Cancer of FDA staffer’s wife helps quicken drug approvals
But some fear vital safeguards being neglected
By Gardiner Harris
New York Times

BETHESDA, Md. — Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.

So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.

He was also Mary’s husband.

In her struggle with cancer and ultimately her death in November, Mary Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the FDA: a speeding up of the drug approval process.

Pazdur’s three-year battle with cancer was a factor, they say, in Richard Pazdur’s willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.

Others worry that the emotions of a loving husband have short-circuited vital safeguards.

“Rick Pazdur is the most important person in the cancer world,’’ said Ellen Sigal, the founder and chairwoman of Friends of Cancer Research, an advocacy group. Now that he has watched his wife die of the disease, she said, “you can’t go through something like this and not be changed by it.’’

Certainly there has been a change at the powerful agency. Since Mary Pazdur learned she had ovarian cancer in 2012, approvals for drugs are faster than at any time in the FDA’s modern history.

Although companies go through a yearslong discovery and testing process with new drugs before the formal application process with the FDA, the average decision time on drugs by Pazdur’s oncology group has come down to five months from six months.

That is a major acceleration in a pharmaceutical industry where every month’s delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.

When asked specifically how his wife’s illness had changed his work at the FDA, Pazdur said he was intent on making decisions more quickly.

“I have a much greater sense of urgency these days,’’ Pazdur, 63, said in an interview. “I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate.’’

But in 2012, he said, Congress also passed a law that gave the FDA more money and a new pathway to work more closely with drug makers when a medicine may save lives.

Another important change in the same period, he said, was a surge in advances in genetic research that made some medications more effective and easier to test.

In 2014, Pazdur approved a drug for widespread use against ovarian cancer that an expert advisory panel had previously voted, 11 to 2, against authorizing. Mary Pazdur did not take the drug, her husband said, because it was targeted at a form of cancer that was genetically different from hers.

Despite the sympathy for Pazdur after the loss of his wife, some are uneasy about the FDA’s increasing embrace of what they consider to be soft science and rapid approvals. “I respect Rick Pazdur enormously,’’ said Fran Visco, president of the National Breast Cancer Coalition. “But I am worried that the FDA is losing sight of the incredible importance of making sure drugs save lives.’’

Still others see a windfall for drugmakers that are getting their products to market faster.

“The FDA is more beholden to industry now than at any time since I became a close observer of the agency in 1971,’’ said Dr. Sidney Wolfe, who with Ralph Nader founded Public Citizen’s Health Research Group. “Too many decisions FDA now makes are driven by industry concerns, and as a result people are getting hurt.’’

Cancer medicines not only often fail to save patients but can accelerate their deaths and make their last weeks far more painful. As it turned out, Mary Pazdur suffered terribly from taking a second experimental drug in a clinical trial, in which her husband had no role.

After the experimental drugs failed, Mary Pazdur decided to enter hospice care. On the morning of Nov. 24, she died holding her husband’s hand. She was 63.