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Unredacted information shows unbelievable greed of Teva Pharmaceuticals

Christian Fernsby ▼ | February 11, 2020
Newly unsealed information shows for the first time the extent to which Teva Pharmaceuticals USA and its predecessor Cephalon lied about the uses and risks of their fentanyl drugs to boost sales.

KEY POINTS
  • The scale of Teva and Cephalon’s lies and deception was revealed in a newly unredacted Complaint
  • Attorney General Mark Herring: Decades long campaign to boost sales and deceive the public
  • "Teva and Cephalon blatantly lied about the usage, the efficacy, and the risks of their extremely dangerous and addictive drugs"

Teva Pharmaceuticals USA
Health in America   Teva Pharmaceuticals USA
The scale of Teva and Cephalon’s lies and deception was revealed in a newly unredacted Complaint in Attorney General Mark Herring’s lawsuit against the companies for their role in creating and perpetuating the opioid crisis through their unlawful, decades long campaign to boost sales and deceive the public about these drugs.

Topics: Teva

The unredacted Complaint shows how the companies took opioids the FDA had only approved for treating cancer patients’ pain and aggressively marketed them for a wide variety of prohibited off label uses and encouraged non cancer treating doctors, a third of whom were primary care physicians, to misprescribe these powerful drugs; discloses the FDA’s previously unknown stern warnings about the drugs, which the companies subsequently ignored; and shows how the companies manipulated clinical trial data to hide what they knew about their drugs’ addiction and overdose risks and how they exaggerated the drugs’ overall efficacy and benefits.

“Teva and Cephalon blatantly lied about the usage, the efficacy, and the risks of their extremely dangerous and addictive drugs in order to make billions of dollars in profit,” said Attorney General Herring.

“Families in Virginia and around the country have been devastated by the ongoing opioid epidemic, which has its roots in the boardrooms and marketing departments of companies like Teva and Cephalon.

This unredacted Complaint reveals how these opioid manufacturers had absolutely no problem with putting human lives at risk in order to make as much money as they could.

I will not stop until pharmaceutical companies are held accountable and shoulder the financial burden for their role in creating and prolonging the opioid crisis.”

Since 2007, fatal fentanyl overdoses in Virginia have risen by nearly 1,600%, from just 48 in 2007 to more than 800 in 2018.

In the same period, nearly 10,000 Virginians have died of a heroin or opioid overdose, including 5,700 from a prescription overdose, and nearly 3,500 from a fentanyl overdose, all while Teva/Cephalon made huge sums of money from its fentanyl drugs.

In October 2019, Attorney General Herring filed suit against opioid manufacturer Teva/Cephalon for engaging in what he alleges was an unlawful, complex, decades long campaign to boost sales of fentanyl the most potent narcotic currently approved for human use by marketing its rapid acting fentanyl drugs for unapproved and unsafe uses, and by knowingly and intentionally downplaying the risks of its drugs while overselling the benefits.

Newly unsealed information shows for the first time the extent to which Teva Pharmaceuticals USA and its predecessor Cephalon lied about the uses and risks of their fentanyl drugs to boost sales.

The scale of Teva and Cephalon’s lies and deception was revealed in a newly unredacted Complaint in Attorney General Mark Herring’s lawsuit against the companies for their role in creating and perpetuating the opioid crisis through their unlawful, decades long campaign to boost sales and deceive the public about these drugs.

The unredacted Complaint shows how the companies took opioids the FDA had only approved for treating cancer patients’ pain and aggressively marketed them for a wide variety of prohibited off label uses and encouraged non cancer treating doctors, a third of whom were primary care physicians, to misprescribe these powerful drugs; discloses the FDA’s previously unknown stern warnings about the drugs, which the companies subsequently ignored; and shows how the companies manipulated clinical trial data to hide what they knew about their drugs’ addiction and overdose risks and how they exaggerated the drugs’ overall efficacy and benefits.

“Teva and Cephalon blatantly lied about the usage, the efficacy, and the risks of their extremely dangerous and addictive drugs in order to make billions of dollars in profit,” said Attorney General Herring.

“Families in Virginia and around the country have been devastated by the ongoing opioid epidemic, which has its roots in the boardrooms and marketing departments of companies like Teva and Cephalon.

This unredacted Complaint reveals how these opioid manufacturers had absolutely no problem with putting human lives at risk in order to make as much money as they could.

I will not stop until pharmaceutical companies are held accountable and shoulder the financial burden for their role in creating and prolonging the opioid crisis.”

Since 2007, fatal fentanyl overdoses in Virginia have risen by nearly 1,600%, from just 48 in 2007 to more than 800 in 2018.

In the same period, nearly 10,000 Virginians have died of a heroin or opioid overdose, including 5,700 from a prescription overdose, and nearly 3,500 from a fentanyl overdose, all while Teva/Cephalon made huge sums of money from its fentanyl drugs.

In October 2019, Attorney General Herring filed suit against opioid manufacturer Teva/Cephalon for engaging in what he alleges was an unlawful, complex, decades long campaign to boost sales of fentanyl – the most potent narcotic currently approved for human use – by marketing its rapid acting fentanyl drugs for unapproved and unsafe uses, and by knowingly and intentionally downplaying the risks of its drugs while overselling the benefits.

The unredacted Complaint also reveals for the first time the scope of Cephalon’s illegal sales practices at this time.

It shows Cephalon aggressively targeted non cancer prescribers and doctors with sales and promotional visits, including doctors specializing in “primary care, family medicine, physical medicine, and neurology,” even though the drugs were only FDA approved to treat cancer patients.

The unredacted Complaint also reveals Cephalon’s “ride ‘em up ride ‘em down policy,” which encouraged salespeople to repeatedly target high prescribers up until the point authorities stepped in and stopped the prescriber.

As the Complaint explains: “as a high performing Florida salesperson put it about a high prescribing doctor…‘i[f] I knew that this physician was in town practicing medicine, I would’ve been in there three times a week pushing him to write more Actiq’”.

Cephalon even “affirmatively told salespeople not to report or flag doctors who salespeople knew were prescribing Fentora off label for the wrong conditions”.

The unredacted Complaint reveals a previously unknown series of meetings between the FDA and Cephalon in 2004, in which top FDA officials warned Cephalon that the use of Actiq by non cancer patients was “staggering…the Agency is very concerned that the situation that occurred with Oxycontin may happen again.” The FDA told Cephalon its sales practices were creating a “significant public health” problem, by providing non cancer patients with a product so powerful it put them at risk of an immediate overdose.

The unredacted Complaint also reveals that Cephalon did not substantially change its practices with the introduction of Actiq’s successor Fentora, in 2006, a rapid release fentanyl tablet.

The company kept targeting providers who were prescribing Fentora for back pain, and other non cancer conditions, and it kept turning a blind eye to the resulting problems.

The unredacted Complaint discloses clinical trial data showing that Cephalon and then Teva, which acquired Cephalon in 2011, knew Actiq and Fentora were widely abused and misused by clinical trial patients and knew the drugs were showing potentially alarming diminution in pain relief the longer the patients used them.

The unredacted Complaint reveals that data from clinical trials of Fentora showed that the drug “increased the risk of addiction while bringing fleeting and diminishing relief” and that “patients taking Actiq or Fentora for months or longer exposed themselves to extremely high risks and diminishing pain relief.” According to the unredacted Complaint, in one 18 month clinical trial patients had a:

31% increase in pain episodes per day, from 3.5 to 4.6 episodes/day;

Took 26% more Fentora tablets per day, from 3.5 to 4.4 tablets/day; and

Had a 42% increase in their average daily Fentora dosage, from 2,162 mcg/day to 3,088 mcg/day.

The companies ghostwrote publications in prominent academic journals, like Cancer, that deliberately misled prescribers and patients about these potential declines in the opioids’ pain relieving properties over time.

As the unredacted Complaint notes of the Cancer publication about a long term study of Fentora use by cancer patients, “the actual study data…suggested the opposite of what Cephalon claimed: that the patients who were in study for 12 months or more actually experienced a decline in analgesic efficacy, suggesting an increase in incremental tolerance to Fentora because they were taking more and more doses per day of Fentora and other opioids.” The unredacted Complaint shows that Teva made efficacy claims a “key pillar” of its marketing campaigns for Fentora from 2008 to the present, all while relying on misleading data.

Additionally, the companies were well aware of, but largely did not disclose, alarming clinical trial data about misuse, abuse, and addiction involving Fentora.

The unredacted Complaint details how clinical trial patients in long term cancer and non cancer trials, none of whom had a history of substance abuse, started exhibiting alarming drug seeking behaviors, what the companies called “aberrant drug related behavior.”

For example, in one non cancer long term clinical trial there were frequent incidents of abuse and misuse:

11 patients overdosed;

One patient’s husband overdosed;

35 patients reported their Fentora stolen;

Dozens of patients dropped out of the trial without accounting for the 100 plus Fentora tablets they had been given; and

Five study centers reported Fentora stolen from supposedly secured lockers.

The company claimed in limited disclosures to regulators like the FDA and its European Union counterpart, that the rates of aberrant drug related behavior in study patients were around 17%.

Both the FDA and the EU thought this was alarming, and Cephalon’s internal discussions showed that medical staff believed this 17% rate could rise to “more than 41%” if patients took Fentora and other opioids for a year or more.

The unredacted Complaint also alleges that in marketing materials and publications disseminated to healthcare providers, academics, and the public, Teva and Cephalon knowingly omitted this data, failing to list these serious cases of misuse and abuse in its tables of adverse events, all while claiming its products were “generally safe” and “well tolerated.”


 

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