Hidden Dangers: Japanese Officials Ignored or Concealed Dangers

If such a quake struck, electrical power could fail, along with backup generators, crippling the cooling system, the lawyers predicted. The reactors would then suffer a meltdown and start spewing radiation into the air and sea. Tens of thousands in the area would be forced to flee.

Although the predictions sound eerily like the sequence of events at the Fukushima Daiichi plant following the March 11 earthquake and tsunami, the lawsuit was filed nearly a decade ago to shut down another plant, long considered the most dangerous in Japan — the Hamaoka station.

It was one of several quixotic legal battles waged — and lost — in a long attempt to improve nuclear safety and force Japan’s power companies, nuclear regulators, and courts to confront the dangers posed by earthquakes and tsunamis on some of the world’s most seismically active ground.

The lawsuits reveal a disturbing pattern in which operators underestimated or hid seismic dangers to avoid costly upgrades and keep operating. And the fact that virtually all these suits were unsuccessful reinforces the widespread belief in Japan that a culture of collusion supporting nuclear power, including the government, nuclear regulators and plant operators, extends to the courts as well.

Yuichi Kaido, who represented the plaintiffs in the Hamaoka suit, which they lost in a district court in 2007, said that victory could have led to stricter earthquake, tsunami and backup generator standards at plants nationwide.

“This accident could have been prevented,” Mr. Kaido, also the secretary general of the Japan Federation of Bar Associations, said of Fukushima Daiichi. The operator of the plant, Chubu Electric Power Company, temporarily shut down Hamaoka’s two active reactors over the weekend, following an extraordinary request by Prime Minister Naoto Kan.

After strengthening the plant’s defenses against earthquakes and tsunamis, a process that could take a couple of years, the utility is expected to restart the plant.

Japan’s plants are all located in coastal areas, making them vulnerable to both quakes and tsunamis. The tsunami is believed to have caused the worst damage at the Fukushima plant, though evidence has begun emerging that the quake may have damaged critical equipment before the waves struck.

The disaster at Fukushima Daiichi, the worst nuclear accident since Chernobyl, directly led to the suspension of Hamaoka here in Omaezaki, a city about 120 miles southwest of Tokyo. But Mr. Kan’s decision was also clearly influenced by a campaign, over decades, by small groups of protesters, lawyers and scientists, who sued the government or operators here and elsewhere.

They were largely ignored by the public. Harassment by neighbors, warnings by employers, and the reluctance of young Japanese to join antinuclear groups have diminished their numbers.

But since the disaster at Fukushima and especially the suspension of Hamaoka, the aging protesters are now heralded as truth-tellers, while members of the nuclear establishment are being demonized.

On Friday, as Chubu Electric began shutting down a reactor at 10 a.m., Eiichi Nagano, 90, and Yoshika Shiratori, 78, were battling strong winds on the shoreline leading to the plant here. Mr. Shiratori, a leader of the lawsuit, led the way as Mr. Nagano followed with a sprightly gait despite a bent back. The two men scrambled up a dune, stopping only before a “No Trespassing” sign.

“Of course, we’re pleased about the suspension,” Mr. Nagano said, as the strong wind seemed to threaten to topple him. “But if we had done more, if our voices had been louder, we could have prevented the disaster at Fukushima Daiichi. Fukushima was sacrificed so that Hamaoka could be suspended.”

Unheeded Warnings

In 1976, a resource-poor Japan still reeling from the shocks of the oil crisis was committed fully to nuclear power to achieve greater energy independence, a path from which it never strayed despite growing doubts in the United States and Europe.

 

Drug That Stops Bleeding Shows Off-Label Dangers

 

The studies present a cautionary tale, researchers say, that makes clear the pitfalls of a common medical practice — using new drugs in situations in which they have never been rigorously tested. The drug, sold as NovoSeven, was approved for people who lack a gene to make a particular blood-clotting protein called Factor VIIa and for certain people with hemophilia who can’t tolerate another drug that can stop bleeding.

The drug, which is Factor VIIa, is made by baby hamster kidney cells that have the gene for Factor VIIa added to them. The baby hamster cells secrete the protein into a solution containing newborn calf serum, and the protein is then extracted from that solution and purified. It takes a year to produce — most of that time, nine to 10 months, is devoted to testing the drug for purity and safety. The drug costs $10,000 a dose, but can be a lifesaver for these patients.

It is also used for other patients, according to the new studies, in The Annals of Internal Medicine. In fact, the small group for whom it was approved accounts for only 3 percent of the 18,000 times a year the drug is used in hospitals. Ninety-seven percent of the time when it is used in hospitals, it is given to patients with other reasons for bleeding, including having heart surgery or a hemorrhagic stroke, in which bleeding in the brain causes damage.

For such patients, one of the papers concluded, the drug not only fails to improve survival, it increases the likelihood of a blood clot in the heart or brain, resulting in a heart attack or the kind of stroke in which blood flow to a part of the brain is blocked. The drug is also used in trauma surgery, and in that use as well it fails to show improved survival. In trauma patients who receive the drug, however, there do not appear to be more clots than would otherwise occur.

“It’s scary,” said Dr. Jerry Avorn, a professor of medicine at Brigham and Women’s Hospital in Boston who wrote an editorial commenting on the studies. “This is a powerful drug, and we don’t fully understand it,” said Dr. Veronica Yank of Stanford, an author on both papers.

In heart surgery, the researchers report, one out of every 20 people given Factor VIIa would be expected to have a serious clot in the heart or brain. When the drug is used to control bleeding in or around the brain, as in patients suffering from hemorrhagic stroke, one out of 17 patients would get a dangerous clot at the higher dose that is often used and one out of 33 would get a clot in situations where doctors used a lower dose.

The clots, said Dr. Yank, can occur anywhere in the body, obstructing blood vessels. “Some patients got more than one clot,” she added.

Doctors say they give the drug because they can see an immediate effect: The bleeding stops. “It’s very dramatic,” said Dr. Mark Gladwin, chief of pulmonary and critical care medicine at the University of Pittsburgh Medical Center. And so, he added, “there is a very compelling motivation to use it.”

And the doctors who use the drug during surgery may not see a longer-term effect — clotting — which can occur days later. And they would have no way of knowing if the drug saves lives in the long run. Dr. Gladwin pointed out that doctors routinely administer drugs for unapproved uses.

Companies cannot promote drugs for such uses, but doctors are free to prescribe them. Novo Nordisk, the maker of the Factor VIIa drug, says that it does not promote unapproved uses and that it worked with the Food and Drug Administration to include warnings against such uses on the drug’s label.

As for the high cost, insurers pay for Factor VIIa as part of the general cost of treating hospitalized patients, so the drug may not be specifically identified. “Typically, the health plan would not know that it was used,” said Susan Pisano, a spokeswoman for America’s Health Insurance Plans, an industry group. Payment for Factor VIIa “would be part of a global payment,” she said.

Trauma surgeons were among the most enthusiastic early adopters of Factor VIIa, but they were also among the first to curtail use.

“I have used it, and virtually every trauma surgeon in the world who has access to it has used it,” said Dr. Ernest Moore, chief of surgery at Denver Health, an affiliate of the University of Colorado.

Many doctors got interested when they saw a paper, about a decade ago, describing an Israeli soldier who had a gunshot wound to the abdomen, got Factor VIIa, and was saved from what it seemed would have been certain death. In addition, research studies indicated that Factor VIIa was important in initiating clotting, giving credibility to the report.

As trauma surgeons began using the drug, Dr. Moore said, they had “the unforgettable experience of seeing people who were bleeding to death suddenly stop bleeding.” And, he added, “there is no question that in the right circumstances it can be a miracle treatment.”

But trauma surgeons’ unbridled enthusiasm for Factor VIIa was tempered recently when studies began to show no survival benefit.

He is using it less often now, as are many other trauma surgeons, Dr. Moore said. It is not clear that other medical specialties had a similar awakening, but some institutions, like the University of Pittsburgh Medical Center, have taken steps to control the drug’s use. The Pittsburgh hospital began requiring that doctors who wanted to use Factor VIIa get permission from a hematology consultant.

The one exception was patients who were bleeding into the brain, taking a blood thinner and about to have emergency neurosurgery. The consultants often refuse permission, said Dr. Franklin Bontempo, director of the coagulation laboratory at the University of Pittsburgh Medical Center.

Some doctors want to use it for routine bleeding in trauma patients or in patients having liver transplants. That is unnecessary, they often are told. Others call because a patient is bleeding into the lungs, coughing up blood, and the doctor is, quite understandably, worried, wanting to give Factor VIIa to make the bleeding stop. In that situation, Dr. Bontempo said, the hematologist will suggest other methods. “Often that takes care of the problem,” he said.

The lesson in the story of Factor VIIa, Dr. Yank said, is that anecdotal reports, even ones citing results as powerful as bleeding cessation, can be misleading. Using a drug for an unapproved use can be risky. A single measurement of outcomes can miss the big picture of risks and benefits. And the risk-benefit picture for the approved use may be quite different from what occurs when the drug is used in other situations

“You may be correct in assuming the drug has the same benefits,” Dr. Yank said, “but then again, you may not.”