2008 CSUCI BIOL503 Ethics Part 6: Science Fraud

Slide 1: Ethics: Part 6, Science Fraud Biotechnology Law and Regulation CSUCI, Biol 503, Spring 2008 K. Pessin Spring 2008 CSUCI2008 KPBiol503 1

Slide 2: Ethics: Science Fraud Who polices science fraud?  Falsifying data  Plagiarism  Authorship/ownership  Concealing financial ties  CSUCI2008 KPBiol503 2 Spring 2008

Slide 3: Ethics: Science Fraud *** http://www.nytimes.com/2005/12/20/science/20rese.html?ex=1154404800&en=5d6282103b1681e8&ei=5070 CSUCI2008 KPBiol503 3 Spring 2008

Slide 4: Ethics: Science Fraud http://www.councilscienceeditors.org/index.cfm Committee on Publication Ethics http://www.publicationethics.org.uk/ CSUCI2008 KPBiol503 4 Spring 2008

Slide 5: Ethics: Science Fraud “The Office of Research Integrity (ORI) promotes integrity in biomedical and  behavioral research supported by the U. S. Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science (OPHS), within the Office of the Secretary of Health and Human Services (OS), in the U.S. Department of Health and Human Services (HHS). “ CSUCI2008 KPBiol503 5 Spring 2008

Slide 6: Ethics: Science Fraud http://www.bioethics.net/journal/j_articles.php?aid=838#top CSUCI2008 KPBiol503 6 Spring 2008

Slide 7: Ethics: Science Fraud 10 years of fake data to get grant money. Criminally sentenced “One year and one day” “I needed to meet payroll…” http://ori.dhhs.gov/misconduct/cases/press_release_poehlman.shtml http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html?pagewanted=3 CSUCI2008 KPBiol503 7 Spring 2008

Slide 8: Ethics: Science Fraud Whistleblower Walter DeNino, Poehlman's research assistant at the University of Vermont http://www.cbsnews.com/stories/2005/06/21/eveningnews/main703359.shtml "In some cases, some patients improved in terms of heart disease risk and energy expenditure," DeNino said. "After menopause." But the idea of healthier women after menopause jeopardized the foundation of Poehlman's work, so he did the unthinkable: he fabricated the data to make it fit his theory. DeNino confronted him and turned him in to the university; they found it wasn't the first time. Once Dr. Poehlman's fraud was exposed, the horrible implications were clear. Years of research which doctors relied on to treat menopausal women were now in serious doubt. ... Susan Real was in one of those faked studies. Back then, she was a bodybuilder entering menopause and, by volunteering for Poehlman's research, was hoping to "make a difference." Now, she knows she didn't. "I was outraged. I felt exploited. And I was really amazed that anyone would be doing something like that," Real said. CSUCI2008 KPBiol503 8 Spring 2008

Slide 9: Ethics: Science Fraud Dr. Eric Poehlman, faked data supporting use of horomone replacement therapy. http://news.bbc.co.uk/2/hi/health/6182445.stm The Scientist 2005, 6(1):20050328-02 http://www.the-scientist.com/news/20050328/02/ Aftermath of science fraud: Widely cited paper supporting use of hormone replacement therapy post-menopause based on fake data. Use of HRT may be linked to breast cancer. Did fake data contribute to millions of cases of breast cancer? CSUCI2008 KPBiol503 9 Spring 2008

Slide 10: Ethics: Science Fraud http://ori.dhhs.gov/documents/newsletters/vol14_no3.pdf Post-doc, fake data. Result: 5 year ban from any government research. CSUCI2008 KPBiol503 10 Spring 2008

Slide 11: Ethics: Science Fraud http://ori.dhhs.gov/documents/newsletters/vol14_no3.pdf Falsifying everything Former felon •Conceals rap sheet •Gets job enrolling cancer trials •Enrolls everyone whether they should be excluded or not •Patient dies. CSUCI2008 KPBiol503 11 Spring 2008

Slide 12: Ethics: Science Fraud Woo Suk Hwang http://www.sciencemag.org/cgi/content/full/312/5776/980/F2 CSUCI2008 KPBiol503 12 Spring 2008

Slide 13: Ethics: Science Fraud •Prosecutor’s report: http://www.sciencemag.org/cgi/reprint/311/5757/23.pdf •Faked data to look like 11 cloned human stem cell lines; •Misappropriated $3MM, into 63 bank accounts, false tax returns, etc.; •Bioethical lapses in paying female subordinates for oocytes; •“Strict Korean lab culture, subordinates must obey unethical bosses. . .”; •Political/lobbying ties for funding, not transparent. . . CSUCI2008 KPBiol503 13 Spring 2008

Slide 14: Ethics: Science Fraud NY Times, January 24, 2006 CSUCI2008 KPBiol503 14 Spring 2008

Slide 15: Ethics: Science Fraud http://www.gpoaccess.gov/fr/index.html CSUCI2008 KPBiol503 15 Spring 2008

Slide 16: Ethics: Science Fraud Plagiarism  http://www.publicationethics.org.uk/reports/1998/13e.pdf/view CSUCI2008 KPBiol503 16 Spring 2008

Slide 17: Ethics: Science Fraud CSUCI2008 KPBiol503 17 Spring 2008

Slide 18: Ethics: Science Fraud http://www.contactmusic.com/news.nsf/article/petty%20turns%20blind%20eye%20to%20chili%20peppers%20plagiarism_1001106 CSUCI2008 KPBiol503 18 Spring 2008

Slide 19: Ethics: Science Fraud http://www.sciencemag.org/cgi/reprint/311/5763/928.pdf CSUCI2008 KPBiol503 19 Spring 2008

Slide 20: Ethics: Science Fraud Dr. Schatten was duped by wrongful eggs before -- by his colleagues at UC Irvine’s lab – 2 of whom “fled the country” rather than submit to criminal charges. http://www.foxnews.com/story/0,2933,178982,00.htm l CSUCI2008 KPBiol503 20 Spring 2008

Slide 21: Ethics: Science Fraud Financial Interest  All authors disclose all potential conflicts of interest; http://jama.ama-assn.org/cgi/reprint/296/2/220 Includes specific financial interests and relationships and affiliations; Complete disclosures including declaration of no conflicts of interest;. Authors will continue to complete and sign an authorship responsibility form that includes statements on conflict of interest as well as funding and support. CSUCI2008 KPBiol503 21 Spring 2008

Slide 22: Ethics: Science Fraud CSUCI2008 KPBiol503 22 Spring 2008

Slide 23: Ethics: Science Fraud Financial Interest  Corporate affiliation database check http://www.cspinet.org/integrity/ CSUCI2008 KPBiol503 23 Spring 2008

Slide 24: Ethics: Science Fraud Should government panels include  representatives who have financial ties to companies that may have a stake in the proceedings? Dr. Evil Horse Doctor Witch doctor Hillbilly Doctor CSUCI2008 KPBiol503 24 Spring 2008

Slide 25: Ethics: Science Fraud http://www.usatoday.com/news/health/2004-11-29-fda-graham_x.htm Posted 11/29/2004 10:34 PM     Updated 11/29/2004 10:39 PM Quiet scientist no more By Rita Rubin, USA TODAY Graham and his collaborators found that Vioxx users had a higher rate of heart attacks and sudden cardiac deaths than Celebrex users. Graham says his superiors pressured him to soften his conclusions before presenting them at the August meeting in France. In a news release the day before the Senate hearing, acting FDA commissioner Lester Crawford said Graham voluntarily revised his conclusions. "FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces," Crawford said. Graham paints a different picture: "When you live in a climate of fear, retaliation and intimidation, no decision that one makes is entirely voluntary." http://www.ucsusa.org/news/press_release/fda-scientists-pressured.html CSUCI2008 KPBiol503 25 Spring 2008

Slide 26: Quiz You are editor of a scientific journal. You have a patent  application being prepared, but it is not yet filed. A scientist submits an article which discloses your invention. The author’s work may predate yours, and publishing the paper may put your patent rights in jeopardy. You:  A. Send the article back with comments to the author’s supervisor that the science is fraudulent.  B. Put the paper at the bottom of the stack and don’t respond to any of the author’s requests for status.  C. Recuse yourself, and disclose the presence of the manuscript to your patent lawyer. CSUCI2008 KPBiol503 26 Spring 2008

Slide 27: Ethics: Science Fraud CSUCI2008 KPBiol503 27 Spring 2008 http://www.latimes.com/news/local/la-me-doping11dec11,0,2817972.story?coll=la-headlines-california

Slide 28: Ethics: Science Fraud http://www.wada-ama.org/rtecontent/document/2007_List_En.pdf CSUCI2008 KPBiol503 28 Spring 2008

Slide 29: Ethics: Science Fraud http://www.latimes.com/news/local/la-me-doping11dec11,0,2817972.story?coll=la-headlines-california CSUCI2008 KPBiol503 29 Spring 2008

Slide 30: End: Ethics, Part 6, Science Fraud CSUCI 2008 Biol 503 K. Pessin Spring 2008 CSUCI2008 KPBiol503 30

Slide 31: Ethics: Summary Acts may be legal, yet unethical.  For human testing , as set forth in the Nuremberg Code and its progeny, the  patient comes first before society and science. There continue to be issues with voluntary consent among economically vulnerable populations. Animal testing is currently justified by some measurement of human benefit.  Ethical issues arise where progeny cells aren’t necessarily connected to who  produced them. The “Tissue Industrial Complex” is big business with ethical issues when body  parts and samples are put into the market place. “Neuroethics” issues arise when techniques allow us to think we can predict  how someone will act. Science fraud is growing and difficult to police in a global environment  overwhelmed with scientific publications. There is no unified framework for policing science fraud. CSUCI2008 KPBiol503 31 Spring 2008

Slide 32: Class 1: Ethics End Next: Class 2, Torts BIOL503, CSUCI Biotechnology Law and Regulation 2008 K. Pessin Spring 2008 CSUCI2008 KPBiol503 32

Slide 33: Just for fun Ali G. “Medical Ethics” http://www.youtube.com/watch?v=YjR8ljTSjM8 CSUCI2008 KPBiol503 33 Spring 2008