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Pharmacogenomics in Clinical Practice: Where Do We Go From Here?

In an interview with Medscape, Mark J. Ratain, MD, Professor of Medicine at the University of Chicago and Founding Director of the University's Center for Personalized Therapeutics, pointed out that pharmacogenomic testing needs to move from the realm of reflex lab testing to part of the physical exam….

“I think we need to take genetic testing out of the domain of laboratory testing and move it to the domain of physical examination. It can then be one more piece of information for the physician to consider and we wouldn't need to focus on the cost.”

“There are a lot of things we do during a physical examination that have never been demonstrated to be cost-effective. Physicians look at their patients' toes as part of an annual physical. Have you ever seen a study that shows that looking at your toes is cost-effective?”“We need to conceptualize genetic testing as a part of the physical exam rather than as a laboratory test that needs to be ordered so you can have the information at the time you are seeing the patient. For example, if you're starting a patient on warfarin, or you are considering whether to start him on warfarin, and you already know that he is going to metabolize warfarin a lot more slowly or that he's going to be a lot more sensitive to it, you can take that into account in the same way you would probably use a lower dose if your patient were frail or elderly. That is where I think the field needs to move.”

“The solution is one that we are piloting here, which is to genotype all patients for all polymorphisms that may affect drug response. You'll then have the results when you need them and your costs will be much lower than doing each test as a one-off laboratory test.
In the current system, you see the patient and want to prescribe a drug, and you say to yourself, ‘Maybe I should order a pharmacogenetic test. But I don't know how to do that, I don't know how long it is going to take to get results, and I don't know if my patient is going to get reimbursed for it. Oh, who cares. I am just going to prescribe the drug.'

“Unless someone says that you can't prescribe the drug without doing the test, or unless we change the way we look at how pharmacogenomic testing should be incorporated into clinical practice, the system is unlikely to change.”

DNA in the News

Another case-control study published in October pointed out increased risk of stent thrombosis for patients taking Plavix with variations in a gene called CYP2C19. Patients with adverse events were two times more likely to have half of the gene be non-functional. Called intermediate metabolizers, this represents about one-third of patients. Patients with no CYP2C19 function, called poor metabolizers, were seven times more likely to have an adverse event. About 2-4% of Caucasians, 10% of Africans, and 20% of Asians are poor metabolizers. If you or a loved one is taking Plavix, ask about DNA Drug Sensitivity Testing.

See more at theheart.org/article/1300023.do

Bringing Personalized Prescribing to the Community Pharmacy

An interview with Brian Hocum, PharmD of Wasem’s Pharmacy who has recently made personalized prescribing available to at-risk customers.

Why do you think genetics is important?
I tell my patients that through DNA technology, we are able to determine what type of drug metabolizer they are. I explain how this information can be used to help predict if they are at risk of having bad reactions to drugs (too much drug exposure) or poor response to drugs (too little exposure to the medication). Genetics is important because it allows Health Care Providers, like myself, to predict who will have “bad reactions” or “poor responses” to medications.

How would you define personalized prescribing in your own words?
‘Personalized prescribing” is the analysis and incorporation of patient specific factors (i.e. CYP450 metabolizing capacity–derived from DNA testing) prior to prescribing, dispensing and/ or choosing new medications (including OTC, vitamins, herbals) and doses. While we typically think of “prescribing” as something only Physicians do, I feel “personalized prescribing” is something we can all embrace; Physician, Pharmacist & Patient.

Why did you decide to launch this program at Wasem’s?
As a Pharmacist working in a community pharmacy, my number one goal is to serve the patients of the community. Our services are what bring patients into the store and they are what keep them coming back for years. Keeping patients safe through more informed medication and dose choices is the best service we can provide and “personalized prescribing” is the best tool I know of to do so.

What efforts have you made to educate physicians and patients in your community about personalized prescribing?
We have in the past and continue to educate the community through newspaper advertisements, co-marketing posters and speaking with community volunteer groups like the Rotary, Lion’s club and retirement centers.

Since pharmacists are able to order laboratory tests in Washington State for the purpose of monitoring drug therapy, I often find that the prescribers are unacquainted with “personalized prescribing.” I send them a fax describing what the genetic results mean, and any alternate medications or dose adjustments that they might considered based on the results. The response has been all positive. Doctors are noting the recommendations in their patient charts. I plan to host a dinner soon for Health Care Providers to educate them about “personalized prescribing.”

You have now made several successful interventions on a patient’s behalf; can you share one of these stories?
Yes, here is one of the first testimonials I received after a successful pharmacogenetic intervention. This patient struggled with adverse drug reactions her whole life, and was relieved that science and technology are finally beginning to understand and incorporate “personalized prescribing:”

“Thank you so much for guiding me through the new way to approach medication. Armed with the letter to my health care provider, I feel confident that finally my doctor will be able to adjust some of my medications. Maybe some day genetic testing will be a routine procedure before prescribing meds. How much misery and money could be saved if we get it right the first time…”

Did You Know?

In March of 2010, the FDA put a warning on the Plavix (clopidogrel) product insert that patients with a certain DNA variation of CYP2C19 (pronounced sip-2C19) were at high risk of treatment failure resulting in major cardiac problems or even death.

CYP2C19 is not just involved in Plavix metabolism, it is involved in the metabolism of ~10% of medications.

Other common medications processed by CYP2C19 include:
· voriconazole
· Prilosec
· Prevacid
· Aciphex
· Nexium
· Soma
· Lexapro
· Silenor
· Dexilant

Embassies Crack Down on Third-party Immigration DNA Tests

Third-party resellers of DNA testing abound on the internet. Unfortunately, many of them are unfamiliar with strict requirements for immigration DNA testing. The problem has become so pronounced that many Embassies are now requiring petitioners to contact AABB-accredited laboratories directly.

Natalie Messelt from the US Embassy in Addis Ababa stated, “A petitioner must independently choose his or her own AABB lab, make the appointment, and go to the collection site directly. The collection site must then send the specimen to the main AABB lab testing site directly,
through the lab's internal, controlled system. Third-party vendors include, but may not be limited to, private companies or clearinghouses that serve as intermediaries to make appointments on behalf of petitioners or beneficiaries. The authority for collecting DNA specimens in the United States resides exclusively with the AABB labs and their directly affiliated collection sites.”

The immigration process is complex and lengthy, don’t risk delays and unneeded additional expenses of retesting – contact the AABB labs directly.

Personalized Prescribing: Making the Most of Medicare Preventive Services

Many people don’t realize that personalized prescribing based on DNA testing is covered by most public and private insurers if a healthcare provider believes it is medically necessary. Be sure to ask about personalized prescribing at your next annual wellness visit.

Medicare offers a number of preventive services, including a free annual wellness visit so your doctor can identify health risk factors and recommend steps you can take to reduce those risks. Your doctor will evaluate your personal and family medical history, as well as current medications, and order tests. (See page 3 for complete description.) The goal of these visits is to prevent disease and to improve your overall health and well-being.

More and more physicians are including medication risk assessments to identify drug side-effects and interactions that may be causing problems along with the standard risk assessments for depression, heart disease, and cancer. If you’re taking four or more prescription drugs or one, such as Plavix, with a warning about genetics on the label, your doctor may order DNA Drug Sensitivity Testing to help optimize your prescriptions. Typically covered by insurance if ordered by a qualified healthcare provider, personalized prescribing helps doctors determine both “drug-to-drug” and “drug-to-DNA” interaction risk.

The comprehensive personalized prescribing program analyzes all the prescription drugs, herbal preparations, and over-the-counter medicines patients are taking for their combined interaction risk, and for their compatibility with a patient’s unique DNA profile.

“With this tool, no longer is it a trial and error proposition as to what drug and dose to prescribe; we can now do it scientifically with a much better outcome for the patient.”

- J.E. Block, MD, FACP, Tulsa, Oklahoma

As the number of drugs an individual is taking goes up, so do the risks of a serious or even fatal reaction. If these drugs are being prescribed by more than one doctor, are self-prescribed, such as herbals, or purchased from more than one source, the risks go up even more.

A questionnaire is now available that allows patients to quickly calculate their risk for adverse drug reactions and treatment failures to help determine if they are a candidate for DNA Drug Sensitivity Testing and a Personalized Prescribing evaluation. Based on information compiled from NIH, the FDA, and www.medsandaging.org, you can download the questionnaire at www.HealthandDNA.com/risk.pdf or request copies for yourself or a medical office by calling 800-523-3080 now.

Sources: U.S. Centers for Disease Control and Journal of the American Medical Association

DNA in the News

Caltech researchers recently developed an artificial neural network from human DNA molecules. They chose DNA molecules because they can act like circuits, computing data, transmitting information and processing it. The team then tested the intelligence of their creation with a series of trivia questions– the test tube brain scored 100%. Learn more in the July 21^st issue of the journal Nature.

DID YOU KNOW?

Human beings differ only in 0.1% of their overall DNA; in the other 99.9%, they are identical. One of the ways our DNA differs the most is in the coding for the enzymes that process the majority of the most commonly prescribed drugs. These enzymes vary more than any others known.
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A complete 3 billion base genome would take only 3 gigabytes of storage space, which would fit on memory cards now commonly used in many digital cameras.
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The codeine product insert warns that nursing mothers may cause harm to their babies if ,like 7% of the population, they have duplications of a gene called CYP2D6.

What is the Medicare Preventive Visit?

The information provided is directly quoted from Medicare.gov

The "Welcome to Medicare" preventive visit helps you and your doctor develop a personalized plan to prevent disease, improve your health, and help you stay well. A few things you should know:

· It's free. There’s no copayment or deductible for the visit.

· It’s easy to use this benefit. Just call your doctor when you sign up for Medicare.

· You can sign up for the visit during the first 12 months you have Medicare. After the first year, you can get a yearly “Wellness” visit for free.

· It’s comprehensive. The visit includes a review of your medical history, preventive tests and screenings, and planning for a healthy future.

· The visit is covered by Original Medicare (Part B) and Medicare Advantage Plans. Under

the new healthcare law, the visit is now free along with a number of preventive screenings and services (like mammograms and colonoscopies).

What should I expect during the visit?

During the visit, your doctor will:

· Record and evaluate your medical and family history, current health conditions, and prescriptions.

· Check your blood pressure, vision, weight, and height to get a baseline for your care.

· Make sure you're up-to-date with preventive screenings and services, such as cancer screenings and shots.

· Order further tests, depending on your general health and medical history.

Following the visit, your doctor will give you a plan or checklist with free screenings and preventive services that you need.

What you should bring to your "Welcome to Medicare" preventive visit:

· Medical records, including immunization records. Even if your current doctor does the visit, gather as much medical information as you can to make sure nothing is overlooked.

· Family health history. Try to learn as much as you can about your family's health history before your appointment. The information will help you and your doctor better understand what screenings you should get and what to watch for in the future.

· Prescription drugs. Bring a list of any prescription drugs, over-the-counter drugs, vitamins, and supplements that you currently take, how often you take them, and why.

Don't delay. Schedule your annual preventive wellness visit today! Ask your healthcare provider, or visit www.medicare.gov for more details.

Healthcare Provider? Ready to Make
Personalized Prescribing Part of Your Practice?
Contact Genelex at 800-523-3080 and ask for a Medical Accounts Specialist. We can help you take the guesswork out of prescribing at no cost to your patients or your practice.

Patient? Is Personalized Prescribing Right for You?
Contact Genelex at 800-523-3080 or visit www.HealthandDNA.com.

New Plavix Study Confirms Importance of Genetic Testing

Almost all of the deaths and major cardiovascular events observed in Plavix patients occurred in poor metabolizers of a liver enzyme called CYP2C19, according to data from the GIFT sub study of GRAVITAS presented at American College of Cardiology 2011 annual meeting. Poor metabolizers are people who lack the DNA coding required for their bodies to make CYP2C19, which acts on about 10% of medications. Approximately 2-4% of European origin individuals, 10% of Africans, and up to 20% of Asians are CYP2C19 poor metabolizers. Plavix is a prodrug, taken in an inactive form that requires CYP2C19 to activate it. Additionally, the study found that doubling Plavix dose from 75 to 150 mg improved platelet reactivity results in the one-third of patients who are intermediate metabolizers, but had no impact on poor metabolizers of CYP2C19.

“The thing that hit me in the face was that virtually all of the events were in those [poor
metabolizers].”

- Dr. Gibson, Duke University

Dr. C. Michael Gibson and Dr. Ajay Kirtane from Duke University discussed the study, and both commented that the FDA boxed warning about Plavix genetics was premature until seeing this data. Dr. Kirtane stated, “I’m wondering if maybe we should spend more effort trying to find these non responders for the homozygous gene [poor metabolizers].

Watch the Duke cardiologists discuss the study at www.vimeo.com/22008430

Read details of the study at: www.theheart.org/article/1208199.do

Blood Lines and DNA Differ, Implications for Native Americans

Most people think DNA is the same as blood lines; if their mother is 25% Native American, they expect to be 12.5%, but DNA doesn’t work that way.

According to family folklore, your great grandmother was a full blooded Choctaw Indian, but genealogical research is unable to uncover any information about her history. Many Americans have a story similar to this. Unfortunately, if family members did not make it onto the roles, Native American ancestry is almost impossible to confirm without DNA testing.

If Native American ancestry was passed through a line of unbroken males or unbroken females, Y-STR or mtDNA testing can be used to confirm Native American ancestry, but this is rarely the case. The only option remaining is ethnicity DNA testing, which looks at the percentage of ethnic markers you carry associated with European, Native American, East Asian, and African ancestry. Keep in mind that if your mother is 25% Native American, that does not mean you automatically have 12.5% Native American markers. The easiest way to understand this is to picture two decks of 100 cards of which you are dealt 50 from each. If one of the decks has 25 Native American cards and 75 other cards, you can get anywhere from 0 to 25 of the Native American cards in your hand. Although genes passed tend to be in a similar range as blood lines, there is no guarantee that they will be. Having the genetic markers is great for confirmation of Native American ancestry, but lack of markers doesn’t disprove it. DNA testing can be useful, but it has limitations.