One or two nights a week, I get a call from an unknown number. On the other end is a frightened patient — or more often, a parent — searching desperately for a treatment that might save a life.
Too often, I can’t help. Time and again, tragically, the only difference between a patient receiving a potentially life-saving treatment or not is government bureaucracy. The Food and Drug Administration needs to ensure that the government is keeping pace with the latest scientific developments.
Not long ago, the parents of a 21-year-old woman from Italy called me. She had colon cancer — a diagnosis that was once almost unheard of in someone so young, but is now disturbingly common. Her parents requested an immunotherapy combination that my company is currently developing. After many delays, she finally began treatment. She is still alive. However, she almost didn’t get the chance.
I have received multiple requests from a doctor at a major hospital in the United States, seeking to use this treatment on children diagnosed with cancer. Regulatory lawyers keep telling me that providing it will risk a rebuke from the FDA.
I know what it’s like to run out of options. Before I left Istanbul in the 1970s, my mother was diagnosed with breast cancer. Surgeons there removed her breast. I brought her to the United States for experimental treatments, hoping for a cure. We lost her. The doctors told us, as they told so many families then, that the best they could do was cut the cancer out with a knife.
That loss changed my life. I left a career on Wall Street and returned to my previous work in science, founding Agenus in the 1990s to provide patients with better options.
Decades later, the options for cancer patients are still far too limited, not because of a lack of scientific talent or resources but because of a regulatory culture that lags the latest and most innovative science. The appointment of Marty Makary as FDA commissioner was widely received as a sign that this would change, spurring hopes for researchers and, above all, for patients and their families. Makary has done excellent work in attacking what is likely the root of the problem for many cancers — unhealthy, ultraprocessed food — but now the agency must confront the cancer crisis head-on.
Though cancer death rates have dropped by nearly one-third since I began this work 30 years ago — primarily due to a massive decline in smoking — about half of cancers are actually rising in incidence for younger generations. We still can’t fully explain the reasons for this, but the facts are undeniable. Children today are twice as likely to develop gastrointestinal cancer as my generation, and colorectal cancer is projected to be the leading cause of cancer death for Americans under 50 within the next five years. This is a ticking time bomb for two generations of Americans. America’s growing population of young cancer patients demands that the FDA evolve faster than the cancer cells that threaten their lives.
Since the 1980s, the standard of care for these cancers has been chemotherapy, radiation and surgery, each of which can bring devastating downsides in exchange for all too little survival benefit. Chemotherapy is essentially poison — with the hope that the cancer dies before you do. Radiation can lead to permanent infertility, and surgery sometimes leaves patients hooked up to a colostomy bag and unable to control their bowel movements for the rest of their lives. Younger patients in the prime of life especially want less toxic treatments that lead to a cure. The most scientifically advanced nation in history surely can and must do better than cutting, burning and poisoning.
Americans deserve an FDA that delivers on promises to accelerate innovation. Science continues marching forward. Discoveries are being made. A new generation of immunotherapies is in development that work differently from earlier, less-effective and more toxic therapies, giving patients much better options than my mother had.
I believe that one day cancer care will be done not with a knife, but by teaching the immune system to kill cancer. Yet, this future will be possible only if the FDA can keep pace with the speed of science.