Wednesday, August 26, 2009

The High Cost of Veterinary Ignorance

I have good news this flu season. And the good news is that the U.S. Government is not paying too much attention to Scott Weese over at the "Worms and Germs" blog.

His advice: Throw away all your medicines as soon as they hit their expiration date.

Instead, the U.S. Department of Health and Human Services (HHS), is listening to the FDA's Francis Flaherty and his team which have actually done the work on drug expiration dates.

So too is the Center for Disease Control (CDC), the U.S. Department of Defense (DoD) and the Department of Homeland Security (DHS).

Instead of tossing out billions of dollars worth of drugs, such as Tamiflu and antibiotics, the U.S. Government is keeping those drugs on the shelf, secure in their efficacy despite the fact that many are years past their "expiration" date.

Why is this good news for America?

Simple: Not only does this save tax dollars, but it may also save lives.

To put a point on it: If the U.S. followed Scott Weese's advice to throw everything down the drain as soon as a manufacturer's expiration date was crossed, we might not have the Tamiflu we now need as we enter this Fall's flu season.

How many American lives might that cost?

Who knows, but with up to 90,000 deaths now predicted by the CDC due to Swine Flu this Fall, I think the number "zero" is not in the mix.

Even when told about the FDA expiration date research and the Strategic National Stockpile of drugs kept by the Center for Disease Control, Scott Weese has not bothered to find out what kind of drugs are kept, or how long they are kept for.

Here's a hint: Thousands of TONS of antibiotics and other drugs (such as Tamiflu) are kept for YEARS past their putative expiration dates.

The fact that many common drugs, including Tamiflu, pill, capsule and caplet antibiotics, are safe and effective for years past the manufacturer's suggestion, is not closely held information.

As Johns Hopkins Health Alerts notes.

Think of expiration dates -- which the U.S. Food and Drug Administration (FDA) requires be placed on most prescription and over-the-counter medications -- as a very conservative guide to longevity....

In a study conducted by the FDA on a large stockpile of medications purchased by the military, 90% of more than 100 medications were safe and effective to use years after the expiration date. More recently, the FDA approved two-year extensions on expiration dates for a number of drugs, including the antibiotics Cipro (ciprofloxacin), penicillin, and tetracycline ....

If your medications have been stored under good conditions, they should retain all or much of their potency for at least one to two years following their expiration date, even after the container is opened.

The good news is that HHS has pre-positioned flu drugs, antibiotics, and other emergency medical supplies in 50-ton "Push Packs" around the nation. As The Richmond Times Dispatch notes:

The Strategic National Stockpile contains medications and supplies that would be needed in a mass disaster or other emergency. Examples of emergencies include a pandemic flu outbreak, hurricanes and terrorist attacks.

The stockpile includes such drugs as the flu medicine Tamiflu and the antibiotic Ciprofloxacin, as well as medical supplies, such as those for administering drugs intravenously or for keeping a patient's airway open.

Virginia, for instance, received 280,000 treatment courses of flu drugs from the federal stockpile in the recent H1N1 swine-flu scare. The state already had nearly 800,000 treatment courses of antivirals in its own stockpile.

A stockpile can consist of drugs on hand in an existing inventory, or it can be vendor-managed inventory that a state has contracted to purchase.

According to the U.S. Centers for Disease Control and Prevention, the federal stockpile is routinely checked to make sure the items are within their recommended shelf life. That's done by making quarterly checks on some items and an annual inventory, which includes inspections of environmental conditions, security and overall package maintenance.

Now that it looks as if the stockpile drugs sent to states might not be needed anytime soon [note: this article was written in May of 2009], what happens, for instance, to the 280,000 extra treatment courses Virginia received?

States will likely get to keep the drugs, a state official said.

The shelf life of some stockpile drugs can be extended beyond their expiration date under the Food and Drug Administration's Shelf Life Extension Program. That effort started as a way for the Department of Defense to save money by not having to throw away drugs that were still usable just because the expiration date had passed.

Tamiflu has qualified for that program. Batches or lots of Tamiflu in the stockpile that meet rigorous testing standards can have the shelf life extended from five years to seven years.

When drugs from the stockpile are used, it's done under FDA Emergency Use Authorizations. The FDA issues special letters to consumers and special prescribing instructions for health-care providers.

In fact, as the FDA web site notes, Tamiflu expiration dates, even for oral suspensions (liquid) are being extended by two years.

Tamiflu is not an antibiotic, of course, but the point is even more true for pill, capsule and caplet antibiotics, which have proven shelf lives that extend for YEARS past the manufacturer-contrived or pharmacy-invented expiration date printed on the side of the bottle.

As Dr. Francis Flaherty, Director of the U.S. FDA's expiration testing program noted a few years back:

"Manufacturers put expiration dates on for marketing, rather than scientific, reasons. It's not profitable for them to have products on a shelf for 10 years. They want turnover."

In short, short expiration dates are, for the most part, little more than a scam.

The fact that potent pill antibiotics are being stored for YEARS past the manufacturer's made-up expiration date is not a closely held secret. As the White House web page on the Strategic National Stockpile notes:

[Strategic National Stockpile] efficiency measure is focused on reducing the cost of replacing inventory by extending the shelf life of products that remain efficacious after their original manufacturer's expiration date through a Shelf Life Extension Program (SLEP). By extending the shelf-life of a product, the program does not need to spend money to replace that product as quickly or as often. The program's assets now include large amounts of antibiotics that cannot be rotated back into the market and chemical/nerve agent with no commercial use. Where possible, the program rotates stock in the market to avoid expiration of supplies through its vendor managed inventories. ... The program's annual efficiency measure is dollars saved per dollar invested in the Food and Drug Administration's Shelf Life Extension Program (SLEP) for available projects.

The Shelf Life Extension Program (SLEP) has found that cipro, a common pill antibiotic, is good for more than seven years past its putative expiration date.

Doxycyclin, amoxycillin, penicillin, and cephalexin are similarly long-lived if kept in a medicine bottle at normal room temperature.

It's not just Uncle Sam that stores Tamiflu and antibiotics for years at a time. The City of Los Angeles, for example, notes that its pre-positioned antibiotics have a shelf life of approximately four (4) years.

The National Institute of Health notes that the U.S. Department of Health and Human Services has a contract with Bayer, the maker of Cipro, to rotate its stock every three years -- two years longer than the expire date you will find on the same drug if you buy it at your local pharmacy.

This last point is not a small matter.

I find it hard to believe that Scott Weese does not know the difference between a manufacturer's expiration date (2-3 years) and the even more bogus date put on by dispensing pharmacies (typically 6-months or a year) which are designed to get patients to toss good medicines down the drain even faster.

I am going to be charitable here, however, and assume ignorance rather than malevolence.

After all, as pharmacist and U.S. Army Colonel George Crawford has noted:

"Nobody tells you in pharmacy school that shelf life is about marketing, turnover and profits."

And clearly no one tells you in veterinary school either. Scott Weese is living proof of that!

Bottom line: Just because a guy is a veterinarian does not mean he knows anything about drug expiration dates, generic drugs, drug manufacturing, or drug marketing.

No doubt Mr. Weese got into veterinary school by blindly regurgitating everything he was told.

If that's the case, I suspect there a few more medical mysteries he has yet to discover.

What? You say vaccinating every dog and cat every year is not needed and increases immunity disorders? How can that be true?

What? Branded drugs are no different than their generic analogs? That cannot be right!

What? A pet's generic drug needs can be filled for a few dollars at the local WalMart or Costco? There's no need to get your meds directly from the vet? Can that possibly be true?

What? Manufacturers have a financial reason to suggest you should toss out perfectly good drugs and buy more? Dispensing pharmacies have this same incentive? Unbelievable!

The good news is that on this last question, at least, the U.S. Government has voted with its wallet and with its eyes wide open.

As a consequence, perhaps a few lives may actually get saved this Fall. And wouldn't that be nice?!

A final note: A flu vaccine is the best way to make sure you stay healthy this Fall. If you are unlucky enough to come down with the flu, antibiotics will NOT help as the flu is caused by a virus.

Tamiflu might help to alleviate symptoms. That said, rest, a lot of hot fluids, and chicken soup will generally work wonders in a week or so. Give that a try.


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