Kirstin R Matthews | Rice University (original) (raw)

Papers by Kirstin R Matthews

In 2011, courts in both the United States andEuropean Union handed down decisions related to hum... more In 2011, courts in both the United States andEuropean Union handed down decisions related to human embryonic stem cell (hESC) research. In both cases, the definition of research was challenged – but the two courts reached different opinions. In the US case, Sherley v.Sebelius, research was defined as a specific project. The US District Court of Appeals did not link research utilizing existing hESC lines to the act of destroying a human embryo in order to create the line, which is not eligible for federal funding. In contrast, the Court of Justice of the European Union in the Brüstle v. Greenpeace case determined inventions related to hESCs were unpatentable since they resulted from research that involved the destruction of human em-bryos. In this article, we will compare and contrast these two court cases, the politics related to the rulings, and their impacts. We find that these cases significantly impacted current research and have the potential to negatively impact future stem cell research and development. However, the long-term effects of the cases remain to be seen, and there is a chance that these cases could actually strengthen this area of science. Ultimately, we feel that stem cell polices must be straightforward and supported by the public to prevent courts and judges from making decisions on science, which are disruptive to the progression of research.

The Zika outbreak serves as a reminder that global health and neglected tropical diseases (NTDs) ... more The Zika outbreak serves as a reminder that global health and neglected tropical diseases (NTDs) can affect local health. This issue brief argues that continued investments in global health and the study of emerging pathogens could yield better tools to fight infectious diseases long before they become a problem in the developed world.

If the federal government is expected to act in the national public interest, safeguarding the co... more If the federal government is expected to act in the national public interest, safeguarding the continued development of the country’s home-grown science and technology (S&T) should be a top priority. Such development has been central to the prosperity of America’s market-oriented economy and has contributed to an elevated standard of living. Through adequate education it also has the potential to increase the scientific literacy of the electorate, which is crucial in the formation of reliably informed public opinion on science related policy issues such as funding for stem cell research, strategies for environmental conservation, and reforms for public education. Enhancement of American science, technology, engineering, and math (STEM) education at all levels, even early childhood, is therefore a justifiable federal priority.

Regenerative medicine and stem cell research are exciting new fields. But as the fields progress ... more Regenerative medicine and stem cell research are exciting new fields. But as the fields progress toward clinical therapies, controversies emerge. Hype surrounding stem cell research has caused an increase in their use in interventions that are not clinically proven. Furthermore, the regulatory agencies have a lot of difficulty dealing with cell therapies, which are distinctly different from drugs and medical devices they more commonly approve. To move the field forward, advocates, regulators and scientists need to come together to find new options for stem cell research oversight that protects both the patients and the research field.

Regenerative medicine and stem cell research are exciting new fields. But as the fields progress ... more Regenerative medicine and stem cell research are exciting new fields. But as the fields progress toward clinical therapies, controversies emerge. Hype surrounding stem cell research has caused an increase in their use in interventions that are not clinically proven. Furthermore, the regulatory agencies have
a lot of difficulty dealing with cell therapies, which are distinctly different from drugs and medical devices they more commonly approve. To move the field forward, advocates, regulators and scientists need to come together to find new options for stem cell research oversight that protects both the patients and the research field.

Despite the political nature of stem cell research, this area of science continues to flourish in... more Despite the political nature of stem cell research, this area of
science continues to flourish in the USA. In 2011, the NIH funded approximately US$1.2 billion in stem cell research – a steady increase from past years – with US$123 million devoted to human embryonic stem cells. According to the ISI Web of
Science, more than 4000 US authored stem cell publications
were produced in 2011, accounting for approximately 38% of the world total. Approximately a quarter of these publications were collaborations with authors from other countries.

In 2012, scientists discovered a deadly new virus in Saudi Arabia. The infection, now designated ... more In 2012, scientists discovered a deadly new virus in Saudi Arabia. The infection, now designated as Middle Eastern Respiratory Syndrome (MERS), presented in the patient
with flu-like symptoms and eventually caused fatal complications. Since then, MERS has spread from Saudi Arabia to over a dozen countries. As of June 11, 2014, the World
Health Organization (WHO) has reported 699 confirmed cases of MERS, with 209 of these resulting in deaths—a nearly 30 percent case fatality rate (CFR). Surprisingly little effort has been made to prepare for the pandemic risk that MERS represents. According to published accounts, politics within Saudi Arabia may have compromised necessary research into
the virus. In order to prepare for potential pandemics (including, but not limited to, MERS), all governments should make efforts to foster academic freedom and international
scientific collaborations. To deal with the current threat that MERS poses, health care policies should focus on preventing further spread of the disease through infection control measures.

Stem cells obtained from umbilical cord blood (CB) have been used to treat over 80 different dise... more Stem cells obtained from umbilical cord blood (CB) have been used to treat over 80 different diseases and have become a standard treatment for many types of leukemias, lymphomas, and inherited immune system disorders. CB transplants have
been carried out in humans for over 25 years, and hundreds of clinical trials are currently under way investigating CB’s therapeutic potential for a wide range of disorders, including autism, diabetes, cerebral palsy, and spinal cord injury. Extensive storage facilities have also been established in the
United States and around the world to collect, test, and freeze CB for later use in medical procedures. However, a divide between two different banking models—public versus private—has emerged, presenting policy challenges. US guidelines on CB banking remain variable, and no mandatory
international guidelines exist. To help organize and coordinate efforts across the country, US policymakers should implement regulations with high quality standards for both private and public banks, a commitment to ethical practices, and an
investment in educational campaigns and training programs for all steps of the CB banking process.

Chagas disease—the third most common parasitic infection in the world—affects approximately 7.5 m... more Chagas disease—the third most common parasitic infection in the world—affects approximately 7.5 million people, mostly in Latin America. Population mobility between Latin America and the rest of the world has led to increasing detection of Chagas disease in the United States, Europe, Japan, and other parts of the world in the last decade. Those living in poverty, including in the United States and Mexico, are at risk of Chagas disease infection due to poor quality housing that leads to infestation by the disease-carrying insect, the kissing bug. The actual extent of the disease burden in Mexico, where the disease is endemic, and the United States is unclear due to limited diagnosis and surveillance. To help reduce outbreaks, the US and Mexican governments should implement surveillance programs, initiate vector control programs (as needed), increase awareness among health care providers, and fund research for the development of Chagas vaccines and treatments.

West Nile, dengue, and chikungunya are all caused by arthropod-borne viruses (arboviruses), which... more West Nile, dengue, and chikungunya are all caused by arthropod-borne viruses (arboviruses), which are transmitted primarily via mosquitos. In total, they result in more than 100,000 annual infections in the United States and Mexico. This number is predicted to increase as the mosquito populations carrying arboviruses move northward due to climate change and general migration of the mosquitos and infected individuals. Unlike other neglected tropical diseases (NTDs) that are more common in rural areas, these arboviruses are often found in poor urban areas as well as suburbs and more affluent neighborhoods. Despite the increasing risks in the United States and Mexico, policymakers have made little effort to prevent future outbreaks. The US and Mexican governments should collaborate towards comprehensive vector control programs and awareness campaigns for these mosquito-transmitted diseases. Furthermore, additional research on preventative measures, including the development of vaccines, would dramatically limit the spread of these debilitating diseases.

In the United States, human papillomavirus (HPV) infections affect more than 79 million men and w... more In the United States, human papillomavirus (HPV) infections affect more than 79 million men and women and account for more than 4,000 deaths from cervical cancer each year (Markowitz et al. 2014). Globally, an estimated 530,000 new cases of cervical cancer—almost always caused by HPV—are diagnosed annually. In 2006, the US Food and Drug Administration (FDA) licensed the first HPV vaccine to prevent the spread of four prevalent forms of the virus associated with cervical cancers and genital warts. These vaccines hold
the potential to save thousands of lives, especially as no cure currently exists. However, the political controversy that has erupted regarding the HPV vaccine has limited its acceptance
and use among the public. This issue potentially jeopardizes an opportunity to reduce cancer rates in Texas and the broader United States.

The U.S. Food and Drug Administration (FDA) has two major objectives: (1) “assuring the safety, e... more The U.S. Food and Drug Administration (FDA) has two major objectives: (1) “assuring the safety, efficacy, and security of human and veterinary drugs” and other medical interventions, and (2) “advancing public health by helping to speed product innovation.” These aims are addressed through research and clinical trials, a sometimes lengthy process designed to clearly assess the safety and efficacy of experimental interventions. However, these two charges can conflict at times as the public pressures the FDA for quick access to new treatments and interventions yet also expect approved treatments to be safe.

A major movement of patient advocates has worked since 2014 to hasten access to experimental interventions in the U.S. As a result, a number of state legislatures have passed “Right to Try” laws, which are designed to give terminally ill patients access to early investigational drugs before full FDA approval and before they are available under the FDA’s “expanded access” policy. Right to Try laws highlight a growing conflict between patients and the FDA, and arguably make the safety and efficacy of unproven drugs secondary to speedy access during the test phase.

In this paper, we review the background and purpose of the FDA, the clinical trials process, and the history of the FDA’s expanded access policy as well as the Right to Try movement and the collection of laws it has produced. Finally, we discuss how Right to Try laws impact the FDA and patients’ rights in the United States and recommend ways to promote faster access to safe treatments.

On September 29–30, 2015, Rice University’s Baker Institute for Public Policy, the National Schoo... more On September 29–30, 2015, Rice University’s
Baker Institute for Public Policy, the National
School of Tropical Medicine at Baylor College
of Medicine, and the END Fund collaborated on
a high-level summit to address the neglected
tropical diseases (NTDs) and related diseases of
poverty shared between the United States and
Mexico. More than 150 local doctors, scientists,
students, and community leaders attended
the event, which examined the causes and
implications of NTDs in the United States and
Mexico, advances in research and development to
fight NTDs, and effective public policy efforts for
NTD elimination. Presenters included Mitchell
Wolfe, deputy assistant secretary at the U.S.
Department of Health and Human Services Office
of Global Health, Mercedes Juan Lopez, Mexico’s
secretary of health, and Roberto Tapia-Conyer,
director general of the Carlos Slim Foundation.
This report reviews the impact and
prevalence of NTDs in the United States and
Mexico. This report also will address key policy
challenges and make recommendations for
reducing NTDs in these two countries. Reducing
the multifaceted impact of NTDS will require
coordinated policies between these two countries
that focus on preventive measures and access
to therapies as well as the development of new
treatments and vaccines.

The term “neglected tropical diseases” (NTDs) refers to a group of parasitic, viral, and bacteria... more The term “neglected tropical diseases” (NTDs) refers to a group of parasitic, viral, and bacterial diseases that cause substantial and often debilitating illnesses, affecting more than one billion people globally. In the United States, addressing NTDs focuses largely on developing safe and effective mechanisms to prevent and treat NTDs. Furthermore, new or existing treatments must be made available to those in need—often people living in poverty or extreme poverty (less than $2 a day). But research, development, and delivery of these interventions is costly and relies mostly on funding from the federal government. With pressure to limit government expenditures, decisions regarding the allocation of limited resources entail balancing priorities, which involve many, often unarticulated or implicit, ethical judgments. This report highlights some of the central ethical issues pertaining to NTD policy development and argues that ethical considerations should be included in the policy development process. We conclude that the United States should develop an NTD policy to further reduce the prevalence and impact of NTDs both within and outside our borders.

Molecular Immunology, 2004

Carboxypeptidase N (CPN) is a plasma zinc metalloprotease, which consists of two enzymatically ac... more Carboxypeptidase N (CPN) is a plasma zinc metalloprotease, which consists of two enzymatically active small subunits (CPN1) and two large subunits (CPN2) that protect the protein from degradation. CPN cleaves carboxy-terminal arginines and lysines from peptides found in the bloodstream such as complement anaphylatoxins, kinins, and creatine kinase MM (CK-MM). By removing only one amino acid, CPN has the ability to change peptide activity and receptor binding. CPN is a member of a larger family of carboxypeptidases, many of which also cleave arginine and lysine. Because of the highly conserved active sites and the possible redundant functions of carboxypeptidases, it has been difficult to elucidate the role of CPN in disease processes. The future use of gene ablation technology may be the most appropriate way to understand the function of CPN in vivo.

The Journal of Immunology, 2001

Regenerative medicine and stem cell research are exciting new fields. But as the fields progress ... more Regenerative medicine and stem cell research are exciting new fields. But as the fields progress toward clinical therapies, controversies emerge. Hype surrounding stem cell research has caused an increase in their use in interventions that are not clinically proven. Furthermore, the regulatory agencies have
a lot of difficulty dealing with cell therapies, which are distinctly different from drugs and medical devices they more commonly approve. To move the field forward, advocates, regulators and scientists need to come together to find new options for stem cell research oversight that protects both the patients and the research field.

Molecular Immunology, 2004

The Journal of Immunology, 2001