Time magazine (Nov.2) has a recent article of note, "You don't know him but he may be the biggest winner in health-care reform. So who loses?" In it, a particular paragraph caught my eye:

    The Federal Trade Commission (FTC), though, argued in June that giving biologics makers any period of exclusivity at all could actually stifle innovation. Biologics are so much more complex and expensive to produce than traditional drugs that the barriers to would-be "biosimilar" competitors are already high, the FTC said. Giving biologics further protection—particularly the 12 years of exclusivity that the industry wants—would merely encourage firms to tinker with what they have rather than drive them toward "new inventions to address unmet medical needs."

The authors, Karen Tumulty and Michael Scherer, are speaking to the controversy re patent exclusivity on expensive biologics, which will soon comprise a hefty share of the pharmaceutical industry's product base as well as their future profits.

The principle sentence here would be the first, that the industry would be driven to produce "me-too" biologics instead of bringing out truly innovative drugs.    What happens now in the pharmaceutical industry when a patent drug expires is that the drug maker produces a similar drug, the active metabolite for example (Nexium from Prilosec), or another drug form, controlled release say (Ambient CR from Ambien). Instead of trying to market a new, unique drug for diabetes or blood pressure, the drug companies instead follow the less expensive pathway of producing drugs that offer no significant difference in efficacy than those already on the market.

If, however, these companies could not count on the easy play of "me-too" then the economics of medicine would start to pressure those corporations into a more risky territory, giving the green light to more R & D in areas that desperately need true innovation.

The medicines that are being sampled in doctor's offices now are merely another ACE inhibitor, another beta-blocker, another sulfonylurea, another this and another that. Oh, it might last longer, sure. Big deal. It also costs a lot more, with no or little increase in effectiveness. That is one reason behind the big push to get sales reps out of physician offices. The newer agents being pushed are often just expensive alternatives that are given out free at the start but greatly increase the over-all burden to health-care as a whole down the line.

Of course, given the huge influence that the industry has on congressmen/women there is no hope for change. What a waste.


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