May 2003, nearly 20 million doses of fake Lipitor (atorvastatin) had to be pulled from US pharmacy shelves.
As FDA and Pfizer investigated the problem, thousands of US consumers were purchasing fake Viagra (sildenafil) of unknown
composition imported from South America and Asia.
Stopping the Procrit Hemorrhage
|
Not long before, Colombian authorities broke up a criminal counterfeiting ring that was mixing boric acid, floor wax, and
yellow highway paint, pressing the mix into tablets, and packaging it in blister packs that were almost identical to those
made by Warner Lambert for its menstrual pain reliever, Ponstan (mefenamic acid). At the same time, counterfeiters were manufacturing,
packaging, and selling millions of fake artesunate tablets to malaria patients throughout Southeast Asia. Unfortunately, the
tablets contained no active ingredients, reportedly leading to the death in 2002 of the head of Vietnam's Wildlife Protection
Office-and untold others.
This article explores the problem of pharmaceutical counterfeits: What they are, where they come from and how big the problem
is, as well as who is combating it, how, and at what cost. It also raises the question: How long will pharma companies have
to deal with the problem?
Stopping the Procrit Hemorrhage cont.
|
A Murderous Trade In the April 6, 2002, issue of the British Medical Journal, Paul Newton, MD, of Oxford University's Center for Tropical Medicine
published the editorial, "Murder by Fake Drugs." He reported, "The accumulated evidence suggests that mortality and morbidity
arising from this murderous trade are considerable, especially in developing countries." He spoke of adverse effects caused
by the absence of active ingredients or the presence of harmful ingredients, such as acidosis in children caused by the substitution
of aspirin for other substances. "Fakes," he said, "have also given rise to the misperception of drug resistance," such as
in reports about artesunate in Cambodia.
Although no one knows for sure how many deaths counterfeit drugs have caused, conservative estimates are in the thousands.
Perhaps the best known case occurred in Haiti in 1990, when 89 children died after taking cough syrup containing antifreeze.
In 1996, more than 2,500 Nigerians reportedly died after receiving a fake meningitis vaccine. In the 1990s, there were deaths
in the United States associated with the use of fake gentamicin, which, in legitimate form, is a powerful antibiotic. No one
knows the US mortality or morbidity rate caused by recent cases of fake Lipitor, Procrit (epoetin), Epogen (epoetin), Nutropin
(somatropin), Neupogen (filgrastim), Serostim (somatropin), Zyprexa (olanzipine), Gamimune (immune globulin), Oxycontin (oxycodone),
Combivir (lamivudine), and Viagra.
Counterfeiting has become a political problem as well as a health hazard. On June 24, 2003, the US House Commerce Oversight
Committee grilled John Taylor, FDA associate commissioner for regulatory affairs, and William Hubbard, FDA's associate commissioner
for policy and planning, just a month after the agency reported it had mistakenly released more than 1,000 packages containing
counterfeit Viagra from its Miami international mail facility. As he began his questioning, Representative Peter Deutch (D,
Florida) "congratulated" FDA for taking "an already bad situation at the Miami facility and [turning] it into complete chaos."
FDA has, in fact, become very focused on the issue. As reports of counterfeit medications continue to appear in the Wall Street
Journal and the New York Times, on 60 Minutes, and in other media, and as the political ante rises, the issue of what to do
about counterfeit pharmaceuticals will affect how every pharma company does business.
How Many Fakes Are There? The first question most people ask about counterfeit drugs is "How big is the problem?" The answer is "Nobody knows." Counterfeiters
don't report what they do, and no data-collection company has the information.
One frequently cited statistic is that "the World Health Organization estimates that 7–10 percent of the world's drugs are
fakes." In fact, WHO never made such an estimate. The 7–10 percent number came from a participant at one of WHO's early conferences
on counterfeiting, and it was subsequently picked up as folk wisdom.
A few published studies say the counterfeit rate is much higher. In 2001, Oxford's Newton did an analysis of fake malaria
medicine in Southeast Asia. Supported by WHO, he and his colleagues bought 130 samples of artesunate-mostly tablets in blister
packs-from 104 shops and performed chemical analyses on them. The results were shocking: 38 percent of the samples contained
no active ingredients.
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