I’m not enough “in the know” - others will be - but it does seem logical that, had Vioxx taken on the CV warning the FDA advisory committee suggested (fourteen months before the whittled down version appeared), we might well have heard DTCAs from Pharmacia/Pfizer:

“CELEBREX: The only new arthritis medication with no increased risk of heart attack or stroke!!! And…gentler on the stomach!!”

Of course, neither claim (especially the latter), would be borne out by the facts as we know them. FDA may have tried to reign them in on the latter, but we know that - in those years when Dan Troy oversaw marketing warnings - there hardly were any.

What about this statement from Bayman the lawyer for Glaxo

“Bayman told the paper that the FDA has the exclusive power and authority to approve drugs as safe, to label those drugs with warnings, and has warned of the dangers of “overwarning.” “To put warnings on - which some people say would only be on there to insulate manufacturers from liability - if that warning is not based on good scientific evidence, that really runs the risk of deterring people from seeking treatment. That’s why the FDA’s job is to strike a balance.”

When is a warning not a warning? Which warnings should we be warned about? Nausea, vomiting and water retention are o.k. to know about but we mustn’t tell them about suicidal tendencies? Do we have good scientific evidence that nausea, vomiting and water retention are/can be scientifically proven as being linked to the drug? No we don’t but we report it anyway.

Patients on these drugs must be closely monitored by healthcare professionals. Their close family members need to be educated on the risks of this drug. You cannot write a script for these things then send a person off into the world. However, these drugs are sold on the basis of how they are supposed to save money to the healthcare system because these patients do not require close monitoring as what would normally happen in seriously depressed cases. Mild cases shouldn’t be medicated, lifestyle changes need to be managed.

One question I have is, how much did the treating physician do to make sure the patient was followed. What did the doctor know. Call the treating doctors to the witness stand, let them say what information they had or did not have from Glaxo. Let them tell us about the CME they received on this product.

There is a great opportunity here to bring this information to the general public.

Many years ago, as a young academic, I studied ad content and found that the provision of “negative” information about a drug actually increased the believability of the ad. This research was done over 25 years ago and I’m not current with what has transpired in the literature.

Isn’t it that the labeling is hitched up to marketing? That new labeling on a competitor drug may trigger a new catch phrase in marketing.

To anyone, what marketing impacts do BBWs have besides precluding reminder ads and ensuring that the boxed warning appear in other ads?

Given the reality, why do you think Merck fought so hard against the changed label on Vioxx? Do you think it would have really hurt it against Celebrex?

I don’t have the exact numbers, but the FDA required something like 25 BBWs between 1975-2000. They required about 50 between 2004-2007. Have the actual drugs really decreased in safety that much? Each additional BBW dilutes the impact of the other. I would closely consider any legislation that makes the label less useful to inform health care decisions.

The reason adding a warning to a drug label doesn’t make any impact in sales is that the labels are already so unwieldly they become useless and warnings get lost in the shuffle. Hopefully the new labels with their more stringent adverse reaction requirements and highlights page will result in prescribers at least looking at the highlight portion more often.

The “over-warning” argument has essentially no empirical basis, btw, but it’s been a favorite of the preemptors for a long time.

The perhaps sad fact is that labels, with the possible exception of black boxes with a lot of publicity, rarely make any difference whatsoever re: rx’ing. Classic example is how Vioxx sales changed not a whit after famous label change finally happened after all those months. One can probably assume same result if that warning had really been a warning, rather than a “precaution.”

Publicity and controversy, however, do make a difference. Avandia and Vytorni/Zetia rx’ing best recent examples.