Know your sources...

iVillage Member
Registered: 11-06-2009
Know your sources...
41
Mon, 11-16-2009 - 4:20pm

How do you rank the reliability of information?

iVillage Member
Registered: 02-20-2006
Tue, 11-17-2009 - 1:57pm
Thanks for posting that!
"The intuitive mind is a sacred gift and the rational mind is a faithful servant. We have created a society that honors the servant and has forgotten the gift."
~Albert Einstein
"The intuitive mind is a sacred gift and the rational mind is a faithful servant. We have created a society that honors the servant and has forgotten the gift." ~Albert Einstein
iVillage Member
Registered: 11-06-2009
Tue, 11-17-2009 - 2:02pm

Anectdotal evidence should always be reviewed.

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 2:19am

http://www.the-scientist.com/templates/trackable/display/blog.jsp?type=blog&o_url=blog/display/56151&id=56151

Study ethics, NIH!"
Posted by Bob Grant

View comments(11) | Comment on this news story

The government agency tasked with funding crucial life science research needs to focus more attention on ethical quandaries and nefarious business practices that often obscure the path from discovery to public benefit, says a strongly worded letter to Francis Collins, the director of the National Institutes of Health (NIH), signed by more than 100 biomedical researchers, journal editors, and health care administrators in the US.

"...we ask that you acknowledge the research gap on the effect of conflicts of interest and commercial influence on medical decision making," the letter reads, "and set in motion a process that leads to recognition of the importance of funding studies on research ethics, the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge."

"It would be great to raise awareness, and maybe have them actually do an RFA on this," said Adriane Fugh-Berman, director of PharmedOut, a group seeking to educate physicians on how the pharmaceutical industry influences prescribing practices, which spearheaded the writing and dissemination of the letter. PharmedOut, based at Georgetown University's School of Medicine, launched three years ago with the help of a chunk of the $430 million settlement drug maker Pfizer paid in 2004 after pleading guilty to encouraging the off-label prescription of its anti-seizure drug Neurontin.

Fugh-Berman, who is also an associate professor in Georgetown's department of physiology and biophysics, admitted that part of the impetus for the letter was the PharmedOut project's empty coffers. "We've been out of money for a year," she told The Scientist. "It's been very difficult to get money for projects."

An NIH spokesperson said this morning that the agency has not yet "officially received" the letter, though a copy of it can be accessed at PharmedOut's website. Collins is expected to review the letter sometime today or tomorrow, the spokesperson told The Scientist.

"I think there's just so much evidence out there that this is a problem area, there probably should be increased funding there," Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health and a signatory on the letter, told The Scientist.

"In any budget -- whether you're the head of NIH or anywhere else -- there's always discretionary money for things that come up," she said. "NIH has had funding from the Office of Research Integrity, via small grants, for a number of years" to look into such ethical issues, she added, but the amount of money allocated to study them has been "fairly small."

The letter is signed by several other prominent figures in the biomedical community, including Jerry Avorn, the Harvard MD who invented "academic detailing," the widely-employed practice of educating doctors in cost-effective prescribing practices, Virginia Barbour, chief editor of PLoS Medicine, and Howard Brody, director of the Institute for the Medical Humanities at University of Texas Medical Branch.

Fugh-Berman added that the strong support for the letter, which ended up being passed around and posted on listservs by researchers, was a surprise. "The response to it was amazing when we sent it out to scientists," she said. "It was really sort of unexpected." The letter's signers also include a handful of researchers and administrators outside of the US -- from the UK, Canada, India, Australia, and South Africa. "It jumped the pond," Fugh-Berman said.

# Related stories:NIH may start policing conflicts

# NIH to act on conflicts within 1 year

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 2:23am

http://blogs.wsj.com/health/2009/07/07/jama-eases-stand-on-public-complaints-about-conflicts/

JAMA Eases Stand on Public Complaints About Conflicts

By David Armstrong

amaThe editors of the Journal of the American Medical Association are backing off a controversial policy to gag anyone complaining about study authors who fail to disclose conflicts of interest, the WSJ reports.

The new policy comes in an editorial in this week’s issue of JAMA. Many portions of the editorial are identical to an online editorial posted in March. In addition to modifying the policy on speaking publicly about conflict of interest-related complaints, the new version of the editorial omits some material in the previous version.

Gone are several paragraphs from the March editorial that attacked Jonathan Leo, a Tennessee researcher who says he was threatened by JAMA editors after publicly disclosing a conflict-of-interest problem he found with a JAMA study published last year. JAMA Editor in Chief Catherine DeAngelis called Leo a “nobody and a nothing” when asked about him by the Health Blog earlier this year. See the post here.

In the March editorial, the JAMA editors accused Leo of “a serious ethical breach of confidentiality” by writing publicly about the conflict of interest that was unreported in the study while JAMA editors were conducting an investigation. Leo says he decided to go public with the conflict-of-interest problem in the study after waiting months for JAMA editors to correct it themselves.

As for the new version of the editorial, Leo says he is “glad…that “they no longer maintain their allegations that I violated a confidentiality agreement and was guilty of an ethical breach.”

JAMA editors declined to comment.

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 2:27am

A video that will make you question the source:

http://www.brasschecktv.com/page/377.html

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 2:34am

Know your sources indeed.

http://www.nytimes.com/2008/12/12/business/13wyeth.html?_r=1

Drug Maker Said to Pay Ghostwriters for Journal Articles

By DUFF WILSON
Published: December 12, 2008

Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer.

A sequence of documents showing how a medical writing firm hired by Wyeth developed an academic article about hormone therapy.

The letters, sent electronically Friday by Senator Charles E. Grassley, ask Wyeth and DesignWrite, a medical writing firm, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.

The letters are part of a continuing investigation by Mr. Grassley, a member of the Senate Finance Committee, into drug industry influence on doctors.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

Phone calls and e-mail messages to Wyeth and DesignWrite were not immediately returned.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

One article was published as an “Editors’ Choice” feature in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after a big federal study called the Women’s Health Initiative linked Wyeth’s Prempro, a combination of estrogen and progestin, to breast cancer. The May 2003 article said there was “no definitive evidence” that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.

At the peak of hormone therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal finding, sales of the hormone drugs plummeted.

The drugs, which contain cancer warnings on the label, are still approved to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.

The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth’s diet pills, Redux and Pomdimin, withdrawn in 1997 after being linked to heart and lung problems.

But the documents Mr. Grassley released Friday provide a detailed look at the practice — from the conception of ideas for journal articles through the distribution of reprints.

The articles all involve reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that that expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.

When accusations of ghostwriting have cropped up in patient lawsuits over its hormone drugs, Wyeth executives to date have insisted that their publication practices were legitimate and that the listed authors played significant roles in journal articles.

But the documents released Friday include a “publication plan tracking report” by Wyeth showing 10 articles in which manuscripts were completed by the company before they were sent to the putative author for review. Any revisions were subject to final approval from the company, according to the tracking report.

Such activities would seem to run afoul of medical journal guidelines. The International Committee of Medical Journal Editors says authorship means “substantive intellectual contributions” including conception or analysis of the subject and drafting or critical revision of the document. The World Association of Medical Editors says ghost authorship — which it defines as a substantial contribution not mentioned in the manuscript — is “dishonest and unacceptable.”

Congressional investigators were given the documents about a month ago by James F. Szaller, a personal injury lawyer in Cleveland who has sued drug makers. Mr. Szaller collected the documents from court filings and made reference to some in an article he wrote last year for a law magazine, Trial.

“For the last three years, I’ve looked at ghostwriting at Wyeth,” Mr. Szaller said in a telephone interview. “There is a mammoth amount of material. The problem is that almost all of it is still under seal.”

In Friday’s letter, Mr. Grassley asked Wyeth to list all scientific reports prepared for the company by DesignWrite since Jan. 1, 1995, to describe the named authors’ “extent of involvement” and to disclose fees paid to DesignWrite, authors and others. He also requested “all internal and external correspondence, communications and meeting minutes regarding each of the DesignWrite-prepared studies.”

The letter to DesignWrite requested all manuscripts prepared for Wyeth since 1995, along with information on related payments and a description of the author’s involvement.

The May 2003 article supporting Prempro was signed by Dr. John Eden, an associate professor at the University of New South Wales and director of the Sydney Menopause Center in Australia. Wyeth executives suggested that Dr. Eden write such a paper in 2000, according to the documents, and had the outline and draft manuscript written for him. The Archives of Internal Medicine rejected the paper before it was published in The American Journal of Obstetrics and Gynecology — with no mention of Wyeth or DesignWrite connections.

Dr. Eden did not respond to an e-mail request for comment.

In another case, documents show, Dr. Lila E. Nachtigall, a New York University professor and director of its Women’s Wellness Center, was recruited by Wyeth as author of a 1999 journal article extolling hormone treatment after the manuscript had already been drafted.

Dr. Nachtigall, reached by telephone Friday afternoon, said she had written all of the approximately 1,000 articles and three books she has had published. Asked about the Wyeth documents, she said, "If they came up with the idea or gave me an outline or something, I don’t remember that at all." Dr. Nachtigall, who is still practicing at age 75, added: "It kind of makes me laugh that with what goes on in the Senate, the senator’s worried that something’s ghostwritten. I mean, give me a break."

Two months before the negative findings of the federal study were released, a May 2002 memo to DesignWrite employees said that Michael S. Dey, who was president of Wyeth’s Women’s Healthcare Business unit, asked a committee to increase the number of positive journal articles related to another of its hormone replacement drugs, Premarin. “Mike would like us to publish at least 1 study per month,” the memo said.

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 2:36am

http://www.brasschecktv.com/page/524.html

Another video regarding knowing your sources -

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 3:01am

http://findarticles.com/p/articles/mi_m0EIN/is_2008_April_17/ai_n25333711/

Pharmaceutical Ghostwriting Trend Mars Credibility of Research and Negatively Impacts Patient Safety
Business Wire, April 17, 2008

New Policy Brief by The Prescription Project highlights pervasiveness of pharmaceutical ghostwriting and recommends steps to restore credibility to academic writing

BOSTON -- A new article in the Journal of the American Medical Association (JAMA) showing how Merck used ghostwriters to hide of the perils of Vioxx (http://jama.ama-assn.org/cgi/content/full/299/15/1800) is only one example of how ghostwritten academic articles can impact patient safety, according to a Policy Brief released today by The Prescription Project. Ghostwriting was also integral in generating positive reports on Neurontin, Zoloft, Paxil, and Fen Phen, all drugs which were later found to have undisclosed or underreported side effects.

The Prescription Project's Ghosts in the Machine, Addressing the Conflict between Medicine and Industry-Sponsored Ghostwriting provides a clear analysis of how ghostwriting works, its prevalence, case studies where ghostwriting helped manipulate data in favor of the medication being studied, and clear recommendations on how to restore credibility to academic writing. For the full brief, www.prescriptionproject.org/newscenter/reports_publications.
> "Ghostwritten articles in medical journals give the appearance of objectivity," said Allan Coukell, Policy Director of the Prescription Project. "In fact, doctors may be making their prescribing decisions based on articles that conceal the extent of industry influence over the content."

Ghosts in the Machine details the ways in which ghostwriting harms patients, including: influencing physician prescribing habits using inaccurate or incomplete data, suppressing negative data from less successful clinical trials, manipulating results by selective reporting of data, creating a demand for off-label uses for drugs and identifying "new" diseases (designed to support sales of a specific prescription) and their miracle therapies.

To restore trust in the medical profession, The Prescription Project recommends a wide array of steps designed to eliminate ghostwriting, including:

* Standards for all journal authors that include unrestricted access to all data, full participation in the writing and editing of any article that bears their name, and disclosure of any financial relationship.

* Recognition of the role of medical communications companies in any published article.

* Consistent guidelines for authorship and disclosure of conflicts adopted by all medical journals, professional medical associations and academic medical centers

* A full investigation into the incidence and impact of ghostwriting by state and federal lawmakers, attorneys-general and agencies with oversight authority.

"Medical journals are designed to be an unbiased source of factual information," said Coukell. "By adhering to both JAMA's new recommendations and the more comprehensive approach outlined by the Prescription Project, doctors can be sure they are not putting their patients at risk when they make decisions based on journal articles."

About The Prescription Project

The Prescription Project is led by Community Catalyst in partnership with the Institute on Medicine as a Profession. Created with The Pew Charitable Trusts, the Project promotes evidence-based prescribing and works to eliminate conflicts of interest in medicine caused by pharmaceutical marketing to physicians by working with academic medical centers, professional medical societies, public and private payers, and state and federal policymakers. For more information, please visit www.prescriptionproject.org.

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 3:21am

Close your ears Jon, this is gonna hurt...

Yes, know your sources and know that if you trust your government, you MUST have a problem with being too naive.

{You know, a person can be proud of their country without being proud of those who run it!}

This (I think it came out today) is easily verified. Just watch and see how many other preventative measures will no longer be necessary, all of a sudden. Our government wants total control over our health-care, they are already trying to weasel out of paying for what we have been brainwashed to believe is "preventative medicine". Before they even get the bill passed, they are cutting corners! If they start now and do it slowly over time, less of us will notice.

I'm guessing Jon will call me paranoid here, but we'll revisit this thread a year from now and see where we are then. My guess is that we will recall that it all began with cancer screenings...

All of a sudden, everything we've ever been told about preventing breast and prostate cancer is wrong. New studies indicate that changes should be made to the "standards" of preventive care. Why now? (It will be fun to discover when those studies took place.)

It's obvious what they are doing, I won't even go into it. But I am sure there are those who will believe very differently.

I don't trust my government officials at all. So anything coming from the CDC or FDA - I take with a grain of salt! (And usually want to throw-up afterwards.)

KNOW your sources!

iVillage Member
Registered: 07-17-2005
Thu, 11-19-2009 - 3:30am

http://jama.ama-assn.org/cgi/content/full/286/10/1232

Sponsorship, Authorship, and Accountability

Frank Davidoff, MD; Catherine D. DeAngelis, MD,MPH; Jeffrey M. Drazen, MD; John Hoey, MD; Liselotte Højgaard, MD,DMSc; Richard Horton, FRCP; Sheldon Kotzin, MLS; M. Gary Nicholls, MD; Magne Nylenna, MD; A. John P. M. Overbeke, MD,PhD; Harold C. Sox, MD; Martin B. Van Der Weyden, MD,FRACP,FRCPA; Michael S. Wilkes, MD,PhD

JAMA. 2001;286:1232-1234.

As editors of general medical journals, we recognize that the publication of clinical research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical trials data have been gathered and are presented in an objective and dispassionate manner. This discourse is vital to the scientific practice of medicine because it shapes treatment decisions made by physicians and drives public and private health care policy. We are concerned that the current intellectual environment in which some clinical research is conceived, study subjects are recruited, and the data analyzed and reported (or not reported) may threaten this precious objectivity.

Clinical trials are powerful tools; like all powerful tools, they must be used with care. They allow investigators to test biological hypotheses in living patients, and they have the potential to change the standards of care. The secondary economic impact of such changes can be substantial. Well-done trials published in high-profile journals may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor. But powerful tools must be used carefully. Patients participate in clinical trials largely for altruistic reasons—that is, to advance the standard of care. In the light of that truth, the use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool.

Until recently, academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The intellectual and working home of these investigators, the academic medical center, has been at the hub of this enterprise, and many institutions have developed complex infrastructures devoted to the design and conduct of clinical trials.1-2 The academic enterprise has been a critical part of the process that led to the introduction of many new treatments into medical practice and contributed to the quality, intellectual rigor, and impact of such clinical trials. But, as economic pressures mount, this may be a thing of the past.

Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis. As trials have become more sophisticated and the margin of untreated disease harder to reach, there has been a great increase in the size of the trials and consequently in the costs of developing new drugs. It is estimated that the average cost of bringing a new drug to market in the United States is about $500 million.3 The pharmaceutical industry has recognized the need to control costs and has discovered that private nonacademic research groups—ie, contract research organizations (CROs)—can do the job for less money and with fewer hassles than academic investigators. Over the past few years CROs have received the lion's share of clinical trial revenues. For example, in 2000 in the United States, CROs received 60% of the research grants from pharmaceutical companies, as compared with only 40% for academic trialists.1

As CROs and academic medical centers compete head to head for the opportunity to enroll patients in clinical trials, corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally.4 Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavorable to the sponsor's product. Such issues are not theoretical. There have been a number of recent public examples of such problems,5-6 and we suspect that many more go unreported.

As editors, we strongly oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor. Such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. Because of our concern, we have recently revised and strengthened the section on publication ethics in the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication," a document developed by the International Committee of Medical Journal Editors (ICMJE) and widely used by individual journals as the basis for editorial policy. The revised section follows this editorial. (The entire "Uniform Requirements" document is currently undergoing revision; the revised version should be available at the beginning of 2002.) As part of the reporting requirements, we will routinely require authors to disclose details of their own and the sponsor's role in the study. Many of us will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish.

We believe that a sponsor should have the right to review a manuscript for a defined period (eg, 30-60 days) before publication to allow for the filing of additional patent protection, if required. When the sponsor employs some of the authors, these authors' contributions and perspective should be reflected in the final paper as are those of the other authors, but the sponsor must impose no impediment, direct or indirect, on the publication of the study's full results, including data perceived to be detrimental to the product. Although we most commonly associate this behavior with pharmaceutical sponsors, research sponsored by governmental or other agencies may also fall victim to this form of censorship, especially if the results of such studies appear to contradict current policy.

Authorship means both accountability and independence. A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication. We encourage investigators to use the revised ICMJE requirements on publication ethics to guide the negotiation of research contracts. Those contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publish—the hallmarks of scholarly independence and, ultimately, academic freedom. By enforcing adherence to these revised requirements, we can as editors assure our readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names. The authors can then stand behind the published results, and so can we.

AUTHOR INFORMATION

Editorials represent the opinions of the authors and THE JOURNAL and not those of the American Medical Association.

The Authors Are Members of the International Committee of Medical Journal Editors.

The section on publication ethics from the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" follows below. The full revised "Uniform Requirements" will be published later.

Conflict of Interest

Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships with other persons or organizations that inappropriately influence (bias) his or her actions. The potential of such relationships to create bias varies from negligible to extremely great; the existence of such relationships does not necessarily represent true conflict of interest, therefore. (Relationships that do not bias judgment are sometimes known as dual commitments, competing interests, or competing loyalties). The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony, patents) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. Conflicts can occur for other reasons, however, such as personal and family relationships, academic competition, and intellectual passion.

All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest. Disclosure of these relationships is particularly important in connection with editorials and review articles, because bias can be more difficult to detect in those publications than in reports of original research. Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Editors should publish this information if they believe it will be important to readers in judging the manuscript.

Potential Conflicts of Interest Related to Individual Authors' Commitments

When authors submit a manuscript, whether an article or a letter, they are responsible for disclosing all financial and personal relationships between themselves and others that might bias their work. To prevent ambiguity, authors must state explicitly whether potential conflicts do or do not exist. Authors should do so with the manuscript on a conflict of interest notification page, providing additional detail, if necessary, in the accompanying cover letter.

Investigators should disclose potential conflicts to study participants, and should state in the manuscript whether they have done so.

Editors also need to decide when to publish information disclosed by authors about potential conflicts. If doubt exists, it is best to err on the side of publication.

Potential Conflicts of Interest Related to Project Support

Increasingly, biomedical studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias and otherwise discredit the research.

Scientists have an ethical obligation to submit creditable research results for publication. As the persons directly responsible for their work, researchers therefore should not enter into agreements that interfere with their access to the data or their ability to analyze the data independently, to prepare manuscripts, and to publish them. Authors should describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state. Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases of other sorts; some journals therefore choose to include information about the sponsor's involvement in the methods section of the published paper.

If a study is funded by an agency with a proprietary or financial interest in the outcome, editors may ask authors to sign a statement such as, "I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis." Editors should be encouraged to review copies of the protocol and/or contracts associated with project-specific studies before accepting such studies for publication. Editors may choose not to consider an article if a sponsor has asserted control over the authors' right to publish.

Conflicts of Interest Related to Commitments of Editors, Journal Staff, or Reviewers

Editors should avoid selecting external peer reviewers with obvious potential conflicts of interest, for example, those who work in the same department or institution as any of the authors. Authors often provide editors with the names of persons they feel should not be asked to review a manuscript because of potential conflicts of interest, usually professional. When possible, authors should be asked to explain or justify their concerns; that information is important to editors in deciding whether to honor such requests.

Reviewers must disclose to editors any conflicts of interest that could bias their opinions of the manuscript, and they should disqualify themselves from reviewing specific manuscripts if they believe such disqualification would be appropriate. As in the case of authors, silence on the part of reviewers concerning potential conflicts may mean either that such conflicts exist that they have failed to disclose or that conflicts do not exist. Reviewers must therefore also be asked to state explicitly whether conflicts do or do not exist. Reviewers must not use knowledge of the work, before its publication, to further their own interests.

Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues they might judge. Other members of the editorial staff, if they participate in editorial decisions, must provide editors with a current description of their financial interests (as they might relate to editorial judgments) and disqualify themselves from any decisions where they have a conflict of interest. Editorial staff must not use the information gained through working with manuscripts for private gain.

Editors should avoid submitting to their own journal reports of original research to which they have contributed as authors. If they do so, they should recuse themselves from the editorial process and delegate editorial decisions on those manuscripts to other members of the editorial staff.

Editors should publish regular disclosure statements about potential conflicts of interests related to the commitments of journal staff.

Author Affiliations: Dr Davidoff is editor emeritus, Annals of Internal Medicine; Dr DeAngelis is editor, JAMA; Dr Drazen is editor-in-chief, New England Journal of Medicine; Dr Hoey is editor, Canadian Medical Association Journal; Dr Højgaard is editor-in-chief, Tidsskrift for Den norske laegeforening (Journal of the Norwegian Medical Association); Dr Horton is editor, The Lancet; Mr Kotzin is executive editor, MEDLINE/Index Medicus; Dr Nicholls is editor, New Zealand Medical Journal; Dr Nylenna is editor-in-chief, Norwegian Medical Association; Dr Overbeke is executive editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine); Dr Sox is editor, Annals of Internal Medicine; Dr Van Der Weyden is editor, The Medical Journal of Australia; and Dr Wilkes is editor, WJM Western Journal of Medicine.

REFERENCES

1. Henderson L. More AMCs finding growth from reform. CenterWatch Newsletter. 2000;7(6):1,10-13.
2. Kowalczyk L. Medical schools join forces: Harvard, others aim to give drug firms faster OK's on clinical trials. Boston Globe. July 28, 2000:C4.
3. Mathieu MP. Parexel's Pharmaceutical R&D Sourcebook, 1998. Waltham, Mass: Parexel International Corp; 1999.
4. Rennie D. Thyroid storm. JAMA. 1997;277:1238-1243. FREE FULL TEXT
5. Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S for the 806 Investigator Team. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 106/L CD4 cell counts: a randomized controlled trial. JAMA. 2000;284:2193-2202. FREE FULL TEXT
6. Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis KS. Withholding research results in academic life science: evidence from a national survey of faculty. JAMA. 1997;277:1224-1228. FREE FULL TEXT

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When Health Policy Is the Problem: A Report from the Field
Spitz and Abramson
Journal of Health Politics, Policy and Law 2005;30:327-366.
ABSTRACT

Changing Conclusions on Secondhand Smoke in a Sudden Infant Death Syndrome Review Funded by the Tobacco Industry
Tong et al.
Pediatrics 2005;115:e356-e366.
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The commercialization of clinical research: who pays the piper, calls the tune?
Freemantle and Stocken
Fam Pract 2004;21:335-336.
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Instructions for Authors
Arch Gen Psychiatry 2004;61:102-102.
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Towards a European Network for Multiple Sclerosis Trials (ENMST)
Kappos et al.
Mult Scler 2003;9:627-629.
ABSTRACT

Instructions for Authors
Arch Gen Psychiatry 2003;60:1056-1056.
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Association of Funding and Conclusions in Randomized Drug Trials: A Reflection of Treatment Effect or Adverse Events?
Als-Nielsen et al.
JAMA 2003;290:921-928.
ABSTRACT | FULL TEXT

Industry Funding of Clinical Trials: Benefit or Bias?
Chopra
JAMA 2003;290:113-114.
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Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review
Bekelman et al.
JAMA 2003;289:454-465.
ABSTRACT | FULL TEXT

Manuscript Criteria and Information
Arch Gen Psychiatry 2003;60:103-103.
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Colloid Use in the Critically Ill
Cook
ANN INTERN MED 2002;137:370-371.
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Lessons Learned From Recent Cardiovascular Clinical Trials: Part II
DeMets and Califf
Circulation 2002;106:880-886.
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Prevalence of Honorary and Ghost Authorship in Cochrane Reviews
Mowatt et al.
JAMA 2002;287:2769-2771.
ABSTRACT | FULL TEXT

Association of Journal Quality Indicators With Methodological Quality of Clinical Research Articles
Lee et al.
JAMA 2002;287:2805-2808.
ABSTRACT | FULL TEXT

Responsibilities of investigators
Sade and McKneally
J. Thorac. Cardiovasc. Surg. 2002;123:837-838.
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Responsibilities of investigators
Sade and McKneally
Ann. Thorac. Surg. 2002;73:1364-1365.
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Early Toronto experience with new standards for industry-sponsored clinical research: a progress report
Naylor
CMAJ 2002;166:453-456.
FULL TEXT

New Instructions for Authors: Enhancing Clarity and Accountability for Readers
Glass and Coyle
Arch Gen Psychiatry 2002;59:14-14.
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Conflict of interest and the British Journal of Psychiatry Author's reply Response from Neurolink Editor's response
Wright et al.
Br. J. Psychiatry 2002;180:82-83.