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Bitter Pill

Ever since her husband’s death, Kim Witczak has pushed politicians and pharmaceutical companies to consider a simple question: Can drugs used to treat depression actually cause depression—or worse?

Bitter Pill
Photo by Mark Hooper

(page 2 of 2)

The drug industry took note, and according to David Healy’s seminal Let Them Eat Prozac, researchers at Eli Lilly were so concerned about side effects while testing the SSRI Prozac that some participants were given additional medication to keep them calm. These tests, says Healy, were among those that got the blockbuster drug of the late 20th century approved.

“Akathisia as a cause of suicide is completely logical,” says John Michael Bostwick, a psychiatrist in practice at the Mayo Clinic and specialist in suicide research. “It’s been known about for 15 years, but the average general practitioner might not know about it. The problem as I see it is one of follow-up. If you don’t warn people what could happen, and you don’t follow up, there is no way to respond to this potentially life-threatening side effect…. Part of it seems to me this idea that we can toss out [a prescription for] antidepressants and say, ‘See you.’ ”

Although it wasn’t until she spoke to Swan that Kim realized Woody’s symptoms and suicide could be related to the drug, the possible connection wasn’t news within the pharmaceutical industry. Five years earlier, a Pfizer scientist had written a journal article exploring the possibility that an SSRI could induce akathisia and acknowledged privately that a disorientation similar to that experienced by Woody could be induced by antidepressants.

Indeed, as early as 1998, internal Pfizer correspondence described patients who “stood outside their bodies and observed the feelings but were unable to express them.” Pfizer scientist Roger Lane responded, “What you are describing does indeed occur on all antidepressants. No one is exactly sure why.” The 1993 package insert for Zoloft lists this “depersonalization” as a symptom experienced during trials for the drug but “not necessarily caused by it.” (An attorney for Pfizer asserts that the company did not substantiate a direct link between SSRIs and akathisia.)
“Zoloft has been used safely and beneficially by literally millions of patients since it went on the market more than 14 years ago,” says Bryant Haskins, a Pfizer spokesperson. “The comprehensive medical data, of which there has been a great deal collected over those 14 years since Zoloft was launched in 1992, strongly indicate that allegations linking the medicine to suicide are not supported by scientific fact.”

MANY CLINICIANS see a risk in not prescribing SSRIs. “Untreated depression is more dangerous in terms of suicide risk than treated depression,” says David Adson, a professor of psychiatry at the University of Minnesota. Although Adson says he “had a handful of patients who reported suicidal thoughts when they first went on an antidepressant,” he isn’t convinced of the need for further warnings. “The cause and effect get murky,” he says.

Kim’s latest trip to Washington, D.C.,
with her brother-in-law, Eric Swan

One of the largest analyses of suicide risk in clinical trials of antidepressants, however, conducted by psychiatrist Arif Khan and published in the Archives of General Psychiatry in 2000, found that suicides are no less common in people taking antidepressants than in those taking a placebo. After reorganizing the clinical-trials data to account for what he said was “miscategorized” data, Healy later published a paper that argued for a threefold greater risk of suicide while on an antidepressant, yet it failed to raise concern. While the overall risk is low, Healy said in a 2004 interview, “I think in the U.S. since these drugs have been launched, there have been at least 2,000 excess deaths by suicide than there would have been.”

The greatest number of suicides potentially related to Zoloft, according to a 1999 study by Pfizer in the United Kingdom, has occurred in persons between the ages of 31 and 40, taking 50 milligrams of the drug, within 15 to 30 days of taking it. Woody fit the profile exactly.

Last year, Kim resolved a lawsuit she had filed against Pfizer that Fortune magazine once called “the most consequential SSRI side-effects lawsuit on the industry’s horizon.” But her desire to prevent other tragedies is undiminished. “This has helped me keep my focus, and to give me purpose,” she says. “I knew that Woody would want me to do this. We didn’t have kids. I think this is my legacy. I can leave this as Woody’s legacy.”

That legacy would be especially considerable if it were to include the development of a comprehensive clinical-trial-research database for all prescription medications sold in Minnesota. (The most recent national legislation, the Kennedy-Enzi Enhancing Drug Safety and Innovation Act of 2006, covers only new research.) Among the supporters of the legislation proposed in Minnesota is the Consumers Union, publisher of Consumer Reports, which says it cannot effectively evaluate drugs without testing data.

“What the Minnesota bill does is go back into drugs currently on the market…the drugs you and I are taking today,” says Kim. “The side effect that Woody died from, akathisia, was first seen in clinical trials. That would be in this database.”

Nationally, Kim continues to campaign for a comprehensive warning label and, most recently, a website and toll-free number to be used for reporting side effects. The latter would be required to appear on all television advertisements by pharmaceutical companies.

In the backyard of the home she once shared with Woody, Kim has just installed a waterfall. She is learning to calm herself with yoga. And, although she continues to focus most of her considerable energy on advocacy work, she has returned to work part-time on a freelance basis for her former employer. “Kim has great character and a great sense of right and wrong,” says Pat Fallon, chairman of Fallon Worldwide. “She can simplify complicated issues to their essential truths.” For Kim, the most essential truth is that, while she can’t undo the past, she can help ensure that its mistakes are not repeated. That Woody mattered.

Paul Scott is a freelance writer based in Rochester.

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