What normally happens when someone manipulates clinical trial data and mislabels drugs . . .

By Robert Malone, MD, MS - December 28, 2023

A Twitter comment on Christmas eve sent me down a rabbit hole that is so unbelievable (due to the sheer audacity of the characters involved) that I am still reeling.

This complicated warren of malfeasance and criminal activity involved one of the most intriguing buried news stories that finally got wrapped up in 2023, after more than a decade of litigation by the US Department of Justice (DOJ). This was the settlement of the DOJ case against Indivior Solutions corporation (the Buprenorphine division of Reckitt Benckiser - a UK based corp.).

Buprenorphine is an opioid used to treat opioid use disorder, acute pain, and chronic pain. This is yet another big case involving a powerful synthetic opioid, much like the infamous Purdue Pharma case. In this instance, the fraud involved an opioid formulation (Suboxone film) for children.

Indivior’s crimes involved falsifying data and making false statements to Massachusetts’s Medicaid program (MassHealth) in order to expand sales of their drug Suboxone for use by children. In other words, what is at issue here is fraudulent clinical data and marketing of an opioid.

In the end, Drugmaker Indivior Solutions paid almost TWO BILLION in criminal and civil liabilities over its marketing of opioid-addiction treatment Suboxone, as announced by the US Justice Department (DOJ) in 2020, and the final DOJ court cases against the executives of the company were won and sentences were announced in 2020. In addition, the HHS and FDA penalties brought against Indivior executives who allegedly knew or should have known about the fraud were not completed until 2023. Those executives were Tim Baxter, Indivior Global Medical Director, the direct supervisor of Dr. Jane Ruby, and Indivior ex-CEO Shaun Thaxter.

Who is Dr. Jane Ruby?

According to her website, Dr. Ruby holds two earned doctorates, one in Psychology & the 2nd in Education. Dr. Jane Ruby also holds two master’s degrees, one in Advanced Practice Nursing and the other in Health Economics and International Pharmacoeconomics. Dr. Jane Ruby is not a physician.

Details and Context:

In 2012, the company (Indivior Solutions) sent fraudulent data to MassHealth indicating that Suboxone had the lowest rate of accidental pediatric exposure of all drugs that contain the opioid buprenorphine. MassHealth is the consumer branch of the Massachusetts Department of Health and Human Services and oversees the Medicaid and the Children’s Health Insurance Programs (CHIP) for that state. Shortly after the company provided the fraudulent data, MassHealth announced it would provide access to the drug to households with children under the age of 6. With this decision, on the basis of what is now established to be fraudulent data, Indivior captured a large market share of MassHealth sales.

Relevant HHS documentation:

“In order to persuade MassHealth to add one of the company’s drugs, Suboxone Film, to the program’s drug formulary – and thus be eligible for Medicaid coverage – a company executive (Dr. Jane Ruby) manipulated data to make it appear that, of the competing drugs, Suboxone presented the lowest risk of accidentally poisoning children. As the company official well knew, the data she submitted was false.”

Court Action:

Much of the Department of Justice and court documents appear to be scrubbed from the Internet or are “under seal*” - as it was a Virginia Grand Jury that delivered the final verdicts. After the ex-CEO Shaun Thaxter was convicted, the HHS Inspector General (IG) excluded him from “participating in all federal healthcare programs for ten years, pursuant to section 1128(a)(1) of the Social Security Act (Act)” and he was barred from doing business with the FDA for five years. Tim Baxter suffered a similar fate, excluding him from program participation (including the FDA) for a five-year mandatory exclusion period. Both appealed the exclusions, but the final appeals were lost in 2023.

Role of Dr. Jane Ruby:

What is interesting is that even though the DOJ has scrubbed many details of the case from the internet, the Department of Health and Human Services HHS laid out the criminal case in detail in their final report dated 2021. The report is so detailed, it is as if they wanted the true history to be known to the world. HHS makes it clear that the person who conducted the fraud was DR. JANE RUBY. From the report . . .

[SNIP]