Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, March 23, 2012

POGO-Freedom of Information and the Public's Right to Know is personal!

Mar 21, 2012
Senate Judiciary Committee Talks FOIA and the Public's Right to Know

Held during Sunshine Week, last Tuesday's Senate Judiciary Committee hearing, "The Freedom of Information Act: Safeguarding Critical Infrastructure Information and the Public’s Right to Know," was timely indeed. A wide range of issues were discussed, from the multi-agency FOIA portal scheduled to launch October 1 to the cybersecurity legislation pending in both the Senate and the House. The broad scope of topics covered perhaps illustrated the need for more hearings about FOIA and open government issues.
Chairman Patrick Leahy (D-VT), a longtime champion of FOIA and open government, said that “excessive government secrecy can come at an unacceptable price.” Last year, POGO and partners urged Congress to fix the over-broad and ill-defined provision relating to critical infrastructure information (CII) that the Department of Defense (DoD) was seeking in the National Defense Authorization Act (NDAA) for 2012. Sen. Leahy and Rep. Carolyn Maloney (D-NY) were successful in narrowing the blanket exemption to FOIA for CII. Their amendment requires DoD not to use FOIA’s CII exemption in cases where the public interest outweighs national security concerns. Jerry Ensminger’s testimony about the latest developments in the cover-up at Camp Lejeune demonstrated that more work needs to be done to ensure implementation of the law.
Witnesses on the first panel included Miriam Nisbet, director of the Office of Government Information Services (OGIS) and Melanie Pustay, Director of Information Policy (OIP) at the Department of Justice (DOJ). In addition to managing DOJ’s FOIA administration, OIP is responsible for encouraging and overseeing agency compliance with FOIA and for ensuring that the President’s FOIA Memorandum is fully implemented across the government. 
Sen. Grassley (R-IA) said that the President’s promise to build the most transparent administration in history has not translated into meaningful open government reform. Sen. Grassley pointed to the DOJ winning the Rosemary Award for worst open government performance in 2011.
Sens. Grassley and Leahy were clearly exasperated that Congress hadn’t received OGIS’s recommendations for improving agency compliance with FOIA. Nisbet said OGIS submitted recommendations to the Office of Management and Budget (OMB) for review over a year ago. "We haven’t received them yet,” said Leahy. “The law requires us to receive them. When will we receive them?"  He then offered to drive over to OMB to pick the recommendations up himself. When pressed, Nisbet promised to get “something” to Congress within a month.
Appearing in the second panel were Ken Bunting of the National Freedom of Information Coalition (also the executive director of the Missouri School of Journalism), Jerry Ensminger, a retired Marine Sergeant who is working tirelessly to uncover the truth surrounding the Camp Lejeune water contamination scandal, and Paul Rosenzweig, a visiting fellow to the Heritage Foundation and cybersecurity consultant.
Committee members asked DOJ’s Pustay to comment on DOJ winning the infamous Rosemary Award. Pustay said, “I feel like we have a really strong record, and I stand by it.” They also raised the allegation that she proposed a dozen regressive FOIA regulations. One of those was a rule revision proposed last March that would authorize government agencies to lie to FOIA requestors by denying the existence of certain sensitive records—something POGO strongly opposed.
Pustay went on to argue that a 2011 Supreme Court ruling had left federal agencies vulnerable and unable to protect against public disclosure on cybersecurity matters. In Milner v. Department of Navy, the Court threw out the broad use of FOIA Exemption Two, which many agencies used to deny FOIA requests and withhold information. Pustay said DOJ wants to replace the exemption that the Court threw out. She told the Committee that the Milner decision endangered “a wide range of sensitive material whose disclosure could cause harm.” However three other remaining FOIA exemptions can safeguard this information. If the Court’s decision represents such a threat to public safety, Sen. Grassley asked, why hasn’t DOJ submitted a legislative proposal to protect this information?
Ken Bunting warned the Committee that a vague, overly broad provision in the pending cybersecurity bill could serve as the basis for withholding important information from the public (POGO also has big concerns about this provision). “When cybersecurity and critical infrastructure legislation addresses public disclosure, we believe it should contain at a minimum: a tight definition of the information to be exempted; a sunset for the law itself; a sunset for the protection attached to the information; and a public-interest balancing test that allows legitimately protected information to remain protected, but information being withheld primarily to protect the government from embarrassment to be disclosed,” Bunting said.
Public interest star witness Jerry Ensminger testified on why access to information through FOIA matters and how the critical infrastructure classification can be used to keep Americans in the dark. He shared the moving and disturbing story of his personal battle to uncover the truth at Camp Lejeune. The Navy and Marine Corps have apparently strong-armed the Agency for Toxic Substances and Disease Registry (ATSDR) into redacting key portions of a report on the Camp Lejeune water system—redactions that the report’s author say compromised the report’s scientific integrity.
In his testimony, Ensminger noted that most of the documents and information that the Department of the Navy and the Marines Corps are labeling CII have been in the public domain for more than a decade, some for nearly 50 years. The Navy has failed to even mention the new public interest balancing test in its efforts to withhold scientific information on the Camp Lejeune water wells.
Paul Rosenzweig emphasized that the cyber threat is real and said complete transparency might make us less secure, claiming that FOIA exemptions on the basis of critical infrastructure are necessary. While POGO recognizes the need to shield some information from full dissemination to the public for national security purposes, we urge Congress to proceed with caution before enacting unnecessarily far-reaching exemptions. As Sen. Sheldon Whitehouse (D-RI) alluded to in one of his final questions for Rosenzweig, the potential for those with something to hide to abuse of the law is simply too great.
Suzanne Dershowitz is POGO’s public policy fellow.
Thank you, POGO! 
March 4, 2009 FOI/CDRH responded "after searching our files, we did not find the requested records" for my brother, Steven Baker's, patient-submitted 11/18/2008 FDA/MedWatch Adverse Event report MW5009052. Joint replacements are the #1 expenditure of Medicare. These devices are approved by the FDA with no clinical testing based upon predicates that may or may not be safe. There is no national registry. There is no way for a patient to make an informed decision just as consumers are able to compare appliances or automobiles. Yet, if a device fails, they are in medical and legal purgatory plus in pain and disfigured. Federal public policy must place patient safety first. Transparency will prevent others from peril and will save taxpayers billions of dollars annually.

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