Submission of public comments on the revision of two Risk Management Systems: TERMS for the multiple myeloma treatment drug Thalidomide, and RevMate for the similar drug Lenalidomide
2012-06-21
On June 21st 2012, we submitted an opinion paper (public comments) to the Ministry of Health, Labor and Welfare concerning the revision of two Risk Management Systems: TERMS for the multiple myeloma treatment drug Thalidomide, and RevMate for the similar drug Lenalidomide.
TERMS and RevMate were drawn up to prevent unborn babies from being exposed to Thalidomide (Thalid Capsules or Thalomid Capsules) and Lenalidomide (Revlimid Capsules), which are both used to treat multiple myeloma and can cause malformations in unborn babies.
However, surveys on patients conducted by TERMS third party panels and RevMate third party evaluation committees have made clear that the systems are huge burdens on patients, so it was suggested that both be revised.
Medwatcher Japan wishes to reduce as much as possible any additional burden on patients already struggling with multiple myeloma which is a difficult condition to be suffering from.
But on the other hand, past cases of drug calamities involving Thalidomide have resulted in many victims. As these cases have shown, the damage brought about by malformations is extremely serious, so victims of drug calamities, patients of multiple myeloma and experts held thorough discussions at a Ministry of Health, Labor and Welfare panel, and TERMS and RevMate were drawn up as a result. The importance of this process must be fully understood and respected by all parties when revising both risk management systems.
The disabilities that follow malformations caused by Thalidomide occur not in the patient but in another person who is not yet born. Therefore, even though the patient accepts that revising TERMS and RevMate could lead to an increased risk of danger, any malformations will occur in the unborn child, not in the patient. As long as the unborn child has no right to self-determination, revising the risk management systems would be unfair.
Based on the above, we are fully aware of the need to reduce patient burden when revising the two risk management systems, but on the other hand believe we have no choice but to address the issue cautiously, focusing on safety so that no malformations occur in unborn babies. When considering how a female patient is defined under the systems, the frequency of regular inspections and any tests to determine comprehension, we have submitted opinions stating that we cannot agree to a proposed easing of TERMS and RevMate.
