Tag: FiercePharma

09/24/19

What Purdue and the Sackler Family Treasure

© dmitry_rukhlenko | stockfresh.com

The New York Times and FiercePharma reported on September 11, 2019 that Purdue Pharma and the Sackler family have reached a tentative settlement with 23 states and nearly 2,300 other plaintiffs (cities, counties, tribes) in the first major opioid settlement. Although specifics of the deal have yet to be finalized, it would involve Purdue filing for Chapter 11 bankruptcy. “The company would be dissolved, and a new one would be formed to continue selling OxyContin and other medicines, with the profits used to pay the plaintiffs.” The settlement does not include an admission by Purdue or the Sackler family of wrongdoing. The agreement was approved by Purdue’s board on Sunday, September 15, 2019 approximately 48 hours after the New York State Attorney General charged members of the Sackler family with transferring $1 billion into Swiss bank accounts.

The tentative deal was reached just six weeks before the start of the first trial before a federal judge in which Purdue is a defendant. But it isn’t clear whether the settlement will absolve the company or family members from all existing and future claims. The NYT reported that because the deal falls short of what some state attorneys general were seeking, several states vowed to continue to pursue legal action. Maura Healey, the Massachusetts attorney general, said, “It’s critical that all the facts come out about what this company and its executives and directors did, that they apologize for the harm they caused, and that no one profits from breaking the law.” Under the deal the Sackler family will pay plaintiffs $3 billion over seven years. Some attorneys general wanted $4.5 billion up front, but the family refused.

A critical sticking point has been the timing of the family’s sale of its global pharmaceutical business, Mundipharma, and the contribution the family would make from the proceeds. Some attorneys general, including those from Massachusetts, New York, New Jersey, Pennsylvania and Connecticut, who have not signed on to the settlement, had been pressing the family to sell Mundipharma immediately and to discontinue manufacturing drugs for international markets.

Often in Chapter 11 bankruptcy, all litigation against a company is stayed. At this time, it is unclear if the Sackler payouts in the settlement would bind them into Purdue’s bankruptcy proceeding “and therefore halt the lawsuits against them as well as the company.” The NYT reported that many of the states have named individual members of the Sackler family as defendants.  The Times said the family members have been intentionally siphoning billions of dollars out of the company since 2007, when Purdue and three of its executives paid a $635 million fine to resolve federal charges related to their “misbranding” of OxyContin. See “Giving an Opioid Devil Its Due” for more on this ruling.

In court filings on Friday, September 13, 2019, New York state Attorney General Letitia James said members of the Sackler family used Swiss bank accounts to transfer $1 billion from the company to itself. She said, “Records from one financial institution alone have shown approximately $1 billion in wire transfers between the Sacklers, entities they control, and different financial institutions, including those that have funneled funds into Swiss bank accounts.” She referred to the proposed deal as “an insult.”

The court filing highlights the activities of Mortimer D.A. Sackler, a former Purdue board member. It alleges that Sackler transferred millions of dollars from trust companies, at least one of which was previously unknown, through Swiss bank accounts to himself as early as 2009. Some of the funds were directed to real estate companies that owned Sackler family homes in Manhattan and the Hamptons, the filings said.

A spokes person for Mortimer Sackler said the decade-old transfers were entirely legal. “This is a cynical attempt by a hostile AG’s office to generate defamatory headlines to try to torpedo a mutually beneficial settlement that is supported by so many other states and would result in billions of dollars going to communities and individuals across the country that need help.” A Purdue Pharma media representative said the company had no comment. The New York Attorney General’s office believes there is more to be learned about the family’s holdings, “and that information is central to arriving at a just settlement.”

FiercePharma noted how Massachusetts Attorney General Maura Healey filed a complaint that alleged members of the Sackler family played a major role in the marketing for OxyContin “and pocketed billions of dollars in profits over the years.” The company used “coffee, ice cream, catered lunches and cash” to tempt doctors to prescribe the drug. It also used face-to-face interactions to conceal a paper trail for its sales tactics and hide the identities of potential witnesses. According to Healey’s filing, when a sales rep emailed a sales pitch to a doctor, a Purdue VP said the company should “fire her now” since the company did not want a record of their communications.

At Purdue’s launch party for OxyContin, Richard Sackler, then the Senior Vice President of Sales, said the launch “will be followed by a blizzard of prescriptions that will bury the competition.” He was also said to support a blame shifting tactic for the deaths and opioid epidemic onto those who became addicted. According to the lawsuit, in a confidential email he was reported to have written that they are “the culprits and the problem.” And that “we have to hammer on the abusers in every way possible.” Healey’s lawsuit said: “By their misconduct, the Sacklers have hammered Massachusetts families in every way possible. And the stigma they used as a weapon made the crisis worse.”

The lawsuit alleges the company deceived doctors and patients to get more people on its opioid painkillers, including OxyContin, by downplaying the risks and overstating benefits. Members of the Sackler family directed the company’s marketing strategy for opioids and worked to cover their tracks, the lawsuit claims.Purdue argued that its marketing was consistent with the FDA’s official labeling on its drugs. And Massachusetts still covers Purdue’s drugs as “brand preferred” in state programs, the company’s new filing contended.

STAT News reported that Richard Sackler was especially involved in efforts to market OxyContin, saying that he pushed staff to pursue deregulation in Germany. He was also alleged to instruct Purdue staff not tell doctors the truth about OxyContin for fear of reducing sales. In 1997, the year after OxyContin was put on the market, Michael Freidman, at the time the head of sales and marketing at Purdue, told Richard Sackler he did not want to correct a false impression among doctors that OxyContin was weaker than morphine. Friedman’s reason was because the myth was driving prescriptions and sales. He said it would be extremely dangerous at this early stage “to make physicians think the drug is stronger or equal to morphine.” Sackler said he agreed.

Friedman was later one of three Purdue executives who pleaded guilty to a misdemeanor charge of “misbranding” OxyContin (See “Giving an Opioid Devil Its Due” linked above for more on this). “No members of the Sackler family were charged or named as part of the plea agreement.” The Massachusetts lawsuit also alleges the Sackler-controlled Purdue board voted that three executives, but no family members, should plead guilty as individuals. Amid concern by the family to maintain the allegiance of two executives, when the case concluded Purdue paid them millions for their silence.

“‘The Sacklers spent millions to keep the loyalty of people who knew the truth,’ the complaint filed by the Massachusetts attorney general alleges.” ProPublica reported the Massachusetts lawsuit claims Purdue paid $5 million to Howard Udell in November 2008, and up to $1 million in November 2009. “In February 2008, the company paid $3 million to Friedman.”

On July 31, 2019, Arizona Attorney General Mark Brnovich filed a complaint in the US Supreme Court charging that members of the Sackler family who owned and controlled Purdue companies, made “billions of dollars off the promotion and sale of opioids.” The lawsuit also claimed members of the Sackler family intentionally transferred billions of dollars from the company into family held bank accounts, “looting” Purdue in the process. “Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family.” From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

The State brings this action because it has evidence that the Sacklers, Purdue, and the other Defendants were parties in recent years to massive cash transfers—totaling billions of dollars—at a time when Purdue faced enormous exposure for its role in fueling the opioids crisis. These transfers threaten the ability of Purdue to satisfy any relief the State may obtain in its pending proceeding against Purdue. The State therefore brings this action to hold the Defendants accountable for their attempts to loot Purdue, and to ensure that the people of Arizona can obtain adequate relief for the devastation that the Sacklers and Purdue have wrought in this state.

FiercePharma reported the suit named eight members of the Sackler family, including the former president and CEO Richard Sackler of Purdue, of ‘strip mining’ the company’s finances. The transfers are thought to have been done in order to set Purdue up for a bankruptcy filing and to avoid paying the potential multibillion-dollar settlements in state and federal courts. A Purdue spokesperson said the US Supreme Court was an improper forum to conduct a trial of the claims being made by Arizona. “This petition was filed solely for the purpose of leapfrogging other similar lawsuits, and we expect the Court will see it as such.”

This dismissal of the Sackler family’s influence over Purdue seems disingenuous. In late 2010, Purdue told the family that sales of the highest dose of OxyContin and the most profitable opioids were lower than expected. That meant an anticipated quarter-end payment to the family of $320 million was at risk of being reduced to $260 million. This prompted an email from Mortimer D.A. Sackler: “Why are you BOTH reducing the amount of the distribution and delaying it and splitting it in two? … Just a few weeks ago you agreed to distribute the full 320 [million dollars] in November.”

ProPublica reported that after the company pled guilty in 2008 to the federal charges of understating the risk of addiction to OxyContin, Richard Sackler advised other family members that it was important to select a new chief executive who was loyal to the family. He allegedly wrote that, “People who will shift their loyalties rapidly under stress and temptation can become a liability from the owners’ viewpoint.” The company installed five new, non-family board members. Yet in hundreds of board votes, the new directors didn’t once oppose the family.

In September of 2014 Purdue began a secret project, code-named Project Tango, to cash in on an industry growing as a result of the opioid epidemic—addiction treatment medication. Dr. Kathe Sackler, sister to Mortimer Sackler and a daughter of the company co-founder Mortimer Sackler, participated in phone calls and urged staff to give the project their “immediate attention.” So, while OxyContin sales were declining, there was an internal team at Purdue calculating how they could enter into the addiction treatment market, which was expanding. See “The Bondage of Buprenorphine” for more on this.

Company documents suggested Purdue wanted to become an “end-to-end pain provider.” They intended to sell buprenorphine (Suboxone). Then in 2015, Purdue became interested in Narcan, calling it a “strategic fit.” Executives even discussed how Purdue’s sales force could promote Narcan to the same doctors who prescribed the most opioids! Ultimately Purdue decided against acquiring the rights to Suboxone and Narcan.

The story of Purdue, the Sackler family and OxyContin, brings two sayings to mind, one biblical: the love of money is the root of all kinds of evil (1 Timothy 6:10a), and one from recovery: denial is not a river in Egypt. The biblical passage in First Timothy passes judgment on Purdue and the Sackler family from the beginning of their attempts to bring OxyContin to market: “But those who desire to be rich fall into temptation, into a snare, into many senseless and harmful desires that plunge people into ruin and destruction. For the love of money is a root of all kinds of evils” (1 Timothy 6:9-10a). The saying on denial highlights how Purdue and the Sacklers have used denial in its various forms from their original marketing of OxyContin, through their attempts to negotiate a way out of the multiplication of lawsuits that are now coming to light. And that leads to another biblical saying, “For where your treasure is, there your heart will be also” (Matthew 6:24).

In an interesting post script, the Wall Street Journal reported on October 4th that according to court records and testimony, Purdue Pharma transferred $12 billion or $13 billion in profits to members of the Sackler family. Neither the Sackler family nor Purdue disputed the reported amounts. They were revealed in bankruptcy court filings on 10/3 and 10/4. They could complicate efforts to settle the lawsuits against the company, by giving credibility to opponents of the tentative deal who think the Sackler family should contribute more than they have agreed. It is not clear when the distributions occurred.

03/18/16

Smoke and Mirrors

© Ivan Mikhaylov | 123rf.com
© Ivan Mikhaylov | 123rf.com

In this commercial, a guy named Herb said he stopped smoking with the help of Chantix: “The urges weren’t like they used to be and that helped me quit.” In the advertisement, which lasted 81 seconds, there were about twenty seconds worth of dialogue on asking your doctor if Chantix is right for you, telling you that Herb quit smoking with the help of Chantix and support and Herb’s 4 to 6 second testimony quoted above. The remainder of the commercial was a review of the potential side effects, which included: behavior changes, hostility, agitation, depressed mood and suicidal thoughts while taking or after stopping Chantix. Now watch this Saturday Night Live skit that essentially reworks all the same warnings about Chantix.

Soon after its approval in 2006, patients and their doctors began reporting adverse events such as suicidal thinking, aggression, depression and agitation. The drug was given a black box warning by the FDA in 2009 and then updated it in 2011. Refer to the medication guide for Chantix for more information on the possible side effects. But that wasn’t the end of concerns with the drug. In December of 2012, Chantix was linked by the FDA to the risk of a higher rate of heart attacks. A month later, the CEO of Pfizer was kept from testifying in court about the safety profile of Chantix because a plaintiff agreed to a settlement with Pfizer. Then in March of 2013, Pfizer agreed to a $273 million settlement for about 80% of the pending Chantix lawsuits.  In July of 2013, Pfizer said: “The resolution of these cases reflects a desire by the company to focus on the needs of patients and prescribers, and return the conversation to how Chantix can help smokers quit.” For more details on this description of the FDA and Chantix, see the various Chantix articles on FiercePharma from which this information was gleaned.

Pfizer began to win a few battles about Chantix. In September of 2014, a judge would not allow sealed court records of thousands of Pfizer documents related to the settled lawsuits to be opened. Out of court settlements with plaintiffs in cases against drug companies is standard operating procedure if it seems the case could be lost in court because then the related documents could be released into the public record. A standard condition of these kinds of settlements seems to require that all the documents that would have become evidence in a trial sealed.

That same month, the FDA approved changes to the medication guide for Chantix, suggesting that the drug might not be at greater risk of psychiatric problems. Pfizer wanted the black box warning removed. Steve Romano of Pfizer said: “Based on all this new information, a boxed warning is not supported. . . . The bottom line is that the label needs to reflect the most current understanding of the product’s benefits and risks.” Their target was a looming October 2014 FDA advisory panel meeting, where the committee would look at Pfizer’s data from observational studies and a meta-analysis of controlled trials conducted after the original side effects were reported.

FDA reviewers of the Pfizer data pointed out limitations with Pfizer’s meta-analyses and concluded that the observational studies “provided evidence of insufficient quality” to rule out an increased risk of suicide, suicide attempt or psychiatric hospitalization. Recent adverse event reports to the FDA were also said to be consistent with the findings that led to the black boxed warning. They noted how “neuropsychiatric side effects disappeared when patients stopped using Chantix, and/or recurred when therapy resumed.” It suggested that removing a black boxed warning had “limited precedent,” and should await the results from a controlled trial to be released in 2015.

The FDA finally announced its ruling in March of 2015. Not only did it keep the black box warning, it added new cautionary advice about Chantix’s interactions with alcohol. Some patients have reported increased drunkenness, blackouts and unusual or aggressive behavior while drinking. Others have had seizures. In September of 2015 Pfizer released the results of its latest study, in yet another attempt to convince the FDA to revoke the black-box warning. This large-scale by Kotz et al. followed 150,000 smokers over 6 months and found that individuals who took Chantix (known as Champix in Europe) were no more likely to have a heart attack then study participants using nicotine replacement therapy or another drug (Zyban) to facilitate smoking cessation. The study also found they were not at a higher risk of depression or self-harm. Three of the study’s authors reported financial ties to Pfizer independent of the study here.

One of the study’s authors, Aziz Sheikh, said that it was “highly unlikely that (Chantix) has any significant adverse effects on cardiac and mental health.” He though the drug’s black box safety warning “may be unnecessarily limiting access to this effective smoking aid.” Emily Wasserman commented this was exactly the kind of assessment Pfizer was looking for with Chantix. In 2014, Chantix grossed $647 million in worldwide sales; $377 million of which was in the U.S.

What was tellingly silent in this study was no further information on the association of Chantix (varenicline) with violence and aggression. A 2010 study, “Prescription Drugs Associated with Reports of Violence Towards Others” found that acts of violence towards other are associated with a relatively small group of drugs. Varenicline (Chantix or Champix) and antidepressants “were the most strongly and consistently implicated drugs.” Dr. Glenmullen, one of the study’s authors, was also one of the experts who unsuccessfully attempted to have thousands of Pfizer documents related to litigation over Chantix’s potential to trigger depression, suicide and violence made public.  Makes me wonder what was in those documents.

On the RxISK website, you can review an article on Chantix and Violence with a sampling of six selected cases taken from the FDA database on adverse events.  One case involved a 24 year old woman who said she was completely out of control by the third day of taking Chantix. She woke her boyfriend up in the middle of the night and started physically beating him. She had suicidal ideation, homicidal ideation and an attempted suicide. Another woman, 28 years old, had a fit of uncontrollable rage after consuming alcohol one evening. She had been taking Chantix for about two weeks. It resulted “in me beating my boyfriend, followed by an attempt to take my own life. An overnight stay in the ER followed.”

Looking like the misdirection practiced by an illusionist, the attention on why Chantix should have its black box warning removed focused on two of the more serious adverse effects—depression and heart attack, but ignored a third—violence and aggression. The potential for violence was also been buried within catch-all categories such as “neuropsychiatric events” or adverse effects on mental health. Indeed, the recent Kotz et al. study admitted that it did not measure neuropsychiatric symptoms that involved aggression. So when the authors said they found no evidence of increased risk of “neuropsychiatric adverse events in smokers using varenicline” we need to recognize that symptoms involving aggression were not measured. They wouldn’t find any evidence for something if they didn’t look for it.

Finally, Paul Christiansen reviewed a recent study published in JAMA that compared the effectiveness of Chantix (varenicline) to the nicotine patch and combination nicotine replacement therapy (C-NRT, a nicotine patch and lozenge). The researchers concluded there were no significant differences in rates of smoking abstinence. “The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.” Christiansen wrote that while the trial suggested there was evidence that varenicline and C-NRT may help lessen craving and withdrawal, there were significant adverse events with varenicline and C-NRT when they were compared to NRT—treatment with a nicotine patch only.

03/11/15

Lair, Liar Pants on Fire

© Wisconsinart | Dreamstime.com
© Wisconsinart | Dreamstime.com

Okay, well perhaps TECHNICALLY Janssen Pharmaceuticals, a division of Johnson and Johnson (J&J) didn’t lie about Risperdal to the public. But thousands of recent lawsuits have charged that there is a troubling side effect in young men who take the medication: gynecomastia. That means it can trigger abnormal breast growth in the males who use the drug.

Mad in America reported that the law firm of Pintas and Mullins (linked above) reported that there were 1,250 pending cases against  J&J (most of which are related to abnormal breast growth) out of which six were selected as “bellweather” trials in 2012. However, Janssen agreed to settle those cases before they went to trial. Janssen also agreed to settle another 80 cases in early 2013. Historically, this has been a regular legal tactic of pharmaceutical companies when they are sued. Peter Breggin has noted how this method and others were used by pharmaceutical companies to neutralize potentially damaging lawsuits against them; and keep the information they contained from becoming public knowledge.

But that doesn’t always work. Pintas and Mullins, Mad in America, Peter Breggin and FiercePharma have reported on past settlements made by Janssen for misleading statements about Risperdal.  In November of 2013 Janssen agreed to pay a $2.2 billion settlement with the federal government for false claims over Risperdal. The company pled guilty to illegally promoting the off-label use of Risperdal with the elderly suffering with dementia or Alzheimer’s in nursing homes. Janssen also settled off-label marketing claims with 36 states and the District of Columbia over Risperdal for $180 million; then with Texas for another $158 million. So I suppose we could say that Janssen was found guilty of lying about Risperdal in these off-label marketing cases.

Recent cases include a lawsuit argued in Philadelphia regarding a 20-year-old man with autism, who took Risperdal to help with irritability caused by his autism. He began taking the drug as an eight-year-old, despite the fact it was only approved for use with adults at that time. FiercePharma reported that the man’s then pediatric neurologist, Jan Mathisen, said sales reps from Janssen had distributed Risperdal samples twenty times between 2002 and 2004, 5 years before the drug was approved for use in autistic children. After a day in court, the autistic man’s mother tearfully said that she was having a difficult time after “Hearing what the pharmaceutical company was doing.”

Janssen claimed that the company’s warnings were complete and proper, and that it did not miss-market the drug. In a statement provided to Blooomberg Business, a Janssen spokesperson claimed that Risperdal “has improved the lives of countless children and adults throughout the world who suffer from debilitating mental illnesses, and it continues to improve patients’ quality of life today.”

Janssen claims that Risperdal’s labels always included warnings of the risk of gynecomastia in adults, and notified doctors that it was not proven safe for use in children. The Pintas and Mullins article said the company claims that the doctor who prescribed Risperdal to the autistic man should be held at fault. In addition,

Janssen is accused not only of illegally marketing Risperdal, but also of paying doctors to speak favorably of the drug. The company paid for gold outings and other flashy incentives to get doctors to prescribe the drug to patients just like the eight-year-old in Alabama. Many of those boys taking Risperdal grew breasts and had to undergo mastectomies.

A former FDA commissioner, David Kessler, testified in Philadelphia that Johnson and Johnson knew as early as 2001 that Risperdal could cause boys to grow breasts—a full five years before the company added the warning about the potential side effect to the drug’s official label. In support of his claim, Kessler pointed to a 2001 study, FUNDED BY J&J that indicated 3.8% of boys using Risperdal in a clinical trial developed breasts. He commented that the study should have been a red flag to the company. According to Bloomberg, the neurologist Mathisen said in his testimony that he would have liked to have known about the study.

A J&J lawyer said that Kessler was a biased witness or “hired gun” because he commonly testified in drug-safety trials since leaving the FDA in 1997 (see articles here and here). She suggested that he was “cutting and pasting” findings from other cases into his conclusions that: 1) officials at Janssen knew Risperdal caused some boys to develop breasts and 2) failed to alert patients, doctors and regulators about it. Kessler disputed her claims saying, “Each case is complex and there is an enormous amount of details associated with them . . . . To say I’ve testified each and every time the same way would be incorrect.” He also indicated where he has testified on behalf of pharmaceutical companies in the past.

As I first wrote this, the trial in Philadelphia was scheduled to take another few weeks. I was rooting for a ruling in favor of the autistic man and his family, which did happen! The Wall Street Journal reported that a Philadelphia jury decided Johnson & Johnson had to pay $2.5 million in damages for failing to warn that Risperdal could cause gynecomastia. The attorney representing the autistic man said: J&J “hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted.”

The settlement is relatively modest, considering what J&J has made from Risperdal. In the seven years between 2003 and 2010, Risperdal grossed more than $24 billion worldwide; 4.5 billion in 2007, the year it went off patent. While there should be enough capital to settle the case without J&J going bankrupt, with the additional 1,200 plus lawsuits, it may be a good time to divest yourself of J&J stock.