Tag Archives: dishonesty in scientific research

DISHONESTY IN SCIENTIFIC RESEARCH: ARE THE PUNISHMENTS FOR BEING CAUGHT SUFFICIENT TO DETER MORE CHEATING? 

 

Cheating at research continues to be a big problem for science! (http://dr-monsrs.net)
Cheating at research continues to be a big problem for science today!     (http://dr-monsrs.net)

Fraudulent research is widely abhorred, but still continues to occur and seems to be increasing.  That must mean either the prevailing standards of professional ethics are degenerating, or the rewards for research misconduct outweigh the penalties for being caught.  Dishonesty is a general and long-standing problem for science, and several causes are known (see: “Why Would Any Scientist Ever Cheat?” ).

A recent case of research misconduct in Japan has received extensive media coverage (see: “A final judgment is given to Haruko Obokata: Misconduct of research!” ).  Here, we take a look at what punishments are being given out in recent scandals with research fraud.  Issues discussed here include whether usual punishments actually will discourage cheating by others, and whether institutions conducting contracted research studies (e.g., universities, medical schools, research institutes) can be trusted to police themselves?

Several earlier articles dealt with dishonesty in science (see: “Introduction to Cheating  and Corruption in Science” , and,  “Why is it so Very Hard to Eliminate Fraud and Corruption in Scientists?” ).  Beginners will find it useful to first read those essays before studying this new dispatch.

Case #1:  Multiple ethical problems and persisting cover-ups at the University of Minnesota Medical School (2008-2016) [1,2]. 

Several different instances of ethical misconduct during studies evaluating new clinical drugs at the University of Minnesota Medical School have shown improper recruitment of subjects and disregard for patient care (i.e., one subject committed suicide!).  Internal and external investigations resulted in disqualifications, felony charges, and accusations of cover-ups.  Dr. Carl Elliott, a professor in the Center for Bioethics at this same institution,  recently authored an insightful article about this unfortunate situation [1].  He states, “Rather than dealing forthrightly with these ethical breaches, university officials have seemed more interested in covering up wrongdoing” [1].  He also notes that official bodies intended to oversee the welfare of patients enrolled in clinical drug trials (i.e., Institutional Review Boards) are given inadequate authority and staffing to deal effectively with clinical research misconduct and cover-ups.

The range of punishments issued by the University of Minnesota in response to criticisms from the Federal Drug Administration and several external review bodies include disqualifications from further research and suspension of some medical licenses.  The obvious cover-up still is ongoing and now is being publicly criticized; no punishments to misguided administrators seem to have been given.

Case #2:  Research misconduct scandal at the Duke University School of Medicine (2007-2010) [3,4]. 

Misconduct by a cancer researcher, Dr. Anil Potti, involved several clinical trials using new genomic tools to determine the best treatment for cancer patients.  His results were produced with many collaborators, and were published with coauthors in very high quality journals.  Allegations of research misconduct arose in part from a medical student, Brad Perez, researching with Dr. Potti; this whistle-blower courageously announced his misgivings to supervisors and university officials.  More questions arose about Dr. Potti’s research results, but an official review found no research misconduct.  Later, that view at Duke slowly changed, forcing its standards for research integrity and mechanisms to investigate allegations of misconduct to be strengthened and improved.

The range of punishments delivered in this case is extensive.  Dr. Potti made financial settlements to settle multiple lawsuits for medical malpractice; in addition, his numerous published research reports were retracted.  In 2010, Dr. Potti resigned his position at Duke.  Subsequently, he obtained new medical licenses in South Carolina and Missouri; the Medical Boards for both states later issued reprimands to him.  There now are many articles and widespread publicity in the popular press, professional medical journals, and the internet about Dr. Potti’s misconduct ; his reputation now is totally destroyed.  It is not clear if any of his collaborators or administrators at Duke were punished.

Case #3: Falsified Research Results and Unprofessional Conduct at the Karolinska Institute (2010-2016) [5-7].  

Current investigations of research experiments by a surgeon, Dr. Paolo Macciarini, are active for allegations of misconduct at the Karolinska Institute, the most prominent medical research center in Sweden.  His clinical research involved implantation of an artificial trachea seeded with the patient’s own stem cells.  Six of 8 patients receiving this experimental treatment have died.  A Swedish TV documentary critical of this surgeon stimulated official investigations.  After more allegations of medical research misconduct, an external assessor concluded that Dr. Macchiarini had falsified his test results; in response, Karolinska Institute announced its support of their star surgeon.

A range of punishments was issued to Dr. Macchiarini.  The Karolinska Institute recently announced that it will sever all ties to Dr. Macchiarini when his contract expires later in 2016. This dramatic controversy resulted in resignations of the Vice-Chancellor at Karolinska, and, the Secretary-General of the Nobel Assembly.  In 2016, the Swedish government initiated a new review into how allegations of misconduct are handled; it seems quite clear that the present handling is inadequate.

General discussion about these cases! 

These different cases of alleged and proven misconduct by professional researchers all show that it is easy to do fraudulent science and get it published.  Only if one is caught cheating and full documentation is acquired does the possibility of criminal punishments arise.  Media attention and input from someone who has the guts to be a whistle-blower speeds up the process of proving research misconduct.

Institutions must always be fair to the accused while the alleged dishonesty is being investigated.  The process for investigations often is unwieldy and easily compromised.  Institutions typically focus attention only on one “bad individual”, who is declared an exception to their high standards for ethical conduct.

What level of punishment is appropriate to discourage others from being dishonest? 

Punishments for research misconduct are not uniform between institutions, and often seem to be rather ineffective.  If a professional research scientist is proven to have falsified research data, is it enough to only have their publications retracted?  Or, must there also be financial penalties?  Is it sufficient to force cheaters to be on leave for 2 years, or should they be dismissed?  Should other institutions be prevented from subsequently employing them?  Should coworkers who participated in the fraud also be punished, and how strongly?  What punishments should be given to administrators for their cover-ups and stonewalling?  These necessary questions are not simple, and have no easy answers.

My own conclusions about these 3 cases! 

I draw several conclusions from the 3 cases just described.  (1) It takes many years for investigations of alleged misconduct to be completed.  (2) The long slow process of dealing with unethical research is made quicker by whistle-blowers and media attention.  (3) Institutions have a strong tendency to deny wrongdoing and minimize allegations of misconduct.  (4) Cover-ups mean that institutions cannot be trusted to police themselves.  (5) Punishments given to faculty for research misconduct vary widely, and, co-researchers and administrators often receive none.  (6) Punishments appear to only minimally deter new offenses by others.

Research dishonesty in laboratories and hospitals is very bad for patients, society, and science.  Unethical practices by researchers hurt trust by other scientists and physicians, and by the public.  Much more attention is needed to solve and deter this very general problem for science.

 

[1]  Elliott, C., 2015.  The University of Minnesota’s medical research mess.  New York Times, The Opinion Pages, May 26, 2015.  Page A19.  Available on the internet at:  http://www.nytimes.com/2015/05/26/opinion/the-university-of-minnesotas-medical-research-mess.html?_r=0 .

[2]  Stone, J., 2015.  Why the Minnesota research scandal threatens us all.  Forbes, May 27, 2015.  Available on the internet at: http://www.forbes.com/sites/judystone/2015/05/27/why-the-umn-research-scandal-hreatens-us-all/#4c1697e9751b .

[3]  Price, J., 2015.  Trial in medical research  scandal at Duke postponed.  The News & Observer, Health Care.  Available on the internet at:  http://www.newsobserver.com/news/business/health-care/article10233812.html .

[4]  Hinks-Jones, L., 2015.  Patients, researchers demand further prosecution in Duke case.  Bloomberg BNA.  Available on the internet at: http://www.bna.com/patients-researchers-demand-n57982065145/ .

[5]  Enserink, M., 2016.  Swedish academy seeks to stem ‘crisis of confidence’ in wake of Macchiarini scandal.  Science, February 12, 2016  351.  Available on the internet at: http://www.sciencemag.org/news/2016/02/swedish-academy-seeks-stem-crisis-confidence-wake-macchiarini-scandal .

[6]  McCook, A., 2016.  Sweden rocked by scientific scandals, re-thinking how it investigates misconduct.  Retraction Watch, February 25 2016. Available on the internet at:  Retraction Watch, February 25, 2016. http://retractionwatch.com/?s=Sweden+rocked+by+scientific+scandals .

[7]  Oltermann, P., 2016.  ‘Superstar doctor’ fired  from Swedish institute over research ‘lies’.  The Guardian, March 24, 2016.  Available on the internet at:  https://www.theguardian.com/science/2016/mar/23/superstar-doctor-fired-from-swedish-institute-over-research-lies-allegations-windpipe-surgery .

 

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WHISTLEBLOWERS IN SCIENCE ARE NECESSARY TO KEEP RESEARCH AND SCIENCE-BASED INDUSTRIES HONEST! 

 

Direct quotations from Dr. Peter Wilmshurst, given in published statements. (http://dr-monsrs.net)

Quotations by Dr. Peter Wilmshurst, taken from various published statements.     (http://dr-monsrs.net)

 

Anyone, even professional scientists with a PhD or MD, can make an honest mistake.  However, falsification or other dishonesty by a research scientist is an inexcusable breach of trust.  Since the goal of research is to find the truth, mistakes or alleged falsehoods must be investigated and corrected, in order to let science progress.  Whistleblowers in science have been rather few, largely because it is so much easier to keep quiet and overlook falsehoods or even criminal misrepresentations; speaking out or initiating inquiries about corruption in research typically leads to counter-allegations, challenges to professional reputation, prolonged court cases, and, only small penalties for proven wrongdoers.  Hence, most doctoral scientists keep quiet, particularly if an allegation involves someone with a higher professional rank; this is known as the “code of silence”.

This article describes the amazing adventures of a clinical and research cardiologist in Britain, Peter Wilmshurst, MD, who became a successful whistleblower.  During his medical research work, he found clear unethical and criminal misconduct by individuals and companies, so he courageously initiated several inquiries.  Unlike many others, Dr. Wilmshurst refused to be silenced by bribes or threats, and ultimately forced honesty to prevail.  Dr. Wilmshurst undoubtedly is nothing less than a heroic medical scientist!

Whistleblowing by Dr. Wilmshurst protected heart patients from a dangerous new drug [1-5]! 

In the 1980’s, Dr. Wilmshurst was invited by a very large pharmaceutical company in the UK to participate in their clinical research trial evaluating the efficacy of a new oral drug intended to strengthen cardiac contractions in patients with heart failure.  His research data showed no effects upon contractility in patients, and revealed very dangerous side effects.  According to the company, research data from their own researchers were strongly and uniformly positive.

When he reported his research results to the manufacturer, he was asked to suppress his negative findings.  Wilmshurst refused to do that, and would not keep quiet about his research results despite threats. Later, it was revealed that several other independent researchers had found adverse results similar to those of Dr. Wilmshurst, but fear had prevented them from announcing their findings.  The company published the results of this clinical trial without including Wilmshurst’s research findings.  The government health agencies, professional medical organizations, and several science journals heard Wilmshurst’s pleas for an official investigation, but all were afraid to do anything!  More and more reports from clinical physicians showed numerous medical problems arising in treated patients; finally, marketing this new drug in the UK and the US was stopped by the manufacturer, but sales and usage continued in some developing countries.  Only after a large write-up about Dr. Wilmshurst and his dispute in the Guardian newspaper (UK) was this dangerous pharmaceutical completely withdrawn from the entire world.

More whistleblowing by Dr. Wilmshurst protected migraine patients from a dangerous new medical device [1-5]!

Dr. Wilmshurst had published a research report in 2000 linking migraine to a fairly common developmental defect in the heart, patent foramen ovale.  His expertise as a cardiologist and medical researcher led to an invitation to be a research consultant in a large clinical trial of a new implantable device manufactured by a small company in the US; with implantation into the heart, this was supposed to close the cardiac defect.  The clinical trial examined whether its use would also stop recurring migraine attacks.  His echocardiogram results for treated patients differed greatly from those gathered by the cardiologists implanting the new devices on behalf of the manufacturer.  The company disputed Dr. Wilmshurst’s research findings and claimed that echocardiograms from the implanting cardiologists were correct, but his results were wrong and invalid.

That company then refused to include his research results within their published report on the clinical trial.  The company’s presentation of their clinical trial at a cardiology meeting in Washington did not mention his divergent interpretations of post-implantation echocardiograms, but Dr. Wilmshurst was in the audience (i.e., he had presented some of his own research at this meeting that did not concern this experimental device).  A reporter interviewed Dr. Wilmshurst at this meeting and published some of his comments about the divergent data for this experimental device.  Two weeks later, the company’s lawyers notified him of a lawsuit in the UK for defamatory libel; several more lawsuits for libel followed.

Media and medical journals began describing Dr. Wilmshurst’s ongoing fight against these lawsuits, which cost him much personal money over several years of worrisome court proceedings.  Perhaps in response to their estimates that all these trials would have a total cost of over 14 million dollars, the small manufacturer abandoned production of the new device and went out of business; the bankruptcy ended the lawsuits.  Dr. Wilmshurst again had successfully fought research misconduct and commercial fraud, thereby saving clinical patients from any grief with this ineffective new device.

Important lessons to be learned from Dr. Wilmshurst’s activities [1-5]. 

Several disconcerting lessons about both dishonesty and honesty in research can be learned from this determined British medical researcher and whistleblower.

(1)  Since scientific research is conducted by humans, it is easily subject to unethical conduct due to government inaction, overriding ambition, personal greed, selfish commercial interest, silence about professional wrongdoing, wrongful self-interest, etc.

(2)  Money and commercial interests make total honesty particularly difficult for scientists in cases where their research results contradict or call into question what is desired; research must seek the truth, and is distorted when it looks for only a predetermined result.

(3)  Industrial companies often can pressure and overwhelm individuals by using their large financial resources for bribes, teams of specialized lawyers in expensive lawsuits, direct threats to impugn professional reputation and personal integrity, etc.

(4)  The most common reaction upon finding dishonesty in science is simply silence and a refusal to become involved; this is very easy to do, but such tolerance of dishonesty can hurt innocent people (i.e., patients) and probably is itself a form of dishonesty.

(5)  The penalties and punishments for dishonesty in research are usually small or absent, which then encourages more dishonesty; some scientists even have a very successful career with repeated dishonesty that is widely known [2].

(6)  Corruption within all aspects of medical research is much more extensive than is commonly thought.

The ultimate goal of science is to find the truth, no matter what it might be.  Independent research is the best human means to decide what is true and what is false.  Whistleblowing serves to promote honesty in business, government, and science.  Court cases usually are initiated to pressure and intimidate whistleblowers to keep quiet or repudiate their earlier research findings and conclusions.  Judges and lawyers do not know enough about science to decide about controversies in research (see:  “What Happens when Scientists Disagree? Part V: Lessons to be Learned When Scientists Disagree” ).  As Dr. Wilmshurst has stated, “The law courts are not the best way to determine scientific truth.” [4].

Peter Wilmshurst is a unique individual, and certainly is a hero! 

Dr. Wilmshurst stands up for honesty even when other research scientists say nothing and ignore obvious wrongdoing, compromise their professional ethics by research misconduct, or show no personal integrity.  His personal characteristics and professional standards as a medical research scientist make him a great role model for young scientists, physicians, and research workers in all the disciplines of science.  He does not fear getting involved and announcing the truth even when that means making shocking disclosures about highly placed figures, esteemed professional organizations, very famous science and medical journals, successful large industrial operations, and, malfunctioning agencies in the national government.

It should be obvious that Dr. Wilmshurst is a very distinctive individual who successfully fought against large manufacturing companies, government agencies, professional medical associations, professional science journals, lawyers and courts, and blatant threats to his reputation as a professional clinical researcher.  He could do all of that because he is an ethical scientist with exemplary honesty, personal courage, and professional integrity.  Whereas he speaks out about dishonesty in research, many others choose to keep silent and refuse to challenge dishonesty and corruption; thus, dishonesty in science is widely tolerated [1].

Peter Wilmshurst should be honored for his career-long dedication to honesty and high professional standards in research!  In 2003, he received the HealthWatch Annual Award in the UK for his work against corruption and fraud in medical science [1].

Further information is directly available from Dr. Wilmshurst on the internet! 

A wonderful video presentation by Peter Wilmshurst, “The Role of Whistleblowers in Improving the Integrity of the Evidence Base”, is highly recommended to all reading this article (see:   https://www.youtube.com/watch?v=Xze-yPubFIY ).

Also highly recommended to all by Dr.M are both the written version of the speech given by Dr. Wilmshurst on the occasion of his receiving the HealthWatch Annual Award for 2003 (see:  http://www.healthwatch-uk.org/20-awards/award-lectures/65-2003-dr-peter-wilmshurst.html ), and, a very recent 2015 interview of Dr. Wilmshurst by R. von Bredow & V. Hackenbroch for Spiegel Online International, “Whistleblower on Medical Research Fraud: ‘Positive Results Are Better for Your Career'” (see:  http://www.spiegel.de/international/zeitgeist/spiegel-interview-with-whistleblower-doctor-peter-wilmshurst-a-1052159.html ).

Concluding remarks.   

Whistleblowers are essential to help keep everyone honest!  Even large companies and very famous scientists can become dishonest, unethical, or unprofessional.  Lack of honesty in scientific research can lead to grave practical problems for unsuspecting innocent people.   For medical research, Dr. Wilmshurst states appropriately, “Truth should not be decided by those with greatest wealth using bullying and threats to make a scientist retract what he or she knows is true.” [4].

[1]  P. Wilmshurst, 2004.  Obstacles to honesty in medical research.  HealthWatch – UK, Newsletter #52, 2003 HealthWatch – UK Award Lecture.  (see:  http://healthwatch-uk.org/20-awards/award-lectures/65-2003-dr-peter-wilmshurst.html ).

[2]  P. Wilmshurst, 2007.  Dishonesty in medical research.  Medico-Legal Journal 75:3-12. (see:  http://www.medico-legalsociety.org.uk/articles/dishonesty_in_medical_research.pdf ).

[3]  R. Smith, 2012.  A successful and cheerful whistleblower.  The BMJ (British Medical Journal) Blogs, October 10, 2012.  (see:  http://blogs.bmj.com/bmj/2012/10/10/richard-smith-a-successful-an.d-cheerful-whistleblower/ ).

[4]  R. A. Robbins, 2012.  Profiles in medical courage: Peter Wilmshurst, the physician fugitive.  Southwest Journal of Pulmonary and Critical Care, April 27, 2012/4:134-141.  (see:  http://www.swjpcc.com/general-medicine/2012/4/27/profiles-in-medical-courage-peter-wilmshurst-the-physician-f.html ).

[5]  P. Wilmshurst, 2012.  Justice Committee – written evidence submitted by Dr. Peter Wilmshurst.  UK Parliament, House of Commons, Select Committee on Science and Technology.  (see:  http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/163/163vw17.htm ).

 

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