All Things Whistleblower: A GAP Blog

Voting Machine Fraud?

A former technician at an electronic voting machine company has alleged that the company, Hart InterCivic, lied to federal election officials “about the accuracy, testing, reliability and security of its voting machines.” From Wired News:

The whistleblower says the company did so because it was eager to obtain some of the approximately $4 billion in federal funds that Congress allocated to states in 2002 to purchase new voting equipment under the Help America Vote Act (aka HAVA).

The whistleblower filed a qui tam lawsuit last year, which remained sealed until last week, when the feds decided they wouldn’t join the litigation.

-- Dylan Blaylock

No Surprise: FDA Deadlines Greatly Increase Safety Risk

In a first-of-its-kind study, medicines that are approved by the FDA close to or at a mandated deadline have been shown to be much less safe than those not approved near a deadline date.

Examples of unsafe drugs to have been approved near a deadline include Vioxx, Bextra, Rezulin, Baycol.

FDA watchdogs and critics are using this opportunity to spread the word about this one (of several) major problems with the FDA drug approval process. How was this system started? From the AP:

Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.

Congress tightened the deadline for most drugs to 10 months in 1997.

And about the study:

Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.

Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.

This latest revelation, along with other major stories that break on what seems like a weekly basis, is yet another reason that the FDA and its drug approval process to be completely revamped.

-- Dylan Blaylock

Warning: Shill Groups May be Hazardous to Your Health

Also in drug safety news, a widely-publicized and controversial 2006 study published in the New England Journal of Medicine (NEJM), that concluded some “80 percent of lung cancer deaths could be prevented through widespread use of CT scans,” has been discovered to have actually been partially funded by a major cigarette manufacturer.

The cigarette maker accomplished this by working with university researchers to set up a shill foundation, which then partially paid for the study. The editor-in-chief of NEJM, along with several other prominent cancer researchers, were “stunned” to learn that this happened. Pending or promoted legislation in several states, which was based on the science behind this study, will probably be shelved.

-- Dylan Blaylock

 

Ruling Undercuts Sarbanes-Oxley Protection

GAP client Mark Livingston has lost a federal appeals court decision, which has effectively rejected his assertions that he should be protected under Sarbanes-Oxley whistleblower protections for Wyeth Pharmaceuticals’ termination of him for exposing a lack of adequate safety training among company workers.

Livingston was hired by Wyeth to ensure the safety of Prevnar, an infant vaccine. Prevnar is one of several early childhood vaccines recommended for every newborn infant by physician organizations, the Centers for Disease Control, and the United States government.

In the course of his tenure at Wyeth, Livingston made repeated complaints relating to lack of compliance with regulatory GMP. He complained that the company did not compliantly train new employees in critical manufacturing and quality assurance positions fast enough in the years 1999-2002 to keep pace with production and sales goals of Prevnar.

According to Livingston, Wyeth repeatedly announced both internally and publicly, that failure to meet Consent Decree and Good Manufacturing Practices (GMP) mandates would negatively impact the company's future. Instead, Wyeth Sanford management kept the production pipeline flowing despite the lack of compliance, therefore materially misrepresenting the true state of operating and financial performance in this fastest growing division of the Wyeth enterprise. The plaintiff spent two years sounding the alarm that those mandates were not being met.   

Mr. Livingston was fired in December 2002 for blowing the whistle on noncompliant training system practices.

Livingston is expected to appeal this recent court decision.

-- Dylan Blaylock

Don't Forget Just How Bad Hanford Is

The Seattle PI ran a front-page article today on the overall terrible state of the Hanford Nuclear Reservation, detailing how a lack of government action and inadequate oversight has turned it into the most polluted nuclear site in the country.

One interesting tidbit from the article:

Regulators have repeatedly dissected the problems with the Energy Department and its oversight of the contractors who do the actual cleanup. Since 1990, the congressional Government Accountability Office has kept Energy on a list of agencies at high risk for fraud, waste, abuse and mismanagement. In a report released last summer, the GAO found that Energy did "little or no review" of contractor invoices before signing off on up to $60 million in monthly charges for work done by Bechtel National, the builder of the waste-treatment plant.

That's $60 million per month, barely reviewed at best. Bechtel is constructing Hanford’s vitrification plant, designed to mix nasty, liquid high-level nuclear waste with glass at extremely high temperatures, in order to achieve solid, slightly-less nasty waste. That project’s cost has ballooned from $4.3 billion to over $12 billion and is nowhere close to completion.

In 2006, GAP exposed that Bechtel knowingly installed defective equipment for the vitrification plant that was supposed to contain high-level nuclear waste. The action, along with several others, severely endangered the lives of Pacific Northwest citizens.

-- Dylan Blaylock

Gayl Update

In news related to the Franz Gayl case, Sen. Ted Kennedy (D-Ma.) wrote a heavily critical letter to Gen. James Conway, who told a Senate committee last month that Marine Corps commanders requested Humvees instead of MRAPs in February 2005. Kennedy wrote Conway that he “misrepresented” the requests, which did call for MRAPs. Kennedy wrote that Conway’s assertions are “contradicted by the request itself.”

Gayl, a civilian Marine Corps official, authored a study showing that the deaths or injuries of hundreds of Marines in Iraq could have been avoided if military officials had granted the 2005 MRAP request. MRAPs are vehicles designed to withstand attacks from improvised explosive devices (IEDs).

-- Dylan Blaylock

The World Bank’s Terrible Lack of Action

After nearly one year’s delay, the World Bank announced that it will further investigate disclosures involving the distribution of defective HIV/AIDS test kits, purchased by one of its health care projects in India. GAP client Dr. Kunal Saha first informed the Bank of the use of the faulty kits in May 2007.

The World Bank’s delayed actions involving this case have been alarming, inadequate, and failed to ensure Indian public health. The Washington Post first reported on this story back in October, but little was done then.

There are more details about this case that must come out publicly, and GAP will work to ensure that they do.

-- Dylan Blaylock

Discussing the UN-Google Relationship

A panel yesterday, which included GAP, discussed the growing friction in relationships between the United Nations and the journalists who follow the organization. One central topic was Google News’ recent delisting of Inner City Press, a Web site that reports on UN whistleblower exposures and claims. GAP helped publicize Google’s wrong decision last month, leading to the outlet’s re-listing. From CNS News:

Often these investigations are not trustworthy because the U.N. is investigating itself and making its own rules, said Beatrice Edwards, international program director for the Government Accountability Project, a watchdog group.

The U.N. has new whistleblower rules, but those often are handled internally, Edwards said.

"If they are subject to retaliation for disclosing fraud or corruption at the U.N., then they would go to a hearing to protest what has happened to them, (but the hearing) is presided over by the institution which they are disclosing perhaps embarrassing information about," Edwards said.

"So they face a forum where the institution itself is both the defendant and the judge. The record of whistleblowers being vindicated or prevailing in these kinds of forums or hearings is very, very poor."

Edwards noted that the U.N., World Bank and other international bodies have diplomatic immunity and are not subject to freedom of information laws.

"If they are able to shut down free press or free speech inside, to the extent that they often try to, then we are really talking about very powerful, very wealthy, lawless organizations," she said.

-- Dylan Blaylock

GAP Client’s Affidavit Affects Immunity Vote

An ABC News story details how the disclosures of a GAP client to key House officials last week helped lead to the stopping of an agreement to grant telecommunication companies retroactive immunity as part of the highly-debated warrantless wiretapping/national security bill. From the article:

Late last week, conventional wisdom said that the House wouldn't stand firm against an effort by big telecommunications companies and the Bush administration to forgive the telcos for any violations of law they committed while assisting with a top secret domestic surveillance program.

But that apparently changed after the whistle-blower group Government Accountability Project made public the assertion by security expert Babak Pasdar that he had once discovered a high-speed data line that may have been a part of a domestic spying program.

These allegations prompted the House officials to write a “Dear Colleagues” letter last week outlining the client’s allegations to other members of Congress. GAP and a coalition of groups sent a letter to all members of Congress yesterday urging them to review our client’s (Babak Pasdar) affidavit before voting on the bill (which debate is scheduled for today). The letter summarized concerns laid out in the affidavit:

“An unnamed major wireless telecommunications carrier may have given the government unmonitored access to data communications from that company’s mobile devices, including e-mail, text messages, and Internet use… [T]he line was configured so that the carrier could have no record of what information had been transmitted. Of equal concern was his allegation that there was no security to protect this line -- an unheard of vulnerability in a carrier environment.”

You can find GAP’s talking points about the affidavit here.

-- Dylan Blaylock

You're Saying You Didn't Watch the Video?

The president of the slaughterhouse company whose workers’ abuses of cattle triggered the largest beef recall in history testified before a House committee yesterday under subpoena.

After making an opening statement that ‘downer’ cows did not enter the food supply, Westland/Hallmark Meat Company President Steve Mendell was shown the Human Society video which indicated otherwise. He then acknowledged that his opening statement was incorrect, and that ‘downer’ cattle had, in fact entered the company’s food supply. He then claimed he had not seen the video, which has been on the Human Society’s Web site for nearly a month.

Other news reports on this story include the LA Times, NY Times, and Chicago Tribune.

-- Dylan Blaylock