Can You Trust Studies About Drug Safety Associated with Drug Makers?

| Dec 11, 2012 | Defective Drugs |

Watch out for studies testing the safety of pharmaceutical drugs when the studies are associated with the drug maker. In Sue Hughes’s report on TheHeart.org, a study conducted by Trinity Partners Consultants found that Pradaxa was better than warfarin when it came to “persistence rates.”

Persistence is medical terminology for the continuation of an event – bleeding, in this case – after the cause has been removed.

In patients with cardiac arrhythmia, stroke from blood clots is a risk factor, so health care providers may prescribe a blood thinner like Pradaxa. The problem with Pradaxa and other blood thinners like warfarin is that these drugs can cause serious bleeding.

The problem with Pradaxa is there is no reversal agent, no “antidote,” so to speak, for serious bleeds. The bleed becomes uncontrollable and the patient may die. What Trinity Partners says is that once the patient stops using Pradaxa after a bleeding event, the persistence rate is better than in a similar case involving the drug warfarin.

But, what the study apparently fails to mention (at least it’s not mentioned in Hughes’s report), is that Pradaxa and warfarin are not the same drug. Pradaxa is not meant for every single patient with cardiac arrhythmia, although it seems to have been marketed that way by drug maker Boehringer Ingelheim. In many cases, warfarin may actually be the better choice.

So here’s the rub: Perhaps no surprise here, but Trinity Partners Consultants, the organization that conducted the “study,” did so as a consultant for the very drug maker that produces Pradaxa: Boehringer Ingelheim.

Source: Dabigatran: Reassuring data on major bleeds