How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour later.

This sets the tone for a profile in The Wall Street Journal, which writes that Pazdur, 55, still makes life-or-death judgments - and gets a lot of criticism as a result. That’s because each decision affects millions of Americans. Pazdur heads the FDA’s Office of Oncologic Drugs, which makes him the gatekeeper for any new cancer med that goes on the US market - and an estimated 30 percent of all drugs that are in an advanced stage of development.

Pazdur’s powerful position puts him at the center of some of the biggest controversies in medicine. Tomorrow, he will be in the spotlight again, as an FDA advisory committee weighs whether to impose further restrictions on blockbuster anemia meds sold by Amgen and Johnson & Johnson, the Journal notes. Yesterday, the agency posted toughly worded documents on its web site, asking the panel to consider whether the FDA should remove its approval for use in cancer patients.

Companies and some patient advocates complain that Pazdur’s decisions and his rigorous standards of evidence have kept drugs from cancer sufferers who sometimes have no other hope, the Journal writes. Drugmakers say approaches like Pazdur’s slow the development and approval of new products.

Last fall, dozens of protestors gathered outside the FDA’s headquarters to complain about the agency’s handling of cancer medicines. Two prostate-cancer patients blamed the agency for rejecting the Dendreon vacccine known as Provenge, which they said helped keep them alive. Later, the group broke into a chant: “Pazdur Must Go! Pazdur Must Go!” On the other side, cancer researchers and other patient groups say Pazdur approves drugs that work and provides a bulwark against those that are unproven and potentially dangerous.

The Journal sums it up nicely by writing that Pazdur’s role crystallizes broader questions about the FDA itself. Amid rapid changes in medical science and soaring health-care costs, Pazdur and the agency face conflicting pressures. Some want the FDA to make it easier for cancer patients and doctors to get access to drugs, by relaxing traditional standards for measuring their benefits. Others want the FDA to set a high bar to protect Americans from drugs with only limited effectiveness.

Pazdur emphasizes the importance of statistical tests over the often compelling stories of individual cancer patients. “We can’t be put in the position of approving a toxic placebo,” he tells the Journal.

But just last month, the FDA surprised some critics by granting permission for Genentech to market Avastin for breast cancer; the drug helped slow the progression of the disease, even though it hadn’t been shown to extend survival, a measure traditionally considered a “gold standard” for cancer-drug approvals. In interviews, Pazdur, whose office reviewed Avastin, called the decision an example of regulatory “flexibility.” But critics say the decision changed standards, and for the worse (read this interview with Breast Cancer Action’s Barbara Brenner).

The son of working-class parents, Pazdur grew up in Calumet City, Ill., south of Chicago. His views have been shaped by the years he and his wife, Mary, an oncology nurse, have spent treating cancer patients, he says. His grandmother died of breast cancer. Two uncles and an aunt were killed by forms of the disease. But he also watched his father - who went blind when Pazdur was a teen and who suffered from diabetes and pulmonary fibrosis - endure the side effects of steroid drugs that didn’t help his condition, the paper writes.

“There’s a heightened awareness I have that drugs can cause harm, and that’s why we do need evidence drugs work,” Pazdur tells the Journal. “These drugs hastened his death.” He says he thinks every day of his father, who died in 1979.

The walls of Pazdur’s suburban townhouse display paintings given to him by patients, and he can recall names and treatment details of people he cared for decades earlier, the Journal writes. Doctors who trained under him say he was gentle but never sugarcoated grim news. He was careful to meet patients’ eyes and often used the phrase, “You need to come to terms with your disease.”

He says, though, that he doesn’t generally become friends with patients, or even allow them to use his first name. In the case of the patient who grabbed his coat, the man’s cancer hadn’t been stopped by standard chemotherapy or an experimental treatment. “What do you tell somebody?” Dr. Pazdur says. “He was just unwilling to accept the inevitable,” he tells the paper.

Pazdur got his first real experience with the FDA when a chemotherapy drug known as UFT, backed by Bristol-Myers Squibb, came up for market review at the agency. Pazdur, who was a professor of medicine at the University of Texas M.D. Anderson Cancer Center, oversaw the main trial of the drug.

A colon-cancer patient had a remarkable response to UFT: The disease, which had spread to his lymph nodes and liver, apparently vanished. Still, Mr. Larry Daspit recalls to the Journal, even after he began to show improvement, Dr. Pazdur would warn him, “Do not think this means you are cured,” seeking to avoid giving him false hope. The FDA didn’t approve UFT. Daspit tells the paper he was surprised and upset by the decision, issued in 2001. “Why deny people that choice?” he asks. Pazdur, who was at the FDA by then, recused himself from the decision.

Pazdur says that when he met with agency officials about UFT, he was struck by “the influence that the FDA had on the entire development of drugs.” He was ready to try something new, he says, so when the position overseeing the agency’s oncology drug-review division came open, he applied and won it in 1999, the Journal writes.

He quickly began reaching out to major interest groups, with the goal, he says, of opening up lines of communication. “He stepped into the role and approached us,” Ellen Stovall, ceo of the National Coalition for Cancer Survivorship, tells the Journal. It was also a politically savvy move: Stovall’s group and others have been strong supporters during Pazdur’s rise at the FDA, according to the paper. In 2005, he was promoted to head a new, more powerful office overseeing all cancer drugs. His original post didn’t include oversight of biotech treatments.

Pazdur now oversees about 125 people, including oncologists, pharmacologists and hematologists. He says verdicts on drugs are driven by consensus among agency reviewers, as well as FDA standards. “We make the decisions on what we believe is the best science,” he tells the Journal. “This is not an issue of personality. It is an issue of looking at the data.”

There is much more, so please keep reading….