The new studies, published in separate medical journals, cap a year of scrutiny and criticism for the FDA's medical devices division. In August, the head of that division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

The new studies didn't examine the safety of the approved devices, and didn't look for differences in the approval process for items that were later recalled. Global sales for heart and blood vessel devices were nearly $76.7 billion in 2008, according to market research firm BCC Research.

One of the new studies, published online Tuesday in the American Journal of Therapeutics, found about 40 percent of pivotal studies lacked precise targets for how safety would be measured. Studies also failed to fully account for what happened to all patients enrolled in the research and omitted important information on patients such as how many had heart disease or diabetes.

"Companies need to better define precisely what they're measuring and at what time point they intend to measure it," said study co-author Dr. William Maisel, director of the nonprofit Medical Device Safety Institute at Beth Israel Deaconess Medical Center. The analysis looked at the research behind 88 heart and blood vessel devices.

Maisel was an FDA consultant and another Beth Israel author was in an FDA fellowship program when the study was done. The FDA cleared their participation after conflict-of-interest screening. Three other authors are FDA staffers.

The second study appears in Wednesday's Journal of the American Medical Association. Researchers from the University of California, San Francisco, examined summaries of the research behind 78 heart and blood vessel devices. It found that many devices were approved based on small studies -- 300 patients on average -- and two-thirds were approved with results of just one study.

"We were surprised at the number of devices approved without high quality evidence," said study co-author Dr. Rita Redberg. The research was supported by the university's medical school.

Both studies looked at devices approved from 2000-2007.

Much is at stake with device approval. In 2008, the U.S. Supreme Court found that federal law bars patients from suing manufacturers for injuries caused by FDA-approved devices.

In contrast, consumers can sue drugmakers over FDA-approved drugs. Drugmakers submit rigorous studies when seeking approval of new drugs, generally they must submit large randomized studies.

Redberg said she believes new leaders at the FDA want to improve the approval process. She joined an advisory committee to the FDA on devices last year, after the years covered by the study.

In both new studies, the researchers looked only at so-called premarket approvals. They didn't include devices cleared through an alternative FDA process -- "510(k) submissions" -- used for less risky devices that are substantially similar to approved devices. The FDA has asked the Institute of Medicine to review its 510(k) reviews, following criticism from safety advocates and government watchdogs.

FDA officials said the University of California researchers looked only at summaries of device approvals, rather than the full research. The FDA said the researchers also made faulty assumptions about device research, which is inherently different from drug research.

The most rigorous research randomly assigns patients to get either the experimental treatment or a standard treatment, or sometimes a placebo. Patients and sometimes doctors are "blinded," meaning they don't know which patients receive the experimental treatment.

FDA officials said requiring randomized studies for second and third generation devices would delay bringing engineering refinements to the market. They said it's often impossible to conduct blinded studies with devices.

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On the Net:

JAMA: http://jama.ama-assn.org

FDA: http://www.fda.gov/

American Journal of Therapeutics: http://journals.lww.com/americantherapeutics

Rasmussen attributes Nelson's precarious position to his reluctant support for his fellow Democrats' healthcare reform legislation.

"Just 17% of Nebraska voters approve of the deal their senator made on Medicaid in exchange for his vote in support of the plan. Overall, 64% oppose the health care legislation, including 53% who are Strongly Opposed," the polling firm says.

It also appears Nelson would get at least a small boost if he shifted positions on the issue -- if he votes to block reform, the number of respondents who say they'd vote for Heineman drops to 47 percent, with 20 percent of those supporters now going to Nelson, who'd be at 37 percent.

It's not all bad news for Nelson, though: 2012 is a long way off, and there's still plenty of time for public opinion in Nebraska to swing away from the GOP. Plus, in three years, reform legislation is likely to be less of a front-burner issue.

Today, The New York Times' Bob Herbert has an excellent column giving the lie to those tactics from the President's most loyal supporters.  Herbert explains why the health care bill -- with its reliance on taxes on so-called "Cadillac" plans -- is far more likely to end up burdening the middle class and reducing health insurance coverage for tens of millions of people:

In fact, it’s a tax that in a few years will hammer millions of middle-class policyholders, forcing them to scale back their access to medical care. Which is exactly what the tax is designed to do. . . .

Within three years of its implementation, according to the Congressional Budget Office, the tax would apply to nearly 20 percent of all workers with employer-provided health coverage in the country, affecting some 31 million people. Within six years, according to Congress’s Joint Committee on Taxation, the tax would reach a fifth of all households earning between $50,000 and $75,000 annually. Those families can hardly be considered very wealthy. . . .

The idea is that rather than fork over 40 percent in taxes on the amount by which policies exceed the threshold, employers (and individuals who purchase health insurance on their own) will have little choice but to ratchet down the quality of their health plans. . . . These lower-value plans would have higher out-of-pocket costs, thus increasing the very things that are so maddening to so many policyholders right now: higher and higher co-payments, soaring deductibles and so forth. . . .

Proponents say this is a terrific way to hold down health care costs. If policyholders have to pay more out of their own pockets, they will be more careful -- that is to say, more reluctant -- to access health services. On the other hand, people with very serious illnesses will be saddled with much higher out-of-pocket costs. And a reluctance to seek treatment for something that might seem relatively minor at first could well have terrible (and terribly expensive) consequences in the long run.

Herbert also explains why the central assumptions of the plan are patently unrealistic.  There are substantive replies one can make to these claims, but Herbert's column demonstrates a truth that has been deliberately distorted by the President's defenders:  the progressive case against the health care bill is not grounded in "ideological purity" or childish anger or any of the other deceitful strawmen that have been created.  It is based on these substantive policy objections.  Along with the extreme burden that will be imposed on those forced by penalty of law to purchase private insurance policies they cannot afford and do not want, the argument has always been that the Senate bill will cause massive amounts of harm both from the perspective of health care policy and generally by filling the coffers of large insurance and pharmaceutical industry interests at the expense of the middle class.

The title of Herbert's column is "A Less Than Honest Policy."  The same can be said of the principal tactics used by the bill's proponents, who have relied far more on the old reliable, trite derision and demonization of The Angry, Purist Left than they have on honest discussions.

And then there is the most painful memory of all: the killer rabbit. On April 20, 1979, a White House photographer captured an image of the beleaguered President Carter using his paddle to fend off a rabbit as it swam toward his fishing boat in Georgia. The photo was suppressed until the Reagan years, and Carter's press secretary explained that the creature was a ferocious "swamp rabbit." But headlines like "President Attacked by Rabbit" gave a comic spin to the widely shared feeling that the U.S. government had become feeble and ridiculous.

I've got those killer-rabbit blues again. And I'm not the only one.

Some Democratic partisans have claimed that the pathetic, lobby-written healthcare bill is the greatest expansion of social insurance in the U.S. since Medicare. Possibly true, but so what? Passing the greatest social reform since the days of LBJ is easy, like being the greatest novelist in Lichtenstein or the greatest tap dancer in Mongolia. There isn't much competition. Since the 1960s our increasingly paralyzed Congress seems to have become incapable of enacting any reform that isn't trivial, or botched, like the creation of the Department of Homeland Security, or corrupted beyond recognition, like the healthcare bill.

Nor is the pathology limited to the legislative branch. Whether under Republicans or Democrats, whether the threat is Hurricane Katrina or Umar Farouk Abdulmuttalab, America seems to be facing a general crisis of state incapacity. Money can be found by Democratic and Republican administrations alike to bail out campaign contributors on Wall Street, but not to repair our crumbling infrastructure.

The U.S. fought and won World War II in less time than it took to adequately protect U.S. soldiers against primitive weapons in Iraq. We are told that we have to stay in Iraq and Afghanistan indefinitely, because withdrawing would be admitting failure. Translation: We haven't won and are unlikely to win in the foreseeable future, if ever.

And now the narrowly averted Christmas massacre in the skies above Detroit. I don't think I'm overreacting when I say that if ever overreaction on the part of a citizenry has been justified, it is now. We the people deserve to be angry. It's not as though Abdulmutallab came up with a clever new tactic while our national security agencies were focused on the last tactic. He used more or less the same tactic as the "shoe bomber," Richard Reid, and nevertheless got through every layer of international and national security.

It's almost as though Osama bin Laden had been allowed through screening at Boston Logan, used a box cutter to hijack a jet, and would have crashed it but for the heroic intervention of other passengers defending themselves after their government failed to defend them.

Forget Democrats and Republicans for a minute. Every American should be asking the same questions: Why are we paying these people?

Our elected leaders and public servants can't do the hard stuff, and they can't do the easy stuff either. They can't provide universal, affordable healthcare, of the kind that all other advanced industrial societies have. They can't give us a system of banking that channels money from depositors to productive enterprises in our country, without being channeled into gambling with obscene profits skimmed off for the gambler-bankers. They can't win wars or avoid unwinnable ones. They can't even repair bridges and keep levees in operating condition, tasks mastered by the relatively primitive ancient Romans and ancient Chinese.

And now, after two invasions justified in the name of the "war on terror," the creation of a cumbersome Homeland Security bureaucracy and a Patriot Act, and countless studies, reports and hearings, it turns out that we Americans may have to defend ourselves against jihadists. First we were told ad nauseam that it was our job to identify possible terrorists in airports and bus terminals and train stations. What next? "Passengers are advised to be prepared to throw themselves if necessary on the flaming traveler next to them in the aircraft, in order to prevent a bomb from detonating. Please watch the demonstration by the flight attendants."

The reality as well as the perception of government incapacity threatens liberalism more than conservatism. After all, if public safety deteriorates, antisocial plutocrats can retreat into doormanned buildings and gated communities and hire their own private security forces, and rural conservatives can amass home arsenals. And if the costs of personal security reduce the room for taxes for public goods, well, then, so much the better, from the perspective of certain strains of anti-government conservatism.

In contrast, America's modest and inadequate system of social democracy rests on economic growth made possible by effective government provision of basic public goods. Economic growth in turn rests on physical security — the protection of citizens against criminals in their midst and hostile or law-breaking foreigners. Libertarians to the contrary, the indispensable preconditions for the free society are effective armed forces and police forces, be they citizen militias or professionals.

Social democracy, in the form both of middle-class social insurance like Social Security and Medicare and means-tested programs for the poor, is a luxury of countries with secure borders and advanced, functioning mixed economies. You can have a generous welfare state only after you have effective soldiers, police forces and intelligence agencies and well-run industries, infrastructure and utilities.

If global war or a civilization-threatening natural catastrophe forced us to choose to save some functions of government at the expense of others, we would put security over wealth and redistribution. We would sacrifice the Social Security Administration and the Commerce Department in order to keep the Pentagon, in the hope of regenerating the fleshy tissue of the economy and the social insurance system in the future around the hard skeleton of the state.

Twentieth-century progressives and liberals took this order of priorities for granted. Theodore Roosevelt the environmentalist and reformer was also police commissioner of New York as well as assistant secretary of the Navy and commander of the Rough Riders. Franklin Roosevelt had a major in navalism and power politics, as it were, and a minor in electrical utilities. FDR came relatively late to the idea of social insurance. Any list of Americans who symbolized New Deal liberalism in the public mind would include Adm. Hyman Rickover of the Navy and the Atomic Energy Commission and David Lilienthal of the Tennessee Valley Authority.

Following the Vietnam War, however, the two parties specialized, with the Republicans specializing in national security and "law and order" and the Democrats specializing in defending existing social insurance programs like Social Security and Medicare and proposing new ones like universal healthcare. Because security against foreign attack and domestic crime comes first, even in the left-liberal tradition, properly understood, it is hardly surprising that Republicans have dominated the presidency except in the 1990s, when the Cold War had ended, and beginning in 2008, when the fear of al-Qaida-inspired jihadism had gone down (perhaps temporarily).

This doesn't mean that progressives should try to prove they are as tough as conservatives by invading countries unnecessarily, or keeping Guantánamo open, or torturing terrorists, or supporting the barbaric death penalty. Nor do they need to adopt neoconservative rhetoric or strategy. But it does mean that the party of activist government is doomed unless it is first and foremost the party of functioning, competent, basic government — national defense, law enforcement and functioning public utilities, including utility banking.

Not all Democrats are progressive, but in our two-party system, the Democrats are the more progressive party. At the moment the relatively progressive party owns the national government, and the national government's first job is to control its own borders, keeping out enemies like Abdulmutallab. National defense requires striving to eliminate illegal immigration and punishing those who break our immigration laws because the same lax law enforcement that permits the "good" illegal immigrant nanny to cross the border and the "good" foreign student to overstay her visa inevitably empowers terrorists and criminals.

Democrats shouldn't see this as an irksome task that is necessary to win the credibility they need for their social insurance reforms. Like the progressives and New Dealers, they should take it for granted. Physical security comes before economic security.

It wasn't my personal duty back in the '70s when I was a high school student to "whip inflation," and it is not my personal duty now to be vigilant in the airport or to be prepared on airplane flights to overpower a would-be mass murderer on a terrorist watch list who has brought easily detected explosives onto the plane. We hire politicians and pay public servants to do these tasks — not to try their best to do them, not to come up with procedures to make it likely they will be done, but to actually do them.

If our officials can't provide the basic goods of an advanced society — secure borders, safe streets, a functioning economic infrastructure — then we need to keep firing them until we find somebody who can do the job.

What the ping-pong plan means for the final product is hard to predict. The House bill is, in many ways, far more progressive than the Senate version — there's a public insurance option as part of the exchanges the bill would set up, a tax on the wealthy to pay for the new insurance subsidies, and a requirement that all employers provide insurance to their workers. The Senate, in contrast, has no public option or anything like it (thanks to Joe Lieberman), pays for the subsidies by taxing expensive health benefit plans and requires only individuals — not employers — to purchase insurance. The House bill also takes effect sooner, in 2013 rather than 2014, though some of the Senate provisions — like a ban on insurers refusing coverage to children with pre-existing medical conditions — would take effect immediately. The House has a national insurance exchange; the Senate would set up 50 state exchanges. On the other hand, the House's abortion provisions are more restrictive than the Senate's. And the Senate bill has a provision for an independent commission on Medicare reimbursement rates that the House bill lacks; that could help cut medical costs, one of the ostensible purposes of the legislation.

House Democrats have come pretty close to drawing a line in the sand over the public option, as well as supporting the employer mandate and opposing the tax on benefits. Rep. Raúl Grijalva, D-Ariz., the co-chairman of the House Progressive Caucus, calls those provisions items that "cannot be dismissed." But key conservatives in the Senate, like Lieberman and Nebraska Democrat Ben Nelson, say they won't vote for a final bill that strays too much from the version the Senate passed Thursday. And since the legislation will, once again, need 60 votes to get past procedural obstacles in the Senate, that's a serious threat.

So the negotiations may focus on making insurance more affordable for the millions of people who will still need help buying the coverage they're required to get. The Congressional Budget Office says the Senate bill would save $132 billion over the next 10 years, and some of that money could be used to expand access to community health clinics and beef up subsidies and other affordability improvements. "You have some money to spare, because you're so deep in the black," one senior Senate Democratic aide says. "You figure out where you can spend some money to help" — both help people get insurance and help keep progressives on board with the bill.

Also, look for the final bill to include as many provisions that take effect sooner, rather than later, as possible. Democrats worry about polls showing the legislation isn't popular with voters, and there is, after all, another election only 11 months away. Being able to point to some concrete examples of how the bill helped people now would ease those worries dramatically. (The Senate Finance Committee has already posted a list of immediate changes the bill would provide, including a ban on dropping coverage for patients who get sick.)

Very tentative informal talks will take place next week, aides say, and staffers from the House and Senate will begin meeting the first week in January. Once the House returns from its winter break, lawmakers will start meeting. Chances are the bill could be ready for passage by late January or early February.