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Shutdown Prompts Rare Government Mix: Imagination and Laughter

A Health and Human Services official, unable to attend a clinical drug trial conference, still made an appearance.

A partly empty parking lot is seen behind a House office building on Capitol Hill in Washington, D.C., as the partial government shutdown enters the third day. (Mandel Ngan/AFP/Getty Images)

The taped speech sounded almost like a confession, even a hostage plea.

“My name is Chris Galvin,” the faceless voice said, blaring out over the microphones in a conference room in the basement of the Hyatt Regency hotel in Bethesda, Md., on Wednesday afternoon. “I’m an analyst with the Office of Evaluation and Inspections for the Office of Inspector General for the Department of Health and Human Services. If you are listening to this, I apologize that I am unable to be there in person.”

Galvin, of course, was shut down, one of almost 800,000 federal employees deemed non-essential and sent home until Congress agrees on a bill to fund the government.

He had been slated to appear at a conference sponsored by the Drug Information Association, a global nonprofit organization. The conference had been scheduled for months, and was meant to wrestle with the push for greater transparency in the world of clinical drug trials.

Almost 100 people showed up, mostly from across the United States, but also from Canada, Denmark and Germany. Most spent at least $595 to attend (except for the media, who graciously were allowed in for free). There were top officials from pharmaceutical companies, leading academics, consultants, patient advocates and two officials from the Canadian government.

What was missing: Their counterparts, the U.S. officials. Suffice it to say, it left some major holes in certain sessions.

In some ways, the conference, held on Tuesday and Wednesday in the hotel’s Haverford suite, with a small stage, inconsistent audio, a large screen backed by beige curtains, and round tables with floor-dragging white tablecloths, is a microcosm of how the country has been MacGyvering its way through the government shutdown. Most people have been finding workarounds, waiting for Congress to quit bickering, hoping that the shutdown will be lifted before something really bad happens, like poor children running out of food or, well, not getting enrolled in clinical trials for new cancer drugs.

In other ways, the conference shows how no stopgap really substitutes for the real thing, even when the real thing is the notoriously cautious and circumspect Food and Drug Administration or its parent agency, HHS.

A pharmaceutical executive and a consultant ended up reading the slides from two U.S. government officials who didn’t record their comments. PowerPoint fatigue set in. And little useful clarity emerged about where the FDA actually stood on enforcing requirements for greater and accurate disclosure of certain clinical trial results.

The determination of the conference to stay on schedule, and to hold sessions even without the government speakers, ultimately came to seem like an odd, but kind of admirable, act of defiance. Elsewhere, other meetings challenged by a distinct lack of government participants just folded. For example, the Privacy and Civil Liberties Oversight Board  — better known as PCLOB —canceled its planned hearing on Friday, after being notified “by a significant number of witnesses that they are unable to testify.”

Galvin, for sure, went beyond the call of duty. He could have just skipped the clinical drug trial conference.

But he prerecorded his speech, even saying “next slide” whenever the moderator was supposed to click ahead in his PowerPoint presentation. (There was one moment when what sounded like a guitar string interrupted the recording, inexplicably. The audience laughed.)

Many of the conference’s participants had been most interested in his final session, “Clinical Trial Disclosure—FDA Enforcement Activities,” held on Wednesday afternoon, and featuring Galvin and Jarilyn Dupont, the director of regulatory policy for the Food and Drug Administration. In fact, some participants mentioned that it was the main reason they traveled to Bethesda, curious what the FDA would say, especially since FDA enforcement of clinical trial disclosure rules so far seems to be just as quiet as their offices this week.

The final session’s moderator, Robert Paarlberg, a pharmaceutical consultant who specializes in global clinical trial disclosure strategy and regulations, did his best. He launched into the enforcement session, using a picture of a kayaker landing on a whale, saying that he didn’t want anyone in the audience to be stuck in that position. Two of the three chairs for speakers, reserved for Galvin and Dupont, sat empty.

First, the lone speaker, Mark Barnes, a lawyer and medical research expert with Ropes & Gray in Boston, spoke about enforcement for about a half-hour. Then Paarlberg turned on the tape of Galvin, while clicking through Galvin’s slides.

At the end, Galvin said: “Once again, I am sorry I was unable to be there and perhaps answer questions. Should you have any questions, feel free to contact me.” Galvin then gave his email address.

There was a pause, before a bit of confused clapping.

“But he can’t answer the email until after this is over,” Paarlberg reminded everyone.

So your point is government employees will not attend a conference unless they are paid?  How unprofessional!

Great story but have the government officials as a whole, ever considered attending regardless, to demonstrate their professioalism and commitment to their jobs / counterparts / careers - its only day three and either way their not getting paid. If their not carefull, once the media hype dies down, no one will miss them! Thats another story.

I think we all are not thinking deeply enough about this so called “shut down” event. It is a symptom of the underlying problem with this current Republican party; a party I can no longer support because I don’t believe they represent the best interest of the American people any longer. The basic problem is the party is now elitist and the philosophy driving its actions is the idea that the wealthy 1% of the population must Govern the country. They truly believe the country must be run by an Oligarchy. And, they are driving events in a direction that will either assure the Super Rich rule the land or that it will take a revolution to stop them.

I have watched them over the years move more and more toward this radical position. They have moved from a party that supported business and fiscal conservatism, knowing that was the best path for growth, to a party of radical, greedy self-serving non-compromising zealots.

As you watch the actions of these people, It’s important you keep in mind that this Republican party is dead serious about installing a form of Government that will remove the common man from any influence on his Government. Vote smart against the people who carry this idea and guard your right to vote with all your energy because it’s all you have to keep this party in check and to prevent their installation of this form of dictatorship.

Reality check

Oct. 4, 2013, 1:19 p.m.

In fact, the government employees are not allowed to attend during the furlough. Whether or not they want to work for free. Those who are “essential” and still required to work are not getting paid either.

Kathy Blackwelder

Oct. 4, 2013, 1:22 p.m.

What most don’t realize, given the comments here and elsewhere, is that these employees are prohibited by law from even volunteering their services.  I cite from a report on NBC: 

“Administration officials now live in fear of a 19th-century law that could get them fired, penalized or even imprisoned if they make the wrong choices while the government is shut down.

The law is the Antideficiency Act, passed by Congress in 1870 (and amended several times), which prohibits the government from incurring any monetary obligation for which Congress has not appropriated funds.

In shutting down the government, most memos cite the law as the reason. The Government Accountability Office says employees who violate the Antideficiency Act may be subject to disciplinary action, suspension and even “fines, imprisonment, or both.”

CNBC has learned that in several executive branch departments, high-level staff members review individual decisions about what government activities to allow for fear of running afoul of the Antideficiency Act. One White House official said he has advised his employees not to check their email or cellphones. Under the act, even volunteering for government service is expressly prohibited.

In a memo to his department employees today, Treasury Secretary Jack Lew cited the law as the reason for reduced staffing.

“For the duration of this impasse, as required by the Antideficiency Act and directed by OMB, the Department will be required to operate with only the minimal staffing level necessary to execute only certain legally exempted activities,” Lew wrote.

The only exemptions to the shutdown concern “emergencies involving the safety of human life or the protection of property,” according to government documents. That has meant airports and the Postal Service are open, Social Security checks get paid and federal prisons and courts will operate as normal as do most national security functions including the military and the Central Intelligence Agency. But national parks and museums are closed along with big parts of the departments of Education and Commerce

Congress passed the law as part of a struggle—dating back to the nation’s founding—for control over the power of the purse. Some presidents, such as Abraham Lincoln during the Civil War, would incur obligations for which Congress had to appropriate funds after the fact.

What is ironic is that Congress in shutting down the government has to at least to some extent given up the power of the purse to the executive branch. Under the broad guidelines of what constitutes an emergency or threat to life or property, OMB now more or less decides what gets funded and what doesn’t. But that latitude is limited by the fear of officials that, sometime after the event, a given decision is found to have been in violation of the Antideficiency Act.”

—By CNBC’s Steve Liesman.

http://www.nbcnews.com/business/143-year-old-law-has-lawmakers-treading-gingerly-during-shutdown-8C11319714

A retired Constitutional lawyer has read the entire proposed healthcare bill. Read his conclusions and pass this on as you wish.

Well, I have done it! I have read the entire text of proposed House Bill 3200: The Affordable Health Care Choices Act of 2009. I studied it with particular emphasis from my area of expertise, constitutional law. I was frankly concerned that parts of the proposed law that were being discussed might be unconstitutional. What I found was far worse than what I had heard or expected.

To begin with, much of what has been said about the law and its implications is in fact true, despite what the Democrats and the media are saying. The law does provide for rationing of health care, particularly where senior citizens and other classes of citizens are involved, free health care for illegal immigrants, free abortion services, and probably forced participation in abortions by members of the medical profession.

The Bill will also eventually force private insurance companies out of business, and put everyone into a government run system. All decisions about personal health care will ultimately be made by federal bureaucrats, and most of them will not be health care professionals. Hospital admissions, payments to physicians, and allocations of necessary medical devices will be strictly controlled by the government.

However, as scary as all of that is, it just scratches the surface. In fact, I have concluded that this legislation really has no intention of providing affordable health care choices. Instead it is a convenient cover for the most massive transfer of power to the Executive Branch of government that has ever occurred, or even been contemplated If this law or a similar one is adopted, major portions of the Constitution of the United States will effectively have been destroyed.

The first thing to go will be the masterfully crafted balance of power between the Executive, Legislative, and Judicial branches of the U.S. Government. The Congress will be transferring to the Obama Administration authority in a number of different areas over the lives of the American people, and the businesses they own. The irony is that the Congress doesn’t have any authority to legislate in most of those areas to begin with! I defy anyone to read the text of the U.S. Constitution and find any authority granted to the members of Congress to regulate health care.

This legislation also provides for access, by the appointees of the Obama administration, of all of your personal healthcare direct violation of the specific provisions of the 4th Amendment to the Constitution information, your personal financial information, and the information of your employer, physician, and hospital. All of this is a protecting against unreasonable searches and seizures. You can also forget about the right to privacy. That will have been legislated into oblivion regardless of what the 3rd and 4th Amendments may provide…

If you decide not to have healthcare insurance, or if you have private insurance that is not deemed acceptable to the Health Choices Administrator appointed by Obama, there will be a tax imposed on you. It is called a tax instead of a fine because of the intent to avoid application of the due process clause of the 5th Amendment. However, that doesn’t work because since there is nothing in the law that allows you to contest or appeal the imposition of the tax, it is definitely depriving someone of property without the due process of law.

The 9th Amendment that provides: The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people; The 10th Amendment states: The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are preserved to the States respectively, or to the people. Under the provisions of this piece of Congressional handiwork neither the people nor the states are going to have any rights or powers at all in many areas that once were theirs to control.

I could write many more pages about this legislation, but I think you get the idea. This is not about health care; it is about seizing power and limiting rights…

Article 6 of the Constitution requires the members of both houses of Congress to “be bound by oath or affirmation to support the Constitution.” If I was a member of Congress I would not be able to vote for this legislation or anything like it, without feeling I was violating that sacred oath or affirmation. If I voted for it anyway, I would hope the American people would hold me accountable. For those who might doubt the nature of this threat, I suggest they consult the source, the US Constitution, and Bill of Rights. There you can see exactly what we are about to have taken from us.

Michael Connelly Retired attorney, Constitutional Law Instructor Carrollton , Texas

CONGRESS MUST BE HELD ACCOUNTABLE BEFORE IT IS TOO LATE.

Here is a previously made claim here by “Larry” of having reviewed the content of ACA proving many of the things we have been reading about on this string.

It starts with the following statement: “... I have read the entire text of proposed House Bill 3200: The Affordable Health Care Choices Act of 2009.”

Do you see the glaring escape clause of reality built into this preface to a following political litany of condemnation sufficient to raise the hackles of any reasonable person ( that is—if they had any visible hackles)?

This, fully justified, if one does not realize that this review did not otherwise reveal that this statement was based upon a proposed version of the bill that actually materialized after considerable review and modification.

But, might this be the kind of confusing material that has been driving the actions of many who post here with condemnation of statements that have never actually seen the light of reality?

Please disreguard my previous statement and simply read the following information offered by Snopes:

http://www.snopes.com/politics/soapbox/connelly.asp

This said it far better than I did.

And most of the system of insurance we have now provides opportunity for all those things to happen, too. Rationing? Yup. “Free” anything? If you consider things already paid for by premiums free, then yup. People in the country illegally getting medical care? How many ERs check your citizenship when you walk through the door today? Et cetera, et cetera.

I am an single uninsured 59yo male citizen who dutifully filled out the 18 pages of forms which concerned me, the whole application is 33 pages. The One reason I downloaded the form instead of filling it out online was expediency. I did it, it’s done..now I won’t get fined.
What ever happens will happen

Laughter?
There is nothing funny at all about what is happening. The only people I see laughing are the folks who realy wanted to “drown the government in the bathtub”.
The folks from outside this country are either perplexed, ( this is way way a democracy works???) or pleased ( “See, I told you that the so-called greatest nation on earth is stupid and hypocritical)

It’s a sad day in our democracy when the Speaker of the House actively undermines democracy for his own ego and a non-existant (Hastert) rule.

No Laughter here!

ken lukaszewski

Oct. 5, 2013, 9:35 p.m.

Nice work Jerry

Mr. Shahislam

Oct. 6, 2013, 5:49 a.m.

The good out of bad is in the answer of this question:
Why the Shutdown occurred just 20 days ahead of time?
Distract global folks’ attention from the due outcome of USA-Russia-Iran + joint venture against “royal-crimes in dark-age fashion (e.g. Saudi Arabian or old kingdom’s politics of brutality -openly at occupied homeland and secretly abroad by supplied huge monetary funds)”
 
The GOOD: Kudos to Obama-Biden-Kerry-Hagel—-the blessed and most successful team among all current, recent and past US Administrations.


This team will be recognized as the BEST of all by Global folks when the captured Field-terrorists at fair & transparent trials shall begin to divulge the names of actual fund providers or brutal-minded thugs of oil & gun politics and /or royals, oil-wealthy-businessmen of religions, bombs in noble disguise etc..


” * Selfless Works & honest Wishes for the Earthly benefit of Mankind in this World only are bound to come true ! “
A wise reader in searching of wisdom would like to visit wwwshahislamDOTcom

clarence swinney

Oct. 6, 2013, 11:36 a.m.

PRESIDENTS 2014 BUDGET
SPENDING
33%—Social Security-Unemployment & Labor
25%—Medicare & Health
17%—Military
————75%—————-
6%—-Interest on Debt
4%—-Veterans Benefits
4%—-Transportation
4%—-Food and Agriculture
2%—-Housing & community
2%—-Education
1%—-Energy & Environment
1%—-International Affairs
1%—-Science
1% Government

REVENUE
46%—Individual Income Taxes
34%—Payroll Taxes
—————-80%———————-
11%—Corporate Income Taxes
4%——Misc.-
3%——Excise Taxes
1%——Custom Duties
Significants—The president projects $3Trillion in tax revenue in 2014,  an increase of 12% relevant to 2013.
The Richest yet how we rank in OECD as percent of GDP
1. Largest percent of population paid lowest wages
2. Lowest tax on corporation profits
3. Lowest tax on individual incomes
4. Inequality—Rich to Poor widest spread since 1929
5. this is sad sad sad indictment on us

Bruce Colquhoun

Oct. 6, 2013, 11:38 a.m.

The essential purpose for a health care system is to get control of rising health costs.  Medicare, and the federal government’s obligation on Medicaid, will take over the US budget in 20 or 30 years, whatever the current estimate is, and that was known to be the original focus on a new law.  This has been an ongoing struggle with this industry that inflates its costs above the rest of the economy for a long time Someday if we continue on our present course, the largest entitlement Medicare will cause the annual payments on the total national debt to surpass US income causing default.  We don’t kill people as a remedy, brand them racist or greedy misers, but study the problem.   
    Reports of an allowable (further increased) US debt tied to GDP are not realistic about dealing with the debt looking back at our history.
    Obamacare focuses on the 15 to 20 percent of uninsured that are treated in hospitals that contribute to other patient’s costs, those that have no money to pay, refuse to pay, or don’t qualify for Medicaid.  The caustic arguing in blogs I think lead the president to this solution.  The uninsured, not a large percentage when one thinks about the insane prices of treatment these days.  In addition to that, the ACA law adds coverage for the pre-condition people of whom would otherwise be sued by a provider having lost their insurance and not having or giving up the cash.  That surrender of payment to be used toward care would also be lost from the ACA law.  That’s one that needs a fix but one that is a focus of those with lots of money of which they might lose, with Congress mostly millionaires one might think of that.
    As it is now everyone does get treatment whether they have ability to pay, their insurance, government, or not, likely always will in some way for humanitarian reasons.  And just because insurance or government pays, does not belay the fact that it still pays way too much and that costs still rise having no lid on provider profits in place.  Europe pays half as much and we gripe they are inefficient.  Not like you can really shop around when the ambulance is making its sounds and you are connected with pipes and drugged, or does it help when they all charge the same super high price with costs reflected in insurance payments.  In fact there is more reason to think that the pricing is more a game, given the recent required disclosure (ACA) of 60 common treatments and what each hospital charges, they were shown huge differences between each other, some a few blocks away, and no association to quality.  It’s as if they thought a certain strategy would be helpful if government had some response to the report but it’s all clouded in hidden amounts that are the actual payment.  Normally private industry is secretive but the whole industry here so expensive.  This game of wholesale versus retail is crazy too.  They cut special deals and likely the care is compromised to maintain profitability.  My mother got a special deal to give a hospital all her Medicare business, and when she got sick she was ignored for 3 days except for a nurse’s aid.
    Republicans want a plan, like in the last election Mr. Ryan mentions, savings accounts.  But I think you still have to provide care to all, even if people are illegals or criminals.  Republicans can’t be pried off their Cadillac plans it seems, are mistaken to think the US has the best quality care with that high price as many reports show.  OK fine, let them pay extra for that, but we should first find out what is costing the rest of us so much in hospitals and probably the only way to get a handle on the rising costs is to limit providers profit.  Leaders need to divest from special interest and stow the political correctness putting in place a system that is not cannibal capitalist, or model of perfection for control freaks (eat your brockoli), but more like a plain old utility reliable and fair.

To get it out of the way, I want to point out that it’s pretty funny that anyone reading the ACA bill (which I, incidentally, actually did, back when it was being debated—I’ll get back to that) with an eye towards Constitutional issues would worry about the poor insurance companies ability to stay in business.

I must have missed that clause in the Constitution.

As to the bill itself, I found it largely offensive, but for different reasons.  First, we’re all sold to the insurance companies, who get to rake in huge profits at the expense of paying for an occasional cancer patient.  Second, there is some shadowplay about letting the treatment be dictated by cost-effectiveness; that’s bad enough in government hands, but basically a death-warrant in the hands of a for-profit bureaucracy looking to hit quarterly quotas.  Other than that, it’s pretty boring and says surprisingly little for all its bulk.

Now, to the shutdown, closing down Health and Human Services in the fall sounds a lot like a pretty bad flu epidemic come the new year.  I hope those people OK with the shutdown are also OK with putting the elderly population at risk.  Pregnant women, too, which sounds to me like a Commie plot to give out free abortions.

Good thing they’ll be getting ObamaCare, right…?

I mean, seriously, how stupid are these people?  I feel like one’s principles can safely be flushed when they’re provably hurting people and failing miserably to achieve the goals decided on by that principle.

And Kathy’s right, by the way.  Furloughed from the government’s standpoint doesn’t merely mean paychecks stop getting printed.  It also often means (unless you’re “essential”) that it’s against the law to act at all in the context of your job.  So going to the conference anyway can have unpleasant legal consequences, which doesn’t sound worth it.

clarence swinney

Oct. 10, 2013, 10:52 a.m.

Bruce Colquhoun

Oct. 6, 12:38 p.m.
The essential purpose for a health care system is to get control of rising health costs.  Medicare, and the federal government’s obligation on Medicaid, will take over the US budget in 20 or 30 years, whatever the current estimate is, and that was known to be the original focus on a new law.  This has been an ongoing struggle with this industry that inflates its costs above the rest of the economy for a long time Someday if we continue on our present course, the largest entitlement Medicare will cause the annual payments on the total national debt to surpass US income causing default.  We don’t kill people as a remedy, brand them racist or greedy misers, but study the problem. 
  Reports of an allowable (further increased) US debt tied to GDP are not realistic about dealing with the debt looking back at our history.
  Obamacare focuses on the 15 to 20 percent of uninsured that are treated in hospitals that contribute to other patient’s costs, those that have no money to pay, refuse to pay, or don’t qualify for Medicaid.  The caustic arguing in blogs I think lead the president to this solution.  The uninsured, not a large percentage when one thinks about the insane prices of treatment these days.  In addition to that, the ACA law adds coverage for the pre-condition people of whom would otherwise be sued by a provider having lost their insurance and not having or giving up the cash.  That surrender of payment to be used toward care would also be lost from the ACA law.  That’s one that needs a fix but one that is a focus of those with lots of money of which they might lose, with Congress mostly millionaires one might think of that.
  As it is now everyone does get treatment whether they have ability to pay, their insurance, government, or not, likely always will in some way for humanitarian reasons.  And just because insurance or government pays, does not belay the fact that it still pays way too much and that costs still rise having no lid on provider profits in place.  Europe pays half as much and we gripe they are inefficient.  Not like you can really shop around when the ambulance is making its sounds and you are connected with pipes and drugged, or does it help when they all charge the same super high price with costs reflected in insurance payments.  In fact there is more reason to think that the pricing is more a game, given the recent required disclosure (ACA) of 60 common treatments and what each hospital charges, they were shown huge differences between each other, some a few blocks away, and no association to quality.  It’s as if they thought a certain strategy would be helpful if government had some response to the report but it’s all clouded in hidden amounts that are the actual payment.  Normally private industry is secretive but the whole industry here so expensive.  This game of wholesale versus retail is crazy too.  They cut special deals and likely the care is compromised to maintain profitability.  My mother got a special deal to give a hospital all her Medicare business, and when she got sick she was ignored for 3 days except for a nurse’s aid.
  Republicans want a plan, like in the last election Mr. Ryan mentions, savings accounts.  But I think you still have to provide care to all, even if people are illegals or criminals.  Republicans can’t be pried off their Cadillac plans it seems, are mistaken to think the US has the best quality care with that high price as many reports show.  OK fine, let them pay extra for that, but we should first find out what is costing the rest of us so much in hospitals and probably the only way to get a handle on the rising costs is to limit providers profit.  Leaders need to divest from special interest and stow the political correctness putting in place a system that is not cannibal capitalist, or model of perfection for control freaks (eat your brockoli), but more like a plain old utility reliable and fair.

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