Doctors who believe Accutane causes suicide are expected to announce in Birmingham, Ala., next week a study to establish whether the cause-and-effect relationship exists, according to doctors set to conduct that study.
The drug manufacturer, Swiss pharmaceutical giant Hoffmann-La Roche -- which says there is no evidence that shows Accutane causes suicide -- is in separate talks with the Food and Drug Administration on the development of another study, according to Roche spokeswoman Carolyn Glynn.
"We have not been able to prove a causal link," said Glynn. "But this is a serious enough issue that we are working on a proactive study. We want to understand this as much as anybody."
FDA officials confirm the talks, but would not discuss the methodology. They said Roche would likely conduct that study but the FDA might require that outside scientists oversee it.
The development of the two studies comes amid increasing controversy over the drug and about a month after the mother of Charles Bishop filed suit April 16, alleging that Accutane made Bishop, 15, fly a Cessna plane into a Tampa high-rise in January.
The group of doctors opposed to the drug said their investigation could take years and will include in-depth studies of suicides among people who may or may not have taken the drug compared with deaths in the general population. The number of suicides and deaths studied could be in the thousands.
Doctors involved in that effort said it is designed to settle the years-long debate over the relationship between the effective medication for severe acne and suicide among young people, who mostly take the drug.
"This has never been done before," said Dr. Donald H. Marks, an Alabama clinical research expert leading that effort. Marks is also involved in litigation against Roche.
Scores of suicides have been blamed on Accutane, which was first approved by the FDA in 1982. Doctors prescribe Accutane, designed to treat serious cases of acne, around 1.5 million times every year, according to IMS Health, a healthcare information company.
Roche warns doctors and patients that suicidal behavior has been reported among patients taking Accutane, but the company says no evidence proves that Accutane is the cause of that behavior.
Angry parents have blamed Accutane for causing suicide. Michigan Democrat Rep. Bart Stupak, whose son B.J. killed himself in May 1999 at the age of 17, told United Press International that further study would do little good because Roche is already ignoring enough evidence to prove a link between the drug and suicide.
"There is a medical, biological and epidemiological explanation of what is going on here," Stupak said.
Marks said his new study is designed to answer the question of causality. "In Roche's mind, the issue of causation has not been settled, so physicians are told that it may cause (suicide) but not that it does cause suicide," Marks said. "We are going to propose that we look at this issue of suicide and Accutane once and for all."
Marks runs the Extant Medical Group, which specializes in the diagnosis, evaluation and treatment of adverse events from medications. Marks is also a former associate director of clinical research at Roche. The study is expected to be announced at a Accutane conference in Birmingham, Ala., next week. Stupak may attend. Funding for the study has not been secured.
Dr. Harry Danawi, an epidemiologist working on the study with Marks, said a team of doctors would investigate as many as 1,000 cases of suicide in the general population to determine how many cases involved Accutane. Those cases would then be compared to at least two other deaths of people of the same sex, and about the same age in the general population. Those "psychiatric autopsies" are intended to provide a profile of the dead.
A high percentage of Accutane users among the studied suicides, as opposed to deaths in the general population among similar individuals, would show cause-and-effect, Danawi said.
Roche officials say there is no evidence proving that Accutane causes suicide, and some scientists have agreed. Accutane's defenders have noted the relatively high incidence of suicide among young people in the general population regardless of Accutane use.
Young people between the ages of 15-24 are among the most likely to commit suicide, at the rate of nearly 4,000 per year, according to the American Association of Suicidology.
When patients get an Accutane prescription, they are handed a medication guide that warns that some users have "ended their own lives."
But the guide also says that, "No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane."