More reasons why the public should be skeptical – educated and alert - about pharmaceutical marketing.  As I said yesterday, there is “less cooperative silence” within the health professions about the cause and effect of mega-marketing and what shows up in the diagnostic codebooks.  Meanwhile patients may have to instigate change in this Supply & Demand practice.  A good patient is proactive, assertive, and inquisitive.  – Karen Watters Cole

Drugmakers Deny Inventing a Disorder
Female Sexual Dysfunction No Ploy to Sell Viagra, Pfizer Says

Reuters, Saturday, January 4, 2003 @ http://www.washingtonpost.com/wp-dyn/articles/A7843-2003Jan3.html

Pharmaceutical companies yesterday rejected a published account claiming they had invented a new disorder known as female sexual dysfunction to build a market for Viagra and similar drugs among women.  An article in the British Medical Journal said researchers with close ties to the industry had defined the new disorder at company-sponsored meetings over the past six years to encourage use of the same medicines that have helped men with impotence.

The author of the article, Australian Financial Review journalist Ray Moynihan, said widely reported statistics that 43 percent of women older than 18 had female sexual dysfunction were misleading.  He traced the origin of the definition of the condition to a May 1997 meeting of researchers and drug company representatives at a Cape Cod hotel.  Moynihan said the 43 percent figure gained prominence when two authors with ties to Viagra's maker, Pfizer Inc., used it in a 1999 article in the Journal of the American Medical Association.

The figure comes from a reanalysis of a 1992 survey of 1,500 women, who were asked whether they had experienced any of seven sexual difficulties for more than two months during the previous year.  The sexual difficulties included a lack of desire for sex, anxiety about sexual performance and difficulties with lubrication.

A Pfizer spokeswoman denied the allegations that the company invented female sexual dysfunction, saying that Viagra -- and upcoming rival products from Eli Lilly and Icos, and from Bayer and GlaxoSmithKline -- had yet to be approved for use in women.  Pfizer made $1.5 billion from Viagra in 2001.

FDA Approves Prozac for Children, Teens
Fri January 3, 2003 06:03 PM ET @ http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=1989748


NEW YORK
(Reuters Health) - The US Food and Drug Administration said on Friday that it has approved Eli Lilly & Co.'s Prozac (fluoxetine) to treat depression and obsessive compulsive disorder (OCD) in children and adolescents aged seven to 17 years.

According to the FDA, Prozac is the first selective serotonin reuptake inhibitor (SSRI) to receive approval for treating depression in children.  The approval was based on two studies of children and adolescents with depression, which showed that the drug produced a statistically significant effect compared with placebo.  The drug also produced a statistically significant effect compared with placebo in studies of children and adolescents with OCD.

Side effects associated with Prozac use among children and adolescents were similar to those observed in adults and included nausea, tiredness, nervousness, dizziness and difficulty concentrating.  The FDA noted that in one of the clinical studies, after 19 weeks of treatment with Prozac, children gained, on average, about 1.1 cm less in height (about a half an inch) and about one kilogram less in weight (about two pounds) compared with children treated with a placebo.  According to the agency, "the clinical significance of this observation on long-term growth is unknown."

Lilly will conduct a phase IV post-marketing study to further evaluate the potential impact of Prozac on long-term growth in children.

Citing figures from the National Institute of Mental Health, the FDA said depression affects up to 2.5% of children and 8.3% of adolescents in the US. OCD affects roughly 2% of the population and typically begins during adolescence or childhood.

Indianapolis-based Lilly lost patent protection on Prozac in August 2001. The drug was once a blockbuster, pulling in sales of $2.5 billion in 2000. Since losing patent protection, several generic formulations of Prozac have flooded the US market, cutting sharply into Lilly's revenues.

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