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“Her death underscored for me the importance


of getting drugs out sooner to patients,” he says. “It also made me understand the importance of drug toxicities. Until you’ve lived with those drugs’ toxicities on a 24-hour basis, you don’t really un- derstand what it’s like.” Standard product labels, he says, don’t give an


accurate picture. He has championed FDA initia- tives to include patients’ descriptions of toxicities, written in language people with cancer and their loved ones can understand. Pazdur notes that cancer drugs are significantly


improving and patients are living longer. “This is a dramatic time,” he says. “After years of basic science working to better understand diseases, we have a better understanding of the immune system and can tailor the drugs.” That’s a vast improvement over the previous roulette wheel approach many trials took. But advances aren’t cures. “I want to make sure


we’re not overly optimistic,” he says. The Pazdurs’ understanding of that reality gave


was how she approached her disease. Cancer can bring out the best or the worst in people. Because of who she was and her religious background, she approached it with great courage.


“One of the greatest gifts my wife gave to me ’’ —RICHARD PAZDUR (MD ’76), PICTURED ABOVE WITH HIS WIFE, MARY, AND THEIR DOG, CLEO Through it all Pazdur, 64, has crafted and


managed the country’s approach to approv- ing drugs that treat cancer—drugs that might give precious extra years to someone stricken, drugs that are the last hope for families in the midst of loss. There are also drugs that might not help cancer patients at all, but rather increase suffering because of their toxicity. If approved, these drugs can make pharmaceutical companies billions. Cancer is feared, deadly, and widespread, and health insurance and government programs pay for expensive treatments that have been ap- proved by the FDA. According to the American Cancer Society,


nearly 1.7 million new cancer cases will be diag- nosed in the United States in 2016; more than half a million will likely die of the disease over the course of the year, making cancer the country’s second leading cause of death. That’s despite a steady stream of breakthroughs, new treatment techniques, and new drugs that are chipping away at the disease. Pazdur’s tenure at the FDA has put him in the firing line in places as public as a series of


22 LOYOLA UNIVERSITY CHICAGO


columns in the Wall Street Journal’s editorial pages (which excoriated him as being an obstruc- tionist) and as personal as letters from indignant investors and desperate families. On the flip side, consumer advocates have complained that the FDA has been swayed by the relentless lobbying, the pleas of cancer patients—and now, the death of Pazdur’s own wife from cancer. Ultimately, he has told his staff to go by one


metric: At the end of the day, is the American public going to be better with this drug than without it? The data shows, according to a New York Times


article, that under Pazdur’s leadership the OHOP began approving new drugs at a faster rate: at an average of five months instead of six. He says much of the change is because the drugs them- selves are better—some of them “slam dunks.” Congress also passed the FDA Safety and Innova- tion Act of 2012, the same year that Mary Pazdur was diagnosed. It’s a bill that allows the OHOP to work with researchers and act with greater urgency. Still, Pazdur admits his wife’s cancer has changed his thinking.


them an advantage when Mary was diagnosed. “We’d seen the movie, we’d read the book,” he says. “Now we were trapped in the story.”


Mary’s friends described her as supportive, prac- tical, and compassionate. She brought that to her final months as well, even though she knew from the beginning of her illness that there was a poor prognosis for her survival. Only about 45 percent of women with ovarian cancer reach the five-year mark after their diagnosis. She fought to take part in one experimental


study with a class of treatment that her husband had no authority over, but when it and other treat- ments failed, Mary recognized and accepted it. She eventually asked her attending physician to put her in hospice. “One of the greatest gifts my wife gave to me


was how she approached her disease,” Pazdur says. “Cancer can bring out the best or the worst in people. Because of who she was and her reli- gious background, she approached it with great courage.” A strong faith is another thing the couple


shared, and Pazdur recalls a conversation after Mary’s death with a priest who knew the couple well. Pazdur, in his understated way, explains he their exchange. The priest told him, “Rick, you’ve gone to Catholic schools, you’re part of a long Catholic tradition. You know that this isn’t the end. Think about it this way: Mary has gone on a long trip to New York. You’ll see her again.” The priest’s words stuck with Pazdur. He re-


members his response, too. “I said, ‘Father, I hope she’s having fun in New


York; I hope she’s maxing out the credit cards. I hope I’ll see her soon. But not too soon.’” L


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