One hundred eighty thousand women will be diagnosed with breast cancer this year. Eighty thousand will
start taking the drug tamoxifen to prevent the recurrence of their ER (estrogen receptor) positive breast
cancers. The treatment is successful in two-thirds of the women who take it. Genelex Corporation (Seattle)
is now offering Tamoxitest™ that could improve this success rate to greater than 90% by addressing both
of the common causes of tamoxifen treatment failure.
Ten-percent of women are unable to produce the enzyme CYP 2D6 essential for tamoxifen effectiveness
and need an alternative treatment. Another 35% have reduced functioning so their physician should
consider a higher dose or other treatments. DNA testing identifies both classes of patients.
Even with the right genetics, interactions with prescription, over-the-counter, and herbal remedies can also
reduce tamoxifen effectiveness. To prevent this, Tamoxitest™ includes access to GeneMedRx. This
interpretive software warns patients and physicians if tamoxifen benefit is at risk and offers safer
alternatives.
“Five years is a long time to take a medicine that may have little to no effect in preventing cancer
recurrence,” states Genelex Corporation’s CEO, Howard Coleman.
Tamoxitest™ is advocated by the National Foundation for Cancer Research and is based on research
completed at the University of Indiana and Mayo Clinic. This simple, but powerful test requiring only a few
cheek swabs is steadily gaining ground with the mainstream medical community.
Los Angeles oncologist Dr. Michael Benjamin, MD is one of the first physicians to embrace this
technology. "The Genelex gene profiling technology is a powerful tool to help my patients. With tamoxifen
testing, we can appropriately individualize treatment based on patients' ability to process the medicine.”
Benjamin regularly advises his patients to take Tamoxitest™.“ Genelex tamoxifen testing helps me be
smarter about who I treat with tamoxifen, and why. I can take the discoveries made in their labs right to the
patient’s bedside,” states Benjamin. “I see it as the wave of the future in medicine.”
Maura, a breast cancer patient, says that she ordered Tamoxitest™ after she was diagnosed. Found to
be an intermediate metabolizer, the patient and her doctor have opened a dialogue about her dose of
tamoxifen. “It was worth the information – and peace of mind – I received,” she concluded. Most
insurance companies cover the test.
Breast cancer patients and healthcare providers can learn more about Tamoxitest™ at
www.Tamoxitest.com.
Dr. Michael Benjamin’s website is www.interactMD.com
A pioneer in the field of human DNA testing, Genelex provides comprehensive DNA testing services. Our DNA Drug Sensitivity Testing and GeneMedRx software have helped physicians find the right drug and dose for their pateints since 2000.
Thursday, October 1, 2009
Tuesday, July 14, 2009
Death of Michael Jackson Illustrates the Danger of Adverse Drug Reactions
The tragic death of Michael Jackson has the potential to create an important "learning moment" for physicians and patients. According to the Journal of American Medical Association, adverse drug reactions are the "4th to 6th leading cause of death" in the US. The published reports of Mr. Jackson's medications illustrate an important issue- any two drugs may be safe in combination but the cumulative effect of many drugs can be difficult to detect and very dangerous, especially in people with reduced drug processing capacity.
Jessica Oesterheld, MD is one of the authors of the best selling Clinical Manual of Drug Interaction Principles for Medical Practice. After analyzing the purported medication list she noted that “many of the concentrations of these drugs would have been dangerously increased.” Propofol often causes accidental death in recreational users. Interactions between propofol and many of the drugs Jackson is alleged to have been taking, such as Paxil, Zoloft and the opioid pain medicines Demerol, Vicodin, and Dilaudid, increase the potential dangers of those drugs.
Dr. Oesterheld's experience with adverse drug reactions led her to collaborate with Dr. Robert Patterson, a fellow clinical psychiatrist and computer programmer. Together they developed GeneMedRx, a tool for analyzing the cumulative effect of the many factors leading to adverse drug reactions including prescription drugs, over-the-counter medicines, foods, herbal preparations, recreational drugs, and genetics that are missed by other drug interaction programs. The dangers inherent in Michael Jackson’s purported drug regimen would have been even greater for individuals with a positive DNA drug sensitivity test who comprise more than half of the population. DNA Drug Sensitivity Testing detects the up to 1000-fold person-to-person differences in drug processing capacity. You can see the "hidden" interactions GeneMedRx predicts at www.HealthandDNA.com/Jackson.
Genelex Corporation, Seattle, Washington is a DNA testing laboratory dedicated to reducing the high levels of morbidity and mortality that result from adverse drug reactions by personalizing medicine with the combination of DNA Drug Sensitivity Testing and GeneMedRx software. For further information, contact Howard Coleman at 206 382-9591 or HCColeman@genelex.com.
Jessica Oesterheld, MD is one of the authors of the best selling Clinical Manual of Drug Interaction Principles for Medical Practice. After analyzing the purported medication list she noted that “many of the concentrations of these drugs would have been dangerously increased.” Propofol often causes accidental death in recreational users. Interactions between propofol and many of the drugs Jackson is alleged to have been taking, such as Paxil, Zoloft and the opioid pain medicines Demerol, Vicodin, and Dilaudid, increase the potential dangers of those drugs.
Dr. Oesterheld's experience with adverse drug reactions led her to collaborate with Dr. Robert Patterson, a fellow clinical psychiatrist and computer programmer. Together they developed GeneMedRx, a tool for analyzing the cumulative effect of the many factors leading to adverse drug reactions including prescription drugs, over-the-counter medicines, foods, herbal preparations, recreational drugs, and genetics that are missed by other drug interaction programs. The dangers inherent in Michael Jackson’s purported drug regimen would have been even greater for individuals with a positive DNA drug sensitivity test who comprise more than half of the population. DNA Drug Sensitivity Testing detects the up to 1000-fold person-to-person differences in drug processing capacity. You can see the "hidden" interactions GeneMedRx predicts at www.HealthandDNA.com/Jackson.
Genelex Corporation, Seattle, Washington is a DNA testing laboratory dedicated to reducing the high levels of morbidity and mortality that result from adverse drug reactions by personalizing medicine with the combination of DNA Drug Sensitivity Testing and GeneMedRx software. For further information, contact Howard Coleman at 206 382-9591 or HCColeman@genelex.com.
Thursday, July 9, 2009
Genelex Medical Director Co-authors Leading Book on Drug Interactions
Genelex’s Medical Director Dr. Jessica Oesterheld recently co-authored the Clinical Manual of Drug Interaction Principles for Medical Practice with other notable drug interaction experts, Dr. Gary Wynn, Dr. Kelly Cozza, and Dr. Scott Armstrong. Here’s what reviewers are saying:
Midwest Book Review: “Filled with complete and comprehensive and up to date research on drug interactions”The wrong mixture of over the counter drugs can be fatal, and doctors and pharmacists must be aware of these lethal combos. Clinical Manual of Drug Interaction Principles for Medical Practice is a scholarly work discussing this very real possibility that can be prevented with the right research and foresight. With the hundreds upon hundreds of new drugs entering the market every year, the research into this subject is now invaluable, as it could save thousands of lives.
Dr. G. Grammer: “Outstanding Reference”
This is the gold standard for drug interactions and should be part of any prescriber's reference set. Meticulously researched, it is the most up to date synopsis of the expanding field of drug metabolism and interactions.
Dr. Oesterheld is also the primary author of the GeneMedRx personalized medication management software. This drug interaction tool helps prescribers easily assess the cumulative risk of multiple drug and gene interactions. Free 30-day trial available at www.GeneMedRx.com.
Midwest Book Review: “Filled with complete and comprehensive and up to date research on drug interactions”The wrong mixture of over the counter drugs can be fatal, and doctors and pharmacists must be aware of these lethal combos. Clinical Manual of Drug Interaction Principles for Medical Practice is a scholarly work discussing this very real possibility that can be prevented with the right research and foresight. With the hundreds upon hundreds of new drugs entering the market every year, the research into this subject is now invaluable, as it could save thousands of lives.
Dr. G. Grammer: “Outstanding Reference”
This is the gold standard for drug interactions and should be part of any prescriber's reference set. Meticulously researched, it is the most up to date synopsis of the expanding field of drug metabolism and interactions.
Dr. Oesterheld is also the primary author of the GeneMedRx personalized medication management software. This drug interaction tool helps prescribers easily assess the cumulative risk of multiple drug and gene interactions. Free 30-day trial available at www.GeneMedRx.com.
Thursday, June 11, 2009
New study confirms importance of tamoxifen CYP2D6 testing
Co-authored by Kristine Ashcraft and Michael Benjamin, M.D at InteractMD.com Mayo study further strengthens the case for genotyping and medication management
In a presentation at the 31st annual San Antonio Breast Cancer Symposium, Mayo clinic researchers further confirmed the importance of the enzyme CYP2D6 in individualizing tamoxifen dosing in breast cancer patients.
Tamoxifen is often prescribed to block the effects of estrogen in breast tissue, preventing breast cancer recurrence in ER+ (estrogen receptor positive) cancers which require estrogen to grow and spread. Previous studies have already revealed that tamoxifen is less effective in women with reduced CYP2D6 activity caused by genetic variations or co-administration with one of the more than 200 other prescription drugs that inhibit CYP2D6, but the mechanism of action for tamoxifen was not well understood.
Tamoxifen is a pro-drug that is metabolized and converted into the metabolites endoxifen and 4HT, both previously believed to play a key role in suppressing estrogen. However, the study shows that endoxifen degrades estrogen receptors in breast cancer cells and is the key metabolite involved in creating a benefit from tamoxifen.
Since CYP2D6 is the enzyme that converts tamoxifen to endoxifen; this new study further indicates that widespread genetic testing and medication management can improve outcomes for many of the 35% of ER positive breast cancer patients who currently fail tamoxifen treatment.
The FDA’s Position
On October 18, 2006, an FDA Advisory Subcommittee was convened to review the tamoxifen research findings to date and to make a recommendation regarding a label change. The consensus of the Subcommittee was that the label should be updated to reflect the fact that postmenopausal candidates for tamoxifen who are CYP2D6 poor metabolizers (by genotype or drug interaction) are at increased risk for breast cancer recurrence. The FDA declined to act on the Advisory Committee's recommendation. This label change has still not been made, and now the case is even stronger.
Call to Action
So, what can be done with this information to reduce the risk of breast cancer recurrence?
First, genotyping should be considered for every ER-positive breast cancer patient taking tamoxifen. Insurance typically covers testing, and alternative therapies exist for treatment for the 10% of patients who are CYP2D6 poor metabolizers.
Second, healthcare providers and patients need to carefully monitor tamoxifen co- administration with other medications, herbals, and over-the-counters. For example, “hot flashes,” a common side effect of tamoxifen, are typically treated with selective serotonin reuptake inhibitors. Fluoxetine (Prozac), paroxetine (Paxil) and high doses of sertraline (Zoloft) are notoriously potent CYP2D6 inhibitors. Additionally, 35% of patients are CYP2D6 intermediate metabolizers and are at risk with less potent inhibitors of CYP2D6 such as the commonly used herbal goldenseal as shown in the GeneMedRx interaction report on page 2.
Genelex is a leading genetic testing company that offers clinical profiling of the CYP2D6 metabolic machinery. They include GeneMedRx drug and gene interaction software with each tamoxifen CYP2D6 test, so healthcare providers and patients can quickly see if co-administered drugs are going to reduce CYP2D6 activity.
The Mayo Clinic study has further confirmed the critical role of CYP2D6 in tamoxifen treatment. It is time to start putting this research to use in the clinic. Visit www.HealthandDNA.com for more information.
In a presentation at the 31st annual San Antonio Breast Cancer Symposium, Mayo clinic researchers further confirmed the importance of the enzyme CYP2D6 in individualizing tamoxifen dosing in breast cancer patients.
Tamoxifen is often prescribed to block the effects of estrogen in breast tissue, preventing breast cancer recurrence in ER+ (estrogen receptor positive) cancers which require estrogen to grow and spread. Previous studies have already revealed that tamoxifen is less effective in women with reduced CYP2D6 activity caused by genetic variations or co-administration with one of the more than 200 other prescription drugs that inhibit CYP2D6, but the mechanism of action for tamoxifen was not well understood.
Tamoxifen is a pro-drug that is metabolized and converted into the metabolites endoxifen and 4HT, both previously believed to play a key role in suppressing estrogen. However, the study shows that endoxifen degrades estrogen receptors in breast cancer cells and is the key metabolite involved in creating a benefit from tamoxifen.
Since CYP2D6 is the enzyme that converts tamoxifen to endoxifen; this new study further indicates that widespread genetic testing and medication management can improve outcomes for many of the 35% of ER positive breast cancer patients who currently fail tamoxifen treatment.
The FDA’s Position
On October 18, 2006, an FDA Advisory Subcommittee was convened to review the tamoxifen research findings to date and to make a recommendation regarding a label change. The consensus of the Subcommittee was that the label should be updated to reflect the fact that postmenopausal candidates for tamoxifen who are CYP2D6 poor metabolizers (by genotype or drug interaction) are at increased risk for breast cancer recurrence. The FDA declined to act on the Advisory Committee's recommendation. This label change has still not been made, and now the case is even stronger.
Call to Action
So, what can be done with this information to reduce the risk of breast cancer recurrence?
First, genotyping should be considered for every ER-positive breast cancer patient taking tamoxifen. Insurance typically covers testing, and alternative therapies exist for treatment for the 10% of patients who are CYP2D6 poor metabolizers.
Second, healthcare providers and patients need to carefully monitor tamoxifen co- administration with other medications, herbals, and over-the-counters. For example, “hot flashes,” a common side effect of tamoxifen, are typically treated with selective serotonin reuptake inhibitors. Fluoxetine (Prozac), paroxetine (Paxil) and high doses of sertraline (Zoloft) are notoriously potent CYP2D6 inhibitors. Additionally, 35% of patients are CYP2D6 intermediate metabolizers and are at risk with less potent inhibitors of CYP2D6 such as the commonly used herbal goldenseal as shown in the GeneMedRx interaction report on page 2.
Genelex is a leading genetic testing company that offers clinical profiling of the CYP2D6 metabolic machinery. They include GeneMedRx drug and gene interaction software with each tamoxifen CYP2D6 test, so healthcare providers and patients can quickly see if co-administered drugs are going to reduce CYP2D6 activity.
The Mayo Clinic study has further confirmed the critical role of CYP2D6 in tamoxifen treatment. It is time to start putting this research to use in the clinic. Visit www.HealthandDNA.com for more information.
Friday, February 13, 2009
Did You Know?
Approximately 95% of the human genome is referred to as “junk DNA” or“non-coding DNA” because it does not directly code for protein molecules as other DNA does. Some believe that non-coding DNA is just an evolutionary artifact and serves no purpose.
Others believe that the function is just not yet understood. Recent research has revealed that noncoding DNA may play an important role in regulating coding DNA, essentially serving as genetic switches that turn genes on or off. By comparing human non-coding DNA segments to other species, Yale researchers located DNA that may be the trigger for the evolution of advanced manual dexterity in humans.
Others believe that the function is just not yet understood. Recent research has revealed that noncoding DNA may play an important role in regulating coding DNA, essentially serving as genetic switches that turn genes on or off. By comparing human non-coding DNA segments to other species, Yale researchers located DNA that may be the trigger for the evolution of advanced manual dexterity in humans.
Wednesday, January 28, 2009
DNA in the News
An Oklahoma man recently made the news because he is still required to pay child support even though genetic testing proved that he was not the father of the child. In Oklahoma, paternity can no longer be contested after the child turns two years old, and the child in question was already five.
Laws vary by state. Georgia passed a law in 2002 allowing men to end child support payments if DNA testing proved they were not the father. Since then, courts there have not only allowed men to end their child support responsibilities, but also required women to repay child support they have received.
Laws vary by state. Georgia passed a law in 2002 allowing men to end child support payments if DNA testing proved they were not the father. Since then, courts there have not only allowed men to end their child support responsibilities, but also required women to repay child support they have received.
Tuesday, January 27, 2009
Watson, co-discoverer of the DNA helix, has recent African roots
James Watson, famous DNA pioneer, was found, in a genetic test, to share approximately 16% of his genes with his African ancestors. A percentage this high is typically seen only in people with an African greatgrandparent.
The news is of particular interest because Watson drew widespread condemnation in late 2007 after making racist comments about the inferior intelligence of Africans. Specifically statingthat he was "inherently gloomy about the prospect of Africa" because "all our social policies are based on the fact that their intelligence is the same as ours – whereas all the testing says not really." The backlash created from Watson’s comments resulted in his resignation as chancellor of Cold Spring Harbor Laboratory in New York state after 39 years.
Mr. Watson is not alone in getting surprising results from an ethnicity test. Many people have ancestry that they are not aware of.
Hopefully, these test results will serve as a reminder to Watson and others that all humans came out of Africa originally, and despite perceived differences, we are far more alike than different. Ethnicity DNA testing, in addition to being a fun way to learn more about your ancestry, may also serve to increase understanding of just how interconnected we are as a human race. As testing becomes more common, people will hopefully begin to abandon the false notion that there are extreme genetic differences between people of different races.
The fact is that the genetic difference between two individuals of the same race can be greater than those between individuals of different races.
The news is of particular interest because Watson drew widespread condemnation in late 2007 after making racist comments about the inferior intelligence of Africans. Specifically statingthat he was "inherently gloomy about the prospect of Africa" because "all our social policies are based on the fact that their intelligence is the same as ours – whereas all the testing says not really." The backlash created from Watson’s comments resulted in his resignation as chancellor of Cold Spring Harbor Laboratory in New York state after 39 years.
Mr. Watson is not alone in getting surprising results from an ethnicity test. Many people have ancestry that they are not aware of.
Hopefully, these test results will serve as a reminder to Watson and others that all humans came out of Africa originally, and despite perceived differences, we are far more alike than different. Ethnicity DNA testing, in addition to being a fun way to learn more about your ancestry, may also serve to increase understanding of just how interconnected we are as a human race. As testing becomes more common, people will hopefully begin to abandon the false notion that there are extreme genetic differences between people of different races.
The fact is that the genetic difference between two individuals of the same race can be greater than those between individuals of different races.
Wednesday, January 14, 2009
DNA Detective Work : Discretely Resolve Relationship Questions
Thanks to CSI, many people are aware that DNA can be extracted from many samples other than swabs or blood. DNA testing clients use this technology to resolve questions of parentage when discretion is required. DNA is the same in any cell in the body that has a nucleus. So as long as a submitted sample has several intact cells, DNA testing can be performed.
Samples that DNA can be extracted from include:
· Dental floss or toothbrush
· Licked stamps or envelopes
· Hair with roots
· Cigarette butts
· Unwashed undergarments
· Cup or bottle
· Chewed gum
· Teeth
· Ear swab
· Used tissue
Genelex is a market leader in this testing and our success rate is very high. In delicate situations, DNA detective work can discretely resolve relationship questions and provide peace of mind.
To find out more, visit www.healthanddna.com
Samples that DNA can be extracted from include:
· Dental floss or toothbrush
· Licked stamps or envelopes
· Hair with roots
· Cigarette butts
· Unwashed undergarments
· Cup or bottle
· Chewed gum
· Teeth
· Ear swab
· Used tissue
Genelex is a market leader in this testing and our success rate is very high. In delicate situations, DNA detective work can discretely resolve relationship questions and provide peace of mind.
To find out more, visit www.healthanddna.com
Tuesday, January 13, 2009
Celiac Disease Underdiagnosed
Approximately 90% of Celiac Disease cases go Undetected even though it affects 1 in 100 Americans.
Celiac Disease, also known as gluten intolerance, is a disorder affecting 1 in 100 Americans. A toxic reaction to gluten (found in barley, wheat, and rye) damages the surface of the small
intestine and interferes with the absorption of nutrients. Due to the exceptionally wide range of difficult to interpret symptoms, 90% of Celiac Disease sufferers are not diagnosed.
Early diagnosis and lifelong treatment with a gluten-free diet is critical for both symptom relief and reducing the risk of developing long-term conditions such as diabetes or GI cancer.
According to a recent NIH study, a typical patient currently endures 11 years of symptoms before an accurate diagnosis is found. Since the traditional approach requires blood tests, small intestine biopsies and six months on a gluten-free diet before confirmed diagnosis, many prefer
Celiac Disease DNA Testing.
Celiac Disease DNA testing is not used to diagnose celiac disease, but can quickly, accurately, and painlessly exclude the diagnosis as you must have certain genetic markers in order to develop Celiac disease. A negative results means that you are not at risk of developing Celiac
disease. A positive result in addition to clinical symptoms indicates the need for referral to a gastroenterologist.
If you are concerned that you may have Celiac Disease, visit HealthandDNA.com for more information or call 800-837-8362 to order your Celiac Disease DNA test.
Celiac Disease, also known as gluten intolerance, is a disorder affecting 1 in 100 Americans. A toxic reaction to gluten (found in barley, wheat, and rye) damages the surface of the small
intestine and interferes with the absorption of nutrients. Due to the exceptionally wide range of difficult to interpret symptoms, 90% of Celiac Disease sufferers are not diagnosed.
Early diagnosis and lifelong treatment with a gluten-free diet is critical for both symptom relief and reducing the risk of developing long-term conditions such as diabetes or GI cancer.
According to a recent NIH study, a typical patient currently endures 11 years of symptoms before an accurate diagnosis is found. Since the traditional approach requires blood tests, small intestine biopsies and six months on a gluten-free diet before confirmed diagnosis, many prefer
Celiac Disease DNA Testing.
Celiac Disease DNA testing is not used to diagnose celiac disease, but can quickly, accurately, and painlessly exclude the diagnosis as you must have certain genetic markers in order to develop Celiac disease. A negative results means that you are not at risk of developing Celiac
disease. A positive result in addition to clinical symptoms indicates the need for referral to a gastroenterologist.
If you are concerned that you may have Celiac Disease, visit HealthandDNA.com for more information or call 800-837-8362 to order your Celiac Disease DNA test.
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