Kia Franklin

Drug Makers’ Innovations Stop at Keeping Competitors Away

This article, Amgen Defends Its Turf as Competition Looms for Anemia Drug, discusses the turf war between two drug companies over an anemia treatment drug used on patients with kidney problems. Amgen, the established name on the market, has pursued a few innovative methods for resisting competition. For example, a chief operator of a medical clinic says Amgen called her with this warning:

If the clinics switched from Amgen’s anemia drug to a new medicine planned by a big competitor, and then the competing drug was knocked off the market by an Amgen patent lawsuit, the chain might have to pay a much higher price to resume using Amgen’s drug.

“And I was like, ‘Did I just meet with the mob?’” said Tracey Mooney, the chain’s chief financial officer, recalling the July 2006 exchange. Amgen, she said, was effectively threatening to turn her clinics, run by the nonprofit Independent Dialysis Foundation, into a money-losing operation.

With the anemia drug accounting for about a third of total costs, she said, Amgen “can make or break me.”

Amgen is also suing its competitor, Roche, for patent infringement. Perhaps a delay tactic, perhaps legitimate. I'll suspend judgment despite evidence that patent infringement suits are a common delay tactic against legitimate competition to hold onto profits as long as a company can, until the company inevitably loses the case. As a counterclaim, Roche accused Amgen of antitrust based on the threat to the above mentioned clinic and other unscrupulous practices. Meanwhile Amgen "argues that its actions were normal competitive practices..." and that, besides, the threats didn't work. (Criminal law equivalent: "These attempted murder charges are bogus! So what I tried to shoot her--the bullet never hit her body!")

A final method against competition--which it hasn't been confirmed that Amgen has used--is to obstruct the competitor's access to testing labs (unnecessarily test random things to clog up all the labs) that the competition needs to get to in order to conduct drug trials, thereby preventing the competition from getting the drug out on the market.

“Every month we delay” Roche’s drug, the consulting firm, BAI, explained in a slide, is the equivalent of $100 million in extra sales for Amgen. It is not clear whether the idea was put into practice.

What's missing here? The civil justice critique.

Interestingly, no where in the article does it mention that in response to competition Amgen is working hard to improve its drug's safety and effectiveness in treating patients. I wonder if that's because Amgen hasn't tried this? Hmmm. Ah well, so much for healthy competition.

The public's safety is clearly a low priority in this turf war, despite recent questions as to the safety of the drug in question. It's all about preserving profits and protecting a monopoly on the market. Even when Amgen's drug was under FDA scrutiny last month, and despite the sad reality that after almost two decades of using the drug physicians weren't being given enough data on the drug's effect on patients, the discussion seemed to hinge on the bottom line. See, e.g., this article calling the FDA's decision a "break" for Amgen (and a "what" for kidney disease patients?).

If the public's health is nowhere in the conversation, why are we then surprised when dangerous drugs make it out to the market, harm the public, and individuals have no other recourse than to take the drugmaker to court David v. Goliath style?

Kia Franklin: Author Bio | Other Posts
Posted at 1:00 PM, Oct 17, 2007 in FDA | Pharmaceuticals
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The drug in question is Epogen which is a naturally occuring human peptide. The issue of safety of the drug is in how to clinically use it.

Right now it is used in dialysis patients who tend to be anemic. Renal failure is related to loss of the natural Epogen. The drug also has use in other chronic anemias as well as in malignancy but these indications are still being worked out. This is what the cited FDA article is all about. It is not that this is a "dangerous Drug" but one that is greatly helping many patients avoid transfusion reactions and complications.

Like many things, the "devil is in the details" and the details are what makes all the importance.

Posted by: throckmorton | October 18, 2007 8:28 AM