How much for your vote, Senator?

It is not a secret that large sums of money have passed from the pharmaceutical and device manufacturers into physicians' hands. This money has been paid not only for such socially beneficial pursuits as research and consulting, but also for lavish gifts and junkets. And interestingly, despite disingenuous assertions to the contrary by many a stake holder, these gifts generated a return on investment -- surprise! It turns out that the spender companies could count on improving their prescription volumes in return for their magnanimity. Well, of course this is really no surprise. After all, we all know that money talks. What has been less clear over the years is whether small, almost inconsequential gifts, might also be influential in changing practices. Social sciences provided us with an answer to this: even gifts of small value create fertile soil for payback. OK, then, the answer became clear: remove all manufacturer influence from the day-to-day world of medicine. And so it has happened that pharmaceutical reps are no longer allowed to bring lunch or pens or pads of paper with the name of their wares on them to the hospitals or offices. Only educational gifts of a certain value are accepted. I will refrain from opining on the journals' and professional societies self-absolution from such rules, as my views on that are beyond the scope of the current post.

Is this removal of potential temptation bad? For someone who can argue each side with equal aplomb, the question is irrelevant: it just is. What interests me a lot more is this: how is it that a 25-cent pen can sway my brethren's prescribing practices, but $1 million in campaign contributions leaves a politician impartial to the contributor's cause? Take Senator Lieberman's claim that $1 million in campaign contributions from the health insurance lobby has not affected how he votes. See for yourselves, in this NYT piece from December 2009:

Campaign finance advocates have attacked Mr. Lieberman as “an insurance industry puppet,” suggesting that he wants to protect private health insurers from competition because he has received more than $1 million insurance company campaign contributions since 1998.

During his 2006 re-election campaign, Mr. Lieberman ranked second in the Senate in insurance industry contributions. Connecticut is a hub of the insurance business, with about 22,000 jobs specifically in health insurance, according to an industry trade group.

In the interview, Mr. Lieberman dismissed assertions that he was doing the industry’s bidding. “It’s hogwash and it’s weak,” he said, noting that he had often sided against the companies. 

Are we really supposed to believe that? What about Blanche Lincoln, when she asserts that $1/2 million in oil money that her campaign has taken has not swayed her legislative priorities, is she for real?

A spokesperson for the Lincoln campaign says that campaign contributions play no role in the senator's public policy decisions.

"This ad is nothing new, just more lies from another outside group seeking to malign Sen. Lincoln's record and bully voters into their agenda," spokeswoman Katie Laning Niebaum told CBS News. 

If a 25-cent pen can hijack a doctor's prescribing practice, how can these sums of money not be hijacking our democracy? And upon whom does the burden of proof fall in this situation?

Here is my solution: less advertising, less mud slinging, less dirty money (a.k.a. special interest contributions). Naïve? Maybe. But totally necessary. Let's do what medicine has done and, a-la Nancy Reagan's advice, "Just say 'NO'!" It's time to bring back our democracy!

$1 million vs. a free pen

Two items have grabbed me so far today: one on your favorite contemporary intellectual (and mine) Sarah Palin, and the other on the "Democratic" senator we love to hate, Joe Lieberman. The common thread is flip-flopping of opinion in favor of ideology.

An editorial in today's Washington Post by Eugene Robinson points out Palin's complete 180-degree turn in her views on climate change. Robinson writes:

Back then, Palin was the governor of a state where "coastal erosion, thawing permafrost, retreating sea ice, record forest fires, and other changes are affecting, and will continue to affect, the lifestyles and livelihoods of Alaskans," as she wrote. Faced with that reality, she sensibly formed the high-level working group to chart a course of action.

This sober view from just one year ago is a complete antithesis to her most recent call in a WaPo op-ed to President Obama to boycott Copenhagen and to deny the "shoddy" science of climate change.

In a similar vein, the New York Times talks about Joe Lieberman's ardent opposition to the Medicare buy-in provision in the Senate healthcare bill, the opposition that now looks to be resulting in complete removal of this provision in order to get the bill passed. What is fascinating about his stance is that just a few years ago, as Al Gore's running mate, Lieberman had proposed exactly the Medicare expansion as the solution to our healthcare woes. In fact, the story contends that even a few months ago the Senator was in favor of this strategy.

So, what has changed for each of these politicians in just a matter of months to make them turn completely away from what they had believed? For Sarah Palin, as Robinson astutely points out, it is clearly her political base:

I predict we'll see more artful dodges of this kind from Palin. She made any number of pragmatic, reasonable, smart decisions as governor -- and now, it seems, will be obliged to renounce them all. Her tea-party legions have one answer -- a shouted "No!" -- for every question.

As for Lieberman, he has his own base to cater to. While the NYT reporter hints at the motivation, the Senator is given full credence in his denial of the accusation:

Campaign finance advocates have attacked Mr. Lieberman as “an insurance industry puppet,” suggesting that he wants to protect private health insurers from competition because he has received more than $1 million insurance company campaign contributions since 1998.

During his 2006 re-election campaign, Mr. Lieberman ranked second in the Senate in insurance industry contributions. Connecticut is a hub of the insurance business, with about 22,000 jobs specifically in health insurance, according to an industry trade group.

In the interview, Mr. Lieberman dismissed assertions that he was doing the industry’s bidding. “It’s hogwash and it’s weak,” he said, noting that he had often sided against the companies. He said he favored a proposal, not included in the health care bill, that would end the insurers’ limited exemption from federal antitrust laws.

Hogwash, really? I am not so sure that I am willing or gullible enough to dismiss $1 million in contributions as hogwash. Again I have to go back to my assertions here and here that it is incumbent upon the person taking the money to disclose any real or potential conflict of interest, and let the public decide whether or how this COI may affect one's stance.

So, is it possible that both Palin and Lieberman are just blowing with their financial winds? Well, if you think that a free pen with a drug's name can alter a physician's prescribing pattern, why is it so difficult to concede that $1 million in contributions and a strong political backing may hold some sway over our politicians?

Conflict of interest in healthcare research

I have been in San Diego for nearly an entire week, and am eagerly getting ready to head back to my beloved New England tomorrow after I chair my last session in the morning on the extra-pulmonary complications of critical illness. Guess what my talk is on? That's right, C diff.

A hot topic at this meeting of the American College of Chest Physicians (affectionately known as Chest) has been conflicts of interest. Yesterday I chaired and spoke at a session talking about what good collaborations look like between the Industry and Academia. Today there was a fascinating session on a related topic, which included talks from Catherine DeAngelis, the Editor-in-Chief of JAMA, as well as Richard Irwin, the Editor-in-Chief of the journal Chest, and two other speakers: Jim Roach, MD, representing the Industry point of view, and Ian Nathanson, MD, who is a part of the Chest COI working group. Although all speakers attempted to be balanced, the sum total amounted, as one would expect, to at least some Industry bashing and finger-pointing. It is interesting to me that, while people do not hesitate, appropriately, to include all fraud and result falsification, they usually conflate these into the "Evils of the Industry", regardless of the funding received by those defrauding the system. Also, what is not mentioned are the denominators of this potential relationship of fraud with manufacturers. The story is usually told thusly: 1). Look at the proportion of research funded by private vs. public funds (~85% of all clinical research, according to Dr. DeAngelis). 2). Look at the systematic reviews that indicate that Industry-sponsored trials are more likely to show results favorable to the product in question (true, but could this be because Industry-funded studies are designed with more precision? Or perhaps it is because of the nature of our regulatory process: early phase studies shed light on what can be expected, and the later phase studies merely build on that information. It is possible that our regulatory path promotes lack of equipoise, but that is a discussion for a different time). 3). Here are a bunch of case studies of fraud that we have uncovered (usually quite a few from the Industry, but also a number not funded by private dollars), 4). Therefore, the fraud is a big problem with Industry-funded work.

If I were structuring a scientific argument in this manner, I would be accused of using ecological data for hypothesis testing. The leaps of faith required are considerable. I do not wish to minimize the abominable behavior exhibited by those with a considerable monetary interest at stake, or by those that have benefitted at the trough: their lack of ethics and concern for the public has brought public cynicism and apprehension about everything we do. However, it is not OK to mitigate this terrible situation by singling out only the most visible potential culprit, made visible simply because of the volume (denominator) of work it supports. This tactic reeks of scape goating for personal gain -- so as to divert the spot light from transgressions of other stake holders, no matter how egregious.

The reason that manufacturers present an easy target is that they have in the past been unethical in so many visible cases. Another reason is that the source of the conflict of interest that exists for the Industry and investigators they fund -- money given for work that will advance the cause of the particular technology the company owns and benefits from financially --is particularly easy to identify. To be sure, we do need to deal with this source of COI carefully if we do not want to lose our credibility completely as the scientific community. At the same time, turning this process into a witch hunt is a mistake. Barring Industry scientists from presenting their work in a CME forum at professional society meetings, fro example, runs counter to the transparency mandate of authorship guidelines. Further, it denigrates the achievements of often prominent and dedicated scientists, and assumes guilt until innocence is proven.

In so many ways, this reactive stance is a response to the Congress's interest in the issue, and the mad rush to deal with it surely reflects an earnest attempt to clean our house. While I salute journals and societies for addressing this difficult issue, if some of the parties are locked out of the discussion, the attempts will look like and amount to nothing more than window dressing. Unless we are willing to overhaul completely how we do medicine in this country and take out the profit motive altogether for everyone (this is in fact my preferred solution, but given how difficult it has been to pass even the current anemic public option, universal socialized healthcare system does not stand a chance), it is critical to be inclusive and to find the most sensible and well thought-out solution to this visible violation of public trust.