-Caveat Lector-

Woman sues after receiving unsolicited Prozac in mail

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (July 4, 2002 12:44 a.m. EDT) - A Florida woman opened her mailbox
last month to find a free box of once-a-week Prozac from her pharmacy chain -
astonishing, she says, since she didn't use Prozac and hadn't asked her
doctor to switch her from another antidepressant to it.

It's not clear how many other patients received unsolicited Prozac - the
woman's attorneys say they know of two more so far - or if the apparent
campaign to sign up new Prozac customers extended beyond south Florida.

Prozac maker Eli Lilly & Co. issued an apology for the incident late Friday
and says it's investigating. The Food and Drug Administration is watching
closely.

The Prozac mailings may mark the first time a powerful prescription drug was
sent to patients neither expecting nor wanting new pills - an apparent twist
on marketing campaigns to persuade patients to switch medications.

"I'm incredulous," said drug safety expert Michael Cohen of the nonprofit
Institute for Safe Medication Practices, who called the mailings dangerous.
"You might have (people) other than the patient picking it up out of the
mailbox and taking it. It could be a child."

The big question: Is mailing patients unsolicited prescription drugs, as if
they were detergent samples, legal?

Laws governing prescription-writing and pharmacy practices vary by state. The
drugstore chain Walgreens maintains it properly filled prescriptions from
doctors' offices and mailed them for free because it had "coupons" from Lilly
to provide reimbursement. The Florida woman's doctors aren't talking.

Lilly issued a statement late Friday saying it was inappropriate to mail
medicine to patients without their request.

"To the extent Lilly personnel may have participated in this program, Lilly
apologizes to those patients affected by it," said spokeswoman Debbie Davis.
"We are investigating this matter vigorously and if company policies were
violated, Lilly will take appropriate action."

The FDA - which regulates prescription medicines, their makers and their
marketing - is monitoring the case to see whether it needs to intervene.

"Although the acts of prescribing and providing the drug likely come under
state jurisdiction, FDA intends to keep an eye on this case because of the
promotion issues it may raise," said spokesman Larry Bachorik.

The Broward County, Fla., woman, identified in court documents only as S.K.,
this week sued her doctors, Walgreens and Lilly, charging invasion of privacy
and improper medical practice.

"Dear Patient," reads a letter accompanying the pills that was signed by her
local doctors. "We are very excited to be able to offer you a more convenient
way to take your antidepressant medication.

"For your convenience, enclosed you will find a FREE one-month trial of
Prozac Weekly," the letter continues, before cautioning patients to stop
their regular antidepressant one day before starting the once-a-week version.


"It really upset me," S.K. said in a telephone interview arranged by one of
her attorneys, Stephen Sheller of Philadelphia.

She said her grandchildren might have opened and swallowed the mailed drug,
and anyone seeing her mail would learn she had depression, which she keeps
private. "Then I started to think, 'Wait a minute, how did they know to send
them to me?'"

S.K. said her doctor maintains the office physicians signed a blank form
letter provided by a Lilly salesman. S.K.'s medical records show no Prozac
prescription, said fellow attorney Gary Farmer Jr. of Fort Lauderdale.

Representatives for the doctors' office, Holy Cross Medical Group, did not
return calls seeking comment.

The lawsuit charges that Walgreens must have allowed access to patient
prescription records, providing Lilly with a list of antidepressant users.
S.K. said she tried Prozac once years ago - the prescription was filled by a
Walgreens in Massachusetts, she contends - but had a bad side effect and
switched to a competing drug that she has used ever since.

Walgreens didn't allow anyone access to patient records and properly filled
prescriptions from doctors' offices for all the Prozac it mailed, said
Michael Polzin from the chain's Deerfield, Ill., headquarters.

He wouldn't say how many samples Walgreens mailed, or how much the Lilly
coupons reimbursed the pharmacy for the drugs. A month's supply of Prozac
Weekly costs about $63 wholesale.

"How would we know the patient didn't know the prescription was coming?"
Polzin asked.

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