Phil Brennan, NewsMax.com
Monday, July 8, 2002

Thanks to new federal regulations designed by ex-President Clinton and backed by President Bush, all kinds of people can now access your most private medical records without your say-so, just as NewsMax.com repeatedly warned.

A lawsuit has revealed that a pharmacy company got its hands on the medical records of a woman and sent her junk mail containing samples of one of its drug products, Prozac Weekly, as a remedy for her medical problem; depression.

The lawsuit made Page One of the New York Times this weekend. Why the surprise? This is exactly the sort of privacy invasion NewsMax.com warned about just before the new so-called medical privacy regulations went into effect earlier this year.

In a March 13, 2001, heads-up, NewsMax.com reported that the regulation allegedly intended to improve the confidentiality of medical records contains a sleeper provision that gives health care providers the right to sell a person's confidential medical information to marketing firms and drug companies.

Under the proposal, NewsMax warned, doctors can even share the information with a "business partner," who can conduct marketing on behalf of a provider.

"It's perfectly legal under the rule for someone to knock on your door and say, 'I've learned from your doctor you have hemorrhoids; would you like to buy this treatment?' " said Bob Gellman, a medical privacy consultant and former congressional staffer.

"You can only opt out after you have been marketed to. I've been working on this issue for 20 years, and it's the worst anti-privacy thing I've seen."

President Bush told Health and Human Services Secretary Tommy Thompson to allow the new rules to go into effect in April last year despite a storm of protests including the tens of thousands of readers who signed a NewsMax.com petition opposing the Clinton regulations.

In the new lawsuit the unidentified plaintiff alleged she got the Prozac, which is used to treat anxiety and depression, in a hand-addressed manila envelope from a Walgreen's drugstore that contained a "Dear Patient" form letter which said "Enclosed you will find a free one-month trial of Prozac Weekly. Congratulations on being one step [closer] to full recovery."

The form letter appeared to have been written by a Lilly sales representative and was signed by the plaintiff's doctor and two other local doctors.

"We are very excited to be able to offer you a more convenient way to take your antidepressant medication," the letter said. "If you wish to try Prozac Weekly, stop your antidepressant one day before starting Prozac Weekly, then take Prozac Weekly once a week thereafter." According to the New York Times' Adam Liptak, that mailing angered the plaintiff, "a 59-year-old home caregiver who filed a class-action lawsuit this week in a state court in Fort Lauderdale, Florida."

"They're going after me because I have a problem," the woman, told the Times.

She agreed to an interview in her lawyer's office, providing her name would not be revealed. "It bothers me to think that somebody could get into my medical records and start sending me dangerous medications."

The lawsuit says the plaintiff, identified only as S.K., has had a diagnosis of depression, "which she maintains in the strictest of confidence due to potential public embarrassment and employment repercussions." It states that she did not have a prescription for Prozac.

"I hadn't been using Prozac for seven years or better," she told the Times. "It was a matter of a few months. It didn't agree with me."

Misuse of Records Charged

The lawsuit names Walgreen's, a local hospital, three doctors and Eli Lilly, which makes Prozac, charging they misused patients' medical records and invaded their privacy. It also accused Walgreen's and the drug company "of engaging in the unauthorized practice of medicine," the Times reported

The plaintiffs' lawyers told the Times they didn't know how many people in addition to their client received the junk mailings. "It could be anywhere from several dozen to several thousand," Gary M. Farmer Jr., one of the lawyers, told the Times.

Dr. Lise Lambert, one of the doctors who signed the "Dear Patient" letter and the plaintiff's physician, is a defendant in the suit. She did not return the Times' calls and her medical group referred the Times' questions to Holy Cross Hospital, which is also named as a defendant.

A hospital spokeswoman said the hospital did not comment on matters in litigation. In early June the hospital issued a statement to the Fort Lauderdale Sun-Sentinel that said, "This particular effort was the result of well-intentioned, respected physicians being given an opportunity to arrange for some of their patients to receive sample medications, at no cost, through proper, licensed pharmacy channels."

The plaintiff told the Times that Dr. Lambert admitted signing blank letterhead, which the Lilly representative added text to and delivered to the drugstore for mailing. Whether or not Dr. Lambert reviewed the letter before signing, the mailing was improper, Dr. David L. Pearle, a professor of medicine at Georgetown University, told the Times.

"It's highly unethical," he said, "because it's clear that the letter is not an outgrowth of the doctor's relationship with the patient."

According to what legal experts told the Times, sending drugs through the mail could be criminal if the recipient does not have a prescription.

Debbie Davis, a Lilly spokeswoman, told the Times that sending unsolicited drugs through the mail was against company policy and inappropriate.

'Appears to Go Beyond'

"While Lilly supports informing people about new treatment options and encouraging them to discuss these options with their doctor, what occurred in Florida appears to go beyond this," she said.

"It is inappropriate for Lilly sales personnel to support programs in which medicine is mailed to patients without the patient's request," she said in a statement.

"We understand why people should be concerned about receiving unsolicited prescriptions in the mail. To the extent Lilly personnel may have participated in this program, Lilly apologizes to those patients affected by it."

Medical privacy advocates have been critical of mailings of targeted marketing materials based on information in patients' pharmaceutical and medical records. They say the mailing of drugs is an unwelcome innovation.

"This is appalling in every possible way," Dr. Pearle told the Times. "It's an escalation of a deplorable practice."

Joy Pritts, senior counsel at the Health Privacy Project in Washington, added that "this is one step beyond what we normally see." She told the Times the Prozac mailing was part of "the increasing trend for the commercialization of health care information."

"It's being bought, sold and used like any other commodity," she said, referring to patients' medical information. "This has nothing to do with treating the patient. This has everything to do with generating profits."

And even more to do with the Bush administration's new rules that allow this sort of thing to happen without the patient giving permission to his or her doctor to release private medical data to every Tom, Dick and Harry.

Read more on this subject in related Hot Topics:
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