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Profile of Hoffmann-LaRoche, Inc.
Hoffman-La Roche (Roche) Ltd. was founded in the 1890's, is presently headquartered in Basle, Switzerland on the scenic Rhine, and informs us of its proud tradition. We have been unable todocument a criminal history of Roche prior to 1973, and the era of the late 1990s seems the mostinteresting. In United States v.Hoffman-La Roche Ltd. and Udo Haas, cause number CR 97-00083before the U. S. District Court in San Francisco, the government charged Hoffman- La Roche Ltd. ofBasle, the parent of Hoffman-La Roche Inc. in New Jersey, with violating the Sherman Anti-Trust Act(15 U S C sec. 1) by means of price fixing and conspiracy to fix and maintain prices of citric acid. OnMarch 26, 1997, Roche pleaded guilty and agreed to pay a fine of $14 million dollars, plus a $200,special assessment. Two years later, Roche was again charged in U. S. District Court in Dallas, cause number 3-99- CR-184, with violating the Sherman Anti-Trust Act for combination and conspiracy to fix prices andallocate market shares of Vitamin A, E, B2, B5, Vitamin C, Beta Carotene, and vitamin pre-mixes. Roche again pleaded guilty and was fined $500 million dollars, plus a $400, special assessment – a thenrecord fine for anti-trust violations. Some co-conspirators were also fined. This 1999 case had otherrepercussions.
Releases from European news services state that Roche and some of its fellow conspirators paid many millions of dollars in fines to the European Union, Canada, and Australia as well. Some countriesgave cease and desist orders. Private lawsuits and some state anti-trust suits resulted as well. A formerRoche executive once in charge of vitamins was incarcerated for four months and was fined $100,000dollars for making untruthful statements to federal investigators. A media conference called by Rochein Basle on 05-21-99 implied that only former executives were involved, none of them top level.
In 1973, Roche’s world product manager secretly informed the E E C that Roche was engaged in price fixing, market sharing with supposed competitors, and otherwise preventing rivals fromexpanding into the vitamin market. Roche would end up being assessed some 600 million Swiss Francsin fines. This episode seems to have occasioned a probe by the U K Monopoly Commission whichlearned that Roche’s U K subsidiary was required to pay fifty times the price for Roche tranquilizersthat was paid in Italy. The Commission required 60% price reduction and other measures.
In the 1960s, Roche tranquilizers, Librium and Valium, yielded generous profits. With those patents expiring in the 1980's, Roche turned its attention to vitamins. With fear and an unestimateddanger of avian influenza (bird flu), it corners another market- Oseltavamir (brand name Tamiflu)- bypurchasing the rights to its manufacture from its originating company. The Philippine Health Ministerhas accused Roche of monopolizing the principal antiviral drug for combating that disease byconcentrating its availability in First World countries rather than Third World countries in S. E. Asiapresently affected. Some skeptics fear Roche will charge all the traffic can bear. The future course ofbird flu remains unpredictable as do any anti–trust consequences for Roche. Hoffman-La Roche Inc. (Roche U S) has sometimes less than a stellar record of giving adequate product warnings to doctors and consumers as well. Roche’s acne medication Accutane is said to haveserious side effects noted in a 1998 F D A letter to doctors: depression, psychosis, rarely suicidal ideation, suicide attempts, and suicide. The F D A also found Accutane promotional advertisements tocontain false and misleading information. It took an F D A letter for Roche U S to strengthen itswarnings. http://www.accutane-side-effects.net This episode does not stand alone. On 01-05-98 the F D A New Jersey District Director informed the President and C E O of Roche U S that it was not submitting Adverse Drug Experiencereports within the required fifteen working days while noting a 2 year to over 8 year delay for 13 of itsproducts, some 5 years for Bactrim. A 05-29-03 letter from the F D A Director of the Division of DrugMarketing , Advertising, and Communications to the president and C E O of Roche U S complained ofRoche’s direct to consumer promotional materials for Xeloda, an anti-cancer drug, that was misleadingas it failed to present risk information as to serious potentially life threatening risks while makingunsubstantiated efficacy claims as well.
It seems that what a serious “Black Box Warning” gave, promotional material for consumers took away. A video reportedly downplayed adverse events through patient testimonials minimizing theseverity and importance of risks. The letter requested that Roche U S cease dissemination of these andsimilar materials, formulate a plan of action to disseminate accurate and complete information toaudiences who received the violative materials, and send a written statement of intent to comply.
http://www.fda.gov/foi/warning_letters/g4059d.htm

Source: http://www.focus-on-indiana.org/pdf/Roche.profile.pdf

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