Yet Another Pharmaceutical Company Develops Mania

Six!!!   In a blogpost on April 30, I noted, "Five drug companies so far have been proven to have a vested interest in expanding the diagnosis of bipolar disorder for their own profit."  This statement followed a series of posts in which I had described settlements that five different companies had made with the U.S. Department of Justice (DOJ) for the illegal marketing of one of their drugs that had been FDA-approved for something other than bipolar disorder, and not for use in mania (off-label marketing).  They ain't supposed to do that.

The marketing was directed at doctors, not at the general public, and included the usual wide variety of amazingly clever manuevers big PhARMA has created over the years to trick physicians into prescribing drugs off-label. I describe many of their tricks in my new book.  As part of the settlements, the companies were fined big bucks. Of course, as I shall show shortly, the amount of the fines paled in comparison to the amount of money the companies made doing their nefarious business (see also my August 17 post, So Sue Me).

Readers may not know that once a drug is approved by the FDA for any indication, doctors may then prescribe the drug for anything that they want to.  It is all perfectly legal.  It is illegal for the drug companies, however, to discuss possible off-label uses with doctors.  Not that the law ever really stopped them.

I'd like to thank reader Duane Sherry (even if he thinks I'm just a lowlife psychiatrist) for alerting me to the sixth Department of Justice judgment against a big pharmaceutical company for off-label marketing a drug for bipolar disorder.  According to a DOJ press release just yesterday:

"WASHINGTON – Novartis Pharmaceuticals Corporation has agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products, the Justice Department announced today.

According to the agreement reached with the government, the East Hanover, N.J.-based company will plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for the off-label promotion of Trileptal in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration (FDA) approved Trileptal as an anti-epileptic drug, for the treatment of partial seizures, but not for any psychiatric, pain or other uses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as "unapproved" or "off-label" uses.

In addition to the criminal fine and forfeiture, Novartis has agreed to pay $237.5 million to resolve civil allegations under the False Claims Act that the company unlawfully marketed Trileptal and five other drugs, and thereby caused false claims to be submitted to government health care programs. Specifically, the civil settlement resolves allegations that Novartis illegally promoted Trileptal for a variety of uses, including psychiatric and pain uses, which were not medically accepted indications and therefore not covered by those programs. In addition, the agreement resolves allegations that the company paid kickbacks to health care professionals to induce them to prescribe Trileptal..."

The government's memorandum,  published on line (http://www.justice.gov/usao/pae/News/Pr/2010/Sept/novartis_entryofplea.pdf), stated, "The information alleges that NPC misbranded Trileptal by marketing it for off-label uses from July 2000 through at least June 2004. (Information, par. 17). In January 2000, the FDA had approved Trileptal for the treatment of partial seizures in persons with epilepsy...When sales of Trileptal did not meet expectations, NPC re-launched the drug to market Trileptal for the unapproved uses of neuropathic pain and bipolar disease, and profited from this off-label campaign by hundreds of millions of dollars."

Hmmm.   A $422.5 million fine on profits of hundreds of millions of dollars.  And one "biological" psychiatrist I had a debate with on line said the DOJ were "thugs" for going after these ever-so-honest companies.

The Novartis case was not quite as bad for patients with actual bipolar disorder (as opposed to the patients given a phony bipolar diagnosis according to some new criteria that were literally pulled out of the asses of certain "experts") as the previous five cases, because there is some reason to believe that Trileptal may actually have some efficacy for mania prevention. It is a molecule nearly identical to another drug called Tegretol.  Tegretol and Trileptal are both medicines used for epilepsy.  Tegretol was the first anticonvulsant, as well as the first drug of any sort other than lithium, that was used for prevention of mania in manic-depressive illness, now called bipolar disorder.

There were not a lot of studies done on Tegretol for use in mania prevention, and the ones that were done were somewhat equivocal.  Still, it was widely prescribed by psychiatrists back in the 1980's to bipolar patients who were not able to tolerate lithium, and clinically it seemed to be fairly effective.  Back in those days, there were no good alternatives to lithium other than antipsychotic drugs, which had a lot of problems.  It was also a time when patients had to have actual manic episodes and not "mood swings" in order to qualify for the diagnosis.  The drug company that manufactured Tegretol never did any large-scale studies to see if the clinicians' opinion was justified.

Trileptal, as mentioned, is only slightly different than Tegretol, and works just as well for epilepsy with fewer side effects.  Of course, that does not mean that it will also work just as well for mania prevention.  The fact that Novartis did not do the necessary studies makes me wonder if they really believed that it might work.