Immuno-oncology drugs and agents with novel MoAs to further influence treatment paradigms in cancer indications in 2020, says GlobalData

As 2020 commences for the pharmaceutical industry, Fern Barkalow, PhD, Senior Director of Oncology and Hematology, as well as members of her analyst team at leading data and analytics company GlobalData comment on some of the key trends that will continue to influence clinical development in both solid tumors and hematological cancers in 2020, including the influence of immuno-oncology (IO) drugs on treatment paradigms and increased clinical research into drugs with new mechanisms of action for various cancers. 

Dr. Barkalow notes that market analyses underway on her team at GlobalData have revealed a major role for IO drugs, particularly combination approaches, in reshaping the treatment paradigm in several cancer indications.

Elena Tzima, MS, Oncology Analyst at GlobalData, comments: “The treatment paradigm in renal cell carcinoma (RCC) is shifting from tyrosine kinase inhibitor (TKI) monotherapy to immune checkpoint inhibitor combinations. Immune checkpoint inhibitors are increasingly taking over the first-line of therapy.  Although TKIs will not disappear from the treatment algorithm they will be overtaken by immune checkpoint combinations in first line and will be pushed down to later lines of treatment.”

On the other hand, ongoing market research at GlobalData in bladder cancer has revealed variable trends predicted for uptake of the checkpoint inhibitors in the 7MM that are due in part to cost issues but also a result of the introduction of novel therapies in an area that has just recently seen a large increase in approvals of targeted therapies.

Barath Muralidharan, MBS, Oncology Analyst at GlobalData, notes: “We will see increasing use of checkpoint inhibitors for bladder cancer in Japan and the EU for advanced disease despite the pushback from payers for these premium priced drugs.  However, in the US, there will continue to be a slight decline in overall sales of checkpoint inhibitors due to the launch of Balversa and Padcev in 2019, which according key opinion leaders interviewed by GlobalData, will see increasing adoption in the treatment of advanced bladder cancer in 2020.”

Dr. Barkalow continues: “While IO drugs will certainly continue to dominate oncology drug development, 2020 will see a high degree of clinical research in other drug classes with new mechanisms of action, which promise to go a long way to fulfilling unmet needs for more therapy options in certain cancers.”

Sakis Paliouras, PhD, Oncology Analyst at GlobalData, comments: “Since 2017, the previously-limited options for acute myeloid leukemia (AML) patients upon relapse have been enriched with agents of greater tolerability. Starting in 2020 and over the next 5-10 years, more novel drugs with different mechanisms of action will be proceeding to late-stage development and be poised to enter the AML treatment landscape. This should allow sequential treatment and extension of patients' survival over multiple lines of therapy."

Another area of high unmet need, triple negative breast cancer (TNBC), will see developments in 2020 as both checkpoint inhibitors and novel antibody-drug conjugate drugs gain approvals. 

Adam Pearson, PhD, Oncology analyst at GlobalData, comments that: “Checkpoint inhibitors will move closer towards becoming the standard of care in first-line metastatic TNBC patients who are PD-L1 positive, with further approvals expected in 2020 for Tecentriq, and a probable approval for Keytruda in this population of patients.”  

Not only will there be more checkpoint inhibitor options leading to further uptake in TNBC patients. 

Dr. Pearson also notes that: “In 2020, we are expecting to see approval for the antibody-drug conjugate, sacituzumab govitecan in later lines of therapy in TNBC after previously being rejected on issues related to ‘chemistry, manufacturing, and control matters’.  GlobalData has noted enthusiasm from key opinion leaders concerning this drug and it will likely be approved in Q1 2020. Sacituzumab govitecan will be a welcome addition to the increasingly personalized arsenal to tackle triple negative breast cancer and provide a drug, with a novel mechanism of action, to treat a historically difficult to treat cancer.”

Dr. Barkalow concludes: “As we enter this next decade, the shift away from chemotherapies and even some targeted therapies as standard of care in a variety of cancer indications, towards safer and more effective IO combinations and therapies of novel mechanisms of action will be even more pronounced than in previous years, which is good news for patients as well as drug development stakeholders.

Ontario continues to improve access to treatment for children and adolescents living with ADHD who are prescribed INTUNIV XR®*

Ontario publicly reimburses INTUNIV XR® (guanfacine hydrochloride extended-release tablets) for both adjunctive and monotherapy treatment of children and adolescents with ADHD

TORONTO, Jan. 24, 2020 /CNW/ - Takeda Canada Inc. is pleased to announce that effective January 31, Ontario will publicly reimburse INTUNIV XR® (guanfacine hydrochloride extended-release tablets) for the treatment of attention deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents (6 to 17 years old) in the following settings:  

  • As an adjunctive therapy to psychostimulants; 
  • As monotherapy in patients who have significant intolerance to psychostimulants and who have had an inadequate response to either atomoxetine or other non-stimulant alternative(s). 

INTUNIV XR® is a selective alpha2A-adrenergic receptor agonist.1 In Ontario, this funding provides an additional treatment option for children and adolescents (6 to 17 years old) in whom response to stimulant therapy has been suboptimal.1

"ADHD is a complicated and chronic disease, and I've seen first-hand how challenging it is for parents and their children to find a treatment plan that works for them," said Heidi Bernhardt, President and Executive Director of the Centre for ADHD Awareness Canada. "I applaud the government of Ontario for granting families access to an additional treatment option to help their children manage their ADHD." 

ADHD is among the most prevalent mental health conditions in childhood.2 Five to nine per cent of children and adolescents in Canada are living with ADHD,3 a condition that can cause poor school performance, behavioural challenges, and difficulties at home and with friends.2 Medication plays an important role4 in managing common symptoms including inattention, hyperactivity and impulsivity.2

"Takeda is committed to providing innovative treatment options to Canadians with ADHD," said Gamze Yüceland, General Manager, Takeda Canada Inc. "We are pleased to learn that the Ontario government will improve access for patients by listing INTUNIV XR® as both a standalone and combination therapy on the Ontario Drug Formulary." 

To learn more about the eligibility criteria for reimbursement of INTUNIV XR®  visit http://www.health.gov.on.ca/en/pro/programs/drugs/odbf_mn.aspx

About INTUNIV XR®
INTUNIV XR® (guanfacine hydrochloride extended-release tablets) is an oral, once-daily treatment for attention deficit/hyperactivity disorder (ADHD). Its active ingredient, guanfacine, is a selective alpha2A-adrenergic receptor agonist.1

INTUNIV XR® was approved by Health Canada in July 2013 as monotherapy for the treatment of ADHD in children aged 6 to 12 years, and as adjunctive therapy to psychostimulants for the treatment of ADHD in children, aged 6 to 12 years, with a sub-optimal response to psychostimulants.5 In September 2015, Health Canada extended both indications for INTUNIV XR® to include adolescents aged 13-17.6

The efficacy of INTUNIV XR® in the treatment of ADHD was established in two placebo-controlled monotherapy pivotal trials in pediatrics, and in one placebo-controlled monotherapy trial in adolescents (aged 13-17 years). A fourth study further evaluated the safety and efficacy of INTUNIV XR® as adjunctive therapy to psychostimulants.1

INTUNIV XR® is also publicly reimbursed in the province of Quebec as part of the RAMQ (Régie de l'assurance maladie du Québec) "Exceptional medications" section of the List of Medications,7 in association with a psychostimulant, for the treatment of children and adolescents suffering from attention deficit disorder with or without hyperactivity, for whom it has not been possible to properly control the symptoms of the disease with methylphenidate and an amphetamine used as monotherapy. Before it can be concluded that the effectiveness of these drugs is sub-optimal, they must have been titrated at optimal doses.8

About ADHD
Attention deficit/hyperactivity disorder is a neurodevelopmental disorder characterized by the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years.1For an ADHD diagnosis, the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work), and at home.1Approximately 75 per cent of patients continue to meet the diagnostic criteria as the child moves into adolescence, and over half of patients will continue to present with clinically significant impairment into adulthood.2

About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. 

Additional information about Takeda Canada is available at www.takeda.com/en-ca   

*INTUNIV XR® is a registered trademark of Shire LLC, a Takeda company.

References

__________________________
1INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, January 23, 2019.
2Statistics Canada. Childhood Conditions. Available at: https://www150.statcan.gc.ca/n1/pub/82-619-m/2012004/sections/sectionc-eng.htm. Accessed January 2020.
3Canadian ADHD Resource Alliance (CADDRA): Canadian ADHD Practice Guidelines, Fourth Edition, Toronto ON; CADDRA, 2018.
4Cutler AJ, Mattingly GW. Beyond the pill: new medication delivery options for ADHD. CNS Spectr. 2017;22(6):463-474. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149449/. Accessed January 2020.
5INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, July 5, 2013.
6INTUNIV XR. Product Monograph. Toronto, ON: Shire Pharma Canada ULC, September 8, 2015.
7Régie de l'assurance maladie du Québec (RAMQ). Pharmaceuticals; Exceptional Drugs. Available at: http://www.ramq.gouv.qc.ca/fr/professionnels/pharmaciens/medicaments/medicaments-patient-exception/Pages/index-formulaires-mc.aspx#I. Accessed January 2020.
8Régie de l'assurance maladie du Québec (RAMQ). List of Medications. Available at: http://www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_12_18_en.pdf. Accessed January 2020.

Novacap to Sell Majority Stake in Intelerad Medical Systems

Novacap, founders, and management shareholders will reinvest alongside new partner

MONTREAL, Jan. 23, 2020 /CNW Telbec/ - Novacap, the Canadian-based private equity firm, announced today that it has entered into a definitive agreement for the sale of a majority stake in Intelerad Medical Systems ("Intelerad"), a global provider of medical imaging software and enterprise workflow solutions to Hg, a U.K.-based private equity firm specialized in software and service businesses. 

The transaction is expected to close in the first quarter of 2020, following the satisfaction of customary regulatory approval. 

With over 400 employees and offices in Canada, USA, UK and Australia, Intelerad specializes in diagnostic viewing, reporting and collaboration solutions for radiologists. The company, who serves over 300 hospitals, imaging centers, clinics and radiology groups, enables increased productivity and streamlined medical imaging workflows. Intelerad's solutions are instrumental at improving its clients' efficiency while allowing them to deliver superior outcomes for both patients and healthcare providers. 

Under the ownership of Novacap, Intelerad made significant investments in all areas of the business, including in research and development, to position the company as a leading global provider of medical imaging software, managed services and AI-augmented workflow solutions and to strengthen its customer-first focus. Over the last 4 years, Intelerad more than doubled its revenue, with the ongoing addition of new clients and the accelerated growth of its existing customer-base, which includes some of the largest hospitals, health systems and imaging service providers around the world. During the same period, the number of employees grew from 277 to over 400 today. 

In 2018 under the leadership of Paul Lepage, newly appointed CEO of Intelerad, the company acquired Seattle-based Clario Medical, the provider of the state-of-the-art Clario SmartWorklistTM which intelligently manages reading workflows and optimizes reading quality and efficiency, and is being used as the backbone of the largest radiology practices and imaging centers. 

"In 2016, Novacap TMT IV fund invested in Intelerad, confident that we would accelerate the growth of the business while allowing the development of best in class enterprise medical imaging solutions, supported by Intelerad's intrapreneurial culture. Today, I strongly believe that we surpassed our initial objectives, and helped define the strategic roadmap sustaining a strong growth. I am proud and convinced that the management team with the new ownership will continue to contribute to the future company's success,'' said François Laflamme - Senior Partner at Novacap - TMT.  

"From the day Novacap came on board, it was clear to us founders that the team had the passion, expertise and dedication necessary to bring Intelerad to great heights.  Novacap has exceeded our expectations, and we thank them and the Intelerad team for their hard work in bringing us to this enviable position today. We look forward to working with Hg to make a difference in healthcare." said Randall Oka, co-founder of Intelerad.

Paul Lepage, Chief Executive Officer at Intelerad, said: "Partnering with an Hg-led consortium will give us access to a huge pool of knowledge in global healthcare technology and the opportunity to significantly advance the company's strategy. We are thrilled to continue focusing on our customers success and creating superior outcomes for healthcare providers and their patients with such talented people. I welcome our new investors, and also thank the Novacap team and our colleagues who all worked so hard to get us into this strong position, as well as our customers and partners for their continued trust over the last 20 years. Looking forward to exciting times ahead."

Novacap was advised by Piper Jaffray, Deloitte and McMillan

ABOUT NOVACAP 
Founded in 1981, Novacap is a leading Canadian private equity firm with $3.6 billion of assets under management. Its distinct investment approach, based on deep operational expertise and an active partnership with entrepreneurs, has helped accelerate growth and create long-term value for its numerous portfolio companies. With an experienced management team and substantial financial resources, Novacap is well-positioned to continue building world-class businesses. Backed by leading global institutional investors, Novacap's deals typically include leveraged buyouts, management buyouts, add-on acquisitions, IPOs, and privatizations. Over the last 38 years, Novacap has invested in more than 90 companies and completed more than 130 add-on acquisitions. The company has offices in Toronto, Ontario and Brossard, Quebec. For more information, please visit www.novacap.ca.

ABOUT HG
Hg is a European investor in software and services businesses, with increasing global presence, having built a team of 200 people over 25 years.  Hg is a specialist investor, committed to building businesses that change the way we all do business, through deep sector specialisation and dedicated operational support.
Hg partners with the businesses and management teams it invests in. Hg has over 30 operational professionals providing practical support to management teams to help them realise their growth ambitions. Hg shares best-practice 'playbooks' and leverages Hg's executive and portfolio network as a powerful tool for knowledge sharing across comparable businesses.
Based in London, Munich and New York, Hg has funds under management of approximately $12 billion serving some of the world's leading institutional and private investors. For further details, please visit the Hg website: https://hgcapital.com/ 

ABOUT INTELERAD MEDICAL SYSTEMS
Founded in 1999, Intelerad is a medical imaging software provider that specialises in diagnostic viewing, reporting and collaboration solutions. Headquartered in Montreal, Intelerad has over 400 employees located in various offices in Toronto and Calgary (CA), Seattle (US), Hertfordshire (UK) and Melbourne (AU). The company serves over 300 healthcare organizations around the world, with a particular strength in radiology groups, imaging centers, clinics and reading groups as well as a strong presence in hospital radiology departments.

SOURCE Novacap Management Inc.

Health Canada Approves KEYTRUDA® (pembrolizumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (RCC)

Approval Based on Results of KEYNOTE-426, Where KEYTRUDA® in Combination with Axitinib Reduced the Risk of Death by Nearly Half Compared to Sunitinib

  • Renal cell carcinoma (RCC) is the most common form of kidney cancer, representing 80 per cent of all cases1
  • The five-year survival rate for advanced RCC is currently estimated to be 8 per cent2

KIRKLAND, QC, Jan. 23, 2020 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib), a tyrosine kinase inhibitor, for first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA® in combination with axitinib (KEYTRUDA®-axitinib combination) compared to sunitinib. 

For Canadians living with advanced renal cell carcinoma, the cancer has spread beyond the kidney to other areas of the body.3 While the five-year survival rate for patients living with Stage 1 RCC is currently estimated to be 81 per cent, those living with advanced (Stage 4) RCC face an 8 per cent chance of survival.4

"It's important that Canadians living with renal cell carcinoma, an aggressive form of cancer, have access to new treatment options that are well tolerated and can improve survival outcomes," said Dr. Sebastien Hotte, medical oncologist at McMaster University. "The approval of pembrolizumab, or KEYTRUDA®, in combination with axitinib, is an important advancement in treatment that physicians can now consider in managing patients newly diagnosed with advanced RCC."  

"For kidney cancer patients whose cancer has spread beyond the kidney and metastasized in other parts of the body, their disease is much more aggressive. For these patients, there is a need for additional treatment options," Dr. Pierre Karakiewicz, medical oncologist at the Centre hospitalier de l'Université de Montréal (CHUM). "Health Canada's approval of pembrolizumab in combination with axitinib represents an important advancement in the treatment of kidney cancer that helps extend survival outcomes for patients living with advanced renal cell carcinoma."

In the Phase 3 KEYNOTE-426 trial, KEYTRUDA® in combination with axitinib demonstrated a statistically significant reduced risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005). For progression-free survival (PFS), the KEYTRUDA®-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84]; p=0.00012). The objective response rate (ORR), an additional efficacy outcome measure, was 59% for patients who received the KEYTRUDA®-axitinib combination (95% CI, 54-64) and 36% for those who received sunitinib (95% CI, 31-40) (p<0.0001). The observed safety profiles of pembrolizumab plus axitinib were as expected on the basis of the known profiles of these drugs, although the incidence of grade 3 or 4 elevations in liver enzyme levels in the pembrolizumab-axitinib group was higher than previously observed when each agent was used as monotherapy.5  

This is the first indication for KEYTRUDA® in advanced RCC, and the first anti-PD-1 therapy as part of a combination regimen that significantly improved OS, PFS and ORR versus sunitinib in patients with advanced RCC. 

"We welcome Health Canada's decision to offer a new evidence-based treatment option to patients living with advanced renal cell carcinoma," said Stephen Andrew, Executive Director of Kidney Cancer Canada. "This immuno-oncology combination represents an important milestone in our community and offers new hope to patients and their caregivers." 

About Kidney Cancer 
In most cases, kidney cancer starts in the cells that line the tubules, which are tiny tubes that collect the waste materials and chemicals from the blood moving through the kidneys.6 This type of cancer is known as renal cell carcinoma (RCC), accounting for 80 per cent of all cases.7RCC is considered advanced when the cancer has metastasized, or spread, beyond the primary cancer site.8 The five-year relative survival rate for patients suffering from advanced, metastatic (Stage 4) kidney cancer is estimated to be 8 per cent.9

In 2019, an estimated 7,200 Canadians were diagnosed with kidney cancer and 1,900 Canadians died from kidney cancer.10 Known risk factors for kidney cancer include smoking, hypertension, obesity, and occupational exposure to some chemicals.11

About KEYTRUDA® 
KEYTRUDA® is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 

KEYTRUDA® was first approved in Canada in 2015 and currently has 14 indications in several disease areas, including advanced renal cell carcinoma (RCC), bladder cancer, non-small cell lung carcinoma (NSCLC), classical Hodgkin lymphoma and melanoma.

Merck's Research Program
Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 750 trials studying pembrolizumab across a wide variety of cancers and treatment settings. This clinical program seeks to understand the role of pembrolizumab across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with this medication, including exploring several different biomarkers.

Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

About Merck Canada
For over a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. 

Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTubeand Twitter.

Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2017 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

Rini KN-426, NEJM 2019;380:1116-27.

Please see the product monograph for KEYTRUDA® (pembrolizumab) at: https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf

References
___________________________
1De P., Otterstatter, M.C., Semenciw, R., et al. Trends in incidence, mortality, and survival for kidney cancer in Canada, 1986-2007. Cancer Causes Control 2014;25(10):1271-1281.
2Canadian Cancer Society. Survival statistics for kidney cancer. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/prognosis-and-survival/survival-statistics/?region=on. Accessed on October 8, 2019.
3Canadian Cancer Society. Cancerous tumours of the kidney. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/cancerous-tumours/?region=on. Accessed on January 22, 2020.
4Canadian Cancer Society. Survival statistics for kidney cancer. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/prognosis-and-survival/survival-statistics/?region=on. Accessed on October 8, 2019.
5 Rini B. I, Plimack E.R, Stus V, et al. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. NEJM 2019;380:1116-27.
6Canadian Cancer Society. What is kidney cancer? Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/?region=on. Accessed on October 9, 2019.
7De P., Otterstatter, M.C., Semenciw, R., et al. Trends in incidence, mortality, and survival for kidney cancer in Canada, 1986-2007. Cancer Causes Control 2014;25(10):1271-1281.
8Canadian Cancer Society. Cancerous tumours of the kidney. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/cancerous-tumours/?region=on. Accessed on January 22, 2020.
9Canadian Cancer Society. Survival statistics for kidney cancer. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/statistics/?region=on. Accessed on October 8, 2019.
10Canadian Cancer Society. Kidney cancer statistics. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/statistics/?region=on. Accessed on October 8, 2019.
11Canadian Cancer Society. Risk factors for kidney cancer. Available at http://www.cancer.ca/en/cancer-information/cancer-type/kidney/risks/?region=on. Accessed on January 22, 2020.

SOURCE Merck

Federal Government Misled Public on E-Cigarette Health Risk: CEI Report


WASHINGTON, January 22 – A new report from the Competitive Enterprise Institute calls into question government handling of e-cigarette risk to public health, especially last week after the U.S. Centers for Disease Control and Prevention (CDC) tacitly conceded that the spate of lung injuries widely reported in mid-2019 were not caused by commercially produced e-cigarettes. 

Rather, the injuries appear to be exclusively linked to marijuana vapes, mostly black market purchases - a fact that the Competitive Enterprise Institute pointed out nearly six months ago. The CDC knew that, too, but for months warned Americans to avoid all e-cigarettes. 

“The Centers for Disease Control failed to warn the public which products were causing lung injuries and deaths in 2019,” said Michelle Minton, CEI senior fellow and co-author of the report.

“By stoking unwarranted fears about e-cigarettes, government agencies responsible for protecting the health and well-being of Americans have been scaring adult smokers away from products that could help them quit smoking,” Minton explained. 

Now that the CDC has finally began to inform the public accurately, it’s too little too late, the report warns. The admission has done little to slow the onslaught of prohibitionist e-cigarette policies sweeping the nation, and the damage to public perception is already done. 

Nearly 90 percent of adult smokers in the U.S. now incorrectly believe that e-cigarettes are no less harmful than combustible cigarettes, according to survey data from April 2019. Yet the best studies to-date estimate e-cigarettes carry only a fraction of the risk of combustible smoking, on par with the risks associated with nicotine replacement therapies like gum and lozenges. Meanwhile, traditional cigarettes contribute to nearly half a million deaths in the U.S. every year.

The CEI report traces the arc of CDC and FDA messaging and actions, starting in late June 2019, about young people hospitalized after vaping. Concurrent news reporting ultimately revealed, though virtually never in the headline, that the victims were vaping cartridges containing tetrahydrocannabinol (THC), the key ingredient in cannabis, with many admitting to purchasing these products from unlicensed street dealers. Yet for months the CDC consistently refused to acknowledge the role of the black market THC in the outbreak, which had a ripple effect on news reporting and on state government handling of the problem.

By September 2019, over half of public opinion poll respondents (58 percent) said they believed the lung illness deaths were caused by e-cigarettes such as Juul, while only a third (34 percent) said the cases involved THC/marijuana.

The CEI report warns that federal agencies should not be allowed to continue misleading the public about lower-risk alternatives to smoking.

View the report: Federal Health Agencies’ Misleading Messaging on E-Cigarettes Threatens Public Health by Michelle Minton and Will Tanner.

Got a Kink in Your Back from Training? How to Straighten It Out

No matter what steps you take to protect your spine, a back injury can occur in the blink of an eye. While those types of injuries usually aren’t too dangerous, you will need to focus on your recovery if you want to avoid long-term health problems.

Keep Moving

It might be tempting to remain sedentary after you injure your back, but that could end up making the discomfort much worse. As long as the injury is relatively minor, you need to move around as much as possible. Going for walks, swimming, and stretching are all great options for those who are struggling with back pain. The extra movement is going to keep the blood flowing to the muscles, and that will speed up your recovery.

Try Heat and Ice

For soft tissue damage, hot and cold therapy can be incredibly beneficial. Immediately following the injury, you should try putting hot and cold packs on your back for a few minutes at a time. The heat packs will improve blood flow to the area while relaxing the tense muscles. Your cold packs are going to numb the area and reduce inflammation.

Use Over-the-Counter Painkillers Sparingly

Over-the-counter painkillers are a great option for temporary pain relief, but those drugs shouldn’t be thought of as a long-term solution to your back pain. Most medical experts agree that you shouldn’t rely on OTC painkillers for more than a few days at a time, and you must drink plenty of water when you are taking those pills. You also have the option of using a topical painkiller if you want to avoid oral painkillers. Topical painkillers usually provide you with immediate pain relief, and they can be applied multiple times a day.

Visit a Chiropractor

Scheduling a chiropractic appointment is another important step in this process, and that type of doctor could ease your pain and speed up your recovery. During your visit, the chiropractorwill most likely locate the area where the pain is coming from and relieve tension through joint manipulation. They might also be able to loosen the muscles so that more blood can get to the damaged tissue.

As a general rule, you should always head to the doctor if your back pain is debilitating or has lasted for more than a few days. Ongoing back pain could be the result of a serious medical issue that needs to be treated by a professional.

Warning Labels Should Make Clear Vaping is Not Risk-Free, Contains Nicotine, But is a Better Choice Than Smoking: RBH

TORONTO, Jan. 21, 2020 /CNW/ - Health Canada continues to affirm that vaping is a less harmful choice than smoking and this message needs to be reflected on new warning labels for vape products – Rothmans, Benson & Hedges Inc. recommended today in a submission to Health Canada on proposed new vaping regulations for advertising, promotion and labelling.  

While RBH generally supports the harm reduction approach of Health Canada, RBH proposes that Health Canada:

  • Improve health warnings: add to the draft warning labels by including a statement consistent with those on Health Canada's website such as "vaping is less harmful than smoking"
  • Amend advertising, promotion and display rules: revise advertising and point-of-sale display restrictions at general retail to include branded harm-reduction messaging as a form of public-service announcement; 
  • Expand the definition of vaping products: through regulation, define heated tobacco products as vaping products.

RBH is calling for a balanced approach and shares Health Canada's conclusion that vaping should be restricted for youth, but remain an accessible reduced-risk alternative for existing adult smokers for as Health Canada says, "giving people who smoke access to less harmful options than cigarettes, could help reduce health risks and possibly save lives."

A balanced regulatory approach is critical for both immediate and long-term public health objectives.  In the immediate term, maintaining adult access to vaping products and information about such products will help today's 4.5 million Canadian smokers switch to a less harmful product, if they do not quit. In the longer-term, tough new regulations will help guard against a new generation of young Canadians becoming nicotine users.

This regulatory approach is consistent with proposals included in RBH's recommendations in Unsmoke: Ideas for a Smoke-Free Future

Health Canada has set a target to reduce smoking rates to five per cent by the year 2035.  RBH believes that with the right policies and the right technologies this target can be achieved sooner. 

QUOTES: Peter Luongo, Managing Director, RBH

  • We want to Unsmoke Canada. That means if you don't smoke, don't start. If you smoke, quit. If you don't quit, change. 
  • Vaping or any smoke-free alternatives to cigarettes are not for youth, never smokers or former smokers. 
  • We support tough new rules for responsible marketing and retailing to reduce the access and appeal of vaping to youth. 
  • Tough vaping rules will help prevent a new generation of users. 
  • Vaping products should only be designed and marketed for adult smokers who are seeking an alternative to continued smoking. 
  • Warning labels on vaping products should inform consumers that these products are not risk-free and contain nicotine, which is addictive. Warning labels should also inform smokers that vaping is a better alternative to smoking. 
  • We need a strong national approach. Regulating tobacco vaporizers as vaping products would harmonize provincial and federal laws to the potential benefit of existing adult smokers, giving them reasonable access to better alternatives to cigarettes from coast to coast to coast. 
  • We need a regulatory balance that allows existing smokers to switch from cigarettes to a less harmful alternative, if they choose not to quit entirely. 
  • Innovation has led to better alternatives for adults who would otherwise continue to smoke cigarettes. 
  • The best choice for any Canadian is to never start smoking or vaping, or to quit entirely.

A complete copy of RBH's submission to Health Canada is available upon request. 

About Rothmans, Benson & Hedges Inc. 
Rothmans, Benson & Hedges Inc., an affiliate of Philip Morris International Inc., is one of Canada's leading tobacco companies and employs nearly 800 people across the country with its headquarters in Toronto and a factory in Québec City. RBH is a certified Top Employer 2019 in Canada for excellence in employee conditions.

SOURCE Rothmans, Benson & Hedges Inc.

The Chicken or the Egg—and the Rooster

by Jane M. Orient, M.D.

Children who grow up on a farm learn the “facts of life” at an early age, such as the observation in an old song: “They’re laying eggs now/ Just like they used ter/ Ever since that rooster/ Came into our yard.”

All species that propagate by sexual reproduction have two sexes, and every new organism arises from one male and one female gamete. Except in the rare hermaphroditic species, every organism has two different parents, one male and one female, permitting the wonderful variety that exists in the natural world.

One can debate endlessly about the role of nature or nurture in molding a person—or animal—but sex is 100 percent nature. It is not “assigned.” It is recognized at birth, or on a prenatal ultrasound—or hundreds of years later in a skeleton. If there is ambiguity, it is a medical emergency. The newborn needs to be seen immediately by a pediatric endocrinologist because he might die from adrenal insufficiency.

Sexual differentiation begins long before any visible differences—the Y chromosome affects every cell in the body. Skilled persons can sex chicks soon after they hatch.

Gender is a subjective concept these days. If there are not two, how many are there? Three, 50, 83, hundreds? New ones keep getting named. Doctors are being told to be hyperaware so as to treat each patient appropriately, as defined by the person’s self-identity. How about, instead of trying to stuff people into artificially created gender/racial/ethnic boxes, treating everyone as an individual?

There is some yang in every yin, and some yin in every yang, but the yin and the yang exist and are not the same. There is not a womb in a trans-woman, but there is in a trans-man who has not had it removed. We do patients a terrible disservice by pretending to treat organs that aren’t there, or by ignoring organs that are.

Roosters are different, as I learned visiting a farm, where I was attacked by the Bad Rooster. I might have been pecked to death, save for the timely intervention of an 8-year-old boy who thought boys were supposed to protect girls. (I will be his friend for life.)

This brings us to the reason for wanting to sex chicks. A farmer doesn’t want to waste money raising a chicken that doesn’t lay eggs. You only need a few roosters. They fight and are disruptive. Similarly, if you are raising sheep or cattle, you want to be the one who is in charge of the herd—so you castrate most of the males.

Now, if your goal is to have a compliant society of dependent serfs, you need to geld (“detoxify”) the males or make them irrelevant. A father in each family protects his own and works hard so his offspring can thrive. But strong families can thwart the designs of would-be rulers.

For decades, we have tried using Big Daddy/ Big Brother government to look after the flock, and herd it in the proper direction. The results are terrible: poverty, despair, delinquency, drug abuse, and crime.

The stated goals of the growing transgender movement sound noble: make a troubled minority happy, and do away with patriarchy, discrimination, and oppression. And by the way with overpopulation. This assumes we are smarter than Mother Nature.

If we could turn a lot of boys into girls, or at least non-boys, and shame the rest, there would be fewer roosters. True, some girls want to become boys, but while they can grow a beard they cannot increase their muscle strength by 40 percent and their lung capacity by 25 percent, nor can they match a genetic male in bone density and body size. What prevents men from crushing women physically is civilization. Boys must be trained not to hit girls. But if a man “identifies” as a woman, “she” can dominate women in prisons, shelters for abused women, and female sports. The rooster attitude may persist along with the strength.

Would we be better off with women in charge? Women like Catherine the Great, Elizabeth I, “Bloody Mary,” or a modern radical feminist? Or how about a bureaucratic technocracy in which your every thought and deed is monitored—as in Orwell’s 1984.

To eliminate Thought Crime under Ingsoc, it was necessary to make people believe the absurd: that two plus two is not equal to four.

It is equally absurd to say that boys can be turned into girls, or vice versa. But people are being punished professionally for asserting that there are two and only two sexes, determined and fixed by biology.

Could we get rid of natural, complementary sex, and strong men, without getting rid of humanity?

###

Jane M. Orient, M.D. obtained her undergraduate degrees in chemistry and mathematics from the University of Arizona in Tucson, and her M.D. from Columbia University College of Physicians and Surgeons in 1974. She completed an internal medicine residency at Parkland Memorial Hospital and University of Arizona Affiliated Hospitals and then became an Instructor at the University of Arizona College of Medicine and a staff physician at the Tucson Veterans Administration Hospital. She has been in solo private practice since 1981 and has served as Executive Director of the Association of American Physicians and Surgeons (AAPS) since 1989. She is currently president of Doctors for Disaster Preparedness. She is the author of YOUR Doctor Is Not In: Healthy Skepticism about National Healthcare, and the second through fifth editions of Sapira's Art and Science of Bedside Diagnosis published by Wolters Kluwer. She authored books for schoolchildren, Professor Klugimkopf’s Old-Fashioned English Grammar and Professor Klugimkopf’s Spelling Method, published by Robinson Books, and coauthored two novels published as Kindle books, Neomorts and Moonshine. More than 100 of her papers have been published in the scientific and popular literature on a variety of subjects including risk assessment, natural and technological hazards and nonhazards, and medical economics and ethics. She is the editor of AAPS News, the Doctors for Disaster Preparedness Newsletter, and Civil Defense Perspectives, and is the managing editor of the Journal of American Physicians and Surgeons.

PrescribeIT® Launches in Newfoundland and Labrador

TORONTO, Jan. 20, 2020 /CNW/ - Citizens of Newfoundland and Labrador can now benefit from the convenience and safety of e-prescribing with the launch of PrescribeIT® in Bonavista.

PrescribeIT® is a national e-prescribing service developed by Canada Health Infoway (Infoway), which enables prescribers to safely and conveniently transmit a prescription electronically between a prescriber's electronic medical record (EMR) and the pharmacy management system (PMS) of a patient's pharmacy of choice. By enhancing communication and improving workflow between prescribers and pharmacists, electronic prescribing helps to facilitate better health outcomes and improve continuity of care for patients. 

Dr. Hamdi Magrabi and Dr. Logendraj Selvarajah in the community of Bonavista are the first prescribers in Newfoundland and Labrador to use PrescribeIT®. The first electronic prescriptions were received by Jason Ryan, pharmacist at the Bonavista pharmacy.

"PrescribeIT® is a seamless integration that is much more convenient and secure for my patients, as it eliminates the step of taking a paper prescription to a pharmacy and eliminates misplaced or forgotten prescriptions," said Selvarajah.

"PrescribeIT® is also much more secure than sending a prescription by fax, and it gives me greater assurance that my patients will get the medication they need," said Magrabi. "It also frees up more time to spend on patient care."

"Taking a patient-first approach, e-prescribing is a major step that will advance patient safety, improve the coordination of care and impact health outcomes," said Stephen Clark, President and CEO, Newfoundland and Labrador Centre for Health Information. "As a key objective of the provincial electronic medical record program, eDOCSNL, e-prescribing enables a direct link between prescribers and pharmacists that will help reduce medication errors, improve medication adherence and speed up health care delivery. We are proud to be a partner of this national initiative and help advance digital health in Newfoundland and Labrador."  

"Eastern Health is pleased to use the PrescribeIT® technology in Bonavista, enabling participating physicians to send electronic prescriptions to community pharmacies. This tool aids in providing quality care and service to the people in the communities we serve, while partnering with others who share a commitment to quality health care and improved health and wellbeing," said Ron Johnson, Vice President, Information Services and Rural Health, Eastern Health.

"We are thrilled to launch PrescribeIT® in Newfoundland and Labrador," said Michael Green, President and CEO, Canada Health Infoway. "It's an important step in helping health care providers in the province deliver better care for patients. It's also part of our ACCESS Atlantic initiative to improve health outcomes by improving access to care."

In addition to Newfoundland and Labrador, PrescribeIT® is operating in New Brunswick, Ontario and Alberta, and agreements are in place with six other jurisdictions.

About the Newfoundland and Labrador Centre for Health Information (NLCHI)

NLCHI is a Provincial Government agency responsible for managing, protecting and providing secure and confidential access to quality health information to support: the management of patient care; research; health system planning; and, enabling the public with access to their own health information. NLCHI leads the delivery of provincial eHealth solutions such as the electronic health record, HEALTHe NL, and electronic medical record program, eDOCSNL. Visit www.nlchi.nl.ca.

About Eastern Health 

Eastern Health is the largest, integrated health authority in Newfoundland and Labrador employing approximately 13,000 dedicated employees and more than 600 medical staff, and is supported by more than 2,000 volunteers, including members of numerous auxiliaries and fundraising foundations. With an annual budget of approximately $1.5 billion, the authority offers the full continuum of health and community services including public health, long-term care, community services, hospital care and unique provincial programs and services. Serving a population of more than 300,000, Eastern Health's geographic boundaries extend from St. John's west to Port Blandford including all communities on the Avalon, Burin and Bonavista Peninsulas. Visit www.easternhealth.ca.

About Canada Health Infoway

Infoway helps to improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health across Canada. Through our investments, we help deliver better quality and access to care and more efficient delivery of health services for patients and clinicians. Infoway is an independent, not-for-profit organization funded by the federal government. Visit www.infoway-inforoute.ca/en/.

About PrescribeIT®

Canada Health Infoway is working with Health Canada, the provinces and territories, and industry stakeholders to develop, operate and maintain the national e-prescribing service known as PrescribeIT®. PrescribeIT® will serve all Canadians, pharmacies and prescribers and provide safer and more effective medication management by enabling prescribers to transmit a prescription electronically between a prescriber's electronic medical record (EMR) and the pharmacy management system (PMS) of a patient's pharmacy of choice. PrescribeIT®will protect Canadians' personal health information from being sold or used for commercial activities. Visit www.prescribeit.ca/.

CDC Confirms Black Markets, not "Vaping," Caused Outbreak
Michelle Minton 

A new report from the U.S. Centers for Disease Control and Prevention (CDC) puts the final nail in the coffin of the idea that the spate of lung injuries that occurred beginning last summer were caused by “vaping.” The CDC admitted this week that the injuries appear to be exclusively linked to marijuana vapes—not nicotine e-cigarettes, most of which were purchased on the black market, a fact that CEI knew nearly six months ago. 

According to the latest CDC findings, only one in six of the patients with the vaping-related lung injuries reported purchasing THC vapes from commercial sources. Some news outlets have interpreted this to mean that approximately 16 percent of the cases involved legally purchased cannabis vapes. But, as Jacob Sullum at Reason points out, this is incorrect. The CDC’s definition of “commercial” includes not only licensed dispensaries, but also pop-up shops, which are decidedly illegal in states with legal marijuana. Furthermore, the definition includes “stores,” without clarifying what this means. It is possible “store” includes bodegas and corner shops, which have been known to sell illegal drugs.

Thus, excluding the 3 percent of consumers who bought their THC at pop-up shops and the 2 percent who purchased them at “stores” other than dispensaries, only 11 percent of the cases reported buying their products at commercial outlets. Even that figure may be inflated, as it only reflects behavior reported by patients who may, for whatever reason, choose not to report purchasing or using cannabis products obtained from non-commercial sources.

As Sullum notes, it is still entirely possible that some of the cases were caused by legally purchased cannabis at licensed outlets. The manufacturers of cannabis products or components may have unkowingly adulterated their products with the ingredient or ingredients that caused the lung injuries. They should be held accountable for this, as all legal purveyors would be. But that does not mean that cannabis vapes—certainly not vaping as an entire category—is dangerously underregulated. Even sellers of vegetables sometimes err, causing widespread outbreaks of dangerous food-borne pathogens. The response in those cases is neither panic nor a leap to ban all lettuce. It merely calls for better standards and, perhaps, different types of oversight.

Instead of such a measured response to improve consumer safety, the outbreak of “vaping-linked” lung injuries prompted hysteria, leading to passage of bans on nicotine e-cigarettes—not even responsible for the outbreak—and a federal prohibition on all flavored e-cigarettes (excluding only tobacco and menthol.) These bans were pushed by dogmatic anti-tobacco interests, who exploited the early confusion over the outbreak.

The increasing evidence that cannabis—not nicotine—vapes were the cause of the illnesses did little to slow the march toward a new war on e-cigarettes. Even this latest confession from the CDC is unlikely to cause any reversals in state or federal policy on e-cigarettes.

Instead of instituting better safety regulations and incentivizing consumers to purchase products legally, U.S. lawmakers have chosen to embrace prohibition, once again. As I wrote in July, this will do nothing to prevent future outbreaks caused by black market products. In fact, by creating an even larger black market, including not only cannabis, but also nicotine e-cigarettes, bans all but guarantee that future outbreaks will be more frequent and widespread.