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There has been a spate of fraudulent incidents that could affect the safety and efficacy of pharmaceutical products. Although no adverse impacts to health have been confirmed at this point, such acts undermine trust in medical care and cannot be overlooked.
Major generic drug manufacturer Sawai Pharmaceutical Co. has announced that it conducted quality tests of a stomach medicine it was selling using a method that is not approved by the government.
The fraud occurred in a test to determine whether there were any issues with the way the medicine dissolves in the stomach. In order to achieve the desired results, the contents of the drug were removed from capsules that had deteriorated over time and were difficult to dissolve, and the medicine was placed into other capsules.
Workers tasked with the test did not think this was a problem, and this method continued for eight years. The company has said it is voluntarily recalling the drugs manufactured at its Kyushu plant where the wrongdoing took place.
Cases of misconduct have continued to emerge in the generic drug industry. Generic drugmakers have been hit by operation suspensions one after another, resulting in drug shortages. This time, however, it was discovered at a major player in the industry. The lack of awareness of compliance in the industry is nothing short of serious.
In addition, there have also been revelations of irregularities in clinical trials for new drugs and medical equipment.
Irregularities were found in 123 cases of clinical trials, such as data falsification, at Medipharma, a company that supports medical institutions conducting clinical trials. In 25 of these cases, the government had already approved the manufacture and sale of the product, and it had already been commercialized. The fraud had been repeated for more than 10 years.
An on-site inspection by the Health, Labor and Welfare Ministry confirmed that some of the trials were conducted on people who did not meet the conditions for the clinical tests. In some cases, drugs were not administered at the scheduled time, but records were rewritten as if they had been.
In some cases, employees participated in training sessions on behalf of the physicians in charge of clinical trials, who should have received the training. It must be said that the involvement of medical institutions is suspected.
Was there an intention to reduce the burden of conducting clinical trials and securing test subjects? The health ministry must investigate the matter, including whether such fraudulent practices are rampant in the entire industry, and take strict action.
Although it is said that the efficacy and other factors of the drugs have so far not been found to be a problem in any of these cases, it is necessary to thoroughly examine whether there have been any negative effects on patients.
It is also problematic that such wrongdoing has gone unchecked for so long.
The ministry must strengthen its monitoring and work to prevent recurrence. Companies should also work to eliminate fraudulent practices on their own.
In recent years, the view of placing importance on “science-based medical treatment” has become widespread. Common medical care has shifted from relying on doctors’ experience and intuition to diagnosing and treating patients based on data. If fraudulent data on drugs goes unchecked, scientific medical care will not be possible.
