International health panel says treat all HIV infections

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Panel Urges Expanded Use of Antiretrovirals for HIV

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Few Patients Should Get Metal-on-Metal Hip Implants, FDA Panel Says

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FDA panel sees little use for metal-on-metal hips

Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices.

"I do not use metal-on-metal hips, and I can see no reason to do so," said Dr. William Rohr of Mendocino Coast District Hospital, who chaired the meeting.

For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last 10 years some surgeons began to favor all-metal implants, after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation.

But recent data gathered from foreign registries shows the devices fail at a higher rate than older implants. That information comes on top of nearly 17,000 reports to the FDA of problems with the implants, which sometimes require invasive surgery to replace them.

The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. The long-term effects of elevated metal levels in the bloodstream are not clear, though some studies have suggested links to neurological and heart problems.

About 400,000 Americans get a hip replacement each year to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008. Doctors have begun turning away from the implants amid several high-profile recalls, including J&J's recall of 93,000 metal hips in 2010.

FDA's experts said Thursday that patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. However, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium and other metals

For patients who are not experiencing pain, panelists said annual X-rays would be sufficient to monitor their implants.

If the FDA ultimately follows the group's advice, U.S. recommendations would be less involved than those already in place overseas.

Earlier this year U.K. regulators recommend that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies.

FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.

"The truth is there are different types of hips and different types of patients," said Dr. William Maisel, FDA's chief scientist for devices, in an interview last week. "Understanding the characteristics of patients who experience adverse events is very important."

Women and overweight people are among the groups that are more likely to have an implant failure.

With little definitive data on U.S. hip implants, the agency has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market.

FDA scientists say the studies will help "fill in the blanks" on a number of scientific questions, including the long-term effects of metal particles.

But public health advocates say it could take a decade before that information is available.

"Keeping these metal-on-metal hips on the market for the next five to 10 years while research is conducted is not ethical," said Diana Zuckerman, president of the National Research Center for Women & Families, during a public comment session at the meeting. "If the companies want to sell metal-on-metal hips, they should be required to prove their safety first."

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FDA panel backs broader use of Edwards heart valve

A panel of heart experts said Wednesday that the government should expand approval of the first artificial heart valve designed to be implanted without major surgery, despite limited information about some long-term side effects.

The Food and Drug Administration's panel of outside cardiologists voted 11-0 with one abstention that the benefits of broader approval for Edwards Lifesciences' Sapien valve outweigh the risks.

The valve is currently approved for patients who aren't healthy enough to undergo the more invasive open-heart surgery, which has been used to replace the aortic valve for decades.

If FDA follows the group's advice, the implant will be approved for patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.

The FDA is not required to follow the panel's advice, though it often does. A decision is expected later this year.

Edwards Lifesciences Corp. presented data from a pivotal trial showing that patients implanted with its heart valve survived about as long as those who underwent surgery. One year after the operation, 76 percent of patients implanted with the heart valve were still alive, compared with 73 percent of those who had undergone open-heart surgery.

The numbers were close enough to meet the study's goal of showing that Sapien's survival rate was at least as good as surgery. But panelists raised a number of concerns about the valve's side effects and the accuracy of the company's trial results.

Patients who got the Sapien valve had a higher rate of stroke immediately following the procedure when compared to surgery, though rates evened out over time. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber.

Elsewhere, panelists noted that the death rate among men was more than 3 percent higher than that for women with the Sapien valve.

In each case, panelists said more follow-up data would be needed to define the scope and severity of these issues.

Irvine, Calif.-based Edwards plans to conduct two follow-up studies to evaluate long-term safety as well as differences in gender outcomes.

About 300,000 U.S. patients suffer from deterioration of the aortic heart valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA.

Every year about 50,000 people in the U.S. undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

The Sapien valve is usually threaded through the femoral artery via a small incision in the leg, and then guided up to the heart via catheter. An alternate procedure inserts the valve through a small incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve. The device is made from cow tissue and polyester supported by a steel frame.

Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the valve.

In the most recent quarter Edwards reported Sapien sales of $121.5 million, with the U.S. contributing $41 million. For the full year Edwards expects sales of $530 million to $600 million.

Shares of Edwards Lifesciences Corp. fell 27 cents Wednesday to close at $90.54. They rose 59 cents to $91.13 in extended trading following news of the panel's vote.

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FDA Panel Votes Against New Use for Blood Thinner Xarelto

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FDA panel recommends Gilead's Quad for HIV

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FDA Panel Seems to Back Pill to Help Prevent HIV

HealthDay – 19 hrs ago WEDNESDAY, May 9 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration appears to support the use of the drug Truvada as a means to help prevent HIV infection in people at high risk.

Those individuals might include highly sexually active gay or bisexual men, or the partners of people already infected with HIV, the virus that causes AIDS.

The advisory panel is meeting Thursday to mull whether or not to recommend Truvada as a preventive agent. However, a report released by the FDA this week ahead of the meeting suggests the experts do believe the drug is safe and effective for this use.

There are potential drawbacks to using the medication in this way, however. Truvada -- which combines two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva) -- is very expensive and may cause side effects. And although doctors can already prescribe it to people trying to avoid HIV infection, critics say it's too early to officially allow it to be promoted for that use.

On the other hand, those who support marketing the drug as a preventive agent say it can help high-risk people avoid the disease, especially if they don't use condoms or if they want an added layer of protection.

"I don't see it as a panacea, but it's an option, and that's important," said Dr. Kenneth Mayer, an AIDS specialist and medical research director of The Fenway Institute at Fenway Health in Boston. "Some people won't use a condom, but will say, 'if you give me another option, I'll use that.'"

Truvada works to prevent HIV from replicating in the body's cells. Mayer explained that in someone who is not yet infected but is exposed to HIV, the drug may prevent the virus from reproducing even if it's already invaded cells. As a result, he said, "the virus cannot start turning the newly exposed person's body into a 'factory' to produce more HIV particles."

A study published in 2010 in the New England Journal of Medicine found that Truvada cut the risk of HIV infection by almost 44 percent in those at highest risk for contracting the virus, namely sexually active gay and bisexual men. The risk reduction climbed to nearly 73 percent among study participants who took the pill 90 percent of the time, the researchers added.

On Thursday, the FDA advisory panel will meet and come up with advice for federal officials about the possible marketing of the drug as a preventive agent by its manufacturer, Gilead Sciences.

The research suggests that people who use Truvada daily along with condoms would gain an added layer of protection, because condoms aren't 100 percent effective. But one organization, the AIDS Healthcare Foundation, worries that wider use of the drug could lead to more infections by discouraging people from bothering to use condoms.

"Why would you take this medication if you intended to use condoms?" asked the group's president, Michael Weinstein, in an interview with Bloomberg News. He used a sartorial metaphor to elaborate how unlikely that might be: "You've got to be really paranoid about your pants falling down to wear a belt and suspenders."

A. David Paltiel, a professor at Yale School of Medicine, said his research has shown that the use of preventive drug treatments should reduce the risk of infection overall. Still, he said, it's unknown if "people (would) take more chances because they feel protected by a 'chemical condom.'"

Potential markets for Truvada as a preventive drug, Mayer said, include gay men who have sex with more than one man and any committed couple in which one person is HIV-positive, including some heterosexual couples who want to have children.

Mayer, who has conducted research into the drug, said that allowing the marketing will probably lead to an increase in its usage for prevention. But, "this is not a one-time, end-of-the-problem approach like a shot of penicillin to treat an infection like syphilis," he said. "Also, it involves someone perceiving that he or she is at risk, or a provider being comfortable enough to ask about a person's risk. We know that a lot of health providers don't like to talk to their patients about sex."

Truvada can also cause a long list of side effects, including gastrointestinal problems. And it's costly, with prices in the United States tagged at about $26 a day or $10,000 a year. Still, a study released this year found the drug would be cost-effective if used extensively by gay and bisexual men at high risk of becoming infected.

For his part, Paltiel said his research came to the same conclusion: That widespread usage of the drug in high-risk people would be "as cost-effective as other widely accepted public health and medical interventions."

More information

Find out more about HIV/AIDS at the U.S. National Library of Medicine.

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FDA panel urges approval for Pfizer arthritis drug

"An advisory committee to the US Food and Drug Administration on Wednesday urged US regulators to approve a new treatment for rheumatoid arthritis made by the pharmaceutical giant Pfizer. (AFP Photo/Timothy A. Clary)" title

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U.S. Panel Rejects Ovarian Cancer Screening

HealthDay – 1 hr 22 mins ago TUESDAY, April 10 (HealthDay News) -- A leading U.S. government panel has renewed its 2004 recommendation that women at average risk for ovarian cancer not get screened for the disease.

The currently used blood test and transvaginal ultrasound may cause more harm than benefit for those patients, according to draft recommendations issued Tuesday by the U.S. Preventive Services Task Force.

"Currently, the task force does not recommend screening for ovarian cancer," said Dr. David Grossman, a member of the task force and senior investigator with Group Health Research Institute in Seattle. "The tests that we have, unfortunately, just aren't very accurate and, with a lot of false positives, a lot of women get harmed with unnecessary biopsies and surgeries."

Women with a family history of ovarian cancer should be referred for genetic testing and counseling, the recommendations also state.

Two methods are currently used to test for ovarian cancer, a blood test which looks for the tumor marker CA-125 and a transvaginal ultrasound, Grossman explained.

However, a large study published last year found no difference in mortality between women who were randomly assigned to receive a blood test plus the ultrasound compared to those who had "usual care."

What's more, some 10 percent of women who underwent screening received a false-positive result and one-third of these had an ovary removed unnecessarily.

Another study estimated that 33 surgeries were needed to diagnose one case of ovarian cancer using the blood test/ultrasound screening.

Preliminary data from yet another trial, ongoing in the United Kingdom, also turned up false-positive results in about 10 percent of women undergoing screening. Half of those women had surgery and about 4 percent of these experienced a major complication from the surgery.

Like many screening tests, the blood test plus ultrasound for ovarian cancer "doesn't work, is potentially dangerous and also costs a lot of money," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La.. "You're giving people a false sense of security, and it creates a lot of false positives which ultimately results in a lot of unnecessary surgeries."

Yet, many doctors still perform the tests because women demand it, Brooks noted.

With no new data affirming the benefit of CA-125 screening plus ultrasound, the new draft recommendations essentially reaffirm 2004 recommendations.

They are also in line with recommendations from the American Cancer Society and the American Congress of Obstetricians and Gynecologists (ACOG), Grossman said.

This leaves women with no good test to screen for ovarian cancer, considered a "silent killer" because symptoms are often noticed too late to be treatable.

"At the present, we do not have a good screening test for ovarian cancer," Brooks said.

And there are no other techniques on the horizon, Grossman added.

The draft recommendations will be posted on the task force website, and physicians and members of the public and of professional societies are invited to comment.

Final recommendations may be out in as soon as two months, Grossman said.

More information

The U.S. National Cancer Institute has more on ovarian cancer.

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Panel backs sharing studies of lab-made bird flu

The U.S. government's biosecurity advisers said Friday they support publishing research studies showing how scientists made new easy-to-spread forms of bird flu because the studies, now revised, don't reveal details bioterrorists could use.

The decision could end a debate that began in December when the government took the unprecedented step of asking the scientists not to publicize all the details of their work.

The research, by two scientific teams

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Beer Madness, Round 1: Our panel goes straight to Helles

Astrid Riecken/FOR THE WASHINGTON POST - Church Key manager Brett Weinrieb serves another round of beer samples during the Washington Post's annual Beer Madness which takes place at Church Key.

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Beer Madness, Round 1: Our panel goes straight to Helles

Astrid Riecken/FOR THE WASHINGTON POST - Church Key manager Brett Weinrieb serves another round of beer samples during the Washington Post's annual Beer Madness which takes place at Church Key.

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