U.S. readies for Yemen President Saleh, refuses to divulge details
Washington, D.C., United States (AHN) – The United States on Monday confirmed issuance of visa to ailing Yemeni President Ali Abdullah Saleh for a limited time to undergo medical treatment but refused to divulge time-period for which the visa is issued.
“We have issued a visa for Ali Abdullah Saleh,” said Victoria Nuland, the State Department spokesperson, adding, “It is strictly for medical treatment, and our expectation is that he will leave the United States when his medical treatment is complete.”
Asked to comment on the time period for which this visa is issued, Nuland said, “He’s got a visa for the period that he anticipated the medical treatment would last. If the treatment goes on longer and he needs to apply for an extension, he would do that with Homeland Security.”
Yemeni political players are expecting to utilize President Saleh’s absence to move the country “on a concrete transition plan to a more democratic Yemen,” said Nuland, adding, “We do believe that Saleh’s absence from Yemen at this critical juncture might, in fact, facilitate that dialogue and facilitate the transition process.”
Agreeing that, “it might be helpful to the transition process that he’s out of the country now,” Nuland reiterated, “It (the visa application) was not approved for political purposes. It was approved for medical treatment. The timing, we think, is fortuitous, however, and we hope that the Yemenis will use the time well.”
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Hepatitis B vaccine recommended for diabetic adults
Washingotn, D.C., United States (AHN) – New government guidelines recommend the hepatitis B vaccine for all unvaccinated adults, aged 19 to 59, with type 1 and type 2 diabetes.
The U.S. Advisory Committee on Immunization Practices says the immunization should be done as soon as possible after adults in this age group are diagnosed with diabetes. Unvaccinated adults older than 59 can receive the hepatitis B vaccination at the discretion of their doctor.
Between 700,000 and 1.4 million people in the U.S. are infected with the hepatitis B virus, the Centers for Disease Control and Prevention reports.
Chronic HBV infection damages the liver and can lead to serious illness and death. More than 15 percent of adults with chronic HBV infection develop cirrhosis and liver cancer.
People with diabetes are at an increased risk for HBV infection, which can occur through minute amounts of blood from an infected person who has shared a medical or glucose monitoring device.
The hepatitis B virus thrives outside the body and is easily transmitted. Transmission is possible if finger-stick devices or blood glucose monitors meant for one person are used by more than one person without appropriate cleaning or infection control measures.
The new recommendations for hepatitis B vaccination for diabetics is outlined in the Dec. 23 issue of the CDC’s Morbidity and Mortality Weekly Report.
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Few women get breast reconstruction after mastectomy
New York, NY, United States (AHN) – Despite the known cosmetic and psychological advantages, few women undergo breast reconstruction after a mastectomy.
Researchers from Columbia University Medical Center say that fewer than one in four women with invasive cancer opt for the immediate reconstruction of their breast, while more than one in three with early stage cancer opted for and received the procedure.
For the study, the researchers looked at data representing 15 percent of U.S. hospitals. They found 108,992 women with invasive breast cancer who underwent a mastectomy, and 14,710 women with early stage cancer who did.
From 2000 to 2010, 23.4 percent of those women with invasive cancers got immediate reconstructive surgery, and 36.4 percent of those with early stage cancers did.
Women younger than 50, with commercial health insurance, were most likely to get the surgery.
Along with older women, blacks and rural residents were less likely to get reconstructive surgery.
The biggest predictor of whether women got immediate reconstruction was insurance.
Doctors noted that the findings are surprising. While they acknowledge that many women opt not to go through more surgery, they say some women may not be aware of the option or the insurance coverage for it.
The findings were presented Thursday at the San Antonio Breast Cancer Symposium.
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CDC: U.S. teens not eating enough fruits, vegetables
Atlanta, GA, United States (AHN) – U.S. teens are not eating enough fruits and vegetables, according to a new study by the U.S. Centers for Disease Control and Prevention.
The findings, based on data complied from nearly 10,800 students in grades nine through 12 who took part in the National Youth Physical Activity and Nutrition Study 2010, found median consumption was 1.2 times per day for both fruits and vegetables.
Median fruit consumption was much higher among males than females, and much higher among grade nine students than among students in grades 10 and 12.
A little more than 28.5 percent, or one in four, of the high school students ate fruit less than once a day, and 33.2 percent ate vegetables less than once a day.
Only 16.8 percent of students ate fruit at least four times a day, and only 11.2 percent ate vegetables at least four times a day.
Vegetable consumption was lowest among Hispanic and black students, the study found.
Researchers said the findings show that most high school students do not meet the daily fruit and vegetable recommendations, and more needs to be done to see the recommendations are met.
The researchers wrote in the Nov. 25 issue of the CDC’s Morbidity and Mortality Weekly Report, “The infrequent fruit and vegetable consumption by high school student highlights the need for effective strategies to increase consumption.”
Steps have already been taken at schools throughout the country to remove sugary snacks, sodas, high fat, high salt and low nutrient dense foods. New programs such as farm-to-school initiatives, school gardens and salad bars aim to improve access to both fruits and vegetables.
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More American patients seek treatment abroad to escape high medical costs
Washington, D.C., United States (AHN) – The number of Americans heading abroad for medical care rose sharply last year amid high health care costs and a poor economy in the United States, according to medical tourism industry figures.
Some of their preferred locations for life-saving surgeries and other procedures are India and Mexico, the health information company Health Digital Systems reported.
Surgeries like hip replacements, dental implants and heart bypasses can cost half as much in Southeast Asia and Latin America compared with the United States.
Among the six million Americans who traveled abroad for medical care last year, 45 percent traveled to Asia, 26 percent to Latin America and 2 percent to the Middle East, according to industry statistics.
Health care officials in the countries treating foreigners are upbeat about their patients. Medical tourism, primarily from the United States and Europe, represents a nearly $100 billion a year industry.
Mexico’s Health Ministry recently produced a report saying “the globalization of health services can offer excellent medical care at lower costs than developed countries.”
The health ministry has developed a strategic plan to encourage medical tourism by continuing “the effort to improve the perception of public safety and promote [Mexico's] image as a global capital of culture and entertainment.”
Any success by Mexico’s health providers in reaching American patients is most obvious in border cities like Monterrey, Tijuana and Chihuahua, according to the Health Digital Systems. Pharmacies, hospitals and medical specialty practices have sprung up to take care of them.
However, patients also assume risks by trusting their health care to foreign medical standards.
Only 2 percent of Mexico’s hospitals have earned “Joint International Commission” certification.
The certification means a hospital and its staff have met international standards that would allow them to be reimbursed by foreign medical insurance companies.
India’s medical tourism industry is losing patients to competing hospitals in Singapore, Thailand and Malaysia amid concerns about poor sanitation.
Indian hospitals have been struggling with a “superbug” that is resistant to disinfectant.
As a result, some patients are reporting they become sick when they enter Indian hospitals for other treatments.
Nevertheless, the discount price of foreign medical treatment is creating a backlog of patients for hospitals with good reputations.
Mediescape, an Indian medical tourism company, reports that India’s hospitals offering medical services to patients from the United States and Europe say their booked up to December.
Between 15 percent and 20 percent of India’s hospital income now comes from medical tourism, according to industry data.
There were 800,000 foreign patients in India last year. They are expected to generate a $3 billion a year industry for India by 2015, up by more than a third from 2010.
Behind the figures on rising medical tourism is the desperation of patients who cannot afford health care in the United States, where about 40 percent of the population lacks adequate medical insurance, according to U.S. government statistics.
Some Americans are even treating themselves for serious ailments, not always with successful outcomes, according to a recent survey by TMD Limited, a medical tourism company.
“Today we are seeing many breast cancer patients that self-treated for years,” said Antonio Jimenez, a doctor raised in New Jersey who now runs the Hope4Cancer Institute in Mexico’s Baja California. “Unfortunately, cancer treatment is not a do-it-yourself project.”
Many of the women search for treatments on the Internet.
“We see more and more women who have spent thousands of dollars on supplements and wonder cures they used at home,” Jimenez said. “When those treatments fail, they look for a clinic that can help.”
The American Cancer Society reports that 230,480 American women will be diagnosed with breast cancer this year. Of those, 39,520 will die.
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Former Rep. Mark Foley recovering from cancer surgery in Florida
Orlando, FL, United States (AHN) – Former U.S. Rep. Mark Foley is recovering from an operation to remove cancer cells in his prostate.
The 56-year-old lawmaker successfully underwent surgery late Friday in an Orlando hospital. He was diagnosed several weeks ago after skipping his annual check-up.
A former Lake Worth vice mayor and state lawmaker before being elected to Congress in 1994, Foley was said to have been considering running for mayor of West Palm Beach last year. He stepped down in 2006 from his congressional seat, at the time chair of the House Caucus on Missing and Exploited Children, a day after a report accused him of sending sexually explicit messages to a male House page.
The report said the congressman sent the text messages in 2004 but other House pages later came forward and accused him of inappropriate conduct as far back as his first year in office.
Upon his resignation, the six-term congressman checked into a rehabilitation facility and revealed that he is gay. He returned to the public stage in 2009 as host of a political radio talk show in North Palm Beach.
Foley was not sanctioned by the House Ethics Committee, nor was then-House Republican Speaker Dennis Hastert, who had known about Foley’s history with male pages and had faced calls to resign.
The Florida Department of Law Enforcement also did not charge the former congressman in connection with the allegations after a “thorough and comprehensive investigation.”
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Soaring Health Costs Pinned On Medical Devices
United States (KaiserHealth) – While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.
The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.
Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. “Better regulation of medical devices has the potential to reduce health care costs,” said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.”
“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”
Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off “innovation.”
The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health care reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.
The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest – especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back. Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax.
“Device manufacturers will have to cut R&D or may be forced to lay off employees due to this disastrous tax,” the letter said.
Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment. There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials.
While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.
Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products. After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM’s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.
The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.
“As the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,” said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.
Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company’s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.
Last week, the House Oversight and Government Reform Committee called in the FDA’s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. “In some cases, the conveyor belt for medical devices has come to a grinding halt,” charged Rep. Trey Gowdy, R-SC., who chairs the health subcommittee.
Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to “do a far better job to make the process more efficient without compromising our standards for safety and efficacy.”
Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.
The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market. But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.
The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.
The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products – say, the four or fifth statin to come to market for lowering cholesterol – must still go through rigorous clinical trial testing. While that doesn’t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.
Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices. The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings.
A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only’ percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.
“Yes, the FDA’s getting tougher and it’s long overdue,” said the study’s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. “Too many things were sailing through without clear evidence they were safe and effective.”
She cited last December’s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication. Last week Redberg of UCSF told the oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. “Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,” she said.
– Provided by Kaiser Health News.
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Taking Niacin Does Not Prevent Heart Problems
Giving a high dose of niacin to people with heart disease who are already taking a cholesterol-lowering statin does nothing more to prevent heart attacks and strokes, U.S. government researchers …
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FDA Warns Not to Feed SimplyThick to Premature Infants
Washington, DC, United States (AHN) – Do not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.
This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and die
SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff—himself a neonatologist—explains that the thickening agent is added to infants’ formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.
The Problem
FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.
Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.
At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.
This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.
At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.
In the meantime, adds Klontz, parents should stop using the product even if their babies don’t appear to be sick. “Why take the risk?” he asks.
Symptoms to Watch for
- bloated stomach
- greenish-tinged vomiting
- bloody stools
Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
You or your health care professional may report side effects related to using SimplyThick to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:
Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;
Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.
What FDA Is Doing
FDA is actively investigating the link between SimplyThick and the illnesses and deaths. FDA will provide updates as information is made available.
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FDA weighs revoking approval of Abbott drug
U.S. regulators will ask outside experts if the agency should revoke approval of Abbott Laboratories’ heart medicine Trilipix for use with a cholesterol-lowering statin drug, according to draft questions released on Monday.
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