New book adds fuel to the debate over drug safety

A new book that purportedly “exposes the dark side of America's pharmaceutical trade” could expose a rift between drug manufacturers and the companies that distribute their products. Dangerous Doses: How Counterfeiters Are Contaminating America’s Drug Supply, by investigative journalist Katherine Eban, was released Monday.
A new book that purportedly “exposes the dark side of America's pharmaceutical trade” could expose a rift between drug manufacturers and the companies that distribute their products.

Dangerous Doses: How Counterfeiters Are Contaminating America’s Drug Supply, by investigative journalist Katherine Eban, was released Monday.
File photo
Rep. Steve Israel (D-N.Y.): “Drugs can change hands up to a dozen times.”


Its author already has appeared on the CBS “Early Show” and been featured in U.S. News & World Report and other publications, and an excerpt appears in Vanity Fair this month. The book aims to reveal the shortcomings of the distribution system that make the supply chain vulnerable to counterfeit and adulterated drugs.

The publicity push for the book could prompt the interest of a public already worried about drug safety as a result of several highly publicized events, such as the withdrawal of Merck’s prescription painkiller Vioxx last year. That public interest could translate into congressional interest, drawing the distributors into the larger debate about drug safety that so far has focused on pharmaceutical companies and the Food and Drug Administration (FDA).

Rep. Steve Israel (D-N.Y.) seized on the release of the book as an opportunity to reintroduce a bill called “Tim Fagan’s Law” that is named after a teenage constituent whose life was threatened by counterfeit medication.

At a press conference Monday, Israel appeared with Eban and the investigators who are the subjects of her book to tout his bill.

“What [Americans] don’t know is that, between the manufacturer and pharmacy, prescription drugs can change hands up to a dozen times, in a shady gray market, where they can be tainted, diluted, relabeled and counterfeited,” Israel said.

As described in Dangerous Doses, the drug used by Fagan “was bought and sold out of a strip club in Miami” on its way to the retail pharmacy that sold the drug to Fagan’s family, Israel said.

The release of the book coincides with intense scrutiny of drug-safety issues in Congress and the continuing debate over allowing the importation of drugs from abroad.

The Pharmaceutical Research and Manufacturers of America (PhRMA) has been fighting the drive for importation by underscoring the weaknesses of the domestic drug supply chain. PhRMA Senior Vice President of Communications Ken Johnson said the book “raises some similar concerns that we have.”

PhRMA identifies the structure of the distribution system as the root cause of the proliferation of counterfeit drugs. The book “highlights a growing problem about how counterfeiters are infiltrating America’s drug supply,” Johnson said. Importing drugs from abroad is “only going to make the problem worse,” he added.

That position could cause friction with the drug distributors, which have long resisted a new regulatory regime governing their sector.

The Healthcare Distribution Management Association (HDMA) issued a strongly worded statement the day Dangerous Doses was released, but did not acknowledge the book itself. “One counterfeit drug is too many and these criminals must be stopped,” association President and CEO John Gray said.

The distributors maintain that the renegade actions of a handful of bad actors should not reflect on the industry at large, which includes some of the largest healthcare companies in the country. “It is important to know that there is a clear difference between the legitimate business of distribution and these criminals who thrive on figuring out ways to attack our healthcare supply chain,” said Gray.

The HDMA’s stance could be undermined by PhRMA’s contention that the system, not isolated criminals, is to blame.

Both organizations are members of the Partnership for Safe Medicines. The umbrella group includes more than 50 members ranging from pharmacists to patient advocates.

PhRMA and the HDMA were among the partnership members that participated in a conference call last week to finalize the wording of a press release issued Monday. The statement describes the book as a “wake up call for America on the growing consumer threat of counterfeit drugs.”

The solutions outlined by the release — such as harsher penalties for distributing counterfeit drugs and using radio-frequency identification to track a drug’s “pedigree” — are basically consistent with the HDMA’s long-held positions.

Peter Lurie, deputy director of Public Citizen’s Health Research Group, questioned the sincerity of the distributors’ statements on drug pedigrees.

The FDA has delayed full implementation of a paper pedigree regulation for years, Lurie said, because of the objections of the distributors, who have maintained that the costs are not justified by the effectiveness of paper records. In the meantime, Lurie observed, there is no reliable accounting of a given drug’s journey from the manufacturer to the retailer.

Families USA Executive Director Ron Pollack described PhRMA’s implication that imported drugs would further compromise the integrity of the distribution system as a “bogus claim.” Pollack acknowledged that “the potential for mischief” is inherent in the system but argued that an importation system that included safeguards against counterfeits — including pedigrees — would protect consumers.

Securing the safety of the domestic drug-supply chain “is not the most complex safety issue to grapple with,” Pollack said. A lack of political will to face the issue has contributed to the failure of federal authorities to act, he suggested.