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MedicalResearch.com Exclusive Interviews with Medical Research and Health Care Researchers from Major and Specialty Medical Research Journals and Meetings Editor: Marie Benz, MD [email protected] July 16 2015 For Informational Purposes Only: Not for Specific Medical Advice.

MedicalResearch.com: Medical Research Exclusive Interviews July 16 2015

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Page 1: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

MedicalResearch.comExclusive Interviews with Medical Research and

Health Care Researchers from Major and Specialty Medical Research Journals and Meetings

Editor: Marie Benz, MD [email protected]

July 16 2015

For Informational Purposes Only: Not for Specific Medical Advice.

Page 2: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

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Read more interviews on MedicalResearch.com

Page 3: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Most Young Cancer Patients Receive Intensive Measures At End of LifeMedicalResearch.com Interview with:Jennifer Mack, MD, MPH

Pediatric oncologistDana-Farber/Boston Children’s Cancer and Blood Disorders Center

Medical Research: What is the background for this study? What are the main findings?

Dr. Mack: This study evaluated the intensity of end-of-life care received by adolescents and young adults (AYAs) with cancer. Little was previously known about the kind of end-of-life care these young patients receive. We evaluated the care of 663 Kaiser Permanente Southern California patients who died between the ages of 15 and 39 between the years 2001 and 2010. We found that more than two-thirds of adolescents and young adults received at least one form of intensive end-of-life care before death. This includes chemotherapy in the last two weeks of life (11%), more than one emergency room visit in the last month of life (22%), intensive care unit care in the last month of life (22%), and hospitalization in the last month of life (62%).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 4: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Most Young Cancer Patients Receive Intensive Measures At End of LifeMedicalResearch.com Interview with:Jennifer Mack, MD, MPH

Pediatric oncologistDana-Farber/Boston Children’s Cancer and Blood Disorders Center

• Medical Research: What should clinicians and patients take away from your report?• Dr. Mack: A majority of dying young people with cancer receive intensive measures at the

end of life. Older patients who know they are dying usually do not want to receive intensive measures, which are associated with a poorer quality of life near death. High rates of intensive measures raise the concern that young people may experience unnecessary suffering at the end of life. However, it is also important to recognize that adolescents and young adult patients may have different priorities than older patients, and may be more willing to accept intensive measures in order to live as long as possible. Clinicians, patients, and family members should talk about what is most important to patients at the end of life so that their values can be upheld, whether patients prioritize doing everything possible to live as long as possible or focus on quality of life.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 5: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Most Young Cancer Patients Receive Intensive Measures At End of LifeMedicalResearch.com Interview with:Jennifer Mack, MD, MPH

Pediatric oncologistDana-Farber/Boston Children’s Cancer and Blood Disorders Center

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Mack: Future research should further examine end-of-life decision-making for adolescents and young adults, including the reasons for receipt of intensive measures.

• Citation:• Mack JW, Chen LH, Cannavale K, Sattayapiwat O, Cooper RM, Chao CR. End-of-Life Care Intens

ity Among Adolescent and Young Adult Patients With Cancer in Kaiser Permanente Southern California. JAMA Oncol. Published online July 09, 2015. doi:10.1001/jamaoncol.2015.1953.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 6: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Pupil Response To Sad Faces Linked To Increased Risk of Depression In ChildrenMedicalResearch.com Interview with:Katie Burkhouse, Graduate Student andDr. Brandon Gibb Ph.D Professor of Psychology

Director of the Mood Disorders Institute and Center for Affective ScienceBinghamton University

Medical Research: What is the background for this study? What are the main findings?

Dr. Gibb: One of the strongest risk factors for depression is a family history of the disorder. However, even among this at-risk group, the majority of children of depressed parents do not develop depression themselves. For those who do become depressed, the depression can severely and negatively affect their social and academic functioning, become chronic or recurrent over the lifespan, and increase risk for suicide. What is needed therefore, is a good indicator of which children may be at greatest risk for depression so that interventions can be targeted to these individuals. We believe that pupil dilation may represent one such marker. Changes in pupil dilation are associated with activity in the brain’s emotional circuits and have been linked in previous research to the presence of depression. What my graduate student Katie Burkhouse found is that, even among children who are not currently experiencing symptoms of depression, the degree to which their pupil dilates when they look at pictures of sad faces predicts their risk for developing clinically significant episodes of depression over the next two years. The findings were specific to pupil responses to sad faces and were not observed when children looked at happy or angry faces suggesting that there is something specific to how the children were processing sad images.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 7: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Pupil Response To Sad Faces Linked To Increased Risk of Depression In ChildrenMedicalResearch.com Interview with:Katie Burkhouse, Graduate Student andDr. Brandon Gibb Ph.D Professor of Psychology

Director of the Mood Disorders Institute and Center for Affective ScienceBinghamton University

• Medical Research: What should clinicians and patients take away from your report?• Dr. Gibb: This study adds to a growing body of research suggesting that subtle changes in

pupil dilation can provide a window into how the brain processes emotional information and can help us determine which individuals are at greatest risk for depression themselves. We believe that one day these types of tests could be included as part of children’s regular pediatrician visits and help identify which children may be at risk for depression.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 8: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Pupil Response To Sad Faces Linked To Increased Risk of Depression In ChildrenMedicalResearch.com Interview with:Katie Burkhouse, Graduate Student andDr. Brandon Gibb Ph.D Professor of Psychology

Director of the Mood Disorders Institute and Center for Affective ScienceBinghamton University

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Gibb: Katie’s study is exciting because it’s the first to show that pupillary reactivity to images of sad faces predicts the onset of depression. However, before we can develop a standardized test of depression risk based on these findings, more research is needed to make sure that the findings replicate and to determine whether pupil dilation can be used to predict depression risk in children even if they do not have a family history of the disorder. We are optimistic about this research and hope that we will be able to standardize the test so that it can be used as a general screen for depression risk.

• Citation:• Katie L. Burkhouse, Greg J. Siegle, Mary L. Woody, Anastacia Y. Kudinova, Brandon E. Gibb.

Pupillary Reactivity to Sad Stimuli as a Biomarker of Depression Risk: Evidence From a Prospective Study of Children.. Journal of Abnormal Psychology, 2015; DOI: 10.1037/abn0000072

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 9: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

3-Drug Combination May Better Reduce Nausea-Vomiting During ChemotherapyMedicalResearch.com Interview with:Junichi Nishimura MD, PhDAssistant professorOsaka University in Japan

Medical Research: What is the background for this study? What are the main findings?

Dr. Nishimura: Oxaliplatin is classified as moderately emetogenic chemotherapy and 2-drug combination antiemetic therapy is recommended for Oxaliplatin based chemotherapy including FOLFOX and XELOX in all guidelines for antiemesis. Nausea and vomiting are still frequent adverse events which decrease the patient’s QOL. However, there was no study investigating whether 3-drug combination antiemetic therapy (5HT3 receptor antagonist+dexamethasone+aprepitant) reduce chemotherapy-induced nausea and vomiting. In this study, we conducted a multicentre, randomized phase III study to evaluate the usefulness of the combined use of aprepitant in colorectal cancer patients treated with Oxaliplatin based chemotherapy. In this phase III study, 3-drug combination therapy significantly increased the inhibition rate of vomiting which was the primary endpoint of this study. Moreover, the inhibition rate of nausea, complete response (no vomiting and no rescue medication use), and complete protection (no vomiting , no rescue medication use and no moderate or worsened nausea) was significantly higher in aprepitant group in overall and delayed phase. We, next, compared the inhibition of vomiting and nausea between males and females in delayed phase. When patients were grouped by sex regardless of the assigned treatment group, females were more affected by nausea and vomiting than males. Finally, in female, aprepitant did significantly prevent nausea and vomiting as well as increased chance of complete protection.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 10: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

3-Drug Combination May Better Reduce Nausea-Vomiting During ChemotherapyMedicalResearch.com Interview with:Junichi Nishimura MD, PhDAssistant professorOsaka University in Japan

• Medical Research: What should clinicians and patients take away from your report?• Dr. Nishimura: The 3-drug combination antiemetic therapy might be an antiemetic treatment

option for oxaliplatin based chemotherapy in colorectal patients who were not controlled their vomiting and nausea.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 11: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

3-Drug Combination May Better Reduce Nausea-Vomiting During ChemotherapyMedicalResearch.com Interview with:Junichi Nishimura MD, PhDAssistant professorOsaka University in Japan

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Nishimura: Casopitant, which is another NK1 receptor antagonist, were reported to have no significant effects in colorectal patients receiving oxaliplatin based chemotherapy compared with recommended 2-drug combination antiemetic therapy. We need more data about the effectiveness of 3-drug combination therapy in colorectal patients treated with Oxaliplatin to conclude whether aprepitant is recommended antiemetic therapy for Oxaliplatin based chemotherapy.

• Citation:• Nishimura J, Satoh T, Fukunaga M, et al, et al. A phase III trial of aprepitant in colorectal

cancer patients receiving oxaliplatin-based chemotherapy (SENRI Trial). Ann Oncol. 2015;26 (suppl 4; O-001). – See more at: http://www.onclive.com/conference-coverage/2015-world-GI/adding-aprepitant-improves-control-of-oxaliplatin-related-nausea-vomiting-in-crc#sthash.0gjjzcCI.dpuf

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 12: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Novel Anti-Metabolite Offers New Therapeutic Option For Resistant Colon CancerMedicalResearch.com Interview with:Howard S. Hochster, MDAssociate Director, Yale Cancer CenterProfessor of Medicine, Yale School of Medicine

New Haven, CT 06520

• Medical Research: What is the background for this study? What are the main findings?

Dr. Hochster: TAS-102 is a novel anti-metabolite, recently combined with a metabolic inhibitor to make it orally bioavailable and active in the treatment of cancer. In pre-clinical studies, it is non-cross reactive with 5FU. What this means practically is that we have another chemotherapy agent that can be used for patients with colon cancer. This drug will be an addition to the approved chemotherapy agents 5FU, oxaliplatin and irinotecan. It may be combinable with these and with targeted agents to provide new active regimens.

• The main findings of the study were published in NEJM, May 15, 2015. The study enrolled 800 patients randomized (2:1 ratio) to drug vs placebo. Patients with advanced colon cancer who had been treated with all the previously approved drugs were eligible. The drug was active in reducing time to tumor growth (Progression Free Survival) by 50% and improved overall survival for treated patients by about 25%.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 13: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Novel Anti-Metabolite Offers New Therapeutic Option For Resistant Colon CancerMedicalResearch.com Interview with:Howard S. Hochster, MDAssociate Director, Yale Cancer CenterProfessor of Medicine, Yale School of Medicine

New Haven, CT 06520

The data I presented at ESMO included a further analysis on specific genomic subsets of patients within the 800 patient study. All patients were tested locally for RAS mutations and about 50% had such mutations (as expected). There was no differences in benefit or toxicity for those with RAS wild-type tumors or RAS mutated tumors. We also looked at those with BRAF mutations, but only 15% of patients were tested and this mutation occurs in about 8% of colon cancer, so we had very few patients with BRAF mutation. Given this limitation, it appeared that this did not make a difference for benefit or toxicity either.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 14: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Novel Anti-Metabolite Offers New Therapeutic Option For Resistant Colon CancerMedicalResearch.com Interview with:Howard S. Hochster, MDAssociate Director, Yale Cancer CenterProfessor of Medicine, Yale School of Medicine

New Haven, CT 06520

• Medical Research What should clinicians and patients take away from your report?• Dr. Hochster: TAS-102 is currently under review at the FDA and will receive a decision this

year. I expect it should be approved based on approval of other agents with similar benefits in such studies. This will give patients a new therapeutic option after they have exhausted all others and possibly newer treatment options for earlier lines of therapy in the future.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 15: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Novel Anti-Metabolite Offers New Therapeutic Option For Resistant Colon CancerMedicalResearch.com Interview with:Howard S. Hochster, MDAssociate Director, Yale Cancer CenterProfessor of Medicine, Yale School of Medicine

New Haven, CT 06520

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Hochster: The next steps include combinations with irinotecan, with oxaliplatin and with biologics including bevacizumab. These regimens can be eventually incorporated into the new treatment paradigms and guidelines. We will be working on how this drug works after patients have been receiving 5FU and when tumors are resistant to 5FU.

• Citation:• Presented at 2015• European Society for Medical Oncology | ESMO• Hochster H, Hager S, Pipas JM, et al. KRAS and BRAF gene subgroup analysis in the Phase 3

RECOURSE trial of TAS-102 versus placebo in patients with metastatic colorectal cancer. Ann Oncol. 2015;26 (suppl 4; O-010) – See more at: http://www.onclive.com/conference-coverage/2015-world-GI/improved-os-pfs-demonstrated-by-tas-102-regardless-of-kras-status#sthash.GYh8XDQX.dpuf

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 16: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Substance Abuse and Tobacco Linked To Longer Term Opioid UseMedicalResearch.com Interview with:W. Michael Hooten, M.DProfessor of AnesthesiologyMayo Clinic

• Medical Research: What is the background for this study? • Dr. Hooten: The purpose of the study was to investigate a gap in knowledge related to the

progression of short-term opioid use to longer-term use.• Medical Research: What are the main findings?

Dr. Hooten: The main findings are that a history of substance abuse or tobacco use is associated with the progression from short-term to a longer-term pattern of opioid prescribing.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 17: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Substance Abuse and Tobacco Linked To Longer Term Opioid UseMedicalResearch.com Interview with:W. Michael Hooten, M.DProfessor of AnesthesiologyMayo Clinic

• Medical Research: What should clinicians and patients take away from your report?• Dr. Hooten: Physicians and patients should be aware that a history of substance abuse and

smoking may be risk factors for longer patterns of opioid use.• Medical Research: What recommendations do you have for future research as a result of

this study?• Dr. Hooten: In future research, we plan to focus on the potential effects that the initial opioid

dose may have on longer-term patterns of opioid use.• Citation:• Incidence and Risk Factors for Progression From Short-term to Episodic or Long-term Opioid P

rescribing: A Population-Based Study.• Hooten WM, St Sauver JL, McGree ME, Jacobson DJ, Warner DO.• Mayo Clin Proc. 2015 Jul;90(7):850-6. doi: 10.1016/j.mayocp.2015.04.012.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 18: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Postmenopausal Hormones Linked To Decreased Colon Cancer RiskMedicalResearch.com Interview with:Dr. Hannah Arem Ph.D. M.H.S. Postdoctoral FellowNutritional Epidemiology BranchDivision Cancer Epidemiology and Genetics

National Cancer Institute

• MedicalResearch: What is the background for this study?• Dr. Arem: In the United States, men are more likely to develop colorectal cancer (CRC) than

women. In large prospective studies, researchers observed that women who reported taking menopausal hormone therapy (MHT) containing estrogen had a 30-40% lower risk of colorectal cancer, compared to women who did not report menopausal hormone therapy use, suggesting an anti-carcinogenic role for estrogen.

• We investigated the relationship between estrogen exposure (hormonal and reproductive factors) in relation to survival (risk of death) among women diagnosed with colorectal cancer.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 19: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Postmenopausal Hormones Linked To Decreased Colon Cancer RiskMedicalResearch.com Interview with:Dr. Hannah Arem Ph.D. M.H.S. Postdoctoral FellowNutritional Epidemiology BranchDivision Cancer Epidemiology and Genetics

National Cancer Institute

• MedicalResearch: What are the main findings?• Dr. Arem: We found a 20% lower risk of death overall among women who reported current

menopausal hormone therapy use at study entry (HR=0.79, 95% CI 0.66-0.94) and a 24% lower risk of death from colorectal cancer (0.76, 0.59-0.99), compared to women who reported never using menopausal hormone therapy.

• Among women in our study, we observed no statistically significant associations for colorectal cancer mortality with oral contraceptive use, menarche age, age at first birth, parity, or menopausal age.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Arem: Our study was designed to investigate a mechanistic role for estrogen on

carcinogenesis for research purposes. We do not expect these findings to influence clinical practice or behavior.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 20: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Postmenopausal Hormones Linked To Decreased Colon Cancer RiskMedicalResearch.com Interview with:Dr. Hannah Arem Ph.D. M.H.S. Postdoctoral FellowNutritional Epidemiology BranchDivision Cancer Epidemiology and Genetics

National Cancer Institute

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Arem: Future studies should focus on the mechanisms by which exogenous estrogen exposure might affect tumor progression and colorectal cancer survival.

• Citation:• Reproductive and hormonal factors and mortality among women with colorectal cancer in th

e NIH-AARP Diet and Health Study• H Arem, Y Park, A S Felix, A Zervoudakis, L A Brinton, C E Matthews and M J Gunter• British Journal of Cancer , (23 June 2015) | doi:10.1038/bjc.2015.224

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 21: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious DiseaseMedicalResearch.com Interview with:Dr. J. Todd Kuenstner MDClinical LaboratoriesCharleston Area Medical Center, Charleston, Virginia

West Virginia School of Medicine, Charleston, West Virginia

Medical Research: What is the background for this study? What are the main findings?

Dr. Kuenstner: Prior to the advent of recent antiviral therapies with sustained virologic response rates (SVR) of 94%, ultraviolet blood irradiation (UVBI) was proposed as a method to improve the outcome of treatment with interferon and ribavirin which had an virologic response rates of 50%. This therapy was invented by Dr. Emmett Knott in 1928 and used to treat viral and bacterial infectious disease in the 1930s through the 1950s and an estimated 60,000 treatments were conducted in the United States by 1948. The AVIcure hemo-irradiator is a modification of the Knott Hemo-irradiator and meets contemporary safety standards.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 22: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious DiseaseMedicalResearch.com Interview with:Dr. J. Todd Kuenstner MDClinical LaboratoriesCharleston Area Medical Center, Charleston, Virginia

West Virginia School of Medicine, Charleston, West Virginia

This study describes the FDA phase II controlled clinical trial that was conducted before the advent of sofosbuvir and ledipasvir with the AVIcure hemo-irradiator using ultraviolet blood irradiation (UVBI) for the treatment of 10 patients infected with the hepatitis C virus (HCV). This study is significant because of the potential of this device for treating other infectious diseases with few treatment options. This therapy was safe and beneficial in the 10 patients that were studied. At the nadir of the viral load, the mean reduction of hepatitis C viral load was 45% (p=0.0048) or 0.35 log viral load (p=0.015). Three of the patients in the group achieved a greater than 0.5 log viral load reduction at some point in the trial. The phase I controlled clinical trial of UVBI in patients with HCV infection on 10 patients (submitted for publication) showed that 7 of 10 patients had a greater than 0.5 log reduction in viral load and a mean viral load reduction of 56% and a mean log viral load reduction of 0.60 (p=0.039).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 23: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious DiseaseMedicalResearch.com Interview with:Dr. J. Todd Kuenstner MDClinical LaboratoriesCharleston Area Medical Center, Charleston, Virginia

West Virginia School of Medicine, Charleston, West Virginia

In the phase II clinical trial, 8 of 10 patients also showed a concurrent reduction in their serum transaminase levels, mean reduction in AST of 15% (p=0.0069) and mean reduction in ALT of 19% (p=0.0031). The above phase II trial results were achieved in spite of two therapeutic “holidays” of 7 weeks duration during the trial and during these therapeutic “holidays” the patients did not receive any treatments.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 24: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious DiseaseMedicalResearch.com Interview with:Dr. J. Todd Kuenstner MDClinical LaboratoriesCharleston Area Medical Center, Charleston, Virginia

West Virginia School of Medicine, Charleston, West Virginia

• Medical Research: What should clinicians and patients take away from your report?• Dr. Kuenstner: This controlled clinical trial in a viral infection, combined with two controlled

trial reports in the Russian medical literature on the use of combination UVBI and antibiotics for more rapid resolution of tuberculosis and the extensive United States medical literature on the Knott Hemo-irradiator from 1930 through 1950 indicate that this therapy is useful for the treatment of infectious diseases. In recent years, increasing resistance to existing antimicrobial agents indicates the need for alternative strategies in combating infectious diseases.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 25: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinical Trial of Ultraviolet Blood Irradiation For Resistant Infectious DiseaseMedicalResearch.com Interview with:Dr. J. Todd Kuenstner MDClinical LaboratoriesCharleston Area Medical Center, Charleston, Virginia

West Virginia School of Medicine, Charleston, West Virginia

• Medical Research: What recommendations do you have for future research as a result of this study?• Dr. Kuenstner: This device should be evaluated for the treatment of infectious diseases with few or no

treatment options. Such diseases include multidrug resistant Mycobacterium tuberculosis, multidrug resistant Salmonella typhi, Mycobacterium avium complex, and dengue, chikungunya, Ebola, Marburg, West Nile and influenza viruses. Studies of patients who have failed existing therapies for other infections including malaria, human immunodeficiency virus and hepatitis B virus are also indicated.

• We also believe that this device will be very useful in the treatment of Crohn’s disease and other diseases traditionally considered “autoimmune” but in our view caused by Mycobacterium avium paratuberculosis (MAP). We recently published a series of case reports describing the resolution of Crohn’s disease and complex regional pain syndrome in two patients who were treated with combination UVBI and antibiotics following demonstration of MAP positive blood cultures. Controlled clinical trials of UVBI are planned in these diseases.

• Citation:• The treatment of infectious disease with a medical device: results of a clinical trial of ultraviolet blood

irradiation (UVBI) in patients with hepatitis C infection• J. Todd Kuenstnera, b, , ,Shanker Mukherjeec,Stuart Wegd,Trish Landrye,

Thomas Petrie• International Journal of Infectious Diseases• Volume 37, August 2015, Pages 58–63• doi:10.1016/j.ijid.2015.06.006

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 26: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Intestinal Microbiome May Contribute To Burn PathologyMedicalResearch.com Interview with:Mashkoor A. Choudhry, PhDProfessor of Surgery, Microbiology & Immunology Burn & Shock Trauma Research InstituteStritch School of Medicine Loyola

University Chicago Health Sciences DivisionMaywood, IL 60153

• Medical Research: What is the background for this study? What are the main findings?

Dr. Choudhry: Intestine is the major reservoir of bacteria in the body. We observed that gut bacterial composition is altered after burn injury. We found that burn causes a significant increase in Enterobacteriaceae, a group of bacteria that has the potential to be harmful for the host. Dysbiosis of the healthy intestinal microbiome is associated with a number of inflammatory conditions.

• Medical Research: What should clinicians and patients take away from your report?

Dr. Choudhry: Although based on limited number of patients, our findings suggest that changes in the intestinal microbiome can potentially contribute to pathology associated with burns, however more studies are required to establish this link.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 27: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Intestinal Microbiome May Contribute To Burn PathologyMedicalResearch.com Interview with:Mashkoor A. Choudhry, PhDProfessor of Surgery, Microbiology & Immunology Burn & Shock Trauma Research InstituteStritch School of Medicine Loyola

University Chicago Health Sciences DivisionMaywood, IL 60153

• Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Choudhry: As I indicated above that our current study is based on limited number of patients, so more studies are needed to confirm these findings with large burn patient population. Additionally more research is also needed to investigate the mechanism by which burn injury results in the dysbiosis of normal gut microbiota.

• Citation:• Burn Injury Alters the Intestinal Microbiome and Increases Gut Permeability and Bacterial Tra

nslocation.• Zachary M. Earley, Suhail Akhtar, Stefan J. Green, Ankur Naqib, Omair Khan, Abigail R. Cannon

, Adam M. Hammer, Niya L. Morris, Xiaoling Li, Joshua M. Eberhardt, Richard L Gamelli, Richard H. Kennedy, Mashkoor A. Choudhry

• Published: July 8, 2015DOI: 10.1371/journal.pone.0129996

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 28: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Phthalate Replacements May Contribute to High Blood Pressure in YouthMedicalResearch.com Interview with:Leonardo Trasande, MD, MPPAssociate Professor, Department of Pediatrics;Associate Professor, Department of Environmental

Medicine;Associate Professor, Department of Population HealthNYU Langone Medical Center

• Medical Research: What is the background for this study?• Dr. Trasande: Phthalates are environmental chemicals widely used in consumer and personal

care products, and often found in plastic to increase flexibility. Di-2-ethylhexylphthalate (DEHP) is of particular interest because industrial processes to produce food frequently use plastic products containing DEHP. Because recognition of potential health risks related to DEHP exposure has increased, DEHP is being replaced by di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP), two phthalates with similar chemical properties. Specifically, DINP is used in plastic products for food packaging, and DIDP is used in furnishings, cookware, medications, and several other consumer products. These alternatives have not been substantially studied for toxicity in laboratory studies because these studies are not required for regulatory approval: unlike the EU, in the US the current regulatory framework assumes that chemicals are safe until proven toxic.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 29: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Phthalate Replacements May Contribute to High Blood Pressure in YouthMedicalResearch.com Interview with:Leonardo Trasande, MD, MPPAssociate Professor, Department of Pediatrics;Associate Professor, Department of Environmental

Medicine;Associate Professor, Department of Population HealthNYU Langone Medical Center

• Medical Research: What are the main findings?• Dr. Trasande: We examined DINP and DIDP levels in urine samples from children and

adolescents (6 to 19 years old) who participated in the National Health and Nutrition Examination Survey between 2009 and 2012, to assess if these levels were associated with blood pressure measurements. Diet, physical activity, gender, race/ethnicity, income, and other factors that can contribute to increased blood pressure were also included in the analysis. A significant association was found between high blood pressure and DINP/DIDP levels in study participants. This is not a cause-and-effect relationship but it suggests that phthalates may contribute to increased blood pressure.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

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Phthalate Replacements May Contribute to High Blood Pressure in YouthMedicalResearch.com Interview with:Leonardo Trasande, MD, MPPAssociate Professor, Department of Pediatrics;Associate Professor, Department of Environmental

Medicine;Associate Professor, Department of Population HealthNYU Langone Medical Center

• Medical Research: What should clinicians and patients take away from your report?• Dr. Trasande: Children and adolescents exposed to DIDP and DINP, currently used as DHEP

replacements, have significantly increased blood pressure. This adds to the increasing body of evidence on the harmful effects of these environmental chemicals. Simple steps that could be taken to limit exposure include not microwaving food in plastic containers or covered by plastic wraps, and avoiding using the dishwasher for plastic food containers: high temperatures make more likely for these chemicals to leach into food. Plastic containers labeled with the numbers 3, 6 or 7 (inside the recycle symbol usually at the bottom of the container) should also be avoided, as these codes indicate the presence of phthalates.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 31: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Phthalate Replacements May Contribute to High Blood Pressure in YouthMedicalResearch.com Interview with:Leonardo Trasande, MD, MPPAssociate Professor, Department of Pediatrics;Associate Professor, Department of Environmental

Medicine;Associate Professor, Department of Population HealthNYU Langone Medical Center

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Trasande: Further studies are required to identify the underlying mechanisms and to investigate the long-term effects of exposure to these chemicals. This is particularly important during pregnancy and early childhood, and might reveal different and/or more persistent effects on health. There are ample opportunities for policy prevention in the current regulatory void, and these studies will form the basis for much needed regulatory interventions to limit exposure to ubiquitous environmental chemicals with the potential to increase cardiovascular risk.

• Citation:• Leonardo Trasande and Teresa M. Attina. Association of Exposure to Di-2-Ethylhexylphthalate

Replacements With Increased Blood Pressure in Children and Adolescents. Hypertension, July 2015 DOI: 10.1161/HYPERTENSIONAHA.115.05603

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 32: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Ejaculatory Issues Common and Not Helped By Testosterone TreatmentMedicalResearch.com Interview with:Darius A. Paduch, MD, PhD Associate Professor of Urology and Reproductive MedicineDirector Sexual Health and Medicine Research

Director of Male Infertility FellowshipCo-Director Male Infertility Genetics Laboratory Weill Cornell Medical College Dept of UrologyNew York, NY 10065

• Medical Research: What is the background for this study? What are the main findings?

Dr. Paduch: Ejaculatory dysfunction, inability to ejaculate or delayed ejaculation affects 10-8% of men. Inability to ejaculate either intravaginally or at all is independent of erectile function.

• Men with normal erection may take very long time to ejaculate (>30 min) or not able to ejaculate at all. The men in our study had either normal erections or minimal erectile dysfunction.

• Men of all ages have spontaneous erections but don’t ejaculate just from erection, it is progression of arousal and activation of spinal cord motor generator for ejaculation which is necessary for ejaculation.

• One of important factors in our ability to ejaculate is testosterone (T), testosterone allows for normal function of CNS centers for ejaculation, it is a modulator and is necessary; preadolescent boys don’t ejaculate because their spinal cord centers for ejaculations are not mature – process dependent on testosterone. However testosterone is just one of many neurotransmitters and hormones needed of normal ejaculation.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 33: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Ejaculatory Issues Common and Not Helped By Testosterone TreatmentMedicalResearch.com Interview with:Darius A. Paduch, MD, PhD Associate Professor of Urology and Reproductive MedicineDirector Sexual Health and Medicine Research

Director of Male Infertility FellowshipCo-Director Male Infertility Genetics Laboratory Weill Cornell Medical College Dept of UrologyNew York, NY 10065

• Actually our study showed that in men who achieved normal levels of testostosterone the ejaculatory function have improved. As this was first double blinded and randomized clinical trial we had to report our results based on radomization to testosterone treatment or placebo. Unfortunately only 70-80% of men treated with topical testosterone preparation will achieve normal testosterone level , we simply didn’t reach statistical significance based on randomization and considering relatively low number of patients in each group. But in men who achieved normal testosterone levels the difference was statistically significant.

• Testosterone should not be used to treat any conditions, including ejaculatory dysfunction, in absence of low testosterone level.

• EjD is very common but it bares significant embarrassment stigma, it is difficult for the couple to bear fact that male partner can’t ejaculate, it also creates issues within couple and question about attraction and fidelity.

• We have previously showed that treatment with tadalafil improves ejaculatory and orgasmic dysfunction and these data has been published.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 34: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Ejaculatory Issues Common and Not Helped By Testosterone TreatmentMedicalResearch.com Interview with:Darius A. Paduch, MD, PhD Associate Professor of Urology and Reproductive MedicineDirector Sexual Health and Medicine Research

Director of Male Infertility FellowshipCo-Director Male Infertility Genetics Laboratory Weill Cornell Medical College Dept of UrologyNew York, NY 10065

• This study was focused on effect of testosterone, but its main significance was it’s design: we developed new tools to assess ejaculatory function and learned a lot about when patients or their partners start to be bothered by EjD. If time to ejaclate takes > 30 min

• We are now looking into novel and available pharmacotherapy modulating dopaminergic and canabioid signaling and reward mechanisms. I am also very excited about our potential work in direct spinal cord motor generator nano stimulator, this could be very useful for men with spinal cord injuries and diabetic patients. We paved the road for others and I am sure new treatments are just a matter of time.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 35: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Ejaculatory Issues Common and Not Helped By Testosterone TreatmentMedicalResearch.com Interview with:Darius A. Paduch, MD, PhD Associate Professor of Urology and Reproductive MedicineDirector Sexual Health and Medicine Research

Director of Male Infertility FellowshipCo-Director Male Infertility Genetics Laboratory Weill Cornell Medical College Dept of UrologyNew York, NY 10065

• Medical Research: What should clinicians and patients take away from your report?• Dr. Paduch: Message to clinician: in 2015 we need to understand that sexual experience is

much more than just having rigid penis, disorders of ejaculation, orgasm, desire and arousal are common but poorly understand in men.

• For centuries we were thought that only women fail to achieve orgasm . The work of my team at WCMC and our collaborators at Eli LillY has shown that not only EJD is common, but failure of orgasm affects men same as women. We hope that by sharing our research we will stimulate further interest in this area and bring more funding from pharma and federal sources to treat this common yet not understood condition.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 36: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Ejaculatory Issues Common and Not Helped By Testosterone TreatmentMedicalResearch.com Interview with:Darius A. Paduch, MD, PhD Associate Professor of Urology and Reproductive MedicineDirector Sexual Health and Medicine Research

Director of Male Infertility FellowshipCo-Director Male Infertility Genetics Laboratory Weill Cornell Medical College Dept of UrologyNew York, NY 10065

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Paduch: We are focusing in my lab on identifying if genetic mutations and single nucleotide polymorphisms modulate delayed ejaculation and how small RNAs affect nerve and vascular function in the penis and modulate sensory processing in the spinal cord and brain. This research would uncover completely novel pathways of treatment of male sexual dysfunction

• Citation:• Paduch DA, Polzer PK, Ni X, Basaria S. Testosterone Replacement in Androgen-Deficient Men

With Ejaculatory Dysfunction: A Randomized Controlled Trial. Journal of Clinical Endocrinology & Metabolism. 2015.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 37: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• MedicalResearch: What is the background for this study?• Dr. Novak: Diabetes mellitus (DM) is a major contributor to morbidity and mortality.

Type 2 diabetes mellitus affects more than 44 million people in the U.S., and its numbers are growing rapidly, affecting up to 27% of older adults. Diabetes mellitus accelerates brain aging by about 5 years1, manifests as a widespread generalized atrophy2, and promotes earlier onset of vascular dementia and Alzheimer’s disease (AD).3,4 Diabetes mellitus -related atrophy manifests as worse cognitive function, memory, and gait, especially during a dual task, 5,6 and even a tight glycemic control did not improve cognitive function in participants of the large clinical trials 7.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 38: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• MedicalResearch: What are the main findings?• Dr. Novak: Sixty-five participants (aged 66± 9.2 years) 35 with T2DM and 30 non-diabetic

controls participated in this study. After 2 years of follow-up, participants with T2 Diabetes mellitus had diminished vascular reactivity in the brain (an ability to increase blood flow in responses to a task or metabolic demands) and performed worse on multiple cognitive tasks (in particular verbal learning and memory). In T2DM group, lower cerebral vasoreactivity correlated with worse performance on daily living activities. Specifically, the lower vasodilatation (ability to increase blood flow) was associated with worse mental functions. In addition, those with higher markers of inflammation had greater decline in vascular function in the brain.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 39: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Novak: Impaired blood flow regulation in the brain may accelerate brain aging and

functional decline. Worse performance on daily activities, worse memory or slower gait speed 8 in older diabetic adults may thus hallmark a decline in ability to regulate blood flow in the brain.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 40: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Novak: There is a need for new therapies focused on prevention of T2 Diabetes mellitus related decline in older population that would be focused on improving vascular control and reducing the impact of T2DM on the brain. Our pilot study has shown that insulin administered sprayed into the nose may have potential benefits for learning and memory 9, 10. We will test this approach in our new clinical trial. Maintaining optimal T2DM control in combination with exercise and active healthy lifestyle regimen is very important for T2DM adults.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 41: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• Reference List• Franke,K., Gaser,C., Manor,B., & Novak,V. Advanced BrainAGE in older adults with type 2 diabetes

mellitus. Front Aging Neurosci. 5, 90 (2013).• Cui,X., Abduljalil,A., Manor,B., Peng,C.K., & Novak,V. Multi-Scale glycemic variability: A link to gray

matter atrophy and cognitive decline in type 2 diabetes. PLoS. One. 9, E86284E (2014).• Xu,W.L., Qiu,C.X., Wahlin,A., Winblad,B., & Fratiglioni,L. Diabetes mellitus and risk of dementia in the

Kungsholmen project: a 6-year follow-up study. Neurology 63, 1181-1186 (2004).• Korf,E.S., White,L.R., Scheltens,P., & Launer,L.J. Brain aging in very old men with type 2 diabetes: the

Honolulu-Asia Aging Study. Diabetes Care 29, 2268-2274 (2006).• Last,D. et al. Global and regional effects of type 2 diabetes mellitus on brain tissue volumes and

cerebral vasoreactivity . Diabetes Care 30, 1193-1199 (2007).• Novak,V. et al. Adhesion molecules, altered vasoreactivity, and brain atrophy in type 2 diabetes.

Diabetes Care 34, 2438-2441 (2011).• Launer,L.J. et al. Effects of intensive glucose lowering on brain structure and function in people with

type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol. 10, 969-977 (2011).• Jor’dan,A., Manor,B., & Novak ,V. Slow gait speed-an indicator of lower cerebral vasoreactivity in type 2

diabetes mellitus. Frontiers in Aging Neuroscience Frontiers in Aging Neuroscience 6,135 (2014).• Novak,V. et al. Enhancement of Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes.

Diabetes Care 3, 751-759 (2014).• Zhang,H. et al. Intranasal insulin enhanced resting-state functional connectivity of hippocampal regions

in type 2 diabetes. Diabetes 64:687-688 (2015).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 42: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Type 2 Diabetes Linked to Decreased Brain Blood Flow and Cognitive AbilityMedicalResearch.com Interview with:Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division

Director Syncope and Falls in the Elderly LaboratoryBeth Israel Deaconess Medical CenterBoston, MA

• Citation:• Chen-Chih Chung, Daniela Pimentel, Azizah J. Jor’dan, Ying Hao, William Milberg, and Vera

Novak. Inflammation-associated declines in cerebral vasoreactivity and cognition in type 2 diabetes. Neurology, July 2015 DOI: 10.1212/WNL.0000000000001820

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 43: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Diabetic Severity May Predict Risk of DementiaMedicalResearch.com Interview with:Wei-Che Chiu, MD, PhDNational Taiwan University College of Public Health,Cathay General Hospital and Fu Jen Catholic UniversityTaipei, Taiwan

• Medical Research: What is the background for this study?• Response: Diabetes mellitus is a common risk factor for dementia and accounts

for 6–8% of all cases of dementia in older populations. Cognitiveimpairment is associated with the presence of diabetic complicationsand diabetic severity, but the effects of diabetic severity ondementia are unclear. Our study was to investigate the associationbetween the severity and progress of diabetes and the risk ofdementia.

• Medical Research: What are the main findings?• Response: The diabetic severity and progression reflected the risk

of dementia, and the early progress in diabetic severity could predictthe risk of dementia in new-onset diabetic patients.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 44: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Diabetic Severity May Predict Risk of DementiaMedicalResearch.com Interview with:Wei-Che Chiu, MD, PhDNational Taiwan University College of Public Health,Cathay General Hospital and Fu Jen Catholic UniversityTaipei, Taiwan

• Medical Research: What should clinicians and patients take away from your report?• Response:• 1. The risk of dementia was increased from the diabetes onset and was

associated with the diabetic complication severity and progression.• 2. Progress of the diabetic severity in the early years of diabetes

could predict the risk of dementia.• 3. The prevention of diabetic progression is important to reduce the

risk of dementia.• 4. The diabetic complication severity was another indicator of the

risk of dementia from the blood sugar.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 45: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Diabetic Severity May Predict Risk of DementiaMedicalResearch.com Interview with:Wei-Che Chiu, MD, PhDNational Taiwan University College of Public Health,Cathay General Hospital and Fu Jen Catholic UniversityTaipei, Taiwan

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: Because the etiology of dementia is varied, the mechanisms ofthe diabetic severity and progression on the different types ofdementia should be further investigated.

• Citation:• Wei-Che Chiu, MD, PhD et al. Progess of Diabetic Severity and Risk of Dementia. Journal of

Clinical Endocrinology & Metabolism, July 2015 DOI: 10.1210/jc.2015-1677

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 46: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Anti-depressant Amitriptyline May Inhibit Adenovirus InfectionsMedicalResearch.com Interview with:Prof. Urs Greber, PhDProfessor of Molecular Cell BiologyInstitute of Molecular Life SciencesUniversity of ZurichZurich, Switzerland

• Medical Research: What is the background for this study? What are the main findings?

Prof. Greber: This study has addressed two fundamental questions in virology – how do non-enveloped viruses which are lipid-free penetrate through cell membranes, and how is this process tuned by host lipids?

• We found that certain neutral lipids, ceramide lipids, were unregulated during the entry process of human adenovirus into cells. The ceramide lipids enhanced the uptake of viruses into cells by endocytosis, and they boosted the disruption of endosomal vesicles which carried the virus,, and thereby enhanced infection.

• The ceramide lipids were found to be produced by the enzyme acid sphingomyelinase (ASMase), which was secreted from lysosomes to the plasma membrane upon virus attachment to cells.

• ASMase is a clinical target, and can be inhibited by the antidepressant amitriptyline, a small chemical compound, which is widely used to treat mental disorders.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 47: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Anti-depressant Amitriptyline May Inhibit Adenovirus InfectionsMedicalResearch.com Interview with:Prof. Urs Greber, PhDProfessor of Molecular Cell BiologyInstitute of Molecular Life SciencesUniversity of ZurichZurich, Switzerland

• Medical Research: What should clinicians and patients take away from your report?• Prof. Greber: The anti-depressant amitriptyline inhibits infection of cells with human

adenovirus. This virus causes respiratory, ocular and intestinal disease.• Medical Research: What recommendations do you have for future research as a result of

this study?• Prof. Greber: Future research will show if amitriptyline can be used to treat viral disease in

humans.• Citation:• Stefania Luisoni, Maarit Suomalainen, Karin Boucke, Lukas B. Tanner, Markus R. Wenk, Xue Li

Guan, Michał Grzybek, Ünal Coskun, Urs F. Greber. Co-option of Membrane Wounding Enables Virus Penetration into Cells. Cell Host & Microbe, 2015; 18 (1): 75 DOI: 10.1016/j.chom.2015.06.006

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 48: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Athletes With Shoulder Instability Better Able To Return To Sport After Arthroscopic RepairMedicalResearch.com Interview with:Brett D. Owens, MDProfessor of Orthopaedic SurgeryBrown University Alpert Medical SchoolProvidence, RI

• Medical Research: What is the background for this study? What are the main findings?

Response: Last year at this meeting we presented the results of a prospective multicenter study of collegiate contact athletes who experienced in-season shoulder instability events. While most were able to return to sport within a week, only roughly one quarter were able to successfully return without recurrent instability. We continued to follow this cohort and 39 athletes with additional eligibility the subsequent season. We found that 90% of the 29 who underwent arthroscopic stabilization successfully returned the next season compared with 40% of the 10 underwent nonoperative treatment

• Medical Research: What should clinicians and patients take away from your report?• Response: Arthroscopic stabilization of shoulder instability events in collegiate athletes

results in a greater than 5 times increased likelihood of successful return to play in the following season compared with nonoperative treatment.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 49: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Athletes With Shoulder Instability Better Able To Return To Sport After Arthroscopic RepairMedicalResearch.com Interview with:Brett D. Owens, MDProfessor of Orthopaedic SurgeryBrown University Alpert Medical SchoolProvidence, RI

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: This works underscores the importance of early arthroscopic stabilization of shoulder instability in high risk patients.We need to continue to explore the incremental risk associated with each recurrent instability event in athletes to provide optimal counseling.

• Citation:• Abstract presented at the American Orthopaedic Society for Sports Medicine• Treatment of shoulder instability helps return collegiate athletes to playing field

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 50: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Shape Differences of Brain Important For Individualized Precision MedicineMedicalResearch.com Interview with:Chun Chieh Fan Ph.D student USCD Cognitive Science andProfessor Anders M. Dale Ph.D Department of Cognitive Science,

University of California, San Diego School of Medicine

• Medical Research: What is the background for this study? What are the main findings?

Response: The shape of human skull is closely associated with the ancestral background. Forensics uses it for determining ethnicity. Anthropologists use it to infer neuroanatomical change in human evolution. Yet it is unclear the inner content of skull, human brain, contains how much information about individual’s ancestry.

• Our study found that different continental ancestries are associated with unique cortical folding patterns. Even for contemporary populations in modern day USA, a melting pot of ethnicities, cortical folding patterns are highly predictive of the percentage of each continental ancestry, as determined based on the person’s genotype. These shape differences between ancestral heritages are not necessarily related to brain function. It is highly possible that the shape differences are resulting from a random process accumulated along human history, without significant functional consequences.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 51: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Shape Differences of Brain Important For Individualized Precision MedicineMedicalResearch.com Interview with:Chun Chieh Fan Ph.D student USCD Cognitive Science andProfessor Anders M. Dale Ph.D Department of Cognitive Science,

University of California, San Diego School of Medicine

• Medical Research: What should clinicians and patients take away from your report?• Response: Our findings are particularly important for individualized, or “precision”, medicine.

If a clinician wants to know where an individual patient’s brain size or shape measures fall relative to age- and sex-matched norms or growth charts, it is essential that these norms be based on individuals with similar ancestral background. Otherwise, the comparisons can be misleading, and confounded by irrelevant ancestry effects. Building on the approach described in the Current Biology paper, we believe it will be possible to calculate personalized norms or growth charts for a range of brain measures, incorporating genetic information from each individual patient, which may enable earlier, and more sensitive detection of brain pathology or abnormal development.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 52: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Shape Differences of Brain Important For Individualized Precision MedicineMedicalResearch.com Interview with:Chun Chieh Fan Ph.D student USCD Cognitive Science andProfessor Anders M. Dale Ph.D Department of Cognitive Science,

University of California, San Diego School of Medicine

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: One natural extension of the study will be to investigate the specific genes and gene variants involved in the shape differences among ethnic ancestry groups. This effort will be greatly facilitated by ongoing large, multi-site studies involving brain imaging and genotyping.

• When combined with large biobanking, precision medicine, and health outcomes research initiatives, the “Big Data” approach described in the Current Biology paper may allow for creation of personalized risk scores, incorporating quantitative measures from brain imaging, genomic information, ethnicity, family history, and molecular biomarkers, with much greater diagnostic and prognostic utility than current approaches.

• Citation:• Modeling the 3D Geometry of the Cortical Surface with Genetic Ancestry• Fan, Chun Chieh et al. Chun Chieh Fan ,Hauke Bartsch,Andrew J. Schork,Chi-Hua Chen,Yunpen

g Wang,Min-Tzu Lo,Timothy T. Brown,Joshua M. Kuperman,Donald J. Hagler Jr.,Nicholas J. Schork,Terry L. Jernigan,Anders M. Dale

• the Pediatric Imaging, Neurocognition, and Genetics Study• Current Biology (Cell Press)• DOI: http://dx.doi.org/10.1016/j.cub.2015.06.006

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 53: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Study Confirms Validity of Bova Score For Pulmonary Embolism PatientsMedicalResearch.com Interview with:David Jimenez PhD, FCCPRespiratory Department and Medicine DepartmentRamon y Cajal

Hospital IRYCIS, and Alcala de Henares UniversityMadrid Spain

• Medical Research: What is the background for this study? What are the main findings?

Dr. Jimenez: Normotensive patients that have an estimated high-risk for pulmonary embolism (PE)-related complications (i.e., intermediate-risk PE) might benefit from surveillance in an intensive care setting or from the administration of specific advanced therapy. The Bova score was developed for identifying these patients. This study confirms the validity and reproducibility of the Bova score.

• Medical Research: What should clinicians and patients take away from your report?• Dr. Jimenez: Clinicians should combine clinical variables, and markers of right ventricular

dysfunction and myocardial injury to identify the sickest normotensive patients with acute symptomatic pulmonary embolism.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 54: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Study Confirms Validity of Bova Score For Pulmonary Embolism PatientsMedicalResearch.com Interview with:David Jimenez PhD, FCCPRespiratory Department and Medicine DepartmentRamon y Cajal

Hospital IRYCIS, and Alcala de Henares UniversityMadrid Spain

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Jimenez: Prospective studies should further address the safety and efficacy of early recanalization procedures for intermediate-risk pulmonary embolism patients who are identified with the proposed criteria.

• Citation:• Validation of a model for identification of patients at intermediate to high risk for complicatio

ns associated with acute symptomatic pulmonary embolism• Fernández C, Bova C, Sanchez O, et al. • Chest • 2015;148(1):211-218. doi:10.1378/chest.14-2551.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 55: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Atrial Fibrillation Increase Leading To More Hospitalizations and Higher CostsMedicalResearch.com Interview with:Azfar B. Sheikh, M.D.Internal Medicine Resident PhysicianStaten Island University HospitalNew York

• Medical Research: What is the background for this study?• Dr. Sheikh: The background of this review article circles around the impact of

atrial fibrillation on epidemiology, trends in hospitalizations, costsassociated with hospitalization and outpatient care, in the UnitedStates. This article also describes the benefits of newer treatmentmodalities compared to the standard of care with regards tosymptomatic improvement and prevention of thromboembolism. Thesefindings are supported by several cost-utility analyses/

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 56: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Atrial Fibrillation Increase Leading To More Hospitalizations and Higher CostsMedicalResearch.com Interview with:Azfar B. Sheikh, M.D.Internal Medicine Resident PhysicianStaten Island University HospitalNew York

• Medical Research: What are the main findings?• Dr. Sheikh: The main findings of the study are:• The cost of hospitalization is three times higher for patients with

atrial fibrillation than those without atrial fibrillation.• 5 million new cases are being reported annually.• The incidence of atrial fibrillation is projected to increase from

1.2 million cases in 2010 to 2.6 million cases by 2030. Due to thisincrease in incidence, the prevalence of atrial fibrillation isprojected to increase from 5.2 million cases to 12.1 million cases by2030.

• The most common co-moribidites associated with atrial fibrillationwere hypertension, diabetes mellitus, and chronic obstructive lungdisease.

• According to the NIS database, the atrial fibrillation.hospitalization rate has increased from 1552 to 1812 per one millionUS residents per year from 2000 to 2010 (relative increase 14.4%).

• According to the NIS database, the mortality associated with atrialfibrillation hospitalizations has decreased significantly from 1.2% in2000 to 0.9% in 2010 (relative decrease 29.2%).

• The median length of stay in the hospital is 3 days and increasesproportionally with a rise in CHADS2 score.

• The largest source of direct healthcare costs associated withatrial fibrillation is hospitalization. According to the NIS database,the mean cost of inpatient atrial fibrillation hospitalizationincreased significantly from $6401 in 2001 to $8439 in 2010 (relativeincrease 24.0%). The mean cost of atrial fibrillation hospitalizationalso increases proportionally with a rise in CHADS2 score.

• In the outpatient setting, the highest costs were associated withphysician office visits in comparison to emergency room and urgentcare visits.

• With regards to prevention of thromboembolism, the new oralanticoagulant agents (dabigatran, rivaroxaban, and apixaban) have beenfound to be more cost-effective compared to warfarin.

• Left atrial catheter ablation is more effective than rate controland rhythm control. It is more cost-effective in younger patients whoare moderate risk for stroke.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 57: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Atrial Fibrillation Increase Leading To More Hospitalizations and Higher CostsMedicalResearch.com Interview with:Azfar B. Sheikh, M.D.Internal Medicine Resident PhysicianStaten Island University HospitalNew York

• Medical Research: What should clinicians and patients take away from your report?• Dr. Sheikh: Clinicians should pay strong attention to the risk factors associated

with atrial fibrillation. Their practice should emphasize onpreventing and limiting the progression of risk factors attributed tothe development of atrial fibrillation. Once the patients havedeveloped atrial fibrillation, the clinician should consider the useof new oral anticoagulant agents over warfarin unless acontradindication exists limiting their use. They should also considerearly referral to a cardiac electrophysiologist for ablation in ayounger patient population who are at moderate risk for stroke. Thosewho are not candidates for ablation should be managed using the ratecontrol strategy.

• Patients also need to emphasize their attention towards the reversiblerisk factors associated with atrial fibrillation. They should havefrequent follow up with their primary doctors to optimally manage eachcondition associated with atrial fibrillation.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 58: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Atrial Fibrillation Increase Leading To More Hospitalizations and Higher CostsMedicalResearch.com Interview with:Azfar B. Sheikh, M.D.Internal Medicine Resident PhysicianStaten Island University HospitalNew York

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Sheikh: In the future, additional cost-utility analyses are required for• comparing each of the new oral anticoagulants amongst each other.• comparing cryoballoon ablation to radiofrequency ablation.• comparing each device used for left atrial appendage closure amongst each other.• Citation:• Trends in Hospitalization for Atrial Fibrillation : Epidemiology, Cost, and Implications for the F

uture

• Sheikh, Azfar et al.Progress in Cardiovascular Diseases

• DOI: http://dx.doi.org/10.1016/j.pcad.2015.07.002

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 59: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What is the background for this study?

Dr. Jones: Heroin use and overdose deaths have increased significantly in the United States in recent years. Most heroin users have a history of nonmedical use of prescription opioid pain relievers as well, and an increase in the rate of heroin overdose deaths has occurred concurrently with an epidemic of prescription opioid overdoses.

• Although it has been postulated that efforts to curb opioid prescribing, resulting in restricted prescription opioid access, have fueled heroin use and overdose, a recent analysis of 2010–2012 drug overdose deaths in 28 states found that decreases in prescription opioid death rates within a state were not associated with increases in heroin death rates; in fact, increases in heroin overdose death rates were associated with increases in prescription opioid overdose death rates.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 60: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• In addition, a study examining trends in opioid pain reliever overdose hospitalizations and heroin overdose hospitalizations between 1993 and 2009 found that increases in opioid pain reliever hospitalizations predicted an increase in heroin overdose hospitalizations in subsequent years. Thus, the changing patterns of heroin use and overdose deaths are most likely the result of multiple, and possibly interacting, factors. Moreover, there is a lack of research examining recent trends in the prevalence of other substance use among persons using heroin, especially among the high-risk population of heroin users who meet diagnostic criteria for heroin abuse or dependence.

• We wanted to better understand how heroin use is changing and identify the demographic and substance using groups that are at greatest risk for use. Knowing this information can help prevention efforts.

• HHS Secretary Sylvia M. Burwell has made addressing opioid abuse, dependence, and overdose a priority and work is underway within HHS on this important issue. The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices, increasing the use of naloxone – a drug that reverses symptoms of a drug overdose, and using medication-assisted treatment to slowly move people out of opioid addiction.

• The Obama Administration is also committed to tackling the prescription drug and heroin epidemic, proposing significant investments to intensify efforts to reduce opioid misuse and abuse.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 61: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What are the main findings?

Dr. Jones: Heroin use has increased significantly across most demographic groups. There were significant increases in heroin use among demographic groups that have had historically lower rates of heroin use, including women, the privately insured, and people with higher incomes. In fact, the gap between men and women, low and high incomes, and people with Medicaid and private insurance have narrowed in the past decade.

• Heroin use is occurring in the context of broader poly-substance use, including marijuana, alcohol, cocaine, and prescription drugs. The use of heroin with other substances increases the risk of overdose. Nearly all (96%) people who reported heroin use also reported using at least one other drug in the past year. More than half (61%) used at least three other drugs.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 62: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Among heroin users in 2011-2013:• 45% had past-year prescription opioid painkiller abuse or dependence• 36% had past-year alcohol abuse or dependence• 25% had past-year cocaine abuse or dependence• 24% had past-year marijuana abuse or dependence• As heroin abuse and dependence have increased, so have heroin-related overdose deaths.

From 2002 through 2013, the rate of heroin-related overdose deaths nearly quadrupled.• The strongest risk factor for heroin abuse or dependence was opioid pain reliever abuse or

dependence followed by cocaine abuse or dependence.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 63: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What should clinicians and patients take away from your report?• Dr. Jones: Clinicians can follow best practices for responsible painkiller prescribing to reduce

opioid painkiller addiction, the strongest risk factor for heroin addiction. This entails• 1) using state prescription drug monitoring programs and asking patients about past or

current drug and alcohol use prior to considering opioid treatment;• 2) prescribing the lowest effective dose of an opioid and only the quantity needed for each

patient; and• 3) linking patients with substance use disorders to effective substance abuse treatment

services, including the use of medication assisted treatment for people with opioid use disorders.

• Patients and others can learn more about the risks of using heroin and other drugs and become trained in how to recognize and respond to an opioid overdose. For people who are struggling with substance abuse problems, they can call 1-800-662 HELP for assistance.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 64: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Heroin Addiction Most Often Preceded by Opioid AbuseMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.H.Senior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: More research is needed to evaluate the impact of interventions designed to reduce prescription opioid and heroin abuse. We also need to conduct additional research to further understand the risk and protective factors for heroin initiation and heroin addiction.

• Citation:• Vital Signs: Demographic and Substance Use Trends Among Heroin Users — United States, 20

02–2013• Weekly• July 10, 2015 / 64(26);719-725

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 65: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinically Silent Maternal Cancer Detectable By Prenatal TestingMedicalResearch.com Interview with:Diana W. Bianchi, M.D.Executive Director, Mother Infant Research InstituteVice Chair for Research and Academic Affairs, Department of Pediatrics

Tufts Medical Center

Medical Research: What is the background for this study? What are the main findings?

Response: Noninvasive Prenatal Testing (NIPT) is the fastest growing genetic test. It has been available since late 2011. Over 2 million tests have been performed worldwide. Cancer in pregnancy is rare, and only occurs in 1 in 1,000 pregnant women. About 0.2 per cent of noninvasive prenatal tests that use sequencing of maternal plasma DNA have a so-called “false positive” result. In most cases this is not an error, but there is a biological explanation for the discrepancy between the abnormal noninvasive prenatal test result and a normal fetal chromosome result obtained from a diagnostic procedure, such as amniocentesis or chorionic villus sampling (CVS). We are very interested in the underlying biological explanations for the false positive cases, and it turns out that a clinically silent tumor in the mother is one of them. The mother’s tumor is shedding DNA into her blood that is detected by the prenatal test.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 66: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinically Silent Maternal Cancer Detectable By Prenatal TestingMedicalResearch.com Interview with:Diana W. Bianchi, M.D.Executive Director, Mother Infant Research InstituteVice Chair for Research and Academic Affairs, Department of Pediatrics

Tufts Medical Center

• In a large clinical dataset of over 125,000 pregnant women who had a DNA sequencing screen for fetal chromosome abnormalities there were 10 women who were subsequently found to have cancer. We retrospectively analyzed the DNA sequencing results in 8 of these women and found that they had abnormalities in multiple areas of the genome, suggesting that it was DNA from the tumor that was shed into the maternal blood and being detected by the prenatal screen.

• The noninvasive prenatal sequencing test result that was most suggestive of a cancer risk was the presence of more than one aneuploidy. This finding was present in 7 of the 10 women who had cancer.

• In three of the eight women we studied it was the abnormal prenatal test result that triggered a subsequent work-up that led to the diagnosis of cancer.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 67: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinically Silent Maternal Cancer Detectable By Prenatal TestingMedicalResearch.com Interview with:Diana W. Bianchi, M.D.Executive Director, Mother Infant Research InstituteVice Chair for Research and Academic Affairs, Department of Pediatrics

Tufts Medical Center

• Medical Research: What should clinicians and patients take away from your report?• Response: Make sure that the patient knows that the noninvasive prenatal test sequences

both her own DNA and the DNA from the placenta, so an abnormal result does not necessarily mean that something is wrong with the baby. All abnormal noninvasive prenatal test (NIPT) results need to be confirmed with a fetal diagnostic karyotype. The patient should not take irrevocable action until she has the results of the fetal karyotype. Cancer is only a possible explanation if there is a discrepancy between the Noninvasive Prenatal Testing result and a normal fetal karyotype (obtained by amniocentesis or CVS).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 68: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Clinically Silent Maternal Cancer Detectable By Prenatal TestingMedicalResearch.com Interview with:Diana W. Bianchi, M.D.Executive Director, Mother Infant Research InstituteVice Chair for Research and Academic Affairs, Department of Pediatrics

Tufts Medical Center

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: We need to do a prospective study to determine what is the pattern of genome imbalance that is most closely associated with a risk of cancer. Furthermore, we need to determine what is the appropriate subsequent medical work-up for pregnant women who have highly unusual noninvasive prenatal testing results, such as the detection of multiple aneuploidies.

• Citation:• Bianchi DW, Chudova D, Sehnert AJ, et al. Noninvasive Prenatal Testing and Incidental Detecti

on of Occult Maternal Malignancies. JAMA. Published online July 13, 2015. doi:10.1001/jama.2015.7120.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 69: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Women’s Out-of-Pocket Expenses For Contraceptives Drop After ACAMedicalResearch.com Interview with:Nora V. Becker MD/PhD candidateDepartment of Health Care Management and Economics

Wharton School, University of Pennsylvania, in Philadelphia.

Medical Research: What is the background for this study? What are the main findings?

Response: The Affordable Care Act mandates that private health insurance plans cover prescription contraceptives with no consumer cost sharing. The positive financial impact of this new provision on consumers who purchase contraceptives could be substantial, but it has not yet been estimated. Using a large administrative claims data set from a national insurer, we estimated out-of-pocket spending before and after the mandate. We found that mean and median per prescription out-of-pocket expenses have decreased for almost all reversible contraceptive methods on the market. The average percentages of out-of-pocket spending for oral contraceptive pill prescriptions and intrauterine device (IUD) insertions by women using those methods both dropped by 20 percentage points after implementation of the ACA mandate. We estimated average out-of-pocket savings per contraceptive user to be $248 for the IUD and $255 annually for the oral contraceptive pill.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 70: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Women’s Out-of-Pocket Expenses For Contraceptives Drop After ACAMedicalResearch.com Interview with:Nora V. Becker MD/PhD candidateDepartment of Health Care Management and Economics

Wharton School, University of Pennsylvania, in Philadelphia.

• Medical Research: What should clinicians and patients take away from your report?• Response: Privately-insured patients should take away from our study that their financial

options for contraception have changed because of the ACA. More effective, longer-term methods like IUD or the implant used to require a large up-front payment of several hundred dollars, and now should be available without any copays and deductibles. Clinicians, especially those who provide well-woman services, should mention this to their patients as well. This is still a new law and many women may not realize that their insurance coverage has changed.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 71: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Women’s Out-of-Pocket Expenses For Contraceptives Drop After ACAMedicalResearch.com Interview with:Nora V. Becker MD/PhD candidateDepartment of Health Care Management and Economics

Wharton School, University of Pennsylvania, in Philadelphia.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Response: The next big question for researchers is how will these changes in out-of-pocket price affect the rates of birth control use in the U.S. There are two types of contraceptive use that could be affected. Overall rates of use of any birth control method could increase, and the distribution of methods chosen could also change. How women respond to these price changes will depend on how price-sensitive they are to the out-of-pocket cost of contraceptives. There is not much research on this in the U.S., but what little we have suggests that women may be fairly price-insensitive, suggesting that perhaps overall rates of use might not change substantially. I’d speculate that where we are more likely to see a response is in the type of method chosen; women may choose longer-term methods at higher rates now that the up-front cost of these methods has been lowered to zero. It’s too soon to know for sure what the final effects will be; this is an area where it will be important to continue studying the long-term impacts of the ACA.

• Citation:• Women Saw Large Decrease In Out-Of-Pocket Spending For Contraceptives After ACA Mandat

e Removed Cost Sharing • Nora V. Becker and Daniel Polsky• Health Aff July 2015 34:71204-1211; doi:10.1377/hlthaff.2015.0127

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 72: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Lack of Sleep May Impair Memory Functions In Stressful SituationsMedicalResearch.com Interview with:Jonathan Cedernaes M.D., Ph.D.Department of NeuroscienceUppsala UniversitySweden

• Medical Research: What is the background for this study? What are the main findings?• Dr. Cedernaes: Sleep is known to facilitate the formation of long-term memory in humans, by

transferring newly learned memories from short-term to long-term memory stores. Studies however indicate that even shorter periods of sleep – including naps – can ensure access to different types of memories under normal restful conditions. Furthermore, while some studies have shown that acute sleep loss can exacerbate e.g. physiological responses to acute stress, it it has not been studied whether shortened sleep in combination with acute cognitive stress can have a negative impact on the retrieval of newly learned memories.

• With this background in mind, we conducted a study where we aimed to investigate how nocturnal sleep duration impacts this memory transfer, and to what extent long-term memories formed by sleep remain accessible after acute cognitive stress.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 73: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Lack of Sleep May Impair Memory Functions In Stressful SituationsMedicalResearch.com Interview with:Jonathan Cedernaes M.D., Ph.D.Department of NeuroscienceUppsala UniversitySweden

We recruited 15 participants who in each of two sessions first underwent a learning session in the evening, during which they learned 15 card pair locations on a computer screen. Then, in one of the two experimental session, subjects slept for half a night (4-hr), instead being able to sleep for a full night (8-hr) in the other session. On the morning after each sleep condition, we had the subjects try to recall as many card pair locations as possible. We found that following half a night of sleep (4-hr), participants were equally able to recall memories for the learned card pair locations, as after a full night of sleep (8-hr). However, we also showed that the ability to retrieve memories following 30 minutes of acute stress, in the morning after these two sleep conditions, was different depending on whether the participants had slept for 8 or 4 hours. Following short sleep, the 30-min long stress exposure reduced the participants’ ability to recall the card pair locations that the participants had learned the previous night by around 10%. In contrast, no such stress-induced memory impairment was observed when the same men were allowed to sleep for a full night.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 74: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Lack of Sleep May Impair Memory Functions In Stressful SituationsMedicalResearch.com Interview with:Jonathan Cedernaes M.D., Ph.D.Department of NeuroscienceUppsala UniversitySweden

• Medical Research: What should clinicians and patients take away from your report?• Dr. Cedernaes: On the basis of our study findings, we have two important take home

messages:• First, even though losing half a night of sleep may not impair memory functions under

baseline conditions, the addition of acute cognitive stress may be enough to lead to significant impairments. These impairments can possibly be detrimental in real-world scenarios, e.g. for medical health professionals who often have to go without sleep for long periods but also often face stressful situations in which they need to be able to access information stored in their long-term memory.

Second, interventions that allow people who usually don’t get enough sleep to sleep longer, including delaying school start times and greater use of flexible work schedules, may improve their academic and occupational performance by ensuring optimal access to memories under stressful conditions.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 75: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Lack of Sleep May Impair Memory Functions In Stressful SituationsMedicalResearch.com Interview with:Jonathan Cedernaes M.D., Ph.D.Department of NeuroscienceUppsala UniversitySweden

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Cedernaes: An important next step will be to investigate how chronic sleep loss and/or more chronic stress may interact to impair the ability to retrieve memories that are consolidated during sleep. It will also be interesting to study how individual factors such as genetics may determine how vulnerable people are to the effects of acute or chronic stress when they have not slept enough.

• Citation:• Cedernaes et al. Short sleep makes declarative memories vulnerable to stress in humans.

Sleep, 2015

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 76: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

• MedicalResearch: What is the background for this study? • Dr. James: Post-traumatic stress disorder (PTSD) is experienced by some people after a

traumatic event. While many people who’ve been involved in traumatic events don’t experience PTSD, those who do typically have repeated visual intrusive memories of certain moments in vivid detail that pop back into mind, seemingly out of the blue. For example, with PTSD after a car crash might repeatedly ‘see’ the moment the other car crashed into them.

• The recommended treatment for PTSD is cognitive behaviour therapy, a talking therapy that has been demonstrated to work well. But it is only delivered once intrusive memories have become established and PTSD is diagnosable – i.e. at least one month after the traumatic event occurred. At present, there is nothing readily available for use soon after trauma that has been shown to prevent symptoms building up and PTSD becoming established.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 77: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

• In previous laboratory work our research team showed that playing Tetris shortly after viewing events with traumatic content (e.g. film footage of road safety campaigns – what we call an experimental trauma) could reduce intrusive memories of those events in healthy volunteers over the following week [2, 3] when played in a 4-hour time window after viewing. We reasoned that this was because having to follow and track the shapes, colour and movement of the coloured blocks in Tetris soon after seeing the experimental trauma (the film) disrupted aspects of the visual memory of that event from being ‘laid down’ in the sensory part of the brain, whilst leaving memory for the narrative and meaning of the events unaffected.

• However, it is hard to reach people so soon after a traumatic event in the real world and memories for events become ‘fixed’ in mind within hours after an event making them difficult to change. Therefore it was important to show whether we can change older, established memories of trauma.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 78: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

• MedicalResearch: What are the main findings?• Dr. James: To our knowledge, this work is the first to show that it is theoretically possible to

disrupt involuntary intrusive memory for events that are ‘fixed’ in mind, in the current study a memory for an experimental trauma that is 1 day old. The study addressed memory ‘reconsolidation’ and used a simple cognitive blockade procedure (rather than drugs or a more complex task) involving 3 steps;

• 1) reactivation of the memory (volunteers viewed non-traumatic still images from the film watched 24 hours earlier,

• 2) a wait period of 10 minutes to allow for memory for the experimental trauma to ‘become malleable’, then

• 3) Tetris game play to interfere with the malleable memory, and reduce the occurrence of subsequent intrusive memories over the week.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 79: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

We showed that merely playing ‘Tetris’ (without prior reactivation) did not reduce intrusions – by analogy, distraction by enjoyable computer games alone may not help. Further, just being exposed to reminders of the event (without Tetris play afterwards) did not reduce subsequent intrusion frequency – by analogy then, simply recalling/talking about a trauma in the absence of the cognitive task, may not help reduce intrusive memories. Rather, it is the critical combination of both reactivating the trauma memory followed by a short break and then playing ‘Tetris’ that is necessary to reduce the occurrence of later intrusive memories.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 80: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. James: The first key take-home message is that these findings relate to experimental

research that is still in the early stages, so no immediate clinical implications can be drawn.• Our research uses an experimental trauma to study intrusive, visual images that pop back to

mind involuntary as an analogue of intrusive memories that are the hallmark symptom of post-traumatic stress disorder (PTSD).

• From a research perspective our findings indicate that it may be possible, under certain conditions, to render old memory for emotional events as less intrusive, even for memories have consolidated and are established in mind. Further research is needed to develop this approach as a potential intervention to reduce intrusive memories. Again, we are keen to emphasise that this research is still in the early stages, and careful steps need to be taken to translate findings from the laboratory to the clinic.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 81: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

May Be Possible To Use Video Games To Block PTSD Intrusive MemoriesMedicalResearch.com interview withDr. Ella James, Post-Doctoral Investigator ScientistMedical Research Council Cognition and Brain Sciences UnitCambridge, UK.

• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. James: Again, it is important to highlight that findings thus far are from laboratory-based experimental research. However, a future step is to investigate whether findings can be extended to real-world traumatic events, e.g. after traumatic events while people are waiting in Hospital Emergency Departments.

• Citation• [1] James, E. L., Bonsall, M. B., Hoppitt, L., Tunbridge, E. M., Geddes, J. R., Milton, A. L., & Hol

mes, E. A. (2015). Computer game play reduces intrusive memories of experimental trauma via reconsolidation update mechanisms. Psychological Science, OnlineFirst. doi: 10.1177/0956797615583071

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 82: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Putting More People On Statins Would Be Cost Effective and Improve Heart HealthMedicalResearch.com Interview with: Dr. Ankur Pandya Ph.D.Assistant Professor of Health Decision ScienceDepartment of Health Policy and Management

Harvard T.H. Chan School of Public Health Boston, MA

• Medical Research: What is the background for this study? What are the main findings?

Dr. Pandya: The American College of Cardiology and the American Heart Association (ACC-AHA) cholesterol treatment guidelines were controversial when first released in November 2013, with some concerns that healthy adults would be over-treated with statins.

• We found that the current 10-year ASCVD risk threshold (≥7.5%) used in the ACC-AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (incremental cost-effectiveness ratio of $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (≥4.0%) or $150,000/QALY (≥3.0%).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 83: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Putting More People On Statins Would Be Cost Effective and Improve Heart HealthMedicalResearch.com Interview with: Dr. Ankur Pandya Ph.D.Assistant Professor of Health Decision ScienceDepartment of Health Policy and Management

Harvard T.H. Chan School of Public Health Boston, MA

• Medical Research: What should clinicians and patients take away from your report?• Dr. Pandya: It would be cost effective to treat 48-67% of all adults aged 40-75 in the United

States with statins.• We found that our results were sensitive to patient preferences for taking a pill daily.

Specifically, most patients don’t mind taking a pill daily; for these types of individuals, an ASCVD threshold as low as ≥3.0% (i.e., 67% of adults treated) was cost-effective. But for patients that associate substantial disutility with act of taking a pill daily (disutility of -0.009), the optimal ASCVD threshold could be as high as ≥15.0% (i.e., 39% of adults treated).

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 84: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Putting More People On Statins Would Be Cost Effective and Improve Heart HealthMedicalResearch.com Interview with: Dr. Ankur Pandya Ph.D.Assistant Professor of Health Decision ScienceDepartment of Health Policy and Management

Harvard T.H. Chan School of Public Health Boston, MA

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Pandya: Given the importance of patient preference on the optimal treatment threshold, it would very useful to see more studies that further quantify the quality-of-life impacts of cardiovascular disease prevention efforts (such as a taking a pill daily, other forms of medical treatment, behaviors such as diet and exercise, etc.).

• Citation:• Ankur Pandya, Stephen Sy, Sylvia Cho, Milton C. Weinstein, Thomas A. Gaziano. Cost-

effectiveness of 10-Year Risk Thresholds for Initiation of Statin Therapy for Primary Prevention of Cardiovascular Disease. JAMA, 2015; 314 (2): 142 DOI: 10.1001/jama.2015.6822

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 85: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Co-ingestion of Benzodiazepines and Opioids Contributes to Overdose and DeathMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.HSenior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What is the background for this study?

Dr. Jones: Opioid analgesics and benzodiazepines are the two most common drug classes involved in prescription drug overdose deaths. In 2010, 75% of prescription drug overdose deaths involved opioid analgesics and 29% involved benzodiazepines. Opioid analgesics and benzodiazepines are also the most common drugs associated with emergency department visits due to nonmedical use of prescription drugs.

• Combined opioid and benzodiazepine use has been suggested as a risk factor for overdose death.• Opioids and benzodiazepines have complex drug interactions and in combination can result in

synergistic respiratory depression, but the exact mechanisms by which benzodiazepines worsen opioid-related respiratory depression are not fully understood.

• Widespread co-use of benzodiazepines and opioids has been documented in both chronic pain and addiction treatment settings. Studies suggest that among patients who receive long-term opioids for chronic non-cancer pain, 40% or more also use benzodiazepines. Among patients who abuse opioids, benzodiazepine abuse also is prevalent, and co-users report using benzodiazepines to enhance opioid intoxication.

• This study builds on the prior literature by analyzing trends on how the combined use of opioids and benzodiazepines in the U.S. contributes to the serious adverse outcomes of nonmedical use–related ED visits and drug overdose deaths. A better understanding of the consequences of co-use of these medications will help identify at-risk populations, inform prevention efforts, and improve the risk–benefit balance of these medications.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 86: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Co-ingestion of Benzodiazepines and Opioids Contributes to Overdose and DeathMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.HSenior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

Medical Research: What are the main findings?

Dr. Jones: From 2004 to 2011, the rate of nonmedical use–related Emergency Department visits involving both opioid analgesics and benzodiazepines increased from 11.0 to 34.2 per 100,000 population. During the same period, drug overdose deaths involving both drugs increased from 0.6 to 1.7 per 100,000. Statistically significant increases in Emergency Department visits occurred among males and females, non-Hispanic whites, non-Hispanic blacks, and Hispanics, and all age groups except 12–17-year-olds. For overdose deaths, statistically significant increases were seen in males and female, all three race/ethnicity groups, and all age groups except 12–17-year-olds. Benzodiazepine involvement in opioid analgesic overdose deaths increased each year, increasing from 18% of opioid analgesic overdose deaths in 2004 to 31% in 2011.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 87: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Co-ingestion of Benzodiazepines and Opioids Contributes to Overdose and DeathMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.HSenior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What should clinicians and patients take away from your report?• Dr. Jones: This study describes the increasing public health burden of opioid analgesic and

benzodiazepine co-ingestion. Interventions to reduce morbidity and mortality from the co-ingestion of these drugs will require a multifaceted approach, including prescriber education, state-level policies, and enforcement practices that hold providers accountable for appropriate prescribing; federal regulatory actions that improve safe use of these medications; community-level prevention; and coordinated treatment for pain, mental health, and substance use disorders, which often co-occur. Raising provider and public awareness is an important step toward the advancement of policies and programs designed to achieve a better balance between the benefits and risks associated with these medications.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 88: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Co-ingestion of Benzodiazepines and Opioids Contributes to Overdose and DeathMedicalResearch.com Interview with:Christopher M. Jones, Pharm D., M.P.HSenior advisor, Office of Public Health Strategy and Analysis

Office of the Commissioner, Food and Drug Administration

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Jones: More research is needed to better understand patterns and trends in benzodiazepine prescribing—and particularly co-prescribing with opioids—and to assess the effectiveness of strategies to reduce inappropriate co-prescribing and co-use of these drugs. Further research is needed to examine use, abuse, and overdose associated with specific opioids and benzodiazepines and combinations; the role of alternate routes of administration; and the potential for abuse-deterrent technologies to reduce opioid–benzodiazepine abuse and its adverse health consequences.

• HHS Secretary Sylvia M. Burwell has made addressing opioid abuse, dependence, and overdose a priority and work is underway within HHS on this important issue. The evidence-based initiative focuses on three promising areas: informing opioid prescribing practices, increasing the use of naloxone – a drug that reverses symptoms of a drug overdose, and using medication-assisted treatment to slowly move people out of opioid addiction.

• The Obama Administration is also committed to tackling the prescription drug and heroin epidemic, proposing significant investments to intensify efforts to reduce opioid misuse and abuse.

• Citation:• Am J Prev Med. 2015 Jul 2. pii: S0749-3797(15)00163-4. doi: 10.1016/j.amepre.2015.03.040. [Epub

ahead of print]• Emergency Department Visits and Overdose Deaths From Combined Use of Opioids and Benzodiaz

epines.• Jones CM1, McAninch JK2.Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 89: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Primary Care Continuity Reduced Emergency Department Use and HospitalizationsMedicalResearch.com Interview with:Nadereh Pourat, PhDProfessor, Department of Health Policy and Management, UCLA Fielding School of Public Health

Adjunct Professor, UCLA School of DentistryDirector of Research, UCLA Center for Health Policy Research

Medical Research: What is the background for this study? What are the main findings?

Dr. Pourat: We have succeeded to insure most of the uninsured population in the U.S., but now have to figure out how to reduce costs while improving health. We had the opportunity to examine the role of continuity with a primary care provider, which is one of the pathways that looked promising in improving health and reducing costs. We were evaluating a major demonstration program in California called the Health Care Coverage Initiative (HCCI) and one of the participating counties implemented a policy to increase adherence by only paying for visits if patients went to their assigned providers. We examined what happened to patients who always or sometimes adhered to their provider versus those who never adhered. We found that adherence or continuity reduced emergency department use and hospitalizations. This would lead to savings because of the high costs of these services.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 90: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Primary Care Continuity Reduced Emergency Department Use and HospitalizationsMedicalResearch.com Interview with:Nadereh Pourat, PhDProfessor, Department of Health Policy and Management, UCLA Fielding School of Public Health

Adjunct Professor, UCLA School of DentistryDirector of Research, UCLA Center for Health Policy Research

• • Medical Research: What should clinicians and patients take away from your report?• Dr. Pourat: The study shows that both patients and clinicians would benefit from continuity

with the primary care provider. Clinicians can actually make a difference in helping patients: they can teach patients about self-care and help them manage their conditions better. Patients would benefit from following through with treatment plans and experience less medical error and duplication of services which are potentially harmful. Continuity fosters rapport and trust between patients and providers and can be beneficial to both.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 91: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Primary Care Continuity Reduced Emergency Department Use and HospitalizationsMedicalResearch.com Interview with:Nadereh Pourat, PhDProfessor, Department of Health Policy and Management, UCLA Fielding School of Public Health

Adjunct Professor, UCLA School of DentistryDirector of Research, UCLA Center for Health Policy Research

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Pourat: We need more studies that look at how else we can improve health care delivery, now that the Affordable Care Act has sharpened the focus on the Triple Aim of better care, better health, and lower costs. We cannot achieve these aims without changing the way we practice medicine or seek care. We need studies that show what we need to do differently and what results we can expect. It is an important and iterative process.

• Citation:• In California, Primary Care Continuity Was Associated With Reduced Emergency Department

Use And Fewer Hospitalizations • Nadereh Pourat, Anna C. Davis, Xiao Chen, Shelley Vrungos, and Gerald F. Kominski• Health Aff July 2015 34:71113-1120; doi:10.1377/hlthaff.2014.1165

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 92: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Only About 10% US Adults Eat Sufficient VegetablesMedicalResearch.com Interview with:Latetia V. Moore Ph.D. MSPHEpidemiologist, Centers for Disease Control

• Medical Research: What is the background for this study?

Dr. Moore: For this study, CDC researchers analyzed the average daily fruit and vegetable intake from the 2013 Behavioral Risk Factor Surveillance System (BRFSS) for the 50 states and the District of Columbia (DC) and the percent of each state’s population meeting fruit and vegetable intake recommendations. BRFSS is the sole source of dietary information (systematic surveillance) for most states.

• Medical Research: What are the main findings?• Dr. Moore: Researchers found that in every state less than 1 in 5 adults in the U.S. are

consuming enough fruits and about 1 in 10 are consuming enough vegetables. Estimates ranged from 8% meeting fruit recommendations in Tennessee up to 18% in California, and for vegetables from 6% in Mississippi to 13% in California.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 93: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Only About 10% US Adults Eat Sufficient VegetablesMedicalResearch.com Interview with:Latetia V. Moore Ph.D. MSPHEpidemiologist, Centers for Disease Control

• Medical Research: What should clinicians and patients take away from your report?• Dr. Moore: There are significant health benefits associated with eating fruits and vegetables.

These foods provide essential nutrients and help to reduce the risk for leading causes of illness and death. Eating more fruits and vegetables helps to manage body weight when consumed in place of foods high in added sugars and fat. Clinicians could counsel adult patients to ensure their healthy eating pattern consist of the recommended 1 ½ to 2 cups per day of fruit and 2 to 3 cups per day of vegetables. A cup is about a large banana or 12 baby carrots.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 94: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Only About 10% US Adults Eat Sufficient VegetablesMedicalResearch.com Interview with:Latetia V. Moore Ph.D. MSPHEpidemiologist, Centers for Disease Control

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Moore: Future research is needed to understand how to increase demand and consumption of fruits and vegetables, as well as research on ways to encourage healthy eating patterns during childhood. We need to evaluate what strategies make it easier for adults to choose healthier foods. Recommendations include exploring what effect better placement, pricing, and promotion of fruits and vegetables in grocery stores, restaurants, worksites, and communities has on intake. It is also important to look at how childcare, schools, and school districts can influence children’s eating habits when they implement federal nutrition standards for meals and snacks and serve fruits and vegetables whenever food is offered.

• Citation:• Adults Meeting Fruit and Vegetable Intake Recommendations — United States, 2013• MMWR Weekly• July 10, 2015 / 64(26);709-713• Latetia V. Moore, PhD1; Frances E. Thompson, PhD2 (Author affiliations at end of text

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 95: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Aspirin Inhibits Growth of Mesothelioma Cells in Mouse ModelMedicalResearch.com Interview with:Haining Yang MD Ph.DAssociate Professor Thoracic Oncology ProgramUniversity of Hawaii Cancer CenterUniversity of Hawaii, Honolulu, HI

Medical Research: What is the background for this study?

Dr. Yang: Mesothelioma is often caused by asbestos and other carcinogenic mineral fibers. When these fibers lodge in the pleura, mesothelial cells and macrophages try to phagocytize and eliminate them. They cannot and undergo programmed cell necrosis, which leads to the release of HMGB1 into the extracellular space. HMGB1 is a Damage DAMP that starts a chronic inflammatory process that overtime may lead to malignancy. Mesothelioma cells develop out of an environment that is rich in HMGB1 and are often dependent on HMGB1 for their own growth. In fact, most mesothelioma cells actively secrete HMGB1 extracellularly to promote their own tumor growth. Accordingly HMGB1 levels are high in the serum of mesothelioma patients (reviewed in Yang and Carbone, Clinical Cancer Res 2013). We tested several anti-inflammatory agents to see if we were able to reduce HMGB1-indiced mesothelioma cell growth, and none of them worked except for aspirin, that led us to conduct a series of experiments in vitro and in vivo to test the hypothesis that aspirin inhibited HMGB1 and that by doing so inhibited mesothelioma growth.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 96: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Aspirin Inhibits Growth of Mesothelioma Cells in Mouse ModelMedicalResearch.com Interview with:Haining Yang MD Ph.DAssociate Professor Thoracic Oncology ProgramUniversity of Hawaii Cancer CenterUniversity of Hawaii, Honolulu, HI

Medical Research: What are the main findings?

Dr. Yang: We found that aspirin inhibits the growth of human mesothelioma cells in a xenograft model, moreover in vitro experiments demonstrated that this effects was specifically mediated via inhibition of HMGB1 and not via COX2 inhibition. We propose that the so far enigmatic anticancer activity of aspirin is mediated via inhibition of HMGB1 and that aspirin may help delay the onset of mesothelioma and may help inhibit the growth of mesothelioma

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 97: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Aspirin Inhibits Growth of Mesothelioma Cells in Mouse ModelMedicalResearch.com Interview with:Haining Yang MD Ph.DAssociate Professor Thoracic Oncology ProgramUniversity of Hawaii Cancer CenterUniversity of Hawaii, Honolulu, HI

• Medical Research: What should clinicians and patients take away from your report?• Dr. Yang: Recent studies conclusively demonstrated that taking daily aspirin reduces the

incidence of colon cancer and of other inflammatory related malignancies -which are also associated with increased serum levels of total HMGB1. Our finding provide a mechanistic rationale to these findings indicating that the anticancer activity of aspirin is at least in part related to its ability to inhibit HMGB1. In addition our findings suggest that patients at risk for mesothelioma, for example workers exposed to asbestos, similarly to patients at risk for colon cancer, may benefit from daily aspirin taken over the course of several years. Whether aspirin will also reduce mesothelioma growth in humans, as observed in mice, remains to be seen.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 98: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Aspirin Inhibits Growth of Mesothelioma Cells in Mouse ModelMedicalResearch.com Interview with:Haining Yang MD Ph.DAssociate Professor Thoracic Oncology ProgramUniversity of Hawaii Cancer CenterUniversity of Hawaii, Honolulu, HI

• Medical Research: What should clinicians and patients take away from your report?• Dr. Yang: Recent studies conclusively demonstrated that taking daily aspirin reduces the

incidence of colon cancer and of other inflammatory related malignancies -which are also associated with increased serum levels of total HMGB1. Our finding provide a mechanistic rationale to these findings indicating that the anticancer activity of aspirin is at least in part related to its ability to inhibit HMGB1. In addition our findings suggest that patients at risk for mesothelioma, for example workers exposed to asbestos, similarly to patients at risk for colon cancer, may benefit from daily aspirin taken over the course of several years. Whether aspirin will also reduce mesothelioma growth in humans, as observed in mice, remains to be seen.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 99: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Panel Recommends Improvements in Estrogen Testing AccuracyMedicalResearch.com Interview with:Hubert W. Vesper, PhDDirector, Clinical Standardization Programs in the National Center for Environmental Health, Centers for Disease Control and Prevention

Co-author, “Measuring Estrogen Exposure and Metabolism: Workshop Recommendations on Clinical Issues”Co-chair of the PATH Steering Committee

• Medical Research: What is the background for this study? What are the main findings?

Dr. Vesper: Accurate data on estrogen levels are needed to ensure appropriate and effective patient care. Research studies found high inaccuracies among different estrogen tests, especially at low estrogen levels commonly observed in postmenopausal women, men and children.

• Accurate estrogen measurements can be achieved through standardization. Stakeholders should support standardization efforts of the Centers for Disease Control and Prevention (CDC) or alternative strategies to arrive at estrogen measurement methods that are accuracy-based and reliable.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 100: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Panel Recommends Improvements in Estrogen Testing AccuracyMedicalResearch.com Interview with:Hubert W. Vesper, PhDDirector, Clinical Standardization Programs in the National Center for Environmental Health, Centers for Disease Control and Prevention

Co-author, “Measuring Estrogen Exposure and Metabolism: Workshop Recommendations on Clinical Issues”Co-chair of the PATH Steering Committee

• Medical Research: What should clinicians and patients take away from your report?• Dr. Vesper: These are the first recommendations on clinical issues related to estrogen testing

developed by an expert group from the clinical, research and public health communities. The panel recommendations were developed based on discussions at an estrogen measurement workshop hosted by the Endocrine Society, AACC and the Partnership for Accurate Testing of Hormones (PATH).

• The recommendations inform about the importance of accurate estrogen testing and activities to improve and maintain high quality estrogen tests. Accurate estrogen tests ensure consistent patient assessment and care, reduce the need for retesting of patients, and enable the implementation of research findings in patient care.

• As they select from among the current assays, clinicians and researchers should consider the purpose of the test and select the most appropriate estrogen measurement method for the situation.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

Page 101: MedicalResearch.com:  Medical Research Exclusive Interviews July 16 2015

Panel Recommends Improvements in Estrogen Testing AccuracyMedicalResearch.com Interview with:Hubert W. Vesper, PhDDirector, Clinical Standardization Programs in the National Center for Environmental Health, Centers for Disease Control and Prevention

Co-author, “Measuring Estrogen Exposure and Metabolism: Workshop Recommendations on Clinical Issues”Co-chair of the PATH Steering Committee

• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Vesper: Clinicians and researchers currently use several methods to measure estrogen, including Immunoassays and mass spectrometry-based assays. Research is needed to evaluate the different approaches for validation of estrogen assay accuracy. Studies should be conducted to assess the general applicability of current methods and to obtain further information about the strengths and limitations of each approach.

• Citation:• L.M. Demers, PhD, et al. Measuring Estrogen Exposure and Metabolism: Workshop

Recommendations on Clinical Issues. Journal of Clinical Endocrinology & Metabolism, April 7, 2015. DOI: 10.1210/jc.2015-1040

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.