Thalidomide must be regulated
Written by Writer on Friday, October 10th, 2008
Thalidomide must be regulated
Masayuki Takata / Yomiuri Shimbun Staff Writer
Thalidomide, a drug infamous for its shocking side effects in the past, will soon be approved by the health ministry for the treatment of multiple myeloma, a type of blood cancer.
In 1958, the drug was put on sale in Japan as a sedative and for treating stomach complaints. But the babies of pregnant women who took thalidomide to ease morning sickness were found to have defects. In Japan, 309 people were recognized as patients suffering from thalidomide-induced disorders.
The drug was banned in 1962.
It is very rare for a drug proven to have caused disorders to receive official approval again.
Behind the unusual move by the Health, Labor and Welfare Ministry is the growing number of doctors and patients importing the drug on their own.
In the late 1990s, thalidomide was recognized overseas as being effective for treating multiple myeloma. Seventeen countries, including the United States and Australia, have approved the drug.
Some patients in Japan began importing thalidomide around 2000, and imports have followed an upward trend each year since then. In fiscal 2006, thalidomide imports totaled about 590,000 tablets, a threefold jump from 160,000 in fiscal 2001.
Based on the figures, up to 1,500 people are believed to have taken the drug over the period.
Looking at the notifications issued for the importing of unauthorized drugs, the number of those for thalidomide stands out.
With thalidomide’s effectiveness in treating intractable or relapsing diseases becoming increasingly well-known, patient groups have demanded that the drug be approved in Japan as soon as possible since the number of doctors currently administering the drug is very limited.
In 2006, Fujimoto Pharmaceutical Corp., based in Matsubara, Osaka Prefecture, filed an application with the health ministry for approval to produce the drug.
In screening the application, the ministry gave most weight to the fact that many people had suffered from thalidomide-induced disorders previously.
Given the drug’s tragic past, the ministry made it an absolute requirement that Fujimoto Pharmaceutical take specific measures to prevent the recurrence of drug-induced disorders.
Fujimoto Pharmaceutical was obliged to introduce safety steps to ensure that pregnant women would not take thalidomide and that people in general would not use the drug by mistake.
The ministry placed another condition on approval. By having representatives of those suffering from thalidomide-induced disorders and people stricken with multiple myeloma attend the negotiations over safety measures, steps could be devised to everyone’s satisfaction.
Based on the conclusion of the discussions, the ministry’s Pharmaceutical Affairs and Food Sanitation Council recommended approval of the drug last Friday, paving the way for the resumption of sales of thalidomide in the country for the first time in 46 years.
The envisioned approval will provide about 30 percent of the 14,000 patients suffering from intractable or relapsing diseases with health insurance coverage for the use of thalidomide.
Fujimoto Pharmaceutical submitted measures requiring doctors, pharmacists and patients to register in advance of use and provide relevant information to be collected via fax when prescriptions are made, so a record can be kept of the recipients of all the tablets.
A framework was also established to allow those suffering from thalidomide-induced disorders, patients of multiple myeloma and ministry officials to be members of a third-party committee responsible for checking whether the after-sales administration of drugs functions appropriately.
But even with the introduction of this strict system, the prevention of lax prescription giving or irresponsible drug-taking is really another matter.
Concerned parties need to try to fully understand the unfortunate history and the dangers of the drug to ensure safe prescriptions and drug-taking.
Even in recent years, in Brazil, for example, people were found to have suffered from disorders caused by thalidomide, a fact that shows drug-induced disorders are not a thing of the past in the world.
The spread of the Internet has made it easy to purchase drugs distributed in foreign countries.
Before an approved drug becomes widely available, it is now almost inevitable that the use of domestically approved drugs and unapproved imports occurs, resulting in a double standard in the way the treatment is handled.
With thalidomide set to be approved, the ministry is said to be establishing a new framework for registering the usage of imported drugs and treatment methods used, for which there are currently no regulations.
However, since the ministry has no intention of making the new framework binding, it remains to be seen how many doctors will voluntarily register.
In the past, there have been reports that family members of patients taking thalidomide had used the drung as a sleeping pill and that the drug had been passed on to other patients.
The new approval of thalidomide has served as an opportunity to bring to light the so-called drug-lag problem in which the drug screening process in the country is so much longer than those in foreign countries.
While the ministry has worked to speed up the drug screening process by increasing the number of officials involved, its efforts have stopped with the formation of a research team to study cases of unapproved drugs in use in foreign countries.
But the health ministry should look into regulating the use of unapproved drugs as soon as possible.
The administration of pharmaceutical affairs is responsible for saving the lives of patients, while preventing drug-induced disorders. In this respect, the recent recommendation for the approval of thalidomide brings us no further than the starting line with regard to the issues involved.
