By Scott L. Friedman
Last week, an Advisory Committee to the Food and Drug Administration (FDA) recommended sweeping and historic restrictions on the use of products containing acetaminophen, which, if implemented by the FDA, will save the lives of many Americans. These restrictions will surely translate into a significantly reduced incidence of acute liver injury in hospitals throughout the United States, meaning that many of these individuals will never become patients of hepatologists, transplant surgeons and other health care professionals who care for these catastrophic cases.
This stunning success reflects the sustained leadership and passion of one of AASLD’s most respected members and former Secretary-Treasurer, Dr. Will Lee of UT Southwestern, who was the driving force behind the Acute Liver Failure Study Group (ALFSG) sponsored by NIDDK, which provided 12 years of iron-clad data linking acetaminophen-containing products to an unacceptable rate of acute liver injury in our country. AASLD members should also take special pride in this achievement because of the Association’s enduring commitment to the issue throughout its 60 years, but especially since 2001, when we first partnered with the FDA and the pharmaceutical industry to host a workshop on drug-induced hepatotoxicity. From 2002 to 2006, a steering committee met annually to discuss evolving information about drug toxicity, and we formally established a Hepatoxicity Special Interest Group in 2007 in response to growing interest in this critical area. Over 120 articles have been published in HEPATOLOGY focusing on clinical and experimental aspects of acetaminophen, including major studies by the ALFSG, opinion pieces, peer reviewed manuscripts and meeting summaries. The AASLD has also been a nexus for sharing information and updating investigators and practitioners about drug-induced liver injury through several activities at our Annual Meeting, including Early Morning Workshops, the Hyman J. Zimmerman Lecture and other State-of-the-Art Lectures, and peer-reviewed oral presentations and posters.
At the FDA Advisory Committee meeting this week, the AASLD was officially represented by Dr. Timothy Davern of California Pacific Medical Center (formerly of UCSF), whose comments were quoted four times during the committee’s discussions in supporting their recommendations. Particularly compelling was his admonition that the FDA had earlier this year withdrawn the over-the-counter weight loss supplement Hydroxycut® (which contains no acetaminophen) after only 23 reports of adverse liver events (http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm155817.htm), whereas acetaminophen-related liver deaths had continued to exact an unacceptable toll with no FDA restrictions. Also in attendance throughout the entire meeting was AASLD’s government liaison, Lyle Dennis of Cavarocchi, Ruscio, and Dennis Associates, who worked tirelessly behind the scenes to ensure our participation and visibility.
The FDA Advisory Committee, which was composed of 37 outside experts, urged the agency to eliminate all prescription painkillers containing acetaminophen, including Vicodin® and Percocet®. The committee also recommended reducing the strength of over-the-counter analgesics containing acetaminophen, and requiring prescriptions for 500 mg acetaminophen doses (see highlights of the committee’s recommendations in this issue of AASLD eNews; see the complete FDA 
summary.
This success story illustrates the importance of AASLD’s long-term commitment to issues that are vital to our patients and members through enhanced advocacy, effective partnering with government agencies and industry, and outstanding educational programs. Despite this great achievement in reducing liver injury from acetaminophen, the larger issue of drug-induced hepatotoxicity remains one of the most morbid, costly and poorly understood challenges in medicine and drug development. The NIDDK is currently conducting an in-depth analysis of this issue through its multicenter Drug- Induced Liver Injury Network (DILIN) study. AASLD will also continue to play a leading role in attacking this problem.
On behalf of AASLD, I congratulate and thank Dr. Lee, the Acute Liver Failure Study Group and its many participants, and the NIDDK for their tenacity and focus, which will save the lives of many patients we’ll never treat.