Wikileaks.org, a website on which whistleblowers may anonymously break stories of government and corporate transgressions, has gone offline and will remain so while it looks for funding. The home page featured a message saying that Wikileaks had received "hundreds of thousands of pages from corrupt banks and other information pertaining to the Iraq war, China, the United Nations” and that it does not currently have the resources to release the documents. Wikileaks has featured thousands of sensitive documents regarding the September 11 attacks, Guantánamo Bay and the Church of Scientology, among others. Neil Gordon of the Project on Government Oversight commented on Wikileaks, saying: "We think there's nothing but good that can come from sites like Wikileaks. It provides places for whistleblowers to provide documents anonymously, which is often the only way you can uncover corruption."

In a controversial move, drug maker GlaxoSmithKline has decided to finance a documentary about eating habits in order to increase its sale of a weight loss drug they produce. While corporations often financially support films, as a rule they do not directly finance films with the hope of translating that support into profit. Some in the film industry are worried that the film will function more like a commercial for the weight loss drug and less like a documentary.

In public health news today, ABC News reports that despite talk of a push for greater drug safety, the number of drugs approved in 2009 was similar to the number approved in years before.

An article from Frank Chiropractic reported that drug research is full of conflicts of interest that threaten drug safety, using GAP’s 2009 report, The ABC’s of Drug Safety, as its main evidence. One conflict, for example, is that while drug companies continue to grow, the FDA continues to experience cutbacks, thus threatening regulation and oversight.

A physician and a community hospital in Minnesota agreed to pay almost $850,000 after another doctor blew the whistle on fraudulently billing of Medicare for "unreasonable and unnecessary" hospitalizations. Under a federal law, the whistleblower received $203,150.

In other news, the New York Times featured an editorial by two members of the 9/11 Commission arguing that the government should examine the entire intelligence and airline safety system to determine if the failures that lead to 9/11 and the failed Christmas Day terror attempt are endemic or fixable. Obviously, despite the commission’s recommendations, major lapses are still apparent.

By Helena Bottemiller

The Government Accountability Project (GAP) held a conference yesterday focused on the important role whistleblowers play in protecting the food supply, exploring ways to empower more food workers to speak out against inhumane and unsafe practices in the food system.

Written by GAP Public Health & Safety Associate Jonathan Cantú. Versions of this op-ed also appeared in the Ashville Citizen-Times (NC), Sun Advocate (UT), Columbia Daily Herald (TN), and Davis Standard Examiner (UT).

The Food and Drug Administration’s management has got it wrong again: The agency’s troubles aren’t due to bad public relations. At least they weren’t until recently.

2008 has been yet another tormented year for the FDA. February brought Congressional hearings into the agency’s lax regulation of fatal drugs. March brought a Congressional report scorching the FDA for its woefully inadequate inspection of foreign products entering the US, shockingly illustrated by that month’s Chinese ingredient-tainted Heparin scandal that involved at least 81 American deaths. The summer months brought the FDA’s long struggle to contain a salmonella outbreak that it attributed to tomatoes but was caused by peppers.

What was the FDA’s response to this string of spotlighted failures? To hire a marketing firm to remake the agency’s public image. Comically, the FDA botched that task, too. Investigative reports show the agency circumvented the mandated competitive bidding process in order to steer the PR contract to a Washington, D.C.-based consulting firm.

by GAP Public Health and Safety Associate Amanda Hitt

Recent food scares are prompting American consumers to double-check food product labels — not just where items are coming from, but the precise ingredients and chemicals being ingested. But what if the labels are themselves misleading? You would hope this would be illegal, but Food and Drug Administration (FDA) guidelines allow for this every day.

Consumers should be able to rely on the reassuring “100 percent Beef” label on the package when making a purchase. But from the label, you would never know that much of the commercial beef on the market actually contains a chemical commonly found in floor cleaners! Anhydrous ammonia, which appears nowhere on the label, is now being intentionally added to meat by one of the nation’s largest beef distributors.

Beef Product Inc. (BPI) sells its ammoniated product (used in frozen hamburger patties, taco meats, low-fat hot dogs, beef-stick snacks) to major fast-food chains and food distributors as well as the federal Child Nutrition Program.

Written by GAP Executive Director Mark Cohen. Versions of this op-ed also appeared in: The Roanoke Times (VA), Springfield News-Leader (IL), KC Community News (KS), Mountain Mail Newspaper (CO), Athens Messenger (OH), Daily Republican Register (IL), Portsmouth News Herald (NH), Fall River Herald News (MA), Hugo Daily News (OK), Seacoast Online (ME), and Aventura News (FL)

Congress recently missed an opportunity to make meaningful changes in the way drug-makers peddle their often dangerous products. Wooed or intimidated by pharmaceutical corporations’ lobbying might, the Senate and House passed an FDA reauthorization bill that caters to the marketing interests of drug manufacturers and broadcasters, virtually ignoring public safety. Fortunately, not all courts are as willing as Congress to turn a blind eye to the distorting impact of direct-to-consumer (DTC) advertising.

The issue facing state Supreme Court justices this summer in West Virginia v. Johnson & Johnson was whether drug manufacturers are subject to the same duty as other manufacturers to warn consumers about their product risks. The traditional view was that they were not. Courts reasoned that prescription drugs are unique because they are taken at the direction of a “learned intermediary,” a licensed physician. The manufacturer need only inform physicians of risks; drug-makers have no legal obligation to warn the patient whatsoever.

But as the West Virginia Supreme Court concluded – and New Jersey’s highest court before it – this doctrine is an anachronism, borne of a completely different epoch in American medicine. In a 1948 wrongful death suit, the trial court noted that the manufacturer never advertised or made any representations about the product to the patient. How then could it be liable? The drug’s use was solely the choice of a doctor – the “learned intermediary.”

Written by GAP Food and Drug Safety Director Mark Cohen

Dan Troy laments the development of what he terms “a whistleblower culture” at FDA (FDA Webview, 4/12). The former chief counsel of the agency made this remark at the recent annual conference of the Food and Drug Law Institute. There is too much irony here: Ask an FDA scientist or medical officer what drove them to blow the whistle and they are apt to cite the anti-regulatory culture fashioned by this very same Dan Troy.

Troy was appointed chief counsel by George W. Bush in 2001, the first Bush appointee to the agency. He apparently had earned his stripes by aggressive advocacy on behalf of Pfizer while in private legal practice.

Troy was the FDA chief counsel who led the First Amendment charge against regulating misleading drug advertising. He was the FDA chief counsel who fished around for opportunities to intervene in state court suits on behalf of drug and device manufacturers against injured plaintiffs. He was the FDA chief counsel who, irony of ironies, wrote Retroactive Legislation, arguing that laws should only apply prospectively. Yet it is Troy’s Rule at FDA preempting prescription drug injury suits from state court — a rule issued after most Vioxx personal injury suits were filed — that now threatens to cause the retroactive dismissal of thousands of Vioxx injury claims.