Counterfeit Avastin?

Big story in the WSJ, but I’m not surprised in the least. Three points:

1. Amazingly, the FDA has no public surveillance system for counterfeit drugs in the US.

2. Despite high-profile discussions at WHO, the story doesn’t carefully distinguish mere patent infringement (legal drugs with proper ingredients parallel imported into the US) from public health hazards (substandard, dangerous drugs not made by any reputable manufacturer). From the careful wording of the story, it appears that mere patent infringement is involved. That is a significant issue, missed by the reporters.

3. Publicly, the industry treats counterfeit drugs as a “foreign” problem, but high US prices for patented medicines makes us the most lucrative market for criminals. Back in 2006, I wrote:

When criminals market cocaine, they need to deliver the expected (and observable) biochemical effect: customers want to get high. Delivering a placebo will not only destroy customer loyalty and repeat business, but it may also result in violence. However, many patented drugs do not deliver an effect that is immediately observable to the patient. If a patient takes a placebo instead of a drug such as atorvastatin calcium (Lipitor), the patient may not notice the lack of therapeutic effect for months. By the time it is noticed, it may be very difficult to re–trace the supply chain to the point where the counterfeit was introduced. Some commentators reluctantly acknowledge that counterfeit drugs are something of a “perfect crime.” For drugs that do not produce an immediately observable therapeutic effect, criminals need not go to the trouble to procure and ship the actual drugs. Any placebo will do, at a fraction of the cost…

KO

UPDATE:  best comment from the Avastin story on Phamalot:

Counterfeit suggests someone made fake drugs, but it is possible that these vials contain the real deal manufactured by or for or under a license from Genentech, which is owned by Roche. The question is whether these are truly counterfeit medicines, or whether a smart distributor bought the drugs at a low price in Europe or elsewhere and shipped them to the US.

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