Friday, May 18, 2007

Bitter Pill

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

IN HER SOUTH MINNEAPOLIS HOME, Kim Witczak keeps an oversized collage of photos of her late husband. Woody, as he was known to his friends, could be counted on to do what it took to get the funny shot. Statues were impersonated, museum dioramas trespassed, horsey rides given to nephews. He greeted the camera with a cheery salute his wife still can’t really explain. Woody looks like the least-depressed person you ever met.

But four years ago, not long after starting a new job, Woody began feeling anxious and had difficulty sleeping. The 37-year-old had no history of depression, and his doctor didn’t believe he was depressed. But, in keeping with common medical practice, Woody was given a prescription for Zoloft, the selective serotonin reuptake inhibitor (SSRI) antidepressant manufactured by Pfizer.

“He didn’t like drugs,” Kim recounts, “but he figured he would take them so he could get some sleep.” During his first several weeks on the medication, Woody experienced some expected side effects, including sweating and diarrhea. Kim, then an advertising executive with Fallon Worldwide, was on a photo shoot in New Zealand much of that time. When she returned, Woody for the most part seemed like himself, with the exception of a disturbing episode: One day in late July, he came home from work with his blue dress shirt drenched in sweat, burst into tears, and collapsed to the floor. “Help me, help me, Kim,” Woody said, “I don’t know what’s happening.” He told her he had been driving around for hours thinking about ending his life, and that he wanted “to beat this feeling in my head”—a sensation that made him feel as if his head was floating above his body. He raised his hand and turned his palm toward his face.

“It’s right here,” Woody said, “looking down at me.” Kim thought her husband simply needed to calm down—which he did, after they prayed and performed some deep-breathing exercises together.

A few weeks later, on August 5, 2003, Woody was busy making plans. He ran three miles around Lake Harriet, made sales calls, and purchased airline tickets for a bachelor party in Las Vegas and a wedding in St. Louis. Kim, who was in Detroit, spoke with her husband early in the day and again around 10 p.m. They discussed celebrating their 10th wedding anniversary in Thailand. But while Woody had been bright and engaged earlier in the day, by evening he sounded distracted. “He was almost zombie-like,” Kim says. “I just remember him going ‘yeahhhhh.’ Just this howling sound.”

When Woody didn’t show up for a meeting the next day, Kim had her father go to her house. He found Woody hanging in the garage. His final act was apparently so unplanned that he had to Google the word “noose.” Woody, who commonly left his wife a message when he went on an errand, didn’t leave a suicide note.

PEOPLE WHO KILL THEMSELVES on ants do so, we are told, because they are depressed. If they had not been diagnosed with depression, well, that would just mean the doctor missed it, the condition was in its early stages, or the family was in denial. But what if none of those things were true? What if a drug made to treat a condition that causes suicide could make a person commit suicide? That question has come to dominate and define Kim Witczak’s life.

In the last three years, Kim has traveled to Washington, D.C., more than 25 times to testify to her belief that selective serotonin reuptake inhibitor (SSRI) medications can induce suicide. The first time she appeared before the Food and Drug Administration (FDA), Kim was up until five in the morning rehearsing her remarks. “You’re in this room with all the experts, and here comes little old Kim from Minnesota,” she recalls. “I laugh sometimes now and say, ‘Good one, Woody, you leave me to take on the drug companies and the federal government?’ ”

Kim’s brother-in-law, Eric Swan, who has accompanied her to Washington, says, “You know what’s in the back of everyone’s mind: ‘How do you know there wasn’t an underlying disorder?’ You feel pretty alone in that room.” And while the broad community of mental-health advocates and nearly all of psychiatry defends the drugs as safe and effective, Kim is bolstered by like-minded families and researchers armed with neuropsychological arguments and clinical stories. Many of these stories appear on WoodyMatters.com, the website Kim helped establish in Woody’s honor. She also has granted an option for the film rights to her husband’s story to a producer.

Much of Kim’s time in Washington is spent advocating for a comprehensive warning to be placed on the label of antidepressants that says the drugs can make some people want to take their life. Last year, an FDA advisory panel recommended that the existing warning be amended to include everyone up to age 25 after a raucous hearing during which Kim testified. She and dozens of others told stories of loved ones lost to seemingly unexplainable suicide while on antidepressants. But Kim isn’t satisfied with the ruling.

In Minnesota, Kim is working with legislators Kathy Sheran of Mankato and Tom Huntley of Duluth to make ours the first state to require drug makers to release all clinical-trial results dating from 1990 to a publicly accessible database. “The public needs to be educated in the decisions they make and aware of the potential risks and side effects involved when taking medication,” Sheran says.

WOODY NEVER TOLD his doctor about the side effects he experienced while taking Zoloft. “I don’t think he ever thought it was the drug,” says Kim. “I know I didn’t think it was the drug.” But after the coroner left the Witczak home with Woody’s prescription bottle, his brother-in-law became suspicious. Swan got on his computer, entered search terms for Zoloft and suicide, and began reading about the debate over antidepressants and suicide. He learned about akathisia, the drug-induced agitation whose name means “without sitting.” It took several weeks for him to share his research with Kim. “I was reluctant to tell her at first,” says Swan. “Who was I to intrude at that time?”

Even if Woody had spoken to his doctor about his state of mind, many in the medical community have little knowledge of akathisia, which causes pronounced physical restlessness in some, dread and inner turmoil in others. The condition is thought to affect 5 to 35 percent of those on antipsychotic-drugs; some believe it is triggered by a drop in brain dopamine levels as antidepressants raise serotonin.

Akathisia first appeared in the medical literature in connection to heart patients who were testing a tranquilizer known as reserpine for hypertension at the Mayo Clinic. Reserpine would eventually become one of the first antidepressants, and it made some nondepressed people depressed. A few became suicidal.

 
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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1 comment:

Mark said...

Loved the first image of the pill/bullet in gun