Publishing scandals spark resignation

The editor-in-chief of an online, open source medical journal that was tricked into accepting a nonsensical fake article for publication, in return for an $800 publishing fee, has resigned.

Bambang Parmanto, a University of Pittsburgh information scientist, resigned from his editorship at The Open Information Science Journal(TOISCIJ) after reading a story on The Scientist's website yesterday (June 10) that described a hoax paper submission to the journal. Editors at journal claimed to have peer reviewed the article and slated it for publication pending the submission of $800 in "open access fees."

"I didn't like what happened," Parmanto told The Scientist. "If this is true, I don't have full control of the content that is accepted to this journal." Parmanto said that he had never seen the phony manuscript that was accepted by TOISCIJ. "I want to lessen my exposure to the risk of being taken advantage of."

Parmanto, who became editor-in-chief of TOISCIJ when Bentham launched the journal last year, said that he had reviewed manuscripts for inclusion in the journal previously, but that he made up his mind to resign from his volunteer position "because of the potential for abuse," of the kind uncovered by the hoax. Parmanto did add, however, that the perpetrators of the hoax -- Cornell grad student Philip Davis and Kent Anderson, executive director of international business and product development at the New England Journal of Medicine -- were also guilty of some degree of unethical behavior.

"This is a process based on trust," he said. "An author should submit something legitimate, and the process on the review side should decide if a paper is worth publishing or not. In this case, the process was broken on both sides."

A member of a sister publication's editorial advisory board also quit, saying he no longer wanted his name associated with the company.

The fake article was generated by a computer program that strung the words together.

The resignations are the latest twist in a growing scandal that has involved ghostwriters and fake journals sponsored by drug companies to promote their medications -- which turn out later to have serious side effects.

Ghostwriters used by Lily to promote drugs in journals

Eli Lily & Co. employees acted as ghostwriters, preparing favourable scientific papers on the company's top-selling anti-psychotic drug that later appeared in medical journals under the names of real doctors and researchers claiming to have written them.

Later non-ghostwritten articles found the drug, Zyprexa, causes added risk of developing diabetes.

Eli Lilly & Co. officials wrote medical journal studies about the anti-psychotic Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting,” according to unsealed company files.

Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to documents filed in drug-overpricing suits against the Indianapolis-based company, the largest manufacturer of psychiatric medicines.

Drugmakers’ use of ghostwriters has created “a huge body of medical literature that society can’t trust,” said Carl Elliott, a University of Minnesota bioethicist who has written about the practice.

Lilly sought to make Zyprexa “the number one selling psychotropic in history,” according to a 2000 plan distributed to its product team. The memo was among more than 10,000 pages of internal documents unsealed last month in lawsuits by insurers and pension funds seeking to recoup money spent on the drug. They allege Lilly exaggerated Zyprexa’s effectiveness.

“Plaintiffs are releasing one-sided, cherry-picked documents obtained in discovery to selected news media in an effort to try their cases” there, said Lilly spokeswoman Marni Lemons. “Lilly remains prepared to defend ourselves against all of these allegations in the appropriate venue, a court of law.”

Lily joins other top drug makers involved in revelations about questionable scientific studies -- and even fake scientific journals -- published as little more than marketing tools for medications that later turned out to have dangerous side effects, including Merck & Co., and Pfizer Inc.

Medical ethicists quoted in the Bloomberg story about Lily said it was akin to plagiarism for doctors and researchers allowing their names to appear on ghostwritten articles. Barton Moffatt, a Mississippi State University bioethicist, called it "academic misconduct" and predicted that as the scandal grows researchers could find themselves fired over the practice.

John Buse, a former president of the American Diabetes Association who was listed as lead author of an article prepared with a Lily staffer in the Journal of Clinical Epidemiology, said researchers can develop a "stockholm Syndrome" with the drug companies they're are dealing with.

“I’m not saying that the pharmaceutical industry captures me,” Buse said. “But to the extent that the relationship has something above and beyond medicine, science, you know, it could cloud one’s judgement.”

Buse added that many researchers develop emotional attachments to drugs they’ve discovered or studied extensively.

“There’s this natural tendency for people to fall in love with your drug: it’s like your child,” Buse said. “So you have a hard time accepting criticism.”

Also this week, Zyprexa was approved in the U.S. for use by teenagers.

'Nonsense' science article offered publication -- for a fee

Using a bit of mischief, researchers at Cornell University and the New England Journal of Medicine have exposed the dangers of open access scientific journals after they were able to get a nonsensical article past editors of the Open Information Science Journal recently.

All they had to do was submit an $800 (US) "access fee" to the journal, blogger Bob Grant said in his blog for The Scientist magazine.

Philip Davis, a PhD student in scientific communications at Cornell University, and Kent Anderson, executive director of international business and product development at the New England Journal of Medicine, submitted the fake manuscript to The Open Information Science Journal (TOISCIJ) at the end of January. Image:

Davis generated the paper, which was titled "Deconstructing Access Points," using a computer program -- called SCIgen -- created at the Massachusetts Institute of Technology. He and Anderson signed the work using pseudonyms (David Phillips and Andrew Kent). The two listed the "Center for Research in Applied Phrenology" (CRAP) as their home institution on the paper, which featured fictitious tables, figures and references.

"I wanted to really see whether this article would be peer reviewed," said Davis. "[Our paper] has the look of an article, but it makes no sense."

Davis told The Scientist that he got the idea for this "little experiment" after receiving scores of spam emails soliciting article submissions and invitations to serve on editorial boards of open access journals from Bentham Science Publishers, TOISCIJ's publisher. According to its website, Bentham publishes "200 plus open access journals" that cover disciplines from bioinformatics and pharmacology to engineering and neuroscience. "One of the things that made Bentham catch our eye," Anderson said, "was that they were so aggressively soliciting manuscripts."

The two wrote about the incident today on the Scholarly Kitchen, the Society for Scholarly Publishing blog that they run.

The journal claimed the article had been peer-reviewed -- standard practice for scholarly journals -- but the two researchers received no review notes on their article. They were tempted to pay the $800 to see if their article would actually be published, but decided that would be unethical.

Grant tried to get the journal's side of the story, but was not successful.

I called Richard Morrissy, who's listed as the US contact for Bentham Science Publishers on the company's website, but he declined to answer my questions and instead directed me to his supervisor, Matthew Honan, who works in Bentham's France office. Honan does not have a phone number, according to Morrissy, and he did not reply to an email (which was CC'ed to Bentham's marketing team in Pakistan) by the time this article was posted.

Despite the obvious humour here, the incident also points to potential dangers, especially as one of the world's leading pahrma companies Merck & Co. finds itself in a fake publishing scandal of its own.

Open access journals generally charge authors fees to publish research papers. For example, BioMed Central journals charge up to $2265 in "article processing fees," and publishing in the PloS family of journals costs authors between $1300 - $2850. With institutional libraries, including Cornell's, and granting institutions, such as the Wellcome Trust and the Howard Hughes Medical Institute, offering to pay open access publication fees for faculty authors and grantees, the potential for abuse may be increasing. "It's almost an inevitability that you might have several publishers tempted to take advantage of this relatively easy money," said Anderson.

By the way, here's an excerpt from the opening of the article in question:

"Compact symmetries and compilers have garnered tremendous interest from both futurists and biologists in the last several years. The flaw of this type of solution, however, is that DHTs can be made empathic, large-scale, and extensible. Along these same lines, the drawback of this type of approach, however, is that active networks and SMPs can agree to fix this riddle."

 

More trouble for Merck

Already embroiled in a scandal over fake scientific journals it funded to promote its products, pharma giant Merck & Co. is now the subject of a law suit alleging that it misled customers into charging too much for prescriptions of cholesterol pills.

Also named in the suit over medications Zetia and Vytorin was Schering-Plough Corp., which Merck bought in March.

The companies have known for years -- and failed to make public -- that Zetia doesn’t reduce fatty arterial plaques that can cause heart attacks and strokes, according to the complaint filed June 5 in Philadelphia federal court. The suit, brought by the Pennsylvania Employees Benefit Trust Fund, seeks to recoup more than $9 million spent on the two drugs since October 2002. 

“Merck and Schering-Plough entered into, and through various overt acts implemented, an agreement between themselves to illegally promote Vytorin and Zetia,” lawyers for the fund said in the complaint.

Sales of Zetia and Vytorin fell 12 percent last year to $4.5 billion after two studies showed the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin. Vytorin combines Zetia and Merck’s simvastatin, a statin-class drug the Whitehouse Station, New Jersey-based company markets as Zocor.

Merck and Schering-Plough developed Vytorin to help further the profitable life of Zocor, which lost its patent protection in June 2006, according to the complaint. Generic Zocor alone costs 3 cents a pill compared to about $3 a pill for Vytorin, the complaint said.

“We believe the companies acted responsibly and appropriately and we intend to defend this lawsuit vigorously,” Ron Rogers, a spokesman for Merck, said today in a phone interview.

Schering-Plough spokesman Lee Davies said that company hasn’t yet been served with a copy of the complaint but plans to defend itself.

“Vytorin and Zetia have been shown to reduce LDL- cholesterol based on numerous clinical studies, and they have been approved by the FDA for that indication,” Davies said in an e-mailed statement.

The companies allegedly “suppressed” the results of a January 2008 study called Enhance that showed the drugs worked no better at clearing arteries than the generic drug simvastatin, according to the complaint. The companies also used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic, the complaint said.

Meanwhile, according to Forbes magazine, Merck is facing "new questions about the company's drug development prowess" after its hoped-for next big heart drug rolofylline came back with disappointing results from clinical trials.

Merck publishing scandal widens

Pharmaceuticals giant Merck & Co. is refusing to answer questions about a growing scandal involving its publication of fake scientific journals that were, in fact, little more than promotions for its products.

Originally thought to have published six such journals, it now turns out Merck bought and paid for nine journals -- with 13 more in the works.

News of the fake journals broke in April in The Scientist when it reported that Merck had paid Australian publisher Elsevier to print Australasian Journal of Bone and Joint Medicine (AJBJM), without revealing that the publication was created and paid for by Merck.

The "vast majority"of articles in AJBJM during its 2002 to 2005 publishing life were favourable articles about Merck drugs Fosamax and Vioxx -- two medications that have been linked to dangerous side effects.

Fosamax is an osteoporosis drug that has been linked to cancer.

LegalView reports on the recent Fosamax side effects, which have caused patients to not only consider new medications but to discuss the potential for a Fosamax class action lawsuit as well. In January, two medical journals, The New England Journal of Medicine and the Journal of the American Dental Association provided a one-two punch against the drug’s manufacturers, Merck and Co., reportedly linking the drug to such side effects as esophageal cancer and jaw bone die-off. Patients of the osteoporosis drug are advised to contact a medical professional to discuss the drug and its alleged dangers.

Vioxx, an anti-inflammatory, was pulled off the market after independent studies found a link to increased heart attack and strokes.

Merck, in what Summer Johnson calls "passing the buck" in the respected blog.bioethics.net, is refusing to answer questions about the publishing scandal, referring all questions to Elsevier -- which says it is reviewing its policies and admits the publications never should have been called journals.

Johnson is having none it:

Simply because Elsevier took the bait doesn't mean Merck is off the hook. Elsevier is rightfully taking the heat for agreeing to create entire divisions of publications that an Elsevier spokesperson admitted "should not have been called 'journals'." What an admission! What to call a publication such as these really is the question--perhaps they will fade into oblivion such that we will not have to give them a name. Not a chance. ...

If Elsevier really wants to put this scandal behind them, they must throw the doors open wide and disclose everything--including how much they were paid. Eventually the facts will come out. When they do--and I'm only guessing the figure is astronomical--Elsevier will look like they were hiding some very dirty laundry. Merck already is passing the buck and leave Elsevier holding the bag. Thus far it looks like they are succeeding. 

The nine fake journals are: The Australasian Journal of Bone and Joint Medicine, the Australasian Journal of Neurology, the Australasian Journal of Hospital Medicine, the Australasian Journal of General Practice, the Australasian Journal of Cardiology, the Australasian Journal of Cardiovascular Medicine, the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Clinical Practice, and the Australasian Journal of Musculoskeletal Medicine. 

The 13 planned fakes are: The Australasian Journal of Pediatrics, the Australasian Journal of Obstetrics and Gynecology, the Australasian Journal of Dentistry, the Australasian Journal of Infectious Diseases, the Australasian Journal of Pain Management, the Australasian Journal of Respiratory Medicine, the Australasian Journal of Sexual Health, the Australasian Journal of Psychiatry, the Australasian Journal of Asthma, the Australasian Journal of Gastroenterology, the Australasian Journal of Hospital Pharmacy, the Australasian Journal of Depression, the Core Journals in Oncology. 

 

The ultimate silk purse

Researchers in China claim to have figured out a way to coax cells from any part of a pig's body -- they used cells from a pig's ear and bone marrow -- into any type of cell in the body, just like embryonic stem cells.

The breakthough could set the stage for pigs being raised to grow organs for humans for transplantation, the researchers say.

Lead researcher Dr Lei Xiao, of the Shanghai Institute of Biochemistry and Cell Biology, said many other attempts had been made to transform adult cells from animals such as pigs into "pluripotent" stem cells, but they had failed.

He said: "Therefore, it is entirely new, very important and has a number of applications for both human and animal health."

Dr Xiao's team reprogrammed cells taken from a pig's ear and bone marrow, using a cocktail of chemicals introduced into the cells via a virus.

Tests showed that the reprogrammed cells were capable of becoming any of the cell types that make up the three layers in a developing embryo.

Dr Xiao said pigs were a potentially ideal source of organs for transplant, as their organs were similar in function and size to those found in humans.

In its blog,the American Journal of Bioethcis quipped that the breakthrough could help save the pig's reputation after the swine flu scare.

Medical researchers have long looked to pigs as a potential source of human organs in a field known as xenotransplantation, saying it could help with chronic shortages of organs from transplant.

Professor Chris Mason, an expert in regenerative medicine at University College London, said: "This breakthrough to produce pig stem cells potentially reinvigorates the quest to grow humanised pig organs such as pancreases for diabetics and kidneys for chronic renal failure.

"The clinical use of humanised porcine tissues and organs (xenografts) has moved a long way forward in recent months with successful small-scale clinical trials.

There's a certain "yuck" factor for many people, however, and animal rights activists and religious groups have objected to the idea.

Dr Sebastien Farnaud, science director of the Dr Hadwen Trust for Humane Research, said: "Persisting with highly speculative research that would see us use sentient animals as little more that living organ grow-bags, is not only ethically unsupportable but also scientifically dubious.

"Creating pig stem cells does not necessarily remove the risk of organ rejection but even more worrying is the risk of infecting patients and the wider public with pig viruses."

Glow in the dark monkeys

Dubbed a "biomedical supermodel" by the journal Nature, a genetically modified monkey that glows in ultraviolet light has been developed by a team of Japanese researchers.

But it isn't the "Victorian freak show" qualities of the research that has scientists so excited. It's the potential for the breakthrough to help with future medical research.

 That's because -- unlike past glow-in-the-dark primates -- these marmosets were able to pass their modification on to their offspring. That means scientists may be able to develop monkeys that have been genetically modified to have human conditions. This would make them ideal for medical research.

Scientists have genetically engineered many other species to be research tools. Mice in particular have been created with a wide assortment of characteristics and diseases that mimic human ailments.

But because mice are so genetically different from humans, scientists have long sought to breed primates to provide better disease "models." Although scientists have been able to genetically modify individual monkeys, they had never before succeeded in getting the new traits to pass down through generations - a crucial step for creating large enough numbers for research.

The monkeys were developed by Erika Sasaki and her team at the Central Institute for Experimental Animals in Kawasaki, Japan, by adding a jellyfish gene to marmoset embryos that made them glow green. Last month, a male was born using sperm from one monkey, and two more glowing marmosets have been born since. One was killed when its mother bit it. The scientists plan to create families of monkeys that develop neuro-degenerative diseases.

“This is potentially very exciting,” said Kieran Breen of the Parkinson’s Disease Society. “Because primates are much closer to humans than mice, we’ll have a new animal model to work with.”

Not everyone was so excited, however.

The research was condemned by animal rights proponents, who said it paves the way for the producing of colonies of primates conceived expressly to suffer a plethora of cruel illnesses and undergo potentially painful and dangerous medical experiments.

Because the work marks the first time a species so closely related to humans has been genetically altered in this way, some also worried the same techniques would be used on chimps or other primates even closer to humans or to try to endow people with desirable genetic traits.

The BBC spoke to leading animal right activists in Britain, who questioned the need for such work.

Jarrod Bailey, science consultant to the British Union for the Abolition of Vivisection (BUAV), says he is "disappointed" both ethically and scientifically with the results.

"This sort of research on animals as sentient as monkeys and apes does not have public support," he told BBC News.

Furthermore, he thinks the underlying science is flawed. Animal researchers, he said, "have failed in research to find treatments for Aids, for hepatitis, for malaria, for strokes. Many treatments for strokes work in monkeys but don't work in humans."

"Monkeys do not predict human response and do not tell us about human disease," he added.

 

Altruistic vaccines

I wrote an article in today's Toronto Star about a novel way to fight Dengue Fever -- or potentially any other disease passed on by mosquitoes.

The idea is an "altruistic vaccine" that does nothing to help the person actually getting the shot. Instead, the person's blood is rendered poisonous to any mosquitoes who bite the vaccinated person -- making the little critters unable to spread the disease.

The vaccine is being developed at Queensland University, in a part of Australia with a fast-growing Dengue problem. Global warming is being blamed for its rapid spread. The Bill and Melinda Gate Foundation is funding the work.

All vaccines have some altruist qualities to them, ethicist Angus Dawson told me, in that governments fund vaccination programs to prevent the spread of disease. Altruistic drugs take that one step further by giving no direct benefit to the person getting the shot.

That much is in the story.

What I couldn't fit in was Dawson's observation that the research is an example of society continuing to look for technological solutions to problems with wider causes.

It would perhaps be more ethical, says Dawson, founding director of the Centre for Professional Ethics at Keele University in Britain and now a visiting ethicist at the University of Toronto's Joint Centre for Bioethics, to address the long-term, underlying causes of disease spreading in general -- such as poverty, lack of access to proper care and global warming.

 He's right, of course, but I won't hold my breath.

Flu ethics articles available free

Articles and editorials published in the American Journal of Bioethics over the past few years on pandemics and how to handle them are now available for free to help health officials figure out what to do about swine flu.

Presumably, for in the general public, the articles will also provide something to measure the actions of health officials and politicians against.

Here's a list of available articles:

Ethics, Pandemics, and the Duty to Treat by Heidi Malm, Leslie P. Francis, Robert Hood, Thomas May, Saad B. Omer, Daniel Salmon 2008; 8(8):4

OPCs: Carrots and Sticks: Keeping Healthcare Workers on the Job in a Public Health Disaster by Tia Powell 2008; 8(8):20

Health Care Workers' Willingness to Work in a Pandemic by Dorothy E. Vawter, J. Eline Garrett, Karen G. Gervais, Angela W. Prehn 2008; 8(8):21

Suppose They Gave an Epidemic and Nobody Came? by Neil Schluger 2008; 8(8):23

Not in My Job Description by Joanne Godley 2008; 8(8):25

Specifying the Duty to Treat by Michael J. Selgelid, Yen-Chang Chen 2008; 8(8):26

Ethics and Epidemics by Daniel K. Sokol 2008; 8(8):28

A Duty to Treat During a Pandemic? The Time for Talk is Now by Tracey M. Bailey, Thomas J. Marrie, Rhonda J. Rosychuk, Olive Yonge 2008; 8(8):29

The Duty to Care in a Pandemic by Joint Centre for Bioethics Pandemic Ethics Working Group 2008; 8(8):31

Without Consent: Moral Imperatives, Special Abilities, and the Duty to Treat by Nadia Sawicki 2008; 8(8):33

Public Health and Duties to the Population during a Pandemic by Kenneth Kirkwood 2008; 8(8):35

Remembering the "Pan" in "Pandemic": Considering the Impact of Global Resource Disparity on a Duty to Treat by Alison Reiheld 2008; 8(8):37

Healthcare Professionals and the Reciprocal Duty to Treat During a Pandemic Disaster by Darren P. Mareiniss 2008; 8(8):39

Pandemic Influenza and the Duty to Treat: The Importance of Solidarity and Loyalty by Mitchell A. Klopfenstein 2008; 8(8):41 EDITORIAL: A 1918 Flu Memoir by Ricki Lewis 2008; 8(8):3

EDITORIAL: Don't Be Chicken: Bioethics and Avian Flu by Laurie Zoloth, Stephen Zoloth 2006; 6(1):5

EDITORIAL: Risk and Trust in Public Health: A Cautionary Tale by Matthew K. Wynia 2006; 6(2):3

EDITORIAL: Markets and Public Health: Pushing and Pulling Vaccines into Production by Matthew K. Wynia 2006; 6(3):3

EDITORIAL: Strange Bedfellows? Reflections on Bioethics' Role in Disaster Response Planning by Jessica W. Berg, Nicholas King 2006; 6(5):3

EDITORIAL: Ethics and Public Health Emergencies: Rationing Vaccines by Matthew K. Wynia 2006; 6(6):4

EDITORIAL: Ethics and Public Health Emergencies: Restrictions on Liberty by Matthew K. Wynia 2007; 7(2):1

EDITORIAL: What Vaccination Programs Mean for Research by Jeffrey P. Kahn 2007; 7(3):3

EDITORIAL: Ethics and Public Health Emergencies: Encouraging Responsibility by Matthew K. Wynia 2007; 7(4):1

EDITORIAL: Mandating Vaccination: What Counts as a "Mandate" in Public Health and When Should They Be Used? by Matthew K. Wynia 2007; 7(12):2

Such articles would normally cost about $37 (Canadian). No word on how long they will be available.

Swine flu on Facebook

The American Journal of Bioethics has set up a Facebook group to provide up-to-the-minute information on the current swine flu outbreak.

Launched today, pandemic.bioethics.net is your leading source for bioethics news, commentary and scholarship related to swine flu (H1N1), vaccine research, public health policy and more.

Whether you want up-to-the minute news updates, to comment on what we are writing here at bioethics.net, or to post your own news stories and to write your own comments via Twitter or Facebook, pandemic.bioethics.net is the primary source on the Internet for ethics and pandemics.

Available starting today also via our website, AJOB and Taylor and Francis have made available all pandemic-related publications for a six-month period. Links to those publications are available at blog.bioethics.net and pandemic.bioethics.net.

To learn more and to join in on the dialogue, visit us on Facebook, bookmark our URL, or select any of the links above.

Summer Johnson, PhD

The group already has links to several articles related to pandemic planning, including one on mandating vaccinations, another on ensuring people live up to their responsibilities during a pandemic and one on rationing vaccine.

It's an open group, so anyone can join and invite others to join.