Can DES Survive? The fate of drug-eluting stents
The sales of drug-eluting stents (DES) continue to fall as the controversy of their benefits and safety rages on. DES used to be the rave of in percutaneous coronary intervention (PCI). Since the approval of Cordis CYPHER™ sirolimus-eluting stent in 2003, followed by TAXUS™ paclitaxel-eluting stent a year later, DES have raked in billions of dollars for the pharmaceutical industry in the last 3 years.
Then came the bad news in 2006, when DES came under attack during the World Congress of Cardiology in Barcelona as reports of late stent thrombosis and myocardial infarction trickled in. The COURAGE (NJEM Vol. 356:1503-1516) trial also put doubts on the benefits of DES over mainstream medical therapy.Will DES survive this? Or will it go the way of LYMErex™?* The most recent report on DES from a Danish trial is encouraging. According to Jensen et al. (JACC Vol. 50:463-470), “the minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.”
However, DES sales worldwide continue to decline and doctors are opting back to bare metal stents. Unless the next generation of DES shows better efficacy and safety profiles, the DES era may actually be over.
*Note: LYMErex™ was the vaccine against Lyme borreliosis approved by FDA in 1998. A class action suit due to safety issues was filed in 1999. In the end, Lymerex was cleared but the damage was done. Sales never picked again and the product was withdrawn from the market in 2002 due to lack of demand.
New Drug Application in Europe
Do you think that getting approval for a new drug in the US is a real pain? Try your luck in Europe. One may wonder how it can be so different on the two sides of the Atlantic after the guidelines for Common Technical Document (CTD) were set in place. Well, we shouldn’t forget that the US is a single country while Europe is a whole continent. Below is a very brief overview of the procedures a new drug applicant has t
o go through to break into the European market.
The European Medicines Agency (EMEA) is the EU counterpart of the US FDA as the main regulatory institution. In addition, each member state has its own regulatory board. We are talking here about 27 member states and 3 EFTA countries, making it 30 countries in total. There are three procedures to get a drug approved in Europe and there are strict guidelines as to which products should follow which procedure.
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The Centralised Procedure is obligatory for products which include among others, drugs against HIV and cancer and products derived by recombinant DNA and monoclonal antibody technologies. In 2008, some more products will be obliged to follow this procedure. The end result of this procedure is a single marketing authorisation and a single trade name for all 30 countries.
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The Decentralised Procedure (DCP) is for products not qualified for the centralised procedure and have not received a marketing authorisation in any of the EU/EFTA countries. It involves parallel submissions to the member states chosen by the applicant. The end results are several marketing authorisations and different trade names.
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The Mutual Recognition Procedure (MRP) is for products which have already been granted a marketing authorisation from an EU/EFTA country. If the applicant wants to expand this authorisation to other countries, then this is the way to go. The end results are similar to those of the DCP.
Take note that for both DCP and MRP, the submission dossier should be translated into the official languages of the countries in question.But don’t worry. Complicated as they may be, all submission procedures actually follow well-defined steps and strict timelines. And - they work!!!
Information transfer between hospitals and general practice: problems and solutions
The study by Kripalani et al. (JAMA Vol. 297:pp. 831-841) is an excellent systematic review about communications between hospitals and primary healthcare providers in different countries. And the results are quite alarming.
General practitioners (GPs) express a general dissatisfaction with the lines of communication between hospitals and practice. It seems that information transfer from hospital to GPs after patient discharge is rather slow, if not completely neglected, at the expense of the patients’ follow-up care. In many cases, reports are untimely and incomplete, and relevant clinical information, including diagnostic test results and change of medications, are often missing. No data is available about the safety repercussions of this communication deficit but the study reports that 25% of follow-up care visits are adversely affected.
In the US, it does not help that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) guidelines give hospitals 30 days to come up with discharge summaries. This one-month time frame is simply too long and not quite patient-oriented.
The use of information technology can be an important tool in solving this communication problem but hardware and software standardization needs to be tackled first before computer-generated discharge reports can be routinely available.