Wednesday, September 16, 2015

Sweet dreams are made of this (Musings on personalized medicine)

Please stay tuned - revisions are sure to come
September's blog derives from increased marketing of medical treatments and clinical laboratory tests as personalized medicine tailored to the individual characteristics and needs of each patient. Seems like a great idea, right?  

After all, in the age of 'selfies' it's all about me. 

The title is from a 1983 ditty by the British duo, the Eurythmics (Annie Lennox and David Stewart). 

PERSONALIZED MEDICINE
'Personalized medicine' is a term that drives me nuts.  This April I blogged about molecular blood typing being marketed as personalized medicine:
  • While my guitar gently weeps (Musings on the seduction of technology) [Further Reading]
Five years ago I had sniffed its perfumed allure with the blog
  • Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) [Further Reading]
WAIT, THERE'S MORE
Now a new variation has arisen, the latest and greatest 'term du jour' ('term d'année?') is Precision Medicine:
  • Red blood cell transfusion. Precision vs imprecision medicine  [Further Reading]
One sentence in the article stood out as a red flag:
'Although currently not practical, providing extended antigen matching by molecular techniques to all patients should improve typing accuracy and reduce alloimmunization.'
If past is prologue, even if impractical and relatively expensive, eventually molecular genotyping will be done for all transfusion recipients. After all, who can resist the sales pitch of personalized and precision medicine?

BANDWAGON
Certainly the United States, with its private health care system, cannot resist and has jumped on the bandwagon. Similarly, so has Canada, UK and other industrialized nations. 

As to the developing world, well they're stuck making do with 20thC medicine, un-personalized and un-precision.

Of course, a genuine case can be made to tailor tests and treatments to individuals, especially those with special needs such as blood group genotyping for sickle cell and thalassemia patients. 

But why the rush to personalized / precision medicine as embodied by molecular blood genotyping? It's likely because of the reasons cited in 'While my guitar gently weeps':
  • To be seen as 'with-it' hipsters on DNA's bandwagon vs being old-fogeys who resist change; 
  • Way for TM organizations to develop business lines and increase earnings in age of blood conservation; 
  • Self-interest for those who specialized in molecular technology; 
  • No humans interpreting serologic test results must be safer; 
  • High-throughput automation decreases costs by eliminating staff, with their salaries, benefits, and pensions.
Plus it's good for private enterprises that develop and market test systems and health profession leaders who want to be seen as in the real world of business efficiency. 

ANATOMY OF A SALES PITCH 
Today, many businesses promote and sell stuff that we do not  need. The aim is to trick us into thinking we need the latest and greatest. 

Consider Apple's iPhone. The premise is that potential buyers don't even know what they want until Apple tells them. They don't really need to market it because all geeks know they must have one to be part of the in-crowd. 
  • It's the same reason why all TM docs know their facilities must do molecular typing.
Apple builds beautiful products and justifies price with features and benefits no one else can match. Whether you need the features is another matter. But once you've seen them, Apple will make you think you do. 
  • Similarly, serologic blood typing cannot match molecular typing. Whether you need the benefits of molecular typing is a moot point.
Apple built one of the most hardcore fan bases of any product, called Apple fanboys/fangirls and, before the iPod/iPad/iPhone revolution, macophiles. I was one and would show disdain for Windows every chance I got. 
  • Today, molecular red cell genotyping fans abound and can barely suppress a sneer when mentioning serology and immunohematology. The fan base of influential TM leaders is hard to combat and develops a momentum all its own.
It's worth recalling that whether selling an iphone, tablet, used car or botox, a good sales rep will FOCUS ON

1. BENEFITS and VALUE, NOT PRICE
Some examples [My comments]: 

Before molecular genotyping transfusion service labs had to use inefficient, labor-intensive serologic assays. 2
[PL: Red cell serology is passé, based on inefficient testing that costs more because of paying laboratory technologists for their time.]
Now in the 21st century and with the emergence of precision medicine, inexpensive molecular typing paired with powerful bioinformatics has enabled mass-scale red blood cell genotyping. 2
[PL: Get with the 21stC. Molecular typing is cheap (really?) and it's twinned with bioinformatics. Bioinformatics sounds pretty darn impressive. We've got datasets coming out the wazoo.]
Web-based data storage and analytics are revolutionizing the provision of antigen-negative blood with an efficiency scarcely conceived of just a decade ago. 2
[PL: You'll be on the bleeding edge and very, very efficient. Plus it's analytics, for gawd sake. And 'analytics leverage data in a particular functional process (or application) to enable context-specific insight that is actionable'.  
Wowsa! Leverage,data, process, context-specific, and actionable in the same sentence. I'm in jargon heaven. Gotta love analytics.]
2. EMOTIONS, NOT REASON
Blood incompatibility remains a significant problem with lifelong consequences that adds to the burden of healthcare delivery and may result in life-threatening delays in care.3

If an antigen-negative patient receives blood from an antigen-positive donor, it could trigger an immune reaction, where the blood recipient’s immune system develops antibodies that can attack and reject the donor RBCs.3
[PL: If you buy our product you will prevent the dreaded immune response and save patient lives. You don't wanna kill folks, do you buddy?]
With today’s dual focus on improving health outcomes and lowering healthcare costs, preventing alloimmunization is the ultimate goal in transfusion medicine. Accordingly, a best practice for the hospital or transfusion center is to create a patient phenotype profile with the PreciseType test before a patient receives his or her first-ever transfusion.3
[PL: Do you dig what TM's ultimate goal is? It's about preventing alloimmunization. (Who knew!) Are you into best practices, a thought leader? Because if you are, you better buy our kit right now, before some patient gets immunized!]
NAYSAYERS
There are those who question the orthodoxy of personalized / precision  medicine and caution against potential pitfalls.  Two examples that examine personalized medicine from a broad perspective:

1) 'Why you shouldn't know too much about your own genes.' [Further Reading] Sample quote: 
  • Here is the under-appreciated corollary to the new age of personalized medicine: just because you can do a genetic test, doesn't mean you should.
2) Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. [Further Reading1Sample quote: 
  • 70 million Baby Boomers, now or soon-to-be over age 60, seek to live not just longer, but healthier and more productive lives. 
  • When they fully understand and embrace personalized medicine, it will create an unprecedented level of consumer demand. 
  • When physicians feel they may incur liability for not offering a test that provides information on optimal care, the impetus toward adoption will be even greater.
LEARNING POINTS
Eventually, everywhere in the developed world, red cell matching of patient and donors will routinely be done by molecular blood typing. It will be precision medicine, personalized medicine done using kits supplied by foreign companies and performed by minimally trained, inexpensive local staff supervised by a well educated lab professional.

If employers plan wisely, staff can be hired part-time or casual so they won't need to worry about benefits and pensions. 

In Canada government health care money will flow abroad, giving sustenance to anonymous investors of Immucor, et al. They'll leverage our health care dollars where they WON'T do the most good for our communities, all in the name of efficiency and safety.

POSTSCRIPT
Am I similar to 19thC Luddites, protesting against new labour-economizing technologies? Maybe, though I'm not against technology per se and have embraced computers and the Internet from the get-go.

But, hot damn! I'm gonna get my genome profile done because it's all about me. And I can get it done for $199 CDN by 23andme...not that I really want to know.

And if I ever need a blood transfusion, I'm not into being second class and will demand complete molecular antigen typing with donor blood. Not that I'll get it now but definitely one day. None of that passé serology for me!

FOR FUN
A great song, one of my favorites, that highlights the allure of molecular blood typing and personalized / precision medicine. 
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
'Sweet dreams are made of this
Who am I to disagree?'
As always, comments are most welcome.

FURTHER READING

1. Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. (Free full text)
2. Klein HG, Flegel WA, Natanson C. Red blood cell transfusion. Precision vs imprecision medicine. JAMA. Pub online 10 Sept. 2015. (Free full text)
3. Immucor: PreciseType™ HEA Test 

Other
Carolyn Johnston. Why you shouldn't know too much about your own genes. (Washington Post, 11 Sept. 2015)

USA FDA: Paving the way for personalized medicine. FDA’s role in a new era of medical product development  

US News & World Report. Personalized medicine

USA White House. Next steps in developing the precision medicine initiative

Prior Related Blogs
While my guitar gently weeps (Musings on the seduction of technology) |  April 2015

Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) | Dec. 2010