Monday, December 29, 2003

Now this article provides plenty of thought for Public Policy majors. Andy Ho always does a good job of making science accessible to the layman, but without cheapening or dumbing down his content. Since The Straits Times only keeps articles for 3 days, the column in question has been reproduced for your reading pleasure :)

Inoculating the world against the wrong flu
By Andy Ho
SENIOR CORRESPONDENT

IF YOU are not one of the 300,000 Singaporeans who have taken the flu shot, count yourself lucky.

The current vaccine against influenza A was made to be used against a strain first isolated in Panama in 1999. However, there is a new strain plaguing the world, called Fujian, which bears 23 significant mutations, some of which are very dramatic, Harvard bioengineer Henry Niman told The Sunday Times.

This means that the vaccine now in use will offer less than the usual 70 to 90 per cent protection rate, and probably way below 50 per cent, since 75 per cent of the cases are now Fujian.

First identified in China (Beijing), the United States (Massachusetts) and Japan (Osaka) late last year, Fujian was already causing severe illness in Australia and New Zealand by February this year.

Coincidentally, that is also the time of the year when the major pharmaceutical firms decide, in collaboration with governments, what flu strains to manufacture the annual vaccine against.

Most knew about the emerging Fujian strain, but decided to stick with Panama anyway.

How was that decision made in the US, the nation so far worst hit by the Fujian flu?

Badly.

Its Vaccines and Related Biological Products Advisory Committee in the Food and Drug Administration (FDA) made the fateful call on March 18. A transcript of its proceedings can be read on the FDA website.

Except for a lone voice of dissent - and two abstentions - 17 physicians and public health specialists voted to bring back the Panama shot.

A close reading of the questions posed shows that, though experts in their own fields, few seemed familiar with genetics or vaccine production. Instead, they appeared dependent on the presentations by two speakers who briefed them before a vote was taken.

People about to cast an important vote are duty-bound to do some homework beforehand but the proverbial dog could have eaten all their homework, save for one person.

Came decision day, three sins committed went unexpiated because only one member could recognise them.

First, the threat that the new strain would likely pose was underplayed.

Fujian was already spreading geographically and had caused disease in the southern winter, thus heralding a new epidemic.

Moreover, the fact that two of the 23 mutations in Fujian had first appeared in the 1968 pandemic, then disappeared, only to reappear now, was nowhere noted in their deliberations.

If they had only studied the genomes of the flu strains available on the Internet, they would have seen the telltale mutations.

Second, they were told that there was no way to produce the Fujian vaccine, the strain having failed repeatedly to grow in chicken eggs. The Europeans and Japanese were experiencing similar difficulties.

(The difficulty in growing the virus should have been a broad hint that Fujian was significantly different from Panama.)

In fact, there were other ways to grow the virus - through cell cultures alone, or through cell cultures followed by transfer of the rapidly growing virus into eggs.

The Japanese did successfully grow the Fujian virus in a cell culture and transfer it into eggs. These could have been used to begin making the vaccine.

But the Americans refused the same procedure, fearing that cell cultures might introduce other extraneous agents, some potentially cancerous, into the vaccine.

In fact, chicken eggs might also introduce similar agents but, never mind, eggs have always been used.

The FDA was unlikely to approve the use of viruses that had been through a cell culture even once, the participants at the vaccine advisory committee were told.

And even if it did, approval would take months - too late to use them this season because manufacturing the vaccine using eggs takes eight months and so must commence by early April if they are to get to market by the cold season at year's end.

Yet, had they done their homework, they would have come across a firm called Solvay Pharmaceuticals with one cell culture licensed for use in vaccine production.

Using cell cultures alone without subsequent transfer into eggs produces vaccines much faster, possibly in time even for use this season.

This had been successfully tried out on an industrial scale in Austria last year, where the vaccine worked safely and effectively in 2,500 volunteers.

In addition, having voted to use the old Panama strain, it behooved the American health authorities to inform the public that this year's flu shot wasn't going to offer much protection against the expected bug.

They didn't - and yet they are still telling at-risk groups to take the shot.

I'm befuddled: Annual shots are recommended because the flu virus keeps changing, the experts say. Yet the strain used in making the influenza A vaccine has remained completely unchanged since 2000, even though the virus has mutated.

The 17 members of the committee seemed to have voted less on the science and more on regulatory considerations and industrial concerns - decidedly not their areas of expertise too.

Had the vote been 20 against Panama, it might have forced the FDA's hand to make a quick decision about using the licensed cell culture to produce the Fujian.

But it's too late now for the families whose children have died from Fujian. Looks like a long winter ahead for the Americans.

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I bring this article to your attention, because these are the kind of situations that Public Policy (at least the way I was taught it at the University of Chicago anyway) equips people to study. At first glance, it's easy to conclude that the decision-makers were negligent or even amoral (this seems to be Mr Ho's slant as well).

This is in no way a criticism of Mr Ho's writing, but I observe that lots of people (not including Mr Ho) think that government policy is a matter of the right people waving a magic wand. It's a whole lot more complicated than that. I wish more people would appreciate the sheer difficulty in coordinating different groups all with their own agendas. I wish more would consider the political give-and-take decision-makers play to get the best deals for their interests. I wish more people were able (or willing) to grasp the concept that routine and organisational processes can and often do blind a person to change -- even if she is the most upright person in the world.

This is why the world needs good Public Policy majors.

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