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Monday Briefing
February 6, 2012 |
Nearly 4,600 U.S. children hospitalized with broken bones, traumatic brain injury and other harm from physical abuse, report says. The assessment by Yale researchers, who calculated figures for 2006, found that 300 of the abused children died. The study is the first broad U.S. estimate of serious injuries due to child abuse. The researchers said that serious physical abuse is a bigger threat to infant safety than sudden infant death syndrome, and called for a national prevention campaign. Reuters, HealthDay
Fracking fears spur Virginia county to reject gas drilling in the Marcellus Shale. Rockingham County’s refusal to approve a permit sought by Carrizo Oil and Gas reflects growing concerns about water contamination from the controversial drilling technique known as fracking, even among those who support gas exploration. Virginia has 7,700 natural gas wells in operation, but none extracts gas from the Marcellus Shale, where rich gas reserves are entombed. Fracking uses high-pressure blasts of water mixed with sand and chemicals to break up rock and release gas from the shale. The Washington Post
More than 20 percent of nonsmoking teens are exposed to secondhand smoke in cars, federal study finds. The researchers said exposure is declining, but they expressed concern that it still is common. Their survey found that, among nonsmoking students, the percentage exposed to smoke in cars fell from 39 percent in 2000 to 22.8 percent in 2009. The researchers urged more states to ban smoking in cars carrying kids. California and three other states already have such laws. HealthDay, Reuters
Global environmental organization emerges as key issue for June’s Rio Summit. France, which claims the backing of 100 countries, has proposed transforming the United Nations Environment Programme into a new worldwide super-agency. Both the U.S. and Canada, however, oppose the idea and instead have backed strengthening the existing agency. The issue will be a key topic at the global environmental forum scheduled for June 20-22 in Rio de Janeiro. Agence France-Presse, The Guardian
Concerns emerge in Britain about a possible new outbreak of mad cow disease. Government health officials are considering monitoring for the fatal brain disease about 30,000 patients known to have received numerous blood transfusions. The proposed research could shed light on how the disease develops and the extent of the health threat, especially among patients who repeatedly receive transfusions. Since the first cases emerged in the mid-1990s, 175 people in Britain have died from the disease, which is linked to eating infected beef. Daily Mail, Birmingham Mail
Settlement may be reached soon in negotiations over Gulf of Mexico oil spill. BP and negotiators for federal and state governments are frantically working to craft a settlement so they won’t have to leave billions of dollars in potential pollution fines and spill damage payments in the hands of a U.S. district judge. The trial is set to begin on Feb. 27. Experts say the negotiations are intended to reach a global settlement that will resolve U.S. criminal and civil charges and compensate federal and state governments for damages. Negotiators also are trying to resolve private claims. The Times-Picayne (New Orleans)
Moody’s Investors Service says major U.S. railroads can afford safety technology. The Wall Street advisory firm issued a special report stating that the rail industry’s leaders, “with $60 billion in annual revenue and several billion dollars in cash … have the wherewithal” to pay for safety systems known as Positive Train Control, or PTC. Republicans in the House of Representatives introduced a bill last week to delay the federal deadline for PTC from 2015 to 2020. As FairWarning has reported, the rail industry is pushing to scale back and delay the systems, which override human error to prevent train wrecks. The installation and operation of PTC systems for passenger and freight trains is projected to cost $13 billion.
Recalls: Jammy Sammy sandwich bars, Healthy People weight loss supplements
Compiled by Stuart Silverstein
Leave a CommentFriday Briefing
February 3, 2012 |
Pilots raise safety concerns about letting drones fly in U.S. skies. Congress has pushed regulators to clear the way for the small unmanned aircraft to be used domestically by law enforcement agencies and businesses. Flights are expected to be restricted to remote areas and to no more than a few hundred feet off the ground. ...

Avastin Shouldn’t Make the FDA Give Up on ‘Accelerated Approval’ of Drugs
By Henry I. Miller and Jeff Stier on August 18, 2010
An important but obscure aspect of the Food and Drug Administration’s regulation of drugs has been in the news in recent months. Called “accelerated approval,” this “quick-on, quick-off” mechanism for medicines to reach the marketplace can work to the advantage of drug companies and needy patients alike.
Introduced almost two decades ago, accelerated approval permits the FDA to issue what amounts to a limited, or conditional, approval of a new drug that is intended for a “serious or life-threatening disease” and for which there is an “unmet medical need.”
Such an approval has two defining characteristics. First, it can be based on clinical trials that do not yet show an improvement on a definitive health endpoint such as increased longevity, reduction in the incidence of heart attacks or cancer cure, but merely on a “surrogate endpoint” that is thought to correlate with clinical benefit. Examples of surrogate endpoints are the shrinking of a tumor or improvement in a laboratory value such as “good” cholesterol.
Second, the drug sponsor (company) must perform confirmatory trials to prove that the medicine is effective in meeting a definitive endpoint, at which time the approval is converted to a standard, unconditional approval. If the studies fail to provide such confirmation, the FDA can pull the drug from the market.
You can read the rest of the article here.
Posted in Commentary