Tuesday, April 15, 2008

Ethics, Pharma, and the Blogosphere

An article in today's New York Times - "Citing Ethics, Some Doctors Reject Industry Pay" - will warm the heart of bloggers, present company included. Here is the key passage (I have added the emphasis):

Dr. Peter Libby, chief of cardiovascular medicine at Harvard’s Brigham and Women’s Hospital, said that when he first began receiving offers from drug companies, in the early 1980s, they seemed like a natural reflection of his burgeoning reputation.

“When you start emerging as an opinion leader or as a researcher who has knowledge and expertise, the pharmaceutical industry takes an interest in either having you consult to help them with their research or to speak,” he said.
Dr. Libby wanted to assist. Like many scientists, he feels that it is important for researchers to consult with drug companies to help develop therapies and set up studies. He never owned stock in companies that he consulted for. He always disclosed the fact that he consulted and spoke for companies. And, he added, he thought that he was protected from accusations of favoring any particular company’s products because he consulted for so many.

“I lived safely in that comfort zone for many years,” Dr. Libby said.

Then he was hit with a moment of truth. He had spent four years working without pay to help create a public television series, “The Mysterious Human Heart.” The project was, he thought, a worthy effort to educate the public about what heart disease was and how to prevent it. He was proud and pleased when the series was broadcast in October.

But to his dismay, bloggers immediately attacked him and the other medical experts who appeared on the programs for having consulted for manufacturers of pharmaceuticals and medical devices, Dr. Libby said, adding: “They said we were biased. What I thought was four years of public service was impugned.

“That was a wake-up call for me. I was singed in the blogosphere.”

This year, he made his decision. He would continue speaking at forums sponsored by the pharmaceutical industry and would continue consulting for companies. But he would no longer accept payment.

I assume that Dr. Libby was troubled by postings on thoughtful, "evidence based" blogs that he respected, not by cranks. Given that assumption, the blogosphere appears to have been providing the crucial public function of "mirror, mirror, on the wall."

Dr. Libby's program may not have been influenced at all by the industry associations of its participants. When a judge has lunch with a gangster they may be discussing how best to support Mother Theresa's charity, but when a photo of the lunch is published the judge has to resign. Judges are worthless if we can't trust them. Just so with physicians and researchers.

Pharmaceutical companies are not gangsters (excepting a few), but we know that even small gifts can skew opinions. Dr. Libby made the right decision.

Bloggers - keep at it!


GhostOfTyrone said...

Hi Jim,

Excellent point. Online media, most especially forums and blogs, is proving to be an increasingly legitimate and effective tool. Paul Levy - on his blog 'Running A Hospital'- posted a brief article that spoke to the key element of this effectiveness: the real-time capabilities of the on-line community that is absent from "traditional" media venues. Paul was referring to Wikipedia's ability to instantly correct errors once they are detected, but I think the point carries well to this topic.

Like your analogy to the judge and the gangster points out, the ability of the blogosphere to provide real-time and accurate feedback on virtually any topic will continue to expand so long as those involved handle this ability with the same respect and principles shown by those in the 'mainstream' media - and in taking a look at the current state of the 'mainstream', the bar may not be set very high.

Here is a link to Paul Levy's post that I referenced above.


Anonymous said...

I whole heartedly understand the conflict with taking pharma money, yet it seems important to manage this concern systemically. All research and research related endeavors (consulting, advising, education) cannot be done as "pro bono" work. Likewise since much research is industry funded, not accepting funds from industry for speaker/consulting/advisory boards may be good practice, but it is important to think about what is really happening with regard to conflicts. The practical problems are apparent and touched on by the 3rd interviewee.

First, people who adopt this practice are not being compensated for their time and effort, and though one's commitment to good research and medicine may be strong, the loss of compensation may lead to having fewer voices of objectivity in the dialogue. E.g. an objective opinion leader may be willing to go to Rome for an unpaid educational program, but what about podunk, USA for the general practitioners who can't afford to go to Rome, and does that really improve the "practice" of medicine.

Second, this practice takes high ground on superficial funds, but I suspect that research funding is the basis of real conflicts of interest - ongoing salary support for research from industry funded money trials. You can give up the gravy, but what about your livelihood - can you give up putting food on the table for your family or doing the work that you feel passionate about? Whether or not one receives remuneration for consulting/advisor services is small compared to the portion of one's research budget depends upon getting funding from pharma. And it may be easier for some disciplines where there is ample public funding to pursue independently funded research only, while others may be limited, not because of the merits, but because of politics/economics.

The reality is that our research agenda is significantly driven by industry money, and there are few clinician research environments where one's research activities, individually and institutionally, are free from the taint of industry. Individual prestige as a published author and institutional prestige associated with research endeavors are not to be underestimated in their creation of conflicts of interest with regard to the often less visible relationship with industry.

I applaud these efforts by these individuals, yet I wonder whether truly reflective and objective people most needed will leave the conversation, what the implications of this practice will be for the next generation of MD-researchers and how this practice will impact research and clinical practice.

I sense there may be a hidden opportunity to develop better routes for medical professionals with research interests to pursue these efforts and to receive compensation for their research-related services in a way that minimizes all of these conflicts of interest.

Bottom line is that there needs to be more independent funding of research and research-related endeavors - education, consulting, advisory boards, etc. Whether that is government driven, the creation of a "neutral" clearinghouse for research funding and compensating edu/adv/consulting activities (perhaps like a private-public endeavor a la World Bank), innovative practice payment structures that enable physician-researchers to draw salaries from their clinical practice/field sufficiently to support their livelihood. (such as a VC fund model where one raises capital then funds a portfolio of initiatives or think Kiva for research protocols where MDs "rate" importance of research initiatives based on their clinical relevance and choose what research to fund), or perhaps looking at models of journalism, not without its frailties, as a framework for creating clearer boundaries between research and related activities and funding sources.

While it is true, judges have rules and are bound by conduct that honors the perception of impropriety, I would suggest scrutinizing the analogy a bit more thoroughly. One doesn't often find judges doing work without compensation. The ethos to work for free and for public good is much stronger in medicine than in the law. Consider that a "lawyer in training" junior associate makes a $80-120k while a "doctor in training" resident makes, if lucky, a salary in the $50k range. That a lawyer in training gets raises and bonuses year after year, while a doctor in training gains knowledge and experience and remains in this pay scale for 3+ years.

Likewise, for outside observers of the law, one might attribute to judges that they lack conflicts of interest, but it is important that while one might consider it imprudent for a judge to sit down to lunch with a "gangster", does one consider it imprudent for a judge to play golf with a corporate executive? Depending upon your "station" in life, you may or may not perceive that as a conflict of interest, but while the former might be cause for recusal from a case due to public outcry, (I would be surprised if a judge would resign over that) the latter clearly does not create an issue (not even duck hunting with a party to the lawsuit). I think it is important to be honest about the analogies we draw.

Also, since judges may have limitations on external funding, one might look to see whether and how much judges engage in research activities. There is FAR less research about the practice of justice than there is about the practice of medicine. Remember, it is public health research and external entities like the IOM that highlighted the frailties of the law in handling medical malpractice. Those legal evaluations and reforms have not been initiated by judges or even legal academics. To the extent that these kinds of compensation are barred/limited, one needs to remember that at least on the federal bench, appointments are for life with comfortable compensation, but physician-researchers do not have this privilege.

As the kind of tenured position intended to promote objectivity in academia are on the decline and a current trend toward reducing the overhead payments in research, one can only surmise that a reduction in the buffers of neutrality may be a hidden cost. "Fear" and "scarcity" seem to be highly effective tools in creating environments that lead to focus on self-survival and minimize the consideration of conflicts of interest. These concerns may require a more holistic, prudent approach than individuals claiming integrity by offering services for free, though that is a laudable first step. Perhaps this dilemma will be a tipping point to seize a ripe opportunity for innovative problem solving...

Jim Sabin said...

Hi Ian and Anonymous -

Thank you for these comments.

Ian - thank you for the link to Paul Levy's posting. Paul's blog is a wonderful example of creative use of the blogosphere. He uses it to cultivate exchange with a wide health policy community, but it is also a way for him to talk on an almost daily basis with the staff and associated physicians at the Beth Israel Deaconess Medical Center.

Anonymous - your wide ranging comment is very thoughtful and constructive. I hope you are right about the possibility of a tipping point in the relationship between the pharmaceutical & device industries and the research community. As I see it, the major problem is not that research is done with funding from or in concert with industry, but rather that there have been so many examples of corrupt science - non-reporting of negative results, changing of endpoints to make a study come out "right," and the like - that research has become an arm of marketing. I agree that while individual decisions to decline funding may be admirable personal steps, a new and trustworthy approach is needed. The problem is in the area of clinical studies, not basic research. The pharmaceutical & device industries need more leaders like Paul Levy, who are prepared to cultivate a radical transparency in their field. The ball is in industry court right now to come up with new structures, like the ones you envision, to allow for a relationship with the research community that respects the best of both sectors. I think the days of phony "blockbuster" drugs is over.



Anonymous said...

Recently published on: www.beforeyoutakethatpill.com

Historically, information sources provided to American citizens were limited due to the few methods available to the public, such as radio, TV, or news print. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with arguably great elation, there is the internet, which can be rather beneficial for the average citizen.
Soon after the advent of the internet well over a decade ago, web logs were created, that are now termed ‘blogs’. At that time the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved into addressing topics that often were not often addressed in mainstream media, as they crossed previously existing political and social lines. In addition, blogs provide immediate contributions by others, the readers of the posts of the blog authors, instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers or magazines.
The authors of blogs vary as far as their backgrounds and intent of what they choose to address on their blogs exactly, just as with other media forms. Some are employed by the very media sources that existed before them. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that bloggers like to write, they may not be quality writers, yet several are in fact journalists, as well as doctors and lawyers, for example. But to write is to think, which I believe is a good quality one should have.
Yet presently, blogs have become quite a driving force for those with objectives and issues often opposed by others, and therefore have become a serious threat to others. These others may be politicians, our government, or corporations- all of which have been known to monitor the content of certain blogs of concern to them for their potential to negatively affect their image or their activities previously undisclosed. This is why blogs, on occasion, have become a media medium for whistleblowers, which will be addressed further in a moment.
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow in addition to the comments of its readers the posting of authentic internal or confidential documents that typically are not created to be viewed by the public, yet are acquired by certain bloggers. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter published by pharmaceutical company AstraZeneca on his blog site, and this newsletter was given to him by AstraZeneca's employees who called themselves the ‘AZ Group of Seven’- with the intent of this group being to bring to the attention of others the illegal activity of off-label promotion of one of AZ’s cancer drugs promoted by their employer. Yet this particular concern by AZ seven, by surprise, is not what caught the attention of so many who viewed the posted newsletter by Dr. Rost and was read with great interest by others. It was instead a comment included in this newsletter that was stated by former regional AZ manager Mike Zubalagga, who was being interviewed by a district manager in this newsletter. Mr. Zubalagga, who in this newsletter posted on Dr Rost's blog site, referred to doctors’ offices as ‘buckets of money’, which caught the attention of several readers. This and other statements by this man were in fact published in this newsletter clearly not reviewed before its publication. . Again, the statement and the newsletter created by AZ was indeed authentic and further validated due to the content being in the written word, which added credibility.
Mr. Zubalagga was fired the next day due to this ‘buckets of money’ comment due to the effect it had on the image of his employer. His manager resigned soon afterwards from AZ.
Blogs, one can safely conclude, reveal secrets.
And there have been other whistleblower cases on various blogs in addition to this one described a moment ago, which illustrates the power of blogs as being a very powerful and threatening media medium of valid information disclosure that others cannot prevent from occurring.
This, in my opinion, is true freedom of information- largely free of embellishments or selective omissions. It’s a step towards communication utopia, perhaps, yet a force that has the ability to both harm and protect many others.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made, as with other media sources. Of course, documents that are authentic is an example of a good validation source. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs, which may be a type of Socratic learning.
Like other written statements, some on such internet sites are composed with respect of the written word. Others are not. It's the freedom that may be most appealing of this new medium which has the ability to convert citizens into journalists who want to contribute to an issue of their concern they share with the blogger often with great conviction and accuracy.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information disclosed on blogs could potentially be adverse to our well-being.
Ignorance is bliss, but knowledge is power.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear

Jim Sabin said...

Hi Dan -

Thank you for this story about AstraZeneca. I hadn't known about it. It sounds like a powerful example of whistle blowing from within the company, using a blogger to bring the facts to the public. Done well that's an important feature of democracy and free speech!