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"Prozac Backlash"
Now a decade later, Lilly has targeted Dr. Joseph Glenmullen, whose book "Prozac Backlash" has apparently incensed Lilly executives.

Glenmullen, a clinical instructor in psychiatry at Harvard Medical School and a clinician at the Harvard University Health Services, says he wrote the book because he was alarmed by the number of patients who were reporting severe side effects from the serotonin- boosting antidepressants including Prozac, Paxil, Zoloft, and Luvox. "The two most upsetting side effects were patients becoming suicidal on the drugs, and the development of disfiguring facial tics," he said in an interview.

After obtaining hundreds of pages of FDA documents through the Freedom of Information Act, as well as internal Lilly memos that are part of the public record in lawsuits filed against the drug company, Glenmullen wrote that Lilly had tried to downplay side effects of Prozac for years.

Lilly alerted newspapers and TV stations to the book and began a campaign to discredit the author, saying that Harvard Medical School professors were unfamiliar with his work and didn't recognize his name. Glenmullen, a graduate of Harvard Medical School, is one of 415 clinical instructors in medicine at Harvard.

Blast from a critic
Chief among Glenmullen's critics is Mass. General's Rosenbaum, a professor of psychiatry at Harvard Medical School, who, in a written statement sent to the Globe calls "Prozac Backlash" a "dishonest book" that is " manipulative" and "mischievous."

But Rosenbaum's objectivity has also been questioned. Not only was his 1991 study on Prozac and suicide criticized by at least two sets of researchers as well as the FDA, documents obtained by the Globe show that Rosenbaum's relationship to Lilly is a cozy one: he has served as a Prozac researcher and sat on a marketing advisory panel for Lilly before Prozac was launched.

When asked in an interview why he was speaking out against Glenmullen's book, Rosenbaum said that the suicide controversy was "old news" and that the book presents the information as new research. He noted that akathisia is "pretty rare" and that "it doesn't occur more than in people given a placebo."

But because there is no official reporting system for drug side effects, no one knows how common drug side effects are, said Larry Sasich, a research analyst at Public Citizen in Washington, D.C.

"There is no active surveillance system to look at adverse events," he said. "Unless something very unfortunate happens and a large number of people are harmed in a unique way, no one is going to look at it; nobody ever puts two and two together."

Sepracor's patent
On April 12, the Federal Trade Commission opened the way for Lilly to market Teicher's, Barberich's, and Young's new Prozac, for which Sepracor holds the patent. The new Prozac, R-fluoxetine, is a modified form of an ingredient found in Prozac, which, according to Sepracor, not only has fewer side effects but more potential uses and benefits than the original.

In making the decision, the FTC rejected arguments from its lawyers and the generic drug industry that the agreement unfairly limits generic Prozac competition.

According to a Sepracor press release dated April 13, the company will receive an upfront payment and license fee of $20 million from Lilly and an additional $70 million based on the progression of the drug. Sepracor will receive royalties, and in exchange, Lilly will get the exclusive world rights to R-fluoxetine for all indications and uses. Lilly will be responsible for the development of the drug, regulatory submissions, product manufacturing, marketing and sales, according to the release.

Glenmullen wonders whether the new Prozac will, in fact, be little more than an effort to prolong the life of a product with a soon-to- expire patent.

Although it is touted as having fewer side effects, no one knows what effects may surface once large numbers of people begin taking it for months or years. In the epilogue to his book, he simply says: "Like any new drug, it too will be an ongoing experiment."

SIDEBAR: Profits from Prozac Eli Lilly and Co.'s popular antidepressant Prozac is by far its bestseller among its family of pharmaceuticals. Percentages indicate changes over previous year.

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