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More quotes from Pazdur showing what a heartless hypocrite he is.

POWERFUL MEDICINE
FDA Cancer Czar Stirs Debate On Agency's Role Anemia-Drug Tussle
Puts Pazdur on Spot; Father's Early Death
By ANNA WILDE MATHEWS

March 12, 2008; Page A1

Over 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. The doctor says he declined, because he believed further treatment wouldn't help. The patient died less than an hour later.

Dr. Pazdur, 55 years old, still makes life-or-death judgments. But now, each one affects millions of Americans. As head of the Food and Drug Administration office that regulates oncology drugs, Dr. Pazdur is the gatekeeper for any new cancer medicine that goes on the U.S. market -- and an estimated 30% of all drugs that are in an advanced stage of development.

Companies and some patient advocates complain that Dr. Pazdur's decisions and his rigorous standards of evidence have kept drugs from cancer sufferers who sometimes have no other hope. Drug makers say that approaches like Dr. 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 a treatment 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 Dr. Pazdur approves drugs that work and provides a bulwark against those that are unproven and potentially dangerous.

Dr. Pazdur's role crystallizes broader questions about the FDA itself. Amid rapid changes in medical science and soaring health-care costs, Dr. 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.

Around 1.4 million cases of cancer are expected to be diagnosed in 2008, and 565,650 Americans are expected to die of cancer this year. Still, better detection and better treatments have steadily improved the odds for many patients. For people diagnosed between 1996 and 2003, the five-year survival rate was 66%, up from 50% for those diagnosed between 1975 and 1977.

'Toxic Placebo'

Dr. 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 says.

But just last month, the FDA surprised some critics by granting permission for Genentech Inc. to market the drug Avastin for breast cancer; the drug helped slow the progression of the disease, even though it hadn't been shown to extend patients' lives, a measure traditionally considered a "gold standard" for cancer-drug approvals. In interviews, Dr. Pazdur, whose office reviewed Avastin, called the decision an example of regulatory "flexibility."

Patients' Paintings

The son of working-class parents, Dr. 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 Dr. Pazdur was a teen and suffered from diabetes and pulmonary fibrosis -- endure the side effects of steroid drugs that didn't help his condition.

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

The walls of Dr. Pazdur's suburban town house display paintings given to him by patients, and he can recall names and treatment details of people he cared for decades earlier. 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 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."

A Drug Denied

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

One of his colon-cancer patients, Larry Daspit, had a remarkable response to UFT: The disease, which had spread to his lymph nodes and liver, apparently vanished. Still, Mr. Daspit recalls, 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. Mr. Daspit says he was surprised and upset by the decision, issued in 2001. "Why deny people that choice?" he asks. Dr. Pazdur, who was at the FDA by then, recused himself from the decision.

Dr. 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.

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," says Ellen Stovall, chief executive of the National Coalition for Cancer Survivorship. It was also a politically savvy move: Ms. Stovall's group and others have been strong supporters during Dr. Pazdur's rise at the FDA. 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.

Dr. Pazdur now oversees around 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 says. "This is not an issue of personality. It is an issue of looking at the data."

'The Decider'

Patricia Keegan, who oversees the biotech-drugs division under Dr. Pazdur, says he is "very open to listening to all sides before he makes a decision," but for new drug approvals, he is "the last person to weigh in, the decider."

Dr. Pazdur has had run-ins with higher-level FDA officials. Early last year, amid safety questions about the anemia drugs made by Johnson & Johnson and Amgen, Dr. Pazdur told the companies they should stop promoting the products. Johnson & Johnson says its lawyer contacted the FDA's chief counsel, a Bush administration appointee named Sheldon Bradshaw, about Dr. Pazdur's directive.

After that, Mr. Bradshaw told Dr. Pazdur that such an order would infringe on the companies' free-speech rights, according to a person with knowledge of the matter. Dr. Pazdur then "clarified" that the FDA was only requesting a voluntary halt, according to an account that Johnson & Johnson provided to Congress. A congressional committee opened an investigation into promotion of the anemia drugs in March 2007.

Amgen declined to comment. Johnson & Johnson says, "It is important to preserve [the company's] ability to communicate with health-care providers and patients, particularly when there is important new safety information about its products."

Under Scrutiny

As Dr. Pazdur's power has grown, his words and actions are parsed with some of the same intensity as Federal Reserve chief Ben Bernanke's.

Old friends say he won't let them pick up the check at dinner, because they may research a drug that could come under FDA review. The job is hard to get away from: Mary Pazdur says a volunteer with a local rescue group for Maltese dogs -- an interest for her because of the couple's own pair of the tiny pooches, Cleopatra and Rebel -- once asked her to find out the fate at the FDA of a canine drug. FDA drug deliberations are confidential, and the couple says Dr. Pazdur doesn't discuss them at home.

At one point, Dr. Pazdur says the FDA received a complaint that Mrs. Pazdur's work in a clinical trial at the National Institutes of Health constituted a conflict for him. In fact, the type of product involved wasn't under his oversight. "You have to have a thick skin," Mrs. Pazdur says.

Chorus of Critics

Editorialists, bloggers and advocacy groups have zeroed in on him -- with criticism for denying some drugs and for approving others. Just 8% of cancer-drug candidates end up winning FDA approval, according to the Tufts Center for the Study of Drug Development. But most of the dropoff occurs long before they reach the agency, when they fail in studies. The FDA drug-approval rate for oncology in fiscal 2005-06 was fairly typical compared with other therapeutic categories, according to statistics from Parexel International Corp., a pharmaceutical-services firm.

Dr. Pazdur took flak over the FDA's 2003 decision to approve the AstraZeneca PLC lung-cancer drug Iressa. It helped shrink tumors in only 10% of patients in a limited study, while other clinical trials showed no significant benefit. But when an FDA advisory committee weighed Iressa, several patients spoke movingly about the medicine. The panel voted for approval, overruling a prominent statistician. The agency followed suit.

Then Iressa failed to show it could extend patients' lives in a large study. Dr. Pazdur says he awoke in the middle of the night, agonizing over what to do. In 2005, Iressa's use was severely restricted. Afterward, Dr. Pazdur sometimes internally cited Iressa as an example of the risk of approving a drug based on limited statistical evidence, according to people who have worked with him. The FDA's "decision has to be based on data," he says, speaking generally. "We don't approve drugs on testimonials."

Dr. Pazdur's approach has earned him a vigorous chorus of critics. He "has been a lethal disaster for cancer patients," says Steve Walker, a co-founder of the Abigail Alliance for Better Access to Developmental Drugs, an advocacy group. Mr. Walker and others criticize decisions like the FDA's 2006 rejection of Genta Inc.'s drug, Genasense, for a form of leukemia.

In a company-sponsored study of 241 people, patients taking Genasense were more likely to see signs of disease totally or nearly eliminated. But the FDA said the finding was of "questionable clinical significance." Patients taking Genasense didn't live longer, or show improvement in a broader measure of effectiveness, the agency said. The advisory committee voted against approval, and the drug was rejected.

Genta is appealing. The company's chief executive, Raymond Warrell, says his product was "held to a standard that far exceeds what anyone could reasonably require." The company has won support from a number of leukemia experts, some of whom have been researchers on Genta-sponsored studies.

Dr. Pazdur says the FDA is willing to give patients access to drugs that aren't approved, if approved treatments haven't worked. Some companies limit patient access to experimental therapies. Genta says it has a "compassionate use" program in the U.S. that allows patients access to its drug Genasense.

Dr. Pazdur dismisses personal criticism from what he calls "citizens against Pazdur." The attacks are often from "bullies," he says, and are "just an attempt to direct frustration, not the real issue of whether the drug works or not."

Write to Anna Wilde Mathews at [e-mail]2

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