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Thursday, April 10, 2014

An MS Patient's story: 11 Years Gimpy and the Lessons Learned

Posted: 10 Apr 2014 07:20 AM PDT

Last month I “celebrated” the 11th anniversary of my MS diagnosis with part one of Lessons Learned (click here), which looked at some of the insights my grappling with the disease had revealed about life, both the one lived inside my head and the kaleidoscopic swirl of the world around me. Along with the expected liberal dose of anguish, the disease has also brought with it some unexpected flashes of understanding, and maybe even something akin to a bit of wisdom. Not to say that I’ve got much of anything figured out, but I have at times gained a sense of clarity that was most often missing back when I was healthy.

My decade plus grapple with chronic progressive disabling illness has also taught me a hell of a lot about modern medicine and medical research. Admittedly, these are lessons I naturally would rather have not had to learn, but I didn’t have much choice in the matter. Multiple sclerosis is an enigmatic disease, and the rarer, progressive forms of the disease are particularly inscrutable, but my affliction managed to wake within me a long dormant inner scientist, or an at least inner scientist wannabe, who finds a lot of this stuff fascinating, frustrating, infuriating, and maybe sometimes even a little bit fulfilling. I sure do wish that wake-up call had come in the form of something much less horrific, but again, that wasn’t up to me. If nothing else, the time since my diagnosis has made for quite an education.

When I was living my long-ago and far away healthy life, my interactions with the world of medicine were usually brief and fairly perfunctory, even if I did have a pretty good working knowledge of disease due to my well hewn hypochondria. I took comfort, though, in the seemingly nonstop procession of blaring headlines and breathless news items regarding the latest medical breakthroughs, which painted a picture of modern medicine as something close to a bright and shiny miracle machine, ever more able to conquer devastating illness and fix broken bodies.

When I got sick, however, it didn’t take long for me to come to the uncomfortable realization that I’d been somewhat hoodwinked, that although some specific areas of medicine had seen huge advances, large parts of the modern medicine miracle machine so often portrayed in the media are in fact held together by shoestring and chewing gum. High-tech and expensive shoestring and chewing gum to be sure, wielded by some dedicated and knowledgeable people, but in far too many cases not much more effective than the shoestring and chewing gum that existed half a century ago.

Tremendous breakthroughs have been made in the surgical arena, where procedures that are now done daily would have been looked on as the stuff of fantasy 50 years ago. It wasn’t until 1954 that the first kidney transplant was performed, and over the next 15 years transplants of lungs, livers, and hearts were first successfully achieved. These procedures, all lifesavers, are now common if not routine. The advents of bypass surgery and angioplasty have been incredible game changers in the field of cardiac medicine, and neurosurgery too has witnessed advances barely dreamt of just a few decades ago. Surgery has become increasingly less invasive and much more survivable. Back in 1989 I suffered a detached retina, resulting in a surgery that required a four-day hospital stay and a two-month convalescence. Today, the same procedure is done on an outpatient basis. Incredible.

When it comes to treating many diseases, though, shockingly few tangible advances have been made in the last 50 years. Antibiotics have revolutionized the treatment of diseases caused by bacterial infections, but wide swathes of other illnesses have proven incredibly hard to crack. Neurologic diseases such as ALS, Parkinson’s, Alzheimer’s, and other less common maladies of the nervous system remain as untreatable as ever. The so-called autoimmune illnesses like diabetes, lupus, multiple sclerosis, and rheumatoid arthritis continue to stymie researchers, and though some of these diseases now have treatments that improve quality of life, none have divulged any of the secrets that might lead to a cure. Despite massive amounts of time and money spent on research, many cancers remain just as deadly today as they were in years past. Though some specific malignancies such as those of the breast, prostate, and lung are much more survivable today than ever before, the overall cancer death rate has decreased, astoundingly, only 5% since 1950 (click here)! When it comes to the vast majority of cancers, medicine has learned how to keep those afflicted alive somewhat longer, and there is of course much to be said for that, but it hasn’t found a way to keep them from dying of their malignancies. All in all, many diseases, though perhaps better understood, remain devastating and deadly despite the efforts of the modern medicine establishment. The situation makes me want to howl in dismay.

Naturally, the disease I’m most intimately familiar with is MS. Surely, there have been significant advances made in treating the relapsing remitting form of the disease, but the progressive flavors of the disease remained wicked, untamed, and diabolical beasts. Though the mysteries of MS are slowly being unraveled, the advances have been incremental, and each new discovery seems to only open the door for more questions. Just a little over 20 years ago there were no treatments for even relapsing remitting multiple sclerosis (RRMS), aside from the use of intravenous steroids to help calm down active relapses. The disease was considered by many doctors to be a “diagnose and adios” illness, for which not much could be done. Today, there are 10 FDA approved disease modifying drugs on the market, with a handful more on the way. None of these drugs is perfect, with a wide variance of effectiveness, tolerance, and potentially dangerous – and even deadly – side effects among them, but they have improved the quality of life of people with RRMS, in many cases dramatically.

I was intensely skeptical and harshly critical of some of these drugs when they were first introduced, thinking that their risks would far outweigh any potential benefits, but time and mounting evidence has softened my views. Facts are facts, and the preponderance of evidence shows that when administered properly to diligently monitored patients, even those MS drugs considered the most dangerous have had tremendous positive impact on many of the relapsing remitting patients who take them, at times even allowing some patients to live lives free of any evidence of disease activity, and experienced neurologists have learned to manage the risks involved quite well. That said, the status quo remains unacceptable. There is still nothing for us “progressives”, and all of the current MS drugs tinker to a lesser or greater extent with the workings of the intensely complex human immune system, the product of tens of millions of years of evolution. It’s clear that the aberrant immune response that has become the hallmark of MS is in reality a symptom of a much greater and as yet undiscovered ill, and continued focus on that immune response will not lead to a cure. Unfortunately, the very success of the immunosuppressant agents used to treat MS has made the search for the ultimate cause of the disease all the more difficult. Why? Because, quite simply, our system for medical research is flat out broken.

Up until about 20 or 30 years ago, most medical research was done on behalf of governments and academia, for whom profit potential didn’t much play into the equation. Since the 1980s, though, more and more research has been funded by the big pharmaceutical companies, and today upwards of 75% of all medical research is powered by pharmaceutical company monies, with that number growing ever higher due to our current economic and political climate. Though some of the business practices of these companies can be nauseating, there’s nothing inherently evil about the companies that develop, market, and manufacture pharmaceutical products.

It’s vitally important when thinking about these Big Pharma companies to keep in mind that they are publicly traded for-profit entities, and as such they are mandated by law to be beholden to their shareholders, not to the end-users of their products – otherwise known as patients. This dynamic creates some inherent conflicts of interest, as the mission of any business is to generate ever-increasing profits, and when it comes to medicine greater profits do not always translate into greater therapeutics. In some cases, the very reverse may be true.

Simply put, the job of a drug company CEO is not necessarily to produce the most effective drugs, but the most profitable. In point of fact, if a pharmaceutical CEO put medical potential above profit potential he could very well be breaking the law. Therefore, pharmaceutical company research monies pour into projects that stand the greatest chance of generating terrific profit, which are likely not efforts that might upend an already lucrative business model. This is why so many of the new drugs we see are of the “me too” variety, variations on older drugs that have already proven their profit potential. The corrosive influence of big money generated by blockbuster drugs has thoroughly infiltrated our medical research model, skewing the focus of much medical research from purely scientific to also encompass the predilections of the marketplace.

For their part, researchers, as well-intentioned as they may be, must pay the rent and feed their families just like everybody else, and so are drawn to projects most likely to receive generous funding, which are these days are those that have the attentions of the big pharmaceutical companies. Thus we have on our hands a kind of highly dysfunctional perpetual motion machine, fueled by people performing their jobs to the best of their abilities, which unfortunately is not constituted to produce the results most desired by legions of sick people and the professionals who treat them.

The problem is insidious, and is at this point woven into the very fabric of the system. Though this system has certainly come up with its share of medical advances, it hasn’t produced much in the way of cures, and in fact can stymie potentially paradigm shifting research that doesn’t present any obvious profit potential and/or threatens the status quo. Older drugs that might be repurposed for the greater good, or natural and alternative remedies that might be as effective as pharmaceutical products stand very little chance of receiving the research dollars needed to prove their worth simply because they have no potential to generate tremendous amounts of cash. Radical new concepts are often shunned not out of evil intent but for cold business reasons, as bringing them to fruition would be cost prohibitive, and even if successful they could kill the proverbial goose that lays the golden egg. We have turned diseases into multibillion-dollar industries and the sick into consumers in a topsy-turvy medical research environment in which success is most often measured in dollars earned, not diseases eradicated or people cured. What’s the answer? Got me, I’m too busy slowly watching myself becoming a complete cripple.

So, where does this leave me after my 11 year struggle with MS? Well, conflicted, to say the least. I’ve met incredibly dedicated professionals who are literally obsessed with finding the cure for MS, filling me with hope. Simultaneously, though, I’ve come to understand that despite these folk’s best efforts, the system within which they work is fundamentally flawed, a fact which fills me with consternation. That gleaming tower that modern medicine appeared to be when I was healthy has instead been revealed to be more a product of spin and public relations than reality. I’ve evolved as a person and a patient, as I’ve come to understand that there are no absolutes when it comes to life and medicine, and especially when it comes to a disease as devilish as multiple sclerosis.

Despite the mysteries of the disease and the madly dysfunctional research model that is now the norm, each day I read some stimulating new bit of research, or talk to a researcher wholly dedicated to the cause, and can’t help but nurture a persistent optimism, even in the face of my relentlessly progressing disease and the tremendous obstacles that stand between me and the realization of my dream to once again be whole. Stem cells may hold the answer, or anti-HIV drugs, or something completely unexpected that may pop out of some far away test tube tomorrow. We can only hope that if and when such a discovery is made, it manages to see the light of day.

Really, though, I just want to take a walk…


Marc Stecker




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Wednesday, April 9, 2014

New Multiple Sclerosis Medical Tool Helps Treat MS Bladder, Bowel Symptoms

MS bladder and bowelMultiple sclerosis (MS) is an autoimmune disease that affects upper motor neurons in the brain and lower motor neurons in the spinal cord.  Damage occurs to the myelin sheath, fat wrappings around axons, which causes nerve signals (action potentials) to slow down or stop.  This poor electrical conductance leads to a lack of neuron to neuron communication. Symptoms can vary including muscle weakness, slurred speech, bowel and bladder issues, impaired vision and possibly paralysis.  Bowel and bladder symptoms include constipation, stool leakage, frequent urination and urinary incontinence.
A recent clinical trial in Australia was led by Louise Kurczycki, a nurse from Melbourne-based Monash University, to determine better ways of managing MS symptoms.  The trial facilitated a team of scientists to develop a new screening tool that aids in identification of bladder and bowel symptoms in MS patients.
Kurczycki notes, bladder and bowel symptoms are common in multiple sclerosis and can have profound effects on an MS patients quality of life and self esteem.  If these symptoms are left untreated, urinary problems can have long-term effects.  Research has elucidated the benefit of treating bladder/bowel problems, however symptoms are often disregarded or tolerated by MS patients and overlooked or poorly managed by healthcare professionals.
Eastern Health MS service at Monash University previously trialled a screening tool to determine the extent of urinary and bowel issues in 100 MS patients.  Researchers reported they found many had urinary and bowel problems, including incontinence, and had not informed their neurologist or MS nurse.
The next stage of the trial will try to identify whether therapy initiated by a continence nurse improves and reduces the burden and impact of bladder symptoms.  Kurczycki adds, “Identifying continence issues is vital in MS to reduce the possibility of longer term bladder and bowel dysfunction, and contribute to improved quality of life for people with MS.”
MS patients participating in the trial who are identified as having bladder issues will be offered either immediate therapy or individualized information to help deal with their specific problem.
Source: BioNews

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Tuesday, April 8, 2014

Mallinckrodt Pharmaceuticals to Buy Questcor - makers of ACTHAR (tm) Gel

The Irish company agrees to pay $5.6 billion for Questcor, an Anaheim firm that makes drugs primarily to treat chronic autoimmune and inflammatory disorders.



Questcor’s primary drug Acthar is used to manage difficult-to-treat autoimmune and inflammatory conditions.Questcor’s primary drug Acthar is used to manage difficult-to-treat autoimmune and inflammatory conditions.

Irish pharmaceutical giant Mallinckrodt Pharmaceuticals said it will pay $5.6 billion in cash and stock for a fast-growing Anaheim bio-pharmaceutical firm that specializes in treating multiple sclerosis, the companies announced Monday.

The deal for Questcor Pharmaceuticals Inc. would give Mallinckrodt drugs that primarily treat chronic autoimmune and inflammatory disorders. Questcor's Acthar Gel, used in the treatment of multiple sclerosis, accounts for most of the company's sales.  

The proposed Questcor acquisition would be the second large purchase Mallinckrodt makes in Southern California this year.

In February, Mallinckrodt agreed to pay about $1.4 billion for Cadence Pharmaceuticals of San Diego. Cadence makes the specialty drug Ofirmev, an injectable version of acetaminophen that has been used to treat as many as 7 million patients since it was introduced in January 2011. Acetaminophen is the active ingredient in Tylenol.

Under terms of the deal, shareholders of Questcor — formed in 1999 in the merger of Southern California companies RiboGene Inc. and Cypros Pharmaceutical Corp. — will be paid $30 in cash and 0.897 of a share of Mallinckrodt stock for each share of Questcor common stock they own.
Based on the closing price of Mallinckrodt and Questcor shares Friday, that amounts to a total value of about $86.10 per share of Questcor, a 27% premium.

If the deal is approved, Mallinckrodt shareholders will own 50.5% of the combined company; former Questcor shareholders will own the remaining stake. The transaction has been approved by the boards of the two companies but is still subject to a vote by shareholders.
The joining of the two firms is expected to be finalized in the third quarter of this year, the companies said.

Acquiring Questcor “will substantially increase the scale, diversification, cash flow and profitability of our business,” said Mark Trudeau, Mallinckrodt's chief executive. “With Questcor, combined with our recently completed acquisition of Cadence Pharmaceuticals, the new Mallinckrodt will have a significant, established presence with prescribers, payers and hospitals.”

Acthar Gel was used to help treat about 7,400 patients in 2013, according to Questcor's most recent earnings statement. It had net sales of $761.3 million in 2013, up 49.6% from the year before. It has been approved by the U.S. Food and Drug Administration for 19 conditions.



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Monday, April 7, 2014

Genzyme to Resubmit Lemtrada(TM) Application for FDA Review

April 7, 2014

CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 07, 2014-- 
Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that following constructive discussions with the U.S. Food and Drug Administration (FDA) the company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter.
Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.
Genzyme(R) is a registered trademark and Lemtrada(TM) is a trademark of Genzyme Corporation.
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Finally, a way to track Research Studies: Europe votes for clinical trial transparency

2nd April 2014

It’s soon going to be the law in Europe that drug clinical trials are publicly registered and results reported. MEPs have today voted by a huge majority to adopt the Clinical Trials Regulation, 547 in favour and 17 against. This is fantastic. It will mean that researchers will in future know about trials as they are happening and will be able to scrutinize results soon after their end. This is all  due to the efforts of people all over Europe, including many patients who took part in clinical trials, who have pressed their MEPs to set the future straight in this way. Now we want to see recognition and use of the contribution that they and thousands of others have made in the trials that have already been conducted.

The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not generally be considered commercially confidential and will:

• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.

• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.

• Require that a summary understandable to a lay person of what was found in the trial is published on the register.

• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.

• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.

• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.

• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.



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