Repeal and Replace?

03/30/2010 06:08 PM |

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Pryor To Voting

03/30/2010 05:51 PM |

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Take two aspirin and call me in November

03/30/2010 05:43 PM |

Starting in January, you will no longer be able to tap your HSA to cover aspirin, vitamins and other over-the-counter medications, unless they are prescribed by a doctor. 

Patient choice:  strike one.
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Berwick and the Angry Itch

03/29/2010 08:51 AM |

Donald Berwick as CMS Administrator? By all accounts a good choice. But what does it mean for the upcoming battle royale over comparative effectiveness and patient choice?

According to Robert Pear, “Dr. Berwick could help shield the White House from Republican charges that Mr. Obama’s policies would lead to the rationing of care or even a government takeover.”

This conditional shield comes courtesy of remarks Dr. Berwick made last December. Speaking at the annual conference of the Institute for Healthcare Improvement (which he heads), he challenged the audience thus, “Over the next three years, reduce the total resource consumption of your health care system, no matter where you start, by 10%. Do that without a single instance of harm, without rationing effective care, without excluding needed services for any population you serve.”

Okay – sounds good and we should give Dr. Berwick the benefit of the doubt that when he says he’s against the rationing of “effective care,” he means effective care that’s defined by an MD in the field – and not Uncle Sam, MD inside the Beltway.

But vigilance is required, especially now that it’s precisely Uncle Sam who is going to be paying more and more of the bills for this “effective care.” And vigilance is even more important considering that AHRQ (now the nation’s leading practitioner of comparative effectiveness studies) plans to hire a PR firm to help create a “publicity center” for comparative effectiveness reports and materials.

If you recall the debacle that followed the government’s “publicity center” efforts behind CATIE and ALLHAT – you know why vigilance is the order of the day.

The “angry itch” is the desire for payers (both public and private) to opt for the least expensive treatment rather than the one that’s best for the patient. An itch that’s often penny-wise and pound-foolish.  An itch that’s dangerous when scratched.

Let’s all wish Dr. Berwick great success.  He has big shoes to fill and a tough road ahead.

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Head 'em off at the (innovation) pass

03/26/2010 07:03 AM |

The UK has launched a pilot of its "Innovation Pass" process, which will provide £25 million in funding for medicines that treat very rare diseases but are not evaluated at launch by the National Institute for health and Clinical Excellence (NICE).

Innovation passes were first proposed in the UK's office for life sciences' Life Sciences Blueprint, issued last year. The government has run a public consultation on the proposals since then.

There’s a maximum spending cap of only £8 million per year for each individual product – and uncertainty over long-term funding. The pilot is to run for three years, but government funding of £25 million has only been arranged for the first year.

Products included in the pilot Innovation Pass scheme will automatically be appraised by NICE after the end of three years, raising the suspicions that they could be rejected for use in the UK national health service (NHS) at that stage.

NICE giveth and NICE taketh away since it will set up and run an advisory committee that will select products based on defined criteria. These criteria include the medicine being a significant medical innovation (acting at a new target receptor, for example), it should satisfy an unmet clinical need, and is expected to have a substantial impact. Additional studies to gain further clinical data should be planned.

The government will pay an amount to the pharmaceutical company for supplying the medicine based on a price-volume agreement (the number of patients multiplied by the price), rather than paying for each dose of drug dispensed. This is to ensure a financial return for the company. Products would normally be submitted for consideration at around the same time as they are filed for marketing approval.

BUT … the sum asked for by the company will be judged to be reasonable or not by a governmental/NHS panel that will look at the cost of therapeutically similar medicines, the actual cost of the medicine in other European countries, and the cost of its research and manufacture.

This judgment on whether the cost is reasonable or not will then be passed to NICE's advisory committee, which will produce a list of drugs for funding, which will be approved by government ministers.

Sounds familiar.

NICE work … if you can get it.

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A Goodman is hard to find

03/25/2010 08:54 AM |

FDA Chief Scientist Jesse Goodman to Representative Rosa DeLauro (D/CT and Chairwoman of the Agricultural Appropriations Subcommittee), "I think what FDA really needs is a 5- to 10-year building effort/re-building effort. And it's not just rebuilding to what was. I think it's being a part of building the science of the future."

Bravo.  By all means. Rather than look backwards to “the good old days” (whatever that means) let’s improve and move forward. It’s not rocket science – but it’s good to hear the agency’s Chief Scientist say it. 

And change starts from within.  According to Goodman, "What I want to do is begin to use the resources we have and the leadership we have to encourage and identify and free-up some of the time of our promising junior and mid-level people to beef up their education. Because if we just do it as leaders of the center or agencies, that doesn't have all the transformational power."

Absolutely right.  When I served at the FDA (along with Jesse), one of the most valuable lessons I learned was that dictates from “on high” don’t get the job done.  Real change happens because all levels of the agency understand and embrace the philosophy of those changes. Change may begin at the top – but success or failure is determined by the agency’s 11,000+ career professionals.

Change is never easy but, as W. Edwards Deming commented, "Change is not required.  Survival is not mandatory."

Goodman: “"It's very challenging. It's almost like taking the current state of the agency from sort of always swimming to keep our heads just above the water to something that is a truly outstanding scientific partner and really has the power and relationships it needs. And by power I don't mean power over people, but the mental and scientific tools to have the ability to make decisions. So it's a process and it's going to take a while and we need to get the best and the brightest."

Now maybe Representative DeLauro will finally embrace the Reagan/Udall Foundation.

We’ll see.

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"Gee I Hope This Works"

03/24/2010 12:04 PM |

Excellent article by the Washington Post's Ruth Marcus on the need to humble in our predictions about the impact (negative and positive) of healthcare reform and to be a bit more precise in our analysis going forward.  Specifically, we should be asking: Will this improve health? Make care more affordable and convenient? Extend life? Reduce health disparities? Accelerate the seach for cures?  I think her article provides a template for anyone wishing to gauge the value of health care reform going forward. 

- 24 March 2010, The Washington Post  (By Ruth Marcus)

The conventions of political pontification do not allow for admissions of uncertainty or ambivalence. Thus, Sunday night's House debate on health care featured bombastic declarations from both sides about the impending disaster (Republicans) or nirvana (Democrats) being ushered in.
In fact, the occasion called for more humility than hyperbole, however unlikely that may have been given the setting. If I were a member of Congress, my floor speech before casting a yes vote would have boiled down to:

Gee, I hope this works.

One of the astonishing aspects of the health-care debate is how little is actually known about the implications of a change this far-reaching. Everyone has a theory, and a model to match, but even some of the most fundamental questions remain the subject of debate.

On the most basic of all -- does having health insurance lead to better health? -- the evidence is solid but not unanimous. The Institute of Medicine , reviewing the literature in 2009, found that "the body of evidence on the health consequences of health insurance is stronger than ever before. . . . Simply stated: Health insurance coverage matters ."

But a study that same year by Richard Kronick, a former health-care adviser to President Bill Clinton, found "little evidence to suggest that extending insurance coverage to all adults would have a large effect on the number of deaths in the United States ." Kronick's study has been criticized because it did not adjust for the fact that those in poor health are more likely to seek insurance. But the disagreement underscores the difficulty of knowing precisely what changes are in store.

To take another example, one common assertion has been that the uninsured end up getting health care -- just more expensive health care, in emergency rooms and when conditions have worsened, with the costs passed on to the rest of the population. The notion that the tab is being picked up one way or another makes intuitive sense.

A new National Bureau of Economic Research paper by Michael Anderson, Carlos Dobkin and Tal Gross questions this assumption. The researchers examined health-care consumption by 19-year-olds who had just been dropped from their parents' coverage. They found that not having insurance resulted in a 40 percent reduction in emergency room visits -- "contradicting the conventional wisdom that the uninsured are more likely to visit" the emergency room and a 61 percent drop in hospital admissions.

"Overall, these results suggest that an expansion in health insurance coverage would substantially increase the amount of care that currently uninsured individuals receive and require an increase in net expenditures," the authors write. Emergency room visits could increase by 13 million annually, and hospital admissions by 3.8 million, they project.

So prudence is in order when tinkering with such an interconnected system and when making confident predictions about the effects of reform, for good or ill. Will younger adults, who account for about half the population of uninsured non-elderly adults, sign up for coverage -- or will they pay the fine instead? How will that decision affect premium levels and the adequacy of federal subsidies?

Will the expansion of coverage create a shortage of health-care providers and result in higher prices, or will, for example, higher Medicaid payments for primary-care doctors stem an exodus of doctors from the program? Will employers add coverage because workers facing the mandate to obtain insurance will press for it, or will they drop it because it will be cheaper to pay the penalty and let employees fend for themselves?

Will increased coverage of preventive care save money because diseases will be caught earlier -- or will the added cost of widespread screening exceed the economic benefits? The Congressional Budget Office has concluded that, "for most preventive services, expanded utilization leads to higher, not lower, medical spending overall ."

The legislation is a risk worth taking. Millions of Americans are without insurance, a national scandal that should have been addressed long ago. Rising health-care costs threaten the nation's fiscal security, and the new law holds the promise of beginning to stem the increases.

The status quo is unsustainable. A new study by the Urban Institute shows how, without reform, the numbers of the uninsured will rise, employers will continue to drop coverage and premiums will climb.

Still, for those who express cocky certitude about how this is going to turn out, the best prescription is a generous dose of caution
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Time Should Go To School on Statins and Women

03/24/2010 11:29 AM |

Is it that Time is running out of money or that what's left of the editing there is too busy finding ways to run anti-Israel pieces...but when you start a story about the gender specific risks and benefits of statins, it might be  prudent not to overstate the risks to the point of absurdity and paint an otherwise smart and accomplished woman as a hopeless victime:

Lynne Newhouse Segal was the picture of robustness. At 59, the slim former lawyer was an avid runner, golfer and yoga practitioner. Segal, who lives in San Francisco, was healthy by nearly every measure — except her cholesterol level, which a routine test four years ago revealed was high. High cholesterol is a key risk factor for heart disease, especially in a patient Segal's age and with her family history (several close relatives had had heart attacks), so her doctor put her on a cholesterol-lowering statin drug as a preventive measure.

Oh, but dark clouds soon gather...

But Segal's statin ended up preventing her from living a heart-healthy lifestyle. A month after she started taking the drug, she suffered muscle pain so severe, she had to stop all physical activity and was unable to sleep at night. Although her husband, who was worried about her risk of heart attack, pleaded with her to stay on the drug, she discontinued using it. The muscle pain receded. "My husband was scared for me. Doctors scare you. But I was in so much pain, I told him I would have rather died than stay on them," says Segal.

That grim situation could have been avoided, researchers say.

How about asking for another type of statin?  That's what Marilyn Goldberg, age 75, did after suffering muscle pains so severe she complained to her husband Mort and son Bob (that's me) almost daily... And she did, about 4 or 5 times until she found one that worked.  And now the pains are gone and her cholesterol is really low.

But you see, Marilyn is not a set piece or prop in some Obama-esque sob story about how we the people are screwed by uncaring corporations.  She is a responsible person taking action on her own behalf...

Rather died? 

I don't want to harp on this self-pitying because I am half-convinced that it is only half-true.  That's because much of the "reporting" in the Time article on women and statins is half-baked.   You read the piece sensing that women receive NO benefit from statins and tons of risk.  In fact, there are many sub-groups and many situations where that is not the case.  

The issue at hand is whether statins should be given to women who do not have high cholesterol at all but have other risk factors because cholesterol is not a very good marker for heart disease in women...  (my emphasis)

The JUPITER study was designed to test whether other markers of heart disease in relatively healthy older women and men predicted heart disease by giving them statins to reduce a protein called CRP.   If CRP was reduced and nasty events that lead to hospitalizations or death were reduced after taking a solid dose of the statin then the study could claim to show that CRP testing in combination with statins reduced the incidence of heart disease in relatively healthy women and men.  And since women do not seem to benefit from reduced cholesterol levels (in the absense of other risk factors) the CRP -statin link is a pretty big deal for primary prevention.

As for the side effects.. When you draw the blood for CRP you can also draw blood to see if you will metabolize specific statins in ways that cause muscle pain, blurry vision, etc.   There are tests for that.   The question is whether the statin used in the JUPITER study (Crestor) can be substituted with other statins. 

Now that is what the TIME article should have been about.  But I guess the magazine had to devote resources to another hit piece on Israel.  

Read more: http://www.time.com/time/magazine/article/0,9171,1973295-1,00.html#ixzz0j6iRw0r3

Read more: http://www.time.com/time/magazine/article/0,9171,1973295-1,00.html#ixzz0j6iJUqhy

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Sending Companion Diagnostics out to Pazdur

03/24/2010 09:39 AM |

ChemGenex has agreed to meet with the FDA discuss developing a validated assay test for determining which patients might benefit from its experimental chronic myeloid leukemia (CML) treatment Omapro (omacetaxine mepesuccinate).

"This is a comparative efficacy claim that somebody is making here, so the level of proof has to be there," said Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research. "The message is that the agency is trying to get across is that attention has to be paid to these in vitro diagnostics." ChemGenex announced the initiative shortly after the FDA's Oncology Drugs Advisory Committee voted 7-1 to require such testing before approving Omapro, which is targeted at CML patients who have failed Novartis' Gleevec (imatinib).

Speaking of Novartis, the ChemGenex situation is another important example of the role companion diagnostics can play in bringing new drugs to market.

In August 2009, Novartis’ two-year effort to revive its Prexige pain pill (after it was rejected by the FDA) spurred discussion of developing the first genetic test to identify those who may suffer the liver damage that arises in some patients. The test, according to Michael Nohaile (the head of Novartis’s molecular diagnostics unit) would be obligatory for patients to obtain a prescription.

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.

Exciting stuff -- but once these diagnostics are developed, will payers reimburse?  In the wake of the payer disquietude over spending $400 on a diagnostic test to determine whether a patient should be given warfarin, it’s very much an open question. (Even more peculiar considering that conservative estimates project using the warfarin diagnostic -- specifically called out in the amended FDA label -- will prevent 85,000 serious bleeding events and 17,000 strokes annually in the United States. And this “safer use” is estimated to save $1.1 billion annually. 

Stay tuned.

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Now I Understand...

03/23/2010 08:36 AM |

Good thing we've got the important elements of the bill squared away....

Two headlines on the same day... March 22

Major health care changes won’t take place until 2014

Delays could help Obama’s reelection hopes

Key elements of health reform would start soon

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All the news that's unfit to print

03/23/2010 07:47 AM |

The Pink Sheet reports on "renewed optimism" that the European Union's proposed legislation on allowing drug makers to provide information to patients on prescription-only medicines will again start moving through the legislative process. The latest thinking, however, is strongly focused on the rights of patients to receive such information, rather than industry's right to disseminate it.

An interesting and important finesse – the rights of a patient to the information but no “right” for industry to provide it.  Hm.

Suggested amendments emerged on March 10 from European Parliament Member Christofer Fjellner. He's reviewing the proposed legislation for the EU parliament's Committee on the Environment, Public Health and Food Safety.

For patients, Fjellner contends that information on pharmaceuticals should only be made available to patients who are actively searching for it, i.e., information should be "pulled" by the patient rather than "pushed" by industry. Fjellner believes that  companies should not be allowed to make available information on prescription-only medicines on television or in newspapers or magazines. He believes the Internet is the appropriate medium for providing information to patients.

And maybe he's right -- but is there really a difference?  If a pharmaceutical company makes available information on a web page – why is that different than making it available in other media?  Hm. And what about patients who do not have access to the Internet -- what about their rights?

Fjellner's stance comes as a response to a ruling from the European Court of Justice, which concluded in April 2009 that current legislation could be applied to independent journalists. One journalist, Frede Damgaard, was considered to have broken the ban on DTC advertising by writing about a particular prescription-only product, a ruling that has caused an outcry in the media.

For more on this issue, see “Eighty-Sixing Free Speech.” 

The environment committee will vote on the patient information proposals in June. After that a plenary vote of all European Members of Parliament will be held in September. It will then go to the Council of the EU for further consideration.  Read More & Comment...

The Good News

03/22/2010 09:07 AM |

After a feisty year of debate, Congress has passed healthcare reform legislation. Once enacted, it will increase the numbers of Americans with health insurance as well as both the size and scope of government. There’s also the very real danger that the legislation will further erode the stake that physicians have to practice both the art and science of medicine.

And the numbers?  Staggering when you consider they are absurdly under-scored.  According to Douglas Holtz-Eakin (director of the Congressional Budget Office from 2003 to 2005), if you strip out all the gimmicks and games and rework the calculus, a wholly different picture emerges: The health care reform legislation would raise, not lower, federal deficits, by $562 billion.  Even with readjustment, it will make the Social Security trust fund look like Fort Knox.  The day the President signs this into law could be viewed by a near-future generation of Americans as a day of infamy -- if we let it.

So here’s the good news – the solution is innovation.

We have to embrace innovative technologies for medical records and prescribing.  We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less then the current $1 billion plus delivery charge.  We need innovation in access and reimbursement policies that rewards speed-to-best-treatment rather than more lower-cost patients per hour.

Will more people have access to health insurance?  They will and that’s a good thing. But, let’s be honest, we’re not talking about erasing the word “uninsured” from the American healthcare dictionary – we’re just redefining what it means.

We have to embrace the fact that we will all pay more in taxes (yes, all of us) eventually. And, ultimately, we will be okay with that. Americans are always willing to do what’s right for their fellow citizens.  As Winston Churchill said, “Americans always want to do the right thing – after they have tried everything else.”  Even so, many of our fellow Americans will receive less comprehensive healthcare benefits than they are receiving now. 

So we’d better start taking innovation – of both the incremental and discontinuous varieties – seriously.  And that means both spending more on harder developmental R&D (with concomitant higher investment risks). In this regard, the new legislative language on the development of FOBS (follow-on biologics or, if you prefer, biosimilars) is a good thing.  (And don’t ever call them generic biologics!)

There’s lip service to the need for more robust comparative effectiveness – although this is a battle yet to be either defined (comparative effectiveness or cost effectiveness or clinical effectiveness?) or fought (do we need a U.S. version of NICE?). And a battle royal it will be.  In addition, there’s as yet-to-be reconciled language on a Medicare advisory board that could very well morph into a national formulary body. L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning.

Of course we bid adieu to the infamous Medicare Part D Doughnut Hole.  Pax vobiscum. The Medicare prescription drug benefit is coming in hundreds of millions of dollars under budget already and consistently has 90% + approval ratings by America’s savvy seniors. Medicare Advantage programs?  Don’t ask.

Now insurance companies can’t turn anyone down because of a pre-existing condition (bravo!) but they can’t charge higher premiums for people who have them?  This isn’t an elegant or economically viable solution and will have to change.  Otherwise it’s just a slow march to a single-payer system.

Over the past year, we spent a lot of wasted time throwing around terms like “death panels” but, at the end of the day, we didn’t even begin to address the elephant-in-the-room issue of how much of our national treasure we spend on end of life care.  We will have to address this highly volatile and divisive issue – and sooner rather than later.

The legislation doesn’t do anything really significant about driving young, healthy people into the insurance pool.  The anemic penalties (which don’t even kick-in right away – the demographics and politics aren’t too hard to figure out) actually disincentivize youthful participation.  After all, why not pay the monthly penalty (which is less than even a very affordable monthly insurance premium) if, when you do face a medical emergency, you can’t be turned down or charged more? Nor does the bill create any sort of national insurance pool – where we can all benefit from a 50-state economy of scale insurance marketplace.

Some of the best things about the bill are what is does not do.

No drug importation.  (Sorry! Senator Dorgan.  Hooray! Peggy Hamburg.)  And the Non-Interference Clause remains the law of the land.  When originally drafted (wisely by then Senators Daschle and Kennedy), we knew then what we need to remember now, that (1) direct government negotiations for Medicare drug prices won’t (according to numerous government studies and leading economists) lower Medicare drug prices and (2) it is the next slippery step towards even broader price controls.  And price controls equal choice controls.

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Canaries in the Coal Mine

03/21/2010 11:06 PM |

My early prediction of a healthcare bill death in the wake of Scott Brown's election was premature.  To underestimate the persistence of those who have devoted their lives to government  run health care was a mistake.  And it should be going forward too. 

That applies to the goal of carving up Medicare and controlling healthcare spending through greater government regulation on access to and higher taxes on innovation, with the objective and/or on consequence of discouraging investment overall in order to expand healthcare entitlements:

Washington State, which has made much of it's position as leader in biomedical innovation is a bellweather  of what it to come:

tinyurl.com/ydpvubs

Non-Profits, Investors Worry About Proposed Washington State Tax Surcharge Increase

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Casey at the battlements

03/19/2010 03:40 PM |

It's deja vu all over again.

As the Ol' Perfessor (Casey Stengel) would say, "You can look it up."

Here's what then-Senator Obama had to say in 2005 about reforms in the Temporary Assistance for Needy Families (TANF) welfare program that he and other Democrats opposed:

“The TANF program affects millions of American children and families and deserves a full and fair debate. Under the rules, the reconciliation process does not permit that debate. Reconciliation is therefore the wrong place for policy changes and the wrong place for the proposed changes to the TANF program. In short, the reconciliation process appears to have lost its proper meaning. A vehicle designed for deficit reduction and fiscal responsibility has been hijacked to facilitate reckless deficits and unsustainable debt.”

Yep -- he was against it before he was for it.

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From Bauhaus to the People's House

03/19/2010 08:10 AM |

Bauhaus guru Walter Gropius said, "Less is more." But it was Mies van der Rohe (known to New Yorkers as the designer of the Seagram Building) who opined, "but more tastes better."

The Congressional Budget Office has released its latest estimate of the price tag of the House of Representative's healthcare reform bill. At $940 billion, this version of reform will cost more than the measures passed by the House and Senate late last year. More is not always better.

CBO also says the bill will reduce the deficit by $130 billion over the next 10 years and by $1.2 trillion over the following decade. That’s right. It will reduce the deficit by significantly increasing federal spending.  Only in America.

While they’re at it, they should also predict the weather for the next decade.

Let’s face it: Uncle Sam has a poor track record of forecasting how much new programs will cost. Medicare’s progenitors, for example, stated in 1967 that the entitlement would cost $12 billion by 1990. Actual Medicare spending in 1990 amounted to $110 billion — nearly 10 times the initial estimate. Oops.

CBO’s deficit-reduction estimates are further divorced from reality because they don’t include as much as $371 billion in new spending to fix reimbursement rates for doctors who treat Medicare patients. Imagine that — health reform legislation that doesn’t include payments to doctors. Only in Washington, DC.

Absent congressional action, Medicare reimbursement rates will fall 21 percent next year. Congress has no intention of letting that happen. But the Democrats have decided that they don’t have to include this so-called “doctor fix” in their healthcare reform package — even though it’s critical to preserving Medicare.

No wonder the CBO was able to conclude that the Democrats’ health reform package would reduce the deficit by $130 billion. The bean-counters simply ignored the $371 billion in spending needed to fix Medicare reimbursement rates.

Democrats point to the favorable CBO score as proof that their health reform package is a model of fiscal responsibility. But it’s likely that the next generation of lawmakers will look back on these cost estimates with the same astonishment reserved for Medicare’s naïve forecasters back in 1967.

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What CER Really Means

03/18/2010 10:16 PM |

Underpowered, cut rate head to head studies that prove nothing worlks better than something..  David Nathan's take on NAVIGATOR, a prototype for CER studies that will show no clinical beneift...

http://content.nejm.org/cgi/content/full/NEJMe1002322

The finding that valsartan failed to have an effect on either of the cardiovascular-disease outcomes but had a positive effect on the incidence of diabetes is surprising. Previous studies of ACE inhibitors and ARBs have suggested that these drugs have a beneficial effect on cardiovascular disease in patients with diabetes, and the lower blood pressure achieved would be expected to result in a reduction in cardiovascular disease. In the NAVIGATOR study, the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.

The results from the NAVIGATOR study do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect. Although the authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia, valsartan was relatively weak in preventing diabetes, and it did not lower the rates of cardiovascular disease. The prevention of diabetes remains a critical public health priority, but for now we should steer away from these two drugs and use effective lifestyle interventions and, in selected persons, metformin to combat the epidemic.  Read More & Comment...

Ad(s) Infinitum

03/18/2010 09:16 AM |

PhRMA is supporting a new advertising campaign supporting health care reform legislation.

The new television ad, "Finish," along with two previously-released ads, "Covered" and "You Choose," began airing March 17 in targeted districts across the country where House Democrats undecided on how to vote might need a push to vote in favor of the reform package.

"It's been a long road, but now we've never been closer to common sense health reform," a voice in the "Finish" ad says. "Reform that leaves health care decisions to patients and their doctors, covers pre-existing conditions, and lowers out of pocket costs. A new path that lowers the deficit. Congress, keep fighting for health reform - all the way to the finish."

The 15-second clips in support of health care reform were produced by Americans for Stable Quality Care, a non-profit coalition of a number of organizations - including PhRMA, the Biotechnology Industry Organization, Families USA and the American Medical Association.

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The Big Dig

03/17/2010 06:45 AM |

Health reform is a rough ride, so here’s a germane quote from America’s favorite rough rider -- Teddy Roosevelt:

 

“When you are in a hole – stop digging.”

 

Germane, because of some new poll numbers on health care reform.

 

According to a new national poll from GfK Roper (sponsored by CMPI-Advance), 70% of Americans oppose using budget reconciliation to pass health care reform and 60% believe it is unfair for House leadership to have the option to introduce a procedural rule that would “deem” the Senate health care reform bill as being passed without actually voting on the legislation itself.

 

Americans do not support for increasing Medicare payroll taxes for the high wage earners (46% support, 47% oppose) or reducing what doctors and hospitals are paid for their services (45% support, 48% oppose).  The survey shows that Americans are evenly split in their belief that the Congressional health care proposal will increase taxes and premiums for the 73 million Americans with health insurance (as estimated by the Joint Committee on Taxation).

 

Other findings include:

 

·      81% of those polled strongly oppose health care reforms that would increase insurance premiums for healthy people to offset premiums of people who wait until they are diagnosed with an illness to purchase insurance.

 

·      80% oppose allowing the government to decide what kind of health care coverage Americans are able to purchase.

 

·      87% oppose having a government panel recommend or decide what medical procedures or medical advances your doctor can use or your health plan can pay for.

 

·      84% support reforms that would allow people to buy health insurance across state lines.

 

·      3 out of 4 Americans oppose healthcare reforms that would raise taxes and cut Medicare benefits to pay for health care subsidies for expanded coverage for the uninsured.

 

·      84% support healthcare reforms that would let people get lower premiums for getting or staying healthy.  

 

Complete survey results can be found here.

 

Madame Speaker – stop digging.

 

Survey Methodology

 

GfK Roper completed 1,000 interviews, made up of male and female adults (in approximately equal number), all 18 years of age and over.  The interviews were conducted between March 12 and March 14, 2010. The margin of error for this study is ± 3 percentage points. 

 

Sampling for this study was conducted using a national probability sample of all exchanges and area codes across the continental United States. All interviews were conducted using a computer-assisted telephone interviewing system. Statistical weights were designed from United States Census Bureau statistics.

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A Vote That Really Matters

03/16/2010 11:44 PM |

For some reason neither the media or the NEJM bothered to report on the results of this poll which, more than any other, will have a direct impact on the future of health care.
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Deal of Fortune

03/16/2010 08:00 AM |

From the pages of Politico ...

Pharma tries to protect its deal
By: Chris Frates

As Democrats scramble to finish drafting health reform legislation, drug lobbyists are working overtime to ensure that the final bill doesn’t bust the $90 billion deal they have with the White House and Senate Democratic leaders.

For the past few days, drug industry lobbyists have huddled with Democratic staffers to work out how to structure the fees drug makers will pay under reform while still making good on Democrats’ promise to close the gap in seniors’ drug coverage. Last winter, the industry pledged $10 billion to help close the coverage gap in addition to the $80 billion deal it had struck earlier in the year.

Drug makers were asked to sign off on multiple solutions, giving Democrats backup options should any of the fixes run into problems passing muster with the Senate parliamentarian, who, because of procedural rules, essentially has the final say over what’s included in the legislative package.

With billions of dollars hanging in the balance, there was “real heartburn with the bill over the weekend and over the last week,” an industry source said.

The industry also decided to drop its push to be carved out from an independent Medicare payment advisory board – vowing instead to fight it if it becomes law, sources said. The board would essentially force cost cutting measures on lawmakers, limiting the influence of outside groups like PhRMA to lobby the outcome.

With all the drama of reform coming down to the wire, the players’ nerves are rubbed raw, said one insider. Still, the industry expects its deal to hold.

Democratic are racing to finish a reconciliation bill that could pass the House this week and win Senate approval before Congress breaks for the Easter recess at the end of the month. Democrats are crafting the bill so it only needs 51 votes to pass, bypassing the Republicans’ filibuster threat.

But Republicans pounced on the wheeling and dealing as another symptom of what’s wrong with reform.

“All we hear about is the arm-twisting and the horse-trading that’s going on over there behind the scenes – the mad dash ahead of the big vote. And once again, Americans can’t believe what they’re hearing,” Senate Republican Leader Mitch McConnell said Monday on the chamber floor. “The drug lobbyists were here in the Capitol over the weekend huddling with Democrat staffers to make sure their interests would be protected in the final bill. This is precisely the kind of thing Americans rebelled against after the last vote on this bill.”

Also Monday, senior pharmaceutical industry sources denied a New York Times report that the industry has invested $12 million in new, pro-reform advertising. PhRMA has not signed off on a new ad campaign, no ad copy has been approved, nothing has been done, said the sources, who are intimately familiar with the situation.

"I cannot say this more emphatically, it's not true," said one source, who is not authorized to speak publicly.

In fact, the White House has been leaning on the industry to buy positive ads to provide air cover to wavering House members, whose districts have been inundated with opposition advertising. But the drug makers are holding out until they see, and sign off on, the final reconciliation bill, industry sources said.

As a key White House ally, the drug industry has been the money behind much of the pro-reform advertising this past year. Drug makers' decision to hold out could mean there will be little in the way of pre-vote cover. But, if the industry supports the final bill, it's almost guaranteed a post-vote blitz of thank you ads praising lawmakers who voted yes will air and they will likely see support through Election Day.

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