-expletive that can adequately describe that number: Yikes!

Now, moving on to the NMSS and its peer reviewers; the National Multiple Sclerosis Society utilizes nine standing committees to review research grant proposals for MS research. As previously noted these committees are comprised not only of physicians, but also PhD researchers as well as lay experts in various related fields. It should be noted that the Open Payments Data website contains only information on pharmaceutical payments to licensed physicians, so while the PhD researchers who sit on these committees might occasionally benefit from pharmaceutical company largesse, such payments wouldn’t show up in the database. It should also be emphasized that the physicians on the following list are not evil people; far from it, they are simply professionals legally taking part in an insanely dysfunctional medical system. I'm sure that those who actively treat patients care deeply about those patients. I’ve even had the occasion to meet one or two of these doctors, who I would without hesitation describe as quite brilliant. Still, the pernicious influence of pharmaceutical company money can’t be discounted, even if it works only on a subconscious level.

The two committees I chose to investigate are those that include licensed MDs and which seemed most likely to play a role in making decisions on human stem cell trials. Here then, a list of MD peer reviewers who sit on NMSS advisory committees who accepted pharmaceutical payments from August through December 2013, and the amount of money they received. These totals exclude any funds paid for medical research efforts:

MDs On The NMSS "Research Programs Advisory Committee" Who Received Pharma Money

· Dr. Bruce Cohen, Northwestern University Medical School – $224.87

· Dr. Anne Cross, Washington University – $4311.28

· Dr. Stephen Hauser, UCSF – $4184.86

· Dr. Mary Hughes, Neuroscience Associates – $13.62

· Dr. Aaron Miller, Mount Sinai School of Medicine – $26,855.11

· Dr. Michael Racke, Ohio State University Medical Center – $5733.86

MDs on the NMSS "Clinical and Translational Research Committee" Who Received Pharma Money

· Dr. Laura Balcer, University of Pennsylvania – $2281.36

· Dr. Bruce Cree, UCSF – $74,965.41

· Dr. Philip Dejager, Brigham and Woman's Hospital – $15,294.97

· Dr. Edward Fox, MS Clinic of Central Texas – $76,760.44

· Dr. Omar Khan, Wayne State University – $112,964.52

· Dr. Andrew Pachner, UMDNH-New Jersey Medical School – $29,995.44

Yes, in the mere five months covered by the records of the Open Payments database one of the NMSS research committee physicians received over $112,000 from pharmaceutical companies, two received over $74,000 each, and two more received over $25,000 each. When considering these numbers, ask yourself whether you would trust the recommendations of a film critic who was found to be receiving generous payments from some of the movie studios which produced the films he was reviewing? Would you allow that critic to decide which scripts should be greenlighted and made into movies if you knew that some of those scripts might in some way damage the profit-making abilities of the studios from which he was receiving payments? Me neither.

I’ve often railed that the NMSS should immediately stop accepting funding in any form from the pharmaceutical companies, if only to avoid even the slightest hint that those funds might influence the Society’s actions. I’m confident the goodwill generated by the Society taking such a public stand would far outweigh any financial hit they might incur, and in fact would be priceless. After looking into the pharmaceutical monies received by physicians who serve with the NMSS in research decision-making capacities, I find myself aghast at my discoveries. Even if the doctors involved are nothing but well-intentioned, as I’m sure they are, I would think it impossible that the tens or even hundreds of thousands of dollars they receive from pharmaceutical companies would have no influence on their decision-making process, perhaps even only on a subconscious level. If these payments didn’t result in tangible benefits for the pharmaceutical companies making them, they wouldn’t be made. Large corporations are not in the habit of handing out millions of dollars a year for no good reason. This may be good business, but it makes for bad medicine.

I urge the NMSS to immediately institute a policy forbidding physicians who sit on any of their decision-making committees from accepting pharmaceutical monies for any reason. The confluence of the interests of for-profit corporations with the clinical practice of medicine and medical research cannot be anything but corrosive. These practices will only stop when we as patients and those who love us rise up and demand action. It’s horrendous enough to be stricken with a dreadfully heinous disease intent on robbing those it attacks of their very humanity; to find oneself simultaneously caught in the misguided, tangled mess that is the modern medical industrial complex can crush the soul. It’s time for those of us stricken with MS to make our voices heard, to make a stand and demand that the largest MS advocacy organization in the world take the initially painful but ultimately crucial steps towards living up to their mandate; to not preserve the status quo but instead eradicate once and for all the fetid scourge of multiple sclerosis, a mission I fear impossible when done in concert with corporate entities whose own legal mandate is to turn illness into industry.

The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here). I would ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, making pains to avoid personal attacks. The goal is not to antagonize, but to foment change that would benefit both the National Multiple Sclerosis Society and the patients it is meant to serve.

I leave you with the following brilliant piece of video from the HBO TV program Last Week Tonight, featuring John Oliver. This incisive and hilarious segment illustrates better than I ever could just how insane is the current state of Big Pharma/physician relationships. Please, please watch, learn, and enjoy…

Bits and Pieces: Multiple Universes Edition (includingLemtrada,theMS-Gut Connection, Progressive MS, Pharma to Doctor Payola,andmore…)

(For those receiving this via email, this post contains videos which can be viewed on the Wheelchair Kamikaze website – click here)

I’ve been reading about the very real possibility of the existence of multiple universes, a collection of hypotheses which state that our universe is actually part of a Multiverse made up of perhaps an infinite number of parallel or alternate universes (click here). As fantastical as this might sound, more and more physicists and cosmologists are coming to accept the notion that our universe is but one of many. In fact, most of the latest cosmological theories and mathematical models of existence point directly to the reality of a physical realm comprised of multitudinous universes, as well as many dimensions beyond the three which our tiny little brains can experience and comprehend.

The form that these multiple universes might take varies from theory to theory, from each universe abiding to its own unique set of physical laws and properties (and therefore some being quite bizarre and very different from our own), to a limitless number of universes similar to this one, with perhaps only subtle changes distinguishing each. The latter model supposes that there may even be an infinite number of like universes each playing out different timelines based on the boundless possible choices each of us makes on a daily basis. In other words, there could very well be universes out there where I don’t have MS, or where I finished that novel I started in 1988, or where my parents never got divorced. Of course, that would also mean that there are universes in which my parents never even met, in which case those universes would have never been graced by my presence. Such a pity.

Given the fact that I have way too much time on my hands and have been able to parse my old healthy life rather obsessively and in minute detail, picking out key instances when a different decision or action on my part might very well have resulted in an entirely different existence, maybe even one devoid of this damnable creeping paralysis, I find the idea of multiple or parallel universes extremely appealing. It gives me great pleasure to imagine a universe in which I am at this very moment driving a sleek convertible sports car way too fast down the Pacific Coast Highway. Or a universe where I would have never spent a minute watching a Tom Cruise movie (sorry, he makes my skin crawl). Or one in which my wife Karen and I just returned home from a long, leisurely walk in the park, strolling arm and arm with effortless grace and ease. How nice to think that all of these scenarios could very well be playing out as I write this, in universes coexisting with our own. Hey, the greatest minds in science say it's possible, and who am I to argue with the greatest minds in science?

Alas, here I am rooted in this universe, in which it’s time for yet another edition of Bits and Pieces, my semi regular compendium of mostly MS related news and items of interest. I hope you find this batch interesting, enjoyable, or at least tolerable, and here’s to the notion that in most other universes there’s no such thing as MS and thus no reason for some alternate version of me to write this blog or for some alternate version of you to read it.

Anyway, on with the show (I apologize in advance for the length of this post, but as I was writing it news broke that the MS drug Lemtrada had been approved by the FDA, which is a pretty big deal, so make yourself comfortable, this may be a long one)…

♦ Reversing a decision it made late last year, the FDA has approved the powerful drug Lemtrada for use in MS patients (click here). Since the drug was initially denied approval in the USA last December it was approved in over 40 other countries, including most nations in the European Union. US patients and neurologists had been agitating for its approval since last year’s FDA denial, as the drug had been shown to be remarkably effective in trials and had been used off label for some years to treat MS patients here in the USA (it was previously known as Campath). One MS neurologist I spoke to soon after the initial denial was quite upset by the FDA’s actions, telling me that the drug had not only rescued one of his patients who had been ravaged by a particularly aggressive case of relapsing remitting MS, but had actually allowed the patient to recover all the way from completely bedridden to back to work.

Lemtrada (chemical name alemtuzumab) is an intravenous drug that works by wiping out a patient’s existing immune system and then allowing it to reconstitute, presumably without the autoimmune tendencies that many believe play a major role in the MS disease process. In some respects, this is the same mechanism as HSCT, the type of stem cell therapy in which a patient’s immune system is ablated using a powerful chemotherapy regimen and then rebooted using the patient’s own bone marrow derived stem cells. It appears that Lemtrada achieves this same goal in less dramatic fashion.

Unlike all other existing MS disease modifying drugs, Lemtrada is not meant to be used indefinitely by the patients to whom it is given. Instead, the drug is administered intravenously for five consecutive days, and then again one year later for three consecutive days. Some patients may require additional infusions at some point down the line, but most do not. Trials have shown that in about 70% of patients with active RRMS the drug eliminates all signs of disease activity (relapses and new lesions) for at least three years after treatment, and in some cases for many years more. In other words, Lemtrada has been shown to put the long-term kibosh on all MS symptoms for the majority of patients with active relapsing remitting disease who have gone through the treatment protocol without further dosing, a result not seen with any other existing MS drug therapy. Some patients have even experienced a reversal of their symptoms, regaining neurological function that had been lost to the disease. As has been the case for all MS drugs so far, Lemtrada unfortunately has no apparent benefit for patients suffering from progressive MS.

These astounding results do not come without risk, however, as a majority of treated patients develop some secondary autoimmune disorders (most often autoimmune thyroid disease, which can typically be controlled with medication), and a small percentage (1%-3%) develop a very serious autoimmune blood disorder, which if caught early can be remedied before any harm is done. As might be imagined, the long term effects on MS patients by a drug this powerful are hard to predict, but the drug has been used to treat patients suffering from various blood cancers for decades. For these reasons, patients treated with Lemtrada must be monitored very closely (most likely in the form of monthly blood tests) for years after their last infusion of the drug.

In the UK, Lemtrada has been approved as a first-line therapy for patients with highly active RRMS. Here in the USA, the FDA has approved Lemtrada only as a third line drug, to be given to patients whose disease has not previously responded to two different MS therapies. This restriction may prove to be problematic, since there are indications that early treatment with the drug provides patients with the best chance for success, in the form of a complete and long-lasting remission of all MS signs and symptoms. For a full discussion of Lemtrada and its associated issues, I urge you read this article recently posted on the always informative Multiple Sclerosis Research Blog, which is maintained by neurologists at Barts and the London Medical School in the UK (click here).

Lemtrada could be a game changing drug for many RRMS patients, particularly those hardest hit by the disease, but the drug’s risk/reward scenario may prove daunting to many patients and neurologists. It will be very interesting to see how adoption of this drug plays out over the coming months and years. Will the prospect of years without any disease symptoms whatsoever tempt patients to try Lemtrada despite the drug’s potentially serious side effect profile?

Wouldn’t it be nice if researchers could come up with a highly effective MS therapy that didn’t scare the living shit out of the patients who it is supposed to help? Perhaps in an alternate universe all forms of MS can be effectively treated with hot fudge sundaes. I hope some version of me is living in that universe.

Edited To Add: a reader who has worked with this drug in her job as an oncology nurse left the following comment, which I thought valuable enough to place into the body of this post.:

As a former oncology nurse, I am familiar with Campath and this drug scares me. You can say that it has been used in treatment for blood cancer for years, but you may not know is that it is not used often and the practice I worked for stopped giving it in our usual outpatient clinic because of severe infusion reactions. There were even deaths, although that did not happen at our facility. I treated several patients with the drug and the infusion reactions were significant. The dosage and frequency of treatment is likely very different for MS, but I have seen what it can do and it is definitely a big gun that should be used very carefully.

As I previously noted, Lemtrada (the same drug as Campath) is used differently to treat MS than it was to treat cancer, but the concerns raised are certainly valid. Infusion reactions are reactions that occur while the drug is being given intravenously to a patient. Such reactions were noted in the Lemtrada MS trials, but were not deemed to be dangerous enough to prohibit the approval for the drug for use in the treatment of active relapsing remitting MS. Still, yet another variable to consider when presented with the option of using Lemtrada to treat your disease. As always, knowledge is power, and I thank Mary Beth Knapp for contributing this information.

Edited Again to Add: the folks at the Multiple Sclerosis Research Blog have posted some very interesting and valuable information on taking the risk out of Lemtrada. One of the topics discussed are infusion reactions, so this is a very pertinent and important read (click here).

♦ There has been a lot of chatter recently about the relationship between the gut and the nervous system, with evidence pointing to a direct connection between dysfunction within the digestive system and disorders of the brain and spine. One study found a relationship between a disease known as “leaky gut syndrome” and multiple sclerosis and other inflammatory diseases, at least in mice (click here). Researchers found that mice with leaky gut syndrome had higher levels of inflammatory immune cells and lower levels of immune cells that suppress inflammation, leading those mice to suffer more severely when induced to develop the mouse version of MS (on a side note, the mouse version of MS is an absolutely horrible mimic of the human disease and I usually tend to discount almost all studies that rely on it, but in this case the findings are backed up by similar observations in people).

A fascinating article in the New York Times explored the relationship between celiac disease and disorders of the nervous system (click here). Celiac disease is an autoimmune disorder of the gut triggered by the gluten proteins contained in wheat and other grains. The article details several cases in which diseases supposedly rooted in the central nervous system, like dementia and autism, were completely reversed when patients were found to have celiac disease and put on gluten-free diets. Pretty amazing stuff, which only further fuels my suspicion that many if not most MS patients (and patients suffering from other nervous system disorders) are afflicted with some as yet unidentified systemic disease rather than one confined strictly to the brain and spinal cord. Unfortunately, modern medicine has become so specialized that each physician tends to focus only at those areas of their particular expertise when examining a patient without giving enough thought to other areas of physiology that might be impacting the patient’s condition, in effect missing the forest for the trees.

Other studies have looked at the trillions of single celled organisms that populate the gut (known as the gut biome), and found that the gut biome of MS patients is often markedly different than those not suffering from the disease (click here). Normally the relationship between our bodies and the microbes that inhabit the gut is mutually beneficial. However, it seems that in patients with MS and some other immune related diseases the mix of microbes in the gut is noticeably altered. There is so much mounting evidence that links the gut biome to MS that four major US multiple sclerosis research centers have formed the MS Microbiome Consortium to further investigate the role of the microbiome in multiple sclerosis. Turns out that 80% of our immune system is contained within our gut. Who knew?

If you find all of this interesting and who would like the chance to discover just what little buggers are residing in your gut, then you’re in luck! The Human Food Project is currently running the American Gut program, which for $99 will provide a kit with which you can sample your saliva, skin, and poop (I know, yuck) to find out precisely what microbes are living on and in you (click here). The Human Food Project will do a complete DNA analysis of your samples and return a full report. The American Gut program is a crowd funded research effort, so your $99 will not only go towards purchasing your sampling kit but also help fund this ongoing project. I ran all of this info past the naturopath who works at my MS clinic before signing up, and she said that there is no guarantee that the results of this analysis will turn up anything actionable, but that you never know. At worst I’d be helping out with a valuable research initiative. Good enough for me, so I’m currently awaiting the arrival of my saliva/skin/poop testing kit. BTW, for readers residing in the UK, there is also a UK Gut program, so all you British folks can participate as well (click here).

♦ I’ve previously written about the problem of misdiagnosing MS on quite a few occasions, and here I go again. It’s estimated that between 5%-15% of patients diagnosed with MS are not actually suffering from the disease but instead from one of the dozens of other conditions that can mimic multiple sclerosis, a notion that is quite disconcerting to say the least. I myself am suffering from some strange mix of increasingly debilitating symptoms that may or may not be multiple sclerosis, so this issue is of particular interest to me. The website EmaxHealth has recently run a series of short and easily digestible articles on this subject, all of which are worth reading. The first is titled simply “Misdiagnosing Multiple Sclerosis” (click here). Other articles in this series include “Is the Diagnosis of Lupus or Multiple Sclerosis?” (click here), “Is It Multiple Sclerosis or Transverse Myelitis?” (click here), and “Is Multiple Sclerosis Mainly an Autoimmune Disease?” (click here). As I’ve also stated previously it’s easy to drive yourself nuts with this kind of information, so be careful, but if you suspect you may have been misdiagnosed these articles could be very valuable reading.

♦ Progressive multiple sclerosis is a particularly nasty form of the disease, in which patients don’t suffer from the onset of MS attacks (relapses), but instead suffer a steady neurologic decline without ever returning to their previous level of functionality. If I do have MS, it’s of the progressive type, and I’ve been forced to watch myself go from slight limp to nearly complete gimp over the last 11 ½ years without any respite or period of stability. Take it for me, this sucks. Roughly 10% of MS patients suffer from progressive disease from the outset, a form of MS called Primary Progressive (PPMS). A substantial number of people with relapsing remitting disease (RRMS) eventually transition to Secondary Progressive disease (SPMS), at which time they stop experiencing relapses and remissions and instead start accumulating ever-increasing neurologic dysfunction. Currently, there are no effective treatments for any form of progressive multiple sclerosis.

The International Progressive MS Alliance (click here) was formed in 2012 to specifically address the vexing problems posed by progressive multiple sclerosis, and to speed up research and the development of therapies aimed specifically at this form of the disease. The Alliance recently announced the funding of 22 research projects in nine countries, all aimed at helping to unravel the mysteries of progressive MS and to eventually smite this horrendous beast (click here). Let’s hope the Alliance realizes its ambitious goals sooner rather than later, as patients suffering from progressive MS have for too long been ignored by the medical research community.

They say a picture is worth 1000 words, so a video must be worth millions, and the following video put out by The International Progressive MS Alliance sums up the horrendous nature of progressive MS and the problems the disease presents to researchers better than any of my long-winded blog posts ever could. Please watch, but I’ll try to sum up the message of the video in one word: “Help!”



♦ I’ve always found it mind-boggling that pharmaceutical companies are allowed to pay off the doctors who prescribe their drugs. Of course, these actions are never quite as blatant as bald-faced bribery, and instead these payments are dressed up as speakers’ fees, trips to educational seminars, meals provided to office staff, etc. Despite this song and dance, the fact remains that many doctors receive significant amounts of money from pharmaceutical companies, and let’s face it, Big Pharma wouldn’t be doling out all that dough if they didn’t believe it was influencing the actions of the doctors receiving their “generosity”.

If you’ve ever wondered just what kinds of gifts, honorariums, and other payments your doctors may be getting from their pharmaceutical masters (oops, I mean partners), you are now in luck, at least if you live in the USA. Courtesy of the much-maligned Affordable Care Act, a new website is now online that allows patients to enter their doctors' name, click a button, and discover just what pharmaceutical company payments their physicians received in 2013 (click here). I just entered the name of one of my physicians and came up with four pages of pharmaceutical company payments to him, most for “food and beverage” expenditures. It sure is nice to know that he and his staff are well fed.

Let me be clear, I genuinely like this doctor, but the fact that pharmaceutical companies are legally allowed to engage in this kind of crap makes me want to vomit in my mouth. Perhaps if we all print out the info we get from this website and present it to our physicians, along with some pointed questions, our esteemed doctors may think twice about engaging in such activities. Whoops, there I go, crossing over into yet another parallel universe. Silly me.

♦ Okay, now that this blog post is threatening to rival the length of Webster’s Unabridged, I’ll mercifully bring it to a close. As has become my tradition (and I really do enjoy creating my own traditions) I’ll end this edition of Bits and Pieces with a music video by an artist in the “retro-soul/neo-soul” genre. This time around I present you with Sharon Jones, a sublime belter who simply oozes all of the innumerable and unquantifiable qualities that define the notions of funk and soul. This video dates back to 2007, so I guess it’s kind of old at this point, but Sharon Jones is still going strong and deserves as much attention as she can get. Though the video looks like it was made in the 1960s, trust me, it’s a product of the 21^st century, although it was shot with vintage TV cameras that its producers bought on eBay for about 50 bucks. So get ready all you cuties to shake your booties to the infectious sounds of Sharon Jones and the Dap-Kings, a righteous, mighteous, and out of sighteous infection for which I want no vaccination! Bring it on…

Tecfidera (BG 12) And PML

If you are currently taking Tecfidera, please take part in my Tecfidera patient poll (click here).

Over the last month or so, there’s been a rising crescendo of concern among MS patients about the possible link between the newly approved oral MS drug Tecfidera (formally known as BG 12) and the deadly brain infection PML (Progressive Multifocal Leukoencephalopathy). I’ve received many anxious emails on the subject, and Internet MS forums and Facebook pages are rife with alarm over the perceived recent spate of bad Tecfidera news.

As long-time readers of this blog know, I’m not a big fan of Big Pharma, to say the least. In fact, I hold them in regard only slightly higher than the New York Yankees, who I am convinced are the essence of evil incarnate on earth. But I am also not a big fan of fear mongering, and when reviewed objectively, the facts behind the alleged link between Tecfidera and PML simply don’t warrant the level of anxiety recent reports have fomented. In fact, it seems that rivalries in the Big Pharma sandbox may be playing a role in all the hyperbole, but more on that later.

As most MSer are aware, PML is a brain infection that most often occurs in patients experiencing severe immunosuppression, such as those suffering from HIV/AIDS. In the context of MS, the infection is most closely linked to the drug Tysabri, whose mechanism of action often reduces immune system surveillance of the central nervous system quite drastically, opening up the possibility of opportunistic infection by the JC virus, which causes PML. Of course, it is this same mechanism of action that makes Tysabri so effective (the latest figures indicate that Tysabri therapy results in an 81% reduction in relapses, a 64% reduction in disease progression, and one in three RRMS patients appear to be free of disease activity for a prolonged period of time – click here for an exhaustive breakdown of Tysabri, its effectiveness, and PML). Despite Tysabri’s efficacy, PML is a real concern for those taking it, as 347 Tysabri patients have contracted the potentially deadly infection (approximately 120,000 patients are currently taking the drug).

Recently, it was revealed that four cases of PML occurred in German patients taking the psoriasis drug Fumaderm, from which Tecfidera was derived. It’s important to note that although the two drugs are similar, they are not identical. Fumaderm is a compound of dimethyl fumarate and three other related chemicals. Tecfidera is made only of dimethyl fumarate. Fumaderm has been used to treat psoriasis in Germany and some other European countries for about 20 years, with much success (click here), and is generally considered to have a benign side effect profile.

Both Tecfidera and Fumaderm do have immunosuppressive properties. In Tecfidera’s phase 3 DEFINE trial, it was found that the drug reduced lymphocyte counts in treated patients by about 28%. Lymphocytes are immune system cells whose mission it is to combat infection. These same cells are implicated in the MS disease process, and it is this depressive effect on lymphocytes that could well account for Tecfidera’s abity to fight the symptoms of MS. However, 4% of trial subjects (1 in 25) experienced a more severe form of lymphopenia (the medical name for a reduction in lymphocyte counts) which could make them vulnerable to opportunistic infections, requiring them to cease taking the drug. Recovery of lymphocyte counts after cessation of Tecfidera should be quite robust, based on  years of experience with Fumaderm. (Click here for the entire DEFINE trial report)

A look at the four Fumaderm PML cases is quite revealing (click here.-site requires free membership, well worth it). In one case, the patient was not actually taking Fumaderm, but a version of the drug made by a compounding pharmacy which included a chemical not found in Fumaderm, which could have resulted in a formulation more potent or otherwise problematic than the factory produced drug. Another patient had sarcoidosis, a potentially deadly autoimmune disease, and had previously been treated with powerful immunosuppressive drugs. A third Fumaderm PML patient had cancer, and had been treated with Efalizumab, a drug in the same family as Tysabri that has a known risk of PML.

Two of the Fumaderm PML patients had severely depressed lymphocyte counts for two and five years respectively before developing PML. In Germany, the prescribing guidelines for Fumaderm require that patients get blood tests done to check cell counts every month for the first six months they are on the drug, and then every two months thereafter to check for depleted lymphocyte counts. If patients are found to have significant lymphopenia, the guidelines call for dosages to be adjusted or the drug stopped altogether. Apparently, this regimen was not followed in these two cases, as the patients’ lymphopenia was somehow allowed to persist until they developed PML. It’s quite likely that had the lymphopenia been addressed far earlier, neither patient would have contracted PML.

So, what should concerned patients take away from all of this? Tecfidera does depress white blood cell counts, and this effect quite likely plays a large role in its therapeutic value. However, 4% of treated patients can be expected to experience a more severe drop in lymphocyte counts, which could open them up to opportunistic infections like PML if left untreated for an extended period of time. That’s the bad news. The good news is that this drop in cell counts is easily detected by standard blood tests. Once such a decrease is detected, the drug can be stopped and any potential danger averted.

For reasons that I can’t explain, the FDA guidelines for Tecfidera only require blood tests done before treatment is initiated and then once yearly for the duration of treatment. Based on the Tecfidera trial data, as well as the experience gathered from the 20 year history of Fumaderm use in Europe, the requirement of just one blood test a year seems misguided. I’m currently waiting for my insurance company to give me the okay to start Tecfidera, and my neurologist is requiring blood tests every other month for all of his Tecfidera patients. As noted above, two of the Fumaderm PML patients had severely depressed lymphocyte counts for two and five years, so blood testing every other month should provide more than ample opportunity to catch any potential problems well before they become very real concerns.

I am by no means a doctor, just a well educated patient, but I would strongly advise all patients starting Tecfidera to insist that the neuro’s test their blood for lymphocyte counts at least every other month. Doing so should largely eliminate any chance of PML and set many a mind at ease. Despite its similarities to its cousin Fumaderm, Tecfidera is a brand-new drug, and although all signs point to it being a very safe medicine, I think it prudent to err on the side of caution. If your neuro resists, print out the DEFINE trial results and show him/her the data on lymphopenia, which can be found on the ninth page of the study. I always urge patients to educate themselves and to self advocate. Here’s the perfect opportunity to do both.

In short, all of the recent concerns about Tecfidera and PML appear to be hugely overblown. To put things in context, Tysabri has seen 347 cases of PML in approximately 260,000 patient hours of drug exposure. Fumaderm has seen four cases of PML in approximately 180,000 hours of drug exposure. It’s been noted that Fumaderm is not generally given as a long-term therapy. However, at least one study researched psoriasis patients who have taken the drug for up to 14 years, with no apparent added risk associated with long-term use (click here). Based on the DEFINE trial results, the large majority of Tecfidera patients, 96%, should experience no problems whatsoever with lymphopenia. Regular blood testing should ensure that patients who do experience clinically significant drops in lymphocyte counts avoid any potential problems.

The fact that Tecfidera is an oral drug that appears to be almost twice as effective as the injectable CRAB drugs, and may have neuroprotective properties to boot, should make it a very valuable weapon in the arsenal against MS. Like all of the current MS drugs, it is not a cure, but it will hopefully bring many patients some significant relief from this terrible disease. Using all of my self-control, I'll refrain from going on my usual rant about how the focus of pharmaceutically funded MS research on immune system suppression and modulation does absolutely nothing whatsoever in the effort to find a cure for the disease, but it doesn't. And that sucks. There, I said it. I couldn't help myself.

Oh, I almost forgot. About those shenanigans in the Big Pharma sandbox: it appears that the reports of potential problems with Tecfidera were first brought to the attention of the FDA and the general public by Teva Pharmaceuticals, makers of Copaxone, one of the CRAB drugs that are currently considered the first-line drugs given to new MS patients (click here). Guess which MS drugs are most threatened by the potential success of Tecfidera? Yup, the CRABs, of which Copaxone is currently the most prescribed. With Copaxone sales of $4 billion (yes, billion) in 2012, Teva has about 4 billion reasons to try to delay Tecfidera’s entry into the market, or to stir up concern among the drug’s potential consumers. Not that I would ever accuse any Big Pharma players of partaking in such underhanded behavior. Gee, I sure hope the Yankees win the World Series…

Not.

(For a comprehensive overview of the how's and why's of Tecfidera, please see my previous post on the topic, by clicking here)

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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