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Health

How Four Decades Of Congressional Inaction Left Americans Vulnerable To Faulty Medical Devices

Spurred by thousands of American women who were being injured due to faulty IUDs, President Gerald Ford signed the Medical Device Amendments of 1976 into law, granting the Food and Drug Administration (FDA) greater regulatory oversight regarding the safety and effectiveness of medical devices intended for widespread distribution. It was a historic consumer protection law intended to preserve public health and safety — but the legislation was also riddled with regulatory loopholes, particularly with respect to products that were already out in the market. Now, almost forty years later, Americans are still feeling the impact of the incomplete legislation as they encounter a multitude of common medical devices, including lethal products, that haven’t undergone adequate testing.

As The Atlantic reports, the medical device regulation bill contained lax provisions for classifying the safety of devices that are similar to products already available on the market, meaning that many contemporary devices do not have to undergo thorough testing simply because they were considered safe enough back in 1976:

The legislation created varying safety standards for devices that the FDA would deem as low, medium, and high risk. Medium-risk products, like surgical stitches, could be sold without first being tested on people under most circumstances, provided the device was “substantially equivalent” to one already on the market. For high-risk devices, like artificial hearts, companies were generally required to test their products in people and demonstrate to FDA that the products were safe and effective.

The law applied immediately to new types of devices and directed the FDA to retroactively classify existing ones, with one caveat: Products that were already on the market when the law passed would effectively be regulated as medium-risk until FDA officially classified them. The unfortunate result has been that some high-risk devices have won approval without being tested in people.

This interim solution was not supposed to last 37 years. Yet nearly four decades since Congress passed the Medical Device Amendments, the FDA still has not classified some of the temporarily “grandfathered” devices. As a result, potentially high-risk devices are continuing to reach the market without ever being tested in people.

The contemporary high-risk products that still have not undergone human testing due to the loophole include aortic balloons for heart surgeries and automated external defibrillators (AEDs). After thousands of faulty hip replacements caused a public health outcry over the last several years, Congress finally took action in 2012 to give the FDA more authority to re-classify the so-called “grandfathered” products. But while the FDA has taken action to re-label hip replacements, “19 grandfathered device types remain unclassified.”

Unfortunately, congressional procrastination on public health and safety measures is depressingly standard, as the FDA’s regulatory powers consistently lag behind until a crisis erupts to force lawmakers to make a change. Last year’s deadly deadly meningitis outbreak stemming from lax standards at a Massachusetts-area compounding pharmacy illustrates the trend perfectly. Lawmakers eventually responded to that crisis by introducing legislation to give the FDA more power to oversee the largely unregulated compounding pharmacy industry — but only after the outbreak resulted in the deaths of over 30 Americans, and the FDA director Margaret Hamburg begged a Senate health committee to give the agency more oversight.

Health

House Republicans Trip Over Each Other To Introduce Competing Bills To Defund Planned Parenthood

Mitt Romney made his desire to defund Planned Parenthood a central part of his pro-life credentials during his failed presidential campaign — but even though Romney didn’t ascend to the White House, attacks on Planned Parenthood aren’t fading away anytime soon. State level efforts to defund the women’s health organization are moving forward in Texas and Oklahoma, and members of the 133th Congress are so eager to introduce national legislation to block federal funds to Planned Parenthood that two Tennessee congresswomen both introduced identical versions of the same bill this week.

As the Huffington Post notes, Reps. Marsha Blackburn (R-TN) and Diane Black (R-TN) both hope to prevent Planned Parenthood from receiving federal funding for their family planning and preventative health services, and rushed to introduce a bill to do so during the first few days of the legislative session. But perhaps they were a bit too eager, since both bills are actually exactly the same proposal:

Tennessee Reps. Marsha Blackburn (R) and Diane Black (R) separately reintroduced a bill during the first two days of the 2013 legislative session that would prohibit Title X family planning grants from being awarded to any organization that performs abortions. The bill, first introduced by former Rep. Mike Pence (R-Ind.) in the 112th Congress, primarily targets Planned Parenthood, which receives about $340 million a year in Title X funds for non-abortion health and family planning services. Both bills amend Pence’s original bill to include exceptions for rape, incest and to protect the life of the mother. [...]

The day after Blackburn circulated her bill, Black introduced the same bill. One of Black’s staffers pointed out to HuffPost that her bill has the same number as Pence’s original bill and said that Pence, the governor-elect of Indiana, had specifically given Black his blessing to carry it on. Black’s bill has 38 cosponsors and endorsements from all the same organizations that Blackburn’s has.

The two legislators are unconcerned about their overlapping legislative agendas; they may simply sign on to co-sponsor each other’s bills. “The fact that there are multiple members interested in this issue proves that Planned Parenthood is not going to be let off the hook. We welcome the attention of all members to the subject,” Blackburn told the Huffington Post. “It helps build momentum.”

The Republican congresswomen believe their double push to block federal grant money from Planned Parenthood clinics is necessary in spite of the Hyde Amendment, a 1976 federal law that already prohibits taxpayer dollars from funding abortion services. The major fuel to anti-abortion advocates’ fire is a recent report noting Planned Parenthood’s activities during its last fiscal year, when the organization received $542 million in taxpayer funding and performed about 334,000 abortions. Anti-choice lawmakers like Blackburn argue that even though those taxpayer dollars don’t directly fund abortion procedures, they still indirectly allow the women’s health group to continue performing abortions because they don’t have to worry about fully funding their other programmatic areas.

Ironically, continued Republican crusades against Planned Parenthood may actually be helping perpetuate the organization’s funding cycle. A post-election poll confirmed that women’s issues, including ensuring secure funding for Planned Parenthood, were a decisive factor in November’s election. Sixty four percent of all voters said they heard something about Romney’s intent to defund Planned Parenthood, and 62 percent disagreed with that position — potentially spurring voters to make increased donations to the organization during the election cycle to lend their support.

Politics

Americans Prefer Cockroaches, Traffic Jams and Nickelback To Congress

As the nation braces itself to hit the debt limit as early as February 15, Congress is as gridlocked as ever. Republican lawmakers are now suggesting they will resist raising the debt ceiling, risking a government shutdown and a default on U.S. credit. The last fight over the debt ceiling in August 2011 led to an unprecedented downgrade of U.S. credit and billions of wasted taxpayer dollars.

Americans were paying attention during 2011′s fight, and their approval rating of Congress plunged to an all-time low soon after the credit downgrade. A record 82 percent of respondents said at the time they disapproved of the job Congress was doing. Now, on the verge of another debt ceiling crisis, that number has risen to 85 percent.

Public Policy Polling decided to figure out just how much Americans hate Congress by asking respondents to compare their feelings about their lawmakers to a list of other unpopular things. The results were not pretty:

Lice: 67% Congress: 19% approval
Brussel Sprouts: 69% Congress: 23%
Replacement refs: 56% Congress: 29%
Colonoscopies: 58% Congress: 31%
Root canals: 56% Congress: 32%
Traffic jams: 56% Congress: 34%
Used car salesmen: 57% Congress: 32%
Carnies: 39% Congress: 31%
France: 46% Congress: 37%
Nickelback: 39% Congress: 32%
Genghis Khan: 41% Congress: 37%
Political pundits: 37% Congress: 34%
Donald Trump: 44% Congress: 42%
Cockroaches: 45% Congress: 43%


Congress did beat out North Korea, Lindsay Lohan, the Ebola virus, gonorrhea and the Kardashians.

Climate Progress

Congress In Contempt, Part 2: How Can We Fix Our Broken Legislature?

Will the freshman House members of the 113th Congress earn their pay?

by Bill Becker

This is part 2 of a 2-part series on Congressional gridlock. You can read part 1 here.

The 112th Congress is not the first that didn’t earn its pay.  President Truman criticized the 80th Congress as a do-nothing bunch in the 1940s.  In December 1881, the New York Times printed this familiar complaint as the 47th Congress was about to begin:

The manner in which Congress is commencing business fairly suggests the question, Will the session be worth its cost? The average expense of one session exceeds three million dollars…The last session yielded a slender return for this expenditure…What the country desires from Congress this Winter is that it shall act promptly and judiciously on the great public questions which stand open.

Today, the cost of running the Legislative Branch is approaching $5 billion a year. Few of us would disagree that we are getting far too little for our money; that Congress is better at worrying the country than worrying about the country; and that it is now so dysfunctional that it seems unable to face any significant issue without a crisis, and sometimes not even then.

Several readers who responded to Part 1 of this post were skeptical that Congress can be fixed. They pointed out that the gerrymandering of congressional districts has institutionalized polarity by dividing the country into red and blue; that unbridled campaign money and K-Street lobbying deeply corrupt the legislative process; and that members of both parties support customs and rules that deadlock the legislative process.

As I noted in Part 1, Congress’s dysfunction causes inefficiencies and waste not only in the Legislative Branch, but also the Executive by delaying passage of budgets and leaving key government jobs unfilled.  But the impacts go far beyond the Beltway.  Uncertainties about if Congress will act on critical national issues, and when it will act, cause economic instability, keep capital investment on the sidelines, delay infrastructure projects, confuse the stock market, add to the financial insecurity of the poor and elderly, undermine the ability of workers and their families to cope with joblessness, allow environmental degradation, and delay government help for our growing number of disaster victims. We need to take this personally.

The easiest reaction is to argue about who’s to blame – a conversation that dominated the responses to Part 1. Solutions are more difficult.  Is the Legislative Branch irretrievably broken, or is there something we citizens can do? Here are some questions I hope will advance a conversation about fixes.

Bright Spots? Are there opportunities for reform? There may be a few bright spots on which we might build. First, if 90-95% of Americans disapprove of Congress’s performance, are conditions ripe for a voter revolt?

One reader pointed out that voters are most willing to protest when their personal oxen are gored. In December, Congress threatened everyone’s ox at a sensitive time and personal level – higher taxes and fewer benefits in a high-unemployment economy.

Second, whatever we think of the Tea Party, it demonstrated that citizen movements can still have political clout.

Third, despite the Citizens United decision, special interests and billionaire kingmakers were not able to buy last November’s presidential election.  That offers some hope in a fight against the grip of special interests.  Being outspent does not mean being outgunned.

Given all this, one wonders whether it’s possible to launch a cross-partisan voter movement that makes the Tea Party look…well, like a tea party.  It would not promote any particular public policy; rather it would pressure members of Congress to do the  fundamental things they are elected to do.

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Politics

Ten People We Are Grateful Are No Longer Members Of Congress

Under the Twentieth Amendment, “[t]he terms of the President and Vice President shall end at noon on the 20th day of January, and the terms of Senators and Representatives at noon on the 3d day of January.” Accordingly, as of this very moment, many members of 112th Congress are now unemployed. Here are ten that we are particularly grateful will no longer be able to contribute to federal legislation:

Jim DeMint

It’s more ‘see you soon’ than ‘goodbye’ for former Sen. Jim DeMint (R-SC), who will take his far-right, tea party-loving persona over to the conservative Heritage Foundation. DeMint leaves a bleak legacy. Over his time in Congress, he’s gained notoriety for his anti-union, gay-bashing, anti-abortion, anti-obamacare, pro-austerity positions, among the most extreme in the Senate.

Todd Akin

Former Rep. Todd Akin (R-MO) thought he was moving up in the world when he abandoned his House seat to seek a spot in the Senate. Instead, Akin’s campaign made a crash landing after he told a radio host that victims of “legitimate rape” can’t get pregnant because “the female body has ways to try to shut that whole thing down.”

Ron Paul

Most members of Congress leave politics with a few new laws to their credit if they are lucky, former Rep. Ron Paul (R-TX), however, can take credit for reviving generations worth of terrible ideas and building a national movement behind his poor grasp of the Constitution and basic economics. Paul believes the Departments of Energy, Education, Agriculture, Commerce, Health and Human Services, Homeland Security and Labor are all unconstitutional — as are Social Security and Medicare, which he compared to “slavery.” He would return to the gold standard. And he thinks states can simply nullify federal laws they don’t feel like following. Yet it is a testament to the grip Paul has on America’s lunatic fringe that his supporters will whip themselves into a frenzy every time anyone dares to question his ill-considered views. Don’t believe us? Just wait and see what they write in comments on this very post.

Joe Lieberman

Former Sen. Joe Lieberman (I-CT) likes war, a lot. He was a leading proponent of the war in Iraq. He cheerleaded for war in Iran, and even pushed for more belligerence against Syria. Lieberman once defended waterboarding. He accused President Obama of “encourag[ing] Israel’s enemies.,” and he once called for Social Security cuts to pay for “war with Islamist extremists.” Lieberman loves Fox News, and he ended his tenure in the Senate will a call to raise the Medicare retirement age.

Joe Walsh

Now-former Rep. Joe Walsh (R-IL) got himself kicked out of Congress by continuously bashing his opponent, a female war veteran and amputee who Walsh said was not a “true hero.” The tough-talking Congressman also once said that Muslims are “trying to kill Americans every week,” and once screamed at his own constituents.
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Politics

The Worst Moments Of The 112th Congress

Today is the last day of the 112th Congress, and it will go down as one of the least productive and most partisan legislative classes in all of American history. But there are a few things that Congress did — or didn’t do — that will stand out as its worst moments:

Almost shut down the government and hit the debt ceiling.


Back in August of 2011, Congressional Republicans took the United States to the brink of an unprecedented credit default by refusing to agree to any tax increase. Republican hijinks resulted in the downgrading of U.S. credit for the first time in history and cost taxpayers $18.9 billion. Congressional approval ratings also plunged to a record low.

Let the Violence Against Women Act expire.


Because of some Congressional Republicans’ opposition to extending protections for LGBT and Native American victims of domestic violence, the House GOP allowed the Violence Against Women Act to expire this year. The bill has enjoyed bipartisan support during every other reauthorization vote. And for a good reason: It is a hugely effective piece of legislation. Now, the program that created a rape crisis hotline, outlawed stalking, and protects victims of heinous violence is hanging in limbo. House Republicans also attempted to change the definition of rape itself in order to deny legal abortions to women who have suffered statutory rape or incest.

Advanced the Ryan Budget.


The House approved Rep. Paul Ryan’s (R-WI) radically destructive budget proposal in April 2011, despite outcry from economists, clergy members, and even would gut food aid, Medicaid and Medicare, and other essential safety net programs. An estimated 48 million people would have been kicked off their health insurance, and more than 1 million students would have had their federal Pell grants eliminated.

Voted 33 times to repeal Obamacare.


The House has voted to repeal President Obama’s Affordable Care Act 33 times, even after the Supreme Court affirmed the law’s legitimacy. Since January 2011, Congressional Republicans wasted 88 hours and $50 million on their failed attempt to repeal health care reform. Repealing the ACA would take away insurance from an estimated 30 million people, while adding over $100 billion to the deficit. After he appeared to accept defeat following Obama’s reelection, House Speaker John Boehner (R-OH) quickly renewed efforts to undermine its provisions even as public approval for the law grows.
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NEWS FLASH

Report: Petraeus To Tell Congress He ‘Knew’ Of Attackers Behind Benghazi Attack | CNN’s Barbara Starr reported on the Situation Room today that a source tells her that in tomorrow’s closed-door hearings on Capitol Hill, former CIA Director David Petraeus intends to tell lawmakers that he “knew” that the Sept. 11 attack on a U.S. diplomatic mission in Libya was carried out by the Ansar al-Sharia militia group. He will also indicate that his initial briefing to Congress, in which he indicated that the attack was spurred by protests in Cairo against an anti-Islamic video, was both based on intelligence available at the time and later disproved. Starr cautioned CNN host Wolf Blitzer that the issue was still very complex and that while the perpetrators have possibly been identified, “a combination of many factors” may be involved in the motivation behind the attack.

Alyssa

‘Parks and Recreation’ Open Thread: Unity

This post discusses plot details from the November 8 episode of Parks and Recreation.

After last week’s blockbuster engagement episode of Parks and Recreation, I realized that I’ve been operating for some time now on the assumption that this is Parks‘ last season. Ben and Leslie’s lives are closest to arriving at the shape that will carry them forward into the future. And I’m glad to see the other characters’ storylines starting to gain momentum.

I loved seeing Leslie’s enthusiasm about her engagement, whether she’s explaining that her ring is “a non-conflict diamond”–but of course–explaining that their love story begins “In 1832, Ben’s great, great, great grandfather, Theodore Wyatt, a bastard,” or telling the camera that “I’m so happy I want to shout it from the rooftops,” only to have Ben tell us “And she has. We’ve gotten several noise complaints.” And it was both funny and good setup for next week’s appearance by Vice President Joe Biden for Leslie’s big plan to bring together their families to be a “Unity Quilt,” of which she tells Ben “Out of respect I didn’t include any images of the only other man in the world who’s as sexy as you: Joe Biden.”

I didn’t think, however, that Ben’s family worked as well as it might have. Even though the first season of Parks and Recreation was something of a mess, it was always clear to me what Leslie inherited from her mother, and how she’d grown beyond her. She got the ambition and the drive, but Leslie is a more open, joyful person than her mother. The introduction of Ben’s parents, on the other hand, was entirely oriented towards the Unity Quilt joke, towards them as bitter, obnoxious people and as a result, it felt kind of flat. Having Jonathan Banks play a Bizarro World version of Mike from Breaking Bad was mildly funny, but as a television in-joke, it felt less integrated into the world of Parks than Ben and Leslie’s obsession with Game of Thrones. And I genuinely have no idea what Ben has in common with these people, who are the sum of their fractiousness such that they can drive Leslie to flee her house, telling Ben “I grabbed all of the brownies from the dessert table and four bottles of wine. Get in the cab. We’re going to Australia.”

Some readers have suggested that Ben’s family is a metaphor for partisan gridlock, but I’m not quite sure that I agree–and if it is, I think it’s a somewhat inadequate critique of our politics. There aren’t substantive differences between Ben’s parents–they’re simply divided by old enmity. They can be reconciled to politeness and decent behavior by Leslie and Ben’s demands because they agree on their love for their son. But gridlock in Washington is driven by substantive policy differences, and where the parties do agree on desirable outcomes, major gaps on what they believe are the best methodology for achieving those outcomes. And putting Ben and Leslie outside the system as magically unifying figures would flatten reality, too. As President Obama learned in his first term, asking doesn’t get you very far with people whose professional survival depends on destroying you. Ben and Leslie are products of politics, and most interesting when they get caught up in the contradictions, compromises, and potential for selling out that their chosen field throws in their way.
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Election

Top Five For Obama’s Second Term To-Do List

Across the country last night, voters cast their ballots largely in favor of progressive policies and progressive candidates, topping it off with a decisive victory for President Obama. With a slim majority in the Senate and the House still held by Republicans, Democrats have little time to waste before they start working to get the votes needed to implement their progressive agenda. Here are the top five progressive policies Obama and Congress should get to work on right now:

1. Immigration reform.


Obama’s directive telling the Department of Homeland Security to stop deporting young, undocumented students and service members was a good start, but Obama has promised full immigration reform. With 75 percent of the Latino vote, immigration advocates have pinned their hopes on Obama’s re-election. Plus, there are plenty of Republicans who have embraced a pro-immigrant, pro-reform stance who might prove helpful allies in the fight to make our immigration system more fair and more open.

2. Climate change legislation.


Early on in Obama’s first term, he tried to push the Waxman-Markey “cap and trade” bill. But it stalled in the Senate, was left there forgotten, and climate change was hardly mentioned again. In his victory speech last night, though, Obama said, “We want our children to live in an America… that isn’t threatened by the destructive power of a warming planet.” That claim could be backed up by any number of pieces of legislation to reduce carbon emissions and prepare for an already-warming planet.

3. LGBT equality.


Obama has announced his personal support for marriage equality, but it’s time for him to turn his personal respect for the LGBT community into a set of actions. Congress can begin by passing the Employee Non-Discrimination Act, which would stop employers from firing a person simply because he or she is LGBT — a right that most people think is already afforded to LGBT Americans. He can also focus on fully repealing the Defense of Marriage Act.

4. Marijuana reform.


Last night, referendums to make marijuana legal for recreational use passed in Colorado and Washington. In Massachusetts and Montana, voters approved other initiatives to destigmatize marijuana use. The drug has been decriminalized in more than half of the United States. It makes sense for the country: Drug incarceration is responsible for about a quarter of the people in prison in the US, and those are largely low-income African American men. GQ reported earlier this election cycle that Obama would “pivot” to the drug war in his second term — and with Colorado and Washington now clashing with federal law, that pivot might need to happen soon.

5. Helping homeowners.


The new term will allow Obama to appoint a new head for the Federal Housing Finance Agency — an important move, since the current acting director blocked aid for struggling homeowners. A new FHFA director could help homeowners by forgiving mortgage debt, which would help the still-struggling housing market, and a lot of individuals and families, and would provide a boost to the economy as a whole.

Security

Pelosi Attacks Republicans For Withholding Embassy Security Funding

Nancy Pelosi

House Minority Leader Nancy Pelosi on Tuesday shot back at Republicans criticizing the Obama administration after the fallout of the Libya Consulate attacks, pointing out that they withheld hundreds of millions of dollars the State Department had asked for last year for embassy security and construction.

House Republicans wrote to Secretary of State Hillary Clinton suggesting that the Obama administration was negligent in providing security for the consulate in Benghazi where four U.S. diplomats were killed in an attack on Sept. 11 and asked Clinton for more information. Noting that the investigation into what happened is still ongoing, Pelosi, in an interview with CNN, asked, “how can you ask the secretary to come before the information is known?”

The Minority Leader then pointed out that it was Republicans who may have some responsibility in the matter, as they turned down the administration’s request for nearly $300 million for embassy security:

PELOSI: It’s also important to note that the Republican appropriation in Congress gave the administration $300 million less than it asked for for the State Department, including funding for security.

BLITZER: Are you suggesting that there was a financial aspect to what happened in Benghazi, Libya. That the U.S. was not enough money to protect American diplomats?

PELOSI: No what I’m saying is Congress has the right of oversight but it also has the power of the purse. … We also have to look to ourselves for that funding question. $300 million less than what the administration asked for.

Watch the clip:

CAP senior fellow and budget expert Scott Lilly noted last month that in the last two years, Congress has cut the Obama administration’s request for funding to increase diplomatic staffing and boost embassy security:

[E]ven more inexcusable are the repeated and deep cuts made to embassy security and construction. Thousands of our diplomatic personnel are serving overseas in facilities that do not come close to meeting the minimal requirements for security established by the so-called Inman commission’s report on overseas diplomatic security to President Ronald Reagan’s secretary of state more than two decades ago.

Nor is it likely to change anytime soon. In the 2011 continuing resolution, Congress, at the insistence of the House of Representatives, slashed the president’s request for embassy security and construction and forced another cut in fiscal year 2012. Altogether Congress has eliminated $296 million from embassy security and construction in the last two years with additional cuts in other State Department security accounts.

Lilly notes that more funding cuts for the U.S. Foreign Service are set to come under the sequestration required under the Budget Control Act. “Those cuts are largely the result of the draconian and unrealistically low budget caps placed by House Budget Committee Chairman Paul Ryan (R-WI) on all discretionary spending,” Lilly said.

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