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The AACR's Statement on the Administration's Executive Order on Immigration
In response to the Trump administration's Executive Order on Immigration, the American Association for Cancer Research, along with the American Society of Hematology (ASH), Association of American Cancer Institutes (AACI), American Society for Radiation Oncology (ASTRO), American Society of Pediatric Hematology/Oncology (ASPHO), and the LUNGevity Foundation released a joint statement expressing deep concern about the administration's executive. The full statement is included below. If you wish to send a letter to Congress or the administration regarding the executive order, you can do so here.
Statement from ASH, AACR, AACI, ASTRO, ASPHO, and LUNGevity Foundation on the Administration's Executive Order on Immigration
(WASHINGTON) — As the world's leading organizations representing laboratory researchers, physician-scientists, clinicians, the nation's cancer centers, and patient advocates committed to improved care for patients with cancer and blood diseases, we express our deep concern about the administration's executive order that has denied U.S. entry to people who bring unique expertise to the practice of medicine and the conduct of cancer and biomedical research. Our nation depends on the contributions of the greatest minds from around the world to maintain the high quality of our biomedical research enterprise and health care services.
The benefits of scientific collaborations are amplified by our diversity. Limiting the exchange of ideas, practices, and data across cultures has the potential to significantly retard scientific progress and adversely affect public health. Any loss of researchers and physicians will render the United States less competitive over time, and our traditionally strong research institutions and the patients they serve will be negatively affected.
We remain deeply concerned that restricting travel will prohibit participation in scientific meetings, where cutting-edge science and treatment methods are often first introduced. These in-person meetings and other global exchanges are vitally important because they provide unparalleled opportunities for collaborations and information-sharing. Such scientific and medical meetings are absolutely essential to the conquest of cancer and blood diseases.
Much of the progress that has been achieved against cancer and blood diseases has been fueled by researchers from all corners of the world. For this progress to continue it is going to require an even greater commitment to collaborations among international organizations, governments, public and private institutions, and individuals dedicated to this cause.
Therefore, we respectfully call on the administration to consider the negative impact of its executive order on our nation's ability to attract the world's best scientific and clinical talent to participate in the fight against cancer and blood diseases, irrespective of their country of origin. This includes those immigrants who are inspired by the opportunity to bring their scientific curiosity and intellect to our country.
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Recognizing the Cancer Research and Advocacy Community on World Cancer Day
This article originally appeared as a guest post for World Cancer Day by AACR CEO Dr. Margaret Foti on Research!Ameria's blog.
On this World Cancer Day, the American Association for Cancer Research (AACR) would like to thank the thousands of laboratory researchers, physician-scientists, healthcare professionals and patient advocates around the globe and recognize their commitment to increasing the number of cancer survivors who are alive today. In the U.S., thanks to decades of federally funded cancer research supported by the National Institutes of Health (NIH) and National Cancer Institute (NCI), we have seen a steady rise in the number of Americans who survive a cancer diagnosis.
Our continued commitment to preventing and curing cancer comes at a time when, despite all the incredible progress, one American continues to die every minute of every day from cancer, while in that same minute, five more Americans receive a cancer diagnosis. These are not just statistics. These are our loved ones, our friends, and our colleagues. Each of the 1,685,210 new cancer cases and 595,690 estimated cancer deaths this year in the U.S., out of 8.2 million worldwide, represents a real life that has been or may be lost.
The AACR's sixth annual Cancer Progress Report highlights how advanced cancer treatments and diagnostics are finally making their way to market, due in large part to years of federally funded research. We're particularly encouraged by the increasing success of immunotherapeutics, which are treatments that supercharge the body's immune system to fight against cancer cells. Hundreds of other advanced therapies, however, remain in the pipeline, and without sustained, robust, and predictable annual federal funding increases for the NIH and NCI, safe and effective advanced cures will take longer to make their way from labs to patients.
With the passage of the Beau Biden Cancer Moonshot as a part of the 21st Century Cures Act (Cures), we now have an unprecedented opportunity to further reduce cancer incidence, morbidity, and mortality. This initiative, which aims to double our progress in half the time, received a commitment of funding in Cures totaling $1.8 billion over seven years. It will enable the NCI to jump-start research projects in specific focus areas recommended by the Cancer Moonshot Blue Ribbon Panel to accelerate progress in cancer prevention, detection, diagnosis, and treatment.
The AACR is calling on Congress and the Trump administration to provide the NIH with a $2 billion increase for FY 2017 before the current continuing resolution that funds the federal government expires at the end of April. We are in an unprecedented era of scientific discovery that holds enormous promise for new advances in cancer treatment and prevention that could save lives around the world. Now is the time for policymakers worldwide to prioritize and invest in lifesaving cancer research. We remain committed to working with scientists and all stakeholders to ensure that the promise of cancer research is translated into lifesaving advances for patients around the world. We know that the science can and will bring us there.
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Richard Pazdur Appointed as Director of FDA Oncology Center of Excellence
On Jan. 19, the U.S.
Food and Drug Administration (FDA) made an announcement
on behalf of outgoing FDA Commissioner Robert Califf, that Richard Pazdur had
been appointed director of the Oncology Center of Excellence (OCE). Oncology is
the first disease area at the FDA to have a coordinated clinical review of
drugs, biologics and devices across the agency’s three medical product centers.
The OCE will facilitate clinical review of oncology products by bringing
together FDA’s experts to collaborate.
referred to as the “Cancer Drug Czar” by the media, has led the FDA’s Office of
Hematology and Oncology Products (OHOP) since 2005. During this time, he and
his colleagues have worked to speed the availability of therapies for cancer
patients, especially when the drugs are the first available treatment or have
advantages over existing therapies. On an annual basis, approximately 30
percent of all new drugs approved by the FDA are oncology products, and under
his leadership, the office has approved many novel, innovative treatments for
patients, such as the recent approvals of immune checkpoint inhibitors, immune
modulators and many of the targeted therapies that have not only extended
patient lives but which have also improved the quality of their lives.
On behalf of the
American Association for Cancer Research (AACR), Chief Executive Officer Margaret
Foti, PhD, MD (hc) and AACR President Nancy Davidson, MD, extended congratulations
to Dr. Pazdur on his appointment as director of the FDA OCE. “This is a great
time for the entire cancer research and patient care community. It is hard to
imagine anyone more qualified than Dr. Pazdur for this important new position,”
said Dr. Foti. “During his tenure at the FDA, Dr. Pazdur has provided
extraordinary, steadfast leadership to improving cancer treatment via the
approval of safe and effective drugs for cancer patients. He has also embraced
regulatory science to truly inform and improve the way in which new cancer
medicines are evaluated for their safety and efficacy.”
“The AACR looks
forward to working with Pazdur and his staff in the months and years to come,
as they have worked for years to build collaborative partnerships with
academia, industry, other government agencies, scientific societies, and
patient advocacy organizations to improve both the pace and the quality of new
cancer drugs reaching patients,” said Dr.
Davidson, who is also the executive director of the Fred
Hutch/University of Washington Cancer Consortium. “We are indeed at an
inflection point in cancer research and in how we are preventing and treating
cancer. This is the result of decades of dedicated efforts to increase our
knowledge and understanding of the more than 200 diseases called cancer, as
well as because of the extraordinary commitment from individuals like Pazdur
and his colleagues to effectively employ a variety of regulatory tools such as
master clinical trial protocols, expedited approval pathways, including the
agency’s new breakthrough therapy designation and clinical trial enrichment
strategies for approving targeted therapies in oncology.”
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Revisions to the Common Rule Released
thousands of individuals, including cancer patients and survivors, make the selfless
choice to participate in federally funded cancer research so that effective preventive
strategies and treatments continue to make a difference in the lives of those
affected by cancer.
Because the samples
and data provided by these research participants have the potential to
positively impact the lives of millions of patients long after they have been
collected, research and patient advocacy groups and organizations, including
the American Association for Cancer Research, have long worked to reconcile the
need to protect the safety and privacy of research participants with the needs
of researchers in a rapidly changing scientific landscape.
Current protections based
on basic ethical principles for federally funded research involving human
subjects stem from the Federal Policy for the Protection of Human Subjects,
known as the “Common Rule,” published in 1991.
Since then, the field
of biomedical research has evolved dramatically. The Common Rule had not been updated to reflect
those changes until this month. On Jan. 18, the U.S. Department of Health
and Human Services (HHS) and 15 other federal agencies issued a final rule
intended to safeguard individuals who participate in cancer and other
biomedical research, while making it easier for scientists to conduct
lifesaving research on samples provided by these individuals.
In developing the
new regulations, HHS and other Common Rule agencies issued a Notice of Proposed
Rulemaking and invited comments from the public. In January 2016, the AACR
together with the Association of American Cancer Institutes (AACI), American
Society of Clinical Oncology (ASCO), and American Society of Radiation Oncology
(ASTRO) sent a letter voicing support for many of the proposed revisions, while
expressing concern about certain elements. In all, HHS received more than 2,100 comments
about the proposed rule.
One of the
provisions of the proposed rule that concerned the AACR referred to the use of
biospecimens (blood, cancerous tissue, urine, etc.) that become available from
clinical care or research. Under current regulations, if identifiable
information had been removed from these samples so that they could not be
traced back to the individuals who donated them, then researchers could have
used these samples for future studies without having to obtain new consent forms
from the donors.
Earlier drafts of
the proposed changes would have required additional consent for future use of
de-identified samples, which would have placed a large administrative and
financial burden on scientists and research institutions.
The AACR’s January 2016
letter suggested removing that requirement, and we were pleased to see that the
final rule signed on Jan. 18 removed that requirement.
While not all our
concerns are addressed, such as the lack of harmonized guidelines for reporting
adverse reactions, we are confident that the final rule, which will come into
effect in 2018, represents a positive step in the right direction. Here’s a
look at several
other changes to the way research is conducted on human subjects.
Meanwhile, we look
forward to continuing our work with HHS and other Common Rule agencies on
behalf of researchers, patients, and advocates to further strengthen
protections for the privacy and safety of research participants and reduce
administrative burdens on researchers.
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