BMS - Plavix: Dolan's trial concern

Peter Dolan, the chief executive of BMS, has said that the early launch of generic Plavix could threaten the product's entire on-going clinical trials program.

"While we are working hard to minimise the impact of this action on the company, we are concerned as well about the negative implications it will have for patients," said Dolan in a letter to BMS staff yesterday.

"Bristol-Myers Squibb and Sanofi-Aventis have a long-term R&D plan for Plavix [clopidogrel] that cannot be sustained if we no longer have exclusivity for this product," he warned.

LOL

So Peter, since you have raised the subject of clinical data, let's take a look at some:

1) The CHARISMA Study in the New England Journal of Medicine.

The study compared Plavix and aspirin to aspirin alone in 15,603 patients who had clinical cardiovascular disease or were at high risk of suffering a first event.

These patients were then followed up for about 2 years for myocardial infarction, stroke or cardiovascular death.

At the end of the study there was no significant difference between the two groups in the primary outcome.

There was a tendency to harm in the group that received Plavix and aspirin as there were a greater number of cases of severe bleeding, however this was not statistically significant.

This study demonstrates that there is no reason to add Plavix to aspirin therapy as there is no incremental benefit for the patient but there may be an increased risk of harm.

In fact, clinicians who prescribe antiplatelets for primary and secondary prevention of uncomplicated cardiovascular disease should avoid using Plavix and aspirin in combination.


2) A POEM published in the BMJ in May 2005 presented the results of a study comparing aspirin and PPI with Plavix. The study showed that while there were bleeding complications in the Plavix group there were none in the aspirin and PPI group.

Conclusion: In patients with significant GI history who need an antiplatelet for secondary prevention, consider using aspirin and omeprazole in combination instead of Plavix.

3) "The message is clear; that warfarin is superior to Plavix," said Stuart Connolly, the lead investigator and director of the cardiology division at McMaster University in Hamilton, Ontario at the last AHA meeting.

BMS had hoped to show that Plavix could be substituted for warfarin in atrial fibrillation patients as warfarin use requires extensive monitoring, a special diet and inconvenient lifestyle changes for patients due to a high risk of bleeding.

Rather than demonstrating that Plavix was just as good at stroke prevention in that patient population, however, the planned four-year study was stopped after about 17 months when safety monitors found a 47% increase in a range of adverse heart events (stroke, MI, embolism or death), including a 75% increase in stroke in the Plavix group.

4) Finally!

Plavix's financial success to date has never been about great clinical trial data.

It's always been about SALES & MARKETING!

It's all about the Benjamins, baby!

BMS have made a very expensive silk purse out of a sow's ear!

Insider, and most clinicians worth anything, would probably not care a toss if every ongoing Plavix study was stopped tomorrow.

Perhaps, Peter, you should be focussing your thoughts onto other possible future trials?