Celebrex Problems – What Should Pfizer Do?

PM-THREAD 1204-1

SUBJ: What Should Pfizer Do?
AUTH: John Mack
DATE: December 20, 2004
Dear PHARMA-MKTING member:

Today, the Financial Times (FT) reports that the FDA — in light of recent news about Celebrex — will issue a new ruling in a few days regarding the entire class of COX-2 inhibitors, including withdrawal.

No doubt, FDA is being pressured because of the entire mishandling of the Vioxx situation in which it was accused of being too slow to act.

FDA also seems to be considering broader reforms of it drug approval process.

All this is a result of a domino effect from Vioxx. You might also say that it is a storm that had its roots in the seeming flapping of a butterfly’s wings – a study of the long-term effects of Vioxx. It was a butterfly at the time because Merck claimed the result was not significant. It shows what one company may consider insignificant can influence an entire industry, not to mention the livelihood of the service industry that depends upon the continued health of the pharma industry!

I think that not just the FDA needs to look at itself. The drug industry also needs to look at itself if it wishes to become “Healthy Pharma 2010” (TM). [This is the title of a book I want to write or a conference I’d like to produce. Call me if you are interested!]

Pfizer’s CEO, Hank McKinnell, was quoted in the FT as saying, “…we can’t get any respect.” This Dangerfield comeback is a dangerous attitude. Hey, pharma execs, are you serious? The pity defense? Get over yourselves already!

What should Pfizer be doing right now instead of crying into its beer and circling its wagons? [OK, enough with the metaphors!]

Well, for one thing Pfizer should make it easier for the public and physicians to access the facts (e.g., the two clinical trials under discussion: the NCI APC cancer trial, which showed increased cardiovascular risk and the PreSAP cancer trial, which showed no problems).

I first looked at Celebrex.com and found nothing about these trials, even on the physician side of the site. Only links to the Pfizer press release and the FDA statement on the consumer side of the site were included (the FDA itself claims not to have studied all the facts! OMG!!!!)

The Pfizer.com site has, of course, a press release, which is unfortunately quoted all over the press, making press sites worthless as an unbiased source — or at least worthless in terms of allowing me to dig deeper and find the clinical trial data. (If you search Google for these trials, you are lead most often to the Pfizer PR or these worthless news sources, not to the trail data itself.)

If you are smart enough to go the NCI site (source of the APC trial) you might find more information if you dig deep enough. And forget about the Amer College of Rheumatogology site, which is the top-linked resource under treatment guidelines on Celebrex.com. Not a word about Celebrex under “What’s New”; also nothing under Drug Alerts and Information.

Of course, I could eventually find all the data I need from these trials if I continued to search more than I have. But what about the general public and even physicians who are even busier than I am? Pharma companies should make it easier to locate all kinds of trial data about their drugs. What companies do now is link to top-level sites like medical associations for general disease information. Not many use the product.com site to link to specific trial information.

I know that the FDA would balk if only favorable trials were listed and that’s been used as an excuse not to list any specific trials. But you could offer an exhaustive, unbiased list without any FDA regulatory concerns.

I’ve heard a lot about pharma companies now listing clinical trials that they support, but where are the easily accessible links from product and corporate sites to this information?

What is needed is a little more transparency, better designed and more complete information resources that are easily navigatable for consumers and physicians alike.

This will probably fall of deaf ears for marketers, who are mainly tasked with promoting the positive aspects of products and spinning the negative aspects.


John Mack

SUBJ: Pfizer gambles by not being first source of info about Celebrex risks
AUTH: John Mack
DATE: December 21, 2004
Dear PHARMA-MKTING member:

Yesterday I suggested that Pfizer should make it easier for the public and physicians to access the facts about Celebrex (e.g., the two clinical trials under discussion: the NCI APC cancer trial, which showed increased cardiovascular risk and the PreSAP cancer trial, which showed no problems), especially via the celebrex.com public website where most patients and physicians would go first for more information.

Instead, Pfizer has taken down the celebrex.com site entirely as part of its withdrawal of all Celebrex advertising.

What we are left with are the same inadequate links to the Dec 17 Pfizer press release and the pitiful FDA statement, which tells patients to talk to their docs (Hey, FDA! Where should docs go to for info?).

I would note that an article in today’s WSJ claims that Pfizer is gambling — from a liability and lawsuit standpoint — by not withdrawing Celebrex from the market. Plaintiff’s attys could claim that Pfizer knew Celebrex was dangerous but continued to sell it.

Well, how’s it going to look that all the ads were halted? This tactic seems to be designed to protect DTC rather than Pfizer or Celebrex itself (some DTC critics used the Vioxx situation to lambast DTC in general). Plaintiff’s lawyers can now say, “Pfizer knew something was wrong. Why else did they stop advertising Celebrex? They sinisterly wanted to keep a low puplic profile while continuing to sell Celebrex.”

As the WSJ article also suggests, Pfizer could help itself — as I suggested yesterday — by “putting all the risk information out there, alerting doctors and patients and letting them make the choice.”

What better way to do that than use the power of the Internet? This is a great opportunity for Pfizer to give us direct links to information about both studies via the celebrex.com website. Are they worried about the FDA telling them that they cannot do that? It’s a bit late for that – the cow has already left the barn!


John Mack

AUTH: David Reim
DATE: December 21, 2004
Someday the pharmaceutical industry will realize that the Internet can be both Promotion and Education (the latter is something mass media can not do). If consumers can not get official information (i.e. Education) from Pfizer directly (via the Celebrex web site) they are going to go to one of two places: their physician or their lawyer.

David Reim

AUTH: Jack Pfister
DATE: December 21, 2004
If you were to award them the benefit of the doubt, you could just say that they realize their promotional dollars are better spent elsewhere since any amount of advertising is unlikely to “untarnish” the product. That does not explain David or John’s comments about taking down the Web site, since those costs are negligible, once the content is populated.

Perhaps they are transferring the budget to Bextra, to prepare for that defense, which is sure to come?


AUTH: John Mack
DATE: December 21, 2004

“award” may not be the right word. 😉

What they should do with the promotional dollars they are saving (I doubt that they are saving much anyway) is to spend them on Public Service Announcements that present the facts.

You can’t do this on TV effectively, unless the main thrust of the TV ads are to direct viewers to the Celebrex Web site for full information disclosure. Use the science to make your case. Put all the evidence before the public and let them make a decision.

And don’t be condenscending to consumers! That is don’t just tell them to go to their docs for help (the docs are probably as ignorant about the trials as they are!). Tell them to go to Pfizer/Celebrex — the real expert!

Instead, form a consumer’s perspective, Pfizer has seemingly left the room in the middle of the debate! Maybe they plan on coming back. I hope so.



AUTH: Mick Majid
DATE: December 21, 2004
Internet has been both Promotion and Education for the pharma industry to reach the consumer. To disengage from the consumer at this very crucial moment when the consumer needs the most education is a very questionable strategy. There are ways to keep the Celebrex website to keep the connect with the consumer and keep the legal wolfs away.

Mick Majid

AUTH: Terry Nugent
DATE: December 21, 2004
What if all NSAIDs increase risk of MI and CVA but have never been double blinded properly? Perhaps every one you test will prove to elevate risk. Then what? Pull them all and put every patient on aspirin and PPIs?

AUTH: Terry Nugent
DATE: December 21, 2004
The plot thickens. Now a study in Archives of IM reports that people who have recently stopped using NSAID therapy are about 50% more likely to experience an acute MI than nonusers, and that the authors found that recent NSAID discontinuation, but not current or past use, raised the risk of acute MI.

What’s a doctor to do? One physician was quoted in the media here in Chicago as advising patients “It’s up to you.” Which may be the best answer from a legal risk management perspective.

But for that matter, what’s a lawyer to do? Who do you sue? Everybody, as usual, I suppose.

AUTH: Brian Towell
DATE: December 23, 2004
You’re absolutely right John,

As I alluded to following the Vioxx discussion thread, Celebrex was up for immediate ‘class-distinct’ suspicion.

Pfizer are in a weak position however you look at it, and their primary DUTY (interesting word rarely used in Pharma) now is to serve and reassure all patients on Celebrex with the right information that enables them to make the right choices.

The long-term damage to the role of selective C0X-2’s in pain management is probably already embedded in the decision tribes out there, which is a shame, as there are different emerging molecules which could well obviate the CV risks that now appear to be associated with systemic & sustained COX-2 inhibition. It would be something of a catastrophe if a drug that has shown enormous promise through development, at massive cost to the developer, were not to successfully reap what it has sown because of the failure of other less sophisticated molecules in the same ‘class’. A new molecule that has the remarkable ability to concentrate in inflamed tissues (where it resides long-term, locked in by it’s own physical chemistry) while remaining systemic drug is rapidly excreted from systemic circulation. Outcome: sustained effect with minimal/short-term systemic load.

So I would now be saying to the marketplace (if i were in the position of this fascinating emerging COX-2 product) we are not the same as the rest, we have real and positive reasons to be considered as an advance in treatment, at the same time focussing on all of the other COX-2 receptor sites that are also adversely affected by sustained systemic inhibition (eyes, kidneys etc.)

To be blighted with suspicion before you have emerged is a painful consequence of other products’ failures.

A mechanism-based strategy will not help here, but a physico-chemical-based strategy most certainly will.

I will watch this particular space with some considerable interest.

Have a Happy Christmas, or holiday, or whatever all you Pharma folks out there like to do!


AUTH: John Mack
DATE: December 23, 2004
Slowly, the Celebrex.com site is coming back and now includes an “FAQ” page for consumers that includes references to some peer-reviewed literature.

The Celebrex.com site is important because studies show that consumers and physicians turn to the Internet more and more for drug information and the first place they are likely to look is the product website (not to mention that celebrex.com is the first site listed by Google upon search).

More, of course, could be done. There could be, for example, more information for physicians and pharmacists. Pfizer sent letters, I am sure, to physicians and pharmacists after the Vioxx withdrawal. These letters went into a bit of detail about current trials of Celebrex indicating no cardiovascular problems. You can still find these letters on other Internet sites; see, for example, http://www.pharmacistelink.com/product/highlights/pdfs/20041026celebrex_faq_pi.pdf

A lot of angst has been exhibited about making sure that physicians see what pharma is telling consumers (to offset criticism of DTC and give docs a heads up for dealing with consumer questions elicited by DTC). What about showing consumers what pharma companies are telling docs and pharmacists?

I used to own and run a website called pharminfonet.com. We archived all kinds of information about drugs such as reviews of clinical trials reported at scientific meetings, dear doctor letters, medwatch notices, etc. We didn’t dumb it down for consumers because the site was really aimed at healthcare professionals. You know what? More than 50% of the 20,000 visitors per day were consumers!

Celebrex.com, like other product websites, used to have a health professional side. This separation is a joke; anybody can access it (“Nobody knows you are a dog on the Internet!” and nobody knows your not a doctor either). Why bother? If this is an FDA guideline, let’s ignore it!


Pharma companies should have contingency plans so that they can turn their web sites on a dime! Shame on them for taking days to respond to a crisis! The crisis site should have been waiting in the wings for immediate turn on.


John Mack


I have received additional comments from other members that did not make it to the list for various technical or other reasons. One of these is reproduced below (there was another, but I lost it!). I will keep the identity of the commentator confidential as I have not asked his/her permission to reprint the comments here;

How much of a “gamble” is it? Merck acted with a high level of corporate responsibility, a “partner in health care” approach, and was lambasted anyway. Perhaps Pfizer is simply learning from Merck’s experience that it does not matter which way you dispense information. You will be vilified. If that is the case, why expose yourself to potential problems by allowing for a forum to feed that process? (By the way, I think it is a shame that the public, and even many of us in industry, cannot usefully distinguish the difference in these approaches!)

This damned if you do and damned if you don’t defense really applies only if you continue to run the same kind of ads or web site after the crisis breaks as before. What I suggested was to run aggressive public service ads in place of the regular DTC and convert the web site into an information rich resource and maintain a high degree of visibility as the most complete source of information about your product.

To leave the room in the middle of the debate is questionable in my opinion. It gives the appearance that you have retreated and are talking to your lawyers rather than being forthright and transparent.

There is a difference between what Merck did and what Pfizer faces. First, there was plenty of evidence going back years about problems with Vioxx that Merck seemingly tried to suppress. That, if true, was not a “partner in health” approach. Many physicians complained vehemently, especially those that claimed to have been threatened by Merck. So far, it does not appear that Pfizer is in a similar situation — there is plenty of evidence out there that Celebrex does not cause cardio problems and so far as I know Pfizer has not tried to suppress any evidence – at least that’s not part of the current debate.

The second difference is that Merck withdrew Vioxx completely. Ergo, case closed with regard to PSAs or web site support. They chose to take the path of not defending the product. Pfizer has not withdrawn Celebrex and has chosen to defend it. Therefore, it should use all the means at its disposal to do so — including PSAs on TV and the web site. My beef is that it is not doing as much as it should, IMHO.

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