Death By Prescription
Accutane is a prescription medication for the treatment of a particular strain of acne. It can also be lethal to many users. Accutane was first formulated in the early 1970's by the Hoffman- Roche Pharmaceutical Company but they chose not to market it at that time due to the horrendous birth defects that could result from its use by pregnant woman. Roche submitted its "new" drug application in July 1981 and the FDA approved it less than a year later on May 21, 1982.
1982-1988 - Thousands of women were warned only that the drug caused birth defects in animals, and no precautions were taken. "Between 1982-1988, more than 1000 babies were born missing ears, major organs and portions of the brain. Others were stillborn. Still others were aborted."
March 3, 1997 - France - French studies showed users of Accutane/Roaccutane suffered from severe depression and suicidal ideation. French equivalent of FDA ordered warning to consumers.
By 1985 Roche was receiving reports that Accutane was causing depression, suicidal ideation and actual incidents of suicide. They chose to ignore these reports, claiming : "The number of suicides observed in the U.S. in the Accutane-exposed cohort is much less than would have been predicted... There is plainly no excess of observed suicides in the Accutane-exposed population (32) compared to what would be predicted in the age-matched general population." The death toll attributable to this medication continued to rise and by the late 1990's reports put a conservative figure in the hundreds lost to Roche’s drug. The FDA believes this number could be 10 times higher than the known reports. By 1998, Accutane had become Hoffman-Roche's second largest selling drug, bringing in a reported $800 million dollars.
Number of Accutane Adverse Drug Reactions Worldwide
In May 1998- Roche issued a letter to the I. M. B which disclosed that there were 40, 000 Adverse Drug Reactions (ADRs) on the Roche database in respect of Accutane
A review of all ADR data recorded since that time by all leading National Health Authorities suggest that the number of ADRs presently held on the Roche database in respect of Accutane is in excess of 55,000
Studies show that only 1 in 10 serious ADRs are ever reported. In fact some studies suggest that only 1 in 100 adverse reactions are ever reported (FDA acknowledge that the level of reporting of ADR's could be as low as 1 in 100)
If we apply a factor of 10 to the number of adverse reactions recorded for Accutane, this indicates that more than half a million people have suffered severe side effects from the ingestion of Accutane, which gives some idea of the number of people and the scale of suffering caused by this drug.
Publication by Bigby et al (1988) showed that 22% of Accutane ADRs relate to psychiatric disorders.
Roche has not provided a full list of all ADR's held on Roche database’s worldwide for Accutane. The FDA and other national agencies do not have the worldwide list. The dermatologists who prescribe this drug day after day do not have the ADR list.
So, how many cases of suicide, suicide attempt, suicide ideation, psychiatric and physical side effects are recorded on the Roche worldwide database. Is the figure now 800 or several thousand? We urge the FDA and every other national agency to obtain the full ADR list from Roche.
Our son Nathan’s first prescription for Accutane was filled on April 1, 1999 with his treatment lasting through September of 1999. His prescribed dosage was a maximum 40 mg daily for the first month and than was boosted to 80 mg a day for the next 5 months. One year later on January 24, 2001 he was dead. By the time Nathan had his first prescription for Accutane filled on April 1, 1999, Roche had already been directed by the FDA to include a warning insert that states:
WARNINGS - Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary. No mechanism of action has been established for these events.
Roche did not recall all unsold packages of Accutane and replace the inserts with the additional warnings mandated by the FDA. One can only imagine what their reasoning was for not recalling all unsold boxes. And, why didn’t Roche send a warning letter to all current and previous users ? Could it be that it would have cut into their profit margin that year ? Whether the FDA ordered them to replace the inserts isn’t relevant. If Roche was operating in a ethical manner, it should have, of its own volition, replaced the outdated inserts and notified all current and past users. They should have done it because it was the right thing to do. Keep in mind that Roche is making in excess of $800 MILLION dollars a year on this medication.
Our son was not informed that his use of Accutane could cost him his life by the prescribing physician. No warnings were given to him beyond advising him that he would need to have a test done to see that Accutane was not effecting his liver. His physician's degree of incompetance was tantamount to reckless endangerment.
On that April 1st day in 1999 when our lovely, beautiful son put that first Accutane capsule in his mouth, his fate was sealed. Without the warnings that should have been given to him, Nathan began a downward spiral that he could not understand or control. Instead of a miracle cure for his acne, Accutane became a poison in his system that gradually robbed him of his desire to live and induced a hopelessness that ended when he took his own life.
On January 23, 2001 the day before our son lost his life, the FDA put into effect more stringent warnings about the psychological side effects of using this medication. The FDA has changed its rules regarding the drug so that doctors must now get patients to sign a consent form. It says the patient understands all the risks associated with Accutane, including depression and suicide. Pharmacists must also hand out a detailed warning brochure from the FDA, called a Medguide. Accutane is one of just three drugs in the United States that has ever been required to come with a Medguide. This has come about 18 YEARS after the first cases began showing up ! 18 years of unheeded and untreated depression and literally hundreds of unnecessary deaths. How many more mothers, fathers, husbands and wives must lose their loved ones to Roche’s bottom line before they are stopped ? How do these men and woman who have made the yea and nay decisions over the years on marketing Accutane sleep at night? What could they possibly be thinking ? How do you justify your income against an unnecessary toll in human lives and suffering ?
Accutane was one of Roche Laboratory’s biggest money makers. It does cure acne but it is not a cure for cancer, heart disease or some other terminal illness. If it could cure one of these, then perhaps its risky use could be justified; but it is not. At the very least this drug should have severe limitations on its use, with stringent controls on which doctors may prescribe this drug as well as which pharmacies may sell the medication. The best action that the FDA could take in protecting our sons & daughters from this modern day plague would be an outright ban on its manufacture and use.
As of this date 01/05/2012 Accutane has become a generic drug and Hoffman-Roche no longer sells the medication. It has become a very controlled drug due to the hard work of Rep Bart Stupak who lost his son because of this medication.