You probably wouldn’t put Microsoft on the list of companies in the market to hire former FDA officials, but the software giant snagged a top medical-device regulator today.

Donna-Bea Tillman, head of the office of device approvals, says her jump to Microsoft isn’t as unusual as it may seem. She told colleagues in a memo she has long had “a love for all things computer.”

Tillman elaborated in an interview with the Health Blog, saying she moonlighted writing software programs for engineering and biomedical experiments when she was in graduate school at Johns Hopkins doing biomedical engineering. “This is a match made in heaven,” she said of her new job.

Microsoft, Google and other technology companies are trying to get in on the medical information-technology bonanza, which was given a boost with $20 billion in last year’s economic stimulus package. Microsoft is also trying to get its Washington health group a higher profile.

IT can play a big part in comparative effectiveness research for medical treatments, Tillman said, adding, “If you want to buy a car, you can get information comparing everything in Consumer Reports, but I can’t get that if I get a disease.”

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

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.

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.

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.

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.

“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.

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.