Importing Canada’s cheaper prescription drugs instead of lowering US prices?

 

President Trump’s proposal to import cheaper drugs from Canada made a lot of Canadians angry.

Canadians are hopping mad about Trump’s drug importation plan. Some of them are trying to stop it. (STAT News, August 12, 2019)

From the article:

“You are coming as Americans to poach our drug supply, and I don’t have any polite words for that,” said Amir Attaran, a professor at the University of Ottawa, who calls the plan “deplorable” and “atrociously unethical.” “Our drugs are not for you, period.”

The Canadian healthcare system negotiates the price of drugs, which is why their drugs are cheaper.  Why can’t the US government do the same?

An Oncologist’s Perspective on Medical Aid in Dying

HuffPost Camidge MAID

Thank you Dr. Camidge for sharing your experience as an oncologist with Medical Aid in Dying (MAID). All terminally ill patients deserve the right to have their wishes honored this way.

Why I Wrote The Rx That Helped My Cancer Patient Die

in HuffPost 26-Jun-2019

 

Swimming in federal alphabet soup (SACHRP version)

I’m pleased to share that I’m now officially a federal employee–I’m a newly minted member of HHS OHRP SACHRP.

Say what? Let’s spell out the acronyms.

HHS = US Department of Health and Human Services (HHS) is an agency of the Executive Branch of the US Government. The Secretary of HHS is a member of the President’s Cabinet. The HHS mission is “to enhance and protect the health and well-being of all Americans.”

OHRP = Office for Human Research Protections (OHRP) is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS. OHRP “provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).”

SACHRP = Secretary’s Advisory Committee on Human Research Protections (SACHRP) “provides expert advice and recommendations to the Secretary of HHS on issues pertaining to the protection of human subjects in research.”

So why does this matter?

I’ll know more about my role after I attend my first meeting in Washington DC at the end of July. I hope to provide a patient perspective on (and hopefully help influence) the conduct and ethics of cancer research and clinical trials. Three potential areas of clinical trials I’d like to see clarified are (1) reimbursement of patient expenses for cancer trial participation, (2) the use of social media during a clinical trial, such as communication between patients in the same trial, and (3) reasonable guidelines to increase patient access to test results generated by their samples and data sharing between research projects.

Below is the official announcement posted this morning on the OHRP listserv. I am one of seven new SACHRP members just appointed to a three-year term. I’m in a pretty accomplished group!

———————————

OHRP wishes to express our sincere appreciation to all nominees who requested consideration for membership on the Secretary’s Advisory Committee on Human Research Protection (SACHRP).

We are pleased to announce the appointment of the following new members:

  1. Mary Ellen Allen, J.D.

Mary Ellen Allen is Assistant General Counsel, Specialist, Healthcare Law Group, at Genentech, Inc. She has extensive experience and expertise in human subject protections and clinical research, including FDA regulations and guidelines, privacy, GCP, compliance, diagnostics and innovation. As Associate General Counsel, Specialist at Genentech she supports the company’s global clinical development programs and provides legal support regarding General Data Protection Regulation (GDPR) Readiness and implementation, data sharing, and personalized healthcare matters. She is Legal Lead for Roche’s Human Genetics initiatives, including Individual Return of Genomic Results to Study Participants program, and supports the Roche Bioethics organization, including pre-approval and post-trial access to investigational drugs, and am a member of Roche Bioethics Network, Roche Scientific and Ethics Advisory Group Operating Committee, and Roche global Pharma Biorepository Governance Committee.

  1. Jyoti Angal, D.S., MPH

Dr. Angal is the Director of the Regulatory Knowledge Core within the Collaborative Research Center for American Indian Health, funded by NIMHD that provides a platform to bring together tribal communities and health researchers from multiple disciplines to work together in the development of cutting-edge transdisciplinary research that will address the significant health disparities experienced by American Indians in South Dakota, North Dakota and Minnesota. In her role, she provides leadership to tribal partners to establish independent, systematic research review processes, including setting up a tribal research review board. Her interests include building capacity for ensuring the highest standards for human subjects protections. In addition to her position, she provides regulatory oversight for several NIH funded longitudinal research studies. Dr. Angal is also the Director of Clinical Research at Avera Research Institute Center for Pediatric & Community Research, Avera McKennan Hospital and University Health Center, Sioux Falls, SD.

  1. Linda Coleman, JD, CIP, CHC, CHRC, CCEP-I

As the Director of the Yale University Human Research Protection Program, Ms. Coleman serves as the Human Research Protection Administrator for the University and is responsible for the oversight and administration of Yale’s comprehensive Human Research Protection Program, which includes providing administrative and regulatory support for the Yale IRBs, RDRC, and RIDC. In her role, she is responsible for a number of functional duties including, serving as the lead for inquiries regarding audits and inquiries from regulatory agencies and accreditation bodies; assessing HRPP policies and practices for operational efficiency and compliance with applicable laws, guidelines, accreditation standards, and local context requirements; and collaborating with University stakeholders on operational initiatives related to research. Ms. Coleman also serves on several Yale University committees including the Institutional Conflict of Interest Committee, Investigator Conflict of Interest Committee, Institutional Biosafety Committee, Institutional Research Compliance Committee, Data Safety Monitoring Committee, and other committees focused on research policy matters.

  1. Janet Freeman-Daily, MSc, ENG

Janet Freeman-Daily is a stage IV Lung Cancer Survivor and Patient Advocate. In her previous career, Janet was an aerospace systems engineer where, among other things, she learned to be a technical translator.  She now brings that same experience and science to lung cancer via writing, blogging, public speaking, as well as collaborating with other patients, care partners, advocates, healthcare providers and researchers.  Janet is active on social media with her own blogspot, Gray Connections, and is a moderator of #LCSM Chat, promoting ePatient self-advocacy.  When asked what her goal is, Janet says, “I intend to keep advocating for lung cancer patients until I’m out of treatment options and energy.” She is co-founder, The ROS1ders at ros1cancer.com (05/2015-present) and Global ROS1 Initiative, and co-developer and Project Director, Hope with Answers video conversations, in collaboration with Lung Cancer Foundation of America (LCFA) and International Association for the Study of Lung Cancer (IASLC).

  1. Robert “Skip” Nelson, M.D., M.Div. Ph.D.

Dr. Nelson is currently Senior Director, Pediatric Drug Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Before joining Johnson & Johnson in January 2018, Dr. Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration, providing consultation throughout FDA on clinical and ethical issues arising in the development of FDA-regulated products for children, and serving as a standing member of the internal FDA Pediatric Review Committee. Dr. Nelson was a member and then Chair of the FDA Pediatric Advisory Committee prior to joining FDA in 2006.

  1. Walter L. Straus, M.D., MPH, FACP, FCPP

Dr. Walter Straus is Associate Vice-President and Therapeutic Area Head for Infectious Disease Therapeutics and Vaccines in Global Clinical Safety and Pharmacovigilance at Merck and Co., Inc. In this capacity his team serves as the company’s patient safety steward, and is responsible for overseeing aggregate clinical safety assessment of late stage products in development as well as post-licensure safety monitoring and assessment for all Merck vaccines and infectious disease therapeutics.  During his tenure at Merck, he has been a co-author on corporate policies pertaining to human research protection and corporate responsibility. He is a member of the Board of Directors of Public Responsibility in Medicine and Research, a member of the Executive Committee of the Harvard Multi-Regional Clinical Trials Network, and a Fellow of the American College of Physicians and of the College of Physicians of Philadelphia.

  1. Consuelo H. Wilkins, MD, MSCI

Consuelo H. Wilkins, MD, MSCI, is the Executive Director of the Meharry-Vanderbilt Alliance and Associate Professor of Medicine at both Vanderbilt University Medical Center and Meharry Medical College. Dr. Wilkins is a clinical investigator and engagement researcher who is an Associate Director of the Vanderbilt Institute for Clinical and Translational Science, where she oversees programs in community engagement and team science. Dr. Wilkins is currently a Principal Investigator of the Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health, which focuses on decreasing disparities among African Americans and Latinos using precision medicine; and the Vanderbilt Recruitment Innovation Center, a national center dedicated to enhancing recruitment and retention in clinical trials. She is widely recognized for her innovative work developing and testing methods and tools to engage patients and communities in research and was recently named director of the Engagement Core of the All of Us Research Program, a national precision medicine project which will enroll a million or more participants.

8 years in the Cancerverse

ROS1der cofounders Lisa Goldman, Janet Freeman-Daily and Tori Tomalia at the C2 Awards Ceremony in New York City May 2, 2019.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, I was diagnosed with stage IIIa non-small cell lung cancer (NSCLC). I had traditional chemo and radiation. Once treatment ended, my cancer immediately spread to a new site. Then I learned about online patient communities, and biomarker testing for genomic alterations, and clinical trials. I had more chemo and radiation. My cancer spread again. Then I tested positive for ROS1+ NSCLC, and entered a clinical trial. Now my  cancer has been undetectable by scans for over 6.5 years thanks to research.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, the majority of lung cancer patients were diagnosed after the cancer had already spread, and half the patients died within a year of diagnosis. Now we have lung cancer screening for those at high-risk of lung cancer, to catch the disease in early stages when it is curable. We have new therapies that are allowing some patients to live well for 4 years or more. In 2011, the standard of care guidelines published by the National Comprehensive Cancer Network for non-small cell lung cancer were updated about once every 5 years.  Now the guidelines are updated about 5 times a year to keep pace with the record number of new treatment approvals that are proving effective for an every-increasing number of patients.

Eight years ago today, I first heard the words, “You have lung cancer.”

In 2011, I had no idea what cancer advocates did. I’d never met any. As I began to feel better, I wondered why I was still alive when so many others had died. Gradually I began supporting others in online forums, telling my lung cancer story, learning about treatment options and research, and sharing my patient perspective with the lung cancer community, medical professionals, and policy makers in hopes of increasing funding, acclerating research, and improving outcomes for other lung cancer patients. Now there are dozens of other lung cancer patients and caregivers advocating as well.

Eight years ago today, I first heard the words, “You have lung cancer.”

From that singular moment of disbelief and panic, I started on a journey that has changed my priorities, and my approach to life in general.  I now focus on living life to the best of my ability (whatever my abilities might be at the moment), on what matters most to those I love, on what will make a difference for other lung cancer patients–especially those who have my rare type of cancer.

I wonder what the next 8 years will bring.

 

Want to be a #lungcancer patient research advocate? Inaugural @IASLC STARS program application period is open!

    • Have you or a family member been diagnosed with lung cancer?
      Are you already active in providing lung cancer support and/or education to others?
      Do you want to ramp up your advocacy work and learn more about the science of lung cancer research?

    THEN …

    Apply for the brand-new STARS (Supportive Training for Advocate in Research and Science) program!  STARS was developed by the IASLC (International Association for the Study of Lung Cancer) in collaboration with international lung cancer patient research advocates and advocacy nonprofits.

    Those accepted in the program will be assigned a mentor from their own country, meet and learn lung cancer science from researchers, develop science communication skills, and attend the World Conference on Lung Cancer (WCLC) in Barcelona, Spain in September 2019.

    To learn more and to find the online application, click here:
    https://www.iaslc.org/supportive-training-advocates-research-and-science-stars

    The application period is open from March 8 to May 1, 2019. Hope you’ll apply!

    Ah, the life of a research advocate …

    Life as a lung cancer research advocate can require a lot of travel. This week I’m in Washington DC for two meetings.

    Monday I participated as the sole patient advocate in the National Cancer Institute’s Small Cell Lung Cancer (SCLC) working group meeting, along with some of the top US researchers in this disease. The meeting will provide fodder for the NCI’s report to Congress about the Recalcitrant Cancers Act.

    Thursday I’ll be one of several patient advocates at the National Institutes of Medicine for a meeting on data sharing, along with medical institutions, pharma, and healthcare payers. Data sharing in the electronic age involves more than just who can see your medical records. We patients and family members have already participated in several phone calls in preparation for this meeting. It will be interesting to hear what the other stakeholder groups think are the main barriers to data sharing, and what we should do about them.

    In between, I’m trying to get caught up on expense reports and writing projects while adjusting to a new time zone. I hope my inputs make a enough difference for patients to make the travel worthwhile.