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Why Does BMS Compare Opdivo with Placebo?Reporter’s Notebook
  • By Park Gi-taek
  • Published 2017.02.08 14:33
  • Updated 2017.07.04 18:56
  • comments 0

People pay much attention to and have interests in immunotherapy for cancer. The reason is simple: Its efficacy is better but the side effects are much less than the existing chemotherapy or target anticancer drugs. Even people can expect a full recovery. The efficacy is being proved by clinical trials. It isn’t only applied to a specific cancer, but to various cancers.

It is true thorough tests should be taken because it doesn’t have a long history used in clinical fields. High price is another problem. But doctors and patients are raising their expectations from positive researches.

The research, ONO-4538-12, released by ONO Pharma Korea and BMS Pharmaceutical Korea is a case in point. Opdivo (ingredient name: Nivolumab) is effective in melanoma, non-small-cell lung cancer, renal cell carcinoma of kidney, lymphoma, and head and neck cancer.

But the ONO-4538-12 research compared Opdivo with Placebo.

The research subjects were patients who weren’t recovered from gastric cancer with existing standard treatments or who had progressive or recurrent gastric cancer. But is it ethically appropriate to provide placebo to patients who suffer from progressive or recurrent gastric cancer?

Besides the ONO-4538-12 research, there are a few similar cases to compare with placebo in clinical trials for patients who suffer from serious diseases such as cancer etc. Why?

In conclusion, placebo can be the best option in clinical trials for terminally-ill patients. The answer from the medical department at BMS Pharmaceutical Korea is as follows.

“Generally, in case of clinical design of a controlled trial, Standard of Care (SoC) is used in the controlled group. If there is a drug whose effect is proved, Soc is used. Otherwise, Best Supportive Care (BSC) will be used in a controlled group.

In this case, placebo can be used to satisfy double-blind condition. You may not understand why drugs for treatment aren’t included in a controlled group. But if drugs whose efficacy isn’t proved are used in the group, they can provide potential harm to patients. Especially it is highly likely to do harm to patients if toxic anticancer drugs are used.

It may be difficult to judge the efficacy of test drugs when research results are released. For example, if controlled drugs aren’t effective or less effective than placebo because of toxicity, the efficacy of test drugs might not be proved.”

The ONO-4538-12 research was conducted for patients who couldn’t be treated with SoC. Placebo can be the best BSC because follow-up measures can give pains and cause side effects to them. Of course, the clinical design got the approval from IRB (Institutional Review Board) of the organizations that took part in the clinical trials.

BMS Pharmaceutical Korea said, “if researchers plan to do research to provide drugs whose effect aren’t proved in a controlled group, ethical issues can be raised.”

Media has reported the negative effect of clinical trials in terms of side effects and patients’ treatments. But we don’t need to make a hasty conclusion given the fact that there are clinical trials based on detailed plans to reduce pain for patients with different types of cancers.

pkt77@docdocdoc.co.kr

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