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[e-drug] Wall Street Journal on expired drug (donations)


  • From: "Mark Raijmakers, Wemos" <mark.raijmakers@wemos.nl>
  • Date: Thu, 30 Mar 2000 10:39:24 -0500 (EST)

E-drug: Wall Street Journal on expired drug (donations)
-------------------------------------------------------------------------

Forwarded to me from the US, the Wall Street Journal (WSJ)
on drug donations and expired drugs. The contribution in the
WSJ on pharmaceuticals is split into two sections: 'major
business news' on donations of expired drugs and a 'page one
feature' analysis of the reasons behind expiry-date setting
of medicines.

The 'major business news' is a very business minded article
paying no attention to the complexity of drug donations'
practice suggesting developing countries should accept
expired drugs because the US military has done tests that
prove them usable. The article is not providing any
arguments why expired drug donations are or should not be
accepted in many donations' cases. It also doesn't pay
attention to the context of drug donations to developing
countries where in the majority of cases expired drugs
cannot be tested like the US military has done.

The 'page one feature' analysis will certainly provoke a lot
of discussion about the real reasons of expiry-date setting.
The WSJ article merely suggests that marketing or economical
reasons are the reasons of expiry-date setting although some
quality arguments are also incorporated into the article.

For you that remember ... on the e-drug mailing list there
has been an extensive discussion on expired drug donations
between May 8 and May 23, 1997. More than 10 e-druggers
participated in this discussion which provides some
interesting viewpoints on the issue of donating expired drugs.

Regards,
Mark Raijmakers

---------
[Reprinted under the fair use doctrine of international copyright law]

March 28, 2000

Major Business News

Poor Nations Spurn Free Drugs If Too Close to Expiration Date

By LAURIE P. COHEN
Staff Reporter of THE WALL STREET JOURNAL

In the U.S. military, expired drugs are routinely left
on the shelf after FDA testing shows they are still
safe and effective. Meanwhile, charitable groups and
developing nations often reject drug-company donations
of much-needed medications that are nearing their
expiration dates.

Why the incongruity?

The World Health Organization in 1996 urged countries
to refuse free drugs that didn't have at least a year
left before expiration. WHO said there had been many
"inappropriate donations."

The $55 million in drugs contributed to Armenia after
a 1988 earthquake was the "wake-up call to the donor
world," says Jonathan Quick, an official of WHO. Many
had already expired, according to WHO.

The issue grew hotter in 1997, when the New England
Journal of Medicine reported that at least half of the
drugs donated during the war in Bosnia were unusable,
in most cases because they had reached their
expiration dates. The article said the effort "may
have been used to dump outdated supplies" to gain tax
breaks and avoid millions of dollars of disposal costs.

Turned Away

Reflecting the new militancy on the issue, officials
in Haiti, Kenya, Egypt and Peru in 1998 refused more
than two million cartons of antibiotics and pain
relievers because were due to expire within a year.
The same year, the Catholic Medical Mission Board
turned away $32.4 million in drugs because some had
only eight months to a year left before expiration.

Yet most drugs the Food and Drug Administration
retests for the U.S. military prove safe and potent
long past their expiration dates. And even Philippe
Autier, a doctor who was an author of the New England
Journal article, says he has used expired antibiotics
in the Honduran jungle. "We know that most expired
drugs will pose no danger, so when we have no other
choice, we use them," he says.

Asked why drugs with less than one year to expiration
are shunned by international medical groups, Robin
Gray, a WHO medical officer, says that recipients of
donations deserve the same protections as U.S.
citizens. If expired drugs weren't potentially
harmful, he reasons, the FDA wouldn't require
expiration dates. He says he wasn't aware of the FDA
retesting and extending of drugs for the military.

Some see a political agenda lurking in the issue.
"This is an anti-pharmaceutical-industry,
anti-U.S.-motivated attack," contends Glenna Crooks, a
former Reagan administration health-policy adviser who
is a consultant to several drug companies. "Are we
destroying drugs that could be used? Yes," she says.

To the suspicion that companies donate short-dated
drugs to get tax deductions and save disposal costs,
the companies respond that they also can get
deductions for destroying drugs. But the deductions
aren't as large.

Civilian Effort

Some U.S. pharmaceutical companies and aid
organizations, regarding the WHO guidelines as too
restrictive, banded together in 1997 to work with WHO
on revising them. Their Partnership for Quality
Medical Donations eventually endorsed the guidelines
after WHO changed them last year to allow for
occasional exceptions to its one-year rule.

The FDA's Shelf Life Extension Program for the
military has been used once on drugs for a civilian
relief effort. With medicine critically scarce in
Russia after the Soviet system collapsed, the FDA
tested expired batches of an intravenous solution for
dehydration called Lactated Ringers, extending its
shelf life before it was sent abroad by Project Hope.

Jack Bode, an official of the Millwood, Va.,-based
relief group, says that in the current environment,
the shipping of expired drugs, even those whose dates
had been extended by the FDA, "wouldn't happen again."

Yet Mr. Bode, who has spent the past eight years
working with refugees in Somalia, Rwanda and
elsewhere, has this observation: "Has anyone been
harmed by expired drugs? Maybe. But I can definitively
tell you that a lot of people died because they didn't
get expired drugs."

-------

March 28, 2000

Page One Feature

Many Medicines Are Potent Years Past Expiration Dates

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.

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 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 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.

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 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.

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.

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 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.

Write to Laurie P. Cohen at laurie.cohen@wsj.com
__________________________________________________________

Wemos Foundation
P.O. Box 1693
1000 BR Amsterdam - The Netherlands
Tel.+31-20-4.688.388 / fax 4.686.008
http://www.wemos.nl
__________________________________________________________

Web-site on drug donations in seven languages:
http://www.drugdonations.org
__________________________________________________________

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