Gynecology

CHICAGO – The presence of scar tissue may protect against synthetic mesh erosion following vaginal prolapse repair, according to findings from a retrospective case-control study.

The findings provide further support for the existing American College of Obstetricians and Gynecologists recommendation that vaginal mesh repair should be reserved for women with recurrent prolapse, and may be helpful for preoperative counseling in these patients, according to Dr. Nicholas Kongoasa of Saint Peter’s University Hospital, New Brunswick, N.J.

"Women are four times less likely to have mesh erosion if they have previously undergone prolapse repair, and that mesh should be reserved for those who fail primary repair," Dr. Kongoasa said in an interview.

Dr. Kongoasa was unable to make his presentation at the scheduled session at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Patients in the study included all those who underwent mesh-augmented pelvic floor repair between June 1, 2008, and Dec. 31, 2011. All surgeries were performed by a single surgeon using polypropylene mesh. Of 810 mesh-augmented pelvic floor repair surgeries, 688 involved no prior vaginal prolapse surgery and 142 were in patients with a prior vaginal prolapse repair.

The two groups did not differ with respect to mean operating time, intraoperative complications, postoperative complications, hospital stay, or prolapse recurrence. Also, they were similar in terms of demographics and pelvic organ prolapse quantification staging with the exception of prior hysterectomy in the prior surgery group.

During follow-ups of 1-4.5 years, mesh erosion occurred in 10.6% of those with no prior vaginal prolapse surgery, and in 2.8% of those with prior vaginal prolapse surgery (odds ratio, 4.1).

Among those with mesh erosion, no differences were seen between those with and without prior surgery with respect to time to diagnosis or location and size of erosion.

"The large number of cases and the high odds ratio warrant that this subject be further investigated by future prospective studies," he said.

The study was limited by its retrospective nature and the fact that some patients who experienced complications may have sought care elsewhere.

As for why previous surgery may protect against mesh erosion, "my personal theory is that there is generally less blood supply to the previously operated area, and this may lead to less inflammation and reaction to the foreign body," he said.

Dr. Kongoasa reported having no disclosures.

CHICAGO – The presence of scar tissue may protect against synthetic mesh erosion following vaginal prolapse repair, according to findings from a retrospective case-control study.

The findings provide further support for the existing American College of Obstetricians and Gynecologists recommendation that vaginal mesh repair should be reserved for women with recurrent prolapse, and may be helpful for preoperative counseling in these patients, according to Dr. Nicholas Kongoasa of Saint Peter’s University Hospital, New Brunswick, N.J.

"Women are four times less likely to have mesh erosion if they have previously undergone prolapse repair, and that mesh should be reserved for those who fail primary repair," Dr. Kongoasa said in an interview.

Dr. Kongoasa was unable to make his presentation at the scheduled session at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Patients in the study included all those who underwent mesh-augmented pelvic floor repair between June 1, 2008, and Dec. 31, 2011. All surgeries were performed by a single surgeon using polypropylene mesh. Of 810 mesh-augmented pelvic floor repair surgeries, 688 involved no prior vaginal prolapse surgery and 142 were in patients with a prior vaginal prolapse repair.

The two groups did not differ with respect to mean operating time, intraoperative complications, postoperative complications, hospital stay, or prolapse recurrence. Also, they were similar in terms of demographics and pelvic organ prolapse quantification staging with the exception of prior hysterectomy in the prior surgery group.

During follow-ups of 1-4.5 years, mesh erosion occurred in 10.6% of those with no prior vaginal prolapse surgery, and in 2.8% of those with prior vaginal prolapse surgery (odds ratio, 4.1).

Among those with mesh erosion, no differences were seen between those with and without prior surgery with respect to time to diagnosis or location and size of erosion.

"The large number of cases and the high odds ratio warrant that this subject be further investigated by future prospective studies," he said.

The study was limited by its retrospective nature and the fact that some patients who experienced complications may have sought care elsewhere.

As for why previous surgery may protect against mesh erosion, "my personal theory is that there is generally less blood supply to the previously operated area, and this may lead to less inflammation and reaction to the foreign body," he said.

Dr. Kongoasa reported having no disclosures.

CHICAGO – The presence of scar tissue may protect against synthetic mesh erosion following vaginal prolapse repair, according to findings from a retrospective case-control study.

The findings provide further support for the existing American College of Obstetricians and Gynecologists recommendation that vaginal mesh repair should be reserved for women with recurrent prolapse, and may be helpful for preoperative counseling in these patients, according to Dr. Nicholas Kongoasa of Saint Peter’s University Hospital, New Brunswick, N.J.

"Women are four times less likely to have mesh erosion if they have previously undergone prolapse repair, and that mesh should be reserved for those who fail primary repair," Dr. Kongoasa said in an interview.

Dr. Kongoasa was unable to make his presentation at the scheduled session at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Patients in the study included all those who underwent mesh-augmented pelvic floor repair between June 1, 2008, and Dec. 31, 2011. All surgeries were performed by a single surgeon using polypropylene mesh. Of 810 mesh-augmented pelvic floor repair surgeries, 688 involved no prior vaginal prolapse surgery and 142 were in patients with a prior vaginal prolapse repair.

The two groups did not differ with respect to mean operating time, intraoperative complications, postoperative complications, hospital stay, or prolapse recurrence. Also, they were similar in terms of demographics and pelvic organ prolapse quantification staging with the exception of prior hysterectomy in the prior surgery group.

During follow-ups of 1-4.5 years, mesh erosion occurred in 10.6% of those with no prior vaginal prolapse surgery, and in 2.8% of those with prior vaginal prolapse surgery (odds ratio, 4.1).

Among those with mesh erosion, no differences were seen between those with and without prior surgery with respect to time to diagnosis or location and size of erosion.

"The large number of cases and the high odds ratio warrant that this subject be further investigated by future prospective studies," he said.

The study was limited by its retrospective nature and the fact that some patients who experienced complications may have sought care elsewhere.

As for why previous surgery may protect against mesh erosion, "my personal theory is that there is generally less blood supply to the previously operated area, and this may lead to less inflammation and reaction to the foreign body," he said.

Dr. Kongoasa reported having no disclosures.

Ethicon, a Johnson & Johnson company, has temporarily halted sales of its laparoscopic power morcellators for the treatment of uterine fibroids, following concerns that the devices could spread cancerous tissue in women with unsuspected uterine sarcoma.

The company is suspending global sales, distribution, and promotion of its three morcellation devices until the role of morcellation for patients with symptomatic fibroid disease is redefined by the Food and Drug Administration (FDA) and the medical communities.

The suspended products include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator.

"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," the company said in a statement. "However, interpretation of the available epidemiological evidence is complex, and it is difficult to diagnose certain malignancies in advance of surgery."

On April 17, the FDA issued a safety communication to patients and physicians warning that if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s chances of long-term survival.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

The FDA recommended that physicians not use laparoscopic uterine power morcellation in women with known or suspected uterine cancer and that they carefully consider all the available treatment options for women with symptomatic uterine fibroids.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

Ethicon, a Johnson & Johnson company, has temporarily halted sales of its laparoscopic power morcellators for the treatment of uterine fibroids, following concerns that the devices could spread cancerous tissue in women with unsuspected uterine sarcoma.

The company is suspending global sales, distribution, and promotion of its three morcellation devices until the role of morcellation for patients with symptomatic fibroid disease is redefined by the Food and Drug Administration (FDA) and the medical communities.

The suspended products include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator.

"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," the company said in a statement. "However, interpretation of the available epidemiological evidence is complex, and it is difficult to diagnose certain malignancies in advance of surgery."

On April 17, the FDA issued a safety communication to patients and physicians warning that if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s chances of long-term survival.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

The FDA recommended that physicians not use laparoscopic uterine power morcellation in women with known or suspected uterine cancer and that they carefully consider all the available treatment options for women with symptomatic uterine fibroids.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

Ethicon, a Johnson & Johnson company, has temporarily halted sales of its laparoscopic power morcellators for the treatment of uterine fibroids, following concerns that the devices could spread cancerous tissue in women with unsuspected uterine sarcoma.

The company is suspending global sales, distribution, and promotion of its three morcellation devices until the role of morcellation for patients with symptomatic fibroid disease is redefined by the Food and Drug Administration (FDA) and the medical communities.

The suspended products include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator.

"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," the company said in a statement. "However, interpretation of the available epidemiological evidence is complex, and it is difficult to diagnose certain malignancies in advance of surgery."

On April 17, the FDA issued a safety communication to patients and physicians warning that if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s chances of long-term survival.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids."

The FDA recommended that physicians not use laparoscopic uterine power morcellation in women with known or suspected uterine cancer and that they carefully consider all the available treatment options for women with symptomatic uterine fibroids.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

CHICAGO – Dr. Laurie J. McKenzie, who is a member of the ACOG Committee on the Scientific Program and the medical faculties of the University of Texas and Baylor College of Medicine, Houston, interviews Dr. Michael M. Frumovitz of the University of Texas MD Anderson Cancer Center, Houston, the presenter of the John I. Brewer Memorial Lecture on cervical cancer screening.

During a video interview at the annual meeting of the American Congress of Obstetricians and Gynecologists, they discuss reductions in cervical dysplasia that have already been seen with HPV vaccination in Australia and note the barriers to HPV vaccination in the United States. Dr. Frumovitz predicts that HPV testing will ultimately replace Pap smears for primary screening in most cases and discusses the potential for high-resolution microendoscopy to change how cervical lesions are diagnosed and treated.

CHICAGO – Dr. Laurie J. McKenzie, who is a member of the ACOG Committee on the Scientific Program and the medical faculties of the University of Texas and Baylor College of Medicine, Houston, interviews Dr. Michael M. Frumovitz of the University of Texas MD Anderson Cancer Center, Houston, the presenter of the John I. Brewer Memorial Lecture on cervical cancer screening.

During a video interview at the annual meeting of the American Congress of Obstetricians and Gynecologists, they discuss reductions in cervical dysplasia that have already been seen with HPV vaccination in Australia and note the barriers to HPV vaccination in the United States. Dr. Frumovitz predicts that HPV testing will ultimately replace Pap smears for primary screening in most cases and discusses the potential for high-resolution microendoscopy to change how cervical lesions are diagnosed and treated.

CHICAGO – Dr. Laurie J. McKenzie, who is a member of the ACOG Committee on the Scientific Program and the medical faculties of the University of Texas and Baylor College of Medicine, Houston, interviews Dr. Michael M. Frumovitz of the University of Texas MD Anderson Cancer Center, Houston, the presenter of the John I. Brewer Memorial Lecture on cervical cancer screening.

During a video interview at the annual meeting of the American Congress of Obstetricians and Gynecologists, they discuss reductions in cervical dysplasia that have already been seen with HPV vaccination in Australia and note the barriers to HPV vaccination in the United States. Dr. Frumovitz predicts that HPV testing will ultimately replace Pap smears for primary screening in most cases and discusses the potential for high-resolution microendoscopy to change how cervical lesions are diagnosed and treated.

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

mdales@frontlinemedcom.com

On Twitter @maryjodales

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

mdales@frontlinemedcom.com

On Twitter @maryjodales

CHICAGO – Dr. Rosanne M. Kho discussed patient selection for vaginal approaches in an interview with Dr. Daniel M. Breitkopf of the Mayo Clinic in Rochester, Minn., at the annual meeting of the American Congress of Obstetricians and Gynecologists.

Dr. Kho of the Mayo Clinic in Phoenix noted that there are only a few contraindications to the vaginal approach and emphasized the importance of incorporating lessons from robotic and minimally invasive surgery into vaginal hysterectomy. Dr. Kho warned of an impending health care crisis as a result of inadequate training in vaginal approaches.

mdales@frontlinemedcom.com

On Twitter @maryjodales

CHICAGO – "Every Woman, Every Time," Dr. Jeanne A. Conry’s presidential theme, was front and center at the President’s Program at the annual meeting the American Congress of Obstetricians and Gynecologists. In this exclusive video interview, Dr. Conry spoke with Dr. Lesley Regan about her presentation on basic rights to health care and Dr. Mark Hanson about the role of obstetrician-gynecologists in preventive health initiatives to reduce noncommunicable diseases. Prof. Regan leads global women’s health efforts for the Royal College of Obstetricians & Gynaecologists in London and chairs the Committee for Sexual and Reproductive Rights for the International Federation of Gynecology and Obstetrics.

Prof. Hanson, director of the academic unit of human development and health at the University of Southhampton in the United Kingdom, has focused his work on new ways to reduce disease processes and improve health by championing preventive interventions during preconception, throughout pregnancy, and in infancy and childhood.

The program also included Dr. Tyrone Hayes, professor of biology at the University of California, Berkeley, whose research findings on the impact of environmental chemicals on health demonstrate why industry must bear the burden of proof for safety before products are introduced.

CHICAGO – "Every Woman, Every Time," Dr. Jeanne A. Conry’s presidential theme, was front and center at the President’s Program at the annual meeting the American Congress of Obstetricians and Gynecologists. In this exclusive video interview, Dr. Conry spoke with Dr. Lesley Regan about her presentation on basic rights to health care and Dr. Mark Hanson about the role of obstetrician-gynecologists in preventive health initiatives to reduce noncommunicable diseases. Prof. Regan leads global women’s health efforts for the Royal College of Obstetricians & Gynaecologists in London and chairs the Committee for Sexual and Reproductive Rights for the International Federation of Gynecology and Obstetrics.

Prof. Hanson, director of the academic unit of human development and health at the University of Southhampton in the United Kingdom, has focused his work on new ways to reduce disease processes and improve health by championing preventive interventions during preconception, throughout pregnancy, and in infancy and childhood.

The program also included Dr. Tyrone Hayes, professor of biology at the University of California, Berkeley, whose research findings on the impact of environmental chemicals on health demonstrate why industry must bear the burden of proof for safety before products are introduced.

CHICAGO – "Every Woman, Every Time," Dr. Jeanne A. Conry’s presidential theme, was front and center at the President’s Program at the annual meeting the American Congress of Obstetricians and Gynecologists. In this exclusive video interview, Dr. Conry spoke with Dr. Lesley Regan about her presentation on basic rights to health care and Dr. Mark Hanson about the role of obstetrician-gynecologists in preventive health initiatives to reduce noncommunicable diseases. Prof. Regan leads global women’s health efforts for the Royal College of Obstetricians & Gynaecologists in London and chairs the Committee for Sexual and Reproductive Rights for the International Federation of Gynecology and Obstetrics.

Prof. Hanson, director of the academic unit of human development and health at the University of Southhampton in the United Kingdom, has focused his work on new ways to reduce disease processes and improve health by championing preventive interventions during preconception, throughout pregnancy, and in infancy and childhood.

The program also included Dr. Tyrone Hayes, professor of biology at the University of California, Berkeley, whose research findings on the impact of environmental chemicals on health demonstrate why industry must bear the burden of proof for safety before products are introduced.

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

Applying topical liquid lidocaine to the vulvar vestibule prior to penetration allows for comfortable intercourse in breast cancer survivors with severe menopausal dyspareunia, according to findings from a randomized, controlled study involving 46 women.

During a double-blind phase of the study, patients randomized to apply 4% aqueous lidocaine had less intercourse pain than those who applied saline (median pain scores of 1.0 and 5.3 out of 10, respectively), according to Dr. Martha F. Goetsch of Oregon Health and Science University, Portland, who will report the finding at the annual meeting of the American Congress of Obstetricians and Gynecologists.

During an open-label phase of the study in which all patients were allowed to apply lidocaine, 37 of 41 (90%) reported comfortable penetration, and sexual distress scores decreased from a median of 30.5 to a median of 14. Additionally, 17 of 20 women (85%) who were abstaining from intercourse because of the discomfort had resumed penetrative intimacy, said Dr. Goetsch, whose abstract was awarded first prize among oral presentations by ACOG.

Patients included in the study were estrogen-deficient breast cancer survivors with severe penetrative dyspareunia not associated with pelvic muscle or organ pain. All had severe vulvovaginal atrophy. During the 1-month blinded phase of the study, the women applied either the lidocaine or the saline to the vulvar vestibule for 3 minutes prior to penetration. Effects of twice-weekly tampon insertion or intercourse were documented in a diary. No partners complained of numbness resulting from the lidocaine.

The findings are notable, because breast cancer survivors number in the millions in the United States alone.

"They often suffer from severe dyspareunia and are urged to refrain from using estrogen, which is the therapy most effective for dyspareunia in menopause," Dr. Goetsch said in an interview.

Furthermore, prior research has focused primarily on vaginal atrophy as the cause of dyspareunia in postmenopausal women.

"This study showed that pain could be prevented even though atrophy was unchanged," she said, noting that this suggests that perhaps atrophy is the wrong therapeutic focus.

"Success came with therapy to the vestibule, not the vagina," she said.

Dr. Goetsch reported having no disclosures.

TAMPA – Paradigm changes drive radical changes in science, according to Dr. Leroy Hood, a renowned scientist and inventor who joined forces with Ohio State University to create the P4 Medicine Institute to "drive innovative approaches to disease prevention and maintenance of health and wellness by applying systems biology to medicine and care delivery."

P4 medicine (Predictive, Preventive, Personalized, Participatory) "is really the convergence of three megatrends in medicine: systems medicine on one hand, big data and its analytics on the other hand, and patient-activated social networks," Dr. Hood, president of the Institute for Systems Biology, Seattle, said at the annual meeting of the Society of Gynecologic Oncology.

As an invited presidential lecturer at the meeting, Dr. Hood described the two central features of systems medicine and how they will facilitate P4 medicine. The first feature is the idea that in the next 5-10 years, individuals will have a "virtual cloud of billions of data points."

"Biological networks exist at the level of genes, the level of proteins, the level of cells, the level of organs, and obviously at the level of the individual through social networks. What is really critical is that in disease, that ‘network of networks’ becomes disease-perturbed and it alters the nature of the information it can handle. If you can capture that altered information, you gain fundamental new insights into biological mechanisms and you can design new strategies both for diagnosis and for therapy," Dr. Hood said.

What is lacking in American medicine, however, is the second feature of systems medicine: an understanding of the dynamics of how these disease-perturbed networks change with time throughout the course of the disease.

P4 medicine differs from evidence-based medicine in that it is proactive rather than reactive; it is focused on the individual and, increasingly, on wellness; it is "all about creating, for each patient, this global data cloud that gives us deep insights into the individual" and that produces predictive and actionable models of wellness and disease; and, most fundamentally, it "argues that the current clinical trial system is totally broken," Dr. Hood said.

"The idea that for a cancer diagnosis, you take 30,000 patients, give them a placebo drug, extract from the patients and put in curves their responses, and from those curves you make generalizations about how to treat the population and how well the drug has done, is wrong in every way. Each individual is different genetically and environmentally," he explained, noting that P4 medicine analyzes "the unique individual and then aggregates those into groups in accordance with what environmental opportunities you’d like to explore."

Acceptance of this new health care concept will depend upon patient-activated social networks, he said.

"I think that’s the only way we can change the incredibly conservative nature of both physicians and the health care system itself," he added.

P4 medicine is mainly about two things – quantifying wellness and demystifying disease, he said.

In contemporary health care, with regard to these two fundamental concepts, three major things have been missing: metrics for wellness, the ability to do longitudinal studies of disease, and the ability to do studies at the point of initiation. A study now underway based on the concept of P4 medicine will allow for all three.

It is a Framingham-like longitudinal study that aims to enroll 100,000 individuals who will be followed for 20-30 years. Participants will quickly be divided into two groups, including those who remain well or improve in health, and those who transition from wellness to disease.

Very soon, the study population will be large enough to see all major diseases, including cancer.

"But the really important point is that we’ll have multiple data points all the way across this longitudinal study so we can go back to the earliest origins of the divergence of wellness to disease for a particular patient, and we can look at mechanisms and new approaches to diagnostics, and hopefully change that disease trajectory very early on to a wellness trajectory," he said.

The first phase of the study, which launched in March, will enroll 1,000 individuals within a year, working up to 10,000 and ultimately to 100,000.

The plan is to collect numerous measurements, including "physical trait kinds of measurements," clinical chemistries, and special measurements of the gut microbiome and organ-specific blood protein fingerprints to monitor wellness-to-disease transitions in the brain, heart, and liver.

"And all of these data will be integrated together by analytics to create these models for each individual that are all focused on identifying and prioritizing a series of actionable traits.

In the short-term, Dr. Hood predicts that the longitudinal study will allow for creation of models for each individual to optimize wellness and minimize disease. In the intermediate term, the data from the well people will be mined for metrics of wellness. Long term, the study will generate a database that elucidates factors associated with the transition from wellness to disease, allowing alteration of the trajectory of disease for many patients.

"My own view is that in a 10- to 15-year period, the wellness industry will be independent from the health care industry, and its total market cap will far exceed that of the health care industry. What is exciting to think is that now, today, we’re just beginning to create the companies that will be the Googles and the Microsofts of the wellness industry. It really is a unique and exciting kind of opportunity," he said.

There’s no way to predict how long it will take for P4 medicine to be fully realized.

"But we are in a unique position now, for the first time, to begin looking at the dynamics of not one human disease, but many different human diseases," he said.

TAMPA – Paradigm changes drive radical changes in science, according to Dr. Leroy Hood, a renowned scientist and inventor who joined forces with Ohio State University to create the P4 Medicine Institute to "drive innovative approaches to disease prevention and maintenance of health and wellness by applying systems biology to medicine and care delivery."

P4 medicine (Predictive, Preventive, Personalized, Participatory) "is really the convergence of three megatrends in medicine: systems medicine on one hand, big data and its analytics on the other hand, and patient-activated social networks," Dr. Hood, president of the Institute for Systems Biology, Seattle, said at the annual meeting of the Society of Gynecologic Oncology.

As an invited presidential lecturer at the meeting, Dr. Hood described the two central features of systems medicine and how they will facilitate P4 medicine. The first feature is the idea that in the next 5-10 years, individuals will have a "virtual cloud of billions of data points."

"Biological networks exist at the level of genes, the level of proteins, the level of cells, the level of organs, and obviously at the level of the individual through social networks. What is really critical is that in disease, that ‘network of networks’ becomes disease-perturbed and it alters the nature of the information it can handle. If you can capture that altered information, you gain fundamental new insights into biological mechanisms and you can design new strategies both for diagnosis and for therapy," Dr. Hood said.

What is lacking in American medicine, however, is the second feature of systems medicine: an understanding of the dynamics of how these disease-perturbed networks change with time throughout the course of the disease.

P4 medicine differs from evidence-based medicine in that it is proactive rather than reactive; it is focused on the individual and, increasingly, on wellness; it is "all about creating, for each patient, this global data cloud that gives us deep insights into the individual" and that produces predictive and actionable models of wellness and disease; and, most fundamentally, it "argues that the current clinical trial system is totally broken," Dr. Hood said.

"The idea that for a cancer diagnosis, you take 30,000 patients, give them a placebo drug, extract from the patients and put in curves their responses, and from those curves you make generalizations about how to treat the population and how well the drug has done, is wrong in every way. Each individual is different genetically and environmentally," he explained, noting that P4 medicine analyzes "the unique individual and then aggregates those into groups in accordance with what environmental opportunities you’d like to explore."

Acceptance of this new health care concept will depend upon patient-activated social networks, he said.

"I think that’s the only way we can change the incredibly conservative nature of both physicians and the health care system itself," he added.

P4 medicine is mainly about two things – quantifying wellness and demystifying disease, he said.

In contemporary health care, with regard to these two fundamental concepts, three major things have been missing: metrics for wellness, the ability to do longitudinal studies of disease, and the ability to do studies at the point of initiation. A study now underway based on the concept of P4 medicine will allow for all three.

It is a Framingham-like longitudinal study that aims to enroll 100,000 individuals who will be followed for 20-30 years. Participants will quickly be divided into two groups, including those who remain well or improve in health, and those who transition from wellness to disease.

Very soon, the study population will be large enough to see all major diseases, including cancer.

"But the really important point is that we’ll have multiple data points all the way across this longitudinal study so we can go back to the earliest origins of the divergence of wellness to disease for a particular patient, and we can look at mechanisms and new approaches to diagnostics, and hopefully change that disease trajectory very early on to a wellness trajectory," he said.

The first phase of the study, which launched in March, will enroll 1,000 individuals within a year, working up to 10,000 and ultimately to 100,000.

The plan is to collect numerous measurements, including "physical trait kinds of measurements," clinical chemistries, and special measurements of the gut microbiome and organ-specific blood protein fingerprints to monitor wellness-to-disease transitions in the brain, heart, and liver.

"And all of these data will be integrated together by analytics to create these models for each individual that are all focused on identifying and prioritizing a series of actionable traits.

In the short-term, Dr. Hood predicts that the longitudinal study will allow for creation of models for each individual to optimize wellness and minimize disease. In the intermediate term, the data from the well people will be mined for metrics of wellness. Long term, the study will generate a database that elucidates factors associated with the transition from wellness to disease, allowing alteration of the trajectory of disease for many patients.

"My own view is that in a 10- to 15-year period, the wellness industry will be independent from the health care industry, and its total market cap will far exceed that of the health care industry. What is exciting to think is that now, today, we’re just beginning to create the companies that will be the Googles and the Microsofts of the wellness industry. It really is a unique and exciting kind of opportunity," he said.

There’s no way to predict how long it will take for P4 medicine to be fully realized.

"But we are in a unique position now, for the first time, to begin looking at the dynamics of not one human disease, but many different human diseases," he said.

TAMPA – Paradigm changes drive radical changes in science, according to Dr. Leroy Hood, a renowned scientist and inventor who joined forces with Ohio State University to create the P4 Medicine Institute to "drive innovative approaches to disease prevention and maintenance of health and wellness by applying systems biology to medicine and care delivery."

P4 medicine (Predictive, Preventive, Personalized, Participatory) "is really the convergence of three megatrends in medicine: systems medicine on one hand, big data and its analytics on the other hand, and patient-activated social networks," Dr. Hood, president of the Institute for Systems Biology, Seattle, said at the annual meeting of the Society of Gynecologic Oncology.

As an invited presidential lecturer at the meeting, Dr. Hood described the two central features of systems medicine and how they will facilitate P4 medicine. The first feature is the idea that in the next 5-10 years, individuals will have a "virtual cloud of billions of data points."

"Biological networks exist at the level of genes, the level of proteins, the level of cells, the level of organs, and obviously at the level of the individual through social networks. What is really critical is that in disease, that ‘network of networks’ becomes disease-perturbed and it alters the nature of the information it can handle. If you can capture that altered information, you gain fundamental new insights into biological mechanisms and you can design new strategies both for diagnosis and for therapy," Dr. Hood said.

What is lacking in American medicine, however, is the second feature of systems medicine: an understanding of the dynamics of how these disease-perturbed networks change with time throughout the course of the disease.

P4 medicine differs from evidence-based medicine in that it is proactive rather than reactive; it is focused on the individual and, increasingly, on wellness; it is "all about creating, for each patient, this global data cloud that gives us deep insights into the individual" and that produces predictive and actionable models of wellness and disease; and, most fundamentally, it "argues that the current clinical trial system is totally broken," Dr. Hood said.

"The idea that for a cancer diagnosis, you take 30,000 patients, give them a placebo drug, extract from the patients and put in curves their responses, and from those curves you make generalizations about how to treat the population and how well the drug has done, is wrong in every way. Each individual is different genetically and environmentally," he explained, noting that P4 medicine analyzes "the unique individual and then aggregates those into groups in accordance with what environmental opportunities you’d like to explore."

Acceptance of this new health care concept will depend upon patient-activated social networks, he said.

"I think that’s the only way we can change the incredibly conservative nature of both physicians and the health care system itself," he added.

P4 medicine is mainly about two things – quantifying wellness and demystifying disease, he said.

In contemporary health care, with regard to these two fundamental concepts, three major things have been missing: metrics for wellness, the ability to do longitudinal studies of disease, and the ability to do studies at the point of initiation. A study now underway based on the concept of P4 medicine will allow for all three.

It is a Framingham-like longitudinal study that aims to enroll 100,000 individuals who will be followed for 20-30 years. Participants will quickly be divided into two groups, including those who remain well or improve in health, and those who transition from wellness to disease.

Very soon, the study population will be large enough to see all major diseases, including cancer.

"But the really important point is that we’ll have multiple data points all the way across this longitudinal study so we can go back to the earliest origins of the divergence of wellness to disease for a particular patient, and we can look at mechanisms and new approaches to diagnostics, and hopefully change that disease trajectory very early on to a wellness trajectory," he said.

The first phase of the study, which launched in March, will enroll 1,000 individuals within a year, working up to 10,000 and ultimately to 100,000.

The plan is to collect numerous measurements, including "physical trait kinds of measurements," clinical chemistries, and special measurements of the gut microbiome and organ-specific blood protein fingerprints to monitor wellness-to-disease transitions in the brain, heart, and liver.

"And all of these data will be integrated together by analytics to create these models for each individual that are all focused on identifying and prioritizing a series of actionable traits.

In the short-term, Dr. Hood predicts that the longitudinal study will allow for creation of models for each individual to optimize wellness and minimize disease. In the intermediate term, the data from the well people will be mined for metrics of wellness. Long term, the study will generate a database that elucidates factors associated with the transition from wellness to disease, allowing alteration of the trajectory of disease for many patients.

"My own view is that in a 10- to 15-year period, the wellness industry will be independent from the health care industry, and its total market cap will far exceed that of the health care industry. What is exciting to think is that now, today, we’re just beginning to create the companies that will be the Googles and the Microsofts of the wellness industry. It really is a unique and exciting kind of opportunity," he said.

There’s no way to predict how long it will take for P4 medicine to be fully realized.

"But we are in a unique position now, for the first time, to begin looking at the dynamics of not one human disease, but many different human diseases," he said.

The Food and Drug Administration on April 24 approved the cobas HPV test as a first-line screening test for primary cervical cancer.

The cobas HPV test uses a sample of cervical cells to detect DNA from 14 high-risk human papillomavirus types. The test, which is approved for women aged 25 years and older, identifies HPV 16 and 18. It can concurrently detect 12 other types of high-risk HPVs, according to the FDA.

The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. Those who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.

The cobas HPV test results should be used along with patient screening history and risk factors, and current professional guidelines when making clinical decisions, the FDA advised.

The test, which is manufactured by Roche Molecular Diagnostics, was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test. With the current approval, the cobas test can now be used as the primary cervical cancer screening test.

The approval means women will have more screening options, said Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health.

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer," Dr. Gutierrez said in a statement.

Despite some concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously on March 12 to support expanding the approval of the cobas HPV test to include first-line use for primary cervical cancer screening. Some panelists noted that it will be up to professional societies to integrate the new test into their practice guidelines and to educate physicians and patients about its use.

The decision to approve the test was based on the results of the ATHENA trial, a prospective study of 47,208 women in the United States, and 3-year follow-up data. The results indicate that HPV testing alone provides greater protection against CIN3 (cervical intraepithelial neoplasia grade 3) and invasive cervical cancer than does cytology alone, and that primary HPV testing provides a similar level of protection against CIN3 and invasive cervical cancer as does cotesting with HPV testing and cytology, according to Roche.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The Food and Drug Administration on April 24 approved the cobas HPV test as a first-line screening test for primary cervical cancer.

The cobas HPV test uses a sample of cervical cells to detect DNA from 14 high-risk human papillomavirus types. The test, which is approved for women aged 25 years and older, identifies HPV 16 and 18. It can concurrently detect 12 other types of high-risk HPVs, according to the FDA.

The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. Those who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.

The cobas HPV test results should be used along with patient screening history and risk factors, and current professional guidelines when making clinical decisions, the FDA advised.

The test, which is manufactured by Roche Molecular Diagnostics, was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test. With the current approval, the cobas test can now be used as the primary cervical cancer screening test.

The approval means women will have more screening options, said Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health.

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer," Dr. Gutierrez said in a statement.

Despite some concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously on March 12 to support expanding the approval of the cobas HPV test to include first-line use for primary cervical cancer screening. Some panelists noted that it will be up to professional societies to integrate the new test into their practice guidelines and to educate physicians and patients about its use.

The decision to approve the test was based on the results of the ATHENA trial, a prospective study of 47,208 women in the United States, and 3-year follow-up data. The results indicate that HPV testing alone provides greater protection against CIN3 (cervical intraepithelial neoplasia grade 3) and invasive cervical cancer than does cytology alone, and that primary HPV testing provides a similar level of protection against CIN3 and invasive cervical cancer as does cotesting with HPV testing and cytology, according to Roche.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The Food and Drug Administration on April 24 approved the cobas HPV test as a first-line screening test for primary cervical cancer.

The cobas HPV test uses a sample of cervical cells to detect DNA from 14 high-risk human papillomavirus types. The test, which is approved for women aged 25 years and older, identifies HPV 16 and 18. It can concurrently detect 12 other types of high-risk HPVs, according to the FDA.

The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. Those who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.

The cobas HPV test results should be used along with patient screening history and risk factors, and current professional guidelines when making clinical decisions, the FDA advised.

The test, which is manufactured by Roche Molecular Diagnostics, was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test. With the current approval, the cobas test can now be used as the primary cervical cancer screening test.

The approval means women will have more screening options, said Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health.

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer," Dr. Gutierrez said in a statement.

Despite some concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously on March 12 to support expanding the approval of the cobas HPV test to include first-line use for primary cervical cancer screening. Some panelists noted that it will be up to professional societies to integrate the new test into their practice guidelines and to educate physicians and patients about its use.

The decision to approve the test was based on the results of the ATHENA trial, a prospective study of 47,208 women in the United States, and 3-year follow-up data. The results indicate that HPV testing alone provides greater protection against CIN3 (cervical intraepithelial neoplasia grade 3) and invasive cervical cancer than does cytology alone, and that primary HPV testing provides a similar level of protection against CIN3 and invasive cervical cancer as does cotesting with HPV testing and cytology, according to Roche.

mschneider@frontlinemedcom.com

On Twitter @maryellenny