Wednesday, September 2, 2009

Pfizer Assessed Record Fine--Why We Need a Reminder of Our Mission

The AP has released the details of the record $2.3B fine assessed against Pfizer for off-label marketing of Bextra and other drugs:

Readers of this blog, all half dozen of you, might be wondering what my reaction to this news is. A few more recent readers of the blog might imagine that I'd be chortling about the evil drug industry finally getting their just desserts.

So it may be time to stop, take a deep breath, and remind ourselves of why we are here. As the old saying goes, we have been up to our ass in alligators for a good while now--anyone recall which swamp we came to drain?

One major point to be followed by a minor point.

Major point: My purpose in writing HOOKED and later in starting this blog has never been to vilify the pharmaceutical industry. I take for granted that we live in a capitalist society and that in such a society it is a good thing to make a profit by selling products or services that people want. Moreover, the drug companies could have chosen to be Philip Morris, or run gambling casinos. Instead they have chosen to try to make a profit by selling substances that can contribute, sometimes in very significant ways, to improving human health. They have also undertaken some degree of risk by not only selling old substances but trying to discover new, helpful and safe substances. All that is behavior ideally to be rewarded and honored.

Like most institutions that intend to do good, the drug companies also occasionally do wrong. When they do so, we should make note of it and there should be appropriate consequences. The new $2.3 hit on Pfizer is presumably such an instance of serious wrongdoing that we hope is being appropriately punished. (You might argue that for the major players in the U.S. drug industry, even $2.3B is peanuts, but that is another discussion.) But that is a very different matter from saying that an entire industry, and the people who work for it, are all evil.

This blog exists for an entirely different reason--to hold an ethical mirror up before the medical profession and to ask what our relationship is and should be with the pharmaceutical industry. When we became doctors, we did not get up and swear an oath to maximize sales and profits. We got up and took an oath to put the patient's interests, and by implication the public's health, ahead of our own. To what extent, then, can professionals be true to that oath and still engage in activities that suggest a very close tie with the interests of the pharmaceutical industry?

After doing the 6-7 years of research that went into HOOKED, I concluded that physicians lining their stomachs and pockets with the largesse frequently provided by the industry was behavior ultimately inconsistent with that professional obligation. I concluded that this did not mean, "medicine = good, pharmaceutical industry = bad." Rather it meant: "Medicine and pharmaceutical industry = different interests." There may be a significant conflict of interest between what is good for drug company sales and what is good for the public health. This conflict is not ubiquitous; but it occurs often enough so that it is an important feature of the ethical landscape. That led me to conclude that how physicians relate to the industry should be reformed in major ways--some of which, since HOOKED was published 2-1/2 years ago, have actually come to pass.

In passing I will note that this is one of the biggest bones I have to pick with the ACRE crowd as discussed in a number of previous posts. My ability to say that I am not accusing the drug industry of being evil, just pointing out that the professional ethics of medicine requires that we not identify our interests with theirs, depends totally on the ethical meaningfulness of the idea of conflict of interest. ACRE has been doing its level best to trash that idea--to say that if you see COI at the medicine-Pharma interface, you are either prejudiced, or logically muddled, or envious. If I did not have the concept of COI to employ as an ethical tool, then I would be forced into the silly position of arguing, "medicine = good, pharmaceutical industry = bad." Myself, I would rather have COI.

So when I read about the $2.3B Pfizer fine, my question is--where and how were the docs involved? What role did we play? It would be wrong if Pfizer ended up with egg on its face and the docs who all made this possible--the hired shills/speakers, the "key opinion leaders," the researchers all too happy to spin or doctor the research data, the docs who put their names on ghostwritten articles if there were any-- walked away smelling like roses.

OK, are we clear now on what the basic issues are?

Minor point--at the risk of appearing to contradict what I have just said at length, I will focus on one sentence out of the AP article. I mention it lest you think I was being overly critical of the industry in a recent post (yesterday to be precise) when I wrote the following:

Even as far back as 1984, before the really cutthroat era of marketing competition we have seen since then, we did not have an industry that aimed to keep well within the bounds of law and ethics, and where only a few bad apples transgressed. Instead we had an industry, and apparently still do today, where skating as close to the edge of the ethical and legal thin ice as possible is the day-to-day business plan. When a skater falls through the ice we cannot dismiss it as an unfortunate aberration. We must see that this is a predictable outcome of deliberately chosen corporate strategy.

We now read from the AP that part of the reason the Pfizer settlement was so high compared to previous legal penalties was that Pfizer was viewed as a repeat offender:

"Mike Loucks, the U.S. attorney in Massachusetts ... said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs."

I rest my case.


Unknown said...

Thanks for the objective comments instead of playing the blame game. I often tell my patients that I wouldn't want to try to treat disease without pharmaceuticals. I need to keep in mind that my goals are different than the goals of the pharmaceutical industry. Too often people indulge in black/white rhetoric which just turns into a mudslinging match. I like the distinctions you make. Thanks.

Dom said...

Thanks Howard.