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THE SEARCHLIGHT MESSENGER
THE SEARCHLIGHT MESSENGER
Children with Super-Refractory Status Epilepticus Respond to Sage Therapeutics’ GABA-A Receptor Modulator
|Posted on November 15, 2014 at 9:12 PM||comments (12)|
Orphan designated drug SAGE-547 was recently used successfully to treat super-refractory status epilepticus (SRSE) in two pediatric patients. The report by Broomall et al  is available at the Annals of Neurology (online ahead of print). SAGE-547 is being developed by Sage Therapeutics.
Super-refractory status epilepticus is frightening version of status epilepticus, which on its own can be a life-threatening condition (35,000 of a total of 150,000 die from it each year). When a patient presents with status epilepticus, they are usually treated with benzodiazepines, and if no response, they are treated with second-line, anti-seizure drugs.
If the seizure persists after the second-line therapy, the patient is diagnosed as having refractory status epilepticus and placed into a medically induced coma. After 24 hours, an attempt is made to wean the patient from the anesthetic agents to evaluate whether the seizure condition has resolved. If seizures persist following the weaning attempts, the patient must be maintained in the medically induced coma and is diagnosed as having super-refractory status epilepticus. There are currently no therapies approved for refractory, or super-refractory, status epilepticus.
SAGE-547 is a neurosteroid allopregnanolone that acts as a positive allosteric modulator of synaptic and extrasynaptic GABA receptors. Internalization of synaptic GABA receptors may be responsible for super-refractory status epilepticus.
In the report by Broomhall and colleagues, treatment with SAGE-547 allowed the general anesthetic infusions for these patients to be weaned with resolution of status epilepticus. No drug-related serious adverse events were reported. Both patients were treated with SAGE-547 under emergency-use Investigational New Drug Applications.
Mark Wainwright, MD, PhD, director of the pediatric neurocritical care program at Northwestern University Feinberg School of Medicine and senior author of the study said:
"Refractory status epilepticus is a medical emergency with high risk for poor outcome. In both of these cases, the patient had been put in a medically induced coma to control seizures, and there were multiple unsuccessful attempts to wean the patient from anesthetic agents prior to treatment."
"There are no truly effective treatments for refractory status epilepticus - it is incredibly exciting to work with a new therapy that may help both pediatric and adult patients affected by this disorder."
According to a press release, the following is known about the two patients' treatment:
The first patient was treated at Ann & Robert H. Lurie Children's Hospital of Chicago, was an otherwise healthy 11-year-old girl who presented with SE caused by an autoimmune disorder with antithyroid and anti-glutamic acid decarboxylase antibodies. She received an infusion of SAGE-547 over five days, after which pentobarbital sedation was weaned and discontinued. Over the remainder of the hospitalization she had intermittent, controllable seizures. She was transferred for inpatient rehabilitation, regained her ability to walk, and is now back at home, continuing to show cognitive improvement, reading, doing arithmetic and playing the piano.
The second patient, a two-year-old girl, presented with SE associated with a febrile illness. SAGE-547 was infused over four days and tapered off between 96 and 120 hours. SE resolved after SAGE-547 treatment and 12 days following the completion of treatment with SAGE-547 all anti-seizure therapies were discontinued. She was transferred to inpatient rehabilitation and is now able to walk and speak. In both patients, there were no drug-related serious adverse effects detected by any of the laboratory tests used.
Stephen Kanes, M.D., Ph.D., chief medical officer of SAGE and co-author of the study stated:
"Our ongoing Phase1/2 clinical trial has yielded promising results in adult patients with super-refractory status epilepticus, and we are excited about the possibility of delivering this treatment to children, as well."
|Posted on June 21, 2014 at 1:41 AM||comments (31)|
This is a follow up to my article, "Marijuana and Colorado, a Doctor's Perspective". The venture capitalists are moving in. This was inevitable, as I talked about it in my article. It has become difficult for any investor to ignore the glaring reality of an American "Medical Cannabis economic boom" coming sooner than most are ready for. Start paying attention.
The latest on Novus from Venture 17 and The Trinity Venture Capital Group. Read on.
Novus (NDEV) Aims to Fill Key Void in Cannabis Industry
The U.S. legal cannabis industry is expected to reach $2.34 billion in size by the end of the year, according to ArcView Market Research. With additional states expected to legalize the drug over the next five years, the same group believes that the U.S. industry could reach $10.2 billion in size by 2018. These growth rates have attracted both investors and lawmakers interested in shoring up tax revenue.
Despite these gains, cannabis continues to be classified by the federal government as a Schedule I Controlled Substance alongside drugs like heroin and cocaine. Conflicting federal and state laws surrounding the burgeoning industry have been a source of widespread confusion, which has led many insurance companies to refuse coverage for medical marijuana treatments for patients in need.
In this article, we'll take a look at a company that aims to change those dynamics by introducing a health insurance program geared towards medical marijuana patients.
Lack of Insurance
Medical marijuana has been shown to be effective in treating a wide variety of different medical conditions, including pain, nausea, and appetite. In addition to these conditions, companies like GW Pharmaceuticals plc (GWPH) are extensively studying the drug for its potential use in treating major conditions like childhood epilepsy, Crohn's disease, and certain types of cancer.
Since many health insurance companies work with federal programs like Medicare and Medicaid, they must adhere to all federal laws including those that classify medical marijuana as a Schedule I Controlled Substance. The result is a significant lack of insurance coverage for patients that require medical marijuana, legal on a state level, to treat serious medical conditions like childhood epilepsy.
Novus Acquisition & Development Corp. (NDEV) aims to capitalize on the void in the marketplace by establishing a health insurance program for medical marijuana patients. These efforts are being led by Ms. Andrea Lopez, MSM, AHFI, who has more than 15 years of experience in healthcare compliance, delivery, and development of insurance policies for large companies.
Novus Acquisition & Development Corp. also aims to provide structured protocols for physicians that are compliant with each state's regulation and federal recommendations in order to ensure they are on the level. The team conducts full-scale risk management analyses in order to mitigate business liability and promote workplace safety for employers, municipalities, and businesses.
With its focus on the healthcare side of the business, the company's solutions differ from compliance related solutions provided by other publicly traded companies like Integrated Cannabis Solutions Inc. (IGPK). ICS provides regulatory assistance to new and existing legal cannabis businesses, including dispensaries, that are trying to navigate their way through the heavily regulated industry.
The healthcare compliance side of the business also represents significantly less risk for investors than the growing side of the business. While growing operations under Canada's new MMPR are relatively safe, including companies like Abattis Bioceuticals Inc. (OTC:ATTBF) or Creative Edge Nutrition Inc. (FITX), there may be risks associated with companies operating dispensaries in the U.S.
Growing Need for Compliance
The need for effective healthcare insurance and compliance solutions are only likely to increase as the medical benefits of cannabis become more apparent. GW Pharmaceuticals' cannabinoid based Sativex® has already been approved in 25 countries and received Fast Track status from the FDA and plans to release top-line Phase III cancer pain data toward years end.
With medical cannabis use being increasingly justified, there's also growing concern among the public about the risks involved. Two high-profile Colorado deaths were recently tied to the over-consumption of cannabis "edibles" containing high levels of THC. These developments underscore the importance of additional risk management practices, especially in a new industry with few existing rules.
Businesses are also increasingly in need of compliance solutions. Employers cannot discriminate against employees simply because they possess medical marijuana cards, and no employer wants to face the prospect of a lawsuit for unlawful termination of an employee. Compliance solutions from companies like Novus can help businesses avoid these types of situations.
And finally, medical marijuana patients are in great need of insurance programs to help lower their costs and provide affordable coverage. The proven use of medical marijuana to treat conditions like childhood epilepsy has left many parents without a lot of options financially, which has created strong demand for insurance programs like the ones being developed by Novus.
Stay tuned for continued posts on this important issue.
|Posted on June 8, 2013 at 11:24 PM||comments (160)|
While teaching my campus based class on Professional Development this term, it became evident that I needed to write this article. It seems every term, the subject of “What should I do with my money, Dr. Counce?” always comes up. They are truly eager to learn, but young college students in their twenties struggle with the task of managing their money, let alone getting it to work for them. And really, because no one has ever shown most of them this part of the free enterprise system we live in.
Honestly, how many of you who went to public schools like I did, ever learned about economics and investment vehicles before college? What’s an annuity, what’s an IRA, what’s a 401 K. What’s a stock, a mutual fund, and an index fund? These are all topics you could ask any eighteen year old, and quite frankly, they will have no clue. Forget about discussing value rated index funds, IPOs, the Options market. And don’t forget about REITs. It’s like “deer in the headlights”.
They are taught by their parents to save money in a savings account, and that their biggest investment is buying a house. Sure, this has come down generation after generation from our wise and frugal Depression era parents, and grandparents, but is the thing that pushes the youngster into a mindset that implies “I will never be an investor, and will never have more than my house is worth”.
This obviously is the worst advice we could hand down to our children. Just look what happened to all of those homeowners in 2007 through 2010. Where is their investment now? Not to mention that they feel stuck, as they have no idea about other investment vehicles, because their parents didn’t either, and neither did their grandparents.
As an investor, I have some very hard and set rules. So generally the students get an ear full from me. Of course you have to learn these markets, pick your poison, then move in an educated and equitable direction. Yeah, there is always risk. Needless to say, I have little time to cover everything from balance sheets and valuation to the difference between index funds, including “cap funds”, fundamental funds, and valued funds. And then there is the Bond market. Wow! I can see their brains rushing for a way to process all of this. Then there is the difficulty of wrapping their arms around “ten percent of the people have ninety percent of the money”, and didn’t do it by flipping houses. Here’s another one. Those in the ten percent are using Your money to make more money. Just ask your banker or any venture capitalist.
So in this article I will touch on a little of each of the above topics, and try to put it “in English”. In addition, I will mention my rules. Yeah, they’re simple. First, entrust no one, including those with close ties to you, with your money, the knowledge of your worth , your investment techniques, or where you keep cash on hand. Your wife? Maybe, but certainly not your girlfriends or boyfriends, period! I mean it! “But she loves me”, yeah, how many times have I heard that one?
I have to tell you, I nearly blew this rule myself, two years ago. Whew! That was close! Obviously this rule is somewhat difficult to live up to, but a reminder for all of you, to be careful and aware. I have also seen greed rear its ugly head with friends. What am I telling you? I’m telling you to keep your mouth shut.
Be the guy next door. Nobody needs to know about your cash, except you. That’s right, do not attract attention. You don’t need a Big house or a Big car, just ask Warren Buffet.
Secondly, educate yourself firmly, and professionally. Know the investment world like you know your own craft. When you talk, make them pay attention to you. Don’t just network, own the network. You can start with publications and news-letters. There are many, but a little expensive for the young professional starting out. Many of them are slanted one way or the other, explaining why their techniques and analysis give you the best returns. Remain objective and unbiased. I recommend the news-letter from the American Association of Individual Investors (AAII). They are a non-profit group here to put tools and education into your hands and afford you awareness.
Published monthly, The AAII Journal provides you with a continuing stream of insight and ideas that focus on how you can improve your investment results. The Journal doesn’t tout “Must Buy Lists” or speculative “Stock Tips”, but rather stresses hands-on participation in your financial future through education and understanding. Here’s the other thing. The AAII Journal doesn’t contain advertising, and they promote an unbiased posture. Their website is easily navigated. The cost? $30 will get you annual membership. Do it.
I would also recommend that you watch CNBC at least an hour every day, Monday through Friday. You will get tickers from the New York Stock Exchange (NYSE), and the NASDAC, as well as commodities. They have good discussions on every issue in the investment world. Sometimes they get a little dramatic, and sensationalist, but it's excellent information you can use. At our office we always have it on all the screens with the sound turned down very low. Not an hour goes by without something I see out of the corner of my eye, catching my attention. It is usually something equitable you might not see in The Wall Street Journal until a week has gone by. Yeah, I know.
Thirdly, bank most of your assets in trusts so that it is not easy to get to or make liquid, even for you. Liquidity, basically is how fast your assets can be turned into cash.
Next, find good, smart, and forthcoming partners that keep their mouths shut. Surrounding yourself with business savvy investment partners is critical, and your money is safe because you’re working together and investing together. For young professionals, this can be done through an investment club. You can glean more and earn more with experts in the investment world. Find them.
And lastly, start a charity. Sure, it has tax advantages, but you shouldn’t look at it that way. See it for what it is. “Giving back” is very big with me. Give to charity to benefit others, relieve poverty, and advance the community, period. You can find detailed information on starting a non-profit foundation easily at any public library. You can find funding at razo.com; crowdwise.com; indiego.com; and kickstart.com.
Because they are new to the world of banking and finance, one of the first things I teach my students on this topic, is how to bank and work with money right now. We discuss “paying yourself first”, and how to make money go to work for you, in addition to finding a place to park it. I discuss my investment heroes and gurus, and also recommend their books.
Let’s talk about how you get paid from your employer. You should make sure your check is electronically deposited to your main bank. That’s right, you’ll need 3 banks. Why? The first one is a receiving tank. From this bank you “pay yourself first”. How? Earmark at least 10% to invest. This, you electronically move to a money market vessel that channels moneys into different market investment vehicles.
So what’s the third bank for? It’s for all the things you purchase as a “consumer”. Deposit however much you need to pay your bills, and buy your toys, here.
You now have a bank that feeds your investment bank and consumer bank. You did this to screen your investments from your merchant accounts. Do not allow the bank you write checks against, to interface with your investment bank. Your debit bank is there only for purchasing consumables. Your merchants see only this bank. Again, all of this can easily be done online.
Remember though, that if you have a 401K (a pre-tax retirement vehicle offered by employers), the 401K can be your investment bank. Again, toss 10% here. What’s nice about 401Ks is that your employer also matches your investment. Some, 100%, some 50%, and so on. If your employer offers it, take it seriously. If you put in one thousand dollars and your employer matches 100%, two thousand dollars are now making money for you at probably 10%. “Really?” Yeah, really, $200 the first year on each $1000 you put in, and don’t forget the thousand you got from your employer. Don’t touch it.
Here’s the rub though. 401Ks are different packages of stocks we call mutual funds (a diversified stock portfolio). Some are “safer’ and some are “more risky”. Your human resources office will help you pick one. Keep in mind, you can contact the fund managers and manipulate the stocks held, yourself. A lot of people don’t know this. That means study the stock market and its indices. I kid you not! In addition, always remember that many Americans lost everything in their 401Ks during “The Recession Depression” of 2007. Yeah, there is always risk. Thanks, George.
Here’s a curve ball. If you have a 401K, set up that third investment bank anyway. Why? Because you need to apply some heavy risk now and again. You will want a place to conduct business as a speculator, and entrepreneur. You can immediately place these profits, which are usually large if done right, into a long-term holding called a Roth IRA (Roth Individual Retirement Account).
Yeah, IRAs. Here’s the deal. Traditional IRAs are much like a private 401K without matching funds, done with your pre-tax dollars; Roth’s are done with post tax dollars. They are great tax shelters, but both have very tight ceilings at a $5000 contribution per year. They generally are used when rolling over a 401K from let’s say, a previous employer. When you think about this, it’s perfect for the young professional starting out.
“But I don’t have a 401K . What do I do”? The first thing they hear from me is, “do not open a savings account”. Oops, really? This is another dogma our parents pushed onto us unrelentingly. Why would I tell my students that? Because if you take $100 and put it in a savings account today, next year it will be worth a whopping $101.50. Wow! You made a buck fifty! Let’s go get coffee! I may not have enough. Are you kidding me?
If you work with a valued index fund, that $100 will be worth $140 next year. Get it? A forty percent return is not unreachable if you know what you’re doing. If you make the current US Bond rate, the $100 will be worth $107 next year, still six to seven times more than a savings account can obtain for you. This isn’t rocket science.
So, what now? We open that Sharebuilder, Scottrade or E-Trade account, is what we do now. We start looking at different investment options. All of the stocks you see in The Wall Street Journal and much more will be available to you. From the NYSE and the NASDAC, to foreign markets, they are all there. It is a vast sea, and can be intimidating to newcomers. Study their tutorials and do research first. Don’t forget to read the AAII journal for guidance.
It is here that you can pick a company that is public (issues shares called stock in the company). You can pick one or 2 initially to get started. Study them, find there price per share, then buy. You now own shares in a company. Leave them alone. Wow! That was easy. You can also sell when you want, but remember each time you buy or sell, you are trading stock, and you will be charged on average, about $10 a trade.
As you start to educate yourself, you will find out things like, IPOs (initial public offerings). These are companies that have come out of the private sector and are now issuing stock to interested buyers. Keep in mind that companies generally do this when one of three things are happening. The company wants to make vast improvements and expand; needs liquidity to make major acquisitions; or pay off creditors. This is speculation, people. Study hard what they can bring. Wouldn’t it have been great to get in on Google’s IPO in the late 1990’s?
You will also learn about the DOW index (Dow Jones Industrial Average) and the S&P 500 (Standard and Poor’s 500 index), in addition to others like The Russell 1000. These are indexes (indices) that measure economic performance of the top companies on the NYSE and NASDAC. Also called Exchange Traded Funds, or Index funds, they are very stable compared to the rest of many trade options, and are long term vehicles. Here’s the quick and dirty.
Funds like the S&P are what we call cap funds that rate out on companies trading billions, like Apple®. Many experts agree that funds we call fundamental and an even tighter fund we call value-rated or value funds can actually earn more when you study. These pick up moderate to small companies with more dynamic room to move, and are not generally watched by big brokers, because they’re too busy calculating value on the giants. Warren Buffet pays very close attention to these and so should you. Don’t be afraid to invest in them.
You can also trade bonds here. Bonds are long term contracts of generally guaranteed rates. Like when you hear about “a bond issue” to build a highway. When you buy these bonds, you’re giving the builders cash to build with an interest rate guaranteed to you. Bonds are long term vehicles used to stabilize most diversified portfolios.
FET funds (Foreign Exchange Trading) are too volatile for the young investor and require constant vigilance. I consider this market like day-trading. You are above this.
Do not step into the Options Trading side of the market. You are not ready. It is a true Speculative Market and can take cash out of your pockets as fast as a “Long Straddle” can make you a fortune. Study it for now and know it’s there. Many brokering investment portals like E-Trade will ask for a letter of credit just to work the Options Trading side of the NYSE. Careful here, I mean it!
Do not forget about REITs. REITs are Real Estate Investment Trusts. These are essentially Real Estate Stock you can buy and sell like the stocks at the NYSE. Did you ever want to own a sky scraper or a hotel? This is one way to do it. Study them carefully, just like stocks. Pick them, buy them, and leave them alone. You now own part of a building, infrastructure or Real Property.
Your news letter will help guide you through these instruments and make a choice that best suits your agenda. Remember, study, study, study. Use experts that are around you. I don’t mind being stopped after class to discuss an investment you want to make. Remember to use the AAII website for help too.
Now you see why you can’t just run in and start buying stock willi nilli. You have to walk in educated and slightly guarded. Here’s another curve ball. What we just discussed is only the tip of the iceberg. Start reading and talk to me.
Let’s talk about my stock market heroes and why they are. Just click their images, and see their books.
Benjamin Graham (May 8, 1894 – September 21, 1976) was a British-born American economist and professional investor. Graham is considered the first proponent of value investing, an investment approach he began teaching at Columbia Business School in 1928 and subsequently refined with David Dodd through various editions of their famous book Security Analysis. Graham's followers include Warren Buffett, William J. Ruane, Irving Kahn, and Walter J. Schloss. Buffett, who credits Graham as grounding him with a sound intellectual investment framework, described him as the second most influential person in his life after his own father.
His book, Security Analysis, with David Dodd, was published in 1934 and has been considered a bible for serious investors since it was written. Graham wrote that investment is most intelligent when it is most businesslike, a statement which Warren Buffett regarded as the most important words about investment ever written.
Warren Buffett (born August 30, 1930), is an American business magnate, investor, and philanthropist. He is widely considered the most successful investor of the 20th century. Buffett is the primary shareholder, chairman, and CEO of Berkshire Hathaway and consistently ranked among the world's wealthiest people. He was ranked as the world's wealthiest person in 2008 and as the third wealthiest person in 2011. In 2012, Time named Buffett one of the most influential people in the world.
Buffett is called the "Wizard of Omaha", and is known for the value investing philosophy and for his personal frugality, despite his immense wealth. Buffett is also a notable philanthropist, having pledged to give away 99 percent of his fortune to philanthropic causes, primarily via the Gates Foundation.
Joel Greenblatt (born December 13, 1957) is an American academic, hedge fund manager, investor, and writer. He is a value investor, and adjunct professor at the Columbia University Graduate School of Business. He is the former chairman of the board of Alliant Techsystems and founder of the New York Securities Auction Corporation.
Greenblatt is a graduate of the The Wharton School at the University of Pennsylvania, receiving his B.S. in 1979 and M.B.A. in 1980. The Wharton School is considered to be the best business and economics college in the United States. Many billionaires have been produced by this school.
David L. Bach is an American financial author, television personality, motivational speaker, entrepreneur and founder of FinishRich.com. Bach, is best known for his Finish Rich Book Series and Automatic Millionaire Series of motivational financial books under the Finish Rich® Brand. He has written 12 books since 1998 with over seven million copies in print. Eleven of Bach’s books have been national bestsellers, including nine consecutive New York Times bestsellers, two of which were consecutive Number One New York Times bestsellers (The Automatic Millionaire and Start Late, Finish Rich).
I truly hope this article was a good primer, and helps you to see a little more clearly how education is absolute to managing your money, but moreover, putting it to work.
For more on this very important subject, please go to The Conservatory Book Store, or your public library, where you will find detailed information on everything we talked about in this article.
|Posted on January 25, 2013 at 10:38 PM||comments (108)|