Dear Mr Epstein
It is fascinating to see you were back in Tokyo less than six months since your last public visit to once again bow deeply in apology on behalf of Novartis to both the Japanese health ministry and Japanese public for the behavior of NPKK executives, managers and employees. It is also fascinating to hear that the significance of the issues that are now in the public domain have moved from denial of data manipulation relating to a drug claim to the purposeful and illegal destruction of Adverse Event data that is critical to patient safety and global drug safety awareness.
It is unsurprising you claim you were “completely shocked” about what has happened in Japan; the disclosures strike at the very heart of the Novartis organisation and its global reputation. You have already stated that you fully expect that more issues will emerge as the depth of illegal, fraudulent and potentially life threatening cover-ups are disclosed over the coming months. Like the Richter scale, Novartis are on a logarithmic progression of impact; what was a tremor now feels like a high magnitude earthquake. What is unknown at this point in time is how big and if the epicenter is actually at Novartis HQ in Basel.
At the September 2013 press conference in Tokyo you claimed that the issues around falsification of data and resultant claims regarding Diovan were because of the lack of training and controls in the Japanese organisation. You fired some people, you restricted some executives pay and you also transferred Eric Cornut, Novartis global chief commercial officer to Japan as the new chairman of NPKK. It is an interesting that Mr Cornut did not appear to be present at the April 2014 press conference. He above all should now fully understand the depth and scale of the problems that have occurred in Japan. His apparent absence and lack of any reference to the work he has been doing since last September perhaps, in itself, tells a story.
You have implied that the problems are still isolated to Japan and that the NPKK was operating as a self-sufficient entity and that compliance, governance and control was left to NPKK, but this time you are answering to a much more damning set of revelations. You had three top Japanese executives “resign”. You also maintain that there is no direct culpability at a Novartis HQ in Basel.
How so?
Novartis is a global company and operates in one of the most highly regulated industries in the world. The drug regulations and regulatory agencies are there to manage risk to the public from errant pharma company practices and prevent poorly tested, dangerous, or unnecessary drugs getting to market. All of the regulatory legislation and governance frameworks rely on pharma companies operating rigorous self-governing processes and controls. Regulatory conformance, ethics, operational excellence and transparency are not “guiding” principles for pharma, they are the pillars of trust needed to support safe drug development and commercialization processes. Patient safety and confidentiality lies at the core of the whole healthcare ecosystem.
How the Novartis PR machine is driving communication positioning is interesting. Novartis is globally governed by documented processes in the form of SOPs. It has a very sizable global audit function. Novartis globally conforms to cGxP. It has a whistle-blower programme that affords every employee the right to report any serious issue that they discover, anonymously if necessary, without fear of reprisal. The whistle-blower processes operate totally independent of functional line management and organisational structure.
You also have thousands of global resources around the world that work in conjunction with the CPOs. As well as audit, these include clinical teams, analysts, statisticians, market access specialists, Quality Assurance, Drug & Regulatory Affairs specialists and global brand teams. You also drive mandatory annual training for every employee on the Novartis’ Code of Conduct. This training is rigorously controlled to ensure that every employee, without question, completes it.
So is it feasible that Novartis HQ in Basel had absolutely no knowledge of what was happening in Japan? If “plausible” is the answer, then no regulator in the world can have a shred of confidence in Novartis’ ability to be held accountable for its regulatory obligations in any CPO because Novartis HQ itself does not know what is going on. If you don’t know, then you also don’t know that other CPOs are not suffering the same problems and that “cooking up of data”, through fabrication, adjustment or destruction to provide advantageous drug product positioning is not the norm within the company.
If Novartis HQ in Basel did know about these problems, they are not localized issues as claimed. If there has been any form of cover-up or “blind-eyeing” that anyone in Novartis HQ in Basel is implicated in, then Novartis HQ become directly culpable; you are the masters. If this is ultimately established, then Novartis’ reputation and brand will lie in ruins and the firing of executives with potential criminal liabilities will not stop in Japan. The long term success of the company may also be critically compromised.
As Novartis Pharma division head, you are accountable for compliance to all legal and regulatory requirements across your entire division. You stated that “the Japanese unit needs innovative changes”. No, the Japanese unit and other “units” needs to conform to the local laws and regulatory governance laid down by both the regulator and the company’s global regulatory governance processes.
There are five questions that need to be answered to provide transparency on what has really happened and help us all to understand how wide the underlying problems are:
1. Were the employees in Japan, including the executives, terminated immediately without severance (i.e. no accelerated stock, salary, bonus or any form of ex-gratia payments) that their employment contract would have been afforded to Novartis for their violation of the Novartis Code of Conduct?
2. Did the company offer any employees or executives in Japan any form of legally binding “compromise agreement” that set out conditions of confidentiality on departure including restrictive “gagging” clauses?
3. When did the Oncology unit at the NPKK last undertake an audit driven by a Novartis HQ audit team that included clinical management practices; and were any issues reported that have reference to or are relevant to the issues now being presented?
4. Have any cases of impropriety been raised by any employee through the “whistle-blower” programme, either though the Business Practices Officer (BPO) or other channels open that relate to the issues in Japan or any other regulatory or ethical issues within the company globally?
5. Where was Eric Cornut during the April 2014 Tokyo press conference?
It is fascinating to see you were back in Tokyo less than six months since your last public visit to once again bow deeply in apology on behalf of Novartis to both the Japanese health ministry and Japanese public for the behavior of NPKK executives, managers and employees. It is also fascinating to hear that the significance of the issues that are now in the public domain have moved from denial of data manipulation relating to a drug claim to the purposeful and illegal destruction of Adverse Event data that is critical to patient safety and global drug safety awareness.
It is unsurprising you claim you were “completely shocked” about what has happened in Japan; the disclosures strike at the very heart of the Novartis organisation and its global reputation. You have already stated that you fully expect that more issues will emerge as the depth of illegal, fraudulent and potentially life threatening cover-ups are disclosed over the coming months. Like the Richter scale, Novartis are on a logarithmic progression of impact; what was a tremor now feels like a high magnitude earthquake. What is unknown at this point in time is how big and if the epicenter is actually at Novartis HQ in Basel.
At the September 2013 press conference in Tokyo you claimed that the issues around falsification of data and resultant claims regarding Diovan were because of the lack of training and controls in the Japanese organisation. You fired some people, you restricted some executives pay and you also transferred Eric Cornut, Novartis global chief commercial officer to Japan as the new chairman of NPKK. It is an interesting that Mr Cornut did not appear to be present at the April 2014 press conference. He above all should now fully understand the depth and scale of the problems that have occurred in Japan. His apparent absence and lack of any reference to the work he has been doing since last September perhaps, in itself, tells a story.
You have implied that the problems are still isolated to Japan and that the NPKK was operating as a self-sufficient entity and that compliance, governance and control was left to NPKK, but this time you are answering to a much more damning set of revelations. You had three top Japanese executives “resign”. You also maintain that there is no direct culpability at a Novartis HQ in Basel.
How so?
Novartis is a global company and operates in one of the most highly regulated industries in the world. The drug regulations and regulatory agencies are there to manage risk to the public from errant pharma company practices and prevent poorly tested, dangerous, or unnecessary drugs getting to market. All of the regulatory legislation and governance frameworks rely on pharma companies operating rigorous self-governing processes and controls. Regulatory conformance, ethics, operational excellence and transparency are not “guiding” principles for pharma, they are the pillars of trust needed to support safe drug development and commercialization processes. Patient safety and confidentiality lies at the core of the whole healthcare ecosystem.
How the Novartis PR machine is driving communication positioning is interesting. Novartis is globally governed by documented processes in the form of SOPs. It has a very sizable global audit function. Novartis globally conforms to cGxP. It has a whistle-blower programme that affords every employee the right to report any serious issue that they discover, anonymously if necessary, without fear of reprisal. The whistle-blower processes operate totally independent of functional line management and organisational structure.
You also have thousands of global resources around the world that work in conjunction with the CPOs. As well as audit, these include clinical teams, analysts, statisticians, market access specialists, Quality Assurance, Drug & Regulatory Affairs specialists and global brand teams. You also drive mandatory annual training for every employee on the Novartis’ Code of Conduct. This training is rigorously controlled to ensure that every employee, without question, completes it.
So is it feasible that Novartis HQ in Basel had absolutely no knowledge of what was happening in Japan? If “plausible” is the answer, then no regulator in the world can have a shred of confidence in Novartis’ ability to be held accountable for its regulatory obligations in any CPO because Novartis HQ itself does not know what is going on. If you don’t know, then you also don’t know that other CPOs are not suffering the same problems and that “cooking up of data”, through fabrication, adjustment or destruction to provide advantageous drug product positioning is not the norm within the company.
If Novartis HQ in Basel did know about these problems, they are not localized issues as claimed. If there has been any form of cover-up or “blind-eyeing” that anyone in Novartis HQ in Basel is implicated in, then Novartis HQ become directly culpable; you are the masters. If this is ultimately established, then Novartis’ reputation and brand will lie in ruins and the firing of executives with potential criminal liabilities will not stop in Japan. The long term success of the company may also be critically compromised.
As Novartis Pharma division head, you are accountable for compliance to all legal and regulatory requirements across your entire division. You stated that “the Japanese unit needs innovative changes”. No, the Japanese unit and other “units” needs to conform to the local laws and regulatory governance laid down by both the regulator and the company’s global regulatory governance processes.
There are five questions that need to be answered to provide transparency on what has really happened and help us all to understand how wide the underlying problems are:
1. Were the employees in Japan, including the executives, terminated immediately without severance (i.e. no accelerated stock, salary, bonus or any form of ex-gratia payments) that their employment contract would have been afforded to Novartis for their violation of the Novartis Code of Conduct?
2. Did the company offer any employees or executives in Japan any form of legally binding “compromise agreement” that set out conditions of confidentiality on departure including restrictive “gagging” clauses?
3. When did the Oncology unit at the NPKK last undertake an audit driven by a Novartis HQ audit team that included clinical management practices; and were any issues reported that have reference to or are relevant to the issues now being presented?
4. Have any cases of impropriety been raised by any employee through the “whistle-blower” programme, either though the Business Practices Officer (BPO) or other channels open that relate to the issues in Japan or any other regulatory or ethical issues within the company globally?
5. Where was Eric Cornut during the April 2014 Tokyo press conference?