Re: the naproxen issue, this excerpt from FDA’s 2001 warning to Merck related to what I assume were some of the same promotional approaches used in Australia:

“There are no adequate and well-controlled studies of naproxen that support your assertion that naproxen’s transient inhibition of platelet aggregation is pharmocodynamically comparable to aspirin or clinically effective in decreasing the risk of MIs. Therefore, your representation that naproxen prolongs bleeding time and inhibits platelets identically to aspirin is misleading, and minimizes the potential seriousness of this finding. As you know, the reason for the difference between Vioxx and naproxen has not been determined; it is also possible that Vioxx has pro-thrombotic properties.”

I understand that Merck made considerable effort to find studies that providing evidence of naproxen’s inhibition of thrombi to any degree approaching aspirin. When I last heard anything, there were no such studies. So the judge’s comment that there was a “valid scientific basis” to the naproxen hypothesis surprised me.

Peterson’s compensation was not awarded out of his claims of negligence. The judge says “As to the negligence aspect, I have found that there are two respects in which the first respondent fell short of what was required in the reasonable discharge of its duty of care: its failure to warn the applicant’s doctor of the signal of potential cardiovascular risk which arose in March 2000, and the emphasis given by its sales representatives to the safety of Vioxx in their discussions with the doctor.” However, he goes on to say that, in Peterson’s particular case, he is not convinced that Peterson would have ceased taking Vioxx had he and his doctor been warned.

Peterson was awarded compensation under Australia’s Trade Practices Act. The judge found that Vioxx was not fit for the purpose it was being sold. I haven’t yet been able to work out whether Justice Jessup considers that it was always “unfit for purpose” because of the inherent (if unknown) cardiovascular risk, or whether it became unfit when the VIGOR results were known by MSD and not communicated, safety having been a previous selling feature.

As to your comment about pre-emption, the TGA derives its authority from the Therapeutic Goods Act. (Here, if you’re very interested: http://www.comlaw.gov.au/ComLaw/Management.nsf/current/bytitle/67A98FD37A0824C8CA256F710006F162?OpenDocument&mostrecent=1) There are clauses in it about the conferring of powers and duties in State law to Commonwealth officers, and also about conferring jurisdiction on the Federal courts, so I assume the balancing was all sorted out when the Act came into force, but I admit it’s all a bit beyond me.

Namaste

” Although the results of that trial showed that there were, at a statistically significant level, more cardiovascular thrombotic events in patients in the Vioxx arm than in the naproxen arm, there was, and there remains, a valid scientific basis to suppose that naproxen, if taken conscientiously, was protective against such events to an extent about equivalent to the effect of aspirin.”

As I’ve understood it, the last sentence was rejected as without evidence by FDA at the time. So presumably Merck was able, finally, to dig up some supporting naproxen data?

Namaste

I note the following sentence especially:

“Ultimately, they did come up with a form of advice which I have held to be sufficient for the purposes of the applicant’s negligence case.”

So, despite spin to the contrary, and legal technicalities, the judge clearly believed there was sufficient evidence of negligence in this case.

You may read the full 100 plus pages, right here (courtesy the keen eyes of Robyn Clothier, in my comments!), but I’ll quote just a little of finding 904:

“. . . .the misleading conduct was constituted by the failure to draw to the attention of doctors and other health care professionals the cardiovascular risk message that emerged from VIGOR. The respondents [Merck and MSD Australia] criticised the applicant [Graeme Peterson] for not having articulated the terms that any such advice would embody. Not having done anything, however, they are in no position to make that criticism. Ultimately, they did come up with a form of advice which I have held to be sufficient for the purposes of the applicant’s negligence case. But before that occurred, MSDA’s failure to provide any qualification to what was then contained in the Product Information did, for the reasons I have given, amount to misleading conduct. . . .”

Namaste

http://www.theheart.org/article/966827.do