The History of Accutane
Over the past 30 years in the United States, close to 13 million people have used the prescription drug Accutane to treat severe forms of acne. Acne treatment has been around since the 1930s when medical professionals used high dosages of Vitamin A (retinoic acid) to subdue the body’s production of sebum – an oily and waxy substance secreted from sebaceous glands that causes acne. Improving on this discovery of Vitamin A’s ability to treat acne, the Swiss health care company Hoffmann-La Roche (Roche Pharmaceuticals) developed isotretinoin, a derivative of retinoic acid, in 1982. Although Accutane was initially developed as a chemotherapy drug to kill cancer cells, Dr. Gary Peck began using isotretinoin to eliminate one of the primary causes of severe acne.
After two years of testing, Accutane arrived on the market in September 1982 as a radical new form of acne medication. Once it hit the market, doctors began regularly prescribing it to treat severe and cystic acne that other medication could not effectively treat and cure. The drug was so revolutionary and celebrated by the medical community that Dr. Peck received U.S. Department of Commerce Inventor’s Award as well as a Meritorious Service Medical from the U.S. Public Health Services in 1983. Since its discovery, Accutane was known to cause minor side effects, but the extent of those side effects was still unknown. Accutane under Scrutiny Although it was known since the drug’s introduction that it could possibly cause birth defects, the issue became publicized in the late 1980s when research began revealing the link between Accutane and heart, brain, and other birth defects. Accutane became under scrutiny even more in 2000 when reports surfaced that pregnancies from women taking the drug went underreported or not reported at all since the drug first hit the market in 1982. Along with heart and brain defects, Accutane was also linked to mental retardation and other developmental disorders. Two years later, in February of 2002, Roche Pharmaceuticals lost its patent on Accutane (Isotretinoin). Losing the patent gave other companies the chance to enter the market with a generic and cheaper form of the drug. This introduction of new competition significantly cut into Hoffman-LaRoche’s revenue stream, decreasing profits and market share. Then, in 2006, the American Journal of Gastroenterology reported a link between Accutane and inflammatory bowel disease (IBD). This disorder includes two medical conditions – Crohn’s disease and ulcerative colitis. The FDA responded to these reports by requiring Accutane to include a black box warning label on all containers to alert health care providers and patients of the potential dangers of the drug. After patients began filing and winning numerous lawsuits against the pharmaceutical company for the links between Accutane and digestive disorders, Hoffman-LaRoche officially took Accutane off the market on June 29, 2009. This act discontinued the manufacturing and distribution of Accutane in the United States and eleven other countries. The decision to remove the drug from the market was caused by the high cost of defending personal injury lawsuits, as well as the significant decrease in market share. |