"It is a classic case," said Rep. Bart Stupak, D-Mich., describing what he said is the company's attitude toward reports of suicide. "First deny, then blame the patient."
Stupak is investigating an alleged link between suicide and the anti-acne drug Accutane, also manufactured by Roche. The company did not respond to a request for comment on Stupak's remarks, but it has repeatedly said there is no evidence that either Accutane or Lariam causes suicide.
Lariam, also known as mefloquine, has been prescribed to more than 22 million people worldwide and is commonly prescribed to Americans vacationing in high-risk malaria areas. It also is given to Peace Corps volunteers, U.S. soldiers and other government workers. The U.S. military partnered with Roche to create the drug prior to its approval for use in the United States in 1989.
The UPI report published Tuesday found that mounting evidence suggests Lariam has triggered mental problems so severe that in a small percentage of users it has led to suicide.
Russell Gerber, chief of the epidemiology unit at the Peace Corps said it is possible Lariam causes suicide, but that it has not occurred among Peace Corps volunteers. "It is certainly possible. We have not seen it," Gerber said.
Gerber told UPI that side effects associated with Lariam are generally mild, and said the Peace Corps instructs volunteers to switch to alternatives such as doxycycline if problems develop. He said there is no statistically significant data indicating that Lariam can cause the kind of psychosis that can lead to suicide.
Stupak began investigating Accutane and suicide after his son B.J. killed himself in May 1999 at the age of 17 while taking the drug. Stupak intends to hold a congressional hearing on the matter later this year.
In an interview with UPI Thursday, Stupak said Roche, a Swiss pharmaceutical giant that has U.S. headquarters in Nutley, N.J., is exhibiting a similar pattern with both drugs.
With Accutane, Roche has said that teens are statistically more likely to commit suicide, and that can be exacerbated by low-self esteem because of acne, Stupak said.
With Lariam, internal documents obtained by UPI show the company tracked reports of suicide among Lariam users, but said the deaths might be due to travel stress, pre-existing conditions or societal breakdown.
An internal Roche safety report on Lariam from 1994, for example, said
suicidal behavior among users might be associated with "the progressive break down of traditional values" and family structure, substance abuse and unemployment, not to Lariam use.
In the UPI story, Roche spokesman Charles Alfaro would not say whether Roche believes the drug can cause suicide, citing pending litigation. In general, he said, "Roche takes the issue of safety very seriously and is diligent in monitoring the safety of all its drugs."
"If you take Lariam ... or Accutane, it is all the same thing," Stupak said. "It is always due to other factors."
Stupak told UPI both Accutane and Lariam are emblematic of a larger problem: drugs prescribed to treat or prevent disease or physical problems can have severe and unexpected psychological side effects that doctors and patients do not know about.
The Food and Drug Administration -- which tracks drug side effects and can act if it has evidence a drug is too dangerous or needs stronger warnings -- is particularly unlikely to be alerted to the problems, Stupak said.
The government's voluntary system of reporting "adverse events" relies on doctors and others to figure out such problems and then decide to report suspected side effects to drug companies and the government.
Stupak said doctors can be deterred by concerns about legal liability for having prescribed a drug with damaging side effects. He said he believes that means that the more severe the side effects -- such as suicide -- the less likely it is to be reported.
In a two-month investigation of Lariam, UPI found:
-- In thousands of pages of internal Roche documents obtained by UPI spanning a decade, the company tracked increasing reports of suicides, suicidal behavior and other mental problems among Lariam users. A 1994 Roche safety report noted that because Lariam can cause depression and depression can lead to suicide, "a causal link to Lariam can in theory not be ruled out."
-- Dozens of soldiers, Peace Corps volunteers, other government workers and private travelers said they had no history of mental illness before taking Lariam, but then attempted or considered suicide. Families gave similar accounts of several who succeeded in killing themselves.
-- The U.S. Food and Drug Administration's files contain reports over the past four years of 11 suicides, 12 suicide attempts, 41 cases of thinking about suicide and 144 cases of depression among Lariam users. The FDA says in general, drug side effects are reported in 1 percent to 10 percent of cases.
-- A statistical analysis of FDA data, commissioned by UPI, indicated that Lariam users are five times more likely to report having mental problems that could lead to suicide than those taking a different drug -- the antibiotic doxycycline -- also used to prevent malaria.
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