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Prozac indignation
How a little-known Harvard clinician needled sleeping giant Eli Lilly

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By Craig Offman

May 17, 2000 |  On a Friday afternoon last month, Dr. Joseph Glenmullen, author of "Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives," left his office at Harvard University Health Services to visit New York. While he was away, two men from Eli Lilly & Co., the pharmaceutical company that produces Prozac, paid his office an unscheduled visit. Given what Glenmullen writes about the drug, he assumed they weren't there for his autograph.

Eli Lilly maintains that the visit was a routine sales call to the clinic. One of the representatives even left a card. But whatever the reason for Eli Lilly's call, the Indianapolis giant has loomed large in the psychiatrist's life since his harshly critical look at the long-term effects of antidepressants was published April 5.

Lilly representatives and other critics have slammed the book as misleading and lacking in scientific rigor. A company letter to an Indianapolis reporter called it "the work of a storyteller, not a scientist" and concluded that it was "a fear-mongering publication." The book has also grabbed the attention of ABC's "20/20," which interviewed Glenmullen and Eli Lilly representatives for a segment on antidepressants. The segment, taped last month, has yet to air. Some speculate that the delay is linked to the network's relationship with Lilly, which has been a prime-time advertiser on ABC since early April when the book was released.

Glenmullen argues that his critics' objectivity is tainted by the fact that many of them receive money from Lilly. But even some researchers who have no connection with Lilly -- who have, in fact, been harsh critics of Prozac and other antidepressants -- have problems with Glenmullen's book. Two major researchers have accused him of simply recycling their ideas without acknowledgment.

Glenmullen is a 49-year-old Harvard Medical School graduate and untenured clinical psychiatry instructor at Harvard University. He says he first noticed the side effects of antidepressants on his patients in private practice 10 years ago, but his research on the subject has never appeared in any medical journal.

His 338-page book, begun in 1996, relies on dozens of studies from medical journals, magazine articles, FDA documents and Glenmullen's own clinical experience to chronicle the dangers of Prozac-type antidepressants and suggest alternative therapies.

Some of the side effects he enumerates -- sexual dysfunction, weight gain and tremors -- have been well documented. "The fact is that any drug, and certainly all of the antidepressants, have side effects," says Dr. Harvey Ruben, the director of continuing education for the department of psychiatry at Yale University.

What has raised eyebrows is Glenmullen's statistics. "Prozac Backlash" says that the selective seratonin reuptake inhibitors, or SSRIs, in Prozac lead to sexual dysfunction in 60 percent of all users. Prozac's packaging, by contrast, asserts that that 2 to 5 percent of users will suffer such problems. (Eli Lilly now maintains a figure in the 20-30 percent range and plans to update its literature.)

Glenmullen also suggests another long-term side effect of antidepressants: suicide. He estimates that between 1 and 3 percent of his patients became suicidal on antidepressants, a percentage experts consider serious. He also believes Eli Lilly has suppressed this information.

The Boston Globe recently published an internal Lilly document that revealed that the company was aware that akathisia -- a severe agitation that can lead to suicide -- occurs in at least 1 percent of users. It also mentions that the patent documentation for a new version of Prozac, R-fluoxetine, says the update will not produce such existing side effects as suicidal thoughts, self-mutilation and akathisia (listed as "one of [Prozac's] more significant side effects" in the patent). The patent is assigned to Marlborough, Mass., pharmaceutical company Sepracor, which will co-produce the drug with Lilly.

Lilly, however, claims that the Food and Drug Administration gives Prozac a clean bill of health in that regard. "In 1991, a panel of experts appointed by the FDA found no credible evidence of a causal link between the use of antidepressant drugs, including Prozac, and suicidal or violent behavior," the company said in a statement. The FDA still stands by its conclusions.

. Next page | America's favorite drug


 
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