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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

There has been a genuine decline in semen quality over the past 50 years. There is lot of controversy about this as there are limitations in studies that have attempted to address it. Sperm count is of considerable public health importance for several reasons. First, sperm count is closely linked to male fecundity and is a crucial component of semen analysis, the first step to identify male factor infertility.

 

Reduced sperm count is associated with cryptorchidism, hypospadias and testicular cancer. It may be associated with multiple environmental influences, including endocrine disrupting chemicals, pesticides, heat and lifestyle factors, including diet, stress, smoking and BMI. Therefore, sperm count may sensitively reflect the impacts of the modern environment on male health throughout the life course.

 

This study provided a systematic review and meta-regression analysis of recent trends in sperm counts as measured by sperm concentration (SC) and total sperm count (TSC), and their modification by fertility and geographic group. Analyzing trends by birth cohorts instead of year of sample collection may aid in assessing the causes of the decline (prenatal or in adult life) but was not feasible owing to lack of information.

 

This rigorous and comprehensive analysis found that SC declined 52.4% between 1973 and 2011 among unselected men from western countries, with no evidence of a ‘leveling off’ in recent years. Declining mean SC implies that an increasing proportion of men have sperm counts below any given threshold for sub-fertility or infertility. The high proportion of men from western countries with concentration below 40 million/ml is particularly concerning given the evidence that SC below this threshold is associated with a decreased monthly probability of conception.

 

Declines in sperm count have implications beyond fertility and reproduction. The decline reported in this study is consistent with reported trends in other male reproductive health indicators, such as testicular germ cell tumors, cryptorchidism, onset of male puberty and total testosterone levels. The public health implications are even wider. Recent studies have shown that poor sperm count is associated with overall morbidity and mortality. While the current study is not designed to provide direct information on the causes of the observed declines, sperm count has been plausibly associated with multiple environmental and lifestyle influences, both prenatally and in adult life. In particular, endocrine disruption from chemical exposures or maternal smoking during critical windows of male reproductive development may play a role in prenatal life, while lifestyle changes and exposure to pesticides may play a role in adult life.

 

These findings strongly suggest a significant decline in male reproductive health, which has serious implications beyond fertility concerns. Research on causes and implications of this decline is urgently needed.

 

References:

 

https://academic.oup.com/humupd/article/doi/10.1093/humupd/dmx022/4035689/Temporal-trends-in-sperm-count-a-systematic-review

 

https://www.ncbi.nlm.nih.gov/pubmed/6688444

 

https://www.ncbi.nlm.nih.gov/pubmed/8458929

 

https://www.ncbi.nlm.nih.gov/pubmed/9777833

 

https://www.ncbi.nlm.nih.gov/pubmed/19934213

 

https://www.ncbi.nlm.nih.gov/pubmed/27075904

 

https://www.ncbi.nlm.nih.gov/pubmed/12849857

 

https://www.ncbi.nlm.nih.gov/pubmed/8612826

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3-D printed ovaries produce healthy offspring

Reported by: Irina Robu, PhD

Each year about 120,000 organs are transplanted from one human being to another and most of the time is a living volunteer. But lack of suitable donors, predominantly means the supply of such organs is inadequate. Countless people consequently die waiting for a transplant which has led researchers to study the question of how to build organs from scratch.

One promising approach is to print them, but “bioprinting” remains largely experimental. Nevertheless, bioprinted tissue is before now being sold for drug testing, and the first transplantable tissues are anticipated to be ready for use in a few years’ time. The first 3D printed organ includes bioprosthetic ovaries which are constructed of 3D printed scaffolds that have immature eggs and have been successful in boosting hormone production and restoring fertility was developed by Teresa K. Woodruff, a reproductive scientist and director of the Women’s Health Research Institute at Feinberg.
What sets apart these bioprosthetic ovaries is the architecture of the scaffold. The material is made of gelatin made from broken-down collagen that is safe to humans which is self-supporting and can lead to building multiple layers.

The 3-D printed “scaffold” or “skeleton” is implanted into a female and its pores can be used to optimize how follicles, or immature eggs, get wedged within the scaffold. The scaffold supports the survival of the mouse’s immature egg cells and the cells that produce hormones to boost production. The open construction permits room for the egg cells to mature and ovulate, blood vessels to form within the implant enabling the hormones to circulate and trigger lactation after giving birth. The purpose of this scaffold is to recapitulate how an ovary would function.
The scientists’ only objective for developing the bioprosthetic ovaries was to help reestablish fertility and hormone production in women who have suffered adult cancer treatments and now have bigger risks of infertility and hormone-based developmental issues.

SOURCE
https://www.economist.com/news/science-and-technology/21715638-how-build-organs-scratch


New Treatment in Development for Glioblastoma: Hopes for Sen. John McCain

Reporter: Aviva Lev-Ari, PhD, RN

We wish all patients diagnosed with Glioblastoma to be able to benefit from the advancements in Sciences reported, below

SOURCE

Glioblastoma Is A Grim Diagnosis, But There Are Some Signs Of Hope

Karen Weintraub, July 20, 2017 Updated July 21, 2017 5:33 PM

 

Advancements in Crossing The Blood-Brain Barrier

Paula Hammond, of MIT’s Koch Institute of Integrative Cancer Research: “We believe we have a handle on a good stealth mechanism. Now, we’re looking at enhanced uptake,” she said. “We have to begin to think a little bit about how to get nature on our side on this one.”

At the Brigham, researchers are trying another approach to getting across the blood-brain-barrier: prying open holes in its armor with beams of ultrasound. Although normally used to take cool pictures during pregnancy, multiple beams of ultrasound aimed at the same area can make blood vessels of the brain “leakier,” according to research at the Brigham.

 

Advancement in Stem Cells against Tumors

There’s also a possibility that stem cells may be useful for tracking down and killing tumor cells. Khalid Shah, director for the Center for Stem Cell Therapeutics and Imaging at Brigham and Women’s Hospital, has been experimenting with delivering engineered stem cells directly to tumor sites after surgery.

William Curry at Mass. General, is that the longer a patient with glioblastoma can hang on, the better their chances of getting one of these new treatments.

“The longer you stay alive and the longer you maintain good neurological function, the more eligible you one may be to see the benefits and the fruits of a lot of the research that is really accelerating right now,” he said.

SOURCE

Glioblastoma Is A Grim Diagnosis, But There Are Some Signs Of Hope


M&A of Online health publisher, WebMD Health Corporation by KKR & Co.: Dynamics in Health Care Media, Web-Health and Health Information Markets

Reporter and Curator: Aviva Lev-Ari, PhD, RN

 

The New York-based WebMD Health Corp., health-information provider (WBMD) was acquired by KKR & Co., deal reached on 7/24/2017.  The deal, approved by the WebMD board, is expected to close in the fourth quarter of 2017.

New management at KKR was announced: Co-Presidents and Co-Operating Officers:

  • Joe Bae, and
  • Scott Nuttall

They are replacing Henry Kravits and George Roberts, who started KKR in 1976. 

  • J.P. Morgan Securities LLC is WebMD’s financial adviser 
  • Shearman & Sterling LLP is WebMD’s legal adviser.
  • Simpson Thacher & Bartlett LLP is KKR’s Internet Brands’ legal adviser.

 

WebMD’s chairman Martin Wygod said Monday’s deal was the culmination of a sale process that reached 100 possible buyers as is seen as the best possible premium for shareholders. Though Monday’s deal is struck at a substantial premium to WebMD’s beginning-of-year share price it is roughly the same price as the company’s May 2016 highs. Over the past three and five years, WebMD has returned 15% and 190% respectively, indicating the company’s volatile run on public stock markets as a midcap web health brand.

Herald Chen, head of KKR’s technology industry team, “KKR and Internet Brands are pleased to be investing behind the experienced WebMD management team and trusted WebMD platforms. The combined portfolio of leading vertical internet assets will be a powerful one.”

https://www.forbes.com/sites/antoinegara/2017/07/24/kkr-strikes-deal-to-buy-health-information-giant-webmd-for-2-8b-and-a-former-partner-scores/#6f3f567b2730

Founded in 1996, WebMD has grown into one of the most popular health websites for consumers and medical professionals, attracting more than 70 million monthly unique visitors in 2016, according to analytics company comScore Inc (SCOR.PK). WebMD was founded by Jeffrey Arnold, who became a billionaire at age 29 when the company merged with Healtheon Corp. in 1999.

https://research.tdameritrade.com/grid/public/markets/news/story.asp?docKey=1-SN20170724000559&provider=CBSMarketWatch

Internet Brands, which launched as CarsDirect.com in 1998, licenses and delivers its content and internet technology products and services to small and medium-sized businesses. It was acquired by KKR in 2014 for $1.1 billion from two other private equity firms, Hellman & Friedman LLC and JMI Equity.

Under KKR, the company has expanded its portfolio of brands to include Demandforce and Fodor’s Travel.

A deal would make WebMD the latest healthcare media company to be sold. In December, j2 Global Inc’s (JCOM.O) digital media arm Ziff Davis LLC acquired Everyday Health Inc, a U.S. operator of health-related websites, for $465 million, including debt.

SOURCE

http://uk.reuters.com/article/us-webmd-m-a-kkr-exclusive-idUKKBN1A80US

https://www.wsj.com/articles/kkr-co-near-deal-to-buy-webmd-1500851095

 Results for WebMD 4Q2016

 

Fourth quarter revenue was $207.5 million, compared to $192.1 million last year, an increase of 8%. Advertising and sponsorship revenue grew 8% to $171 million, compared to $158.3 million in the prior year period. Breaking down our advertising and sponsorship revenue further:

• revenue from biopharma and medical device clients increased 11% compared to the prior year period; and

• revenue from OTC, CPG and other clients was comparable to the prior year period.

Health services revenue was $28.8 million, an increase of 6% compared to $27.2 million in the prior year period. Information services revenue was $7.7 million, an increase of 16% compared to $6.6 million in the prior year period. Fourth quarter net income increased 32% to $36.2 million or $0.73 per diluted share compared to $27.5 million, or $0.60 per diluted share in the prior year period. Fourth quarter Adjusted EBITDA increased 16% to $78.1 million, or 38% of revenue, compared to $67.4 million, or 35% of revenue, in the prior year period. Capital expenditures were $5.3 million in the quarter. Operating cash flow was approximately $66.9 million in the quarter. This includes a cash tax benefit of $28 million related to the use of our tax NOL’s generated by stock based compensation which, as required by GAAP, are included in the financing section of the cash flow statement rather than in the operating section.

SOURCE

TRANSCRIPT OF Q4 2016 WEBMD EARNINGS CONFERENCE CALL – Feb. 16, 2017

http://files.shareholder.com/downloads/WBMD/4075514959x0x929898/89CBE95F-8CF1-4234-B809-D93060391CE5/WBMD_Q4_16_TRANSCRIPT.pdf

Current Portfolio of Assets in Health-related Websites: Outcome of 

M&A of WebMD by KKR 

The deal brings together WebMD’s websites, such as

with those owned by KKR unit Internet Brands Inc, including businesses serving 50,000 health practices and boast a big footprint in cloud web hosting geared towards practitioners such as dentists, chiropractors, veterinarians, eye doctors and therapists. Its operating businesses include

 

SOURCES

http://www.cnbc.com/2017/07/24/webmd-to-be-acquired-by-kkr-for-66-point-50-a-share-in-cash.html

https://www.forbes.com/sites/antoinegara/2017/07/24/kkr-strikes-deal-to-buy-health-information-giant-webmd-for-2-8b-and-a-former-partner-scores/#6f3f567b2730

The DEAL

 

…On a P/E basis the deal price represents 32.4x our 2017 GAAP EPS estimate of $2.05 and 31.7x our 2018 estimate of $2.10. EVDY received 9.6x FY1 and 7.5x FY2 Adj. EBITDA last year when it was acquired by JCOM. On an EV/Adj. EBITDA basis we estimate the deal represents 10.7x 2017E EBITDA and 10.1x 2018E EBITDA, which is well above the multiple that EVDY received. This news is a significant positive given that the deal price is slightly above the range we had been assuming, and there had been some news commentary recently that WBMD was having some challenges agreeing on a price with prospective buyers.

SOURCE

http://www.barrons.com/articles/kkr-deal-revives-webmd-shares-1500903910

WebMD Is Said Near a Sale to K.K.R.

The health publisher WebMD could soon join a stable that also houses DentalPlans.comVeinDirectory.org and AllAboutCounseling.com.

K.K.R. is near to an all-cash deal to buy WebMD Health Corporation, which owns WebMD.com,Medscape.com and MedicineNet.comReuters and The Wall Street Journal reported.

The deal would bring all the WebMD websites into K.K.R.’s company Internet Brands.

WebMD, which has a market capitalization of $2.1 billion, had said in February that it would explore its options after a slowdown in pharmaceuticals advertising.

SOURCE

From: CNBC Morning Squawk <morningsquawk@response.cnbc.com>

Reply-To: CNBC <reply-feef1278736c00-23_HTML-4897801-7204331-344@response.cnbc.com>

Date: Monday, July 24, 2017 at 8:34 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Earnings, Fed hold keys to Wall Street’s recent record run

 

 


FDA: CAR-T therapy outweigh its risks tisagenlecleucel, manufactured by Novartis of Basel – 52 out of 63 participants — 82.5% — experienced overall remissions – young patients with Leukaemia [ALL]

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Basel, July 12, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

“The panel’s unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need,” said Bruno Strigini, CEO, Novartis Oncology. “We’re very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review.”

Acute lymphoblastic leukemia comprises approximately 25% of cancer diagnoses among children under 15 years old and is the most common childhood cancer in the US[1]. Effective treatment options for patients with r/r ALL are limited. In pediatric and young adult patients with B-cell ALL that have relapsed multiple times or become refractory to treatment, the five-year disease-free survival is less than 10-30%[2],[3],[4].

CTL019 was first developed by the University of Pennsylvania (Penn) and uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses as well as persistence of CTL019 after it is infused into the patient, which may be associated with long-lasting remissions in patients. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers. Children’s Hospital of Philadelphia (CHOP) was the first institution to investigate CTL019 in the treatment of pediatric patients and led the single site trial.

SOURCE

https://www.novartis.com/news/media-releases/novartis-car-t-cell-therapy-ctl019-unanimously-10-0-recommended-approval-fda

RISKS:

During the 2015 tisagenlecleucel trial, 47% of participants experienced an

  • extreme inflammatory reaction known as cytokine release syndrome, severe cases of which are called cytokine storms. The syndrome — characterized by symptoms such as high fevers and organ failure — can be life-threatening. But
  • Novartis says trial clinicians were able to manage the reaction successfully in all cases.
  • Neurological problems such as seizures and hallucinations were also relatively common but temporary,
  • the Novartis team reported. This is in stark contrast to some other CAR-T trials that have,
  • over the past year, reported the deaths of several participants from severe brain swelling.
  • Novartis’s therapy is not identical to the CAR-T cells used in those trials, which were administered in adults, but the deaths cast a pall over the entire field.

To generate a batch of tisagenlecleucel, white blood cells are purified from a sample of a patient’s blood and shipped to a central processing centre. There, staff use a virus to insert into the T cells genes that encode a cellular receptor — called a chimaeric antigen receptor — that will recognize leukaemia cells.

SOURCE

Engineered cell therapy for cancer gets thumbs up from FDA advisers

Treatment shows promise in young people with leukaemia, but safety risks abound.

Heidi Ledford, 12 July 2017

http://www.nature.com/news/engineered-cell-therapy-for-cancer-gets-thumbs-up-from-fda-advisers-1.22304?WT.ec_id=NEWSDAILY-20170713


Palestine-Israel Conflict

by Avi Goldreich, used by courtesy of Think-Israel.org

Translated from the Hebrew by Nurit Greenger.
Original Hebrew version can be read here.

The time machine is a sensation that nests in me when I am visiting Mr. Hobber old books store in Budapest, Hungary. Hobber learned to know my quirks and after the initial greeting and the glass of mineral water (Mr. Hobber is a vegan) he leads me down the stairs to the huge basement, to the Jewish “section.”

The Jewish section is a room full of antiquity books on subjects that Mr. Hobber sees to be Jewish. Among the books there are some that are not even worthy their leather binding. However, sometime, one can find there real culture treasure. Many of the books are Holy Books that may have been stolen from synagogues’ archives: Talmud, Bible, Mishnah, old Ashkenazi style Siddur, and others. Customarily, I open them…

View original post 906 more words


In Europe, BigData@Heart aim to improve patient outcomes and reduce societal burden of atrial fibrillation (AF), heart failure (HF) and acute coronary syndrome (ACS).

Reporter: Aviva Lev-Ari, PhD, RN

 

PRESS RELEASE

The objective of BigData@Heart is to develop a data-driven translational research platform of unparalleled scale and phenotypical resolution, with the aim to improve patient outcomes and reduce societal burden of atrial fibrillation (AF), heart failure (HF) and acute coronary syndrome (ACS).

AF, HF and ACS are major drivers of cardiovascular disease (CVD), which causes more than 3.9 million deaths each year across Europe – accounting for 45% of all deaths (49% of deaths among women and 40% of deaths among men) – with 1.3 million of these deaths occuring before the age of 75 years. Of the total cost of CVD in the EU (€210 billion a year), around 53% (€111 billion) is due to health care costs, 26% (€54 billion) to productivity losses and 21% (€45 billion) to the informal care of people with CVD.(i)

Currently, the management of AF, HF and ACS is complicated by their complex aetiology and heterogeneous prognoses. This renders the response to therapy unpredictable, with large variations amongst individuals and, importantly, small or undetectable treatment effects in large patient trials. Also, tolerability of medications and adherence to current treatments shows wide variations. Aside from the medical need, drug development pipelines from early target validation through to late post-marketing work have proven to be slow and high-risk. The lack of high-resolution biomarkers and computable definitions frustrates progress in the development of successful CVD therapies. There is a clear need for a better definition of CVD through improved biomarkers and endpoints, as well as its outcomes and prognoses.

BigData@Heart uniquely brings together key players and stakeholders in the CVD field to address these challenges. The clinical researchers involved have been instrumental in shaping current AF, HF and ACS treatment and management in Europe. They will join forces with leading epidemiologists, big data scientists, leading cardiovascular practitioners, pharmaceutical industry scientists, experts in ethics and legal aspects, and patient organisations from across Europe. The BigData@Heart consortium will develop a data-driven translational research platform which will be aiming at delivering clinically relevant disease phenotypes, scalable insights from real-world evidence, best-practices in drug development, and personalised medicines through advanced analytics.

For the first time, BigData@Heart will assemble European-wide consented cohorts (conventional research data), electronic health records (EHRs) in population settings (e.g. CALIBER, ABUCASIS, MONDRIAAN), hospital based EHRs, disease quality improvement registries (e.g. SWEDEHEART, NICOR, SwedeHF), clinically recorded imaging data, and trial data (covering over 75,000 patients).

BigData@Heart will deliver population relevant disease-based datasets (with > 5 million cases of HF, AF and ACS and healthy population cohorts > 16 million people accruing a further > 500,000 cases on follow up) and phenotypic depth with biomarker, behavioural, clinical, imaging data and genomic information with genome-wide association study (GWAS) consortia in each disease (AFGen, HERMES, GENIUS-CHD).

 

This project will develop and test a framework that will enable big data driven cardiovascular research, including the development of:

  • New definitions of diseases and outcomes that are universal, computable, and relevant for patients, clinicians, industry and regulators.
  • Informatics platforms that link, visualise and harmonise data sources of varying types, completeness and structure.
  • Data science techniques to develop new definitions of disease, identify new phenotypes, and construct personalized predictive models.
  • Guidelines that allow for cross-border usage of big data sources acknowledging ethical and legal constraints as well as data security.

The ultimate expected impact of BigData@Heart on science, industry, policies, and patients includes a better understanding of heart disease, the development of new therapy targets, improved drug and device development/utilisation, and laying a scientific foundation for progress in the personalised treatment and management of CVD.

 

BigData@Heart is a 5-year, € 19 million project supported by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry.  The pharmaceutical industry contributes half of BigData@Heart’s budget, while the other half is funded by the European Commission.

 

BigData@Heart Structure and Participants

The consortium is being jointly led by Prof. Diederick E. (Rick) Grobbee from the University Medical Center Utrecht (UMCU) and Dr. Gunnar Brobert from Bayer and consists of 19 partners coming from academia, medical associations, pharmaceutical industry, SMEs and patient organisations:

  • University Medical Center Utrecht (UMCU)
  • Charité – Universitätsmedizin Berlin (Charité)
  • European Society of Cardiology (ESC)
  • European Heart Network (EHN)
  • University College London (UCL)
  • University of Cambridge (CAM)
  • International Consortium for Health Outcomes Measurement (ICHOM)
  • Fundación para la investigación del Hospital Clinico de la Comunidad Valenciana (INCLIVA)

‘BigData@Heart will show how big data can drive progress in the treatment and management of CVD’, Prof. Diederick E. (Rick) Grobbee, University Medical Center Utrecht (UMCU)

 

For more info: www.bigdata-heart.eu

SOURCE

From: IMI BigDataAtHeart <info=vitaltransformation.com@mail231.atl171.mcdlv.net> on behalf of IMI BigDataAtHeart <info@vitaltransformation.com>

Reply-To: <us15-13fc61bdf7-d3376746c8@conversation01.mailchimpapp.com>

Date: Monday, July 10, 2017 at 6:05 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Press Release: Big Data for Better Hearts: Breaking new ground for millions of patients with heart disease in Europe