Holding the Government Accountable

POGO Wins National Journalism Prize for Reporting on FDA

The Project On Government Oversight has won a national journalism prize for its coverage of potentially deadly weaknesses in the Food and Drug Administration’s oversight of prescription drugs.

The Society of Professional Journalists announced today that POGO’s “Drug Problems” investigation received a Sigma Delta Chi Award for online reporting.

Others honored with Sigma Delti Chi awards for work published in 2015 include The Wall Street Journal, the Associated Press, The Washington Post, and The New York Times.

“We’re honored to be included in such distinguished company and grateful to the Society of Professional Journalists for recognizing this work,” POGO Editor-in-Chief David Hilzenrath said. “We hope the award helps focus attention on the problems POGO spotlighted.”

POGO’s award-winning reporting drew on thousands of pages of FDA documents, many obtained through the Freedom of Information Act, and a decade of data from different sources. The reporting, which began in 2013, took POGO deep into the science of experimental drugs and the technical details of vast, far-flung clinical trials sponsored by drug makers and relied upon by decision-makers at the FDA.

POGO’s coverage showed how the FDA has set low standards and approved drugs based on flawed trials.

One of the trials featured in POGO’s reporting was co-chaired by medical researcher Robert Califf, who has since become commissioner of the FDA.

The award to POGO comes as Congress is working on legislation that could lower hurdles to FDA approval of new drugs and speed them to market.

Among POGO’s wide-ranging findings:

●The FDA rarely imposes sanctions on doctors who mismanage clinical trials, even when FDA inspections uncover violations of the most serious kind. A trial POGO examined in-depth employed dozens of doctors who had been faulted by the FDA in inspections of earlier trials, including repeat and three-time offenders.

●Outside advisors enlisted by the FDA to help review experimental drugs have had financial relationships with pharmaceutical companies. Some advised the agency to approve a particular company’s drug and went on to receive substantial compensation from that same company.

●Former members of FDA advisory committees have been paid to help drug companies prepare for advisory committee hearings.

●To win FDA approval, drug makers are supposed to show that the new drug is “non-inferior” to one already on the market. However, the FDA uses the term “non-inferior” loosely. In the case of one widely advertised drug, the FDA set the bar so low that the product could be approved if it was proven only 50 percent as effective as an inexpensive generic drug in use since the 1950s.

The first article in POGO’s “Drug Problems” series examined the FDA’s handling of Pradaxa, the first in a new generation of blood thinners to win FDA approval.

Another article in POGO’s series spotlighted the potentially fatal unreliability of blood-testing devices used in the care of many patients taking the decades-old blood thinner warfarin (also known by the brand name Coumadin) and in a clinical trial that compared the relatively new blood thinner Xarelto to warfarin. Based on the clinical trial in question, the FDA more than four years ago approved Xarelto for patients with a heart condition known as atrial fibrillation.

Since POGO published that report, the FDA has held a day-long meeting on problems with so-called point-of-care warfarin-monitoring devices and has indicated that it plans to tighten applicable standards.

In addition, the FDA has been taking a fresh look at data related to the Xarelto trial. In light of the same issue, the FDA’s European counterpart recently reexamined the trial. The European regulator found many discrepancies in data gathered during the trial but decided those discrepancies did not warrant changing its assessment of Xarelto’s risks and benefits.

POGO received the Sigma Delta Chi Award in the category of non-deadline reporting by independent websites, meaning those not associated with print or broadcast media organizations. The SPJ says its awards “recognize the best in professional journalism.”

POGO’s reporting team included John Crewdson, Hilzenrath, Michael Smallberg, and Charles R. Babcock. Lydia Dennett provided fact-checking and editorial support. Danni Downing edited the text. Leslie Garvey did the web design and graphics. With Garvey, Pam Rutter worked on production.

Earlier this year, based on the same body of work, the Association of Health Care Journalists awarded POGO second prize for coverage of health policy in a category for large organizations. Much bigger and more widely known organizations that received prizes from the health care journalists’ association included The Wall Street Journal, The Boston Globe, The Los Angeles Times, and NPR.

In March, the Society of American Business Editors and Writers named POGO a finalist for its “Best in Business” award for reporting on health care.

In addition, the National Institute for Health Care Management recently named POGO a finalist for its digital media award. That prize “recognizes excellence in digital media that improves understanding of health care topics through analysis grounded in empirical evidence,” the foundation says.

The articles in the package cited for the Sigma Delta Chi Award are “Dangerous Decision-Making at the FDA,” “FDA Approves Antidote for Pradaxa, Calls It ‘Necessary,’” “Nominee to Head FDA Led Clinical Trial FDA Faulted,” “Duke Reassessing Data From Trial Led By FDA Nominee,” and “European Regulator Investigating Trial Led by FDA Nominee.”

Related and follow-up coverage can be found here.

Photo of John Crewdson
John Crewdson

John Crewdson, a former senior investigator at the Project On Government Oversight, won a Pulitzer Prize for coverage of immigration while reporting for The New York Times. His 55,000-word Chicago Tribune history of the discovery of the AIDS virus garnered the George Polk Award for medical reporting. Crewdson was a finalist for the Pulitzer Price in explanatory reporting for his expose of the inadequacy of emergency medical equipment aboard commercial airlines. That reporting resulted in decisions by every major U.S. and foreign airline to begin carrying portable defibrillators, credited with so far saving more than 300 lives.

Crewdson holds an undergraduate degree in Economics summa cum laude from the University of California. He later studied politics at Queen's College, Oxford.

Crewdson began his career as a copy boy with The New York Times, where he worked for 13 years as a Washington reporter and national correspondent before moving to the Chicago Tribune. At the Tribune, he spent 28 years as national editor, metropolitan editor, West Coast bureau chief, senior writer, senior correspondent, and associate Washington editor. He later worked as an investigative reporter for Bloomberg News.

Crewdson is the recipient of many other awards, including the Sigma Delta Chi bronze medallion, the New York Deadline Club's Goldberg award, the New York Newspaper Guild's Page One Award, the Chicago Headline Club's Peter Lisagor award, the American Bar Association's Silver Gavel award, National Press Foundation Everett McKinley Dirksen Award for Distinguished Reporting of Congress, the National Press Club’s Lee Walczak Award for Political Analysis, and honorable mention for the Toner Prize for Excellence in Political Reporting.

Crewdson and his wife Prudence have two sons and live in Bethesda, Maryland.

David Hilzenrath
David Hilzenrath

David Hilzenrath joined POGO as editor-in-chief in June 2012. Before that, he was a journalist for The Washington Post.

Hilzenrath has led POGO’s investigative staff to nine awards for excellence in journalism, including the Robert D.G. Lewis Watchdog Award and three prizes for investigative reporting.

As a reporter on The Washington Post’s financial desk, he wrote extensively about the intersection of business and government. He reported on the financial crisis, the regulation of the financial industry, and the Securities and Exchange Commission, including the policing of Wall Street. He probed subjects as diverse as the finances of presidential candidates, offshore banking and money-laundering, executive compensation, the Deepwater Horizon disaster, federal tax policy, and accounting fraud. He wrote about corporate scandals from Enron and WorldCom to Fannie Mae, Freddie Mac, Bernie Madoff, and MF Global. His reporting on systemic conflicts of interest in the auditing of Corporate America helped provide a roadmap for reform. Hilzenrath scrutinized efforts to overhaul health care under presidents Obama and Clinton and has reported in depth on the business-driven transformation of the health care system.

He was a contributing author of Landmark: The Inside Story of America’s New Health Care Law and What It Means for Us All (Public Affairs, 2010). His honors while at The Post included the Morton Mintz Award for Investigative Reporting and the Bill Pryor Memorial Grand Prize for Writing. He has appeared on radio and television, including NPR, MSNBC, CNBC, Fox News, and C-SPAN.

Hilzenrath studied at the University of Michigan through the program now known as the Knight-Wallace Fellowship. He is an honors graduate of Harvard College, where he majored in government.

Photo of Michael Smallberg
Michael Smallberg

Michael Smallberg’s investigations at the Project On Government Oversight (POGO) focused on federal regulators’ oversight of the financial services industry and the government’s inspector general system. His work included a multi-part probe of the revolving door at the Securities and Exchange Commission, which spurred the government to tighten ethics rules.

Smallberg has appeared on CNN and has been quoted in The New York Times, The Washington Post, and The Wall Street Journal. He is the recipient of three Dateline Awards—in business journalism, investigative reporting, and feature series—from the Society of Professional Journalists’ Washington, D.C. chapter. He joined Bloomberg Government in September 2015. Smallberg earned a B.A. in American History from Brown University.

Photo of Charles R. Babcock
Charles R. Babcock

Charles Babcock was an investigative reporter and editor at The Washington Post for 30 years. He also worked at Bloomberg News and The Courier-Journal in Louisville, his hometown. He is a graduate of Ohio Wesleyan University, the Fletcher School of Law and Diplomacy at Tufts, and served as an Army lieutenant in Vietnam. He was a Pulitizer Prize finalist in 1990 and was co-winner of the Gerald Loeb and Everett Dirksen awards for 2011.