Tonya L Uhlman
May 4, 2015
Cross Cultural Perspectives
Dr. Fritz Hoffmann-La Roche founded the now multinational pharmaceutical company Roche in 1896 in Switzerland. (F. Hoffmann-La Roche, 2014) The Roche Company was founded during the Industrial Revolution in Europe. Its founders recognized that the industrial manufacturing of medicines would be a major advance in the fight against disease, and they were right. In 1898 Roche developed a cough syrup called Sirolin, which was an immediate success. After World War I, Roche developed a line of vitamins and was able to gain a footing in the U.S. market by making its first investments in New York and Nutley. Although their vitamin products were a huge success, the leadership at Roche decided that they should avoid a dependency on vitamins and they intensified their pharmaceutical research. During this time, Roche researchers discovered a compound of benzodiazepine that sedates without causing drowsiness. This discovery propelled them into success and today Roche is a global presence.
Roche as a company is very concerned about ethics. They have an established group, the Roche Scientific Ethics Advisory Group (SEAG), which offers advice and counsel on a broad range of ethical matters. The group is comprised of independent, multi-cultural experts from all different fields in the pharmaceutical industry. The SEAG helps Roche follow set global standards involving research and testing. Every physician involved in pharmaceutical development must take the following vow: “The health of my patient will be my first consideration”. (2nd General Assembly of the World Medical Association, 1948).
Although Roche goes to such lengths to ensure that they make quality products, dangerous pharmaceuticals do get through. One such drug is isotretinoin, more commonly known as Accutane. The drug was developed in 1982 by Dr. Gary Peck of Roche to treat cystic acne, along with a number of other diseases and disorders. The drug was a huge success and within one year of patenting the drug, Dr. Peck received the Inventor’s Award from the U.S. Public Health Services.
Accutane was a huge success and helped treat over 13 million patients since its debut in 1982. However, many terrible side effects began to surface. Many lawsuits arose claiming that the drug caused inflammatory bowel disease, even the actor James Marshall sued the company claiming that the drug caused him to suffer so severely from gastrointestinal disease that it resulted in a four-month long hospital stay and the eventual removal of his colon. (Feeley, 2011).
Another extreme side effect of isotretinon is suicidal tendencies. In 2011 a young man named Jesse Jones was found dead in the U.K. after taking the drug. Since his death, his parents have campaigned to have the drug banned and have even made a documentary about the drug. (Murfitt, 2012)
If the claims of gastrointestinal and suicidal side effects were not enough, the issue of Accutane causing birth defects is even worse. The risk of a pregnant woman taking Accutane giving birth to a baby with birth defects is so high that the women wanting to take the drug for acne must sign up for an iPledge account and agree to take two forms of birth control for the duration of their time taking the drug. iPledge is a very successful way to eliminate fetal exposure to isotretinon through their restricted distribution program. A woman of childbearing age can only get Accutane for acne if they log in to iPledge in front of their doctor and even so, they can only get one month’s prescription at a time. (iPledge, 2005)
Due to the extreme side effects of Accutane, Roche recalled the drug in 2009. It is now only available through prescription for severe cases only. However, although the product was recalled in the United States, Roche did not do a worldwide recall. Labeled now under the name Roaccutane, the drug is sold in the United Kingdom,