Another Accutane Death

Floor Speech

Date: Feb. 1, 2006
Location: Washington, DC
Issues: Drugs

ANOTHER ACCUTANE DEATH -- (House of Representatives - February 01, 2006)

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The SPEAKER pro tempore. Under a previous order of the House, the gentleman from Michigan (Mr. Stupak) is recognized for 5 minutes.

Mr. STUPAK. Mr. Speaker, on this first day of the Second Session of the 109th Congress, I sadly inform the House of Representatives of another Accutane death. I will enter into the RECORD an article from the Appleton Post Crescent. The article is dated today, February 1, 2006. If I may, I would like to quote from this newspaper.

``Justin Zimmer shot himself January 15 in his bedroom, a shocking suicide his family struggles to comprehend and fears may be tied to Justin's acne medication.

``The day of Justin's death, the family had returned home from a meeting to discuss a trip planned by Justin's church youth group.

``His parents, Wendy and Warren, left for the grocery store. An hour later they pulled into the driveway and learned Justin was dead.

``How could their happy, high-achieving teen, who couldn't wait to take his driver's test on his 16th birthday Thursday, end a life of so much promise?

``All the Zimmers and their other two children are left with are questions, and the only answer they can come up with to explain his death is Accutane, the prescription drug Justin started taking in December for severe acne.''

I wish to extend my heartfelt condolences to the Zimmer family. I, too, know the struggle and heartache and pain that they are going through as I lost my son B.J. on May 14, 2000.

To go on the article says that the FDA and the drug manufacturer of Accutane, Roche, indicated that the rate of depression among Accutane users is 1.5 times higher than among nonusers, according to a December 7, 2004 report in USA Today.

As Mr. Zimmer said, `` `They can snap in as little as an hour. I'd just as soon see it off the market,' '' meaning Accutane. `` `If this can happen to a kid with all this going for him, think what could happen to a kid who's struggling?' ''

`` `They shouldn't sell it to anyone ..... ' ''

Another doctor, ``an Appleton dermatologist, said he has looked at a number of studies and has no qualms about prescribing isotretinoin,'' which is the medical term for Accutane.

He goes on and says, this dermatologist, `` `It's something we're concerned about and we ask about, but we don't see any scientific evidence to say there is an increased risk for it.' '' He said the side effects, including the potential for depression and suicide, are there, but he is not concerned about it.

Mr. Speaker, I have come to this floor before, and I have brought forth this PET scan of the frontal orbital cortex. If you take a look at it, this is the medical evidence that directly links Accutane to depression and suicide ideation and suicide in the users of Accutane.

If you take a look at it, here is the baseline of Accutane over on my far right. That is the frontal orbital cortex of the brain. When you take a look there is all the red in the picture over here, that is the baseline. Four months later they take a PET scan of the brain over here, post-Accutane, 4 months on Accutane. Notice there is very little redness in this front part of the brain, the frontal orbital cortex, the front part of the brain we know causes depression.

The reason why there is no redness is because the metabolism of the brain has been stopped or affected by the use of the Accutane. In this particular slide, this person had a 21 percent decrease in brain activity while on Accutane.

So, when this dermatologist says there is no medical evidence, there is. Here is the direct evidence. This has been published in the American Journal of Psychiatry last year. Also, there are animal tests which show the same thing, how Accutane actually destroyed a brain in these animals.

We can even take it one step further. This person who has this PET scan here, if you gave this person, a number of dermatologists said they would monitor them, if you give this person the Beck's depression test, which is standard indication of signs of depression to see if the person is suffering from depression, this person who had a 21 percent decrease in brain activity passed every one of them. The only reason why they knew something was going on besides the PET scan was the personal behavior had changed. Unless you are monitoring that person all the time you never would know that from the Beck's depression test because it did not show a change in personality.

Getting back to the young man that unfortunately took his life on January 15, his parents went on to say, `` `He had an appointment this Thursday to take his driver's test and it was one of the few times he'd take off of school. We were shopping for cars.'

``Justin was sensitive and shy, with a ready smile and a penchant for perfection, said his parents. At school, he was sophomore class president, and ranked No. 1 in his class with straight A's. He was in wrestling, football and baseball.''

Mr. Speaker, we presented these findings of this PET scan to then-Secretary of Health and Human Services Secretary Thompson and also to then Mr. Crawford, and we are still waiting for answers back as to these PET scans and what it shows.

Mr. Speaker, there are so many unanswered questions. My time has expired. I look forward to continuing this discussion on this serious drug, and it should be pulled from the market.

The article I previously referred to is as follows:
[From the Post-Crescent, Feb. 1, 2006]

Accutane Blamed in Suicide
(By Kathy Walsh Nufer)

MENASHA.--Justin Zimmer shot himself Jan. 15 in his bedroom, a shocking suicide his family struggles to comprehend and fears may be tied to Justin's acne medication.

The day of Justin's death, the family had returned home from a meeting to discuss a trip planned by Justin's church youth group.

His parents, Wendy and Warren, left for the grocery store. An hour later they pulled into the driveway and learned Justin was dead.

How could their happy, high-achieving teen, who couldn't wait to take his driver's test on his 16th birthday Thursday, end a life of so much promise?

All the Zimmers and their other two children are left with are questions, and the only answer they can come up with to explain his death is Accutane, the prescription drug Justin started taking in December for severe acne.

Accutane is a brand name of the anti-acne drug isotretinoin, which went on the market in 1982.

It has become controversial because of its serious side effects, including birth defects, mental disorders and even suicide.

Those side effects, however, are so rare that many doctors think they statistically are insignificant, and the Food and Drug Administration only warns people to be aware of them, not to abstain from using the drug.

The Zimmers blame their son's death on the drug, said Warren, who was aware of the side effects but saw no warning signs in his son's behavior.

``That's why we felt it necessary to get this out. We want parents to know just how sudden this can come on. If we can save someone, maybe his death isn't a total loss and someone else doesn't have to go through this.''

U.S. Rep. Bart Stupak, D-Mich., whose son committed suicide in 2000 while taking Accutane, has pressed for more public warnings about the link between depression and isotretinoin, more restricted distribution and more tracking of side effects.

The Zimmers say they have talked to countless people who know someone taking isotre-tinoin. ``It's more prevalent than you think,'' Warren said.

The couple now urges parents to take their teens off the medication if they are on it.

``They can snap in as little as an hour,'' Warren said. ``I'd just as soon see it off the market. If this can happen to a kid with all this going for him, think what could happen to a kid who's struggling?''

``They shouldn't sell it to anyone under 18,'' Wendy said.

Adrianne Marsh, a spokeswoman for Stupak's office, said Tuesday the FDA has attributed about 200 suicides to the drug so far and last spring put out an isotretinoin alert.

Dr. Charlie Kagen, an Appleton dermatologist, said he has looked at a number of studies and has no qualms about prescribing isotretinoin.

``It's something we're concerned about and we ask about, but we don't see any scientific evidence to say there is an increased risk for it,'' he said of the side effects, including the potential for depression and suicide.

``There's a suggestion it (Accutane) might play a role, but statistically we can't say it does. Well over 6 million people in the U.S. alone have used it since 1982. ''

Side effects are explained in the medication guide Roche Laboratories, the maker of Accutane, puts out for patients.

The literature notes that some patients may become depressed or develop such symptoms as sadness, anxiety, irritability, anger, thoughts of violence and suicide.

Patients sign a consent form, agreeing to stop using the medication if they notice any symptoms, and are required to meet with their doctor once a month, which Justin did.

Justin, who had taken Accutane for a month before his death, had tried other topical acne medications with little luck, said his parents. He had decided on Accutane, which is prescribed when other treatments don't work, after discussing it with his dermatologist.

He also had discussed the side effects with his parents.

``It's not that we took it lightly,'' said Warren. ``We were watching for warning signs.''

``We saw nothing,'' said Wendy. ``I could talk to him about things, and he promised he would come to me if anything bothered him.''

When police asked the Zimmers what they thought happened, Warren noticed the prescription slip for Accutane on the kitchen counter.

Justin's last appointment with the dermatologist had been Jan. 12 and on the slip was the orange sticker giving the pharmacist the OK for a new 30-day supply.

Warren and Wendy Zimmer insist their son's suicide had to be related to the drug.

``He had so much going for him,'' said Warren. ``He was good at everything he did. He respected everybody. He didn't have an enemy in the world.''

``He had an appointment this Thursday to take his driver's test and it was one of the few times he'd take off of school. We were shopping for cars.''

Justin was sensitive and shy, with a ready smile and a penchant for perfection, said his parents. At school, he was sophomore class president, and ranked No. 1 in his class with straight A's. He was in wrestling, football and baseball.

``He had an undefeated season in wrestling and was so looking forward to baseball,'' Wendy said. ``He'd been sleeping with his baseball glove by his pillow.''

Justin planned to join the military, Warren said. ``He was a big `CSI' fan. Who knows where he would have gone? He had a heck of a start on life.''

The Zimmers can't say enough about the support of family, school personnel and the community, especially Menasha students, through their ordeal. ``When we came home from the wake there were 100 kids in our front yard having a candlelight vigil. They encircled us. It was so healing,'' Wendy said.

Even so, Warren said he is beset by ``streaks of anger'' when he thinks about Justin's death.

``Your life changes so quickly in a matter of an hour. You go to the grocery store and come back and you don't have five people at home anymore. You have four.''

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