Former FDA drug reviewer Ron Kavanagh, BS Pharm, PharmD, PhD, RPh, has alerted President Trump and new administration officials/nominees to structural misconduct at the FDA, undisclosed prescription drug risks affecting Department of Defense (DOD) troops, adults and children and suppression of whistleblower findings by government agencies.
FDA Drug Reviewer Alerts
Dr. Kavanagh, who earned his PharmD at the University of Texas and a PhD at the University of Washington, was fired from the FDA in 2008 for reporting such concerns to Congress, the Federal Bureau of Investigation (FBI) and criminal investigators in the Department of Health & Human Services (HHS) and the Office of Inspector General (OIG). Subsequently, he shared his findings with the Office of Special Counsel (OSC), the Department of Justice (DOJ), his congressman Representative Jamie Raskin and the Biden White House.
In his communication to Representative Jamie Raskin, Dr. Kavanagh copied Sen. Charles Grassley, Sen. John Thune, Sen. Charles E. Schumer, Rep. Mike Johnson, Rep. Steve Scalise and other Congress members.
Concerns Dr. Kavanagh is now sharing with new administration officials include:
- Pyridostigmine bromide (PB), a drug to protect troops from nerve agents, is ineffective according to animal studies and could kill or harm troops. (It recently received approval for an extended-release form.)
- Approvals of medications like the Alzheimer drug Aduhelm, opioids, Modafinil and Veozah result from FDA wrongdoing and lapses and pose serious, even deadly risks to patients.
- “Fen-Phen“ like toxicities from antipsychotics like Saphris, Seroquel, Zyprexa which affect 5HT2B, a binding protein, are commonly misdiagnosed as sudden infant death syndrome (SIDS0 and can also cause third trimester abortions of wanted pregnancies.
- Diversity initiatives at the FDA have resulted in political favoritism and non-promotion of native-born Americans. (“One new foreign hire told he was glad to be at the FDA so he could get back at the US for being an imperialistic country,” says Dr. Kavanagh.
- FDA personnel enable Medicaid and Medicare fraud possibly costing taxpayers hundreds of billions of dollars.
- US governmental agencies’ failure to act on whistleblower information and abridging of citizens petition rights.
Risks to Public Ignored
Despite Dr. Kavanagh’s scientific and medical expertise and knowledge of FDA laws and drug kinetics and pharmacodynamics, he says that during his employment government agencies shut out his messages – and have done so since then. After submitting initial disclosures to OSC, Dr. Kavanagh received a teleconference with two disclosure unit attorneys who were assigned to his case and he subsequently supplied 1,200 additional documents. Surprisingly, the OSC, headed by Hampton Dellinger, known to be whistleblower friendly, found the disclosures did not meet the “likelihood threshold” prompting Dr. Kavanagh to submit a reconsideration request.
Do Government Agencies Care About Dangerous Drugs Approved by the FDA?
Antipsychotics and their metabolites exert receptor effects that can cause dangerous toxicities. The risks are why laws require that such actions be studied by the FDA but the cautionary testing was never done asserts Dr. Kavanagh. “I later found evidence that the FDA had known of these receptor effects for years and the effects had been seen in children with other antipsychotics,” he says.
Using the government Adverse Event Reporting System and information from eHealthMe, a clinical trial database designed to impart more transparency to health care, Dr. Kavanagh says that there have been hundreds of infant deaths from such drugs over the years.
Will A New Administration Listen?
After more than a decade of whistleblowing government officials and agencies about FDA loopholes and laxity, Dr. Kavanagh believes partisan politics and even personal self-interest could explain the stonewalling he has encountered.
Nonetheless, he says serious risks to military personnel and US adults and children persist.
Government officials are “deliberately misbranding drugs by covering up serious adverse effects that can maim and harm people.” Dr. Kavanagh says he hopes a new administration will restore transparency and public health integrity.
