Screen All Baby Boomers for Hepatitis C, Expert Panel Says

This generation has highest rate of infection, likely contracted decades ago

By Steven Reinberg

HealthDay Reporter

MONDAY, June 24 (HealthDay News) -- All adults born between 1945 and 1965 -- the baby boom generation -- should be screened for the hepatitis C virus along with injection-drug users and anyone transfused before 1992, according to new recommendations from the U.S. Preventive Services Task Force.

The guidelines, released Monday, mirror recommendations from the U.S. Centers for Disease Control and Prevention and provide a long-awaited policy from the task force, an independent panel of experts.

"For everyone born between 1945 and 1965 we recommend a one-time screening," said task force member Dr. Kirsten Bibbins-Domingo, an associate professor in residence at the University of California, San Francisco, School of Medicine.

People in this age group account for three-quarters of all hepatitis C cases in the United States, Bibbins-Domingo said. Many contracted the disease decades ago but don't know it.

Hepatitis C -- a leading cause of liver damage and liver disease in the United States -- is considered a silent killer because it progresses without any indications of illness. More than 30 percent of U.S. patients needing liver transplants have end-stage liver disease related to hepatitis C.

"The challenge is that many people have hepatitis C and don't have signs and symptoms of the disease," Bibbins-Domingo said. "Those people should be identified and consider treatment."

An estimated 3.9 million people are infected with hepatitis C in the United States, the task force said. Unlike other types of hepatitis, there is no vaccine for hepatitis C.

In its 2004 statement, the task force advised against routine screening of adults without symptoms and high risk of infection. It also said it had too little evidence to recommend for or against routine screening for adults with high risk of infection.

It became apparent, however, that two-thirds of infected people weren't getting screened, while treatment was becoming more successful.

"Many people appear to benefit from treatment," Bibbins-Domingo said. "That is what led the task force to conclude that it is beneficial for people to find out they have hepatitis C in order to seek treatment."

Dr. Marc Siegel, an associate professor of medicine at NYU Langone Medical Center in New York City, said he welcomes the new guidelines, which were published June 25 in the Annals of Internal Medicine.

"I am absolutely thrilled that the U.S. Preventive Services Task Force, which has had a head-in-the-sand approach toward screening, has come out for a one-time screening for hepatitis C," Siegel said.

Siegel encourages everyone at risk to get tested.

Screening for hepatitis C involves a simple, inexpensive blood test. Those who test positive usually receive a course of antiviral medication over several months. Most people have no detectable virus following treatment, Bibbins-Domingo said.

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FDA Panel Votes to Change Tight Restrictions on Diabetes Drug Avandia

Controversial decision comes after a second look at major data review focused on heart risks

By Dennis Thompson

HealthDay Reporter

THURSDAY, June 6 (HealthDay News) -- An expert advisory panel to the U.S. Food and Drug Administration voted narrowly Thursday to recommend changing tough safety restrictions on the diabetes drug Avandia, which was all but banned nearly two years ago because of reported links to heart problems.

The panel's decision came after a review of data that suggested the medication might not be as harmful as once thought.

However, because of initial concerns over cardiovascular safety, Avandia had been taken off drugstore shelves and its use restricted to patients who first signed a waiver saying they understood the possible risks. The drug was also dispensed only through specially registered pharmacies.

But the new recommendation might change all that. Thirteen members of the 26-person panel voted to alter the safety restrictions, the Associated Press reported, while seven voted to remove the restrictions altogether. Five panelists voted to keep the restrictions in place, while one panelist voted to withdraw Avandia from the marketplace.

The exact nature of any changes to current restrictions are yet to be decided. The FDA is not obligated to follow its advisory panels' decisions, but it usually does.

The panelists spent the past two days reconsidering evidence from an independent review by Duke University researchers of Avandia's original clinical trial, called RECORD. That review did uncover some previously unreported cases of heart complications and deaths, but the Duke team concluded that those cases did not significantly raise the overall risk of heart disease.

"I'm considerably reassured, in light of the reanalysis, that the magnitude of risk we're talking about here is not very great," Dr. Dale Hammerschmidt, of the University of Minnesota, who voted on Thursday to modify the safety limits, told the AP.

The drug's maker, GlaxoSmithKline, which had funded the Duke review, said it was satisfied with the panel's decision.

"We appreciate the committee's thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee," the company's chief medical officer, Dr. James Shannon, said in a statement. "We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling."

Not everyone is likely to be so pleased. The FDA's reconsideration of Avandia's safety has prompted stinging criticism from the drug's detractors, who say the agency is trying to save face following a very public embarrassment over the drug.

"This is a drug that has essentially been off the market in almost the entire world for the last three years. It has been banned in most countries, and is available in the United States under such strict requirements that only 3,000 patients now take it," said Dr. Steven Nissen, the Cleveland Clinic cardiologist who first led the charge against Avandia. "It's really about the FDA wanting to clean up its image, not about whether the drug is actually safe or unsafe."

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FDA Panel to Consider Brain Stimulator for Epilepsy

Title: FDA Panel to Consider Brain Stimulator for Epilepsy
Category: Health News
Created: 2/21/2013 10:35:00 AM
Last Editorial Review: 2/21/2013 12:00:00 AM

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FDA Panel Backs New Type of Diabetes Drug

Jan. 16, 2013 -- An FDA advisory panel has given its blessing to canagliflozin (Invokana) for the treatment of type 2 diabetes.

The panel voted 10 to 5 in favor of the drug’s approval, but did express concern about heart and stroke risks. The FDA is not obligated to follow the advice of its panels, but it usually does. The FDA is expected to give its decision in March.

Taken by mouth once a day, the drug could be the first in a new class of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Canagliflozin works to reduce the amount of blood sugar (glucose) reabsorbed by the kidneys. This results in glucose being expelled in the urine.

Preliminary data suggest that people who take the new medication have lower glucose levels and also lose weight. Studies of the new drug are ongoing.

The drug is being developed by Johnson & Johnson subsidiary Janssen Research & Development.

Despite recommending approval of the new drug, panel members expressed concerns about risks of heart disease and stroke. But data on studies evaluating this risk were insufficient.

They also expressed concerns about the use and safety of this drug in people with kidney disease. As such, some panel members recommended that people with kidney damage do not use this  drug if it is approved.

In January 2012, the FDA voted against another SGLT2 inhibitor, dapagliflozin, due to concerns about a cancer risk. This drug was approved in the European Union in November 2012. There is no cancer risk seen with canagliflozin.

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