The Long Road After Doing Right – A Medical Representative’s Heartfelt Plea After Four Years of Job Restriction | FRIDAY DIGITAL

The Long Road After Doing Right – A Medical Representative’s Heartfelt Plea After Four Years of Job Restriction

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Discovered company misconduct, reported and consulted with superiors, faced harassment, and then recommended to resign.

In a world where doing the right thing is rewarded is what many people hope for. However, the reality is that it’s not always the case.

X (formerly Twitter) account holder under the name “Kobayashi Maru” is currently involved in litigation after being unfairly treated, such as having their job restricted, following a public interest report regarding corporate misconduct.

Kobayashi joined a foreign pharmaceutical company, Alexion Pharma LLC, in 2013 as a Medical Representative (referred to as “MCC” within the company, due to requiring advanced knowledge specialized in rare diseases).

The issue began when Kobayashi noticed misconduct related to the drug “Soliris,” indicated for paroxysmal nocturnal hemoglobinuria (PNH), shortly after joining the company. Kobayashi reported and consulted with their superior, and made an internal report, but faced harassment and was recommended to resign. The situation continued to deteriorate from there.

“Since the addition of atypical hemolytic uremic syndrome (aHUS) as an indication for Soliris in September 2013, the company began inappropriate promotional activities, promoting the use of our products to patients outside the approved indications. Promoting off-label use is a violation of pharmaceutical affairs law, and as a result, there were multiple deaths among patients who used the drug off-label.

Four medical associations expressed concern over this situation, urging caution against the easy off-label use. However, the company only temporarily halted the use of inappropriate materials, then promptly resumed and reinforced these activities.” (Kobayashi, continued)

Alexion Pharma GK is the Japanese subsidiary of Alexion AstraZeneca Rare Diseases, the rare disease division of the AstraZeneca Group (PHOTO:AFRO)

Whistleblowing to Alexion Japan ⇒Required to sign an Acknowledgement which makes whistleblowing difficult ⇒Whistleblowing to U.S. parent company

Although there were complaints from customers, the company’s response remained the same, and Mr. Kobayashi filed an internal report with Alexion’s Japanese subsidiary in March ’16. However, the company requested Ms. Kobayashi to sign a confirmation form, which would have made it difficult for her to report the matter internally.

The U.S. company informed her that it would have Nagashima Ohno & Tsunematsu investigate the matter as a third-party organization, but “the investigation was in name only, and the findings were that serious irregularities were outside the scope of the investigation.


Escalating Power Harassment ⇒ “Whistleblower Report” to the Ministry of Health, Labor and Welfare

The power harassment escalated from there, and Mr. Kobayashi was unable to overlook the fact that off-label patients were dying without proper information, so he filed a public-interest report with the Ministry of Health, Labor, and Welfare in February 2017.

The following month, the Ministry of Health, Labour and Welfare issued administrative guidance to Alexion in writing. According to Kobayashi, “As far as I know, this was only the second time administrative guidance had been issued to a pharmaceutical company for advertising.”

Furthermore, the Ministry of Health, Labour and Welfare subsequently conducted an investigation at Alexion’s headquarters, and in February 2019, instructed Alexion to revise the package insert for Soliris.

However, shortly thereafter, Kobayashi was transferred.

“In July 2019, I filed a lawsuit to invalidate the transfer, but from 2020 onwards, I began to have my work restricted. Additionally, in August 2020, through a second transfer, I was placed in a department with no work assigned solely to me.”

If I’m the only one in a department with no work, then everyone would think there’s no need for a transfer. However, the lawsuit to confirm the invalidity of the transfer resulted in my defeat.

Feeling that the Whistleblower Protection Law really needs to be revised to truly protect whistleblowers, otherwise similar things will happen like what happened to me, I started a signature campaign for the amendment of the Whistleblower Protection Law. Meanwhile, last May, the company completely eliminated my assigned tasks.

“Until mid-May, there was some work for less than an hour, but since then, there has been absolutely no work.

Feeling that this was too much, from 2021, I reported internally to AstraZeneca, the parent company, through the internal reporting channel, about the misconduct at Alexion Pharmaceuticals and the fact that I’m being sidelined. However, no appropriate action was taken.”

So, in January this year, I filed a damages claim lawsuit regarding harassment. Additionally, I’m considering filing a petition to reverse the demotion from a managerial position (senior manager, grade 9) to a non-managerial position (D, fourth from the bottom) and the reduction in base salary, citing the integration of personnel systems with AstraZeneca as the reason.

In the second part of this interview, we will hear about the treatment of his colleagues who raised their voices along with Mr. Kobayashi, and their current situation, which has made it difficult for them to change jobs.

■ “Whistleblowers in Pharmaceutical Companies: Revise the Whistleblower Protection Act! For more information and to sign the petition, click here.

  • Interview and text by Wakako Takou

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