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Defining Personalized Medicine

The term personalized health care is often used these days. It is an exciting outgrowth of our better understanding of the human genome. We now know that our genetic makeup impacts the way we respond to certain treatments.

For example, in this month’s issue of Biological Psychiatry, there’s an article (Lee et al. 2007) about a link between a certain genetic variant and the drug Zyban, which helps people quit smoking. It seems that people who have the variant were less likely to have resumed smoking six months after taking Zyban.

There are numerous medicines doctors prescribe now only if a certain genetic condition exists. In other words, treatment is personalized based on genetic history of a patient.

I worry when we use the phrase personalized medicine, for some, it creates a mental picture of a patient having one-of-a-kind pharmacology developed specifically for them, based on their phenotype, environment and genetic make-up.

That model, while appealing, raises doubts. Intuitively, people develop questions about the scalability and sustainability of trying to treat a population of people in that fashion.

The vision we are moving toward, in my mind, is best described as mass personalization. Using a thorough understanding of a person’s genetic and clinical history, a doctor will select a combination from a group of biological and chemical treatment tools.

I sense our vision will be better understood and accepted if we begin to paint a picture more familiar and comfortable to patients, providers and payers. As consumers we have become quite familiar with mass customization in many of the things we purchase.

When I bought my first set of golf clubs, I bought a set the golf professional had on the shelf. After many years, I decided to buy new ones. The technology has improved and there were several aspects of my game that would fall into the category of needing treatment.

This time, I was confronted with a different experience. The golf professional and I measured my height and arm extension (my phenotype) and inventoried my game (genetic and health history) until we knew what the best length and flexibility of the new golf clubs shaft should be, the angle of the housel, the weigh distribution of the club head and grips to fit my touch.

The golf professional said to me, “now that we know how you align your clubs (medication) with your game (ailments), we can fit you properly. We carry ten different models of club with different combinations; the X20 Long has most of the attributes you need.”

I bought a set of clubs, off the shelf that was personalized to me. This company is now engaged in mass customization.

Now, I want to say, tongue in cheek, I have a vision of the golf improvement in the future. It personalized golf. There will emerge a system of electronic golf records. These records will be interoperable between golf courses so no matter where I play, each shot will be tracked. The genetic tendency I seem to have for slicing the ball will be well documented. So, as I need golf clubs in the future, they will be personalized to remedy my ailments.

In fact, because there will be so many golfers like me with electronic golf records, researchers will be able to gather data to invent new tools to cure the common slice and three putt green.

All kidding aside, we do need to begin defining personalized medicine in ways people can understand. We have the technology now to make health care much more personal and much more efficient.

More on this later.

www.hhs.gov/myhealthcare


Lee A.M., Jepson C., Hoffmann E., Epstein L., Hawk L.W., Lerman C. et al. (2007): CYP2B6 Genotype alters abstinence rates in a Bupropion smoking cessation trial. Biological Psychiatry 62: 635–641.

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To: The Honorable George W. Bush, President

Dear President Bush:

Please say it ain't so, Mr. President. I hope that the quotes from Secretary Leavitt in today's USA Today article (excerpted below) are inaccurate. I hope that the President I voted for twice would not possibly be advocating for yet another part of the liberal, Democrat Party platform. Surely Mr. President, you learned this lesson in the wake of the "immigration reform" debacle.

Mr. President, there are a significant number of Americans currently without health coverage, or "between" coverages as they move from one job to another. As a self-employed person for the past two years, I have found it difficult to find affordable coverage for my family.

The problem is that government mandates have forced health insurance providers to focus on group coverage to large employers. As a result, individual and small business purchasers are left behind, forced to pay a large premium because they are not part of a large employee group.

The large multi-national companies are shedding employees, and will continue to do so. The economic engine of this country for the new century is small business and individual entrepreneurship. The 20th Century model of 30-year employees and traditional pensions is no more - replaced by a more dynamic workforce comfortable with changing jobs and even careers several times during their working years. If you want to help Americans afford health coverage, reduce regulation and expand programs like the health care savings account (HSA). Any law that expands individual choice and portability of health care coverage will help reduce the number of uninsured.

For example, removing or increasing the cap on tax-deductable HSA contributions would be a blessing, especially as we 40-somethings plan for and save for our retirement years (we don't expect Social Security or Medicare to be there when we reach retirement, and we would prefer to fund our own future needs anyway!). Also, prohibiting insurance providers from discriminating against individuals and small businesses in terms of higher rates and fees would be a huge help.

Finally, if you want a big dramatic step, advocate for replacing employer-managed health insurance with individual choice. Americans should be able to purchase health insurance the same way we purchase life insurance. As has happened in the life insurance industry, greater competition would drive down health insurance rates and open up new market opportunities for businesses.

Universal health care (whether government operated or government-controlled) is a trap and a dead end disaster for America. This is another "no new taxes" moment for a Bush Presidency. Please make the right choice to support and push for greater individual choice in health coverage!

Respectfully submitted,

Rodney C. Nanney
Ypsilanti, MI

______________________________
Clinton unveils details of her health care plan

By Richard Wolf, USA TODAY

9/18/2007


……

Clinton unveiled her plan as Health and Human Services Secretary Mike Leavitt said President Bush wants to achieve universal health care before he leaves office.

Leavitt told the USA TODAY editorial board that Bush will veto a Democratic plan emerging from Congress that would add $35 billion in taxpayer subsidies to the Children's Health Insurance Program over five years. In doing so, Leavitt said, Bush will urge Congress to join him in seeking coverage for all Americans.

"He'd like to see the larger debate begin," Leavitt said. "The very best opportunity we have may well be in the next 15 months."

……

Posted by: Rodney Nanney | September 18, 2007 at 11:09 AM

Personalized health care is a bit misleading. Individualized? Genetically matched?

That has always been the skill of a good doctor. Not to dispense medicine as knee jerk reaction after walking down some decision tree but to know ones patients and their families. Genetics takes this one step further.

Does this also mean there will be Male and Female dosage recommendations?

What governs how we will use the information? Is one group more prone to disease or expensive treatment than another? The movie "Gattaca" comes to mind (http://www.imdb.com/title/tt0119177/ and http://en.wikipedia.org/wiki/Gattaca) What one does with the information can be more important than the information.

Hopefully this also leads the way to find who is and is not vulnerable to pandemic like H5N1.

Regards,
Allen

Posted by: Allen | September 18, 2007 at 02:00 PM

I question the value of personalized medicine in many applications... who determines if the cost is worth the benefit? In the Zyban example, one could argue that it is less expensive to prescribe Zyban for all patients trying to quit smoking than prescribe a genetic test for all of these patients; in addition, Zyban worked for some patients that did not have the genetic variant – would personalized medicine exclude them from treatment? In the golf example, one wonders how much more Secretary Leavitt paid for his personalized golf clubs and how much happier they ultimately made his golfing experience... versus just a new set of clubs. Then again, Secretary Leavitt also bore the financial implications of his decision... unlike many doctors and patients in the US healthcare system.

Posted by: Rick Hays | September 18, 2007 at 02:56 PM

Based on this experienced American clinician’s 38 years of private office-based practice, Secretary Leavitt’s definition of “personalized medicine” is practical and consumer-oriented. And, I understand his golf analogy.

In a nation transitioning from the 57-year-old employer-based private and the 42-year-old, government-controlled public healthcare insurance plans to a consumer-driven marketplace, personalized medicine must be based on the wide distribution and use of solid clinical evidence and the best practical applications of genomics research.

Being able to apply these new personalized healthcare services cost-effectively is completely dependent on firmly establishing the “four cornerstones” for healthcare improvement in the United States. This national Value-Driven Healthcare initiative was launched by President Bush and HHS Secretary Leavitt a little more than one year ago. (See: http://www.hhs.gov/valuedriven and http://www.hhs.gov/myhealthcare).

For those readers willing and able to focus on the economic rather than the political, ideological or epistemological aspects of their knowledge-based comments, I think the following link to the recent opinions of some of America’s leading healthcare policy experts will be useful in advancing the important perennial debate on the best infrastructure for durable and self-sustaining healthcare reform.

http://article.nationalreview.com/?q=ZTJmMGU4ZmEyNzY0NDk2MTZjZDU0YmE5YzcyNWYzZjk=

Bob Coli, MD

Posted by: Bob Coli, MD | September 20, 2007 at 03:54 PM

Stressing the benefits of this type of screening would help most of the public accept these advancements. As you know drugs are approved based on their efficacy and safety for all patients.

Effective drugs that work for only a subset of patients or drugs that would have been rejected because of side effects on some people are currently rejected for everyone.

When we look at the number of drugs that are being developed based on our new understanding of genetic pathways, this is the only way to forward. If we isolate those groups that can benefit we open new possibilities for medical advancement and make drug treatments safer and more effective for all.

Ron Teitelbaum
President
US Medical Record Specialists
www.USMedRec.com

Posted by: Ron Teitelbaum | September 27, 2007 at 03:28 PM

Aperion Communities has developed a plan to tie homeownership to health insurance for first time home buyers just starting out and their young families. Our first community has broken ground in Ft. Worth, Texas. It makes sense to start here since 24.6% of the Texans does not have health insurance. Texas ranks 50th in the nation on this issue. Our first phase is 854 homes with the entire build out being 8700 homes on 2900 acres. We are working closely with IBM, Microsoft, Whole Health Management, Simplicity Health, the Ft. Worth School District, the FDA and Professor Regina Herzlinger at Harvard Business School to refine Aperion's program and make it available for people to live a preventative healthy lifestyle that can be voluntarily monitored and rewarded for continued success. Everything is coming together nicely and we think it will work. We have developed a Smart Home that is beta testing the home monitoring equipment now.

I was recently at Santa Monica's Milken Institute for a lecture on health care where your name came up and heard that you visited the Swiss to evaluate their health program. I would like you to recommend a few people that we can contact there as well so we can continue to evaluate good ideas that we can bring back, tweak a bit and implement now. We plan on being there December 16 - 20, 2007.

I would appreciate a contact telephone number where we can chat briefly.

Thank you.
Rick Abelson
Vice President
Aperion Companies

Posted by: Rick Abelson | November 21, 2007 at 05:14 PM

When a doctor has only 6 minutes to spend with a patient who presents with a complex medical history, there is no such thing as personalized health care.

Patients present with complaints and what does a doctor do? He prescribed a medication, not bothering to check the PDR to see if there are any contraindications based on what medications the patient is taking or what allergies the patient has. I myself always ask the doctor are there are contraindications based on the medications I am taking and my history of allergies to certain medications and foods, to which I often receive a blank stare. Sometimes the doctor pulls out the PDR; other times, he does not. That's when I do my own research.

Doctors do not treat illnesses directly, per se; they treat the symptoms and hope that the body's immune system itself will be able to overcome the disease. I know I am using a broad brush approach in this post; but by and large, what I say is true.

With regard to medications, I abhor the "one medication fits all" approach. We are all different and react to medications differently. We take a medication and if we develop a rash, diarrhea, etc., we are instructed to stop taking it. This hit-and-miss approach is not good and has gotten us into a lot of trouble. For example, we face a big problem with antibiotics being more and more ineffective. They have been overprescribed almost to the point of being lost as a viable treatment option.

It is appalling the number of drugs that have been pulled from the market only after they have been used for years and have just been proven to have done more harm than good. And then when some side effects of other drugs are discovered, a black box warning label is added. Is this supposed to take the drug companies off the hook and put the burden on the patient/ consumer? I'd much rather go without the drug and take my chances. It seems that medication treatment has turned into Russian Roulette, and I'm not willing to play that game with my health.

Personalized medicine would be great since we are all so different, but with HMOs are you kidding me? Just trying to get a proper diagnosis/treatment is miraculous in and of itself.

Posted by: medical transcription employment | September 28, 2008 at 08:32 PM

With regard to personalized medicine, in a perfect world when we are born, we would all undergo genetic testing to see if we would be predisosed to any genetic diseases as we age. There are so many genetic disorders that take years--maybe even decades--to properly diagnose, that many people suffer needlessly. Just watch the show Mystery Diagnosis and you'll see what I mean. Too often people are misdiagnosed and if their symtpoms persist, usually no further medical investigation/intervention is forthcoming. Many patients are referred for psychiatric evaluation. This is a terrible disservice to patients.

However, the drawback to genetic testing would come into play when insurance companies would be allowed to refuse coverage to people on the basis of pre-existing conditions.

There has to be put in place a better medical healthcare system than the one we have now. I don't know if a hybrid between our current set-up and universal healthcare is possible, but due to the genetic diseases that are prevalent and the amount of people who suffer from them and are not diagnosed on a timely basis, something much better needs to be implemented.

Posted by: medical transcription employment | September 28, 2008 at 09:06 PM

In looking over this project, I see no explicit indication that it provides for integration of medical and dental care and data, in spite of the general understanding of the interrelationships of oral and systemic health. Please see: According to the World Health Organization (WHO), “The strategy is that oral disease prevention and the promotion of oral health needs to be integrated with chronic disease prevention and general health promotion as the risks to health are linked.” Further, “The objectives of the WHO Global Oral Health Programme, one of the technical programmes within the Department of Chronic Disease and Health Promotion, imply that greater emphasis is put on developing global policies based on common risk factors approaches and which are coordinated more effectively with other programmes in public health. The policy of the WHO Global Oral Health Programme emphasises that oral health is integral and essential to general health, and that oral health is a determinant factor for quality of life.” Also, with regard to health information technology, “The WHO/FDI goals for oral health by the year 2000 urged Member States to establish oral health information systems, and this remains a challenge for most countries of the world. The WHO Oral Health Programme is prepared to assist countries in their efforts to develop oral health information systems which include data additional to epidemiological indicators.” (Petersen, 2008) According to WHO’s “Global goals for oral health 2020,” (Hobdell et al., 2003) Goal 2 is “To minimize the impact of oral and craniofacial manifestations of systemic diseases on individuals and society, and to use these manifestations for early diagnosis, prevention and management of systemic diseases,” and Objective 6 states, “To integrate oral health promotion and care with other sectors that influence health, using the common risk factor approach.”

Posted by: Valerie J H Powell RT(R) PhD | November 30, 2008 at 10:34 PM

Personalized medicine is available to (nearly) everyone today who knows their family health history. We all have different disease risks based upon our genetics. Fortunately we can determine these risks by observing which diseases run in our family. If a person is aware of a family history of colon cancer and they take steps to treat and prevent it early, they are then practicing personalized medicine.

Family health history is free and easy to collect. There is a new website and tool at ItRunsInMyFamily.com that helps people create their family pedigree and enter in diseases that run in their family. By being aware of diseases that run in the family, an individual can take steps to treat and prevent diseases before they occur. The website is free and open to the public.

Brandon M. Welch
Founder & Creator ItRunsInMyFamily.com

Posted by: Brandon M Welch | December 29, 2008 at 12:04 PM

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