The survey revealed that only 24% of the women received contraception counseling and while SMART required women to use two forms of birth control simultaneously while taking Accutane, only 62% of the women reported using any birth control and only 29% of those women reported using two forms.
According to the rules, women were required to have two negative pregnancy tests before receiving a prescription, but 76% said they did not have a second pregnancy test
When asked about the requirement of receiving a pregnancy test each month before refilling a prescription, 35% of the women surveyed said they did not have monthly pregnancy tests.
In addition, only 53% of the women reported signing the informed consent required by SMART prior to taking the drug.
Julia Robertson, coordinator of the Birth Defects and Genetics Program at the Utah Department of Health in Salt Lake City, and lead author of the study, said the failure to avoid pregnancy had resulted in a high rate of abortions and at least one baby born with severe birth defects.
The survey confirmed that the SMART program was not being followed by women or doctors, mainly because the program was not mandatory. The results of the study appeared online on October 14, 2005, in the journal Birth Defects Research (Part A): Clinical and Molecular Teratology.
The survey also revealed that the majority of women were prescribed Accutane off-label for less severe acne than is recommended by the SMART program.
At the December 11, 2002, hearing, the subcommittee discussed the problem of "off-label" prescribing to patients without severe cystic acne and some experts estimated it to be as high as 90% among women.
During the hearing, Roche's North American president and CEO, George Abercrombie, denied promoting Accutane for patients not suffering from severe acne. When confronted with print advertisements that featured teenage models with little or no visible acne, Mr Abercrombie pointed out that the ads did not specifically mention Accutane and said they were intended to make consumers aware that there were treatments for severe acne.
That statement went over like a lead balloon. "What you just said is not a truthful statement," Congressman Peter Deutsch (D-FL), told him. "You're beyond the straight-face test, I'm sorry."
Due to the failure of the SMART program, and the continuation of babies born with birth defects, in March 2006, the FDA implemented the iPledge program, which basically follows the same rules as the SMART program, but doctors and patients are no longer on the honor system.
IPledge requires a woman to have two pregnancy tests before the initial prescription for Accutane is written, and to have a monthly pregnancy testing before each refill. But now, the prescribing doctor is required to register the test results in the computerized iPledge system, and the woman must fill her prescription within seven days.
In addition, the woman must agree to use two forms of birth control while using the drug and she must also register with the iPledge system to certify that she is using two forms of contraception.
It could be said that Roche has between 300 and 450 good reasons to keep selling Accutane off-label to as many women as possible each month, because according to an August 21, 2006 article by the Associated Press, the daily pill costs between $10 to $15 a pop.
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/accutane_sideeffects.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
According to the rules, women were required to have two negative pregnancy tests before receiving a prescription, but 76% said they did not have a second pregnancy test
When asked about the requirement of receiving a pregnancy test each month before refilling a prescription, 35% of the women surveyed said they did not have monthly pregnancy tests.
In addition, only 53% of the women reported signing the informed consent required by SMART prior to taking the drug.
The survey confirmed that the SMART program was not being followed by women or doctors, mainly because the program was not mandatory. The results of the study appeared online on October 14, 2005, in the journal Birth Defects Research (Part A): Clinical and Molecular Teratology.
The survey also revealed that the majority of women were prescribed Accutane off-label for less severe acne than is recommended by the SMART program.
At the December 11, 2002, hearing, the subcommittee discussed the problem of "off-label" prescribing to patients without severe cystic acne and some experts estimated it to be as high as 90% among women.
During the hearing, Roche's North American president and CEO, George Abercrombie, denied promoting Accutane for patients not suffering from severe acne. When confronted with print advertisements that featured teenage models with little or no visible acne, Mr Abercrombie pointed out that the ads did not specifically mention Accutane and said they were intended to make consumers aware that there were treatments for severe acne.
That statement went over like a lead balloon. "What you just said is not a truthful statement," Congressman Peter Deutsch (D-FL), told him. "You're beyond the straight-face test, I'm sorry."
Due to the failure of the SMART program, and the continuation of babies born with birth defects, in March 2006, the FDA implemented the iPledge program, which basically follows the same rules as the SMART program, but doctors and patients are no longer on the honor system.
IPledge requires a woman to have two pregnancy tests before the initial prescription for Accutane is written, and to have a monthly pregnancy testing before each refill. But now, the prescribing doctor is required to register the test results in the computerized iPledge system, and the woman must fill her prescription within seven days.
In addition, the woman must agree to use two forms of birth control while using the drug and she must also register with the iPledge system to certify that she is using two forms of contraception.
It could be said that Roche has between 300 and 450 good reasons to keep selling Accutane off-label to as many women as possible each month, because according to an August 21, 2006 article by the Associated Press, the daily pill costs between $10 to $15 a pop.
Information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/articles/accutane_sideeffects.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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