The Congressional hearing focused on Accutane's link to birth defects, depression, and suicides.
Roche claimed that only 2,300 pregnancies had occurred among Accutane users since its introduction to the market. However, Congressman Bart Stupak (D-MI), whose son committed suicide while on the drug, disputed that assertion, citing a 1999 Roche report indicating that in a single three month period that year, 93 unwanted pregnancies were reported and 42 abortions occurred.
The committee also discussed the unnecessary health problems caused by the high rate of "off-label" use of Accutane by individuals who did not have recalcitrant cystic acne, the only condition the drug is FDA approved to treat.
Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified that, "A proportion of people treated with this drug in the last decade had mild acne and should've been treated with other drugs."
In fact at the time, the off-label use of Accutane was so prevalent, that some experts estimated that the improper use was close to 90% among women.
Of course Roche denied that the company was promoting Accutane for individuals not suffering from severe acne. When shown a number of print ads for Accutane that featured teenage models with little or no visible acne, George Abercrombie, Roche North American president and CEO, claimed that the ads did not mention Accutane specifically and were intended to make consumers aware that there were treatments for severe acne.
"What you just said is not a truthful statement," Congressman Peter Deutsch, (D-FL), said. "You're beyond the straight-face test, I'm sorry."
Currently under new FDA regulations, Accutane can only be prescribed to women who are enrolled in a federally regulated distribution program called iPLEDGE. To obtain the drug, women must comply with a number of requirements that include completing an informed consent form, and obtaining counseling about the risks associated with Accutane and birth defects and the requirements for the safe use of the drug.
The goal of iPLEDGE is to prevent any pregnancies in women taking Accutane. To that end, the program requires women to be on birth control for at least one month before taking the drug and to undergo 2 pregnancy tests before taking Accutane.
During treatment with the drug, women must take 2 approved forms of birth control simultaneously and have a pregnancy test each month.
Under the program, physicians must be registered with iPLEDGE and can only prescribe Accutane to patients who are registered and meet all the other requirements of iPLEDGE.
In addition, the drug can only be dispensed by a pharmacy registered with iPLEDGE, and pharmacies can only purchase Accutane from wholesalers who are registered with the program.
Last month, another serious side effect of the drug was reported in a study published in the August 2006, American Journal of Gastroenterology, that confirmed that people taking Accutane have an increased risk of developing inflammatory bowel disease (IBD).
IBD includes serious and extremely painful conditions like Crohn's disease and ulcerative colitis. Since Accutane, was approved in 1982, numerous cases have surfaced linking the drug to IBD, but no a systematic review of the association had ever been conducted until now.
Researcher, Dr Corey Siegel, from Dartmouth-Hitchcock Medical Center in New Hampshire, and colleagues reviewed all reports of Accutane associated IBD that were submitted to the FDA through the MedWatch system since the program began in 1996.
For the study, the researchers used a standard adverse drug reaction probability scale to gauge the likelihood that a particular IBD condition was caused by the use of Accutane.
Roche claimed that only 2,300 pregnancies had occurred among Accutane users since its introduction to the market. However, Congressman Bart Stupak (D-MI), whose son committed suicide while on the drug, disputed that assertion, citing a 1999 Roche report indicating that in a single three month period that year, 93 unwanted pregnancies were reported and 42 abortions occurred.
The committee also discussed the unnecessary health problems caused by the high rate of "off-label" use of Accutane by individuals who did not have recalcitrant cystic acne, the only condition the drug is FDA approved to treat.
Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, testified that, "A proportion of people treated with this drug in the last decade had mild acne and should've been treated with other drugs."
Of course Roche denied that the company was promoting Accutane for individuals not suffering from severe acne. When shown a number of print ads for Accutane that featured teenage models with little or no visible acne, George Abercrombie, Roche North American president and CEO, claimed that the ads did not mention Accutane specifically and were intended to make consumers aware that there were treatments for severe acne.
"What you just said is not a truthful statement," Congressman Peter Deutsch, (D-FL), said. "You're beyond the straight-face test, I'm sorry."
Currently under new FDA regulations, Accutane can only be prescribed to women who are enrolled in a federally regulated distribution program called iPLEDGE. To obtain the drug, women must comply with a number of requirements that include completing an informed consent form, and obtaining counseling about the risks associated with Accutane and birth defects and the requirements for the safe use of the drug.
The goal of iPLEDGE is to prevent any pregnancies in women taking Accutane. To that end, the program requires women to be on birth control for at least one month before taking the drug and to undergo 2 pregnancy tests before taking Accutane.
During treatment with the drug, women must take 2 approved forms of birth control simultaneously and have a pregnancy test each month.
Under the program, physicians must be registered with iPLEDGE and can only prescribe Accutane to patients who are registered and meet all the other requirements of iPLEDGE.
In addition, the drug can only be dispensed by a pharmacy registered with iPLEDGE, and pharmacies can only purchase Accutane from wholesalers who are registered with the program.
Last month, another serious side effect of the drug was reported in a study published in the August 2006, American Journal of Gastroenterology, that confirmed that people taking Accutane have an increased risk of developing inflammatory bowel disease (IBD).
IBD includes serious and extremely painful conditions like Crohn's disease and ulcerative colitis. Since Accutane, was approved in 1982, numerous cases have surfaced linking the drug to IBD, but no a systematic review of the association had ever been conducted until now.
Researcher, Dr Corey Siegel, from Dartmouth-Hitchcock Medical Center in New Hampshire, and colleagues reviewed all reports of Accutane associated IBD that were submitted to the FDA through the MedWatch system since the program began in 1996.
For the study, the researchers used a standard adverse drug reaction probability scale to gauge the likelihood that a particular IBD condition was caused by the use of Accutane.
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