First of all, how are you and your family doing in these COVID-19 times?
Dr. Raymond Woosley: Like other families, we have been affected by the pandemic due to the many changes in our daily lives and our quality of life.
However, so far, we are very fortunate that we haven’t had family members hospitalized or lost to the virus.
Tell us about yourself. What led you to found AZCERT?
Dr. Raymond Woosley: I grew up in rural Kentucky and was the second member of my family to graduate from college and the first to obtain a graduate degree because of my parents’ strong emphasis on education. In college, I found chemistry and biochemistry fascinating. This led to a Ph.D. in pharmacology and a short stint in the pharmaceutical industry with Meyer Labs, now better known as Glaxo. I found working for a small drug company interesting, and I learned a lot about developing new and safer medicines. An important lesson I learned was that I could not directly affect healthcare without a medical degree. Shortly after that, I left the drug industry and enrolled in the University of Miami, School of Medicine. At Miami, I learned that both medicine and pharmacology could be integrated into the relatively new discipline, clinical pharmacology. After medical school, I was fortunate to be accepted for internal medicine training and a clinical pharmacology fellowship at one of the nation’s leading programs, Vanderbilt University.
After training in clinical pharmacology and cardiology at Vanderbilt, I remained on the faculty to launch a new interdisciplinary program, the Vanderbilt Cardiac Arrhythmia Center. After thirteen very productive and successful years at Vanderbilt, I was recruited to Georgetown University Medical School to serve as Chairman of the Pharmacology Department. I joined the Chairman of Medicine, Dr. John Eisenberg, to create a clinical pharmacology center that focused on the new and exciting pharmacogenetics field. In 2000, I was recruited to be Vice-President and Dean of Medicine at the University of Arizona, where I remain on the faculty today. In 2005 and again, in 2012, I created two non-profit organizations to advance two important programs that were not ideally suited for academia. The first was the very successful Critical Path Institute (C-Path), which was launched in partnership with the Food and Drug Administration and successfully brought new and innovative testing methods to drug development. The other non-profit, the Arizona Center for Education and Research on Therapeutics (AZCERT), actually began in 1999 as one of fourteen centers funded by the federal Agency for Healthcare Research and Quality (AHRQ) and is my main focus today.
AZCERT is dedicated to the safe use of medicines and has, for twenty years, conducted research and educational programs to reduce the harm from drugs and drug-interactions, especially those that cause cardiac arrhythmias and sudden death.
How does AZCERT innovate?
Dr. Raymond Woosley: AZCERT innovates because two basic principles guide it; 1) The safe prescribing of medicines cannot rely only on the prescribers’ memory but must be embedded in systems throughout healthcare, and 2) To make lasting change in medical practice will require credibility and trust.
Two examples of AZCERT’s successful innovation are 1) the process we have created to assess drug safety and place drugs in risk categories (the Adverse Drug Event Causality Analysis, ADECA) and 2) the clinical decision support system (MedSafety Scan) that makes drug safety information immediately accessible to the public, healthcare providers and research scientists. The results of our research on drug safety is posted on the CredibleMeds website (www.CredibleMeds.org), which has over 2,000 visitors each day and 175,000 registered followers in 190 countries. AZCERT values its credibility and does not accept support or funding from companies that would create a perception of potential bias. The information on medicines safety is also provided in a smartphone app free in over 75,000 iOS and Android devices.
How has the coronavirus pandemic affected your business, and how are you coping?
Dr. Raymond Woosley: The pandemic has directly affected AZCERT because it created the need for the rapid development of new drug treatments. The medical community is racing to examine currently available medications to see if they could be repurposed as treatments for COVID-19. In this rush, many people have overlooked the known toxicity of several drugs and their potential harm, including sudden death.
Two of these drugs, hydroxychloroquine, and chloroquine, gained tremendous attention and were even given “Emergency Use Authorization” by the FDA so that doctors would prescribe them with only minimal evidence of their efficacy for treating COVID-19. AZCERT was overwhelmed by the general press and the medical press with requests to provide analysis of the potential risk of these drugs and to help correct the outdated drug labels being provided by many of the manufacturers for these generic drugs. Our publications and blog postings helped call attention to the need for care when using these drugs.
COVID-19 also prompted AZCERT to accelerate the launch of a new decision support platform for safe prescribing, MedSafetyScan (MSS). MSS builds upon twenty years of AZCERT’s experience, providing credible information on the safe use of medicines and the results from an FDA-funded project to develop a clinical decision support (CDS) system for hospitals. Like the hospital-based CDS system now in place in many hospitals around the world, MSS calculates a risk score for each patient’s risk of developing dangerous changes in their electrocardiogram that are associated with sudden death. In addition, MSS performs an analysis to detect the potential for major drug interactions. Unlike most systems in use today, MSS only reports those recommended by the FDA or Medicare/Medicaid. Finally, MSS identifies only the highest risk patients. When they are detected, MSS sends the prescriber an advisory with suggestions for managing or mitigating the risk of drug-induced harm specific to each patient’s profile.
Because many of the drugs being tested for treatment of COVID-19 have a known risk of QT prolongation and because the most ill COVID-19 patients have other risk factors for sudden death, AZCERT released MSS to the clinical researchers and healthcare providers to use the web-based version of MSS free of charge. Over 2,500 clinicians in 75 countries have registered to use MSS, and the initial feedback is very positive.
Making MSS available free to the medical community for use in clinical research or caring for patients with COVID-19 has been a rewarding experience in many ways.
However, it has not been without costs due to loss of opportunity to license MSS and the underlying technology (QTdrugs), which would create a revenue stream needed to maintain, market, and augment the technology.
Did you have to make difficult choices, and what were some of the lessons you have learned?
Dr. Raymond Woosley: Offering MSS for use by COVID-19 researchers and healthcare providers was difficult because of the potential impact on future revenues. The feedback on MSS that we have gotten from so many COVID-19 investigators has taught us that the program is solid and provides users perceived value that can now be evaluated in trials that assess its effect on clinical outcomes.
How are you dealing with stress and anxiety that comes from having to accelerate this process?
Dr. Raymond Woosley: I deal with the stress and anxiety by remembering the hundreds of patients, some friends, and family members, who have suffered severe harm from mistakes in medication prescribing. I manage the stress by knowing that our work is important and provides solutions to problems that have eluded medicine for decades.
Who are your competitors, and what distinguishes your services from theirs?
Dr. Raymond Woosley: Our competitors are mostly for-profit companies that provide medical information to healthcare systems and prioritize the risk of litigation over prescribers’ needs and patient safety.
We offer better products for prescribers based only on credible and valid science and have the functionality to support optimal clinical practice without interfering with it.
Any final thoughts?
Dr. Raymond Woosley: Innovation is often measured by the market size of a product. While market success is essential for utilization and, therefore, impact, products that reduce harm and improve lives are also needed in our current healthcare environment.