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New Models for Market Access

Dec 27, 2011• 2

By Ulf Staginnus

I cannot resist writing one more time about the entire market access discussion currently ongoing everywhere, as I believe many of those numerous articles and reports are missing the point.

It is amusing, at least to me, to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches, etc. all over the place, basically suggesting how the industry just needs to throw a few more people with fancy titles here and there, coupled with slight organizational changes, onto the problem and involve stakeholders and—guess what?!—actually talk to patients and perhaps even payers and all of a sudden, like Alice in Wonderland, everything will be good, after all.

The uncomfortable truth is, it won’t be. All this “noise” is only good for one thing, paying the bills of the consultants, which is fine, too, as I have been one myself so I can understand. But it will not address the problem the research-based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry’s survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.

Digitizing Human Beings

Dec 26, 2011• 12

By Eric J. Topol, MD

Our day-to-day lives were reformatted when the consumer mobile wireless device era, beyond cell phones, was ushered in by iPods in 2001 and followed in short order by Blackberries, smartphones, e-readers, and tablets. Nurturing our peripatetic existence, we could immediately and virtually anywhere download music, books, videos, periodical, games and movies. Television is soon to follow. But these forms of digital communication and entertainment are a far cry from digitizing people.

This decade will be marked by the intersection of the digital world with the medical cocoon, which until now have been largely circulating in separate orbits. The remarkable digital infrastructure that has been built—which includes broadband Internet, cloud and supercomputing, pluripotent mobile devices and social networking― is ripe to provide the framework for a most extraordinary upgrade and rebooting of medicine.

When I was finishing my internal medicine training in 1982 the term “digital” in medicine referred exclusively to the rectal examination. Now, 3 decades later, there are 4 domains of what comprises digital medicine―genomics, wireless sensors and devices, imaging and health information systems. Each of these digital medical technologies are on exceptionally accelerated growth curves. In 2012, complete DNA sequencing of all 6 billion bases of a diploid human genome will be accomplished in 2 hours at a price well under $4000. Already DNA sequencing is having an impact in medicine for specific gene-drug interactions, targeting of cancer therapy by defining tumor driver mutations (comparing somatic versus germ-line DNA), and demystifying life-threatening idiopathic diseases. Just a few years ago wireless sensors got their start for consumers in the health and fitness space, with wearable accelerometers in running shoes, bracelets, necklaces or clips. Now a brain wave sensor can be used to continuously monitor one’s phases of sleep and wakefulness.Continue reading…

There Is an Incubator Bubble. And It Will Pop.

Dec 26, 2011• 6

By WADE ROUSH

In any market where the number of new businesses triples in the course of two years, you know that something unusual is going on. (And make no mistake—most venture incubators are businesses, founded and funded by people hoping for real returns, whether social, financial, or both.) You naturally begin to wonder whether a bubble is forming, in the classic sense of an episode of vertiginous growth disconnected from economic fundamentals such as market demand. And since bubbles are, by definition, unsustainable, you wonder what’s going to happen when they pop.

If you ask me, there is clearly an incubator bubble. Whatever your opinion about the existence of a bubble in the larger world of Internet startups—Sarah Lacy and Dan Primack offered interesting, opposing views on that this week—it’s hard to imagine that today’s tepid consumer and business markets have room to absorb all of the products and services offered by the hundreds of new startups that the incubators are now churning out each year.

It’s a given that only a few of the startups going through the incubators will strike it rich while the rest languish or die—that’s the nature of the startup game. What I’m saying is that without higher-than-normal success rates, many of the incubators themselves could find it difficult to stay in business.

Here’s why. Most of these operations are organized along the Y Combinator model: they provide startups with $15,000 to $25,000 in seed funding and about 12 weeks of mentorship and product development assistance, and in return they take an equity stake, usually around 6 percent. They profit when incubated startups get big and successful enough to be acquired. (As far as I know there isn’t a single example of an incubated company going public.) Doing the math, let’s say you’re the founder of an incubator and you fund 20 companies a year at $25,000 each, in return for a 6 percent stake. To achieve respectable returns on that $500,000 you laid out—let’s say a 3x return, not even figuring in your operating costs and the value of the time you put into mentoring the companies—you need one of your alumni companies each year to achieve an exit in the $25 million range (or two at half that, and so on). And that’s assuming your stake isn’t diluted by later funding rounds. It’s quite a gamble, and I just can’t see the economics being very compelling for any but the largest, best-funded, most prestigious incubators—i.e., Y Combinator and TechStars.

Mind the Gap

Dec 23, 2011• 22

By Stephen J. Downs

It’s a simple idea – show patients the notes that doctors write about them– but it’s also a dangerous idea … in the best sense of the word. It’s dangerous because the very idea forces a conversation and in the course of that conversation, some uncomfortable tensions surface. Jan Walker and Tom Delbanco, co-directors of OpenNotes, a project supported by the Robert Wood Johnson Foundation’s Pioneer Portfolio that enables patients to see their doctors’ notes via secure e-mail after a visit, published a preliminary set of results from their first study. Actually, it’s just a pre-study: they surveyed doctors and patients about their expectations of how the OpenNotes idea would play out. And what they found is fascinating – and uncomfortable.

Doctors and patients are clearly divided about the expected benefits and consequences of the OpenNotes intervention. On a wide range of possible benefits, ranging from a greater sense of control to increased medication adherence, doctors are more skeptical than patients. But what really jumps out are the responses to questions of whether patients would find the notes more confusing than useful, and whether the notes would make them worry more. The gap is dramatic. In each case, most doctors said “yes” while less than one in six patients agreed. Ouch. That’s a big gap and my sense is that we should be talking about what it means. From my perspective, it appears that many doctors are underestimating their patients and that this underestimation could lead to less patient engagement and ultimately poorer care. Call it a hunch.

Health 2.0 News

Dec 23, 2011

The VA’s Facebook strategy, funding for Jawbone’s health care device unit and a new list of the top data breaches of 2011 — over at Health 2.0 News

We Have Cancer

Dec 22, 2011• 21

By John Halamka, MD

Cancer. It’s a word that creates fear and uncertainty. Many of the doctors I know use the word “hate” whenever they discuss their feelings about cancer.

Last Thursday, my wife Kathy was diagnosed with poorly differentiated breast cancer. She is not facing this alone. We’re approaching this as a team, as if together we have cancer. She has been my best friend for 30 years. I will do whatever it takes to ensure we have another 30 years together.

She’s has agreed that I can chronicle the process, the diagnostic tests, the therapeutic decisions, the life events, and the emotions we experience with the hope it will help other patients and families on their cancer treatment journey.

Here’s how it all started.

On Monday, December 5, she felt a small lump under her left breast. She has no family history, no risk factors, and no warning. We scheduled a mammogram for December 12 and she brought me a DVD with the DICOM images a few minutes after the study. On comparison with her previous mammograms it was clear she had two lesions, one anterior and one posterior in a dumbbell shape. I hand carried the DICOM images to the Breast Center team at BIDMC.

On December 13 she had an ultrasound guided biopsy which yielded the diagnosis – invasive ductal carcinoma, grade 3.

Is Nanotechnology the New GMO?

Dec 21, 2011

By Marion Nestle

Food Navigator reports that UK experts are demanding public debate and regulation of nanomaterials in foods. Without that, they warn, nanotechnology risks “facing the same fate as genetically modified (GM) foods in consumer perceptions.”

Nanotechnology is about manipulating materials on the scale of atoms or molecules, measured in nanometers (nm), one billionth, or 10⁻⁹, of a meter.

Many companies are already using nanomaterials in agriculture, food processing, food packaging, and supplements. This is not something the public has heard much about. Food companies often don’t know whether or not they are using these materials.

Nanotechnology science is new, and the industry is unregulated.

The FDA’s nanotechnology web page links to a quite thorough 2007 report from a task force, but the agency’s only guidance to date tells companies how they can find out whether they are using nanomaterials.Continue reading…

Startup Incubator Healthbox Announces Its First Class

Dec 21, 2011

By Laura Montini

Chicago-based startup accelerator Healthbox Chicago-based startup accelerator Healthbox announced the inaugural class of ten companies to begin its program in January 2012. Healthbox comes from Sandbox, which manages the Blues venture funds. Healthbox’s program is similar to incubators Rock Health in San Francisco and Blueprint in New York City. But instead of the $20,000 Rockhealth gives (taking no equity), Healthbox will give class members $50,000 in seed capital in exchange for 7% equity, and the companies will also have access to a mentor network, forums led by business experts and a collaborative workspace–(they may though have to move to the wilds of Chicago). The program will culminate in April with Investor Day where participants will present their businesses to a targeted group of investors. Healthbox received hundreds of applications from 26 states and eight countries with concentrations on provider workflow, consumer health, informatics, pharmacy and more. Here are the companies that made the final cut:

Twenty-First Century Personalization of Health Care

Dec 20, 2011• 3

By Charis Eng, MD, PhD

The public perception of “personalized medicine” is askew: the term is often viewed as a common treatment option for rare genetic disorders. The truth is that the power of genetic and genomic information allows physicians to offer personalized health care to their patients.

Yet personalized health care is not new: ABO blood typing is a superb example of widespread genetics-based personalized healthcare dating back to World War II, and continues to have universal applicability and will for centuries to come.

Consider a more recent example: common associations for breast cancer accounts for almost three percent of all breast cancers whereas a “rare mutation” (BRCA1-2) alone accounts for 10 percent of all breast cancers. There are currently at least nine other breast cancer predisposing genes which help knowledgeable healthcare providers make the correct diagnosis and inform patients of risks of other cancers.

Scenario Planning in a Post-ACO and Post-ACA World

Dec 20, 2011• 1

By Jaan Sidorov, MD

In a prior post, I provocatively suggested that providers, hospital boards and policymakers should hedge their bets and prepare for the possibility of a “post-ACO world.” If the Group Practice Demo’s disappointing results are any guide, the likelihood of a happy ending for accountable care organizations is on numerical par with Congress’ approval rating. While I like the mutual “win-win” theoretical construct that underlies ACO gain sharing, it also recalls a life-lesson: want you want and what you get are usually two different things.

So, if the Feds have to eventually retreat on the non-success of ACOs, what will be left in its wake? More on that in future posts.

And while the uncertainty surrounding ACOs isn’t bad enough, I have also been astonished by the battered Euro, the appearance of hospital-employed cardiologists and the absence of a Lady Gaga Christmas album. Accordingly, I have learned my lesson and assume nothing.