June 4, 2010

EPA Issues New SO2 Standards

This week, the Environmental Protection Agency (EPA) released new standards for sulfur dioxide (SO2), replacing the existing 24-hour and annual standard with a new one-hour exposure standard of 75 ppb. Additionally EPA is revising their monitoring network to ensure broader monitoring of SO2 levels throughout the U.S.

Sulfur dioxide is an important pollutant in the U.S. that warrants increased attention by EPA. The current standard, first established in 1971, fails to protect the public from the adverse health effects of SO2 exposure and a stricter standard is needed.

The scientific understanding of the health effects of SO2 is more comprehensive than when the standard was first established. Clinical and epidemiological studies demonstrate adverse health effects from exposure to SO2 concentrations even well below the previous EPA standard of 140 ppb. EPA has concluded, and the ATS concurs, that there is a causal link between SO2 exposure and reduced lung function. Clinical studies have shown increased respiratory symptoms in healthy individuals from 15-minute exposure to SO2 concentrations at 200 ppb. Patients with asthma experienced symptoms from exposure to 100 ppb during exercise.

The ATS strongly supports EPA's action today. While the ATS supported a stricter one-hour standard of 50 ppb, we note EPA's announcement is a significant improvement over the previous standard that will dramatically improve the nation's air quality.

RESEARCH

ATS Urges Support for NIH Funding

This week, the ATS sent a letter to all Senators urging them to join a letter authored by Sen. Casey (D-PA) supporting $35 billion in funding for the NIH in 2011. In the letter, ATS President Dean Schraufnagel, M.D., thanks senators for funding the NIH's American Reinvestment and Recovery Act but reminds them that this funding will end in 2010. "Without a significant funding increase to sustain research begun under the ARRA, the NIH will be forced to reduce the number of research grants funded, which will result in a loss of jobs in many states and the halting of vital research into the diagnosis, treatment and prevention of disease affecting million around the world such as COPD, lung cancer, asthma and tuberculosis," wrote Dr. Schraufnagel. Sens. Stabenow (D-MI), Schumer (D-NY) Feingold (D-WI) and Akaka (D-HI) have joined Sen. Casey's letter.

Friends of NIEHS Letter to Congress

Also this week, the Friends of the National Institute of Environmental Health Sciences (NIEHS), which the ATS chairs, sent a letter to key members of Congress to raise awareness about the Institute's work studying environmental influences on disease development. The letter, signed by twenty-five public health, environmental health, child and women's health and medical associations, highlights some of the groundbreaking research findings from NIEHS, such as discovery of one of the first breast cancer susceptibility genes and the impact of lead on child development, as well as some of the agency's current research priorities, including the consequences of air pollution on respiratory conditions and the many health effects of global climate change.

CLINICAL PRACTICE

FDA Issues Final Labeling for LABAs

This week, the Food and Drug Administration (FDA) finalized labeling changes for long-acting beta agonists for the treatment of asthma. In February, FDA announced its intent to add new warnings to LABA labels regarding its use in the treatment of asthma.

The new recommendations in the updated labels state:

• Use of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
• LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
• LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
• Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
• Pediatric and adolescent patients who require the addition of an LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and an LABA, to ensure adherence with both medications.

For complete information on the FDA announcement, please visit:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213836.htm

FTC to Delay "Red Flags" Rule

This week, the Federal Trade Commission (FTC) announced that it is delaying enforcement of the Red Flags rules through 2010, giving Congress additional opportunity to pass legislation to exempt physician offices and other business with less than 20 employees.

The red flags rule is intended to help major institutions like banks and creditors prevent identity theft of client information. The physician community, lead by the AMA, is fighting to prevent these rules from being applied to physicians. The underlying law requires "creditors" to take steps to protect client's personal information, and because physician's offices often don't require payment at the time of service, the FTC determined that physicians meet the definition of "creditors." The AMA has initiated court action to challenge that interpretation.