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From: " Ilena Rose " <ilena@...>

Sent: Monday, April 09, 2001 12:38 PM

Subject: Name Game Shenanigans of the Pharmaceutical Cartel

Women's pill is really Prozac

>

> By LEWIS KRAUSKOPF

> Staff Writer

>

> About nine months ago, Eli Lilly & Co. won

> federal approval to market its drug Sarafem for

> a severe form of premenstrual syndrome.

>

> Available as a pink-and-lavender capsule,

> Sarafem, according to Eli Lilly's Web site for the

> drug, " is the first and only FDA-approved

> treatment for both the mood and physical

> symptoms of Premenstrual Dysphoric Disorder

> (PMDD). "

>

> Sarafem, however, isn't a new chemical

> discovery. It is a repackaged, renamed version

> of the Indianapolis company's globally popular

> antidepressant, Prozac -- they are chemically the

> same, though Prozac capsules are colored green

> and cream.

>

> It is common for drug companies to seek Food

> and Drug Administration approval to market a

> drug for more than one therapeutic use, as Lilly

> did. But an FDA representative could recall only

> a few situations in which the drug was then

> renamed.

>

> On Tuesday, Lilly's marketing campaign for

> Sarafem came under fire from a New Jersey

> healthcare group, which said " it has grave

> concerns about the marketing of Prozac under a

> new name. "

>

> " The big issue is people ought to know what

> they're taking, " said Dave Knowlton, chairman

> of the quality and data committee of the Health

> Care Payers Coalition of New Jersey. " Why isn't

> the name of this drug Prozac? That should be

> the name of it. "

>

> Eli Lilly said Tuesday that it used a different

> name because the repackaged drug is treating a

> different condition. The company said it states

> in its patient education and advertising that

> Sarafem contains the same active ingredient as

> Prozac.

>

> " PMDD and depression are two distinct

> disorders, " said , a spokeswoman

> for Eli Lilly. " Prozac is probably one of the

> most well-known trademarks in the industry

> closely associated with depression. . . . Since

> PMDD is not depression, we felt an additional

> trademark would help women differentiate

> PMDD from depression. "

>

> The active ingredient for Prozac and Sarafem is

> fluoxetine hydrochloride. Under Prozac,

> fluoxetine is approved by the FDA for treating

> people with depression, bulimia, and

> obsessive-compulsive disorder.

>

> PMDD's symptoms include severe mood

> swings, irritability, and physical symptoms such

> as bloating. It affects 3 percent to 5 percent of

> menstruating women, according to Lilly.

>

> By marketing the drug under the name Sarafem,

> the company said it is easier to educate women

> about PMDD.

>

> But the New Jersey coalition, which is a

> non-profit group of businesses and unions that

> offers state residents health-quality information

> and access to health-care providers, said that the

> company's direct-to-consumer advertising

> campaign for Sarafem is making the disorder

> seem more widespread than it is.

>

> " They are inappropriately implying that this

> drug is for a much more mainstream condition

> than what it's indicated, " Knowlton said.

> " They're not going on prime-time ads to market

> this to 3 percent of the population. "

>

> Bob Kirby, an analyst with ,

> predicts that Sarafem sales will peak at about

> $100 million a year, a tiny amount compared to

> the $2.6 billion brought in last year by Prozac,

> which stands to lose its patent protection this

> year.

>

> Kirby suggested that Lilly may be using the

> name Sarafem because Prozac could carry a

> stigma for some people.

>

> " There might be a reluctance to take a drug

> classified as an antidepressant when you want to

> take it for " PMDD, Kirby said.

>

> Eli Lilly isn't the only company marketing a

> drug under different names. GlaxoKline

> PLC has been selling its antidepressant

> Wellbutrin as a quit-smoking drug under the

> name Zyban since 1997. Both products have the

> same active ingredient, bupropion.

>

> A patient who is depressed and wants to quit

> smoking could unintentionally take an overdose

> of bupropion by using both Wellbutrin and

> Zyban, the Institute for Safe Medication

> Practices warns. To prevent that, the group

> advises patients to provide a list of all their

> medications to all healthcare professional who

> treat them.

>

> Staff Writer Krauskopf's e-mail address is

> krauskopf@...

>

>

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