Real and imaginary conflicts of interest: a helpful guide

What is a Conflict of Interest (COI)?

The term COI is sometimes used inappropriately as a weapon by one party to attempt to discredit others.

We see this more and more frequently in the stem cell field with boosters of for-profit, non-FDA vetted adult stem cell clinics attacking scientists for supposed COIs for what…..apparently for simply being a stem cell scientist.

Onlookers may be confused about this. Being an interested party or having an interest in a general sense in something like stem cells is not a COI.

So what is and is not a COI?

Wikipedia largely concurs with the COI training I’ve received for years as a professor with this definition:

conflict of interest (COI) occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.

Some hypothetical examples from the biomedical field below can be instructive.

  • Someone who publicly promotes a biotech stock on a blog or in a newspaper article also owns shares in that stock without disclosing to readers that they own the stock.
  • Someone that promotes a specific medical clinic to patients as safe and effective secretly receives payments from that clinic.
  • A physician who recommends a procedure to patients involving a medical device (e.g. say a special scalpel) does not disclose that she receives money from the company that makes the device.
  • A biotech company (or a scientist working for them) that owns the patent for drug X gives free vacations to doctors who prescribe it frequently.

A COI involves an action directly driven by a selfish motivation. Again, having an interest in something does not necessarily equate with a COI.

The word “conflict” is key.

So what kinds of COI are being suggested by pro-dubious clinics proponents against critics of such clinics?

In the stem cell field, we hear about supposed secret plots by the FDA and Big Pharma to slow or kill stem cell therapies (e.g. Dan Ecklund made such a claim on 60 Minutes) and alleged COIs by scientists who are involved in such imaginary nefarious schemes.

Rather than real, these accusations of COIs seem to be used as a tool by fans of unapproved stem cell treatments and for-profit clinics to attempt to discredit critics of such treatments and muddy the waters.

In fact, most stem cell scientists who are involved with biotech companies or have stem cell-related patents (I myself do not fall into either group at the moment, but there is certainly nothing wrong with industry collaborations and who doesn’t want a patent?) want to promote stem cell therapies, not drugs sold by Big Pharma. Therefore the accusations make no sense.

So when academic scientists raise concerns about stem cell treatments or dubious clinics I believe their motivation is not related to some COI, but rather it is because the scientists are genuinely concerned about the lack of proof of safety and efficacy of the treatments.

Patients may get hurt. There is real risk.

Logically what would an academic scientist have to personally gain by pointing out risks and problems associated with the non-FDA vetted, for-profit stem cell industry?

The answer is nothing.

So when you read or hear someone who is a fan of dubious, for-profit stem cell clinics accusing a scientist of a COI, remind yourself what exactly a COI is and what it isn’t and look to see if the accuser provides any facts or logical basis for their accusation.

Ironically, often it is the accuser/fan of for-profit adult stem cell clinics who themselves might have the COI because they receive money from the clinics or from patients.

4 Comments


  1. Useful post Paul. Always glad to see someone tackling the ‘elephant in the room’ as you are very fond and adept at doing.

    I agree that research scientists such as yourself would not appear – on the face of it – to have any conflict of interest when opining on non-compliant ‘stem cell’ clinics (I’m not going to say ‘for profit’ because there is nothing inherently wrong in being ‘for profit’ and this certainly doesn’t distinguish them from many – if not most – of the hospitals/clinic providing regulatory compliant stem cell treatments.) Because of your lack of clinical training or experience you may have a credibility problem (as I do) but provided you (and I) don’t pretend to have expertise you do not then that is for the reader to decide.

    The question I’m more interested in is whether someone who works for a non-compliant clinic has a conflict of interest with respect to addressing the question of whether the existing regulatory paradigm should be changed.

    I would argue such a person is without question in conflict of interest when addressing the question of whether or not a patient should receive a treatment from their clinic or participate in a clinical trial. I believe they would also be in COI when opining on whether their clinic’s treatment is compliant with the regulation or on the issue of whether their clinic’s treatment is good value or on the question of whether there is good data to support their therapeutic claims.

    Where it get’s trickier – I submit – is on the question of whether the existing regulation should be changed. This is a policy question. On this question the monetary benefit is indirect. Those working in an organization that provides compliant treatments are equally conflicted or not as those working in a company providing non-compliant treatments. I submit the professional motivations for each perspective are just that and do not go so far as to constitute a conflict.

    Another observation. In this debate often an accusation of a COI is hurled at someone in an attempt to entirely discredit their opinion or suggest that they are not entitled to express it. In my opinion, provided a COI is clearly disclosed or transparent, one should be encouraged to hold and express any opinion. The audience is entitled to give whatever weight it wants to the opinion in light of the conflict. When critics point to the conflict of someone expressing an opinion it simply addresses the credibility of the speaker to make that point; it does not discredit the point.

    One may disagree with the opinion expressed by those working for non-compliant clinics on regulatory policy issues and/or one may argue they are not being as transparent as they should be about their conflict but we must not advocate they be silenced.

    I think it is important to have a two-sided debate, for instance, about the sufficiency of clinical evidence required to bring a treatment to patients. Often we hear from the ‘establishment’ that only the evidence from a full gamut of regulatory-cleared clinical trials is sufficient to bring safe and effective treatments to patients. Yet the off-label-use and minimally-manipulated exemptions are examples of how treatments can be commercially provided to patients in a perfectly compliant and intended pathway with very little clinical evidence and certainly not after robust clinical trials.

    On this issue, the non-compliant clinic folks have a different perspective than the ‘establishment’. I don’t believe either has a conflict in this debate though both have professional motivations for their perspectives.

    Thanks for the continued forum you provide for discussion on this and other important issues, Paul.

    –Lee


  2. Conflict of interest in a spectrum of situations is looked at here http://ebhc.wikispaces.com/EBHC++Making+Sense+of+Conflict. Sometimes it is helpful to step back from extrapolation and observe how other sectors view this arena.

    I would think that very few are on the extreme edges of the spectrum and a great many are doing the best they can with an area of science that has grown so rapidly that all are struggling to maintain the balance between progress and regulation


  3. Conflict of Interest when abused does partner with scientific misconduct so here are some resources on scientific misconduct as well. http://ebhc.wikispaces.com/EBHC+Scientific+Misconduct+ I think what also needs to be said is that it is not the conflict of interest in and of itself that is always a problem it is instead the lack of transparency surrounding a conflict particularly in scientific papers and when these papers could serve to veer from addressing regulation, utility, safety concerns or non effectiveness

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