In my wildest dreams, I could never have imagined being drawn into a story of intrigue involving my own government’s efforts to hide, from the public, reports of psychiatric drugs associated with cases of murder, including homicides committed by youth on the drugs. But that is precisely the intrigue I now find myself enmeshed in.
The saga began several years ago. My child had the misfortune of being born during the last month of eligibility for kindergarten, and was subsequently labeled with A.D.H.D. – which stands for August Date Hikes Diagnosis. While other Americans with the same chronological impairment such as Man Ray and Robert Ringling managed to make something of themselves despite being born in the month of August, it seemed my child was doomed to failure from the get-go, unless provided lifesaving stimulant medication.
With an abiding uneasiness about both the alleged disorder and its miracle remedy, as they were presented to me, I set out to understand as much as I could about stimulant medications, prescribed disproportionately to the youngest children in the class.
It wasn’t long before I stumbled upon the FDA Adverse Event Reporting System (FAERS), also referred to as MedWatch. The FDA publishes quarterly FAERS data files on its website containing hundreds of thousands of reports of various drug adverse events. Though unencrypted, the FAERS files might as well be, as the data appear hieroglyphic to the average person who is not a database expert, including myself at the time.
With the aid of the internet and with a lot of trial and error, I taught myself to write Structured Query Language (SQL) code to decipher the FAERS files. I first plumbed the depths of the adverse event data searching for reports of pediatric fatalities associated with stimulant medications, and found hundreds of them. Expanding my queries to include all psychotropic medications, I eventually identified nearly 2,000 pediatric fatalities. (More on the pediatric psychotropic fatalities in a future post.)
As I contemplated the gravity and the scale of the human tragedy, I began to wonder what drug side effects these children experienced at the time of their deaths. The FAERS data files yielded answers: cardiac arrest, respiratory arrest, hepatoxicity, multi-organ failure, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Neuroleptic Malignant Syndrome, completed suicide, homicide . . . Wait, what? Homicide, as a drug side effect? Then I saw it again: Murder.
The light bulb went off. I performed a query for homicide or murder as a drug side effect. To my astonishment, there were over 700 reports in FAERS of homicides linked to psychotropic medications.
In October 2014, I submitted a Freedom of Information Act (FOIA) request to the FDA to obtain copies of the FAERS homicide reports. After ten months of “Foot Dragging and Alibis,” which is what Rep. Joe Barton (R-TX) once suggested the agency’s acronym stood for, the FDA still had not produced a single report. Frustrated with the FDA’s stonewalling, I filed a federal lawsuit in August 2015. Within three months of filing the FOIA lawsuit, the FDA coughed up over 3,000 pages of FAERS reports.
However, hundreds of pages were completely redacted, while many hundreds more were heavily redacted. A letter from Deputy Director of Information Disclosure Policy Howard Philips attested that the records were redacted in accordance with the FOIA statute, and other applicable laws. The FDA claimed that the redaction of information was justified under FOIA’s privacy exemption.
To add some perspective, according to the HHS Freedom of Information Annual Report, among 10,145 FOIA requests the FDA processed during fiscal year 2015, the privacy exemption was applied only 24 times. Federal regulations require the FDA to “make the fullest possible disclosure of records to the public” in response to FOIA requests.
All but the case numbers were redacted in 47 of the FAERS homicide reports that the FDA released. The FDA had suppressed all of the report information for these cases: age, gender, drug name(s), reported drug reaction(s), case narrative, etc. The wholesale censorship of entire FAERS reports turned out to be an untenable action on the part of the FDA.
Pursuant to 21 CFR 20.81, the FDA cannot properly withhold any record that contains data or information that have been previously disclosed in a lawful manner to a member of the public. The age, gender, drug name(s), and reported drug reaction(s) had already been publicly disclosed in FAERS data files available on the FDA’s website. It was based on this publicly available information that I was able to ascertain and request the case reports involving homicide in the first place.
I fired off a letter to then-Acting Commissioner Stephen Ostroff, protesting the FDA’s improper withholding of public information, citing the federal regulation prohibiting such conduct. A month later, I received a second production of records totaling over 3,000 pages. The agency did not acknowledge any wrongdoing, or even explain what was different about the new document dump. This time around, though, the FDA had not redacted age, gender, drug name(s), and reported drug reaction(s), but the case narratives remained entirely redacted.
Insofar as the FDA had released the case narratives of hundreds of the other FAERS homicide reports, albeit heavily redacted at times, I surmised that the case narratives of these 47 reports in particular must contain information that was damaging either to the pharmaceutical companies, the FDA, or both.
Here are four examples of medication-linked homicide case narratives that were being withheld.
The narrative in this case report, when it was initially sent to me, was completely redacted by the FDA. This is what I received: