Section 1: Basics of Personalized Medicine
What is Personalized Medicine?
Personalized medicine is the way that healthcare is moving in the future. It is a proposed model that customizes healthcare based on the individual's genetics. Instead of just assessing your symptoms and prescribing you a medicine that may or may not fix the problem, personalized medicine looks to have doctors personalize your healthcare to you and what's right for you in the context of your genetics. In this model, medical decisions, practices, and products will be tailored specifically for each individual. The focus shifts from reaction to a disease instead of prevention. Personalized medicine works to make medicine predictive, preventive, personalized and participatory.
How Does Personalized Medicine Work? (click me)
This is how prescription medicine works now. A large group of people getting put on the same prescription because they all exhibit the same illness. However, the drugs don't work the same way for all people, especially on a combination of drugs.
Personalized medicine is the way that healthcare is moving in the future. It is a proposed model that customizes healthcare based on the individual's genetics. Instead of just assessing your symptoms and prescribing you a medicine that may or may not fix the problem, personalized medicine looks to have doctors personalize your healthcare to you and what's right for you in the context of your genetics. In this model, medical decisions, practices, and products will be tailored specifically for each individual. The focus shifts from reaction to a disease instead of prevention. Personalized medicine works to make medicine predictive, preventive, personalized and participatory.
How Does Personalized Medicine Work? (click me)
This is how prescription medicine works now. A large group of people getting put on the same prescription because they all exhibit the same illness. However, the drugs don't work the same way for all people, especially on a combination of drugs.
So personalized medicine works to treat the person, not the disease. By analyzing a person's genetics, doctors can make decisions to treat the illness based off of what drugs will work best with a patient's genes.
What Are the Benefits of Personalized Medicine? (click me)
What Are the Benefits of Personalized Medicine? (click me)
How Has Personalized Medicine Helped Patients Already?
"Blood clots. Before the availability of genome-based molecular screening, the dosing of Warfarin, which is prescribed 21 million times a year, was a dangerous game in which too little of the drug could trigger more clots and too much could lead to excessive bleeding.
Since 2007, the U.S. Food and Drug Administration has recommended genotyping for all patients being assessed for therapy involving Warfarin. Genotyping allows prescription of drug therapy regimens only to individuals expected to benefit from that specific drug at that specific dosage.
Colorectal cancer. Metastatic colorectal cancer kills 50,000 Americans every year, more lives than are lost to breast cancer and AIDS combined. Among the drugs most frequently used in treating colon cancer is cetuximab (sold as Erbitux by Bristol-Myers Squibb). For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can be now be determined through a simple test. Because cetuximab is effective only in colon cancer patients with normal KRAS protein, treatment with the drug can be withheld from the 40 percent of patients for whom it would prove ineffective. Alternative therapies can be pursued immediately instead.
Breast Cancer. Just as molecular diagnostic testing of tumors determines which colon cancer patients are most likely to benefit from drug therapy using cetuximab, women with breast tumors can be screened to determine which receptors, if any, their tumor cells contain.
For example, the cells of the highly aggressive "triple-negative" breast cancer have no estrogen, progesterone, or human epidermal growth factor receptors, which are essential to the efficacy of current anti-breast cancer therapies. The application of personalized medicine eliminates both the considerable expense and precious time of trial-and-error treatments and helps clinicians to determine quickly which breast cancer therapies are most likely to succeed." (http://genetichealth.jax.org/personalized-medicine/what-is/applications.html)
What Are the Challenges of Tailoring Medicine to Individuals or Small Numbers of People?
How Could Personalized Medicine Reduce Health Care Costs in the United States? (click me)
Why Are Doctors and Scientists Excited about Personalized Medicine? (click me)
Medicine becomes MORE effective.
"Blood clots. Before the availability of genome-based molecular screening, the dosing of Warfarin, which is prescribed 21 million times a year, was a dangerous game in which too little of the drug could trigger more clots and too much could lead to excessive bleeding.
Since 2007, the U.S. Food and Drug Administration has recommended genotyping for all patients being assessed for therapy involving Warfarin. Genotyping allows prescription of drug therapy regimens only to individuals expected to benefit from that specific drug at that specific dosage.
Colorectal cancer. Metastatic colorectal cancer kills 50,000 Americans every year, more lives than are lost to breast cancer and AIDS combined. Among the drugs most frequently used in treating colon cancer is cetuximab (sold as Erbitux by Bristol-Myers Squibb). For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can be now be determined through a simple test. Because cetuximab is effective only in colon cancer patients with normal KRAS protein, treatment with the drug can be withheld from the 40 percent of patients for whom it would prove ineffective. Alternative therapies can be pursued immediately instead.
Breast Cancer. Just as molecular diagnostic testing of tumors determines which colon cancer patients are most likely to benefit from drug therapy using cetuximab, women with breast tumors can be screened to determine which receptors, if any, their tumor cells contain.
For example, the cells of the highly aggressive "triple-negative" breast cancer have no estrogen, progesterone, or human epidermal growth factor receptors, which are essential to the efficacy of current anti-breast cancer therapies. The application of personalized medicine eliminates both the considerable expense and precious time of trial-and-error treatments and helps clinicians to determine quickly which breast cancer therapies are most likely to succeed." (http://genetichealth.jax.org/personalized-medicine/what-is/applications.html)
What Are the Challenges of Tailoring Medicine to Individuals or Small Numbers of People?
- Regulatory Oversight
How does the FDA regulate to compare and test the validity of different sequencing platforms and diagnoses? - Intellectual Property Rights
When it comes to DNA sequencing and genes, what belongs to the general public and what belongs to an individual as intellectual property? - Reimbursement Policies
How will health insurance be impacted? - Patient Privacy and Confidentiality
How can you ensure that a person's entire genetic sequencing on a computer is completely secure? - Complex Biology
How do you ensure that the patient's understand ALL of the implications of getting their genome sequenced ?
How Could Personalized Medicine Reduce Health Care Costs in the United States? (click me)
Why Are Doctors and Scientists Excited about Personalized Medicine? (click me)
Medicine becomes MORE effective.
- Shift the focus from reaction to prevention
- Predict susceptibility to disease, improve disease detection, preempt disease progression
- Customize disease-prevention strategies
- Prescribe more effective drugs and avoid prescribing drugs with predictable side effects
- Reduce the time, cost, and failure rate of pharmaceutical clinical trials
- Eliminate trial-and-error inefficiencies that inflate health care costs and undermine patient care
Discussion Questions
1. Why might some drug companies resist the move to more personalized care?
2. How might people with asthma, cystic fibrosis, or cancer benefit from personalized medicine?
Sources
1) http://genetichealth.jax.org/personalized-medicine/what-is/applications.html
2) http://www.thehugojournal.com/content/7/1/1
3) http://prescriptions.blogs.nytimes.com/2010/11/16/drug-companies-pursue-personalized-medicine-approach/?_r=1
4) http://genetichealth.jax.org/personalized-medicine/what-is/applications.html
5) http://theconversation.com/treating-illness-and-preventing-disease-with-genetic-testing-22996
1. Why might some drug companies resist the move to more personalized care?
2. How might people with asthma, cystic fibrosis, or cancer benefit from personalized medicine?
Sources
1) http://genetichealth.jax.org/personalized-medicine/what-is/applications.html
2) http://www.thehugojournal.com/content/7/1/1
3) http://prescriptions.blogs.nytimes.com/2010/11/16/drug-companies-pursue-personalized-medicine-approach/?_r=1
4) http://genetichealth.jax.org/personalized-medicine/what-is/applications.html
5) http://theconversation.com/treating-illness-and-preventing-disease-with-genetic-testing-22996