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.
In physics, extensive collaborations, access to colleagues’ data and rigorous peer review make it extremely difficult for individual researchers to bend the rules. Furthermore, physics does not harbor the types of ethical minefields characteristic of the biosciences. No thorny questions arise pertaining to human or animal life, nor do physicists commonly grapple with the ethical haze of intellectual property when patents and money are at stake. Things seem to be black and white in physics. But are they?
Elaine Howard Ecklund, Kirstin R.W. MatthewsJune 1, 2015
Clinics offering stem cell treatments routinely use professional athletes as spokespersons and imply clinical benefits despite the absence of robust data to support the claims. In the future, regulators should oversee the clinics’ promotional campaigns to ensure the validity of the claims, as well as the safety of consumers.
In addition to their therapeutic potential, cord blood banks raise ethical and regulatory questions, especially in emerging markets in the Arab world. In this article, the authors review cord blood banking in five countries in the region (Jordan, Saudi Arabia, Egypt, Qatar, and the United Arab Emirates) that were selected for their different CB banking policies and initiatives.
Monica M. Matsumoto, Rana Dajani, Kirstin R.W. MatthewsFebruary 13, 2015
This report describes the problems associated with unproven stem cell treatments, focusing on those without FDA approval undertaken by NFL players in the past five years.
The human papillomavirus (HPV) affects over 80 million Americans, causing more than 40,000 cases of HPV-associated cancers in the U.S. In 2006, the FDA licensed the first HPV vaccine, which could help save thousands of lives; no cure for HPV currently exists. However, the political controversy raised by the vaccine has limited its acceptance and use. Such resistance potentially jeopardizes an opportunity to reduce cancer rates in Texas and the broader United States.
Kirstin R.W. Matthews, Monica M. MatsumotoOctober 6, 2014
Stem cells from umbilical cord blood (CB) can be used to treat over 80 different diseases, including many types of leukemia, lymphoma and inherited immune system disorders. Extensive storage facilities in the United States and around the world collect, test and freeze CB for later use in medical procedures. However, the divide between two different banking models — public versus private — presents policy challenges. This policy report examines the difference between public and private cord blood banks and offers recommendations for US policymakers to improve cord blood banking and ensure high quality standards.
Monica M. Matsumoto, Kirstin R.W. MatthewsOctober 6, 2014
A deadly virus named MERS has spread from Saudi Arabia to over a dozen countries since 2012. While the chances for widespread infection are remote due to the virus's low human-to-human transmission rate, all governments should nevertheless support academic freedom and scientific collaboration to keep local outbreaks of viruses like MERS from becoming serious pandemics.
Kirstin R.W. Matthews, Monica M. Matsumoto, Jon FlynnJuly 25, 2014
Biotechnology scientists must be aware of the broad patent landscape and push for new patent and licensing guidelines, according to a new paper from the Baker Institute.