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Tuesday, May 8, 2012

States Pick up Where Feds Left Off in Fining Drug Companies for Deceptive Advertising




After the Feds did their job, the states are now getting into the action.  Pharmaceutical companies are now starting to be fined in state courts for fraudulent promotion of their psychiatric medications.

Anyone who is still wondering why there has been an explosive increase over the last two decades in the use of two classes of psychiatric medications  - so-called “atypical” antipsychotic medication and anti-convulsants - for the treatment of a variety of diagnoses for which they are not indicated need look no further than to my previous posts about U.S. Department of Justice fines levied against pharmaceutical companies for said fraudulent promotion. (2/17/10, 3/22,10, 3/27/10, 4/28/10, 4/30/10, 10/1/10, 12/20/10).  

This blog has also focused on how, with an enthusiastic assist from pharmaceutical companies, the definitions of the psychiatric disorders for which the drugs actually are indicated have been expanded to the point where they are in danger of becoming FUBAR’S (F***’d up beyond all recognition).

To summarize what the US Department of Justice previously found:

May, 04. American pharmaceutical manufacturer Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of Neurontin.  One of these uses was for bipolar disorder.  Studies later indicated the drug was ineffective for bipolar disorder.

January, 2009. Eli Lilly pays a settlement to the DOJ of $1.4 billion for concealing side effects and off-label marketing of Zyprexa just as their biggest seller, Prozac was about to go off patent in 2001.

September, 2009. Pfizer agrees to a settlement for $2.3 billion for off label marketing of several drugs including the atypical anti-psychotic Geodon

April 2010 - AstraZeneca fined $520 million – off label marketing of Seroquel.

April 2010 - Ortho-McNeil-Janssen Pharmaceuticals Inc., fined $81 - off label marketing of Topamax.

September 2010 - Novartis Pharmaceuticals Corporation fined $422.5 million off label marketing of Trileptal.

December 2010 – Elan Pharmaceuticals fined $203 million – off label marketing of Zonegran.

Now the states of South Carolina and Arkansas have fined Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for overstating the effectiveness and minimizing the risks of their antipsychotic medication Risperdal.




The following summaries of what happened are paraphrased without permission from the American Psychiatric Association’s Psychiatric News.  These legal actions were also widely reported by the press throughout the country.

First was South Carolina, from January of 2012:

A South Carolina judge upheld a $327 million civil penalty against Johnson & Johnson for overstating the safety and effectiveness of Risperdal.  A  jury had decided that they violated consumer protection laws by sending doctors a misleading letter in 2003 about this. The jurors also determined that the warning-label information was deceptive.  They found that the company had falsely claimed that Risperdal was better than competing drugs in a letter was sent to some 700,000 doctors nationwide,. The Food and Drug Administration (FDA) issued the company a warning letter about false and misleading claims that minimized risks such as diabetes and overstated the drug’s benefits. South Carolina’s law allows a judge to decide whether the company can be fined as much as $5,000 for each letter sent to South Carolina doctors.

Arkansas got involved just recently:

Johnson & Johnson "lied to patients and doctors" in its claims about Risperdal, said Arkansas Attorney General Dustin McDaniel, after a jury found the company guilty.  This is the latest case regarding fraudulent claims about the company's second-generation antipsychotic). The jury determined that the company downplayed and hid risks associated with the drug, which has been linked to increased risk of stroke and death in elderly dementia patients and to seizures, weight gain, and diabetes. After the jury's decision, Arkansas Circuit Court Judge Tim Fox, issued a penalty of $1.19 billion for the nearly 240,000 violations of the state's Medicaid fraud law. The New York Times reported that he also fined the company $11 million for violations of the state's deceptive practices act. 

Like the title to one of my previous posts, the hits just keep on coming.  Unfortunately, the companies are treating these fines as a cost of doing business and are still making huge profits on these medications.  They know quite well that the damage has already been done.


With Rispiridal, it’s kind of a shame, since in my clinical experience its side effect profile in some ways actually does compare somewhat favorably with two of its main competitors -  for patients who are actually psychotic, of course.

8 comments:

  1. The DOJ is almost criminally negligent itself for not seeking prison sentences for the shot-callers at these companies.

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  2. OK, but even for psychosis, I still sense the "anti-psychotic" medications are not directly addressing the source of the problem.

    Seroquel is used for sleep.... for our military men in service. Sleep is what it does to psychotic patients too, once they are able to calm down enough to feel the effects of the drug.

    For many in crisis, it takes an anti-anxiety chaser. Without that, the anti-psychotic does not work so well for sleep.

    Believe me, I have been there.

    ReplyDelete
    Replies
    1. Smitty,

      You're absolutely right about Seroquel being used for sleep - and totally inappropriately so - and hardly just in the military. It's widespread:

      http://davidmallenmd.blogspot.com/2011/02/antipsychotics-are-for-psychosis-not.html

      A truly horrific trend.

      But antipsychotic meds can often effectively help control delusions and hallucinations (even when caused by LSD). Of course they don't cure anything, unfortunately.

      Delete
  3. Also, I think lying... when it comes to pharmaceutical.. should be a heinous crime.

    After all, the drug companies are making it mighty difficult for good doctors to honor the Hippocratic Oath: First do no harm.

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  4. Psychiatric diagnosis has already passed FUBAR. The DSM-5 validation failed on bread-and-butter diagnoses such as depression and anxiety -- agreement among clinicians using the DSM-5 guidelines was poor.

    I'm really glad the states have found this auxiliary source of income. First pharma picks their pockets, then they get some of it back.

    ReplyDelete
    Replies
    1. Hi Altostrata,

      I think you're referring to some new data on the reliability of the new diagnoses, not the validity.

      The newest field trials of the DSM-V show that reliability (the percentage of practitioners who agree on a given patient's diagnosis) has gone down markedly from the DSM-IV, which was markedly worse than that of the DSM III.

      While this says nothing about whether a diagnosis is valid (real), it sure seems like reverse progress to me.

      The validity of the new diagnoses and diagnostic criteria is certainly up for debate as well. As you know, I think those have deteriorated as well in many cases.

      Delete
    2. You're right, I erred.

      Once it goes FUBAR, what's next?

      Delete
  5. nice posting.. thanks for sharing.

    ReplyDelete