House UnAmerican Activities Editorial

08/11/2009 03:49 AM |

http://blogs.usatoday.com/oped/2009/08/unamerican-attacks-cant-derail-health-care-debate-.html

We have taken great pains to distance ourselves -- and those individuals who have attended town hall meetings of their own volition -- from the handful of individuals and one or two nut jobs who sought to shout rather than ask tough questions even as certain poitical operatives have sought to lump us, them and all into one seething hateful mob.

That is politics as usual.

But the editorial today by Speaker Pelosi and House Majority Leader Hoyer -- mostly unmentioned by the same media who covered the handful of angry Americans as if they were the vanguard of some neo-Bund movement -- calling those who assemble and organize against a misguided effort to increase government control over healthcare as "unAmerican.

Here is the key quote:

"An ugly campaign is underway not merely to misrepresent the health insurance reform legislation, but to disrupt public meetings and prevent members of Congress and constituents from conducting a civil dialogue. These tactics have included hanging in effigy one Democratic member of Congress in Maryland and protesters holding a sign displaying a tombstone with the name of another congressman in Texas, where protesters also shouted "Just say no!" drowning out those who wanted to hold a substantive discussion.

Let the facts be heard

These disruptions are occurring because opponents are afraid not just of differing views — but of the facts themselves. Drowning out opposing views is simply un-American. Drowning out the facts is how we failed at this task for decades."

Those who oppose or criticize are part of an ugly campaign to drown out opposing views and suppress the facts.   Thus we are unAmerican. 

Have you been or are you now part of any campaign to oppose health care reform.  If so, you are drowning out the facts.  And if you were oppose health care reform you obviously endorse hanging opponents in effigy.

I think the exchange between Joseph McCarthy and Joseph Welch sums up the tactics and desperate moral compass of Ms. Pelosi and Mr. Hoyer with respect to enacting single payer healthcare reform. I can't generalize to anyone else ...

http://en.wikipedia.org/wiki/Joseph_N._Welch

On June 9, 1954, the 30th day of the hearings, McCarthy accused Fred Fisher, one of the junior attorneys at Welch's firm, of association (while in law school) with the National Lawyers Guild (NLG), a group which J. Edgar Hoover sought to have the U.S. Attorney General designate as a Communist front organization (see Army-McCarthy hearings). Welch wrote off Fisher's association with the NLG as a youthful indiscretion and went after McCarthy for dragging the young man's name before a nationwide television audience with no prior warning or previous agreement to do so:

"Until this moment, Senator, I think I have never really gauged your cruelty or your recklessness. Fred Fisher is a young man who went to the Harvard Law School and came into my firm and is starting what looks to be a brilliant career with us...(L)ittle did I dream you could be so reckless and so cruel as to do an injury to that lad. It is true that he will continue to be with Hale and Dorr (Welch's law firm). It is, I regret to say, equally true that I fear he shall always bear a scar needlessly inflicted by you. If it were in my power to forgive you for your reckless cruelty I would do so. I like to think that I am a gentle man, but your forgiveness will have to come from someone other than me."

When McCarthy tried to go on the attack once more, Welch stepped in again and famously rebuked:

"Senator, may we not drop this? We know he belonged to the Lawyers Guild...Let us not assassinate this lad further, Senator. You have done enough. Have you no sense of decency, sir? At long last, have you left no sense of decency?"

McCarthy tried to ask Welch another question about Fisher, and Welch cut him off:

"Mr. McCarthy, I will not discuss this with you further. You have sat within six feet of me and could have asked about Fred Fisher. You have brought it out. If there is a God in Heaven it will do neither you nor your cause any good. I will not discuss it further. I will not ask Mr. Cohn any more questions. You, Mr. Chairman, may, if you will, call the next witness."

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Health Reform Goes Pink

08/10/2009 11:52 AM |

Pink Sheet, that is.

Two items of note (courtesy of the Pink Sheet) that are urgently important, but getting little attention.

1. Non-Interference

The House health care reform bill passed by the Energy and Commerce Committee directs HHS to negotiate drug prices directly with manufacturers for the Medicare Part D program, but it does not authorize HHS to establish a national formulary.

That leaves the provision vulnerable to being stripped out as the bill proceeds through Congress -on the basis that it may not reduce costs.

The Congressional Budget Office, in past estimates, has consistently concluded that savings generated from direct government price negotiation under Part D would be negligible unless HHS could bring some bargaining leverage to the table.

In a 2007 analysis, then CBO Director (now OMB Director) Peter Orszag wrote: "Negotiation is likely to be effective only if it is accompanied by some sort of pressure on drug manufacturers to secure price concessions."

Specifically, "the authority to establish a formulary, set prices administratively, or take regulatory actions against firms failing to offer price reductions could give the [HHS secretary] the ability to obtain significant discounts."

He added that "in the absence of such authority, the Secretary's ability to issue credible threats or take other actions in an effort to obtain significant discounts would be limited."

2. Comparative Effectiveness

Although it was not introduced during the House Energy and Commerce Committee's markup of the health care reform bill, an amendment prepared by Rep. Donna Christensen, D-V.I., that would create a public-private institute to oversee comparative effectiveness research activities remains in play and could be a part of the final package that is voted on by the House.

Christensen was given the go-ahead to introduce the amendment during the markup, but time constraints kept the amendment, which was filed with the committee, from being introduced for consideration. A staffer for Christensen said the representative has a commitment from Energy and Commerce Chairman Henry Waxman, D-Calif., to work on adding the amendment to the final House bill. The amendment would replace the current language in H.R. 3200 that places coordination of comparative effectiveness research activities within the Agency for Healthcare Research and Quality. The current language creates an independent CER commission to oversee the center, recommend research priorities and conduct stakeholder outreach.

According to a fact sheet on Christensen's amendment, it would create an independent public-private institute governed by a board of directors consisting of the HHS secretary, the directors of AHRQ and the National Institutes of Health, and 20 additional members appointed by GAO representing a broad range of stakeholders, including patients and consumers, physicians, public agencies (CMS and state and federal health programs), private payers, drug and device manufacturers, non-profit health research organizations, quality measurement/decision support organizations and organizations conducting minority health research.

The amendment, co-sponsored by fellow committee Democrat Jay Inslee, Wash., and Republicans Greg Walden, Ore., and Fred Upton, Mich., has a lot in common with the approach that Senate Finance Committee Chairman Max Baucus would like to get into that committee's version of the bill.

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AP becomes part of Obama Counter Campaign

08/07/2009 11:05 PM |

Here's AP's Erica Werner taking up the Obama cause to swat away "disinformation" about health care reform:

Support for Obama's approach to health care has dropped in the polls, and the White House sought to address some oft-repeated claims.Among them: Will Medicare benefits be cut? Will government bureaucrats ration care? Will the elderly get progressively less care and then have euthanasia presented as an option?

Sebelius answered: No, no and no.

She said the administration wants to save money in Medicare by eliminating unnecessary procedures and hospital readmissions, among other things, but that there was no desire to eliminate needed benefits. She contended that insurance companies already ration care and that Obama wants to give doctors more control, not less.

As for the euthanasia claim: "Nothing could be less true ... that is just not part of the conversation," Sebelius said.

The rumor has become widespread and seems to stem from a provision in the House bill that would require Medicare to pay for direct consultations with health care professionals. Sebelius noted that no one would be required to use the benefit and said it would help many families. "

Notice any response from people that might have information -- cited and sourced (contra the Sebelius generalities) to the contrary?

Nada.

Nice work, Erica.  Is this on top of your AP salary?

Read article here

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LaRouchies Pollute Healthcare Debate

08/07/2009 09:27 PM |

When I heard that the other N word (Nazi) was being used or represented by people at town hall meetings it took me about two seconds to realize that those spewing the garbage were none other than LaRouchies who see the rise of fascism behind every government action. See sick site below...

Read it here

Let's be clear: there is nothing Nazi-like about any of the healthcare proposals.  Just writing that, makes me sick.  What is even sicker is how the LaRouche zombies are able to insinuate themselves into rallies, meetings, etc. without being called on it.   Which explains how Borat got made I guess. 

In any event,  it is up to those people and organizations who are genuinely concerned about a government takeover of healthcare to express those opinions with passion, conviction and through democratic action.  And at that same time it might behoove them to call out those who would use the Nazis plan to exterminate the Jews as a metaphor for healthcare reform as beyond the pale of civilized discourse.  


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Dobbs Story

08/07/2009 06:47 PM |

My discussion of Great Britain's National Health Service and NICE (from Thursday night's Lou Dobbs program) can be found here.


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Skip to my Lou

08/07/2009 01:09 PM |

Yesterday healthcare in the United Kingdom was the focus of a segment on the Lou Dobbs Show.  Lou’s lead in to the segment (reported on by Kitty Pilgrim) was, “In fact almost 60 percent of Britons believe the system requires fundamental change. Kitty Pilgrim has our report.”

KITTY PILGRIM, CNN CORRESPONDENT (voice-over): Go to a doctor in Britain, you won't have to pay when you leave. It's the same at the hospital. All health services are publicly funded by the National Health Service, funded by taxes. For that reason, a survey revealed only two percent of people in the U.K. who had a medical problem did not seek treatment because of costs. Peter Pitts (ph) of the Center for Medicine in the Public Interest, a nonpartisan research group, says the upside to the U.K. health system is universal coverage.

PETER PITTS, CTR. FOR MEDICINE IN THE PUBLIC INTEREST: The NHS delivers healthcare today in the classic British tradition of muddling through. It’s mediocre care for everybody.

PILGRIM: The British government sets the budget and is charged with determining what will and will not be paid for. Critics point out that cutting-edge drug treatments for Alzheimer's, cancer and other severe conditions are often not included on a list of medicines that the government agency known as NICE will allow for reimbursement. Peter Pitts says it's a system that has real shortcomings.

PITTS: You can either accept a one size fits all health care system, which really doesn't fit anybody all that well, which is really terrific if you're not sick or very sick. But once you have cancer or advanced stages of lots of diseases and you really need cutting-edge medicine that system is really not equipped to provide it with excellence as ours is here.

PILGRIM: Now a 2007 study found that 57 percent of the people in the U.K. said the system really needed significant overhaul. Some in the U.K. have decided to opt out of the national health system and pay for private medical coverage. It is available. But anyone taking on private medical care has to opt out of the national health system, so a telling point is in the last decade some British companies are actually offering private health care as a recruitment perk for their employees.

Video posting of the complete segment shortly.

On a related and very timely note, the Times of London reports today that:

“Medical leaders have warned that shortages of doctors, nurses and other clinical staff are putting the NHS under unsustainable pressure as a generation of health workers enters retirement amid cutbacks in junior doctors’ working hours.

The number of vacancies for hospital doctors, dentists, nurses and midwives has risen for the first time in five years as trusts struggle to recruit and retain staff. New data from the NHS Information Centre revealed that more than one in twenty medical and dental posts were vacant at the end of March, in some cases for months at a time, while thousands of nursing and midwifery posts were also unfilled.

Of the total number of vacant posts, one in five — 5,500 jobs — had been left unfilled for three months or more, suggesting long-term problems with recruitment. Senior staff leaving the service and the reluctance of younger people to replace them were blamed for the shortfalls as total vacancy rates increased across most staff groups. Doctors’ leaders have also warned that the European Working Time Directive, which from this month limits junior doctors to a maximum 48-hour week, could create shortages, leaving trusts to rely on temporary or locum staff.”

The complete Times story can be found here.

These times demand the Times (of London).

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Ratcheting it up a Peg

08/06/2009 03:16 PM |

More comments on this shortly.

FDA NEWS RELEASE

FDA Commissioner Sets Out Vision on Enforcement to Support Public Health

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., today outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations.

“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Commissioner Hamburg told a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington, D.C. “We must get the word out that the FDA is on the job.”

Commissioner Hamburg said that some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” She added that the pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”

Commissioner Hamburg highlighted six initial steps designed to hone the effectiveness and timeliness of the FDA’s regulatory and enforcement system:

– Set post-inspection deadlines. The FDA will establish a clear timeline for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.

– Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.

– Work more closely with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.

– Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.

– Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.

– Develop and implement a formal warning letter “close-out” process.” If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.

By taking these steps, Commissioner Hamburg said, the FDA will ensure that “violative inspection results are taken seriously, that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”

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When Moore is Less

08/06/2009 01:37 PM |

Wow.  Busy day what with the front page article in the New York Times and some very savvy reporting in the Wall Street Journal. Who said August was going to be slow? Talk about a food fight at recess!

All that to say that the window seems to be somewhat open to actually discussing the … facts! I know, who would ever have thunk it.

Taking advantage of this new opportunity, I’ve penned a new op-ed on the Reuters “Great Debate” site.  Here’s a taste:

“In SiCKO, Michael Moore portrayed the British National Health Service and the Canadian health system as particular exemplars of excellence. He backed it up with a lot of statistics, but statistics, as the saying goes, are like a bathing suit. What they show you is interesting, but what they conceal is essential.

And what SiCKO concealed was that systems such as those in the United Kingdom and Canada are cost-based rather than patient-centric models. Facts, no matter how inconvenient to one’s argument, must not be ignored.

Citizens of countries with government-run health care systems experience long wait times, a lack of access to certain treatments and, in many instances, substandard medical care. For example:

• The five-year survival rate for early diagnosed breast cancer patients in England is just 78 percent, compared to 98 percent in the U.S.

• A typical Canadian seeking surgical or other therapeutic treatment had to wait 18.3 weeks in 2007, an all-time high, according to The Fraser Institute.

• The average wait time for bypass surgery in New York is 17 days compared to 72 days in the Netherlands and 59 days in Sweden.

• More than half of Canadian adults (56 percent) sought routine or ongoing care in 2005. Of these, one in six said they have trouble getting routine care.

• Eighty-five percent of doctors in Canada agree private insurance for health services already covered under Medicare would result in shorter wait times.

• Approximately 875,000 Canadians are on waiting lists for medical treatment.

If we’re going to look to other healthcare models for solutions, we must uncover and study their problems. Health care is too important to allow reform by sound bite. “Drugs from Canada” is as much a false promise as “free” healthcare. Such are the fallacies that political rhetoric hath wrought."

The complete op-ed can be found here.

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Help the White House Fish for Disinformation

08/06/2009 02:49 AM |

Have you seen the creepy youtube from the White House Office of Healthcare Reform seeking help to rat out people like me and Peter who spread disinformation through emails, casual conversations and passing notes in school about health "insurance" reform (which is it guys?)

Here it is...



Well, ok...

So how about Obama vs. Obama. Is that fishy disinformation?

Here is the President's response -- captured in the clip provided by The Disinformation Czarina -- to a question posed by Jake Tapper about whether people will have to change plans or not:

"Well, all right- when I say if you have your plan and you like it, and your doctor has a plan- or you have a doctor and you like your doctor, that you don't have to change plans, what I'm saying is the government is not going to make you change plans under health reform. Now, are there going to be employers right now, assuming we don't do anything- let's say that we take the advice of some folks who are out there and say, "Oh, this is not the time to do health care. We can't afford it. It's too complicated. So, let's take our time," et cetera. So let's assume that nothing happened. I can guarantee you that there's the possibility for a whole lot of Americans out there that they're not going to end up having the same health care they have. Because what's going to happen is, as costs keep on going up, employers are going to start making decisions. We've got to raise premiums on our employees. In some cases, we can't provide health insurance at all. And so there are going to be a whole set of changes out there. That's exactly why health reform is so important."

Left unsaid in all this is whether the government will try to keep you from changing plans if you want (which happens in all bills) or using Medicaid as a dumping ground for people. And the President pretty cheery about the possibilities of a government run plan being lots cheaper than a private plans:

"So there are going to be some ground rules that are going to apply to all insurance companies. Because I think the American people understand that, too often, insurance companies have been spending more time thinking about how to take premiums and then avoid providing people coverage than they have been thinking about how can we make sure that insurance is there; health care is there when families need it. But, I'm confident that, if- you know, I take those advocates of the free market to heart when they say that, you know, the free market is innovative and is going to compete on service and is going to compete on, you know, their ability to deliver good care to families. And if that's the case, then this just becomes one more option. If it's not the case, then I think that that's something that the American people should know."

Is that because he knows government can set prices and low-ball private companies who are forced to charge young and healthy people higher premiums to subsidize sick and health people.

That's also in all the bills.

Is Obama vs the actual legislation fishy?


Want more? Go to www.handsoffmyhealth.org Get knee deep in disinformation. As Orwell said, “In a time of universal deceit, telling the truth becomes a revolutionary act.”


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The Trap Door Beneath the "Seat at the Table"

08/05/2009 12:44 PM |

It must be nice to believe that Uncle Sam, MD can be the reincarnation of Marcus Welby.  Similarly, it must be nice to believe that veganism is the answer to our national healthcare woes.  And it must be nice to believe that a national healthcare system run by the government minus any free-market incentives isn’t socialism. Therefore, it must be nice to be Congressman Dennis Kucinich.  He believes all of the above.

As already mentioned, (http://www.drugwonks.com/blog_post/show/6904)  the former Boy Mayor and I spent the better part of an hour Saturday debating healthcare reform on Fox Business Channel.  My favorite bit (and its right up front, so have look) was when he said that, just because the government would pay the bills and specify the treatments, doesn’t mean the government would be “in control.”

To which I replied (and with all due respect) that he was “living in fantasyland.”

The complete debate can be found here.

http://drugwonks.com/podcasts/peter-pitts-on-fox-business/

Kucinichcare.  What a concept.

In the meantime, the gloves are off elsewhere too. Got this e-mail yesterday and it’s worth passing along:

FISHY CLAIMS

We Answer The White House's Call For "Disinformation" On Government-Run Health Care

THE WHITE HOUSE'S BLOG: "There is a lot of disinformation about health insurance reform out there, spa nning from control of personal finances to end of life care ... Since we can't keep track of all of them here at the White House, we're asking for your help. If you get an email or see something on the web about health insurance reform that seems fishy, send it to flag@whitehouse.gov." (Macon Phillips, "Facts Are Stubborn Things," The White House's "Briefing Room" Blog, 8/4/09)

WE FOUND FISHY CLAIMS ABOUT KEEPING YOUR DOCTOR AND YOUR INSURANCE PLAN ...

"If you have insurance that you like, then you will be able to keep that insurance. If you've got a doctor that you like, you will be able to keep your doctor." http://tinyurl.com/mj5od2

"If you like your doctor, you will be able to keep your doctor. Period. If you like your health care plan, you will be able to keep your health care plan. Period. No one will take it away. No matter what." http://tinyurl.com/mzkrz9

AND FISHY CLAIMS ABOUT SO-CALLED "PUBLIC PLAN" AND CONSUMER CHOICE ...

"Now, the public plan I think is a important tool to discipline insurance companies. What we've said is, under our proposal, let's have a system the same way that federal employees do, same way that members of Congress do, where -- we call it an 'exchange,' or you can call it a 'marketplace' -- where essentially you've got a whole bunch of different plans." http://tinyurl.com/krmgqn

"That's why I've said that I think a public option would make sense. What that then does is, it gives people a choice ... You don't have to do anything. But if you don't have health insurance, then you have an option available to you." http://tinyurl.com/moq36h

AND A FISHY CLAIM ABOUT KEEPING HEALTH CARE COSTS DOWN ...

"What I've said is our top priority has to be to control costs... And I've said very clearly: If any bill arrives from Congress that is not controlling costs, that's not a bill I can support. It's going to have to control costs. It's going to have to be paid for." http://tinyurl.com/krmgqn

AND A FISHY CLAIM ABOUT TAXING MIDDLE CLASS

"And while they're [Congress] currently working through proposals to finance the remaining costs, I continue to insist that health care reform not be paid for on the backs of middle-class families." http://tinyurl.com/lkvgsp

So to help the surely inundated White House, we've already debunked these "fishy" statements at BarackObamaExperiment.com

Was anyone really ever wearing gloves in the first place?  Hard to act polite when that "seat at the table" had a trap door beneath it.

Meanwhile, on the topic of when “cost” means “co-pay,” a new op-ed in today’s edition of Speaker Pelosi’s hometown newspaper, the San Francisco Chronicle.  It begins as follows:

Higher co-pay, fewer prescriptions filled

Peter Pitts

“One of the major threats to patient health hasn't received nearly enough attention during the recent negotiations in Washington over comprehensive health care legislation. Millions of Americans aren't sticking to their pharmaceutical drug regimes. As a result, they're compromising their own care, and putting themselves at risk of developing more serious - and more costly - conditions.

According to a recent study by Wolters Kluwer Health, fewer Americans are filling their drug prescriptions. In the fourth quarter of 2008, U.S. patients neglected to fill 6.8 percent of on-patent prescriptions - a 22 percent increase compared to the first quarter of 2007. (On-patent prescriptions are those for which there is no generic alternative to the brand-name drug.)

Why? Drug prices. It's not that the cost of prescription drugs is rising - it's patients' out-of-pocket costs, or co-pays. One of the reasons for this is that insurance companies, reluctant to foot the bill for brand-name medications, have been refusing to cover more brand-name prescriptions.

In the fourth quarter of 2008, in fact, health insurers denied coverage for 10.8 percent of brand-name drugs - a jump of 21 percent from the first quarter of 2007.

And it's not because the medicines themselves are becoming more expensive. Between 1998 and 2003, prescription drug costs increased by $22.48 per person. Meanwhile during that same period, the average health insurance premium went up by $104.62 per person.”

For the rest of the story, see here.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/08/04/EDP0193SR1.DTL

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Cash for Clunkers: AHRQ Studies Chelation Therapy and Scans the Horizon for Costly New Drugs

08/04/2009 05:57 PM |

This is exactly what taxpayers were hoping to get for the $1 billion ...

A study to look at whether drinking rice milk and strapping autistic kids down and filling them with dimercaptosuccinic acid cures their disease compared to playing wiwth gluten free Play-do...?

Read more here

Studies that seek to squeeze down the cost of using drugs and technologies for cancer and arthritis in Medicare without regard to variations in genetics, age, race, comorbidity and all the other things comparative effectiveness was supposed to take into account...  or as  Kaiser Health "News" reports:

Comp. Effectiveness Promises Better, Cheaper Health Care But Critics Link It To Rationing

Read story here

Don't know how I even got the two confused. Sorry. How stupid of me... Won't happen again....

AHRQ supports many important health care services research activities.  However it's comparative effectiveness program is second rate, anti-innovation and is now being politicized by those in Congress and in the Obama administration who want to find money to pay for a government takeover of health care.  Add to that, "stakeholders" are skewing the agenda and the science, allowing federal dollars to be devoted to study junk science about autism "cures" and vaccine dangers ...
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Mr. Rogers' Neighborhood II

08/04/2009 12:01 PM |

HR 3200 would formalize a comparative effectiveness research center within AHRQ (the Agency for Healthcare Research and Quality). An independent CER commission would be formed to oversee the center, recommend research priorities and conduct stakeholder outreach.

Our friend and colleague (and House Energy & Commerce Committee member) Congressman Mike Rogers (R, MI) sponsored an amendment that says "in no case may any research conducted, supported or developed by the Center for Comparative Effectiveness Research, the Comparative Effectiveness Research Commission, or the Federal Coordinating Council for Comparative Effectiveness Research be used by the federal government to deny or ration care."

Pleased to report that the amendment passed, despite a “nay” from Mr. Waxman.

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Good News, Bad News

08/03/2009 03:35 PM |

The good news....

The Eshoo version of protecting patients and data exclusivity for new biotech drugs sailed through the Waxman controlled Energy and Commerce Committee...

"One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March.  In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed.  The amendment was passed by the Committee by a comfortable 41-11 margin.  Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA).  The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors)."

The bad news....

House Compromise Would Let Medicare Negotiate Drug Prices

"The government would be authorized to negotiate prices in Medicare’s prescription drug program under an agreement Energy and Commerce Committee Democrats struck Friday on its health overhaul bill.

The panel, rushing to finish its part of the huge bill before leaving later in the day for the August recess, was expected to vote on the drug pricing provision as part of a package of amendments aimed at satisfying the competing demands of liberal and conservative Democrats...."

.....The second amendment, according to a summary of the agreement, would make a number of less controversial changes to the bill, including requiring that the public plan use a formulary to control its drug cost.

The third amendment would authorize HHS to negotiate drug prices paid by Medicare — something long fought by the pharmaceutical industry.

The amendment also would require insurance plans selling policies through a new “exchange” created by the bill to request permission from the government before increasing their premiums faster than the rate of medical inflation, one lawmaker said.

Read article here.

Price controls. Not controversial?

Meanwhile in an announcement that was striking for it's coincidence....

Agencies Seek to Use Stimulus Funds to Find Cheaper Health Care

By JANE ZHANG

"Federal health agencies, seeking to hand out stimulus funds to research the effectiveness of various medical treatments, said they will include projects that look in part at the cost of drugs and other treatments.

The approach -- which was unveiled in a report to Congress this week by the Agency for Healthcare Research and Quality and the National Institutes of Health, both agencies under the Department of Health and Human Services -- could provide more fodder to conservatives worried that the government might use the results of such studies to limit health care to consumers.

Administration officials have said they want to use stimulus funds to help doctors and patients choose more-effective treatments and ultimately, help rein in rising health-care costs. Democrats are considering including measures that would support such research as part of health-care legislation making its way through Congress."

".... Nicholas Papas, an HHS spokesman, said under the stimulus law, Medicare can't use the research to deny coverage to patients."

Of course not! But what about delaying access to new treatments or, requiring prior authorization or paying less for covered treatments which, as research shows, leads to reduced use? 

Read more here

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Two-Part Harmonization

08/03/2009 01:33 PM |

FDA NEWS RELEASE

For Immediate Release: August 3, 2009
Contact: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA, European Medicines Agency Launch Good Clinical Practices Initiative
Collaborative effort aims to ensure appropriate conduct of clinical trials

The U.S. Food and Drug Administration and the European Medicines Agency (EMEA) today announced an agreement to launch a bilateral Good Clinical Practices (GCP) Initiative, designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly, appropriately and ethically. The initiative will begin with an 18-month pilot phase on September 1, 2009 and will focus on collaborative efforts to inspect clinical trial sites and studies. Products regulated by the FDA’s Center for Drug Evaluation and Research in the United States, and by the EMEA for the European Union will be the focus of the initiative.

“Collaboration with international allies like the EMEA will lead to exciting opportunities for progress in public health,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This important effort will help to strengthen safeguards for participants and others involved in clinical studies.” 

Key objectives of the FDA-EMEA GCP initiative will be:

--To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.

--To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.

--To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.

“The clinical development of medicines is a global undertaking,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “With limited resources available to address the global nature of clinical research, this is an outstanding opportunity for the FDA and the EMEA to work together to carry out inspections and share information.”

At the conclusion of the pilot phase, a joint assessment will be made by the FDA and the EMEA, with the scope and process modified and amended as needed.

"This is another initiative that will further strengthen the very robust relationship between the FDA and the EMEA," said Murray M. Lumpkin, M.D, Deputy Commissioner for International Programs. "This will allow both the FDA and the EMEA to leverage each other's GCP inspectional resources so both of us can use our resources to assure more of the clinical trials submitted to both agencies are of the highest quality."

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Of NDAs and Companion Diagnostics

08/03/2009 12:33 PM |

According to Bloomberg, Novartis AG’s two-year effort to revive its Prexige pain pill after it was rejected by U.S. regulators has spurred the development of the first genetic test to identify who will develop drug side effects.

Novartis may re-submit a marketing application for Prexige to the Food and Drug Administration this year along with a genetic test that can detect who may suffer the liver damage that arises in some patients, said Michael Nohaile, the head of Novartis’s new molecular diagnostics unit. The test would be obligatory for patients to obtain a prescription, a first for the drug industry, he said.

“This is a very real opportunity now,” Nohaile said in an interview at the company’s Basel, Switzerland, headquarters. “We already have an agreement from many authorities that the data are good and that they are excited about it. This could be a launch this year or next.”

While a growing number of treatments are marketed as personalized medicine, with genetic tests to allow doctors to determine which patients will benefit, Prexige would be the first with a test to ensure safety. Drugmakers see testing as a way to persuade regulators and insurers to approve and pay for the medicines by showing that they’re effective.

Novartis is counting on the test to reassure doctors and patients. With a test showing that a certain drug will be safe, Nohaile said, “We can go to doctors and say it moves it out of the realm of choice into the realm of malpractice if you don’t use this drug.”

Click here for the entire Bloomberg article.

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What do you call a medical home without a physician?

08/03/2009 12:03 PM |

What do you call a medical home without a physician?  Well, for starters, you can call it HR 3200.

HOUSE HEALTH-CARE BILL WOULD ESTABLISH 'MEDICAL HOME' FOR THE ELDERLY AND DISABLED
By Marie Magleby

(CNSNews.com) - The House health-care reform bill proposes to decrease hospital visits by establishing a “medical home pilot program” for elderly and disabled Americans.
 
Such a medical home would not require a physician to be on the staff, and therefore could be run solely by nurse practitioners and physician assistants. Medical homes also would practice “evidence-based” medicine, which advocates only the use of medical treatments that are supported by effectiveness research.
 
But physicians’ groups say the legislation could lead to restrictions on which treatments may be used for certain conditions, despite the fact that some patients might require a unique or unconventional approach. It also may lead to dumping Medicare/Medicaid patients in facilities that are not required to have physicians on staff.
 
The Center for Medicine in the Public Interest (CMPI) expressed its concerns in a report that explains why statistical evidence does not always reflect reality of effective medicine.
 
“‘One size fits all’ rarely does,” the report said. “From clothes to shoes to hats, few people find that items carrying that label work with their individual bodies. So why do we entrust the health of our bodies -- one of the most important assets we have -- to a one-size-fits-all mentality?”

Here’s the rest of the story.

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The Non-Profitism Manifesto

08/01/2009 09:59 PM |

I was on Fox Business Channel’s “Your Questions, Your Money” today.  One of my fellow talking heads was none other than Congressman (and perennial presidential candidate) Dennis Kucinich.

With so many articulate, high-powered brains talking about healthcare reform these days, it’s refreshing to debate someone like the former Boy Mayor from Cleveland.  He’s so deeply entrenched in Kumbaya fantasyland that it’s really the next best thing to the Daily Show.  Except that it’s not funny.

Mr. Kucinich tried to convey his message of a healthcare system that was paid and provided for by the federal government – but wasn’t run by the government.  Um, right.

He also wanted to make it very clear that he wasn’t for “socialism,” but rather for a national healthcare system that ran like a “non-profit.  Welcome to Kucinichcare via “non-profitism.”

It’s an interesting rhetorical finesse – but isn’t a system that’s run by the government minus any free-market incentives well, socialism? 

Maybe Mr. Kucinich should introduce a bill called “the Non-Profitism Manifesto?”

Video shortly.

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Post Hoc

08/01/2009 02:02 AM |

From today's edition of the Washington Post:

How to Encourage Biotech Innovation

There's no evidence to suggest that granting makers of biologic drugs 12 years of market monopoly "would drive costs even higher" for these drugs. In fact, shortening the monopoly period is likely to raise the price of biologics.

Academic research shows that a biologic producer needs more than 12 years of exclusive sales to break even on the development costs of a new drug. If a firm faces competition from biosimilars any earlier, it would probably raise prices for its innovator biologics, as it must recoup its initial investment within a much smaller monopoly window. As a result, cutting-edge medicines would become even less affordable.

Peter Pitts
President
Center for Medicine in the Public Interest
New York

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Mr. Rogers Neighborhood....

07/31/2009 05:04 PM |

Mike Rogers has spoken -- with deep conviction and from personal experience as a cancer survivor --  twice at CMPI forums about the need to avoid one size fits all approaches to evaluating health care technologies...and now he has translated his passion into action by introducing an amendment to the Waxman healthcare bill that would ban the use of comparative effectiveness studies in rationing or denying access to new technologies or care. Incredibly, Waxman and many others on the committee raised objections to the amendment...

Read more here.

Meanwhile, the increasingly anti-pharma fiercepharma can't say enough about how horrible it is that CER can't be used to deny people access to  new drugs and devices...  Because if people die in the pursuit of denying drug companies profits, that's just the cost of advancing one's ideology...   My advice, to the fierce proponents of public options and government guided decisions... why not enroll in Medicaid and tell the rest of us lesser mortals what it's like?  Put your lives where your mouthpieces are (or is??)

Read here

Meanwhile, I will move to Mr. Rogers' neighborhood. 
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Is it recess yet?

07/30/2009 12:25 PM |

The Wall Street Journal reports, “Declining popularity of the health-care overhaul reflects rising anxiety over the federal budget deficit and congressional debate over the most contentious aspects of the legislation, including how to pay for it. The poll also shows concern over the role of government in determining personal medical decisions.”

The New York Times reports, “President Obama’s ability to shape the debate on health care appears to be eroding as opponents aggressively portray his overhaul plan as a government takeover that could limit Americans’ ability to choose their doctors and course of treatment.”

Translation:  Americans are really concerned that healthcare reform has moved from the “first principle” of  providing insurance to the uninsured to a big power grab that would turn Uncle Sam into Uncle Sam, MD.

And concern is most definitely warranted.

Nowhere is this more important then when it comes to the issue of comparative effectiveness.  Current legislative drafts generally refer to “clinical effectiveness” – a more appropriate term.  But, when you peel back to onion what most pro-big government advocates mean is “cost effectiveness.”  These terms are not (nor should they be) interchangeable.

For more on this issue, have a look at the Reuters “Great Debate page.  The relevant article is, “In determining healthcare cost, one size doesn’t fit all.”

America is waking up.  It’s going to be a long, hot summer.

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