State attorney general sued drug company
Abbott: state paid excessively to Johnson & Johnson for Risperdal
Austin Statesman
By Tim Eaton
Jan.8, 2012Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998. Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen’s schizophrenia drug Risperdal, the lawsuit says. The state also questions the companies’ marketing practices and alleges that the companies misled state health officials about the drug’s effectiveness, the risk of side effects and its suitability for pediatric use. The trial is scheduled to begin 9 a.m. today in Judge John Dietz’s 250th state District Court in Travis County…
Texas got involved with Risperdal litigation about six years ago, when Abbott’s office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania. Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes. Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies’ track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug’s effectiveness…
The lawsuit says that Johnson & Johnson and its subsidiaries employed suspect tactics in order to sell Risperdal in the public sector, which promised to be especially lucrative. Eighty-five percent of Risperdal’s revenue was projected to come from the public sector, because schizophrenic adults tend to be poor and uninsured. "Understanding the need to obtain significant government buy-in to achieve their financial goals for Risperdal, defendants set their sights on a state with one of the largest Medicaid populations in the country — Texas," according to the filing by the state and Jones. But getting a state like Texas to put a drug on a list of preferred medications — which the companies ultimately accomplished — can be a tremendous undertaking.
The lawsuit discusses the challenge for the companies to persuade decision-makers in Texas’ public medical agencies to make the move — despite what it said was evidence that the drug is more expensive and no more effective than older medications, the state and Jones say in their lawsuit. Johnson & Johnson and the related companies even created a special business unit called the Public Health Systems and Reimbursement Department designed to push the drug in the public sector, the lawsuit says. The companies also had to navigate the Texas Medicaid Program’s cost-savings measures, and to do so the companies employed a campaign that included misrepresentations about the drug’s effectiveness and superiority over other drugs, the state alleges.
The state’s case outlines allegations of kickbacks — "money going directly to key decision-makers," the lawsuit says — paid more than a decade ago to several doctors employed by the state’s Health and Human Services Commission to give Risperdal preference over other antipsychotic drugs. Jones’ lawsuit claims that Risperdal became part of the treatment plan because of the drug companies’ "improper influence" over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. Shon had served as a paid Janssen consultant and traveled the country promoting the Texas plan… Jones’ legal team also charged that the company perfected its marketing skills in Texas before reaching out to the other states in which it pushed for expanded Risperdal prescriptions…
Nine hours and counting from now the TMAP/J&J suit finally makes it to a courtroom and the jury selection begins. I’ve only known about this case for a year. But for Allen Jones, it has been a decade since he first got the scent of the wrongdoing alleged in this case. The whistle-blower suit itself was filed eight years ago. I have no clue what it would be like to have something like this on my mind every day for a decade, much less what it would feel like to finally be going to court and testifying in a matter of days. Certainly, the financial stakes are high – the lawyers speak of a billion dollars. But there will be other high stake issues at play in this courtroom. This case brings up so many of the deceptive practices that characterized the invasion of the pharmaceutical industry into academic psychiatry and psychiatric practice, all put into action behind closed doors. With this case, there are added twists. J&J targeted public mental health care. The taxpayers of the State of Texas were the victims along with the State’s mentally ill in hospitals, clinics, and prisons. TMAP was run by academic psychiatrists from Texas’ medical schools
, and the psychiatrists who administered TMAP, traveling the country as TMAP evangelists to other States, were employed by the Texas Mental Health system. It’s hard to wrap my mind around the fact that the State’s own academic and institutional doctors were themselves agents of Johnson & Johnson in defrauding the State’s taxpayers and the State’s mentally ill. Getting this story into the public eye is as important as any punitive damages that might come in this suit. Let the games begin…
But for Allen Jones, it has been a decade since he first got the scent of the wrongdoing alleged in this case. The whistle-blower suit itself was filed eight years ago. I have no clue what it would be like to have something like this on my mind every day for a decade, much less what it would feel like to finally be going to court and testifying in a matter of days.
Herein lies one big problem for advancements in healthcare. Life today is busy and complicated, and if YOU are not the one living with it (whatever “it†is)—day in and day out—it becomes merely a “matter of interestâ€, to be followed as time and energy permit.
After reading this post and your preceding post re: PTSD, I look at the fellow I married—diabetic since age 14. I’ve shared 47 years of his 56 year journey. I consider myself loving, committed, empathetic and sympathetic. I joined his battle when he saw the familiar tools he needed to treat his disease withdrawn by corporations that could make bigger profits with patented, synthetic offerings. I commiserated with him when early warriors were silenced. I transcribed letters to opinion leaders and decisions makers; I typeset the book he compiled describing why diabetes is too profitable to cure. We pled with charitable advocates “advocate for us, too.†(We sadly discovered the corporate nature of leading charitable advocates.)
Our battle was on our minds every day, for most of a decade. But we were outsiders—mere patients, consumers, cogs in the medical/pharma wheel, without standing to blow the whistle. Our information and opinion were anecdotal. We had no ‘standing’, no privilege to open the doors to the courthouse. Without a cause of action—without proof that others’ actions had measurably (physically) harmed or killed—we had no place to turn. Those in the best position to assist—medical professionals—were as much captives of BigPharma as the new breed of psychiatrists you so eloquently describe. Where your specialty practitioners were dispensing the latest/greatest psychopharmaceutical, hubby’s doctors were convinced by pharma talk that new HUMAN insulins were ‘just like the human body makes; who wouldn’t want to take human (as opposed to dirty, animal-derived) insulin.’ This argument often became determinative in physician selection. As is often the case, corporations (which are NOT people) can—and do—OUTLAST their detractors. While not surrendering—by daily choosing and fighting to simply continue living—the energy has waned, and we observe other cases, like Jones/J&J/TMAP, with interest and silent hope that maybe, this time, David will again prevail over Goliath.
And during this decade-long battle, it struck me that regardless of my love and empathy, when we “took a breakâ€, I could not live in hubby’s head or his skin. Simple activities (gardening, exercise) illustrate the divergence in our lives. If I labor intensively, I can hit the kitchen or hit the recliner without a second thought. Grabbing rest, sleep or sustenance requires no intermediary action. When hubby feels hungry, or thinks a nap would be beneficial, he must first check his bG level and decide whether he is “too highâ€, “too low†or “just right†for whatever activity/inactivity he anticipates. He does this from the time his feet hit the floor in the morning until he takes a final bG (and adjustment of insulin/food) and turns out the light at night. And he has done this for 56 years. Only total unconsciousness prevents diabetes from intruding into his very being. In your PTSD article you speak of the ‘defect’ that attends this diagnosis—the mental anguish caused by the label ‘DEFECTIVE.’ Have you considered how chronic illness can/may also recognize such a label? How does that affect one’s being?
I hope Allen Jones is rewarded for the time and effort his immersion in this issue has cost. But there is a tiny flicker inside of me that enviously whispers, “At least HE gets his day in court.â€
Thanks for your reporting of this important issue.
Melody,
And thank you for the view from the inside. One of the things I learned treating people with PTSD is that a civilian can’t really know what a veteran knows. There’s a constant feeling of being misunderstood, and it’s there because it’s true. The same thing is true for the chronically ill – a medical loneliness that’s palpable, but hard to describe. The complication of being let down by the medical community just adds another piece to the burden. Your empathy for your husband’s plight is exemplary and I expect, sustaining to him. No guilt for the flicker of envy. How could you feel otherwise?
Thanks for the comment…
vis a vis biomarkers
writing about type II diabetes treatment
The idolatry of the surrogate
BMJ 2011; 343 doi: 10.1136/bmj.d7995 (Published 28 December 2011)
Cite this as: BMJ 2011;343:d7995
“The US Institute of Medicine defines surrogates as “biomarker[s] intended to substitute for a clinical endpoint [and] expected to predict clinical beneï¬t (or harm . . .) based on epidemiologic, therapeutic, pathophysiologic, or other scientiï¬c evidence.—
“. Much of the evidence for clinical interventions is based on their effect on surrogate outcomes rather than those that matter to patients such as quality of life or …”
Recent studies have challenged the assumption that reliance on surrogates can accurately predict the effect of treatment on hard outcomes.”