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The very real story of how one woman prevented a national tragedy by doing her job.

Frances Oldham Kelsey believed thorough research saves lives. She was so right.

The very real story of  how one woman prevented a national tragedy by doing her job.
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Seventh Generation

Dr. Frances Oldham Kelsey had only been with the Food and Drug Administration for about a month when she was tasked with reviewing a drug named thalidomide for distribution in America.

Marketed as a sedative for pregnant women, thalidomide was already available in Canada, Germany, and several African countries. It could have been a very simple approval. But for Kelsey, something didn't sit right. There were no tests showing thalidomide was safe for human use, particularly during pregnancy.


Kelsey in her office at the FDA in 1960. Image by the U.S. Food and Drug Administration.

When Chemie Grünenthal released thalidomide in West Germany years earlier, they called it a "wonder drug" for pregnant women. They promised it would treat anxiety, insomnia, tension, and morning sickness and help pregnant women sleep.

What they didn't advertise were its side effects.

Because it crosses the placental barrier between fetus and mother, thalidomide causes devastating — often fatal — physical defects. During the five years it was on the market, an estimated 10,000 babies globally were born with thalidomide-caused defects. Only about 60% lived past their first birthday.

In 1961, the health effects of thalidomide weren't well-known. Only a few studies in the U.K. and Germany were starting to connect the dots between babies born with physical defects and the medication their mothers had taken while pregnant.

At the outset, that wasn't what concerned Kelsey. She'd looked at the testimonials in the submission and found them "too glowing for the support in the way of clinical back up." She pressed the American manufacturer, Cincinnati's William S. Merrell Company, to share research on how their drug affected human patients. They refused. Instead they complained to her superiors for holding up the approval. Still, she refused to back down.

A sample pack of thalidomide sent to doctors in the U.K. While more than 10,000 babies worldwide were born with thalidomide-related birth defects, FDA historian John Swann credits Dr. Kelsey with limiting the number of American babies affected to just 17. Image by Stephen C. Dickson/Wikimedia Commons.

Over the next year, the manufacturer would resubmit its application to sell thalidomide six times. Each time, Kelsey asked for more research. Each time, they refused.

By 1961, thousands of mothers were giving birth to babies with shocking and heartbreaking birth defects. Taking thalidomide early in their pregnancy was the one thing connecting them. The drug was quickly pulled from shelves, vanishing mostly by 1962.

Through dogged persistence, Kelsey and her team had prevented a national tragedy.

Kelsey joins President John F. Kennedy at the signing of a new bill expanding the authority of the FDA in 1962. Image by the United States Food and Drug Administration.

In 1962, President John F. Kennedy honored Kelsey with the Federal Civilian Service Medal. He thanked her for her exceptional judgment and for preventing a major tragedy of birth deformities in the United States:

“I know that we are all most indebted to Dr. Kelsey. The relationship and the hopes that all of us have for our children, I think, indicate to Dr. Kelsey, I am sure, how important her work is and those who labor with her to protect our families. So, Doctor, I know you know how much the country appreciates what you have done.”

But, she wasn’t done yet. Later that year, the FDA approved new, tougher regulations for companies seeking drug approval, inspired in large part by Kelsey’s work on thalidomide.

Reached via email, FDA historian John Swann said this about Kelsey’s legacy: "[Her] actions also made abundantly clear to the nation the important public health role that drug regulation and FDA itself play in public health. The revelation of the global experience with that drug and America’s close call indeed provided impetus to secure passage of a comprehensive drug regulation bill that had been more or less floundering during the time FDA was considering the application."

Kelsey continued to work for the FDA until 2005. She died in 2015, aged 101, just days after receiving the Order of Canada for her work on thalidomide.

Bureaucratic approval work is rarely thrilling and not often celebrated. That's a shame because it's so critical.

People like Kelsey, who place public health and safety above all else — including their career — deserve every ounce of our collective respect and admiration.

Everyone can all use a little lift at the end of the week, and we've collected some of this week's best stories to provide just such a pick-me-up. Here are 10 things we want to share, just because they made us so darn happy.

1. Introducing Lila, the U.S. Capitol Police's first emotional support dog.

After the traumatic experiences of January 6th, Capitol Police officers could definitely use some extra support. Lila, a two-year-old black lab, will now serve as the department's first full-time emotional support dog. Look at that sweet face!

2. Speaking of the Capitol, take a look at this week's gorgeous solar eclipse behind the dome.

NASA Administrator Bill Nelson shared the stunning "ring of fire" image on Twitter. Always a treat when nature gives us a great show.


3. Colorado sees its first wild wolf pups in six decades.

In the 1940s, the gray wolf was eradicated in Colorado by trappers and hunters, with the support of the federal government. Whoops. This week, Colorado Parks and Wildlife has announced the first evidence of wild wolf breeding in the state, a sign of hope for the endangered species. Read more about the discovery here.

Photo by M L on Unsplash


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Everyone can all use a little lift at the end of the week, and we've collected some of this week's best stories to provide just such a pick-me-up. Here are 10 things we want to share, just because they made us so darn happy.

1. Introducing Lila, the U.S. Capitol Police's first emotional support dog.

After the traumatic experiences of January 6th, Capitol Police officers could definitely use some extra support. Lila, a two-year-old black lab, will now serve as the department's first full-time emotional support dog. Look at that sweet face!

2. Speaking of the Capitol, take a look at this week's gorgeous solar eclipse behind the dome.

NASA Administrator Bill Nelson shared the stunning "ring of fire" image on Twitter. Always a treat when nature gives us a great show.


3. Colorado sees its first wild wolf pups in six decades.

In the 1940s, the gray wolf was eradicated in Colorado by trappers and hunters, with the support of the federal government. Whoops. This week, Colorado Parks and Wildlife has announced the first evidence of wild wolf breeding in the state, a sign of hope for the endangered species. Read more about the discovery here.

Photo by M L on Unsplash


4. 30-year-old singer with terminal cancer amazed and inspired with her performance on America's Got Talent.

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Each year, an estimated 1.8 million people in the United States are affected by cancer — most commonly cancers of the breast, lung, prostate, and blood cancers such as leukemia. While not everyone overcomes the disease, thanks to science, more people are surviving — and for longer — than ever before in history.

We asked three people whose lives have been impacted by cancer to share their stories – how their lives were changed by the disease, and how they're using that experience to change the future of cancer treatments with the hope that ultimately, in the fight against cancer, science will win. Here's what they had to say.

Celine Ryan, 55, engineer database programmer and mother of five from Detroit, MI

Photo courtesy of Celine Ryan

In September 2013, Celine Ryan woke up from a colonoscopy to some traumatic news. Her gastroenterologist showed her a picture of the cancerous mass they found during the procedure.

Ryan and her husband, Patrick, had scheduled a colonoscopy after discovering some unusual bleeding, so the suspicion she could have cancer was already there. Neither of them, however, were quite prepared for the results to be positive -- or for the treatment to begin so soon. Just two days after learning the news, Ryan had surgery to remove the tumor, part of her bladder, and 17 cancerous lymph nodes. Chemotherapy and radiation soon followed.

Ryan's treatment was rigorous – but in December 2014, she got the devastating news that the cancer, once confined to her colon, had spread to her lungs. Her prognosis, they said, was likely terminal.

But rather than give up hope, Ryan sought support from online research, fellow cancer patients and survivors, and her medical team. When she brought up immunotherapy to her oncologist, he quickly agreed it was the best course of action. Ryan's cancer, like a majority of colon and pancreatic cancers, had been caused by a defect on the gene KRAS, which can result in a very aggressive cancer that is virtually "undruggable." According to the medical literature, the relatively smooth protein structure of the KRAS gene meant that designing inhibitors to bind to surface grooves and treat the cancer has been historically difficult. Through her support systems, Ryan discovered an experimental immunotherapy trial at the National Institutes of Health (NIH) in Bethesda, MD., and called them immediately to see if she was eligible. After months of trying to determine whether she was a suitable candidate for the experimental treatment, Ryan was finally accepted.

The treatment, known as tumor-infiltrating lymphocyte therapy, or TIL, is a testament to how far modern science has evolved. With this therapy, doctors remove a tumor and harvest special immune cells that are found naturally in the tumor. Doctors then grow the cells in a lab over the next several weeks with a protein that promotes rapid TIL growth – and once the cells number into the billions, they are infused back into the patient's body to fight the cancer. On April 1, 2015, Ryan had her tumor removed at the NIH. Two months later, she went inpatient for four weeks to have the team "wash out" her immune system with chemotherapy and infuse the cells – all 148 billion of them – back into her body.

Six weeks after the infusion, Ryan and Patrick went back for a follow-up appointment – and the news they got was stunning: Not only had no new tumors developed, but the six existing tumors in her lungs had shrunk significantly. Less than a year after her cell infusion, in April 2016, the doctors told Ryan news that would have been impossible just a decade earlier: Thanks to the cell infusion, Ryan was now considered NED – no evaluable disease. Her body was cancer-free.

Ryan is still NED today and continuing annual follow-up appointments at the NIH, experiencing things she never dreamed she'd be able to live to see, such as her children's high school and college graduations. She's also donating her blood and cells to the NIH to help them research other potential cancer treatments. "It was an honor to do so," Ryan said of her experience. "I'm just thrilled, and I hope my experience can help a lot more people."

Patrice Lee, PhD, VP of Pharmacology, Toxicology and Exploratory Development at Pfizer

Photo courtesy of Patrice Lee

Patrice Lee got into scientific research in an unconventional way – through the late ocean explorer Jacques Cousteau.

Lee never met Cousteau but her dreams of working with him one day led her to pursue a career in science. Initially, Lee completed an undergraduate degree in marine biology; eventually, her interests changed and she decided to get a dual doctoral degree in physiology and toxicology at Duke University. She now works at Pfizer's R&D site in Boulder, CO (formerly Array BioPharma), leading a group of scientists who determine the safety and efficacy of new oncology drugs.

"Scientists focused on drug discovery and development in the pharmaceutical industry are deeply committed to inventing new therapies to meet unmet needs," Lee says, describing her field of work. "We're driven to achieve new medicines and vaccines as quickly as possible without sacrificing safety."

Among the drugs Lee has helped develop during her career, including cancer therapies, she says around a dozen are currently in development, while nine have received FDA approval — an incredible accomplishment as many scientists spend their careers without seeing their drug make it to market. Lee's team is particularly interested in therapies for brain metastases — something that Lee says is a largely unmet need in cancer research, and something her team is working on from a variety of angles. "Now that we've had rapid success with mRNA vaccine technology, we hope to explore what the future holds when applying this technology to cancers," Lee says.

But while evaluating potential cancer therapies is a professional passion of Lee's, it's also a mission that's deeply personal. "I'm also a breast cancer survivor," she says. "So I've been on the other side of things and have participated in a clinical trial."

However, seeing how melanoma therapies that she helped develop have affected other real-life cancer patients, she says, has been a highlight of her career. "We had one therapy that was approved for patients with BRAF-mutant metastatic melanoma," Lee recalls. "Our team in Boulder was graced by a visit from a patient that had benefited from these drugs that we developed. It was a very special moment for the entire team."

None of these therapies would be available, Lee says without rigorous science behind it: "Facts come from good science. Facts will drive the development of new drugs, and that's what will help patients."

Chiuying "Cynthia" Kuk (they/them) MS, 34, third-year medical student at Michigan State University College of Human Medicine

Photo courtesy of Cynthia Kuk

Cynthia Kuk was just 10 years old when they had a conversation that would change their life forever.

"My mother, who worked as a translator for the government at the time, had been diagnosed with breast cancer, and after her chemotherapy treatments she would get really sick," Kuk, who uses they/them pronouns, recalls. "When I asked my dad why mom was puking so much, he said it was because of the medicine she was taking that would help her get better."

Kuk's response was immediate: "That's so stupid! Why would a medicine make you feel worse instead of better? When I'm older, I want to create medicine that won't make people sick like that."

Nine years later, Kuk traveled from their native Hong Kong to the United States to do exactly that. Kuk enrolled in a small, liberal arts college for their Bachelor's degree, and then four years later started a PhD program in cancer research. Although Kuk's mother was in remission from her cancer at the time, Kuk's goal was the same as it had been as a 10-year-old watching her suffer through chemotherapy: to design a better cancer treatment, and change the landscape of cancer research forever.

Since then, Kuk's mission has changed slightly.

"My mom's cancer relapsed in 2008, and she ended up passing away about five years after that," Kuk says. "After my mom died, I started having this sense of urgency. Cancer research is such that you work for twenty years, and at the end of it you might have a fancy medication that could help people, but I wanted to help people now." With their mother still at the forefront of their mind, Kuk decided to quit their PhD program and enter medical school.

Now, Kuk plans to pursue a career in emergency medicine – not only because they are drawn to the excitement of the emergency room, but because the ER is a place where the most marginalized people tend to seek care.

"I have a special interest in the LGBTQ+ population, as I identify as queer and nonbinary," says Kuk. "A lot of people in this community and other marginalized communities access care through the ER and also tend to avoid medical care since there is a history of mistreatment and judgement from healthcare workers. How you carry yourself as a doctor, your compassion, that can make a huge difference in someone's care."

In addition to making a difference in the lives of LGBTQ+ patients, Kuk wants to make a difference in the lives of patients with cancer as well, like their mother had.

"We've diagnosed patients in the Emergency Department with cancer before," Kuk says. "I can't make cancer good news but how you deliver bad news and the compassion you show could make a world of difference to that patient and their family."

During their training, Kuk advocates for patients by delivering compassionate and inclusive care, whether they happen to have cancer or not. In addition to emphasizing their patient's pronouns and chosen names, they ask for inclusive social and sexual histories as well as using gender neutral language. In doing this, they hope to make medicine as a whole more accessible for people who have been historically pushed aside.

"I'm just one person, and I can't force everyone to respect you, if you're marginalized," Kuk says. "But I do want to push for a culture where people appreciate others who are different from them."