Gil Roth04.30.08
I've refrained from writing about The Problem With Heparin for several issues now. Since we're not a daily or weekly, I thought I could let the story unfold a bit, and not come off as an idiot or a shill. I didn't understand the nature of what went wrong. Now I see that this isn't a story that will unfold; it's one that's going to grow more complex, just like Heparin's supply chain.
Recently, the FDA's commissioner let a Senate panel know that the contaminant found in the product, chondroitin sulfate, was likely there because of economic gain.
(How Gil hears it: "It was greed, not bioterrorism.")
More recently, a Chinese official cast doubt that the contaminant is responsible for the allergic reaction that's led to 62 known deaths, contending that the U.S. processing plant may be at fault. No one in authority has stated that the contaminant actually is responsible for the reactions, so he isn't technically wrong.
(How Gil hears it: "So the product you bought from our country was cut; big deal!")
And even more recently, the FDA posted its (redacted) warning letter to the API provider in China, citing, among other things, its use of crude material sourced from a supplier that it had already determined was "unacceptable."
(How Gil . . . well, heck, you may as well read the FDA's own words on this one: "[Y]ou state that the firm received and used heparin crude materials from a workshop that had been designated by your firm in a 'pre-audit' as 'unacceptable' and that was ultimately not approved by your firm. Your firm used this crude material in the production of API lots that were shipped to the United States.")
I'm not out to bash China or any other developing markets; I figure everyone has the right to make a buck. But just like the crises in our credit markets, it seems to me that the strangling complexity of the problem is part-and-parcel of the problem. That is, the complexity of these global supply chains is almost by definition going to lead to a lack of accountability, with potentially fatal consequences.
In a recent "Innovation" article in BusinessWeek, I read about how Airbus may learn valuable lessons from the problems Boeing has suffered in putting together its next-generation airliner. Some of these lessons involve taking more time between finalizing the plane's design and assembling the first ones (24 months instead of the 18 months that Boeing took) and allowing contractors to do more of the design work themselves (?).
The most important lesson, though, seems to be the need for Airbus to "simplify its supply chain" on the A350:
(How Gil hears it: "Supply chain? We're passing the buck on this one! Have fun flying!")
Recently, the FDA's commissioner let a Senate panel know that the contaminant found in the product, chondroitin sulfate, was likely there because of economic gain.
(How Gil hears it: "It was greed, not bioterrorism.")
More recently, a Chinese official cast doubt that the contaminant is responsible for the allergic reaction that's led to 62 known deaths, contending that the U.S. processing plant may be at fault. No one in authority has stated that the contaminant actually is responsible for the reactions, so he isn't technically wrong.
(How Gil hears it: "So the product you bought from our country was cut; big deal!")
And even more recently, the FDA posted its (redacted) warning letter to the API provider in China, citing, among other things, its use of crude material sourced from a supplier that it had already determined was "unacceptable."
(How Gil . . . well, heck, you may as well read the FDA's own words on this one: "[Y]ou state that the firm received and used heparin crude materials from a workshop that had been designated by your firm in a 'pre-audit' as 'unacceptable' and that was ultimately not approved by your firm. Your firm used this crude material in the production of API lots that were shipped to the United States.")
I'm not out to bash China or any other developing markets; I figure everyone has the right to make a buck. But just like the crises in our credit markets, it seems to me that the strangling complexity of the problem is part-and-parcel of the problem. That is, the complexity of these global supply chains is almost by definition going to lead to a lack of accountability, with potentially fatal consequences.
In a recent "Innovation" article in BusinessWeek, I read about how Airbus may learn valuable lessons from the problems Boeing has suffered in putting together its next-generation airliner. Some of these lessons involve taking more time between finalizing the plane's design and assembling the first ones (24 months instead of the 18 months that Boeing took) and allowing contractors to do more of the design work themselves (?).
The most important lesson, though, seems to be the need for Airbus to "simplify its supply chain" on the A350:
In the past, it awarded contracts to some 250 key contractors on each aircraft. But Klaus Richter, a new procurement chief recruited last year from BMW, has winnowed that number to about 70. The suppliers, in turn, are expected to assemble their own teams of subcontractors. The challenge will be making sure that those outfits, which account for as much as one-third of production costs, have the technical knowhow and manufacturing capacity to deliver what Airbus needs. "The lower-tier supplier base," says Kirk Bozdogan, an aerospace researcher at the Massachusetts Institute of Technology, "is the Achilles' heel."
(How Gil hears it: "Supply chain? We're passing the buck on this one! Have fun flying!")