DDMAC goes for 2(.0)

09/21/2009 11:32 AM |

Time to get out and dust off your Part 15 mojo for the November 12-13 "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools" meeting.

It's about time.

According to the announcement:

"... FDA recognizes that the Internet possesses certain unique technological features and that some online tools that may be used for promotion offer novel presentation and content features. Another emerging issue involves the reporting of adverse event data because such information may initially be revealed using social media platforms in the context of Internet promotion for FDA-regulated medical products."

The complete announcement can be found here.

Groovy baby.

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Reverend Jesse Jackson tackles health care

09/19/2009 01:48 AM |

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Did he really say that?

09/18/2009 06:27 PM |

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Poll Dancing

09/18/2009 03:41 PM |

Opposition to Health Care Plan Hits New High of 56%

Friday, September 18, 2009

Fifty-six percent (56%) of voters nationwide now oppose the health care reform proposed by President Obama and congressional Democrats. That’s the highest level of opposition yet measured and includes 44% who are Strongly Opposed.

Just 43% now favor the proposal, including 24% who Strongly Favor it.

Date	Approve	Disapprove
Sep 16-17	43%	56%
Sep 15-16	44%	53%
Sep 14-15	42%	55%
Sep 13-14	45%	52%
Sep 12-13	51%	46%
Sep 11-12	48%	48%
Sep 10-11	47%	49%
Sep 9-10	46%	51%
Sept 8-9	44%	53%
Aug 25-26	43%	53%
Aug 9-10	42%	53%
Jul 26-27	47%	49%
Jul 20-21	44%	53%
Jul 10-11	46%	49%
Jun 27-28	50%	45%

 
But the overall picture remains one of stability. While the numbers have bounced a bit following nationally televised appearances by the president to promote the plan, opposition has generally stayed above 50% since early July. Support has been in the low to mid 40s.

The number who Strongly Oppose the plan has remained above 40% and the Strongly Favor totals have been in the mid-20s. This suggests public opinion is hardening when it comes to the plan that is currently working its way through Congress.

However, now just 48% say that health care reform plan is at least somewhat likely to pass this year, a figure that has been trending down in recent days. That figure includes 17% who say passage is Very Likely.

Rasmussen Reports has been tracking support for the health care plan on a daily basis since the president's speech to Congress last week intended to revitalize the troubled initiative.

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Rumble, Rumble -- Pelosi in Trouble

09/18/2009 08:33 AM |

From the pages of Washington Monthly:

RUMBLINGS ABOUT A BLUE DOG BETRAYAL.... Rep. Bill Cassidy (R) of Louisiana told a conservative talk-show host this morning that Blue Dogs Democrats have been quietly reaching out to conservative Republicans about a GOP-friendly health care reform plan.

"I'm having Democrats come to me, to speak to me as to what House Republicans are putting up," Cassidy told a conservative news radio program. "And when I mention our patient-centered plan...they want to have more conversations regarding that."

Cassidy was referencing the bill H.R. 3400, introduced by some House GOP lawmakers as an alternative to the bill favored by most Democrats.

"Some of my Democratic colleagues are approaching me now, saying we are not going to vote for H.R. 3200, can we talk about some of our ideas," Cassidy explained. "I'm very encouraged by this."

This isn't the first time this has come up, but it's gone almost entirely overlooked, in part because it seems hard to believe.

Last week, The Hill had a report, citing "GOP sources," claiming that Rep. Mike Ross (D-Ark.), the leading Blue Dog on health care policy, has been "keeping a back channel open" to Rep. Charles Boustany (R-La.) about a possible reform deal. The sources said Ross and Boustany have "secretively ... been in talks for weeks."

And as far back as July, Boustany claimed that Blue Dogs and conservative Republicans were having "conversations" about a center-right compromise that would effectively reject everything Democrats had proposed.

At this point, the only people talking about this publicly seem to be conservative Republicans. Whether there's anything to this is entirely unclear. Maybe this has to do with a negotiating ploy. It might even be little more than a psych-out.

But if Cassidy's comments this morning were accurate, Blue Dogs could be part of a rather massive betrayal. If the conservative Democrats decide, en masse, that they'll support a conservative Republican approach to reform -- premised on the notion that American families already have too much insurance -- but not a Democratic package, the consequences would be devastating.   Read More & Comment...

Media Tries To Bail Out Baucus

09/17/2009 04:46 PM |

Ceci Connolly's piece on the marvels of the Baucus bill captures the complete disengagement of the political process and parasite class involved in health care reform from the essential fabric of representative government.    As long as "stakeholders" are numb and happy, all is well.  Screw the people who will be forced to pay more money for a small number of health plan choices that are more expensive yet demonstrate no greater benefit than less costly forms of coverage,  accept cuts in Medicare and Medicaid without regard to individual need.   

It seems that since Obama became President, Washington has become more detached from public sentiment...  Ceci just channels the delusion such disregard is not only acceptable but essential to being politically effective...

Read the article here.
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The Hidden Costs of Social Engineering

09/16/2009 06:13 PM |

My favorite quote about liberalism is from Lionel Trilling: (“We must be aware of the dangers which lie in our most generous wishes. Some paradox of our nature leads us, when once we have made our fellow men the objects of our enlightened interest, to go on to make them the objects of our pity, then of our wisdom, ultimately of our coercion.”)

Thus stands the clueless observation of Drew Altman who maintains that by such time in the future the annual cost of health care will be $30k a  year:

For the worker share of the premium alone, the average amount paid by families increased from $1,543 in 1999 to $3,354 in 2008. 

But that's according to the Book of Kaiser which believes that all health care coverage should include all the benefits and first dollar amounts that the Kaiser Foundation social engineers deem ok.  Which is why the Baucus bill eliminates choice of any coverage other than the most expensive Kaiser model

Meanwhile, consumer expenditure data shows that Americans on average spent $945 a year on health insurance premiums in 1999 or two percent of the average pretax income. In 2007 the average was $1545 a person or a whopping 3 percent of pretax income.  In both cases, that amount was less than what a person spent, on average, for dining out or entertainment. 

Drew tells us that... the average cost of a family health insurance policy in 2009: $13,375....premiums in 2019 will average a whopping $30,803, a very scary number.

Let's set aside the mythical nature of that number, how it reflects pretax wage increases on the one hand and a one size fits all benefit package replete with mandated services on the other.  Let's set aside the fact that the average yearly family premium in the individual health market with a $2000 deductible with the same benefits Drew drools for is $4500.   SOURCE: eHealth, Inc.

Instead, let's focus on Drew's solution for making the scary number go away:

"One obvious implication is that we need to get more serious about reaching agreement on ways to slow the rate of increase in health care costs.  But consensus on measures that would put a real dent in the health cost trajectory has been hard to achieve. Even simple first steps, such as comparative effectiveness research to collect data on what works and what does not in medical practice, have proven controversial, requiring language in draft legislation disavowing that they will ever be linked to payment."

www.kff.org/pullingittogether/091509_altman.cfm

Poor Drew.  America lacks the will to require government to ration care explicitly.  But he should take heart that much of Congress has bought into to the element of the liberal vision:  a one size fits all, overpriced health plan that will be hard to pay for and three times as expensive as what most of us would choose if we actually had the choice. 

It's not about cost. It is about coercion. 

 

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Anger, Frustration and the Red Army

09/16/2009 04:10 PM |

What were the town hall meetings and tea parties all about? Healthcare reform? Sure. But the anger exhibited by our fellow citizens was clearly grounded in a much broader frustration over the continuing growth of government. The current debate over healthcare reform was a lightening rod -- and the results have been explosive.

And that's not surprising when you consider that healthcare reform, as positioned by the President and many senior members of Congress, would represent the biggest increase in the size and expense of government in our lifetime.

Many who favor such programs point to Great Britain and their National Health Service (the NHS) as a desirable model of single-payer delivery. But small government it ain't. Consider this: the NHS is the single largest employer in Great Britain. In fact, it's the world's fourth largest employer -- only the Chinese People's Liberation Army, Wal-Mart, and the Indian Railways directly employ more people.

Americans believe that the healthcare reform packages being considered by Congress would result in ever bigger government. They're right. Whether or not that's the right thing to do is another matter.
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A Fat VAT?

09/15/2009 02:02 PM |

In May, I opined on giving Americans a tax deduction based on a healthy BMI (Body Mass Index). 

My article can be found here.

Yesterday, Brian Sullivan of Fox Business News blogged on a similar idea.  His blog can be found here.

Today, Brian and Degan McDowell and I discussed the idea on air.  My point is that, when it comes to healthcare reform, we seem to be discussing everything except diet and exercise ... and personal responsibility.

We talked about tax incentives (the "carrot") as well as the political time bomb of a fat VAT (the "stick").

All things considered -- a very timely conversation.

The complete video interview can be found here.

As Julia Child would say: "Bon Appetit!"
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Passing the Buck on Personalized Medicine?

09/15/2009 02:25 AM |

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Will ACORN Be a Health Exchange Navigator?

09/14/2009 09:40 PM |

Sure looks that way:

"Section 3105 of the Kennedy bill says American health Benefit Gateways would be created in every state, serving as a health insurance exchange. A "Navigators" program would award grants to public and private entities to "conduct public education; distribute fair and impartial information regarding health plans; [and] assist with enrollment and provide information that is culturally and linguistically appropriate for the population." The bill stipulates that both health insurance issuers and current independent insurance agents would be prohibited from participating in the Navigators program."

Read more here.

And here is what ACORN is already doing:

"Moving toward maximum eligible participation in federal and state benefits programs is one of ACORN’s key national priorities. ACORN will begin transitioning many of its offices to the Nets2Ladders screening platform (Nets2Ladders is also a key strategic partner with H&R Block). Nets2Ladders offers a powerful, automated benefits enrollment platform that will increase the efficiency and effectiveness of enrolling low-income families in federal and state benefits programs. This software integrates tax return and benefit information so that the information that is collected while filing the tax return is automatically updated into the benefits screening tools, reducing the amount of time needed to add a benefit screening component. Beginning in January 2008, ACORN will conduct benefits screening and enrollment in approximately 26 states, meaning that anyone visiting an ACORN Tax and Benefits Access Center in these states can also quickly be screened for up to 15 federal, state, and local assistance programs, including:

• Food Stamps

• Medicaid

• State Children’s Health

Insurance Program (SCHIP)

ACORN’s new screening platform will generate complete applications that are then printed out for clients, saving them countless hours of trouble and heartache and more importantly dramatically increasing their chances for actually qualifying for these important programs. By January 2010, all 50 states will be covered by the ACORN screening and enrollment platform"

Read more here

Will Congress ban ACORN and other politically-motivated groups from grabbing control of health care at the grass roots level with federal funding?

Exchanges we can believe in....
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It's D-Lovely

09/11/2009 06:19 AM |

Health reform, that is. Or it could be.

President Obama's effots to sell lawmakers and the American public on the merits of his proposals have been hamstrung by his preference for a big-government solution to the nation’s healthcare woes. While it’s true that reform is needed, there’s no need to completely remake the health sector. Instead, the president should borrow from more hands-off reforms, like Medicare Part D, which have been both successful and popular in the past.

A recent survey revealed that 92 percent of beneficiaries were satisfied with their drug coverage in 2008. And, at last tally, Part D was costing about 30 percent less than initial budget projections. The program’s popularity as well as its cost-effectiveness can be attributed in large part to its use of the private-sector competition.

Part D allows Medicare participants to choose from a variety of government-subsidized yet privately-administered drug plans. Seniors get to choose from a number of plans and decide for themselves which one best suits them. Meanwhile, insurers must compete to offer high-quality plans at reasonable prices.

But does Part D really work? The numbers speak for themselves: in 2004 nearly one in four seniors lacked drug coverage. By 2006, when Part D took effect, that statistic dropped to seven percent.

Democratic lawmakers could use this success as a roadmap for expanding coverage while avoiding the kind of drastic government intervention that inspired such rancor in opponents of the public option.

In other words, create a program that allows insurers to compete to offer those 8-16 million chronically uninsured Americans the best plan. The government could then provide subsidies to make that plan even more affordable. This would by no means be easy to implement. But it wouldn’t be revolutionary either, since the policy’s basic framework has already proven to work well.

President Obama is in desperate need of fiscally responsible healthcare reform ideas. A Part D-like insurance program might be exactly what he’s looking for.

For more on this, see a new article in Reuters' "Great Debate" series here.


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About President Obama's speech

09/10/2009 07:03 PM |

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Boustany’s No Zany

09/10/2009 06:51 PM |

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The "Character of Our Country"

09/10/2009 07:36 AM |

Last night the President summoned “the character of our country.”

But his attempt to create an atmosphere of bipartisan support evaporated with the turn of a single phrase:

“I will not stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what’s in the plan, we will call you out.”

Threats to those who honestly oppose his ideas?  Or does that also apply to those (such as Speaker Pelosi) who accused our fellow citizens of being “anti-American” for venting their honest frustrations at town hall meetings?

No question this speech was largely an exercise about reasserting the President’s leadership.  Did that happen?  Will, for example, Henry Waxman decide that he is now obligated to the agreements the President reached with, among others, PhRMA?  If Mr. Waxman remains unobligated, will the President “stand by” or will he “call him out.”

 “If you like your healthcare plan, you can keep it.”  But “your healthcare plan” could be more expensive – or your employer may cease to offer it at all. As the old Yiddish proverb goes, “A half-truth is a whole lie.”

And as far as the tax on “gold-plated” insurance policies, here’s what Robert Pear wrote in the New York Times, “Proponents say the idea … would encourage employers to buy cheaper, less generous coverage for employees, thereby reducing excessive use of medical services.”

“Excessive use?”  According to whom? And what does “gold-plated” mean? No details offered.

Pear continues, “But many House Democrats and labor union leaders have resisted those proposals, saying the tax would often be passed on to employers and to workers in the form of higher premiums” and “that could be seen as violating a campaign promise not to raise taxes on anyone making less than $250,000 a year."

The President’s for a “not for profit” public plan – but “We should remain open to other ideas that accomplish our ultimate goal.”  Translation:  “I’ll sign a bill without a public plan.” 

And the left cringes.

Welcome news that the President supports a yet-to-be written initiative to create pilot projects intended to curb medical malpractice lawsuits.  But who will co-pilot this idea in Congress.  That’ll be interesting to see -- or to see if it really happens.

Strangely lacking – a timeline, or even a call for one.

As Senator John McCain commented post-speech on the Larry King Show, “Facts are stubborn things.”

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Technologically Challenged

09/09/2009 05:10 AM |

Is innovation the problem or the solution?  Well, it depends who you ask and what you’re talking about.  The issue at hand is the future of medical technology innovation and the question is – are we willing to trade tomorrow for today?  Or, put another way – are we willing to focus on short-term costs savings and jeopardize long-term patient outcomes?

Here’s what Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had to say in response to the proposed $40 billion tax on medical devices and diagnostics that is included in a draft health care reform proposal from Senator Max Baucus, chairman of the Senate Finance Committee:
 
“This tax will raise the cost of care for all patients, especially those in greatest need of advanced treatments and diagnostics.  It is a form of double taxation, since a portion of the hundreds of billions in cuts aimed at our customers, including hospitals, nursing homes, and home health care agencies will be passed on to us.  Moreover, the tax will fall most heavily on the small and emerging companies that are the backbone of our industry, often driving development of cutting-edge treatments and cures, and are least able to pay new taxes.  Additionally, the fee imposed on clinical labs raises serious concerns in view of other cuts to payments for lab services.”
 
“While AdvaMed supports broad-based health care reform and has been working to achieve that important goal, we cannot support a proposal that unfairly singles out the medical technology industry for a tax on innovation on top of the billions in cuts that the industry would already have to absorb within the health care reform proposal.  We will continue to work with congressional leaders and the White House to further real health reform and to eliminate this counterproductive proposal from any reform package considered by the Congress.”

Real reform doesn't pay for itself by standing on the throat of innovation.

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FDA Promoting Off-Label Use?

09/08/2009 08:08 AM |

From the Pink Sheet:

FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting. Pazdur told the Oncology Drugs Advisory Committee not to consider the need to have Genzyme's Clolar (clofarabine) available to treat elderly acute myeloid leukemia patients in voting whether or not a randomized trial should be required prior to the drug's approval for the new indication.

ODAC was convinced that clofarabine is active in getting elderly AML patients into remission, but ultimately voted 9-3 that the additional trial did need to be conducted prior to its approval - regardless of the enormous disease and patient population challenges that have stood in the way of conducting such trials thus far. "This really is a level of evidence question that we're asking here," Pazdur said. "We're not asking 'can a randomized study be done,' 'would you like a randomized study to be done,' 'would it be nice if a randomized study were to be done.' The vote is: for a level of evidence for approval - cognizant that this does set precedence for other drugs - is a randomized study necessary in the proposed indication. Right now, availability is not an issue ... There are many ways of getting this drug [through] off-label use."

Hmm.

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Sharp DARRTS

09/04/2009 03:56 PM |

Jenkins blamed the lapses on "long-standing limitations in staffing and information technology resources," saying that "competing workload priorities prevented us from the level of oversight and review of the entire portfolio of [postmarketing requirements] and [postmarketing commitments] that we would have desired …With new resources and congressional directives, FDA is committed to ensuring proper drafting and review of the entire portfolio going forward.”

Among the changes, each Center for Drug Evaluation and Research division now has a designated postmarketing study coordinator and a postmarketing study tracking coordinator.

In general, the deputy division director for safety - a position established under the agency's Safety First initiative - has assumed the postmarketing study coordinator job, and the safety regulatory manager will handle postmarketing study tracking. "These people as their full-time job are managing the safety and postmarketing study portfolio for their division," Jenkins said.

According to Jenkins, new policies and procedures are in place to "improve consistency in developing" postmarket requirements and commitments and lead to "better designed studies and trials with effective and realistic time frames for initial completion.” He added that other changes have been made to improved tracking and reviewing, including standardizing policies and procedures across CDER review divisions and offices.

A new postmarketing study database implemented at the end of July as part of the Document Archiving and Records Retention System (DARRTS) includes increased capacity for data capture, tracking and report generating.  Read More & Comment...

Giving the Finger -- A New Low

09/03/2009 05:06 PM |

According to the AP:

THOUSAND OAKS, Calif. — California authorities say a clash between opponents and supporters of health care reform ended with one man biting off another man's finger.

Ventura County Sheriff's Capt. Frank O'Hanlon says about 100 people demonstrating in favor of health care reforms rallied Wednesday night on a street corner. One protester walked across the street to confront about 25 counter-demonstrators.

O'Hanlon says the man got into an argument and fist fight, during which he bit off the left pinky of a 65-year-old man who opposed health care reform.

A hospital spokeswoman says the man lost half the finger, but doctors reattached it and he was sent home the same night.

She says he had Medicare.

O'Hanlon says the attacker fled but authorities have a good description.

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Bextra Credit

09/03/2009 11:33 AM |

No doubt there will be much pontificating and punditry surrounding the Pfizer settlement.  That the matters at hand happened in the past and under different management will be largely ignored.  (And the fact that they did certainly doesn’t make any past malfeasance less serious.)  That being said, a few personal observations.

The people I know at Pfizer are honest and honestly dedicated to advancing both the business aims of their company and (even more importantly), the public health.  These are not mutually exclusive objectives. They are proud of what they do – and rightfully so.

Don’t give up the ship.

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