Gần đây, Trung Quốc có vẻ “lên mặt” với các nước phương Tây rằng họ có nhiều bài báo khoa học nhất thế giới. Điều này thì chắc chẳng ai nghi ngờ, bởi vì với một dân số khổng lồ, một dân tộc thông minh, và một chính sách thông thoáng cho Hoa kiều, thì trước hay sau Trung Quốc sẽ dẫn đầu thế giới về năng suất khoa học. Nhưng đó là nói về lượng, chứ còn chất thì chắc Trung Quốc còn thua xa các nước tiên tiến khác. Hay tính trên đầu người thì Trung Quốc chắc chẳng hơn gì nước ta!
Tuy nhiên, bài báo dưới đây cho thấy sự phát triển của TQ có một bức tranh đen tối khác: gian dối. Theo như bài báo này, nhiều giáo sư và sinh viên mướn người khác viết luận văn, viết báo cáo khoa học, và đó là một sự gian dối trong khoa học không thể chấp nhận được. Như vậy, Trung Quốc chẳng những nổi tiếng làm hàng hóa giả, mà còn làm khoa học giả dối. Chúng ta biết rằng họ làm xe ôtô giả, điện thoại giả, quần áo giả, thức ăn giả … Chẳng những làm giả mà còn độc hại. Thức ăn của Trung Quốc thì nổi tiếng là có hại cho người tiêu dùng, đến nổi FDA ra lệnh phải đặc biệt chú ý đến hàng hóa Trung Quốc. Hình như gian dối là một nét văn hóa của người Trung Quốc trong thời tranh tối tranh sáng này, và có lẽ chính vì thế mà nhiều nước trên thế giới tỏ vẻ nghi ngờ Trung Quốc.
Ai cũng biết nhiều nhà khoa học TQ gian dối, nhưng khó mà bắt tận tay, vì họ gian manh … rất Á châu. Thế nhưng cũng có tập san Anh phát hiện sự gian dối của một nhóm khoa học TQ và rút lại gần 70 bài báo khoa học từ nhóm này. Dù biết rằng số nhà khoa học TQ gian dối chỉ là số nhỏ, nhưng đó cũng là tín hiệu để chúng ta đặt câu hỏi về bất cứ một công trình nào từ TQ. Những câu hỏi đặt ra là: họ làm có đúng không, có sửa dữ liệu không, có ngụy tạo dữ liệu không, làm có đúng theo qui định về y đức không, v.v…
Thật ra, nói Trung Quốc gian dối trong khoa học cũng không công bằng, vì một số nhà khoa học Việt Nam ta cũng gian dối. Tôi có một anh bạn là bác sĩ, từng có thời viết luận án thuê cho các thạc sĩ và tiến sĩ, mà sống thoải mái. Mấy tuần gần đây, chúng ta thấy nạn đạo văn và luộc sách tràn lan đến mức báo động. Chẳng những sinh viên và nghiên cứu sinh đạo văn, luộc sách, mà ngay cả cấp giáo sư cũng thế. Câu chuyện hiện vẫn đang ồn ào về vụ luộc cuốn sách về kinh tế của một giáo sư ở Sài Gòn cho thấy tình trạng này gần như hết thuốc chữa. Thật ra, có blogger chất vấn rằng chắc gì tác giả cuốn sách bị luộc một mình sáng tác toàn bộ cuốn sách, mà rất có thể tác giả cũng “mượn” ý tưởng hay dữ liệu nghiên cứu từ nước ngoài. Người viết sách giáo khoa trước hết phải là một chuyên gia có uy tín, tức là đã từng làm nghiên cứu và có công bố quốc tế, sau đó gom góp những công bố của mình đưa vào sách. Còn những bản dịch từ sách giáo khoa nước ngoài, những mượn ý tưởng và dữ liệu từ ngoài, v.v… thì không thể xem là sáng tác nguyên thủy được.
Chẳng riêng gì các giới khoa học Trung Quốc và Việt Nam gian dối, mà ngay cả một số nhà khoa học phương Tây cũng gian lận. Hiện tượng viết thuê hay “ghost writing” đã từng được nêu lên nhiều lần trong các diễn đàn khoa học quốc tế. Tác phẩm ma là do tác giả ma viết. Tác giả ma là người viết mướn, nhưng không đứng tên tác giả. Thay vào đó, tác giả là những nhà khoa học có tên tuổi, tuy họ chẳng viết câu văn nào nhưng lại được các công ti dược trả tiền. Nói trắng ra, họ bán tên tuổi, bán “thương hiệu” với cái giá khá hậu hĩ (từ 5000 USD đến 10000 USD một bài). Tạo ra tác phẩm ma là một “chiêu thức” mà kĩ nghệ dược phương Tây đã sử dụng rất thành thạo. Trong 2 bài trước đây, tôi có nói qua về kĩ nghệ này, vốn nằm trong chiến lược “y học thực thị”.
Một điều tôi không ngờ là một anh bạn tôi cũng dính dáng vào vụ bài báo ma. Anh ta là John Eden, một giáo sư sản phụ khoa có tiếng ở Úc và một giáo sư tầm cỡ trường quốc tế. Tôi quen John từ những năm đầu thập niên 1990s, lúc đó tôi theo đuổi dự án về di truyền qua mô hình sinh đôi (twin study), còn John và một cô nghiên cứu sinh người Iran thì miệt mài với polycystic ovary syndrome (PCOS). Họ đến tôi để hợp tác cách áp dụng mô hình sinh đôi vào nghiên cứu PCOS. Chúng tôi khá thành công với vài công trình mà đến nay chắc trích dẫn đã trên 100 lần. Bẵng đi một thời gian dài, chúng tôi mỗi người theo đuổi dự án khác nhau nên ít liên lạc. Đến tuần vừa qua đọc trên báo thấy Quốc hội Mĩ điều tra công ti Pfizer và Wyeth, và tên anh ta bị nêu trước Quốc hội Mĩ như là một chuyên gia dính dáng vào các thương vụ bài báo ma. Cứ như bài báo này thì John quả thật đứng tên trong một bài báo ma, nhưng anh ta nói là bị công ti lừa gạt. Riêng tôi thì thật khó tin một nhân vật có tên tuổi và giàu có như John mà lại dính dáng vào thương vụ này! Âu cũng là một kinh nghiệm khi làm việc với kĩ nghệ dược.
Quay trở lại câu chuyện sáng tác ma ở Trung Quốc và trước những lùm xùm về luộc sách hiện nay ở nước ta, tôi nghĩ cũng cung cấp cho giới quản lí vài bài học cần thiết. Ở ngoài này, đạo văn là một vi phạm khoa học nghiêm trọng. Nghiên cứu sinh có thể bị thu hồi bằng cấp, giáo sư có thể bị cảnh cáo hay đuổi việc. Còn ở nước ta thì chưa có những qui định về đạo đức khoa học rõ ràng, nên chắc sự việc sẽ được … cho qua (như nước chảy qua cầu). Có người đòi người luộc sách xin lỗi, nhưng tôi thấy chuyện xin lỗi rất ư là thừa. Vấn đề không phải là xin lỗi mà là ngăn ngừa tình trạng như thế xảy ra trong tương lai. Do đó, tôi nghĩ trước hết các trường đại học cần phải có một chính sách và qui trình minh bạch để xử lí các vấn đề đạo văn và vi phạm đạo đức khoa học (đạo văn và luộc sách là một hình thức vi phạm đạo đức khoa học). Nhưng vấn đề là ngừa hơn là xử lí. Ở Việt Nam chưa có môn học về ethics hay đạo đức khoa học. Do đó, cần phải đưa môn đạo đức khoa học vào chương trình giảng dạy cấp đại học, thậm chí trung học, để các em biết đạo đức khoa học là gì, ít ra là phân biệt được thế nào là đạo văn, thế nào là trích dẫn.
Cần phải nói thẳng rằng đạo văn, luộc sách, sáng tác ma, v.v… là những hành động phản đạo đức khoa học và không chấp nhận được. Sự hiện diện của những tệ nạn trong giới học thuật và xã hội là một tín hiệu cho thấy nền giáo dục và khoa học của ta có vấn đề. Nhưng cách xử lí của các giới chức còn cho thấy hình như họ chưa nhận thức được sự nghiêm trọng của vấn đề. Việt Nam đang nói chuyện “đại học đẳng cấp quốc tế” mà không xử lí được mấy vấn nạn về vi phạm đạo đức khoa học thì tôi e rằng giấc mơ đẳng cấp quốc tế còn xa vời lắm.
Rampant cheating hurts China's research ambitions
By GILLIAN WONG, Associated Press Writer Gillian Wong, Associated Press Writer – Sun Apr 11, 12:49 am ET
LIUZHOU, China – When professors in China need to author research papers to get promoted, many turn to people like Lu Keqian.
Working on his laptop in a cramped spare bedroom, the former schoolteacher ghostwrites for professors, students, government offices — anyone willing to pay his fee, typically about 300 yuan ($45).
"My opinion is that writing papers for someone else is not wrong," he said. "There will always be a time when one needs help from others. Even our great leaders Mao Zedong and Deng Xiaoping needed help writing."
Ghostwriting, plagiarizing or faking results is so rampant in Chinese academia that some experts worry it could hinder China's efforts to become a leader in science.
The communist government views science as critical to China's modernization, and the latest calls for government spending on science and technology to grow by 8 percent to 163 billion yuan ($24 billion) this year.
State-run media recently exulted over reports that China publishes more papers in international journals than any except the U.S. But not all the research stands up to scrutiny. In December, a British journal retracted 70 papers from a Chinese university, all by the same two lead scientists, saying the work had been fabricated.
"Academic fraud, misconduct and ethical violations are very common in China," said professor Rao Yi, dean of the life sciences school at Peking University in the capital. "It is a big problem."
Critics blame weak penalties and a system that bases faculty promotions and bonuses on number, rather than quality, of papers published.
Dan Ben-Canaan is familiar with plagiarism.
The Israeli professor has been teaching for nine years at Heilongjiang University in the northeastern city of Harbin. A colleague approached him in 2008 for a paper he wrote about the kidnapping and murder of a Jewish musician in Harbin in 1933 during the Japanese occupation.
"He had the audacity to present it as his own paper at a conference that I organized," Ben-Canaan said. "Without any shame!"
In a separate case, he gave material he had written to a researcher at the prestigious Chinese Academy of Social Sciences. He said he was shocked to receive a book by the academic that was mostly a copy and translation of the material Ben-Canaan had provided — without any attribution.
The pressure to publish has created a ghostwriting boom. Nearly 1 billion yuan (more than $145 million) was spent on academic papers in China last year, up fivefold from 2007, a study by Wuhan University professor Shen Yang showed.
One company providing such a service is Lu's, in Liuzhou, a southern industrial city. His Lu Ke Academic Center boasts a network of 20 to 30 graduate students and professors whose specialties range from computer technology to military affairs.
Lu, a 58-year-old Communist Party member, is approached by clients through Internet chat programs. Most are college professors seeking promotions and students seeking help on theses. Once, 10 students from the same college class put in a collective request for him to write their papers, he said.
"Doing everything on your own, independently, should be possible in theory, but in reality it is quite difficult and one will always need some help," Lu said. "This is how I see it. I don't know if it is right."
Even in the business of selling research papers, there are cheats. Among the papers bought and sold in 2007, more than 70 percent were plagiarized, the Wuhan study found.
Early last year, Internet users found that the deputy principal of Anhui Agricultural University had committed plagiarism in as many as 20 papers. The university removed him from his post but allowed him to continue teaching.
In June, the principal of a traditional Chinese medicine university in the city of Guangzhou was accused of plagiarizing at least 40 percent of his doctoral thesis from another paper.
And in March, the state-run China Youth Daily reported a 1997 medical paper had been plagiarized repeatedly over the past decade. At least 25 people from 16 organizations copied from the work, and more doctors are expected to be named as the investigation by two students using plagiarism-detecting software continues, the report said.
Fang Shimin, an independent investigator of fraud, said he and his volunteers expose about a hundred cases every year, publicizing them on a Web site titled "New Threads."
"The most common ones are plagiarism and exaggerating academic achievement," Fang said.
The papers retracted by the British journal came from researchers at Jinggangshan University in southeastern China. The editors are checking other papers from the same institution, and say more retractions are expected. Calls and e-mails sent to Zhong Hua and Liu Tao, the two researchers named as lead authors of the papers, were unanswered. Other researchers contacted at the university too did not respond.
The journal, Acta Crystallographica Section E, publishes discoveries of new crystal structures, much of it from legitimate Chinese research.
"Chinese authors have submitted thousands of high quality structures to Acta E, which represent an important contribution to science," wrote Peter Strickland, managing editor of Journals of the International Union of Crystallography, which owns Acta E, in an e-mail. He said it was the first time fraudulent papers had been found in any of the journals.
Richard P. Suttmeier, an expert in Chinese science policy at the University of Oregon, said the problems can be traced to China's efforts to modernize its science system in the 1980s and early 1990s when research accountability and evaluation were still weak.
In trying to find ready measures of achievement, China emulated Western practices and began to focus on high-quality publications, but with mixed results, he said.
The problems could hurt the country's ambition of becoming a global leader in research, Suttmeier said.
"I suspect there will be less appetite for non-Chinese scientists to collaborate with Chinese colleagues who are operating in a culture of misconduct," he said.
Last month the Education Ministry released guidelines for forming a 35-member watchdog committee. Also, in a faxed reply to questions, it said it has asked universities to get tough.
Rao, the Peking University dean, remains skeptical.
Government ministries are happy to fund research but not to police it, he said. "The authorities don't want to be the bad guy."
DR John Eden was on holiday in Tasmania when he found out he was under investigation by the US government.
It was just before Christmas 2008, and Eden - an associate professor at the University of NSW and one of Australia’s leading researchers on women’s health - got an email from a New York Times reporter bearing unpleasant news: the Senate Finance Committee in Washington had just identified him as one of several researchers who allegedly put their names to “ghost-written” scientific papers paid for by the multinational drug firm Wyeth Pharmaceuticals.
It was Eden’s first intimation of a controversy that has since swept through the world of medical research, taking his reputation along for the ride. Wyeth, it was claimed, had tried to downplay the dangers of its billion-selling hormone-replacement drugs for menopausal women by secretly sponsoring dozens of scientific articles that supported the drugs. One of the offending articles had appeared under Eden’s name in the prestigious American Journal of Obstetrics & Gynecology in 2003.
Via a shaky internet connection in Launceston, Eden watched aghast as headlines such as “Doctor named in US drug inquiry” circulated the internet. By Christmas Eve The New York Times was reporting that the journal that published his paper had launched its own investigation. His superiors at the university, meanwhile, were seeking an explanation. “It wasn’t much of a Christmas holiday,” recalls the 53-year-old director of the Sydney Menopause Centre.
Since then the scandal has all but disappeared from the news here, and even Eden himself was unaware of the revelations that have followed. For since late last year more than 1000 documents from Wyeth’s internal files have appeared on the internet, a trove of confidential emails, memos and reports that lay bare the details of the company’s “strategic publications” scheme. They show that Wyeth orchestrated the production of more than 40 scientific papers - including Eden’s - as part of a calculated strategy to increase sales of its Premarin hormone-replacement drugs. The papers deliberately focused on reassuring research about the drugs at a time when mounting evidence showed that women taking them suffered higher risks of breast cancer, strokes and heart disease.
To Eden, the documents are both a shock and an embarrassment. They reveal the full details of Wyeth’s role in his paper – and even show that one of the drug company’s senior executives testified that Eden did not actually write it. That’s a claim Eden adamantly denies, saying he had full control of the article’s contents. But he says he now realises the drug company duped him into helping push its commercial agenda. “I feel stupid - angry,” he says. “I look back and ask myself: How could I have been so naive?”
For a lot of women, the issue has deeper significance, for it goes to a question that has rattled around medical science for decades. How safe is hormone replacement therapy (HRT)? And how much of the scientific literature that doctors rely on to judge such questions is influenced by the hidden hand of the $750-billion-a-year drug business?
A rocky history
Just as the contraceptive pill freed generations of women from the tyranny of unwanted pregnancy, menopausal drugs have long been sold as female emancipation in a tablet – an antidote to the late-life spectre of “the change”. Initially prescribed to ameliorate the hot flushes and mood swings of menopause, HRT was embraced by many women as a proverbial elixir of youth that was said to improve skin, pep up sex, make bones sturdier and ward off heart disease and senility. The US author Gail Sheehy captured her generation’s evangelical enthusiasm for the drugs in her best-selling 1992 book The Silent Passage.
The rocky history of these drugs is inextricably tied up with drug giant Wyeth - recently acquired by Pfizer for $US68 billion - which marketed the blockbuster menopause treatment Premarin. Launched in the early ’40s by Wyeth’s sister company Ayerst Laboratories, Premarin became the best-selling drug in the US after the publication of Feminine Forever, a hit 1966 book by New York GP Robert Wilson. Wilson pronounced that menopause was a disease and estrogen was the cure which would transform women from shrivelled “castrates” into late-blooming roses. Only after his death was it revealed that Ayerst had helped finance his work.
Sales of estrogen drugs slumped in the late ’70s after it was discovered they caused uterine cancer, but their popularity surged again after scientists discovered that administering an additional hormone, progesterone, solved that problem. Sales spiked even further in the late ’80s when Wyeth - by then fully merged with Ayerst - began heavily promoting HRT as a preventative for osteoporosis, prompting doctors to recommend long-term use of the drugs to promote longevity.
With 70 per cent of the market, Wyeth’s menopause drugs were approaching annual sales of $US1 billion in 1996. But by then the company had a new problem - the year before, a survey of more than 80,000 US women published in The New England Journal of Medicine had shown that those on HRT suffered a significantly higher incidence of breast cancer. The finding appeared to confirm a long-standing fear about the drugs which Wyeth needed to neutralise. The plan it came up with would ignite the controversy that has engulfed Dr John Eden and dozens of other leading menopause researchers.
The full details have only become available since last year, when US courts began releasing hundreds of internal Wyeth documents that the company had produced under subpoena as it fought damages claims brought by women who blame Premarin for their breast cancer. The University of California has since collated the documents into a database called the Drug Industry Document Archive.
The documents show that in 1996 - as Wyeth launched its new menopause treatment Prempro - the company enlisted the help of a New Jersey medical communications company called DesignWrite, founded by a former journalist, Mitch Leon. DesignWrite proposed that its staff work with Wyeth to create a range of research papers on HRT that would be published in major medical journals in order to “set the scientific agenda” and “minimise [the] impact of negative findings”.
How these papers would be written was described in unequivocal terms. “The first step is to choose the target journal best suited to the manuscript’s content, thus avoiding the possibility of manuscript rejection,” DesignWrite’s proposal stated. “DesignWrite will then analyze the data and write the manuscript, recruit a suitable well-recognized expert to lend his/her name as author of the document, and secure the author’s approval of its content.” The ultimate aim was “to establish a greater need for estrogen/hormone replacement therapy while allaying unrealistic fears that physicians and patients have concerning the therapy.” Wyeth initially hired DesignWrite to prepare 20 scientific papers at a cost of $US464,000.
One of Wyeth’s senior marketing executives, Jamie Durocher, has since elaborated on how the program worked while testifying in an Arkansas courtroom in 2007. Durocher said Wyeth staff typically came up with the subject matter of the various articles based on their scientific knowledge; DesignWrite would then prepare an outline, send it to a scientist who had been targeted as the eventual author, and then “move towards preparing a draft based on the author’s guidance”.
Wyeth had no problem finding willing participants, because many clinicians already had close ties to the company and were keen proponents of HRT. Like many drug companies, Wyeth funnelled millions of dollars to scientists conducting clinical trials of its drugs; it also funded major women’s health organisations such as the North American Menopause Society. By December 2000, Wyeth had 41 papers in production, some of them with authors marked as “to be decided”. The papers were targeted at more than two dozen science journals, and their prospective authors included some of the world’s most high-profile researchers into menopausal drugs.
Dr John Eden came to Wyeth’s attention because his clinical studies of women being treated for breast cancer at the Royal Hospital for Women in Sydney suggested that high doses of progestin – the extra hormone in Wyeth’s new drug Prempro – could actually reduce recurrence of the disease. This appeared to contradict studies that showed progestin increased the breast cancer risk. In June 2000 Wyeth flew him to New York to present his research at a company-hosted symposium, and at dinner on the opening night he met the Wyeth marketing executive Mark Barbee. A month later, Barbee emailed Eden to say that the Australian’s research was “invaluable to us as we move our business forward”, offering the assistance of a writer to turn the presentation into a published paper.
Eden says today that he had no idea that Wyeth was in the process of financing more than 40 such papers. “If I had any idea, I would have said, ‘Forget it’,” he asserts. Like many researchers, he was used to getting editorial assistance from librarians and university staff, and he had accepted honoraria from drug companies for many years. He says Wyeth’s offer did not strike him as untoward.
DesignWrite was a one-stop shop - it drafted, edited and revised manuscripts for scientists, then provided them with a complete package of material to expedite publication, including template letters addressed to the target journals and the suggested names of peer-reviewers. If queries were raised in the peer-review process, DesignWrite would perform rewrites. All the time, the company was liaising with Wyeth to ensure the papers suited the company’s commercial needs. In one email a Wyeth executive urged the company to find additional scientists who would be “advocates” for its drugs; another Wyeth staffer suggested “repurposing” some papers to help improve market expansion in South America.
The Eden paper is cited in a trail of Wyeth documents that provide a case study of how the process worked. Shortly after Wyeth flew Eden to New York in June 2000, the company’s marketing staff met with DesignWrite and - according to the minutes of that meeting - “John Eden was suggested as the author of a breast cancer paper questioning the role of progestin as a causative factor”.
After Eden accepted Wyeth’s offer of a writer’s assistance, DesignWrite hired a young West Coast microbiologist, Caron Pruiett, to write an 8-10 page manuscript entitled Breast Cancer & Progestins, based on an outline and bibliography provided to her. Pruiett, who at that time worked in a laboratory examining cattle faeces and wrote science papers to supplement her income, was instructed to pay particular attention to “why progestins may not be responsible for the incidence of breast cancer in hormone replacement therapy (HRT) users”.
DesignWrite paid Pruiett $US3000 for her work, which resulted in an 11-page “draft outline” with 70 footnotes. But the draft paper caused some disquiet inside Wyeth: at a meeting in July 2001, DesignWrite agreed to revise it after concern was raised about “[the] message with respect to pipeline products”. At another meeting a month later it was decided the draft would be reviewed by Wyeth’s marketing department before being sent to Eden.
Shown a copy of Pruiett’s draft paper, Eden says he has no recollection of ever seeing it, although more than half of it later appeared in his published paper. He acknowledges, however, that DesignWrite may have prepared the first draft based on the PowerPoint slides from his New York presentation. “What happened was that the draft would come [and] I would say, ‘No, this is wrong, move this around, do this, do this’, and send it back,” he recalls.
What he didn’t realise, he says, is the role Wyeth had played in formulating the paper and monitoring its contents. “They certainly never made it clear that they were going to read the paper,” he says. “Whether they made suggestions or not I don’t know - I don’t want to know, to be honest - but the fact that this DesignWrite were giving it to [Wyeth’s] people to look at - I’m offended. I’m highly offended.”
DesignWrite’s files show its staff working closely with Eden over a period of more than a year, sometimes suggesting changes and offering to carry out edits. A November 2001 note reads: “manuscript sent to author for review”; the following month Eden sent revisions back and in March 2002 he submitted the paper to the Archives of Internal Medicine in Arizona. When the journal rejected the article, DesignWrite sent Eden a new covering letter, this time addressed to the American Journal of Obstetrics & Gynecology in Ohio.
Eden’s paper was still being assessed by that journal when a bombshell landed on the world of menopause research: in July 2002 the US National Institutes of Health announced it was abandoning a major study of 16,000 women taking Prempro because they were suffering significantly higher rates of breast cancer, strokes and heart disease. The Women’s Health Initiative study concluded that women on Prempro had a 26 per cent higher risk of breast cancer, 29 per cent more heart attacks and double the rate of blood clots.
The announcement was a disaster for Wyeth, whose menopause drugs had just reached $US2 billion in annual sales. The worldwide alarm it sparked was exemplified by the front-page headline in Sydney’s Daily Telegraph, which urged “CALL YOUR GP”. Not only were the breast-cancer risks of HRT confirmed, the purported long-term benefits of the drugs were thrown into question.
In late 2002, Eden quickly revised his paper to take in the new findings. Unbeknown to him, DesignWrite’s staff were scrutinising it to look for “anything that the client [Wyeth] might have an issue with”. The final paper argued that there was no definitive evidence linking progestins to breast cancer – a message Wyeth must surely have thought timely. It was published in May 2003, as the Editor’s Choice article in the American Journal of Obstetrics & Gynecology. In a notation at the end, Eden acknowledged the “editorial assistance” of Karen Mittelman and Stephen Parker, but failed to mention that they worked for DesignWrite, or that Wyeth had paid for their work.
“I look back now and I think, ‘Why did I do that?’” he says, admitting it was an error of judgment. “I wrote the paper, I acknowledged the two people who helped me. My mistake was not mentioning that they were funded by Wyeth.”
Laughing off the scandal
John Eden was not alone in failing to acknowledge Wyeth’s contribution to his paper - other researchers recruited into the company’s “strategic publications” program did likewise. As a result, little was known about it until December 2008, when the US Senate Finance Committee released a raft of internal Wyeth documents it had obtained as part of an investigation into medical ghost-writing. Among them were details about the Eden paper.
At the time, Eden refused to comment other than to say he stood by his article. Wyeth dismissed the headlines, saying it had exercised no control over the content of the articles and had not paid the researchers for them. Some of those researchers have since laughed off the controversy. Dr Leon Speroff, a former professor of obstetrics at Oregon Health Sciences University, told Milwaukee’s Journal Sentinel newspaper he saw nothing wrong with putting his name to a paper written by DesignWrite’s staff. “If you don’t like the way it works,” he said, “that’s your business.” Speroff’s paper was a critique of the evidence linking HRT with breast cancer; DesignWrite’s internal files indicate it was written by a staff member with a PhD in dietary science. In May 2001, Speroff sent her an email saying: “You did a super job of writing this paper – succinct and makes the points very well.”
Another high-profile expert involved in Wyeth’s program was the author and New York University professor Lila Nachtigall. She denied her paper was ghost-written but commented that the Senate’s investigation “kind of makes me laugh”.
Others are not so sanguine. Professor Alastair MacLennan of the University of Adelaide was co-editor of the journal Climacteric in 2000 when Professor Rogerio Lobo of Columbia University submitted a paper to him for publication. The article, which listed the British researcher Dr Mark Whitehead as co-author, argued that low-dose HRT therapy has “tremendous potential” for improving women’s health. It was one of many papers Wyeth paid for as it prepared to launch a low-dose HRT pill. Lobo emphatically denies the paper was ghost-written. But Climacteric, which published the paper in 2001, has launched an investigation after MacLennan became aware of several documents on the Drug Industry Document Archive, among them a 26-page draft of the article which DesignWrite sent to Lobo in November 2000.
MacLennan is no longer an editor of Climacteric and says he is reluctant to comment until the matter has been fully investigated. But he has proposed that it publish a discussion of the broader issue of “parties with vested interests” potentially influencing the content of papers. “If the veracity of the authorship is in doubt the new editors and the editorial board may choose to publicly withdraw the Climacteric and Index Medicus [the index of medical scientific journal articles] record of this publication,” he says.
Dr Eden, meanwhile, says he feels like an “idiot” after The Weekend Australian Magazine showed him documents detailing Wyeth’s hidden role in his paper. “To me, this is clear-cut – they had an agenda and they made me part of their agenda without telling me … It goes toward integrity and we academics take that really seriously. Looking back, I’m embarrassed to think I didn’t realise that. I was deceived.”
The embarrassment for Eden is compounded by the testimony of Wyeth’s Jamie Durocher before the Arkansas District Court in 2007. Asked who wrote the Eden paper, she replied: “The manuscript was written, as we’ve seen, by a medical writer, but based on Dr Eden’s agreement with the outline and the subject matter. And of course, Dr Eden had reviewed the full manuscript, made changes to the manuscript … and obviously states that this is his manuscript.”
Eden rejects that account, saying the paper is entirely grounded in his work and he had no contact with anyone from Wyeth during its preparation. A comparison of DesignWrite’s draft version and the final published paper shows they are substantially different, and the American Journal of Obstetrics & Gynecology informed Eden two weeks ago that its investigation had concluded it was not ghost-written, was unbiased and was of high scientific quality. “This is one of the best papers I’ve ever written,” he says. “I had control. But from my perspective,” he adds, “it’s tainted.”
Dissenting opinions on HRT
In February the national institutes of health in the us reaffirmed its finding that the risks of HRT outweigh the benefits, saying new analysis showed it doubled the risk of heart disease within two years. The announcement followed an earlier bulletin which stated that “overall risks, including risks of stroke, blood clots and cancer, remain high”.
Eden is one of many menopause clinicians who argue that those risks have been grossly exaggerated. The NIH study, he points out, showed that breast cancers increased by only eight women per 10,000 per year; this was widely publicised as a 26 per cent increase (from 30 to 38 women per 10,000), leaving many women with the mistaken belief that they have a 26 per cent chance of getting breast cancer.
“Women were absolutely terrified,” he says. “And often unfortunately it’s fanned by some doctors. I mean, the number of women I’ve talked to who say, ‘I was told my HRT gave me breast cancer’ … These are the things women are told, and that spreads through the population.” The result, he says, is that many women with severe and debilitating symptoms are not getting treatment.
But Dr Andrew Penman, CEO of the NSW Cancer Council, points out that the risks are cumulative, so that a woman on HRT for 10 years doubles her risk of breast cancer. That is not trivial, he says, and the nine per cent decline in breast cancer which has been recorded since women began shunning the drugs in 2002 supports that. Asked about Wyeth’s financing of scientific papers on HRT safety, Penman says the “review” papers of the type Wyeth paid for are often influential because their authors have an eminence in their respective fields. “It’s not for me to judge the merits or motivations that lay behind any one of these articles,” he says. “But it does raise the issue of whether the process of scientific publication has been used for proprietary purposes.”
The revelations about Wyeth follow other pharmaceutical industry scandals, most recently when Merck & Co was shown to have promoted its anti-arthritis drug Vioxx by secretly financing a journal, The Australasian Journal of Bone & Joint Medicine, which was full of pro-Vioxx articles. It has since been revealed that five other journals published by the prestigious Elsevier company were financed by drug companies. Public health experts in the US have decried such practices, saying they call into question the reliability of the scientific literature on which many GPs base their decisions.
Pfizer, which bought Wyeth last year, defends Wyeth’s publishing activities as “responsible” and denies the articles on HRT were ghost-written. “Medical writing companies assisted authors only in drafting manuscripts, and authors themselves had total control of the content of these papers,” says spokesman Christopher Loder. He adds that since last year Pfizer has begun fully disclosing its financial relationships with physicians, medical organisations and patient advocacy groups. Loder does not respond directly to Eden’s claim that Wyeth deceived him, although he notes that Eden stands by the contents of his article.
Pfizer is now fighting a raft of lawsuits in the US from women who developed breast cancer while taking Premarin or Prempro. Some of those cases have been settled out of court, others the company has lost – although it has announced plans to appeal. Meanwhile, sales of HRT drugs have plummeted since 2002 and some have been taken off the market.
For researchers such as Eden, the US litigation casts a long shadow. “My research budget is smaller than it’s ever been,” he says. “No one wants to fund HRT research; it’s a problem, it really is.” In his younger years in academia, he remembers, colleagues spurned the “dirty money” of the drug industry, but over the past 20 years it has become a hallmark of the synergy universities encourage their staff to pursue. The week before our interview, he had flown to a drug-industry sponsored conference in Florence, using an air ticket provided by a drug company. “I’m an expert in my field. I need to interact with these companies,” he says. “My group here takes part in these very, very important large clinical trials. I have to have relationships with them.”
Not long after the Wyeth ghost-writing scandal broke, Eden made a personal resolution to donate all his drug industry honoraria to charity. Now he’s wondering whether that’s enough. “How do you trust them?” he asks. “Well, trust is gone.”