Latest Drugwonks' Blog
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.”
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
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
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.
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.
"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.
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.
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.
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
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.
