Opioids, Fraud and Indivior’s Two Billion Dollar Fine
What normally happens when someone manipulates clinical trial data and mislabels drugs.
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.
However, 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:
“On or about October 2, 2012, Dr. Jane Ruby, Indivior’s medical affairs manager, advised Petitioner and other executives that a MassHealth official had reached out, requesting a meeting. Dr. Ruby wrote, “I am very excited at this opportunity to share the pediatric data.” She asked to attend the meeting alone as “the situation is very delicate.”
She assured the executives that the meeting would be successful and “things will change in Massachusetts.” Petitioner (ex-CEO Shaun Thaxter) agreed that “we commercial people should not attend this meeting.
On or about October 10, 2012, RADARS gave Dr. Ruby the Massachusetts-specific analysis, but the results were not what she had expected or hoped for. They showed that, among the three categories of drugs (Suboxone Film, Suboxone Tablet, and buprenorphine-only tablets, like Subutex Tablet), the buprenorphine-only tablets had the lowest rate of unintended pediatric exposure. (1.8 exposures per 10, 000 units versus 2.7 exposures for Suboxone Film and 3.3 exposures for Suboxone Tablet). IG Ex. 2 at 7 (Information ¶ 25).8
Dr. Ruby did not give Dr. Jeffrey an accurate version of the RADARS analysis. Instead, she manipulated the data by adding the two tablet rates together in order to show that Suboxone Film had the lowest rate of unintentional pediatric exposure in Massachusetts, when, in fact, it did not.
On or about October 16, 2012, she emailed the false data to MassHealth, claiming, also falsely, that she had received the calculations from RADARS. She forwarded a copy of her email to Indivior’s global medical director (Tim Baxter). IG Ex. 2 at 7-8 (Information ¶ 27).
On or about November 19, 2012, Dr. Ruby responded to a follow-up question from Dr. Jeffrey by sending an email that contained a chart with information from an Indivior promotional brochure.
The chart she sent compared Suboxone Film with Suboxone Tablet, showing that Suboxone Film had a substantially lower rate of pediatric exposure. But Dr. Ruby eliminated from the chart a third line of data, which showed Subutex’s rate of pediatric exposure. In light of her prior misleading email, “the chart without the third line of data failed to reveal facts material to MassHealth prior to its updated formulary decision.”
By not including the Subutex data, Dr. Ruby “reinforced her false and misleading claim that Massachusetts-specific data showed Suboxone Film as having the lowest rate of unintended pediatric exposure in the state.” IG Ex. 2 at 8-9 (Information ¶ 28); see IG Ex. 5 at 40-41 (Dr. Jeffrey explaining why eliminating the third line mattered).
Dr. Ruby subsequently received additional data on unintended pediatric exposures; it showed that Suboxone Film did not have the lowest rate of unintended pediatric exposure in Massachusetts.
She did not provide that data to MassHealth, telling other Indivior employees (although not Petitioner) that her rationale for withholding the additional data was “don’t ask, don’t tell.” IG Ex. 2 at 9 (Information ¶ 29).9
Dr. Jeffrey characterized his receiving this (false) data as the “pivot point” upon which the agency decided to change its policy on Suboxone film. IG Ex. 5 at 38; see IG Ex. 5 at 55 (indicating that the data Dr. Ruby provided mattered).”
In or about December 2012, MassHealth issued a press release, citing Indivior’s nation-wide pediatric exposure-rate data and announcing that it would “provide access” to the film formulation to members who were prescribed Suboxone and lived in households with children under the age of six. IG Ex. 2 at 9 (Information ¶ 30).”
Indivior did not correct the false and misleading statements it made to MassHealth until December 2015, approximately two years after the government began an investigation.”
The CEO was convicted by the DOJ, based on the fact that (from the HHS document):
“He was involved in the initial strategy to use pediatric poisoning data to persuade MassHealth to approve Suboxone Film. IG Ex. 2 at 6 (Information ¶ 22).
- He received data from poison control centers on unintended pediatric exposure. IG Ex. 2 at 5 (Information ¶18).
- He knew that Dr. Ruby planned to share pediatric data with MassHealth officials and specifically asked that two other executives, whom he named, attend the meeting. IG Ex. 2 at 6 (Information ¶ 23).
- Finally, he knew that Dr. Ruby planned to share state-specific data with MassHealth. IG Ex. 2 at 6-7 (Information ¶ 24).
Yet, as involved as he was in this entire process, Petitioner (Shaun Thaxter) opted not to know exactly what data Dr. Ruby shared with the MassHealth officials. It was his job to know that.”
The ex-CEO Shaun Thaxter, was convicted because- according to HHS – he SHOULD have known what data Dr. Jane Ruby had supplied to the state of Massachusetts and that the data were fraudulent.
Dr. Jane Ruby’s role in creating fraudulent data, omitting critical data on the risks of Suboxone for children and submitting those fake data sets to the state of Massachusetts is clearly established by official HHS documents.
According to the HHS, Jane Ruby is the person who created the fraudulent clinical data and submitted it to the state of Massachusetts.
The Federal government eventually brought criminal charges against her supervisors for those crimes and of course, brought charges against the company itself, which resulted in two billion dollars worth of fines and liabilities – but it appears that she herself WAS NEVER CHARGED.
Why was Dr. Jane Ruby Never Charged?
Enquiring minds what to know – why does it appear that Jane Ruby never charged? Did she turn states evidence as part of a bargain with the federal government?
If so, what was that bargain? Why has all information concerning her role in this scandal been scrubbed from the internet except the information available via HHS websites?
Why has the DOJ sealed information concerning her role in this fraudulent activity involving falsified clinical data and fraudulent marketing of a potent opioid product to children?
See more here substack.com
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Tom
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Fines are useless since big pharma can even get the government to pay them. The only thing that will come close to stopping these anti-human murderers is extended prison time and/or death.
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Typhus
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Hmmm strange days
Such a simple criminal thang, that took 10 years to conclude. And Ms Jane Scott free? So many possibilities. Was she an under cover agent? A Setup appears. Something deeper is happening. No such things going on with the Pharma purveyors of depopulation…or the DARPA behind them.
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