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.

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.

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.  

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

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.

“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.

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.

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.