Patients feeling the effects of rise in counterfeit drugs
By Mary Pat Flaherty and Gilbert M. Gaul
Washington Post
She had made peace with the indignities of chemotherapy: the baldness and the vomiting. And she had learned to brace for the pain that broke in waves during the end stages of her breast cancer. But the bone-deep fatigue that settled over Maxine Blount was different and troubling.
"I couldn't get out of bed. I was really tired, worn out, exhausted," she said. Even the costly injections she relied on to rejuvenate her did not help.
"The girls at the cancer suite," as Blount called her nurses, figured it out first, remembering a recent warning about counterfeit medicines in circulation. They checked a remaining vial from the set of four Blount had bought in March 2002 at her drugstore in St. Peters, Mo.
She had bad medicine.
Already weak herself, Blount was taking a weakened version of Procrit, which fights fatigue and anemia. Testing confirmed her dose was one-twentieth the strength listed on the packaging — packaging that was so authentic-looking it fooled health inspectors.
Blount died last October at age 61.
Cases of bad drugs up
At a time when more Americans are relying on medication, their chances of receiving a drug that is fake, diluted or mislabeled have never been so great.
Last summer, a drug wholesaler was forced to recall nearly 200,000 counterfeit and mislabeled Lipitor tablets after patients complained that their medication tasted bitter. In May 2002, investigators discovered that nearly 110,000 bottles of cut-strength Epogen had passed undetected into the open market. In the past three years, counterfeit, adulterated or diluted medications have been found in drug wholesaler warehouses in Maryland, Kentucky and California. Some of the drugs were distributed in Hawai'i, Texas, Washington, Arkansas, Tennessee, Louisiana, Mississippi and Alabama.
The state Department of Health said Hawai'i typically doesn't see instances of fake or mislabeled drugs. Perpetrators tend to concentrate on states where there are many wholesalers of pharmaceutical drugs.
But there was one recent high-profile case in Hawai'i involving IPC Pharmacy and its owner, Bergen Brunswig. Brunswig is the predecessor of AmerisourceBergen, a national drug distributor.
In 2001, Bergen settled a lawsuit filed by the state for $4 million after being accused of medical fraud. The company allegedly sold recycled pills that nursing homes had returned.
Last month, a Honolulu Circuit Court judge said a separate class-action lawsuit against AmerisourceBergen and IPC Pharmacy can proceed, according to attorney Tom Grande.
National recall notices in the past two years strip the problem to its bare, numeric essence: Procrit Lot P002384, Serostim Lot MNK612A, Epogen Lot P002970, Nutropin Lots L9504A3 and L9101A4.
While FDA regulations explicitly demand that drugmakers tell the agency about many other problems with medications — from testing failures to adverse reactions — manufacturers who know their product is being counterfeited are not required to report it. The FDA favors a voluntary industry reporting program, contending that introducing a new rule and getting it through Congress would take years, said William K. Hubbard, senior associate commissioner for the FDA.
Regulations lagging
The largest counterfeiting operations net millions of dollars and involve networks of front companies able to distribute thousands of boxes of medicines at a time.
For buyers with low profit margins, the ballooning price tags on many pharmaceuticals provide incentives to scout for a deal.
"So long as the same pill can have 20 different prices on it — which it can, depending on who it's being sold to — you open the door to all kinds of problems," said Donald deKieffer, an international trade lawyer who tracks pharmaceutical counterfeiting.
Counterfeiters have also been aided by a regulatory system that is struggling to catch up. Even as increasing reports of counterfeiting surfaced nationwide earlier this year, the FDA insisted it was not a major threat. Then came congressional inquiries and this summer's $55 million Lipitor recall.
In July, the FDA formed a task force on counterfeiting. The agency also said bogus products "virtually indistinguishable from the authentic versions" posed "a potentially serious health risk." The FDA blamed some of the rise on wholesalers who "ignore warning signs indicative of illegal or unethical behavior."
Advertiser staff writer Deborah Adamson contributed the information on Hawai'i.
