SOCIOPATHY AND STANDARD OPERATING PROCEDURE IN PHARMA

A Note on Pharmaporn

Every few days, it seems we get a new one-liner from the annals of trial materials. “We may need to seek them out and destroy them where they live,” said a Merck insider about Vioxx critics. “"Thus far, we have buried Trials 15, 31, 56…”, writes John at AstraZeneca. Trial 15, as it turns out, showed the diabetic risks of Seroquel. This is the same study about which we also read company players congratulating each other for their “smoke and mirrors” success in downplaying its significance.

The examples go on. Endlessly. But what I am always left with is the question of what we do with such “material.” All the defense arguments have a degree of truth. It would be a rare company (or individual) who didn’t write a bad-looking email at some point. Materials of this sort sometimes reveal what is a widely shared marketing plan. At other times, they may represent the views of a lone sociopath.

Perhaps the most recurring theme—when the issue of fraud or cover-up is broached in these communications—is that other companies are doing it “so why shouldn’t we.” All of us learned from our mothers about what “just because others are doing it” means. The relevance here is the question of whether these assertions are rationalizations (and, inevitably, self-fulfilling) and/or whether they represent an accurate snapshot of standard industry practice, at least in the marketing-of-blockbusters arena.

Understandably, people from within industry almost never comment on this question. That was true on Pharmalot when there was plenty of opportunity. Again, this makes sense for all the relevant reasons—the great majority of people in a company have no involvement with such goings-on; there is the anticipation of vicious push-back by critics; there is probably also the anticipation of sanctions from within the company if one’s identity is uncovered.

The rest of us are left with the question of what to make of these bits and pieces. Like porn of other kinds, there is undeniably a certain titillation in the face other people’s corruption. Many of us carry an “inner church lady.”

But lives are, indeed, on the line. My guess is that nothing good will happen to change these aspects of industry short of revulsion within companies robust enough to clean up their scuz. Strongly as I oppose preemption, I think that it will take whistleblowers, not private plaintiffs, to do the job. Only insiders can distinguish, and document, what represents the views of lone cowpokes versus the orchestrated strategy of a significant coterie of senior management.

Unfortunately, the latter appears to be the most common.

SEROQUEL: WHERE THERE'S SMOKE, THERE'RE MIRRORS

Scuzzophrenia

The Seroquel cover-up story continues to develop, as reported in yesterday's Washington Post.

http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html

Every time you think it can't get worse, it gets worse. As many will know, a number of the court documents were summarized and made public a week ago by the Wall Street Journal. The Post reporters have brought us a few more particulars about "study 15," the "cursed one, which was still a bit of a mystery.

No longer.

AstraZeneca, Seroquel, and Trading Ethical "Distinction"

Seroquel and the Process of Corruption

As many here will know, there have been a number of stories today about Astra Zeneca's alleged cover-up of studies indicating the diabetes risks of Seroquel. The Wall Street Journal Stories have been particularly informative. Here is a brief snippet (which will remind some of you of our peanut thread--truth is sometimes a lot like fiction):

"In an Aug. 15, 2005, voicemail message addressed to company salespeople, an AstraZeneca employee named Christine Ney followed up on a "weight and diabetes sell sheet" they had recently been sent. The sales representatives should assuage doctors' fears about their patients' weight gains, she said in the voicemail, by telling them that data showed no causal link between diabetes and the drug.

"Our objective is to neutralize customer objections to Seroquel's weight and diabetes profile," Ms. Ney said, according to a transcript of the voicemail message. She then instructed representatives to "refocus the call" away from diabetes to the drug's tolerability, the transcript shows."

What is compelling about the internal documents that have been released through the WSJ is the process in which obviously well-intentioned people begin the slide toward corrupt practices. In most respects, these documents are like many others that have come to light. The Ney directive, for example, reads more or less like "dodgeball" revisited. What distinguishes these documents, I think, is that some of them reflect the very moment of ethical choosing--where decisions are made either to suppress known data or not. It is relatively rare for the general public to get a glimpse at the process at that particular juncture.

Perhaps most compelling is an email from John Tumas, one of the AZ publication managers involved in decisions about whether or not to suppress negative studies. In a confidential 1999 email ("Exhibit 13"), Tumas writesto his colleagues:

"Please allow me to join in the fray

There has been a precedent set regarding 'cherry picking' of data. This would be the recent Velligan presentations of cognitive function data from Trial 15 (one of the buried trials). Thus far, I am not aware of any repercussions regarding interest in the unreported data.

That does not mean that we should continue to advocate this practice. There is growing pressure from outside the industry to provide access to all data resulting from clinical trials conducted by industry. Thus far, we have buried Trials 15, 31, 56, and are now considering COSTAR [a trial comparing Seroquel to Risperdal].

The larger issue is how do we face the outside world when they begin to criticize us for suppressing data. One could say that our competitors indulge in this practice. However, until now, I believe we have been looked upon by the outside world favorably with regard to ethical behavior. We must decide if we wish to continue to enjoy this distinction.

The reporting of the COSTAR results will not be easy. We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.

Best regards,

John"

There are many ways to read this note. Tumas searches for a middle way--not to "bury" this trial, as others have been buried, but to "diminish the negative findings." The importance of AZ's relatively good ethical reputation (particularly in comparison with Janssen, as other communications make clear) is not trivial. But it is a "distinction" which may or may not be worth trading away.

I will save wider reflections for another post. Here, I will simply say that I do not believe any system of exteral _sanctions_--criminal, civil, or regulatory--will be the key that impacts decisions like the one with which John Tumas struggles. It is rather about reputation (facing the "outside world"), about competition, and--perhaps on some level--about living with oneself. The last, sad to say, is speculative. Either way, Tumas is not directly worried about trial lawyers or the FDA/DOJ. He is worried about Janssen. And, further out on the horizon, about "pressure" to provide access to all data. And, even further out, about some vague sense that someday it could all unravel. As, of course, it now has. [Tumas could "not be reached for comment" the Journal reports.]

On one level, these are issues of the moral choices that individuals make. On another, these are issues about a business model and incentive structure that make moments like Tumas's not only possible, but ubiquitous. That is to say, entirely typical.

I do not think it is an overstatement to suggest that Tumas's decision can stand as a microcosm for the industry as a whole. And the core question is whether the business model and incentive structure can be changed in ways that save people like Tumas from, almost inadvertently, doing moral violence both to themselves and, not long after, to a great many others.

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Addendum: The NYT version of the story can be found at:
http://www.nytimes.com/2009/02/28/business/28drug.html?_r=1&emc=tnt&tntemail1=y