Friday, May 08, 2009

Attacking "Crusaders" Against Conflicts of Interest with Logical Fallacies

An editorial appeared in the latest edition of Nature Medicine that suggested "crusaders" are making much too much fuss over insignificant "competing financial interests." [Anonymous. A really serious conflict. Nature Medicine 2009; 15: 463-4]

The Editorial's Arguments

Instead of regarding all conflicts of interest as part of a "monolithic scourge," it suggested we should only attack them in two specific situations.

Bad Conflicts of Interest

The first is when it leads to falsification of research data:

If there is one reason we need to worry about CFIs [competing financial interests], it is because they could lead to misconduct whenever a researcher has a financial incentive to fabricate data. So, if a clinical trial goes ahead on the basis of fraudulent preclinical work or if a drug is approved on the basis of false clinical data, the problem is more profound than can be addressed by the declaration of a CFI. Researchers or clinicians who produce sham data to continue receiving funds from a company must be subject to severe disciplinary actions from their institutions and funding bodies.

The second is when it leads to withholding of data in certain circumstances:

Companies that conceal negative data from regulators to receive approval for their drug should face not only fines but also penalties as serious as criminal charges. In any case, the focus should move away from CFI declarations and toward exposing and punishing scientific misconduct.

Some Conflicts of Interest are Unavoidable

On the other hand, the editorial asserted that conflicts of interest are unavoidable in certain situations.

But even though a lot has been written about this subject, it is seldom acknowledged that not all CFIs are equally insidious and that 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, either by independently developing them into products or by selling them to the highest bidder. In the US, the Bayh-Dole Act has protected this right for nearly three decades, and CFIs that result from a university's right to enact this policy should not raise eyebrows.

Bad Outcomes of the "Crusade" Against Conflicts of Interest

In addition, the editorial argued that because of excess attention paid to minor or unavoidable conflicts of interest, bad things may happen. Clinical trials would be discouraged.
However, the fact remains that clinical trials are very expensive, and only the pharmaceutical sector has both the incentive and the deep pockets to pay for them.

And innovation would be slowed.

A third issue that is rarely acknowledged is that the stridency with which the CFI crusaders fight financial interests has created a milieu in which pharmaceutical firms have increasingly less breathing space to conduct their business, leading to a further slowing of drug development.

Finally, the editorial exhorted:


Let us instead accept that 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.
Logical Fallacies and Inflammatory Rhetoric

It is discouraging to see such sloppy thinking and inflammatory rhetoric appear under the masthead of a prominent journal. How was the thinking sloppy? Let me count the ways, and explain the logical fallacies used by the editorial to support its contention.

Arguing that Conflicts are Unavoidable Using False Dilemmas and Appeals to Common Practice

The editorial suggests some conflicts of interest may be unavoidable, even necessary for the advancement of science. To do this, it provided a series of false dilemmas and appeals to common practice. A false dilemma is an argument that x and y are mutually exclusive, when they are not. An appeal to common practice is an argument that because something is common practice, it is necessary, moral, correct, or the only course possible.

The editorial argued that researchers would not work for free, implying that if drug and device companies could not pay researchers to perform clinical trials, no clinical trials would be done. This is a false dilemma, because it is based on the unstated assumption that there is no other possible source of payment for clinical trial researchers other than the companies whose products the trials evaluate. It may be true that it would be hard to get anyone to conduct clinical trials for free, but there is no law of nature that dictates that all clinical trials must be financed directly by companies whose products are the subjects of these trials, or that prevents clinical trials from being funded by government agencies and/or non-governmental organizations disinterested in whether the results favor one treatment or another. Such disinterested sponsors paying researchers would not create conflicts of interest.

The editorial argued that if academic institutions and their employees cannot benefit financially from "the fruits of the advances made in their laboratories," there would be no drug and device development. This is a false dilemma, because it is based on the unstated assumption that the only setting for drug and device development is academic institutions. There is no natural law, however, that restricts drug and device development to academic institutions, or prevents drug development to be done by drug and device companies, or by independent laboratories. The editorial also appended an appeal to common practice. Bayh-Dole may be the current law in the US, but it is hardly natural law.

The editorial argued that without the "deep pockets" of the "pharmaceutical sector" and device companies, no one would pay for clinical research. This was a repetition of the false dilemma noted above. There is no natural law that prevents government and non-governmental organizations from sponsoring clinical trials. The editorial again appended an appeal to common practice. Current laws and social conventions have made drug and device companies extremely profitable, but continuation of their profitability is hardly inevitable.

Red Herrings to Distract from Other Bad Effects of Conflicts

While the editorial identified two particularly bad kinds of conflicts of interest, it ignored other instances that could be equally bad. This was something of a red herring. Although the two examples of bad effects of conflicts of interest were undeniably important, they distracted from other bad effects which the editorial chose to ignore.

The editorial correctly identified falsification of data as bad, but ignored the entire catalog of ways in which clinical research studies can be manipulated to make them more likely to favor a sponsor's product. See our posts (here and here) and the links contained therein for multiple examples of such manipulation.

The editorial noted that concealing data from regulators in order to win drug approval is bad, but ignored all the instances in which data has been suppressed outside of the regulatory process to make drugs or devices seem more efficacious or less dangerous than they really are. See this link for some of our posts containing relevant examples. If it is bad to fool people who must make regulatory decisions, why is it not so bad to fool physicians and patients who must decide whether to use drugs or devices?

The editorial further ignored that conflicts that affect how research is conducted or reported may be linked to conflicts that affect how research is disseminated or used in decision making. The clinical researcher who is paid by a drug or device company to conduct a clinical trial may also be an academic physician paid by the same company as a consultant or through a speakers' bureau to give talks and presentations, and write review articles favorable to the company's product. If it would be bad for the researcher to falsify data to make the product look better, why would it be acceptable for the researcher to act as a huckster for the product while pretending to be a disinterested academic? See this link for posts discussing stealth marketing, and this one for posts discussing the use of key opinion leaders.

Ambiguity and Ad Hominem Attacks Inflating the Bad Effects of Fighting Conflicts

While the editorial minimized the bad outcomes of conflicts of interest, it resorted to ambiguity and inflammatory language to exaggerate what might happen were conflicts to be reduced.

Its most dire prediction of the results of reducing conflicts was that doing so would create a "milieu" in which "pharmaceutical firms have increasingly less breathing space." Literally, this statement was nonsense. Metaphorically, it did not make a clear argument that these highly profitable companies (and even more profitable device companies) could not survive in a "milieu" in which their products were tested by researchers which the companies could not influence. This was not clearly a logical fallacy, but just word-play presented a reasoned argument.

Given how prevalent political correctness is, repeatedly characterizing people concerned about conflicts of interest as "crusaders" is inflammatory indeed. Being called "pharmascolds" is one thing, but "crusader" in some circles is regarded as equivalent to racist, a nasty term to label those who promote the separation of clinical research and medical education from commercial interests. Thus, the editorial winds up with a rather nasty version of an ad hominem attack.

We have seen numerous examples of the use of logical fallacies in defense of conflicts of interest, often by authors who were themselves conflicted. It is especially sad to see the editors of a scholarly medical journal employ such logical fallacies in the defense of conflicts of interest.

ADDENDUM (11 May, 2009) - See also the comments by Dr Doug Bremner in the Before You Take That Pill Blog.

ADDENDUM (20 May, 2009) - For an example of how the term "crusader" has become politically incorrect in the US context, see this article in the Boston Globe.

10 comments:

Bernard Carroll said...

Your critique of the Editorial in Nature Medicine is right on target, Roy.

The chaff thrown up about intolerance, stridency, crusade and inquisition just gives comfort to those who want to deflect attention from the ethical issues they have been tagged with.

Your point about appeals to common practice is important. That tactic is akin to the naturalistic fallacy described by G.E. Moore – the claim that the way things are is necessarily for the best. In this case the Editorial largely endorses the status quo. That was startlingly apparent when the Editorial suggested there is no problem in having academic investigators act as marketeers for the corporations.

The Editorial’s recommendation for a truce is especially problematic. Calling for a truce assumes there is already a war. If there is a war it is because the society of ethical cooperators in clinical science has been under attack by venal and corrupt defectors. It is like the tension between hawks and doves in sociobiology. When academic institutions and professional organizations failed to rein in the defectors, a new level of pushback called altruistic punishment by the cooperators appeared. The Editorial gets it exactly backwards – the defectors are not the victims.

Bernard Carroll.

Anonymous said...

Wow! This post combined with the comments of Dr. Carroll leave me questioning the editors of Nature Medicine. I am neither a doctor nor scientist, but when I find such a convoluted argument for supporting ongoing financial conflicts, given the weekly revelations of misdeeds, I must question the science behind much of what we perceive to be fact.

In the last week I have read equally questionable logic supporting pricing and adding a questionable drug to a mandated guideline. Over three decades ago, in my undergraduate classes, I learned about behavioral modification in my sales and sales management classes. This knowledge seems to have been lost, or perverted, to achieve a questionable financial goal?

Steve Lucas

MedInformaticsMD said...
This comment has been removed by the author.
MedInformaticsMD said...

Roy,

I have my doubts that many people with COI in science today can fully understand your arguments. They imply an ability to relate logical thought and abstraction to what are essentially social matters, as opposed to scientific ones. Might it be a bad assumption to assume those who can do the latter, can also do the former?

Perhaps part of the problem is mental dullness on these issues. Being a good scientist does not imply sociolegal competence or finesse.

For instance, when several prominent Yale faculty a few years back tried to misappropriate my work for their own ends, I believed they were just playing dirty politics by not listening to rational argument on why this was wrong.

However, with the passage of time, it occurs to me that perhaps they were just too mentally limited to understand reasoned arguments in a non science domain (e.g., ethics).

-- SS

Anonymous said...

You point out what you perceive to be the authors logical fallacies, but your own argument is based on a rarely recognized, but rampant illogical argument, what I call "Fantasy Fallacy"

Fantasy #1: If you think some entity other than the drug companies are going to spend the money it takes to evaluate new compounds in phase I, II and III, you live in fantasy land. How on earth would a government agency decide which company's compounds for a condition were most worthy of evaluation? Can't you begin to envision the snail's pace by which the whole evaluation, selection and implementation of trials would occur if government bureaucrats were reponsible for the process?

Fantasy #2: If you think that "independent labs" are going to have the intellectual firepower, infrastructure and money to replace academic institutions from playing the leading role in identifying new biological targets to treat disease, you live in fantasy land.

Fantasy #3: If you think scientists and physician-researchers are going to stay up late, work weekends, sacrifice family time without a signficant financial incentive, you live in fantasy land.

Bottom line: adopting your proposals would GREATLY slow the development of medical science. Maybe that is OK, given that it all costs so much, but don't put forward the fantasy that progress wouldn't be harmed immensely.

I do agree with you though, about researchers serving on speaker's bureaus. Though I don't agree with your slandering term of "hucksters", it is clear that it is difficult to maintain true neutrality about a product when one is paid to speak about it. This is a shame though, because the people best positioned in terms of knowledge to educate other physicians about a new drug are the ones who conducted the clinical trials on the compound.

Roy M. Poses MD said...

Anonymous,

"Fantasy #1" Maybe the drug companies could choose the drugs worthy of evaluation, with a little help from the FDA? Choosing the drugs for evaluation and the evaluations themselves need not be done by the same people or organizations. Why couldn't the government spend the money?

"Fantasy #2" Who said that universities should not do any drug development? It wasn't me in the post above

"Fantasy #3" Who said scientists should work without pay? It wasn't me in the post above. At least do me the courtesy of reading my posts before responding. I argued that clinical trials could be paid for by government or not-for-profit groups, and that they would directly or indirectly pay the scientists.

For the most part, I did not make proposals, but instead questioned the assumptions implicit in the editorial. But what evidence do you have that any specific proposals I made would slow "the development of medical science."

Finally, it is ridiculous to dub the term "huckster" as a slander.

Finally, your last comment may be true, but why can't those clinical trials be funded by somebody other than the company which has something to gain if the results turn out in favor of its product?

Anonymous said...

"Why couldn't the government spend the money?" -- Are you serious??!!??!! Do you read the papers? Do you understand the meaning of $1.7 trillion deficit?

"Who said that universitites should not do drug development." I didn't say you said that. I noted you were arguing that there are o(or should be/could be) comparable organizations to do such research. I say that's fantasy.

"Who said scientists should work without pay? It wasn't me." Hey - I didn't say you said that, either. You should read MY post more carefully! The point is that the EXTRA effort and commitment it takes to get results will be disincentivized by the reduction in the profit motive. If you diminish financial reward, you get less effort, and thus less progress. It's as simple as that. I suspect you don't work in the private sector.

It's nice of you to agree with me, on the same point that I agreed with you.

To slander is to defame, or to threaten the good name or reputation of a person. When you use the term huckster, you are saying the lecturer is using shady methods to make a sale. No doubt a few members of speakers bureaus are "bought and paid for", but most I know try to take a open approach and encourage discussion about treatment options. While not perfect, they do approach such meetings more from an education than a sales approach. Huckster does not apply, and unreasonably maligns them.

Roy M. Poses MD said...

Anonymous,

I obviously do read the papers, and have heard of the deficit.

There are a number of plausible ways the government could raise money specifically for this purpose. They are just not likely to be popular with drug and device companies.

Re the scientists' compensation - Why would payments from somewhere other than the companies who make the products being evaluated necessarily be too low to give the scientists incentives to do good work? On the other hand, there is now much anecdotal evidence that financial reward does not always correlate with performance. Think about why we have that huge deficit. We were lead into the global financial collapse by people making huge amounts of money. Huge incentives may attract people more interested in getting rich than in performing well.

Finally, there is considerable anecdotal evidence (some of it mentioned on this blog) that many people who are paid by drug/ device/ biotech etc companies to give talks tend to give talks that favor the companies' interests. On the other hand, there is also evidence that companies will quickly stop paying speakers who say things that challenge the companies' interests.

MedInformaticsMD said...

Roy, it seems "anonymous" cannot break free from the fallacy of appeal to common practice. Nothing other than common practice can work in his or her mind, because ... it just can't work.

This also reflects a failure of imagination, which is rampant in biomedicine today.

Quiact said...

Conflicts of interests are essentially gifts in one form or another.

There is not a rating scale with conflicts of interests. They either exist, or they do not.

The conflicts are corruptive in that they atrophy the reliability that has, as a result of conflicts of interests, been potentially compromised due to interests now being unstable, as the objectives and responsibilities of those remunerated are now flawed and are no longer aseptic as they should be.

Falsified clinical research and witholding negative data in medical and pharmaceutical research occurs and in many ways is encouraged- this bastardization of the scientific method.

This is due to the autonomy of those involved in such research allowing if not implementing conflicts of interests to occur, and they occur often.

Guidelines are either ignored or absent regarding these issues, as well as true regulation, which is clearly needed to assure the safety of American citizens.

Another example of conflicts of interest is the revolving door between congress and the DOJ with, say, huge law firms that represent those corporations who are often guilty of crime and wrongdoing.

Bad things happen to good people in health care due to this marriage made in hell that few are aware exist. The consequences of what continues to be allowed harms and prevents the restoration of the health of others.

Dan Abshear