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FDA Fired Device Whistleblowers

January 30, 2012
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The Food and Drug Administration fired six device division reviewers after they complained to Congressional staffers that the agency was approving unsafe or inadequate medical devices. The charge? Leaking confidential business information. The evidence? Personal gmail-account emails viewed on government computers that the agency monitored without employee knowledge, the Washington Post reported this morning.

The six have filed suit for wrongful discharge, as well they should. While there were probably crucial details left out of a short newspaper story and probably unknown to the reporters, there seems little doubt that the actions and comments of the six scientists were driven by differing interpretation of scientific evidence behind the approval of new devices, several of which involved detecting cancer. Firing someone for bringing that to the attention of Capitol Hill staffers after the agency has moved in what they believed was the wrong direction would seem to be a direct violation of the nation’s whistleblower protection laws.

It’s doubly disturbing that the firings occurred in mid-2010 when the debates swirling around the agency involved the inadequacy of the scientific standards being applied to medical devices through its 510(k) process, where new devices can be approved without clinical trials because they are deemed almost the same as the device they are replacing in the marketplace. One has to wonder if these firings were connected to that debate, which remains unresolved.

Obama Fails to Curb Defense Spending

January 27, 2012
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Offering a military budget designed to head off charges that he’s weak on defense, President Obama on Thursday unveiled a Pentagon spending plan that fails to cut any major procurement programs and calls for spending $36 billion more on the military in 2017 than it will spend this year.

Though billed as a cumulative cut of $259 billion over the next five years, that reduction is based on previous budget proposals that presumed the military spending would continue to grow as fast as it has over the past decade, when spending more than doubled. Total military spending, including $115 billion for the war in Afghanistan and recently-ended conflict in Iraq, totaled $646 billion this year, up from $310 billion in 2001.

Secretary of Defense Leon Panetta, who unveiled the broad outlines of the budget plan at a Pentagon press conference, repeated a theme that administration officials have sounded since last August’s debt ceiling deal, which imposed minor cuts in military spending. The deal poses the threat that there will be a significant 10-year reduction of $500 billion in military spending through sequestration if Congress doesn’t come up with alternatives.

“Sequestration would be a doubling of the cuts,” Panetta said. “That would require they take place through a meat axe approach that would hollow out the force and do severe damage to our national defense for generations.”

Liberal critics immediately scoffed at such assertions and blasted the limited cuts in Obama’s post-Iraq spending plan, which they point out would be the smallest post-war build-down of modern times. Read more »

Obama’s Pentagon Budget in One Chart

January 26, 2012
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Even with sequestration, above Cold War average

Massachusetts Miracle: Romney’s Health Care Reform Plan Works

January 26, 2012
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It’s too bad former Massachusetts Gov. Mitt Romney doesn’t want to talk about his state’s health care reform legislation on the campaign trail. If he did, he’d have a pretty good story to tell.

The reform plan, which President Obama used as a model for the national reform, lifted the number of insured residents in the Bay State from 86.6 percent in 2006 to 94.2 percent in 2010, according to a new study published yesterday by Health Affairs.

An expansion of public programs didn’t account for the gains. The number of people with employer-based coverage rose to 68 percent of the adult population in 2010 from 64.4 percent four years earlier. This is exactly the opposite of what many business groups are claiming will happen after the national reform goes into effect in 2014.

Moreover, out-of-pocket expenses declined for the average beneficiary. The number of people reporting they paid 10 percent of their family income on health care fell from 9.8 percent to 6.1 percent over the four years. Again, early fears that the Massachusetts reform would lead to a major shift in costs to consumers have not panned out.

However, the out-of-paycheck share of insurance premiums for family coverage did rise 10.1 percent over the period. But even that is pretty good news. The 2 ½%-a-year average increase is significantly below the rest of the nation’s rise in insurance costs. Still, the authors of the study concluded that “affordability of health care remains a challenge as the Bay State, like the rest of the nation, continues to struggle with rising health care costs.”

True enough. But the state is doing much better than average in terms of affordability. And it leads the nation in terms of access to insured care for its citizens.

Romney says every state should have a choice in how it tackles the problem of insuring the uninsured while lowering costs. If pressed for a good example of what works and what doesn’t, he might want to point to his own handiwork.

Stents for Stroke Prevention A Risky Proposition

January 26, 2012
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Sen. Mark Kirk, Republican of Illinois, suffered a debilitating stroke on Monday, a tragedy for him and his family. Ironically, it occurred on the eve of one of the more important Medicare meetings of the year, which convened Wednesday at the Baltimore headquarters of the Center for Medicare and Medicaid Services to discuss the best ways to prevent strokes in at-risk older adults.

Kirk, only 52, is reportedly asking for his Blackberry from his hospital bed, a good sign. He was stricken at an age when strokes are relatively rare and survival likely. But two-thirds of the 829,000 people who suffer strokes each year are over 65, and 85 percent of the 136,000 deaths each year from stroke are among that Medicare-eligible population.

No wonder that CMS, which pays the health care bills for the nation’s 45 million seniors, is concerned. The cost of treating the nearly half million Medicare beneficiaries who survive a stroke each year is staggering. It’s not just the hospitalizations, which can last a week or more, but the long-term rehabilitation and care. Many stroke victims are permanently disabled. Preventing strokes can be very cost-effective.

Physicians have long wondered how to prevent strokes. Sometimes there are warning signs: slurred speech, or the sudden loss of eyesight in one eye. People with chronic hypertension and under high stress or who are obese are clearly at risk. Nearly a century ago, medical scientists noticed that strokes were often preceded by a narrowing of the carotid artery that feeds the brain. As imaging technologies evolved, it became possible to identify people with severe plaque build-up.

Technologies to reduce blockages soon followed. Drug treatment became possible with the development in the 1950s through 1980s of blood thinners and new drugs to lower blood pressure and cholesterol. Surgeons developed an operation to clean out that major artery called carotid endarterectomy.

And then, in the late 1990s and early in the last decade, the medical device industry developed carotid stents to prop open the crucial blood vessel leading to the brain. Though more expensive, physicians and hospitals increasingly used the procedure, and performed it on asymptomatic patients deemed at risk because of the plaque seen in imaging studies.

Now imagine you’re a person identified by your physicians as being seriously at risk of a stroke because of blockage in your carotid artery, even though you have no overt symptoms of disease. Which of these technologies, if any, should you use? While there isn’t clear cut medical evidence for you or your doctor, there are clear cut risks from the operations. Read more »

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