Vioxx 'risks can be immediate'

A pharmacology expert, whose medical career reportedly spans some 50 years, has speared Merck with a damning claim that Vioxx (and other COX-2 inhibitors) are highly likely to cause unstable blood clots that can cause heart attacks and strokes.

ìThe probability is very high,î Benedict Lucchesi, of the University of Michigan, told a New Jersey court, adding that the danger risks to patients could be heightened from as early as first treatment with the drug - even after just one day.

Lucchesi, who is understood to have enjoyed positive working relationships with Merck in the past, told the judge and jurors that just ìa single dose can lead to an adverse event, such as a heart attack or strokeî and that this assertion was ìbased on scienceî.

His indictment is a significant ingredient in the ongoing trial as Lucchesi is the first expert to testify on behalf of a claimant against the beleaguered pharma firm Merck. His plaintiff had taken Vioxx intermittently for only two months before he suffered a heart attack.

Merck, which has stuck to its `18-month' safety barrier claim for patients on Vioxx, contested that the plaintiff's age (60), condition and sedentary lifestyle caused his heart attack, and not its drug.

Yet, Lucchesi also pointed out that, despite a likelihood that all ìCOX-2 inhibitors can lead to thromboembolic eventsî, it was in his opinion ìmostly Vioxxî that suffered from this side effect. His testimony also brought to light the ìbig probability that Vioxx does pose a risk to patients with underlying disordersî.

Despite his attacking stance, under cross-examination the pharmacology expert conceded that Vioxx was probably safe for most people - but that this group does not include those with heart or kidney problems, or who are pregnant.

Merck has published a document on (www.vioxx.com) citing contraindications, warnings and precautions, in which it states:

• 'Treatment with Vioxx is not recommended in patients with advanced renal disease. If Vioxx therapy must be initiated, close monitoring of the patient's kidney function is advisable.'

It notes the risk of `renal papillary necrosis and other renal injury', but attributes these possibilities to the `long-term administration of NSAIDs' - and not only Vioxx - adding that `discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state'.

The company also states that:

• 'In late pregnancy, Vioxx should be avoided because it may cause premature closure of the ductus ateriosus.'

• 'Vioxx should be introduced at the lowest recommended dose in patients with fluid retention, hypertension, or heart failure.'

The list and explanation of potential problems appears to be quite comprehensive and the company remains adamant that it acted responsibly regarding its powerful marketing history for the drug, and in its global withdrawal of the product (September 2004) when the cardiovascular side effects became apparent and supported by scientific evidence.

However, prosecuting lawyers continue to try and prove that Merck knew about the side effects before and during it promoted use of the drug in patients. In his testimony, Lucchesi commented that he did not know how Merck's scientists ìcould not know the potential for harmî.

The trial is ongoing.