The discussions of pharmaceutical industry and ethics seemed relevant to this particular controversy. Risperidone
is an antipsychotic medication currently approved for autistic disorder,
bipolar disorder, and schizophrenia. Sold as Risperdal, it was a blockbuster
drug for Janssen Pharmaceuticals (part of Johnson & Johnson), bringing in
$30 billion in profit. Although this drug is commonly used, its origins are
surrounded in controversy.
Risperdal was developed after
Johnson & Johnson’s patent life for its other antipsychotics ended. It was initially
approved solely for treatment of schizophrenia in adults. Johnson &
Johnson, however, utilized illegal marketing methods to cater to other
populations and indications in the 1990s and 2000s. Despite disapproval from
the FDA, the company adopted a number of methods to promote the drug, including
paying doctors consulting fees for prescribing the drug and lobbying states to
give formulary preference to Risperdal over generic antipsychotics. Risperdal
was marketed as effective for treating symptoms such as agitation and confusion
in dementia patients. Johnson & Johnson also partnered with Omnicare, a
long-term care pharmacy. Under this agreement, long-term care doctors and
pharmacists would recommend the use of Risperdal and profits would be shared
between the two companies. Johnson & Johnson also created a sales force to specifically
target older individuals. Marketing was also directed towards children for
unapproved (at the time) indications such as autism, OCD, and ADHD. The company
even considered giving lollipops and toys with samples of the drug. By the year
2000, about 20% of Risperdal sales were for children and teens, and by 2004, the
drug was bringing in over $3 billion annually. Use in children was not FDA
approved until 2006.
In addition to illegal
marketing, Janssen Pharmaceuticals was accused of inaccurately disclosing the
risks of the drug on the label. Company scientists were blamed in depicting
risk levels for side effects to be lower than they actually were. Prescribers
and users were not well-informed about the risk of stroke in the elderly or the
risk of male gynecomastia. By the time proper warnings were put on labels, some
males had been taking the drug for years and had already begun developing
breasts that can only be removed by mastectomy.
Due to
these issues, Johnson & Johnson faced multiple lawsuits resulting in
millions of dollars payed to men who experienced gynecomastia. The company plead
guilty to illegal marketing to the elderly and misbranding and paid over $2
billion in penalties and settlements. These payments, however, pale in
comparison to the billions of dollars that the company made in profits. As
mentioned in a previous class, this was “just the cost of doing business.”
Furthermore, the executives in charge of marketing did not face repercussions. For
example, Alex Gorsky, who was in charge of marketing during the controversy,
ended up being promoted to CEO, making millions annually, and receiving awards
for “integrity” and “social responsibility.”
Although
much of the publicity around the Risperdal issue is negative and lacks the
company’s perspective, the controversy highlights many problems in the
regulation of drug marketing. This case demonstrated a company’s disregard for
FDA mandates and lax application of safety regulations. Furthermore, there was
minimal to no consequences for company executives. Going forward, I feel there
has to be greater transparency and accountability in the pharmaceutical
industry. In previous classes, I learned how companies can withhold data, and I
feel that this complicates decision making by prescribers and patients. There have
been efforts to curb the pharmaceutical industry’s marketing tactics, and I
think further control is needed to ensure that the race for profits does not
jeopardize patient care.
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