Saturday, September 10, 2005

Opinion writing disguised as medical research

In my recent post about the controversial JAMA article on fetal pain I suggested that financial relationships with pharmaceutical companies are not the only conflicts of interest that need to be disclosed. What else should be disclosed? The fetal pain article raised issues about two of the authors. We learned from the New York times that Dr. Eleanor Drey held opinions against proposed fetal pain legislation which could constitute bias. The Chicago Tribune also reported that she was an abortion provider. Another author, Susan Lee, had worked as an attorney for an abortion rights group. Though some disclosure was clearly needed it is unclear how it should have been accomplished. Readers needed to know about an author’s role as an abortion rights activist and another author’s role (and perhaps opinions) as a provider. But what other questions should be asked? Do we need to know about an author’s religious beliefs, or how an author voted in the last election? Certainly the notion of disclosure could be carried to undesirable extremes.

In the popular news media there is concern that opinion pieces are disguised as objective journalism. I wonder if a disclosure policy would help settle the debate about media bias and increase the credibility of news organizations. In medical literature we now have a similar concern that opinion writing could be disguised as research reporting. While the JAMA paper sparked particularly heated discussion there are many other examples of potential bias in medicine, largely under the radar screen and less emotionally charged.

In my own field of hospital medicine early studies suggested that the hospitalist model was associated with improved outcomes. But the fact that some of the papers were written by leaders in the hospitalist movement [1] [2] raises the possibility of bias. Similarly, papers which showed improved outcomes with a closed ICU model of care were authored by leaders in pulmonary-critical care medicine or published in journals affiliated with the specialty. This paper reported excessive rates of product withdrawal and post-marketing drug labeling changes, implying ineffective FDA procedures. Missing from the disclosure, however, was that one of the authors is an activist whose organization has a long history of lobbying on the issue.

Surprisingly little has been written about conflicts of interest in medical research except as they pertain to the influence of drug companies, although a few writers have acknowledged that there are other biases. Shaughnessy and Slawson for example, recognizing that expertise in a field creates bias, suggested that experts should not write reviews, and that we should not read papers written by experts. Sackett, similarly noting the bias of experts, wrote that as soon as one becomes an expert he or she should retire from teaching or writing in the field of expertise (whereupon he announced his retirement from teaching and writing about his field of evidence based medicine). This article on medical professionalism in NEJM took a broad view of bias and suggested for example that ophthalmologists or dermatologists rather than gastroenterologists should advocate for colon cancer screening.

These solutions seek to eliminate bias and are extreme. We can’t eliminate bias entirely. Disclosure, however, may heighten readers’ skepticism and provide a healthy opportunity for critical appraisal. I hope the debate surrounding the fetal pain article will not be hijacked by hate speech, but rather will broaden our awareness of bias and the importance of disclosure. It’s not just about the drug companies.


Anonymous said...

Excellent commentary and blog. Linked in from

Best regards,

Quinten Black, MD

james gaulte said...

I wonder if we should consider Shaughnessy and Slawson as experts, experts in determining the best way to get to the truth of a matter.If so according to their argument, we should not listen to them.Somehow I find it hard to accept the notion that we should not at least listen to experts in their area of expertise.I believe the best reviews have input from both methodology experts and subject matter experts as do the ACCP thrombosis guidelines.

james gaulte said...

I wonder if we should consider Shaughnessy and Slawson as experts, experts in determining the best way to get to the truth of a matter.If so according to their argument, we should not listen to them.Somehow I find it hard to accept the notion that we should not at least listen to experts in their area of expertise.I believe the best reviews have input from both methodology experts and subject matter experts as do the ACCP thrombosis guidelines.

Ruth said...

Banning experts from writing about their own field of expertise is counterproductive. Afterall, to whom would we turn to for accurate information, if not the experts. However, I agree when you sadi that readers should be made aware of any possible bias or conflict of interest. I appreciate the fat that in nature, for example, they have "Competing Interests Statement" at the end of some articles, where authors declare financial or other conflict-of-interest issuess on the subject matter.

Greg P said...

One of the things to consider is the ambiguity of the term "expert". What does it really mean?

These days many experts are self-proclaimed experts. Look at the hordes of doctors giving "expert opinion" in legal battles.

I would contend that "expert" is not a valid scientific or medical term. One may have much experience and even show some expertise in an area should be backed up by something to describe the nature of this expertise. Someone may have done much research in a given area yet not necessarily be an "expert."

Expert has more to do, it seems, with power. The power to unilaterally proclaim something to be fact, without contradiction. But on a practical level, it really only means your opinion carries some weight. How much? Who knows?

susanna in alabama said...

I'm a non-medically trained writer who has worked with medical researchers in writing up their findings, and I'm also a PhD student in the social sciences. Bias is inescapable in any human endeavor, and science is no exception. In fact, given its nature, science should be first to admit its biases under the heading "limitations". That said, clearly transparent research lends itself to review for bias. When rationale, hypothesis development, sample selection and study methods/analysis are fully explicated, knowledgeable people can tell if there's a problem. Perhaps an option is to present research findings as stand-alones, then present discussion/analysis as a clearly separate thing, thereby establishing its role as conclusions based on the research and informed by hypothesis/bias, rather than as necessary inferences that any expert in the field would see (with the implication that if you don't see it the same way, it's because you're not an expert). We need our expert scientists to keep up their research; we need their findings to be the intellectual property of us all.

Anonymous said...

Published on

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others, yet sponsored by a pharmaceutical company, would be at the top of the list. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and sterile that is completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated.

Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds.

Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of community patient care clinics. Because of this structure, investigators of these trials are likely void of necessary research experience or quality regarding their research purpose and ability to ensure its sterility. These quite numerous CROS are for- profit, with some CROs making billions of dollars a year.

The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for the studied drug of thiers. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.

Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.

Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns.. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent.

More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.

Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, which would require independent clinical trial sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health.

Knowledge is power, and is also possibly a lifesaver.

“Ethics and Science need to shake hands.” ……. Richard Cabot

Dan Abshear
Author’s note: What has been written was based upon information and belief