March 11, 2009

Painkiller Trial Raises Questions for FDA, Pfizer

In February 2005, the U.S. Food and Drug Administration (FDA) called a three-day hearing to review the risks of three painkillers known as COX-2 inhibitors. From its inception, the hearing — conducted by an FDA advisory panel — was beset by controversy. One of the COX-2 drugs, Vioxx, had recently been withdrawn from the market for safety reasons. The FDA had also removed and then reinstated one of its own experts from the panel, and there were published reports of suppressed drug safety data regarding not just Vioxx, but another COX-2 inhibitor, Celebrex. Emotions were running high as the 32-member panel of outside advisers assembled in a Hilton Hotel ballroom in Gaithersburg, Maryland, to hear testimony from scientists, patients, and drug company representatives on the risks and benefits of the painkillers. Read more

February 26, 2009

The “Soft Underbelly” of Development?

Diana Johns had just moved into her four-bedroom, 6,500-square-foot Leesburg, Virginia, home in 2002 and was thrilled with its elegant pillars, golf-course views, and expansive, sunny rooms. But the bleating alarm tied to the home’s “nonconventional” septic system signaled that beneath the surface, something was terribly wrong. Read more

February 19, 2009

Coal Ash: The Hidden Story

Pat Nees never liked the water at the Moose Lodge. Almost everyone in tiny Colstrip, Montana, drank and dined at Lodge #2190, but the well water was notorious — it smelled like a sewer. It felt oily, gritty from sediment. Lodge members braving a drink — Nees among them — frequently doubled over from indigestion. Read more

December 22, 2008

Did the FDA Miss Signals on a Troubled Heart Drug?

It has been a rough eight months for the drug maker Actavis, Inc. and its powerful heart drug, Digitek. Following repeated Food and Drug Administration (FDA) criticisms of its manufacturing processes, Actavis Totowa, a subsidiary of Actavis, issued a recall of Digitek on April 25, after discovering that some of the tablets were twice as thick as intended, and thus contained double the dose meant for a patient. Digitek is so potent that even a slight increase in dosage can be toxic or fatal. In August, Actavis closed a plant in Little Falls, New Jersey, that manufactured Digitek, to institute “remediation” efforts; that closure also effectively shut two other Actavis facilities that provide laboratory and packaging services. In October, two members of the House of Representatives launched an inquiry into the FDA’s oversight of Actavis. Then, just last month, the U.S. Justice Department asked a federal judge to permanently enjoin Actavis and Actavis Totowa from manufacturing drugs until the firm could demonstrate compliance with FDA “Good Manufacturing Practice” requirements. Read more

December 19, 2008

Big Tobacco’s New York Black Market

For New York Governor David Paterson, there was no good option.

Faced with a crushing state deficit, angry American Indians, and uncooperative tobacco companies, Paterson on December 15 signed into law a bill designed to take on one of America’s most lucrative black markets: the underground trade in cigarettes flowing through the state’s 10 Indian reservations. Read more

December 18, 2008

As FCC Chair Martin Resigns, He Leaves Controversial Legacy

WASHINGTON – Among the legions of predictable, starched-shirt regulators that populate Washington, outgoing Federal Communications Commission Chairman Kevin Martin has been a conundrum. Read more

December 16, 2008

Pets and Pesticides: Let’s Be Careful Out There

Last June Diane Bromenschenkel applied a flea-and-tick product to her English pointer, Wings, so the dog wouldn’t get ticks while hunting pheasant in the tall grasslands of western Idaho. Wings, a healthy five-year-old with a sleek white coat and a chocolate brown mask, enjoyed long walks in the woods, bacon treats, and burying things in the yard. But three months after the pesticide was applied, the animal was dead. Read more

November 19, 2008

Outsiders Target Indian Land for Risky Business

Deep in the foothills, miles above California’s Sacramento Valley, the 640-acre home of the Cortina Band of Wintun Indians lies empty except for six houses, a graveyard, and the spot where the band’s ceremonial roundhouse once stood. Read more

October 28, 2008

A Curious Process for Valuing Land in Loudoun County

Officials in one of the nation’s fastest growing counties defeated a plan to purchase nearly 100 acres of land, at a cost of more than $200,000 per acre, from the largest developer in the county after the Center for Public Integrity reported that the developer was simultaneously claiming the land was worth only about $35,000 per acre for tax purposes. Read more

September 30, 2008

Global Warming: Heated Denials

Stand-up comedian Tim Slagle was on a roll. In a lunchtime routine tailored to 400 conference attendees, Slagle was killing ‘em with jokes about, well, global warming. Read more