The Project On Government Oversight (POGO) Blog

Safety Board Calls Nuclear Lab's Earthquake Resistance Analysis 'Technically Inadequate'

By MIA STEINLE

An ongoing government analysis of an important nuclear weapons laboratory’s ability to withstand earthquakes may be flawed, according to a federal oversight panel.

The analysis of how the plutonium facility at Los Alamos National Laboratory would hold up in a strong earthquake “is technically inadequate” in several ways, the oversight panel wrote in a July 18 letter to the Department of Energy.

“Timely action must be taken to fully understand if additional building modifications are required,” the oversight board said.

The Defense Nuclear Facilities Safety Board said in the letter that it “remains concerned by the seismic integrity of the Plutonium Facility,” adding that the ongoing analysis has “profound implications for ensuring public health and safety.”

The analysis in dispute is being performed by the Department of Energy’s semiautonomous National Nuclear Security Administration (NNSA) and by the contractors that operate the New Mexico laboratory.

Asked for comment, NNSA spokesman Joshua McConaha said his agency is working on a response to the oversight panel.

"Regardless of any future improvements, the risk to the public from operations at [the Los Alamos plutonium facility] remains very small," he said, adding that "the facility is operating well within the safety objectives established by [Department of Energy] safety policy, and public safety is adequately protected."

The oversight panel’s criticism comes one month after the panel issued a report that found that Los Alamos National Laboratory had underestimated the amount of radiation that could leak from the plutonium facility as a result of an earthquake. As the Project On Government Oversight reported, the panel concluded that the radiation could be more than four times as intense as the laboratory had estimated.

Nuclear Weapons Lab Underestimates Risk of Radiation Leak, Study Finds

By MIA STEINLE

One of the nation’s main nuclear weapons labs has sharply underestimated the amount of radiation that could leak from the facility as a result of an earthquake, according to a federal advisory panel.

The radiation could be more than four times as intense as the Los Alamos National Laboratory predicted in a safety analysis last year, according to a recent report by the Defense Nuclear Facilities Safety Board.

The New Mexico laboratory’s analysis included “multiple, substantial deficiencies,” wrote Peter S. Winokur, chairman of the advisory board. The higher estimate calls for “additional safety controls” and “prompt action,” he added.

The report’s findings raise questions about the safety and reliability of Los Alamos, which says its work includes ensuring the safety and reliability of the U.S. nuclear weapons stockpile.

GlaxoSmithKline Fined in Biggest Healthcare Fraud Case in U.S. History

Pharma heavyweight GlaxoSmithKline is paying a $3 billion fine in the largest healthcare fraud case in U.S. history. The company was accused of promoting various drugs for uses other than what they had been approved for and of having failed to give the Food and Drug Administration safety information on the diabetes drug Avandia.

While $3 billion is a mind-boggling sum for the average person to comprehend, is it just the cost of doing business for the giant pharmaceutical company? Should we believe the company's claims that it has cleaned up its act?

Go to the jump to see some of the reaction on Twitter and then leave us a comment on what you think.

Bill Moving Through the House Today Sanctions Greater FDA Secrecy

By SUZANNE DERSHOWITZ

Yesterday, POGO and a range of other good government organizations sent a letter to House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI) and Ranking Member Rep. Henry Waxman (D-CA) opposing a harmful provision of the Food and Drug Administration Reform Act of 2012 (H.R. 5651).

As stated in the letter, Section 812 of the bill would allow the FDA to deny public access to “any information relating to drugs obtained from a Federal, State, or local government agency, or from a foreign government agency, if the agency has requested that the information be kept confidential.” This could have real negative consequences by unnecessarily increasing secrecy at the FDA and restricting the public’s right to know about critical health and safety risks.

The House is scheduled to vote on this legislation today, and POGO is urging Members to remove (or substantially narrow) Section 812 before it’s too late. In the Senate version of the bill (S. 3187), Senator Patrick Leahy (D-VT) offered an amendment aimed at addressing these problems. The Senate unanimously adopted his amendment, which limits the scope to cover information voluntarily provided by foreign governments, requires that requests to keep information confidential be in writing, and specifies a time frame after which the information will no longer be considered confidential.

As we wrote in the letter, we understand that the intent of the provision is to promote information-sharing between foreign governments and the FDA. The language in H.R. 5651, however, is misguided. The Freedom of Information Act (FOIA) already provides exemptions to safeguard against the release of these kinds of protected records. Section 812 goes beyond its intent—it is written so broadly that it could prevent the release of information that the FDA is currently required to disclose.

What’s at stake here is the public’s access to information about how the FDA conducts the people’s business. In a bid for government openness and accountability, concerned organizations and individuals are urging Congress to strike down this provision.

Suzanne Dershowitz is POGO's public policy fellow.

Follow @SuzieDershowitz

Photo via GenBug.

NRC Commish's Stunning Lack of Candor Should Make President Rethink Renomination

MIA STEINLE

As the end of Kristine Svinicki's term on the Nuclear Regulatory Commission (NRC) approaches, the White House has announced that President Obama will nominate the Republican for another term. However, Senate Majority Leader Harry Reid (D-NV) is speaking out against the nomination, saying that Svinicki lied to Congress about her involvement in a controversial Department of Energy (DOE) project during her tenure there.

As Huffington Post recently reported, Reid’s spokesman said that the Senator opposes Svinicki “because she lied to Congress about her past work on Yucca Mountain,” a DOE nuclear waste repository project that was ultimately cancelled by Congress in 2011 after many years of opposition from Reid, among others.

It’s obvious that Svinicki was neither clear nor forthcoming about her involvement on the project during her 2008 confirmation hearing for the NRC. Senator Barbara Boxer (D-CA), chairman of the Senate Environment and Public Works Committee, said in the hearing that she had concerns about Yucca Mountain due to public health risks, and she later asked Svinicki if she had worked on “transportation and waste disposal issues related to Yucca Mountain” during her time at the DOE’s Civilian Radioactive Waste Management Office. As Huffington Post noted, “Svinicki gave a drawn-out answer”:

FOIA Friday: 21 Previously Unreleased FDA Inspection Reports

FOIA FRIDAY

This week's document: Internal emails from the Department of Energy's Energy Information Administration responding to a New York Times article on fraking.  Document dates: June and July, 2011 Every Friday, POGO will strive to make one document available that we or others have obtained through the Freedom of Information Act (FOIA), especially documents that have not previously been posted online. Some of these documents will be more important than others, some may only be of historical interest— although relevance is in the eye of the beholder. POGO is doing this to highlight the importance of open government and FOIA throughout the year.

By DANA LIEBELSON and BRYAN RAHIJA

As part of our Sunshine Week coverage last month, POGO released a Food and Drug Administration (FDA) inspection report outlining problems the agency discovered at Invacare, a company that makes medical beds. But that inspection report was just one of a handful that POGO obtained through a Freedom of Information Act (FOIA) request. Today, we’re releasing those other reports. 

These inspection reports give the public insight into the companies and products the agency inspected. While the FDA has created a database that gives the public access to cursory information on these reports, the FDA should consider proactively making the reports themselves publicly available.

Here are snippets from five reports that caught our eye, plus a list of the other inspection reports we obtained. 

Inspection of Marina Medical Instruments (maker of forceps and retractors)

Date of inspection: 12/3/2008-12/5/2008

Notable FDA Observation: “Adequate quality requirements that must be met by suppliers and contractors were not established, defined, documented, and implemented.”

Excerpt: “In a follow-up to complaint in March 2007 regarding rupture of cuff of Uterine Manipulator inside a patient’s uterus, there was no investigation documented by Marina Medical.”

Inspection of American Catheter Corp (maker of catheters)

Date of inspection: 6/10/2009-6/17/2009

Notable FDA Observation: “[Company] did not implement the procedure covering the sterilization process for the 9100 Series and 9100L Series Cholangiogram Catheters.”

Excerpt: “I randomly selected 20 continuous temperature records and found 9 of 20 continuous temperature records covering the [Redacted] portion of the sterilization process had deficiencies.”

Inspection of Munroe Regional Medical Centre (maker of EsophyX device) 

Date of inspection: 9/14/2009-9/21/2009

Notable FDA Observation: “Written Medical Device Reporting (MDR) procedure did not include an internal system which provides for the timely and effective identification and evaluation of events.”

Excerpt: “A patient [suffered] a torn esophagus during a procedure utilizing the EsophyX device…your Director of Materials Management determined the event was not reportable injury…although CT scans performed at your facility showed fluid leaking into the chest cavity.”

Inspection of Suncoast Laboratories (maker of hearing aids)

Date of inspection: 11/17/2008-12/1/2008

Notable FDA Observation: “Lacked management control procedures [with hearing aid devices].”

Excerpt: “I asked Mr. Haddad to show me the firm’s training records. He promised to provide the records next day. Throughout the inspection, he was unable to show employee training records. Later, he admitted he did not have any.”

Inspection of Healthline Medical Products, Inc (maker of shower commode chairs) 

Date of inspection: 11/3/2008-11/7/2008

Notable FDA Observation: “[The company] failed to implement a corrective action regarding a complaint showing the failure of the Shower Commode Chair… assembly guide found to be inadequate.”

Excerpt: “Healthline investigation failed to determine the possible root-cause of [a] cracked seat…connector failure…and loose joint.”

Other FDA inspection reports POGO obtained through FOIA (listed in order of inspection end date)

• Inspection of IVD Research Inc, maker of in-vitro diagnostic devices, 10/09/08
• Inspection of Amrex Zetron Inc, maker of electrotherapy equipment, 11/03/08
• Inspection of  Stat Medical Devices, Inc., maker of lancing devices, 12/05/08
• Inspection of Therasage LLC, maker of heating pads, 1/13/09
• Inspection of Electro-Tech Products Inc, maker of transcutaneous electrical nerve stimulators, 2/17/09
• Inspection of ARJ Medical, Inc., specification developer of urinalysis reagent strips, 3/09/10
• Inspection of Linvatec Corp. dba ConMed Linvatec, maker of surgical instruments, 3/26/09
• Inspection of  Neo Imagery Technologies, Inc, maker of diagnostic imaging workstations, 5/01/09
• Inspection of Alphatec Spine, Inc, maker of spinal implants, 5/18/09
• Inspection of  Clearwater Products, LLC, maker of colonic irrigation system, 8/25/09
• Inspection of  Magnificent Medical Equipment, Inc. DBA Tony Riso Company, 11/19/09
• Inspection of  Hyperbaric America LLC, maker of hyperbaric systems, 12/02/09
• Inspection of DexCom, Inc, maker of the Seven Continuous Glucose Monitoring System, 2/08/10
• Inspection of Care Tech Industries, Inc., maker of recirculating air cleaners, 06/10/10
• Inspection of Zander Scientific Inc. DBA Zander, maker of air purification system, 7/14/10
• Inspection of Toby’s Nose Filters, Inc., maker of nose filters, 9/23/10

 

Dana Liebelson is POGO's Beth Daley Impact Fellow. Bryan Rahija edits POGO's blog.

Follow @dliebelson

Follow @bryanrahija

New Podcast: A Father Talks About His Quest for Justice at Camp Lejeune

By ANDRE FRANCISCO

For 30 years, Marines and their families at Camp Lejeune in North Carolina used water contaminated with known carcinogens to cook, clean, and bathe. Jerry Ensminger was a drill instructor at Camp Lejeune and his daughter Janey was exposed to the contaminated water during her first trimester. Janey died of leukemia when she was nine years old.

Since finding out that the water at Camp Lejenue may have been connected with his daughter's death, Jerry has been on a quest to learn the truth about Camp Lejeune and to get justice for the contamination victims--as many as one million Marines and their family members, according to some estimates. Jerry's story was recently chronicled in the acclaimed documentary Semper Fi: Always Faithful, which was short-listed this year for an Academy Award.

POGO recently sat down with Jerry to talk about his story and the contamination at Camp Lejeune.

• Download the latest podcast
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• Previous podcasts
  

If you want to do something after listening to the podcast, you can go to POGO's Camp Lejeune Action Center to support Jerry's efforts and find ways you can help. For additional information, you can go to The Few, The Proud, The Forgotten, a website set up for the victims of the contamination.

Andre Francisco is POGO's Online Producer

Follow @andrefrancisco

Photo by POGO's Pam Rutter.

Is the White House Hiding the Influence of Special Interests on Crafting Regulations?

By DANA LIEBELSON and BRYAN RAHIJA

Click here to join POGO's Un-Do Influence Campaign: a movement to reclaim Washington

Senior government officials are ignoring a White House directive that requires disclosure of key documents in the federal rulemaking process, thus hiding the potential influence of special interests on the writing of government regulations, according to a letter POGO sent yesterday to President Obama.

POGO's concern relates to--and bear with our wonkiness for a moment--how the Office of Information and Regulatory Affairs (OIRA)--the White House office within the Office of Management and Budget (OMB) responsible for reviewing federal regulations that protect public health and safety--and rulemaking agencies are interpreting Executive Order (EO) 12866.

This EO, issued by President Bill Clinton in 1993, requires OIRA to publicly disclose all documents exchanged between OIRA and the rulemaking agencies during the crafting of new regulations. The EO also requires the rulemaking agency to identify to the public any changes made at the suggestion or recommendation of OIRA. President Obama reaffirmed the EO last year in his own executive order.

POGO readers should care because failure to heed the requirements in this EO could substantially harm the public interest. POGO’s letter cites one recent example in which OIRA apparently weakened a final rule on disclosure of conflicts of interest held by researchers who receive funding from the National Institutes of Health (NIH).

Part of the problem, POGO argues, is that OIRA and agencies have flouted these transparency requirements since the 1990s:

Un-Do Influence: Obama's Lobbyist Ban is Tough (Except When It Isn't)

Facepalm Ratings Guide = Stupefying example of everything that's wrong with the system. = Outrageous; shameless, even. = Worthy of rebuke. = Even if there's no conflict of interest, appearances matter.

---------------------------- Click here to join POGO's Un-Do Influence campaign.

By JOE NEWMAN

For a guy who likes to talk about keeping lobbyists out of his administration, President Barack Obama sure doesn't mind making some notable exceptions.

Now comes the latest dust-up involving Vice President Joe Biden's hiring of Steve Ricchetti to be a senior advisor. That's the same Steve Ricchetti whom the Obama campaign in 2008 attacked for being a lobbyist/bundler for then Sen. Hillary Clinton.

Listening to the administration spin the hire is pretty funny. Ricchetti hasn't personally lobbied since 2008. What was he doing instead? He was running his, um, lobbying(!) firm.

Obama has taken legitimate and laudable steps to slow the revolving door between lobbying firms and the White House and reduce private interests' disproportionate influence on executive branch policymakers. The restrictions he passed upon taking office were unprecedented, and intended to reduce industry influence peddling. 

But then there are those waivers and exceptions. Those are fine by us if they're used to bring public interest lobbyists into the fold. Not so much when they're granted to, say, a lobbyist for a top defense contractor. 

Look, lobbying, per se, isn't a bad thing. There's a place in our democracy for it—citizens, and that includes those paid to represent special interests, have a right to directly petition their elected leaders.

But one only has to look to Jack Abramoff to see how the system can be corrupted when lobbyists with access to piles of cash are able to buy influence through gifts, perks, campaign contributions and in the worst cases—bribes.

President Obama was right to want to distance himself from their influence. But if you're going to talk the talk, you've got to expect to some flak when you (or your vice president) bend your own rules. Sorry, Mr. President, the buck stops with you—you and Vice President Biden earned four facepalms.

***

Penn's Awkward Silence on Academic Integrity

SUNSHINE WEEK: Firm Failed to Respond to Medical Bed Deaths, FDA Doc Shows

By DANA LIEBELSON

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host documents obtained by the Freedom of Information Act (FOIA). POGO has long investigated issues related to public health, and today's document shows how FOIA can be used to make important information available to the public. Read more about POGO's plans for Sunshine Week here. 

Invacare Corporation, a manufacturer of medical beds, failed to take adequate corrective action even after receiving complaints that their beds allegedly caused multiple consumer deaths, according to a Food and Drug Administration (FDA) inspection report dated August 2010.

The document is part of a broader set of FDA inspection reports in the Los Angeles and Florida districts that POGO obtained via Freedom of Information Act (FOIA) request. Inspections by FDA can be triggered—as in this case—if the agency receives consumer complaints that a medical device is unsafe.

The inspection report states that Invacare “failed to take corrective action in response to reports of entrapment involving Invacare medical beds sometimes resulting in death.”

In one of many complaints to the firm outlined in the document, an Invacare bed and bed rail was allegedly involved in a bed entrapment death of an 11-year-old child—but, despite the death involving its product, Invacare did not get pertinent information such as the bed model number, patient size, and whether there was a history of entrapment with that particular model of bed rail.

Drug Busts, Hurricanes, and Torture, Oh My! 10 Key Inspector General Investigations

By DANA LIEBELSON

With the release of POGO's new Inspector General (IG) vacancy tracker, we've sparked discussion about the important role IGs play in government oversight. We've also encouraged President Obama to appoint IGs in a timely manner, and asked the Senate to consider nominees promptly.

But let’s get real—the work of federal watchdogs isn’t exactly sexy. I’d wager you could walk from one end of the National Mall to the other and not pass a single person who could identify an Inspector General by name. However, recently, IGs are behind some of the biggest headlines and savings in U.S. government. Ever heard of the numerous scandals involving Solyndra? Bernie Madoff? Hurricane Katrina? Then you’ve probably run across a case that your trusty federal IG helped shed light on. Read on to learn more about ten of these important cases.    

>> >> Click Here to See 10 Key Inspector General Investigations << <<

TORTURE	DEEPWATER	HURRICANES	PATRIOT ACT	HUMVEES
DRUGS AND OIL	BERNIE MADOFF	$6.6 BILLION	SOLYNDRA	FOOD SAFETY

 

Dana Liebelson is POGO's Beth Daley Impact Fellow.

Follow @dliebelson

The Big Pharma Bind: Punishing Health Care Fraud Without Punishing Health Care Consumers

By NEIL GORDON

USA Today reports that the world's largest pharmaceutical companies have paid billions of dollars in fines over the past few years for misconduct such as ripping off Medicare and Medicaid, yet are still allowed to continue participating in these programs.

Pfizer has racked up almost $3 billion in fines, penalties, and settlements since 2002. The bulk of that occurred in September 2009 when Pfizer agreed to pay $2.3 billion to settle federal and state civil and criminal allegations that it had illegally marketed drugs by promoting them for non-approved uses and submitted false claims to Medicare and Medicaid.