Judicial Watch • FDA

FDA Archives | Judicial Watch

Judicial Watch has obtained new information indicating that the U.S. government is likely covering up a scandal involving an Army sergeant who apparently took a controversial anti-malaria drug—in contradiction to guidelines—before going on a rampage in Afghanistan.

The 39-year-old married father of two, Sergeant Robert Bales, was on his fourth deployment in a decade when he attacked and murdered 16 Afghan civilians (initial reports said it was 17) on March 11, 2012. Judicial Watch immediately launched an investigation and obtained documents from the Food and Drug Administration (FDA) that raised huge suspicions that Bales may have been given the anti-malaria drug, mefloquine hydrochloride, long known for its severe neurological side effects.

The Department of Defense (DOD) has refused to confirm or deny if Bales took mefloquine, but the FDA records obtained by JW indicate that he probably did because he was an otherwise “affable” man who became uncharacteristically psychotic and aggressive, a change common among those treated with mefloquine. The files detail more than 2,000 episodes of adverse reactions to mefloquine during a 15-year span, including 87 deaths associated with the drug. Of the deaths, 39 were recorded as suicides by the agency and a dozen as homicides.

This is why in 2009 the DOD removed mefloquine as the drug of choice in the treatment of malaria. Furthermore, the drug is specifically prohibited in the treatment of patients with head injuries, and in particular, a traumatic brain injury (TBI). It is also contraindicated for patients with post-traumatic stress disorder. Bales reportedly suffered a traumatic brain injury in Iraq in 2010.  If so, DOD policy would have prohibited administration of the drug to Bales.

Now a report submitted to the Irish Medicines Board practically confirms that mefloquine was administered to Bales in contradiction to the guidelines because he had suffered a documented TBI. The document was made public by a longtime Army psychiatrist, Dr. Elspeth Cameron Ritchie, who retired in 2010 and heads the District of Columbia’s Department of Mental Health. In a national news magazine, Dr. Ritchie writes that important details have been redacted in the report and Bales isn’t mentioned by name, “but it’s unlikely there was another soldier with a traumatic brain injury in this time frame connected to 17 homicides (that was the original number; further investigation concluded 16 people had died).”

The document describes a negative side-effect to a medication and in this particular case details a “medically confirmed” event of homicide by a soldier taking mefloquine. It suggests that on March 29, 2012 the company that makes the drug, Roche, received a report that someone involved in the homicide of 17 civilians had been taking mefloquine. On April 11, Roche forwarded the document to the FDA, as it is required to do.

Dr. Ritchie is not surprised in fact, a week after Bale’s 2012 rampage the former veteran Army psychiatrist questioned whether the sergeant was on the anti-malaria drug, writing this in the same publication: “In the national quest to understand what motivated Army Staff Sergeant Robert Bales to leave his compound in the middle of the night, and allegedly gun down 16 men, women and children, there have been many motives already put forth. These include a “witches brew” of post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), marital problems, alcohol use, seeing a friend wounded, anger over frequent deployments, and not getting a promotion.”

She continues: “Yet none of these seem sufficient, especially given the reports of a sunny, affable man who had two small children. I would like to introduce a few other ideas, related to the concept that he might have had a brief psychotic episode. Psychosis means being out of touch with reality, having delusions or hallucinations, either because of medication or other brain insults.

“When I am examining a patient whose crimes seem out of character, which I do as a forensic psychiatrist, I always want to know if their behavior was due to a medical illness, medication, or illicit alcohol or drug use. One obvious question to consider is whether he was on mefloquine (Lariam), an anti-malarial medication. This medication has been increasingly associated with neuropsychiatric side effects, including depression, psychosis, and suicidal ideation.”

Earlier this month Sergeant Bales pled guilty, avoiding a trial that perhaps could have shed more light on what really happened. During his military court hearing, Bales said he couldn’t explain why he did it. “I’ve asked that question a million times since then, and there’s not a good reason in the world for why I did the horrible things I did,” he told the military judge. He is will probably spend the rest of his life in prison.

If, as the Irish Medicines Board report indicates, mefloquine was administered to Bales in contradiction to the guidelines, the Army certainly has some culpability in the massacre. Records obtained by JW reveal that, despite its directive to limit the use of mefloquine, the DOD is buying large quantities. Since 2010 the agency purchased 2,250,925 tablets of the drug at a cost of $5,487,130 over a period of 27 months, according to the records obtained by JW from the Defense Logistics Agency.

 

In the latest scandal to rock the Food and Drug Administration (FDA), a veteran chemist at the beleaguered agency has been sentenced to prison for using “sensitive inside information” to engage in illegal insider trading that fattened his bank account by millions.

The Justice Department says the corrupt FDA chemist (Cheng Yi Liang), who worked in the Office of New Drug Quality Assessment, traded on multiple occasions by using non-public information obtained through the agency’s password-protected internal tracking system for new drug applications. Liang made nearly $4 million off the deals and recently reached a plea agreement with federal prosecutors. This week he was sentenced to five years in prison.

Perhaps the FDA will find a way to keep him on its payroll.  A few years ago a congressional report exposed that government scientists convicted of felonies are allowed to conduct essential drug and biologics research because the FDA doesn’t bother removing them, even though federal law demands it. This means Liang may very well get his job back after he’s done serving time.   

His case is simply the most recent of many controversies to hit the federal agency responsible for protecting public health and safety. In the last few years the FDA has been embroiled in a number of transgressions, mostly involving its failure to enforce federal laws to please wealthy pharmaceuticals that pay hundreds of millions of dollars in “fees.”

In fact, the appalling arrangement has even been documented in various federal probes. One scathing congressional report outlines in detail how the FDA allows companies that annually pay it more than $400 million in fees to compromise public safety.

Judicial Watch has exposed one deadly example—Gardasil— that was fast-tracked by the FDA to protect against cervical cancer. JW uncovered droves of government records listing thousands of adverse reactions associated with the vaccine, which is manufactured by pharmaceutical giant Merck. They include paralysis, convulsions, blindness and dozens of deaths. Based on the records JW published a special report detailing Gardasil’s approval process, side effects, safety concerns and marketing practices.

JW has also exposed FDA secrecy. A few years ago JW reported how the agency avoided publicly disclosing information about an approval process by rebranding the product for veterinary use. It involved the first genetically engineered animal for human consumption—genetically modified fish—and the FDA wanted to keep the gory details from Americans who would eventually it.

 

 

 

A few months after the Obama Administration bragged about enacting “sweeping” legislation to protect the nation’s food supply, experts at a federal symposium reveal that half of what Americans eat comes from foreign countries not covered by the measure.This leaves the nation vulnerable to bioterrorism via tainted food, according to experts participating in the FBI’s International Symposium on Agroterrorism. The annual event, taking place in Kansas City this week, aims to protect the world’s food supply from terrorism through information-sharing and collaboration among governments, the private sector and academia.The world-renowned agroterrorism experts attending this year’s symposium have some rather worrisome news for Americans, despite the president’s political horn-tooting. Because it’s nearly impossible to know where 50% of our food comes from, it’s becoming increasingly difficult to protect consumers from tainted supplies as well as intentional bioterrorism attacks.In fact, a director at a special Homeland Security Food Protection and Defense program saysmore foreign companies are registered with the Food and Drug Administration (FDA)—the government agency that regulates the industry—to sell products in this country than domestic firms. That means federal regulators in the U.S. have little control or say over the fast-growing food global market.You wouldn’t know that from reading the Obama Administration’s promotion of the Food Safety Modernization Act, which claims to “set in motion sweeping improvements to the security and safety of our nation’s food supply.” When Obama signed the measure earlier this year the White House issued a press release referring to it as “historic legislation” that will establish “science-based standards” for safe production and harvesting of fruits and vegetables to minimize the risk of serious illness or death.The legislation also “significantly enhances” the FDA’s ability to oversee food products coming into the U.S. from other countries each year, according to the release, which also claims that only an “estimated 15 percent” of the U.S. food supply is imported. The agroterrorism experts, many of them on the government’s payroll, assure its more like 50%. Then again, they were quoted in the media not a skewed White House press release.

Sign Up for Updates!