The Unyielding Campaign of a Whistleblower from a Pharmaceutical Company | FRIDAY DIGITAL

The Unyielding Campaign of a Whistleblower from a Pharmaceutical Company

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“I thought I did the right thing.”

After blowing the whistle on corporate misconduct, X (formerly Twitter) user “Kobayashi Maru” faced unjust treatment such as being sidelined at work and is now pursuing legal action. It all began when Kobayashi noticed irregularities concerning the drug “Soliris” indicated for paroxysmal nocturnal hemoglobinuria (PNH) shortly after joining the company. Despite reporting and consulting with superiors, Kobayashi faced harassment and was encouraged to resign. The situation continued to worsen from there.

Part 1] “I thought I did the right thing,” one MR’s tearful plea after four years of dry work due to internal reporting and a public-interest report to the Ministry of Health, Labor, and Welfare.

“I have never regretted my decision to file a whistleblower report. It’s a matter in which a patient died.”

Colleagues feel unable to speak up due to demotions followed by reassignments or pressure to resign.

It’s a tragic story, much like something out of a movie or drama. When asked if there wasn’t an option to consult with colleagues and fight together, Kobayashi explains:

“When the warning came from the academic society in ’14, some within the company’s MCC took it seriously and tried to unite by forming a MCC meeting group. However, the company crushed this effort, treating it as an attempt to dismantle the union. People who spoke out in meetings about criticism from clients or questioned the evidence of off-label use were encouraged to resign by the company and are no longer with it. With employees demoted from grade 9 to grade 8 and transferred to the PMS department, an atmosphere of silence opposing the company’s actions emerged. Despite this, some employees, each with their own families and lives, advocated for me to be reinstated to my original MCC position. I am truly grateful for their support.”

When asked if she considered anonymous reporting given the immense personal risk, Kobayashi says:

“I had already filed an internal report, so it was easy for the company to deduce that I was the one who reported to the Ministry of Health, Labour, and Welfare.

In fact, since I had reported internally to the company and to the US parent company, it would have been easy for the company to deduce that I also reported to the Ministry of Health, Labour, and Welfare. However, the court’s decision was that ‘without evidence that the transfer was retaliation for reporting, it’s not valid.’ 

In essence, a company engaged in wrongdoing wouldn’t logically say, ‘You reported us to the authorities, so go to the expulsion room.’ There wouldn’t be evidence for that.”

Regarding the possibility of leaking information anonymously to the media, Kobayashi notes:

“Even if reported to the media, it might not be covered, and the company might not care.

For example, for companies like Alexion, whose customers are hospitals and operate in B2B marketing, media coverage might not affect them as much. Despite some coverage in industry papers and local news outlets, internally, the company announced an improvement in its reputation during the first quarter.”

The possibility of changing jobs also puts me in a difficult situation.

Kobayashi explains that she is in a situation where she cannot restart as a medical representative (MR) elsewhere. MR is a profession that requires certification, and to renew this certification, one needs to complete two components: basic education through self-learning on an MR learning portal and practical training provided by the company.

“I have repeatedly asked the company for training, but I have not been allowed to participate in practical training. Therefore, I cannot renew my certification as before (limited to basic MR education). This makes it difficult for me to transition to another company.”

While Kobayashi’s whistleblowing has significant significance, the personal sacrifices are too great. If someone were to discover wrongdoing in their company and couldn’t overlook it, what should they do? Kobayashi, based on her experience, says,

“I encourage individuals who notice misconduct or problems within their company to keep records. Secondly, they should consider what to do if appropriate action is not taken after internal reporting. Can the whistleblower be safe in a company that suppresses internal reports? In case of suppression, it’s better to decide on actions after considering whether the matter can be reported externally. Additionally, since it is extremely stressful, I recommend having a regular doctor to deal with stress-related health issues.”

Regarding the current issues with the Whistleblower Protection Act, Kobayashi points out:

“In Article 11 of the Whistleblower Protection Act, companies are required to take necessary measures and to a certain extent, companies of a certain size have established internal reporting mechanisms. However, there is no guarantee of proper response. While the Whistleblower Protection Act prohibits dismissal or disadvantageous treatment, the victim must prove in court that they suffered disadvantages due to whistleblowing. This proof is extremely difficult and feels almost like proving the existence of the devil.

In my case, I whistleblowed to the Ministry of Health, Labour, and Welfare, and the ministry issued administrative guidance to the company and instructed them to revise the accompanying documents. Shortly after that, I was transferred. However, the court did not presume that the transfer was motivated by improper reasons, despite all the recorded diaries and recordings being considered as circumstantial evidence.”

Kohiko Yasuhara, Kobayashi’s lawyer, states:

“The internal reporting system is supposed to encourage voices that are not easily raised and promote the self-cleansing function of companies, which is the original purpose of the system. However, in reality, the function is to identify dissatisfied or potentially harmful individuals within the company.

The Whistleblower Protection Act aims to create a reporting system for public interest and ensure that whistleblowers do not suffer disadvantages. However, in reality, many disadvantages are incurred. The loss in this case was due to the company’s authority and discretion in deciding where to place employees. Whether it’s internal reporting or public interest reporting, the original purpose of the system is not being fulfilled. I feel that these systems are dying if things continue like this.”

The real reason behind work drying up.

Furthermore, it is clarified that work drying up is indeed a form of retaliation for internal or public interest whistleblowing, but it’s not necessarily because the company doesn’t want to provide work.

“The fear lies in providing work would entail providing information. Therefore, to prevent the disclosure of information, they refrain from assigning work. While companies and employers have an obligation to pay wages, legally speaking, there is no obligation to ‘provide work.’ Whether this is right or wrong is a separate issue. On the flip side, the right to demand work (employment claim) is not granted to the employee. However, of course, it’s not permissible to refuse work as a retaliation for internal whistleblowing, as in this case. But in general, there’s an argument that there is no legal obligation to provide work or grant employment claims. There are legal barriers that aren’t easily overcome in court.

Within this context, we, as representatives, would like to assist individuals like Kobayashi in their efforts and contribute to institutional revisions to ensure that the internal reporting system fulfills its original purpose and functions as intended.”

 

“I have never regretted my whistleblowing, because it is a matter in which a patient died.”

When asked if she regrets sacrificing herself for public interest whistleblowing and jeopardizing her career, Kobayashi said,

“I have never regretted whistleblowing. It’s about patients who have died.

During my job interviews for the position of MR, I always said, ‘The combination of the product itself and information about the drug is what makes it a proper medication that can be effective. That’s why I want to help patients by providing this information through my work.’ I said the same thing during the interview for Alexion’s MCC position. I cannot overlook the fact that patients are dying because they cannot obtain correct information in off-label use cases.”

However, she also expressed her struggles,

“I admit that my mindset when I said, ‘There is a whistleblowers’ protection system, so I’ll deal with any disadvantages myself,’ during the meeting with the Ministry of Health, Labour, and Welfare was naive. I didn’t think that the Whistleblower Protection Act would be so ineffective.

That’s why the person who whistleblows after me started a petition for the amendment of the Whistleblower Protection Act, so that they wouldn’t have to sacrifice their careers like I did.

Whistleblowing is for others, not oneself. I believe sacrificing one’s career for it should not be necessary.”

The company, meanwhile, has been taking a defensive stance since January, assigning simple tasks of less than an hour per day, while showing a combative attitude during the first session of Kobayashi’s lawsuit held online on April 5th. Additionally, a petition for the amendment of the Whistleblower Protection Act has gathered over 1600 signatures.

 

■Change.org “Pharmaceutical Company Whistleblowers: Reform the Whistleblower Protection Act! For more information and to sign the petition, click here.

  • Interview and text by Wakako Takou

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