The government's announcement that tests for pharmaceutical products that are directly connected to the lives of the people were fabricated is shocking. According to a study by the Korea Food and Drug Administration the fabrications took place at four of the eleven testing centers, and documents from the rest of them had differences in their in-house documentation and the documentation they submitted to the government. The techniques they used to fabricate test results were bold. They either plagiarized the results of other tests or never engaged in clinical tests, and in once case a laboratory even destroyed its original documentation to as to avoid the ongoing investigation. These research centers account for 90 percent of all testing services, so that means the fabrication of results on pharmaceutical effectiveness was an everyday and widespread occurrence.
It's hard to believe that it was not just for-profit institutions but also university research centers in which the public has much confidence. It would never be too much to call it a "second Hwang Woo Suk affair." It was an unimaginable crime to trample on the lives of the people with poor pharmaceutical products. When a product loses its effectiveness it is more than a problem of delayed recovery. Depending on the dosage of one's epilepsy medication, there can be fatal side effects. We will have to wait and see the final results of the inquiry, but everyone involved needs to be held responsible to the full extent of the law.
This whole affair originated in the intense competition among domestic pharmaceutical companies to fix prices charged insurance companies at levels higher than competitors. The prosecution needs to see whether there were secret agreements between producers and the institutions that were supposed to do the testing.
The fundamental origin of the problem lies with government authorities. Saying they were going to reduce the number of prescriptions for expensive "original" products they encouraged the production of imitations, but then they didn't engage in any oversight whatsoever. They went right along and approved products having seen only reports submitted by research centers that had done testing funded with money given by producers. This latest investigation would have been impossible had it not been for a specific internal complaint. The authorities need to be held responsible for throwing the people's safety aside by being stingy with insurance finances.
So far close to 4,000 products have been approved by the authorities following bioequivalence tests. If only to prevent public distrust of all pharmaceutical products, the government needs to focus all means at its disposal on tracing the products on the market in order to comfort the people's concerns.
The Hankyoreh, 26 April 2006.
[Translations by Seoul Selection]
[Editorial] Pharmaceutical Companies, Researchers in Trouble |
