PHARM: Millions of Americans Look Outside U.S. for Drugs

[Guest guest]

> washingtonpost.com

>

> Millions of Americans Look Outside U.S. for Drugs

> Desire for Low Prices Often Outweighs Obeying Law

>

> By Mary Pat Flaherty and Gilbert M. Gaul

> Washington Post Staff Writers

> Thursday, October 23, 2003; Page A01

>

> Fifth of five articles

>

> PORT OF ANDRADE, Winterhaven, Calif. -- William Brooks has a good job and

> good prescription drug benefits. He also has rosacea, a skin ailment he

> treats with an ointment. His employer's health plan picks up most of the

> cost, leaving him to pay only $14 when he fills his prescription.

>

> But Brooks said he can buy the ointment for $6 -- and does -- " over

there, "

> jutting his thumb toward the narrow road into Los Algodones, Mexico, a few

> hundred feet away. " I seem to be getting the same thing, " he said.

>

> Brooks, 48, is one of millions of Americans who have turned to Mexico and

> other countries in search of bargain drugs.

>

> What makes him different is this: He is the director at the Andrade port

of

> entry for the U.S. Bureau of Customs and Border Protection, in charge of

> stopping prescription drugs from illegally entering the country.

>

> The port director embodies a national contradiction: Although U.S. law

bans

> nearly all imports of foreign medications, Americans are bringing in those

> drugs in record numbers.

>

> Mexico, Canada and other countries have become the discount pharmacies for

> many Americans, those looking simply to save money as well as the

uninsured

> struggling to pay for their medications.

>

> In the process, the nation's drug distribution chain is being breached,

> exposing consumers to risk and swamping regulators, according to state and

> federal records and interviews with dozens of federal agency officials,

> state investigators, academics and security specialists for the

> pharmaceutical industry.

>

> Customs estimates 10 million U.S. citizens bring in medications at land

> borders each year. An additional 2 million packages of pharmaceuticals

> arrive annually by international mail from Thailand, India, South Africa

> and other points. Still more packages come from online pharmacies in

Canada.

>

> At peak season at Andrade, when snowbirds flock to the desert crossing

west

> of Yuma, Ariz., 13,000 people a day return from Mexico, " and nearly

> everyone has medications, " Brooks said. " The pharmaceuticals are

absolutely

> the draw. " In northern Mexico, farmacias edge out strip joints and

cantinas

> on many of the main drags.

>

> At San Ysidro, Calif., which abuts Tijuana, Mexico, 90 million people a

> year cross, leaving inspectors there with an average of five seconds to

> size up what travelers may have in their packages, supervisory inspector

> Joseph W. Misenhelter said. " Medications are only one of our concerns. "

>

> At the Washington Dulles International Airport mail site, between 10 and

15

> tractor-trailer loads of international parcels arrive daily. Enforcement

> agents who peer through X-ray scanners and scour labels looking for pills

> and vials are " pulled a lot of ways, " with terrorism -- not illegal

> pharmaceuticals -- as their first priority, Dulles chief inspector Hal

> Zagar said.

>

> The Food and Drug Administration said that nearly all of the medications

> brought in from foreign sources by individuals are illegal and possibly

> unsafe. But agency officials have said they do not want to be the ones

> seizing medications from seniors. Customs and border inspectors who are

the

> frontline enforcers of federal law allow in most pharmaceuticals, because

> " we are not in the business of taking away medication from people who need

> it, " as Brooks said.

>

> The debate over allowing Americans to take advantage of cheaper drugs from

> overseas has been a recurring battle in Congress for the past three years.

> Proposals have ranged from allowing imports from about 30 countries to

> allowing them only from Canada. That debate continues, with the issue of

> opening the borders now linked to the question of whether to add a

> prescription drug benefit to Medicare.

>

> As those congressional debates continue, however, many Americans have

> reached their own decisions, buying foreign medication pill by pill and

> package by package.

>

> Top FDA officials say sheer volume makes inspecting every package at the

> border or in the mail impossible. Customs inspectors set aside packages

> that appear to be medications so an FDA inspector can decide whether they

> can be released to the buyer. But the agency does not have inspectors on

> site every day, even at large border crossings and mail facilities.

>

> In 2001, the FDA proposed that all medication mailed into the United

States

> be returned to its sender, except for a fraction that doctors could import

> for gravely ill patients. The proposal went in a memo to Health and Human

> Services Secretary Tommy G. Thompson. Two years later, the memo remains

> unanswered.

>

> The FDA is trying to develop strategies to assess risks and identify prime

> targets for enforcement. " We can't win this playing man to man, " FDA

> Commissioner Mark B. McClellan said.

>

> If the FDA decides to hold packages, citizens can appeal, a process that

> can take months and creates huge backlogs of stored medications. It also

> lands the agency at the center of an emotional debate on how to make

> medication more affordable.

>

> " We get beat up, " said William K. Hubbard, the FDA's senior associate

> commissioner. " It's more phone calls from the Hill. The politics of

seniors

> drives the political issue and will for a while until we give people a way

> to get their drugs here. "

>

> Laura M. Nagel, deputy administrator of the Drug Enforcement

> Administration, is concerned about prescription narcotics and other

> controlled substances coming across the borders and by mail. She said she

> has " nothing but sympathy for these poor, lower-pay-grade customs

> inspectors who are becoming pharmacists as they work against the tide. "

>

> But after years of promises that the FDA would take action, Nagel's

> sympathy is at its end: " I want my law enforced. "

> Exception to the Rule

>

> As the forces reshaping the U.S. drug distribution system come to bear on

> the country's gatekeepers, " discretion " -- a word that Brooks and customs

> inspectors near San Diego and Laredo, Tex., all used -- has overtaken

> regulation.

>

> U.S. officials draw a bright line at smuggled medications or obvious

> counterfeits or drugs that have been rejected for the U.S. market. But a

> traveler who has a prescription and buys no more than a three-month supply

> of medication for his own use will most likely be allowed in.

>

> Even that allowance strays from the original 1954 regulation, revised in

> 1988, for travelers who bring in foreign medication. Known as the

> personal-use exemption, the 1988 revision came when AIDS was surging and

> domestic treatments were scarce. The FDA responded by saying that patients

> with life-threatening illnesses under a doctor's care could import a few

> months' worth of medications, even if the drugs were not approved in the

> United States.

>

> But that exemption opened the floodgates. It rapidly became abused and

> misquoted by everyone from Congress members to Internet pharmacy owners

who

> say anyone is entitled to bring in a three-month supply of any medication.

> In the absence of enforcement, foreign imports poured in. Today, the

result

> is confusion.

>

> The FDA's " lax " response to abuses of the personal importation exemptions

> coupled with the rise of the Internet has led to " a massive problem, " said

> Benjamin England, a former regulatory counsel at FDA headquarters and

> 17-year veteran of the agency now in private practice in Washington.

>

> " It didn't take long for someone to fill the opening that created, and now

> you've generated a whole market, " he said. " By the time FDA recognized the

> problem, the economic engine was running wide open and it was out of their

> hands. They let it become a political issue because they didn't address it

> when they should have, and that's where they're stuck. "

>

> An incident this summer in Miami was " a real train wreck, " England said.

>

> In May, the FDA released nearly 2,140 mail packages of counterfeit Viagra

> that had been seized seven months earlier in Miami because they did not

> appear to be made by Viagra's manufacturer, Pfizer Inc., according to

> customs and FDA records. Samples from the packages, mailed from Belize,

had

> been sent to the FDA for testing. In January, the lab concluded that some

> pills were less than full strength and others some were overly strong -- a

> more serious risk, given Viagra's side effects. Despite that information,

> the FDA headquarters released the packages to the U.S. customers who had

> ordered them. Some of the FDA's Miami staff questioned that decision:

> " Shouldn't we refuse entry particularly on a Rx drug like Viagra? " one

> wrote in an e-mail. The reply from a supervisor: " We released it because

we

> do not have the resources to deal with mail entries. "

>

> The FDA headquarters has since said it made " a mistake " and sent letters

to

> customers warning them that the agency could not vouch for the safety of

> the foreign shipment. But the FDA did not share with consumers what the

lab

> tests had found, a copy of the letter shows. An FDA spokesman later said

> that the agency had sent a standard letter.

>

> Since 2000, customs officials have asked the FDA for written guidelines on

> what ought to be held for FDA inspection. If the FDA will not ban

virtually

> everything -- as current law demands -- what should customs stop?

>

> Three times since 2000, FDA officials have testified they are preparing

the

> answers. But written guidance has yet to come, Elizabeth Durant, director

> of trade programs for customs, told a congressional committee this past

summer.

>

> " If FDA told us to just ship it back, we could ship it back, " she said.

>

> In addition to the personal-use exemption, regulators struggle with

another

> loophole.

>

> The DEA is moving to close an opening through which painkillers and other

> controlled substances cross U.S. land borders. Since 1970, travelers who

> obtained a prescription narcotic abroad -- presumably for a medical reason

> -- were allowed to bring it home without a U.S. prescription. In 1998, to

> stop widespread abuse, the law was amended to limit a traveler crossing

> from Mexico or Canada to an amount less than " 50 dosage units " of any

given

> drug.

>

> Some travelers just shifted to carrying in their drugs in increments of 49

> doses apiece.

>

> " An exemption for legitimate travelers has got bastardized, " said

Elizabeth

> A. Willis, chief of drug operations for the DEA. The DEA now is proposing

a

> limit of 50 doses total per trip -- a change that would cut but not

> eliminate the traffic, Willis acknowledged.

> Americans Invade Mexico

>

> Hugo Moreno, all pumped-up chest and wraparound sunglasses, flashes a

> dazzling smile and tilts his chin: " What are you looking for? We'll have

> it. C'mon over, look at these prices. "

>

> He works the sidewalk in front of the " Purple Pharmacy, " as the big shop

> directly across the border in Los Algodones has come to be called by

> American customers who cannot manage its proper name, " Pharmacia Liqui's. "

>

> With his running patter, Moreno, 23, has undeniable curb appeal, slinging

> jargon he picked up at college in Arizona, winking to the men as he points

> out the Viagra prices, bending down to boost an older woman with a cane

> from the street to the pavement.

>

> " In there, " he says nodding toward the clerks, " you need to know a little

> something about medicines. Out here, " he says with a grand sweep of his

> arms, " it's all personality. "

>

> Not that Moreno would have to work hard. Americans flock here.

>

> Even on a slow June morning, license plates from throughout the Southwest,

> Midwest and West could be seen on cars whose doors opened to let out

> gaggles of white-haired men and women. Trunks popped to release canes,

> walkers and at least one portable oxygen tank -- every bit of that

> equipment summoned to aid an older person in a slow and deliberate walk to

> Los Algodones's pharmacies.

>

> Painted as purple as Barney, Liqui's is anything but subtle. A sandwich

> board posts prices for hot brand names -- Lipitor, Fosamax, Premarin,

> Captopril -- that translate into a list of maladies hitting older

> Americans: high cholesterol, osteoporosis, menopausal effects, heart

> failure. Sheets of paper -- 144 in all -- curtain the store's front

> windows, each one an " especial. "

>

> Inside, bottles of drugs sit in glass cases. Many are generics, some made

> in Mexico, others repackaged in Mexico with their manufacturing site not

> apparent. Others, with Spanish labels, say they were made in Germany or

> Panama.

>

> Medications, including bottles labeled as the blood thinner Coumadin --

> which requires a prescription in the United States and regular blood

> testing to monitor dosages -- could be bought off the shelf.

>

> Dick Kujawa, 63, and his daughter, Dee Blake, of Mesa, Ariz., studied the

> prices. A recently retired warehouse worker, Kujawa lost prescription drug

> coverage when he shifted onto Medicare. His daughter and her husband run

an

> Internet-based business, " and don't have health insurance because it's so

> high for self-employed people, " she said.

>

> She was shopping for an antibiotic. Her father takes medications for high

> cholesterol, high blood pressure and heart failure. His drug bills run

> about $700 every three months, he said. A sign offering Zocor, a

> cholesterol medicine, caught their attention. At about $28 for 30 pills,

> each 80 milligrams, that cost would be half what he pays in the United

> States, he said.

>

> " That's worth the trip, even if it is the generic, " he said. Guessing

> whether a drug is the same might not be the best system, he said, but " it

> should be embarrassing to our country that we have to come down here for

> medicine, period. "

>

> Inside the Purple Pharmacy, Virginia Plowman, 65, of Mesa scanned the list

> of medications in her hand, some hers, some from friends. Until she turned

> 65 and had to rely on Medicare, she " didn't think about drug costs. I

> always had insurance. "

>

> The price for Zetia, another cholesterol-lowering drug, disappointed her.

> At $31 for 20 pills of 10 milligrams, it cost more than the $50 she paid

at

> home for 90 pills. But she had already seen savings on Prilosec and

> Celebrex that she was considering but was determined to shop around " since

> that's what I'm here for. "

>

> While Los Algodones retains a rustic air, the main street of Tijuana has

> converted to a veritable medication mall. The painted burros are still

> there for tourist photos and so are the leather stores. But along a street

> once thick with strip clubs and bars, farmacias dominate, with " we have

> English " and signs for " smoothees " jostling signs for menopause

medication.

>

> Ignacio Romo, head of the pharmacists association in Tijuana known as

Union

> de Farmacias y Boticas de Tijuana, winces at the explosion of pharmacies

> along Revolucion Avenue. Romo, who has run one small drugstore in a

Tijuana

> neighborhood since 1951, said " it's become anarchy " along the avenue.

> Speaking through an interpreter, he said he worries " the professionalism

of

> pharmacists is being degraded " by shops that post clerks in medical coats

> but offer no real expertise. " Just because you dress like a nun doesn't

> make you one, " Romo said.

>

> Elsewhere in Los Algodones and Tijuana, doctors were offering to write

> prescriptions for controlled substances in exchange for $20 or $30, no

> medical exam needed. A pharmacy in Los Algodones had preprinted and signed

> prescription pads on hand to give to American buyers in case they were

> challenged at the border. Another pharmacy in Los Algodones sold an

> American a generic antibiotic that was unapproved in the United States. A

> clerk in white coat packed it in a baggie and suggested the American hide

> it in a pocket to get it past customs.

>

> In both towns were American shoppers who insisted they were saving at

least

> half on drugs they need for chronic illnesses. Joyce Ernst, 65, of Las

> Vegas looked over the pills offered for sale and scanned the Physicians'

> Desk Reference, confident she could tell by sight if they matched the

drugs

> she bought back home.

>

> She decided against a full complement of Pariet, a treatment for stomach

> ulcers, because the pills looked slightly different. She bought just seven

> tablets to alternate those with her U.S. medicine " as a test. It's worth a

> shot. " She bought Xenical, which aids in weight control, because at $90 it

> was $30 less than what she had paid the previous month at her drugstore --

> a bill she carried in her hand as she ducked in and out of the pharmacies

> lined nearly door-to-door along Revolucion Avenue in Tijuana.

>

> http://www.washingtonpost.com/wp-dyn/articles/A2883-2003Oct22.html

>