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Cross-Cultural Perspectives

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Cross-Cultural Perspectives
Jillian A. Gaudio
ETH/316
Professor Clark-Washington
Nov. 9th, 2011

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, Australia, The Netherlands, China, Germany, and in many more countries. Roche is not the only pharmaceutical company to do this; many other companies take advantage of the more lenient regulations of other countries, especially in the Third World. Companies will spend millions of dollars in promotion to the country’s government health services in order to secure a contract with them. After the contract has been signed, the pharmaceutical company is able to sell the drugs that have been banned or restricted in other countries. Sometimes they even sell them expired or near-expiration drugs. In the Third World, international companies send promoters to woo the doctors into prescribing their drugs to their patients. In Columbia there is a promoter for each doctor and in Brazil there is a promoter for every three doctors. (Cultural Survival Inc, 2010) To remedy this issue, organizations such as the World Health Organization (WHO) and the Bundeskoordination Internationalismus (BUKO) coordinate quality assurance committees that examine the activities of pharmaceutical industry in the Third World. The WHO has set a standard for pharmaceuticals that are supposed be followed worldwide. Pharmacovigilance, the practice of monitoring the effects of medicinal drugs after they have been licensed for use, is a big obstacle for the WHO. Over the past 10 years, using a spontaneous reporting system (SRS), there has been a huge growth of African countries participating in pharmacovigilance. In 1995 only 5 countries participating but by the end of 2010 23 countries had sent in reports. These SRS’s are easy to establish and cheap to run and are very effective in identifying products that need to be recalled from the market. (Pal, Dodoo, Mantel, & Olsson, 2011) Companies like Roche should follow the standards that the WHO has set for pharmaceutical companies. If Roche wants to remain a multi-national company, they should be concerned about the safety of all their drugs. If Accutane was not safe to distribute in the United States, it should not be distributed anywhere else either, no matter what the country’s regulations are. In order to be seen as a trusted company, Roche should only sell drugs they know are safe for their patients. If a drug is a failure, then it should remain undistributed, it should never be given to the Third World as a means of ‘getting rid of it’ for less of a monetary loss. Roche’s SEAG committee should work hand-in-hand with the WHO to ensure that all Roche’s pharmaceuticals are safe to use for everyone in the world.

Works Cited
2nd General Assembly of the World Medical Association. (1948, 09). The Declaration Of Geneva. Geneva, Switzerland.
Cultural Survival Inc. (2010, 2 11). Medicinal Drugs in the Third World. Cultural Survival Quarterly .
F. Hoffmann-La Roche. (2014, 8 11). Retrieved 11 7, 2014, from Roche: http://www.roche.com/index.htm
Feeley, J. (2011, 3 10). Roche Accutane Acne Drug Caused for Actor, Brian Dennehy Says. Bloomberg . iPledge. (2005). iPledge. Retrieved 11 9, 2014, from iPledge Program: https://www.ipledgeprogram.com/AboutiPLEDGE.aspx
Murfitt, N. (2012, 11 17). My happy son killed himself after taking the 'wonder cure' for acne: Warning from father of talented musician who was prescribed Roaccutane before commiting suicide. Daily Mail .
Pal, S., Dodoo, A., Mantel, A., & Olsson, S. (2011). Pharmacovigilance and Safety of Medicines. The World Medicines Situation 2011 .

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