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This is not mine, but if you write at all, it is worth the read
February 12, 2012 – 6:10 pm
Where no man has gone before …
January 31, 2012 – 12:45 pm
Following the adventures of Captain James T. Kirk, Mr. Spock, Bones and the rest was one thing that my family of five could agree on when I was growing up. And though I could never quite commit to Captain Picard and William Riker in the same way as the original Star Trek I wouldn’t change the channel either if I was looking for an hour to kill. So, it won’t surprise you to learn that today, when I come across Star Trekian - like innovation, it gets my attention.
Huffington Post and others, have recently reported on the development of a new device which, with a bit more engineering, could rival the Tricorder, that nifty hand-held, tell-all diagnostic tool that Dr. McCoy and just about anyone else, would use to assess full internal damage to any of our fallen heroes.
The promising advance leverages tetraherz x-rays, those actually used in full body scanners at airports, and nanotechnology to focus those rays in a narrow beam, significantly improving their effectiveness. The envisioned scanner could detect changes in DNA and tissue abnormalities, non-invasively, and in real time.
It’s a ways away, but a legit development project, currently being worked on by scientists and engineers in Singapore and London, and recently reported on in the prestigious physicist journal, nature Photonics.
Live long and prosper.
MacGyver and Standard of Care
January 16, 2012 – 12:00 pm
In Thailand, the battle against cervical cancer is being waged with household vinegar and carbon dioxide-filled tanks from soda bottling plants. Turns out that acetic acid (vinegar), when spread on the cervix, turns pre-cancerous areas white. Tumors have more DNA, and less water, than other areas. The spots are then frozen off with a shot of carbon dioxide (cryotherapy).
The NY Times calls it ingenuity. And there are resistors, health care professionals who describe it as ‘poor care for poor people’. But the program, in part funded by the Gates Foundation, has already treated thousands of women. And not one of the 6000 women recruited for the first trial eleven years ago have developed cervical cancer.
Though the technology is basic (do we even call it technology?), and has been available for years, we are still witnessing classic innovation adoption, significant behavioral change, and a resetting of the standard of care. Like Gawande’s Checklists, and Simmelweis’ washing hands, standard of care setters sometimes have little to do with breakthrough discoveries based on new technologies, and more to do with breakthrough discoveries based on human insight and common sense.
Yet the path to the standard of care finish line remains just as challenging:
- PROTECT the therapy through credible trials and understated claims
- Insure the PROMISE is relevant to the recipient
- Engage appropriate champions to PROSELYTIZE
- Once sufficiently educated and aligned, PROPEL the innovation into the mainstream.
And bring a little common sense to the table.
Consistent. Not predictable.
January 13, 2012 – 6:00 am
“The FDA wants the original radiologist to re-read all of the six-month trial CT scans, as well as having an additional radiologist review them. Here we have another example of the FDA changing the game on a company. The FDA originally went along with the company’s trial design, which included assessing bone healing by CT scan, but now complains that CT scan is not the standard way to evaluate such things. Unfortunately, the FDA has not told the company what degree of consistency it expects/demands between the initial reading and the re-read, nor between the different reviewers.”
picked up from an analyst’s write up of a recent FDA decision on BioMimetic’s Augment product for bone healing.
This is a highly visible and sensitive area given all of news surrounding Medtronic’s INFUSE BMP. And we can understand, even perhaps tolerate, FDA’s desire to not make a mistake. But how many hurdles does a small innovator have to jump over to get to market? And when running on razor thin capital to begin with, is it any wonder that venture and early stage investor money is getting harder and harder to come by?
If you talk to venture people, particularly medical device people, they will invariably point to the inconsistency of the FDA as one of the most significant reasons for holding off on investing.
the FDA should never be predictable. But it should always strive to be consistent.
Innovate or …
January 10, 2012 – 6:00 am
Kodachrome
You give us those nice bright colors
You give us the greens of summers
Makes you think all the world’s a sunny day, oh yeah!
I got a Nikon camera
I love to take a photograph
So Mama, don’t take my Kodachrome away
–Paul Simon, “Kodachrome”
What does the impending demise of Kodak and the unpredictability of the FDA have in common? Tell tale signs of self-made and bureaucratically imposed obstacles to innovate.
Good remains the enemy of great.
Slow down, you move too fast
January 8, 2012 – 12:00 pm
From New York Times blog:
a family recounts their trials and tribulations of moving their 90+ year old dad nine times in six months: combination of illness, misaligned professional care, medical history lagging behind the moves, resulting in condition complications.
“When treatment plan details disappear, health problems can snowball.”
Dialing back Dialysis
August 3, 2011 – 6:00 am
An article on dialysis in the New York Times a while back caught my eye.
Asking Kidney Patients to Forgo a Free Lifeline, points out that (1) end stage renal disease is the only chronic, terminal disease that gets special treatment from the federal government and (2) the law, when passed in the ’70′s, probably intended to help younger patients maintain healthy, productive quality of life. It hasn’t really turned out that way: most of the 400,000 plus dialysis patients in this country are well beyond 60; many suffer from other terminal diseases.
So the central question raised in the article: can we dial it back.
For me, it raises that classic question we put before physicians when considering adopting new treatment: would you use/prescribe this for your mother?
Another reason to drink coffee
July 22, 2011 – 12:44 pm
First the report came out of Harvard: a study of over 45,000 men: those who typically drank more than six cups of coffee a day were almost 20% less likely to develop prostate cancer.
Then just this month, another report: Coffee drinkers half the chance of carrying nasal MRSA, the superbug highly resistant to current antibiotic treatments.
Apparently, coffee is heavily laden with antioxidants. Which leads us to red wine: resveratrol is an antioxidant that some suspect leads to healthy hearts.
So now I’m pretty much set: my two grande bolds in the a.m.; my two glasses of red wine in the p.m.
Exercise in the middle to deal with my middle. Life is good.
An Open letter to Dr. Hamburg
July 12, 2011 – 1:01 pm
Dr. Hamburg:
I am the founder of the oldest and largest advertising agency dedicated exclusively to working with companies developing products that promise to change the standard of care. This includes, of course, medical devices and diagnostics, which have been core to our practice for over thirty years. I work directly with over thirty companies, and have worked with over 300.
When I ask my clients, today, what’s keeping them up at night, what is the most challenging business issue they face, to the person, they say the FDA.
The FDA has always had to maintain a delicate balance: protecting patient safety and promoting efficacy while lubricating the pathway of innovation. No one is asking you to abdicate that. But this deer in the headlights, this CYA behavior, the unpredictability, inconsistency, unreliability of the FDA, as several of my colleagues have much more eloquently shared with you today, is frustrating and debilitating. It is destroying innovation, taking out jobs, dulling competitiveness, and keeping patients from accessing best available treatment options.
There was a leader of FDA who led. He showed commitment. He had vision. And gave his organization and all of us a sense of purpose. His leadership was marked by a clarity recent administrations have lacked. Dr. Koop left a legacy that we all can be proud of. And a lesson for future Commissioners.
I wonder, Dr. Hamburg, now that you see the daunting complexity of your task, if you are having second thoughts for taking it on. I hope not. It may sound like we are asking much of you. That is not correct. We ask only one thing: that you lead.
Publicly declare the need to improve the agency. Publicly acknowledge the issues. Publicly commit to clarity and to consistency. This is where the turnaround will begin. We want to believe. Make us believers.
Gecko? Gecko!
July 1, 2011 – 6:00 am
Grateful Dead and medical device innovation? Changing standards and changing standard of care?
I smiled and twirled while reading the Forbes story of Jay Chimenti’s foray into the world of medical device innovation.
Chimenti, unlike many of his predecessors sitting at the Dead keyboards, appears to be helping people live, and this is just very cool.