The Aword

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1990: Li ([1]), a Chinese author, wrote a comparison of Myodil and Omnipaque, a water-based dye.


The author concluded:

"The side effects and toxicity of omnipaque as a contrast medium in myelography were less than those of myodil. However, myodil myelography might be useful and not abandoned in those areas where local economic conditions and facilities were less favorable."

This must surely raise the question of whether the more toxic dye is still in use in countries where economic considerations combine with poor facilities.

The 1990s: the clouds gather...

1990 saw the first substantial media coverage of related-related arachnoiditis.

Journalist Scott Kerbey of Inside Edition contacted the FDA about a patient who had attempted to sue Alcon, failing because of the Statute if Limitations.

The FDA noted that there had been 16 reports of Pantopaque-related arachnoiditis on their files between 1977 and 1989.

The FDA were also concerned about the impact of a popular TV show, Geraldo Riviera, which had included a piece on arachnoiditis.

In August 1990 a Wall Street Journal article was published on the subject of Pantopaque.

Shortly after these events, Alcon issued an Increased Frequency Report (IFR) of adverse incidents for the period March-September 1990 compared with February 1989-Feb. 1990. (25 reports rather than 12).

This was decidedly interesting timing.

It may of course simply suggest that the increased awareness of the condition led to greater incidence of reporting...

...or the more serious implication is that Alcon realised that they were due to come under closer scrutiny now the matter was in the public domain and that this necessitated an apparently more proactive stance from them.

If the latter is at all true, it does of course call into question the efficacy of the licensing authority.

The FDA, we are unsurprised to learn, took no further action.

[1] Li SW Zhonghua Shen Jing Jing Shen Ke Za Zhi 1990 Aug; 23(4): 240-2, 256 [A comparison of myodil and omnipaque as contrast media in myelography]