It’s Getting Weird Out There

I told you things were about to start getting weird with the H1N1 virus – especially concerning how to prevent or treat the virus.

That wasn’t a risky prediction, but already things are getting weirder than I thought they would.

Dead jawbone

Researchers in Hong Kong say they’ve come up with a way to fight a wide range of flu viruses – throw inappropriate drugs at them.

The University of Hong Kong team reports that when Reclast and Aredia (two osteoporosis drugs made by Novartis AG) were applied to human cells infected with flu viruses (including H1N1 and H5N1), additional white blood cells were produced, which killed infected human cells.

I’m not familiar with Aredia, but Reclast…yeah – a little too familiar.

A couple of months ago we sent you a Code Red regarding a dangerous new Reclast development. The FDA reported that in a span of less than two years, 24 cases of kidney damage were linked to Reclast use. Seven of those patients died.

Other serious Reclast side effects include osteonecrosis of the jaw (literally, dead jawbone), abnormal heart rhythm, and hypertension. According to the Reclast website, more common side effects are the standard adverse events we see with so many drugs: nausea, vomiting, diarrhea, and (no kidding) “flu-like symptoms.”

You: “Doc, I took the Reclast for my flu and now I’m having flu-like symptoms.”

Doctor: “Perfect! That means it’s working!”

The Hong Kong researchers told Reuters Health that they plan to test Reclast and Aredia on animals and eventually humans. But if H1N1 should escalate out of control, don’t be surprised to find doctors going ahead and using these drugs on flu patients.

By the way, a single dose of Reclast costs about $1,000. Enjoy!

Getting better with age

Meanwhile, Tamiflu continues to be treated like the drug that will save the world.

Tamiflu, of course, is the antiviral that may shorten the duration of the flu by about one day. Also if you suspect you’ve been exposed to a virus, Tamiflu may help you fight off the flu, although flu strains are likely to develop resistance when the drug is widely used as a preventive.

And that’s it. There’s no evidence at all that Tamiflu saves lives. But in a world that’s as nervous as a shaved cat over H1N1, the public wants to hear only one thing: We’ve got a drug for that.

And that’s why international health officials have decided that any Tamiflu supply that’s about to reach its expiration date isn’t a problem…it’s aged to perfection!

Since 2004, Roche Holding AG (the maker of Tamiflu) has distributed about 220 million treatments of the drug worldwide. The packaging states that Tamiflu doses are good for five years after manufacture, but the Associated Press reports that countries with huge stockpiles have recently reset the expiration clock. The U.S., Australia, the European Union and others have decided to extend the shelf life two years.

World Health Organization officials have given their blessing to this extension. And why not? As I’ve noted in past e-Alerts, the setting of expiration dates is a fairly arbitrary business. So most drugs and supplements that are stored properly are still useful beyond their expiration date. How much further? No one knows. It’s mostly guesswork, so why not add a couple of years?

But here’s the odd wrinkle: The two-year extension applies only to the use of Tamiflu in patients with H1N1 – not patients with seasonal flu. So the older stuff, which is potentially less effective, is FINE for treating the more deadly H1N1, but for seasonal flu you’re going to want the fresh stuff.

It doesn’t make sense. Unless you’re a drug company bean counter. In which case you absolutely want pharmacies, doctors, and Tamiflu hoarders to throw out their stashes after five years and purchase fresh doses.

Do you think that’s going to wash for anyone holding a five-year-old box of Tamiflu? Roche executives might as well get used to it: Seven years is the new expiration.

Source:
“Osteoporosis Drugs Effective in Killing Flu Viruses” Reuters Health 8/14/09, reutershealth.com
“WHO: Anti-Flu Drug Can Be Stored 2 Years Longer” Alexander G. Higgins, Associated Press, 8/18/09, ap.org


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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