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The Significance of Fighting a Trial

Author: Setsuo Ide

Editor: Chiharu Kawasaki

This article was translated from an article posted at MRIC on April 20, 2021.

As I fought the drug lawsuit against Eli Lilly and Company, the meaning of going to trial changed. In the beginning, what sustained me in my fight against Big Pharma was my rage at the absurdity of Eli Lilly and Nippon Shinyaku's attempts to cover up side effects. Through fighting the case, I realized the current state of medicine is driven by a few people's desires. The realization made me think about what I could do to change the situation as an ordinary doctor who has been practicing medicine for 50 years. It has become my reason to be in court.

My drug lawsuit became public, and I began to think that making everyone aware of the reality of drug makers who "pursue profit" without regard for the sacrifices of patients might be a clue for everyone to think about the way proper and sincere medicine should be. Many young people aspire to a career in medicine to contribute to medical care, and many doctors work hard day and night for their patients with a sense of mission. I want to protect the honesty and sincerity of medical care. That is what motivated me to fight the trial.

The side effects I experienced from Zartia (tadalafil), a drug for dysuria, developed in the form of a cerebral anemia attack about a year after I started taking the medication. That led to a drop in blood pressure (30-40 mmHg) and orthostatic hypotension. The drop in blood pressure caused a lack of oxygen to the tissues, clinically presented as easy fatigue, malaise, and other physical ailments. The pharmacological effect of tadalafil caused side effects, disuse atrophy of vascular smooth muscle, and "layoff" vascular smooth muscle.

I reported in detail to the manufacturer, Eli Lilly Japan, and the distributor, Nippon Shinyaku, about the side effects risks of the dysuria drug Zartia (tadalafil). Since May 2019, Nippon Shinyaku Co. has manufactured and marketed the drug. However, both companies' responses to the side-effect reports were flippant and lacked any sense of seriousness. "We are gathering information at Lilly's headquarters in the U.S.!" was the repeated response. Six months after the side effect report, we finally received a response from Eli Lilly and Company, but it was lukewarm. There was no further response regarding the side effects, and I got the impression that they were trying to sweep the issue under the rug.

The discussion was cut short, and the only recourse I had was to go to court. I had never been involved in a court case in my life. However, I knew that if I kept my mouth shut when I realized the unprecedented side effects of "disuse atrophy and the “layoff” of vascular smooth muscle," I would regret it as a person and as a doctor until my death.

What the drug trial showed me was Eli Lilly's lack of ethics as a pharmaceutical company. The side effect I brought the case on was caused by pharmacological action, a mechanism-based side effect. It was a side effect that Eli Lilly, the drug manufacturer, naturally knew could happen. However, Eli Lilly's attitude was not to fight over the fact of the side effects but to use all kinds of trial techniques such as accusations, misleading, sophistry, lies, difficulties, and provocations to hold the plaintiff accountable and cover up the fact of the side effects. They attempted to mislead the judge and even desecrate the trial. Eli Lilly's trial brief was riddled with lies, and the company was willing to do anything as long as it made them win the case. There was not a shred of concern for what the patients had gone through because of their production.

Along the way of fighting the trial, I became aware of the corruption of the medical industry brought by the pharma money. The enormous profits, the blockbusters, which are products with annual sales of more than 100 billion yen that are created with the best of intentions and the "disguisement of side effects". Here we call the money pharmaceutical companies to pay for doctors to win prescriptions pharma money. I felt a great sense of urgency about the pharma money undermining the medical care. My faith in medicine, that "medicine is for the patient," was pretty much distant from the reality I learned through and the belief I had in medications could be even called delusional. I was confronted with the fact that pharmaceutical companies make drugs "only for the pursuit of profit. The attitude of drug producers who ignore the dangers of side effects of their medications and pursue profits shook me.

The side effects of tadalafil are severe and life-threatening. Tadalafil, under the trade name Adsilca, is used to treat patients with pulmonary arterial hypertension (PAH), an incurable disease. The side effect of tadalafil, a drop in blood pressure, leads to sudden death and right heart failure for PAH patients, and Adsilka is rather an absolute contraindication for PAH. I complained about the danger of Adcirca's side effects to the physicians in leadership positions in developing guidelines for the treatment of pulmonary hypertension and asked them to take reasonable steps to protect patients. Still, none of the dozen or so physicians responded.

That is when I learned of the pharma money database created by the Waseda Chronicle. I was stunned to learn that pharmaceutical money was rampant. Some doctors in leadership positions were receiving millions to tens of millions of dollars a year from pharmaceutical companies in the form of lectures and advisory fees to promote their products.

I myself was so disgusted by the rampant use of pharmaceutical money that it made me feel ashamed to be a doctor. There was Pandora's box in the pharmaceutical industry, where ineffective drugs were made into blockbusters while spreading their side effects, sold worldwide, and the side effects were not disclosed. While researchers were raising the issue of the dangers of SSRIs for depression, those companies kept selling the SSRIs under the slogan "Depression is a common cold of the mind," ignoring the risk of increased suicides and creating an "SSRI sensation." For some time, I have felt a wave of irresolvable anger toward the "SSRIs," which are drugs for depression.

The Waseda Chronicle is an investigative journalism group formed by freelance journalists and students at Waseda University who aspire to become journalists. When I learned about the Waseda Chronicle, my immediate reaction was” Japan hasn’t got depraved yet!” Its spirit of young people defending healthcare from pharma money gave me a refreshing feeling on my daunting feeling came from the lawsuit. They A database of pharma money was created by Dr. Masahiro Kami and the Waseda Chronicle. The database is created to make it easier for the general public to know the number of money doctors receive from pharmaceutical companies. And they expect that it would put the brakes on the doctors who engage in black market activities, thereby preventing the corruption of the medical industry by pharma money. The database of pharmaceutical money in Germany is called Finde Dienen Arzt and it says, "Check your doctor's pharma money and find the doctor for you. And find your doctor for you."

My trial was finally going to be expert testimony. At trial, I held myself accountable as a plaintiff and stood tall against Eli Lilly and Company's relentless and flippant trial tactics. However, I am concerned about whether the expert witness will understand the mechanism of the side effects I claim in the event of an expert opinion. I sent him a long letter of more than 20,000 words. I am an old country doctor, but I am very grateful to you for your immediate response. I sent him a long letter of more than 20,000 words. He responded immediately, and I am very grateful to him for that.

I am an old doctor living in the countryside, and I consider this drug lawsuit the culmination of my 50 years of life as a doctor. I sincerely hope that you will lend me your help for the sake of sound medical care in Japan.


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