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Family sues over son�s suicide By Chris Bristol A powerful acne drug that may cause depression as a side effect is at the center of a lawsuit that blames a teenager�s suicide on a Medford dermatologist and pharmaceutical giant Hoffmann-La Roche. The lawsuit, filed Jan. 8 in Jackson County court, claims Dr. David Trask failed to warn Joshua Simonetti�s parents of the risk of suicide linked to Accutane � a warning required by the Food and Drug Administration since 1998, more than a year before their son began using it. At the same time, the Simonettis accuse Roche of issuing outdated Accutane product information that did not include the FDA-required warnings. The suicide link gained wide attention in October when Michigan Congressman Bart Stupak blamed his 17-year-old son�s suicide on Accutane. In December, the FDA told Congress it plans to require that doctors make their patients sign a warning brochure outlining side effects � including the possible but unproven link to suicide. According to the lawsuit, Joshua Simonetti had been using Accutane for six months when he committed suicide on Jan. 7, 2000, at the age of 15. His parents, Michael and Amy Simonetti, seek unspecified damages on grounds of negligence, wrongful death and product liability. The Simonettis "would not have allowed ... their son to use Accutane if they would have been advised of the risk of suicide," the lawsuit says. A spokeswoman for Roche did not return a phone call seeking comment Friday. Carmen Borovac, Trask�s office manager, warned that many people use Accutane and expressed fear that a story about the lawsuit could cause panic. The FDA has cautioned there is no scientific proof that Accutane causes depression or suicide, she noted. "There needs to be an awareness, but no panic for sure, because they haven�t totally tied it down," she said, referring to the suicide link. "The possibility is there, but there�s a lot of other factors involved." Dermatology experts say Accutane can cure very severe acne and should be restricted to such cases. Some critics complain it is prescribed too widely and that as many as 500,000 Americans try it each year. The drug has been on the market since 1982 and is believed to be Roche�s second-best selling product with sale of $800 million in 1998. As with most drugs, Roche warns that Accutane has side effects, particularly chapped lips and dry skin. Its best-known risk remains birth defects � a risk so severe that women are supposed to use two forms of birth control while taking it. Over the years the FDA has received 66 reports of suicides among users or former users of Accutane. A cause-and-effect relationship has never been proven, however, and experts warn that acne itself may be to blame. Based on a three-year study, French authorities in 1997 required Roche to list "suicide attempt" as a possible side effect. The FDA came to a similar conclusion the next year. But the Simonettis claim they never received such warnings, even though their son did not begin taking Accutane until more than a year later, in May 1999. According to the lawsuit, Trask gave them a pamphlet (copyrighted in 1997) that made no mention of the suicide risk. The pamphlet mentions depression, but explicitly warns only of "changes in mood." Product information about Accutane now carries an explicit warning. According to a sample package insert posted on the Roche Web site, Accutane "may cause depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient." The Simonettis couldn�t be reached for direct comment. Their lawyer, George Mavris of Crescent City, Calif., was in court Friday and did not return a phone call. But according to an Internet posting dated Dec. 29, a person who identified herself as Amy Simonetti of Brookings said she only recently made the Accutane connection. "We weren�t told of the new warnings," the posting read. "I just found out a month ago about the new warnings because my brother heard it being discussed on the radio." The message was posted on a Web site operated by the Dublin-based Roaccutane Action Group, which claims that health authorities in the United Kingdom have documented over 500 reports of suicide, suicide attempts and suicide thoughts in connection with Accutane. (Roaccutane is the U.K. version of Accutane). The Web site has dozens of messages posted by people who claim they suffer from mental problems as a result of using Accutane. The Simonetti posting also shows she was convinced that Accutane, not acne-related depression, was to blame for her son�s suicide in part because her son�s acne had cleared up. "Accutane did its job, but now my son is gone forever," she wrote. "Wake up people before another sweet, trusting child dies." Borovac, Trask�s office manager, cautioned that there are two sides to the story. "We don�t know the whole story yet, because there were a lot of issues there with the (Simonetti) family," she said. "That all needs to be investigated." Sites with Accutane information include www.house.gov/stupak/accutane, www.accutaneaction.com and www.rocheusa.com on the Web. Reach reporter Chris Bristol at 776-4487, or e-mail [email protected] Mail Tribune Home | Ottaway Newspapers, Inc. | Dow Jones & Co., Inc. | Privacy | Contact Us Copyright � 2000 Mail Tribune, Inc.