The Numbers
Sources: Top 200 Pharmaceutical Sales 2009 - U.S. Sales and Prescription Information 2009
The Shenanigans
About a year ago, patients began trooping into the office of UCLA
psychiatrist Andrew Leuchter, asking whether an antipsychotic drug
called Abilify "might be right for them." Few appeared to be
delusional, plagued by hallucinations or suffering fearsome mood
swings. Mostly, they were depressed or anxious, and frustrated by the
pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek
out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising
campaign touting Abilify as an "add-on" treatment for depression. For
the first time since the arrival of a new generation of antipsychotic
medications -- six drugs called the "atypicals" because they work
differently from the earlier generation of antipsychotic drugs -- the
makers of one, Abilify, had been granted the legal right to market to
a vast new population of patients beyond those with schizophrenia or
bipolar disorder. - source
OK. Nothing wrong with some advertising, right? We know the rules.
Advertising and Marketing - Pharmaceutical manufacturers make
substantial investments on marketing to consumers and physicians,
which may influence consumer demand and physician prescribing
practices. Furthermore, the most heavily advertised products tend to
be newer, more expensive drugs. This results in overall increases in
spending. - source
The guys at Healthcare Finance News are bullish...
The broad clinical profile of atypical antipsychotics allows them to
target a spectrum of psychiatric indications, increasing access to a
wider variety and larger number of patients and therefore driving
sales prescriptions and revenues. Pursuing indication expansion,
AstraZeneca’s Seroquel (quetiapine) and Eli Lilly’s Zyprexa
(olanzapine) became the biggest selling antipsychotics in 2008 with
global sales of $5.5 bn and $5.4 bn respectively. - source
2007: Fine: $515 million. Oops.
In 2007, Bristol-Myers Squibb and a subsidiary paid $515 million to
settle federal and state investigations into marketing of its
antipsychotic drug Abilify. - source
2009: $615 million penalty for the federal criminal charge.
[Eli Lilly & Co.]’s internal documents, which number about 10,000
pages, were unsealed as part of suits against the drugmaker by health
insurers and pension plans seeking to recoup monies spent on Zyprexa.
The insurance plans contend the papers indicate that Lilly promoted
the antipsychotic to doctors treating elderly patients even after
March 2001.
The plaintiffs cite documents including a 2002 business plan calling
for expanding prescriptions in off-label use. They also point to notes
from Lilly sales representatives through 2003 recording efforts to
press doctors to prescribe elderly patients Zyprexa for mood symptoms,
irritability and insomnia. - source
2009: Fine: $520 million.
AstraZeneca becomes the fourth pharmaceutical giant in the last three
years to admit to federal charges of illegal marketing of
antipsychotic drugs, a lucrative category of medications that have
quickly risen to the top of United States sales charts. Aggressive
sales and promotional practices have helped expand the use of powerful
new antipsychotic drugs for children and the elderly. - source
Manageable side effect
In 2001, marketing executives advised salespeople not to duck
questions about whether Zyprexa caused some users to gain weight,
according to an internal memo.
“Acknowledge weight gain but present it as a manageable side effect,”
Lilly advised its sales force, according to the documents. “With most
customers, we will continue to address the diabetes concern only when
it arises,” the December 2001 document said. “Get back to selling!” -
source
Smoke and mirrors
The company has argued that people who were found to have diabetes
after taking Seroquel already had diabetes or had existing conditions
that made them at high risk of the disease.
According to company e-mail unsealed in civil lawsuits, AstraZeneca
“buried” — a manager’s term — a 1997 study that showed Seroquel users
gained 11 pounds a year, while publicizing a study that claimed users
lost weight. Company e-mail messages also refer to doing a “great
smoke-and-mirrors job” on unfavorable studies. - source
Of course nobody did anything wrong...
In its statement, Lilly said the settlement did not change its views
that Zyprexa is a safe and effective treatment for mental illness.
"We wanted to reduce significant uncertainties involved in litigating
such complex cases," Sidney Taurel, Lilly’s chief executive, said in
the statement. - source
The Bottom Line.
"Is there evidence that antipsychotics are widely prescribed unnecessarily like the article implies?"
Yes. In fact, there is evidence that the article is right about many things.
However, it would be better served if it did not take liberties with statistics.
