New drugs often loom as a last hope for terminal-cancer patients who have exhausted without success all forms of conventional treatment available. Sometimes, though, drugs cause serious side effects and completely betray patients’ expectations. Two such incidents have occurred recently, giving us reason to think again about this problem.

The cases involve a new drug, Iressa, which is used to treat lung cancer, and an old drug, Thalidomide, which has quietly re-emerged even though it is not authorized by the Ministry of Health, Welfare and Labor and was proven in the past to have been responsible for limb deformities in human fetuses.

In the roughly six months since the oral drug Iressa went on sale, it has been used by an estimated 20,000 people. For 124 of the users who have died during this period, the suspected cause of death is the drug’s side effects, which include pneumonia. This figure may increase as the investigation develops further. It would be extremely problematic if so many people were found to have died from the side effects of a new drug. Given the speedy approval of the drug by the Health Ministry and its rapid, widespread use, one cannot help but feel that insufficient caution has been taken.

As a new type of drug that targets the particles that appear in cancer cells, Iressa attracted much attention even in its developmental stage. Word spread that it had few side effects. The Health Ministry approved marketing of the drug in July of last year, just five months after the application was submitted. Since Japan tends to be slow in approving drugs, the timing of the decision concerning Iressa was certainly unusual. In fact, the drug has yet to be approved in any other country.

Clinical tests in Japan showed a success ratio of 27 percent — better than results in Europe and America. However, tests in Japan were conducted on only 102 people. Furthermore, information that a large number of deaths from pneumonia were occurring among users of the medicine overseas was somehow overlooked. Less than 2 percent of patients taking Iressa have developed pneumonia, but it is difficult to distinguish early symptoms of pneumonia from those of a common cold. Often a diagnosis comes too late to begin effective treatment.

Both doctors and patients should be well aware of the possible side effects that Iressa can produce in patients’ lungs. It has been pointed out that other cancer drugs have similar side effects, but obviously the greater the risk that the side effects may be fatal, the less acceptable the drug. Cancer drugs must be administered more carefully.

The conditions for administering Iressa have been tightened since the number of deaths linked to its use was disclosed. For example, the doctor prescribing the medicine must be a lung-cancer specialist, and treatment now requires four weeks of hospitalization. Iressa has proved effective in shrinking cancer cells in some patients, but it is uncertain whether the drug prolongs life. Greater transparency is needed regarding both the benefits and dangers of this drug.

The other development is the growing use of the unauthorized drug Thalidomide, which is being privately imported and prescribed by some doctors. Thalidomide is being used to treat such diseases as multiple myeloma, a bone-marrow cancer. In the past Thalidomide was used as a soporific, but it was banned in 1962 after it became apparent that it caused deformities in fetuses. Thalidomide is thought to be effective in temporarily alleviating the symptoms of cancers such as multiple myeloma. An increasing number of patients are said to be resorting to this drug. Its import is estimated to have expanded from 160,000 tablets in fiscal 2001 to 400,000 in 2002.

This is a worrisome situation. Clinical tests and other studies must be quickly conducted in Japan to determine whether Thalidomide is really effective and necessary as a cancer drug. Otherwise, use of banned drugs in large amounts will only encourage the development of black-market activities. The solution is to maintain strict conditions on the use and distribution of Thalidomide, while making it available to patients on the basis of a diagnosis by a responsible doctor. The government should consider formulating rules that allow for its use in exceptional circumstances.

When it comes to medicine, the bottom line is simple: Use of drugs that carry a high risk of causing harmful side effects must not be allowed. If a drug is effective, it should be used properly. The government, pharmaceutical companies, and doctors must respect this standard and promote anticancer drug treatment that benefits patients.

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