Scandalous Science

August 2014 By Jaime deBlanc ACFE Research Editor For five years, a group of scientists at Iowa State University had been hot on the trail of a scientific breakthrough: a vaccine for the HIV virus. Their initial results showed that rabbits treated with the vaccine developed antibodies to HIV — an incredibly promising outcome, since it suggested that a human vaccine could also be created.

August 2014

By Jaime deBlanc

ACFE Research Editor

 

For five years, a group of scientists at Iowa State University had been hot on the trail of a scientific breakthrough: a vaccine for the HIV virus. Their initial results showed that rabbits treated with the vaccine developed antibodies to HIV — an incredibly promising outcome, since it suggested that a human vaccine could also be created. The lab’s findings generated enormous excitement in the scientific community; the National Institutes of Health (NIH) awarded the research team millions of dollars in funding to continue its research.

 

The only problem? The research team’s remarkable results were faked. In mid-2013, the university discovered that Dr. Dong-Pyou Han, a member of the research team, had doctored the lab samples to make the vaccine appear effective. Han’s colleagues on the project were now looking at years of wasted work, and Han faced four felony counts of making false statements to a government agency.

 

It’s rare for scientists to face criminal charges for research fraud. However, in Han’s case, the enormous amount of money involved — almost $19 million in grants from the NIH over the course of several years — prompted the state to file federal charges against him, making Han one of only a handful of scientists in the past 30 years to be brought to trial for research fraud.

 

The publicity over the Iowa State scandal has sparked discussion on the topic of scientific fraud. How common is it? What are its effects? And how can anti-fraud professionals assist in preventing it?

 

What is Scientific Fraud?

Scientific fraud can take two forms: (1) falsifying or fabricating research data and (2) using research funds for personal purposes. Often, these two forms of fraud occur in tandem — as in the case of South Korean researcher Hwang Woo-Suk, who not only fabricated data in his cloning research but also embezzled $3 million of research money for his personal use.

 

There are a number of reasons why a scientist might commit fraud. Tight funding and intense competition for grants create strong incentives for scientists to present extraordinary results. The desire for fame and prestige, promotion or tenure or simply a viable career might drive a scientist to falsify data. In addition, a scientist might lack proper training regarding ethical practices in the workplace. And researchers who witness coworkers or supervisors “bending the rules” might assume that this is an acceptable practice within the industry.

 

Indeed, there is evidence to show that many scientists consider “bending the rules” to be the norm. Some studies show that up to 40 percent of researchers were aware of, but did not report, scientific misconduct in their workplace. The Office of Research Integrity (ORI), which investigates research misconduct on behalf of the Secretary of Health and Human Services, estimates that there are 2,300 cases of misconduct among NIH-funded researchers each year. Misconduct can include everything from fudging results (“massaging” data so that it more strongly conforms to desired results) to outright faking outcomes (as in the infamous case of William Summerlin, who faked successful skin transplants from black mice to white mice by marking the skin of the white mice with a black felt-tip pen).

 

What Are Its Effects?

The impact of scientific fraud is wide-ranging and serious. Faked results take a toll on the reputation of the research institution as well as the government agency that funds it:

 

Dong-Pyou Han’s fraud, apart from costing the NIH millions of dollars in taxpayer money, negatively impacted the reputation of the university and the public’s faith in scientific research.

 

A fraud, if undiscovered, can lead to physicians administering dangerous or pointless treatments, or to patients making ill-informed decisions:

 

In 1998, Andrew Wakefield published a fraudulent study linking the occurrence of autism in young children to the MMR vaccine. In the wake of this study (later revealed to have been funded by a law firm planning to sue vaccine manufacturers) many parents chose not to have their children vaccinated — a choice that led to a rise in illness and fatalities from measles, mumps and rubella.

 

Research trials, when conducted for the profit of doctors and pharmaceutical companies, do little to improve patients’ health and can even endanger lives:

 

In the late 1990s, psychiatrist Richard Borison conducted multiple drug trials for large pharmaceutical companies, siphoning millions of dollars of research funds into a private, for-profit company controlled by him. While profiting from these trials, Borison falsified data to make new psychiatric drugs appear more effective and less dangerous than they really were.

 

In the most extreme cases, scientific fraud can lead to loss of life:

 

In 2005, Paul Kornak defrauded the sponsors of cancer studies by submitting false paperwork and allowing subjects who did not qualify to participate in a clinical study. One study subject died as a result of his negligence. Kornak was later convicted of criminally negligent homicide.

 

How Can It Be Prevented?

Although the impact of scientific fraud is serious, there’s no single body or group in charge of detecting, investigating and prosecuting it. Although the ORI oversees investigations of NIH-funded scientists, it doesn’t have the authority to prosecute, and it almost never refers cases to the criminal justice system for prosecution. When fraud is discovered, the consequences for researchers tend to be minor — a retracted paper or a ban from seeking funding for a period of time.

 

Ivan Oransky of Retraction Watch, a blog that reports on scientific fraud, notes that “most investigators who engage in wrongdoing, even serious wrongdoing, continue to conduct research at their institutions.” In a July 2014 article in the British Medical Journal, Dr. Zulfiqar Bhutta of the Centre for Global Child Health in Toronto urged organizations to take a stronger stance against scientific fraud: “It is time to regard such behavior in the same category as criminal fraud and deal with it accordingly.”

 

Anti-fraud professionals who work in the medical or science fields, or who work for the agencies that fund them, should clearly outline the cost of scientific fraud to their employing institutions and convey the importance of audits. To the question of what the audits would cost and who would pay for them, scientist and author J. Leslie Glick suggests the response should be: “What does it cost not to conduct such audits, and who pays for that?”

 

Glick goes on to say: “Organizations that pay for research should pay for data auditing, since the cost of auditing will be more than offset by the savings resulting from fewer funds spent on unproductive research.” He estimates that the cost of auditing a modestly sized research institution could be as low as 0.4 percent of the total budget. Research institutions should consider undertaking not just financial audits, but also data audits — audits that examine the accuracy of research conclusions. In a data audit, the auditor looks for red flags of fraudulent research data, such as:

 

A large amount of data output, given the size of the laboratory or number of personnel

Research results that appear too good to be true

Difficulty in gaining copies of the original data

Other scientists experiencing difficulty when trying to reproduce the results

 

Auditors who discover scientific fraud should consider referring the case to law enforcement when appropriate. In the past two decades, prosecutors have successfully brought the following charges against scientists who committed fraud:

 

18 U.S.C. §1001	Making False Statements to a Government Agency
18 U.S.C. §1341	Wire Fraud
18 U.S.C. §1346	Mail Fraud
18 U.S.C. §1347	Health Care Fraud
21 U.S.C. §§ 331(e), 333(a)	Failure to establish and maintain accurate clinical records in connection with an FDA approved study
31 U.S.C. §§ 3729–3733	False Claims Act

 

Scientific fraud is an enduring problem, and detecting it requires awareness and vigilance. By shining a spotlight on this type of misconduct, CFEs and research institutions can greatly reduce the occurrence and impact of scientific fraud.