Excellent!

http://brianduriemd.myeloma.org/?q=content/revlimid-receives-frontline-approval-us

Revlimid Receives Frontline Approval in the US

Submitted By Dr. Brian GM Durie On Fri, 02/20/2015 - 03:30
In a highly anticipated decision announced this week, the US Food and Drug Administration (FDA) approved the use of Revlimid® in the frontline setting based upon the results of the FIRST trial (which I have discussed in the IMF’s presentation on news from the 2014 American Society of Hematology meeting here). Ongoing Revlimid/dexamethasone was clearly superior to a previous standard of care, Melphalan/Prednisone/Thalidomide (MPT), as well as shorter-duration use of Revlimid/Dexamethasone (Rd).
This approval consolidates what has been widespread off-label use of Revlimid in the frontline setting in the US for several years. Practitioners and patients in the US are very fortunate that the off-label mechanism has allowed flexible use of Revlimid, including its use in the popular Velcade®/Revlimid/dexamethasone combination for induction therapy.
The FDA has also added much more detailed guidance than in the past, recommending stem-cell harvesting after the first four cycles of therapy, if possible, and much closer blood-count monitoring. There is also a particular caution about the potential risk of second primary malignancies (SPMs) in the post-transplant Revlimid maintenance setting. With these caveats it is important to note that ongoing use of Revlimid (so-called continuous therapy) is supported by this decision.
The likely approval of frontline Revlimid in Europe in the coming weeks is much more significant for European patients and physicians. Right now, frontline use is not possible. The pending approval will allow use specifically of Revlimid plus low-dose (weekly) dexamethasone exactly as used in the FIRST trial. This is a key point—the triple combination of VRd will not be immediately approved. Use is restricted to the FIRST trial protocol schedule only. This restriction is becoming an increasingly troubling problem because of the difficulty of completing multiple trials to encompass all the potential treatment combinations. Regulators use the lack of data to restrict the expense of broader use. This is an artificial constraint in that the efficacy and safety of many other combinations is widely known and well documented in the medical literature.
Implications of drug approvals in 2015 and beyond
What is frequently not so clear is the exact comparative efficacy and safety of different combination regimens. For example, how does VRD (Velcade/Rev/DEX ) compare to VCD (the CyBorD regimen) as a primary induction treatment?  Without a direct head-to-head comparison, one can say that the percentage and depth of responses and overall outcomes are rather similar. Both three-drug regimens are also safe, well tolerated, and more active than the two-drug combinations of Rev/dex (just approved) or Velcade/dex, also previously approved. Regulators, however, can point to the substantial cost savings of using VCD versus VRD, as well as the benefit of saving Revlimid for use in an approved relapse setting after VCD.  How best to combine and sequence drugs is a legitimate question without an immediate, clear answer, for sure!
In the US,  selecting among available therapy options falls into the realm of the treating physician working within NCCN guidelines and currently allowed off-label use, neither of which requires validation based on clinical trials of direct comparators. In Europe and elsewhere around the globe, the American scenario  cannot occur. Regulators require trial comparisons.
Thinking about the number (and potential cost) of trials needed to resolve all these questions is mind-numbing! In the interim, cost and regulatory control become the final arbiters limiting new drug use to the exact trial schedule(s) – IF the cost can be justified using trial endpoints and quality-of-life indicators.
Layered on top of comparative drug efficacy are safety concerns in particular circumstances. In the FIRST trial, ongoing Revlimid use as a frontline approach is both safe and very efficacious. But does this mean that similar ongoing use of Revlimid as post-transplant maintenance can be viewed equally? Lingering concerns remain about how best to use Revlimid as post-transplant maintenance. Is Revlimid maintenance recommended for many patients, but not all? Should maintenance be indefinite or for a defined period to maximize benefit? Revlimid used along with oral melphalan or as consolidation and maintenance immediately after high-dose intravenous melphalan, as in the IFM trial, may carry an extra risk of SPMs, including otherwise unexpected lymphoid malignancies such as ALL. It is thus difficult to give blanket approval for the use of any drug in all circumstances—no matter how efficacious and safe overall. 
Should treatment decisions fall within the realm of the primary physician, as they do here in the US? Or should options be left to the discretion of regulators, as is the case elsewhere in the world?
There is much to celebrate as Revlimid is fully available in the frontline setting, but many issues that will limit ideal global access and use remain to be resolved.
Dr. Durie sincerely appreciates and reads all comments left here. However, he cannot answer specific medical questions and encourages readers to contact the trained IMF InfoLine staff instead. Specific medical questions posted here will be forwarded to the IMF InfoLine. Questions sent to the InfoLine are answered with input from Dr. Durie and/or other scientific advisors and IMWG members as appropriate, but will not be posted here. To contact the IMF InfoLine, call 800-452-CURE, toll-free in the US and Canada, or send an email to infoline@myeloma.org. InfoLine hours are 9 am to 4 pm PT. Thank you.
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Obamacare will add to Dems' 2016 problems | WashingtonExaminer.com

Obamacare will add to Dems' 2016 problems | WashingtonExaminer.com



Cry me a river...



Obamacare will add to Dems' 2016 problems

BY  |  
Next month will mark five years since the Affordable Care Act became law. Obamacare was supposed to be popular by now, but it's not. And as far as President Obama and the Democrats who passed it are concerned, the law's current approval rating might be as good as it gets. That could be a serious problem for the party in 2016.
The most recent Kaiser Family Foundation poll on Obamacare, released last week, shows that 40 percent of Americans have a favorable opinion of the law, while 46 percent have an unfavorable opinion and the rest don't know or won't say. There have been some slight ups and downs over the years, but public opinion seems pretty set: A plurality of Americans has disapproved of Obamacare virtually since the day it was passed.
The basic problem is that Barack Obama promised his healthcare plan would benefit everybody. It doesn't. Under Obamacare, the government subsidizes the health coverage of some Americans while making it more expensive for others. People who have faced higher premiums, higher deductibles, and narrower choices of doctors know they're getting a bad deal.

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Obamacare was designed to win the loyalty of a large number of Americans by offering subsidies not just to the lowest-income bracket but also to those with an income of over $90,000 a year for a family of four. But a lot of middle-class people aren't feeling much benefit.
So it is no surprise that the only group of Americans who like Obamacare in the latest Kaiser poll are those who make less than $40,000 a year — and even they aren't all that enthusiastic about it. Forty-two percent of Americans in that income range have a favorable opinion of Obamacare, while 38 percent have an unfavorable opinion and 19 percent don't know.
There is pretty intense disapproval in the next bracket up, those Americans making between $40,000 and $90,000 a year — a group that supposedly would benefit from Obamacare. A solid 57 percent have an unfavorable opinion of the law, while 33 percent have a favorable opinion and ten percent don't know.
People with incomes above $90,000 have an unfavorable opinion of Obamacare that's pretty much the same as the public's overall.
Another way of looking at how few people have benefited from Obamacare is this question from Kaiser: "So far, would you say the healthcare law has directly helped you and your family, directly hurt you and your family, or has it not had a direct impact?" Fifty-seven percent of those surveyed say Obamacare has not had a direct impact on them. But of those who have been affected, 16 percent say they have been helped, while 25 percent say they have been hurt. How can a law like that be broadly popular?
In recent months Democratic strategists have become very nervous about their prospects with white working class and middle class voters who have been abandoning the party in the Obama years. As the liberal analyst John B. Judis, writing in a new article, "The Emerging Republican Advantage," in National Journal explains, those groups have long distrusted government's ability and inclination to do much for them. For example, Judis notes that studies of middle class voters have "found that those with college but not postgrad degrees exhibited more marked opposition than any other educational grouping to government spending, and to policies that promised to redistribute income from the rich to the poor."
That's Obamacare. "In 2010 — angry about Obama's stimulus program and believing that the Affordable Care Act had cost too much without truly benefiting them — [middle class voters] once again began returning to the Republican camp," Judis writes.
Democrats have already paid a pretty high political price, losing control of the House in 2010 and the Senate last year. But the price-paying is probably not over.
Of course President Obama will continue to defend Obamacare until he leaves office and beyond. Hillary Clinton, should she be the Democratic nominee in 2016, will perhaps be more flexible in implementing the law, or more open to tweaking it, but on the most fundamental level will be stuck defending it.
Meanwhile, middle class voters will probably have the same opinion of Obamacare when they go to the polls on Nov. 8, 2016, as they do today. Of course other factors will play a role in those voters' decisions, but Obamacare will be part of it.
In the new poll, Kaiser asked whether voters are "tired of hearing about the debate over the healthcare law and think the country should focus more on other issues" or whether they "think it is important for the country to continue the debate over the healthcare law." Fifty percent of those polls want the debate to continue, while 45 percent are tired of it.
That means the debate will go on, and not in the Democrats' favor.
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BE THE MATCH #SWABFACE

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Multiple Myeloma: International Myeloma Foundation: Guide to Myeloma Acronyms and Abbreviations

Multiple Myeloma: International Myeloma Foundation : • about myeloma : newly diagnosed? : Guide to Myeloma Acronyms and Abbreviations



BMT, IgD, and MRI - it's all here!



jc
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Our American Revival





A secret squirrel video - I like it and I like Scott Walker.
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Nanotechnology May Provide More Effective Cancer Treatment

Nanotechnology May Provide More Effective Cancer Treatment



Go little dudes!



jc



SINGAPORE: A study led by National University of Singapore researchers on cancer treatment has yielded promising results that could mean a more effective way of treating the disease via nanotechnology, with fewer side effects.
Still in its early stages, with clinical trials on people two years away, the study’s findings show that when the widely-used but toxic chemotherapy drug Epirubicin is attached to nanodiamonds, chemo-resistant cancer cells are less able to pump the drug out of the cell, allowing a reservoir of the medication to form and kill more cells. This results in a smaller chance of tumours forming again following standard chemotherapy.
In addition, the new drug-delivery system is also designed to be PH-resistant, such that the drug is released significantly only in an acidic environment, such as in cancer cells and not while it is flowing through the bloodstream.
This minimises side effects, making it a potential alternative for patients who cannot tolerate standard chemotherapy drugs.
The study is led by National University of Singapore Assistant Professor Edward Chow, who is junior principal investigator at the Cancer Science Institute Singapore. It is conducted in collaboration with Professor Dean Ho of the University of California Los Angeles and Professor Li Jianzhong at Peking University.
The findings were first published online in ACS Nano, the official journal of The American Chemical Society, in December last year.
Asst Prof Chow explained: “This method has proven to be safer than chemotherapy because, in nanodiamond-Epirubicin form, more (of the drug) gets to the cancer cell and, once it enters the cell, it does not immediately kill the cell but, rather, provides a reservoir of drug that eventually kills the cancer cell.”
He added: “Lab tests show that the use of nanodiamond-Epirubicin has no side effects so far ... it is removed through defaecation.”
Although researchers initially looked at tackling liver cancer, the drug-delivery system can be used to treat a range of difficult cancers, particularly those driven by chemo-resistant cancer stem cells.
Nanodiamonds are about five nanometres in diameter — one nanometer is one billionth of a metre — and are shaped like footballs. This prevents them from combining into larger structures that may be harmful and toxic, which is a major concern of introducing nanomaterials into the body.
Asst Prof Chow said: “Every test that we’ve run shows that it’s very safe ... But a lot of work still has to be done and we’re still in the stage of demonstrating a certain level of safety to test it on humans … We hope to roll it out in clinical trials in two years.”
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Nice...

http://www.theblaze.com/stories/2015/01/05/blogger-with-terminal-cancer-who-begged-brittany-maynard-not-to-end-her-life-pens-incredible-blog-post-about-her-journey-i-pray-i-would-live-well-and-fade-well/

Christian Blogger Pens Incredible Message as She Enters Hospice — Just Months After Begging Brittany Maynard Not to Take Her Own Life: ‘I Pray I Would Live Well and Fade Well’

A Christian author and blogger with terminal cancer who desperately — but unsuccessfully — tried to convince cancer-patient Brittany Maynard to reconsider her November decision to end her life through doctor-assisted suicide has been admitted to hospice care.
Kara Tippetts, 38, of Colorado Springs, Colorado, published a blog post December 29, detailing her continued health struggles, sharing insights about the valuable lessons her health crisis has taught her and explaining that she finds immense comfort in Jesus even as she faces death.
“I’m learning what it is to die by degrees. Parts of my body failing, parts of my abilities vanishing, and what then?” Tippetts, a mother of four, wrote. “Yesterday, I kept thinking — I drove for the last time and didn’t realize it was the last time. I don’t remember the last time in the drivers seat or the music we played.  I just realized I will likely never again drive.”
Kara Tippetts has entered hospice (Image via Kara Tippetts/Facebook)
Kara Tippetts has entered hospice (Image via Kara Tippetts/Facebook)
She went on to explain that she heard her husband, Jason, “make the impossible phone call” to hospice on December 29, telling staffers there that his wife was dying. A spokesperson for her publisher later confirmed that Tippetts has entered hospice care, according to Deseret News.
“So, there it is. My little body has grown tired of battle and treatment is no longer helping,” shecontinued. “But what I see, what I know, what I have is Jesus. He has still given me breath, and with it I pray I would live well and fade well. By degrees doing both, living and dying, as I have moments left to live.”
Reflecting the sentiment she shared in her October letter to Maynard in which she begged the 29-year-old woman not to take her own life before cancer claimed it, Tippetts wrote in her latest blog post that, though she is dying, she still has the chance to love, to laugh and to cry.
“I do not feel like I have the courage for this journey, but I have Jesus — and He will provide it. He has given me so much to be grateful for, and that gratitude, that wondering over His love will cover us all,” she wrote. “And it will carry us — carry us in ways we cannot comprehend. It will be a new living and trusting for many in my community. Loving with a great big open hand to my story being the good story — even when it feels so broken.”
Tippetts concluded her blog post by imploring readers to trust in Jesus, not to pity her and her family and to pray for her and walk with her to her “last breath.”
“Will you trust Jesus that He knows the moments, He holds the moments, and He will take me away to the land of no more tears at exactly the right moment — and He will also shepherd and love my people after that last breath,” she wrote.
Read her entire blog post here.
Kara and Jason Tippetts (Image via Kara Tippetts/Facebook)
Kara and Jason Tippetts (Image via Kara Tippetts/Facebook)
Back in October, Tippets thanked Maynard for sharing her story in an open letter and said that she understands what it’s like to know that one’s life is coming to a close — but added that she believes Maynard would be making a terrible mistake by ending her life through doctor-assisted suicide.
“Suffering is not the absence of goodness, it is not the absence of beauty, but perhaps it can be the place where true beauty can be known,” Tippetts wrote, claiming that people aren’t meant to choose when they take their last breath. “In your choosing your own death, you are robbing those that love you with the such tenderness, the opportunity of meeting you in your last moments and extending you love in your last breaths.”
Maynard went through with her plan to end her life on November 1, ignoring Tippetts’ pleading.
Regardless, Tippetts is clearly cherishing her final moments and inspiring others in the process.
(H/T: Deseret News)
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