amateur booty pic…

Re: Janet’s point, yeah, lots of factors. As has been pointed out many times, and especially during the current administration, by the time DDMAC reviews material it is often no longer in use. Not much control there….

Does the WLF believe that promotional materials are OK even if they directly contradict facts known by a company, or, indeed, by FDA?

This was my initial question - whether “false and misleading” in a promotion to docs context ought to be viewed differently (as far as liability) than knowing misinformation in clinical studies?

I still hear of MDs who believe that celecoxib is safe (according to some, the only safe option) with warfarin. There is clear documentation to the contrary, including in the prescribing information. However, though acetaminophen, opiates (not desirable) and non-acetylated salicylates (which hardly anyone even remembers) are still reasonable choices - safer and cheaper - no one likes to be reminded of that.

This does not mean that physicians as a group are stupid; rather, I think, hopeful, trusting, willing to please, and a little less skeptical than would be healthy for everyone involved. Kind of like the human equivalent of black lab retrievers - though with generaly less drool.

Thanks for the excellent discussion and references to other sources. In answer to the promotional material question, when I was on the PhRMA side of things, we used to seek out the competitors promotional material and “home-made bread” to point out any misleading claims to DDMAC. The same was done to the companies I worked for. The rationale for this was not to ensure that physicians were not mislead or confused or to protect patients, it was merely to mess with the other guy’s marketing and sales operations.

Here’s a slightly different scenario: an atypical antipsychotic is promoted shizophrenia and bipoar disorder to a group of physicians - pick any one of the following: Child and Adolescent Psychiatrists, Pediatricians or Family Practitioners. Samples are left, even though these physicians never treat an adult patient who would fall into a category where there was an approved indication?

Is that misbranding? Is the prescriber left entirely holding the liability bag? Lets say a child is allegedly injured due to the prescribers decision to use the medication for presummed Bipolar Disorder in a preschooler. If the prescriber’s medication choice was made in part because samples are available and the prescriber was detailed on the drug, hasn’t the company invited a liability suit if the company directed the reps to call on and sample the phsycian?

To me it seems they have.

This is one of the several reasons, I typically avoid prescribing a new drug for several years. I don’t want to be the one using it incorrectly when there is not much know about it in clinical practice.

http://www.wlf.org/Resources/DDMAC/default.asp

I hear what you say about competitors, but I’m wondering if there may not also be a kind of compact - “I won’t rat on your misleading promo if you don’t rat on ours.” That would also be in everyone’s “interest” (except docs and patients).

Once again, all of this would be outside the sphere of potentially relevant grounds for liability if/when preemption goes forward. So I am continuing to work on my Post Preemption Survival Kit.

Re: docs, there appears to be more cynicism but it would take a good study to really know. Anybody know of one?

I believe that the misleading information in Mercks packaging materials should be figured in the liability issue.

Additionally, I think that misrepresentation of information to physicians also needs to be addressed. They are doing this to increase sales only and that could lead to potential harm to the patients, as it certianly did in this case with Merck. As I have said before, the downside of all of this is that Vioxx is a really good drug, if Merck would have managed it better and been more transparent with the cardiotoxicity issue, the drug would have continued to do well for them. It was very aggressive and risky behavior on their part and they are paying the price for it.

It is easy for us to play Monday morning quarterback, but clearly the FDA should have taken a much firmer approach on this second warning.

Like the FDA said, Merck should have disclosed the shortcomings of their data. As it was it completely downplayed that what they were suggesting was merely hypothetical.

Can anyone say if physicians learned anything from this? I wonder if post Vioxx, physicians are less inclined to “fall” for these aggressive type marketing campaigns.

In the end the FDA needs to be more strict in its review of marketing material. It was too easy to become complacent and think that if this was approved, somebody must be checking the data?

This is where we in industry can and should scrutinize each others information. If the FDA misses these issues at least our competitors will not. This way patients and physicians stand a better chance of not bein so misled.

Interesting quesitons…

Yes, as FDA reports, Merck “explained” VIGOR by saying that naproxen must be cardio-protective. But, as I recall, the “headline” of their materials was something to the effect of Vioxx being shown to be fully safe (and this after FDA Advisory had suggested label change in other direction).

It is hard not to believe that this was knowing misinformation.

My sense is that most physicans just focus on the headline if they are using a drug without problems (or obvious ones) with their own patients. They take it as a bit of reassurance to keep doing what they were already doing, just as most of us do in our work. All is well, etc.. Most of us don’t look for reasons to change course but to stay on them.

Since this kind of thing, in promotional stuff, is extremely common - much moreso, I think, than fraud in clinical trials - my more basic question is whether people put this in the category of “business is business” or believe it appropriate and realistic that companies not only should, but generally do, hold themselves to a higher standard.

I do think that the use of false and misleading information such as Merck apparently used should be figured into liability. The assumption the company makes is that marketing materials aid their sales, so if they use misleading materials that make unsubstantiated assertions, they should be liable for that.

There should be some sort of escalating fine for using materials repeatedly–you get one warning letter (because sometimes the pulled material isn’t fraudulent, the FDA just feels it might be interpreted as making a false claim); then if you make the same material claim, you get hit with a big fine.

We’ve occasionally had marketing materials pulled. One recently was some long-term efficacy data that might have been interpreted as implying we have a maintenance indication with the drug. I don’t know if the FDA pulled it or if our DMT did because we are very close to getting the indication and didn’t want to do anything that might jeopardize that. (Ironically, the closer you are to getting an indication, the closer the FDA watches you to see if you talk about it. If you talk about it, then they withhold the indication. That is why sales typically knows so little about new indications and new products–they don’t want us to be able to talk about them and possibly jeopardize approval.)

So was Merck suggesting that the reason Vioxx had a higher rate of MI was because the other NSAID was acting as a cardioprotective agent? They were saying that the Vioxx rate of MI was the baseline, and the other NSAID represented prophylaxis? I can’t believe a phyhsician bought that—we’d all be popping Naproxen and to heck with our tummies.

Question especially for people in industry. If the facts are as the FDA represents them, do you believe that they should have figured into any potential liability?

Alternatively, do you believe that misreprentation in marketing to physicians is the kind of behavior that should appropriately be given a good deal of leeway?

When FDA wrote that Merck’s actions raised “significant public health and safety concerns” do you believe this was appropriately stated? Do you believe that the FDA describing promotional materials that “misrepresented Vioxx’s safety profile” reflects a misunderstanding of legitimate business practice?

These discussions are particularly useful when there are particulars to deal with. We rarely do that.

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FDA Warning Letter to Ray Gilmartin

You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal antiinflarnmatory drug (NSAID), Naprosyn (naproxen).

Although the exact reason for the increased rate of MIs observed in the Vioxx treatment group is unknown, your promotional campaign selectively presents the following hypothetical explanation for the observed increase in MIs. You assert that Vioxx does not increase the risk of MIs and that the VIGOR finding is consistent with naproxen’s ability to block platelet aggregation like aspirin. That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties.

You have also engaged in promotional activities that minimize the Vioxx / Coumadin (warfarin) drug interaction, omit important risk information, make unsubstantiated superiority claims against other NSAIDs, and promote Vioxx for unapproved uses and an unapproved dosing regimen. In addition, in misrepresenting the Vioxx / warfarin drug interaction you also misrepresent Vioxx’s safety profile by minimizing the potentially serious risk of significant bleeding that can result from using Vioxx and warfarin concomitantly.

Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns. Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx’s safety profile.