At Johnson & Johnson, we recognize our fundamental responsibility is to provide patients, consumers and healthcare providers with products that are as safe as possible. We take an evidence- and science-based, ethics- and values-driven approach to medical safety, putting patient and consumer wellbeing first and foremost in our decision-making and actions, with an emphasis on transparency.
The Office of the Chief Medical Officer (OCMO) is a global, functionally independent group responsible for leading medical safety and championing bioethical principles across Johnson & Johnson's Pharmaceutical, Medical Devices and Consumer Health business segments. Johnson & Johnson’s OCMO is constantly reviewing, monitoring and making decisions regarding the safety of our products through people-driven processes, initiatives and policies that are reinforced by a single medical safety standard, to which all our products are held.
See our positions and policies relating to patient safety:
Advances in patient safety in 2019 include:
Sharing real-world data: We believe in the collective power of real-world observational data to complement clinical trial findings, and in sharing our insights to improve health outcomes. As part of the Observational Health Data Sciences and Informatics (OHDSI) community, created by Johnson & Johnson and Columbia University, researchers including scientists from Johnson & Johnson’s Epidemiology team published a paper in The Lancet that presented an analysis of large-scale observational data on hypertension therapy. This analysis, which included nearly five million patients across nine observational databases in four countries, was significant. It uncovered new insights into safety and efficacy differences between classes of hypertension medicines with real insights that can advance clinical practice. Additionally, the findings presented a new paradigm for conducting large-scale observational healthcare science while addressing common biases of observational research.
Women scientists for safety: It is important to ensure that women are included in seeking ways to apply healthcare data to better serve the health of women and enhance the safety of health treatment for women. In September 2019, OHDSI launched its first Women of OHDSI (WoO) leadership group. It provided a forum for women to discuss challenges they face as women working in science, technology, engineering and mathematics (STEM) and propose ideas on how to support and inspire women in STEM to become leaders within the community and their respective fields.
To fully leverage the usefulness of big data in improving patient outcomes, we need to ensure we are harnessing all the best minds. That means engaging both women and men to share their perspectives and ideas on interpreting and utilizing real-world data to drive better, more efficient and targeted medical care.
Real-world evidence in China: In September 2019, the Johnson & Johnson Epidemiology Asia-Pacific team and Medical Device Epidemiology team participated in a Real-World Data (RWD) Study Workshop organized by the China National Medical Products Administration (NMPA), along with other pharmaceutical and medical device companies. The focus of the meeting was on the use of RWD and real-world evidence (RWE) for regulatory decisions for drugs and medical devices, and preceded the NMPA’s publication of guidelines for RWE use for regulatory purposes. The workshop brought together more than 400 participants, including Johnson & Johnson colleagues and regulators from Chinese, Japanese, German and U.S. health authorities. OCMO’s participation in the Chinese NMPA’s workshop on RWD/RWE as subject matter experts helped to frame NMPA regulatory guidelines for using RWE that are feasible, informed and consistent with global guidelines, though adapted to the Chinese situation, through robust and transparent science.
Safety for medical devices: Training operating room teams on how to safely and efficiently use new surgical devices is pivotal to ensuring safe patient care. Following a four-month pilot study of a Medical Device Briefing Tool in six hospitals in Thailand, in August 2019, the results were published by the Journal of Surgical Research. The results of the study, conducted by Ariadne Labs and Johnson & Johnson’s OCMO, showed that the Device Briefing Tool was uniformly viewed as useful and able to fit within existing workflows. Collaborating with Ariadne Labs to develop the Medical Device Briefing Tool and training materials has been an important step for Johnson & Johnson in empowering surgeons and nurses to increase communication and teamwork in the operating room to deliver better, safer patient outcomes.
Improving safety surveillance: We are continuously seeking new ways to improve safety signal detection for real-time surveillance. In 2019, we rolled out an important upgrade to our proprietary Signal Management for Adverse Events in Real Time (SMART) system, which has been a valuable tool to monitor product safety signals with efficiency, sensitivity, and specificity. The upgrade, SMART 6, includes new algorithms to improve focus on key safety alerts. It helps identify new safety risks with enhanced predictive capabilities that increase surveillance coverage and include organized data collection systems, such as registries and patient surveys. SMART 6 also decreases false positive safety alerts, surfacing alerts with solid contextual and supportive evidence. With SMART 6, we can execute improved and more efficient safety surveillance of all Johnson & Johnson pharmaceutical and consumer medicinal products.
Consumer Health products: ingredient safety
The safety of our consumers is and always has been our priority. Our safety assurance process exceeds industry and regulatory standards for baby and beauty personal care products. We continuously evaluate ingredients used in our products and modify formulations, where relevant, in response to consumer preferences, advances in science and our own scientific research. See our Position on Consumer Safety and Care.
Talc safety: During the past year, cases alleging that JOHNSON’s Baby Powder can cause adverse health effects have continued. However, to date each verdict against Johnson & Johnson that has been through the appellate process has been overturned. We sympathize deeply with cancer patients and their families and appreciate that they are seeking answers. However, the science and the facts show that their illnesses were not caused by their use of our talcum-based products. Our website www.factsabouttalc.com includes independent studies from leading universities, research from medical journals and third-party opinions confirming that our talc is safe. The facts are that JOHNSON’s Baby Powder is safe, does not contain asbestos, and does not cause cancer.