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Suicide Victim's Parents Push to Get Acne Drug Off Market

Sep 28, 2005 | Linton Daily Citizen

Belief that Accutane, a prescription acne medication with the chemical name isotretinoin, contributed to the suicide death of their son, Tammy and David Hestand of Bloomfield want to let as many people as possible know the drug's risks.

"It's my honest feeling that a minor, especially under 18, shouldn't be on this medication, because you can't watch them," Tammy said. "To give it to adults and let them take their life into their own hands is one thing, but to give it to someone 21 and under is another. I'm not sure people understand the true risks."

She said young people don't think they're going to die or that anything bad will happen to them. Knowing that if they tell the doctor they're having suicidal thoughts he'll take the "miracle drug" away, Tammy isn't sure they'd admit it.

"I think of it like heroin," she said. "I think people get addicted to it. Like I said my gosh  his skin was beautiful. I think there's a fear factor of having it taken away.

"I can't see kids having responsibility enough to take it."

She said the majority of people taking isotretinoin are between the ages of 18 and 21.

"That freaks me out even more because the majority of those kids are off at college," Tammy said. "Who's watching them?"

Shelley Rosenstock, executive director of public affairs for Roche, the company that markets Accutane, said "the predominant number of Accutane patients is between 15 and 24 years of age."

Even when teens live at home, the Hestands said, it's hard to keep tabs on them 24/7 and, as Tammy pointed out, "Who knows what a teenager is thinking on a good day?"

She and David truly believe everything was fine on the Sunday morning Caleb took his life. She said the family simply noticed that no one had seen Caleb for a couple hours and began to look for him.

"He was fine, then two hours later he was gone," Tammy said.

"It looks like girls go into long-term depressive symptoms, but these high-achieving boys just go from zero to dead in a short time."

But Rosenstock said numerous scientific preclinical, clinical and epidemiological studies have failed to show a cause-and-effect relationship between Accutane and psychiatric events.

"The psychiatric events reported to the company and health authorities in association with Accutane treatment reflect the multiple risk factors in the population of adolescents and young adults," she said. "Suicide among young people occurs at such alarming levels that the U.S. Surgeon General, the Centers for Disease Control and Prevention, and a number of other federal and private groups have issued programs specifically directed at prevention of suicide in this age group.

"Mood disorders among teenagers are widespread and difficult to diagnose. In addition, there is extensive literature more than 50 studies  documenting an association between acne and depression in adolescents."

The U.S. Food and Drug Administration has approved a risk management program called iPLEDGE to make sure females don't become pregnant while taking isotretinoin. But Tammy said her impression is that they're not looking at other Accutane side effects.

According to an FDA patient information sheet on isotretinoin, they assess reports of suicide or suicide attempts associated with the use of isotretinoin. The sheet also states: "All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary."

"It is important to note that the side effects reported in the product label are the result of reports from doctors and patients and do not establish that there is any cause-and-effect relationship between the drug and the particular condition," Rosenstock said.

"Over the years Roche has maintained constant vigilance regarding reports of mood disorders and suicides, and has discussed with them with FDA and other experts. As a result, the professional and patient information, including labeling, packaging, and prescriber and patient educational materials, have been enhanced through the years with comprehensive support materials, such as informed-consent forms and educational information. These changes have reflected prescriber and patient experience and even concerns about which there was no scientific validation, all for the cause of patient safety."

Still, Tammy said, people have been pulling together since 1999 to get isotretinoin off the market. She said a U.S. senator and a U.S. congressman each lost a child who was taking Accutane® to suicide. She said one of the legislators, in particular, has been lobbying for the Accutane recall.

There have been a number of lawsuits against Roche, Tammy said, but it's a matter for the FDA, not the courts, to decide if isotretinoin will be removed from the market.

"VIOXX and others were voluntarily pulled," she said. "It's apparent with this drug they're not going to do anything willingly."

Talking to an Indiana trial lawyer with the Indiana Supreme Court, Tammy learned that if Roche loses Accutane, they'll lose half their profits. She said the company will fight hard to keep it on the market.

The Hestands said they also learned about a group of dermatologists who saw a pattern that wasn't being studied and began their own study. They documented more than 2,900 cases of suicide in Accutane users in the last three months of 1999, Tammy said. Roche stepped in and said the information wasn't accurate, so patients on any other medications, patients with previous mental health problems, and patients affected by various other environmental factors that might cause them to commit suicide, were removed from the study results. That left 173 individuals with absolutely no extenuating factors except that they took Accutane, David said.

"Sitting here in Bloomfield, we didn't know," Tammy said. "We want our neighbors here to know. We want people in Linton to know."

She said they could sue Roche and possibly receive a settlement, according to the lawyer in Indianapolis, but if they did hit the company in the wallet, they wouldn't be able to talk about it.

"It's more important to let people know what's going on," she said.

Looking around the packed Bloomfield High School Gymnasium during Caleb's funeral service, Tammy said, she couldn't help thinking "You can't tell me no one else in this room isn't on it."

She said she's e-mailed the legislators she read about in Washington, D.C., with the full intent of seeing what she and David can do to help spread the word about isotretinoin's potential dangers.

Both Tammy and David are concerned that people will think they're just looking for someone to blame for Caleb's death. But their goal is to spread the word so people will educate themselves before making a decision about using isotretinoin or letting their child take the medication. Tammy encourages people to look it up on the Internet by using a search engine to search for "Accutane" or "acne and suicide." She said she found everything from FDA information sheets to stories like their own posted by parents.

"We were so ignorant and in the dark that when we started talking about it, we were surprised at the people that did know about it and its side effects," Tammy said. "A lot of people in our family said 'Oh gosh, he wasn't taking Accutane, was he?' "

Family members have been spreading the word in their communities, and the Hestands have received a number of calls from parents who've taken their children off isotretinoin after hearing Caleb's story.

"I'm very comfortable to openly say to anybody, 'This medication took our son,' " Tammy said. "That's it in a nutshell. It doesn't feel any different to me than if a serial killer took him. Some people think it should make us feel better because it wasn't something we did, but it doesn't, because it's something that just should not have been."

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