Corker, Blumenthal, Gingrey Praise Senate Passage of GAIN Act in FDA User Fee Reauthorization Bill

Press Release:

GAIN Act Encourages Development of New Antibiotics to Treat Rising Cases of Drug-Resistant Infections

May 24 2012 -

WASHINGTON – U.S. Senators Bob Corker (R-TN) and Richard Blumenthal (D-CT) and U.S. Representative Phil Gingrey, M.D., (R-GA) today praised Senate passage of the GAIN Act (S.1734) as part of the Food and Drug Administration User Fee Reauthorization bill. The GAIN Act, introduced by Corker and Blumenthal in October, and its companion, introduced by Representatives Gingrey and Diana DeGette (D-CO) in the House of Representatives, aim to spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics. Next week the House of Representatives is expected to consider its version of the FDA reauthorization bill, which also includes the GAIN Act.

“The GAIN Act has received strong support from both parties and numerous health care stakeholders because it’s commonsense legislation that provides market incentives to encourage innovation without putting federal dollars at stake,” Senator Corker said. “Antibiotic resistance is a growing issue that we must address now to properly prepare for the future. As Dr. William Evans, director and CEO of St. Jude’s Children’s Research Hospital in Tennessee, has said, ‘We don’t want to find ourselves in a situation in which we’ve been able to save a child’s life after cancer diagnosis only to lose them to an untreatable multidrug resistant infection.’”

“This effort is key to fighting superbugs, a health menace in Connecticut and across the country. Incentives for research and development, and fast track FDA review, are needed to stop these antibiotic-resistant bacteria and infections from spreading,” Senator Blumenthal said. “Senate passage of the GAIN Act exemplifies the progress we can make on key issues when working in a bipartisan fashion. I applaud the Senate passage of the GAIN Act, and urge swift action by the House of Representatives so this bill can become law.”

“As a physician Member of Congress, I understand the critical need for innovative new medicines to combat these ‘superbugs,’" said Rep. Gingrey. "In order to prevent a future public health crisis, my House and Senate colleagues have created the bipartisan GAIN Act to ensure patients have access to life-saving treatments and to decrease the risk of a nationwide, drug-resistant epidemic. In addition to protecting public health, this legislation also seeks to stem the tide of drug developers, investors, and clinical trials from moving overseas. I commend my Senate colleagues for their efforts today.”

The GAIN Act provides incentives to increase the commercial value of innovative antibiotic drugs and streamlines the regulatory process so that pioneering infectious disease products can reach patients. Antibiotic-resistant infections are on the rise, causing nearly 90,000 deaths each year, disproportionately affecting children and the elderly and leading to $26 billion in extra costs annually to the U.S. health care system.

Antibiotic resistant “superbugs” have been increasing over the last decade, with the rate of antibiotic-resistant Staph infections approaching 50 percent. Currently, antibiotic-resistant MRSA infections are responsible for over 17,000 deaths in the U.S. each year, and between 1999 and 2005, MRSA infection-related hospitalizations double from around 127,000 to 278,000. The Centers for Disease Control and Prevention found that late-onset MRSA infections increased 300 percent in neonatal intensive care units ICUs from 1995-2004, increasing average stay by 40 days at an increased cost of $160,000 per patient.

Drug-resistant infections have increasingly affected troops returning from Iraq and Afghanistan, as many of them have been exposed to a new, highly-resistant and contagious strain of Acinetobacter (Iraqibacter) bacteria. Approximately 3,300 service members were treated for drug-resistant Acinetobacter between 2004 and 2009. Among these cases, 89 percent are resistant to at least three classes of antibiotics and 15 percent are resistant to all forms of treatment.

The GAIN Act has been endorsed by 53 groups, including the National Military Vets Alliance, American Medical Association, St. Jude Children’s Research Hospital and Children’s National Medical Center.

Cosponsors of the GAIN Act in the Senate, in addition to Senators Blumenthal and Corker, include Senators Alexander (R-TN), Ayotte (R-NH), Begich (D-AK), Bennet (D-CO), Carper (D-DE), Casey (D-PA), Chambliss (R-GA), Coons (D-DE), Hatch (R-UT), Isakson (R-GA), Kerry (D-MA), Roberts (R-KS) and Tester (D-MT).

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Whooping Cough Spreads in Johnson County (KS)

When Susan Sukstorf read an urgent note reporting a case of whooping cough at her son’s middle school, she tossed it aside with little worry.

"Oh, some kid didn’t get their vaccination. That really stinks for them," she remembers thinking.

Days later the Olathe mom was calling the car pool parents, her 14-year-old son’s best friends and the staff at Frontier Trail Middle School to warn them. A laboratory test — completed only because she casually told her son’s doctor that he had bunked with the ill student at a school trip — confirmed he had whooping cough.

For more, click the link below:


http://joco913.com/news/whooping-cough-spreads-in-johnson-county/

Mayo Clinic Radiology Tech Pleads Guilty to Spreading Hepatitis C 

U.S. Attorney’s OfficeMay 11, 2012

Middle District of Florida(904) 301-6300

JACKSONVILLE, FL—United States Attorney Robert E. O’Neill announces today that Steven Beumel (48, Jacksonville) pleaded guilty to one count of tampering with a consumer product resulting in death, four counts of tampering with a consumer product resulting in serious bodily injury, and five counts of stealing Fentanyl by deception. Beumel faces a maximum penalty of life in federal prison. He was arrested by FBI agents on May 24, 2011 and has remained in custody since his arrest. A sentencing date has not been yet scheduled.

According to court documents, Beumel was a radiology technician at Memorial Hospital from May 1992 through October 2004. He worked as a radiology technician at the Mayo Clinic in Jacksonville from October 2004 through August 2010. Beumel admitted, in court, that he stole syringes of Fentanyl during patients’ procedures and replaced them with syringes of saline contaminated with hepatitis C. Beumel’s tampering occurred from 2006 through 2008 at the Mayo Clinic’s intervetonal radiology unit.

Epidemiologists from the Mayo Clinic, Florida Department of Health, and the Centers for Disease Control (CDC) worked for more than three years to solve the hepatitis C outbreak at the Mayo Clinic. It was eventually linked to Beumel. The Mayo Clinic immediately fired Buemel and reported his actions to law enforcement. The clinic tested thousands of patients who were potentially put at risk by Beumel’s actions. Two patients from that testing effort were linked to Beumel.

The first patient discovered to have hepatitis C linked to Beumel was a liver transplant patient who received a new liver in September 2006. During a radiology procedure in November 2006, Beumel took this patient’s Fentanyl and infected him with hepatitis C. The patient battled hepatitis C for almost four years. He died from complications related to hepatitis C, never knowing how he got it.

This case was investigated by the Federal Bureau of Investigation, the Food and Drug Administration, the Florida Department of Financial Services, and the Jacksonville Sheriff’s Office’s Homicide Unit. It is being prosecuted by Assistant United States Attorney Frank Talbot.