Steve Miles, MD

COVERED NOT COVERED

Social responsibility & misconduct

Authorship/plagiarism

Conflict of interest Fraud Places for Help

IRBs and protecting human subjects

Use of animals Environmental health

& safety, GMOs, toxins,

Intellectual Property Military research

TO MAXIMIZE BENEFITS OF RESEARCH

TO MINIMIZE DAMAGES OF SCANDAL

Produce best quality data.

Serve long term interest of donors.

Preserve reputation of the institution.

Cost to research institutions.

Damage to researchers.

Costs to public policy and clinical, social and agricultural sciences.

Acta Onco 1999;38:89-92

DataManipulation

Authorship Manipulation

1.7% taking another’s ideas 1.3% questionable

relationships with students, clients, subjects

20.6% Changing design under pressure from funder

14.6% Using inadequate or improper research design.

14.3% Dropping data on a gut feeling it is wrong.

6.5% Not presenting data contradicting own findings.

.3% Not disclosing conflicts of interest.

.2% cook data Nature;2005:435:7373400 mailout, 43% return

FraudSchon (Bell Labs) published identical charts of false data to support work on mono-molecular transistors. (PhD retroactively revoked!).

Fraud

Ninov (Lawrence Berkeley National Lab) fabricated discovery of element 110, 111. Fired.

Identical ran-dom noise in two separate measure-ments? How interesting!

Proc of Nat Acad of Sci 10/1/12. J Med Ethics 2011; 37:567-70. All retractions from 2005 – 2008.

~1% of articles (~20,000 /yr) have evidence of misconduct.

Scientist 2006;20:24. .02% of articles

retracted. Retractions by

Authors (63%) (under-duress),

Editors (21%), Journals (6%), Publishers (2%), Institutions (1%).

J Med Ethics 2011; 37:567-70. All retractions from 2005 – 2008

2,047 retracted biomedical and life-science research articles.

Percentage of articles retracted for fraud has increased 10-fold since 1975.

Fraud, not error, accounts for 2/3 of retractions.

USA, Germany, Japan, and China accounted for 3/4 of retractions for fraud

Top 20 cited papers were cited 8000 times; citations continued after retraction.

Proc Nat Acad Sci 10/1/12.

Japanese doctor is heading for record number of retracted research papers

Japanese Society of Anesthesiologists: Yoshitaku Fujii, former associate professor at Toho University, faked 172 research papers. Joachim Boldt is second (89 papers

retracted). BMJ 2012;345:e4596

Andrew Wakefield is notorious with false linking of autism and MMR vaccination.

FINDINGS OF SCIENTIFIC MISCONDUCT NOTICE: DHHS.

PHS finds that Dr. Jacoby engaged in a pattern of dishonest conduct through the commission of 15 acts of data falsification and plagiarism, including additional steps taken to conceal the true nature and origin of the research data, that further demonstrates a lack of present responsibility to be a steward of Federal funds.

PlagiarismFINDINGS OF SCIENTIFIC MISCONDUCT NOTICE: DHHS.

Notice is given that the Office of Research Integrity (ORI) and Secretary for Health have taken final action in the case of Momiao Xiong, Ph.D., The University of Texas Health Science Center.

Dr. Xiong engaged in scientific misconduct by plagiarizing and fabricating data in NIH grant R01 GM64353-01 on which he was a co-investigator. The plagiarized and fabricated data were essential to the scientific validity of the proposed research and were important for NIH's scientific evaluation of the Pigmentation Application.

Duplicate Publication

Editor B. W. Wilson notes that data in two articles published in his journal were identical. The senior author had changed the title, dropped two authors, added one author, and changed the mathematical precision. The original article was not referenced.

The editor sent the two authors three letters.

The first asked for an explanation.

The second insisted on an explanation.

The third banned them from ever publishing in his journal again .

Note to self:

Editors never forget.

Substantial Contribution to: Conception. Design. Drafting intellectual

content. Complex data acquisition. Final guarantee of claims

for the entire paper (accountability).

http://www.icmje.org/roles_a.html

Each Contributor-Author has a disclosed substantial role: Conception and Implementation. Analysis. Drafting intellectual content. Accountability for that piece of the paper.

Each Guarantor-Author takes overall responsibility for the paper as a whole.

Hwang Woo-suk’s “Stem Cells”

2/04-8/05: cloned humans & dog and found stem cells. Publishes numerous papers fraudulently claiming that embryos were created with stem cells-they were created with germ cells. All 11 stem cell lines were frauds.

5-11/05: Hwang coerced lab workers to donate eggs. Lab staff retaliates by leaking fraud.

12/05: US author asks Science to remove him as senior author of Hwang's human cloning paper saying that he did not know data was fabricated. He is not allowed to withdraw.

Acquisition of funding,

Collection of data,

General supervision of the research group alone

Does not constitute authorship.

Contributors not meeting authorship criteria. Persons providing purely technical help,

writing assistance Department chair who provided only general

support. Persons who contributed materially to the

project but not as authors, e.g., “participating investigators” with descriptors of their function

Financial and material support should also be acknowledged.

All persons must give written permission to be acknowledged.

http://www.icmje.org/roles_a.html

The lead author is project manager, director, screenplay writer, producer.

Author assignment, evaluation and ranking should be continuously updated in writing.No paper should be submitted with

an open authorship conflict.

People who write the paper behind the scenes without attribution:

Drug or medical device companies or their PR departments.

Special academic assistants.

Corporate Ghostwriters

75% in industry-sponsored trials. (JAMA 2008;299 1800-12.)

Refoxecoxib (Vioxx) 50% of review ghost authors disclosed support. JAMA 2008;299-1800-12

Ghostwriter: “I was given explicit instructions about what to play up and what to play down—whether to enhance broader off-label use of the pain product or go strictly by the FDA.” Lancet 1999;354:136.

Note to self: Editors call ghostwriting: Undisclosed conflicts of interest Plagiarism and punish it with editorial death!

Financial: “I have a financial interest in this paper being published.”

Intellectual: “I cannot be intellectually fair to this topic.”

Control of authorship: ghostwriting. Seek the Oracle. International Committee

of Medical Journal Editors http://www.icmje.org/

Disclose all. Violators will be punished.

JAMA 2006;295:2270-74.

N=205, p.002

N=39, p.=07N=104, p.001

Avandia – 9/2010

Sales begin. Divided vote, poor data on risks. Minority report dissents.

WHO warns about heart effects.

GSK ordered to post unpub trials because of corporate suppression of data on antidepressant suicides.

GSK internal study (that ignores some MIs) finds 31% heart attack. P=NS. GSK conceals memo.

BMJ: Risks> benefits; withdraw it. UK: Ditto.

Europe stops sales.

FDA restricts sales; divided vote (Avandia speakers vote).

GSK to European Heart Journal: “Withdraw this editorial (critical of Avandia) and refrain from publishing it in any way.”

1999 201020052004 2007

Sales from $3B to $1B/Yr.

NEJM Meta-analysis shows 43% heart attack. Extra deaths~ 47,000. (A peer reviewer leaked review to Glaxo.)

FDA: Stronger label.

Sales:$500 M/Yr.

BMJ 2010:341:c4848.

2006

1 Million Rxs, 22%

A review of 379 unsealed cases of research whistleblowing that were resolved between 1996 and 2005. •$9.3 billion recovered.•$1.0 billion paid to whistleblowers.

• Whistleblowers usually executives or physicians

• 75% were employees of defendant organizations.

• 4% of cases were against pharmaceutical companies but these accounted for $3.6 billion (39%) of total recoveries.

• Annals of Internal Medicine. 149(5):342-9, 2008

A classified Pentagon study found that 80% of marines killed in Iraq died of wounds they would have survived if they had body armor that had been available since 2003.

The Pentagon largely declined to supply it to troops.

The study was leaked and public and congressional action lead to deployment of the armor.

A fake, incoherent and implausible paper by an unpublished author from a non-existent school.

Submitted to 304 open-access journals. 157 journals accepted. 98 journals rejected. 29 journals closed / 20 under review. OMICS, Wolters-Kluwer, Elsevier, Sage—

Most charge publication fees. Science 2013: 342(6154):60-5.

NIH Bioethics Resources http://bioethics.od.nih.gov/researchethics.html

University of Minnesota www.research.umn.edu/ethics/ Policies Links Curriculum Offices

University of Minnesota policies address Academic Misconduct How to report violations of policy or laws Prescribes disciplinary action for false

accusations

National Whistleblowers Center http://www.whistleblowers.org/index.php?

option=com_content&task=view&id=1220&Itemid=190

Health and Human Services Office of Research Integrity

http://ori.hhs.gov/

Case Summary: Mayack, ShaneFindings of Research MisconductOffice of the Secretary, HHS.SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Shane Mayack, Ph.D., Joslin Diabetes Center: Based on the report of an investigation conducted by the Joslin Diabetes Center (Joslin) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shane Mayack, former postdoctoral fellow, Department of Developmental and Stem Cell Biology, Joslin, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH),. . .

Attempted to present two unapproved studies at medical rounds.

Found to have fabricated data in many studies (did not conduct studies, invented patients, forged coauthors’ signatures, etc.).

Grants and honorariums from Pfizer, Merck and Wyeth. Wrote to FDA citing his data on safety and

effectiveness. His studies were widely cited and relied on. Fired as Professor of Anesthesiology and Pain Medicine

at Tufts University in Boston. Medical license permanently revoked. 2010 guilty of health care fraud.

Six months in prison, 3 years of supervised release. Ordered to pay $5,000 fine, return $50,000 to the

government and make $360,000 in restitution to pharmaceutical companies.

FDA permanently barred from assisting drug applications.

Not alone. BMJ 2013;346:f2514, BMJ 2013;347:f5267

Thank you!Slides Available miles001@umn.eduSteven Miles, Center for BioethicsUniversity of Minnesota