No one can dispute that multidrug-resistant “superbugs” are a key public health concern for the 21st century. Better, safe and effective cures are needed. But the 21st Century Cures Act, legislation that will be voted on this week in the House, is not the solution to this problem.
Over 2 million people are infected with antibiotic-resistant bacteria each year, resulting in at least 23,000 deaths. New antibiotics have been slow in coming: No antibiotic with a truly novel mechanism of action has been discovered since the late 1980s. Yet this drought is not the fault of the Food and Drug Administration (FDA), which has long been under tremendous pressure to approve new antibiotics quickly. This pressure was increased even further by a 2012 law that accelerated review for qualifying antibiotics.
Thanks to the current review process for antibiotics, clinical development for these drugs is already quick by industry standards. A new antibiotic takes only seven years to get to market, compared with nine years for cancer drugs.
Quick approval is not without costs. Many of the antibiotics approved over the past decade have suffered from safety and effectiveness problems. For example, tigecycline (Tygacil), an antibiotic that received special accelerated FDA approval in 2005, was slapped with a black-box warning in 2013 stating that the drug increases the risk of death.
By Andrew Gibson
This Saturday, our nation celebrates the 239th anniversary of the signing of the Declaration of Independence. This day should be used to reflect on the ideals and principles upon which this country was founded so as to remind us of the work still to be done in order to achieve goals enshrined in that all-important document.
The Declaration of Independence affirms America’s self-governance. It states that “governments […] derive[e] their just powers from the consent of the governed,” and that all are treated equal under the law. As Public Citizen strives to ensure that all citizens are represented in the halls of power, our members and supporters should keep the founders’ philosophy in mind as we celebrate America’s birthday with our family and friends.
They represent the interests of the tobacco industry,” said Dr. Vera Luiza da Costa e Silva, the head of the Secretariat that oversees the W.H.O treaty, called the Framework Convention on Tobacco Control. “They are putting their feet everywhere where there are stronger regulations coming up.
The big footprint mentioned by Dr. Luiza da Costa e Silva, in today’s New York Times piece, “U.S. Chamber works Globally to Fight Anti-Smoking Measures” is that of the U.S. Chamber of Commerce and their affiliated American Chambers abroad.
The Chamber is a U.S. trade association with an annual revenue of $165 million. It spends more on lobbying than any other interest group in the country and has more than 100 affiliates around the globe. The U.S. Chamber’s positions on public policies around the world, including public health policies, are often perceived as carrying the weight of the U.S. business community. As such, disregarding their positions can carry an implied economic threat.
The influence peddling of the Chamber is evident in many international fights, so it’s unsurprising that pushing back on tobacco control is a top priority for the corporate group. A top executive at the tobacco giant Altria Group serves on the chamber’s board, though the cigarette makers’ payments to the chamber are not disclosed.
Protections against exposure to beryllium allotted to workers are far too weak, especially in the construction industry, where an estimated 23,000 construction workers come in contact with beryllium every day while performing open-air blasting.
Beryllium levels can be extremely elevated due to high dust concentrations on construction sites and can result in chronic beryllium disorder. Patients gradually develop cough, chest pain, progressive shortness of breath, weakness and fatigue. Loss of appetite, weight loss, lung and right-sided heart failure may occur in people with advanced disease.
On September 4, 2014, the Obama Administration’s Office of Management and Budget (OMB) received the U.S. Department of Labor’s (DOL) proposed rule to allow the U.S. Occupational Safety and Health Administration (OSHA) to update the Beryllium standard. As detailed in Executive Order 12866, OMB’s Office of Information and Regulatory Affairs is required to complete its review of such rules within 90 days of receipt, with an additional 30-day review extension allowed if needed.
But eight months have passed, and there is no sign that OMB is close to completing its review.