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Posts Tagged ‘consumer perspective’

In a recent, widely anticipated decision that pertains to rights to some of what makes us us, a federal judge ruled in favor of patients, medical societies, and researchers, who were suing Myriad and the Utah University research foundation, owners of the patent on the two genes whose mutations had been associated with increased risk for breast and ovarian cancer, BRCA1 and BRCA2. Their ownership had allowed them to retain complete rights for these widely prescribed diagnostic tests, which have remained prohibitively expensive for many patients (currently at more than $3,000).

Interestingly, in taking the decision to invalidate such patents, the Department of Justice differs in its opinion from the US Patent and Trade Marks Office (USPTO). Meanwhile the status quo will be maintained. The Biotechnology Industry Organization (BIO), the organization that lobbies for the pharma and biotech companies, has been arguing since the beginning of the case that preventing patenting of human genes will literally impede life science innovation and had stated after the court’s decision that carrying this one out would: “undermine U.S. global leadership and investment in the life sciences”. A variety of people have spoken for and against the decision. The New York Times just wrote an article citing several of them.

The US government filled a “friend of the court” (or “Amicus curiae”) opinion entitled: ”BRIEF FOR THE UNITED STATES AS AMICUS CURIAE IN SUPPORT OF NEITHER PARTY” (you can read the pdf here ). As expected with these types of opinions (see Wiki)- and indicated by its title – the intent was not to support either of the parties. The last point listed in the government’s opinion constitutes a good summary: “Isolated Genomic DNA Is Not Patent-Eligible Merely Because It Is Useful Or Requires Investment To Identify.”

As someone who has dedicated her life to improving human health: I understand the need to recognize and reward discoveries, so that they may continue to advance the available diagnostic and therapeutic interventions. At the same time, in my opinion, a balance needs to found – or maybe a line needs to be drawn. Otherwise, these innovations will remain out of the reach of many patients who need them. The exact balance may not be easy to figure out or accept by consensus.

To what point should we own things we just happened to be the first to discover/figure out? Should various entities (researchers, universities, companies) own pieces of everybody’s proteins, DNA, or maybe their constituent atoms, electrons or the even more ephemeral particles and their interactions? These are all things that make us us. Or, going in the opposite direction, should each disease/syndrome or epidemic have owners that need to be paid before we could proceed with curing them? Am I right to assume that in such case, arrangements and payments would need to be exchanged between the owner of the gene and the person who had discovered the disease, with corresponding arrangements with those who had patented the smaller molecular or atomic pieces of the puzzle? How are we ever going to navigate such complex territorial and legal claims? Maybe Google could develop maps of the human body charting out the parcels to indicate ownership? I am on the opinion that we should only own things we create ourselves. In relation to this specific discussion, I think it is appropriate to own the rights to a new method to test or to control a gene, or a newly created molecule that could be used for diagnostic or therapeutic effect.

I know patients who were unable to take advantage of the BRCA test because of its prohibitive price and who knows how many more cases we might have failed to diagnose and treat because of these legally imposed economic barriers. Can you imagine that currently the actual cost of performing such a diagnostic test is only a few dollars? Would it be possible to compromise by assessing limits on the profit margin of diagnostic tests? I feel that we need to ensure that the initial intent – or what many say is – of our efforts to improve human health is not compromised.

What is your opinion? Should those sequencing one of the genes we all share – and its mutations – gain the exclusive rights to any diagnostic or therapeutic intervention that is related to that gene? Do you know who owns YOUR genes?

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What do Leningrad, cowboys, a Finnish rock band, and the Red Army Choir have in common? They perform together… “Sweet Home Alabama!!!”

OK, this might sound like something I could have made up after having too much eggnog this holiday season, but no, you can check it out for yourself. I’ll venture to say this is the most edgy and innovative interpretation of the old favorite.  The Finish band that calls itself the “Leningrad cowboys” obviously increased its appeal (and credentials?) compared to their earlier interpretation by adding to the mix another unexpected ingredient: the Red Army choir singing in English, vigorously and it seems in the same time nostalgically (although the song might have been the only reason for which many of the singers first heard about Alabama).  While the musical intersection of all these apparently disparate entities might not be something all of us think as great, courtesy of YouTube, at the time I am writing this 2,254,837 people saw the video which is rated as a perfect five star. The masses have spoken!

On my side this discovery strangely connected with the advice received this week from a Nordstrom customer representative: “if you can rock it, go for it!” after I had been contemplating – for some time – buying something that would normally land outside my comfort zone. I tried to make up my mind by briefly positioning the article in front of me – as you can do these days with some online retailers that have embraced “augmented reality” – and glancing in one of those large mirrors between racks. While doing this two separate times, several customers passing by exclaimed: “wow, that really looks good on you!” Maybe they were just trying to be nice, but getting the “independent” encouragement, made me believe that I might be able to “rock it.” I still have to test that idea by actually wearing the item this season… By the way, this experience also indicated to me that the ability to share the result of virtually trying stuff on is a feature that would be tremendously popular (online retailers might want to take note!).

Meanwhile, I thought that the shopping assistant’s “advice” might be just the way we need to start thinking more often in many other areas of our life to step out of our daily boxes. Think how to “rock it” in work-related endeavors, unleashing a remarkably innovative project, maybe? Many times the only limitation is that mental barrier we have created for ourselves. Our analytical brains are very good at creating “acceptable” frameworks for our thinking and behavior, providing all the reasons for which something might fail, including that it just may not fit with what is expected… How many times did you hear: “this is not how we do things around here?” So, here is another way to take a good tally: Do you need to innovate? If successful, can you envision a positive impact of your plan? Are you committed to doing what it takes to bring it to fruition? Are you (physically/mentally) capable of doing it? Then, finally… Why not???

The Finish band and the Red Army choir rocked it in front of huge enthusiastic crowds online and off line. More and more people take their chance – publicly – on testing their ability on TV and many more are watching them religiously. So, are you still a “wall flower,” looking sadly at the dance floor wondering why nobody can see that you can and would like to dance, or are you simply worried about looking out of place? Here is a suggestion for us in 2010: if we THINK we can dance, let’s go for it! At least, we will not forever wonder “what if I tried?” Some of us will get the big prize. It might even be you, but you’ll never know unless you go for it!

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You guessed it! Location, location, location

A new research study from my Alma Mater, McGill University in Montreal, demonstrates major DNA differences between genes in blood cells and tissue cells of the same individual. Specifically, the researchers found a DNA mutation (of the BAK gene involved in cell death) in the tissue cells harvested from patients, but not in their blood cells. This study and other recent ones challenge the major current assumption under which we have operated for years, i.e. that our DNA is the same in all the cells throughout the body, a specific master template faithfully reproduced in each of us. We are not talking cancer where local mutations are known to occur in tumors. What does this mean for you?

–       As a researcher, therapy and/or diagnostic developer, etc., it means that you will likely have to look in the right place in the body, analyzing “the right” (relevant) cells. This is exciting, as it opens up a lot of potential great discoveries, cures and diagnostics. It is also good news for those who had set up or already work with tissue banks (is anybody reading: much more work needed? are we going to run into the needle in the haystack issue?)

–       As a regulator, decision maker, media, etc. you will have to realize that there is much more to come, so you might want to give it a chance… Many have begun not only to openy question the wisdom of genetic testing to derive disease associations, but to actively block any initiative along these lines.

–        As a patient and consumer of health innovation, you might have to be willing to allow removal of tissues (other than blood) from your body for accurate genetic testing. Only you can decide if that is good for you…

Yet another dimension is being added to “personalized medicine”. The biology of our bodies includes features that are manifested and influence locally and systemically (globally). The genetic information is less global than previously thought. Thus the testing, treatment and care will need to be not only tailored to the individual, but also to the specific tissue/body component affected and targeted for prevention or cure of the disease.

So, coming back to the old tried and true wisdom, when it comes to our most precious piece of real estate, our own body, we will need to chose wisely the location (of genetic testing, treatment, etc.)…

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Now and then a scientific discovery about the human body captures the imagination of large audiences like the recent discovery that remnants of our “baby fat” are able to effectively convert calories into heat. For a long time we have assumed that adults completely lose all their brown fat and its benefits, but it turns out some remains in our upper back, in the dip between our collarbones and shoulders and some along our spines. Wow! How could we have missed it in this era of advanced medical knowledge and sophisticated diagnostic imaging?

The news hit hard the media and everybody’s soft spot (no pun intended!) in the same way as the good news that red wine and dark chocolate are actually good for your health (I am continuing to drink to that!). There were many reports describing the “cool new way to lose weight”. The research suggests that a few ounces of brown fat can help burn up to 400 calories a day, the equivalent of one hour of vigorous exercise, if we would simply turn down our heat a few degrees. Imagine being able to lose all those calories, or if you would prefer, being able to ingest an extra half (!) of a burger, by being willing to… shiver a little bit. People responded enthusiastically: could we maybe completely count on our good brown fat to take care of our bad fat, potentially trading our pot belly for a discreet hump?

Our own body might be showing us how to innovate, potentially turning our current assumptions about strategies to lose weight on their head. You can bet creative scientists and agile entrepreneurs are already planning experiments and setting up companies to analyze, detect, stimulate, regenerate, or recreate brown fat.

Why all this buzz about the recent discovery?
It’s fresh and unexpected, defying our current assumptions about ourselves and our ability to know it all.
It is apparently easily accessible.
It could immediately address one of our huge problems, the obesity epidemic.
It’s apparently painless for the consumer.

I went on to wonder: could this also be a simultaneous solution to our obesity problem and our energy crisis? People could be spending less energy heating their homes, maybe they would be willing to live in colder places? My son, the keeper of the truth, immediately reminded me that in the longer term, the effects of global warming might limit the existence of such places. In the short term, he said, with the summer coming to the Northern hemisphere, creating lower ambient temperatures could only mean people are going to use even more energy to cool their houses.

I hope this new science translates into innovation, I have always thought it was beneficial to preserve some of our childhood magic no matter how old we get. For some this might turn out to be a life saver. Meanwhile, I’ll be sticking to my rowing routine I already know is an effective way to burn those irresistible dark chocolate calories I ingest daily. Given the choice, personally I’d rather spend a little time in the sun (producing more vitamin D!) than shivering all day long anyway.

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While browsing the AP 2008 image collection, I was struck by two parallel tales of overindulgence in free lunches that reduced normally majestic creatures to a pitiful state from which they desperately needed to be bailed out… 

Notice the similarity? Any lesson in here?

In this Jan. 11, 2008 file photo, eagles await transfer to a warm U.S. Fish and Wildlife warehouse after being rescued from the cold in Kodiak, Alaska. They were among 50 eagles which dove into the back of an uncovered dump truck full of fish guts and became too wet to fly away. (Image and caption courtesy of AP)

In this Jan. 11, 2008 file photo, eagles await transfer to a warm U.S. Fish and Wildlife warehouse after being rescued from the cold in Kodiak, Alaska. They were among 50 eagles which dove into the back of an uncovered dump truck full of fish guts and became too wet to fly away. (Image and caption courtesy of AP)

usautofreelunch4

In this Dec. 4, 2008 file photo, auto executives, from left, General Motors Chief Executive Officer Richard Wagoner, UAW President Ron Gettelfinger, Ford Chief Executive Officer Alan Mulally, and Chrysler Chief Executive Officer Robert Nardelli testify on Capitol Hill in Washington, before a Senate Banking Committee hearing on the auto industry bailout. (Image and caption courtesy of AP)

The lure of the free lunch brought about the downfall of the free loaders in both examples.

The eagles, seemingly forgetting they were supposed to obtain nourishment through making good use of their mighty arsenal of hunting capabilities, overindulged on scraps. However, in their defense, they probably were mindlessly opportunistic and could not foresee the consequences.

On the other hand, what was the excuse of the US auto industry’s titans? The CEOs were supposed to be aces at their game! Maybe it was the overconfidence and reliance on the status quo that had raised them to such heights: for so long had they relied on the known and tried old routines that they just thought it could go on forever? There were plenty of people who told them otherwise (e.g., see the 2006 MSNBC series ).

Nevertheless, the US Auto industry decision makers determined it was easier to just lobby Congress and continue to sell gas guzzlers, the equivalents of the automotive dinosaurs, rather than to innovate. Their strategy eventually led to a dead-end, and the huge downfall was going to bring along many others.

There is no such thing as a free lunch. If someone gets it for free, someone else – in this case, all of us – will have to pay for it. The US Auto Industry will have to “innovate or die”. The cataclysm should not be a wasted opportunity, just as the disappearance of dinosaurs created the evolutionary break needed by the mammals to colonize the earth.

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We all are, have been, or will be at some point in our lives, users/consumers of medical products, that is unless someone is a “Superman/woman”. We all have thoughts and specific opinions about what we would like or expect. Two great examples were provided by answers to my previous request to define medical innovation. Kathy said:” From a consumer perspective, I want to see new products and care that consider the quality of my life and my body – not the statistical average”. Allen Fahden commented more broadly in response to the same:Life science/medical innovation means to me that the model of reaction to failure gets updated with preventing failure.” Kathy is expressing the growing support for “personalized medicine”, Allen is touching upon the need to shift more towards preventive medicine.

My own view as a consumer is that I subscribe 100% to these two goals. I should say I did not know or discuss with either Kathy or Allen before they offered their visions on life science/medical innovation. Let’s see what might be the answer to these opinions from the other perspectives.

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