Tuesday, May 22, 2007

Advice to GSK on Handling the Avandia Avalanche: Don't Do What Merck Did

Dear GSK,

Already the press is making strong analogies between Avandia and Vioxx (see "Sequel for Vioxx Critic: Attack on Avandia"). But if you are smart, Avandia can still come out of this with a slap on the wrist. Here are a few suggestions for what you should do and, more importantly, what you should NOT do. I base a lot of this on the mistakes that Merck made handling the Vioxx situation:

(1) Don't start training Avandia sales reps to "dodge" questions from physicians as Merck did (see "Get a Load of Those Gams!"). Instead, be proactive with physicians and show them the data you presented to the FDA, which seems to believe these data will vindicate Avandia. Reach physicians quickly through the Internet and avoid having to retrain all your reps to handle this -- they will only f**k it up anyway.
NOTE: Some of GSK's reps have already thrown in the towel anyway, so they cannot be relied upon to take up the cause. A recent post by a rep at Cafe Pharma sums it up: "Face it, once you're on World News Tonight and all the local news shows.....you're done. It's not a class effect, they are only naming Avandia. That's the only name the dumb consumer will hear. Takeda made a boatload of money at Avandia/met expense last year and it looks like it will happen again this year.....amazing!"

P.P.S. I know GSK likes to use sales reps as spokespeople for the good the industry does (see "Sales Reps Make Poor Spokespeople"), but in this case I wouldn't play that card. Your sales reps have a lot of dough to lose if Avandia tanks. They are not unbiased and I think even "dumb consumers" can see this.
(2) Take a page out of Pfizer's book: Keep Avandia on the market and hire the best cardiologist there is -- actually it will have to be the second best; the cardiologist who dissed Avandia in the NEJM (Dr. Nissen of the Cleveland Clinic) is considered one of the best, if not best -- to start a massive study of the cardiovascular effects of Avandia (with the goal of proving that it has no adverse CV effects, of course). Some people thought Pfizer was crazy when it followed this strategy for Celebrex (see "Is Pfizer Crazy or What?"), but that product has survived, albeit a little beaten up.

(3) If there is something you know and are keeping it secret, don't. The last thing you want is a "who knew what, when" investigation by Congress. Merck tried to hide data and was caught with its hand in the cookie jar (see "Merck's Hand in the Cookie Jar").

(4) This is a corollary to #3: Don't mislead the FDA like Merck did (see "Merck Misled FDA According to NJ Jury"). It could bite you in the ass at the jury trials that are sure to follow. FDA is your best friend and friends don't let friends go out on a date with Congress without protection!

(5) Don't run TV ads telling us that "patients come first" like Merck did (see "Patients Come First?"). First of all, the jury is still out on that premise. Secondly, who's going to believe you? Better to save $20 million for something more useful, like inviting us pharma bloggers on a junket or something like that (just kidding folks!). Or you can give us a new installment of "Clarence" the R&D Guy. I like him (see "Clarence," GSK's R&D Guy, Trumps "Jamie," Pfizer Viagra Guy!).

(6) Whatever you do, don't tell us how much it costs to develop drugs like Avandia and imply how lucky we are to have these drugs. Now's not the time for that.

That's my advice for now. Let's see how this plays in Peoria (and Congress) before I offer any other suggestions.

Good luck.

Sincerely,

John Mack

P.P.P.S. I almost forgotone important piece of advice!

(7) Don't fire any whistleblowers! According to the WSJ article, "Yesterday, the Senate Finance Committee chairman, Montana Democrat Max Baucus, and Sen. Grassley sent a letter to Glaxo mentioning 'reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.'" You can silence outside medical professionals, but don't attempt to silence or fire or marginalize internal professionals who may become whistleblowers. Assume that your employees are saving incriminating evidence and some day may reveal it all to Dr. Peter Rost, who currently has a full pipeline of pharma whistleblowers and is undoubtedly looking for more!

Disclosure: John Mack does not own stock in GSK, Takeda, Merck or Lilly u nless it is through Mutual Funds holdings. John Mack also is not currently under contract to consult for GSK, Takeda, Merck or Lilly.

9 comments:

  1. Steve Woodruff8:41 AM

    John,

    Some good advice here. I would add one more:

    Make a Public Pledge

    Something along these lines: "According to the information we have right now, we are convinced that Avandia is a safe and effective treatment. However if, in collaboration with the FDA and clinical researchers, we come to the conclusion in the future that this (or any) drug that we offer has risks that outweigh its benefits, we will immediately withdraw it from the market."

    - Take a strong stand based on current information
    - Show openness to the implications of new (well-founded) information
    - Follow through on the pledge no matter what the cost

    This kind of no-nonsense stance, joined to responsible disclosure and clear communication to the marketplace, will go a long way toward countering the negative view of "Big Pharma" - particularly when there are Vioxx-type side effect problems...

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  2. Steve,

    Thanks for your addition.

    I welcome other readers to submit their own pieces of advice.

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  3. Anonymous9:42 AM

    My prediction is that GSK will use your ideas and not pay you! But at least they can learn from Merck.

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  4. Sigh! You are probably right about not getting paid! I'm not sure, however, that they will follow the advice.

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  5. John. A PR firm would probably have charged GSK $100,000 for that advice. You are stupid to give it away for free.

    Also, you just ruined all the fun we could've had with GSK whistleblowers.

    Finally, GSK is probably too stupid to take things written on blogs serisously, so disregard all of above.

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  6. They should have gotten this advice a long time ago and put the wheels in motion for implementing it. After the story hit the press, such advice is essentially worthless.

    I doubt that they can keep the whistleblowers under lock and key. It just may take some time before you will get any traction with that.

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  7. How come you didnt take too seriously what Peter Rost just put up on his blog? Is it that you don't consider him too credible considering that he has a motive to show Pfizer as an aggressor all too often? Or is it that India and the "scandal" that happened in India too small to matter?

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  8. Salil,

    Thank you for your comments.

    I o take it seriously. But pharmaceutical corruption in India is not my focus, which is more about pharma best marketing practices closer to home.

    Frankly, I am a bit worn out by whistleblower cases and reporting on them, especially when they involve complicated financial deals.

    As I said in my post over at Pharma Blogosphere, I don't want everyone just repeating Peter's story about this. I want to learn more about the back story -- eg, how business is done in India. Maybe this is just the tip of the iceberg?

    But, whatever the extent of it, India is far away from me and there are plenty of other blogs that could/should be writing about this -- like Pharmaceuticals and Healthcare at http://www.pharmaceuticalshealthcare.blogspot.com/

    Why don't you ask Sunil to take it more seriously?

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  9. Hi John,

    Thanks a lot for your response. Also, thank you for putting me onto Sunil's site. I will get in touch with him shortly.

    Have a great day!

    Salil

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