By Phil Bauman

Data, information, interpretation and decision-making are among the vital components of prevention, diagnosis, management and treatment.

The problem we have today is how to gather and manage the data that our bodies radiate.

In order to solve this problem, we have to surmount other problems – which are not just technological but also behavioral, cultural and financial.

But if you want an idea of what an extreme version of data-collection might look like, check out the application Placeme.

Now Placeme is *not* a Healthcare application. What Placeme does do, however, is to continually (in almost real-time) track the places that you visit. No check-ins; no need to enter and data – the application simply runs in the background and does its magic.

When you think about that (from the cultural perspective of today), that’s creepy.

And yet, this “creepy” model is the future. It represents the technological and cultural arc that social software is throwing us. We can fight it (and should in order to flesh out the nuances so we can ensure safety) but in the long-run we shall have to accept the trend and work accordingly.

So think of Placeme in terms of what the ‘Quantitative Self’ movement is attempting to achieve.

Continue reading “PlaceMe: A Creepy Model For Health Information?”

By Angela Garcia

My aunt Marion is in the hospital dying of liver and kidney failure, the result of her 20-year struggle with heroin use. I was told of her imminent death the same day news broke about a vaccine against the drug. “Breakthrough heroin vaccine could render drug ‘useless’ in addicts,” one headline read. “Scientists create vaccine against heroin high,” proclaimed another.

Meanwhile, my aunt finds temporary relief in the ever more frequent administration of opiate pain medication — the very kind of drugs she used illegally.

The idea of an anti-addiction vaccine is not new. For nearly 40 years scientists have been working on vaccines against all kinds of addictions, including nicotine, marijuana and alcohol. There are even trials of vaccines to prevent obesity. None of the anti-addiction vaccines has yet received Food and Drug Administration approval, however, and most of the studies are still in their early stages.

The headlines trumpeting a heroin vaccine were based on a finding that the drug had proved to be effective on mice during trials in Mexico (a nation that could use some good news related to drugs). Scientists now plan to test the patented vaccine in humans. If all goes well, the vaccine could be available in five years — too late for my aunt but providing a glimmer of hope for the estimated 1 million heroin addicts in the United States. Perhaps.

Six years ago, when I was a doctoral student researching heroin addiction in northern New Mexico, I received an email from a scientist studying a possible vaccine against the drug’s use. The study was in rat models, but early results were promising and suggested the likelihood of a therapeutic effect for humans. Aware of the devastating heroin epidemic in New Mexico, which had the highest rate of heroin-related deaths in the Unites States, and of my work trying to understand it, the scientist wanted to offer some hope. He wrote that he could imagine a time when heroin addiction, in New Mexico and around the world, would be a thing of the past. I wanted to believe him, but I was less optimistic.

Continue reading “Heroin Vaccine Won’t Cure What Ails Addicts”

By David Shaywitz, MD

The central dogma of drug discovery is that academic basic research -> industry applied research -> new medical product.  The disappointing number of impactful new medical products have been a source of endless soul searching, and could in theory be attributable to any (and all) of the steps in this model – and might also, as some have suggested, reflect the need for an entirely new conceptual framework.

The latest issue of Nature features a spot-on commentary (subscription only) by Glenn Begley and Lee Ellis (nicely summarized in this terrific Reuters article) that focuses in on the first arrow, the translation of academic oncology basic research into application by industry, and highlights the uncomfortable and inconvenient truth that by now isn’t a very well-kept secret: basic science is unbelievably fragile, and a lot of it doesn’t stand up to serious scrutiny.

This observation is absolutely consistent with my own experience and observations (see here, here, here, and here), as well as with those of Bruce Booth (this is a terrific discussion), and of course the pioneering research of Stanford Professor John Ioannidis, whose work I discussed six years ago (here), and who has been profiled extensively since (e.g. this piece from The Atlantic).

We could spend a lot of time discussing why science is fragile; Begley and Ellis, for example, emphasize the need for a cultural change in the way preclinical research is conducted, particularly in the field of cancer.

At the end of the day, I suspect that the problem involves some combination of the law of small numbers, the appeal of narrative, the structural advantages of reinforcing dogma, and the difficulties of publishing negative results that might challenge it, especially if the dogma was advanced by senior leaders in the field who tend to play critical roles in reviewing papers for high-profile journals and in selecting which new research gets funded.  While the process may ultimately be self-correcting (and I certainly believe that science “works”), the cycle time for this can be a lifetime (literally – in some cases I’ve heard it said you need to wait for someone to pass away before contrary ideas can truly gain traction).

Continue reading “Curing cancer: Too Important — and too Difficult — for University Researchers to Do Alone”

By Laurie Gelb

By the numbers, pharma’s usage of the social media to drive corporate, brand and disease management objectives has never been greater. But how robust are pharma’s channels and programs on Facebook, YouTube, Twitter and other networks?

Consider a few table stakes for digital communication generally:

• Tell the whole truth and nothing but
• If applicable, open comments but police spam and abuse (a concept FB now enforces for all unbranded health pages).
• Support the brand you have while you build the one you want.
• Stratify messages, channels and audiences to support that strategy.
• Develop and monitor KPIs, some qualitative. It’s not just about the money.

Now consider a few typical characteristics of pharma social media content these days:

Continue reading “Pharma, Social Media & Common Sense”

By Kris Newby

It will take more than a Band-aid to fix the medical device market. This was the message delivered by Alex Gorsky, future Johnson & Johnson CEO, to an auditorium full of students and entrepreneurs at the Stanford Biodesign From the Innovator’s Workbench event last week.

Gorsky, who in a few weeks will take the helm of the world’s largest health-care corporation, discussed challenges and opportunities in medical device market, as his company navigates through a turbulent world economy and a string of product recalls.

“It’s a difficult market,” he said. “The days of incremental innovation are over.”

And, while Gorsky thinks population growth will drive up worldwide demand for health care, it’s unclear who will pay for it.

Gorsky sees a fundamental shift in the way medical devices are purchased, which may change the innovator’s design approach. In the United States, buying decisions will shift from surgeons to cost-conscious hospital buyers. And that may create demand for keep-it-simple medical devices – designs that provide 50 percent of the bells-and-whistles of current devices for 15 percent of the cost. In addition, he cited the need for more clinical information on efficacy and safety, to help hospital administrators justify medical device purchases.

As the U.S. struggles to stem rising health care costs, his company will look to emerging markets – especially China – for growth. He predicts that these health care markets will grow at 4 to 5 times the rate of the domestic market.

Continue reading “New Johnson & Johnson CEO Discusses Medical Device Futures at Stanford Event”

By Marilyn Werber Serafini

“Imagine a world without Medicare.” That’s the rallying cry of a new grassroots campaign being unveiled today by the giant seniors group AARP that will include town hall meetings in 50 states and national television ads.

Against a backdrop of proposals to overhaul the popular social insurance program and a presidential campaign likely to address entitlement spending, AARP is launching “probably the biggest outreach effort we’ve ever done on any issue” to activate its 37 million members, said Nancy LeaMond, AARP’s executive vice president.

The group will gather seniors at town hall meetings today in four cities – Richmond, Va.; Columbus, Ohio; Denver, Colo.; and Miami, Fla. – to start a conversation about the program’s future entitled, “You’ve Earned A Say.”  It is also releasing a survey showing that less than half of adults ages 18 to 49 are confident Medicare will be there when they’re ready to retire.

In coming weeks, the group will hold town hall meetings in every state, and also conduct large-scale forums by phone. It recently sent members a survey to assess their views about potential Medicare and Social Security changes.

Groups on the other side of the political spectrum are also galvanizing. This week, a conservative seniors group called the 60 Plus Association put out television ads that targeted five Democratic senators and asked supporters to press them about their support for the Medicare provisions in the 2010 federal health law.

Continue reading “AARP Readying Armies for Medicare Battle”

I’m on the board of ISIS, a wonderful organization led by the irrepressible  Deb Levine, that helps deal head on with issues of youth sexuality, mediated by technology. The annual conference is in three weeks, and there’s a hackathon the day before — Matthew Holt

ISIS is hosting our first ever hack-a-thon, together with our partners TechSoup. A hack-a-thon is a live event bringing together developers, designers, innovators and entrepreneurs to build exciting new apps and tools, in this case to improve young people’s health and wellness.

Theme: The Unmentionables

This short and focused event – 1 day only – will result in the rapid development of interesting concepts and working prototypes that will be developed further by the participating teams back at their desks and at future hack-a-thon events, with ISIS and TechSoup as partners for future product development and distribution.

Challenge: Design an app to solve the challenge of providing honest, real-time, private data from youth and young adults about “unmentionable” activities, like sexual behavior, substance use, sadness, and relationship drama to researchers and program experts who work with youth.

Date: March 31^st, 2012 Continue reading “The first Sex::Tech hackathon”

By Bill Silberg

The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization created by Congress in 2010. Our mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.

We’re committed to continuously seeking input from a broad range of stakeholders to guide our work. So as part of that effort, we’re asking for public comment on our first draft National Priorities for Research and initial Research Agenda, which provide a framework for and identify the broad questions that must be addressed so that patients can make better and more personalized decisions in partnership with their clinicians.

We released the draft priorities and agenda on January 23 for a public comment period that runs through 11:59 pm EST on March 15. You can read the draft priorities and agenda, answer 10 questions about them and provide general comments, here

We encourage you to provide comment through our website, but we’ll also accept input by mail. Responses received through pcori.org will be displayed for public view on the site.

After reviewing public comments and other feedback, PCORI will publish a report summarizing the input and explaining how it led to changes in the draft priorities and agenda. PCORI’s Board of Governors then must adopt the priorities and agenda before primary funding announcements can be issued.

PCORI is counting on you and your colleagues to you to help shape our national priorities and research agenda. Your feedback and perspective will help insure that our work is responsive to the needs of patients and those who care for them.

So please visit pcori.org today to provide comment. And to receive regular updates and funding announcements from PCORI, please subscribe to our mailing list.

Bill Silberg is the Director of Communications at PCORI. Reach Bill at bsilberg@pcori.org.

By Henry Miller

The congressional legislators who oversee the Food and Drug Administration and control the nation’s coffers have shown again that they neither understand drug development nor the regulatory problems that plague it.

In February, Sen. Barbara A. Mikulski(D-Md.) unveiled a bipartisan bill intended to spur innovation in research and drug development for chronic, costly health conditions such as Alzheimer’s disease, cancer, diabetes and heart disease.

According to the press release, the bill will invest “in public-private partnerships to ensure scientists and researchers are able to develop new safe and effective drugs,” shrink product development timelines, increase the number of drugs in the development pipeline and expedite the FDA review process.

However, there is currently plenty in the development pipeline. The federal government is boosting funding for research and development on Alzheimer’s disease; the Department of Health and Human Services alone will allot more than $500 million to it in fiscal year 2013. Moreover, drug companies spend more than $65 billion annually on R&D.

For example, there are now nearly 100 drugs in development for Alzheimer’s disease, dementias and other cognitive disorders, and almost 900 medicines being tested for cancer.

Continue reading “Wrong Rx for the FDA”

By Elaine Waples

Recently, our city hosted the fifth annual national marathon to fight breast cancer. This is not part of the Komen “race for the cure” but rather a grassroots effort that mushroomed from its inception five years ago into the impressive event it is today. Thousands of people participate as runners, volunteers, and cheerleaders clad in the signature color. I must admit, seeing some grown men run twenty six miles wearing pink tu-tus is both awe inspiring and a testament to dedication over self-image.

Its supporters include corporate sponsors, vendors, and exhibitors, and (no surprise) pharmaceutical companies. Its originators are a local TV celebrity breast cancer survivor and a cancer physician at Mayo clinic. It promises to donate 100% of the money to breast cancer research or care. To date, the event has raised millions of dollars and has met its contribution promise. It’s all very worthy, noble and heartwarming.

So why do I get an embarrassingly annoyed feeling when the pink parade makes its way through my neighborhood? After all, isn’t it a victory that so many people today recognize the need for education and awareness about a terrible disease that kills 40,000 women a year? Of course it is. And I have met many women breast cancer survivors who have become warm wonderful friends and I am thrilled for the overwhelming support they have.

The frustration seems even more puzzling in light of the fact that I am a cancer survivor myself. I was diagnosed in 2010 with advanced primary peritoneal ovarian cancer, the most lethal of all gynecological cancers with an alarmingly small overall survival rate. So for the past two years of chemotherapy and difficult treatment, I have struggled to suppress what feels like a petty sentiment about all the pink attention. If I just own up to it, I feel left out and I really want a parade with everyone wearing teal in support of ovarian research and care. My cancer! My body part! A cure for me!
Continue reading “Is My Cancer in the Wrong Body Part?”