Category Archives: Competing interests

Competing interests

A really serious conflict

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Not all financial interests in drug discovery are detrimental, and many are essential for its success. But focusing on perceived conflicts of interest may cause true scientific corruption to go unnoticed, an opinion expressed in the latest Editorial in Nature Medicine (15, 463 – 464; 2009).

The Editorial describes how a laboratory finding is transformed into a new medicine, involving numerous steps and stakeholders. “In a simple case, a researcher discovers and publishes a new target, and an academic or industrial organization decides to commercialize it. After an initial period of development, this organization licenses the target or a lead compound to a pharmaceutical company with a view to take it to the market. The company sponsors clinical trials, the results of which are also published and evaluated by regulatory agencies that ultimately approve the new therapy for its use in humans. The company then promotes its new product to claim the largest possible share of the market. In an ideal scenario, a postmarketing follow-up of the compound gives the regulators further evidence to evaluate the safety and efficacy of the new medicine.”

Money changes hands many times during this process, at various stages and raising several aspects of competing financial interests. The most negative effect of these, of course, is exposing patients to unsafe drugs. Competing financial interests are handled in a range of ways: some institutions have banned staff from consulting for or from owning stock; laws prevent exchange of gifts between doctors and companies; journals often ask authors to declare fiunancial interests as a prerequisite for publication and may ban scientists who report a financial interest from writing reviews or editorials.

The Editorial goes on to argue that it is seldom acknowledged that not all competing financial interests are equally insidious — some are even necessary for the success of translational research. “Scientists who share their expertise with a company and clinicians who agree to conduct a clinical trial have to be compensated for their work in the same way that every other professional ought to be rewarded for his or her labor. To suggest that they should make their contributions freely is disingenuous, and to argue that they should not get involved at all can only slow the development of new medicines. Academic institutions and their employees must be free to benefit financially from the fruits of the advances made in their laboratories”.

A main fear of competing financial interests is that they could lead to misconduct whenever a researcher has a financial incentive to fabricate data. The Editorial proposes that the focus of concern should move away from whether competing financial interests are publicly declared, and towards exposing and punishing scientific misconduct. …" most financial interests do not represent a conflict as a matter of course and that the influence of money is negative only if it leads to scientific fraud—the one infidel we need to burn at the crusader’s stake."

The full Nature Medicine Editorial, which discusses other aspects of this subject, can be found in the May issue of the journal.

Competing financial interest policies of the Nature journals.

Nature Medicine website.

Nature Medicine guide to authors.

Spoonful of Medicine, the Nature Medicine blog.

Straight talking and the myth of ‘independent’ research

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Nature Medicine (14, 1006 – 1007; 2008) features a question and answer session with Senator Charles Grassley. “What would a trim 75-year-old grain farmer have to say about drug safety and the payments given to medical researchers by drug companies? Lots, if he happens to be Charles Grassley, who has represented the state of Iowa in the US Senate since 1980. As the senior Republican on the Senate’s finance and judiciary committees, he has carved out a role as a relentless watchdog who acts as a magnet for whistleblowers in government agencies ranging from the US Department of Defense to the FBI. In the last several years, Grassley has set his investigative sights on issues relating to medicine. A leading critic of the Food and Drug Administration since the surprise withdrawal from the market of Merck’s painkiller Vioxx in 2004, Grassley is now focusing on university researchers funded by the National Institutes of Health who haven’t been properly reporting income from drug companies. Meredith Wadman asked the senator what he hopes to achieve through his investigations.” Read on, at Nature Medicine.

Sen Grassley’s congressional investigation allegeing that some researchers have failed to report all the drug-company money that they have received — and that universities may have been too slow to police them is also subject of the leading Editorial in the current issue of Nature (Nature 455, 835; 16 October 2008, free to access online). A string of internal Emory University documents and e-mails made public last week after a hearing of the US Senate Committee on Finance, chaired by Sen Grassley, allege a web of consulting, lecturing and advisory-board relationships that Charles Nemeroff, chair of the psychiatry department at the University maintained with 16 pharmaceutical companies. According to Nature, Nemeroff is the seventh academic psychiatrist this year that Grassley has exposed as allegedly underreporting drug-company income. His office says that there are more revelations to come. Grassley has begun pressuring the NIH to mete out real punishment — as in pulling grants — to spur institutions to enforce proper reporting. Sen Grassley’s plan to make companies disclose in a publicly accessible database all payments of more than $500 that they make to physicians, and whether this would make it easier for universties to report such payments, is open for debate at the Nature Network Opinion forum.

Researchers and their institutions need to dispel a myth about ‘independent’ research before the media does it for them, according to the latest Nature Biotechnology Editorial (26, 1051; 2008). The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress. Without the exchange of expertise and knowledge between industry and academia, much of medical progress would falter.

This truth remains unspoken because researchers and their institutions like to maintain an aura of lily-white independence from the commercial world. Researchers may feel, and they may be absolutely right, that allowing companies to contribute to payments for trials or research or publications does not threaten their independence of thought or action.

However, that is not how the general public or individual patients see ‘independence’. For them, independence implies no financial ties, no associations, not a smidgeon of influence from commercial interests. This wholly unrealistic view of angelic independence is an impression that the academic world has fostered, if not actively, then at least through a persistent failure to counter it. And it is this view that the Sunshine Act and its database will blow wide open once and for all.

The way to prevent a public and media backlash is for physicians and researchers (and their institutions) to take immediate and active steps now to explain the interdependence of industrial and academic research. It must be the biomedical community that says “we have to talk to these companies” and “their money really helps push medicine forward.” We need to make plain that there can be a win-win-win outcome for doctors, companies and patients alike. That will give patients a better view of the integrated worlds of research and commerce within healthcare and disarm a million trivial investigations based on nothing more than administrative discrepancies.

How journals can help enforce research integrity

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In the Nature Network discussion on ‘repairing research integrity’, David Lewis of the Georgia-Oklahoma Center for Reseach on the Environment, writes: “My feeling is that the only real hope of cleaning up the corruption of the scientific process that federal agencies have increasingly institutionalized and spread throughout academia lies with the editors of scientific journals. They are the Strait of Hormuz through which scientific information flows to the rest of the world”. In an earlier comment in the forum, Dr Lewis wrote: “Every scientific institution that permits academic misconduct to invade its top management levels depends on science journals to publish their data and give their scientists credibility. Publishers and editors simply need to become better educated on how scientific misconduct gets institutionalized in government and academia and then develop effective ways to hold these institutions accountable when it is not corrected.”

This discussion is taking place at the Nature Network Nature Opinion forum in the context of a Nature Commentary article on scientific misconduct. We welcome your views on Dr Lewis’s proposition, at the Nature Network discussion, where you can read his startling account, or as a comment to this post.

The Nature journals’ policies on competing interests (financial and other) are here, and other polices on the ethics of publication can be found here.

Perceived and actual conflicts of interest

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February’s Edtiorial in Nature Medicine (14, 106; 2008) addresses the question of what we mean by ‘perceived’ conflicts of interest. The reader wrote: “This term crops up frequently in the editorials of Nature journals, and I would be extremely grateful if […] you would like to explain the difference between a perceived and an actual conflict of interest.”

The policy in full is described on our Author and Reviewers’ website, but to summarize, perceived competing financial interests [CFIs] are instances in which no competing interest (or conflict) exists, but the potential for financial gain as a result of what is published could give readers the impression of a conflict.

An example given in the Editorial is the publication of sponsored content. “Producing, say, a supplement to Nature Medicine requires financial resources that may not be part of our budget. If we want to publish this content for the benefit of our readers, we must find the money elsewhere. A sponsor may be interested in the topic of the supplement and agree to underwrite the costs. To the casual reader, this may look like a CFI—either the sponsor directly paid for the content, or the journal published on this topic to get money from the sponsor. There is, however, no conflict, because our sponsors never have a say on the editorial content of anything we publish. In fact, all of the editorial content for supplements is often already commissioned before we approach potential sponsors.” For Nature journals, all such content contains a clear statement by the editors, in order to be maximally clear.

We welcome readers’ views about perceived and acutal interests, either in respect of sponsored content or other aspects of the publication process.

Declaring conflicts of interest

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From The New York Times (19 Jan 2008): “The National Institutes of Health do almost nothing to monitor the financial conflicts of university professors to whom it provides grants, a government report found, and the huge federal research agency does not want to start now. The agency does not know the number of conflicts or the nature of them, nor does it track how universities and other institutions went about solving those conflicts, according to a report issued Friday by the inspector general of the Department of Health and Human Services.”

The article goes on to outline NIH’s view that it would be impossible to monitor all their investigators for possible conflicts of interest; but as universities are increasingly being forced to seek funding from new sources, the problem is becoming unmanageable for them, also. According to the New York Times article, NIH investigators filed only 438 conflict-of-interest reports between 2004 and 2006, 89 per cent of which provided no details about the nature of the conflict being reported or how it was managed. Yet NIH awarded more than $23 billion last year to more than 325,000 researchers at over 3,000 universities.

The Nature journals’ policy on competing interests can be found at our author and reviewer website. It states: “competing interests are defined as those of a financial nature that, through their potential influence on behaviour or content or from perception of such potential influences, could undermine the objectivity, integrity or perceived value of a publication.

They can include any of the following:

Funding: Research support (including salaries, equipment, supplies, reimbursement for attending symposia, and other expenses) by organizations that may gain or lose financially through this publication.

Employment: Recent (while engaged in the research project), present or anticipated employment by any organization that may gain or lose financially through this publication.

Personal financial interests: Stocks or shares in companies that may gain or lose financially through publication; consultation fees or other forms of remuneration from organizations that may gain or lose financially; patents or patent applications whose value may be affected by publication.”

See our author and reviewer website for more information.

University researchers and patent infringements

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Academic researchers have regularly ignored patents on key technologies as a strategy to maneuver around patent thickets and freedom-to-operate issues, but they may be more at risk than they realize, write Amy Yancey and C Neal Stewart, Jr of the Department of Plant Sciences at the University of Tennessee, Knoxville, in the current issue of Nature Biotechnology (25, 1225-1228; 2007). From their article:

“The original proponents of patent protection could not have foreseen a world in which the very building blocks of life could be patented or farmers could be prevented from saving seeds from year to year, but our courts, regulators and political leaders are certainly aware of it now. Despite this fact, public policy solutions have been slow in materializing, and the problems may get worse before they improve. It may prove that no silver bullet exists, but with open-source solutions, pressure from open-science advocates like Richard Jefferson and open licensing from universities, anticommons effects can hopefully be avoided or minimized. In the interim, it seems prudent to conduct research on awareness of FTO issues among public university researchers, increase empirical evidence of the innovation-blocking effects of anticommons and patent thickets, evaluate the effectiveness of those organizations seeking to increase collaboration amount public institutions and create new workarounds.”

For further advice, additional reading and references, read the full article at Nature Biotechnology’s website.

Statements of competing interest

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Philip Ball’s column in news@nature.com this week is about Richard Doll, and whether he should have stated in his publications that he received consultancy fees. The Nature journals’ policy on competing interests is summarized here. As ever, we welcome comments from scientists about the practice of declaring such interests, whether financial, ethical or personal, in published papers. How relevant are any or all of these conflicts to the strength of the scientific conclusions reported in a peer-reviewed paper? In particular, we welcome feedback about our own policy, via comments to this post.