As tomorrow rolls in with sub zero temps here in the northland, I am consoled by the fact I am snuggly warm in my home. Facing another year can be a bit uneasy for some. But most look at it as an opportunity to improve the likes of their days here on Earth.

I join in with the rest of you celebrating the year of 2014. I remember back when I was graduating from High School, unable to imagine what his world would be like in 1984. There was a song out there noting the changes we would have to face in 1984, and that song must have hit the charts in about 1970. So to think about all of those past years when we celebrate the new year but I, also, celebrate another birthday. They say with age comes wisdom and those words ring very true for me. I am sickly with chronic illness but I have much to be thankful for.

So today, I praise God for all He gives me. I do my best to obey Him and live in accordance to His requirements to be a good Christian. I am lacking, hugely, like all of us who live in this world of sin, but I know He is full of forgiveness.

Here’s to a wonderful new year with fun aspirations, lofty goals and heavenly appreciation for all.

Six Terrific Truths about Time

31 Dec 2013 Leave a comment

by cttbbelliott in Conglomeration of posties

Here are six terrific truths about time:

First: Nobody can manage time. But you can manage those things that take up your time.

Second: Time is expensive. As a matter of fact, 80 percent of our day is spent on those things or those people that only bring us two percent of our results.

Third: Time is perishable. It cannot be saved for later use.

Fourth: Time is measurable. Everybody has the same amount of time…pauper or king. It is not how much time you have; it is how much you use.

Fifth: Time is irreplaceable. We never make back time once it is gone.

Sixth: Time is a priority. You have enough time for anything in the world, so long as it ranks high enough among your priorities.

I was just thinking about…TIME. USE IT WISELY!

Wishing you a Happy, Healthy and Successful 2014.

‘Til January 2014,

Here’s to your success and brilliance,

As Always,

Reaching out to make a difference….

Love and joy!

Thoughts To Ponder:

“Work to make your life something more than long, because there is no guarantee that it will be.” ~ Chris Widener

“The only thing even in this world is the number of hours in a day. The difference in winning or losing is what you do with those hours.”- Woody Hayes

The morning post

31 Dec 2013 Leave a comment

by cttbbelliott in Conglomeration of posties

Words of truth from a wise Canadian

My website name change effective immediately

31 Dec 2013 Leave a comment

by cttbbelliott in Conglomeration of posties

new name: belliott.vpweb.com

http://websitebuilder.vpweb.com/s/sitebuilder/pages/318607682/

30 Dec 2013 Leave a comment

Found in a box

Miracles happen every day. Sometimes or somebody recognizes the actual miracle. I am so thankful to often recognize God’s works in much of my daily life. Even those stories that He brings to me online affect my daily thoughts. Thank you Lord for all of your blessings!

Link by cttbbelliott

FDA Turns Down MS Drug Lemtrada

30 Dec 2013 Leave a comment

by cttbbelliott in Conglomeration of posties

FDA Turns Down MS Drug Lemtrada

Published: Dec 30, 2013

By John Gever, Deputy Managing Editor, MedPage Today

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The FDA has told Sanofi’s Genzyme unit that it would not approve alemtuzumab (Lemtrada) for multiple sclerosis until the firm performs another trial with an active comparator.

According to a statement issued by Sanofi, “FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.

“Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada.”

The company said it strongly disagreed with the FDA’s decision and vowed to appeal it.

The European Union approved the drug in September. More recently, authorities in Australia and Canada followed suit.

Alemtuzumab targets the CD52 immune cell surface protein, depleting certain classes of cells and inducing a long-lasting reshuffle in the immune-cell mix. The clinically relevant result is a down-regulation of inflammatory activity in MS.

The drug’s mechanism of action allows it to be given very infrequently — in an initial 5-day course of infusions, followed by a second 3-day course a year later.

Key to the decision was Genzyme’s two pivotal trials. Called CARE MS I and CARE-MS II, the studies pitted the drug against beta-interferon, a standard drug for relapsing-remitting MS.

The results generally showed that alemtuzumab was superior to interferon in reducing relapses, with some evidence as well that it reduced progression of disability. Progression was significantly slower in one of the trials but the effect failed to show statistical significance in the other.

In November, an FDA advisory committee determined that alemtuzumab was effective for reducing relapses and that its safety issues should not preclude approval. But panel members also found that the drug’s effect against disability progression remained unproven.

FDA staff members had told the committee that they had strong reservations about the rigor of the clinical trials. Because Genzyme wanted to use an active control that required frequent dosing, a double-blind trial was not feasible. Instead, both CARE-MS studies were conducted on an open-label basis. The drug’s safety was also a major concern, the reviewers said.

Neurologists contacted by MedPage Today prior to the FDA’s announcement expressed hope that the agency would clear the drug for MS.

“While there are very valid concerns about the data interpretation from the trial and safety profile of the drug, there are reasonable levels of efficacy data to support its approval,” said Benjamin Greenberg, MD, of the University of Texas Southwestern Medical Center in Dallas, in an email.

“Given its unique and profound mechanism of action, this drug will have potential uses for specific patients who have the highest need for efficacious interventions.”

Neil Lava, MD, of Emory University in Atlanta, agreed. “Most of the neurologists in the MS community want this medication to be approved. It will be an excellent addition to our MS drug armamentarium,” he said.

Both men said that the drug’s autoimmune side effects are a serious issue, however, requiring that patients in routine practice be monitored and that studies evaluate the risk more carefully.

“A very intense postmarketing surveillance program would be extremely useful for formulating long-term assessments of this medication,” Greenberg said.

Robert Bermel, MD, of the Cleveland Clinic, who helped lead the drug’s pivotal trials, told MedPage Today that he expected approval would come with “a fairly detailed risk mitigation strategy [that] may require monitoring of blood and urine as frequently as once per month for up to 5 years. The logistics of how neurologists will coordinate the necessary monitoring remains unknown.”

He said one population for whom the drug could be well suited is patients with aggressive MS who are poor candidates for natalizumab (Tysabri) because of latent JC virus infection, a risk factor for life-threatening progressive multifocal leukoencephalopathy.

Alemtuzumab had shaped up to be the last really novel treatment for MS to come along for a while.

Over the past decade, treatment options for MS expanded tremendously. The first two specific MS treatments, interferon-beta (Avonex, Betaseron, Rebif) and glatiramer acetate (Copaxone) were approved in the 1990s. Then the range of options exploded beginning in 2004 with the approval of natalizumab followed by the oral drugs fingolimod (Gilenya), teriflunomide (Aubagio), and, most recently, dimethyl fumarate (Tecfidera).

But no others with mechanisms of action differing from these agents are expected to win approval any time soon.

The only such drug in the late-stage pipeline, laquinimod, has been stalled since 2011, when it failed to meet its primary endpoint in a phase III trial. The FDA reportedly told laquinimod’s developers to conduct another phase III trial before it would consider approving the drug. Such a trial began enrolling patients in March of this year, with disability progression as the primary outcome.