President Bush today signed Medicare, Medicaid, and SCHIP Extension Act of 2007, which besides providing other affordable health insurance coverage benefits(such as Medicare and Medicaid), extends State Children's Health Insurance Program (SCHIP) through March 31, 2009.
The White House on Medicare, Medicaid, and SCHIP Extension Act of 2007
"On Saturday, December 29, 2007, the President signed into law: S. 2499, the "Medicare, Medicaid, and SCHIP Extension Act of 2007," which Provides a 0.5 percent Medicare payment increase for physicians for 6 months; (2) extends SCHIP through March 31, 2009; and (3) extends the Medicaid Qualifying Individual provision, Title V Abstinence Education grant program, and Transitional Medical Assistance eligibility for Medicaid beneficiaries for 6 months."
The State Children's Health Insurance Program (SCHIP)*, created by the Balanced Budget Act of 1997, enacted Title XXI of the Social Security Act and allocated about $20 billion over ten years to help states insure more children. The law authorizes states to provide health care coverage to "targeted low-income children" who are not eligible for Medicaid and who are uninsured. States receive an enhanced federal match (greater than the state's Medicaid match) and have three years to expend each year's allotment.
* Source: The National Conference of State Legislatures
Sunday, December 30, 2007
Americans Want - But Can't Spell - Nose Bidet
Nose Bidet
Americans might not be able to spell it, but they are making sure it's in their medicine cabinets this winter. "It" is the nose bidet (no not beday, bedae, or baday) and is more commonly known as the neti pot. In fact, the New York Times recently listed the term nose bidet as one of the buzzwords of 2007.
The word "bidet" has been around since the late 17th or early 18th century, when French furniture maker Mark-Antoine Jacoud invented the plumbing fixture. But when the word "bidet" is coupled with "nose," it gets people's attention.
So, what is it? The nose bidet or neti pot is used to gently cleanse the nasal cavity and ease the suffering from allergy symptoms, sinus infections or any other sinus malady. This process, known as nasal washing, is gaining popularity. Though it has been around for centuries it has recently been rediscovered by modern science as an effective way to treat a wide range of sinus problems.
The most popular neti pot available on the market is SinuCleanse, which was created by Dr. Diane Heatley, an ear, nose and throat doctor at the University of Wisconsin-Madison.
During a segment on the Oprah Winfrey Show, the talk show host referred to a neti pot as a nose bidet. The SinuCleanse marketing team took to the Internet and snatched up nose bidet as keywords, along with several misspellings of the phrase.
Recently, the Oprah segment re-ran.
"We were thrilled when we received a report from Google that our ads had been shown more than 88,000 times that week," said Dave Gallo, president of Med-Systems, the company that manufactures SinuCleanse. "In fact, the neti pot was the most popular search term with 44,000 impressions."
But, not one single person spelled nose bidet correctly.
The following misspellings received the highest number of impressions:
1. nose beday
2. nose baday
3. nose biday
4. nose bedae
5. nose bidae
SinuCleanse bought the AdWords in April. Gallo says, "With more than 30,000 search attempts for 'nose bidet' since then, we're still waiting for someone to spell it correctly."
Americans might not be able to spell it, but they are making sure it's in their medicine cabinets this winter. "It" is the nose bidet (no not beday, bedae, or baday) and is more commonly known as the neti pot. In fact, the New York Times recently listed the term nose bidet as one of the buzzwords of 2007.
The word "bidet" has been around since the late 17th or early 18th century, when French furniture maker Mark-Antoine Jacoud invented the plumbing fixture. But when the word "bidet" is coupled with "nose," it gets people's attention.
So, what is it? The nose bidet or neti pot is used to gently cleanse the nasal cavity and ease the suffering from allergy symptoms, sinus infections or any other sinus malady. This process, known as nasal washing, is gaining popularity. Though it has been around for centuries it has recently been rediscovered by modern science as an effective way to treat a wide range of sinus problems.
The most popular neti pot available on the market is SinuCleanse, which was created by Dr. Diane Heatley, an ear, nose and throat doctor at the University of Wisconsin-Madison.
During a segment on the Oprah Winfrey Show, the talk show host referred to a neti pot as a nose bidet. The SinuCleanse marketing team took to the Internet and snatched up nose bidet as keywords, along with several misspellings of the phrase.
Recently, the Oprah segment re-ran.
"We were thrilled when we received a report from Google that our ads had been shown more than 88,000 times that week," said Dave Gallo, president of Med-Systems, the company that manufactures SinuCleanse. "In fact, the neti pot was the most popular search term with 44,000 impressions."
But, not one single person spelled nose bidet correctly.
The following misspellings received the highest number of impressions:
1. nose beday
2. nose baday
3. nose biday
4. nose bedae
5. nose bidae
SinuCleanse bought the AdWords in April. Gallo says, "With more than 30,000 search attempts for 'nose bidet' since then, we're still waiting for someone to spell it correctly."
FDA Approves Voluven To Treat Serious Blood Volume Loss Following Surgery
FDA approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.
Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.
Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. Voluven expands the volume of blood plasma – the liquid portion of the blood – and thus draws fluid into small blood vessels known as capillaries.
"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution.
In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.
The most common side effects from Voluven were nausea and itching.
Voluven is not recommended for the following:
* patients with known abnormal sensitivity to the synthetic starch used in the product,
* patients experiencing fluid overload
* patients with kidney failure not related to low blood volume
* patients on dialysis
* patients with severe increases in blood levels of sodium or chloride
* patients with bleeding inside the head
Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.
Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany. Hespan is manufactured by B. Braun Medical Inc. of Bethlehem, Penn.
Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.
Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. Voluven expands the volume of blood plasma – the liquid portion of the blood – and thus draws fluid into small blood vessels known as capillaries.
"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution.
In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.
The most common side effects from Voluven were nausea and itching.
Voluven is not recommended for the following:
* patients with known abnormal sensitivity to the synthetic starch used in the product,
* patients experiencing fluid overload
* patients with kidney failure not related to low blood volume
* patients on dialysis
* patients with severe increases in blood levels of sodium or chloride
* patients with bleeding inside the head
Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.
Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany. Hespan is manufactured by B. Braun Medical Inc. of Bethlehem, Penn.
Perrigo Receives FDA Approval OTC Cetirizine Hydrochloride Tablets
Cetirizine Hydrochloride Tablets
Perrigo Company has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.
The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec Tablets, indicated for allergy and hives relief.
According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
Perrigo Company has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.
The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Cetirizine Hydrochloride Tablets, 5 and 10 mg, which will be marketed as Zyrtec Tablets, indicated for allergy and hives relief.
According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
FDA May Allow Pharmacists to Dispense Some Drugs Without a Doctor's Prescription
he U.S. Food and Drug Administration (FDA) is considering adopting a new drug classification that would allow some medications to be sold from behind the counter (BTC)--requiring only a pharmacist's approval instead of a doctor's prescription. It's a move some say could increase consumer choice and lower costs.
FDA representatives met with pharmacists and consumers on November 14 to discuss the idea. "This has been raised several times over the past several years," said Ilisa Bernstein, FDA's director of pharmacy affairs. "The time was right to have a meeting to bring everyone together to discuss it more fully."
Bernstein said the meeting was appropriate because the health care landscape has changed over the past decade and pharmacists are much better trained to be part of a team of health care professionals than they once were.
"Patients are taking a more proactive role in their health care decisions and are more informed because of the Internet and other media," Bernstein explained. "We are particularly interested in whether BTC might improve patient access to safe and effective drug products. If a patient won't or can't go to their doctor because of time or money concerns, is there a health benefit if they can get safe and effective medicines by going to the pharmacy and consulting with their pharmacist?"
Listening Meeting
More than 30 groups representing consumers, pharmacists, pharmaceutical companies, and doctors attended the meeting. A public comment period remained open until December 1.
BTC classification of medication could help patients who can't see a doctor or don't have sufficient insurance, Bernstein said. The classification would most likely apply to some drugs with strong safety records, but FDA has not yet decided which drugs to include.
Bernstein could not say when, if at all, the idea may become a reality in pharmacies across the country.
"At this point, we have more questions than answers," Bernstein said. "This is more of a listening meeting."
Many pharmaceutical and medical associations are still reviewing information and will make recommendations about the value and implementation of BTC medications at the meeting.
Changing Status
Carmita Coleman, executive director of the Student National Pharmaceutical Association and assistant dean of student affairs at San Antonio's University of the Incarnate Word's School of Pharmacy, said the concept of BTC drugs isn't novel.
Many states already have a similar process, Coleman said, for dispensing drugs such as emergency contraceptives. Similarly, other countries, including Australia, Canada, and New Zealand, offer a BTC drug status, according to the FDA docket detailing the meeting.
However, because of the uniqueness of the U.S. health care system, hearing about BTC drugs' impact on other countries was informative but not necessarily applicable, Bernstein said.
"Our system is very different, our practice of pharmacy and medicine is different, and payment for health care is very different," Bernstein explained.
Some presenters at the November 14 meeting discussed how drug prices fall when they move from prescription-only to over-the-counter status.
"Whether they would [likewise fall] if they became BTC is unclear, but there's some indication they would," Bernstein said.
Evaluating Patients
Coleman said each state has standards for pharmacists and the drugs they can dispense without a prescription.
"We're really already doing this," Coleman said. "We give adequate consultation for over-the-counter medications. We have people who come to our counters on a daily basis asking for medications that can help them."
The difference, Coleman explained, is FDA could regulate BTC drugs on a more national level if the rule change passes. If so, she said, the next step to consider is implementation. Pharmacists could better serve patients if given more access to their medical records, Coleman said.
The drug reclassification could help restructure the way Americans approach their medicine, said Mitch Rothholz, chief of staff of the American Pharmacists Association, an industry group based in Washington, DC.
Trained pharmacists could educate patients, help them evaluate risks and benefits, and ensure the medication safely treats their conditions, Rothholz explained.
"[BTC status drugs] would be another tool in the armament of available options to the patient," Rothholz said.
Considering Possibilities
Cynthia Reilly, director of clinical standards and quality at the American Society of Health-System Pharmacists (ASHSP), an association of pharmacists based in Bethesda, Maryland, said pharmacists' easy accessibility could benefit many consumers, especially in rural communities.
BTC drugs' success would depend on continuous communication between the pharmacist and the patient, Reilly said. Pharmacists must be able to view patients' records and monitor their responses.
"It's not simply a 'go to the pharmacy, pick it up, and you're done' approach for these medications," Reilly said.
A new classification could change the way pharmacies approach the distribution of medicines. Chrissy Kopple, vice president of media relations for the National Association of Chain Drug Stores (NACDS), said government affairs and policy experts are still researching the possibilities.
NACDS wants to discuss how the medications would be tracked, how they would be documented, and how patients' records could be kept current, Kopple said.
FDA representatives met with pharmacists and consumers on November 14 to discuss the idea. "This has been raised several times over the past several years," said Ilisa Bernstein, FDA's director of pharmacy affairs. "The time was right to have a meeting to bring everyone together to discuss it more fully."
Bernstein said the meeting was appropriate because the health care landscape has changed over the past decade and pharmacists are much better trained to be part of a team of health care professionals than they once were.
"Patients are taking a more proactive role in their health care decisions and are more informed because of the Internet and other media," Bernstein explained. "We are particularly interested in whether BTC might improve patient access to safe and effective drug products. If a patient won't or can't go to their doctor because of time or money concerns, is there a health benefit if they can get safe and effective medicines by going to the pharmacy and consulting with their pharmacist?"
Listening Meeting
More than 30 groups representing consumers, pharmacists, pharmaceutical companies, and doctors attended the meeting. A public comment period remained open until December 1.
BTC classification of medication could help patients who can't see a doctor or don't have sufficient insurance, Bernstein said. The classification would most likely apply to some drugs with strong safety records, but FDA has not yet decided which drugs to include.
Bernstein could not say when, if at all, the idea may become a reality in pharmacies across the country.
"At this point, we have more questions than answers," Bernstein said. "This is more of a listening meeting."
Many pharmaceutical and medical associations are still reviewing information and will make recommendations about the value and implementation of BTC medications at the meeting.
Changing Status
Carmita Coleman, executive director of the Student National Pharmaceutical Association and assistant dean of student affairs at San Antonio's University of the Incarnate Word's School of Pharmacy, said the concept of BTC drugs isn't novel.
Many states already have a similar process, Coleman said, for dispensing drugs such as emergency contraceptives. Similarly, other countries, including Australia, Canada, and New Zealand, offer a BTC drug status, according to the FDA docket detailing the meeting.
However, because of the uniqueness of the U.S. health care system, hearing about BTC drugs' impact on other countries was informative but not necessarily applicable, Bernstein said.
"Our system is very different, our practice of pharmacy and medicine is different, and payment for health care is very different," Bernstein explained.
Some presenters at the November 14 meeting discussed how drug prices fall when they move from prescription-only to over-the-counter status.
"Whether they would [likewise fall] if they became BTC is unclear, but there's some indication they would," Bernstein said.
Evaluating Patients
Coleman said each state has standards for pharmacists and the drugs they can dispense without a prescription.
"We're really already doing this," Coleman said. "We give adequate consultation for over-the-counter medications. We have people who come to our counters on a daily basis asking for medications that can help them."
The difference, Coleman explained, is FDA could regulate BTC drugs on a more national level if the rule change passes. If so, she said, the next step to consider is implementation. Pharmacists could better serve patients if given more access to their medical records, Coleman said.
The drug reclassification could help restructure the way Americans approach their medicine, said Mitch Rothholz, chief of staff of the American Pharmacists Association, an industry group based in Washington, DC.
Trained pharmacists could educate patients, help them evaluate risks and benefits, and ensure the medication safely treats their conditions, Rothholz explained.
"[BTC status drugs] would be another tool in the armament of available options to the patient," Rothholz said.
Considering Possibilities
Cynthia Reilly, director of clinical standards and quality at the American Society of Health-System Pharmacists (ASHSP), an association of pharmacists based in Bethesda, Maryland, said pharmacists' easy accessibility could benefit many consumers, especially in rural communities.
BTC drugs' success would depend on continuous communication between the pharmacist and the patient, Reilly said. Pharmacists must be able to view patients' records and monitor their responses.
"It's not simply a 'go to the pharmacy, pick it up, and you're done' approach for these medications," Reilly said.
A new classification could change the way pharmacies approach the distribution of medicines. Chrissy Kopple, vice president of media relations for the National Association of Chain Drug Stores (NACDS), said government affairs and policy experts are still researching the possibilities.
NACDS wants to discuss how the medications would be tracked, how they would be documented, and how patients' records could be kept current, Kopple said.
Study Shows More Women Can Avoid Hysterectomy For Common Problem
dysfunctional uterine bleeding
A minimally invasive procedure called endometrial ablation is as effective as hysterectomy in solving a common female complaint called "dysfunctional uterine bleeding" or DUB, according to a new federally-funded study published in the Journal of Obstetrics and Gynecology.
DUB (dysfunctional uterine bleeding) can be described as abnormal bleeding which cannot be attributed to abnormalities of the female reproductive system, pharmacological interaction, intrauterine contraception, or bleeding disorders. It is also referred to menometrorrhagia.
The condition affects up to a third of all women at some point during their reproductive years, usually women over age 30. It is characterized by extremely heavy, erratic menstrual bleeding and is often accompanied by fatigue, pelvic pain and decreased quality of life. The excessive blood loss in DUB can provoke iron deficiency anemia.
"This is a very important study, proving that a minimally invasive procedure -- endometrial ablation -- can solve the problem of excessive bleeding as well as hysterectomy," commented Franklin D. Loffer, M.D., Executive Vice President/Medical Director of AAGL, the professional organization dedicated to the advancement of minimally-invasive gynecologic surgery. "Women should always be offered the least invasive, effective approach to solving her medical problems."
While hysterectomy (the removal of the uterus and in some cases the ovaries and cervix) has a long history of use to cure DUB, newer, less invasive procedures have become available in recent years. These have stirred controversy over whether hysterectomy is overused, particularly for conditions such as DUB for which more conservative approaches may be just as effective and cause fewer complications.
The new study, bearing the acronym of StopDUB for "Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding," was a multi-center, randomized, controlled trial in the U.S. and Canada involving 237 women at 25 treatment centers. The primary complaint causing women to seek surgery was excessive bleeding that had not been mitigated by medical therapy. These women were randomly assigned to receive either hysterectomy or endometrial ablation, a minimally invasive technique that removes only the lining of the uterus (the lining cells are responsible for the bleeding), not the entire organ.
The primary measure of success in the study was women's satisfaction with their treatment, rather than just a clinical endpoint. After three years of follow-up, the vast majority of patients in both groups (93-95%) reported that their problem was solved. The secondary endpoints of pain and fatigue were also similar between the hysterectomy group and the endometrial ablation group.
"Using women's satisfaction as the study goal, rather than clinical endpoints alone, was very astute from our perspective, because the most important outcome is the woman's opinion, not the doctor's," said Dr. Loffer. "Our view at AAGL is always patient-focused: how much pain will there be, how much trauma, how much time lost, what impact on the quality of life? These are the measures that count."
Advantages of the less invasive procedure include shorter hospital stays (hours instead of days), less blood loss, fewer complications and quicker recovery. In many cases endometrial ablation causes menstrual periods to become much lighter and more regular, rather than eliminating them altogether. Many women consider this to be a satisfactory outcome and would prefer to have normal periods rather than lose their uterus.
"Both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. However, hysterectomy was associated with about four times more adverse events and six times as many postoperative infections," said Malcolm Munro, MD, an investigator in the StopDUB Research Group at the David Geffen School of Medicine, University of California Los Angeles. Dr. Munro is also an advisor to the AAGL.
The American College of Obstetricians and Gynecologists (ACOG) recommends that treatment for menorrhagia begin with the least invasive therapy. But, for some women, endometrial ablation may not solve their problem.
"In this study about two thirds of women were able to avoid hysterectomy by having an endometrial ablation procedure while about a third of the patients who had received endometrial ablation ended up having a hysterectomy several years later. This rate is comparable to that seen in other studies," said Munro.
About 600,000 hysterectomies are performed annually in the U.S., making it the second most common major surgery performed on women of reproductive age. There is controversy about how many of these hysterectomies are really necessary. Clearly, 120,000 hysterectomies performed each year for DUB (without uterine pathology) are amenable to endometrial ablation. Moreover, many patients with uterine fibroids and abnormal bleeding can be treated via endometrial ablation. Fibroids account for 40% of hysterectomies each year.
While some doctors may look for anemia as a diagnostic indicator for dysfunctional uterine bleeding, in the StopDUB study women's perception of their problem was the main criterion, supported by clinical measures of excess duration, amount, or unpredictability of flow. "We felt that women should not have to be anemic in order to seek help and have their problem taken seriously," said Munro.
"Based on our results, it is reasonable to recommend that women should select the type of surgery they want for DUB, based on their preferences and situations," concluded Munro.
A minimally invasive procedure called endometrial ablation is as effective as hysterectomy in solving a common female complaint called "dysfunctional uterine bleeding" or DUB, according to a new federally-funded study published in the Journal of Obstetrics and Gynecology.
DUB (dysfunctional uterine bleeding) can be described as abnormal bleeding which cannot be attributed to abnormalities of the female reproductive system, pharmacological interaction, intrauterine contraception, or bleeding disorders. It is also referred to menometrorrhagia.
The condition affects up to a third of all women at some point during their reproductive years, usually women over age 30. It is characterized by extremely heavy, erratic menstrual bleeding and is often accompanied by fatigue, pelvic pain and decreased quality of life. The excessive blood loss in DUB can provoke iron deficiency anemia.
"This is a very important study, proving that a minimally invasive procedure -- endometrial ablation -- can solve the problem of excessive bleeding as well as hysterectomy," commented Franklin D. Loffer, M.D., Executive Vice President/Medical Director of AAGL, the professional organization dedicated to the advancement of minimally-invasive gynecologic surgery. "Women should always be offered the least invasive, effective approach to solving her medical problems."
While hysterectomy (the removal of the uterus and in some cases the ovaries and cervix) has a long history of use to cure DUB, newer, less invasive procedures have become available in recent years. These have stirred controversy over whether hysterectomy is overused, particularly for conditions such as DUB for which more conservative approaches may be just as effective and cause fewer complications.
The new study, bearing the acronym of StopDUB for "Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding," was a multi-center, randomized, controlled trial in the U.S. and Canada involving 237 women at 25 treatment centers. The primary complaint causing women to seek surgery was excessive bleeding that had not been mitigated by medical therapy. These women were randomly assigned to receive either hysterectomy or endometrial ablation, a minimally invasive technique that removes only the lining of the uterus (the lining cells are responsible for the bleeding), not the entire organ.
The primary measure of success in the study was women's satisfaction with their treatment, rather than just a clinical endpoint. After three years of follow-up, the vast majority of patients in both groups (93-95%) reported that their problem was solved. The secondary endpoints of pain and fatigue were also similar between the hysterectomy group and the endometrial ablation group.
"Using women's satisfaction as the study goal, rather than clinical endpoints alone, was very astute from our perspective, because the most important outcome is the woman's opinion, not the doctor's," said Dr. Loffer. "Our view at AAGL is always patient-focused: how much pain will there be, how much trauma, how much time lost, what impact on the quality of life? These are the measures that count."
Advantages of the less invasive procedure include shorter hospital stays (hours instead of days), less blood loss, fewer complications and quicker recovery. In many cases endometrial ablation causes menstrual periods to become much lighter and more regular, rather than eliminating them altogether. Many women consider this to be a satisfactory outcome and would prefer to have normal periods rather than lose their uterus.
"Both endometrial ablation and hysterectomy are effective treatments in women with dysfunctional uterine bleeding. However, hysterectomy was associated with about four times more adverse events and six times as many postoperative infections," said Malcolm Munro, MD, an investigator in the StopDUB Research Group at the David Geffen School of Medicine, University of California Los Angeles. Dr. Munro is also an advisor to the AAGL.
The American College of Obstetricians and Gynecologists (ACOG) recommends that treatment for menorrhagia begin with the least invasive therapy. But, for some women, endometrial ablation may not solve their problem.
"In this study about two thirds of women were able to avoid hysterectomy by having an endometrial ablation procedure while about a third of the patients who had received endometrial ablation ended up having a hysterectomy several years later. This rate is comparable to that seen in other studies," said Munro.
About 600,000 hysterectomies are performed annually in the U.S., making it the second most common major surgery performed on women of reproductive age. There is controversy about how many of these hysterectomies are really necessary. Clearly, 120,000 hysterectomies performed each year for DUB (without uterine pathology) are amenable to endometrial ablation. Moreover, many patients with uterine fibroids and abnormal bleeding can be treated via endometrial ablation. Fibroids account for 40% of hysterectomies each year.
While some doctors may look for anemia as a diagnostic indicator for dysfunctional uterine bleeding, in the StopDUB study women's perception of their problem was the main criterion, supported by clinical measures of excess duration, amount, or unpredictability of flow. "We felt that women should not have to be anemic in order to seek help and have their problem taken seriously," said Munro.
"Based on our results, it is reasonable to recommend that women should select the type of surgery they want for DUB, based on their preferences and situations," concluded Munro.
Top Eight Resolutions For Healthier Year
Each year as the ball drops, New Yorkers resolve to improve their lives and their health by carrying out New Year's resolutions. The right resolution, properly observed, could save your life. So, in the spirit of the season, the Health Department's doctors and other specialists offer eight resolutions to make in '08.
1. Quit Smoking
"Make 2008 the year you quit for good," says Sarah Perl, Assistant Commissioner for the Bureau of Tobacco Control. "Set a quit date now and stick to it. Tell family and friends that you need their help. Consider using medication, which can double or triple your chances of quitting successfully."
If you smoke, quitting is the single most important thing you can do for your health and the health of your family - smoking causes breast, lung, and mouth cancer, as well as stroke and heart disease. After just 24 hours of being tobacco free, your chances of having a heart attack drop. And in 30 days, your lung function improves.
New Yorkers looking to obtain free nicotine patches can visit the Staten Island Ferry Whitehall Terminal in Manhattan on January 3rd and 4th from 12:00PM to 6:00PM or the Kings Plaza Mall in Brooklyn anytime between January 7th and January 11th from 11:00AM-5:00PM.
2. Get to the Doctor
"Don't wait until you're sick to make an appointment," says Dr. Lynn Silver, Assistant Commissioner for Chronic Disease Prevention and Control. "Getting checked for cancer and making sure your blood pressure and cholesterol are under control can prevent serious health problems before they start. If you don't have a regular doctor, get one through your health plan - and if you don't have a health plan call 311 to find out what insurance is available for you and your family."
New Yorkers who have a regular doctor are more likely to have their blood pressure and cholesterol checked and get Pap tests, mammograms and colon cancer screenings. People with doctors are also more likely to seek care and get advice on sensitive issues, such as sexual health and alcohol and drug use.
3. Lose Weight
"You can lower your risk of diabetes, heart disease and stroke this year by working toward a healthy weight," says Dr. Shadi Chamany, Director of Diabetes Prevention and Control. "Losing even a few pounds will make a difference. Set reasonable goals like aiming to lose 1 pound a week, avoiding fad diets and watching what you drink! Just one less soda or other sugar-sweetened drink a day can help you lose several pounds over a year."
Being overweight, even during childhood, can lead to serious health problems such as diabetes, heart disease, asthma, and depression. Most adults need about 1,800-2,000 calories each day. Burn more calories than you eat and pounds will melt away.
4. Get More Exercise
"To help you get moving, choose one fun activity and one realistic lifestyle change," says Cathy Nonas, Director of the Physical Activity and Nutrition Program. "For example, choose an activity you enjoy, like basketball or dancing, and do it more often! A quick and easy lifestyle change is to get off the bus or subway one stop early and walk the rest of the way, or to take stairs instead of elevators when possible. Small steps add up, especially when you do them every day."
Getting at least 30 minutes of moderate, physical activity (such as a brisk walk) at least five days a week is the goal. Physical activity lowers your chances of obesity, diabetes, heart disease, hypertension, depression, arthritis, and osteoporosis.
5. Eat Right
"To get your new year off to the right start, keep a food diary for a few days to see what you are really eating," says Sabrina Baronberg, Deputy Director for Physical Activity and Nutrition "Then try making some simple changes like switching from soda to seltzer or having an apple or orange instead of a bag of chips. Sometimes healthy eating can seem complicated, but the basics are simple: eat more fruits, vegetables, whole grains, and low-fat dairy products. Stay away from processed foods and the added sugars in soda, sweetened teas, and fruit drinks."
6. Drink in Moderation
"Holiday drinking often makes people take a good look at whether their habits are healthy," says Daliah Heller, Assistant Commissioner for Chemical Dependency. "If you have ever thought you should cut down, been annoyed when someone asked you to stop, felt guilty about drinking, or needed a 'wake-up' drink, you may have a problem. Cutting down or quitting is possible. Talk to your doctor, go to an AA meeting or call 311 and ask for Lifenet to get help."
Unhealthy drinking can lead to deadly accidents and acts of violence in the short term, and cirrhosis, cancers, and hepatitis in the long term - not to mention jeopardizing work, finances, and relationships. Men should not have more than four drinks on one occasion or more than 2 a day on average. Women and older adults should not have more then three drinks at once or more than one a day on average.
7. Reduce Stress
"Stress is part of life, but there are lots of ways to manage it," says Trish Marsik, Assistant Commissioner for Mental Health. "Whatever the cause, there are things you can do to feel more in control. Try to avoid unnecessary stress, if possible, and regain control by altering stressful situations or changing expectations. Healthy ways to reduce stress can include getting more sleep, exercising, scheduling some time each day to relax or plan, listening to music, or making the time to talk with a supportive friend. And if you are feeling out of control, you can call 311 and ask for Lifenet to get help."
Besides reducing your quality of life, stress can lead to high blood pressure and many other health problems.
8. Get Ready for an Emergency
"Sometimes you have to think about the unthinkable," says Marisa Raphael, Assistant Commissioner for the Bureau of Emergency Management. "Whether it's a hurricane or an explosion, being prepared in advance will help keep you and your family safe in 2008. Make a plan for your family, put together a supply kit for your home, and get a "go bag" together in case you need to leave."
1. Quit Smoking
"Make 2008 the year you quit for good," says Sarah Perl, Assistant Commissioner for the Bureau of Tobacco Control. "Set a quit date now and stick to it. Tell family and friends that you need their help. Consider using medication, which can double or triple your chances of quitting successfully."
If you smoke, quitting is the single most important thing you can do for your health and the health of your family - smoking causes breast, lung, and mouth cancer, as well as stroke and heart disease. After just 24 hours of being tobacco free, your chances of having a heart attack drop. And in 30 days, your lung function improves.
New Yorkers looking to obtain free nicotine patches can visit the Staten Island Ferry Whitehall Terminal in Manhattan on January 3rd and 4th from 12:00PM to 6:00PM or the Kings Plaza Mall in Brooklyn anytime between January 7th and January 11th from 11:00AM-5:00PM.
2. Get to the Doctor
"Don't wait until you're sick to make an appointment," says Dr. Lynn Silver, Assistant Commissioner for Chronic Disease Prevention and Control. "Getting checked for cancer and making sure your blood pressure and cholesterol are under control can prevent serious health problems before they start. If you don't have a regular doctor, get one through your health plan - and if you don't have a health plan call 311 to find out what insurance is available for you and your family."
New Yorkers who have a regular doctor are more likely to have their blood pressure and cholesterol checked and get Pap tests, mammograms and colon cancer screenings. People with doctors are also more likely to seek care and get advice on sensitive issues, such as sexual health and alcohol and drug use.
3. Lose Weight
"You can lower your risk of diabetes, heart disease and stroke this year by working toward a healthy weight," says Dr. Shadi Chamany, Director of Diabetes Prevention and Control. "Losing even a few pounds will make a difference. Set reasonable goals like aiming to lose 1 pound a week, avoiding fad diets and watching what you drink! Just one less soda or other sugar-sweetened drink a day can help you lose several pounds over a year."
Being overweight, even during childhood, can lead to serious health problems such as diabetes, heart disease, asthma, and depression. Most adults need about 1,800-2,000 calories each day. Burn more calories than you eat and pounds will melt away.
4. Get More Exercise
"To help you get moving, choose one fun activity and one realistic lifestyle change," says Cathy Nonas, Director of the Physical Activity and Nutrition Program. "For example, choose an activity you enjoy, like basketball or dancing, and do it more often! A quick and easy lifestyle change is to get off the bus or subway one stop early and walk the rest of the way, or to take stairs instead of elevators when possible. Small steps add up, especially when you do them every day."
Getting at least 30 minutes of moderate, physical activity (such as a brisk walk) at least five days a week is the goal. Physical activity lowers your chances of obesity, diabetes, heart disease, hypertension, depression, arthritis, and osteoporosis.
5. Eat Right
"To get your new year off to the right start, keep a food diary for a few days to see what you are really eating," says Sabrina Baronberg, Deputy Director for Physical Activity and Nutrition "Then try making some simple changes like switching from soda to seltzer or having an apple or orange instead of a bag of chips. Sometimes healthy eating can seem complicated, but the basics are simple: eat more fruits, vegetables, whole grains, and low-fat dairy products. Stay away from processed foods and the added sugars in soda, sweetened teas, and fruit drinks."
6. Drink in Moderation
"Holiday drinking often makes people take a good look at whether their habits are healthy," says Daliah Heller, Assistant Commissioner for Chemical Dependency. "If you have ever thought you should cut down, been annoyed when someone asked you to stop, felt guilty about drinking, or needed a 'wake-up' drink, you may have a problem. Cutting down or quitting is possible. Talk to your doctor, go to an AA meeting or call 311 and ask for Lifenet to get help."
Unhealthy drinking can lead to deadly accidents and acts of violence in the short term, and cirrhosis, cancers, and hepatitis in the long term - not to mention jeopardizing work, finances, and relationships. Men should not have more than four drinks on one occasion or more than 2 a day on average. Women and older adults should not have more then three drinks at once or more than one a day on average.
7. Reduce Stress
"Stress is part of life, but there are lots of ways to manage it," says Trish Marsik, Assistant Commissioner for Mental Health. "Whatever the cause, there are things you can do to feel more in control. Try to avoid unnecessary stress, if possible, and regain control by altering stressful situations or changing expectations. Healthy ways to reduce stress can include getting more sleep, exercising, scheduling some time each day to relax or plan, listening to music, or making the time to talk with a supportive friend. And if you are feeling out of control, you can call 311 and ask for Lifenet to get help."
Besides reducing your quality of life, stress can lead to high blood pressure and many other health problems.
8. Get Ready for an Emergency
"Sometimes you have to think about the unthinkable," says Marisa Raphael, Assistant Commissioner for the Bureau of Emergency Management. "Whether it's a hurricane or an explosion, being prepared in advance will help keep you and your family safe in 2008. Make a plan for your family, put together a supply kit for your home, and get a "go bag" together in case you need to leave."
Thursday, December 27, 2007
Help Your Pets Cope With Holiday Stress
Some family pets may need extra care to reduce holiday stress, according to a health department spokesperson.
'Your pets will most likely react to the holiday changes in your shared household, as the decorations go up, the holiday party food comes out and the many family and friends visit your home,' said Ella Boyd, VMD, Ocean County Health Department Public Health Coordinator.
'At this special time of year we want to make sure our animals are well prepared to meet the surprises of the season,' said Freeholder Gerry P. Little, liaison to the Board of Health. 'Pets can often become curious or frightened when confronted with new sights and smells that are not part of their normal routine.'
'Pet owners should follow these timely steps to help their pets get through the season in great shape,' said Dr. Boyd.
* Some holiday plants, such as poinsettias, holly, mistletoe and lilies should be kept out of reach, as they can lead to health problems in cats and dogs.
* Many pets will be curious about the holiday tree. Take care with tree decorations. Animals may think some decorations are toys you placed for them and will be tempted to bite or chew them. Cats especially are attracted to tinsel, which can block intestines if ingested. Cats also may think of a holiday tree as an ideal climbing post. Be sure your tree is anchored to the floor and tied back with fishing line if in a room where cats can roam.
* Place a tree skirt around the base of your tree, covering the water storage area so animals won't be tempted to drink from it. Holiday tree water can contain preservatives or harmful bacteria.
* Securely tape tree light cords to the floor. Animals may consider loose cords as play toys and be tempted to bite into them. Also never leave your tree lights on when leaving a pet home alone in the house.
* Cats especially can become stressed when their normal routine is disturbed. Be sure to keep the litter box in a quiet area that is familiar to your cat, and check it frequently.
* Have a safe haven for your animals to retreat to, should the excitement of holiday crowds cause stress or discomfort. Also, assure your animal has up-to-date tags on its collar in case it should run outside when doors are opened for visitors.
* Remind your guests to avoid feeding party food to your pets. Candies, especially chocolates, can cause mild to severe illnesses and reactions in pets. That goes for fatty meats, poultry bones and skin and of course, alcoholic beverages.
* Maintain as close as possible the usual feeding and playtime or exercise schedules for your pets..
* If a pet becomes stressed, it will need more water. This is especially true for dogs, which pant when stressed. Assure your family's pet has plenty of fresh water on hand.
* Remove tags, ribbons and bag handles from discarded gift wrap that can choke or harm your pet, prior to letting the pet play in the gift wrap pile.
* If using candles during the holidays, make sure they are in an area safe from coming into contact with pets. And never leave a burning candle in an unattended room.
'Your pets will most likely react to the holiday changes in your shared household, as the decorations go up, the holiday party food comes out and the many family and friends visit your home,' said Ella Boyd, VMD, Ocean County Health Department Public Health Coordinator.
'At this special time of year we want to make sure our animals are well prepared to meet the surprises of the season,' said Freeholder Gerry P. Little, liaison to the Board of Health. 'Pets can often become curious or frightened when confronted with new sights and smells that are not part of their normal routine.'
'Pet owners should follow these timely steps to help their pets get through the season in great shape,' said Dr. Boyd.
* Some holiday plants, such as poinsettias, holly, mistletoe and lilies should be kept out of reach, as they can lead to health problems in cats and dogs.
* Many pets will be curious about the holiday tree. Take care with tree decorations. Animals may think some decorations are toys you placed for them and will be tempted to bite or chew them. Cats especially are attracted to tinsel, which can block intestines if ingested. Cats also may think of a holiday tree as an ideal climbing post. Be sure your tree is anchored to the floor and tied back with fishing line if in a room where cats can roam.
* Place a tree skirt around the base of your tree, covering the water storage area so animals won't be tempted to drink from it. Holiday tree water can contain preservatives or harmful bacteria.
* Securely tape tree light cords to the floor. Animals may consider loose cords as play toys and be tempted to bite into them. Also never leave your tree lights on when leaving a pet home alone in the house.
* Cats especially can become stressed when their normal routine is disturbed. Be sure to keep the litter box in a quiet area that is familiar to your cat, and check it frequently.
* Have a safe haven for your animals to retreat to, should the excitement of holiday crowds cause stress or discomfort. Also, assure your animal has up-to-date tags on its collar in case it should run outside when doors are opened for visitors.
* Remind your guests to avoid feeding party food to your pets. Candies, especially chocolates, can cause mild to severe illnesses and reactions in pets. That goes for fatty meats, poultry bones and skin and of course, alcoholic beverages.
* Maintain as close as possible the usual feeding and playtime or exercise schedules for your pets..
* If a pet becomes stressed, it will need more water. This is especially true for dogs, which pant when stressed. Assure your family's pet has plenty of fresh water on hand.
* Remove tags, ribbons and bag handles from discarded gift wrap that can choke or harm your pet, prior to letting the pet play in the gift wrap pile.
* If using candles during the holidays, make sure they are in an area safe from coming into contact with pets. And never leave a burning candle in an unattended room.
Florida DOH Cautions Against Winter Carbon Monoxide Poisoning
Carbon Monoxide Poisoning
Florida Department of Health (DOH) urges Floridians to take precautions to prevent carbon monoxide (CO) poisoning during the cold winter months. As temperatures drop, the potential for CO poisonings and deaths rise.
"Carbon monoxide can be fatal if people are exposed to high levels of CO, even for short periods of time," Dr. Lisa Conti, Director of the Division of Environmental Health, said. "Floridians who use indoor gas heaters and fireplaces need to ensure direct exhaust venting to the outside, regularly check and maintain fuel burning appliances, and carefully monitor themselves and loved ones for signs of CO poisoning."
Invisible, odorless and tasteless, CO is a highly poisonous gas produced by burning fuels such as gasoline, natural gas, kerosene, charcoal and wood. Inside a home, CO can come from a gas-fueled furnace, gas water heater, gas clothes dryer, gas ranges, kerosene space heaters, portable generators, gas or charcoal grills, fireplaces or wood stoves. The risk of illness or death increases with the level of CO in the air and the amount of time exposed. Dangerous CO levels can result when home appliances are not properly maintained or when used incorrectly. Anyone who suspects symptoms of CO poisoning should go outside immediately. If a person has collapsed or is not breathing, call 911 for emergency medical assistance immediately from a safer location (outside or from a neighbor's home).
Signs of carbon monoxide poisoning include:
* Fatigue
* Chest pain
* Impaired vision and coordination
* Headaches
* Dizziness, confusion, nausea
How to prevent carbon monoxide poisoning:
* Install and use fuel-burning appliances according to manufacturer instructions.
* Have fuel-burning appliances inspected and serviced annually by a licensed contractor.
* Inspect exhaust ventilation systems, including chimneys, flues and vents, every year>
* NEVER burn charcoal inside a house, garage, vehicle or tent, even in a fireplace.
* Avoid using unvented gas or kerosene heaters in enclosed spaces, especially sleeping areas.
* NEVER leave an automobile running in a garage, even with the garage door open.
* Do not leave the rear window or tailgate of a vehicle open while driving. CO from the exhaust can be pulled inside the car, van or camper.
* Install CO alarms inside the house. Purchase battery operated CO alarms or plug-in CO alarms with battery backup according to manufacturer’s installation instructions.
* The CO alarm should meet the most recent UL 2034 standard, IAS 6-96 standard or the CSA 6.19.01 standard.
* Replace CO alarm batteries once a year and test alarms frequently.
* Replace CO alarms once every five years in accordance with recent recommendations by the U.S. Consumer Product Safety Commission.
* NEVER use a portable generator indoors, including in homes, garages, basements, crawl spaces, sheds and other enclosed or partially enclosed areas. ALWAYS place portable generators outdoors on a dry surface, away from doors, windows, vents and air conditioning equipment that could allow CO to enter.
Florida Department of Health (DOH) urges Floridians to take precautions to prevent carbon monoxide (CO) poisoning during the cold winter months. As temperatures drop, the potential for CO poisonings and deaths rise.
"Carbon monoxide can be fatal if people are exposed to high levels of CO, even for short periods of time," Dr. Lisa Conti, Director of the Division of Environmental Health, said. "Floridians who use indoor gas heaters and fireplaces need to ensure direct exhaust venting to the outside, regularly check and maintain fuel burning appliances, and carefully monitor themselves and loved ones for signs of CO poisoning."
Invisible, odorless and tasteless, CO is a highly poisonous gas produced by burning fuels such as gasoline, natural gas, kerosene, charcoal and wood. Inside a home, CO can come from a gas-fueled furnace, gas water heater, gas clothes dryer, gas ranges, kerosene space heaters, portable generators, gas or charcoal grills, fireplaces or wood stoves. The risk of illness or death increases with the level of CO in the air and the amount of time exposed. Dangerous CO levels can result when home appliances are not properly maintained or when used incorrectly. Anyone who suspects symptoms of CO poisoning should go outside immediately. If a person has collapsed or is not breathing, call 911 for emergency medical assistance immediately from a safer location (outside or from a neighbor's home).
Signs of carbon monoxide poisoning include:
* Fatigue
* Chest pain
* Impaired vision and coordination
* Headaches
* Dizziness, confusion, nausea
How to prevent carbon monoxide poisoning:
* Install and use fuel-burning appliances according to manufacturer instructions.
* Have fuel-burning appliances inspected and serviced annually by a licensed contractor.
* Inspect exhaust ventilation systems, including chimneys, flues and vents, every year>
* NEVER burn charcoal inside a house, garage, vehicle or tent, even in a fireplace.
* Avoid using unvented gas or kerosene heaters in enclosed spaces, especially sleeping areas.
* NEVER leave an automobile running in a garage, even with the garage door open.
* Do not leave the rear window or tailgate of a vehicle open while driving. CO from the exhaust can be pulled inside the car, van or camper.
* Install CO alarms inside the house. Purchase battery operated CO alarms or plug-in CO alarms with battery backup according to manufacturer’s installation instructions.
* The CO alarm should meet the most recent UL 2034 standard, IAS 6-96 standard or the CSA 6.19.01 standard.
* Replace CO alarm batteries once a year and test alarms frequently.
* Replace CO alarms once every five years in accordance with recent recommendations by the U.S. Consumer Product Safety Commission.
* NEVER use a portable generator indoors, including in homes, garages, basements, crawl spaces, sheds and other enclosed or partially enclosed areas. ALWAYS place portable generators outdoors on a dry surface, away from doors, windows, vents and air conditioning equipment that could allow CO to enter.
Florida Governor Launches Discount Drug Card
Governor Charlie Crist announced the launch of the Florida Discount Drug Card, which will provide eligible Floridians savings on drugs at over 3,000 participating pharmacies. An easy-to-use Web site, www.FloridaDiscountDrugCard.com Opens in new window , is available to help consumers learn which drugs are discounted and find participating pharmacies. Participants can also choose a mail order option by calling the Florida Discount Drug Card help line.
"Access to affordable prescription drugs enhances every person’s quality of life as well as the vitality of our state, and many working families and seniors struggle to afford their medications," Governor Crist said. "The Florida Discount Drug Card is easy to use and will help lower the cost of prescription drugs for many who need them."
Governor Crist was joined by Lt. Governor Jeff Kottkamp for the announcement in Tallahassee. Governor Crist, along with Secretary Bob Butterworth of the Department of Children and Families and Secretary Andrew Agwunobi of the Agency for Health Care Administration, will also highlight the program in St. Petersburg, West Palm Beach and Miami. Secretary Doug Beach of the Department of Elder Affairs and State Surgeon General Ana Viamonte Ros joined Lt. Governor Kottkamp for events in Jacksonville, Orlando and Fort Myers.
Pharmacy Participation
Governor Crist invited all pharmacies in Florida to participate in the Florida Discount Drug Card program. Currently, more than 3,000 retail pharmacies have agreed to accept the Florida Discount Drug Card. However, additional pharmacies can continue to enroll in the program. If a consumer learns their pharmacy is not enrolled in the program, the pharmacy can enroll by calling the 24-hour pharmacy help line at 1-800-361-4542 or TTY 1-866-763-9630. The pharmacy will be enrolled on a temporary basis so the consumer’s prescription can be filled immediately. Once the pharmacy signs a contract, it can permanently join the program.
The pharmacy benefits manager Envision Pharmaceutical Services negotiates prices with the pharmaceutical companies and secures volume discounts on prescription drugs. Participating pharmacies agree to the negotiated price for each drug. The savings are then passed on to the customer.
Enrollment and Eligibility
Individuals qualify for the card if they are age 60 and older and do not have prescription drug coverage or if they are in the Medicare Prescription Drug Coverage gap. Individuals, families and seniors under age 60 may be eligible if they have an annual income of less than 300 percent of the Federal Poverty Level and do not have prescription drug coverage. Qualifying annual incomes for individuals under age 60 are up to $30,636 for an individual, $41,076 for a family of two and $61,956 for a family of four. Income limits for other family sizes are also available on the Web site.
To enroll in the program, applicants who do not have prescription drug coverage must provide their name and contact information as well as information about family members. Individuals under age 60 also must provide qualifying income information. The applicant affirms that the information provided on the application is true, complete, and accurate; no additional documentation of income, age, or residency is required.
There is no application fee for the Florida Discount Drug Card; however, there is a one time $1.50 activation fee added onto the posted cost of the first prescription filled only. If the pharmacy’s usual and customary price is lower than the Florida Discount Drug price, the customer will pay the lower price. Additionally, if the customer qualifies for any other prescription discounts, they will always pay the lowest price.
Empowering Consumers
Governor Crist also launched a Web site designed to assist Floridians in search of accurate, trusted, and unbiased health care information. The Web site, developed by the Agency for Health Care Administration, integrates two other health-related Web sites, FloridaCompareCare.gov and FloridaHealthStat.com, into one – www.FloridaHealthFinder.gov Opens in new window . Consumers can find information on more than 1,600 diseases and conditions, lists of health care facilities, information about insurance, medications, a variety of consumer publications and much more.
As Attorney General, Charlie Crist launched the pharmacy pricing website, MyFloridaRx.com, where Floridians compare drugs prices between pharmacies. He also fought for cheaper medicine by taking action against drug companies that kept low cost generics off the market, and brought suit against companies for falsely reporting their wholesale prices.
"Access to affordable prescription drugs enhances every person’s quality of life as well as the vitality of our state, and many working families and seniors struggle to afford their medications," Governor Crist said. "The Florida Discount Drug Card is easy to use and will help lower the cost of prescription drugs for many who need them."
Governor Crist was joined by Lt. Governor Jeff Kottkamp for the announcement in Tallahassee. Governor Crist, along with Secretary Bob Butterworth of the Department of Children and Families and Secretary Andrew Agwunobi of the Agency for Health Care Administration, will also highlight the program in St. Petersburg, West Palm Beach and Miami. Secretary Doug Beach of the Department of Elder Affairs and State Surgeon General Ana Viamonte Ros joined Lt. Governor Kottkamp for events in Jacksonville, Orlando and Fort Myers.
Pharmacy Participation
Governor Crist invited all pharmacies in Florida to participate in the Florida Discount Drug Card program. Currently, more than 3,000 retail pharmacies have agreed to accept the Florida Discount Drug Card. However, additional pharmacies can continue to enroll in the program. If a consumer learns their pharmacy is not enrolled in the program, the pharmacy can enroll by calling the 24-hour pharmacy help line at 1-800-361-4542 or TTY 1-866-763-9630. The pharmacy will be enrolled on a temporary basis so the consumer’s prescription can be filled immediately. Once the pharmacy signs a contract, it can permanently join the program.
The pharmacy benefits manager Envision Pharmaceutical Services negotiates prices with the pharmaceutical companies and secures volume discounts on prescription drugs. Participating pharmacies agree to the negotiated price for each drug. The savings are then passed on to the customer.
Enrollment and Eligibility
Individuals qualify for the card if they are age 60 and older and do not have prescription drug coverage or if they are in the Medicare Prescription Drug Coverage gap. Individuals, families and seniors under age 60 may be eligible if they have an annual income of less than 300 percent of the Federal Poverty Level and do not have prescription drug coverage. Qualifying annual incomes for individuals under age 60 are up to $30,636 for an individual, $41,076 for a family of two and $61,956 for a family of four. Income limits for other family sizes are also available on the Web site.
To enroll in the program, applicants who do not have prescription drug coverage must provide their name and contact information as well as information about family members. Individuals under age 60 also must provide qualifying income information. The applicant affirms that the information provided on the application is true, complete, and accurate; no additional documentation of income, age, or residency is required.
There is no application fee for the Florida Discount Drug Card; however, there is a one time $1.50 activation fee added onto the posted cost of the first prescription filled only. If the pharmacy’s usual and customary price is lower than the Florida Discount Drug price, the customer will pay the lower price. Additionally, if the customer qualifies for any other prescription discounts, they will always pay the lowest price.
Empowering Consumers
Governor Crist also launched a Web site designed to assist Floridians in search of accurate, trusted, and unbiased health care information. The Web site, developed by the Agency for Health Care Administration, integrates two other health-related Web sites, FloridaCompareCare.gov and FloridaHealthStat.com, into one – www.FloridaHealthFinder.gov Opens in new window . Consumers can find information on more than 1,600 diseases and conditions, lists of health care facilities, information about insurance, medications, a variety of consumer publications and much more.
As Attorney General, Charlie Crist launched the pharmacy pricing website, MyFloridaRx.com, where Floridians compare drugs prices between pharmacies. He also fought for cheaper medicine by taking action against drug companies that kept low cost generics off the market, and brought suit against companies for falsely reporting their wholesale prices.
Driving After Holiday Drinking May Take You To Intoxicated Drivers Center
Drunk Driving
It is the season to be jolly, to attend parties and functions where adult beverages are freely offered; but drink and drive and you might end up at the Ocean County Health Department's Intoxicated Drivers Resource Center (IDRC), according to a department spokesperson.
'State law requires judges to order convicted first-time driving while intoxicated (DWI) offenders to attend a 12-hour IDRC course,' said Edward Rumen, department Public Information Officer. 'The course is held on a Friday and Saturday and each client must attend a consecutive two day cycle. Currently each student pays $230 for the course,' he added.
The course covers such areas as symptoms of addiction, social problems with drinking, the heredity factor in alcoholism, environmental issues and other topics. It is presented by licensed, trained specialists within the Health Department's Alcohol and Drugs Services division.
'The course is a mandatory tool designed to alert drivers to the dangers of drinking and driving,' Rumen stated. 'We get all types of people here, but many of them have a family history of alcoholism.'
Rumen said each student completes a self-assessment form required by the state.
'The forms are reviewed by the counselors, who recommend those with more serious problems for a full evaluation, which can result in 16 additional one-hour counseling sessions at an additional cost to them,' he said. 'The evaluations and counseling are conducted at state-approved clinics.'
'Once convicted of drunk driving, a nightmare begins,' Rumen said. 'By the time the ordeal is completed, the average drunk driver will have paid close to $10,000 in fines, court costs, lawyer fees, motor vehicle surcharges, insurance surcharges, license restoration fees, IDRC tuition and other miscellaneous expenses'And that is for a first time conviction.'
'The message about not drinking and driving is getting through to most Ocean County drivers,' said Freeholder Gerry P. Little. 'During the 1990s, the number of IDRC attendees declined yearly. The numbers are starting to creep up again, but the population is significantly higher than a decade ago. It is important that the valuable message about the consequences of drinking and driving get out to our younger drivers most of all. If caught driving while intoxicated, the personal costs can be tremendous, in addition to the loss of license.'
Rumen said the IDRC course is given at least three times a month at the Ocean County Health Department Building on Sunset Avenue in Toms River. 'We are trying to save lives, careers and families by educating first-time offenders to the dangers of alcohol and driving.'
Rumen said every county provides an IDRC course for first-time offenders. 'There are regional centers for second offenders, consisting of an overnight 48-hour session that is offered in lieu of jail. Each subsequent DWI conviction brings with it more severe penalties, as does the blood-alcohol level of the driver at time of arrest,' he said.
It is the season to be jolly, to attend parties and functions where adult beverages are freely offered; but drink and drive and you might end up at the Ocean County Health Department's Intoxicated Drivers Resource Center (IDRC), according to a department spokesperson.
'State law requires judges to order convicted first-time driving while intoxicated (DWI) offenders to attend a 12-hour IDRC course,' said Edward Rumen, department Public Information Officer. 'The course is held on a Friday and Saturday and each client must attend a consecutive two day cycle. Currently each student pays $230 for the course,' he added.
The course covers such areas as symptoms of addiction, social problems with drinking, the heredity factor in alcoholism, environmental issues and other topics. It is presented by licensed, trained specialists within the Health Department's Alcohol and Drugs Services division.
'The course is a mandatory tool designed to alert drivers to the dangers of drinking and driving,' Rumen stated. 'We get all types of people here, but many of them have a family history of alcoholism.'
Rumen said each student completes a self-assessment form required by the state.
'The forms are reviewed by the counselors, who recommend those with more serious problems for a full evaluation, which can result in 16 additional one-hour counseling sessions at an additional cost to them,' he said. 'The evaluations and counseling are conducted at state-approved clinics.'
'Once convicted of drunk driving, a nightmare begins,' Rumen said. 'By the time the ordeal is completed, the average drunk driver will have paid close to $10,000 in fines, court costs, lawyer fees, motor vehicle surcharges, insurance surcharges, license restoration fees, IDRC tuition and other miscellaneous expenses'And that is for a first time conviction.'
'The message about not drinking and driving is getting through to most Ocean County drivers,' said Freeholder Gerry P. Little. 'During the 1990s, the number of IDRC attendees declined yearly. The numbers are starting to creep up again, but the population is significantly higher than a decade ago. It is important that the valuable message about the consequences of drinking and driving get out to our younger drivers most of all. If caught driving while intoxicated, the personal costs can be tremendous, in addition to the loss of license.'
Rumen said the IDRC course is given at least three times a month at the Ocean County Health Department Building on Sunset Avenue in Toms River. 'We are trying to save lives, careers and families by educating first-time offenders to the dangers of alcohol and driving.'
Rumen said every county provides an IDRC course for first-time offenders. 'There are regional centers for second offenders, consisting of an overnight 48-hour session that is offered in lieu of jail. Each subsequent DWI conviction brings with it more severe penalties, as does the blood-alcohol level of the driver at time of arrest,' he said.
Boston Stores To Limit Tobacco Ads
Tobacco Ads
Mayor Thomas M. Menino, joined by Boston public health and school officials, as well as members of youth advocacy groups, today urged convenience stores and liquor stores to adhere to City regulations limiting the advertising of tobacco products to minors.
"We've done a great job in Boston of getting these stores to comply with the law forbidding the sale of tobacco products to minors," Mayor Menino said at the Tropic Food Market in Dorchester. "Now it's time for merchants to abide by the City's sign code that limits advertisements."
He called on neighborhood associations to help the City enforce the code by reporting stores that appear to be in violation to the Inspectional Services Department. Mayor Menino's renewed push comes on the heels of a study done by Sociedad Latina, a Latino youth advocacy group partially funded by the City, that examined tobacco, junk food, and alcohol advertising in stores around Boston.
The survey found that stores in low-income communities had more advertisements than those in more affluent communities. Most of those ads on the windows and doors were placed no higher than three feet, or within eye-level of young children. The majority of the ads were for tobacco products. In addition, the survey found that 34 percent of the tobacco ads are in stores located near a school, a community center, or a playground.
Dr. Barbara Ferrer, executive director of the Boston Public Health Commission, said, "There are serious public health consequences to kids being bombarded with tobacco advertisement at such a young age. Either we act now to limit their exposure or we pay the price later when they start smoking and get sick."
Boston's sign code requires businesses to seek a permit to install a permanent window sign, which cannot exceed 30 percent of the total window space. A permit is not required for a temporary sign, which can stay up for 15 days. But many businesses bypass the permit process and keep the signs up longer than the code allows.
Boston Public School Superintendent Carol Johnson said, "Upon dismissal, many students head to the local convenience store for an after school snack. I believe it is only proper for the stores to respect the health of the students by not subjecting them to a barrage of advertisements for junk food and tobacco products. I commend those stores that abide by the rules and ask the others to consider the well-being of our students."
Mayor Thomas M. Menino, joined by Boston public health and school officials, as well as members of youth advocacy groups, today urged convenience stores and liquor stores to adhere to City regulations limiting the advertising of tobacco products to minors.
"We've done a great job in Boston of getting these stores to comply with the law forbidding the sale of tobacco products to minors," Mayor Menino said at the Tropic Food Market in Dorchester. "Now it's time for merchants to abide by the City's sign code that limits advertisements."
He called on neighborhood associations to help the City enforce the code by reporting stores that appear to be in violation to the Inspectional Services Department. Mayor Menino's renewed push comes on the heels of a study done by Sociedad Latina, a Latino youth advocacy group partially funded by the City, that examined tobacco, junk food, and alcohol advertising in stores around Boston.
The survey found that stores in low-income communities had more advertisements than those in more affluent communities. Most of those ads on the windows and doors were placed no higher than three feet, or within eye-level of young children. The majority of the ads were for tobacco products. In addition, the survey found that 34 percent of the tobacco ads are in stores located near a school, a community center, or a playground.
Dr. Barbara Ferrer, executive director of the Boston Public Health Commission, said, "There are serious public health consequences to kids being bombarded with tobacco advertisement at such a young age. Either we act now to limit their exposure or we pay the price later when they start smoking and get sick."
Boston's sign code requires businesses to seek a permit to install a permanent window sign, which cannot exceed 30 percent of the total window space. A permit is not required for a temporary sign, which can stay up for 15 days. But many businesses bypass the permit process and keep the signs up longer than the code allows.
Boston Public School Superintendent Carol Johnson said, "Upon dismissal, many students head to the local convenience store for an after school snack. I believe it is only proper for the stores to respect the health of the students by not subjecting them to a barrage of advertisements for junk food and tobacco products. I commend those stores that abide by the rules and ask the others to consider the well-being of our students."
Vermonters Encouraged To Enjoy A Sober Holiday
Health Department reminds Vermonters that the healthiest way for adults over the legal drinking age of 21 to enjoy the holiday season is to drink responsibly, or not to drink at all.
Alcohol is a drug that depresses the central nervous system, slowing the activity of the brain. Judgment and restraint are lessened and reflexes are slowed. Nationally, drinking and driving kills someone every 31 minutes and injures someone every two minutes, according to the Centers for Disease Control and Prevention.
“Unfortunately, alcohol use is still considered somewhat of a norm at social gatherings and holiday parties nationwide,” said Barbara Cimaglio, deputy commissioner for the division of Alcohol and Drug Abuse. “Resist the pressure to drink and serve alcohol at social events, serve food, don’t pressure people to drink, and make sure people who have been drinking do not drive.”
Other tips for a safe and sober holiday include always offering alternatives to alcohol to drink at a party so that people have a choice, and to never leave alcohol sitting out where kids can pick it up and drink it.
According to the Distilled Spirits Council of the United States, the $49 billion distilled-spirits industry makes more than 25% of its profits from Thanksgiving to the New Year. Vermont sells nearly 1.5 times the volume of liquor in December than any other month of the year from its 75 liquor and spirit outlets statewide, according to the Vermont Department of Liquor Control.
Alcohol is a drug that depresses the central nervous system, slowing the activity of the brain. Judgment and restraint are lessened and reflexes are slowed. Nationally, drinking and driving kills someone every 31 minutes and injures someone every two minutes, according to the Centers for Disease Control and Prevention.
“Unfortunately, alcohol use is still considered somewhat of a norm at social gatherings and holiday parties nationwide,” said Barbara Cimaglio, deputy commissioner for the division of Alcohol and Drug Abuse. “Resist the pressure to drink and serve alcohol at social events, serve food, don’t pressure people to drink, and make sure people who have been drinking do not drive.”
Other tips for a safe and sober holiday include always offering alternatives to alcohol to drink at a party so that people have a choice, and to never leave alcohol sitting out where kids can pick it up and drink it.
According to the Distilled Spirits Council of the United States, the $49 billion distilled-spirits industry makes more than 25% of its profits from Thanksgiving to the New Year. Vermont sells nearly 1.5 times the volume of liquor in December than any other month of the year from its 75 liquor and spirit outlets statewide, according to the Vermont Department of Liquor Control.
Omega-3s Linked To Prevention Of Parkinson's Disease
Parkinson's Disease
A milestone report links long-chain (marine) omega-3 polyunsaturated fatty acids (PUFAs) with the prevention of Parkinson's disease, according to the December 2007 Fats of Life and PUFA Newsletter electronic publications, which summarize the latest scientific findings on PUFAs.
"Papers with the potential to redirect our thinking about diseases are rare, but this study from Laval University in Quebec City, Canada, might do it for Parkinson's disease," said Editor Joyce Nettleton. "The researchers showed that the consumption of marine omega-3s-mainly docosahexaenoic acid (DHA)-- protected Parkinson's animals from losing their dopamine-producing neurons. Animals without these omega-3s lost 30 percent of these essential cells, a hallmark of the disease. The implication is that sufficient brain DHA might be able to prevent the onset of Parkinson's disease."
The e-newsletters cover other studies linking marine omega-3s and better cognitive abilities in aging. Eating fish regularly or having higher amounts of omega-3s in the blood are characteristic of older people who have escaped dementia or Alzheimer's disease, according to research from France and the Netherlands. In Norway, participants in their 70s who consumed fish at least once a week had superior mental abilities compared with those who avoided eating fish.
Cognitive benefits from omega-3s seem not to be limited to older adults. Research from Australia found that infants consuming breast milk high in DHA had higher cognitive scores at age 21/2 years. The same study showed that mothers taking a high dose of fish oil in their last part of pregnancy increased the amount of omega-3s in their milk and in the infant for at least 6 weeks after delivery.
Research from Spain reported that more frequent fish consumption in children 6 1/2 years of age with higher risk of allergies was linked to significantly lower chance of developing allergic conditions. Evidence now suggests that maternal intake of omega-3s in pregnancy and a child's consumption of fish are associated with lower risk of childhood allergies.
"For all of these reasons, expecting mothers and people at risk for Parkinson's disease should resolve in the new year to consume more marine omega-3s," Nettleton concluded.
A milestone report links long-chain (marine) omega-3 polyunsaturated fatty acids (PUFAs) with the prevention of Parkinson's disease, according to the December 2007 Fats of Life and PUFA Newsletter electronic publications, which summarize the latest scientific findings on PUFAs.
"Papers with the potential to redirect our thinking about diseases are rare, but this study from Laval University in Quebec City, Canada, might do it for Parkinson's disease," said Editor Joyce Nettleton. "The researchers showed that the consumption of marine omega-3s-mainly docosahexaenoic acid (DHA)-- protected Parkinson's animals from losing their dopamine-producing neurons. Animals without these omega-3s lost 30 percent of these essential cells, a hallmark of the disease. The implication is that sufficient brain DHA might be able to prevent the onset of Parkinson's disease."
The e-newsletters cover other studies linking marine omega-3s and better cognitive abilities in aging. Eating fish regularly or having higher amounts of omega-3s in the blood are characteristic of older people who have escaped dementia or Alzheimer's disease, according to research from France and the Netherlands. In Norway, participants in their 70s who consumed fish at least once a week had superior mental abilities compared with those who avoided eating fish.
Cognitive benefits from omega-3s seem not to be limited to older adults. Research from Australia found that infants consuming breast milk high in DHA had higher cognitive scores at age 21/2 years. The same study showed that mothers taking a high dose of fish oil in their last part of pregnancy increased the amount of omega-3s in their milk and in the infant for at least 6 weeks after delivery.
Research from Spain reported that more frequent fish consumption in children 6 1/2 years of age with higher risk of allergies was linked to significantly lower chance of developing allergic conditions. Evidence now suggests that maternal intake of omega-3s in pregnancy and a child's consumption of fish are associated with lower risk of childhood allergies.
"For all of these reasons, expecting mothers and people at risk for Parkinson's disease should resolve in the new year to consume more marine omega-3s," Nettleton concluded.
Wednesday, December 26, 2007
Giving Lotto Tickets To Kids Not Worth The Gamble
With the holiday season in full swing, the International Centre for Youth Gambling Problems and High-Risk Behaviors at McGill University, in conjunction with Loto-Québec, the Atlantic Lottery Corporation (ALC) and Ontario Lottery and Gaming Corporation (OLG), is reminding parents not to gamble with their children's future by giving them lottery tickets as gifts.
"We know that playing the lottery at a young age can increase the potential for problem gambling later in life," said Dr. Jeffrey Derevensky, co-director of the centre and a renowned expert on problem gambling among young people.
In past studies conducted by Dr. Derevensky and his team, approximately 70-80% of Canadian adolescents reported having gambled for money in the preceding 12 months, with as many as 30% gambling on a weekly basis. Many problem gamblers reported taking up gambling during childhood, often with family members, as early as ages 9-10.
Research findings such as these, coupled with the growing concern of adolescent problem gambling in general, prompted the International Centre for Youth Gambling Problems and High-Risk Behaviors to partner with lottery corporations to raise public awareness of the issue of underage gambling. This is the fourth consecutive year McGill has partnered with Loto-Québec, and the second with ALC, to spread this message. OLG has joined the partnership for the first time this year.
Established in 1992, McGill University's International Centre for Youth Gambling Problems and High-Risk Behaviors has been involved in research and treatment, as well as the training of researchers and professionals concerned with youth gambling and other high-risk adolescent activities.
"We know that playing the lottery at a young age can increase the potential for problem gambling later in life," said Dr. Jeffrey Derevensky, co-director of the centre and a renowned expert on problem gambling among young people.
In past studies conducted by Dr. Derevensky and his team, approximately 70-80% of Canadian adolescents reported having gambled for money in the preceding 12 months, with as many as 30% gambling on a weekly basis. Many problem gamblers reported taking up gambling during childhood, often with family members, as early as ages 9-10.
Research findings such as these, coupled with the growing concern of adolescent problem gambling in general, prompted the International Centre for Youth Gambling Problems and High-Risk Behaviors to partner with lottery corporations to raise public awareness of the issue of underage gambling. This is the fourth consecutive year McGill has partnered with Loto-Québec, and the second with ALC, to spread this message. OLG has joined the partnership for the first time this year.
Established in 1992, McGill University's International Centre for Youth Gambling Problems and High-Risk Behaviors has been involved in research and treatment, as well as the training of researchers and professionals concerned with youth gambling and other high-risk adolescent activities.
Researchers Report Breakthrough In Rapid Malaria Detection
Malaria
A research team led by Dr. Paul Wiseman of the Departments of Physics and Chemistry at McGill University has developed a radically new technique that uses lasers and non-linear optical effects to detect malaria infection in human blood, according to a study published in the Biophysical Journal. The researchers say the new technique holds the promise of simpler, faster and far less labour-intensive detection of the malaria parasite in blood samples.
Malaria is a vector-borne infectious disease spread by parasites of the genus Plasmodium. Most common in tropical and subtropical regions, it is a global scourge with 350 to 500 million new cases – and one to three million fatalities – reported annually. Most of the fatalities are concentrated in sub-Saharan Africa, where the resources and trained personnel currently required to accurately diagnose the disease are spread the thinnest.
Current detection techniques require trained technicians to stain slides, look for the parasite's DNA signature under the microscope, and then manually count all the visible infected cells, a labourious process dependent on the skill and availability of trained analysts. By contrast, the proposed new technique relies on a known optical effect called third harmonic generation (THG), which causes hemozoin – a crystalline substance secreted by the parasite – to glow blue when irradiated by an infrared laser.
"People who are familiar with music know about acoustic harmonics," said Dr. Wiseman. "You have a fundamental sound frequency and then multiples of that frequency. Non-linear optical effects are similar: if you shine an intense laser beam of a specific frequency on certain types of materials, you generate multiples of the frequency. Hemozoin has a huge, non-linear optical response for the third harmonic, which causes the blue glow."
Dr. Wiseman and his colleagues now hope to adapt well-established existing technologies like fibre-optic communications lasers and fluorescent cell sorters to quickly move the technique out of the laboratory and into the field.
"We're imagining a self-contained unit that could be used in clinics in endemic countries," said Dr. Wiseman. "The operator could inject the cell sample directly into the device, and then it would come up with a count of the total number of existing infected cells without manual intervention."
A research team led by Dr. Paul Wiseman of the Departments of Physics and Chemistry at McGill University has developed a radically new technique that uses lasers and non-linear optical effects to detect malaria infection in human blood, according to a study published in the Biophysical Journal. The researchers say the new technique holds the promise of simpler, faster and far less labour-intensive detection of the malaria parasite in blood samples.
Malaria is a vector-borne infectious disease spread by parasites of the genus Plasmodium. Most common in tropical and subtropical regions, it is a global scourge with 350 to 500 million new cases – and one to three million fatalities – reported annually. Most of the fatalities are concentrated in sub-Saharan Africa, where the resources and trained personnel currently required to accurately diagnose the disease are spread the thinnest.
Current detection techniques require trained technicians to stain slides, look for the parasite's DNA signature under the microscope, and then manually count all the visible infected cells, a labourious process dependent on the skill and availability of trained analysts. By contrast, the proposed new technique relies on a known optical effect called third harmonic generation (THG), which causes hemozoin – a crystalline substance secreted by the parasite – to glow blue when irradiated by an infrared laser.
"People who are familiar with music know about acoustic harmonics," said Dr. Wiseman. "You have a fundamental sound frequency and then multiples of that frequency. Non-linear optical effects are similar: if you shine an intense laser beam of a specific frequency on certain types of materials, you generate multiples of the frequency. Hemozoin has a huge, non-linear optical response for the third harmonic, which causes the blue glow."
Dr. Wiseman and his colleagues now hope to adapt well-established existing technologies like fibre-optic communications lasers and fluorescent cell sorters to quickly move the technique out of the laboratory and into the field.
"We're imagining a self-contained unit that could be used in clinics in endemic countries," said Dr. Wiseman. "The operator could inject the cell sample directly into the device, and then it would come up with a count of the total number of existing infected cells without manual intervention."
Tips For A Heart-Healthy Season
The holidays can be a hectic time. A leading cardiologist has 10 tips for getting through the season feeling healthier and less stressed.
"For most of us, even if we're healthy the rest of the year, holidays can really take a toll on our stress levels and diets," says Dr. Rita Redberg, director of UCSF Women's Cardiovascular Services and author of numerous books, articles and scientific papers on heart-health and lifetime wellness.
"The average person gains five pounds over the holidays, which is hard on the heart," Redberg adds. "That doesn't mean it's a lost cause, though. What's important to remember, any time we're trying to improve our health, is that even the smallest changes can have a big impact."
A heart-healthy lifestyle includes reducing fat and salt in our diets; eating more fish, fruit and vegetables; maintaining our ideal weight and getting plenty of exercise, Redberg says. And she agrees that this can be tough to achieve during a busy holiday season.
Among her tips:
1. If you have a packed holiday schedule, give the first gift to yourself: Splurge on a healthy treat like out-of-season berries for breakfast and try to do one healthy thing every day.
2. Before a party, eat a high-protein snack, such as nonfat yogurt and a piece of fruit. The protein will give you sustainable energy and make it easier to pass up party foods that are high in fat and salt. The fruit will fill you up and help give you the vitamins you need.
3. Instead of taking that first glass of wine or champagne, start with a glass of bubbly water, with a squeeze of lime. Many of us drink more alcohol (and calories) than we want because we start out thirsty and want something in our hand. Replace one of those drinks with water, and you've cut 100 or more calories from the evening.
4. If you have the choice between olives and canaps or chips, go for the olives -- they're good for your heart, take longer to eat and give you clear evidence (with the pits) of how many you've eaten.
5. Can't resist chocolate? Don't. Instead, look for dark chocolate with intense flavors and savor a small piece of it. If it keeps you from eating that whole box of milk chocolates, it's done the trick.
6. While shopping, instead of cramming into the elevator, take the stairs. Or pass up that parking space closest to the store and walk a little farther. Every step helps.
7. For family meals, look for lean cuts of meat, such as flank steak, pork tenderloin, or chicken without the skin, and broil or grill them to reduce the fat.
8. When serving potatoes, use yams or sweet potatoes instead to increase vitamins and minerals, and try using low-fat buttermilk instead of butter and cream in mashed potatoes.
9. If you find your blood-pressure rising, take a few minutes for yourself. Get a massage or a hot tub at a spa. Even a homemade facial mask or a $5 bottle of bubble bath, used wisely, can give you a season of stress-relief.
10. And finally, remember the spirit of the season. Whether we practice a religion or not, this is a time to pause, reflect on our priorities and spend time with people we love. These actions alone will help you create a lifetime of wellness.
Redberg says she generated the tips after years of seeing her cardiology patients struggle to maintain healthy lifestyles during the holidays, either because they felt more stressed during the holidays or because they simply had trouble eating well and exercising.
Heart disease is the leading killer of both men and women in the United States, but most of its effects can be prevented or delayed through small lifestyle changes, Redberg says. What's most important during the holidays, is to avoid adding further stress to the season by trying to deprive yourself of foods you and your family love, she adds.
"Despite all of the fad diets out there, the current thinking on weight loss and management is not to deprive yourself of the foods you like, but to have them less often or in smaller portions," Redberg says. "As long as your overall diet is moderate in fat and calories, you'll still be able to fit in the foods you love."
Redberg recently co-authored the "Betty Crocker Cookbook for Women, The Complete Guide to Women's Health and Wellness at Every Stage of Life," which focuses its 140 heart-healthy recipes on the simple changes women can make for a heart-healthy life.
She wrote the cookbook in response to the tremendous demand for personal health advice that goes beyond -- eat well and get more exercise, especially for women as they progress through the many biological and nutritional changes in their lives.
An outspoken leader in the field of cardiology, Redberg has dedicated her career to educating the physician community and patients on women's unique risk factors for heart disease. She has spoken widely on the subject and also has written several books, including "Heart Healthy: The Step-by-Step Guide to Preventing and Healing Heart Disease."
She is also widely recognized for her research into the potential value of interventions, especially exercise, to fend off heart disease in women.
"For most of us, even if we're healthy the rest of the year, holidays can really take a toll on our stress levels and diets," says Dr. Rita Redberg, director of UCSF Women's Cardiovascular Services and author of numerous books, articles and scientific papers on heart-health and lifetime wellness.
"The average person gains five pounds over the holidays, which is hard on the heart," Redberg adds. "That doesn't mean it's a lost cause, though. What's important to remember, any time we're trying to improve our health, is that even the smallest changes can have a big impact."
A heart-healthy lifestyle includes reducing fat and salt in our diets; eating more fish, fruit and vegetables; maintaining our ideal weight and getting plenty of exercise, Redberg says. And she agrees that this can be tough to achieve during a busy holiday season.
Among her tips:
1. If you have a packed holiday schedule, give the first gift to yourself: Splurge on a healthy treat like out-of-season berries for breakfast and try to do one healthy thing every day.
2. Before a party, eat a high-protein snack, such as nonfat yogurt and a piece of fruit. The protein will give you sustainable energy and make it easier to pass up party foods that are high in fat and salt. The fruit will fill you up and help give you the vitamins you need.
3. Instead of taking that first glass of wine or champagne, start with a glass of bubbly water, with a squeeze of lime. Many of us drink more alcohol (and calories) than we want because we start out thirsty and want something in our hand. Replace one of those drinks with water, and you've cut 100 or more calories from the evening.
4. If you have the choice between olives and canaps or chips, go for the olives -- they're good for your heart, take longer to eat and give you clear evidence (with the pits) of how many you've eaten.
5. Can't resist chocolate? Don't. Instead, look for dark chocolate with intense flavors and savor a small piece of it. If it keeps you from eating that whole box of milk chocolates, it's done the trick.
6. While shopping, instead of cramming into the elevator, take the stairs. Or pass up that parking space closest to the store and walk a little farther. Every step helps.
7. For family meals, look for lean cuts of meat, such as flank steak, pork tenderloin, or chicken without the skin, and broil or grill them to reduce the fat.
8. When serving potatoes, use yams or sweet potatoes instead to increase vitamins and minerals, and try using low-fat buttermilk instead of butter and cream in mashed potatoes.
9. If you find your blood-pressure rising, take a few minutes for yourself. Get a massage or a hot tub at a spa. Even a homemade facial mask or a $5 bottle of bubble bath, used wisely, can give you a season of stress-relief.
10. And finally, remember the spirit of the season. Whether we practice a religion or not, this is a time to pause, reflect on our priorities and spend time with people we love. These actions alone will help you create a lifetime of wellness.
Redberg says she generated the tips after years of seeing her cardiology patients struggle to maintain healthy lifestyles during the holidays, either because they felt more stressed during the holidays or because they simply had trouble eating well and exercising.
Heart disease is the leading killer of both men and women in the United States, but most of its effects can be prevented or delayed through small lifestyle changes, Redberg says. What's most important during the holidays, is to avoid adding further stress to the season by trying to deprive yourself of foods you and your family love, she adds.
"Despite all of the fad diets out there, the current thinking on weight loss and management is not to deprive yourself of the foods you like, but to have them less often or in smaller portions," Redberg says. "As long as your overall diet is moderate in fat and calories, you'll still be able to fit in the foods you love."
Redberg recently co-authored the "Betty Crocker Cookbook for Women, The Complete Guide to Women's Health and Wellness at Every Stage of Life," which focuses its 140 heart-healthy recipes on the simple changes women can make for a heart-healthy life.
She wrote the cookbook in response to the tremendous demand for personal health advice that goes beyond -- eat well and get more exercise, especially for women as they progress through the many biological and nutritional changes in their lives.
An outspoken leader in the field of cardiology, Redberg has dedicated her career to educating the physician community and patients on women's unique risk factors for heart disease. She has spoken widely on the subject and also has written several books, including "Heart Healthy: The Step-by-Step Guide to Preventing and Healing Heart Disease."
She is also widely recognized for her research into the potential value of interventions, especially exercise, to fend off heart disease in women.
Fish oil has anti-Alzheimer's mechanism
UCLA researchers find anti-Alzheimer's mechanism in omega-3 fatty acids.
It's good news that we are living longer, but bad news that the longer we live, the better our odds of developing late-onset Alzheimer's disease.
Many Alzheimer's researchers have long touted fish oil, by pill or diet, as an accessible and inexpensive "weapon" that may delay or prevent this debilitating disease. Now, UCLA scientists have confirmed that fish oil is indeed a deterrent against Alzheimer's, and they have identified the reasons why.
Reporting in the current issue of the Journal of Neuroscience, now online, Greg Cole, professor of medicine and neurology at the David Geffen School of Medicine at UCLA and associate director of UCLA's Alzheimer Disease Research Center, and his colleagues report that the omega-3 fatty acid docosahexaenoic acid (DHA) found in fish oil increases the production of LR11, a protein that is found at reduced levels in Alzheimer's patients and which is known to destroy the protein that forms the "plaques" associated with the disease.
The plaques are deposits of a protein called beta amyloid that is thought to be toxic to neurons in the brain, leading to Alzheimer's. Since having high levels of LR11 prevents the toxic plaques from being made, low levels in patients are believed to be a factor in causing the disease.
Alzheimer's is a debilitating neurodegenerative disease that causes memory loss, dementia, personality change and ultimately death. The national Alzheimer's Association estimates that 5.1 million Americans are currently afflicted with the disease and predicts that the number may increase to between 11 million and 16 million people by the year 2050.
The researchers examined the effects of fish oil, or its component DHA, in multiple biological systems and administered the oil or fatty acid by diet and by adding it directly to neurons grown in the laboratory.
"We found that even low doses of DHA increased the levels of LR11 in rat neurons, while dietary DHA increased LR11 in brains of rats or older mice that had been genetically altered to develop Alzheimer's disease," said Cole, who is also associate director of the Geriatric Research Center at the Veterans Affairs Medical Center.
To show that the benefits of DHA were not limited to nonhuman animal cells, the researchers also confirmed a direct impact of DHA on human neuronal cells in culture as well. Thus, high levels of DHA leading to abundant LR11 seem to protect against Alzheimer's, Cole said, while low LR11 levels lead to formation of the amyloid plaques.
Fish oil and its key ingredient, omega-3 fatty acids (found in fatty fish like salmon), have been a mainstay of alternative health practitioners for years and have been endorsed by the American Heart Association to reduce the risk of cardiovascular disease.
Fatty acids like DHA are considered "essential" fatty acids because the body cannot make them from other sources and must obtain them through diet. Years of research have shown that DHA is the most abundant essential fatty acid in the brain, Cole said, and that it is critical to fetal and infant brain development. Studies have also linked low levels of DHA in the brain to cognitive impairment and have shown that lower levels may increase oxidative stress in the brains of Alzheimer's patients.
Based on the positive results, the National Institutes of Health is currently conducting a large-scale clinical trial with DHA in patients with established Alzheimer's disease. For those patients, Cole said, it may be too late in the disease's progression for DHA to have much effect. But he is hopeful that the NIH will conduct a large-scale prevention clinical trial using fish oil at the earliest stages of the disease — particularly because it is unlikely that a pharmaceutical company will do so, since fish oil in pill form is readily available and inexpensive.
Still to be determined, he said, "is what the optimal dose should be. It could be that a smaller amount might be helpful, especially in a place like the south of France, where people are already on a Mediterranean diet."
Here in the United States, though, where fish consumption is not very high, the dose may need to be higher.
"There's a deficiency of DHA to begin with," Cole said, "and this may contribute to the low LR11 seen in many Alzheimer's patients."
It's good news that we are living longer, but bad news that the longer we live, the better our odds of developing late-onset Alzheimer's disease.
Many Alzheimer's researchers have long touted fish oil, by pill or diet, as an accessible and inexpensive "weapon" that may delay or prevent this debilitating disease. Now, UCLA scientists have confirmed that fish oil is indeed a deterrent against Alzheimer's, and they have identified the reasons why.
Reporting in the current issue of the Journal of Neuroscience, now online, Greg Cole, professor of medicine and neurology at the David Geffen School of Medicine at UCLA and associate director of UCLA's Alzheimer Disease Research Center, and his colleagues report that the omega-3 fatty acid docosahexaenoic acid (DHA) found in fish oil increases the production of LR11, a protein that is found at reduced levels in Alzheimer's patients and which is known to destroy the protein that forms the "plaques" associated with the disease.
The plaques are deposits of a protein called beta amyloid that is thought to be toxic to neurons in the brain, leading to Alzheimer's. Since having high levels of LR11 prevents the toxic plaques from being made, low levels in patients are believed to be a factor in causing the disease.
Alzheimer's is a debilitating neurodegenerative disease that causes memory loss, dementia, personality change and ultimately death. The national Alzheimer's Association estimates that 5.1 million Americans are currently afflicted with the disease and predicts that the number may increase to between 11 million and 16 million people by the year 2050.
The researchers examined the effects of fish oil, or its component DHA, in multiple biological systems and administered the oil or fatty acid by diet and by adding it directly to neurons grown in the laboratory.
"We found that even low doses of DHA increased the levels of LR11 in rat neurons, while dietary DHA increased LR11 in brains of rats or older mice that had been genetically altered to develop Alzheimer's disease," said Cole, who is also associate director of the Geriatric Research Center at the Veterans Affairs Medical Center.
To show that the benefits of DHA were not limited to nonhuman animal cells, the researchers also confirmed a direct impact of DHA on human neuronal cells in culture as well. Thus, high levels of DHA leading to abundant LR11 seem to protect against Alzheimer's, Cole said, while low LR11 levels lead to formation of the amyloid plaques.
Fish oil and its key ingredient, omega-3 fatty acids (found in fatty fish like salmon), have been a mainstay of alternative health practitioners for years and have been endorsed by the American Heart Association to reduce the risk of cardiovascular disease.
Fatty acids like DHA are considered "essential" fatty acids because the body cannot make them from other sources and must obtain them through diet. Years of research have shown that DHA is the most abundant essential fatty acid in the brain, Cole said, and that it is critical to fetal and infant brain development. Studies have also linked low levels of DHA in the brain to cognitive impairment and have shown that lower levels may increase oxidative stress in the brains of Alzheimer's patients.
Based on the positive results, the National Institutes of Health is currently conducting a large-scale clinical trial with DHA in patients with established Alzheimer's disease. For those patients, Cole said, it may be too late in the disease's progression for DHA to have much effect. But he is hopeful that the NIH will conduct a large-scale prevention clinical trial using fish oil at the earliest stages of the disease — particularly because it is unlikely that a pharmaceutical company will do so, since fish oil in pill form is readily available and inexpensive.
Still to be determined, he said, "is what the optimal dose should be. It could be that a smaller amount might be helpful, especially in a place like the south of France, where people are already on a Mediterranean diet."
Here in the United States, though, where fish consumption is not very high, the dose may need to be higher.
"There's a deficiency of DHA to begin with," Cole said, "and this may contribute to the low LR11 seen in many Alzheimer's patients."
Sunday, December 23, 2007
Seasonal Stomach Virus Arrives In NYC
Norovirus
Illness from a common infection called norovirus has spiked in New York City in recent weeks, the Health Department reported today. Emergency department visits for vomiting and diarrhea, the most common symptoms, have jumped from 300 visits per day to nearly 500 visits per day since November, prompting health officials to remind all New Yorkers to stay home when they are sick and to wash their hands frequently. Norovirus, commonly known as stomach flu, is a seasonal illness that typically peaks during the winter months, here and across the nation.Norovirus rarely causes more than a few days of illness. In addition to vomiting and diarrhea, the symptoms may include nausea, stomach cramping, fever, chills, aches and tiredness.“The best way to stop the spread of norovirus is to wash your hands regularly with soap and stay home from work or school if you are sick,” said Dr. Sharon Balter, Director of Enteric Disease for the Health Department’s Bureau of Communicable Disease. “Norovirus is common at this time of year and is not serious for most people, but it is important to take these steps to keep others from getting sick.”There are no specific treatments for stomach viruses. People with diarrhea or vomiting, particularly young children, should drink plenty of fluids to prevent dehydration, the most concerning consequence of stomach viruses. If an infected person stops urinating or cannot keep fluids down, he or she should seek health care promptly.People can become sick with this stomach virus in several ways, including:
* Eating food or drinking liquids that are contaminated with norovirus
* Touching surfaces that are contaminated with norovirus, and then putting their hands in their mouths
* Having close contact with a person who is sick — sharing foods or utensils, for example, or changing a sick child’s diaper.
How to prevent stomach infections:
* Wash your hands often with soap for at least 20 seconds, especially after using the bathroom, changing diapers, or before touching food.
* Supervise young children washing their hands after using the bathroom and before eating.
* If you are sick with vomiting or have diarrhea, stay at home until you recover – especially if you work in a restaurant or day care.
* If someone is sick, clean and disinfect surfaces that may have become dirty with vomit or stool as soon as possible with a germ-killing cleaner (i.e. a cleaner that has bleach in it).
Throw out any vomit or stool you clean up in sealed plastic bags. Remember to wear gloves when cleaning up contaminated areas and wash your hands after cleaning. Currently, the Health Departments only source of information on noroviral infections in New York City is emergency department data.
This past October, the Health Department proposed to the Board of Health that all New York City laboratories be required to report norovirus cases to the Department. This measure would allow the Health Department to better monitor norovirus trends and target prevention messages. The Board will consider the proposal in January.
Illness from a common infection called norovirus has spiked in New York City in recent weeks, the Health Department reported today. Emergency department visits for vomiting and diarrhea, the most common symptoms, have jumped from 300 visits per day to nearly 500 visits per day since November, prompting health officials to remind all New Yorkers to stay home when they are sick and to wash their hands frequently. Norovirus, commonly known as stomach flu, is a seasonal illness that typically peaks during the winter months, here and across the nation.Norovirus rarely causes more than a few days of illness. In addition to vomiting and diarrhea, the symptoms may include nausea, stomach cramping, fever, chills, aches and tiredness.“The best way to stop the spread of norovirus is to wash your hands regularly with soap and stay home from work or school if you are sick,” said Dr. Sharon Balter, Director of Enteric Disease for the Health Department’s Bureau of Communicable Disease. “Norovirus is common at this time of year and is not serious for most people, but it is important to take these steps to keep others from getting sick.”There are no specific treatments for stomach viruses. People with diarrhea or vomiting, particularly young children, should drink plenty of fluids to prevent dehydration, the most concerning consequence of stomach viruses. If an infected person stops urinating or cannot keep fluids down, he or she should seek health care promptly.People can become sick with this stomach virus in several ways, including:
* Eating food or drinking liquids that are contaminated with norovirus
* Touching surfaces that are contaminated with norovirus, and then putting their hands in their mouths
* Having close contact with a person who is sick — sharing foods or utensils, for example, or changing a sick child’s diaper.
How to prevent stomach infections:
* Wash your hands often with soap for at least 20 seconds, especially after using the bathroom, changing diapers, or before touching food.
* Supervise young children washing their hands after using the bathroom and before eating.
* If you are sick with vomiting or have diarrhea, stay at home until you recover – especially if you work in a restaurant or day care.
* If someone is sick, clean and disinfect surfaces that may have become dirty with vomit or stool as soon as possible with a germ-killing cleaner (i.e. a cleaner that has bleach in it).
Throw out any vomit or stool you clean up in sealed plastic bags. Remember to wear gloves when cleaning up contaminated areas and wash your hands after cleaning. Currently, the Health Departments only source of information on noroviral infections in New York City is emergency department data.
This past October, the Health Department proposed to the Board of Health that all New York City laboratories be required to report norovirus cases to the Department. This measure would allow the Health Department to better monitor norovirus trends and target prevention messages. The Board will consider the proposal in January.
Tuesday, December 18, 2007
Resolutions For A Healthy New You In New Year
The holiday season is a great opportunity to relax, spend time with family, reflect on the past year, and focus on new goals for the next 12 months. These top resolutions, offered by the American Medical Association (AMA), arm people with the knowledge to become a healthy new you in 2008.
"Creating and sticking to a new year's resolution to get healthier is the best gift you can give yourself this holiday season," said AMA President, Ron Davis, MD. "Talk to your physician about your health care plan and what you can do to ensure you remain healthy in 2008 and for many years to come."
Top ten resolutions for a healthy new you in the new year:
1. Eliminate trans fat from diet: Research shows that eating foods high in trans fats raise cholesterol levels and increase the risk of coronary artery disease. Replacing trans fats with healthier fats and oils, such as extra virgin olive oil, can prevent approximately 30,000 to 100,000 premature deaths a year.
2. Get more exercise: Increasing physical activity to at least 30 minutes a day, five days a week can drastically improve overall health and lower the risk of diabetes, high cholesterol and obesity.
3. Quit smoking: Smoking, and being exposed to secondhand smoke, is the leading preventable cause of death in the U.S. When smokers quit, within just twenty minutes of smoking that last cigarette the body begins a series of changes to combat the damage cigarettes cause. Need help quitting? Consider talking to a physician about a smoking cessation program.
4. Keep heart healthy: Heart disease is the number one cause of death in this country. Having cholesterol levels and blood pressure checked regularly by a physician can reduce the chances of heart disease and stroke. People who have a higher risk of heart disease may benefit from taking low-dose aspirin; ask your doctor if this applies to you.
5. Stay away from excess salt: A diet high in sodium increases the risk of cardiovascular disease. Limit salt intake to one teaspoon per day, or half a teaspoon if over 50, to help lower blood pressure and decrease the chances of getting heart disease or having a stroke.
6. Get a flu shot: Getting an annual flu vaccination is the single best way to protect against the virus. With flu season lasting into the spring, vaccination in January or February is still effective and will have significant medical benefit.
7. Screen for cancer: Early detection is often the key to beating cancer. Women over 40 need to schedule an annual mammogram to screen for breast cancer. All patients over 50 years of age should talk to a physician about a colonoscopy to improve the chances of early detection of colon cancer.
8. Protect skin from the sun: Use a sunscreen with an SPF of 15 or higher every day and be sure to increase it to 30 or higher if exposed to the sun for a prolonged period. See a physician every year for a professional skin exam to detect early signs of skin cancer.
9. Vote with the uninsured in mind: The uninsured tend to live sicker and die younger than those with health insurance. In this time of giving to others, be sure to vote in the 2008 election with the 47 million uninsured Americans in mind.
10. Talk to a physician: Many people only see a physician when ill and often overlook the fact that they are great resources for information on losing weight, reducing stress, quitting smoking and other issues that may affect overall health. Feel free to contact a physician with health concerns or questions; he or she can help you achieve your health goals.
"Making even small changes to your lifestyle can help you look and feel great all year," said Dr. Davis. "Eating right and exercising are two resolutions that can improve your overall health and reduce your risk of heart disease, certain cancers, diabetes, stroke, and osteoporosis."
"Creating and sticking to a new year's resolution to get healthier is the best gift you can give yourself this holiday season," said AMA President, Ron Davis, MD. "Talk to your physician about your health care plan and what you can do to ensure you remain healthy in 2008 and for many years to come."
Top ten resolutions for a healthy new you in the new year:
1. Eliminate trans fat from diet: Research shows that eating foods high in trans fats raise cholesterol levels and increase the risk of coronary artery disease. Replacing trans fats with healthier fats and oils, such as extra virgin olive oil, can prevent approximately 30,000 to 100,000 premature deaths a year.
2. Get more exercise: Increasing physical activity to at least 30 minutes a day, five days a week can drastically improve overall health and lower the risk of diabetes, high cholesterol and obesity.
3. Quit smoking: Smoking, and being exposed to secondhand smoke, is the leading preventable cause of death in the U.S. When smokers quit, within just twenty minutes of smoking that last cigarette the body begins a series of changes to combat the damage cigarettes cause. Need help quitting? Consider talking to a physician about a smoking cessation program.
4. Keep heart healthy: Heart disease is the number one cause of death in this country. Having cholesterol levels and blood pressure checked regularly by a physician can reduce the chances of heart disease and stroke. People who have a higher risk of heart disease may benefit from taking low-dose aspirin; ask your doctor if this applies to you.
5. Stay away from excess salt: A diet high in sodium increases the risk of cardiovascular disease. Limit salt intake to one teaspoon per day, or half a teaspoon if over 50, to help lower blood pressure and decrease the chances of getting heart disease or having a stroke.
6. Get a flu shot: Getting an annual flu vaccination is the single best way to protect against the virus. With flu season lasting into the spring, vaccination in January or February is still effective and will have significant medical benefit.
7. Screen for cancer: Early detection is often the key to beating cancer. Women over 40 need to schedule an annual mammogram to screen for breast cancer. All patients over 50 years of age should talk to a physician about a colonoscopy to improve the chances of early detection of colon cancer.
8. Protect skin from the sun: Use a sunscreen with an SPF of 15 or higher every day and be sure to increase it to 30 or higher if exposed to the sun for a prolonged period. See a physician every year for a professional skin exam to detect early signs of skin cancer.
9. Vote with the uninsured in mind: The uninsured tend to live sicker and die younger than those with health insurance. In this time of giving to others, be sure to vote in the 2008 election with the 47 million uninsured Americans in mind.
10. Talk to a physician: Many people only see a physician when ill and often overlook the fact that they are great resources for information on losing weight, reducing stress, quitting smoking and other issues that may affect overall health. Feel free to contact a physician with health concerns or questions; he or she can help you achieve your health goals.
"Making even small changes to your lifestyle can help you look and feel great all year," said Dr. Davis. "Eating right and exercising are two resolutions that can improve your overall health and reduce your risk of heart disease, certain cancers, diabetes, stroke, and osteoporosis."
Study Opens The Door For Avastin Use In Women With Breast Cancer
Avastin (bevacizumab) can proceed to be tested after breast cancer surgery in combination with anthracycline containing regimens. These findings pave the way for Avastin's use as a curative treatment for women with this devastating disease. Data presented today at the San Antonio Breast Cancer Symposium (SABCS) from the E2104 study showed that standard anthracycline-based chemotherapy (doxorubicin) can be added to Avastin after surgical removal of the breast tumour, without a concerning increase in the incidence of cardiac adverse events typically associated with this form of chemotherapy.
These data support the commencement of phase III adjuvant breast cancer clinical programme which will include over 10,000 patients with early stage breast cancer. Avastin already offers women with late-stage (metastatic) breast cancer the chance to live twice as long without their disease progressing (1).
"The unique way Avastin works also lends itself for use in women with earlier stages of breast cancer" said Dr Kathy Miller of Indiana University School of Medicine, USA and principal investigator of the E2104 study. "We now know that Avastin use in combination with anthracyclines does not result in concerning rates of cardiac dysfunction in the adjuvant setting and armed with this evidence Avastin's impact can be fully validated in a large worldwide phase III clinical trial programme."
Data from the E2104 study have shown that cardiac dysfunction is not a major concern with the treatment combination of Avastin and doxorubicin. As presented in SABCS, two patients with symptomatic congestive heart failure were reported in each of the 2 Avastin-containing treatment arms which included more than 100 patients each. This is within the range expected to occur with the use of anthracycline based chemotherapy alone.
Following the completion of the accrual of Avastin adjuvant colon cancer trials and now confirmation of the safety of Avastin in the adjuvant breast cancer setting, the phase III adjuvant breast cancer programme is already recruiting patients. The large adjuvant programme consists of 2 trials in HER- 2 negative breast cancer patients:
-- The E5103 study is set to include 4,950 patients and will compare Avastin with the addition of an anthracycline-containing chemotherapy course versus anthracycline-containing chemotherapy alone.
-- The BEATRICE study will investigate Avastin in combination with standard chemotherapies compared to chemotherapies alone in 2,530 planned patients who are not candidates for hormonal therapy. In addition, Avastin is being investigated in HER-2 positive breast cancer patients post surgery via the BETH trial. This study will investigate the addition of Avastin to Herceptin (trastuzumab) in combination with established chemotherapy regimen.
Worldwide, breast cancer is the leading cause of cancer death in women under the age of 55. Each year there are more than one million diagnoses and more than 400,000 deaths from breast cancer (2).
About E2104
E2104 is a phase II study designed to evaluate the safety and feasibility of incorporating Avastin into an anthracycline containing adjuvant therapy regimen. The study included 226 women with lymph node positive breast cancer who have had already undergone surgical removal (mastectomy) of the lesion and lymph node dissection. The study was sponsored by the National Cancer Institute (NCI), part of the US National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). Patients were sequentially assigned to one of two treatment arms:
-- Treatment arm A received dose-dense combination of doxorubicin and cyclophosphamide with Avastin, followed by paclitaxel and Avastin, followed by Avastin alone. Avastin was given every 2 weeks at a dose of 10 mg/kg for 1 year.
-- Treatment arm B was only different to arm A in that Avastin was introduced after completion of doxorubicin therapy in conjunction with paclitaxel. As with arm A, patients remained on Avastin for 1 year after Avastin initiation.
The primary objective of the study was to determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicin/cyclophosphamide followed by paclitaxel (ddAC>T). Patients were evaluated clinically and with serial assessments of left ventricular function over the course of their treatment and for six months following treatment.
These data support the commencement of phase III adjuvant breast cancer clinical programme which will include over 10,000 patients with early stage breast cancer. Avastin already offers women with late-stage (metastatic) breast cancer the chance to live twice as long without their disease progressing (1).
"The unique way Avastin works also lends itself for use in women with earlier stages of breast cancer" said Dr Kathy Miller of Indiana University School of Medicine, USA and principal investigator of the E2104 study. "We now know that Avastin use in combination with anthracyclines does not result in concerning rates of cardiac dysfunction in the adjuvant setting and armed with this evidence Avastin's impact can be fully validated in a large worldwide phase III clinical trial programme."
Data from the E2104 study have shown that cardiac dysfunction is not a major concern with the treatment combination of Avastin and doxorubicin. As presented in SABCS, two patients with symptomatic congestive heart failure were reported in each of the 2 Avastin-containing treatment arms which included more than 100 patients each. This is within the range expected to occur with the use of anthracycline based chemotherapy alone.
Following the completion of the accrual of Avastin adjuvant colon cancer trials and now confirmation of the safety of Avastin in the adjuvant breast cancer setting, the phase III adjuvant breast cancer programme is already recruiting patients. The large adjuvant programme consists of 2 trials in HER- 2 negative breast cancer patients:
-- The E5103 study is set to include 4,950 patients and will compare Avastin with the addition of an anthracycline-containing chemotherapy course versus anthracycline-containing chemotherapy alone.
-- The BEATRICE study will investigate Avastin in combination with standard chemotherapies compared to chemotherapies alone in 2,530 planned patients who are not candidates for hormonal therapy. In addition, Avastin is being investigated in HER-2 positive breast cancer patients post surgery via the BETH trial. This study will investigate the addition of Avastin to Herceptin (trastuzumab) in combination with established chemotherapy regimen.
Worldwide, breast cancer is the leading cause of cancer death in women under the age of 55. Each year there are more than one million diagnoses and more than 400,000 deaths from breast cancer (2).
About E2104
E2104 is a phase II study designed to evaluate the safety and feasibility of incorporating Avastin into an anthracycline containing adjuvant therapy regimen. The study included 226 women with lymph node positive breast cancer who have had already undergone surgical removal (mastectomy) of the lesion and lymph node dissection. The study was sponsored by the National Cancer Institute (NCI), part of the US National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). Patients were sequentially assigned to one of two treatment arms:
-- Treatment arm A received dose-dense combination of doxorubicin and cyclophosphamide with Avastin, followed by paclitaxel and Avastin, followed by Avastin alone. Avastin was given every 2 weeks at a dose of 10 mg/kg for 1 year.
-- Treatment arm B was only different to arm A in that Avastin was introduced after completion of doxorubicin therapy in conjunction with paclitaxel. As with arm A, patients remained on Avastin for 1 year after Avastin initiation.
The primary objective of the study was to determine the incidence of clinically apparent cardiac dysfunction in patients with lymph node positive breast cancer treated with bevacizumab and dose dense doxorubicin/cyclophosphamide followed by paclitaxel (ddAC>T). Patients were evaluated clinically and with serial assessments of left ventricular function over the course of their treatment and for six months following treatment.
Phosphagenics Announces Successful Phase 1 Transdermal Oxycodone Clinical Trial Results
Phosphagenics announced positive results of its Phase 1 clinical trial that showed its delivery technology, TPM, delivered leading pain-relief drug oxycodone through the skin without causing disruption or irritation of any kind.
These results support Phosphagenics' aims to be the first company to commercialize a sustained release oxycodone patch for the management of chronic pain.
"Oxycodone, with worldwide annual sales of more than $1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitization and irritation," said Dr. Esra Ogru, Executive Vice Presidentof Research and Development at Phosphagenics. "Our trial results show that TPM can deliver oxycodone through the skin in a sustained release formulation without causing skin irritation."
This trial, which was conducted by CMAX (an independent clinical research organization located at the Royal Adelaide Hospital) was a single-centre, single-blinded, pharmacokinetic trial in 16 healthy subjects. The trial endpoints were to evaluate the safety and tolerability of the TPM/Oxycodone formulation and the ability of the TPM technology to deliver oxycodone into the body.
The oxycodone, administered as a single transdermal application, was safe with no adverse events reported. Oxycodone was detected in the subjects for at least 48 hours. The results demonstrate that the formulation is bioavailable and effective in delivering oxycodone into the body.
A collaborative program is now under way with a world leading patch development company to incorporate the current formulation into a patch system. Plans are also underway to undertake a pivotal clinical study in the first half of 2008.
"Developing our pain relief pipeline builds on the success of Phosphagenics' previous transdermal clinical trials and provides a platform for the development of many other products," added Dr. Ogru.
Mr. Harry Rosen, President and CEO of Phosphagenics, said: "Completing this Phase 1 trial was an important milestone for our pain management program. We are delighted to have successfully completed this trial and look forward to progressing to the next phase."
These results support Phosphagenics' aims to be the first company to commercialize a sustained release oxycodone patch for the management of chronic pain.
"Oxycodone, with worldwide annual sales of more than $1 billion, is more potent than morphine with fewer adverse effects; however, oxycodone is not available transdermally due to serious issues relating to skin sensitization and irritation," said Dr. Esra Ogru, Executive Vice Presidentof Research and Development at Phosphagenics. "Our trial results show that TPM can deliver oxycodone through the skin in a sustained release formulation without causing skin irritation."
This trial, which was conducted by CMAX (an independent clinical research organization located at the Royal Adelaide Hospital) was a single-centre, single-blinded, pharmacokinetic trial in 16 healthy subjects. The trial endpoints were to evaluate the safety and tolerability of the TPM/Oxycodone formulation and the ability of the TPM technology to deliver oxycodone into the body.
The oxycodone, administered as a single transdermal application, was safe with no adverse events reported. Oxycodone was detected in the subjects for at least 48 hours. The results demonstrate that the formulation is bioavailable and effective in delivering oxycodone into the body.
A collaborative program is now under way with a world leading patch development company to incorporate the current formulation into a patch system. Plans are also underway to undertake a pivotal clinical study in the first half of 2008.
"Developing our pain relief pipeline builds on the success of Phosphagenics' previous transdermal clinical trials and provides a platform for the development of many other products," added Dr. Ogru.
Mr. Harry Rosen, President and CEO of Phosphagenics, said: "Completing this Phase 1 trial was an important milestone for our pain management program. We are delighted to have successfully completed this trial and look forward to progressing to the next phase."
Surgical Treatment On Breast Asymmetry Improves Quality Of Life
Study suggests that surgical treatment for breast asymmetry (disproportionate breast size) provides an improvement in the quality of life and self-esteem of patients. Breast asymmetry is not uncommon in women; in fact, few women have perfectly symmetrical breasts.
"Breast shape and size irregularities can cause damaging physical and emotional consequences," said Miguel Sabino Neto, MD, PhD, lead author of the study. "While plastic surgery of the breast can provide an aesthetically acceptable result with few complications, it is important to also consider the impact on the physical, social and psychological well-being of the patient."
Thirty-five patients with breast asymmetry were selected for the evaluation of the impact of breast asymmetry surgery on self-esteem and health-related quality of life. Patients that participated in the Brazilian study ranged from ages 16 to 50 years old.
Patients completed the Brazilian version of the SF-36, a quality of life indicator that measures eight dimensions of health status, including physical function, role limitations caused by physical problems, pain, health perception, vitality, social function, role limitations caused by emotional problems, and mental health. Participating patients also completed the Rosenberg Self-Esteem Scale, which evaluates quality of life based on responses to ten questions on the subject of self-esteem. Both were completed before and after surgery at three and six months post-operative follow-up.
A progressive improvement in all dimensions of the SF-36 was observed, with scores that were significantly higher for emotional factors at three months after surgery and for pain, vitality and mental health six months after surgery. Self-esteem was also found to be statistically significant.
"These findings underscore the positive effect that surgical treatment can have on patients with breast asymmetry," said Foad Nahai, MD, Atlanta plastic surgeon, President of ASAPS and Associate Editor of ASJ. "The results of such surgery go far beyond aesthetics, more importantly improving the self-esteem and quality of life of these patients."
"Breast shape and size irregularities can cause damaging physical and emotional consequences," said Miguel Sabino Neto, MD, PhD, lead author of the study. "While plastic surgery of the breast can provide an aesthetically acceptable result with few complications, it is important to also consider the impact on the physical, social and psychological well-being of the patient."
Thirty-five patients with breast asymmetry were selected for the evaluation of the impact of breast asymmetry surgery on self-esteem and health-related quality of life. Patients that participated in the Brazilian study ranged from ages 16 to 50 years old.
Patients completed the Brazilian version of the SF-36, a quality of life indicator that measures eight dimensions of health status, including physical function, role limitations caused by physical problems, pain, health perception, vitality, social function, role limitations caused by emotional problems, and mental health. Participating patients also completed the Rosenberg Self-Esteem Scale, which evaluates quality of life based on responses to ten questions on the subject of self-esteem. Both were completed before and after surgery at three and six months post-operative follow-up.
A progressive improvement in all dimensions of the SF-36 was observed, with scores that were significantly higher for emotional factors at three months after surgery and for pain, vitality and mental health six months after surgery. Self-esteem was also found to be statistically significant.
"These findings underscore the positive effect that surgical treatment can have on patients with breast asymmetry," said Foad Nahai, MD, Atlanta plastic surgeon, President of ASAPS and Associate Editor of ASJ. "The results of such surgery go far beyond aesthetics, more importantly improving the self-esteem and quality of life of these patients."
FDA Approves Thyrogen For Use In Thyroid Cancer Ablation
Thyroid Cancer Ablation
FDA has approved Genzyme's supplemental indication for Thyrogen (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.
"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."
The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.
"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.
Thyrogen Use in Ablation
The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.
In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements andavoid the symptoms associated with hormone withdrawal.
The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.
Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. It is three times more common in women than in men. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as the disease can recur in up to 30 percent of patients.
About Thyrogen
Thyrogen is currently available in more than 45 countries. It was first approved in the United States in 1998 for use in patients with well-differentiated thyroid cancer who have had their thyroid removed as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging. These patients must take thyroid hormone supplements and undergo periodic testing for recurrent or metastatic cancer. Thyrogen allows patients to remain on their hormone supplements during this testing and avoid the debilitating symptoms of clinical hypothyroidism.
With the new approval, Thyrogen may also be used as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients with well-differentiated thyroid cancer who have recently had their thyroid removed and who do not have evidence of metastatic thyroid cancer.
Thyrogen is injected in a muscle, and is available only by prescription. The most common side effects reported in clinical studies were nausea, headache, fatigue, vomiting and dizziness. When using Thyrogen as a diagnostic tool, there is a risk that thyroid cancer cells may not be detected and diagnosis of recurring cancer may be missed.
FDA has approved Genzyme's supplemental indication for Thyrogen (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.
"This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence," said Mike Heslop, senior vice president and general manager of Genzyme's endocrine business. "This is an important milestone in our ongoing effort to expand the clinical applications of Thyrogen to improve patient care."
The American Cancer Society estimates that in 2007, about 33,550 new cases of thyroid cancer will be diagnosed in the United States. Approximately 90 percent of all thyroid cancers are well-differentiated, making those patients candidates for the remnant ablation procedure.
"The development of new treatment options for thyroid cancer patients is critical, as this disease has the fastest rising incidence of all cancers among women in the U.S.," said clinical investigator Paul Ladenson, M.D., professor and director of endocrinology at The Johns Hopkins University School of Medicine. "The availability of Thyrogen for use in remnant ablation is a notable advance, as it permits patients to maintain a good quality of life during the course of their thyroid cancer treatment and follow-up testing."
Thyrogen was initially approved in the U.S. in 1998 and Europe in 2001 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The product helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal. Genzyme received additional European approval for Thyrogen's use during remnant ablation procedures in 2005.
Thyrogen Use in Ablation
The new indication allows Thyrogen to be used in conjunction with radioiodine for the most common approach to treating thyroid cancer. This includes surgical removal of the cancerous thyroid followed by remnant ablation, which destroys any remaining thyroid tissue. This can help reduce the risk of disease recurrence and facilitate follow-up monitoring.
In remnant ablation, patients take a drink or a capsule that contains radioactive iodine, which is taken up by any remaining thyroid cells. To enhance the uptake of radioiodine, the level of thyroid stimulating hormone (TSH) in a patient's bloodstream must be enhanced. Patients currently stop taking thyroid hormone supplements to elevate TSH levels. Doing so, however, often causes side effects associated with hypothyroidism, which may include fatigue, difficulty concentrating, short-term memory impairment and depression. Thyrogen is a recombinant form of TSH that is administered by injection, allowing patients to continue taking hormone supplements andavoid the symptoms associated with hormone withdrawal.
The FDA approved Thyrogen for remnant ablation based on results from a pivotal clinical study which suggest that treatment with Thyrogen is similar to withdrawal from thyroid hormone in achieving ablation, and that it could significantly reduce the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone replacement therapy.
Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. It is three times more common in women than in men. Although well-differentiated thyroid cancer is very treatable, ongoing monitoring is important as the disease can recur in up to 30 percent of patients.
About Thyrogen
Thyrogen is currently available in more than 45 countries. It was first approved in the United States in 1998 for use in patients with well-differentiated thyroid cancer who have had their thyroid removed as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging. These patients must take thyroid hormone supplements and undergo periodic testing for recurrent or metastatic cancer. Thyrogen allows patients to remain on their hormone supplements during this testing and avoid the debilitating symptoms of clinical hypothyroidism.
With the new approval, Thyrogen may also be used as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients with well-differentiated thyroid cancer who have recently had their thyroid removed and who do not have evidence of metastatic thyroid cancer.
Thyrogen is injected in a muscle, and is available only by prescription. The most common side effects reported in clinical studies were nausea, headache, fatigue, vomiting and dizziness. When using Thyrogen as a diagnostic tool, there is a risk that thyroid cancer cells may not be detected and diagnosis of recurring cancer may be missed.
PARI Hydrate Receives FDA Clearance
PARI Hydrate received 510(k) clearance FDA and will be marketed by PARI Innovative Manufacturers for ventilator applications. PARI Innovative Manufacturers, a leading manufacturer of aerosol nebulizers and compressors, developed the PARI Hydrate to revolutionize the way gases are heated and humidified with the aim to reduce contamination risk for patients and give clinicians greater control and understanding of humidification.
"Regulatory clearance of the PARI Hydrate allows clinicians a better way to monitor and customize conditioning of medical gases, because Hydrate is the first and only humidification system that can independently control heat and humidification of medical gases," said Norm Tiffin RRT, vice president of marketing for PARI Innovative Manufacturers. "With Hydrate, clinicians will soon have the ability to customize heat and humidification to each patient's needs."
FDA clearance for high flow gas therapy was granted previously for the Hydrate. With both high flow and ventilator applications now cleared, PARI Hydrate will be available for sale in early to mid 2008.
"Regulatory clearance of the PARI Hydrate allows clinicians a better way to monitor and customize conditioning of medical gases, because Hydrate is the first and only humidification system that can independently control heat and humidification of medical gases," said Norm Tiffin RRT, vice president of marketing for PARI Innovative Manufacturers. "With Hydrate, clinicians will soon have the ability to customize heat and humidification to each patient's needs."
FDA clearance for high flow gas therapy was granted previously for the Hydrate. With both high flow and ventilator applications now cleared, PARI Hydrate will be available for sale in early to mid 2008.
FDA Warns Consumers Not To Use Swad Brand Sindoor
FDA is warning consumers not to use 3.5 oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp, imported by Raja Foods LLC of Skokie, Illinois because the product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food. The Illinois Department of Public Health has confirmed two cases of lead poisoning in consumers who used the product as an ingredient in home cooked meals. Other uses of the product, including as a cosmetic, can also be dangerous due to the high lead levels.
Lead can be toxic to all humans but due to the risks it poses to a developing nervous system, women of childbearing age, pregnant women and their unborn children, and young children should be especially cautious and limit their exposure to lead. Symptoms of lead toxicity include: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. However, people with lead in their blood often do not exhibit symptoms. Permanent damage to the central nervous system from lead exposure can result in learning difficulties in school children as well as cause other long-term health problems such as kidney disease. Anyone who has consumed this product should consult his or her health care provider immediately.
At least 280 packages of Sindoor were distributed to grocery stores that specialize in foods from India in Colorado, Georgia, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Washington, and Wisconsin.
The front label of the bag states "SWAD BEST TASTE IN TOWN SINDOOR", "FOR RECIPE IDEAS VISIT OUR WEBSITE: WWW.RAJAFOODS.COM", and "PRODUCT OF INDIA." The back label states "Imported and Distributed by: Raja Foods, 8110, N. St. Louis Avenue, Skokie, ILL 60076", with a UPC of 0 51179 42236 0 and may have a sticker stating "NONEDIBLE".
Packages of Sindoor can be returned to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-800-7923 x 2860.
Consumers should report adverse events related to this product to MedWatch, the FDA’s voluntary reporting program.
Lead can be toxic to all humans but due to the risks it poses to a developing nervous system, women of childbearing age, pregnant women and their unborn children, and young children should be especially cautious and limit their exposure to lead. Symptoms of lead toxicity include: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. However, people with lead in their blood often do not exhibit symptoms. Permanent damage to the central nervous system from lead exposure can result in learning difficulties in school children as well as cause other long-term health problems such as kidney disease. Anyone who has consumed this product should consult his or her health care provider immediately.
At least 280 packages of Sindoor were distributed to grocery stores that specialize in foods from India in Colorado, Georgia, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Washington, and Wisconsin.
The front label of the bag states "SWAD BEST TASTE IN TOWN SINDOOR", "FOR RECIPE IDEAS VISIT OUR WEBSITE: WWW.RAJAFOODS.COM", and "PRODUCT OF INDIA." The back label states "Imported and Distributed by: Raja Foods, 8110, N. St. Louis Avenue, Skokie, ILL 60076", with a UPC of 0 51179 42236 0 and may have a sticker stating "NONEDIBLE".
Packages of Sindoor can be returned to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-800-7923 x 2860.
Consumers should report adverse events related to this product to MedWatch, the FDA’s voluntary reporting program.
Monday, December 17, 2007
Advertisements For Medical Devices, Implants Should Carry Warnings Of Dangerous Side Effects
Consumers Union has filed a petition with the FDA requesting it require all advertisements for implantable devices -- such as knee, hip and heart valve replacements, cosmetic implants and heart stents -- carry a warning about the possibility of dangerous infections or failures of the devices once they are in the body.
Implantable device makers recently have launched a wave of direct-to-consumer advertisements for their products, and Consumers Union said a review of these ads show that most lack basic information about the possibility of severe or fatal side effects.
"There is no question that many of these devices can restore high quality-of-life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
"We're asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body," Vaughan said.
In light of the rising rate of MRSA and other hospital-acquired infections for surgical patients, CU is requesting device advertisements disclose the potential risk of infection and urge patients to ask their doctor and hospital about infection rates at the facility where the surgery will be performed. Nearly 100,000 people die each year from hospital-acquired infections, and CU is supporting national infection-reporting and prevention legislation (HR 1174, HR 4214 and S 2278).
The Centers for Disease Control infection surveillance report shows hip and knee prosthesis surgery to be a serious source of infection, in some cases a high-risk source, and in some of the reporting hospitals, the infection rate may run as high as 5 percent or more.
Another recent study of 2003 nationwide data for primary total, partial, and revision hip replacements found the rates of readmission for any cause within 90 days of surgery ran between 9 percent for total replacement to 21 percent for partial.
"We do not want to discourage those in pain and facing loss of mobility from seeking out medical advice on implants. But we do believe that unintended side effects, which can include death, can be minimized if the public is better educated to avoid facilities which are not practicing the highest level of anti-infection practices," Vaughan said.
"Placing information about the danger of infection from surgery in device advertisements will speed the day that America's surgical centers and hospitals address this life-and-death problem," he added.
Implantable device makers recently have launched a wave of direct-to-consumer advertisements for their products, and Consumers Union said a review of these ads show that most lack basic information about the possibility of severe or fatal side effects.
"There is no question that many of these devices can restore high quality-of-life in patients, but we are concerned that serious and possibly deadly side effects like infections are consistently understated in these device ads," said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports.
"We're asking the FDA to require clear warnings about the dangers of infection during and following such surgery, and information about how long the devices are likely to last once they are in the body," Vaughan said.
In light of the rising rate of MRSA and other hospital-acquired infections for surgical patients, CU is requesting device advertisements disclose the potential risk of infection and urge patients to ask their doctor and hospital about infection rates at the facility where the surgery will be performed. Nearly 100,000 people die each year from hospital-acquired infections, and CU is supporting national infection-reporting and prevention legislation (HR 1174, HR 4214 and S 2278).
The Centers for Disease Control infection surveillance report shows hip and knee prosthesis surgery to be a serious source of infection, in some cases a high-risk source, and in some of the reporting hospitals, the infection rate may run as high as 5 percent or more.
Another recent study of 2003 nationwide data for primary total, partial, and revision hip replacements found the rates of readmission for any cause within 90 days of surgery ran between 9 percent for total replacement to 21 percent for partial.
"We do not want to discourage those in pain and facing loss of mobility from seeking out medical advice on implants. But we do believe that unintended side effects, which can include death, can be minimized if the public is better educated to avoid facilities which are not practicing the highest level of anti-infection practices," Vaughan said.
"Placing information about the danger of infection from surgery in device advertisements will speed the day that America's surgical centers and hospitals address this life-and-death problem," he added.
Sunday, December 16, 2007
Clinical Trials Show Significant Benefits Of Homeopathy
The clinical research literature in homeopathy is more positive than Ben Goldacre prefers to admit in his article “Benefits and risks of homoeopathy”, published in The Lancet on 16 November [1]. Goldacre claims “Five large meta-analyses of homoeopathy trials have been done. All have had the same result: after excluding methodologically inadequate trials and accounting for publication bias, homoeopathy produced no statistically significant benefit over placebo.” However, a more complete and unbiased assessment of the research evidence gives a very different perspective:
Three of the 5 meta-analyses that Goldacre cites did not reach the negative conclusion he implies, while the other 2 reports have limited interpretation. The first paper assessed 105 trials, 81 of them positive [2]. The authors concluded: "the evidence of clinical trials is positive but not sufficient to draw definite conclusions". The reviews for the European Commission concluded that homeopathy was more effective than placebo (P < 0.001) [3,4] though “the strength of this evidence is low because of the low methodological quality of the trials” (P = 0.082 for the highest quality sub-group of just 5 trials) [4]. The fourth analysis focused on trials of individualised homeopathy only, and thus did not represent the entire research evidence [5]. The most recent review narrowed its analysis to just 8 homeopathy trials compared with 6 in conventional medicine [6]; the negative findings were strongly affected by one particular Arnica trial [7].
Most importantly, Goldacre failed to cite one of the largest meta-analyses, which showed homeopathy can produce significant benefit over placebo. Published in The Lancet 10 years ago, Linde and colleagues analysed 89 trials and found a mean odds ratio of 2.45 (95% confidence interval, 2.05–2.93), in favour of homeopathy [8]. When considering just those trials of “high quality” and after correcting for publication bias, the findings actually remained statistically significant. The main conclusion was that the results “were not compatible with the hypothesis that the effects of homoeopathy are completely due to placebo”. In further analysis, the authors clarified that higher quality trials were less likely to be positive than those of lower quality, though the difference from placebo remained statistically significant until analysis was restricted to just five trials [9]. There was insufficient volume of evidence to enable conclusions to be drawn about the efficacy of homeopathy for any specific medical conditon.
Moreover, Goldacre chooses not to report findings of systematic reviews that did in fact focus on research in particular medical conditions. Seven of 17 such reports to date have been positive for homeopathy: childhood diarrhoea [10]; influenza [11]; post-operative ileus [12]; seasonal allergic rhinitis [13,14,15]; vertigo [16]. Eight of the other 10 reviews were non-conclusive [17-24]; 2 were negative [25,26].
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Abbott Releases New Mom And Baby Yoga DVD
Mom And Baby Yoga DVD
Moms today know the importance of a healthy diet and exercise for their families. And increasingly, research has shown, they are looking for new ways to introduce healthy habits to their babies right from the start. That's why Abbott, the maker of Similac Organic infant formula, has teamed up with Itsy Bitsy Yoga founder Helen Garabedian to release a new mom-and-baby yoga DVD.
Entitled "Play n' Flourish," the DVD introduces babies to yoga routines that can help them learn to stretch, roll and crawl, while helping moms better understand their babies' physical development and abilities. A recent survey of fitness providers found a 40 percent increase in demand for parent-baby fitness classes(1). Additionally, research shows that having a baby triggers greater attention to health and nutrition issues(2).
"New moms really want to share a healthy lifestyle with their babies," says Garabedian, a member of the Similac Moms Alliance community network. "A healthy diet, combined with physical activity, is important for both mom and baby to grow strong. Now, moms everywhere can learn Itsy Bitsy Yoga in the convenience of their own homes."
"Play n' Flourish" offers fun ways for moms to help calm, bond and play with their babies. The DVD, sponsored by Abbott's Similac Organic brand, covers Itsy Bitsy Yoga's most popular poses, is the latest product in Garabedian's line, which also includes books and baby-yoga attire. Moms can purchase Itsy Bitsy Yoga "Play n' Flourish" for $19.99 by visiting the Itsy Bitsy Yoga Web site at www.itsybitsyyoga.com.
Moms can be a part of the Similac Moms Alliance community network, which offers mental, physical and emotional guidance to help build both moms' and babies' strength, by visiting www.similacmomsalliance.com.
About Helen Garabedian
Helen Garabedian is the founder of Itsy Bitsy Yoga, a member of the Similac Moms Alliance and the mother of a toddler. She is a certified Hatha Yoga teacher, a certified infant massage instructor, and one of the first professionals to be certified as an infant developmental movement educator.
About Similac Organic
Similac Organic is the first organic infant formula from a major brand that moms trust to give their baby a strong start in life. Similac Organic is certified USDA organic and is made with wholesome organic milk. In addition, it has the trusted nutritional benefits of Similac Advance, including DHA and ARA, nutrients found in breast milk for brain and eye development.
Similac Organic is available at food, drug and discount stores nationwide, with a suggested retail price of $15.79 for the 12.9-oz Powder and $29.49 for the 25.7-oz Powder. Similac Organic is now also offered in convenient 32-fl-oz Ready To Feed bottles, with a suggested retail price of $6.49.
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FDA Should Regulate Complementary, Alternative Medicine
FDA is preparing new guidelines that threaten new, costly regulation of complementary and alternative medicines (CAM), used by 74.6 percent of adults at some point in their lives. The FDA guidance would define a product based on its "intended use." If vegetable juice were sold to satisfy thirst, for example, it would not be regulated, while if it were used to treat a medical condition (e.g. dehydration), it would be.
Under the guidelines, all items used for medicinal purposes -- including juices, lotions, vitamins and minerals -- could become more expensive and less available. As a result, millions of seniors may be forced to choose conventional treatments within the Medicare system instead of CAM paid for at their own expense, costing taxpayers unnecessary billions.
The FDA proposal, titled, "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," will represent the FDA's official thinking on this topic when finalized, but will not become regulatory policy. However, Congressional investigations frequently have found these types of guidance documents to be "intended to bypass the rulemaking process."
Complementary therapies might include aromatherapy to lessen a patient's discomfort during surgery; alternative therapies might include a special diet to treat cancer instead of chemotherapy. According to the National Institutes of Health, 74.6 percent of adults have used CAM at some point; a 2006 survey finds that close to two-thirds of adults over the age of 50 have used some form of CAM. The Centers for Disease Control estimated that the U.S. public spent between $36 billion and $47 billion on CAM therapies in 1997 alone.
"These changes mean that consumers will be less likely to be able to treat themselves without excessive government interference," said Shannon Benton, executive director of The Senior Citizens League. "Seniors who previously saved money by treating themselves with vitamins, lotions, or protein shakes may now need a prescription -- forcing them to bill Medicare for conventional medical treatments, costing the American taxpayer billions of dollars."
The Senior Citizens League (TSCL) filed comments with the FDA in May protesting the impending guidance. In its comments, TSCL wrote, "Currently, few CAM approaches are reimbursed by Medicare and are therefore paid out of pocket by the consumer. On the other hand, if vitamins and minerals were regulated as 'drugs,' Medicare might be required to pay for those same vitamins and minerals. Such a simple change in status for CAM theoretically could cost the Federal Government billions of dollars annually."
Medicare's trustees forecast that the Medicare trust fund will be exhausted by 2019. The FDA's new proposal risks bankrupting Medicare's trust funds even sooner.
"On behalf of its 1.2 million supporters, The Senior Citizens League is advocating for ways to ensure the long-term stability of Medicare," said Ralph McCutchen, chairman of The Senior Citizens League. "Not only does this secret plan threaten to bankrupt Medicare even sooner, but it takes choices away from seniors when they need them most."
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