If there's any positive news to be known about the fungal meningitis outbreak, linked to tainted injectable medications manufactured by the New England Compounding Center, NECC, is that at long last the reports of new infections and deaths having occurred are coming in more slowly. A consumer watchdog group, Public Citizen, has written a letter to the U.S. Food and Drug Administration asking it to revisit 16 compounding pharmacies to which the agency had issued warnings from 2003 through 2012, in an effort to prevent any such health tragedies in the future.
Recent Case Counts, Deaths in Outbreak Reported by CDC
The U.S. Centers for Disease Control and Prevention is now updating the meningitis outbreak information weekly, rather than daily initially, then later three times a week. The most recent data , updated Nov. 26, reveals a total of 510 infections, 360 of which were meningitis cases, 128 spinal injection site infections only and 14 peripheral joint infection only. Some of the people who have been diagnosed with the fungal meningitis have also experienced spinal injection site infections, but that number is not disclosed. Thirty-six people have died during this outbreak.
Consumer Watchdog Group, Public Citizen, Aims to Prevent Further Tragedies
Public Citizen, a consumer watchdog organization that was formed in 1971, explains that the overriding mission is to ensure all citizens', not just corporations' lobbyists', will be heard in Washington. The group is both nonprofit and nonpartisan and divided into five separate policy groups, including the Health Research Group.
It is the Health Research Group of Public Citizen that has been working to hold the FDA to task not just for the meningitis outbreak, but other concerns such as money to the tune of $20 billion paid out by the pharmaceutical companies to settle allegations of violations.
Today, Public Citizen sent a letter to the FDA regarding needed follow-up to 16 compounding pharmacies that, since 2003, have received a total of 18 warnings from the agency. Five of the 18 warnings from the FDA were in regards to alleged patient injury or death associated with the compounding pharmacies involved; the remaining 13 warnings regarded FDA inspections that revealed conditions at the pharmacies that posed risks to patient safety.
Public Citizen has asked the federal agency to either schedule prompt re-inspections of these facilities or verify that re-inspection has already occurred to ensure the violations no longer exist.
Amid FDA's Requests for More Authority, Group Says FDA Just Needs to Use What it Has
Dr. Margaret Hamburg, commissioner of the FDA, has made requests in both legislative bodies of Congress for further authority be given the federal agency over compounding pharmacies, citing jurisdictional issues with state and local agencies as a major factor in issues such as that found at NECC continuing unabated.
Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, asserted that the FDA doesn't need any additional authority or regulations to be put in place; the agency simply needs to enforce the regulations already in place concerning compounding pharmacies.
Bottom Line
There is no doubt that the meningitis outbreak of 2012 could have been averted at many levels, beginning with the NECC and going all the way to the FDA. Lawsuits have been filed and there will likely be more on the way, but money isn't balm to the individuals and families whose lives have been impacted by this travesty of the American health care system.
Source: http://news.yahoo.com/cases-death-rate-slows-fungal-meningitis-outbreak-224600602.html
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