Latest Drugwonks' Blog

Project Hope

  • 03.02.2010

Jim Pinkerton (one of the smartest --- and tallest – players in the healthcare policy arena) has penned some very nice words about CMPI’s second annual Odyssey Awards dinner on his blog Serious Medicine Strategy.

And his focus is on one of our favorite four-letter words:  Hope.

Hope in New Jersey

The Center for Medicine in the Public Interest (CMPI) held its second annual Odyssey Award Gala Thursday night, and amidst all the discussion of health policy and medicine, here was one mega-topic on the program: Hope.

Sadly, hope is in short supply in Washington these days. On healthcare, which was supposed to be the signature agenda item of the Obama administration, as well as the Democratic majority in Congress, we now see that both the executive and legislative branches are thoroughly bogged down in unpopular bureaucratese. Leaders on both ends of Pennsylvania Avenue are still trying to pass healthcare "reform" that the American people manifestly do not want. What the American people do want health, but health is not what Washington is interested in advancing. Yes, that seems strange, but Washington is a strange town.


Jim’s complete post can be found here:

http://seriousmedicinestrategy.blogspot.com/2010/02/httpwww.html

Online and On point

  • 03.01.2010

In the continuing saga of social media guidance ...

AstraZeneca (NYSE: AZN) today asked the U.S. Food and Drug Administration (FDA) to adopt guidance that will enable AstraZeneca and others to fully engage in real-time, social media conversations that responsibly provide accurate, balanced information on medicines from a known, identifiable and reliable source. 

            AstraZeneca’s proposal was in response to the FDA's September 2009 Call for Comments on their public notice: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

 “AstraZeneca understands the value of social media to engage key stakeholders in today’s technology-driven world,” said Bob Perkins, Vice President, Public Policy and Promotional Affairs. “While we have developed a corporate presence in the digital space, we believe it is increasingly important to participate in online channels to provide accurate and regulated information about our branded products in conversations with patients, caregivers, and health care providers.”

AstraZeneca believes that five principles should be at the core of any company engagement in social media:

  • Truth and Accuracy: Content must be created, developed, or made available that is truthful, balanced, accurate, and not misleading.
  • To Be Respectful:  Encourage product sponsor participation that respects the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship.
  • Protect and Advance Patient Health: Facilitate patient access to quality information for use with their physician to improve their health and protect patients through encouraging accurate and timely reporting on medicine safety.
  • Transparency: Any product sponsor participation should be accomplished in a manner that, at all times, is entirely transparent to other participants as to the role of product sponsors as participants in online discussion.
  • Respect the Views of Others: Acknowledge that patients, caregivers, clinicians and others who participate in social media have their own opinions and that, when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views but to add the product sponsor’s own views to the discussion.

In its comments to the FDA, AstraZeneca proposed a regulatory framework that is consistent with these principles and defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media:

  • Company-controlled, hosted online communications 
  • Company-controlled communications 
  • Real-time, social media participation communications

The company also noted that, “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making.  In our absence, consumers will turn to information sources that are not regulated and not always well informed.”

AstraZeneca believes the company has an obligation to participate in social media in a responsible way to help educate and empower patients, caregivers and prescribers to make informed decisions about its products.

Click here to view AstraZeneca’s full submission: http://www.astrazeneca-us.com/_mshost795281/content/media/FDA-2009-N-0441.pdf

Does silence connote assent? And, if so, assent to what?

On 2/25, AARP announced that it would refrain from further public advocacy of healthcare reform to help, "lower the external political pressure."

Hm.

Please sir, may I have (Sir Thomas) more.

This is a recording

  • 03.01.2010

Whatever happened to “there’s no place for politics at the FDA?” Steve Nissan’s shades-of-Watergate “secret tapes” notwithstanding, the debate over Avandia must be decided based on science and the best judgment of FDA career professionals. 

Secret tapes?  David Graham?  We’ve been down this road before. Let’s get real here folks and let the FDA do its job without political interference.

Jonathan Cohn on why Democrats should just impose an unpopular health care bill on Americans:

"And what about making medical care less expensive? The Democrats' approach is to try a combination of approaches: Eliminating waste, redirecting Medicare payments so that they reward efficiency, altering the tax treatment of insurance, and so on. They admit it will take time and that they are not sure which approaches will work best. But these efforts get at the root causes of rising medical costs--not just profit or administrative inefficiency, but also the tendency towards unnecessary over-treatment."

The liberal logic is that unnecessary treatment is at the heart of rising medical costs (conservatives tend to nod in agreement) and that government regulation can change behavior to eliminate "waste."   The Torah for the Left in implementing this grand scheme is the Dartmouth Atlas. 

But it is increasingly clear that the Dartmouth Atlas is to healthcare reform what the UN Climate Report is to Cap and Trade...  a mass of data and assumptions reinforced by people who believe in the same thing but not in actual biological or clinical facts.   If anything, the effort to eliminate over treatment will make people sicker and undermine innovation, which is the real source of disease prevention and better health.  

Meanwhile,  the Left is also willing to gloss over their willingness to shove 15 million people into Medicaid and what the implications of that will be, on top of cuts to Medicare reimbursement on the supply of hospital and physician services.   Apparently, it thinks that paying little more than half of the going rate is a good way to eliminate "waste."    Does the Left believe that Medicaid delivers great care or can deliver even better care for what it currently pays providers?   Yes it does.  

Finally, Cohn and others lack the guts to admit they are cutting Medicare to pay for an expansion of Medicaid and a tax break for unions.   The "savings"  which may  not materialize are not plowed back into the system.  Oh no, there will be higher taxes for that on top of the new taxes for more expensive,  mandated coverage, which -- the President insists -- is only more expensive because people will want to pay more once they can actually get better coverage.   So you see people really were never concerned about rising premiums after all, they were just waiting for the government to mandate more expensive health care, raise taxes and limit subsidies to a small portion of Americans.  Or more to Cohn's authoritarian purpose, we really shouldn't have a choice because we are too stupid to really appreciate just how great the new health care order will be. 

As I have written before, I hope the Left persists in this strategy.  It will be decimated at the polls come November and health care reform will be better off for it.  

http://www.tnr.com/article/politics/summited-out?page=0,1&utm_source=TNR%20Daily&utm_campaign=26cab0e92c-TNR_Daily_022610&utm_medium=email

The much ballyhooed White House summit on healthcare created no “aha” moments or Daily Show-worthy gaffes and was about as interesting to watch as Olympic curling.

President Obama was hoping, by force of will, intelligence and gravitas to both sway Republican lawmakers to his point of view (aspirational at best) while simultaneously demonstrating to the American people (and particularly American voters) that his proposal was a moderate one (arguable at worst).

From a communications perspective, he was presented with a classic  Nick Naylor moment. The president didn’t realize the odds were 2-1 against. Not only did he have to prove he was right, he had to demonstrate the other side was wrong.

The GOP had an easier task — to have something constructive to offer, not get shrill (and yell “liar!”) or look at their watches. They succeeded.

House Minority Leader, John Boehner, rather than coming across as “Dr. No,” was the man with a plan – an easy-to-explain 6-point plan. Communications 101. The GOP were combative but collegial. Their sound bites were designed to generate nodding “me toos” across America. The Democrats were uncoordinated and visibly unhappy they were unable to paint themselves as the white knights of healthcare reform.

Obama and the Democratic leadership needed a dynamic event that would galvanize public opinion behind their call for immediate and comprehensive healthcare reform legislation. They needed a hard-hitting Olympic hockey game. But there were no stand-up body checks. Instead, the president looked like a professor grading papers and the whole enterprise looked and sounded like C-SPAN – the American equivalent of Olympic curling. Let the spinning begin.

AZ on co-pays

  • 02.25.2010
Not AstraZeneca -- Arizona.

It seems the issue of co-pays getting in the way of care and compliance is catching on.  Have a look at this television news report:

http://www.azfamily.com/news/consumer/Sky-rocketing-co-pays-having--85270547.html

This issue is catching fire because it's that rare combination of facts and common sense working together.

Opie Deepee

  • 02.25.2010

So long DDMAC.  Hello OPDP.

Under a new proposal, DDMAC will be renamed the Office of Prescription Drug Promotion and have two divisions, one to review direct-to-consumer content and the second focusing on professionally directed promotions. In terms of structure, it would remain directly under the Office of Medical Policy within the Center for Drug Evaluation and Research (CDER).

According to Rachel Behrman, the proposed change would take several months to implement, adding the suggested move “does not signal a change in philosophy or attitude” in DDMAC, but rather reflects the importance of the division within the agency and its overall size.

And, as we all know, Opie springs eternal.

Thorns are another matter.

Is DDMAC getting a new moniker?  Buzz is that, at this week's DIA marketing meeting, Dr. Rachel Behrman (Associate Commissioner for Clinical Programs) will reveal both a new name and that Tom's Posse will be elevated to an "Office" within CDER. 

Does a new name mean a new attitude?

Just yesterday, Tom Abram's called upon industry to adopt increased self-regulation and restraint.  Thanks Tom.

"We do what we must, and call it by the best name."


-- Ralph Waldo Emerson

First Buzz Cooper systematically shredded the underlying assumptions of the Dartmouth Atlas with his studies showing that sickness and poverty, not stupid doctors over-treating people who coincidentally all died within two years, explained most of the variation in health care spending. 

Then Peter Bach in his NEJM article revealed that the entire enterprise, the foundation not only of the entire liberal effort to bend the curve on health care through government rationing but of a billion dollar business designed to "coach" people out of treatments for back pain, breast cancer, prostate cancer, etc... all to the financial benefit of hospitals and health plans, is medically bankrupt and statistically corrupt...

Here's Buzz Cooper putting the Atlas through the document shredder:

An important article appeared in today’s NYT, describing a new paper by Peter Bach, which is in today’s NEJM. Peter’s paper (“A Map to Bad Policy“) debunks the Dartmouth Atlas and cautions against its use. As I said in the Wash Post in September, the Dartmouth Atlas is the ”Wrong Map for Health Care Reform.”

More damning even than Peter’s analysis was Elliott Fisher’s reply: “Dr. Fisher agreed that the current Atlas measures should not be used to set hospital payment rates, and that looking at the care of patients at the end of life provides only limited insight into the quality of care provided to those patients. He said he and his colleagues should not be held responsible for the misinterpretation of their data.” Really? It was someone else’s interpretation? OK, Elliott, you’re not responsible. Just stand in the corner.

Peter is not the only leading epidemiologist to debunk Dartmouth in recent days. There’s also the report this week from the U of Wisconsin and RWJ by Pat Remington (another leader), showing that people who have the poorest health (and, therefore, the highest health care costs) live in the poorest counties (see my blog report and an earlier discussion of poverty and health care). And there’s the recent paper by Ong and Rosenthal (co-authored by Jose Escarce, editor of HSR, the leading health services research journal), showing that, when all care is measured (not simply end-of-life care, as measured by Dartmouth), hospitals that provide more have lower mortality, which was confirmed in the current issue of Medical Care by Barnato and associates at the U of Pittsburgh. When it rains, it pours.

What’s doubly important about the death of the Dartmouth Atlas is that it was the cornerstone of health care reform. Right from the start, Peter Orszag, director of OMB and the administration’s architect of health care reform, accepted Dartmouth’s ideological principles that health care spending was driven by doctors and hospitals who over-treated and over-charged, to no benefit. The funds for health care reform were readily available by simply getting rid of geographic differences. That alone would save 30% of health care spending ($700B). And that could be accomplished by making everything look like Mayo (white, middle class and efficient) and by having more primary care physicians (which Mayo doesn’t). And best of all, it could assure that no new taxes would be needed, just as President Obama had promised.

And here's Peter Bach explaining why cost driven health care policy is, well, bad for patients...

Say Hospital A and Hospital B each has a group of patients with a fatal disease. Hospital A gives each patient a $1 pill and cures half of them; Hospital B provides no treatment. An Atlas analysis would conclude that Hospital B was more efficient, since it spent less per decedent. But all the patients die at Hospital B, whereas only half of the patientsdo at Hospital A, where the cost per life saved is a bargain at $2. Although $1 cures are rare, changing the price or efficacy of the pill does not alter the fundamental problem with examining costs alone when cost differences are sometimes associate with outcome differences.

And finally Bach challenges what, until recently, the media, most foundation types, the underachieving liberal health bloggers drank as daily Kool-aid,  that the Dartmouth Atlas controlled for severity of illness by looking at only dead people. 

Another methodologic problem is that Atlas analyses assess hospital efficiency overall on thebasis of costs incurred for nonrepresentative patients — decedents who were enrolled in fee-forservice Medicare. This group varies among hospitals in terms of severity of illness and is notrepresentative of a given hospital’s overall spending pattern. Regarding illness severity, Atlas researchers note on their Web site (www.dartmouthatlas.org/faq/ hospital.shtm) that they focus on “patients who died so that [they can be sure] that patients were similarly ill across hospitals,” further explainingthat “by definition, the prognosis of all patients[who died was] identical — all were dead . . . therefore, variations [in resource use] cannot be explainedby differences in the severity of illness.” But since some hospitals take care of sicker patients than others, the average severity of illness of patients who die also varies among hospitals. This fact is being ignored when all spending differences are attributed to differences in efficiency.

The Dartmouth group has circled the wagons.  Atul Gawande tries to explain how Bach's article, which directly attacks the Dartmouth methodology, reaffirms how brilliant his story about McAllen, based on the Dartmouth Atlas, really was:

"Dr. Peter Bach of Memorial Sloan-Kettering argues against using the Dartmouth measures to financially reward and penalize hospitals. There is a healthy and vital debate about how best to change hospital incentives. None of this, however, calls the Dartmouth researchers’ decades of highly respected work—or their fundamental findings—into question. If anything, the debate reinforces the importance of their research."

http://www.newyorker.com/online/blogs/newsdesk/2010/02/the-cost-conundrum-persists.html#ixzz0gOWwIFNc

Meanwhile Elliott Fisher sought the refuge of the Dartmouth student newspaper to set the record straight:

“There’s a pretty good correlation between treatment of patients over 65 and under 65,” Fisher said.

In a response published in the New England Journal of Medicine, Fisher wrote that Medicare data is closely associated with a single hospital, making it a good measure of hospital effectiveness.

Bach’s final criticism of the Atlas data focused on the variation of illness severity between hospitals. Because of this variation, hospitals that care for patients with very severe illnesses could appear less efficient than those that take care of patients with less severe cases, even if they actually operate with the same level of efficiency, he said.

Fisher responded in the interview that the Dartmouth Atlas data is “carefully adjusted” for variations such as illness severity, poverty and price differences.

Talking to a college student, admittedly, a very smart college student, Fisher can get away with a mixture of evasion and distortions. 

1.  There is no correlation between health care spending between people age 65 and over vs people who are younger unless you truly control for severity of illness which the Atlas fails to do because it never looks at two people from baseline with the same disease over time and compare outcomes.  The Medicare/ non Medicare variance is wide as the Bach article shows.

2.  Dartmouth and Fisher claim to limit who they analyze to those with a list of common chronic diagnoses.  All together, that is about 90% of all people who die in Medicare.  Then they adjust for a few things like primary diagnosis and age and sex and stuff.  They have never shown that they can capture the variability between hospitals in severity of illness and they cannot, even using far more sophisticated measures.  But they do not think they need to risk-adjust for the regional variations stuff.  When MedPac did that, most of the variations went away.

Despite all this, both Gawande and Fisher persist in claiming:
"that Bach’s criticism does not undermine the main finding of the Atlas data: regional variations in health care spending show that higher costs associated with specialized procedures do not necessarily lead to better health outcomes. Costs can be lowered by creating more accountable hospitals and moving away from a “toxic payment system” that creates incentives for unnecessary tests, according to Fisher."

http://thedartmouth.com/2010/02/22/news/atlas

Why would they say that when the entire methodology is shot to hell?

Because both (and not just them) make big money off of speeches, consulting and businesses that push the less is more approach. 

And the commercialization of the Dartmouth Atlas -- coaching people to ration their own care in my opinion --  culiminated in the formation of a company called Health Dialog by the Dartmouth folks.  HD was purchased by a British concern for $750 million.  And HD has lobbyists in Washington pushing the adoptiong of its products in the current health care reform bill. 

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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