EDITORIAL: Iressa drug ruling - asahi.com

The Osaka District Court on Friday ordered the Japanese unit of British drugmaker AstraZeneca Plc to pay compensation to nine of 11 plaintiffs in a suit over side effects caused by the lung cancer drug Iressa.

The district court, however, denied the state's liability, pointing out that the government instructed the company to disclose information about side effects.

Last month, the court recommended a settlement of the case, urging both sides to compromise. It is not unusual that a court's ruling on a legal dispute is not totally in tune with what it said when it recommended a settlement of the case.

When the Osaka court called for a compromise in this case, it said the state was responsible for providing relief for the victims.

It is, therefore, not surprising that the plaintiffs were disappointed at the court's decision not to order the state to pay compensation.

The Tokyo District Court is currently hearing another case concerning Iressa's side effects. It's ruling, scheduled to be handed down next month, will be important.

Of the wide range of issues addressed during the trial, the one that attracted the most attention was how information about the potential risks of a drug should be provided effectively to medical institutions and experts on the assumption that no drug is free from side effects.

Iressa's package insert originally cited four possible "serious side effects." The one cited at the top was "severe diarrhea," and interstitial pneumonia, which was the cause of many deaths from the drug's side effects, was listed last.

Both the drugmaker and the government asserted the order was not important, saying blame for the deaths should be placed primarily on the physicians who prescribed the drug without fully understanding its properties.

Are they right?

In response to a series of deaths from the drug's side effects, an emergency safety warning was issued three months after its approval.

After a highly visible warning that the drug could cause interstitial pneumonia was added at the top of the package insert, the number of cases fell significantly.

This was not the first time package inserts became an issue. Five years before it approved the drug, the health ministry issued a bureau chief directive urging pharmaceutical companies to place important information in upper parts of such documents.

Why did the company fail to comply with the directive? Why did the government fail to take a stronger action to ensure compliance? These questions remain unanswered.

Some people may say these documents are intended for experts who should find such important information wherever it is placed.

However, there was the general perception among experts that Iressa was a good medicine with less side effects mainly because of articles in medical journals.

The district court rightly acknowledged the obligation of a drugmaker to provide information necessary for correct treatments in a way that ensures that the information reaches the "average doctor." This decision is in line with the expectations of the public.

The term "informed consent" has become familiar to the Japanese public.

But ensuring effective informed consent requires doctors to have accurate medical knowledge and address the concerns of their patients head-on.

The Iressa debacle has shown again the importance of tackling the challenge of meeting patients' expectations while securing the safety of new drugs.

Even though it was not held legally liable for the sufferings due to Iressa's side effects, the health ministry, which was criticized by the court for failing to make the best possible response to the problem, has to learn many lessons from the episode.

--The Asahi Shimbun, Feb. 26

via asahi.com

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