Roche/Hoffman-La Roche voted number 1 in list of top 100 corporate criminals of the 1990's. Click here for article
A listing of the top one hundred corporate fraudsters worldwide
(Multinational
Monitor, July/August 1999) showed the Roche defendants at "Number One", being the largest corporate fraudster worldwide in the 1990's.
Summary of Roche Financial Frauds features very brief notes on a few examples of Roche frauds, one of which involved payments/settlements made
by Roche of circa $10 Billion to international suppliers/creditors
that it had defrauded. This largest ever-international fraud also
required payment by Roche of fine of $500 million to the FBI, fine
of $462 million to EU authorities plus fines applied in other countries.
FBI and EU documentation on this fraud showed an extraordinary level
of corruption, lies and misrepresentations made by Roche personnel
at all levels of the organization, from its senior board of directors
in Basal, Switzerland, through the separate Roche board of directors
in each of the countries in which Roche were conducting and perpetrating
the fraud. Roche senior directors and executives received personal
fines and imprisonment, including Roche personnel who were members
of Roche executive committees. This same tier of Roche directors,
managers and members of executive committees are and have been responsible
for dictating the information and misrepresentations on medical
data disclosed to people such as myself, to prescribing doctors,
to national agencies and other parties. The information discovered about the Roche defendants was not just
confined to financial fraud but also extends to illegal medical
frauds.
Summary of Roche Medical
Malpractice and Medical Frauds sets out a small sample of medical
frauds perpetrated by the Roche defendants which include $30 million
criminal fine plus a $20 million civil penalty for defrauding government
health insurance programs by marketing a drug for medical conditions
for which the drug had not received FDA license approval. A separate
case involved payments by Roche subsidiary of $161 million in fines
and penalties for participating in illegal 'kick back' payments
to doctors. Other separate examples include illegal payments made
by Roche/Roche subsidiaries to doctors in return for prescribing
Roche drugs (under the guise that the doctors were conducting research
which research the authorities showed were not being conducted by
the doctors). A separate case involving payments by Roche of $11
million to the US Heart Foundation who, after just one pre trial
study, endorsed the Roche product that was seeking a license for
the treatment of heart disease. A Congressional investigation referred
to Roche, of withholding safety information in its possession on
another drug, Versed, including reports of a number of Versed-associated
deaths as well as withholding important U.S. clinical trial data
to the FDA.
Roche False Advertisements
US Advertisements
In February 1998, the FDA applied increased label warnings for Accutane featuring psychosis and sucide as possible side effects. Roche immediatelty placed advertisements stating that acne causes depression, that Accutane, by clearing acne effectively relieved depression. The FDA were forced to issue two public letters to Roche featured below:
- Following the placement of "false or misleading" material "to promote Accutane for an unapproved use in violation of the Federal Food, Drug and Cosmetic Act and Roche's failure to disclose important risk informaiton in its promotional materials" the US Health Authority (FDA) issed warning letter to Roche, the manufacturers of Roaccutane/Accutane. This letter is available for viewing on the FDA's websight and the address for this particular letter is: http://www.fda.gov/foi/warning_letters/d1905b.pd
- In 1995 the French Health authority was engaged in an investigation on psychiatric side effects of Accutane/Roaccutane and carried out an inspection of adverse reaction reports recorded by Roche. The French agency discovered that Roche had failed to pass on serious adverse reaction reports, received by Roche in France in respect of Accutane/Roaccutane, to the French National agency. Roche issued a statement where they blamed their computers for the failure to pass on the ADR reports.
Roche in the U.S. also failed to pass on Adverse reaction reports to the FDA. Following the failure of Roche to "report data relating to clinical experience for drugs", the US Health Authority (FDA) issed warning letter to Roche, the manufacturers of Roaccutane/Accutane. This letter is available for viewing on the FDA's websight and the address is: http://www.fda.gov/foi/warning_letters/d1058b.pdf
Irish Advertisements
Roche (Ireland), placed a full page advertisment in each of three Irish medical journals published in February/ March 1999 viz. Irish Medical Times, Irish Medical News and Irish Medical Weekly, to which R.A.G. issued a response.
The adverts featured letters by Dr. David R Bickers and Dr Douglas Jacobs, described as independent experts retained by Roche, which letters claimed that Accutane/Roaccutane does not cause the psychiatric side effects listed in the label warnings applied to this drug (featuring depression, psychosis, central nervous system disorders, pseudotumor cerebri, suicide, suicide attempt and suicide ideation etc). The advertisements were an attempt by Roche to reduce and diminish the increased label warnings applied for the drug a few months prior to the insertion of the advertisement.
Our group established that in 1997 Roche had engaged Bickers and Jacobs to make presentations to the FDA in an effort by Roche to avoid the inclusion of psychiatric disorders, including suicide, in the increased label warnings proposed by the FDA at that time. Therefore, when Bickers and Jacobs allowed their name to be featured in Roche advertisements, they failed to disclose their financial involvement with Roche and failed to disclose that their efforts, on behalf of Roche, had failed (FDA proceeded to impose increased label warnings for the U.S in February 1998.
Roche recently applied to the FDA for license for Accutane which would extend Roche Accutane patent for a further 21 years. At the FDA public meeting held in Washington on 19th February, 2000, details of pre trial study results for the proposed Accutane product was presented by Roche. The following points were noted from the Roche presentation:
- Dr. Douglas Jacobs had carried out pre-trial studies in 1999 for the proposed revised Accutane product. Accordingly, Dr. Jacobs, despite his financial and other dealings with Roche,despite his unsuccessful efforts to persuade the FDA not to introduce increased label warnings, despite Jacobs allowing his name to be used in Roche advertisements promoting increased sales of Accutane and attempts to dilute label warnings, Dr. Jacobs is considered to be objective enough to monitor patients in 1999 during trial studies as part of license application for Accutane and to honestly record and report all side effects.
There are numerous examples of medical people in the pay of Roche who carried out pre trial studies on Roaccutane/Accutane in 1980/82 on behalf of Roche, who contineously published articles promoting increased use of Roaccutane/Accutane without any reference to known serious side effects. Such pre trial studies and base data featured in articles produced by medical people in the pay of Roche must be immediately investigated by independent investigators.
Roaccutane Action Group RESPONSE
Dear Editor,
We refer to advert placed by Roche Ireland Ltd., in your journal published in February 1999, which featured copy letter issued by David R. Bickers MD and Douglas Jacobs MD.
The Primetime television program entitled "Cover Up", featured several world experts who commented on the catalogue of serious side effects of this medication. Roche were shown to conceal serious side effects, including those known to it prior to the marketing of Roaccutane, which were not featured in the label warnings when the drug was introduced. Here are the facts:
In May 1997, the FDA (US National Health Agency) discussed with Roche the FDA’s increasing concern regarding the seriousness of psychiatric adverse events being reported with Roaccutane use. Subsequently, they advised Roche of proposals to increase the already explicit label warnings for Roaccutane (viz depression, emotional instability, peudotumorcerebri etc.) to include psychosis, suicide, suicide attempt, and suicide ideation. Roche were asked to make a submission to the FDA. They employed three Consultants namely Judith Jones, Douglas Jacobs and David Bickers. The said three parties were engaged by Roche for the specific purpose of making presentations to the FDA arising from FDA proposals re application of increased warnings featuring suicide, psychosis etc.. On the 29th January 1998 they made their submissions on behalf of Roche. The submissions made by Jacobs and Bickers were apparently based on a review of published scientific journal articles together with a review of Roche internal data made available to the said parties by Roche. The ad gives the impression that Jacobs and Bickers were independent consultants when in fact they were engaged to represent and further the interest of Roche with the FDA.
At the time of the submission made by Bickers and Jacobs to the FDA on the 29th January 1998, there was already in existence a label warning in France introduced approximately 9 months earlier (3rd March 1997) which featured "suicide attempt" as a possible side effect of this drug. A detailed study took place in France, from 1992 to 1994, on the association of depression with Roaccutane/Isotretinoin. The results of this study were presented at the third forum of the National and Provincial Journal of Dermatology at Mount Pellier on the 14th -17th March 1996. Did the American consultants know of the suicide warning in France at this earlier date? It is clear that the representations made by Bickers and Jacobs on behalf of Roche did not persuade the FDA to cancel the proposed increased warnings.
In February 1998, less than one month after the date of the Bickers and Jacobs presentations, the FDA issued public notice to the effect that the label warnings in the US for Roaccutane/Accutane had been increased and expanded viz.
-
"PSYCHIATRIC DISORDERS: Accutane may cause depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Discontinuation of Accutane therapy may be insufficient: further evaluation may be necessary. No mechanism of action has been established for these events.
In the post - marketing period, a number of patients treated with Accutane have reported depression, psychosis and, rarely, suicide ideation, suicide attempts and suicide. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy."
We refer you to the conclusions reached by the FDA in February 1998, which included;
- Many of the ADR reports as well as the published cases describe irritability or uncontrolled anger, headache, fatigue, and severe depression, some with suicidal ideation or action. A few case reports also note hallucinations (visual where specified) or other symptoms of psychosis.
- The rapid resolution noted in many of the reported dechallenge cases suggests that an educational message to practitioners and their patients may prevent significant morbidity, and hopefully mortality.
- Given all the pieces of evidence available, it is difficult to avoid the conclusion that Accutane can adversely affect the adult human brain in clinically significant ways and that Accutane use is associated with severe psychiatric disease in some patients.
- The reported effects on the CNS are not surprising given the profound effects of the drug on the integument , and the common origin of the brain and skin from the neural crest.
Roche have categorically refused to make available full list of ADR’s (Adverse Drug Reactions) held on their database for this drug. Separate representations were made to the Irish Medicines Board seeking their help in obtaining the full list of all ADR’s held on the Roche database, which they have not managed to provide.
In a Roche report dated July 1998, Roche state that there are approximately 40,000 ADR reports held on Roche database in respect of Roaccutane. We have reviewed ADR databases from a number of national and international ADR agencies which indicate that between 10% and 20% of ADR’s reported for Roaccutane relate to psychiatric disorders and central nervous system disorders. Accordingly, this suggests that up to circa 8,000 of the ADRs held on the Roche database may well relate to depression / psychiatric disorders / central nervous system disorders. We would like to know whether Bickers and Jacobs obtained the full list of all adverse drug reaction reports held on the Roche database in formulating the opinions which they submitted in the presentation to the FDA on the 29thJanuary 1998.
We object to the representations contained in the Roche advertisement which states, "The number of suicides in this at risk population (young persons with self-esteem problems due to physical abnormality) was far beneath what one would have expected in this population". It is very well established that there is no correlation between ADR’s reported and general population trends. For example, there are medications sold to hundreds of millions of people which have not attracted ADR reports on depression or suicide. However, the following table sets out comparisons between Roaccutane and five other leading acne prescription medicines and speaks for itself:
| Medication | Suicide | Suicide attempt |
Suicide Ideation |
Est. Patient Exposure |
ADR’s /1m people |
| Dianette | 0 | 3 | 0 | Doxycycline | 0 | 0 | 0 |
| Minocycline | 0 | 2 | 0 | ||
| Tetracycline | 0 | 0 | 0 | ||
| Oxytetracycline | 0 | 3 | 0 | ||
| Total | 0 | 8 | 0 | 300 million | 0.03 |
| Roaccutane | 47 | 67 | 56 | 6 million | 28.34 |
* Estimated combined total of 300 million people treated for acne with Dianette, Doxycycline, Minocycline, oxytetracycline & tetracycline.
On a per million people treated basis, the incidence of suicide/suicide attempt/suicide ideation occurring is approximately 944 times greater for Roaccutane than the 5 other medications combined.
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