Every day there seems to be something in the News about Personalized Medicine. Many people tune it out thinking, “Really? How is our life better? For 20 years, we’ve been hearing the Human Genome Project is going to revolutionize medicine. During the same time, Steve Jobs* revolutionized the music, telecommunications, and computer industries.“

FACT: Personalized Medicine has already changed the lives of hundreds of thousands of people, and it is well on its way to changing the lives of millions.

FACT: Depending on the results of a genetic test, certain medicines can be prescribed that can extend the life of a cancer patient by months or even years.

FACT: Today, the cost to sequence an entire human genome is $5,000. Within the next 2 years, the expected cost to sequence an entire human genome is $1,000, about the price of an MRI.

The goals of this blog are to:

1. Educate consumers about Personalized Medicine
2. Encourage consumers to discuss Personalized Medicine with their physician
3. Provide some guidance as to where to look for more information

What is Personalized Medicine?

Although several definitions exist, “Personalized Medicine” refers to the tailoring of medical care to the individual characteristics of each patient, often by classifying individuals into subpopulations based on their genetic makeup, susceptibility to a particular disease, or response to a specific treatment. Preventative or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not.

NOTE: Many people believe that Personalized Medicine is a medicine that is specifically “personalized” to one individual. To date, such a medicine is an exception as opposed to the rule. To the best of my knowledge, the only such FDA-approved medicine that meets this description is Provenge_® (Dendreon) an immunotherapeutic for treatment of advanced prostate cancer.

Two examples of recently approved, life-extending, personalized medicines (also referred to as targeted therapeutics) are Xalkori_® (Pfizer) for non-small cell lung cancer and Zelboraf_® (Genentech and Daiichi-Sankyo) for metastatic melanoma. These drugs do not “cure” the patient, but they have been shown to prolong patient life. In order to receive either drug, a genetic test must be conducted on the relevant tumor tissue. A physician will take a tissue sample and send it to a lab for genetic analysis.

• Xalkori has been shown to prolong survival for the 3-5% of non-small cell lung cancer patients whose lung cancer tissue is ALK positive.
• Zelboraf has been shown to prolong survival for the 40% of malignant melanoma patients whose melanoma tissue has the BRAF 600e mutation.

In both cases, if the patient’s tissue does not have the particular mutation, neither drug appears to be effective, and payers are not likely to reimburse the treatment.

To date, the majority of Personalized Medicine examples are in oncology, but there are emerging examples in cardiology, particularly for the millions of patients who have received stents and are currently taking Plavix_® (Sanofi Aventis and Bristol-Myers Squibb). Based on recently published research, Plavix does not appear to work for a small percentage of patients with a certain genetic makeup, 2-15% depending on ethnicity. Furthermore, 30% of an additional group of patients might need their Plavix dose dramatically increased for the drug to work effectively.

Engaging with Your Physician

Although I am not a physician, I would recommend that all cancer patients bring up the subject of genetic testing and personalized medicine. Most of these tests are reimbursed by Medicare and private payers.

• If I had melanoma or non-small cell lung cancer, I would want to know if I were a candidate for these new cancer therapeutics.
• If I were taking Plavix after receiving a stent, I would want to know whether the Plavix was working and whether I was taking the right dose.

These are just two examples; there are many more.

When the price to sequence my genome drops to $1,000, will I do it? I think so. That said, assuming I am still healthy, I would want to think through the privacy issues as well as reimbursement (who pays the bill).

What Do You Think?

• Have you or would you feel comfortable raising the subject of personalized medicine or genetic sequencing with your doctor?
• Under what circumstances would you pay $1,000 to sequence your genome?
• How would you feel if someone else would pay the $1,000 but would also have access to your genetic information?

Where to Find More Information

Here are a few sites to learn more about Personalized Medicine. These sites are more directed to consumers than industry.

www.personalizedmedicinecoalition.org

http://health.usnews.com/health-conditions/cancer/personalized-medicine

*NOTE: In Walter Isaacson’s biography Steve Jobs, Walter cites Personalized Medicine as one of the reasons Steve Jobs was able to live as long as he did with pancreatic cancer. Steve was one of the first twenty individuals in the world to have his normal and tumor DNA sequenced. At the time, it cost more than $100,000.