A look through some old boxes from Allie’s childhood turned up this sheet of gold. We’ve deduced that it was penned in or around 1992-93 when she was 11 or 12 years old. If you’ve ever met AJ (in all her kindness & delight), you’ll definitely understand why everyone is especially taken aback when reading through this for the first time. (click to enlarge)

We forget how widespread these sorts of fears were some 15+ years ago. It’s  also funny to recall how we understood human and technological interests to be so fundamentally opposed, or disconnected, back then.

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If you’re curious, Allie got an A on her project. Her teacher’s comment read “May I have perspective? You have caught the feeling many have of computers.”

So we haven’t posted here for a while. Sorry. Between the upcoming HNHN wedding and the new job on my front, it’s been a jam packed summer to say the least.  And as the blogging guilt mounts, it’s funny how I feel increasing pressure to make the next post a doozie (which  in turn makes it mentally tougher to make the time to sit down and actually write something up).

So while I have a few doozies half-written in my head, in the interim I thought I’d fight through the anxiety and put up a quickie to say hi, we’re still here, and we’ve not abandoned this place. In the future I promise not to use terms like quickie and doozie. Obviously I’m a bit rusty.

Via ThisIsIndexed

Monday, May 10 Pathway Genomics’ test is considered a ‘device’ by FDA

The FDA Office of In Vitro Diagnostic Device Evaluation and Safety, sends a letter to James Plante, CEO of DTC company Pathway Genomics Corporation, pointing out that Pathway’s “Genetics Health Report” product appears to meet the definition of “device,” and therefore requires an FDA clearance/approval number. They request that their approval number be provided. [Of note, Pathway DTC genomic testing has been available online since July 2009].

Tuesday, May 11 Washington Post runs story about gene tests being sold in drugstores

The Washington post runs the story that personal genomic testing company Pathway Genomics was getting set to offer their genetic testing kits at Walgreen drugstores across the country.

Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer’s disease, breast cancer, diabetes and other ailments.

The NSGC promptly responds, issuing this Policy Statement (pdf):

“Distributing genetic testing through pharmacies will expose more people to its availability. However, people should first meet with a genetic counselor to determine whether genetic testing is right for them and to prepare for what they might learn,” said Elizabeth Kearney, NSGC’s president.

Daniel Vorhaus of the Genomics Law Report was quick to comment on the news, and published an impressive compilation of media and blogger reactions to the developing story.

Wednesday, May 12 Walgreens revokes decision to sell Pathway’s test in stores

Media outlets continue to follow the story, and FDA officials become increasingly vocal about their lack of support for the retail genetic test kit. Late Wednesday night, news breaks that Walgreens has decided they are revoking their decision to stock the genetic testing kits in stores.

In a statement, Michael Polzin, a Walgreen spokesman said, “in light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter.”

Thursday, May 13 Pathway Genomics and others respond

Pathway Genomics issues a press statement acknowledging the weeks events and the genetic counselling services they provide:

We respect and understand Walgreens’ decision and we are communicating with the FDA about the Pathway Genomics InsightTM collection kit…We believe it is very important that anyone interested in a personal genetic test understand the information that will be contained in his or her report. That is why we have on staff Board certified/eligible physicians and genetic counselors that are available to speak with customers about their reports. We also encourage anyone considering purchasing a Pathway product to speak with our counselors.

Others continue to weigh in on the issue. Notably, Dan Vorhaus helps elucidate some of the complex issues surrounding regulation of direct-to-consumer gene testing and points out that personal genome tests are already available through retail outlets, such as 23andMe tests being sold through Amazon.com. The NSGC public policy blog provides a good summary of the issue from a genetic counselor perspective.

Friday, May 14

So here we are, Friday morning, the day that Pathway’s tests were scheduled to hit drugstore shelves. But instead of curious consumers flocking (or not flocking) to their local Walgreens, we are instead right back in the middle of a DTC regulation debate. A debate that seems to me to be incredibly reminiscent of June 2008, when the California department of Public Health issued “cease and desist” orders against 13 DTC companies. I look forward to watching how this plays out.

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Beyond the actual events of this week, what has been so incredible to me is the quick response and coverage of this story within the genetic counseling community. Because I don’t work in a position where I can monitor twitter, I have relied heavily on the NSGC listserv this week in keeping up on the breaking news. So a big thank you to all those who kept the community up-to-date using this private forum. And I’m impressed with the speed at which the NSGC position statement and public policy blog post were put together. If this same situation had occurred a year ago, I highly doubt the public response from the GC community would not have been so urgent or visible.

Below is our entry (click to download). In hindsight we would have definitely changed up a few things, but that’s what makes a 24 hr deadline so challenging.

The full list of winners is posted here.

Download The PDF

I read an essay recently that presented the concepts of convention and possibility as eternally pitted against one another, on an inevitable crash course. I have been mulling over this concept for a while, and can’t seem to come up with a specific example to refute this theory. And, I actually think it is quite applicable to the current climate of medical genetics.

If I had to choose, I’d side with possibility every time. On the surface it seems that a career in genetics is perfect for someone of this philosophical bent: genetics and (perhaps more appropriately) genomics promise to bring to the world endless possibilities, pushing the frontiers of medicine and society as we know it.  But as with most areas of medicine, there are a significant number of conventions associated with the the day-to-day practice of medical genetics. This, coupled with the extreme focus on possibility in this field certainly creates a source of tension.

An example:

Convention An individual with specific symptoms is referred to genetics. After a complete work-up including medical history, family history and physical exam, the patient is offered genetic testing for one or more genes that are known to be associated with the suspected condition. The testing costs approximately $5500. The results are negative meaning that no disease-causing gene changes were identified. Because the sensitivity of the testing is not 100%, the negative results neither confirm nor rule out the diagnosis. The patient is told to recontact the genetics clinic in the next few years, as we anticipate we will have additional genetic testing to offer in the future.

Possibility For $1000 a healthy individual has their complete genome sequenced– essentially testing of every gene. A massive amount of data is generated, much of which we are not sure how to interpret. The individual may learn some useful information from their genome, and they may not. They may learn about their risks for diseases that they wanted to know about, and they may learn about risks that wish they didn’t know.

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Technology, today’s largest driver of possibility, has a habit of challenging convention (sorry Andy Rooney!) I think this is why I am so intrigued by services such as online and DTC genetic testing, Hello Health and Webicina.

So, how do we avoid an inevitable collision in medical genetics?

Here’s a my proposal for a recipe for change:

2 parts genetics expertise

1 part technology

1 part ethics

mix together, and then stir in

a crumble of convention

a dollop of imagination

a spoonful of collaboration

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Have a recipe you want to share?

The Culture is the Brand

Herb Kelleher (quoted above) is CEO of SouthWest Airlines. Here are a couple more of his thoughts:

“A company is stronger if it is bound by love rather than by fear.”

“If the employees come first, then they’re happy, … A motivated employee treats the customer well. The customer is happy so they keep coming back, which pleases the shareholders. It’s not one of the enduring Green mysteries of all time, it is just the way it works.”

(Wiseman on Luck) Unlucky people tend to be creatures of routine. They tend to take the same route to and from work and talk to the same types of people at parties. In contrast, many lucky people try to introduce variety into their lives.

(Mau) You have to be willing to grow. Growth is different from something that happens to you. You produce it. You live it. The prerequisites for growth: the openness to experience events and the willingness to be changed by them.

(Wiseman) Unlucky people miss chance opportunities because they are too focused on looking for something else. They go to parties intent on finding their perfect partner and so miss opportunities to make good friends. They look through newspapers determined to find certain types of job advertisements and as a result miss other types of jobs. Lucky people are more relaxed and open, and therefore see what is there rather than just what they are looking for. (Full)

(Mau) …Real growth often happens outside of where we intend it to, in the interstitial spaces – what Dr. Seuss calls “the waiting place.”(Full)

Sounds a bit like a Yes Man theory, but I have to agree with the thinking.

PINK: …What I think is going on is that until recently, the business world didn’t much prize people with these kinds of skills [poets, painters and playwrights]. So if you wanted to do those things, you weren’t going to get paid much. Today, these right-brain types are much more in demand. That said, there are maybe fourteen people on the planet who are going to make a living as poets. But, again, there are maybe a million who can use their talents as poets in work as teachers, copywriters, bloggers, journalists, and other professions and business centered on creation.

GODIN: Do you agree with me that every successful organization needs people like this today? Problem solvers, self-drivers, artists?

PINK: Of course. Not even a close call.

GODIN: How then do we merge the two motivations? How do we get people to bring their artist to work?

PINK: Stop treating people like horses and start treating them like human beings. Instead of trying to bribe folks with sweeter carrots or threaten them with sharpen sticks, how about giving them greater freedom at work, allowing them to get better at something they love, and infusing the workplace with a sense of purpose? If we tap that third drive more fully, we can rejuvenate our businesses and remake our world.

Coincidentally, the evening before my meeting with Jill, I attended my first naturopathic medicine appointment. My new family doctor has a patient share with an in-house Naturopathic Doctor (ND), in which my electronically stored medical records can easily be shared between the two. I’ve always been a little curious about naturopathy, and the pure ease of this system provided the added boost to follow through and try it.

During my hour and a half appointment with the ND we discussed in detail my medical history, family history, health concerns and general health goals. My main reasons for seeking naturopathic services are

1. the prevention of disease
2. optimizing my health

As I discussed these goals with the ND it struck me that these very same objectives could drive me to seek personal genome services. I’ve always thought about personal genomics from an academic perspective, and to my surprise, never really put myself in role of the consumer. I’ve certainly thought about the consumers, but always as some abstract group of people most commonly referred to “early adopters.” So for the first time I could envision these services not just as a DTC internet purchase or as a function of specialty medicine, but as part of the primary care setting.

It is not my intention here to debate the efficacy of nutrigenomic products (such as Carolyn’s The DNA Diet, for example) or even the use of genomics in naturopathic medicine, but instead present the current model of naturopathic medicine as a potential model for personal genome services.

Consider this:

People seek naturopathic medicine services for a number of personal reasons. They meet with a professional with specific training in naturopathic medicine, and discuss their concerns. The naturopathic doctor then uses whatever “tools” they feel are most useful to address those concerns. Sometimes the knowledge gained from this service will be used to compliment the patient’s primary medical care, and sometimes not. In settings with a patient-share system with a family doctor, any test results can be easily shared between the two providers to enhance patient care. Generally, the patient can claim at least part of the cost of naturopathic medicine services from their private health insurance plan.

If you read the paragraph above again and substitute “personal genome” for “naturopathic medicine” and “naturopathic doctor” with “genetic counselor/geneticist,” does this seem incredibly plausible to you? It sure does to me.

Watch other spots: Hope, Faith

I have to admit I wasn’t a huge fan of the ‘Where Amazing Happens’ campaign when it launched, but it has since won me over. Clearly the execs over at the NHL have some love for it too.

I understand the beauty of the NBA campaign – memorable executions within a system that offers quick and easy customization for specific markets and last week’s highlights. But as a lifetime NHL fan I can’t help but feel disappointed in their advertising yet again.

On a brighter note, I think the Winter Classic is the smartest bit of marketing the NHL has ever done. This year was no exception, with a great event that neatly balanced hockey tradition and accessibility for fans old and new. Really hope to see more of these sorts of initiatives in the future.