Cardiovascular
The tubes that power X-ray machines are shrinking, improving the clarity and detail of their Superman-like vision. A team of nanomaterial scientists, medical physicists, and cancer biologists at the University of North Carolina has developed new lower-cost X-ray tubes packed with sharp-tipped carbon nanotubes for cancer research and treatment.
The Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area established by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has issued the MAK and BAT Values List for 2009. This year"s list contains 62 changes and new entries.
The number of people killed by individuals suffering from mental illness in England and Wales increased between 1997 and 2005, figures show. The rise occurred in people who were not under mental health care and was not found in mental health patients.
A small trial testing the benefits in multiple sclerosis (MS) of a drug used to treat type II diabetes, in combination with beta-interferon-1a, has been shown to potentially prevent brain cell loss.
"The current debate over government funding for abortion in the health care plan is a reminder of how we have failed poor women," Frances Kissling writes in a Salon opinion piece. According to Kissling, the 32-year-old Hyde Amendment, which prohibits federal funding for abortion services, has played a large role in denying impoverished women access to the procedure. "Restoring those funds has not been a top priority for pro-choice advocates, who sadly concluded that because the public does not care about poor women and is actually hostile to poor women who have sex and become pregnant, it would be futile to put too much capital into reversing Hyde," Kissling writes.However, "we have an opportunity to make amends" by reversing the Hyde Amendment and restoring federal funding for abortion services, according to Kissling. "But the portents are not promising," she writes, adding that a group of "pro-life" Democrats in the House in a recent letter to House Speaker Nancy Pelosi (D-Calif.) "laid down the first major antiabortion challenge to health care reform." In addition, the Obama administration "has refused to rule out including abortion in the health care package, but President Obama is already signaling that the status quo on abortion is likely to endure," Kissling writes."The longer it takes to pass a plan, the more momentum against including coverage for abortion -- and possibly contraception -- will build," Kissling writes, adding that "there is a good chance there will be limits on government funding for abortions in the health care package, if not outright exclusion." A compromise being considered by the House Energy and Commerce Committee would not prohibit or require private insurers offering government plans from covering abortions but would prohibit the use of federal funds to pay for them. "Whether this would result in a reduction of coverage in such plans is unclear, but it is possible," she continues."The timing is critical. The need is great, and growing," Kissling writes, adding, "If abortion services are excluded from the health care reform package, the number of women who will not be able to afford abortions is bound to rise and the number of unwanted children will increase." Kissling concludes, "One hears over and over again that we all agree that the health care system is broken; the status quo is not acceptable. The status quo on coverage for abortion is especially unacceptable" (Kissling, Salon, 7/27).
The Healthcare Association of New York State (HANYS) called on the State Legislature to pass much-needed legislation that will better protect the rights of incapacitated patients and spare family members from the nightmare of helplessly watching their loved one"s health care wishes go unfulfilled.
By a wide margin, health care leaders believe that individuals should have a choice of public and private health plans, and strongly support other central components of health reform such as innovative provider payment reform and a national insurance health exchange with strong standard-setting authority. In addition, two-thirds (68%) of opinion leaders feel it is urgent to enact comprehensive health care reform this year, according to the latest Commonwealth Fund/Modern Healthcare Health Care Opinion Leaders Survey.
SNM and a coalition of eight other organizations have issued a white paper urging Congress to take steps to maintain adequate supplies of Molybdenum-99 (Mo-99), a radioactive substance that is the basis for a common medical isotope used in more than 80 percent of all nuclear medicine procedures.
Lifepsychol is a new healthcare initiative designed to focus attention on ways to support and improve the quality of life of people with long term conditions.
The HealthGrades Fourth Annual Bariatric Surgery Trends in American Hospitals Study released today identifies 88 hospitals as "best" performers (five-star rated), with mortality rates, complication rates and patient lengths of stay that are dramatically lower than poorly rated hospitals.
The Cambodian Ministry of Health has begun training primary education teachers in 12 provinces on HIV/AIDS prevention education, the Phnom Penh Post reports. Health officials said that although children in primary school are not seen as a high-risk population, they need to be educated on the disease. Mean Chhi Vun -- director of the National Center for HIV/AIDS, Dermatology and STDs -- said the students "are a group of people we have to pay attention to because they ... will be the backbone of the nation." Secondary-school aged students currently are receiving HIV/AIDS education, and the programs are being used as a model for the new primary school initiative, according to Pen Saroeun, director of the Ministry of Education"s School Health Department. Some health officials have said that young people are becoming increasingly at risk for HIV, and most outreach efforts target commercial sex workers and their clients and not young people, the Post reports. Saroeun noted that the HIV/AIDS prevention education program has been successful in secondary schools and is the reason the ministry decided to launch the program in primary schools, adding that many students drop out before reaching secondary school. He said, "We will teach them basic knowledge about HIV/AIDS and life skills, such as negotiation skills, how to say "no," goal setting, and how to provide care and support to people living with HIV/AIDS." The ministry plans to double the $100,000 it allocated to HIV/AIDS education spending last year with additional funding from the United Nations Population Fund, according to Saroeun. He added, "If we are successful in those 12 provinces, then we will do it in the other provinces" (Kunthear, Phnom Penh Post, 5/19).
England"s ethnic minorities are just as likely to access GP services as their white counterparts and have similarly positive clinical outcomes, a study published this month has found.
Three studies published on bmj.com examine the merits of conservative versus aggressive treatment policies of women with low-grade abnormal results detected by cervical screening.
For many women, hormone replacement therapy (HRT) can alleviate the physical symptoms associated with the change of life. But despite the initial hype generated by post-menopausal women who noticed a marked improvement in their skin"s appearance while on HRT, dermatologists argue that scientific studies of estrogen do not show definitive improvements for skin rejuvenation of photodamaged skin and the potential risks when used long-term outweigh any potential skin benefits.
ImmuneRegen BioSciences(R), a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC Bulletin Board: IRBS), reports preliminary evidence that its selective Neurokinin 1-receptor agonist Homspera(R) is both active on oral administration and provides therapeutic effects against the current pandemic H1N1 virus infection.
Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) approved Sculptra(R)Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra(R)Aesthetic works gradually to offer natural-looking results that can last up to two years.
Today, there are more ways than ever before to "get a little work done." From skin fillers to fat-reduction procedures, the options are endless for those looking to improve their appearance and boost their self-esteem. But with so many physicians and options from which to choose, consumers can be confused about where to start and who to trust to perform a cosmetic procedure.
As we age, brown spots and splotchy skin are all too often a fact of life. But for people with darker skin, changes in pigmentation can occur without warning at any age and can be very difficult to treat. Fortunately, dermatologists can help people with skin of color diagnose and treat bothersome pigmentation problems.
Trusted health care s and continuity of care may help reduce the risk of prostate cancer deaths in African-American men, according to a study published in the current issue of the journal Cancer. James Mohler, MD, Chair of the Department of Urology at Roswell Park Cancer Institute (RPCI), and William R. Carpenter, PhD, Department of Health Policy and Management at the University of North Carolina, are lead investigators.
Female recipients of kidneys from deceased male donors demonstrate an increased risk of allograft failure in the first year after transplant, but show no increased risk after ten years, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN). The study authors note that proteins on male donor cells may affect the short term success of kidney transplants in women.
A new study reports what scientists term the first scientific evidence that freshly crushed garlic has more potent heart-healthy effects than dried garlic. Scheduled for the Aug. 12 issue of the Journal of Agricultural and Food Chemistry, it also challenges the widespread belief that most of garlic"s benefits are due to its rich array of antioxidants. Instead, garlic"s heart-healthy effects seem to result mainly from hydrogen sulfide, a chemical signaling substance that forms after garlic is cut or crushed and relaxes blood vessels when eaten.
Scott Roeder, the man charged with the May 31 shooting death of abortion provider George Tiller, pleaded not guilty to first-degree murder and aggravated assault at a Wichita, Kan., hearing on Tuesday, the AP/Boston Globe reports (AP/Boston Globe, 7/29). After witnesses described events surrounding the shooting, the judge presiding over the hearing concluded that there was sufficient evidence to try Roeder. Tiller was murdered in the foyer of his church, where he was serving as an usher. According to several church members who testified Tuesday, Roeder occasionally had come to the church in the months before the shooting.The trial is scheduled to begin Sept. 21 (Davey, New York Times, 7/28). At the hearing, Roeder made no public comments, and the not-guilty plea was entered by the public defender representing him in the case (AP/Boston Globe, 7/29).If convicted, Roeder likely will face life in prison, as the case does not meet state criteria for the death penalty. His lawyers declined to comment on their defense plans (New York Times, 7/28).
The Washington Post: "Three Democrats and three Republicans on the Senate Finance Committee are expected to wrap up their arduous multi-week talks in the coming days, and Majority Leader Harry M. Reid (D-Nev.) said he expects a panel vote before the Senate recess, which will begin Aug. 7. Assuming the fragile committee coalition holds, the legislation it produces would scramble the reform landscape by introducing policy ideas that have their origins in the political center. The bill is bound to disappoint liberals."
On Tuesday, President Obama pitched Democrats" health reform plans to senior citizens and assured them that Medicare benefits would not be cut to pay for covering the uninsured, the New York Times reports. Meanwhile, members of Congress said they were "deluged" with constituent calls expressing concern over the future of their Medicare coverage.
"You can think of Congress"s efforts to pay for health reform as being a little bit like a battle to slay a many-headed Hydra," writes the New York Times" economic columnist, David Leonhardt. Congress has floated idea after idea for paying for comprehensive health reform, but their proposals have failed to make ends meet because they "do not raise revenue as quickly as health costs rise." Most new taxes - such as a surtax on the rich proposed in the House - increase only as quickly as the economy, while health costs have inflated much more quickly over the last decade.
Lawmakers push bill to fight Medicare fraud as part of health reform legislation.
Researchers at Dana-Farber Cancer Institute have shown that they can engineer mouse and human cells to produce brown fat, a natural energy-burning type of fat that counteracts obesity. If such a strategy can be developed for use in people, the scientists say, it could open a novel approach to treating obesity and diabetes.
Researchers at the University of Maryland Marlene and Stewart Greenebaum Cancer have found that head and neck cancer patients who test positive for the human papillomavirus (HPV) have much better survival rates than patients who don"t have the virus, according to a new study in the journal Cancer Prevention Research. The researchers also discovered that blacks in the study had a very low rate of HPV infection, and consequently worse survival, which may explain why African-American patients traditionally have had a poor prognosis for head and neck cancer.
Anaesthetists in the UK and Ireland have been issued with new guidelines on how to
A unique event to discuss Autism and employment was held at Goldsmiths, University of London this week. For the first time charities, researchers, business and government were brought together to look at how people with Autism, and related disorders, can be supported effectively into employment.
The Royal Pharmaceutical Society has called for clarification of the responsible pharmacist requirements but will not be asking the Department of Health to amend the commencement date of the regulations.
In what will be the Stem Cell Awareness Association"s seventh awareness rally, past patients, interested physicians, and prospective patients will meet in Manchester to learn about stem cell technologies and discuss the various current treatments available throughout the world.
The American Lung Association will tell the Environmental Protection Agency (EPA) at a public hearing today to adopt even stronger, health-based national air quality standards for nitrogen dioxide (NO2) than what the agency proposed. Lung Association leadership and healthy air advocates will call for tighter standards at the hearing that begins at 9:00 AM at the EPA Potomac Yard Conference Center located at 1 Potomac Yard, 2777 South Crystal Drive in Arlington, Va. Mary Partridge, American Lung Association National Board Chair, is scheduled to speak at 10:15 AM. The hearing will conclude at 9:00 PM.
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, held a conference call yesterday morning, a replay of which is available by dialing (888) 203-1112 and entering passcode 4461002.
Sirona Biochem Corp. (TSX-V: SBM), an emerging biotech company focused on diabetes and obesity, announced today that it has now taken delivery of its first batch of unique SGLT compounds from its French partner TFChem (Rouen, France) for screening and evaluation.
[Is ambulance telephone triage using advanced medical priority despatch protocols able to identify patients with acute stroke correctly? Emerg Med J 2009; 26: 442-5]
By systematically analysing MRI changes occuring in the brains of children with the metabolic disease glutaric aciduria type I researchers at Heidelberg University Hospital have succeeded for the first time in demonstrating reversible and permanent brain damage as well as elucidating its temporal evolution.
A research team comprised of faculty at Worcester Polytechnic Institute"s (WPI) Life Sciences and Bioengineering Center (LSBC) and investigators at CellThera, a private company also located at the LSBC, has discovered a novel way to turn on stem cell genes in human fibroblasts (skin cells) without the risks associated with inserting extra genes or using viruses. This discovery opens a new avenue for reprogramming cells that could eventually lead to treatments for a range of human diseases and traumatic injuries by coaxing a patient"s own cells to repair and regenerate the damaged tissues.
Breast cancer patients have for the first time been recruited from China to take part in an international trial of breast radiotherapy.
A study published online ahead of press in the Gerontology Society of America"s Journal of Gerontology: Medical Sciences reports that the condition of frailty in older adults is associated with a critical mass of abnormal physiological systems, over and above the status of each individual system, and that the relationship is nonlinear. This research is the first evidence that frailty is related to the number of abnormal physiological systems, rather than a specific system abnormality, a chronic disease, or chronological age. It suggests significant alterations in system biology with aging, and underlying frailty. Clinical implications are that prevention and treatment may be more likely to be effective if any given intervention improves multiple systems, not just one.
[Efficacy and safety of comfrey root extract ointment in the treatment of acute upper or lower back pain: results of a double blind randomised placebo controlled multicentre trial Online First Br J Sports Med 2009; doi: 10.1136/bjsm.2009.058677]
Memory is a fundamental function of nerve cells in the brain, and loss of memory is a key symptom in many people with Alzheimer"s disease.
A new report published highlights that 99% of ready-to-eat speciality meats sold in the UK are safe to eat. However the study also reveals that a very small proportion of the meats contained Salmonella or unsafe levels of Listeria monocytogenes.
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:SSS) is pleased to announce the acceptance and publication of the paper entitled "Open labeled, uncontrolled pharmacokinetic study of single intramuscular hCG dose in healthy male volunteers" by the International Journal of Clinical Pharmacology and Therapeutics, Vol. 47, August 2009. This paper was authored by Drs. Alan Moore, President & CEO, Allen Davidoff, VP Product Development and Yan Yang, Clinical Research Associate, all of SCT; Dr. Michael D. Hill of Foothills Hospital at the University of Calgary, and Dr. Steven C. Cramer, from the University of California, Irvine.
OmniComm Systems, Inc. (OTC Bulletin Board: OMCM), a leader in integrated electronic data capture (EDC) solutions for clinical trials announced that a growing US Clinical Research Organization (CRO) has selected OmniComm to provide eClinical solutions in connection with two of the CRO"s Phase IV studies covering approximately 27 sites and more than 700 subjects. Additional details were not disclosed. Phase IV studies take place after a drug has been approved for marketing and are designed to provide broader experience in evaluating the safety and effectiveness of the new medicine in larger numbers of patients, subpopulations of patients, and to compare and/or combine it with other available treatments.
A new analysis finds that women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular antidepressants may be at a higher risk for a breast cancer recurrence.
United Therapeutics Corporation (Nasdaq: UTHR) announced that the United States Food and Drug Administration (FDA) has approved TYVASO (treprostinil) Inhalation Solution for the treatment of pulmonary arterial hypertension (PAH) using the TYVASO Inhalation System (which includes the Optineb-ir device and accessories). TYVASO is indicated to increase walk distance in patients with NYHA Class III symptoms associated with WHO Group I PAH, which includes multiple etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.
WellPoint, Inc. (NYSE: WLP) announced today that it will offer coverage for the administration of the H1N1 (swine flu) vaccine when it becomes commercially available to the general public. The vaccine administration will be covered for members whose benefit plans provide coverage for vaccines.
Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced finalization of the protocol for the Company"s Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the United States Food and Drug Administration (FDA), and patient dosing is expected to commence within the next several weeks.
The future use of Independent Sector Treatment Centres (ISTCs) in the NHS, will be fairer and on the same terms as other providers of NHS services, Health Minister Mike O"Brien announced today.
Janet Davison Rowley, MD, a pioneer in demonstrating that cancer is a genetic disease, will receive the 2009 Presidential Medal of Freedom the White House announced Thursday. President Barack Obama will award the Medals of Freedom, the nation"s highest civilian honor, to Rowley and 15 others at a ceremony Wednesday, August 12.
When the H1N1 flu vaccine becomes available in the fall, pregnant women should be among the first groups vaccinated because of their high risk for serious complications, a Centers for Disease Control and Prevention expert panel said on Wednesday, the Washington Post reports. The 15-member committee advises CDC on vaccine policy. The priority list also includes caretakers of infants, health care workers, children and young adults, and older people with chronic conditions. Anthony Fiore, a physician and epidemiologist at CDC, told the committee that about 6% of H1N1 deaths and hospitalizations are among pregnant women (Brown, Washington Post, 7/30). According to a CDC study published online Wednesday in the journal Lancet, pregnant women who contract the H1N1 virus -- also known as "swine flu" -- are at least four times more likely to be hospitalized than other people with the virus, the AP/Google reports. The study analyzed the first 34 U.S. cases, including six deaths, in pregnant women from April to mid-June of 2009. Although it is not clear if pregnant women are more susceptible to the virus, they have a higher risk of complications after becoming infected. The study"s authors said pregnant women suspected of having H1N1 should be administered Tamiflu as soon as possible, prior to the completion of diagnostic testing. CDC"s Denise Jamieson, the lead author of the study, said that Tamiflu appears relatively safe for pregnant women, despite limited safety data on its use in that population.Most pregnant women who contract H1N1 have mild flu symptoms like a cough or fever, according to the World Health Organization. Jamieson said that CDC does not recommend specific precautions for pregnant women but that doctors should act quickly -- preferably within 48 hours -- if a pregnant woman shows symptoms. She added that the pregnant women who died were basically healthy, and nearly all had viral pneumonia before experiencing acute respiratory problems prior to their death (Cheng, AP/Google, 7/29).CDC"s priority groups include about 159 million people out of a total U.S. population of more than 300 million, the Chicago Tribune reports. The agency expects to have about 120 million doses of the vaccine by the end of October. Officials are confident there will be enough for their target groups because only 20% to 50% of those recommended to receive seasonal flu vaccines seek them out. However, if supplies of the vaccine are unexpectedly restricted, the panel recommended that a smaller group -- about 41 million of the most susceptible to adverse side effects from infection or most likely to spread the virus -- be given priority for the vaccine. This smaller group also includes pregnant women (Maugh, Chicago Tribune, 7/30).
A new rapid urine test for chlamydia in men identified 84% of infections, according to a study of 1,200 men published Tuesday in the British Medical Journal, Reuters reports. Chlamydia is the most common sexually transmitted infection among women and can be treated easily with antibiotics. However, the STI often goes undiagnosed and causes no symptoms in 70% of cases. It can lead to pelvic inflammatory disease, ectopic pregnancy and infertility. It also can make women more vulnerable to HIV.Rapid tests for chlamydia in men often have been inconclusive and uncomfortable, involving a painful swab of the urethra. The developer of the new test, Helen Lee of the University of Cambridge, said, "This has led to many cases of infection in men going undiagnosed and being transmitted to their female partners, with potentially more serious complications." The new test is "both accurate and swift, allowing men attending the clinics to be tested and treated on site in one visit," according to Lee. She said that the test already is approved in France and soon will be available in Italy, Spain, Portugal and other European countries (Reuters, 7/28).
"Congressional Democrats are determined to show progress on health care overhaul by pushing President Barack Obama"s top domestic priority through two critically important committees before they head home for their August break," the Associated Press reports. "In the Senate, negotiators on the Finance Committee say they are nearer to a bipartisan compromise that has eluded them for weeks" (Alonso-Zaldivar and Werner, 7/30).
Two new polls show support for President Barack Obama"s health care efforts slipping over the past month.
Today, U.S. Senators Amy Klobuchar (D-MN), Herb Kohl (D-WI) and Al Franken (D-MN) introduced legislation to reform the Medicare payment system to reward hospitals for quality, efficient care. The Medicare Payment Fairness Act of 2009 would reform Medicare by paying hospitals for the quality, not quantity, of care. These changes would reduce the regional differences in Medicare spending by shifting the nation to a coordinated, integrated delivery system - like Minnesota, Wisconsin, and other states. Studies have shown that more integrated care could save taxpayers an additional $100 billion a year.
"Expanded testing across India in the past three years shows a 2,000 percent jump in the number of HIV cases among children, [Ghulam Nabi Azad] the country"s health minister announced Wednesday," CNN reports. As of May 2009, reports found that nearly 53,000 children are living with HIV in India - up from 2,253 recorded cases in November 2006, Azad said during an address to the parliament (Singh, 7/29).
Columnist Sees "Dawn Of A Global Movement Against Maternal Mortality"
There is growing concern among California HIV/AIDS advocates "that the Golden State will reverse course and see spikes in new HIV cases after Republican Governor Arnold Schwarzenegger this week further slashed the state Office of AIDS budget in order to deal" with a more than $20 billion deficit, the Bay Area Reporter reports (Bajko, 7/30). David Brinkman, executive director of the Desert AIDS Project in Palm Springs, which provides services to people living with HIV in the area, said, "This is the worst-case scenario cut. It"s going to cut, possibly eliminate [HIV] education" (Brambilla, Desert Sun, 7/29).
Migraine headaches are a drain - not only on the estimated 30 million Americans who suffer from them, but on the economy, too. Because pain and other symptoms caused by migraine headaches can be quite severe, it is projected that nearly $13 billion is spent every year in headache treatment and loss of time from work, which no one can afford these days. But according to a new study in Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS), there is hope for severe and frequent migraine sufferers who can"t find relief in conventional remedies.
One of the most well-known psychological tools is the Rorschach Inkblot Test. A viewer looks at ten inkblots, one at a time, and describes what they see. The rationale behind this test is the idea that certain aspects of the subject"s personality will be exposed as they are interpreting the images, allowing for the possible diagnosis of various psychological disorders. However, does the inkblot really reveal all? Psychological Science in the Public Interest, a journal of the Association for Psychological Science, published an exhaustive review of all data on the Rorschach (and other similar "projective" tests) in 2000. Such meta-analyses are major undertakings, so although this report is a few years old, it remains the most definitive word on the Rorschach. According to authors Scott O. Lilienfeld of Emory University, James M. Wood of University of Texas at El Paso, and Howard N. Garb of the University of Pittsburgh, despite its popularity, the Rorschach may not be the best diagnostic tool and practitioners need to be cautious in how they use this technique and interpret their results.
A study by Kansas State University researchers is looking at how children perceive and interact with peers who have various undesirable characteristics, such as being overweight or aggressive.
The second wave of Integrated Care Pilots should be developed among existing promising commissioners and providers to encourage a complete restructuring of the way primary and secondary work together.
Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug Administration (FDA) has approved ACUVAIL(TM) (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery. Cataracts are a leading cause of blindness among older adults and cataract surgery is the most frequently performed surgical procedure in the United States, with more than 3 million procedures performed each year.1
Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ISENTRESS®. The broadened indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatment-experienced adult patients. ISENTRESS is used in combination with other antiretroviral (ARV) medicines for the treatment of HIV-1 infection in adult patients. The indication for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 48 weeks in three double-blind controlled studies. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRT, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
Merck is committed to putting patients first and providing accurate information regarding the efficacy, safety and tolerability of our medicines. Merck offers the following statement concerning the osteoporosis medication FOSAMAX® (alendronate sodium) and reports of jaw problems associated with delayed healing and infection of the jaw often following tooth extraction. The condition is known as osteonecrosis of the jaw (ONJ).
GSK announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES).
The House Energy and Commerce Committee on Thursday continued work on health care reform legislation (HR 3200), passing an amendment that would neither require nor prohibit insurance companies from providing coverage for abortion services, the New York Times reports. The amendment, offered by Rep. Lois Capps (D-Calif.) and approved by a 30-28 vote, excludes abortion services from the "essential benefits package" that would be defined by the government. While the committee"s reform bill includes subsidies to help pay premiums for low-income people, the amendment prohibits these subsidies from paying for abortion services, stipulating that "insurers must use money from private s to pay for any abortion," the Times reports. The amendment also requires that at least one plan covers abortion services and one does not in every part of the country (Herszenhorn/Pear, New York Times, 7/31).The committee also rejected an amendment that would have been a blanket prohibition on abortion coverage in both public and private plans governed by health care reform legislation, except in very limited cases, the AP/Google reports. The amendment initially was approved when conservative Democrats joined Republicans in supporting it. However, hours later, committee Chair Henry Waxman (D-Calif.) invoked House rules that allowed him to call for a second vote on the amendment. It was then rejected by a 29-30 vote when Rep. Bart Gordon (D-Tenn.) changed his vote from "yes" to "no," and Rep. Zack Space (D-Ohio) voted "no" after abstaining the first time (AP/Google, 7/31). The failed amendment was introduced by Reps. Joe Pitts (R-Pa.), Bart Stupak (D-Mich.) and Roy Blunt (R-Mo.) (Amendment text, 7/30).According to the Times, Democrats on the committee also defeated Republican efforts to eliminate a section of the reform bill that would create a public health insurance plan option (New York Times, 7/31). The AP/Yahoo! News reports that the Energy and Commerce Committee is the last of three House committees to act on health care reform legislation. The Energy and Commerce Committee is expected to finish its work on Friday.The Senate has not matched the House"s progress on reform legislation, as bipartisan negotiators on the Senate Finance Committee Thursday said they need more time to produce an agreement for the committee to review (Werner, AP/Yahoo! News, 7/31). The Finance Committee negotiations between three Democrats and three Republicans, including the committee chair and ranking GOP member, are ongoing as they try to agree on a bipartisan bill that can win at least 60 votes on the Senate floor, CQ Today reports (Jansen/Epstein, CQ Today, 7/30).
Intrauterine devices "seem like the perfect form of contraception: simple to use, long-lasting, reversible, hormone-free, economical," Slate columnist Kate Klonick writes. She asks, "So why are American women so late to this party? Perhaps the better question is: Why did they leave the party to begin with?"Klonick explains the benefits of IUDs, calling them a "foolproof method of birth control" and noting that they are 99% effective and "can last up to 10 years." Although IUDs can cost between $300 and $500, it is a one-time expense that is often covered by insurance, according to Klonick. She notes that although efficacy studies show that birth control pills, patches and vaginal rings can be "99% effective in a clinical setting, real-life compliancy -- like forgetting to take the pill at the same time every day -- reduces its success rate." Klonick adds that the availability of hormone-free IUDs makes them an "ideal" option for "women prone to some of the negative effects of hormonal birth control, like weight gain, mood swings, acne or high blood pressure."According to Klonick, IUDs were used by almost 10% of U.S. women taking birth control in the late 1970s but are now used by less than 2% of such women. She writes that Katharine O"Connell, a gynecologist at Columbia University who specializes in contraception, believes IUDs still carry a stigma "due to the erroneous belief that they"re highly dangerous" partly due to a number of deaths that occurred in the early 1970s tied to a specific brand of IUD known as the Dalkon Shield. Because of bad publicity surrounding the devices, "the U.S. pharmaceutical industry abandoned the research and manufacturing of IUDs in the mid-1980s, claiming the devices were no longer profitable," Klonick states. According to O"Connell, most experts now agree that the Dalkon Shield"s problems were related to its design, which made users more susceptible to infection, and a lack of testing for sexually transmitted infections before insertion.There are now two major brands of IUDs -- Mirena and ParaGard -- on the U.S. market, but physican training remains a problem, according to Klonick. She writes that studies show that premedical students are not educated regarding IUDs to the extent they are about oral contraceptive pills. O"Connell also noted that many medical schools limit classes on contraception to one lecture, which often omits IUDs. Klonick writes, "This lack of training can leave many doctors feeling uncomfortable recommending the once-controversial devices to their patients." She adds that many physicians who know how to insert and remove IUDs "still refuse to recommend it to childless patients because of the device"s checkered history." She concludes, "With Mirena advertising on television, the downturn in the economy forcing people to economize, and more women concerned about the long-term effects hormones have on their bodies, perhaps the IUD"s stigma will finally become a thing of the past" (Klonick, Slate, 7/29).
"Healthcare companies are spending millions of dollars and marshaling armies of lobbyists to influence a landmark debate in the U.S. Congress that could dramatically change the way they do business," Reuters reports. "Drugmakers, doctors, insurers and hospitals have opened their wallets, spending more than $1 million a day to buy a voice in the escalating political battle over what could be the broadest revamp of healthcare laws in decades." And "as the debate has unfolded, key lawmakers have seen a surge in campaign donations, and hundreds of lobbyists have jammed Capitol hallways and lined the reception room outside the Senate chamber to talk to lawmakers." Sheila Krumholz, executive director of the Center for Responsive Politics, says "there is a frenzy going on to get in your two cents worth before the legislation reaches the next stage."
"Creating an electronic health record for every American by 2014 is a big part of Obama"s agenda but it may be easier said than done," CNN Money reports. "For one, the cost can be prohibitive - easily running into the tens of millions of dollars. Getting physicians on board can be challenging. And the sheer magnitude of implementing the technology can be overwhelmingly cumbersome - translation: try creating a system for a hospital that serves 600,000 patients." The ambitious idea is to eventually create a network between hospitals and doctors offices all across the nation (Goldman, 7/31).
"A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply [known as adjuvants] would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial," Bloomberg writes. On July 7, the WHO recommended the use of adjuvants - "mixes of oil and water that trigger a stronger response in the body to antigen, the substance that induces immunity" - to increase the global vaccine supply. Though adjuvants are not approved for flu vaccines in the U.S., HHS" decision to declare the H1N1 flu a public health emergency in April gave the FDA the go-ahead to use "unapproved medical products including adjuvants," according to Bloomberg.
According to the latest data in a clinical study supported by St. Jude Medical, Inc. (NYSE:STJ), deep brain stimulation (DBS) therapy for depression may provide sustainable improvement in depression symptoms among patients with major depressive disorder. Study results will be presented at the American Psychiatric Association (APA) meeting in San Francisco.
Taking the most commonly-prescribed anti-diabetic drug, metformin, reduces an individual"s risk of developing pancreatic cancer by 62 percent, according to research from The University of Texas M. D. Anderson Cancer Center, published in the Aug. 1 issue of Gastroenterology.
"American seniors have a lot at stake in this health care reform debate and
While state insurance regulators are working hard to keep most insurance oversight squarely in their hands, they are actively promoting new federal mandates and rules for health insurance-with a major caveat, according to a story in BestWeek U.S./Canada.
New research suggests that 7 out of 10 children in the US have low levels of vitamin, nudging millions of them toward higher risk of bone disease, high
Parents of newborns who tip the scales at less than 5 ÷½ pounds should put some heavy thought to a possible future consequence: kidney disease. Low birth weight babies have a 70% greater risk of developing chronic kidney disease (CKD) in later life, according to research published in the August issue of the American Journal of Kidney Diseases, the official journal of the National Kidney Foundation.
Four simple questions on well-being asked at the start of each session of ongoing couples therapy can greatly increase chances for reconciliation and improved relationships, according to a newly published study. The largest clinical trial with couples to date, it shows that divorce and separation rates for couples that used this feedback technique were 46.2 percent less than that of couples who received therapy as usual. The findings, published in the August 3, 2009, Journal of Consulting and Clinical Psychology, are the results of a 2-year study conducted at the Vestfold Family Counseling Center in Norway by a U.S.-Norwegian team of researchers.
Thomson Reuters with Discovery Logic, Inc. announced that the National Institutes of Health (NIH) has chosen Web of Science((R)) data to power the NIH electronic Scientific Portfolio Assistant (eSPA). eSPA is an information technology system designed to assist NIH grants management officials in creating grant portfolios and tracking research outputs and outcomes, including publications and citations.
A paper just published in the British Journal of Pharmacology reports that a compound originally isolated from a soft coral (Capnella imbricate) could lead scientists to develop a new variety of treatments for neuropathic pain. This composite is collected at Green Island off Taiwan and could be a new option for treatment. Neuropathic pain is chronic and occasionally follows damage to the nervous system. Presently this type of pain is very poorly controlled by the usual analgesics: aspirin like drugs (NSAIDS) or even opioids like morphine. New treatments are urgently required.
Ovarian cancer is any cancerous growth that may occur in different parts of the ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. According to the American Cancer Society it is the 8th most common cancer among women in the USA (excluding non-melanoma skin cancers). In the UK ovarian cancer is the fifth most common cancer among females, after breast cancer, bowel cancer, lung cancer and uterine cancer (cancer of the uterus).
In the final week of debate before the Senate recess, the Finance Committee continues talks on bipartisan legislation, but both Republicans and Democrats are ramping up their health care rhetoric and considering more drastic options.
House Democrats celebrated late last week the passage of a health reform bill out of the House Energy and Commerce Committee, but they still face a lot of work when they return in September, Roll Call reports.
"Confusing claims and outright distortions have animated the national debate over changes in the health care system," the Associated Press reports. The AP lists examples:
A former Clinton administration official said last week that there aren"t enough doctors in America to handle the increase in patients if health reform covers more uninsured, NPR reports.
The House Energy and Commerce Committee passed an amendment to their broad health reform bill giving drug makers 12 years of exclusive rights to market new biologic drugs, "a setback" to the administration and consumer advocates who hoped to make generic drugs more widely available, the Wall Street Journal reports. The panel voted 47-11 on the measure, which "would also allow "evergreening," the practice by pharmaceutical companies of making minimal adjustments to their drugs, such as creating extended-release versions, as a way to lengthen their monopoly."
North Dakota Judge Douglas Herman failed to issue a temporary injunction on Thursday to prevent a state law from going into effect that requires abortion clinics to offer women the chance to view ultrasound images 24 hours prior to obtaining an abortion, the AP/Bismarck Tribune reports. Judge Herman promised to issue an opinion "as soon as possible" on the constitutional challenge to the state law, which is set to take effect on Aug. 1. The Center for Reproductive Rights filed the challenge, arguing that it creates an unnecessary burden on a woman"s right to an abortion.The group also said that a provision in the law is confusing and that the state"s only abortion provider is unsure how to comply. According to the AP/Tribune, the provision in question reads: "The auscultation of the fetal heart tone must be of a quality consistent with standard medical practice in the community." Suzanne Stolz, an attorney for CRR, said the bill"s language could require the Red River Women"s Clinic -- the only abortion clinic in the state -- to offer women the chance to hear audio of the fetal heartbeat in addition to the ultrasound image. She added that the clinic "cannot afford to guess what the law means and hope that it is right."Assistant Attorney General Douglas Bahr said that the law requires the clinic only to offer the option of an ultrasound, not provide one. He added that most people understand that an ultrasound includes both images and audio and that he does not "know why the clinic doesn"t feel it can offer this to the patient." Cass County state"s attorney Birch Burdick, a co-counsel with Bahr, said that although some of the language in the law is "a little confusing," he would not prosecute clinic officials if they make an attempt to apply the law until the judge rules.Tammi Kromenaker, the director of the clinic, said, "We"re disappointed that we did not get an injunction today but we felt that some of our questions were answered," adding that the clinics had offered women the option of viewing an ultrasound for the last 18 months (Kolpack, AP/Bismarck Tribune, 7/31).
Over the past 50 years, the field of wildlife disease as an issue for concern has exploded in significance, mostly because of the increased realization that most emerging human diseases are "zoonotic," that is, diseases that can spread from people to other animals or vice-versa. USGS emeritus scientist Dr. Milton Friend, in an invited talk at the Wildlife Disease Association conference, will explore how and why the field of wildlife disease research has changed over the last 50 years.
Interventional radiology procedures are on the rise in developing countries and there is a significant need for optimization of these procedures to ensure patient safety. Many facilities in these countries lack the concept of patient dose estimation and dose management, putting patients at a higher risk of developing complications due to overexposure from radiation during interventional procedures, according to a study performed by the International Atomic Energy Agency in Vienna, Austria.
A consultation on whether, and if so, how, practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated was launched today by the Department of Health.
As a fetus does not mount an immune response to maternal proteins that cross the placenta, it has been assumed that a fetus would not reject non-genetically matched blood cells (specifically allogeneic blood cells) if they were transplanted while the fetus was in utero. The hope is that this procedure, which is known as IUHCT, could provide a viable approach for treating congenital blood disorders. However, studies using a mouse model of IUHCT indicate that most fetal recipients of allogeneic blood cells lose their transplanted cells 3-5 weeks after transplantation. Alan Flake and colleagues, at Children"s Hospital of Philadelphia, have now identified an immune mechanism responsible for graft failure in this model of IUHCT. Surprisingly, although fetal immune cells eliminated the transplanted allogeneic blood cells, they were triggered to do so by immune molecules known as alloantibodies that they obtained from their mother"s breast milk. The maternal alloantibodies were produced in response to IUHCT and so the authors conclude that in the absence of either a maternal immune response or transmission of the maternal alloantibodies to the fetus, transplanted blood cells should not be rejected, leaving open the door for IUHCT as a potential clinical strategy.
The new medical consensus statement on accelerated partial breast irradiation is an important step toward defining patient selection criteria and highlights the importance of targeting radiation, said two of the nation"s leading APBI physicians.
Heart specialists at St. Joseph Hospital in Orange, Calif. have performed a new procedure in which they repaired a hole in the patient"s heart through a tiny incision, offering the patient a much safer alternative verses open heart surgery.
BioTrends Research Group, Inc. released TreatmentTrends(R): US Nephrology, a syndicated report analyzing treatment practices, attitudes and perceptions based on online survey results from over 200 US Nephrologists. The survey was fielded in late May and focuses on trends in treatment patterns for renal anemia, secondary hyperparathyroidism and hyperphosphatemia.
Feelings of depression could be one reason patients fail to follow their doctors" orders on exercising and eventually become less physically active, a new research review finds.
An article published Online First exposes the facts of the poisoning of Ukrainian President Victor Yushchenko in 2004. It is the work of Professor Jean Saurat, from the Swiss Centre for Human Applied Toxicology, and the University Hospital, in Geneva, Switzerland, and his collaborators. It establishes that there is a need for routine analytical techniques to test for metabolites of TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) which is a type of dioxin and the poison that was used. This will help to provide proper treatment.
"House liberals are offended that Speaker Nancy Pelosi (D-Calif.) mocked their threats to oppose a Democratic healthcare bill, saying leaders are underestimating their frustration over a deal cut with centrist Blue Dogs," The Hill reports. "Rep. Lynn Woolsey (D-Calif.), co-chairwoman of the Congressional Progressive Caucus, on Monday expressed outrage at the comments and said her group is being "laughed at." Woolsey is the author of a letter signed by 60 fellow House liberals vowing to vote against a deal cut with the Blue Dogs ... Woolsey said the signers of the letter plan to "remind leadership" of the group"s support for a "robust public option." "Robust" to liberals generally means similar to Medicare. Liberals are irritated leaders granted Blue Dogs" concessions that prevent the public option from using Medicare rates for reimbursement. They believe that will make care too expensive for many people" (Soraghan and Allen, 8/3).
Major groups are promising that the August recess will be filled with advertising wars trying to manage the message of the health care reform debate, Politico reports.
A report from President Obama"s Council of Economic Advisers finds that "health care reform would be good for small businesses because it would enable them to obtain better insurance coverage for less money," The Denver Business Journal writes. "Small businesses pay up to 18 percent more than large businesses do for the same coverage because of high broker fees, administrative costs and adverse selection, according to the CEA"s report." Christina Romer, chair of the CEA, "said the health care reform bills moving through Congress are specifically designed to address the burden the current health care system places on small businesses. The legislation would create insurance exchanges, where individuals and small businesses could "choose among a multitude of plans that would provide better coverage at lower costs than they could find in the current small group market," the report said." But, The Journal notes: "Many small business groups also doubt that health insurance would be cheaper under the House bills or the Senate HELP Committee bill. Including a government-run plan in the insurance exchange would undermine private insurers, ultimately driving premiums higher, they contend. Not all small businesses would be able to access the exchange. Plus, the bills call for the federal government to establish minimum coverage levels for insurance plans, which could be pricier than what small businesses now provide. (Hoover, 8/3).
Kaiser A small, rural hospital in Missouri is "rolling the dice" on electronic medical records, its CEO tells the Associated Press. The 47-bed hospitals borrowed nearly $1 million to implement an electronic records system, and that"s on top of a $370,000 operating deficit and staff layoffs. The executives are banking on a government bailout in the form of a "$3 million windfall" of stimulus-funded incentives for hospitals to switch to electronic record-keeping.
Efforts to standardize quality measures for medical tourism are underway as Mexico tries to attract medical tourists. Such efforts come after the swine flu outbreak significantly hurt Mexico"s tourism industry, which ranks third as the country"s of foreign income
"Malaria may have jumped to humans from chimpanzees much as AIDS did, U.S. researchers reported on Monday in a [Proceedings of the National Academy of Sciences] study they hope could help in developing a vaccine against the infection," Reuters reports. The researchers found evidence the Plasmodium falciparum parasite that "causes most cases of malaria is a close genetic relative of a parasite found in chimpanzees," the news service writes (8/4).
Large number of individuals, such as recovery and rescue workers, nearby residents and office workers, who experienced intense or prolonged exposure to the World Trade Center attack have reported new diagnoses of asthma or posttraumatic stress 5-6 years after the attack, according to a study in the August 5 issue of JAMA, a theme issue on violence and human rights.
Elderly individuals who have a report of self-neglect or abuse submitted to a social service agency have an associated increased risk of death, according to a study in the August 5 issue of JAMA, a theme issue on violence and human rights.
Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the journal Lung Cancer has published the results of a single-arm phase II trial of ASA404 in non-small cell lung cancer (NSCLC). The trial included patients with both major histological forms of NSCLC: squamous and non-squamous. Positive data from this trial supported the progress of ASA404 into phase III trials in patients with NSCLC of all histologies.
Researchers from The University of Texas at Austin will participate in a $3 million, five-year grant from the National Institutes of Health (NIH) to fight influenza and other diseases by creating models that simulate the complex interplay between human behavior and the spread of disease.
How you eat may be just as important as how much you eat, if mice studies are any clue.
Elevated cholesterol levels in midlife - even levels considered only borderline elevated - significantly increase the risk of Alzheimer"s disease and vascular dementia later in life, according to a new study by researchers at Kaiser Permanente"s Division of Research and the University of Kuopio in Finland. The study appears in the journal Dementia & Geriatric Cognitive Disorders.
Change the lighting; improve your health. It"s a strategy researchers from Case Western Reserve University"s Frances Payne Bolton School of Nursing and the School of Medicine, the Geriatric Research Education and Clinical Center at the Louis Stokes Cleveland Veterans Affairs Medical Center (GRECC), Rensselaer Polytechnic Institute"s Lighting Research Center and GE Consumer & Industrial have begun to test in a long-term care facility where daylight, which has proven health benefits, is not readily available.
Data presented on Sunday at the The International Society of Lung Cancer (IASLC) 13th World Conference on Lung Cancer (WCLC) in San Francisco highlight the screening of over 3,000 patients for MAGRIT (MAGE-A3 as Adjuvant Non-Small Cell LunG CanceR ImmunoTherapy)1, the largest-ever treatment trial in lung cancer. The rapid screening of patients into the MAGRIT trial is unprecedented given so few eligible lung cancer patients (less than 1% in the U.S.2) traditionally enter clinical trials and benefit from the potential hope of novel treatments.
Although lead content in paint has been restricted in the United States since 1978, University of Cincinnati (UC) environmental health researchers say in major countries from three continents there is still widespread failure to acknowledge its danger and companies continue to sell consumer paints that contain dangerous levels of lead.
The fight against obesity has stepped up a gear with the
The GP leading on swine flu for the BMA has told Pulse the planned vaccination campaign will be delayed by "at least six weeks". Such a delay would ruin the Government"s plans of having the first doses of swine flu vaccine available by the end of August. Instead, the vaccine would not become available until October at the earliest - when a major surge of swine flu cases is expected.
The number of Americans under care for depression and other mental illnesses nearly doubled between 1996 and 2006, and the overall cost of treating them jumped by nearly two-thirds, according to the latest News and Numbers from HHS" Agency for Healthcare Research and Quality.
Students and staff, among others in the profession, have the chance to make their views
A new study led by Mayo Clinic researchers has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty without cement injections. The article, "A Randomized Controlled Trial of Vertebroplasty for Osteoporotic Spine Fractures," was released today in the New England Journal of Medicine.
A research team led by Dr. Tony Lam at the Toronto General Research Institute and the University of Toronto discovered a novel function of a hormone found in the gut that might potentially lower glucose levels in diabetes.
Massachusetts officials are proud of their low rate of uninsured people, but the state also hosts the highest health care costs in the country, a problem that jeopardizes their achievement in expanding coverage, NPR"s Morning Edition reports. A commission charged with overseeing the insurance plan for 310,000 government workers recently voted - unanimously - that doing away with the current, fee-for-service model for paying doctors was the first step to controlling those costs. "Massachusetts policymakers want to replace fee-for-service with "global payment" - paying groups of health providers a flat yearly fee for each patient they cover," NPR reports (Knox, 8/5).
The Health and Safety Executive (HSE) is warning employers to ensure they assess the safety of equipment and ensure that it is sufficiently guarded after an employee"s left hand was severely damaged by the rotating blades of a valve that forms part of the extraction system in a metal recycling process.
USAID, "the main U.S. foreign aid agency is in limbo, entering its seventh month without a permanent director despite pledges by the Obama administration to expand development assistance and improve its effectiveness in poor countries," the Washington Post reports in an article examining the agency"s prospects and concerns that changes could reduce its clout. "While [Secretary of State Hillary Rodham] Clinton has championed additional personnel for USAID, aid groups worry that the once-autonomous agency could be swallowed up in the State Department, with long-term development goals losing out to short-term political aims," the Washington Post writes. The article includes comments from development experts and administration officials on USAID"s future.
The WHO on Tuesday maintained that roughly two billion people could become infected with the H1N1 (swine flu) virus, Reuters reports. "By the end of a pandemic, anywhere between 15-45 percent of a population will have been infected by the new pandemic virus," WHO spokeswoman Aphaluck Bhatiasevi said, adding that 30 percent, or 2 billion people worldwide, is the mid point of that estimate. "But the estimate comes with a big health warning: no one knows how many people so far have caught the new strain ... and the final number will never be known as many cases are so mild they may go unnoticed," the news service writes (Lynn, 8/4).
The addition of the anaesthetic lidocaine to radiocolloid injection for sentinel- lymph-node (SLN) mapping in patients with early breast cancer reduces injection pain and improves patient comfort without compromising SLN identification, and should be introduced as standard practice, concludes an Article published Online First and in the September edition of The Lancet Oncology.
Predicting the infection patterns of influenzas requires tracking both the ecology and the evolution of the fast-morphing viruses that cause them, said a Duke University researcher who enlists computers to model such changes.
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
Palomar Medical Technologies, Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, announced the success of a clinical study showing the benefits of the SlimLipo body sculpting laser for laser-assisted lipolysis. Cleared by the Federal Drug Administration (FDA) in April of 2008, the SlimLipo laser is now available with 40 watts of power for faster, more effective treatments.