H1N1 Flu-Vaccine Trials Underline Trouble Getting Drugs into Japan

Apparently there is a massive world-wide pandemic heading our way courtesy of the H1N1 ‘swine’ flu virus. So say WHO and a number of other organizations, including most notably the government and media. But you wouldn’t know it to look at the actions that are not taking place.

At times, the panic has reached ‘fever pitch’ (sorry about the poor pun….), but there is still little evidence that the H1N1 virus is the danger that it is being touted as. Concerns of officials focus more on what may happen if the virus mutates, rather than what actually is happening. And in spite of the fact that the media are playing their part in claiming every infection and every flu-related death as proof positive of an international disaster of massive proportions, actually so far fewer have died from the H1N1 virus than your regular garden variety flu that strikes year after year. That is no reason for complacency of course, just a little ‘dose’ of perspective…

An Asahi story last week highlighted the slowness of the Japanese government to prepare for the worst case scenario. No one of course wishes for such a scenario, but if government actions are to match the rhetoric, preparations would be prudent. Instead, unlike the US, who plan to cover up to 200 million vaccinations by the end of this year, and France who have already begun receiving delivery of vaccines for their public, Japan is still far behind in its plan to vaccinate just 60 million people (or half of the population). Health ministry officials say that they are only likely to handle about 18 million of these domestically, which means that they will need to procure the rest from overseas.

The problem with this is twofold. Firstly, most of the major drug manufacturers around the world are already flat out in production for orders received from other countries like the US, France and Britain. Secondly, while companies such as Swiss manufacturer Novartis AG may be able to help with Japanese orders, the Japanese government is concerned with the immunological agents employed in their production method, a method that has been used in flu vaccines for more than 10 years by Novartis.

The Japanese government are requiring clinical trials to be conducted by Novartis in Japan on about 200 healthy Japanese adults and around 100 children. This is actually a concession by the government. As I mentioned in an earlier post last week, Japanese processes for approving foreign drugs usually require full formal clinical testing in Japan, even if they have undergone stringent testing overseas. The Health Ministry have indicated that overseas drugmakers will be allowed to sell their vaccines without the clinical tests required by the Japanese Pharmaceutical Affairs Act, if they have been approved by drug authorities in other countries. But they still require the small clinical trials before drugs like those of Novartis will be approved, to ‘confirm their safety in Japan’. As if the drug will somehow mutate once it is brought into the country….

In one sence I applaud the Japanese approach to careful and thorough research before jumping into new things. But there are times when this can actually be irresponsible, and there are also times when it becomes downright oppressive (see certain Japanese trade policies of the 70s and 80s….). The whole hullabaloo over the ‘mad cow’ issue and the freeze on US beef imports is a case in point here, where rhetoric far outstripped science. I am no doctor or flu specialist, and I don’t know what will happen with H1N1. But I do know that if the rhetoric is true, then fast actions need to be taken – even at the risk of side effects (which all flu vaccines have in abundance, and which can be as dangerous at times as the flu itself – even for well respected ‘safe’ vaccines). If the rhetoric is just that, then it needs to quieten down and let people get on with taking the regular precautions that all of us with common sense take in order to not get cut down with the flu during flu season….