FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Little kids and sweet drinks
From the U.S. Department of Health and Human Services, I’m Nicholas Garlow with HHS HealthBeat.
Starting off as a little kid with lots of sweet drinks may lead to weight problems later. At the University of Virginia, Mark DeBoer saw evidence in national survey data on 9,600 children who were followed at ages 9 months, and 2, 4 and 5 years.
“Children who consumed sugary drinks regularly were more likely to be overweight and obese at age 5.”
DeBoer says weight went up over time with the amount of sugar, and was quite noticeable at 4 and 5.
DeBoer recommends kids get water and milk, but not sugar-sweetened drinks. He also notes that keeping kids active helps to control weight.
The study in the journal Pediatrics was supported by the National Institutes of Health.
Learn more at healthfinder.gov.
HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I’m Nicholas Garlow.
Thursday, September 19, 2013
VA ISSUES STATEMENT ON HEALTH CARE TREATMENT OF AARON ALEXIS
FROM: U.S. DEPARTMENT OF VETERANS AFFAIRS
Statement from the Department of Veterans Affairs On Aaron Alexis
September 18, 2013
WASHINGTON -- The Department of Veterans Affairs issued the following statement:
Health care treatment
Aaron Alexis received treatment on August 23, 2013, when he visited the emergency room at the VA Medical Center in Providence, R.I., complaining of insomnia. After a medical examination, he was given a small amount of medication to help him sleep and was instructed to follow up with a primary care provider.
On August 28, he went to the emergency room at the VA Medical Center in Washington, D.C., to request a medication refill and attributed his insomnia to his work schedule. He was given a small refill and was instructed to follow up with a primary care provider. On both occasions, Mr. Alexis was alert and oriented, and was asked by VA doctors if he was struggling with anxiety or depression, or had thoughts about harming himself or others, all of which he denied.
Alexis enrolled in VA health care in February 2011. According to VA records, he never sought an appointment from a mental health specialist, and had previously either canceled or failed to show up for primary care appointments and claims evaluations examinations he had scheduled at VA medical centers.
Benefits
Alexis filed a disability compensation claim with the VA and was granted a 20 percent disability rating by VA for orthopedic issues on December 12, 2011, which was increased to 30 percent on December 19, 2012, when he was awarded an additional 10 percent for tinnitus. Alexis received benefits in the amount of $395 monthly. The 30 percent was retroactive to his separation from service.
Statement from the Department of Veterans Affairs On Aaron Alexis
September 18, 2013
WASHINGTON -- The Department of Veterans Affairs issued the following statement:
Health care treatment
Aaron Alexis received treatment on August 23, 2013, when he visited the emergency room at the VA Medical Center in Providence, R.I., complaining of insomnia. After a medical examination, he was given a small amount of medication to help him sleep and was instructed to follow up with a primary care provider.
On August 28, he went to the emergency room at the VA Medical Center in Washington, D.C., to request a medication refill and attributed his insomnia to his work schedule. He was given a small refill and was instructed to follow up with a primary care provider. On both occasions, Mr. Alexis was alert and oriented, and was asked by VA doctors if he was struggling with anxiety or depression, or had thoughts about harming himself or others, all of which he denied.
Alexis enrolled in VA health care in February 2011. According to VA records, he never sought an appointment from a mental health specialist, and had previously either canceled or failed to show up for primary care appointments and claims evaluations examinations he had scheduled at VA medical centers.
Benefits
Alexis filed a disability compensation claim with the VA and was granted a 20 percent disability rating by VA for orthopedic issues on December 12, 2011, which was increased to 30 percent on December 19, 2012, when he was awarded an additional 10 percent for tinnitus. Alexis received benefits in the amount of $395 monthly. The 30 percent was retroactive to his separation from service.
VICE CHAIR JOINT CHIEFS SAYS AIR FORCE MUST MAKE INVESTMENT CHOICES BECAUSE OF SEQUESTRATION
FROM: U.S. DEFENSE DEPARTMENT
Strategy, Threats, Resources Must Balance, Winnefeld Says
By Jim Garamone
American Forces Press Service
WASHINGTON, Sept. 18, 2013 - The tough fiscal environment means the Air Force must make investment choices that protect America and its interests today, but also in the future, the vice chairman of the Joint Chiefs of Staff said at the Air Force Association's annual Air and Space Conference today.
Navy Adm. James A. "Sandy" Winnefeld Jr. said that with less money, it is even more important to make the correct operational and investment decisions.
The threats are out there, the admiral said. In the past, he added, there was enough money to fund responses to those threats to the nation and its interests and allies. But with fewer dollars, he said, it is imperative to prioritize the competing claims on a shrinking defense budget.
Threats run the gamut, "beginning with major nation-states, who have watched the U.S. military's impressive capability -- with some anxiety -- and who are working hard to catch up," Winnefeld said. These states cannot challenge American military superiority head to head, he added, but they will try to do so asymmetrically.
The threats include highly insecure authoritarian states such as Iran, North Korea and Syria. Such nations, the vice chairman explained, conclude that obtaining deliverable nuclear weapons is the best insurance policy for their regimes.
"This also has huge implications, ranging from the importance of limited missile defense to how we might handle a conflict on the Korean Peninsula," Winnefeld said.
And the threat from violent extremists hasn't disappeared, the admiral said. These terrorists have "morphed from a centrally controlled apparatus within a supportive host nation, to a group of highly diversified, feisty and independent yet weakened franchises living mostly in poorly governed or ungoverned spaces," he told the audience.
These groups are learning and have become "operationally wiser" over time, and they still threaten American citizens and interests across the globe, he said.
"There are other threats, including transnational criminal organizations and cyber-empowered individuals," Winnefeld said. "Even the threat of disasters is changing along with the Earth's climate."
The Pentagon's strategy prioritizes these threats, the vice chairman said. But Congress, he added, must provide the Defense Department with the flexibility to manage whatever funds it gets to meet those missions.
Congress should give the department "as much freedom to maneuver as possible within our budgets, and by removing restrictions on our ability to become more efficient," Winnefeld added. Congress needs to remove limitations on the "downsizing glideslopes," the vice chairman said, "where we need to get our old stuff out of the system so we can buy and sustain new stuff."
Congress also needs to authorize a new round of base closures and realignments so the Defense Department can get rid of the 20 percent excess infrastructure it is carrying, Winnefeld said, adding that Congress and DOD officials need to look at personnel accounts as well.
"While everyone here would agree that our magnificent men and women in uniform deserve more than the average bear, we simply cannot sustain our recent growth trajectory in pay and benefits and expect to preserve a properly sized, trained and equipped force," he said.
"Some will fight some of these needed changes, but I would ask you to stand up and understand that the most important benefit we can provide for our people is to train and equip them to fly, fight and win and come home safely to their families," Winnefeld said.
Strategy, Threats, Resources Must Balance, Winnefeld Says
By Jim Garamone
American Forces Press Service
WASHINGTON, Sept. 18, 2013 - The tough fiscal environment means the Air Force must make investment choices that protect America and its interests today, but also in the future, the vice chairman of the Joint Chiefs of Staff said at the Air Force Association's annual Air and Space Conference today.
Navy Adm. James A. "Sandy" Winnefeld Jr. said that with less money, it is even more important to make the correct operational and investment decisions.
The threats are out there, the admiral said. In the past, he added, there was enough money to fund responses to those threats to the nation and its interests and allies. But with fewer dollars, he said, it is imperative to prioritize the competing claims on a shrinking defense budget.
Threats run the gamut, "beginning with major nation-states, who have watched the U.S. military's impressive capability -- with some anxiety -- and who are working hard to catch up," Winnefeld said. These states cannot challenge American military superiority head to head, he added, but they will try to do so asymmetrically.
The threats include highly insecure authoritarian states such as Iran, North Korea and Syria. Such nations, the vice chairman explained, conclude that obtaining deliverable nuclear weapons is the best insurance policy for their regimes.
"This also has huge implications, ranging from the importance of limited missile defense to how we might handle a conflict on the Korean Peninsula," Winnefeld said.
And the threat from violent extremists hasn't disappeared, the admiral said. These terrorists have "morphed from a centrally controlled apparatus within a supportive host nation, to a group of highly diversified, feisty and independent yet weakened franchises living mostly in poorly governed or ungoverned spaces," he told the audience.
These groups are learning and have become "operationally wiser" over time, and they still threaten American citizens and interests across the globe, he said.
"There are other threats, including transnational criminal organizations and cyber-empowered individuals," Winnefeld said. "Even the threat of disasters is changing along with the Earth's climate."
The Pentagon's strategy prioritizes these threats, the vice chairman said. But Congress, he added, must provide the Defense Department with the flexibility to manage whatever funds it gets to meet those missions.
Congress should give the department "as much freedom to maneuver as possible within our budgets, and by removing restrictions on our ability to become more efficient," Winnefeld added. Congress needs to remove limitations on the "downsizing glideslopes," the vice chairman said, "where we need to get our old stuff out of the system so we can buy and sustain new stuff."
Congress also needs to authorize a new round of base closures and realignments so the Defense Department can get rid of the 20 percent excess infrastructure it is carrying, Winnefeld said, adding that Congress and DOD officials need to look at personnel accounts as well.
"While everyone here would agree that our magnificent men and women in uniform deserve more than the average bear, we simply cannot sustain our recent growth trajectory in pay and benefits and expect to preserve a properly sized, trained and equipped force," he said.
"Some will fight some of these needed changes, but I would ask you to stand up and understand that the most important benefit we can provide for our people is to train and equip them to fly, fight and win and come home safely to their families," Winnefeld said.
DOD SAYS MILITARY SALES PROMOTES COOPERATION
FROM: U.S. DEFENSE DEPARTMENT
U.S. Foreign Military Sales Promote Security Cooperation
By Cheryl Pellerin
American Forces Press Service
WASHINGTON, Sept. 18, 2013 - Though 2012 was a banner fiscal year with $69.1 billion in foreign military sales, that program and others like it are not in the business of selling equipment, but rather are promoting military-to-military relationships with international partners, a Defense Security Cooperation Agency official said here yesterday.
Speaking at a ground robotics symposium hosted by the National Defense Industrial Association, Derek Gilman, DSCA's general counsel, said his agency promotes relationships by facilitating the purchase of defense equipment and services, financing, defense education and training and more.
"The idea," Gilman said, "is if partners have U.S. equipment and U.S. training and are following U.S. doctrine, our interoperability is greater with them."
Interoperability also can be leveraged through international acquisition and cross-servicing agreements for sharing such things as ammunition and spare parts, he added.
"That can lead, if you're sharing joint doctrine, to joint exercises and other types of military-to-military cooperation and ... to decades-long relationships -- core relationships -- with partners around the world," Gilman said.
The Foreign Military Sales program is a form of security assistance authorized by the Arms Export Control Act through which the United States may sell defense articles and services to foreign countries and international organizations. Under the program, the U.S. government and a foreign government enter into a sales agreement called a letter of offer and acceptance. The State Department determines which countries will have programs, and the Defense Department executes the program.
DSCA is the central agency that synchronizes global security cooperation programs, funding and efforts across the Office of the Secretary of Defense, the Joint Staff, the State Department, the combatant commands, the services and U.S. industry. The agency is responsible for the policy, processes, training and financial management needed to execute security cooperation within DOD.
The agency's mission areas cover a lot of ground, ranging from foreign military sales and foreign military financing to humanitarian assistance, disaster relief and mine action. DSCA also has programs for international military education and training and partnership capacity building.
DSCA has 12,881 active foreign military sales cases valued at $394 billion, 443 humanitarian projects worldwide, 768 security cooperation officers in 148 countries, 7,344 international students from 141 countries, and 7,090 participants in five regional centers around the world. DSCA does business with 227 countries and international organizations.
Foreign military sales represent the largest percentage of DSCA funds, with $69.1 billion in fiscal 2012, Gilman said, "but $29 billion of that is from the sale of 84 F-15s to Saudi Arabia, along with weapons and training and basing." He said that going forward, the agency expects about $30 billion a year, with about $25 billion in 2013 sales.
"But that's a significant increase over what we've had historically," he added.
Before fiscal 2006, DSCA foreign military sales hovered between $10 billion and $13 billion, Gilman said, adding that the agency has been doing more than twice that amount each year and expects that trend to continue because of an increased emphasis on foreign sales, interoperability and fighting in a coalition environment.
Other DSCA programs include:
-- Foreign Military Financing, $1.1 billion in fiscal 2012-2013: The bulk of this funding goes to Israel and Egypt, with the rest divided among several other countries. Funding amounts go out in grant letters so it is considered a conditional grant to the foreign country. "The money, however, does not go to the foreign country," Gilman said. "It stays in the FMF trust fund in the account for those countries and becomes new-year money. It's obligated upon apportionment, so it continues to be available for the purposes set forth in the current-year congressional budget justification."
-- International Military Education and Training program, $105.8 million in fiscal 2012: "IMET is a significant program whereby we provide education and training to folks from foreign militaries," Gilman said. "It has been a significant aid to the United States over the last 30 years in terms of helping build relationships with those who later go on to be senior members of partner militaries."
-- Special Defense Acquisition: "[This program] allows us to anticipate what the sales are going to be to foreign partners to buy defense articles in advance of those sales of high-demand sorts of items," Gilman explained, "and then to provide those items to our partners."
-- Excess Defense Articles: A major effort is going on now in this longstanding program with regard to Afghanistan, Gilman said, "and how we provide what we anticipate will be a large number of defense articles [there] to our foreign partners. It's a way to make sure we reduce the possibility of waste in terms of demilitarization on the ground in Afghanistan."
Looking ahead for DSCA, Gilman said building interoperability and sustainability and staying ahead of the competition are among the agency's key opportunities and challenges.
DSCA differs from what a customer might see in a direct commercial sale, such as in the Foreign Military Sales program, because the agency provides what Gilman described as a total-package approach. A partner in a direct commercial sale would have to go to several commercial vendors to determine its own commercial requirements, he explained.
"But DSCA will work with partners to say, 'This is the equipment you want to meet a certain need, these are the weapons you'll need to go with that equipment, this is the training you will need [and] these are the requirements you will need on your base,'" Gilman said. "And we can provide all that through letters of offer and acceptance as to an estimate of how much it will cost."
The agency also offers the advantage of the U.S. contracting process, he added, "so we can leverage our ability, especially if they're contracting for something that's already in the U.S. system, because we have an existing contract."
DSCA can leverage the fact that the agency is buying the item to keep the price down for the customer, Gilman said.
"Some customers have a less-than-transparent acquisition system [at home], and they like the transparency the U.S. acquisition system offers them, so there are a number of benefits," he added.
Other countries have had experience with foreign military sales, he said, and they prefer the DSCA approach.
"At the end of the day, we don't care whether they use FMS or DSCA, but what we do care about is that they buy U.S. products in whatever way is most effective for them," he said.
The agency also is seeing more pressure from traditional competitors such as the United Kingdom, France and Russia, and emerging competitors in China, India, Brazil, the European Union and elsewhere, Gilman said.
"China is becoming more and more of a player in the international armaments sales arena, and South Korea is becoming a significant competitor in the international armaments sales arena," he said. "The United States wants to maintain its role as the preeminent competitor for the reasons of building relationships with our partners."
U.S. Foreign Military Sales Promote Security Cooperation
By Cheryl Pellerin
American Forces Press Service
WASHINGTON, Sept. 18, 2013 - Though 2012 was a banner fiscal year with $69.1 billion in foreign military sales, that program and others like it are not in the business of selling equipment, but rather are promoting military-to-military relationships with international partners, a Defense Security Cooperation Agency official said here yesterday.
Speaking at a ground robotics symposium hosted by the National Defense Industrial Association, Derek Gilman, DSCA's general counsel, said his agency promotes relationships by facilitating the purchase of defense equipment and services, financing, defense education and training and more.
"The idea," Gilman said, "is if partners have U.S. equipment and U.S. training and are following U.S. doctrine, our interoperability is greater with them."
Interoperability also can be leveraged through international acquisition and cross-servicing agreements for sharing such things as ammunition and spare parts, he added.
"That can lead, if you're sharing joint doctrine, to joint exercises and other types of military-to-military cooperation and ... to decades-long relationships -- core relationships -- with partners around the world," Gilman said.
The Foreign Military Sales program is a form of security assistance authorized by the Arms Export Control Act through which the United States may sell defense articles and services to foreign countries and international organizations. Under the program, the U.S. government and a foreign government enter into a sales agreement called a letter of offer and acceptance. The State Department determines which countries will have programs, and the Defense Department executes the program.
DSCA is the central agency that synchronizes global security cooperation programs, funding and efforts across the Office of the Secretary of Defense, the Joint Staff, the State Department, the combatant commands, the services and U.S. industry. The agency is responsible for the policy, processes, training and financial management needed to execute security cooperation within DOD.
The agency's mission areas cover a lot of ground, ranging from foreign military sales and foreign military financing to humanitarian assistance, disaster relief and mine action. DSCA also has programs for international military education and training and partnership capacity building.
DSCA has 12,881 active foreign military sales cases valued at $394 billion, 443 humanitarian projects worldwide, 768 security cooperation officers in 148 countries, 7,344 international students from 141 countries, and 7,090 participants in five regional centers around the world. DSCA does business with 227 countries and international organizations.
Foreign military sales represent the largest percentage of DSCA funds, with $69.1 billion in fiscal 2012, Gilman said, "but $29 billion of that is from the sale of 84 F-15s to Saudi Arabia, along with weapons and training and basing." He said that going forward, the agency expects about $30 billion a year, with about $25 billion in 2013 sales.
"But that's a significant increase over what we've had historically," he added.
Before fiscal 2006, DSCA foreign military sales hovered between $10 billion and $13 billion, Gilman said, adding that the agency has been doing more than twice that amount each year and expects that trend to continue because of an increased emphasis on foreign sales, interoperability and fighting in a coalition environment.
Other DSCA programs include:
-- Foreign Military Financing, $1.1 billion in fiscal 2012-2013: The bulk of this funding goes to Israel and Egypt, with the rest divided among several other countries. Funding amounts go out in grant letters so it is considered a conditional grant to the foreign country. "The money, however, does not go to the foreign country," Gilman said. "It stays in the FMF trust fund in the account for those countries and becomes new-year money. It's obligated upon apportionment, so it continues to be available for the purposes set forth in the current-year congressional budget justification."
-- International Military Education and Training program, $105.8 million in fiscal 2012: "IMET is a significant program whereby we provide education and training to folks from foreign militaries," Gilman said. "It has been a significant aid to the United States over the last 30 years in terms of helping build relationships with those who later go on to be senior members of partner militaries."
-- Special Defense Acquisition: "[This program] allows us to anticipate what the sales are going to be to foreign partners to buy defense articles in advance of those sales of high-demand sorts of items," Gilman explained, "and then to provide those items to our partners."
-- Excess Defense Articles: A major effort is going on now in this longstanding program with regard to Afghanistan, Gilman said, "and how we provide what we anticipate will be a large number of defense articles [there] to our foreign partners. It's a way to make sure we reduce the possibility of waste in terms of demilitarization on the ground in Afghanistan."
Looking ahead for DSCA, Gilman said building interoperability and sustainability and staying ahead of the competition are among the agency's key opportunities and challenges.
DSCA differs from what a customer might see in a direct commercial sale, such as in the Foreign Military Sales program, because the agency provides what Gilman described as a total-package approach. A partner in a direct commercial sale would have to go to several commercial vendors to determine its own commercial requirements, he explained.
"But DSCA will work with partners to say, 'This is the equipment you want to meet a certain need, these are the weapons you'll need to go with that equipment, this is the training you will need [and] these are the requirements you will need on your base,'" Gilman said. "And we can provide all that through letters of offer and acceptance as to an estimate of how much it will cost."
The agency also offers the advantage of the U.S. contracting process, he added, "so we can leverage our ability, especially if they're contracting for something that's already in the U.S. system, because we have an existing contract."
DSCA can leverage the fact that the agency is buying the item to keep the price down for the customer, Gilman said.
"Some customers have a less-than-transparent acquisition system [at home], and they like the transparency the U.S. acquisition system offers them, so there are a number of benefits," he added.
Other countries have had experience with foreign military sales, he said, and they prefer the DSCA approach.
"At the end of the day, we don't care whether they use FMS or DSCA, but what we do care about is that they buy U.S. products in whatever way is most effective for them," he said.
The agency also is seeing more pressure from traditional competitors such as the United Kingdom, France and Russia, and emerging competitors in China, India, Brazil, the European Union and elsewhere, Gilman said.
"China is becoming more and more of a player in the international armaments sales arena, and South Korea is becoming a significant competitor in the international armaments sales arena," he said. "The United States wants to maintain its role as the preeminent competitor for the reasons of building relationships with our partners."
IRS ANNOUNCES THE DISBARMENT OF A CPA FOR STEALING FROM DAUGHTER'S TRUST FUND
FROM: INTERNAL REVENUE SERVICE NEWSWIRE
CPA Disbarred for Stealing from Daughter’s Trust Fund
WASHINGTON — The Internal Revenue Service today announced that its Office of Professional Responsibility (OPR) has prevailed in seeking the disbarment of David O. Christensen after he was convicted of theft for misappropriating funds as the conservator of his daughter’s trust account. Christensen’s CPA licenses in Washington and Oregon were revoked previously as a result of his conviction.
In a Final Agency Decision the Administrative Law Judge (ALJ) declined to carve out a request by Christensen for limited practice as a tax return preparer, and instead, disbarred him from all practice before the IRS finding that Christensen’s conviction for theft, and the revocation of his CPA licenses, constituted disreputable conduct under Circular 230. Christensen had argued that he should be permitted to continue to prepare tax returns because his theft conviction resulted from a family matter that had nothing to do with his tax return preparation practice before the IRS.
"OPR strives to protect the integrity of the tax system from unscrupulous and incompetent practitioners regardless of how those traits become known,” said Karen L. Hawkins, Director of OPR.
Agreeing with OPR’s proposed sanction, the ALJ held the seriousness of Christensen’s offense warranted disbarment from practicing before the IRS finding that the “Respondent has displayed a lack of integrity, including in his testimony at trial, in attempting to distinguish his professional actions from his ‘father-daughter’ relationship.”
Christensen is prohibited from any practice (including tax return preparation) before the IRS for a five year period.
CPA Disbarred for Stealing from Daughter’s Trust Fund
WASHINGTON — The Internal Revenue Service today announced that its Office of Professional Responsibility (OPR) has prevailed in seeking the disbarment of David O. Christensen after he was convicted of theft for misappropriating funds as the conservator of his daughter’s trust account. Christensen’s CPA licenses in Washington and Oregon were revoked previously as a result of his conviction.
In a Final Agency Decision the Administrative Law Judge (ALJ) declined to carve out a request by Christensen for limited practice as a tax return preparer, and instead, disbarred him from all practice before the IRS finding that Christensen’s conviction for theft, and the revocation of his CPA licenses, constituted disreputable conduct under Circular 230. Christensen had argued that he should be permitted to continue to prepare tax returns because his theft conviction resulted from a family matter that had nothing to do with his tax return preparation practice before the IRS.
"OPR strives to protect the integrity of the tax system from unscrupulous and incompetent practitioners regardless of how those traits become known,” said Karen L. Hawkins, Director of OPR.
Agreeing with OPR’s proposed sanction, the ALJ held the seriousness of Christensen’s offense warranted disbarment from practicing before the IRS finding that the “Respondent has displayed a lack of integrity, including in his testimony at trial, in attempting to distinguish his professional actions from his ‘father-daughter’ relationship.”
Christensen is prohibited from any practice (including tax return preparation) before the IRS for a five year period.
FDA APPROVES GENERIC VERSION OF XELODA CHEMOTHERAPY PILL
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves first generic capecitabine to treat colorectal and breast cancers
The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths.
“Generic drugs are important options that allow greater access to health care for all Americans,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options.”
According to the National Cancer Institute, it is estimated that 1.6 million people in the United States will be diagnosed with and 580,000 will die of cancer in 2013. It is estimated that 142,820 people will be diagnosed with and 50,830 will die of cancer of the colon and rectum in 2013. An estimated 232,340 women will be diagnosed with and 39,620 women will die of cancer of the breast in 2013.
In the clinical trials for Xeloda, the most commonly observed adverse reactions included: diarrhea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome (pain, swelling, or redness of hands or feet that prevents normal activity); and fever or infection.
It is important that the prescriber know if the patient is also taking a medicine used to thin the blood, such as warfarin. Capecitabine could increase the effect of this medicine, possibly leading to serious side effects. Capecitabine has a boxed warning to alert health care professionals and patients about this risk.
Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Information about the availability of generic capecitabine can be obtained from Teva.
FDA approves first generic capecitabine to treat colorectal and breast cancers
The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths.
“Generic drugs are important options that allow greater access to health care for all Americans,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options.”
According to the National Cancer Institute, it is estimated that 1.6 million people in the United States will be diagnosed with and 580,000 will die of cancer in 2013. It is estimated that 142,820 people will be diagnosed with and 50,830 will die of cancer of the colon and rectum in 2013. An estimated 232,340 women will be diagnosed with and 39,620 women will die of cancer of the breast in 2013.
In the clinical trials for Xeloda, the most commonly observed adverse reactions included: diarrhea; vomiting; nausea; pain, redness, swelling, or sores in the mouth; hand-and-foot syndrome (pain, swelling, or redness of hands or feet that prevents normal activity); and fever or infection.
It is important that the prescriber know if the patient is also taking a medicine used to thin the blood, such as warfarin. Capecitabine could increase the effect of this medicine, possibly leading to serious side effects. Capecitabine has a boxed warning to alert health care professionals and patients about this risk.
Generic drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Information about the availability of generic capecitabine can be obtained from Teva.
GSA MAKES NEARLY A MILLION SELLING BOSTON HARBOR LIGHTHOUSE
FROM: U.S. GENERAL SERVICES ADMINISTRATION
Government Sells Boston Harbor Lighthouse for Nearly $1 Million
September 16, 2013
BOSTON - Today, the U.S. General Services Administration (GSA) announced it has found a new owner for the historic Graves Light in Boston Harbor. David Waller was officially awarded the lighthouse today and will take ownership within sixty days. GSA received an unprecedented $933,888 bid for the lighthouse, which is a record amount for any lighthouse ever sold in the United States.
As part of the National Historic Lighthouse Preservation Act (NHLPA) program, GSA offered the lighthouse to the public through an online auction. So far, more than 100 lighthouses have been sold or transferred out of federal ownership. Through this innovative program, proceeds from the public sales go back into the Coast Guard’s aid to navigation fund, a fund that pays for the equipment, maintenance, and resources (fog horns, lights, battery cells, solar panels, etc.) to continue preservation and maintenance of lighthouses that are still active and federal ownership. .”
"Lighthouses are an important part of our maritime history, both in New England and national heritage. Enthusiastic new owners like David Waller, help us ensure that these architectural treasures will be preserved without burdening taxpayers," said Robert Zarnetske, GSA Regional Administrator for New England.
The open and competitive public auction lasted 25 days between 10 different parties before bidding closed last Saturday. The property boasts 360-degree million dollar views that include the Boston skyline, the harbor, and the Atlantic Ocean. The new owner now possesses a truly historic maritime treasure and iconic property in Boston Harbor.
Graves Light, constructed in 1905 and designed by Royal Luther, is located on The Graves, the outermost island of the Boston Harbor Islands National Recreation Area, nine miles offshore from Boston. At 113 feet, it is the tallest lighthouse in the Port of Boston. The light is a striking conical structure with granite blocks on a granite foundation and includes interior keeper’s quarters.
Since 2000, in partnership with the U.S. Coast Guard and the National Park Service, GSA administers the federal program that transfers ownership of historic lighthouses to caretakers through the National Historic Lighthouse Preservation Act program. GSA also offers lighthouses for public sale at www.realestatesales.gov.
Government Sells Boston Harbor Lighthouse for Nearly $1 Million
September 16, 2013
BOSTON - Today, the U.S. General Services Administration (GSA) announced it has found a new owner for the historic Graves Light in Boston Harbor. David Waller was officially awarded the lighthouse today and will take ownership within sixty days. GSA received an unprecedented $933,888 bid for the lighthouse, which is a record amount for any lighthouse ever sold in the United States.
As part of the National Historic Lighthouse Preservation Act (NHLPA) program, GSA offered the lighthouse to the public through an online auction. So far, more than 100 lighthouses have been sold or transferred out of federal ownership. Through this innovative program, proceeds from the public sales go back into the Coast Guard’s aid to navigation fund, a fund that pays for the equipment, maintenance, and resources (fog horns, lights, battery cells, solar panels, etc.) to continue preservation and maintenance of lighthouses that are still active and federal ownership. .”
"Lighthouses are an important part of our maritime history, both in New England and national heritage. Enthusiastic new owners like David Waller, help us ensure that these architectural treasures will be preserved without burdening taxpayers," said Robert Zarnetske, GSA Regional Administrator for New England.
The open and competitive public auction lasted 25 days between 10 different parties before bidding closed last Saturday. The property boasts 360-degree million dollar views that include the Boston skyline, the harbor, and the Atlantic Ocean. The new owner now possesses a truly historic maritime treasure and iconic property in Boston Harbor.
Graves Light, constructed in 1905 and designed by Royal Luther, is located on The Graves, the outermost island of the Boston Harbor Islands National Recreation Area, nine miles offshore from Boston. At 113 feet, it is the tallest lighthouse in the Port of Boston. The light is a striking conical structure with granite blocks on a granite foundation and includes interior keeper’s quarters.
Since 2000, in partnership with the U.S. Coast Guard and the National Park Service, GSA administers the federal program that transfers ownership of historic lighthouses to caretakers through the National Historic Lighthouse Preservation Act program. GSA also offers lighthouses for public sale at www.realestatesales.gov.
Subscribe to:
Comments (Atom)