Off-Label Prescriptions Versus Off- Label Marketing
Many have heard of“ off-label” drug use in which a doctor prescribes a drug to a patient for a non-FDA approved“ indication.” The use of Retin A products for wrinkles when they are approved for acne is a case in point.
Risperdal and Zyprexa have benefited from such“ off-label” prescribing according to the suit because the drug is given for unapproved conditions like attention-deficit in children, dementia in the elderly and as mood stabilizers in psychiatric patients; related sales calls to child psychiatrists, adolescent mental health facilities and nursing homes have also been noted in the marketing.
Of course, such marketing“ creep” is simply a numbers game. Only one percent of the US actually suffers from schizophrenia— hardly the recipe for a Wall Street blockbuster— so other“ uses” are identified.
While“ off-label” prescribing is legal,“ off-label” promotion of drugs is not legal and both Risperdal and Zyprexa manufacturers have been cited for such illegal marketing in the past: J & J paid more than $ 22 billion for illegal Risperdal promotion and kickbacks and Lilly agreed in 2009 to pay $ 1.415 billion for illegal Zyprexa marketing.
Pharma watchers say such settlement amounts are built into the price of the drugs because they are expected.
New Indications And Changing Illness Definitions
Why are new indications so often added to drugs after they are already in use? For example, AbbVie’ s Humira( adalimumab) which launched the era of aggressively advertised, expensive largemolecule biologics was originally approved for rheumatoid arthritis in adults and subsequently has been given at least ten new indications.
And Risperdal was approved for schizophrenia in 2002 with indications for bipolar 1 and autism-related conditions added later; Zyprexa was similarly approved for schizophrenia with bipolar I, mania / agitation and depression-related uses added later.
According to an editorial in the Lancet there’ s a reason for such“ indication creep” as some in the field call it.
“ The crux of the problem is money. It typically takes over a decade and in excess of a billion dollars to bring a drug to market. This imposes severe financial pressure on the R & D departments of pharmaceutical companies and noncommercial entities embarking on drug development.” Easier to promote new drug uses than develop new drugs.
Other Marketing Machinations
Drugmakers also groom a patent successor as exclusive sales run out. J & J groomed Invega( paliperidone), the primary metabolite of risperidone, for sale shortly before Risperdal faced a“ patent cliff.”
Brand drugs with their monopolyproducing patents are the backbone of Big Pharma revenues and Risperdal faced patent expiration in 2008. Worldwide sales of Invega went on to exceed $ 4.1 billion a year so foresight was useful. Stockholders were thankful.
A New Generation Of Antipsychotics
When new branded antipsychotic drugs like Risperdal, Zyprexa, Seroquel( quetiapine), Geodon( ziprasidone), Abilify( aripiprazole) and Saphris( asenapine) came online, many lauded the apparent end to older antipsychotic drugs like Thorazine( chlorpromazine), Haldol( haloperidol) and Stelazine( trifluoperazine) with their tremor and tardive dyskinesia( TD) side effects.( The new prices were welcome too.) In fact, the new drugs were hailed as“ secondgeneration” antipsychotics(“ SGAs”) and“ atypical” psychotics— prematurely, in some cases, because the drugs still caused the stigmatizing side effects of TD.
Most antipsychotic drugs block dopamine D2 receptors in the brain which normally inhibit prolactin release and the result is elevated prolactin levels. Prolactin is a pituitary hormone that makes milk production after childbirth possible but, at higher levels, is also linked to breast cancer.
In men, prolactin elevation can cause gynecomastia and hyperprolactinemia and in 2019, J & J was ordered to pay $ 8 billion— yes, billion with a“ B”— to a man who developed breasts on Risperdal. J & J called the amount“ grossly disproportionate to the harm done.”
The current Bridgett Brown suit focuses on the same prolactin side effects.
Prolactin levels can be elevated by up to 76.4 percent in Zyprexa use and 94.8 percent in Risperdal use according to the Wisner Baum suit and their link to breast tumor development is undisputed.
As early as 1978, a study in the journal Cancer Research read,“ It is unequivocal that prolactin is an influential hormone in murine mammary tumorigenesis.” In 2006, when Janssen sought a Risperdal indication for“ irritability associated with autism,” the FDA psychiatry division noted such side effects and delayed approvals.
Still, cancer risks and elevated prolactin levels are and have been spun in manufacturers’ clinical trials through the use of small sample sizes, short follow-up times and other procedural deceptions, says the suit. Moreover, the risks in prescribing information that both physicians and patients trust are watered down says the firm.
Beyond a settlement for Bridgett Brown’ s pain, disfigurement and emotional distress lawyers hope to alert doctors and patients to the buried Risperdal and Zyprexa links to breast cancer that have been hidden for too long.
The Trial Lawyer 41