Marrow taken without consent from 31 patients

Two doctors at Keio University Hospital collected bone marrow samples from 31 patients with lung cancer or pneumothorax without the patients' consent, according to the university's school of medicine.

The samples were unrelated to the patients' treatment, the university said.

On Friday, the school said the hospital's general thoracic surgery division violated government ethics guidelines when it conducted two unauthorized clinical research studies involving lung cancer patients and pneumothorax patients. The two doctors in charge of the research--a professor in his 50s and a full-time lecturer in his 40s--will be disciplined, it added.

According to the ethics guidelines on clinical research established by the Health, Labor and Welfare Ministry, doctors are required to first obtain approval from an ethics committee at a medical institution where the research will be conducted, as well as informed consent from the patients.

However, the two doctors had not obtained consent from 26 patients with lung cancer--aged 40 to 84--when they operated on them from October last year to January. The doctors collected two cubic centimeters of bone marrow each from the patients' ribs, the school of medicine said.

Moreover, the two doctors failed to obtain consent from five other patients--most of whom were operated on for pneumothorax--before collecting bone marrow samples from their ribs during surgery. The five patients' bone marrow was collected for comparison with that of the lung cancer patients, according to the school.

In collecting bone marrow, needles one millimeter in diameter are inserted into a patient's bone, thereby physically stressing the patient. So far, none of the patients have suffered any health problems related to the procedure, the school said.

In separate clinical research, the two doctors were also found to have collected blood samples from 136 patients with lung cancer up until the autumn last year--1-1/2 years after the end of the research period approved by the university's ethics committee. They obtained consent from all the patients except for two, whose cases have yet to be confirmed, according to the school.

The research was aimed at determining whether the number of cancer cells in bone marrow or blood could be used to predict postoperative prognoses, the school said.

"I wanted to collect data useful for patients," the professor said when questioned by the university, Makoto Suematsu, dean of the school, said.

"[The two doctors] failed to complete proper procedures as they rushed to produce certain results," Suematsu said. "We'd like to extend our apologies to every patient we caused trouble to."

Yasuyuki Sahara, head of the health ministry's Research and Development Division, said the university reported the case last week.

"We've told the university to review its frameworks for clinical research and in-house screening before developing preventive measures and reporting them to us," Sahara said.