Vaccines, Tamiflu, and a Sobering Video

#212


Today will be a roundup of sorts. Three items on the agenda.


First, we get this news article about GSK (GlaxoSmithKline), producers of a pre-pandemic vaccine for the H5N1 Avian Flu. Admittedly, this reads more like a press release than a legitimate news item. Or perhaps veiled threat, it’s hard to tell. It plays hardball; warning the UK to either fish or cut bait with their decision on buying a vaccine.

GSK predicts unrest if bird-flu mutates
By Katherine Griffiths, City Correspondent
Last Updated: 11:16pm GMT 12/11/2006

Several governments around the world have promised to send in the army to protect GlaxoSmithKline manufacturing plants that produce bird flu vaccine should a pandemic break out, the drug maker's chief executive, Jean-Pierre Garnier, has said.

"People don't realise the disorder which comes from a scary event such as a true pandemic. It is not going to be the time to line up to your friendly pharmacist because there will be hundreds of people there. There will be panic episodes," Mr Garnier said.

The Government is expected to make a decision in the next few weeks on what measures to take to protect the UK should bird flu mutate so that it can be passed from human to human, creating a global pandemic. As well as stocking up on antibiotics and face masks to reduce the risk of infection, the Department of Health is also expected to build a reserve of bird-flu vaccine.

GSK is one of several major pharmaceutical companies working on a vaccine against H5N1, the current strain of bird flu. It has signed a deal to supply its vaccine to Switzerland and an unnamed Asian country. It is in talks with other countries including the UK and US.

"We're hopeful the UK will come to a decision before the end of the year because other countries are knocking on our door," Mr Garnier said.

http://tinyurl.com/sup8l


The WHO (World Health Organization) has expressed concerns as to whether it is premature to be buying up Avian Flu vaccine. The H5N1 virus has yet to mutate to a pandemic strain, and there are no guarantees that any vaccine produced today would confer immunity. Still, in light of the meager defenses we have against a novel virus, there is a market out there.


The idea that vaccine plants would need protection is not surprising, but the public admission is a bit startling. Should a pandemic arrive, people will be desperate for a vaccine. And desperate people sometimes do desperate things.


GSK believes they can produce 100 million doses of vaccine over the next year, and at roughly $10 a shot, that’s a billion dollars worth of sales. One can understand their security concerns.



Our second stop centers around the revelation that Tamiflu may have harmful side effects, particularly in children. This is not new news, but yesterday, it resurfaced with calls to add warnings to the label of Tamiflu sold in the United States.

Panel Urges Abnormal Behavior Warning For Tamiflu

(AP) WASHINGTON Doctors and parents should watch for signs of bizarre behavior in children treated with the flu drug Tamiflu, federal health officials suggested Monday in citing an increasing number of such cases from overseas.Food and Drug Administration officials still don't know if the more than 100 new cases, including three deaths from falls, are linked to the drug or to the flu virus -- or a combination of both. Most of the reported cases involved children.

Still, FDA staff suggested updating Tamiflu's label to recommend that all patients, especially children, be closely monitored while on the drug. They also acknowledged that stopping treatment with Tamiflu could actually harm influenza patients if the virus is the cause of the delirium, hallucinations and other abnormal behavior.

http://tinyurl.com/vlu5p


Between 2000 and 2005, there were reports of 126 possible adverse reactions to Tamiflu, primarily in children under 16, and mostly reported from Japan. This included a number of suicides, and cases of delirium and hallucinating. Twelve months ago the FDA decided there was insufficient evidence to show a direct link between the drug and the reported aberrant behavior.


Over the past year, another 100 new reports have emerged, prompting another review.


Despite the breathless reporting of the newspapers on this, it is axiomatic that there is no such thing as a truly innocuous drug. Even the safest drugs can, on occasion, have unwanted side effects.


Undoubtedly, the anti-Tamiflu crowd will use this to demonize the drug.


The question we must ask ourselves is not whether Tamiflu is 100% safe, but are its risks outweighed by its benefits?


The efficacy of Tamiflu against the Avian Flu is uncertain as of this writing. It appears to help, but there have been no controlled studies of the drug against the H5N1 virus, nor are there likely to be. The evidence is largely theoretical and anecdotal. Still, until more evidence to the contrary is uncovered, it appears to be the best arrow in our limited quiver against this disease.


For now, I concur that a warning label should be added, and parents should carefully monitor their children for disturbances in their behavior while taking the drug. Just as they should when giving their children any medication.



And finally, a video produced by the John’s Hopkins Center for Biodefense Studies, the Office of Emergency Preparedness, The US Public Health Service, and the Department of Health and Human Services (HHS).


This is a good overview, in eight short minutes, of the impact of the Spanish Flu of 1918, and the possible ramifications of a new pandemic. Lots of historical photographs from the great pandemic, and excellent narration.


It is available on youtube.com. Those will a slow dialup connection may find that it takes a while to load. But worth taking the time to watch.

http://tinyurl.com/yjhlf7