Women can take five years aromatase inhibitor therapy
Aromatase inhibitors include anastrozole, made by AstraZeneca under the brand name Arimidex, exemestane, made by Pfizer Inc, under the brand name Aromasin and Novartiss Femara or letrozole.
Breast cancer is the second-leading cause of cancer death among U.S. women, after lung cancer. It kills 500,000 people globally every year and is diagnosed in close to 1.3 million people globally.
About 75 percent of these cancers are estrogen-receptor positive, meaning they are driven by hormones. Tamoxifen was the first drug to block the effects of estrogen and the aromatase inhibitors are the next generation.
Studies have shown that women who took tamoxifen for 5 years were 50 percent less likely to have their cancer return and the aromatase inhibitors have similar effects. But if a breast cancer patient has not gone through menopause, tamoxifen is the only safe hormone-based drug to take.
One of the most important treatments for women with postmenopausal breast cancer is anti-estrogen therapy, ASCOs Dr. Harold Burstein, an oncologist at Harvard Medical School in Boston, said in a statement.
Our panel carefully reviewed the explosion of research that has emerged in the past five years on anti-estrogen drugs, and filled in gaps in our understanding of how best to use these newer treatments, and what the trade-offs and side effects of therapy would be.
Some studies suggest it is safe to take tamoxifen and an aromatase inhibitorusually a pill taken daily — for as long as 10 years in total, the panel said.
While the two drug classes work differently, overall, most women have relatively mild side effects on either drug, ASCO added.
Reporting by Maggie Fox editing by Paul Simao source
I more optimistic about aids vaccine point time have been
Gary Nabel of the National Institute of Allergy and Infectious Diseases, who led the study, said in a telephone interview.
Two of the antibodies can attach to and neutralize 90 percent of the various mutations of the human immunodeficiency virus that causes AIDS, Nabel said.
This is an antibody that evolved after the fact. That is part of the problem we have in dealing with HIVonce a person becomes infected, the virus always gets ahead of the immune system, Nabel said.
What we are trying to do with a vaccine is get ahead of the virus.
AIDS infects about 33 million people globally, according to the United Nations AIDS agency UNAIDS. It has killed 25 million people since the pandemic began in the early 1980s and there is no vaccine or cure, although drugs can help control it.
The virus is difficult to fight in part because it attacks immune system cells and in part because it mutates constantly, making it a moving target for drugs or the immune system.
It has been almost impossible to make a vaccine that will affect the virus. Last September, researchers reported their biggest success yet with a vaccine that appeared to slow the rate of infection by about 30 percent in Thai volunteers, but the trial raised many questions.
MOVING TARGETS
Researchers have been looking for parts of the virus that do not mutate so they can design vaccines that will protect against these constantly changing versions.
Nabels team found two of the antibodies in the blood of a patient infected with HIV who had not become ill despite the infection. Such people are called non-progressors and researchers study their immune systems to find out why they control the virus better than most patients.
They then found the immune system cells called B-cells that made these particular antibodies, using a new molecular device that they invented.
In yet another experiment, they managed to freeze one of the antibodies in the process of attaching to and neutralizing the virus, getting an atomic-level image in a process called x-ray crystallography.
Being able to see what the structure looks like could enable researchers to design a vaccine using a process called rational vaccine design, akin to an established technique for making drugs called rational drug design, Nabel said.
It may also be possible to design gene therapy to help patients make these antibodies themselves, or use an older technique that transfuses the antibodies directly.
One of the antibodies, called VRC01, partially mimics the way an immune cell called a CD4 T-cell attaches to a piece of the AIDS virus called gp120, the researchers said.
The antibodies attach to a virtually unchanging part of the virus, and this explains why they can neutralize such an extraordinary range of HIV strains, Dr. John Mascola, who worked on the study, said in a statement.
The discovery of these exceptionally broadly neutralizing antibodies to HIV and the structural analysis that explains how they work are exciting advances that will accelerate our efforts to find a preventive HIV vaccine for global use, NIAID director Dr. Anthony Fauci added in a statement.
In addition, the technique the teams used to find the new antibodies represents a novel strategy that could be applied to vaccine design for many other infectious diseases.
Editing by Cynthia Osterman source
Because pounds due excess body fatrather larger bones
Because pounds due to excess body fatrather than larger bones or greater muscle mass — are the health concern, researchers have been looking for more precise ways to gauge fat levels. One way is to measure waist circumference, which studies suggest is better than BMI alone in assessing abdominal fat and health risks, such as high blood pressure, diabetes and heart disease, in adults.
Another tactic is to measure neck circumferencewhich, although less studied, seems to be a potential marker of obesity and health risks in adults.
The new study, published in the journal Pediatrics, looked at whether measuring neck circumference has any value in screening children for excess pounds and obesity.
Since BMI is not a precise indicator of body fat, adding a neck circumference measurement could improve childhood obesity screening, lead researcher Dr. Olubukola Nafiu, of the University of Michigan in Ann Arbor, told Reuters Health.
And compared with waistline measurements, measuring the neck would also be quicker and more comfortable for children, Nafiu said, since they can keep all their clothes on for the latter.
Neck circumference is also more consistent in comparison to waist sizewhich can swell after a big lunch, for instance.
For their study, Nafiu and his colleagues measured weight, height, waist circumference and neck circumference in 1,102 children and teenagers ages 6 to 18 who were undergoing surgery at their center.
They found that neck circumference correlated well with both BMI and waist size in boys and girls, as well as younger children and teenagers.
The researchers also pinpointed optimal cutoff points for neck circumference that identified a majority of kids with a high BMI. For example, a 6-year-old boy with a neck circumference of greater than 28.5 centimeters – about 11.2 incheswas nearly four times more likely to be overweight or obese, based on BMI, as a 6-year-old boy with a smaller neck circumference.
In addition to helping screen for obesity, the researchers note, neck measurements might also be useful for spotting kids at risk of sleep apnea, a disorder in which tissues at the back the throat temporarily collapse during sleep to create repeated stops and starts in breathing. Obesity, particularly excess weight in the upper body, is a risk factor.
Nafiu said that in earlier studies, he and his colleagues found that children with a high BMI were at relatively greater risk of certain post-surgery problems they tend, for instance, to take longer to wake up from anesthesia because the drugs concentrate in body fat.
In the future, Nafiu said, the researchers want to look at whether measuring neck circumference before surgery can identify children at greater risk of such problems.
SOURCE link.reuters.com/gus95m
Pediatrics, August 2010. source
The findings were culled from a large
When you look at them all independently, they are all useful for predicting conversion to Alzheimers disease and decline, said Susan Landau of the University of California, Berkeley, whose study appears in the journal Neurology.
The novel thing we did was put them all together in the same statistical model and compared them to see which were the most useful, she said in a telephone interview.
For the study, researchers did memory and brain scan tests on 85 people with mild cognitive impairment who were part of the larger Alzheimers Disease Neuroimaging Initiative study.
The tests included an episodic memory test, in which the patient must correctly remember a list of words. People were also tested to see if they had a variant of the APOE gene linked with Alzheimers disease.
Researchers did magnetic resonance imaging or MRI scans to measure brain volume in the hippocampus, the part of the brain responsible for learning and memory. They also measured proteins called tau and beta-amyloid linked with Alzheimers disease.
And they did an imaging test called positron emission tomography or PET to test for brain function by looking to see how well the brain uses glucose or sugar.
When they compared the effectiveness of each test in predicting conversion to Alzheimers disease, two emerged as the best predictors.
People who had poorer scores on both of those tests were almost 12 times more likely to convert to Alzheimers disease than people who were normal on those two, Landau said.
Patients in the study were between the ages of 55 and 90 and were followed for an average of 1.9 years. During that time, 28 of the 85 participants developed Alzheimers disease.
Landau, who wants to expand the study to confirm the findings, said she thinks they may be useful in helping doctors pick the best tests to predict which patients are most likely to progress to Alzheimers disease within two to three years of testing.
Several teams are working on better ways to detect early-stage Alzheimers disease in hopes of developing drugs that can fight it before it causes too much damage.
Current treatments cannot reverse the course of Alzheimers, a mind-robbing form of dementia that affects more than 26 million people globally.
Editing by Xavier Briand source
While industry observers widely believed astrazeneca
Judge Joseph Farnan, of the U.S. District Court in Delaware, ruled that generic drugmakers who challenged the patent failed to prove it was invalid because it was an obvious invention.
Farnan also ruled that defendants have not established, by clear and convincing evidence, that the 314 patent is invalid as an improper reissue of an older patent.
Judgment will be entered in favor of Plaintiffs and against Defendants on the issues of invalidity and unenforceability of the 314 patent, Farnan concluded in his 44-page ruling.
Crestor, which belongs to the worlds most widely used class of medicines called statins, had sales of 4.5 billion in 2009 and is forecast to reach global sales of 6.5 billion in 2013, according to estimates compiled by Thomson Reuters.
AstraZeneca is pleased with the courts decision upholding the validity of the 314 substance patent, Chief Executive Officer David Brennan said in a statement.
The courts decision reaffirms the strength of the intellectual property protecting Crestor, Brennan added.
The upheld U.S. patent protecting Crestor, known chemically as rosuvastatin, does not expire until 2016, meaning generic versions will likely not hit the U.S. market before then.
They have more clarity on the sustainability of the 2 billion-plus of cash flow that the drug generates in the U.S., said Leerink Swann analyst Seamus Fernandez.
AstraZeneca shares traded on the New York Stock Exchange closed up 4.02, or 9 percent, at 48.74 after the ruling.
The 9 percent jump looks like a little bit of an overreaction to the positive news, said Morningstar analyst Damien Conover, noting that generic competition for top-selling Astra products still looms, such as its antipsychotic Seroquel next year and Nexium acid reflux drug around 2015.
I still think theres some rocky waters ahead for the company, Conover said.
AstraZeneca brought the case against several companies seeking to sell cheap versions of Crestor. They included Mylan Inc, Teva Pharmaceutical Industries Ltd, Sun Pharmaceutical Industries Ltd, Aurobindo Pharma Ltd, Par Pharmaceutical Cos, Watson Pharmaceuticals Incs Cobalt unit, Sandozthe generic division of Novartis AG — and Toronto-based privately held Apotex.
They either could not immediately be reached or declined to comment on the ruling.
In attempting to prove the Crestor patent was invalid, the generic drugmakers attacked it on the grounds it was an obvious invention, was fraudulently obtained and improperly reissued.
The rosuvastatin patent was originally obtained by Japans Shionogi Seiyaku Kabushiki Kaisha.
The generic drugmakers argued that Shionogis legal team withheld documents from the U.S. Patent and Trademark Office in order to obtain the patent through deception, but the judge did not buy that argument.
In his ruling, Farnan accepted AstraZenecas evidence which he said showed instead a time of confusion, personnel change, and overwork in the Shionogi Patent Department that led to their lack of disclosures.
Reporting by Bill Berkrot and Tom Hals, additional reporting by Lewis Krauskopf editing by Andre Grenon and Matthew Lewis source
The conflicting results were released on monday
The medicine was Glaxos second-biggest drug but is much smaller after a safety controversy erupted three years ago.
One analysis of 56 clinical trials found Avandia increased the chances of a heart attack by 28 percent to 39 percent, researchers at the Cleveland Clinic in Ohio said in an update to a 2007 study that sparked debate about the drug.
Dr. Steven Nissen, the lead author and an outspoken Avandia critic, said the results from more than 35,000 patients gave a more complete picture that reinforced his earlier concerns.
A drug that increases the risk of heart attack by a third or more in diabetics represents a huge public health burden, Nissen, the Cleveland Clinics head of cardiology, said in an interview. He said the drug should come off the market.
U.S. Democratic Representative Rosa DeLauro said the newly published data along with earlier findings appear to confirm that Avandia is dangerous and should be pulled from the market.
But a study released at an American Diabetes Association meeting in Orlando, Florida, found diabetics taking Avandia were 28 percent less likely to die or have a heart attack or stroke compared with people who did not take a drug in the same class.
The National Institutes of Health-funded analysis looked at a clinical trial of more than 2,300 diabetics with heart disease. Glaxo provided some funding.
KEEPING OPTIONS
The lead researcher, Sheryl Kelsey of the University of Pittsburgh, said Avandia appears safe in high-risk diabetics whose other risk factors, such as smoking and high blood pressure, are under control.
Kelsey said many of her colleagues support keeping Avandia available. There are people who want to have the choice of diabetes drugs be broad, and Avandia should be an option, she said.
Glaxo shares fell 0.9 percent to close at 34.30 on the New York Stock Exchange. The third study which showed benefits from Avandia was released after U.S. markets closed.
In another study released on Monday, government researchers said an analysis of more than 227,000 U.S. Medicare patients found Avandia was more dangerous to the heart than a rival pill, Takeda Pharmaceutical Co Ltds Actos.
Those findings, reported earlier this month by Reuters and others, were published online by the Journal of the American Medical Association. The lead researcher is Food and Drug Administration reviewer David Graham, who has argued for years that Avandia is too risky.
Top FDA officials have disagreed and Glaxo has vigorously defended the drug, known generically as rosiglitazone.
In February, the FDA said it was again reviewing Avandias risks. The new studies are important contributions to the discussion of Avandias safety, FDA Deputy Commissioner Joshua Sharfstein said in an interview.
The agency and the advisory panel that meets in July will consider those findings plus others, including FDA analyses not yet made public, he said.
The panel could urge keeping the drug on the market with a warning, or it could suggest prescribing limits or a ban on future sales. The FDA usually follows panel recommendations.
The FDA, which approved Avandia 11 years ago, will review all the available evidence, Sharfstein said.
In the meantime, the agency has advised patients to continue using Avandia as directed. The current FDA-approved warning on Avandia says heart attack data are inconclusive.
Avandias use fell sharply after Nissens first study, but it remains widely prescribed with sales of 1.2 billion globally in 2009. For drug giant Glaxo, it is now a small product. U.S. sales for 2009663 million — made up 1.5 percent of the companys 44.25 billion in total sales.
DAMAGE DONE
The new studies could further depress use, but the damage has really been done, Morningstar analyst Damien Conover said. The bigger concern for Glaxo is liability lawsuits if the drug comes off the market, which Conover said was unlikely.
Its hard for me to see anything incrementally thats come out since the FDA has already taken a look at this issue to lead to a withdrawal, Conover said.
Capitol Street analyst Ipsita Smolinski estimated a 30 percent to 40 percent chance the FDA panel would urge severe limits or withdrawal, depending on who sits on the committee.
Glaxo said six randomized clinical trials, the gold standard for medical studies, showed Avandia did not increase the overall risk of heart attack, stroke or death.
The studies from Nissen and Graham are among the largest for Avandia, but they rely on a combination of multiple trials or past Medicare claims. Such studies are considered less reliable than randomized clinical trials.
In a commentary discussing Grahams findings, Dr. David Juurlink of the Institute for Clinical Evaluative Sciences in Toronto argued for erring on the side of public safety.
Accumulating concerns about Avandia make it difficult to advance a cogent argument why, exactly, a patient might want to receive the drug, Juurlink wrote.
Many of the 23 million U.S. diabetics take medicines to lower blood sugar. The goal is to prevent disease complications such as blindness, amputations and heart disease, the leading killer of people with diabetes.
But critics say Avandia seems to contribute to heart damage. Nissens study, published by the Archives of Internal Medicine, estimated one more heart attack would occur for every 37 to 52 people who took the drug for five years.
Grahams analysis, done with researchers at the FDA and the Centers for Medicare amp Medicaid Services, found a 27 percent higher stroke risk for Avandia over Actos, a 25 percent greater risk of heart failure and a 14 percent higher chance of dying.
In older Americans with diabetes, taking Avandia is detrimental to your health and patients are far better off taking Actos, Graham said in an interview.
Both Graham and Nissen have been asked to speak to the FDA panel, Sharfstein said.
Diabetics have many alternatives as 12 classes of drugs are approved to lower blood sugar, Nissen said. They include older generic drugs such as metformin and newer medicines such as Merck amp Co Incs Januvia and AstraZeneca Plc and Bristol-Myers Squibb Cos Onglyza.
Reporting by Lisa Richwine, Susan Heavey, Maggie Fox and Julie Steenhuysen editing by Lisa Von Ahn and Matthew Lewis source
Cows milk protein allergy most common and most dangerous
The finding that giving cows milk very early in life might boost tolerance came as a surprise to lead researcher Dr. Yitzhak Katz of Tel Aviv University in Israel. He and his colleagues simply set out to improve on current estimates of the number of children with the allergy, and to determine how often it is accompanied by an allergy to soy. We werent even looking for a risk factor, he told Reuters Health.
Of 13,000 infants studied, the team found that 66 0.5 percent tested positive for the milk allergyfar fewer than would be expected based on previous population estimates of 1 to 3 percent, they note in the Journal of Allergy and Clinical Immunology.
The researchers also found no link between cows milk and soy allergies, despite some earlier estimates that up to 1 in 3 children with the first allergy also suffered from the second.
Soy is a reasonable feeding alternative for children with cows milk allergy, noted Katz.
But what his team found next most intrigued him. Infants who were first fed cows milk at the age of 15 days or more had 19 times the risk of developing cows milk allergy relative to those exposed earlierduring the first two weeks of life.
Due to common difficulties in digesting the sugar content of cows milk, some pediatricians have discouraged its introduction until a certain age, Dr. Kari Nadeau of Stanford University in California, who was not involved in the study, told Reuters Health.
Now, it seems there might also be benefits to an earlier start. Its nice to know that if you do give small amounts of cows milk to children at an early age, Nadeau said, it could help prevent their immune system from later viewing this milk protein as a foreign substance and reacting unnaturally to it.
Nadeau noted that further research is needed to pinpoint the most optimal window of opportunity and to see how well the exposed babies do as they grow older.
She also cautioned that early feeding of cows milk is no guarantee that a child wont get the allergy. At any point in time, if a child starts developing a rash or vomiting to a food, she said, they should always get checked out by an allergist.
Katz added that the findings should not be interpreted as discouraging breastfeeding. Rather, he recommends simply complementing it with cows milk early on.
Let Dad enjoy some midnight infant bonding, he said, while he delivers a dose or two of cows milk protein.
SOURCE link.reuters.com/zuv24m Journal of Allergy and Clinical Immunology, online June 11, 2010. source
The european medicines agency said its committee
The study, known as a meta-analysis and published by U.S. researchers earlier this month, looked at all the publicly available data and found that patients were 1.2 percent more likely to be diagnosed with a new cancer over four years than people who did not take the drugs.
The CHMP will review the meta-analysis thoroughly, together with any other available non-clinical and clinical data … to clarify whether there is an increased risk of cancer in patients taking these medicines, the drugs agency said in a statement.
Most patients in the trials 86 percent looked at by the U.S. study were taking German drugmaker Boehringer Ingelheims telmisartan, sold as Micardis.
Other drugs in the class include Merck amp Cos Cozaar, sold generically as losartan Atacand, or candesartan, made by the Anglo-Swedish firm AstraZeneca, Diovan or valsartan made by Swiss drug firm Novartis, irbesartan, jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb as Avapro, Daiichi Sankyos Benicar or olmesartan, and Solvay Pharmaceuticals Teveten or eprosartan.
The Medicines Agency said the CHMP would give an opinion after the investigation on whether changes should be made to the product information or risk-management plans for ARBs. source
They said estimated percent dietary sodium comes from
Sodium has become so pervasive in our food supply that its difficult for the vast majority of Americans to stay within recommended limits, said Janelle Peralez Gunn, public health analyst with the U.S. Centers for Disease Control and Prevention who led the study of salt consumption.
Public health professionals, together with food manufacturers, retailers and healthcare providers, must take action now to help support peoples efforts to reduce their sodium consumption, Peralez Gunn said in a statement.
The study said most Americans consume 3,466 milligrams of sodium a day, more than twice the recommended limit. Much of the excess sodium comes from foods like pizza, cookies and meats, it said.
The 2005 Dietary Guidelines for Americans recommend eating no more than 2,300 mg of sodium per day. Proposed new guidelines for 2010 would lower that to 1,500 mg.
Eating too much salt can raise blood pressure, which can cause kidney failure and strokes. The Institute of Medicine in February declared high blood pressure a neglected disease that costs the U.S. health system 73 billion a year.
According to the CDC survey, grain-based foods account for the biggest proportion of salt in the American diet, providing 36.9 percent of the total average intake of 3,466 milligrams.
That is followed by foods containing meat, chicken and fish, which account for 27.9 percent.
Together, these two categories account for nearly two-thirds of the daily salt intake in the American diet, the team said.
The survey, published in the CDCs weekly report on death and disease, is the latest from government researchers looking at sodium intake in the U.S. diet.
In April, the Institute of Medicine called on the U.S. Food and Drug Administration to regulate the amount of salt added to foods to help Americans cut salt.
The FDA has not decided whether to force food companies to cut the salt but many have taken the hint and begun cutting the salt from their foods voluntarily.
Reporting by Julie Steenhuysen Editing by Maggie Fox and Bill Trott source
The risk was same even women took hormone replacement
It is important for women to know that early menopause is a potential risk factor for cardiovascular disease, the number one killer of American women, Dr. Melissa Wellons of the University of Alabama at Birmingham, who led the study, said in a statement.
They can then work harder to improve their modifiable risk factors, such as high cholesterol and blood pressure, by exercising and following a healthy diet, Wellons said.
Doctors should routinely ask older women when they experienced menopause, she said. The average age of menopause is 51.
Her team studied more than 2,500 women who were 45 to 84 when the study started in 2000. Nearly 28 percent of them reported early menopause 446 women or 18 percent had natural menopause and 10 percent had menopause caused by having their ovaries removed.
None of the women had a heart attack, stroke, chest pain known as angina, heart bypass surgery or a suddenly stopped heart before the age of 55.
But after that, the women who had early menopause were more likely to have had one of these things happen than the others. They were more than two times as likely to have one of these heart events, even when the researchers accounted for any extra weight gain.
Nearly 6 percent of women who went though menopause early had some sort of heart event, compared to 2.6 percent of women who had not gone through menopause or who went through it after age 47, they told the meeting.
Our study is observational therefore, we cannot conclude that early menopause somehow causes future cardiovascular disease, Wellons said. However, our findings do support the possible use of age at menopause as a marker of future heart and vascular disease risk.
Before 2002, doctors widely prescribed hormone replacement therapy, or HRT, to lower the risk of heart disease or osteoporosis, both of which go up sharply after menopause.
But use of HRT plummeted in 2002 after the publication of the Womens Health Initiative study, which found an increased risk of ovarian cancer, breast cancer, strokes and other problems from hormone therapy. Studies have also found HRT does not protect against heart disease.
Sales of U.S. market leader Wyeths combined estrogen-progestin therapy Prempro have fallen by about 50 per cent since 2001 to around 1 billion a year. Wyeth is now owned by Pfizer.
Editing by Bill Trott source