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Image by Mohamad Azaam.<\/p>\n
Bridgett Brown, a resident of California, developed breast cancer from using brand-name and generic versions of the antipsychotics Risperdal (risperidone) and Zyprexa (olanzapine) says a new\u00a0lawsuit<\/a>\u00a0from the Wisner Baum law firm.<\/p>\n Neither Brown or her two prescribing physicians knew or \u201chad reason to know\u201d that the drugs could cause breast cancer since the drug manufacturers \u201cobfuscated and disclaimed such risks while promoting these dangerous, expensive drugs over safer, more affordable alternatives.\u201d<\/p>\n Brown suffered disfigurement, physical injury, pain, and emotional distress and demands a jury trial, says the suit. Drug giants Johnson & Johnson or J&J (who marketed Risperdal) and Eli Lilly (who marketed Zyprexa) are among the suit\u2019s major defendants, along with J&J subsidiary Janssen Pharmaceuticals (who marketed Risperdal) and Lilly\u2019s German partner Cheplapharm Arzneimittel Gmbh.<\/p>\n Off-Label Prescriptions Versus Off-Label Marketing<\/p>\n Many have heard of \u201coff-label\u201d drug use in which a doctor prescribes a drug to a patient for a non-FDA-approved indication.\u201d The use of Retin A products for wrinkles, despite being approved for acne, is a case in point.<\/p>\n Risperdal and Zyprexa have benefited from such \u201coff-label\u201d prescribing according to the suit because the drug is given for 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.<\/p>\n Of course, such marketing \u201ccreep\u201d is simply a numbers game. Only one percent of the US suffers from schizophrenia\u2013\u2013hardly the recipe for a Wall Street blockbuster\u2013\u2013so other \u201cuses\u201d are identified. (Who has noticed the new \u201cuses\u201d floated for GLP-1 agonists like Ozempic, courtesy of their manufacturers\u2019 clinical trials and funded researchers?)<\/p>\n While \u201coff-label\u201d prescribing is legal, \u201coff-label\u201d promotion of drugs is not legal, and both Risperdal and Zyprexa manufacturers have been cited for such illegal marketing: J&J paid more than $22 billion for illegal Risperdal promotion and kickbacks in 2013 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.<\/p>\n New Indications and Changing Illness Definitions<\/p>\n Why are new indications so often added to drugs after they are already in use? For example, AbbVie\u2019s Humira (adalimumab) which launched the era of aggressively advertised, expensive large-molecule biologics was initially approved for rheumatoid arthritis in adults and subsequently has been given at least ten new indications.<\/p>\n 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.<\/p>\n