1.Reporters Find Science Journals Harder to Trust, but Not Easy to Verify
2.Big Pharma, Bad Science
3.Ghost Writing for Industry

"Bad science and biased work are not just the domain of the pharmaceutical industry"
http://www.wame.org/pharma.htm

EXCERPTS: The Hwang case was not the first time journals had been duped: recently, editors at The New England Journal of Medicine said they suspected two cancer papers they published contained fabricated data. In December, the same journal said that the authors of a 2000 study on the painkiller Vioxx had omitted the fact that several patients had had heart attacks while taking the drug in a trial. A study on the painkiller Celebrex [originally a Monsanto product] that appeared in The Journal of the American Medical Association was discredited when it was discovered that the authors had submitted only six months of data, instead of the 12 months of data they had collected. (item 1)

"The journal could no longer find enough independent experts... in any given field, you cannot find an expert who has not been paid off in some way by the industry. So the journal settled for a new standard: Their reviewers can have received no more than $10,000 from companies whose work they judge." (item 2)
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1.Reporters Find Science Journals Harder to Trust, but Not Easy to Verify
By JULIE BOSMAN
New York Times, February 13, 2006 http://www.nytimes.com/2006/02/13/business/media/13journal.html

When the journal Science recently retracted two papers by the South Korean researcher Dr. Hwang Woo Suk, it officially confirmed what he had denied for months: Dr. Hwang had fabricated evidence that he had cloned human cells.

Papers from scientific journals like these are routinely picked up by newspapers and news programs.

The journal Science recently retracted two papers by the South Korean researcher Dr. Hwang Woo Suk.

But the editors of Science were not alone in telling the world of Dr. Hwang's research. Newspapers, wire services and television networks had initially trumpeted the news, as they often do with information served up by the leading scientific journals.

Now news organizations say they are starting to look at the science journals a bit more skeptically.

"My antennae are definitely up since this whole thing unfolded," said Rob Stein, a science reporter for The Washington Post. "I'm reading papers a lot more closely than I had in the past, just to sort of satisfy myself that any individual piece of research is valid. But we're still in sort of the same situation that the journal editors are, which is that if someone wants to completely fabricate data, it's hard to figure that out."

But other than heightened skepticism, not a lot has changed in how newspapers treat scientific journals. Indeed, newspaper editors openly acknowledge their dependence on them. At The Los Angeles Times, at least half of the science stories that run on the front page come directly from journals, said Ashley Dunn, the paper's science editor. Gideon Gil, the health and science editor for The Boston Globe, said that two of the three science stories that run on a typical day were from research that appeared in journals.

Beyond newspapers, papers from journals are routinely picked up by newsweeklies, network news, talk radio and Web sites.

"They are the way science is conducted, they're the way people share information, they're the best approximation of acceptance by knowledgeable people," said Laura Chang, science editor for The New York Times. "We do rely on them for the starting point of many of our stories, and that will not change."

There are limits to the vetting that science reporters, who are generally not scientists themselves, can do. Most journal articles have embargoes attached, giving reporters several days to call specialists in the field, check footnotes on an article and scrutinize the results.

"Scientific discoveries are more difficult because they often require in the generalist reporter a good deal of study, follow-up interviews and some guidance on how to make sense of technical matters," said Roy Peter Clark, a senior scholar at the Poynter Institute, which studies journalism. "But I think the scandals do require both a new level of skepticism on the part of the reporter and also maybe some new protocols between scientists and journalists."

The Hwang case was not the first time journals had been duped: recently, editors at The New England Journal of Medicine said they suspected two cancer papers they published contained fabricated data. In December, the same journal said that the authors of a 2000 study on the painkiller Vioxx had omitted the fact that several patients had had heart attacks while taking the drug in a trial. A study on the painkiller Celebrex that appeared in The Journal of the American Medical Association was discredited when it was discovered that the authors had submitted only six months of data, instead of the 12 months of data they had collected.

While the journals have a peer review process that is in part meant to filter out fallacious papers by checking research techniques and conclusions, perhaps the greatest difficulty for science reporters is trying to catch what journal editors have missed.

After hearing the news of Dr. Hwang's fabrications, Mr. Gil of The Globe said he immediately remembered his newspaper's coverage of the stem cell papers.

"We were blown away, in part because we had written those stories on Page 1," Mr. Gil said. "And when we wrote them, we called the leading experts in the world on all this embryonic stem cell stuff, who are here in Boston. And they were as hoodwinked as anybody else."

Despite the fraud cases, most of what the journals publish is basically credible, said David Perlman, the science editor of The San Francisco Chronicle. Among the most prestigious science journals that reporters consult regularly are Nature, Science, The New England Journal of Medicine and The Journal of the American Medical Association.

"I think they and we have been burned enough that they're making efforts," Mr. Perlman said. "They're being more careful now, and I think reporters are too. I definitely have more of a 'Hey, let's look more carefully' attitude now that I did 5 or 10 years ago."

Donald Kennedy, the editor of Science, said in a statement in December that the journal itself was not an investigative body. But when reporting on journal findings, most news outlets fail to caution that studies must be replicated to be truly authenticated.

"Beyond Hwang, the more fundamental issue is that journals do not and cannot guarantee the truth of what they publish," said Nicholas Wade, a science reporter for The New York Times. "Publication of a paper only means that, in the view of the referees who green-light it, it is interesting and not obviously false. In other words, all of the results in these journals are tentative."

The journals' own peer review processes, which are intended to be the first barrier against fraud, have come under criticism lately. A cover story in the February issue of The Scientist said that the top-tier journals were receiving more submissions every year, overtaxing peer reviewers and weakening the screening process.

After the Hwang scandal, Science announced it was considering a set of changes to better prevent fraud: Dr. Kennedy said in January that new rules could include "requiring all authors to detail their specific contributions to the research submitted, and to sign statements of concurrence with the conclusions of the work," as well as "implementing improved methods of detecting image alteration, although it appears improbable that they would have detected problems in this particular case." (Through a spokeswoman, Dr. Kennedy declined to be interviewed and said the editors were currently conducting a review of the episode.)

Some newspapers have adopted guidelines of their own to check for conflicts of interest involving authors of journal articles. The Globe instituted guidelines last July requiring reporters to ask researchers about their financial ties to studies, and to include that information in resulting articles. In its weekly health and science section, The Globe outlines any shortcomings of a study under the heading "Cautions."

Kit Frieden, the health and science editor for The Associated Press, said: "We've always had our own peer review process, where on the major studies we seek outside expert comment. We've always regarded scientific research cautiously because mistakes can be made, and I don't think that's changed."

The growing competition for the most important research among the journals may contribute to mistakes and fabrications, even in the most prestigious of the bunch. But in the end, the severe consequences of presenting fraudulent research generally act as a deterrent, said Mr. Dunn of The Los Angeles Times.

"Unlike financial fraud, where you can bamboozle somebody of their money and disappear and then start over again, in science the researchers are in one place," he said. "If they get caught in this type of thing, their careers are over."
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2.Big Pharma, Bad Science
Nathan Newman
The Nation, July 25, 2002
http://www.thenation.com/doc/20020805/newman20020725

In June, the New England Journal of Medicine, one of the most respected medical journals, made a startling announcement. The editors declared that they were dropping their policy stipulating that authors of review articles of medical studies could not have financial ties to drug companies whose medicines were being analyzed.

The reason? The journal could no longer find enough independent experts. Drug company gifts and "consulting fees" are so pervasive that in any given field, you cannot find an expert who has not been paid off in some way by the industry. So the journal settled for a new standard: Their reviewers can have received no more than $10,000 from companies whose work they judge. Isn't that comforting?

This announcement by the New England Journal of Medicine is just the tip of the iceberg of a scientific establishment that has been pervasively corrupted by conflicts of interest and bias, throwing doubt on almost all scientific claims made in the biomedical field.

The standard announced in June was only for the reviewers. The actual authors of scientific studies in medical journals are often bought and paid for by private drug companies with a stake in the scientific results. While the NEJM and some other journals disclose these conflicts, others do not. Unknown to many readers is the fact that the data being discussed was often collected and analyzed by the maker of the drug involved in the test. An independent 1996 study found that 98 percent of scientific papers based on research sponsored by corporations promoted the effectiveness of a company's drug. By comparison, 79 percent of independent studies found that a new drug was effective. This corruption reaches from the doctors prescribing a drug to government review boards to university research centers.

There have long been worries about the advertising and promotional gifts given to doctors to influence which drugs they prescribe. But it turns out that even deeper financial ties extend to the medical experts setting nationwide professional guidelines for treating conditions ranging from heart disease to diabetes. Surveys have found that nine out of ten experts writing such guidelines have financial ties to the pharmaceutical industry, yet those ties are almost never disclosed in the treatment guidelines, which are often published in medical journals and endorsed by medical societies.

The Food and Drug Administration, for reasons similar to those of the medical journals, routinely allows researchers with ties to the industry to sit on drug approval advisory committees. In many cases, half the panelists on such committees have a financial stake in the outcome, through links to the drug manufacturer or to a competitor.

Increasingly, the industry has converted academic research centers into subsidiaries of the companies. The billions of dollars of academic government funding essentially pays to flush out negative results, while private industry gets to profit from any successful result. Industry now provides 7 percent of university research funding, but they are manipulating the system to gain a far more substantial benefit. At the University of California at Berkeley, Novartis agreed to pay $25 million to the campus in exchange for the first right to patent a range of basic plant research produced by the university.

Where once university research was oriented to producing independent knowledge that any other researcher could access and improve upon, university research is increasingly being locked up in patents. What's more, scientists at universities are often allowed to have stock options in companies benefiting from the research they are conducting. As Dr. Marcia Angell, a former editor of The New England Journal of Medicine, noted in the Baltimore Sun, "What would be considered a grotesque conflict of interest if a politician or judge did it is somehow not in a physician."

And the results are expensive and sometimes tragic for the public. Experimental clinical drug trials are hazardous to participants and, more broadly, critical to those with life threatening conditions who need to know which treatments are fruitless to pursue. Yet researchers on industry payrolls end up pressured to suppress negative results.

At the most basic level, researchers who defy their corporate sponsors know they may lose their funding. When one Toronto scientist revealed in 1998 a serious side effect of deferiprone, a drug for a blood disorder, her contract was terminated. More dramatically, when a number of researchers concluded that Remune, an anti-AIDS therapy, was of little benefit to patients, the company funding their research, the Immune Response Corporation, sued the scientists in 2001 for $10 million for damaging its business.

And these are the examples of scientists who spoke out. Many others just go along with the demands of their corporate sponsors and suppress negative evidence. In the early 1990s, a pharmacologist at the University of California at San Francisco, Betty Dong, found that a generic thyroid hormone worked as well as Synthroid, the brand-name drug made by the funder of the research. According to the Washington Post, the company, Knoll Pharmaceuticals, successfully blocked publication of the findings for seven years. Only in 1997 was this fraud discovered, and in 1999 Knoll had to pay 37 states $42 million to settle a suit for consumer fraud in promoting the superiority of its drug.

This pattern of suppression means that medical knowledge is being stunted and delayed, as other researchers aren't informed of dead ends that might have helped steer their own research. And by locking up knowledge produced at academic centers in patents, what should be free knowledge for the public (free in both the intellectual and economic sense) instead feeds the profit margins of the pharmaceutical industry.

Universities once opposed patents for any academic research. Yale University's 1948 policy on patents stated, "It is, in general, undesirable and contrary to the best interests of medicine and the public to patent any discovery or invention applicable in the fields of public health or medicine." That policy was later abandoned and Yale now holds a key anti-AIDS drug patent jointly with Bristol Myers. Facing massive global protest, Yale last year agreed to relax its patent rules, but the fact that universities routinely now balance who will live and die against their own profit motive is a degradation of their public purpose.

This corruption of academic science is pervasive and the costs are extremely clear, but what is remarkable is how easy it would be to end. Federal and state governments still supply the overwhelming percentage of university research funding. If all such funding was conditioned on ending non-disclosure agreements and on barring the licensing of government-funded results to private industry, the public would benefit both scientifically and financially. We've paid for the knowledge once. We shouldn't have to do so again in increased costs of medicine and increased deaths due to suppressed knowledge.
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3.World Association of Medical Editors Listserve Discussion
January 24, 2005 to January 28, 2005
http://www.wame.org/pharma.htm

Ghost Writing for Industry

[This listserve has been edited to remove identifying details in the case but retain the essential points for educational purposes.]

Dear WAME members,

I edit a general medical journal. We received a manuscript reviewing _____ . We sent it out for peer review and one of the reviewers responded that

"This paper was written by a medical education company (Y) for X, apparently as part of a campaign meant to pave the way for acceptance of ___."

We require a conflict of interest statement from each author of each manuscript before sending the manuscript out for review, and this author did not list X as a conflict of interest. However, I understand that no money changed hands: the "reward" for writing this paper for X (which provided all of the research in a format that could be cut and pasted into the article) is having an easily published article. The article itself stated that "Editorial assistance from Y, was made possible via educational funding from X." Clearly, this is a misrepresentation of the financial relationship between X, the intermediary Y, and the author. The author of the original draft and the person(s) who did the obviously biased literature review is/are not listed as authors.

The reviewer included with the review a copy of the original offer made to the reviewer by Y that included the draft manuscript (complete with title page) and the following header:

[Title]
[Contact for Y]
Client company: X
Project number: [withheld]
Target journal: To be decided
Target audience: Pharmacists, nurses, general practitioners Aim of article: To outline ______.
Number of references: 65

Word count: Approx. 3000 (excluding abstract and references) Number of tables: 1 Number of figures: 0 Current status: First draft [Date]

Comparing the material sent by Y and the submitted manuscript shows some minor editing by the submitting "author," but a lot of it is word-for-word the same between the two documents.

I am writing this for two reasons. First, I wanted to alert WAME members that pharmaceutical companies do this, although I suspect that most of you know that. Second, I would like to know if your journals have specific policies about accepting articles commissioned by drug or device companies to create a "literature" that supports arguments for their products by ghost writing the articles for other "authors" to submit to a journal. Although it is clear to me that this is unethical behavior on the part of X and Y, it is less clear to me how a journal can protect itself from publishing such articles. We were very fortunate to have the article reviewed by an expert in the field who had previously turned down Y's request to edit and submit this article for them.

I would be interested in whether WAME editors have had similar experiences, how they have handled them (we obviously rejected the article but are also contacting the author to discuss the inappropriateness of this approach to publishing "science"), and how they have avoided being victimized in this way.

Bill Tierney

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