Two years later, on September 18, 2000, the FDA's Dermatologic and Ophthalmic Drug Advisory Committee held a meeting to consider Accutane's risks of psychiatric disorders. By that time, the FDA had determined that from 1982 to May 2000, Accutane was associated with 147 suicides and hospitalizations for depression.
The Committee determined that further research was needed to establish Accutane's risks of depression, suicide and other psychiatric disorders, but failed to recommend that the FDA require such studies.
By 2002, the FDA had confirmed 173 cases of suicide among persons taking Accutane since its introduction in 1982. Because suicide figures are based on self-reporting, critics say, that figure is highly suspect. According to the FDA, only about 1% of the suicide adverse events are reported which means the actual figure could be as high as 20,000.
Reports of suicides in persons taking the drug have been reported in many other countries as well. According to the September 19, 2006, Guardian, the Medicines and Healthcare Products Regulatory Authority, in the UK has received 38 reports of people who have died, and 25 of the deaths were the result of suicide.
The World Health Organization has reports of 720 cases of psychiatric problems arising from the use of Accutane, including 84 suicides and suicide attempts.
The drug maker's explanation for the sudden unexpected suicides among teens on Accutane has always been to say that teens were likely to be depressed due to their acne.
"To date," Dr Baily, lead author in the mice study, points out, "the only evidence for any link with patients has come from individual case reports and such patient data is complicated by the psychosocial effects of having severe acne."
The new scientific evidence in her study will hopefully put to rest the ridiculous claim that teens on Accutane commit suicide because they have acne.
However, the news is not likely to offer much solace to all the grieving parents. According to the Guardian article, last year in the UK, Jason Spiller, 16, killed himself after starting the drug in April 2005. The previous year, David Roberts, a 20-year-old, killed himself, and in 1997, Seumas Todd, 20, son of the actor Richard Todd, killed himself while taking the drug.
The father of suicide victim, Liam Grant, 19, from Dublin, is suing Roche in an attempt to prove Accutane caused his son's death. According to the Guardian, Mr Grant has spent �340,000 on studies, including one published by the American Academy of Psychiatry, which scanned the brains of 15 people on Accutane, and 15 people on other acne medication. The study found changes in the part of the brain associated with depression.
The Guardian reports that Roche has offered Mr Grant a settlement of all his costs and the maximum compensation payable in the event of winning the lawsuit against Roche of around �800,000, but without any admission of liability, so Mr Grant has refused the offer.
Suicides by young people on Accutane in the US have continued. On January 15, 2006, 15-year-old Justin Zimmer, of Menasha Wisconsin, shot himself and his parents blame the Accutane he was taking.
For years, Roche has also denied that Accutane causes birth defects. But here again, FDA documents show the agency was aware that the company was suppressing information about the link between the Accutane and birth defects. For instance, in 1998, an FDA memo stated that Roche "had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure."
As far back as 1990, an FDA memo reported that as a result of Accutane's risks of birth defects, "The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects."
The 16-year-old memo also states, "Accutane poses an imminent hazard to public health, and as such should be withdrawn immediately from the market."
Twelve years later, documents introduced at a December 11, 2002, Congressional hearing by the House Oversight and Investigation Subcommittee, revealed a 1998 letter to the FDA from an official at the CDC, that compares Accutane to the infamous cancer and leprosy drug Thalidomide, a well known cause of birth defects, stating, "we simply need to remove the drug from the market."
The Committee determined that further research was needed to establish Accutane's risks of depression, suicide and other psychiatric disorders, but failed to recommend that the FDA require such studies.
By 2002, the FDA had confirmed 173 cases of suicide among persons taking Accutane since its introduction in 1982. Because suicide figures are based on self-reporting, critics say, that figure is highly suspect. According to the FDA, only about 1% of the suicide adverse events are reported which means the actual figure could be as high as 20,000.
Reports of suicides in persons taking the drug have been reported in many other countries as well. According to the September 19, 2006, Guardian, the Medicines and Healthcare Products Regulatory Authority, in the UK has received 38 reports of people who have died, and 25 of the deaths were the result of suicide.
The drug maker's explanation for the sudden unexpected suicides among teens on Accutane has always been to say that teens were likely to be depressed due to their acne.
"To date," Dr Baily, lead author in the mice study, points out, "the only evidence for any link with patients has come from individual case reports and such patient data is complicated by the psychosocial effects of having severe acne."
The new scientific evidence in her study will hopefully put to rest the ridiculous claim that teens on Accutane commit suicide because they have acne.
However, the news is not likely to offer much solace to all the grieving parents. According to the Guardian article, last year in the UK, Jason Spiller, 16, killed himself after starting the drug in April 2005. The previous year, David Roberts, a 20-year-old, killed himself, and in 1997, Seumas Todd, 20, son of the actor Richard Todd, killed himself while taking the drug.
The father of suicide victim, Liam Grant, 19, from Dublin, is suing Roche in an attempt to prove Accutane caused his son's death. According to the Guardian, Mr Grant has spent �340,000 on studies, including one published by the American Academy of Psychiatry, which scanned the brains of 15 people on Accutane, and 15 people on other acne medication. The study found changes in the part of the brain associated with depression.
The Guardian reports that Roche has offered Mr Grant a settlement of all his costs and the maximum compensation payable in the event of winning the lawsuit against Roche of around �800,000, but without any admission of liability, so Mr Grant has refused the offer.
Suicides by young people on Accutane in the US have continued. On January 15, 2006, 15-year-old Justin Zimmer, of Menasha Wisconsin, shot himself and his parents blame the Accutane he was taking.
For years, Roche has also denied that Accutane causes birth defects. But here again, FDA documents show the agency was aware that the company was suppressing information about the link between the Accutane and birth defects. For instance, in 1998, an FDA memo stated that Roche "had not acted in good faith to truly and accurately answer questions relating to Accutane use in women and pregnancy exposure."
As far back as 1990, an FDA memo reported that as a result of Accutane's risks of birth defects, "The magnitude of injury and death has been great and permanent, with 11,000 to 13,000 Accutane-related abortions and 900 to 1,100 Accutane-related birth defects."
The 16-year-old memo also states, "Accutane poses an imminent hazard to public health, and as such should be withdrawn immediately from the market."
Twelve years later, documents introduced at a December 11, 2002, Congressional hearing by the House Oversight and Investigation Subcommittee, revealed a 1998 letter to the FDA from an official at the CDC, that compares Accutane to the infamous cancer and leprosy drug Thalidomide, a well known cause of birth defects, stating, "we simply need to remove the drug from the market."
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