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Physician brunswick review A standable to the layperson and a clear-eyed view of standable to andaclear-eyed thelayperson of view has aknack for makingcomplex matters under a respected figureboth parties. in chaos. After hisdeparture in2019, hehasremained Trump were administration seen to into falling be foring praise hisagencyother offices while inthe anew standardset asFDA Commissioner, earn Dr. of acteristic Gottlieb. Appointed in2017, he ment andbusiness, andhisapproach to leadership. attheFDA,time govern including thebalance of radar, on hesharedtopics hisviews related to his last year, before was on anyone’s the current crisis business,the workings of government andmedia. In to addition expertise, hismedical Dr. Gottlieb and focus on directness That efficiency are char In a conversation Review late the Brunswick with PHYSICIAN’S

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How did being the son of a physician, particularly You first worked at the FDA in 2002, then What prompted us to change our policy as it investment by venture capital and private equity in a psychiatrist, influence your career choice? returned in 2005, and of course in 2017. What related to e-cigarettes was the data in 2018 showing new delivery models that are aimed at helping offer It’s hard to isolate what influence my proximity to long-term changes did you see in the agency? a tragic and shocking rise in the youth use of these more efficient arrangements for delivering care, or doctors had on me. But I was drawn to medicine The most profound change as it relates to new drugs products. We did not foresee that magnitude of new tools to hospitals and other systems for enabling because of the nature of the profession itself. It meant was the growing emphasis on drug safety and signifi- an increase in youth use of these products. In 2017, these outcomes. the opportunity for service and rewarding work, cant investment in the agency’s ability to better evalu- when we first advanced our policy, youth use of while also offering lifelong learning and the chance ate the short- and long-term safety of new medicines. e-cigarettes was declining. The big uptick in kids How does medical training need to change? to be a part of a profession. I also saw medicine as I think this is an appropriate reflection of advances in use of e-cigarettes was shocking to us and was a pub- Medical training already has changed. Medical something that could allow me to continue expand- technology. As our ability to evaluate medicines gets lic health crisis that required strong and immediate students today are much more likely to embrace ing other interests, especially writing. There is a long better through new tools and science, so should our new steps. arrangements where they are employed by systems history of physician authors. When I decided to pur- expectation of the safety of new medicines. as opposed to being independent. When I was train- sue medical school, I was already editing my college People sometimes say that drugs approved 30 What does the US healthcare system receive ing, everyone wanted to own their medical prac- newspaper. I knew I wanted to continue publishing, years ago might not be approved today because of insufficient credit for doing well? “PEOPLE SOME- tice. Today, the majority of medical students want even if I didn’t do it full time. I eventually ended up our higher bar for safety. I don’t think this is true. We deliver very good advanced care in the US and arrangements where they’re salaried employees working on the staff of a number of medical jour- Our expectation of safety has increased, but so too benefit from new medical technology. I think we TIMES SAY THAT of larger systems and have more predictable work nals while I was a student and resident. “THINGS HAVE has our ability to better define the benefits of new take for granted how advanced our care is for seri- DRUGS APPROVED arrangements. The expectations have changed dra- drugs. So, we might be able to reveal more about the ous conditions. We take for granted how much inno- matically, in part driven by the changing desires of How does being a father of three daughters influ- CHANGED A safety of drugs that could weigh against a medicines’ vation is developed largely if not entirely for the US graduating medical students, and in part driven by ence your leadership style and policy thinking? LOT WITH approval. But we also know a lot more about a drug’s market, and how much Americans benefit from changes in the structure of medicine where the kinds It probably influenced me most directly in how potential benefits at the time of approval. So, the risk these advances. Without the investments we make of private practice opportunities that were the norm I managed my team at FDA. Many of the people I RESPECT TO HOW and benefit considerations remain in balance. in advanced care, we may not have the same medi- 20 years ago are no longer as prevalent. worked with also had young children. I knew how INFORMATION What has changed is that we want greater cer- cal innovations that we’re benefiting from. American At the same time, I think students are being important it was to allow people some flexibility to tainty that a drug will deliver its promised benefits. consumers drive innovation. trained to be much more cognizant of cost and effi- work and fulfill their commitments to their fami- GETS SHARED. And when there are side effects, we want to know Where we sometimes don’t succeed is when it ciency. This is good, to a point. You want the impera- lies. I understood how important it was to know about them quickly. At a time when the technology comes to routine care and a lot of tech-based inter- 30 tive to be on achieving the best outcomes for the I THINK FEDERAL YEARS AGO what people’s boundaries were—when they needed for evaluating drugs has gotten a lot more advanced, ventions. We do medicine really well at the high end, patient. But I think physicians should be account- to be offline or adjust their workday to fulfill family AGENCIES HAVE these are reasonable expectations for patients where patients have serious conditions. Where we MIGHT NOT BE able for costs to the patient and understand how cost obligations. So, I tried to make sure we had a work BEEN SLOW TO to have. sometimes don’t do a good job is on the more rou- APPROVED TODAY impacts a patient’s access to care—their ability to culture that embraced these needs. tine aspects of primary care. remain compliant with care—to achieve good out- ADAPT BUT ARE You led—in many ways ignited—significant BECAUSE OF comes. The system should worry about the system- You became FDA Commissioner in 2017. What CATCHING UP.” medical community concern about e-cigarettes, You’ve been most prolific commenting on the OUR HIGHER BAR wide costs. The physician should be focused on their would have been your priorities in 1992? particularly among minors. What drove you to drug industry, but you’ve also noted it’s a rela- patients and cost incurred by patients is a big factor. The priorities evolved over time at FDA as the that decision? tively small percentage of total health spending. FOR SAFETY. opportunity set has changed, along with people’s We believed that electronic nicotine delivery sys- Hospitals represent a much larger segment of I DON’T THINK THIS You’ve created a niche for yourself on social expectations for the agency. In the early 1990s, a tems like e-cigarettes could offer a less harmful health spending. How can they change to help media. Your Twitter account has 57,000 follow- lot of the scrutiny was over the efficiency of the alternative for currently addicted adult smokers, to lower system costs? IS TRUE.” ers. Why do you use social media platforms? review process. There was discussion of a “drug help adult smokers quit cigarettes. E-cigarettes are A lot of the cost and inefficiency in the system is on Social media has been a very effective tool to engage lag” between the US and Europe. The view was that not safe. But they are less harmful than smoking. the services side when it comes to the delivery of care the public and also get information out quickly. drugs targeting important medical conditions were And if a currently addicted adult smoker can fully in hospitals. It’s hard for government policy to impact I found it to be invaluable when I was at FDA as a being approved in Europe months and sometimes quit cigarettes and transition to e-cigarettes, they these trends. It’s hard to set rules in Washington that way to do rapid response but also to offer perspective years before they were approved in the US. So, there can improve their health. are going to drive more efficiency in delivery. Often on breaking issues. I think agency heads are going was a lot of focus on modernizing the review process So, we took some new steps in the summer of what we do in Washington drives the opposite result. to have to rely on social media channels like Twitter to move drugs to market more efficiently. 2017 to more rapidly migrate adult smokers off cig- Politically, it’s also harder to advance policy in more and more. The news cycle moves so fast that in This was also during a time period when FDA arettes by seeking to regulate nicotine in combus- Washington that could be adverse to hospitals. They order to get your information and perspective into was being criticized for not moving to market tible cigarettes to render them minimally or non- are distributed around the country and are generally stories you need to be able to disseminate it through quickly enough drugs targeting HIV. The out- addictive. At the same time, we took steps to help the top employers in their congressional districts. So, these vehicles. growth of that was the FDA Modernization Act bring e-cigarettes through an appropriate series of the hospitals, as a group, have a lot of political influ- Things have changed a lot with respect to how of 1997, which created pathways like accelerated regulatory gates. At the very moment we were seek- ence on Capitol Hill. raul damas is a Partner information gets shared. I think federal agencies approval. In 2017, there were new priorities like ing to regulate nicotine in combustible tobacco, I think as more of the financial risk for the delivery in Brunswick’s New York have been slow to adapt but are catching up. If you opioid addiction, drug pricing, drug safety, and the we saw the e-cigarettes as a potential alternative of care shifts to providers through payment bundles office. Previously, he wait a day to respond to something important, you imperative to help advance new technology plat- for adult smokers who still wanted to use nicotine and other forms of capitation, that’s putting more worked in the White House could have lost the chance to shape the narrative to under President George forms safely, like cell and gene therapy and regen- but would no longer be able to access it from tradi- pressure on provider systems to improve their effi- W. Bush and with Pfizer reflect your goals and incorporate what you believe erative medicine. tional tobacco. ciency. And you’re seeing at the same time a lot of and Purdue Pharma. are key elements to a story. u

brunswick review · 2020 brunswick review · 2020