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The Inadequacy of Increased Disclosure

The Inadequacy of Increased Disclosure
July 16, 2009

In recent years there has been a strong push to attempt to regulate science by increasing disclosure of financial conflicts of interest (FCOI). As well-intentioned as this regulatory approach might be, it is based on flawed assumptions, poses the risk of becoming a self-perpetuating end in itself, and is a distraction from the underlying serious problem.”

It is hard to see how it could be possible that strengthened FCOI disclosures could have a significant effect since we know from the very reports from Sen. Charles Grassley’s Finance Committee that there is next to no enforcement. If the dog is all but toothless now, will someone unscrupulous hesitate much to game the system by simply not reporting? A clever operator will get a lawyer to guide such behavior. But this is hardly the extent of what we should be thinking about.

Conflict of interest rules are supposed to control corruption by recusing those with a financial stake. Corruption is the rational response in systems, so the mythical “rational players” will be corrupt. In political culture corruption is a given and conflict of interest rules have had some effect in legislatures of the USA. But science is not politics.

Scientific culture presumes honesty, but the data says that scientific fraud is large and growing. A recent study quite boggles the mind when one considers that some 9,000 papers were flagged for possible plagiarism with 212 of the first 212 being probable plagiarism on full examination, and to get into the running required substantial matches in the abstracts. It recently came to light that virtually an entire subfield in medicine was a fraud, though it is not clear if it was harmful. I will not belabor this, but basic sense tells us that if the dumbest kind of fraud is so widespread, we doubtless have serious problems elsewhere.

There is little punishment if one is caught in those rare cases when it is discovered. Looking at cases of scientific fraud, one finds that usually no charges are filed and authors don’t necessarily even withdraw their papers. When they do withdraw them, there is little facility for recording that fact, and papers can remain available in NIH databases and others without so much as a warning flag.

There is a European pilot project attempting to make a stab at the problem to mixed review. There is a Scifraud Web site as well that is similarly mixed. At worst, research privileges may be taken away. In one of the few cases I am aware of where charges were filed, the South Korea case, Hwang Woo-Suk was given a prestigious award despite currently standing trial for fraud and being unable to attend the ceremony for that reason. In other words, in science, a life of crime is easy -- at worst one gets a slap on the wrist. For those who commit frauds of various kinds, mostly one wins -- publications generate promotions, grants, etc.

Look at the situation objectively, and one must ask the question. Why bother doing real research if you can scout out what is probably true from some hard-working researchers with real data, then submit a paper that looks perfect "proving the hypothesis" with "all the latest techniques"? As we saw, simple plagiarism of the dumbest kind is probably endemic. There is software that can fake a gel, that can fake flow cytometry data, and one must assume that it is used. Call it “theft by perfection." We have no data at all on such fraud, but anecdotal evidence forming semi-random samples of significant size certainly suggests it occurs in certain areas of bioscience. So if there is great upside in science fraud – where’s the downside?

Perhaps one might be exposed, but even then, unless it’s really high profile, few people will know. Is the chance of being caught even as high as one in 5,000? Those thousands of fake papers say no, and instead suggest the chance of being caught may be less than one in 10,000 or more.

Given all of this, the rational response would be to face the scientific fraud problem head on rather than enact window dressing regulations, and I have a few proposals for how to do that.

The first regulatory change we need is to throw out the statute of limitations regulation that is set at six years. Folks, under current National Institutes of Health rules the case of the midwife toad would not have been exposed! Isn't that ridiculous? Scientists are (or should be) some of the better records keepers on the planet. Yes, records aren’t perfect, nor are memories, but mostly we have them around somewhere, or at least enough of them. We should remember also that scientists have been selected for superior memories and analytic abilities. In the context of science, graduate students are the people who usually find out about fraud first because they see exactly what is going on. The median time for a graduate student to awarding of a Ph.D. is six years; this is a time when they are extremely vulnerable to retaliation.

The second regulatory change concerns intra-university investigations. There is institutional collusion that whitewashes intra-university investigations unless a professor or dean takes up the cause. Flatly, these intra-university procedures don't work for graduate students and post-docs, and those who use them tend to find themselves pariahs. In this way our biosciences system has been systematically eliminating some of the most ethical and capable researchers in training who leave when subjected to retaliation. Keep your head down and don't rock the boat is the watchword in graduate school these days. I get the strong impression that those who went through grad school 30 years ago have little clue how bad it is. Ad hoc committees of arbitrarily chosen people who I believe are sometimes interfered with backstage by chancellors can exhibit phenomenally poor investigative skills when presented with claims. Those who serve on such committees are in a lose-lose position, and have no incentive to be there.

The only way they win is to curry favor with the administration.

Consequently, responsibility for academic misconduct complaints and whistle blower reports must be removed from the institutions in which they occur. I propose that such investigations be turned over to the Justice Department for investigation by an Office of Research Integrity moved into Justice for special adjucation. Researchers should be held personally liable, and they should be charged with criminal conduct, and efforts made to cut deals with them for fingering others in their loose circle. I strongly suspect that fraud appears in clusters linked by human networks in academia as it does elsewhere. Scientific fraud should be a criminal matter at the federal level if federal funds are used. Papers containing fraudulent data should be removed from federally funded databases and replaced with an abstract of the case and link to the case file.

Non-citizen students and post-docs are even more vulnerable to manipulation and extortion than citizens because of their dependence on their professor for a visa. This enables the unscrupulous to exert even more retaliatory power. I suspect the only cure for that is to grant a 10-year visa that will act like a time limited green card to deal with the problem. That way, at least non-citizens can vote with their feet and have some leeway to get away from an unscrupulous scientist.

But we can’t just improve what we do in response, although that is important. We also have to work hard to find our problems, so the third major area for improved regulation is to create scientific transparency. This will make it possible for other scientists to more easily detect fraudulent work. It should be required that data be made available within 12 months of collection to other researchers, on request. (There could be some variation depending on the kind of research.)

The researchers running the study could be given an embargo period of two years (or some other interval chosen by a reasonable formula) to publish based on their data, but there is no reason why other scientists shouldn't be able to see the data before publication during such an embargo. After publication, other researchers should be given access. It is transparency at the most fundamental level that is missing. Since court precedents have given researchers who receive government funds control over their data, because there was no other rule in place, the only way to improve data transparency is to mandate it. At the very least, base data should be released on demand after publication.

Dealing with these fundamentals will yield good results. Most researchers are innocent; they are guilty of little more than reluctance to get involved in the hard work of whistleblowing for no reward. Just tightening the straitjacket on researchers by giving them more hoops to jump through, and forcing them to recuse themselves from their own area of expertise because of financial rewards they earned by hard work will not prevent the unscrupulous from failing to report conflicts that nobody will find if they don’t report them. It will, instead, punish the ethical and financially harm them by taking away just rewards while having next to no impact on the unethical.

In its simplest restatement, science has a two-horned problem. On the one hand, there is an enforcement problem that exists because there is little chance of being caught in any 10-year period, and if one is caught the penalty is barely a slap on the wrist. This is exaggerated by the setting of statutes of limitations to coincide with the interval during which those most likely to find out are ensconced in a feudal serfdom holdover. On the other hand, sometimes huge rewards should legitimately accrue to people who spend their lives working very hard. Protecting such rewards is the entire purpose of our patent system which encourages innovation and the creation of new economic value.

In summary, we cannot fix the enforcement problem in scientific fraud by making it harder for the rewards to occur. We won't even raise the risk premium for fraud by any of the current rule changes proposed. We will, however, slow the pace of research by taking the best researchers off of problems they know best because they are forced to recuse themselves due to financial conflicts of interest.

Doing that, we will penalize researchers. We will also be penalizing top institutions by forcing them to step aside from involvement with furthering what has great economic value to the nation; because where there is conflict of interest, that means that value has been created. We need to attack the real problem head-on if we want to get good results and keep science respectable and economically most productive. The problem is simply scientific fraud.

Bio

Brian Hanley is an entrepreneur and analyst who recently completed a Ph.D. with honors at the University of California at Davis.

 

 

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