No new conclusions on Glaxo’s Avandia yet: FDA
By cialis viagra levitra | May 19, 2010
The U.S. Food and Drug Administration is reviewing data on possible heart risks with GlaxoSmithKline Plc’s diabetes drug Avandia but has not reached any conclusions, the agency said on Monday.
The FDA will hold a public meeting in July 2010 to discuss risks and benefits of the drug, but said in the meantime doctors and patients should continue to use Avandia as directed.
“This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone (Avandia) in the treatment of type 2 diabetes have been made at this time,” the FDA said, referring to the drug’s generic name.
On Saturday, two U.S. senators released a report on Avandia and internal FDA documents. The documents included a 2008 memo from two FDA drug safety reviewers who recommended pulling the drug from the U.S. market after they concluded it was more dangerous to the heart than the rival drug Actos by Takeda Pharmaceutical Co Ltd.
One of the reviewers, FDA critic David Graham, had argued to an advisory panel in 2007 that Avandia should no longer be sold. That panel voted 22-1 to recommend the drug remain on the market.
Glaxo shares fell 2.5 percent to close at $37.32 on the New York Stock Exchange on Monday. Analysts said new attacks on Avandia could add to litigation risks and help rival drugmakers.
Sales of Avandia topped $3 billion in 2006, but fell to $1.2 billion in 2009.
The FDA said on Monday it is reviewing data from a Glaxo-sponsored study known as Record, as well as other studies that look at the cardiovascular safety of Avandia. The FDA will present all of the safety data at a public advisory panel meeting in July.
The FDA decided in November 2007 Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were “inconclusive.”
“We don’t find that available information since that time has really changed the assessment,” Dr. Janet Woodcock, head of the FDA’s drugs center, said on a conference call with doctors on Monday.
Woodcock added, “We feel that it is time for a thorough re-evaluation of all the data of the drug as far as cardiovascular risk, and we are undertaking that right now.”
Results from Glaxo’s Record study, published in the Lancet medical journal in June 2009, showed Avandia did not increase overall heart risks compared with older diabetes drugs.
“We are neither accepting nor rejecting that conclusion. We are going to have to review in great detail the study data as well as audit the study to determine how robust these findings are,” Woodcock said.
Glaxo said the scientific evidence did not establish that Avandia increased heart attack risks and added it had been open in providing information about the drug.
The company “stands behind the safety and efficacy of Avandia when used appropriately and according to its label and maintains that this is an important medicine for the treatment of type 2 diabetes,” Glaxo spokeswoman Mary Anne Rhyne said.
Concerns about Avandia emerged in May 2007 when Cleveland Clinic researchers published a study saying there was a link between the drug and heart attacks.
Jeffrey Holford, an analyst at stockbroker Jefferies, said early loss of Avandia from the U.S. market in mid-2010 would cut 2010 and 2011 earnings estimates by less than 1 percent.
(Reporting by Lisa Richwine, Susan Heavey and Ben Hirschler; editing by Andre Grenon, Leslie Gevirtz and Bernard Orr)
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Blood test tells fetal sex in early pregnancy
By cialis viagra levitra | April 28, 2010
Normally, parents who want to know the sex of their baby before it’s born find out through ultrasound done in the second trimester. A blood test that can be done early in pregnancy is highly accurate at determining the sex of the fetus, however, a new study finds.
The test is important, write the authors of the study, because in some cases, there are medical reasons to determine fetal sex earlier. That has traditionally meant invasive tests, like amniocentesis, which carry a small risk of miscarriage.
Consequently, maternal blood tests that pick up certain markers of fetal sex have been developed and put into use in recent years. So far, research has shown the accuracy of these tests to vary widely, depending on the methods used.
In this latest study, published in the journal Obstetrics & Gynecology, researchers in the Netherlands found that the testing method used at their center was 100 percent accurate in determining fetal sex among nearly 200 pregnant women.
Part of what’s new about the findings is that they show the effectiveness of blood testing as it is done in routine practice — and not just in the research setting, Dr. Ellen van der Schoot, of Sanquin Research Amsterdam, told Reuters Health in an email. The study does not discuss costs, nor when the test might be available to the general public.
Still, the findings, according to van der Schoot and her colleagues, support using the tests in cases where fetal sex is important in detecting or managing certain inherited medical conditions.
For example, congenital adrenal hyperplasia (CAH) is a genetic disorder that causes girls to develop abnormal external genitalia and male-like characteristics like a deep voice and excessive body hair.
It is possible, however, to treat the disorder with the steroid dexamethasone as soon as pregnancy is established, so knowing the fetal sex sooner is better than later.
Similarly, fetal sex is key in genetic disorders linked to abnormalities in the X chromosome. These disorders — such as hemophilia and Duchenne/Becker muscular dystrophy — are almost always seen in boys rather than girls, because boys inherit only one X chromosome, from the mother. (Girls inherit an X chromosome from each
parent.)
In cases where a mother is known to carry an X-linked genetic defect, blood testing for fetal sex tells doctors whether further, invasive testing for the particular genetic disorder should be done. If the fetus is female, invasive tests can be avoided.
In the current study, van der Schoot and her colleagues looked at 201 pregnant women who had blood testing at their lab between 2003 and 2009. The test, done as early as the seventh week of pregnancy, determines fetal sex by looking for two genes found on the Y sex chromosome.
Only men carry the Y chromosome, so when these genes were found in a pregnant woman’s blood sample, the fetus was assumed to be male. When the test did not detect the genes, the mother’s blood was analyzed further to confirm that certain other fetal DNA was present; with that confirmation, the researchers concluded that the fetus was female.
Of the 201 women in this study, blood tests gave conclusive results to 189. In each case, that result turned out to be correct.
The test results also made a significant difference in how the pregnancies were managed from then on, according to van der Schoot and her colleagues. Among the 156 women who underwent testing because of the risk of an X-linked disorder, the results allowed 41 percent to avoid further, invasive procedures to test for the disorder.
In addition, 27 women who’d been taking steroids for possible CAH were able to stop, as the fetus was found to be male.
According to the researchers, the reliability of the blood tests means that invasive procedures are no longer necessary for determining fetal sex early in pregnancy.
Since the introduction of such blood testing, there have been ethical concerns about couples seeking testing solely to find out the sex of the fetus early on — and possibly ending the pregnancy based on that information.
“These concerns are relevant,” van der Schoot said, “and we agree that the test should be applied carefully in a clinical setting upon medical indication.”
SOURCE: Obstetrics & Gynecology
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Erectile Dysfunction Predicts Heart Disease
By cialis viagra levitra | April 21, 2010
Erectile dysfunction is a strong warning sign that a man might be at increased risk for heart attack, stroke and other cardiovascular problems, a long-running study indicates.
“We saw that adjusting for age and Framingham [Heart Study] risk factors, men with erectile function still had a 40 percent increased risk,” said Andre Araujo, director of epidemiology at New England Research Institutes and lead author of a report published online Jan. 19 in the Journal of the American College of Cardiology.
Though adding erectile dysfunction to the list of known risk factors determined by the Framingham Heart Study — cholesterol, smoking, high blood pressure — doesn’t improve the prediction of future cardiovascular trouble, it can be a quick, free addition to risk assessment, Araujo said.
“If a man presents with erectile dysfunction, the physician should work him up for cardiovascular disease,” he said. “It is low cost — indeed, no cost — with no risk associated with it.”
The study is the latest of several that have linked erectile dysfunction to cardiovascular disease. That is to be expected, Araujo said, because the same artery-blocking conditions that reduce blood flow to the heart and brain can also reduce flow to the penis.
The study followed 1,057 men, aged 40 to 70, for an average of 12 years. Overall, 37 percent of the men with erectile dysfunction were in the high-risk category according to the Framingham standards, compared with 17 percent of men without erectile dysfunction.
Once the link to cardiovascular problems was established, “we started modeling to see if we added erectile dysfunction to the Framingham risk profile we could reclassify some men,” Araujo said. “In fact, it doesn’t do much.”
The reason is that the Framingham risk profile is hard to improve on, he said. Over the years, studies of a number of diagnostic techniques — including computerized tomography scanning and various molecular markers, such as inflammation-related C-reactive protein — have been shown not to improve on the Framingham profile’s predictive power.
But those other measures are either costly, require blood tests or carry some risk, whereas erectile dysfunction can be determined by a simple question, Araujo said.
So doctors should ask the question, said Dr. R. Parker Ward, a cardiologist and an associate professor of medicine at the University of Chicago, who has done several studies on erectile dysfunction and cardiovascular risk.
“Why not ask a simple question in the office that will reveal a diagnosis very clearly?” Ward said. “It is cheaper and easier than doing a lipid profile or measuring high blood pressure.”
It’s information that men should offer to their doctors, Araujo said. “Self-reported erectile dysfunction matches what urologists say about the question,” he said. “We should get the message out: If you have an erectile problem, see your doctor.”
Having a doctor ask the question or a man offer the information can lead to preventive therapy that can be lifesaving, Araujo said.
“One of the first signals that a guy has cardiovascular disease is often sudden death,” he said.
SOURCES: Andre Araujo, Ph.D., director, epidemiology, New England Research Institutes, Watertown, Mass.; R. Parker Ward, M.D., associate professor, medicine, University of Chicago;
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Even legitimate opioid use may cause overdose
By cialis viagra levitra | April 14, 2010
Perhaps it’s not surprising, but people who take high doses of opioid painkillers even for legitimate medical reasons are at risk of overdosing, new research shows.
The findings add to the ongoing controversy over this class of potentially addictive drugs, which includes morphine and oxycodone (Oxycontin). When taken in excess, they slow the breathing muscles, and users suffocate.
However, the results do not mean patients should stop taking prescribed medication, experts say.
For the study, published in the Annals of Internal Medicine, researchers followed nearly 10,000 adults who had received at least three opioid prescriptions within 90 days to treat chronic pain such as backache. Of these, 51 experienced at least one overdose, and six died as a result.
The researchers also found that the higher the painkiller dose, the more likely the patients were to overdose. Among those receiving the equivalent of less than 20 milligrams of morphine per day, one in 500 overdosed per year. That compared to about one in 60 among those who received the equivalent of 100 milligrams or more.
Several million Americans now use opioids to relieve disabling chronic pain, and so even relatively small overdose rates could amount to thousands of overdoses every year.
“Opioids carry risks and prescribing them and using them long-term is something that should be done with caution,” said Michael Von Korff, who led the new research.
“I’m not interested in scaring people,” added von Korff of Group Health Cooperative, a nonprofit health-care system based in Seattle, Wash. “If someone is taking a couple Percocet (an opioid painkiller) a day and they are doing fine…I don’t think anybody is particularly concerned about that.”
Yet as prescriptions have skyrocketed over the past two decades, so have fatal overdoses, which now number in the thousands each year.
“As a society, we have underestimated the possible risks from the dramatic increase in use of opioids,” said Dr. Leonard Paulozzi of the U.S. Centers for Disease Control and Prevention, who was not involved in the new study.
People who overdose tend to be drug abusers without a prescription, but until now the risk in people with legitimate prescriptions has been unclear. In the study, overdoses were particularly common among people who had a history of depression or substance abuse.
“The study is really illuminating and insightful, because it’s calling into question the notion that as long as you have legitimate pain, you really don’t have to worry about problems with substance-use disorders,” said Dr. Douglas Gourlay, an anesthesiologist and addiction expert at Mount Sinai Hospital in Toronto, Canada, who was not involved in the study.
However, the findings should not deter doctors from prescribing opioids, he said. The drugs are used mostly as second-line treatment for patients who have failed to get relieve with other painkillers, such as ibuprofen and aspirin.
Instead, doctors ought to pay more attention to assessing patients for abuse potential before they begin treatment, Gourlay said. Several guidelines already recommend careful patient assessment and monitoring, but it’s unclear how widely busy primary care physicians adhere to this practice.
As for patients, Von Korff said, “if you’re using opioids long-term, you should never use more than your doctor prescribed. And if you’re having problems-you’re falling asleep, you feel over-sedated-you should tell your doctor.”
SOURCE: Annals of Internal Medicine
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Zegerid OTC Approved for Frequent Heartburn
By cialis viagra levitra | March 30, 2010
Merck & Co.’s Zegerid OTC (omeprazole/sodium bicarbonate) has been approved by the U.S. Food and Drug Administration to treat frequent heartburn, the company said Wednesday in a news release.
The over-the-counter product, to be available in the first half of next year, contains prescription Zegerid’s original formula, Merck said. The 14-day course of treatment is taken once daily to treat frequent heartburn for up to 24 hours.
Zegerid OTC is a proton pump inhibitor (PPI), which works to suppress stomach acid.
Some 50 million adults in the United States have heartburn symptoms more than twice weekly (defined as frequent heartburn), and as many as 25 million have heartburn daily, the company said.
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Constipation: an early sign of Parkinson’s?
By cialis viagra levitra | March 23, 2010
People with a history of constipation may be at increased risk of developing Parkinson’s disease down the road, research hints.
In a study, Dr. Walter A. Rocca at the Mayo Clinic in Rochester, Minnesota, and colleagues found a history of constipation about two times more frequent in a group of men and women with Parkinson’s disease than in an age-matched group of men and women who did not have the disease.
Parkinson’s disease is a degenerative brain disease that causes body tremors, rigid muscles, and difficulty walking and talking. The disease alters the body’s autonomic nervous system, which controls spontaneous body processes such as heart rate, digestion, salivation, and bowel function.
Chronic constipation is common among people who suffer from Parkinson’s and it has been suggested that constipation may precede the appearance of classic movement symptoms of the disease in some people. For example, in the Honolulu-Asia Aging Study, men who reported less frequent bowel movements had a significantly higher risk of Parkinson’s disease over 24 years than men who reported more frequent bowel movements.
To investigate further, Rocca’s team evaluated about 38 years of medical records of individuals living in Olmsted County, Minnesota. They compared constipation history in 196 men and women who developed Parkinson’s at an average age of 71 years, and 196 Parkinson’s-free “controls” of similar age and gender.
Roughly 36 percent of the Parkinson’s patients had a history of constipation compared with only 20 percent of the controls, a significant difference.
After allowing for differences in age, smoking, coffee drinking, the use of constipation-inducing drugs, and constipation during the 19 years prior to the onset of Parkinson’s disease, Parkinson’s patients remained about two times more likely than controls to have a history of constipation.
The association between constipation and Parkinson’s was evident long before the onset of the disease, the researchers note. “Indeed, the association remained significant when restricted to constipation documented more than 20 years before the onset of Parkinson’s disease,” they note in a report in the journal Neurology.
The findings, say the investigators, suggest that constipation is an early manifestation of the neurodegenerative process underlying Parkinson’s disease. This study, Rocca added in comments to Reuters Health, “adds new evidence to accumulating literature” suggesting that Parkinson’s disease has a very long preclinical period.
However, because constipation has many causes not specifically related to nervous system function it is not a specific marker for Parkinson’s disease, Rocca noted.
Further investigations are needed to confirm and additionally evaluate the potential link between constipation and Parkinson’s disease, Rocca said.
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CT scans may predict survival in colorectal cancer
By cialis viagra levitra | March 16, 2010
Doctors may be able use an advanced X-ray called a CT scan to see whether patients with advanced colorectal cancer are responding to treatment with Avastin and chemotherapy, U.S. researchers said on Tuesday.
Currently, there are no tools besides surgery to see if people with advanced colorectal cancer that has spread to the liver are responding to treatment with chemotherapy and Roche unit Genentech’s cancer drug Avastin.
And many patients with this advanced form of cancer are poor candidates for surgery.
“For the patient, you would have to wait for the tumor to resurface to have a sense for whether the treatment was working,” Dr Jean-Nicolas Vauthey of the University of Texas M.D. Anderson Cancer Center said in a telephone interview.
“We had no good tool to evaluate response,” said Vauthey, whose study appears in the Journal of the American Medical Association.
He said the findings are preliminary and need to be confirmed in a much larger study, but they do suggest CT scans might help doctors offer more personalized treatment for their patients.
Vauthey, a surgeon, said most doctors rely on tumor shrinkage to see if patients are responding to treatment, but he said that is not always a good indicator of response.
In surgery patients, doctors could tell by examining changes in the size and structure of tumors whether a patient was responding to the drug combination — the standard of care for most patients with advanced colorectal cancer — and had a good chance at survival.
Working with radiology specialists, the team applied some of these same characteristics to develop screening characteristics for CT scans.
To test these, the researchers analyzed a total of 234 colorectal liver metastases from 50 patients who had their tumors removed after treatment with Avastin and chemotherapy between 2004 and 2007.
All patients had CT scans at the start and end of the treatment. Radiologists studied the images for changes in the shape and structure of the tumors. They noticed that in patients who had a good response, the tumors changed into almost cyst-like structures with well-defined borders.
And they found they could classify patients into one of three categories, with type 1 patients having a good response and the best chances of survival, and those with type 2 or type 3, having poorer or no response.
The team then analyzed data on 82 patients whose colon cancer was too advanced for surgery. In those patients whose CT scans suggested they had a good response, median survival rose to 31 months, compared with 19 months in those who had an incomplete or no response to the drug, Vauthey said.
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Exercise May Lead to a Smarter, More Successful You
By cialis viagra levitra | March 9, 2010
A strong cardiovascular system in young adulthood may boost brainpower, making for better school grades and more overall success later in life, new research suggests.
Given that most doctors and laypeople know (or should know) the benefits of exercise and its impact on healthy bodies, the authors of a new study, appearing in this week’s online issue of the Proceedings of the National Academy of Sciences, are hoping the findings can influence public policy.
Doctors “have known the principal idea for 3,000 years: A healthy mind lives in an healthy body,” said study senior author H. Georg Kuhn, professor for regenerative neuroscience at the Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, University of Gothenburg in Sweden. “We are aiming at politicians and educators who decide on academic curricula and budgets and how sport fits into the picture of academic success.”
The study also found that genetics played a lesser role in explaining the mind-body link than did environment.
“This gets back to empowerment. You can’t determine that exercise or eating well isn’t going to help you because of your genetic background,” said Dr. Suzanne Steinbaum, a preventive cardiologist at Lenox Hill Hospital in New York City and a spokeswoman for the American Heart Association. “This is showing you that, regardless of genes, what you choose to do and how you choose to live can make a difference.”
The relationship between physical activity and cognitive function has been studied before, but usually in older adults (in relation to dementia) and in children.
And studies that focused on young adults, as these authors did, have tended to be smaller.
“Young adulthood is the time span in which important behavioral habits and cognitive functions are shaped,” explained Kuhn. “It is the period when academic performance has the biggest impact on the future life.”
This is also a time when the central nervous system is still developing, he noted.
The study was an extremely large one, involving 1.2 million Swedish men born between 1950 and 1976.
More than 250,000 of the men were sibling pairs and more than 3,000 were twins, of which 1,432 were identical twins.
The researchers took information from the time the men were conscripted into the military (age 18), which is compulsory in Sweden. This information was then correlated with information on the men’s prior academic performance, how many siblings they had and what socioeconomic class they came from.
Better cardiovascular fitness was associated with higher intelligence, although muscle strength was not, the researchers found.
“The emphasis at gyms is for strength over aerobic capacity but aerobic fitness is where we need to pay our focus,” said Dr. Jonathan H. Whiteson, co-director of the Joan and Joel Smilow Cardiopulmonary Rehabilitation and Prevention Center at NYU Langone Medical Center in New York City.
The twins portion of the analysis showed that environmental factors accounted for more than 80 percent of the equation, and genetics for less than 15 percent.
Any number of factors could explain why better cardiovascular fitness through exercising impacts brain function, including improved blood flow to the brain, diminished anxiety, enhanced mood and less fatigue, Whiteson said.
“We’ve known that aerobic exercise has been associated with improved cognitive performance. We’ve known that from studies dating back from the ’70s,” he said. “They picked the area of young men which may not have had a lot of research. This confirms what we’ve already known about younger and older individuals.”
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Fear of Anxiety May Lead to Depression
By cialis viagra levitra | March 2, 2010
Fear of anxiety may push “above-average” worriers into depression, a new study suggests.
“Anxiety sensitivity has been called a fear of fear,” study author Andres Viana, a graduate student in psychology at Penn State, said in a news release. “Those with anxiety sensitivity are afraid of their anxiety because their interpretation is that something catastrophic is going to happen when their anxious sensations arise.”
Viana and colleagues analyzed questionnaires completed by 94 volunteers, average age 19, who were moderate to high worriers. The questionnaires assessed worry, generalized anxiety and depression.
The responses showed that anxiety sensitivity significantly predicted depression symptoms. The researchers also found that two of the four issues that comprise anxiety sensitivity — the “fear of cognitive dyscontrol” and the “fear of publically observable anxiety symptoms” — specifically predicted depression symptoms. The two other issues — the “fear of cardiovascular symptoms” and the “fear of respiratory symptoms” — weren’t significant predictors of depression.
“What we found was that the fear of the cognitive sensations typical of anxiety, like the inability to concentrate, was related to depression. And we also found that the link exists in people who are afraid of symptoms that could potentially have social implications or symptoms of anxiety that may be subject to negative evaluation,” Viana said.
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U.S. official says mammograms policy unchanged
By cialis viagra levitra | February 27, 2010
U.S. health officials on Wednesday distanced themselves from controversial new breast cancer screening guidelines that recommend against routine mammograms for healthy women in their 40s and said federal policy on screening mammograms has not changed.
In a move likely to reassure American women, U.S. House and Human Services Secretary Kathleen Sebelius said in a statement the U.S. Preventive Services Task Force that issued the guidelines on Monday does not set federal policy and does not affect what services the government will pay for.
Critics of the new guidelines said they would lead to more cancer deaths and expressed fear insurance companies would use them to justify denying coverage for mammograms to women in their 40s.
“The Task Force has presented some new evidence for consideration but our policies remain unchanged,” Sebelius said in a statement.
“Indeed, I would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action,” she said.
The proposed changes address healthy women with an average risk of breast cancer, not women who have a family history of breast cancer or some other special risk.
The guidelines were swiftly rejected by cancer experts, and the American Cancer Society said it would not change its recommendations for routine mammograms starting at age 40.
Recommendations from the U.S. Preventive Services Task Force, an independent panel of experts sponsored by the U.S. Agency for Healthcare Research, typically set the standard for preventive services in the United States.
“There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country,” Sebelius said.
“I want to address that confusion head on,” she said.
“The U.S. Preventive Task Force is an outside independent panel of doctors and scientists who make recommendations. They do not set federal policy and they don’t determine what services are covered by the federal government,” she said.
She said there has been long-standing debate in the United States over when routine screening mammograms should start, and how often they should be done.
“What is clear is that there is a great need for more evidence, more research and more scientific innovation to help women prevent, detect, and fight breast cancer, the second leading cause of cancer deaths among women.”
She advised women to “keep doing what you have been doing for years — talk to your doctor about your individual history, ask questions, and make the decision that is right for you.”
Representative Dave Camp, the ranking Republican on the Ways and Means Committee, said the new guidelines amount to rationing. “This is what happens when bureaucrats make your health care decisions,” he told the New York Times on Tuesday.
Democrats bristled at the suggestion that the new guidelines were motivated by cost, something the panel has denied.
“If we can cut through the Republicans’ political gamesmanship on this issue, the new breast cancer recommendations, as always, were an attempt to put the best possible evidence in the hands of women and their doctors, so they can assess their own risk and benefit,” Congresswoman Rosa DeLauro, a Democrat from Connecticut said in a statement.
“To suggest that our bill, the Affordable Health Care for America Act, does anything other than reduce cost, ensure that insurers stop discriminating against women, and improve the health insurance system for the 192,000 American women diagnosed with breast cancer each year, is absurd,” DeLauro said in a statement.
Breast cancer is the top cancer killer of women globally, killing 500,000 annually.
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