Tips of the Week
Let the DES Recovery Begin
Drug-eluting stents (DESs) were first launched in April 2003. By 2005, the category was racking up sales of $3.1 billion. Then, in September 2006, studies presented at the European Society of Cardiology meeting reported potential problems with thrombosis following DES implants. These studies generated significant media attention which, in turn, led to an FDA hearing on the subject and a congressional review of off-label marketing that included DES practices. As a result, DES sales in the second quarter of 2007 were 42 percent lower than during the same period in 2006.
As The Wall Street Journal reports, however, the market might be on the verge of a turnaround. Ironically, the spark that may relight DES activity comes from the European Society of Cardiology meeting, the same place where the all bad news started in 2006. The latest research indicates that when compared to bare-metal stents, DESs have a 1 percent higher mortality rate instead of the 18 percent originally reported.
The primary rationale for DES use is restenosis, a re-narrowing of the artery which occurred to a high degree after bare-metal stent implantation. Since the restenosis problem hasn’t gone away, the new research showing comparable mortality rates between the two types of stents should go a long way toward increasing comfort levels when choosing DESs.
Prescription Data Restriction Laws Not Just a U.S. Phenomenon
For the last few months, states have been attempting to restrict pharmaceutical company access to prescriber-level data (see story). New Hampshire, Vermont and Maine have already passed laws to prohibit the use of prescription data for marketing purposes, and there are bills under consideration in numerous other states.
The move to prevent pharmaceutical companies from accessing prescription data is also catching on internationally. Germany’s GKV-WSG reforms, which became effective in April, prohibit the use of prescriber-identifiable prescriber data for commercial purposes and Poland’s parliament is currently considering a bill that would prevent pharmacies from selling information captured during prescription drug transactions.
Whether in the U.S. or abroad, the motivation for these law is the same: to reduce the burden that new drugs place on the public purse. The New Hampshire law was overturned in April on grounds that it was overly restrictive of protected commercial speech. Although the state is appealing that ruling, data services in the U.S. have a strong First Amendment argument. In other countries, there are fewer protections for freedom of speech, and drug spending places a much greater strain on central government budgets. One can therefore expect that data restriction laws will be adopted more broadly with European countries leading the way.