Four major brand-name drugs used for epilepsy are expected to lose patent protection and face generic competition between next year and 2010. Those four drugs generated $5 billion in U.S. sales last year.
When a doctor writes a prescription for a brand-name drug, pharmacists are usually permitted in most states to make an automatic switch to a generic judged equivalent by the FDA.
In the late 1990s, the national Epilepsy Foundation, based in Landover, Md., raised concerns about anecdotal reports that some patients experienced seizures and side effects after switching epilepsy drugs. Some of the episodes involved patients who had been switched to a generic from a branded drug. The foundation also worried about cases in which patients were switched from one generic version of a drug to another generic version of the same drug.
The foundation theorized that some generic pills had a meaningful difference from the brands. This difference, it postulated, meant patients were getting more or less of the drug in their blood, causing some of them to have seizures or side effects. Foundation officials floated the idea in a 1999 meeting with the FDA.
The FDA's response: 'Show us the data,' recalls Sandy Finucane, who oversees state and federal policy for the foundation. The agency, unpersuaded by what it saw, stood firm in its long-held position that the difference was too small to have a tangible impact on patients.
In early 2006, the issue re-emerged as legislation requiring doctor permission for switches was proposed in Illinois.
In May 2006, the national Epilepsy Foundation convened a committee of medical experts to examine the question. The committee found a lack of authoritative studies showing that such drug switches cause problems, says its chairman, Steven Schachter, a Harvard Medical School neurologist. Nonetheless, it recommended that doctors give explicit approval for switches, citing anecdotal reports of seizures and noting that such attacks can be serious.
Now, about those ties among the foundation and pharmaceutical companies.
The foundation and its state affiliates receive funding from the epilepsy-drug makers. GlaxoSmithKline PLC and UCB SA donated $500,000 to $999,999 each in fiscal 2006 to the national foundation, according to its annual report. Abbott Laboratories and a Johnson & Johnson unit each contributed $100,000 to $499,999. Representatives of four drug companies sit on the foundation's board, as does PhRMA chief Billy Tauzin.
The foundation says its diverse funding base shields it from undue drug-company influence, and the industry executives on its board didn't participate in discussions of the drug-switching issue. Foundation leaders note that the state bills would generally require doctor permission for several kinds of switches, including when a patient goes from a generic to a brand.
'These are people's lives that we're talking about -- nothing about stock options and stock value and how this would affect [companies'] bottom line. That would be insulting to us to have discussions like that,' says Sindi Rosales, the head of a foundation affiliate in Texas, one of the states that weighed legislation this year. She says pharmaceutical companies are 'fabulous partners' and their help in several areas 'has been amazingly tremendous,' but the companies leave it to the foundation to call the shots.
For their part, company executives describe their lobbying role as limited and say the bills were primarily an initiative of the foundation, although they acknowledge in certain cases that company officials have gotten directly involved. Executives say the aim of these activities is to protect the health of patients.
Here we go again. We have noted before that conflicts of interest may not consciously affect human decision making, and how people affected by conflicts may be genuinely indignant when confronted with suggestions that the conflicts consciously influenced their decision making. But, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult" (see post here).
However, there is ample evidence that conflicts may affect how people think and what they do. Try a thought experiment. If you knew that your organization were getting a large amount of money from donor x, would you be more likely to take a position that directly goes against the interests of donor x, or the opposite?
In any case, this case appears to be yet another example of stealth health policy advocacy or stealth lobbying, and one that may succeed in keeping the costs of drugs rising ever higher.
See Pharmalot's related post here, and the Wall Street Journal's Health Blog's here.