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`http://www.terrierman.com/antibiotics-WSJ.htm
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`http://www.mercola.com/2000/apr/2/drug_expiration.htm
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`By LAURIE P. COHEN Staff Reporter of THE WALL STREET JOURNAL
`
`Do drugs really stop working after the date stamped on the bottle?
`
`Fifteen years ago, the U. S. military decided to find out. Sitting on a $1 billion stockpile of
`drugs and facing the daunting process of destroying and replacing its supply every two to
`three years, the military began a testing program to see if it could extend the life of its
`inventory.
`
`The testing, conducted by the U. S. Food and Drug Administration, ultimately covered more
`than 100 drugs, prescription and over-the-counter. The results, never before reported, show
`that about 90% of them were safe and effective far past their original expiration date, at least
`one for 15 years past it.
`
`In light of these results, a former director of the testing program, Francis Flaherty, says he
`has concluded that expiration dates put on by manufacturers typically have no bearing on
`whether a drug is usable for longer.
`
`Mr. Flaherty notes that a drug maker is required to prove only that a drug is still good on
`whatever expiration date the company chooses to set. The expiration date doesn't mean, or
`even suggest, that the drug will stop being effective after that, nor that it will become
`harmful.
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`"Manufacturers put expiration dates on
`for marketing, rather than scientific,
`reasons," says Mr. Flaherty, a pharmacist
`at the FDA until his retirement last year.
`"It's not profitable for them to have
`products on a shelf for 10 years. They
`want turnover."
`- Dr. Francis Flaherty, Director,
`US FDA expiration testing program
`
`Marketing Issue
`
`"Manufacturers put expiration dates on for marketing, rather than scientific, reasons," says
`Mr. Flaherty, a pharmacist at the FDA until his retirement last year. "It's not profitable for
`them to have products on a shelf for 10 years. They want turnover."
`
`The FDA cautions that there isn't enough evidence from the program, which is weighted
`toward drugs needed during combat and which tests only individual manufacturing batches,
`to conclude that most drugs in people's medicine cabinets are potent beyond the expiration
`date. Still, Joel Davis, a former FDA expiration-date compliance chief, says that with a handful
`of exceptions -- notably nitroglycerin, insulin and some liquid antibiotics -- most drugs are
`probably as durable as those the agency has tested for the military. "Most drugs degrade very
`slowly," he says. "In all likelihood, you can take a product you have at home and keep it for
`many years, especially if it's in the refrigerator."
`
`Manufacturers' View
`
`Drug-industry officials don't dispute the results of the FDA's testing, within what is called the
`Shelf Life Extension Program. And they acknowledge that expiration dates have a commercial
`dimension. But they say relatively short shelf lives make sense from a public-safety
`standpoint, as well.
`
`New, more-beneficial drugs can be brought on the market more easily if the old ones are
`discarded within a couple of years, they say. Label redesigns work better when consumers
`don't have earlier versions on hand to create confusion. From the companies' perspective, any
`liability or safety risk is diminished by limiting the period during which a consumer might
`misuse or improperly store a drug.
`
`"Two to three years is a very comfortable point of commercial convenience," says Mark van
`Arandonk, senior director for pharmaceutical development at Pharmacia & Upjohn Inc. "It
`gives us enough time to put the inventory in warehouses, ship it and ensure it will stay on
`shelves long enough to get used." But companies uniformly deny any effort to spur sales
`through planned obsolescence.
`
`Why Not Longer?
`
`Now that the FDA has found that many drugs are still good long after they have supposedly
`expired, why doesn't it advocate later expiration dates for consumer drugs? One reason is
`that the consumer market lacks the military's logistical reasons to keep drugs around longer.
`
`Frank Holcombe, associate director of the FDA's office of generic drugs, says that in many
`cases a manufacturer could extend expiration periods again and again, but to support those
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`extensions, it would have to keep doing stability studies, and keep more in storage than it
`would like.
`
`Mr. Davis adds: "It's not the job of the FDA to be concerned about a consumer's economic
`interest." It would be up to Congress to impose changes, he says.
`
`As things stand now, expiration dates get a lot of emphasis. For instance, there is a
`campaign, co-sponsored by some drug retailers, that urges people to discard pills when they
`reach the date on the label.
`
`And that date often is even earlier than the one the maker set. That's because when
`pharmacists dispense a drug in any container other than what it came to them in, they
`routinely cut the expiration date to just one year after dispensing. Some states even require
`pharmacists to do this.
`
`Meanwhile, poor countries -- under urging from the World Health Organization -- often reject
`drug-company donations of much-needed medicines if they are within a year of their
`expiration dates.
`
`It isn't known how much of the $120 billion-plus spent annually in the U. S. on prescription
`and over-the-counter medicines goes to replace expired ones. But in a poll done for The Wall
`Street Journal by NPD Group Inc. of Port Washington, N. Y., 70% of 1,000 respondents said
`they probably wouldn't take a prescription drug after its expiration date; 72% said the same
`of an over-the-counter remedy.
`
`"People think that, upon expiration, drugs suddenly turn toxic or lose all their potency," says
`Philip Alper, professor of medicine at University of California at San Francisco. In his own
`practice, Dr. Alper says, "I frequently hear -- from patients who can't afford medicine -- that
`they have thrown away expired drugs." He says companies should be required to test drugs
`for longer periods and set later expiration dates when results warrant.
`
`Some manufacturers first began putting expiration dates on drugs in the 1960s, although
`they didn't have to. When the FDA began requiring such dating in 1979, the main effect was
`to set uniform testing and reporting guidelines. As now required by the FDA, so-called
`stability testing analyzes the capacity of a drug to maintain its identity, strength, quality and
`purity for whatever period the manufacturer picks. If the company picks a two-year expiration
`date, it needn't test beyond that.
`
`Testing for a two-year expiration doesn't initially entail holding a drug for two years. Rather,
`the drug is tested by subjecting it to extreme heat and humidity for several months, then
`chemically analyzing each ingredient's identity and strength. (After the date is set and the
`drug is marketed, testing continues for the full two years.)
`
`The FDA also uses chemical analysis in testing for possible shelf-life extension; it doesn't test
`on human subjects. Testing conditions are such that any medicine that meets, say, the
`standards for a two-year expiration date probably lasts longer, the FDA and drug companies
`agree.
`
`Still Good
`
`Consider aspirin. Bayer AG puts two-year or three-year dates on aspirin and says that it
`should be discarded after that. Chris Allen, a vice president at the Bayer unit that makes
`aspirin, says the dating is "pretty conservative"; when Bayer has tested four-year-old aspirin,
`it remained 100% effective, he says.
`
`So why doesn't Bayer set a four-year expiration date? Because the company often changes
`packaging, and it undertakes "continuous improvement programs," Mr. Allen says. Each
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`change triggers a need for more expiration-date testing, he says, and testing each time for a
`four-year life would be impractical.
`
`Bayer has never tested aspirin beyond four years, Mr. Allen says. But Jens Carstensen has.
`Dr. Carstensen, professor emeritus at the University of Wisconsin's pharmacy school, who
`wrote what is considered the main text on drug stability, says, "I did a study of different
`aspirins, and after five years, Bayer was still excellent. Aspirin, if made correctly, is very
`stable."
`
`Only one report known to the medical community linked an old drug to human toxicity. A
`1963 Journal of the American Medical Association article said degraded tetracycline caused
`kidney damage. Even this study, though, has been challenged by other scientists. Mr.
`Flaherty says the Shelf Life program encountered no toxicity with tetracycline and typically
`found batches effective for more than two years beyond their expiration dates.
`
`Plea From the Air Force
`
`The program dates to a U. S. effort begun in 1981 to increase military readiness by buying
`large quantities of drugs and medical devices for the armed forces. Four years later, more
`than $1 billion of supplies had been stockpiled. The General Accounting Office audited Air
`Force troop hospitals in Europe and found many supplies at or near expiration. It warned that
`by the 1990s, more than $100 million would have to be spent yearly on replacements.
`
`The Air Force Surgeon General's office asked the FDA if it could possibly extend the shelf life
`of these drugs. The FDA had the equipment for stability testing. And because it had approved
`the drugs' sale in the first place, it also had manufacturers' data on the testing protocols.
`
`"Nobody tells you in pharmacy school
`that shelf life is about marketing,
`turnover and profits."
`- Col. George Crawford, pharmacist, and direct of
`the U.S. Army's pharmaceutical shelflife program
`
`Testing for the Air Force began in late 1985. In the first year, 58 medicines from 137 different
`manufacturing lots were shipped to the FDA from overseas storage, among them penicillin,
`lidocaine and Lactated Ringers, an intravenous solution for dehydration. After testing, the FDA
`extended more than 80% of the expired lots, by an average of 33 months.
`
`In 1992, according to the FDA, more than half of the expired drugs that had been retested in
`1985 were still fine. Even now, at least one still is.
`
`Such results came as a revelation for Army Col. George Crawford when he took over
`military oversight of the program in 1997. He is a pharmacist, but "nobody tells you in
`pharmacy school that shelf life is about marketing, turnover and profits," he says. (The drug
`makers don't agree that it is, however.)
`
`How It Works
`
`The military's base for the program is a dingy barracks room in Fort Detrick, Md. There, a
`group headed by Air Force Lt. Col. Greg Russie, who recently took over from Col. Crawford,
`tracks drugs that are near expiration at defense facilities all over the world, selecting many
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`for retesting. They are shipped to the FDA, which sends them to its laboratories.
`
`The FDA's lab in Philadelphia recently tested five automatic injectors containing an antidote to
`chemical poisoning, which were purposely held for three months in conditions even hotter and
`more humid than the FDA requires in consumer testing of drugs. The FDA tested the drug
`contained in the injectors, pralidoxime chloride, by separating its ingredients and measuring
`the strength and quality of each, then applying a computer model to determine whether a
`shelf-life extension was warranted.
`
`The injectors' original expiration date was November 1985. The FDA had retested them
`periodically ever since, each time approving their continued use. The batch, made by Ayerst
`Laboratories, now part of American Home Products Corp.'s Wyeth-Ayerst unit, is 18 years old.
`It is 15 years beyond the expiration date applied by Ayerst. The FDA found it is still good.
`
`A spokesman for Wyeth-Ayerst says it "uses scientific data to establish expiration dates" and
`"tries to have the longest possible dating on products that scientific data supports." The
`company is aware of the FDA retesting program. It says it can't comment specifically on the
`injectors tested by the FDA.
`
`"FDA officials say that during the
`program's 15 years, drug makers have
`never objected to any of its procedures or
`findings. 'They may not have liked what
`we were doing, but they weren't able to
`challenge it," [says Dr. Francis Flaherty,
`Director, US FDA expiration testing
`program]."
`
`A Few Fail
`
`Shelf-life extensions are "intentionally conservative," the FDA's Mr. Flaherty told military
`brass in a 1992 speech. He says that if the agency extended an expiration date by 36
`months, it had concluded the lot would retain all of its safety and efficacy for at least 72
`months.
`
`A very few drugs aren't retested. The military has found that water-purification tablets and
`mefloquine hydrochloride, for malaria, routinely fail stability testing beyond their expiration
`dates, so it has removed them from the program.
`
`Also excluded are large-volume intravenous solutions, such as saline. "We don't like to test
`those," says Col. Crawford. "Not because we can't, but because it would be politically
`sensitive if G. I. Joe was lying in bed and saw it had originally expired three years ago."
`
`Mr. Flaherty has said that while he tested a handful of drug batches that didn't even make it
`to their expiration dates, most drugs were "surprisingly durable." In one instance, he says,
`drugs labeled for room-temperature storage had been kept for two years in a warehouse in
`Oman that averaged 135 degrees Fahrenheit in the daytime. Upon expiration, the drugs,
`which included the local anesthetic lidocaine and atropine, a nerve-gas antidote also used by
`eye doctors to dilate pupils, "were well within the standards for potency and other quality
`characteristics," he says.
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`Stable Molecule
`
`One medicine the FDA has endorsed for extensions is ciprofloxacin hydrochloride tablets, an
`antibiotic marketed by Bayer as Cipro. One batch had an expiration date of March 1989. More
`than 9 1/2 years later, the FDA found the tablets still good; it then extended some of them
`for 18 more months and others for 24 more months.
`
`Albert Poirier, quality-assurance director for Bayer's pharmaceutical division, says he isn't
`surprised because Cipro "is a stable drug molecule" in tablet form. "We go for a shelf life that
`will be safest for patients," he says. "We want the drug to be used up within three years. We
`wouldn't want a patient to have it for 10 years because they'd have an old package insert"
`that might omit new information or contra-indications and because "we'd have no control over
`how they'd store the drug during this time."
`
`Another extended drug is Thorazine, a tranquilizer chemically known as chlorpromazine
`tablets. Batches bearing December 1996 expiration dates -- unused and unopened, as is the
`case with all drugs evaluated in the Shelf Life program -- were tested in July 1998 and
`extended for two years. A spokesman for the maker, SmithKline Beecham PLC, says it applies
`an expiration date 24 months after manufacture. "We think that is the appropriate expiration
`date," he says. "We don't benefit from short expiration dates."
`
`Some other drugs the FDA has extended at least two years beyond their expiration dates are
`diazepam, sold as Valium; cimetidine, sold as Tagamet; phenytoin, sold as Dilantin; and the
`antibiotics tetracycline and penicillin.
`
`Big Savings
`
`On a cost-benefit basis, the program's returns have been huge. The first year, the Air Force
`paid the FDA $78,000 for testing and saved 59 times that sum by not needing to replace the
`drugs. After other services joined, the military from 1993 through 1998 spent about $3.9
`million on testing and saved $263.4 million on drug expense, according to Lt. Col. Russie.
`
`Says Mr. Flaherty: "We've cost the pharmaceutical companies hundreds of millions of dollars
`in sales of new stuff to the Department of Defense."
`
`More than 12 years ago, Messrs. Flaherty and Davis explained the program to drug-company
`chemists at a meeting of the American Association of Pharmaceutical Scientists in
`Woodbridge, N. J., going into detail about how the FDA decided whether to extend a given
`expiration date. Mr. Davis concluded by noting how much the U. S. had saved by extending
`shelf lives instead of "destroying large quantities of still-useful medical products... ."
`
`Mr. Flaherty says the FDA was keenly aware that if its methodology was flawed, or its results
`incorrect even once, its credibility would be attacked. Yet FDA officials say that during the
`program's 15 years, drug makers have never objected to any of its procedures or findings.
`"They may not have liked what we were doing, but they weren't able to challenge it," he says.
`
`The Message to Civilians
`
`While the military is finding it can keep most drugs longer, civilians hear quite a different
`message. For instance, a campaign called the National Expired and Unused Medication Drive
`has collected and destroyed 36 tons of drugs since 1991, says its founder, Kathilee Champlin.
`Ms. Champlin, of Colorado Springs, Colo., says her interest derives from experience working
`with the elderly and seeing how hard it was for them to keep track of all their medications.
`She says she wasn't aware of any FDA program to extend drugs' shelf lives.
`
`Her group has gained sponsorship from the some big drug retailers, including Wal-Mart Stores
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`Inc. It sponsors the campaign to be "a good corporate citizen," says Frank Seagrave, vice
`president of pharmacy merchandising. "We believe that people should dispose of unused
`prescription medicines a year after they get them," he says, adding that Wal-Mart sometimes
`gives people a free bottle of vitamins if they bring in expired drugs.
`
`Johnson & Johnson's Janssen Pharmaceutica unit, a drug maker, also sponsors Ms. Champlin's
`campaign. "We think it's important to educate the public about the risk of taking drugs that
`are expired and to raise public awareness," says a spokesman for Janssen. Both Wal-Mart and
`J&J say that supporting the campaign to discard expired drugs has nothing to do with their
`sales efforts.
`
`Many pharmacists also play a role in shelf lives. The U. S. Pharmacopeia, a not-for-profit
`scientific group that develops standards for the drug industry, urged in 1985 that pharmacists
`set expiration dates at no more than one year if they were dispensing drugs in a bottle other
`than the manufacturer's original packaging. "New containers may let in more moisture and
`heat than the container the manufacturer used for the stability study," accelerating the drug's
`degradation, says the USP General Counsel Joseph Valentino.
`
`The recommendation became a USP requirement in 1997. As a result, "the majority of
`pharmacists shorten the manufacturers' expiration dates" on prescription drugs to one year or
`less, says Susan Winckler, an official of the American Pharmaceutical Association. In fact, in
`17 states, pharmacists now are legally required to do so. Ms. Winckler says shortening the
`dates makes sense because many people store drugs in moist bathrooms. She says the
`one-year rule is "motivated by product integrity and not by profit."
`
`Even the FDA has sometimes pushed for throwing out drugs at their expiration date. Last
`October it co-sponsored, with the National Association of Chain Drugstores and others, a
`campaign that urged women not to use medications beyond the expiration dates because, as
`the brochure put it, "they may not work." Mr. Davis says this shows just how obscure the
`military Shelf Life Extension Program is. "Many people at the FDA have absolutely no idea this
`program exists," he says.
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