A series of posts in both Pharmalot and from former Pfizer top executive-turned-whistleblower Peter Rost illustrate another CME scandal in the making. But it's so complicated, even I, one of the more CME-obsessed bloggers on the web, can barely sort it all out.The major culprit is Pfizer's HIV/AIDS marketing division, which has been desperately trying to market an aging protease inhibitor called Viracept, which has steadily lost market share over the years to competing drugs. The marketing division at Pfizer came up with a "POA", or plan of action, relying heavily on using various forms of company sponsored education to convince prescribers that Viracept, while no more effective than its competitors, is at least safer. In the old days, before company-sponsored CME became the preferred marketing tool for changing physician behavior, Pfizer's pathway to corruption would have been straightforward. Simply create a series of promotional slides that present studies with suspect data and methodology, and make exhuberant pro-Viracept claims. This runs afoul of FDA regulations, which stipulate that any advertising content has to be accurate. Well, Pfizer apparently did make these false claims, and an internal whistle-blower is now telling all.
What's so complicated about this? It's just false advertising, a shady marketing practice which occurs occasionally in all industries. So far, Pfizer's response has been appropriate: They've fired three top sales directors in the HIV/AIDS sales division, and they will be investigating what went wrong.
But another layer of corruption involves a second type of industry education: accredited CME courses. As documented in this Pharmalot posting, and as I've written about in an earlier posting here, the Pfizer sales force had frequently hired the Connecticut cardiologist Dr. Sandip Mukherjee to talk up Viracept in promotional programs. According to an anonymous Pfizer regional manager, Dr. Mukherjee's talks "provides a very positive supportive message on the use of Viracept as part of a viable and safe component of HAART therapy." Basically, Dr. Mukherjee could be counted on to say that Viracept had a relatively benign lipid side effect profile. Fine. There's nothing illegal about hiring a speaker to do advertising for you.
But they screwed up, because the regulations propping up industry-CME activities are so complicated, and change so frequently, that various Pfizer employees just couldn't keep track of all the paper work, and tripped on it.
The first screw up involved confusion about whether Boston Medical Center could use Dr. Mukherjee for a CME certified program. A trail of redacted e-mails shows complete confusion and disarray in the Pfizer camp, which led to an odd scenario in which Mukherjee apparently gave a pro-Viracept lecture at BMC, which was advertised as a CME activity, but which was actually a standard promotional talk.
The second screw-up has something to do with how Dr. Mukherjee was paid. Pfizer, responding to criticism that high payments to hired-gun physicians may tempt them to bias their presentations, recently capped such payments at a maximum of $50,000 per year. The problem is that some physicians are so good at increasing prescriptions of Pfizer products that drug reps all over the country want to use them, and their "cap" gets reached too quickly. This is exactly what happened with Dr. Mukherjee, whose cap was reached in October, meaning that he could not be hired again until January of the next year. But Peter Rost posted internal emails showing that Mukherjee's cap was mysteriously "lifted," allowing him to give extra talks: "They have just adjusted Dr. MacArthur's cap so I am holding great hope that Dr. Mukherjee will be next. Please hold on through the week and hopefully we will have good news soon." The next email presents that news: "Good news, Dr. Mukherjee's cap should be lifted next week, so [name redacted] keep the Nov. 15 talks scheduled with him. We may need to reach out to Tom to see if he can cover the honoraria for one of the talks. I will letyo u know when it is official."
We don't know who "Tom" is or which bucket of money he is in charge of, but this smoking gun does not reflect well on the integrity of Pfizer's honorarium policy.
The bottom line: When your marketing plan is always teetering on the edge of corruption, you're gonna get burned. It's only a matter of time.
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2 comments:
Nice post. I had heard about the initial scandal and the three Pfizer employees being fired, but the rest is new to me. The drug industry is so corrupt that it is hard for me to believe virtually anything they try to tell me. The government and the FDA is doing next to nothing stop it. Until we have a universal healthcare system, I will keep getting my prescriptions filled from foreign online pharmacies.
Crime and Punishment: Enough for Corporate Wrongdoing?
Corporate crime should not be a new concept to many. However, it has evolved into more troubling ways- not only in regards to its severity, but the methods of deterrence now being implemented against corporations. So it may be becoming progressively worse for U.S. citizens as a result.
Rather than speak of all corporations, what will be discussed is government health care fraud. Fraud basically is deception with the potential to harm others. In the case of pharma companies, this may include improper promotion and marketing, meaning that such tactics are or may be deceptive misconduct that may be illegal. In addition, there are the crimes of kickbacks and lesser crimes of misbranding products. Probably more methods of wrongdoing as well do in fact exist and happen. Yet the point is that drug companies should not engage in such wrongdoing to enrich their faceless existence with profiting off those who are ill in illegal ways.
How is such conduct discovered? Typically by whistleblowers who worked for the described pharma company, and such people are rare for a number of reasons. The whistleblower then seeks legal agents and files what is called a qui tam false claims act with a district attorney’s office (Boston or Philadelphia, if you want prosecutors to take you seriously). After the case is filed, the whistleblower verbally acknowledges the charges and evidence to the chosen prosecutors and others.
Such cases usually take years for unclear reasons, yet in the past two years, the settlements from such cases has approached 2 billion dollars after investigations ended that took years, which is tax dollars returned to the American public with these settlements.
So, what has been happening once a pharma company is busted. Criminal indictment by the district prosecutor? Hardly, yet appropriate. Usually, the prosecutor’s objective is to dismiss the case, but give the impression that such activities will not be tolerated by our government. So Corporate Integrity Agreements are mandated to the pharma company, but not really taken seriously, as some have more than one of these agreements active still. It’s an invisible ankle bracelet. A pharma company can and have committed equal or worse crimes while under such an agreement. This Agreement is issued after the deferred or non prosecution agreement is sentenced to the law-breaking corporation, which basically is a pre-trial diversion. Essentialy, it’s just parole, which is supported by the DOJ and the administration. The criminals admit wrongdoing, but not guilt. And they pay a settlement in the neighborhood of hundreds of millions of dollars. Not that shocking, if you consider the income of big pharma companies. These agreements are relatively new and partially a result of suggestions from what was known as a Thompson memo, which basically was created by a DOJ guy as commandments for prosecuting corporations and variables to consider when doing so, which ultimately offered responses as to why a greater degree of punishment was not enforced.
We are one of three countries in the world with the most prisoners behind bars, yet those that do similar if not greater harm to others get out of jail free. Double standard, I would say. Is this behavior by our legal system towards corporations an effective deterrent? Most think not. It rather seems like tacit approval of their conduct. And health care fraud may be more damaging than other types in other industries, yet lack of regulation allows such crimes to continue.
Citizens should make the laws in our country. Justice would then finally exist.
“Corporations cannot commit treason, nor be outlawed, nor excommunicated, for they have no souls.”
---- Edward Coke
Dan Abshear
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