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.
The DOJ is almost criminally negligent itself for not seeking prison sentences for the shot-callers at these companies.
ReplyDeleteOK, but even for psychosis, I still sense the "anti-psychotic" medications are not directly addressing the source of the problem.
ReplyDeleteSeroquel 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.
Smitty,
DeleteYou'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.
Also, I think lying... when it comes to pharmaceutical.. should be a heinous crime.
ReplyDeleteAfter all, the drug companies are making it mighty difficult for good doctors to honor the Hippocratic Oath: First do no harm.
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.
ReplyDeleteI'm really glad the states have found this auxiliary source of income. First pharma picks their pockets, then they get some of it back.
Hi Altostrata,
DeleteI 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.
You're right, I erred.
DeleteOnce it goes FUBAR, what's next?