HEALTH & MEDICAL : View Posts

Welcome to the White House.

Six months ago today, a big part of the Affordable Care Act kicked in as healthcare.gov and state insurance marketplaces went live. And millions of Americans finally had the same chance to buy quality, affordable health care — and the peace of mind that comes with it — as everybody else.

Last night, the first open-enrollment period under this law came to an end. And despite several lost weeks out of the gate because of problems with the website, 7.1 million Americans have now signed up for private insurance plans through these marketplaces — 7.1. (Applause.)

The truth is, even more folks want to sign up. So anybody who was stuck in line because of the huge surge in demand over the past few days can still go back and finish your enrollment — 7.1 million, that’s on top of the more than 3 million young adults who have gained insurance under this law by staying on their family’s plan. That’s on top of the millions more who have gained access through Medicaid expansion and the Children’s Health Insurance Program. Making affordable coverage available to all Americans, including those with preexisting conditions, is now an important goal of this law. (Applause.)

And in these first six months, we’ve taken a big step forward. And just as importantly, this law is bringing greater security to Americans who already have coverage. Because of the Affordable Care Act, 100 million Americans have gained free preventive care, like mammograms and contraceptive care, under their existing plans. (Applause.) Because of this law, nearly 8 million seniors have saved almost $10 billion on their medicine because we’ve closed a gaping hole in Medicare’s prescription drug plan. We’re closing the donut hole. (Applause.) And because of this law, a whole lot of families won’t be driven into bankruptcy by a serious illness, because the Affordable Care Act prevents your insurer from placing dollar limits on the coverage they provide.

These are all benefits that have been taking place for a whole lot of families out there, many who don’t realize that they’ve received these benefits. But the bottom line is this: Under this law, the share of Americans with insurance is up and the growth of health care costs is down, and that’s good for our middle class and that’s good for our fiscal future. (Applause.)

Now, that doesn’t mean that all the problems in health care have been solved forever. Premiums are still rising for families who have insurance, whether you get it through your employer or you buy it on your own — that’s been true every year for decades. But, so far, those premiums have risen more slowly since the Affordable Care Act passed than at any time in the past 50 years. It’s also true that, despite this law, millions of Americans remain uncovered in part because governors in some states for political reasons have deliberately refused to expand coverage under this law. But we’re going to work on that. And we’ll work to get more Americans covered with each passing year. (Applause.)

And while it remains true that you’ll still have to change your coverage if you graduate from college or turn 26 years old or move or switch jobs, or have a child — just like you did before the Affordable Care Act was passed — you can now go to healthcare.gov and use it year-round to enroll when circumstances in your life change. So, no, the Affordable Care Act hasn’t completely fixed our long-broken health care system, but this law has made our health care system a lot better — a lot better. (Applause.)

All told, because of this law, millions of our fellow citizens know the economic security of health insurance who didn’t just a few years ago — and that’s something to be proud of. Regardless of your politics or your feelings about me, or your feelings about this law, that’s something that’s good for our economy, and it’s good for our country. And there’s no good reason to go back.

Let me give you a sense of what this change has meant for millions of our fellow Americans. I’ll just give you a few examples. Sean Casey, from Solana Beach, California, always made sure to cover his family on the private market. But preexisting medical conditions meant his annual tab was over $30,000. The Affordable Care Act changed that. See, if you have a preexisting condition, like being a cancer survivor, or if you suffer chronic pain from a tough job, or even if you’ve just been charged more for being a woman -– you can no longer be charged more than anybody else. So this year, the Casey family’s premiums will fall from over $30,000 to under $9,000. (Applause.)

And I know this because Sean took the time to write me a letter. “These savings,” he said, “will almost offset the cost of our daughter’s first year in college. I’m a big believer in this legislation, and it has removed a lot of complexity and, frankly, fear from my life. Please keep fighting for the ACA.” That’s what Sean had to say.

Jeanne Goe is a bartender from Enola, Pennsylvania. Now, I think most folks are aware being a bartender, that’s a job that usually doesn’t offer health care. For years, Jeanne went uninsured or underinsured, often getting some health care through her local Planned Parenthood. In November, she bought a plan on the marketplace. In January, an illness sent her to the hospital. And because her new plan covered a CAT scan she wouldn’t have otherwise been able to afford, her doctor discovered that she also had ovarian cancer -– and gave her a chance to beat it. So she wrote me a letter, too. She said it’s going to be “a long tough road to kill this cancer, but I can walk that road knowing insurance isn’t an issue. I won’t be refused care. I hope to send a follow-up letter in a few months saying I am free and clear of this disease, but until then, I know I will be fighting just as you have been fighting for my life as a working American citizen.”

And after her first wellness visit under her new insurance plan, Marla Morine, from Fort Collins, Colorado, shared with me what it meant to her. “After using my new insurance for the first time, you probably heard my sigh of relief from the White House.” (Laughter.) “I felt like a human being again. I felt that I had value.”

That’s what the Affordable Care Act, or Obamacare, is all about -– making sure that all of us, and all our fellow citizens, can count on the security of health care when we get sick; that the work and dignity of every person is acknowledged and affirmed. The newly insured like Marla deserve that dignity. Working Americans like Jeanne deserve that economic security. Women, the sick, survivors — they deserve fair treatment in our health care system, all of which makes the constant politics around this law so troubling.

Like every major piece of legislation — from Social Security to Medicare — the law is not perfect. We’ve had to make adjustments along the way, and the implementation — especially with the website — has had its share of problems. We know something about that. And, yes, at times this reform has been contentious and confusing, and obviously it’s had its share of critics. That’s part of what change looks like in a democracy. Change is hard. Fixing what’s broken is hard. Overcoming skepticism and fear of something new is hard. A lot of times folks would prefer the devil they know to the devil they don’t.

But this law is doing what it’s supposed to do. It’s working. It’s helping people from coast to coast, all of which makes the lengths to which critics have gone to scare people or undermine the law, or try to repeal the law without offering any plausible alternative so hard to understand. I’ve got to admit, I don’t get it. Why are folks working so hard for people not to have health insurance? Why are they so mad about the idea of folks having health insurance? Many of the tall tales that have been told about this law have been debunked. There are still no death panels. (Laughter.) Armageddon has not arrived. Instead, this law is helping millions of Americans, and in the coming years it will help millions more.

I’ve said before, I will always work with anyone who is willing to make this law work even better. But the debate over repealing this law is over. The Affordable Care Act is here to stay. (Applause.)

And those who have based their entire political agenda on repealing it have to explain to the country why Jeanne should go back to being uninsured. They should explain why Sean and his family should go back to paying thousands and thousands of dollars more. They’ve got to explain why Marla doesn’t deserve to feel like she’s got value. They have to explain why we should go back to the days when seniors paid more for their prescriptions or women had to pay more than men for coverage, back to the days when Americans with preexisting conditions were out of luck — they could routinely be denied the economic security of health insurance — because that’s exactly what would happen if we repeal this law. Millions of people who now have health insurance would not have it. Seniors who have gotten discounts on their prescription drugs would have to pay more. Young people who were on their parents’ plan would suddenly not have health insurance.

In the end, history is not kind to those who would deny Americans their basic economic security. Nobody remembers well those who stand in the way of America’s progress or our people. And that’s what the Affordable Care Act represents. As messy as it’s been sometimes, as contentious as it’s been sometimes, it is progress. It is making sure that we are not the only advanced country on Earth that doesn’t make sure everybody has basic health care. (Applause.) And that’s thanks in part to leaders like Nancy Pelosi and Dick Durbin, and all the members of Congress who are here today. We could not have done it without them, and they should be proud of what they’ve done. They should be proud of what they’ve done. (Applause.)

And it’s also thanks to the often-unheralded work of countless Americans who fought tirelessly to pass this law, and who organized like crazy these past few months to help their fellow citizens just get the information they needed to get covered. That’s why we’re here today. That’s why 7.1 million folks have health insurance — because people got the word out.

And we didn’t make a hard sell. We didn’t have billions of dollars of commercials like some critics did. But what we said was, look for yourself, see if it’s good for your family. And a whole lot of people decided it was. So I want to thank everybody who worked so hard to make sure that we arrived at this point today.

I want to make sure everybody understands: In the months, years ahead, I guarantee you there will be additional challenges to implementing this law. There will be days when the website stumbles — I guarantee it. So, press, just — I want you to anticipate — (laughter) — there will be some moment when the website is down — and I know it will be on all of your front pages. It’s going to happen. It won’t be news. There will be parts of the law that will still need to be improved. And if we can stop refighting old political battles that keep us gridlocked, then we could actually make the law work even better for everybody. And we’re excited about the prospect of doing that. We are game to do it. (Applause.)

But today should remind us that the goal we set for ourselves — that no American should go without the health care that they need; that no family should be bankrupt because somebody in that family gets sick, because no parent should have to be worried about whether they can afford treatment because they’re worried that they don’t want to have to burden their children; the idea that everybody in this country can get decent health care — that goal is achievable.

We are on our way. And if all of us have the courage and the wisdom to keep working not against one another, not to scare each other, but for one another –- then we won’t just make progress on health care. We’ll make progress on all the other work that remains to create new opportunity for everybody who works for it, and to make sure that this country that we love lives up to its highest ideals. That’s what today is about. That’s what all the days that come as long as I’m President are going to be about. That’s what we’re going to be working towards.

Thank you very much, everybody. God bless you. God bless America. (Applause.) Thank you.

This news is courtesy of www.whitehouse.gov

CONAKRY, Guinea/DAKAR, Senegal, – Amid an Ebola Haemorrhagic Fever (Ebola HF) outbreak, four cases in Conakry have been confirmed yesterday by the Guinean Government. In Guinea’s capital and across the rest of the country, UNICEF is ramping up its activities in support of Guinean authorities to prevent the often fatal disease from claiming even more lives.

Out of 103 suspected cases in Guinea so far, 11 children have reportedly been infected, three of whom have died. Working with the Government and in collaboration with World Health Organization (WHO) and other partners, UNICEF is disseminating information and soon supplies such as chlorine, gloves and soap across Conakry to enable families to avoid contracting the disease and protect themselves.

“In a densely populated city such as Conakry, extremely quick actions must be taken to reduce risks of the Ebola to families,” said UNICEF Representative in Guinea, Dr. Mohamed Ag Ayoya.

“There is no specific treatment for Ebola, which is spread by contact with the bodily fluids of infected people or animals. Therefore prevention is one of the best ways to contain the virus. Access to timely and accurate life-saving information is hence absolutely crucial. This is where UNICEF is focusing its efforts moving forward,” he added.

When the official declaration confirming Ebola HF cases in the southern part of Guinea was made by the Government last week, UNICEF, in collaboration with the Guinean Ministry of Health, sent five metric tons of equipment including calcium hypochlorite, chlorine, gloves, raincoats, plastic mats, blankets, tarpaulins, and syringes to health workers and at-risk communities.

Additionally, when the first signs of the disease appeared, UNICEF distributed 5,500 bottles of liquid chlorine, 50,000 pieces of soap and chlorine powder to medical workers and communities in the affected areas. Rehydration fluids and oral rehydration salts have also been supplied to help with some of the symptoms of Ebola HF, although there is no known cure or vaccine for the disease.

In addition to Ebola HF, cholera, measles, and meningitis epidemics have been putting additional strain on the health system of Guinea. Already supporting the authorities to address these, UNICEF urgently calls on its partners in the international community to make funds available to provide life-saving supplies and logistical support crucially needed now to stop Ebola HF, and these other three epidemics, in Guinea.

About UNICEF
UNICEF promotes the rights and wellbeing of every child, in everything we do. Together with our partners, we work in 190 countries and territories to translate that commitment into practical action, focusing special effort on reaching the most vulnerable and excluded children, to the benefit of all children, everywhere.

This news is courtesy of www.unicef.org

DURBAN, South Africa: On World Tuberculosis Day, IBM (NYSE: IBM) and the KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH) have announced plans to research new treatment approaches to fight tuberculosis (TB) in South Africa. IBM’s Big Data analytics technologies will be put to work on bacterial genetics and drug susceptibility tests to better understand the genomic mechanisms that cause resistance to antibiotics. The ultimate goal is to find new treatments and diagnostic approaches to fight TB.

The scale of the TB problem in Southern Africa is largely a result of HIV infection, lack of integration between HIV and TB treatments and historic challenges in healthcare delivery. Currently South Africa has the world’s third highest burden of TB, with the province of KwaZulu-Natal being the most affected by both drug-susceptible and drug-resistant tuberculosis. Over 100,000 cases of TB are reported every year from this province alone and over 60% are also infected with HIV.

The KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH), which is based at the University of Kwazulu-Natal’s Nelson R. Mandela School of Medicine, is an independent research institute established in 2009 to conduct basic science research into TB and HIV, and translate the scientific findings into new tools to control these deadly diseases. The Institute’s work has boosted the TB and HIV research capabilities of scientists in South Africa. The work with IBM involving its Big Data and deep data analytics technology– will enable K-RITH to understand bacteria genomes from drug-resistant strains of M. tuberculosis– the bacteria that causes TB.

According to Associate Investigator at K-RITH, Dr. Alex Pym, the agreement with IBM is “a significant collaboration” that gives South African scientists access to IBM’s computational expertise in bioinformatics and machine learning. “This will allow us to analyze data in new and imaginative ways and it holds the promise of giving us better insight into the mechanisms of drug resistance, leading to better diagnostic tests,” said Dr. Pym.

The science has benefitted from IBM’s global network of research labs and world leading expertise in computational biology. Researchers from the Haifa, Melbourne, and Africa labs are working together to analyze over 200 TB genomes, each with 4.4 million base pairs, to better understand the complex clinical picture of African tuberculosis infections.

Michal Rosen-Zvi, senior manager of analytics at IBM’s Research Lab in Haifa, Israel said, “TB drug resistance is a far more complex genome by comparison to something like the HIV virus. The bioinformatics or computational tools needed to extract information on the disease are very new, yet cracking the code of this genomic information will help define which treatment combinations work best for different patients and how they work on different strains of TB.”

“For HIV, technology can look at the difference in viral load before and after treatment, and use that to understand whether the treatment was a success. But in TB, there is no single measure that defines the status of the disease. We will need to develop multiple ways to label the treatment outcomes and new methods to indicate whether a treatment was effective,” said Rosen-Zvi.

IBM’s work on other solutions, including the well known EuResist programme, developed to help physicians select the optimal treatments for HIV patients, have paved the way for the use of bioinformatics in disease treatment. EuResist combines large databases and new prediction engines to provide predictive modeling of how HIV would react in a particular person treated with specific combination of drugs. This system, available since 2008, is the world’s largest database containing clinical and genomic information on HIV.

Dr. Pym said, “What we believe is that through the partnership between K-RITH and IBM we can combine and enable TB analytics from IBM to map which antibiotic treatments are successful for which TB strains. And then, by finding the associations between the genetic markers and the correct antibiotic treatment, we can improve treatment protocols. This can make a significant difference to many lives across the globe, let alone Africa.”
Sequencing of the KRITH strains was performed by the Broad Institute, a world leader in genomics, with funding from the National Institute of Allergy and Infectious Diseases of the U.S. National Institutes of Health. Analysis of sequencing data from the K-RITH strains and other organizations in South Africa was given first priority due to the magnitude of TB drug resistance in that country.

The research work at IBM and K-RITH can interact with global initiatives like TBresist, and with leadership and collaboration from organizations such as the CDC Foundation. The intent is to add data from different parts of the world, from different strains of TB, to culture a global database that researchers and physicians can use to determine the best treatment to combat a particular strain of tuberculosis. The impact of this would be more effective treatments for patients and a reduction of the cost of treating tuberculosis in Africa and potentially around the world.
In similar news, last week the New York Genome Center and IBM announced that they will test a unique IBM Watson prototype designed specifically for genomic research as a tool to help oncologists deliver more personalized care to cancer patients.

IBM is making a long term, strategic investment in the future of Africa and the company’s new Africa research lab is at the heart of its operations. IBM has been present in Africa for over 70 years and today has a presence in over 20 African countries, including Tanzania, Senegal, South Africa, Morocco, Egypt, Tunisia, Algeria, Ghana, Nigeria, Kenya, and Mauritius

This news is courtesy of www.ibm.com

PRINCETON, N.J. & NEW YORK–Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

“Today’s FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation,” said Brian Daniels, M.D., senior vice president, global development and medical affairs, Bristol-Myers Squibb. “This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians.”

“As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians,” said Steven J. Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals Business, Pfizer Inc. “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”

The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. Please see complete Boxed Warnings and additional Important Safety Information in this press release.

DVT, a blood clot that forms in a large vein, usually in the lower leg, thigh, or pelvis, can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.

Based on recent data, each year in the U.S. an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE.Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.

“DVT, which may lead to PE, is a serious medical condition,” said Richard J. Friedman, M.D., FRCSC, Professor of Orthopaedic Surgery, Medical University of South Carolina. “The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.”

This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis.

In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.

INDICATION

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

IMPORTANT SAFETY INFORMATION

WARNINGS: (A) DISCONTINUING ELIQUIS IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA

(A) Discontinuing ELIQUIS places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. If anticoagulation with ELIQUIS must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered.

(B) When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins, heparinoids, or Factor Xa inhibitors for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.

The risk of these events may be increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet aggregation inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Monitor patients for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

CONTRAINDICATIONS

Active pathological bleeding
Severe hypersensitivity reaction to ELIQUIS (apixaban) (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS

Increased Risk of Stroke with Discontinuation of ELIQUIS in Patients with Nonvalvular Atrial Fibrillation: Discontinuing ELIQUIS in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If ELIQUIS must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.
Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding including aspirin and other anti-platelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. Patients should be made aware of signs or symptoms of blood loss and instructed to immediately report to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available. Hemodialysis does not appear to have a substantial impact on apixaban exposure. Protamine sulfate and vitamin K would not be expected to affect the anticoagulant activity of apixaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban. There is neither scientific rationale for reversal nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban. Use of procoagulant reversal agents such as prothrombin complex concentrate, activated prothrombin complex concentrate, or recombinant factor VIIa may be considered but has not been evaluated in clinical studies. Activated charcoal reduces absorption of apixaban thereby lowering apixaban plasma concentrations.
Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
ADVERSE REACTIONS

The most common and most serious adverse reactions reported with ELIQUIS (apixaban) were related to bleeding.

TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS

ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

DRUG INTERACTIONS

Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of CYP3A4 and P-gp increase exposure to apixaban and increase the risk of bleeding. For patients receiving 5 mg twice daily, the dose of ELIQUIS should be decreased when it is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). In patients already taking ELIQUIS at a dose of 2.5 mg twice daily, avoid coadministration with strong dual inhibitors of CYP3A4 and P-gp.
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban and increase the risk of stroke.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B

There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for prophylaxis of DVT, which may lead to PE, in patients who have undergone hip or knee replacement surgery.

About Deep Vein Thrombosis and Pulmonary Embolism

DVT is a blood clot in a vein, usually in the lower leg, thigh, or pelvis, which partially or totally blocks the flow of blood. PE is a blood clot blocking one or more vessels in the lungs. DVT causes multiple symptoms including pain, swelling, and redness, and more importantly, can progress to PE, which carries the risk of sudden death.

Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available at www.bms.com.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize Eliquis, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter athttp://twitter.com/bmsnews.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years.

This news is courtesy of www.pfizer.com

Enrollment in the Health Insurance Marketplace continued to rise in February to a five-month total of 4.2 million.

As in January, the percent of young adults who selected a Marketplace plan was 3 percentage points higher than it was from October through December (27 percent versus 24 percent). Based on enrollment patterns in other health care programs, it is expected that more people will sign up as we get closer to the March 31st deadline.

“Over 4.2 million Americans have signed up for affordable plans through the Marketplace,” said HHS Secretary Kathleen Sebelius. “Now, during this final month of open enrollment our message to the American people is this: you still have time to get covered, but you’ll want to sign up today – the deadline is March 31st.”

Key findings from today’s report include:

More than 4.2 million (4,242,300) people selected Marketplace plans from Oct. 1, 2013, through Mar. 1, 2014, including 1.6 million in the State Based Marketplaces and 2.6 million in the Federally-facilitated Marketplace. About 943,000 people enrolled in the Health Insurance Marketplace plans in the February reporting period, which concluded March 1, 2014.
Of the more than 4.2 million:
55 percent are female and 45 percent are male;
31 percent are age 34 and under;
25 percent are between the ages of 18 and 34;
63 percent selected a Silver plan (up one percentage point over the prior reporting period), while 18 percent selected a Bronze plan (down one point); and
83 percent selected a plan and are eligible to receive Financial Assistance (up one point).
Today’s report details state-by-state information where available. In some states, only partial datasets were available.

The report features cumulative data for the five-month reporting period because some people apply, shop, and select a plan across monthly reporting periods. Enrollment is measured as those who selected a plan.

This news is courtesy of www.hhs.gov

WOONSOCKET, R.I., New research conducted by CVS Caremark (NYSE: CVS) and Brigham and Women’s Hospital published online today in Health Affairs, identifies five key features of popular Value-Based Insurance Design (VBID) plans that are associated with the greatest impact on medication adherence. The study, which will also appear in the journal’s March issue, was funded by a grant from the Robert Wood Johnson Foundation’s Changes in Health Care Financing and Organization (HCFO) Initiative.

A variety of pharmacy benefit structures- including copayments, co-insurance and deductibles- help payors contain health care spending by encouraging patients to actively consider and bear the cost of prescription medications. VBID plans take a different approach by reducing the cost to the patient for medications that offer higher clinical benefit with the intent that increased medication use would improve health outcomes and reduce overall health care spending. For example, patients in a VBID plan who have a chronic disease such as high blood pressure may have their out-of-pocket costs (e.g., copay) significantly reduced or eliminated for essential medications to treat their condition.

“For the first time, this research offers high-quality, empirical data on the VBID plan features that appear most effective for stimulating greater medication adherence,” said Niteesh Choudhry, MD, PhD, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and associate professor, Harvard Medical School and the lead author of the study. “The results show that several specific features can improve adherence from between two to five percentage points and this information can help influence how future copayment reduction plans are structured for optimal benefit.”

The researchers evaluated 76 VBID plans provided by CVS Caremark to 33 unique plan sponsors and involving more than 274,000 patients. Based on the analysis, five key features were found to have a greater impact on adherence. These included:

More generous VBID plans (e.g., those plans that had no cost-sharing for generic drugs and low monthly copayments of
Plans that targeted high-risk patients,
Plans that had concurrent wellness programs,
Plans that did not have concurrent disease management programs, and
Plans that made the benefit available only by mail order, offering 90 day prescriptions.
“VBID plans have been popular with employers and health plans as a way to use financial incentives and other methods to encourage medication adherence, improve health outcomes and reduce overall health care costs,” said William H. Shrank, MD, MSHS, senior vice president and Chief Scientific Officer of CVS Caremark, and a study co-author. “In order to optimize the benefits of VBID plans, these findings encourage more generous coverage for generics, greater use of 90-day prescriptions, more careful intervention targeting and expansion of wellness programs, all of which are active initiatives at CVS Caremark.”

CVS Caremark is focused on developing programs to help improve medication adherence. The study described here helps improve the industry’s overall understanding of medication adherence and enables CVS Caremark to develop more targeted, measureable programs to address the underlying behaviors that contribute to nonadherence. CVS Caremark plans to use these research results along with other key information to identify, develop and pilot breakthrough interventions that will help improve medication adherence for the patients we support. The company is currently evaluating and piloting a number of interventions ranging from model development and prediction of adherence behaviors; to the use of medication reminder devices to help combat forgetfulness and improved labeling to address health literacy difficulties; to digital interventions that engage patients to encourage adherence.

CVS Caremark has been supporting a multi-year research collaboration with Brigham and Women’s Hospital to better understand patient behavior, particularly around medication adherence. Annual excess health care costs due to medication non-adherence in the U.S. have been estimated to be as much as $290 billion.

About CVS Caremark
CVS Caremarkis dedicated to helping people on their path to better health as the largest integrated pharmacy company inthe United States. Through the company’s more than 7,600 CVS/pharmacy stores; its leading pharmacy benefit manager serving more than 60 million plan members; and its retail health clinic system, the largest in the nation with more than 800 MinuteClinic locations, it is a market leader in mail order, retail and specialty pharmacy, retail clinics, and Medicare Part D Prescription Drug Plans. As a pharmacy innovation company with an unmatched breadth of capabilities,CVS Caremarkcontinually strives to improve health and lower costs by developing new approaches such as its unique Pharmacy Advisor program that helps people with chronic diseases such as diabetes obtain and stay on their medications.

This news is courtesy of www.cvscaremark.com

The U.S. Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.

Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin.

Patients with both types of generalized lipodystrophy often develop severe insulin resistance at a young age and may have diabetes mellitus that is difficult to control or very high levels of triglycerides in the blood (hypertriglyceridemia) that can lead to inflammation of the pancreas.

“Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalized lipodystrophy and provides a needed treatment option for patients with this orphan disease,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Myalept, an analog of leptin made through recombinant DNA technology, were evaluated in an open-label, single-arm study that included 48 patients with congenital or acquired generalized lipodystrophy who also had diabetes mellitus, hypertriglyceridemia, and/or elevated levels of fasting insulin. The trial showed reductions in HbA1c (a measure of blood sugar control), fasting glucose, and triglycerides.

Anti-drug antibodies with neutralizing activity to leptin and/or Myalept may develop, which could result in severe infections or loss of treatment effectiveness. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with Myalept, so healthcare professionals should carefully consider the benefits and risks of treatment with Myalept in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. Myalept is contraindicated in patients with general obesity. Myalept is not approved for use in patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.

Because of the risks associated with the development of neutralizing antibodies and lymphoma, Myalept is available only through the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Under this REMS program, prescribers must be certified with the program by enrolling in and completing training. Pharmacies must be certified with the program and only dispense Myalept after receipt of the Myalept REMS Prescription Authorization Form for each new prescription.

Myalept is also approved with a Medication Guide and instructions for use that provides patients with important information about the medication. The guide will be distributed each time a patient fills a prescription.

The FDA is requiring seven studies (post-marketing requirements) for Myalept, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies are being requested as post-marketing commitments.

In clinical trials, the most common side effects observed in patients treated with Myalept were low blood sugar (hypoglycemia), headache, decreased weight, and abdominal pain.

Myalept is marketed by San Diego-based Amylin Pharmaceuticals, L.L.C.

For more information:

FDA: Approved Drugs
FDA: Drug Innovation
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This Press Release is courtesy of www.fda.gov

ORLANDO, Fla. — The ability for clinicians to seamlessly collaborate and have mobile, instant and fully functional access to everything from electronic medical records (EMRs) to EKGs is critical in today’s changing world of healthcare. Monday, at the HIMSS14 Annual Conference and Exhibition, Microsoft Corp. showcased how a wide range of health organizations, including prominent partners like Epic and AirStrip, have improved care team collaboration and productivity, expanded mobility, and enhanced patient care through new Windows 8.1 devices and apps and Windows Embedded solutions. With the Windows 8.1 platform of clinical-grade devices, apps and services, including Microsoft Surface, mobile care teams can easily communicate with each other via a variety of methods, gain access to full-function EMRs from anywhere at any time, and use FDA-cleared clinician apps to deliver mobile-based care and guidance.

“The healthcare industry is in a major period of transformation. Finding mobile solutions that can improve clinician productivity, empower patients to improve their health, and address the need to complement existing EMR systems is critical,” said Michael Robinson, vice president, U.S. Health and Life Sciences, Microsoft. “The solutions and developments being announced today underscore how Microsoft technology can be used across various health settings to help clinicians practice patient-centered, team-based medicine and deliver higher-quality care to more people.”

Microsoft’s partners and customers unveiled an array of new enterprise solutions, apps and platforms to better integrate EMRs, improve productivity and engage patients in new ways by using a single mobile device or platform that runs all the programs and apps they need while on the move.

EMRs apps and platforms

Epic’s Hyperspace 2014 app is now compatible for mobile Windows 8 tablets and ultrabooks on Internet Explorer 10 for EpicCare 2014 IU1 (Interim Update). This new compatibility allows clinicians to run Hyperspace directly on a Windows 8 tablet so they can use the full-functionality version of the application to support physicians in inpatient and outpatient settings to manage clinical and revenue cycle workflows.

At HIMSS, Allscripts will be demonstrating its Allscripts Wand for TouchWorks EHR, powered by Windows 8.1, which is currently in use at Resurgens Orthopaedics in Atlanta. Allscripts Wand uses all of the navigation, voice and camera capabilities of the Windows 8.1 tablet to place orders, complete clinical documentation, take clinical photos and update all aspects of the patient’s chart. Because of the app’s ability to run simultaneously on a desktop and a mobile device, clinicians are able to experience the best of all worlds on Windows 8.1 mobile solutions.

UPMC and Caradigm announced the development of a mobile Windows 8.1 tablet-based platform using Surface Pro 2 devices that enables physicians to maintain patient and clinical workflow context while switching between different clinical apps at the point of care.

Patient engagement clinician productivity apps and solutions

AirStrip’s AirStrip ONE Cardiology app is a Windows Phone and Windows 8.1 mobile device cardiac care solution that recently became the first FDA-cleared clinician app for the Windows 8 platform. It allows doctors to evaluate EKGs quickly to determine if a patient suffered a heart attack and needs surgery. For the first time, the Windows 8.1 version of AirStrip ONE Cardiology makes an AirStrip app accessible on any form factor, including desktops, laptops, and wall-mounted or mobile workstations, not just mobile devices. Now, clinicians can access AirStrip ONE Cardiology for Windows from workstations in hospitals and outpatient clinics as well as from tablets and phones while outside the hospital.

Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental needs of children from infancy through young adulthood. The hospital has purchased more than 250 Surface Pro devices and has standardized its executive team on Surface. Microsoft Surface Pro enables Seattle Children’s Hospital to provide clinicians with a modern user interface while also allowing adherence to HIPAA and other strict security regulations in healthcare. Microsoft leveraged the Microsoft Application Acceleration Program (MAAP) and partnered with a business partner, VitalHub, on the development of a modern touch application. The VitalHub application, combined with Microsoft Surface Pro, allows Seattle Children’s staff to view and have basic levels of simple order entry through a touch-enabled interface — improving the experience of both physician and patient.

Aegis Living has equipped staff across its 30 senior living communities with Surface tablets to provide the highest level of resident care and the most productive medication administration to their residents. By using Surface devices, Aegis staff have eliminated paper-based medication records and manual prescription auditing, with an expected savings of more than 11,000 hours each year previously spent auditing prescription records. In addition, staff have easier access to residents’ medical records and prescriptions through a Web-based app, have increased resident safety by eliminating manual data entry, and have more secure, mobile access to resident data whether they are at a resident’s bedside or moving from one resident’s room to another.

Community Health Accreditation Program (CHAP) is the nation’s oldest community-based accrediting body, with more than 5,000 providers and 10,000 sites currently accredited and 85 field auditors continuously working to hold agencies accountable for patient care. CHAP is now using Surface Pro devices to support its new CHAP LinQ accreditation software and provide an important tool for site visitors to observe, interview and document information seamlessly. Unique Surface Pro features, such as the kickstand and digitized pen, work in conjunction with the CHAP LinQ software to enable CHAP’s field auditors to capture more accurate and systematic documentation and ultimately provide the highest quality of home- and community-based care.

Navy-Marine Corps Relief Society has implemented a Windows 8-based application on Surface devices dedicated to helping its visiting nurses provide better home-health patient care experiences for new mothers associated with the Navy-Marine Corps. The application — developed by Microsoft Consulting Services — enables visiting nurses and other mobile caregivers to meet with new mothers and their babies to assess the care they are receiving and serve as their resource and emotional support system. NMCRS’s 55 visiting nurses scattered around the globe are each provided with a Surface tablet so they can use the application to access patient EMRs in near-real time, facilitate faster communication with other clinicians and physicians, and easily answer health-related questions during visits.

Billings Clinic, a 285-bed hospital in Billings, Mont., is the first hospital to partner with Omnicell Inc. to implement remote cabinet functionality. By integrating Omnicell’s automated dispensing cabinets with Windows Embedded technology and a leading EMR system, Billings Clinic can streamline medication administration processes and ensure that pharmacists deliver the right medications to patients more safely and efficiently.

This Press Release is courtesy of www.microsoft.com

UPS® (NYSE: UPS) today announced it has completed the purchase of U.K.-based Polar Speed, an innovative provider of temperature-sensitive pharmaceutical supply chain solutions in the U.K. The acquisition further strengthens UPS’s healthcare network across Europe, providing healthcare companies access to a single source for logistics solutions across the continent.

The purchase is part of UPS’s successful healthcare strategy and brings new value to customers in this growing market. Polar Speed is recognized for its commitment to pharmaceutical logistics customers. It specializes in active temperature-controlled deliveries to hospitals, pharmacies, wholesalers and surgery centers as well as end patients. Polar Speed also offers unique capabilities within the growing homecare direct-to-consumer delivery market. Its customers include some of the best known pharmaceutical brands in the world.

“The acquisition will help UPS meet the needs of healthcare customers who want to reach the important U.K. market offering increased value in managing more flexible and efficient healthcare supply chains,” said Cindy Miller, President UPS Europe. “Our combined services will ensure healthcare companies have access to the best temperature-sensitive transportation solutions and allow us to effectively handle the rising demand for temperature-sensitive pharmaceutical and biologic products.”

“Our organization is extremely excited to join forces with UPS,” said Richard Holmes, Managing Director of Polar Speed. “With our combined solutions, we will continue to provide high-quality service to our customers, and at the same time provide our employees opportunities to help build on the growth momentum UPS has realized in the healthcare market.”
Polar Speed utilizes a fleet of 118 actively monitored temperature-controlled vehicles for transporting both 2-8 degrees celsius refrigerated and 15-25 degrees celsius products in accordance with U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) guidelines. The fleet is outfitted with sophisticated technology, including on-board temperature recorders and alarms to alert drivers of potential temperature excursions as well as a PolarTrack, an online portal linked to a satellite navigation system allowing customers to access real-time delivery status and temperature conditions of their products.

This acquisition adds three facilities with advanced warehousing management systems, full quality assurance services, and an experienced workforce to UPS’s existing global healthcare network, now totaling 45 healthcare facilities. UPS’s healthcare reach and expertise in Europe now includes dedicated healthcare distribution centers in the Benelux area, Central and Eastern Europe, Southern Europe, the Iberian Peninsula and the United Kingdom. UPS alleviates logistics cost pressures for healthcare companies via regional consolidation and distribution while providing greater visibility across their healthcare product supply chain.

“Polar Speed is an excellent strategic and operational fit for UPS because of its focus on quality assurance, compliance, technology and monitoring solutions to protect high-value and sensitive pharmaceuticals during storage and transportation,” said Miller. Polar Speed’s services include pallet and small package delivery, warehousing and distribution, on-site pharmacy services for dispensing patient prescriptions, and a home delivery service for approved patients.

Merrill Lynch International (Bank of America Merrill Lynch), a subsidiary of Bank of America Corporation, acted exclusively for UPS in connection with this transaction. Terms of this acquisition are not being disclosed.
The announcement follows UPS’s acquisition of Hungary-based pharmaceutical logistics company, CEMELOG, the opening of a healthcare facility in Hangzhou, China, and the expansion of six UPS healthcare facilities across North America in 2013.

UPS delivers value to healthcare companies through a broad portfolio of specialized freight, small package transportation, and warehousing and distribution services. UPS’s healthcare network offers services such as temperature-sensitive handling, geographic-specific regulatory compliance, monitoring and security, kitting and labeling, as well as order management and accounts receivable. Services across all locations are accessible via one global IT order management platform. UPS helps healthcare manufacturers meet stringent and often complex regulatory requirements, provides flexibility for a changing business environment and reliably serves an increasingly global customer base.

This Press Release is courtesy of www.ups.com

SAN FRANCISCO & FRANKFURT, Germany, – McKesson Corporation (NYSE:MCK), a leading North American healthcare services and information technology company, announced today that it has reached an agreement with Franz Haniel & Cie. GmbH (“Haniel”) to acquire their entire holding of Celesio shares for EUR 23.50 per share. In a separate and subsequent agreement, McKesson also announced the acquisition of Celesio convertible bonds from Elliott. These agreements are not subject to any closing conditions and the transactions are expected to close within 10 business days. After the close of the agreements with Haniel and Elliott, McKesson will exceed 75% ownership of Celesio shares on a fully diluted basis.

“We are excited to move forward with our acquisition of Celesio,” said John H. Hammergren, chairman and chief executive officer, McKesson Corporation. “We look forward to bringing together the strengths of the McKesson and Celesio organizations so we can provide our customers with more efficient delivery of healthcare products and services around the world. Our customers will benefit from the increased scale, supply chain expertise and sourcing capabilities of the combined company, together with enhanced access to innovative technology and business services.”

McKesson and its wholly-owned indirect subsidiary Dragonfly GmbH & Co KGaA (“Dragonfly”) have informed Celesio of their intention to enter into a domination and profit and loss transfer agreement, with Dragonfly as the dominating party and Celesio as the dominated party, pursuant to Sections 291 et seq. of the German Stock Corporation Act (Aktiengesetz – AktG). McKesson and Dragonfly expect to implement such a domination and profit and loss transfer agreement following the close of the transactions without any further regulatory approval.

McKesson expects to fund a portion of the transaction with cash and has a bridge financing facility in place to fund the balance of the transaction, with permanent financing to be put in place following the close of the transactions. McKesson will consolidate the financial results of Celesio during its fiscal fourth quarter ending March 31, 2014, and McKesson’s earnings will reflect its proportionate share of Celesio’s earnings. McKesson expects the transaction to be $1.00 to $1.20 accretive to adjusted earnings per share on a fully diluted basis in the first twelve months following the close of the transactions, assuming 100% ownership in the outstanding common shares of Celesio. By the fourth year following the implementation of the domination and profit and loss transfer agreement, McKesson expects to realize annual synergies between $275 million and $325 million.

McKesson intends to launch a voluntary tender offer to the remaining minority holders of Celesio common shares. The offer is expected to commence shortly after the close of the transactions.

About McKesson Corporation

McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better. McKesson partners with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit www.mckesson.com.

About Celesio Group

Celesio is a leading international wholesale and retail company and provider of logistics and services to the pharmaceutical and healthcare sectors. The proactive and preventive approach ensures that patients receive the products and support that they require for optimum care.

With 38,000 employees, Celesio operates in 14 countries around the world. Every day, the group serves over 2 million customers – at 2,200 pharmacies of its own and 4,100 participants in brand partnership schemes. With 132 wholesale branches, Celesio supplies 65,000 pharmacies and hospitals every day with up to 130,000 pharmaceutical products. The services benefit a patient pool of about 15 million per day.

This Press Release is courtesy of www.mckessson.com

MOUNTAIN VIEW, CA – September 18, 2013 – Google today announced Calico, a new company that will focus on health and well-being, in particular the challenge of aging and associated diseases. Arthur D. Levinson, Chairman and former CEO of Genentech and Chairman of Apple, will be Chief Executive Officer and a founding investor.

Announcing this new investment, Larry Page, Google CEO said: “Illness and aging affect all our families. With some longer term, moonshot thinking around healthcare and biotechnology, I believe we can improve millions of lives. It’s impossible to imagine anyone better than Art—one of the leading scientists, entrepreneurs and CEOs of our generation—to take this new venture forward.” Art said: “I’ve devoted much of my life to science and technology, with the goal of improving human health. Larry’s focus on outsized improvements has inspired me, and I’m tremendously excited about what’s next.”

Art Levinson will remain Chairman of Genentech and a director of Hoffmann-La Roche, as well as Chairman of Apple.

Commenting on Art’s new role, Franz Humer, Chairman of Hoffmann-La Roche, said: “Art’s track record at Genentech has been exemplary, and we see an interesting potential for our companies to work together going forward. We’re delighted he’ll stay on our board.”

Tim Cook, Chief Executive Officer of Apple, said: “For too many of our friends and family, life has been cut short or the quality of their life is too often lacking. Art is one of the crazy ones who thinks it doesn’t have to be this way. There is no one better suited to lead this mission and I am excited to see the results.”

This Press Release is courtesy of ww.google.com

WOONSOCKET, R.I.-CVS Caremark (NYSE: CVS) announced today that it will stop selling cigarettes and other tobacco products at its more than 7,600 CVS/pharmacy stores across the U.S. by October 1, 2014, making CVS/pharmacy the first national pharmacy chain to take this step in support of the health and well-being of its patients and customers.

“Ending the sale of cigarettes and tobacco products at CVS/pharmacy is the right thing for us to do for our customers and our company to help people on their path to better health,” said Larry J. Merlo, President and CEO, CVS Caremark. “Put simply, the sale of tobacco products is inconsistent with our purpose.”

Merlo continued, “As the delivery of health care evolves with an emphasis on better health outcomes, reducing chronic disease and controlling costs, CVS Caremark is playing an expanded role in providing care through our pharmacists and nurse practitioners. The significant action we’re taking today by removing tobacco products from our retail shelves further distinguishes us in how we are serving our patients, clients and health care providers and better positions us for continued growth in the evolving health care marketplace.”

Smoking is the leading cause of premature disease and death in the United States with more than 480,000 deaths annually. While the prevalence of cigarette smoking has decreased from approximately 42 percent of adults in 1965 to 18 percent today, the rate of reduction in smoking prevalence has stalled in the past decade. More interventions, such as reducing the availability of cigarettes, are needed.

“CVS Caremark is continually looking for ways to promote health and reduce the burden of disease,” said CVS Caremark Chief Medical Officer Troyen A. Brennan, M.D., M.P.H. “Stopping the sale of cigarettes and tobacco will make a significant difference in reducing the chronic illnesses associated with tobacco use.”

In a Journal of the American Medical Association (JAMA) Viewpoint published online this morning, Brennan and co-author Steven A. Schroeder, Director, Smoking Cessation Leadership Center, University of California, San Francisco, wrote, “The paradox of cigarette sales in pharmacies has become even more relevant recently, in large part because of changes in the pharmacy industryMost pharmacy chains are retooling themselves as an integral part of the health care system. They are offering more counseling by pharmacists, an array of wellness products and outreach to clinicians and health care centers.Perhaps more important, pharmacies are moving into the treatment arena, with the advent of retail health clinics. These retail clinics, originally designed to address common acute infections, are gearing up to work with primary care clinicians to assist in treating hypertension, hyperlipidemia and diabetes all conditions exacerbated by smoking.”

CVS Caremark’s decision to stop selling tobacco products is consistent with the positions taken by the American Medical Association, American Heart Association, American Cancer Society, American Lung Association and American Pharmacists Association that have all publicly opposed tobacco sales in retail outlets with pharmacies.

“As a leader of the health care community focused on improving health outcomes, we are pledging to help millions of Americans quit smoking,” said Merlo. “In addition to removing cigarettes and tobacco products for sale, we will undertake a robust national smoking cessation program.”

The program, to be launched this Spring, is expected to include information and treatment on smoking cessation at CVS/pharmacy and MinuteClinic along with online resources. The program will be available broadly across all CVS/pharmacy and MinuteClinic locations and will offer additional comprehensive programs for CVS Caremark pharmacy benefit management plan members to help them to quit smoking. Approximately seven in ten smokers say they want to quit and about half attempt to quit each year.

“Every day, all across the country, customers and patients place their trust in our 26,000 pharmacists and nurse practitioners to serve their health care needs,” commented Helena B. Foulkes, President, CVS/pharmacy. “Removing tobacco products from our stores is an important step in helping Americans to quit smoking and get healthy.”

The decision to exit the tobacco category does not affect the company’s 2014 segment operating profit guidance, 2014 EPS guidance, or the company’s five-year financial projections provided at its December 18th Analyst Day.The company estimates that it will lose approximately $2 billion in revenues on an annual basis from the tobacco shopper, equating to approximately 17 cents per share. Given the anticipated timing for implementation of this change, the impact to 2014 earnings per share is expected to be in the range of 6 to 9 cents per share. The company has identified incremental opportunities that are expected to offset the profitability impact. This decision more closely aligns the company with its patients, clients and health care providers to improve health outcomes while controlling costs and positions the company for continued growth.

This Press Release is courtesy www.cvscaremark.com

Today, the Centers for Medicare & Medicaid Services (CMS) released findings on a number of its initiatives to reform the health care delivery system. These include interim financial results for select Medicare Accountable Care Organization (ACO) initiatives, an in-depth savings analysis for Pioneer ACOs, results from the Physician Group Practice demonstration, and expanded participation in the Bundled Payments for Care Improvement Initiative. Savings from both the Medicare ACOs and Pioneer ACOs exceed $380 million.

“These innovative programs are showing encouraging initial results, while providing valuable lessons as we strive to improve our nation’s health care delivery system,” HHS Secretary Kathleen Sebelius said. “Today’s findings demonstrate that organizations of various sizes and structures across the country are working with their physicians and engaging with patients to better coordinate and deliver high quality care while reducing expenditure growth.”

While ACOs are designed to achieve savings over several years, not always on an annual basis, the interim financial results released today for the Medicare Shared Savings Program ACOs show that, in their first 12 months, nearly half (54 out of 114) of the ACOs that started program operations in 2012 already had lower expenditures than projected. Of the 54 ACOs that exceeded their benchmarks in the first 12 months, 29 generated shared savings totaling more than $126 million – a strong start this early in the program. In addition, these ACOs generated a total of $128 million in net savings for the Medicare Trust Funds. ACOs share with Medicare any savings generated from lowering the growth in health care costs while meeting standards for high quality care. Final performance year-one results will be released later this year.

While evaluation of the program’s overall impact is ongoing, the interim results are currently within the range originally projected for the program’s first year. A great majority of the program’s overall net impact was projected to phase-in over the program’s ensuing performance years. Moreover, through regular webinars; tools for sharing information and best practices; opportunities for ACOs to connect with one another; and other activities, ACOs are being provided the infrastructure and resources to learn from one another and to then diffuse what’s working and what is not.

“Our experience has shown that ACOs can increase quality while lowering costs. As a result of the programs we’ve initiated, our patients have experienced better access to their primary care physician, higher quality measures, and fewer trips to the hospital,” said Dr. Kenneth W. Wilkins, president of Coastal Carolina Health Care. “We look forward to making continued progress and seeing future results, and we are grateful to CMS whose advance funding made these initiatives possible.”

“We are delighted to be participating in the Shared Savings Program because of its goal to reduce costs while simultaneously increasing the quality of care and services we provide to our patients and community,” said Dr. John B. Chessare, president and chief executive officer of the Greater Baltimore Medical Center (GBMC) HealthCare system. “The Shared Savings Program is a tangible reminder of the historic transformation taking place in our health care system and we are pleased to be a part of it.”

An independent preliminary evaluation of the Pioneer ACO Model – the ACO model designed for more experienced organizations prepared to take on greater financial risk –also released today shows Pioneer ACOs generated gross savings of $147 million in their first year while continuing to deliver high quality care. Results showed that of the 23 Pioneer ACOs, nine had significantly lower spending growth relative to Medicare fee for service while exceeding quality reporting requirements. These savings far exceed findings from a previous analysis conducted by CMS, which used a different methodology.

“We are still early on in the program, but are encouraged by these results and are on track to meet our goals for participation in the Pioneer Accountable Care Organization Model”, said Dr. Barbara Walters, executive medical director for accountable care, with the Dartmouth-Hitchcock ACO. “Our strategies of using patient outreach and education and regular follow up for targeted chronic disease programs are allowing us to anticipate patient needs before their health problems become worse. Involvement in the Pioneer Model is helping us provide better treatment for our patients across a wide-range of health challenges.”

CMS also released results today for the Physician Group Practice Demonstration initiatives, which offered incentive payments for delivering high-quality, coordinated health care that generates Medicare savings. The Physician Group Practice Demonstration evaluation report confirmed overall savings over the 5 year experience with 7 out of 10 physician group practices earning shared savings payments for improving the quality and cost efficiency totaling $108 million over the course of the Demonstration. The participating organizations consistently demonstrated high quality of care on a broad range of chronic disease and preventive care measures.

The above models represent just a few initiatives CMS is testing to improve the quality of care delivery, while lowering costs. Today, CMS announced that 232 acute care hospitals, skilled nursing homes, physician group practices, long-term care hospitals, and home health agencies have entered into agreements to participate in the Bundled Payments for Care Improvement initiative. Bundling payment for services that patients receive across a single episode of care, such as heart bypass surgery or a hip replacement, is one way to encourage doctors, hospitals and other health care providers to work together to better coordinate care for patients, both when they are in the hospital and after they are discharged.

This is the largest and most ambitious test ever of a bundled payment model in Medicare or any other payer in the U.S. Through this initiative, made possible by the Affordable Care Act, CMS will test how bundled payments for clinical episodes can result in more coordinated care for beneficiaries and lower costs for Medicare.

This Press Release is courtesy of the US Department of Health and Human Services www.hhs.gov

The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.

The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.

Under the decree, the FDA has issued an order prohibiting Ranbaxy from:

• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey;
• manufacturing API at its Toansa facility for FDA-regulated drug products;
• exporting API from Toansa to the United States for any purpose; and
• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”

The FDA exercised its authority under a provision in the consent decree which permits the agency to extend the decree’s terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality. The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree.

The FDA’s inspection of the Toansa facility, which concluded on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.

The agency is evaluating potential drug shortage issues that may result from this action. If the FDA determines that a medically necessary drug is in shortage or at risk of shortage, the FDA may modify this order to preserve patient access to drugs manufactured under controls that are sufficient to assure quality, safety and effectiveness.

As a result of this action, Ranbaxy is now prohibited from manufacturing API for FDA-regulated drugs at the Toansa facility and from introducing API from that facility into interstate commerce, including into the United States, until the firm’s methods and controls used to manufacture drugs at the Toansa facility are established, operated and administered in compliance with CGMP.

Ranbaxy is required to hire a third-party expert to thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with CGMP. Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility.

The FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Patients who are concerned about their medications should talk with their health care professional before discontinuing treatment.

This Press Release is courtesy www.fda.gov

CINCINNATI–(BUSINESS WIRE)–According to the University of Scranton, each year 45% of Americans make a New Year’s resolution and only 8% successfully achieve their goal*. Prilosec OTC wants to help Hispanic Americans stay on track with their resolutions while keeping frequent heartburn symptoms at bay. Celebrity chef and nutritionist, Chef LaLa, and medical expert, Dr. Jorge Rodriguez, are sharing health and nutrition tips to assist you in managing your frequent heartburn, leaving more time to focus on more important things like enjoying time with friends or kick starting new and healthy lifestyle choices.

Dr. Jorge Rodriguez is no stranger to debunking heartburn myths, educating his patients on what really causes heartburn, and providing them with much needed clarity on managing frequent heartburn.

“With the New Year, I often get patients who are looking for tips on how to change their lifestyles, and one way to do that is to manage frequent heartburn,” said Dr. Jorge. “By adding Prilosec OTC to a proactive health plan, patients are better able to enjoy all of their New Year’s resolutions be they hiking, dancing or eating the foods they love instead of worrying about heartburn.”

Four Tips to Battle Heartburn in 2014
•Stay Active. Dr. Jorge suggests sticking to the number one New Year’s resolution most people make: lose weight. Losing weight helps alleviate pressure from your stomach which assists in preventing frequent heartburn.
•Take a stroll. After enjoying a nice meal with friends or family, Dr. Jorge recommends a leisurely walk to aid in digestion. By walking, your body will allow time for the food to digest and empty from your stomach, and encourage stomach acid to stay down instead of rising.
•Embrace Water. Chef Lala recommends drinking more water. Incorporating plenty of water into your daily routine helps keep heartburn at bay as it helps with digestion and washes out acid.
•Stay alert. Chef Lala suggests staying away from foods and beverages that could trigger your heartburn symptoms (for example, onions, peppermint, chocolate, caffeinated beverages such as coffee, citrus fruits or juices, tomatoes, or high-fat foods).

To request a free sample and to learn about ways you can treat manage your frequent heartburn, visit PrilosecOTCes.com.

This Press Release is courtesy of www.pg.com

The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.

An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.

The FDA is requiring six post-marketing studies for Farxiga:

a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
an enhanced pharmacovigilance program to monitor reports of liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.

Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.

This Press Release is courtesy of www.fda.gov

Abbott Laboratories has agreed to pay the United States $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products, the Justice Department announced today. Abbott is a global pharmaceuticals and health care products company based in Abbott Park, Ill.

“Patients have a right to treatment decisions that are based on their own medical needs, not the personal financial interests of their health care providers,” said Assistant Attorney General Stuart F. Delery of the Civil Division of the Department of Justice. “Kickbacks undermine the ability of health care providers to objectively evaluate and treat their patients, and will continue to be a primary focus of the Department’s health care enforcement efforts.”

The settlement resolves allegations that Abbott knowingly paid prominent physicians for teaching assignments, speaking engagements and conferences with the expectation that these physicians would arrange for the hospitals with which they were affiliated to purchase Abbott’s carotid, biliary and peripheral vascular products. As a result, the United States alleged Abbott violated the Anti-Kickback Act and caused the submission of false claims to Medicare for the procedures in which these Abbott products were used.

“Physicians should make decisions regarding medical devices based on what is in the best interest of patients without being induced by payments from manufacturers competing for their business,” said U.S. Attorney Bill Killian of the Eastern District of Tennessee.

“Offering financial inducements can distort health care decision-making,” said Special Agent in Charge Derrick L. Jackson of the U.S. Department of Health and Human Services, Office of Inspector General in Atlanta. “OIG and our law enforcement partners vigilantly protect government health programs from such alleged abuses.”

Carotid and peripheral vascular products are used to treat circulatory disorders by increasing blood flow to the head and various parts of the body, respectively. Biliary products are used to treat obstructions that occur in the bile ducts.

The settlement resolves allegations originally brought in a lawsuit filed by Steven Peters and Douglas Gray, former Abbott employees, under the qui tam provision of the False Claims Act , which allows whistleblowers to file suit on behalf of the United States for false claims and share in any recovery As part of today’s resolution, Peters and Gray will receive a total payment of more than $1 million.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.

This settlement was the result of an investigation by the Justice Department’s Civil Division, the U.S. Attorney’s Offices for the Eastern District of Tennessee and the Northern District of California and the Office of Inspector General at the U.S. Department of Health and Human Services.

This Press Release is courtesy the USDOJ

The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.

The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances. The product’s ingredients are undergoing further analysis by the FDA.

Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet. An investigation is underway to identify the product’s manufacturer. Consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine, or any other unexplained changes in their health.

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”

In general, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.

This Press Release is courtesy of USFDA www.fda.gov

Doctors, hospitals and other health care providers have formed 123 new Accountable Care Organizations (ACOs) in Medicare, providing approximately 1.5 million more Medicare beneficiaries with access to high-quality coordinated care across the United States, Health and Human Services Secretary Kathleen Sebelius announced today.

Doctors, hospitals and health care providers establish ACOs in order to work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. Since passage of the Affordable Care Act, more than 360 ACOs have been established, serving over 5.3 million Americans with Medicare. Beneficiaries seeing health care providers in ACOs always have the freedom to choose doctors inside or outside of the ACO. ACOs share with Medicare any savings generated from lowering the growth in health care costs when they meet standards for high quality care.

“Accountable Care Organizations are delivering higher-quality care to Medicare beneficiaries and are using Medicare dollars more efficiently,” Secretary Sebelius said. “This is a great example of the Affordable Care Act rewarding hospitals and doctors that work together to help our beneficiaries get the best possible care.”

“This program puts the control in the hands of physicians and allows them to take the lead in an innovative way to deliver the right care to the right patient at the right time,” said Kelly A. Conroy, executive director of the Palm Beach ACO and South Florida ACO. “We are honored to be a Medicare Shared Savings Program Accountable Care Organization, and after 18 months in the program, can proudly say that we have seen measurable success. We are so impressed with our participating physicians’ enthusiasm towards the cultural shift, and it demonstrates that physicians are primed for the future of medicine.”

The ACOs must meet quality standards to ensure that savings are achieved through improving care coordination and providing care that is appropriate, safe, and timely. The Centers for Medicare & Medicaid Services (CMS) evaluates ACO quality performance using 33 quality measures on patient and caregiver experience of care, care coordination and patient safety, appropriate use of preventive health services, and improved care for at-risk populations.

The new ACOs include a diverse cross-section of health care providers across the country, including providers delivering care in underserved areas. More than half of ACOs are physician-led organizations that serve fewer than 10,000 beneficiaries. Approximately 1 in 5 ACOs include community health centers, rural health clinics, and critical access hospitals that serve low-income and rural communities.

Affordable Care Act provisions have a substantial effect on reducing the growth rate of Medicare spending. Growth in Medicare spending per beneficiary hit historic lows during the 2010-2012 period, and this trend has continued into 2013. Projections by both the Office of the Actuary at CMS and the Congressional Budget Office estimate that Medicare spending per beneficiary will grow at approximately the rate of growth of the economy for the next decade, breaking a decades-old pattern of spending growth outstripping economic growth.

This Press Release is courtesy of US Department of Health an Human Services www.hhs.gov

The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used. More information on appropriate hand washing from the CDC may be found here.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.

The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product’s labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.
This Post is courtesy of www.fda.gov