HEALTH MINISTRY BLAMES HIV-TAINTED BLOOD SCANDAL FOR FAILED COVID-19 COUNTERMEASURES
I recently heard similar perturbing remarks from two different public figures concerning the reluctance of the Japanese government to approve home-made vaccines for the coronavirus. Both said they believe the Ministry of Health is hesitant to approve Japanese vaccines because of bitter memories of the fierce criticism the ministry was subjected to over a scandal involving imported HIV-tainted blood products nearly four decades ago.
The remarks came from an influential politician and Kunihiko Miyake, a prominent foreign affairs commentator, who was a guest on the “Prime News” show on BS-Fuji TV on August 25. I don’t think I am too wide of the mark in surmising that behind these remarks were the “special lectures” the ministry regularly invites prominent political and social figures to in order to tell its side of the story concerning public health issues.
These are not normal times. With numerous new cases of infection reported each day, especially among younger Japanese, we are facing a serious national crisis. In combating the scourge of these invisible viruses, the government should have simplified and expedited its usual approval procedure, both for vaccines and new therapeutic products. But developing vaccines and obtaining approval for agents like (anti-viral medication) Avigan continue to proceed at a snail’s pace. The major stumbling block is the Ministry of Health, Labor and Welfare—more specifically its pharmaceutical administrators who steadfastly refuse to modify the approval process. Clearly, fierce battles that have put the vested interests of the pharmaceutical industry on the line have encouraged this posture. In an apparent effort to hide this dark truth, ministry bureaucrats have disseminated the misleading story about the HIV-tainted blood scandal of the mid-1980s. They would have us believe that their concern about not repeating those mistakes—which left deep wounds in the psyche of the ministry—is behind the delay in approving products to counter the COVID crisis.
But do the bureaucrats really remember what the scandal was about? Do they realize what their ministry and their predecessors did, or did not do, at the time? In short, the bureaucrats in charge then ignored critical information that could have saved the lives of patients. Their insensitivity to safeguarding lives showed they absolutely lacked an awareness of their primary responsibility as employees of the Ministry of Health.
The news that a strange illness had occurred among hemophiliacs in the US was first reported in the New England Journal of Medicine toward the end of 1981.
Then in July the following year, the Center for Disease Control and Prevention (CDC) announced that three hemophiliac patients who had been administered unheated blood products died of carinii pneumonia.
Two months later, the CDC named AIDS (acquired immunodeficiency syndrome) a disease resulting from the use of untreated blood products.
In January 1983, Dr. Carol K. Kasper, a physician at the Los Angeles Orthopedic Hospital, wrote in The Hemophilia Bulletin (a private newsletter she published 1981-2006) that hemophiliacs had contracted HIV from concentrated blood products.
In March, the CDC formally announced that unheated blood products were the cause of AIDS among hemophiliacs. The Center urged the pharmaceutical industry to stop manufacturing unheated blood products, directing that they be switched to heat-treated blood products in which the HIV virus had been killed.
What did our health ministry do on its part then? Under its ineffectual drug administration, Japanese hemophiliacs were compelled to continue using unheated products long after the CDC had issued the warning. After idling away two years and four months, the ministry at long last approved heat-treated blood products in July 1985.
But the ministry put the best interests of Japanese pharmaceuticals before the patients’ even after it approved the heated products. With the major pharmaceuticals in mind, especially Green Cross, it tacitly permitted them to provide patients the unheated products they still had in stock before marketing their new products.
Even more unbelievably, the ministry tacitly allowed the pharmaceuticals to adjust the timing of clinical trials to the timetable of Green Cross, which was the furthest behind in heated blood development. In other words, the ministry willfully delayed approval to favor the pharmaceuticals.
Because of the long delay, many hemophiliacs contracted HIV, no small number of them losing their lives.
Imagine the fear the patients felt under such circumstances. What Dr. Takeshi Abe, a hemophilia expert who served as head of a government advisory panel on AIDS, said during a general assembly of the “Association of Hemophilia Patients” on November 23, 1998, could only have aggravated that fear:
“Roughly 90% of the blood products all of you are using are plasmas imported from America…We are gradually beginning to learn that serious diseases—far more deadly than hepatitis—are carried in (the imported unheated blood products) …”
Hemophiliac patients on the floor asked Abe and other panelists for more specific information, but to no avail.
It was not until June 1983 that the ministry finally set up an AIDS study group. And it took more than two more years, as I have earlier pointed out, before the ministry finally approved heated blood products, in July 1985. Even then, it turned a blind eye to the pharmaceuticals cleaning up their inventory of unheated products.
Abe’s Burning Desire to Deliver Therapeutic Medicine to People
Hemophiliac patients—all citizens for that matter—have every reason to express anger at the health ministry and its bureaucracy. The ministry and the hemophiliac specialists who treated them should account for what they failed to deliver at the time. Do they really think they can get away with the feeble excuse that they are unable to grapple squarely with rectifying the nation’s vaccine administration because they are still haunted by the memories of their bitter experience with the HIV-tainted blood products from more than three decades ago?
Ordinarily, it is the right time for the ministry to prove its worth. It should assist companies engaged in vaccine development and help them complete their projects as soon as possible. The ministry would then be able to protect the health of the Japanese people while contributing to economic recovery. The government would then be able to lend a helping hand to needy peoples and nations across the globe.
Japan is significantly different from the US and China in that it is impossible for us to expand our international influence by military force. We must therefore win the trust and cooperation of nations in our own way, providing solid deterrence against China’s hegemonic ambitions. One plausible way of achieving that goal would be for us to become one of the most advanced medical nations capable of helping the world by fully utilizing our technology and resources. On that premise, the Ministry of Health must work hard to lead the nation’s medical community, expediting the completion of Japanese-manufactured vaccines and new anti-viral drugs. Unfortunately, this appears to be a tall order.
On May 15, 2020, I had the pleasure of hosting then Prime Minister Shinzo Abe as an honored guest on my prime time weekly “Genron” Internet TV news show. With immediate approval of Avigan in mind, Abe told me:
“Avigan can be approved by June or July, if a clinical trial is conducted through the ordinary process. But I am hoping that, because it is in great demand, my government will be able to give it the regulatory pharmaceutical approval earlier, provided that its effectiveness can be established through smooth observational and clinical studies.”
Sensing the premier’s eagerness to make an anti-viral available as soon as possible, I was deeply touched by his resolve to deal flexibly with the matter. The health minister, his deputy, and the chief of the ministry’s pharmaceutical and food safety bureau were all in favor of Abe’s idea. But the biggest obstacle again was the ministry’s pharmaceutical administrators, who typically objected to the idea outright. Abe resigned as prime minister four months later, and his idea has yet to see the light of day under the administration of Yoshihide Suga, his successor. The ministry’s pharmaceutical administrators may view their own rules as almighty, but do they attach any importance to people’s lives? As I have explained, the bureaucrats willingly delayed approval of heat-treated blood products and their subsequent delivery to the victims of AIDS caused by HIV-tainted blood products. Are they going to do the same with Avigan? Are the bureaucrats still taking the lives of people lightly?
(Translated from “Renaissance Japan” column no. 965 in the September 9, 2021 issue of The Weekly Shincho)