Data fraud is not a new story in the scientific community. There have been numerous cases where researchers deliberately fabricate, fake or falsify data to produce favorable results of the tested drugs. Whether the underlying reason is to gain academic statuses or to make money, this act is totally unacceptable. In clinical trials, in particular, data misconduct is dangerous because it can mean serious harm to both research subjects and patients using the drug when it comes out in mass production. Let’s have a look at five of the most notorious fraudulent cases in the history of clinical trials below.
On May 1999, the U.S nation was astounded when The New York Times revealed the case of Dr. Robert Fiddes. Around that time, Dr. Fiddes was a rising star in the industry with floods of contracts due to his admirable quickness in recruiting patients for studies. Aside from conducting trials for private companies, he was operating his own business at the Southern California Research Institute.
Following the allegation of one of Dr. Fiddes’ former employees, the Food and Drug Administration (FDA) decided to investigate the case and found evidence of data fraud for over a decade. He had enrolled ineligible patients, even unreal patients, and forced unwilling patients into the trials. Blood readings and electrocardiogram (EKG) results were made up. Upon his 15-month prison sentence, Dr. Robert Fiddes still claimed innocence and firmly believed that he was forced to cheat by the business’s requirements.
Harry W. Snyder Jr. and Renee Peugeot
The married couple, respected scientist Harry W. Snyder Jr. and his nurse wife Renee Peugeot was sentenced to three-year and two-and-a-half-year imprisonment respectively after the research on skin cancer drug treatment BCX-34 was unveiled. FDA turned the case into a criminal investigation because Snyder and Peugeot had intentionally changed the outcomes of the study so that the drug got approved at the cost of participating patients’ health.
According to an article published in The Baltimore Sun, success in the BCX-34 trial would mean a financial boost to the couple since they had stocks in BioCryst, the company sponsoring the study. During the research, the nurse had to measure the sizes of the patches on patients’ skin before and after applying the cream drug. In the beginning, Peugeot traced the patches loosely to make them look bigger, while in the end, she did it tightly to make them seem smaller.
The report by Snyder showed that 59% of the patients enrolled experienced great improvement or complete cure for the disease. It was later found out, though, that the real number was 30% – the placebo either won or drew a tie in the other 70% of patients. Those participating in the research were denied standard treatment to receive a drug that served for nothing.
Perhaps the case of anesthesiologist Yoshitaka Fujii is the most prominent fraudulent case in terms of scale. 172 of his published articles were reported to contain some kinds of fraud, some of which due to a lack of evidence that data had actually been collected. 20 years of Dr. Fujii’s publication had passed before his data misconduct finally came to light.
Following the allegations of Peter Kranke and his colleagues at the University of Wurzburg Hospital in Germany, data in Dr. Fujii’s reports were “incredibly nice.” The occurrence of headaches – a side-effect of the tested drug, were surprisingly similar in multiple reports. Christian C. Apfel from the University of California, San Francisco Medical Center asserted that the probability that the data were true was “less than seven in a billion.”
Besides, Toho University in March 2012 officially announced the dismissal of Dr. Fujii after the board found out that 8 out of 9 of his published articles under the name of the university were from trials conducted without permission. Though his misconduct caused no serious harm, in reality, its scope made it one of the most shameful incidents in the scientific history.
Also in the field of anesthesiology, Joachim Boldt was unmasked a little before Yoshitaka Fujii. According to The BMJ, 88 of his 102 published articles from 1999 were withdrawn after his conviction of data misconduct. The number continued to grow up to 94, reported by Retraction Watch in 2015. Before Fujii, Dr. Boldt was the record holder.
Investigators found out that Dr. Boldt not only conducted trials without any acknowledgment from the Institutional Review Board (IRB) but also fabricated data, forced patients into trials without actual consent, and claimed fundings without performing anything. More dangerous, his claim that colloids – a drug used for patients before going to surgery – and other similar drugs were equally safe based on his fake trials could have put patients’ health at risk.
Previous research had proved that colloids was dangerous; in fact, the drug can result in heavy bleeding and complications including heart and kidney failure. Luckily, no patients were harmed during Dr. Boldt’s research, yet he was fired from the University of Giessen.
Maria Anne Kirkman Campbell
On March 4, 2004, Dr. Kirkman Campbell was sentenced to 57-month imprisonment along with a fine and compensation mounting up to $1.5 million. She was caught after the conduct of the clinical trial for Ketek – one of the most controversial drugs that FDA has approved since by 2006 it had caused 53 cases of liver failure in which four was fatal. The drug was withdrawn from the market in 2007.
Dr. Campbell was found to enroll ineligible and non-existent patients, force participation in the trials and submit blood samples that didn’t belong to the patients. Evidence showed that 200 of the 407 enrolled patients didn’t actually join the trial. She also fabricated data on subject visits when in reality the subjects didn’t come back for a scheduled one. After the case, Dr. Campbell was listed on the FDA Debarment List, which means she is prohibited from practicing any further health services.
Apart from these five notorious cases, there still exist many other in clinical trials in particular and scientific research in general. The great pressure from sponsoring companies to have positive results has greatly contributed to the researchers faking data in order for the outcomes to look nice and clean. Therefore, the FDA and other related authorities should take effective steps to not only quickly detect frauds, but more importantly, to encourage honest practices.
- How a cancer trial ended in betrayal
- A doctor’s drug trial turns into fraud
- Major fraud probe of Japanese anesthesiologist Yoshitaka Fujii may challenge retraction record
- Retraction record rocks community
- Boldt: the great pretender
- Boldt inquiry concludes: False findings in at least 10 studies, but no harm to patients
- Millions of surgery patients at risk in drug research fraud scandal
- Joachim Boldt profile: a glittering career built on charisma and charm
- DHHS-FDA Notice of Opportunity for Hearing; Maria Anne Kirkman Campbell, M.D.
- The FDA and the Case of Ketek
- FDA Debarment List