Thursday, April 5, 2012

From a Failed Vaccine, New Insights Into Fighting HIV

HealthDay – 2 hrs 26 mins ago WEDNESDAY, April 4 (HealthDay News) -- A new study offers insight into why an HIV vaccine failed to protect most people who received it, but it also points to promising new targets for future vaccine efforts.

Scientists believe an HIV vaccine, designed to prevent infection with the virus that causes AIDS, is still several years away. Tests of experimental vaccines have largely been failures so far.

Nevertheless, the prospect of a vaccine remains tantalizing because it could make a major dent in the spread of HIV and AIDS around the world.

The new research "gives us a handle on how the immune system deals with the virus and is affected by a vaccine," said study lead author Dr. Barton Haynes, director at the Duke Human Vaccine Institute at Duke University in Durham, N.C. "It gives us clues and a firm direction to look into."

The study is based on work by more than 100 scientists from 25 institutions, and appears in the April 5 issue of the New England Journal of Medicine.

Haynes and his colleagues examined the results of a 2009 study of an HIV vaccine in Thailand. In a trial involving more than 16,000 people, the vaccine appeared to cut the risk of infection by only 31 percent. That was still considered a major advance over previous vaccines that didn't work at all, Haynes noted.

The vaccine, called RV144, wasn't ready for prime time because it didn't protect enough people, Haynes said. "You want to get it above 50 percent," he said, and some scientists believe the rate should be even higher than that.

Despite the vaccine's failure, the authors of the new study were able to use the data to learn more about how the immune system deals with HIV and how the vaccine changes the "big picture" of the body's response to the virus.

The new research is an "exhaustive molecular analysis," said Dr. Lindsey Baden, an associate professor of medicine in the infectious disease division at Brigham and Women's Hospital in Boston who co-wrote a commentary accompanying the study.

Haynes said one surprising finding is about an antibody -- a soldier of the immune system -- that helps protect against influenza infection. Ironically, the antibody appears to boost the likelihood of HIV infection, he said.

Another finding was that higher levels of antibodies that home in on a particular region of HIV's outer shell, called V1V2, were associated with lower rates of infection with the virus.

This and other information in the study may help researchers come up with theories about where to go next with vaccine development, Baden said. Among other things, it can reveal parts of the immune system that can be most useful in battling the transmission of HIV.

Vaccines are available to fight other kinds of viruses, such as measles and influenza. HIV is unique, however, because it inserts its genetic material into the body's cells.

"When a person gets infected with HIV, that genetic material goes underground," Haynes said. "It's invisible to the body's immune system."

Another challenge is that the virus mutates, becoming a moving target.

"It changes so rapidly in the person who gets infected that even when the immune system does try to control it, in most people the immune system is always playing catch up," Haynes said.

More information

There's more on HIV/AIDS at the U.S. National Library of Medicine.



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Brain Falters Near End of Life, but Games, Puzzles Might Slow Decline

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New Lupus Genes Identified

HealthDay – 2 hrs 26 mins ago WEDNESDAY, April 4 (HealthDay News) -- Three new genes linked to the chronic autoimmune disease lupus have been identified by an international team of researchers.

The analysis of more than 17,000 genetic samples from people of several ethnic groups also pinpointed another 11 genetic regions that may be related to lupus and require further study.

The researchers found that the genes IRF8 and TMEM39a are associated with lupus in European-American, African-American, Gullah (a distinctive group of African-Americans in Georgia and South Carolina) and Asian patients. The gene IKZF3 is only significantly associated with lupus in African-Americans and European-Americans.

The researchers said their findings, which appear in the April 6 issue of the American Journal of Human Genetics, show that the genes that cause lupus aren't always universal.

The next step is to study the three genes to find out exactly what role they play in lupus, said lead author Christopher Lessard, a scientist at the Oklahoma Medical Research Foundation in Oklahoma City.

Lupus affects about 1.5 million Americans, and about 90 percent of patients are women. The disease causes the immune system to become overactive and attack the body's own cells. Symptoms include fatigue, fever, rashes and joint pain.

A combination of environmental and genetic factors cause lupus. Learning more about genetic risk factors may lead to improved diagnosis and treatment of the disease.

More information

The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about lupus.



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Researchers Find Gene Mutations That May Be a Key to Autism

HealthDay – 2 hrs 26 mins ago WEDNESDAY, April 4 (HealthDay News) -- Genetic mutations that arise spontaneously, as opposed to being passed through generations, could play an important role in the development of autism, new research suggests.

Three research teams sequenced the genes of children with sporadic autism, meaning it did not run in their families, and compared the sequences with those of their parents and siblings. Their results were published in three separate articles on April 4 in the journal Nature.

"We found that 15 to 20 percent of sporadic patients could be explained by 'de novo'

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Cancer Diagnosis May Raise Odds for Suicide, Heart Attack Death

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Doctors Detail High Costs of Fighting Malpractice Claims

HealthDay – 2 hrs 26 mins ago WEDNESDAY, April 4 (HealthDay News) -- For doctors defending medical malpractice claims, costs vary widely across specialties and can run into the tens of thousands, even when a patient did not receive a payout, new research shows.

The upshot: Patients end up paying the price in the end, the researchers concluded in their letter published April 5 in the New England Journal of Medicine.

"Higher defense costs and higher malpractice premiums are ultimately passed down to patients through higher physician fees," said co-author Dr. Anupam Jena, a physician at Massachusetts General Hospital, Harvard Medical School, and a senior fellow at the Schaeffer Health Policy Center at the University of Southern California.

According to Jena and his co-authors, cardiologists shell out the most when it comes to malpractice claims -- averaging more than $83,000 for paid claims -- while ophthalmologists spend nearly $24,000 for paid claims.

Expert witnesses, research costs, lawyers' fees and funding overhead costs, such as filing fees, are among the expenses that rack up bills, Jena said.

"The average malpractice claim in our study cost approximately $23,000," he said, adding that the claims that result in payments are more expensive because they take longer to defend, typically up to two years or more.

To come up with defense costs of paid and unpaid malpractice claims by specialty, the authors analyzed costs associated with nearly 27,000 malpractice claims that closed between 1995 and 2005. The claims involved nearly 41,000 physicians who were covered by a national liability insurer.

Jena and his colleagues had examined the same data in a 2011 NEJM study that compared malpractice risk by medical specialty, he said.

"We wanted to follow-up our earlier study by studying the magnitude of defense costs in medical malpractice and to explore how those costs vary by specialty," said Jena.

Why did some specialists rack up defense bills almost four times higher than others? Jena said the chart-toppers, heart and cancer physicians, are more likely to deal with claims linked to a failure to diagnose, and possibly death.

"The damages from malpractice vary, ranging from a missed diagnosis that delays treatment to the unexpected loss of life," he said. "Many cases are complex and those cases can stretch out longer," he said, noting that time is money.

Sonia Suter, an associate professor of law at George Washington University Law School in Washington, D.C., said the letter contains useful information. "It helps inform the ongoing debate about health-care costs and whether or not medical malpractice is contributing to higher costs overall," she said.

"I don't think this letter tells me the whole story, though. It's only one piece of the puzzle," said Suter, adding that she thought obstetrics would have landed higher up on the list. (It's sixth of 25 specialties.)

Dr. Jeffrey Segal is a neurosurgeon and founder and CEO of Medical Justice, a for-profit company that helps physicians deter and manage frivolous medical malpractice lawsuits. He said the letter in NEJM points out not just costs of claims, but the significant number of cases that come through the legal system that aren't won by the patient.

"We see here many claims are coming through that don't have merit. In a perfect legal system, you'd have the dollars going to a patient who is injured by medical negligence," he said. "This reaffirms that it's a system that takes a lot of time and is very expensive."

Segal added, "We've proposed legislation in Florida -- I'm part of a nonprofit that suggests a better way of doing things -- that would help move cases through faster. I'm talking weeks and months instead of years."

Jena said there are some cases where the patient was clearly harmed and, in those cases, it's important that the patient is compensated and compensated early on.

"Waiting two years is not fair," Jena said, and added that a quicker resolution would reduce not just the financial cost to those injured, but the emotional expense as well.

Jena described another solution that might hold promise for reducing malpractice claim costs.

"The University of Michigan hospital system tested a program where they identified errors early on and proactively approached patients and said, 'This is an error that occurred and we apologize, and we'd like to compensate you,'" he said. "Malpractice lawsuits, defense costs, and the time required to resolve claims all went down." He added that this approach of early disclosure needs to be studied further.

Cardiologist Dr. Chip Lavie, medical director of cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans, also weighed in on the new findings.

"I believe if there was substantially less threat of medical malpractice, physicians could practice medicine in a different way, trying to be cost-effective and trying to do the right thing with what is truly best for the patient as opposed to what is the best way to maintain a good defense against any potential subsequent lawsuit," Lavie said.

More information

Visit the Institute of Medicine to see its landmark report on reducing preventable medical errors.



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Mississippi bill may force state's only abortion clinic to close

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Chavez back in Venezuela after more cancer treatment

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Newron agrees Parkinson's drug deal with Zambon

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Sanofi unveils mixed news for Zaltrap cancer drug

Reuters – 20 mins ago PARIS (Reuters) - Sanofi and Regeneron Pharmaceuticals said their Zaltrap drug candidate failed to meet targets in a late-stage study for the treatment of prostate cancer, though U.S. authorities were reviewing it for use in treating colon cancer.

Regeneron had said in December that Sanofi had withdrawn its application for marketing approval for Zaltrap and was planning to resubmit it early this year.

"The study did not meet the pre-specified criterion of improvement in overall survival," Sanofi said, referring to a Phase III study of Zaltrap, also known as aflibercept, in treating prostate cancer.

Sanofi added in a statement on Thursday that the U.S. Food and Drug Administration had granted a priority review to the companies to examine Zaltrap in the treatment of colon cancer. The FDA is due to give a decision by August 4.

Priority review is granted to a drug if preliminary estimates show it has the potential to provide a treatment where no adequate therapy exists or a significant improvement compared with marketed products, Sanofi said.

"Sanofi and Regeneron are committed to the continued development of Zaltrap," Sanofi oncology head Debasish Roychowdhury said in the statement.

(Reporting by Nina Sovich; Editing by James Regan)



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New effort by MDs to cut wasteful medical spending

Old checklist for doctors: order that test, write that prescription. New checklist for doctors: first ask yourself if the patient really needs it.

Nine medical societies representing nearly 375,000 physicians are challenging the widely held perception that more health care is better, releasing lists Wednesday of tests and treatments their members should no longer automatically order.

The 45 items listed include most repeat colonoscopies within 10 years of a first such test, early imaging for most back pain, brain scans for patients who fainted but didn't have seizures, and antibiotics for mild- to-moderate sinus distress.

Also on the list: heart imaging stress tests for patients without coronary symptoms. And a particularly sobering recommendation calls for cancer doctors to stop treating tumors in end-stage patients who have not responded to multiple therapies and are ineligible for experimental treatments.

Dr. Christine Cassel, president of the American Board of Internal Medicine, said the goal is to reduce wasteful spending without harming patients. She suggested some may benefit by avoiding known risks associated with medical tests, such as exposure to radiation.

"We all know there is overuse and waste in the system, so let's have the doctors take responsibility for that and look at the things that are overused," said Cassel. "We're doing this because we think we don't need to ration health care if we get rid of waste." Her group sets standards and oversees board certification for many medical specialties.

The recommendations come at a time when American health care is undergoing far-reaching changes. No matter what the Supreme Court decides on President Barack Obama's health overhaul, employers, lawmakers, insurers and many doctors are questioning how the United States spends far more on medical care than any other economically advanced country and still produces mediocre results overall.

Until now, the health care system has rewarded doctors for volume. Now the focus is shifting to paying for results and coordination. That explains the urgency for doctors themselves to identify areas of questionable spending.

It's unclear how much money would be saved if doctors followed the 45 recommendations rigorously. Probably tens of billions of dollars, and maybe hundreds of billions over time. That would help, but come nowhere near solving, the problem of high health care costs.

The nation's medical bill hit $2.6 trillion in 2010. A major quandary for cost-cutters is that most of the spending is attributable to a relatively small share of very sick people. Just 5 percent of patients accounted for half the total costs among privately insured people, according to a recent study from the IMS Institute for Healthcare Informatics.

Dr. James Fasules of the American College of Cardiology said the goal is to begin changing attitudes among patients and doctors.

"We kind of have a general feeling that if you don't get a test, you haven't been cared for well," said Fasules. "That has permeated American culture now." The new advice isn't meant to override a doctor's judgment, Fasules added, but to inform and support decisions.

The recommendations will be circulated to consumers and doctors by a coalition calling itself Choosing Wisely, which includes employer groups, unions, AARP and Consumer Reports. Neither the insurance industry nor the federal government was involved in process.

Each of the nine medical societies submitted five tests or treatments they viewed as overused. Their work was coordinated by a foundation that's an offshoot of Cassel's group. Eight other medical societies are developing additional recommendations, Cassel said.

The medical societies don't have any power of enforcement, and fear of malpractice lawsuits may well prompt many doctors to keep ordering as many tests as ever.

Insurers will certainly take a close look at the recommendations, but what they do may be limited. That's because most of the questionable tests and treatments in the lists don't particularly stand out in the avalanche of bills processed daily by insurance companies.

Take a recommendation for no annual EKGs for low-risk patients with no heart symptoms. Dr. John Santa, director of the Consumer Reports Health Ratings Center, said he used to routinely order EKG's when he was a general adult medicine practitioner. EKGs cost $50 to $60. A medical assistant would do the tests, and it would take Santa just a couple of minutes to read them. Yet 2 percent to 3 percent of his income came from EKGs, enough to make a difference in a tight year.

"It's very difficult for an insurance company to tell the difference when an EKG is being used as a diagnostic tool and when it is being used as a screening test," said Santa. "It would probably cause more trouble for insurance companies."

The medical groups that participated are: American Academy of Allergy, Asthma & Immunology; American Academy of Family Physicians, American College of Cardiology, American College of Physicians, American College of Radiology, American Gastroenterological Association, American Society of Clinical Oncology, American Society of Nephrology, and American Society of Nuclear Cardiology.



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Gene trawl shows clues, but also complexity, in autism

"A boy with autism is seen at a special school in 2006. Researchers said on Wednesday they had found three more genes implicated in autism and turned up some evidence to explain why the disorder occurs more frequently among children of older parents. (AFP Photo/Liu Jin)" title

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