A recent article in the Wall Street Journal, Pill Push; Industry Fights Switch To Generics for Epilepsy did a great job of explaining the behind the scenes maneuvering, but failed to elucidate the substantive issues.
In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies — a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.
The article dissects in some detail how various interest groups are battling each other at the state level.
Ms. Byrd says several pharmaceutical-company lobbyists offered their support. Abbott lobbyist Guy Mosier “was extremely helpful working with legislators to help them understand the importance and that this piece of legislation was strictly for patient protection,” Ms. Byrd says. Mr. Mosier declined to comment.
Ms. Byrd introduced the bill in the Georgia House in January of this year. At a Feb. 7 hearing of the House’s health committee, Lasa Joiner, executive director of the Georgia Psychiatric Physicians Association, testified in support. Ms. Joiner was at the time also a Glaxo lobbyist, which she didn’t mention at the hearing. In an interview, she said she didn’t raise her tie to Glaxo because the company hadn’t asked her to lobby for the bill.
Two days later, epilepsy patients and parents of patients visited lawmakers’ offices to ask them to support the bill. The Epilepsy Foundation’s Ms. Thompson says drug-company lobbyists accompanied the visitors.
Kimberly Oviedo says her 6-year-old daughter had seizures last year after being switched to a generic version of the epilepsy drug Zonegran. She says she supported the bill because she wouldn’t “want any other person to have to go through what we’ve been through with our kids.” Ms. Oviedo also has a son who suffers from epilepsy.
The bill passed the Georgia House in a 161-0 vote on Feb. 28, but it stalled in the Senate after groups representing pharmacists and generic-drug makers mounted heftier opposition to it in that chamber. Pharmacies often earn bigger profit margins on generics than on branded drugs.
I was confused by this article. Whose side was I supposed to take? Were scientists selling out? Were patients being used as pawns by big pharma? (If you think patient activists are sheep, check the responses to my post on Bexxar and Zevalin.) So I asked an MD friend who has done research on the pharmacokinetics of epilepsy drugs (not for pharma companies, by the way). She told me:
This is great reporting on the potential conflicts of interest, but there isn’t a single word in the article explaining that epilepsy drugs are ones for which there is a narrow “therapeutic window” between the level needed for efficacy and the level that causes debilitating side effects. Epilepsy drugs are among the few drugs for which doctors test blood levels and titrate doses carefully. Furthermore, some epilepsy drugs such as phenytoin have zero-order kinetics, meaning that the body gets rid of the drug at a constant rate that is independent of the level of the drug in the body, making it very hard to maintain a therapeutic drug level. For these reasons it matters a lot whether the patient gets a particular dose of the drug, and 10% variations that are negligible with other drugs can be hugely important in treatment of epilepsy. This makes switches from brand to generic, generic to brand, or even generic to other generic medication potentially destabilizing.
That explanation helped me put things in context.July 18, 2007