“Personalized Health Care: Can it Really Happen?”
by Jay Anders, M.D., MED3OOO/InteGreat Chief Medical Officer and Louis Wright, M.D., FACP, Founder and Senior Advisor to Pathology Service Associates, a MED3OOO company
As physicians today are confronted with new therapies daily, how can we actually consider tailoring therapy to individual patients based on their specific genomes? The ability to tailor current standard therapies based on an individual’s specific genetic makeup seems almost in the realm of Star Trek. Yet today, the mapping of the human genome is starting to allow glimpses of this future with the development of specific sensitivity tests as well as tailored therapies directed at a particular genetic background.
Medicine today is starting to see the introduction of these genetically determined tests in addition to genetically targeted therapy. Here are a couple of specific examples. We have today a test that will determine the sensitivity of any particular patient to the drug warfarin. The warfarin sensitivity DNA test looks for variations in the CYP2C9 and the VKORC1 genes. This test identifies patients who are sensitive to warfarin and who therefore would require a lower dose and may be at risk for bleeding complications. This allows the practitioner to tailor therapy with a standard well-known anticoagulant to the patient's genetic background. The advantages to the patient are fairly obvious. It will shorten the time to reach therapeutic and stable dosing levels as well as avoid potential life-threatening complications.
Another example can be found in the treatment of breast cancer. It has been found that breast cancer patients who have an over expression of the gene HER-2 are sensitive to the drug Herceptin. This drug is specifically known to reduce and prevent metastatic disease. Again, the advantages to patients with this gene makeup are fairly obvious. The ability to identify those patients who will respond to this treatment can save significant healthcare expense. Several additional examples of genetic therapy can be found in the treatment of myeloid leukemia and chronic myelogenous leukemia.
To take advantage of this information, the practicing physician will need to have access to information, at the point of care, on a patient's specific genetic background. Electronic healthcare records, such as IC-Chart, will allow easy access to that information and will provide alerts to the physician to reduce or minimize possible errors in therapy. Electronic healthcare records will also provide a link between the pathologist who is the expert in genetic therapy and the practicing primary care physician who will be delivering the care. As these genetic therapies and tests multiply, data repositories, such as MED3OOO’s M3/IQ™, become invaluable. These repositories will contain the genetic background of whole populations of patients that can be linked to the electronic health record. This will allow the primary care physician to call up at the point of care any needed genetic information to specifically treat any individual patient. The electronic healthcare record allows for a real-time link between this critical information and the primary care physician.
The future of personalized healthcare is bright. There may be a day in the not too distant future where we can predict which patients are predisposed to certain diseases, and also have the ability to turn off the specific genetic expression that created the condition. This will lead to true cures based on targeted genetic therapies.
Click here for a printed version: Clinical Newsletter March 2008
The Clinical Advisory is a clinical publication from MED3OOO dedicated to informing physicians and clinical staff about tools and information to improve the quality of patient care.
Corporate Headquarters: MED3OOO, Inc., 680 Andersen Drive, Foster Plaza 10, Pittsburgh PA 15220. For more information on our clinical initiatives visit ww.MED3000.com or contact Geoff Coleman at Geoff_Coleman@MED3000.com or 1-888-811-2411
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Generic vs. Brand Rx
Most doctors want to help keep their patients’ healthcare costs affordable so that patients are more compliant in taking their medications. One way we can do this is by helping to reduce prescription costs. This can be accomplished through the use of generic drugs. Prescription drugs can be a costly medical expense, especially for older people and those who are chronically ill. We’ve all heard stories about patients cutting pills in half or taking them every other day because they couldn’t afford the ongoing cost. It is especially important for patients with chronic illnesses to follow their treatment plans. Because generic drugs play a key role in making healthcare more affordable, former FDA Commissioner Mark B. McClellan, M.D., Ph.D., made it a priority to encourage their availability. At the same time, FDA experts say there is no question that brand-name drugs are also essential. "Generic drugs are possible only as a result of the development of new innovative drugs, and this innovation requires significant investment," McClellan said. "Without fair compensation from meaningful patent protection, drug research and development would slow or stop."
Gary Buehler, R.Ph., Director of the Food and Drug Administration's Office of Generic Drugs, says, "The FDA ensures a rigorous review of all drugs, and consumers can be assured that generic drugs are as safe and effective as brand-name drug products," he says. “In addition, the FDA continues initiatives to improve access to generic drugs. These initiatives involve streamlining the FDA's review process to get generic drugs into consumers' handsmore quickly”. The FDA continuously evaluates the generic drug review program to find ways to increase efficiency and get quality products into the marketplace to improve the public health.
When prescribing medications for your patients, consider whether generic drugs are right for them. Helping to reduce our patients’ prescription costs may help them to become more compliant. Because at the end of the day, it’s the outcome of the patient that really matters.
Tools
AMA - Report 2 of the Council on Science and Public Health (A-07) – Generic Drugs – Saving Money at the Pharmacy Explains what consumers need to know about generic drugs and the law, including the difference between generic and name brand drugs.
Federal Trade Commission U.S. Food and Drug Administration - Center for Drug Evaluation and Research
U.S. Food and Drug Administration Center for Drug Evaluation and Research - Office of Generic Drugs
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JAMA - Identifying Widely Covered Drugs and Drug Coverage Variation Among Medicare Part D Formularies - Clinicians can find it difficult to know which drugs are covered for their Medicare patients because formularies vary widely among Medicare Part D plans and many states have 50 or more such plans.
Answers.com - Generic Drug Information and Much More
Humana - With prescription drug costs rising, generic alternatives to brand-name medications may help increase your savings. Generic drugs are safe, effective, FDA-approved, and less expensive.
Patient Recall
Using the M3/IQ™ technology and our M3/Connect technology, we can work with you to identify those patients in your practice who should be recalled for needed services. If you would like to discuss either these reports or an automated patient recall process using M3/Connect technology, please contact Geoff Coleman at: Geoff_Coleman@MED3000.com.
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