May 6, 2011
By Webb Millsaps and Leah Voigt*
Researchers Receive $23.4 Million to Research AIDS Vaccine
Scientists at the University of Maryland School of Medicine will be able to move forward nearly decades-long work on a promising HIV/AIDS vaccine after receiving their biggest research gift ever—$23.4 million from a consortium led by The Bill & Melinda Gates Foundation. The money was awarded to the university's Institute of Human Virology (IHV), headed by Dr. Robert Gallo, who helped discover the human immunodeficiency virus that causes AIDS and developed the HIV blood test. The funding was announced Thursday at the institute. Scientists at IHV began research on the AIDS vaccine in 2002 and have seen major breakthroughs on tests using monkeys.
The vaccine being researched would neutralize many different strains of HIV. The researchers say previous vaccine candidates responded only to single strains or narrow ranges of the disease. Scientists have long been frustrated by the AIDS virus' ability to mutate. The virus constantly changes the makeup of the proteins on its surface, making it hard for antibodies to attack the disease. Vaccines developed to battle the disease have proved too weak to meet the task.
The IHV vaccine contains a protein that is normally hidden within the AIDS virus but exposes itself when the virus attaches to a cell before attacking it. The protein doesn't change, unlike the proteins on the outer coat of the virus. The antibodies in the trial vaccine bind to regions common in HIV rather than to the ever-changing protein that may differ in each virus strain.
The Bill & Melinda Gates Foundation has donated $16.8 million to the research, while the Army's Military HIV Research Program has given
$2.2 million. The National Institutes of Health and others also have contributed funds. The foundation also awarded the IHV $15 million in 2007 to go toward developing the HIV/AIDS vaccine.
Gallo and scientists at the IHV will conduct the research along with researchers from the Military HIV Program and Sanofi Pasteur, a drug company that specializes in distributing and developing vaccines.
Andrea K. Walker, UM Researchers Receive $23.4 Million to Research AIDS Vaccine, The Baltimore Sun (May 5, 2011).
Federal Report: More Hospitalizations Caused by Prescription Side Effects
A White House plan would mandate physician training on prescribing opioids, as a federal report shows painkillers are among the top medications sending patients to hospitals. The number of hospitalizations due to medication side effects jumped by more than half between 2004 and 2008, says a federal report that heightened concerns about polypharmacy among an aging U.S. population.
Antibiotics, anti-cancer drugs, benzodiazepines, corticosteroids, insulin, and blood thinners and other cardiovascular drugs were among the leading causes of more than 2.7 million hospital stays and treat-and-release visits to emergency departments in 2008, said the Agency for Healthcare Research and Quality report, released in April.
Kevin B. O'Reilly, Rx Side Effects Causing More Hospitalizations, Am. Med. News (May 2, 2011).
New FDA Guidance on Over-the-Counter Liquid Medication Packaging
The U.S. Food and Drug Administration's (FDA's) new guidance for companies that make over-the-counter (OTC) liquid medications—such as cough syrups and cold remedies—calls for packaging with calibrated dosing devices to prevent accidental overdose.
"Accidental medication overdose in young children is an increasingly common but preventable public health problem," according to a press release from Karen Weiss, MD, of FDA's Center for Drug Evaluation and Research's Safe Use Initiative. One study found that cups included with liquid medications were particularly prone to errors, with some 70% of parents putting more than six mL of liquid into a cup intended for dispensing five mL.
Most liquid medicines already come with a dosing device, such as a cup or a dropper, but FDA would like every liquid drug sold over the counter to have a measuring device, according to a final guidance issued by the agency. Those dosing devices should be clearly marked with liquid units of measurement, such as teaspoon or tablespoon, and the unit of measurement on the cup or spoon should be the same unit of measurement listed on the directions for use.
The dosing device should also not carry any unnecessary markings that might be confusing to the person measuring out the dose, and the markings should stand out enough so they aren't obscured once the liquid product is added. Several recent studies have indicated that children often receive improper doses of liquid OTC medicines because parents give them in household spoons, or because the included dosing devices are poorly marked.
Emily P. Walker, FDA Lays Out Rules for OTC Liquid Meds, MedPage Today (May 5, 2011).
AMA Lobbies Congress on Medicare "Doc Fix"
The annual scramble to prevent next year's scheduled pay cut for doctors who treat Medicare patients kicked off this week with physician leaders calling for a five-year program of guaranteed annual raises and a high-ranking House Republican calling instead for a short-term fix.
The issue—known inside the Beltway as "the doc fix"—is the residue of a law enacted by Congress in the late 1990s that sought to limit the growth of Medicare spending on seniors' healthcare. The law limited physician pay increases to same growth levels as the overall economy, which became known as the sustainable growth rate (SGR). Because healthcare spending over the last decade grew twice as fast as gross domestic product, implementing the SGR would dramatically shrink physician pay as a share of overall Medicare spending. It never happened. Every year members of the American Medical Association (AMA) and specialty societies bombard Capitol Hill with demands to restore the old system. And every year, Congress voids the SGR-mandated cuts.
But that means that every year the size of the scheduled pay cut under the original law grows larger. Unless Congress acts before January 1, physician pay next year will be reduced by 29.4%. The estimated ten-year cost for the doc fix, according to the Congressional Budget Office, is approaching $300 billion. Representative David Camp (R-MI) chair of the House Ways and Means Committee, said on Thursday that finding $300 billion for a ten-year fix "was untenable in the current situation," when Congress and the White House are struggling to find ways to reduce the $1.5 trillion budget deficit. Rather, he said, the Republican-led House will consider a "several-year fix . . . to get out from under this, and then look to the long-term fix." However, even a short-term fix would cost tens of billions of dollars next year, which could wipe out a significant portion of the budget reductions that Republicans are seeking as part of the debt-ceiling negotiations that kicked off yesterday.
Merrill Goozner, Medicare 'Doc Fix' Put on Life Support by AMA Lobby, Kaiser Health News (May 6, 2011).
Theft of Endoscopic and Urology Devices Prompts Infection Warning
Boston Scientific is alerting customers to the theft of a number of women's endoscopy and urology products prior to sterilization, warning that the products may pose an infection risk to patients. The nonsterile products are limited to fifteen individual lots of the endoscopic and urologic devices, which are itemized in a release online. Labels on the stolen devices falsely indicate that the products are sterile, the company said. Low prices, as well as the listed UPN, batch, and lot numbers may be indicative of stolen products. Healthcare professionals should check inventory or incoming product for affected lot numbers and not use any devices affected by the theft.
The devices were stolen sometime around April 8-11 and those that received any of the stolen products are asked to contact Boston Scientific.
Cole Petrochko, Theft of Devices Prompts Infection Warning, MedPage Today (May 5, 2011).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers weekly and appropriate AHLA Practice Groups.
*We would like to thank Adam Mingal, JD (Washington, DC), and Leah Voigt, Esquire (Spectrum Health, Grand Rapids, MI), for providing this week's update.