This is the second time in a week that the FDA warned about a knockoff of an expensive drug. Earlier, it passed on a letter from Amgen about phony copies of its chemotherapy drug Neupogen.
In a letter yesterday, the FDA and Serono Inc., of Norwell, Mass., warned doctors, pharmacists and other health care providers about the discovery of a phony lot of 6-milligram vials of Serono's drug Serostim.A similar attempt to distribute fake Serostim, which is an injected, recombinant form of growth hormone that helps prevent weight loss in people with AIDS, occurred in January. A week's supply of the drug costs $2,100, presenting a lucrative target for fraud.
In the first episode, which involved seven states, "fewer than 20" patients reported using the counterfeit drug, and none had reactions more severe than local irritation, says Carolyn Castel, a spokeswoman for Serono, a division of the Swiss pharmaceutical firm Serono S.A.
This time, only two patients so far have reported taking the fake product. One suffered a minor skin rash, Castel says, and the other noticed discrepancies in the drug's packaging and contacted the company before using it.
Castel says FDA tests of the bad lot revealed that while the vials do contain a small amount of growth hormone, about one-sixth the normal concentration, the product wasn't made in Serono's Puerto Rico facility. "This counterfeit material was not manufactured by Serono and it was not distributed by Serono," she says.
Serono ships Serostim to pharmaceutical wholesalers and distributors, who in turn send the drug to retailers. Officials at McKessonHBOC, one of the larger distributors of Serostim, could not be reached for comment today.
Neupogen faked, too
Last week, regulators reported a counterfeiting scheme involving Amgen's cancer medication Neupogen, which stimulates white blood cells in patients on chemotherapy. David Kaye, a spokesman for the California biotech company, says the FDA is investigating the episode but he would not comment on the extent of the fraud.
In the Amgen case, vials were discovered containing salt solution but no active medication, indicating that the scam didn't occur at the manufacturing stage, Kaye says. While Neupogen has tamper-resistant caps and other safeguards, "the technology's out there that anything that you could think about" copying can be forged, he says.
A 10-vial package of Neupogen can sell for $1,700.
Whoever pulled off the scam replicated almost precisely the packaging from Neupogen. A side-by-side comparison of the real vials, boxes and inserts to the false ones shows them to be remarkably similar, Kaye admits, though a studied eye can detect small differences.
The wave of drug fraud has consumer advocates concerned. "Obviously from our point of view, this is absolutely, incredibly dangerous," says Matthew Grissinger, a medication safety analyst at the Institute for Safe Medication Practices, a nonprofit group in Huntingdon Valley, Pa. "It's sad to see this occur."
While AIDS patients who use bogus Serostim might not suffer severe reactions, the fake drug will not be effective treatment, Grissinger says, adding that the same applies to any patient who takes a fake drug.
The FDA confirmed that it is investigating the counterfeiting of Serostim and Neupogen, but a spokesman for the agency refused to discuss any details of the inquiries.
What To Do
If you use Serostim, check the lot number on the packages. Those marked MNH605A should be considered counterfeit and returned immediately for replacement. Call the company toll-free at (888) 275-7376 for more information.
"If you've taken [Serostim] before, you should examine the product and be sure it's the same product that you're used to," Castel says. "You should also be asking the pharmacy if their supply of Serostim comes directly" from a distributor who gets it from Serono, she adds.
For more on drug safety, visit the Institute for Safe Medication Practices.
Read other HealthDay articles about counterfeit drugs.
To find out what clinical trials are being done on AIDS, check Veritas Medicine.