The Shadow Box (27 page)

Back to the FDA papers.

What Doyle found in them was breathtaking.

Item:

Not long ago, in Nigeria, 109 young children died of
kidney failure after ingesting a chemical solvent. The sol
vent was in a paracetamol syrup—sort of like Tylenol for
children—which had been administered by several Nige
rian hospitals. The product was counterfeit. A wholesale
pharmacist had used the correct active ingredient, acet
aminophen, and even in the right concentration.

But he had purchased an unmarked drum that suppos
edly contained propylene gíycol, the preservative used in
the genuine syrup. The drum actually held diethyelene gly
col, which is used in antifreeze. The pharmacist bottled
this poison, slapped on phony labels, and sold it to the
hospitals.

What was Arnie's argument? That no wholesaler would
take such a risk for such a small reward? Here's one who
clearly did. Ah, but that's in Africa he'd say. In corrupt
and chaotic Nigeria. Couldn't happen here.

Item:

An Iranian counterfeiter, now in prison, was arrested by the U.S. Customs Service. They had been laying for him
because he had once approached a broker with an offer to
sell eight million pharmacy-sized bottles of three major
prescription drugs. The drugs were Tagamet, an ulcer med
ication, three million bottles at $32.15 each; Anspor, an antibiotic, three million bottles at $47.70 each; and Napro-
syn, for arthritis, two million bottles at $237.75 each.

His samples of Naprosyn, the arthritis medicine, con
tained mainly aspirin. They might well have killed patients who had ulcers. But otherwise they looked perfectly legiti
mate. According to the FDA, the Iranian, a man named
Naghdi, had manufactured the counterfeit drug by ob
taining tableting machines, bulk acetaminophen, aspirin,
lactose, and coloring agents.

He bought tableting machines to press the bogus Napro
syn. He commissioned artwork that duplicated the Napro
syn package. He had the tooling to imprint the company trademark on the bottles, bottle liners, bottle caps, and the
tablets themselves. Even the identical bar code.

He supplied fraudulent shipping documents, a fake in
surance policy, and all the necessary paper, on company
letterhead, to show that he had bought this stuff directly from the legitimate manufacturer.

What blew the deal? What tipped the Customs Service?

That broker, in his innocence, called the manufacturer
to ask them if he was getting a good deal at the quoted
prices. The Customs Service and the FDA then set up a
sting to catch Naghdi. They wanted to buy the lot. He
announced that the eight million bottles were already gone
but, if they had the cash and were ready to deal, he could
get them a million bottles of Tagamet at the bargain price
of twenty-seven dollars each. The Tagamet was ware
housed in Tampico, Mexico, ready to be smuggled in.
Shipping would be arranged via someone called Five Star
Distributors of Puerto Rico.

Doyle, at this point, had gone to his calculator. That
first deal, just three drugs, which someone in this country
bought, amounted to more than seven hundred million dol
lars. That's one deal. One time. The second deal, which
never went through, was peanuts by comparison. Only
twenty-seven million dollars.

The Naprosyn alone, two million bottles, totaled more
than $475 million if the Iranian got his asking price. Na
prosyn’ s
legitimate sales
that year, to the domestic market,
were roughly the same amount.

Arnie? Do you still say half is horseshit?

No, I don't suppose you do.

Do you still say that few distributors would knowingly
take the chance? I mean . .  these distributors . . . one
expects them to have names like Blue Cross Pharmaceuti
cals or Mount Sinai Medicines for the Afflicted. They
don't. They have names like Five Star Distributors of
Puerto Rico. Triple-A Cigars of Jersey City. Mucci & Son
Sundries of Miami.

Doyle ran the numbers three times. He could scarcely
believe them himself but there they were. One deal, one
arrest. The Iranian, obviously, had not made this stuff in his garage and sure as hell wasn't in it alone. He was a
broker, a salesman, for an immensely sophisticated opera
tion. Just as clearly, that seven-hundred-million-dollar deal
was only the tip of the iceberg.

Oh, and look at this.

There's a fairly new drug called Zantac, an ulcer drug that has pretty much replaced Tagamet. It doesn't cure ulcers; it just cuts down on the acid your stomach pro
duces. Want to know what the annual sales are? Four
billion dollars. Zantac is, right now, the biggest selling
drug in the world. Four billion dollars on one fucking pill
that's basically a Band-Aid.

What
does
cure ulcers? Antibiotics, it says here, because
ulcers are caused by a viral infection. But they push drugs
like Zantac because there's no money in antibiotics—their
patents have all run out—and because if you cure a dis
ease, where's the repeat business?

Okay, Zantac has the number one spot. Three out of the
next four top sellers are for cardiovascular problems. Heart
attacks. The number one killer. But you know what seems
to ward off heart attacks best? Aspirin. Aspirin and garlic.
Even the FDA says so. In fact, it says that popping an aspirin
during
a heart attack can save one in four lives.
But no maker of aspirin has asked the FDA if they could
market their own product for that purpose. Why should
they? If they did, people might not buy their other
patent-
protected
heart drugs that sell for a couple of hundred
times the price.

An interesting ethical question, right? Here's a better
one. When a drug like Tagamet hits paydirt, everyone else
tries to jump on the bandwagon. But Tagamet was still
under patent. So along comes a Zantac and about six other
drugs, all of which do precisely the same thing but they
do it through a different mechanism. This is how they get
around the patent.

So here's the assignment for our next ethics class. Ex
plain in a hundred words or less, how that is
not
the moral
equivalent of counterfeiting.

No wonder Jake hated these clowns.

Do the drug lords of Colombia know about this?
Wouldn't they like to stop being shot at? Hunted down? If caught, wouldn't they rather get fourteen years, which
is what the Iranian got, and of which he'll probably serve
five, than life without parole? Wouldn't they rather have
a customer base that can't “just say no”? And whose
enforced addictions are paid for by health insurance and
Medicaid? And are a better class of people to boot?

Item:

Only thirty-five criminal investigators in the whole Food
and Drug Administration. There are another twelve hun
dred field investigators but their tasks are more routine,
such as trying to keep drug labs from fudging on test
results and nabbing pharmacists who sell prescription drug samples that are intended strictly for doctors. Of the twelve
hundred, a good many concentrate on agricultural prod
ucts, veterinary medicines, and the like.

Veterinary medicines,
thought Doyle, frowning.

The library computer had kicked out a few items on the
subject. He almost hadn't bothered to copy them because
they seemed no more than marginally related to the larger
subject. Until this moment.

Item:

One firm, Johnson & Johnson, sells a colon cancer drug
called Ergomisol. It was charging thirteen hundred dollars
for a single fifty-milligram dose. But another firm sells
a veterinary drug that has the same active ingredient—
levamisole—-for just fourteen dollars a dose.

It would seem tempting for a cancer clinic to buy the
animal drug in bulk, grind it up, then press it into the
fifty-milligram tablets that would otherwise cost them al
most one thousand percent more.