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Chugai Pharmaceutical used the nonprofit Advanced Clinical Research Organization as a cover to fund a clinical trial of its own anticancer drug Xeloda. Had the doctors running the trial known where their funding really came from?

It was only natural that they did, according to an individual familiar with ACRO.

In an article published in the world-renowned New England Journal of Medicine, the doctors announced that Xeloda reduces the risk of recurrence in breast cancer patients by 30% — astounding results. But their article failed to mention that Chugai Pharmaceutical had funded the trial.

The wonder drug’s credibility was cracking.

In which we attempt to contact Ohno

Breast cancer surgeon Akihiko Ozaki had been first to point out the murky relationship between the clinical trial and Chugai’s donations to ACRO. In September 2017, Ozaki raised his concerns in an article published in the academic journal Science and Engineering Ethics.

At the time, Ozaki was working at the Cancer Institute Hospital of JFCR in Tokyo. Soon after his article was released, Ozaki was summoned by his boss, Shinji Ohno, chief of the hospital’s Breast Oncology Center. Ohno had been one of the doctors conducting the Xeloda trial.

He warned Ozaki that if his article was wrong, it amounted to defamation. And he asked for evidence linking the clinical trial with Chugai Pharmaceutical’s donations to ACRO.

Although Ozaki would eventually be proven right, at the time he had no concrete evidence.

Roughly a year after his talks with Ohno, Ozaki began working with Tansa. And together, we found among ACRO’s accounting documents the proof that Ozaki had been missing: a copy of a bank account passbook, a balance sheet, and an account book.

These documents, alongside the testimonies of individuals familiar with ACRO, confirm that Chugai Pharmaceutical’s donations were intended for the clinical trial.

In November 2019, we asked to interview Ohno.

The Cancer Institute Hospital’s PR department replied, “[According to Ohno,] the contact point for the clinical trial is Dr. Toi at Kyoto University. Please refer your inquiries regarding this matter to him. Thank you for your understanding.”

We were being given the runaround.

Video: Recording of Akihiko Ozaki being questioned by Shinji Ohno

Too busy for an interview

The “Dr. Toi” that Ohno had referred to was Kyoto University Hospital Breast Cancer Unit Director and Professor Masakazu Toi. He was part of the group of doctors that had implemented the Xeloda trial and was in charge of the New England Journal of Medicine article announcing its results.

Ozaki knew of Toi as a talented doctor who put a premium on cleanliness.

On Nov. 29, 2019, we emailed Kyoto University Hospital’s general affairs department, asking for an opportunity to interview Toi by Dec. 4. We said we would happily make the trip to Kyoto or any other location convenient for the doctor.

A few days later, on Dec. 2, we received a response from the general affairs department member in charge of planning and PR: “[Toi] is too busy for an interview.”

That’s fair — the end of the year is a busy time. So we emailed Toi directly on Jan. 7, 2020.

“Happy New Year. Although you were too busy last year, we hope you will accept our request for an interview. Dr. Shinji Ohno referred us to you for our questions regarding the Create-X [Xeloda] trial.”

Three weeks. No response.

We decided to pay Toi a visit.

… To be continued.

(Originally published in Japanese on March 3, 2020. Translation by Annelise Giseburt.)

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