PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: Pfizer risked HIV drug approval "to make it a little harder" for plaintiff's lawyers.

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Pfizer risked HIV drug approval "to make it a little harder" for plaintiff's lawyers.

According to the WSJ today, "Pfizer Inc.'s pipeline was dealt a surprise blow last night, when the FDA delayed the approval of one of its most interesting drug prospects, a new type of medicine for HIV."

I first wrote about the internal Pfizer whistleblower who alleged that Pfizer illegally premarketed the HIV drug maraviroc, before FDA approval, on April 30, 2007.

In response to these allegations, Mark Brown, Vice President, Sales, Pfizer Anti-Infective and HIV/AIDS Divisions on May 3, 2007, issued the following statement to Pfizer's sales force:

"The consequences of pre-approval promotion can be significant, and can go beyond disciplinary action for violation of a Company Policy. The FDA has not approved the Maraviroc label. Nor has the FDA finalized its views on an appropriate risk management plan for Maraviroc. Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan, could prompt the FDA to send Pfizer a Regulatory letter or could lead to other legal action."

Clearly Pfizer realized that the whistleblower's allegations were explosive and could impact the FDA approval of maraviroc.

These events constitute an indictment of Pfizer CEO Jeff Kindler's legal strategy:

Back in 2006 Kindler told the Wall Street Journal, "By virtue of being a large company we have a lot of resources. So we can go to war for a long period of time with plaintiffs lawyers if we need to. None of these cases are threatening the financial viability of this enterprise. We have the resources to take them on and we manage them, I think, very effectively. Plaintiffs lawyers are in business like anybody else. They think about how to most quickly and most easily get their rewards from their business. So we're hoping that when a plaintiffs lawyer is thinking about who to go after maybe they'll think Pfizer's going to make it a little harder for me than so-and-so, so maybe I'll go after so-and-so."

Pfizer had the opportunity to handle the maraviroc scandal internally, and to deal fairly with the whistleblower. Instead the company elected to fight and tried to shut down the maraviroc whistleblower, who then turned to the press.

Below is an e-mail from Pfizer HR, confirming Pfizer's initial investigation of the maraviroc affair. Please note that they write that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.”

The fact that they "may" have taken action certainly doesn't give anyone confidence that anything was done. And very clearly, the fact that they wrote "we have concluded our investigation" is something that indicates they didn't try very hard.

If they had tried harder, they wouldn't have been forced to start a new investigation when I started writing about the maraviroc scandal, and wouldn't have been forced to hire the law firm Ropes & Gray. So, it is easy to conclude that this letter is the smoking gun indicating a corporate cover-up:


In response to this letter, on April 10, 2007, the maraviroc whistleblower's attorney wrote a letter to Thomas “T.R.” Kelley, Office of the General Counsel of Pfizer, in which he stated:

"As a result of blowing the whistle on [redacted], [redacted] is now a pariah among upper level management at Pfizer . . . [redacted] also received a letter from Tina Hester of Pfizer Human Resources warning her that the details underlying his complaint must remain confidential. In addition, she wrote that Pfizer will “not disclose the specific action that may have been taken in response to your complaint.” (Emphasis added). Without knowing what action Pfizer may have taken, what level of confidence can [redacted] have that Pfizer has addressed all of its ethical and legal obligations in this matter? Have federal regulators been informed? Has criminal conduct occurred triggering reporting obligations? I suggest that Pfizer’s so-called “Open Door” policy works both ways. However, not only has Pfizer refused to tell [redacted] what action has been taken in response to [redacted] complaint, [redacted] has been issued a threatening gag order. This hints at a concerted cover-up effort."

In response to this letter, Pfizer sent the following reply:


What happened next is that Pfizer used the redacted e-mails in my maraviroc articles to triangulate and capture the whistleblower and then shut down this person's corporate e-mail account.

No retaliation, of course, simply what you do with a whistleblower who reports allegations about illegal marketing.

For Pfizer there is one final question: Was Pfizer CEO Jeff Kindler's legal strategy "to make it a little harder" for plaintiff's lawyers worth risking approval of a new drug?

After all, Pfizer already has admitted that "The consequences of pre-approval promotion can be significant . . . Any promotional conduct at this point in time could adversely influence the FDA’s views on either the label or the Risk Plan."

So perhaps it would have been a good idea to cooperate with the whistleblower instead of trying to silence her.

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Anonymous Anonymous said...

Let me get this right..does he say there were no additional acts of retaliation? Does that mean they agree there was retaliation initially? WHATTTTTTTTTTTT.....

Anonymous Anonymous said...

What Pfizer has done is open themselves up to another layer of scrutiny from other companies and by the FDA. By allowing the open airing of their dirty laundry they look like pikers, fools, and nitwits. It seems they have called down criticism as to their ability to handle a small matter like an employment issue and turn it into a public nightmare. If they cannot even handle their employees and their attorneys how the hell can they be credible to launch a very sophisticated drug with many safety and pricing issues. It seems eveyone is calling them out to defend themselves....Thank you PR

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