Hype or Hope? Much Touted Oral MS Drug Tecfidera (BG 1. Approved by. FDA. If you are currently taking Tecfidera, please take part in my Tecfidera patient poll (click here). Last week, the FDA approved Biogen’s long- awaited oral MS drug, Tecfidera (formally known as BG 1. Naturally, the news was featured most prominently in the financial sections of newspapers/websites (click here), as an uptick in shareholder value is much more newsworthy than a potentially breakthrough drug that could help hundreds of thousands of patients suffering from a heinous disease. Much was also reported about the drug's yearly price of $5. MS drug pricing. Such are the priorities of our whacked out society. Okay, social commentary over. The Hit List 1 1 Activator Chiropractic TechniquesOfficial web store of Quantum Nutrition Labs. Founded by Dr. Bob Marshall PhD, delivering uncompromising quality & effectiveness, and 100% non-toxic products. XPI The unit is comprised of 3 boards. The Mainboard, witch contains the DSP and a 1 bit PWM DAC for audio as well as headers for a HD44780 LCD, User Interface. GROUND BREAKING FOR WIRTH CHIROPRACTIC SHOWCASES PLANS FOR NEW 4,000 SQUARE FOOT FACILITY. Greenville—Wirth Chiropractic, conducted a ground breaking ceremony for a. DMF was first used for medicinal purposes in a highly effective anti- psoriasis drug called Fumaderm, which has been marketed in Germany since 1. It’s important to note that Tecfidera and Fumaderm are not identical compounds, which must be kept in mind when comparing the actions and side effects of the two drugs. Much might be inferred by reviewing the history of Fumaderm, but trying to make precise, direct comparisons could well in lead to erroneous conclusions. More on that later. In clinical trials, Gilenya was more effective in terms of reducing relapse rates, but concerns about potentially serious side effects (dangerously low blood pressure and pulse rates, potential for opportunistic infections) have kept the drug from reaching . There are some indications that Gilenya may have neuroprotective properties, and it is currently undergoing trials for use against Primary Progressive Multiple Sclerosis (click here). It is one of the few drugs being tested for the progressive forms of the disease. In trials, Aubagio proved to be just about as effective as the CRAB drugs in reducing relapses, and has exhibited some potential in inhibiting disease progression, but the drug comes with two black box warnings (the strongest issued by the FDA) concerning liver toxicity and the possibility that it can cause major birth defects (click here). Tecfidera’s comparatively mild side effect profile, which is comprised primarily of flushing of the skin and gastric disturbances, its high rate of efficacy, and oral dosing have led to the expectation that it will soon be a leader in the multiple sclerosis drug market. Tecfidera’s mechanism of action, which is not fully understood (something that is not uncommon, the action of many pharmaceuticals are not fully understood), appears to be threefold. The drug exhibits immunomodulatory, anti- inflammatory, and antioxidant properties, the combination of which theoretically affords the compound its potency. ![]() 3 1 2 3 “Patient care is based on clinical judgment, experience, and traditions.” “Data are evaluated to show that the patient outcomes are consistently met. The following is a guest post by Preston H. It is an excerpt from his new book entitled 'Chiropractic Abuse—A Chiropractor's Lament'. The Original Metabolic Medicine’s Cancer Cure. Do-it-Yourself Book. Reviewed after 32 years 1967 — 1999. In two large- scale studies, called DEFINE and CONFIRM, Tecfidera reduced relapse rates by approximately 5. By comparison, the CRAB drugs reduce relapse rates by about 3. Tysabri cuts relapses about 6. Whether these drugs impact disease progression has yet to be firmly established. Much of the excitement surrounding Tecfidera involves the prospect that, in addition to its disease modifying characteristics, the drug may be neuroprotective. Neuroprotection is one of the holy grails of MS research. If the cells of the central nervous system can be protected from the ravages of multiple sclerosis, then the progression of the disease can be inhibited. Vertigo dizziness is an extremely distressing syndrome but chiropractic manipulation should only be used with the greatest discretion. If you are currently taking Tecfidera, please take part in my Tecfidera patient poll. Last week, the FDA approved Biogen’s long-awaited oral MS drug, Tecfidera. The notion that Tecfidera may be neuroprotective is based on the fact that one of the drug’s supposed mechanisms of action is the activation of Nrf. Nrf. 2 (click here) is simply a protein that exists within every human cell, inoperative until it is kicked into action by a Nrf. Once activated, Nrf. DNA within, initiating the production of powerful antioxidants. If Nrf. 2 was a bottle rocket, it’s thought that Tecfidera could initiate the process that lights its fuse. Antioxidants (the good guys) are the body’s defense against free radicals (the bad guys), cell damaging oxygen molecules that are released during the biological process of turning food into energy, much like noxious exhaust fumes are released by an automobile engine turning gasoline into energy. Once free radicals are released they act like wrecking balls, smashing through cell walls and inflicting injury. The process by which free radicals do damage to the body’s tissues is known as oxidative stress, which is believed to be one of the primary drivers of MS disease progression, as well as a factor in many other diseases (click here). Therefore, by combating oxidative stress through Nrf. Tecfidera may protect central nervous system tissues from damage by free radicals, which would be a very good thing. Some Facebook pages and websites, including a previous post on Wheelchair Kamikaze (click here), have mistakenly equated Tecfidera with a nutraceutical product called Protandim (click here). In laboratory tests, Protandim has proven to be a powerful Nrf. Tecfidera. However, Tecfidera’s mechanism of action appears to be much more complex and wide- ranging, and not confined only to Nrf. It also effects cytokines (chemical signals that influence the inflammatory process – click here), and down regulates the immune system. This down regulation of the immune system may in fact be the primary driver of Tecfidera’s effectiveness. According to the official report detailing the results of the DEFINE trial (click here), which appeared in the New England Journal of Medicine, “It is difficult to determine whether the therapeutic effect of BG 1. Now back to Fumaderm, Tecfidera’s very effective German anti- psoriasis cousin. Fumaderm's efficacy in treating psoriasis, an autoimmune disease, is well documented, with 5. Since Fumaderm’s primary component, like Tecfidera, is dimethyl fumarate, its side effect profile is similar to Tecfidera’s. Through 2. 0 years of use, the most prevalent Fumaderm side effects have been gastric disturbances (stomach ache, vomiting, and diarrhea) and flushing of the skin, which, according to a paper prepared by Britain’s NHS (click here), can lead to discontinuance and/or noncompliance in 3. In the Tecfidera drug trials, though, dropout rates were negligible, with no significant difference between those patients taking the actual drug and those on placebo. Gastric disturbances and flushing of the skin were the most commonly reported side effects in the Tecfidera trials, but appeared to be manageable and diminished significantly after one month on the therapy. This discrepancy between the patient experience with Fumaderm versus Tecfidera is likely due to the different chemical makeup of the two compounds (Tecfidera is composed only of DMF, while Fumaderm includes DMF and some other derivatives of fumaric acid), and/or to differences in dosing, as patients on Fumaderm generally take a higher dose of DMF than will be given to Tecfidera users. Still, only real world experience will tell us how troublesome these side effects prove to be. Another effect seen in both drugs is leukopenia, a reduction in white blood cell counts. This condition is accompanied by lymphopenia, a reduction in specific white blood cells, including B and T cells, which are the targets of many of the current MS drugs (Tysabri, Rituxan, Gilenya, Aubagio). This suppression of immune system cells may play a part in the two drugs' effectiveness, but can be problematic if the cell counts get too low, as this might open the patient up to opportunistic infections, although none were seen during the clinical trials. Tecfidera induced lymphopenia and leukopenia are reversible with cessation of drug therapy. In its 2. 0 years on the German market, comprising over 1. Fumaderm has been linked to four cases of PML (click here), the opportunistic brain infection associated with Tysabri. While this may initially seem troublesome, it’s important to keep in mind that these cases occurred over a very long time period, and at least one of these patients was using other powerful immunosuppressive drugs. Generally, opportunistic infections are not seen in patients using Fumaderm. During the Tecfidera DEFINE trial, white cell and lymphocyte cell counts dropped an average of 1. Importantly, though, over the two- year run of the trial, no instances of opportunistic infections were reported. It was noted, however, that 4% of trial patients experienced a more serious drop in cell counts (this info can be found on page 1. NEJM article – click here). In Germany, Fumaderm patients are required to have blood tests once a month for the first six months they are on the therapy, and then every other month thereafter, to keep an eye on cell counts The FDA guidelines for Tecfidera only call for yearly blood tests, and though I’m no doctor, this recommendation seems a bit questionable. Even though no opportunistic infections were noted in the two Tecfidera trials, why not err on the side of caution? We’re only talking about simple blood tests, which could head off potential problems before they get started. Some other rare but potentially serious side effects noted in the Tecfidera study were liver and kidney events, although most were mild and reversible. There were no reported incidences of kidney failure. Still, I would think, all the more reason for regular blood tests, especially since so many MS patients are on other drugs that can be liver or kidney toxic. So, what do I make of all this, as an educated patient? Tecfidera seems to be a very promising new drug for MS sufferers, one which might even help those with progressive disease due to its antioxidant, neuroprotective potential. I will very likely begin Tecfidera therapy sometime in the near future, even though my diagnosis is still uncertain and none of the other MS drugs have helped me. I’m encouraged by the fact that Tecfidera is related to a drug that is very effective in treating psoriasis, and has also anecdotally been noted to have a positive effect on a host of other diseases, including sarcoidosis and alopecia. Catalyst: Chiropractors - ABC TV Sciencedownload segment mp. MB)NARRATIONChiropractic therapy is a modern reinvention of the ancient art of spinal manipulation. In recent times, this practice has become steeped in controversy. Emeritus Professor John Dwyer. Much of modern chiropractic, unfortunately, has descended into the realm of quackery. NARRATIONUniversities are being accused of teaching pseudoscience. Dr Michael Vagg. It would be misleading to present that to students. Dr Aidan Mc. Guigan. The results are really speaking for themselves. It comes down to 'the proof is in the pudding'. Belinda. We've been coming for asthma. Kirbie. A little bit of colic and reflux. NARRATIONThis has the medical fraternity up in arms. Dr Steve Hambleton. Well, this is a great concern of the medical profession, that there are some individuals taking their infants and young children to chiropractors. NARRATIONIt's even created factions within the chiropractic industry. Dr John Reggars. I am angered and I am embarrassed for the profession. NARRATIONWill chiropractors become the new family doctor, and are they putting our children at risk? Dr Maryanne Demasi. Now, most people go to the chiropractor for back pain, and, despite its surging popularity, its proven benefit is fairly limited. A review of spinal manipulation showed that it could alleviate lower back pain, but it was no more effective than heat therapy, or even a good massage. NARRATIONChiropractors have an important role in healthcare when it comes to treating musculoskeletal problems. But a new trend is emerging. Emeritus Professor John Dwyer. It's the move into paediatrics, and the enormous number of chiropractors who are trying to set up paediatric clinics and claiming that they can cure a range of paediatric conditions, that is really troublesome. NARRATIONThere have been reports that chiropractors are the new refuge for a range of health problems, like asthma, colic, reflux and autism. Belinda. Last week, Jade had an asthma attack and I rang quickly, and said, 'Can you fit her in?' And they said yes straightaway. We put her in and it stopped, completely stopped. Dr Maryanne Demasi. Wow. Belinda. She was really.. I didn't like to put drugs into their body if it wasn't necessary. So, that's what I found with a GP, that they were very quick to just - quick - write a script and off they go. I didn't feel as if there was a lot of caring, or individual care at least, with the children. NARRATIONWhere babies used to be rare patients, they're now common in a number of clinics. Newborns and toddlers make up over a third of this chiropractor's client base. Man. areas of subluxation that I can feel there that are immediately improved after you adjust it like that. Kirbie. I would definitely send her along to the chiropractor first to see that we couldn't settle her first. I think that's more important than sending them along to a GP. Dr Maryanne Demasi. Were you surprised that they could treat a whole range of medical conditions? Belinda. Yeah, I've been very surprised, because I wasn't.. I wasn't really expecting the answer to be yes to be able to sort out asthma. Dr Aidan Mc. Guigan. I've witnessed myself and read reports of improvements in colic, bed wetting, asthma. There's a lot of word- of- mouth information that is going around the public that someone's child has been helped in that way. So they've come to the chiropractor. Dr Maryanne Demasi. Now, you may be wondering how adjusting the spine could possibly help conditions that have nothing to do with the spine. Well, perhaps a brief history lesson may help explain where this came from. NARRATIONChiropractic therapy was founded in 1. American magnetic healer called 'DD Palmer'. In his building worked a janitor who complained he was hard of hearing. DD Palmer decided to perform an adjustment on the man's spine, and, in a miraculous feat, claimed to have cured him of profound deafness. Palmer hypothesised that aligning the spine unblocked nerve flow through the body and restored the man's hearing. From this, he proposed that a misaligned spine was the cause of virtually all human ailments. Dr Maryanne Demasi. Fast forward to today, and the Chiropractic Association still believes that curing deafness with spinal manipulation is plausible. Dr Tony Croke. Well, it makes sense that.. It would suggest that there was a relationship there. Dr Maryanne Demasi. Between hearing and the spinal column? Dr Tony Croke. Yeah. And there are neural pathways that run from where he was supposed to have been adjusted, up into the brain stem, that can impact on function. NARRATIONJohn Cunningham, a spinal expert, disagrees. Mr John Cunningham. There's no nerves that control hearing that have anything to do with the neck. They all come from the base of the skull, which simply cannot be influenced by any sort of spinal manipulation. I would have concern over someone's appreciation of anatomy if they were to claim that the middle ear and Eustachian tube is affected in any way by a nerve that comes from the spine. NARRATIONTony Croke explains that even the slightest misalignment in the spine can act like a traffic jam in the central nervous system, and lead to disease. In chiropractic circles, it's called a 'subluxation'. Dr Tony Croke. And so it's not necessarily that you have to compress the nerve root on the way out, but, in fact, the messages coming back in can be distorted because of that static in the nervous system travelling back upward. Mr John Cunningham(Laughs) I'm sorry. It's just senseless rubbish. If there is a static, well, why haven't they shown it? If that is the mechanism, they've had all these years to describe it, to.. Why haven't they? NARRATIONDr Michael Vaggr is a pain specialist, and disagrees with the chiropractic theory about traffic jams in the central nervous system. During surgery, he deliberately scrambles the nerve signals to the spine, so that patients can get pain relief. Dr Michael Vagg. We use spinal cord neuromodulators to electrically scramble the information that's going up and down the rear part of the spinal cord. And we see no evidence that that produces anything other than pain relief in most of our patients. So, I think, those observations are not consistent with the chiropractic view that optimum health depends on there being absolutely no interference with nerve function at all. NARRATIONPaediatrician Michael Fahey says the science doesn't stack up. Dr Michael Fahey. The idea that there are energy flows up and down the spine that cause disease in organs doesn't fit with our current understanding of science. There's been a number of systematic reviews which examined chiropractic use for things like asthma, colic, bed wetting, ear infections, and don't show that there's any evidence that chiropractic is effective. If we look at the asthma trial, there's only been one done which has been conducted in a rigorous way, and they compared chiropractic therapy to a sham therapy. There was no change when they looked at the outcomes of respiratory function tests, the objective measures. Man. That's it, let's get to the air flow. NARRATIONExperts say quality of research is lacking. Even though patients swear by it, therapies need to be tested in rigorous trials to remove bias and the placebo effect. Dr Maryanne Demasi. Do you think it could be placebo? Dr Tony Croke. I bring focus to the fact that I want them to feel.. I'm OK with that. Dr John Reggars. Chiropractors have relied on anecdotal evidence, and, I think, because of their fervent belief in what they do, that they disregard or put aside the scientific evidence, which shows that it's either ineffective or inconclusive. NARRATIONJohn Reggars, a chiropractor, says he only treats musculoskeletal problems, and that adjusting newborns is ridiculous. Dr John Reggars. Now you've got an infant. The nervous system is not developed, its bony structure isn't fully developed. So I fail to see how anyone could find a problem with a one- week- old baby by touching their spine, and therefore.. NARRATIONHe says many paediatric conditions resolve spontaneously, like ear infections. Dr John Reggars. We know, from all the literature, that 8. So, if you take your baby to a chiropractor with a middle ear infection, he treats the baby, the baby gets better. Well, he's taking credit for it, and you also think that he's performed a miracle. Dr Maryanne Demasi. What concerns you the most about chiropractors treating very young babies? Dr John Reggars. I don't think the general chiropractor is trained well enough to actually diagnose problems with infants. NARRATIONAnd herein lies the irony. The Chiropractic Association has announced a bold ambition to become the new family doctor. Dr Maryanne Demasi. So chiropractors really want to be the doctors of first choice? Dr Tony Croke. It's a great idea. Dr Maryanne Demasi. Are chiropractors qualified to handle a whole range of medical complaints? Dr Tony Croke. We're five years university trained, and that gives us the capacity to assess and then redirect. So, of course, if you need your tonsils taken out, I'm not your guy. If you need brain surgery, somebody else needs to help you with that. My job is to find and assess whether you need to be just with me, whether you need to be co- managed, or whether you need to be referred completely. NARRATIONNot surprisingly, this aspiration has outraged the Medical Association. Dr Steve Hambleton. Your first point of care in the Australia health system needs to be your family doctor, a medically- trained person, who's comprehensively trained from cradle to grave to look at you and your family and the environment. Dr Maryanne Demasi. Is this a bad reflection on medicine that more and more people are turning to alternatives? Emeritus Professor John Dwyer. I think it is. Dissatisfaction with a quickie turnover turnstile medicine approach is a factor that drives people into the misguided hands of people who are doing the patient no good at all.
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I wasn't the only one who thought this was a problem. Shortly thereafter (with a lot of people pushing) Soma announced there would be a . He said.. we heard from our community that developers want to have for Windows desktop development the same great experience and access to the latest Visual Studio 2. Express level. Today, I’m happy to announce that we will add Visual Studio Express 2. Windows Desktop to the Visual Studio 2. This will bring to the Visual Studio Express family significant new capabilities that we’ve made available in Visual Studio 2. I'm glad folks realized that no- cost desktop software development is important. Open Source projects need free tools like the Express SKUs. Even better that the the Express Desktop SKU gets the new 2. Today Visual Studio has made Visual Studio Express 2. Windows Desktop available and you can go download it now free. The best part is that this one SKU supports C++, C#, and Visual Basic together. With this one free version you can make Win. Forms, WPF, Console or Class Libraries with any or all of Visual Basic, C#, as well as Win. CLR apps using C++. You can also, of course, combine projects over multiple languages into a single solution. You can target both . NET 4. 0 and 4. 5. NOTE: You might wonder, what about a free F#? Why isn't F# included? We've got a free download to add F# support to the free Visual Studio Express 2. Web! Related Links. While Express SKUs don't allow arbitrary add- ins (you need Pro for that) the free SKU does include Unit Testing, Code Analysis, as well as the Nu. Get package manager. It's a bit of a nice coup for my little group that Nu. Get is now included in ALL Visual Studio 2. SKUs, even Express ones. Package management is finally happening in . NET. In the screenshot below I've added a C++ Console app, a Window Forms C# app and a C# Console to a single solution in VS2. Express for Windows Desktop. Just to illustrate one of the reasons I think a free . It's a library for making Windows Services easier to write using . NET. It's up on Git. Hub under an Apache license. The easiest way to get Topshelf is with Nu. Get with simply . Topshelf has some impressive documentation as well, especially for an open source project! Here's a simple Windows Service with a basic heartbeat timer using Topshelf: public class Town. Crier. Anyway, this is just the kind of powerful, useful, and interesting open source library that could be helped by a free Express SKU for Desktop. I'm not involved directly (yet ; ) ) in making decisions this high up, but I (and many, many others) inside and out continue to advocate for balance. In this case I'm very glad that the decision was made to ship this SKU and I hope you all find it useful whether you work in open source or in education. There's more details over at the Visual Studio blog and the team is watching the comments. This week's sponsor: Be part of GENERATION APP. Begin your 3. 0- day journey to create a Windows Store style app and talk 1- on- 1 with a Windows 8 app development pro. Get started today. Microsoft's Visual Studio 2. On July 2. 0, Microsoft declared Visual Studio 2. The latest version of Microsoft's tool suite, as well as . Net 4. 6, have been released to manufacturing and are generally available today. Microsoft made a first community technology preview of Visual Studio 2. Visual Sudio '1. 4) available in June 2. Visual Studio 2. 01. Microsoft's integrated development environment. It also encompasses the . There are updated versions of VB. NET, C#, C++, Type. Script, F# and other languages and tools in VS 2. ASP. Net 5 and all of the . NET core are still designated as preview, even though VS 2. RTM. And Team Foundation Server 2. August.)Microsoft is positioning Visual Studio 2. NET 4. 6 as . However, the additional Windows 1. The expected RTM date of that tooling is July 2. Windows 1. 0 starts rolling out. In March, Microsoft released the pricing and version line- up for Visual Studio 2. There are three primary Visual Studio 2. Microsoft combined Visual Studio Premium and Visual Studio Ultimate into a new single bundle called Visual Studio Enterprise with Microsoft Developer Network (MSDN). The new The Enterprise version sits alongside Visual Studio Professional with MSDN and the free Visual Studio Community SKUs. |
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