NEW YORK/COPENHAGEN — The trail of fake versions of the multibillion-dollar cancer drug Avastin that reached southern California has been traced as far away as Egypt in an investigation by international health regulators.
Danish health authorities first became suspicious about potentially bogus Avastin in December after a legitimate drug distributor in that country sounded the alarm, a spokesman for the Danish Medicines Agency told Reuters on Thursday.
"A Swiss company bought it from Egypt, a Danish company bought it from the Swiss company, and sold it on to a British company," Danish Medicines Agency spokesman Christian Howard-Jessen said. He would not name any of the companies involved or provide further details about the phony drug's origins.
"The Danish company was aware that there was something wrong with it," Howard-Jessen said. "They did what they were supposed to do, tell us about it. The product was never in Denmark, it was always en route from one place to another."
Danish regulators informed their British counterparts, who in turn found that some of the drug had already been shipped to the United States. British authorities said they then informed Swiss drugmaker Roche, which gets about US$6 billion a year from Avastin sales globally, and the US Food and Drug Administration.
The chase after phony Avastin highlights the growing complexity of the global drug supply chain, including both legitimate and counterfeit medicines, and how regulators will be hard-pressed to address potential safety breaches.
"We've known counterfeit products for a long time, and now they are appearing in the official chain of supply and then they are hard to avoid," Howard-Jessen said.
With the drug industry increasingly global, medicines can pass through many hands and nations before reaching patients. The source ingredients for a majority of US drugs come from overseas, further complicating the ability of domestic regulators to track them.
In one recent case that raised major fears over the safety of the drug supply, tainted versions of Baxter International Inc's blood thinner heparin that reached the US market four years ago were traced to ingredients culled from pig farms in China. Just last week, the FDA issued its recommendations for ensuring safe production of that drug.
Cardinal Health Inc, one of the three biggest authorized distributors of Avastin in the United States, said it will only purchase the drug from the manufacturer.
"That's our general approach to protecting supply chain integrity and guarding against counterfeit medicines," a Cardinal spokeswoman said. "We're reminding customers that that's the best way of protecting them from receiving adulterated or counterfit medicines."
Same number, different name
The high cost of medicines in the United States has led some doctors and patients to seek cheaper alternatives from abroad. The potential for huge profit has fueled criminal operations that produce counterfeit drugs across a range of therapeutic categories, including intravenous biotech drugs such as Avastin.
Roche and its US biotech unit Genentech, which manufactures the widely-used cancer drug, confirmed earlier this week that the suspicious Avastin contained none of the medicine's active ingredient bevacizumab.
The FDA is still investigating the scope of the fake Avastin distribution, including whether it extended beyond 19 medical practices which the agency has contacted about buying unapproved medicines from unauthorized distributors. Most of those offices are in southern California.
Earlier this week, the FDA said an overseas company called Quality Specialty Products (QSP) and an affiliate distributor called Montana Healthcare Solutions had sold unapproved medicines in the United States.
The FDA is also looking into another company, Volunteer Distribution based in Gainesboro, Tennessee, that it said distributed QSP and Montana Healthcare products. Genentech confirmed that neither QSP, Montana Healthcare nor Volunteer Distribution were authorized distributors of its drugs.
"Each distributor we partner with has agreed to only purchase Genentech products directly from Genentech," a company spokeswoman said.
Calls on Wednesday to Montana Healthcare Solutions using a phone number on a drug order form obtained by Reuters went directly to a recorded message. It identified the company by the name Montana Healthcare Solutions and listed hours of operation. Messages left were not returned.
A call to the same phone number on Thursday connected to a recorded message that began "Hi, you've reached Miles Clinical Sales."
An email address for Paul Bottomley, the business development director listed on the Montana product order form, ends with .us, which is not typical of US domestic email addresses.
Montana Healthcare Solutions is listed as a privately held company based in South Africa and has a message on its website saying it has no connection to the outfit under investigation.
A call to the Tennessee number listed for Volunteer Distribution was answered by a man who said Reuters had reached a wrong number.
