Wednesday, June 30, 2010

PLoS Medicine: Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

PLoS Medicine: Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies

Medical journals have become dependent on the pharmaceutical industry for their survival, which can have a corrupting influence on their content, argues Smith, the former editor of the BMJ.

Richard Smith
“Journals have devolved into information laundering operations for the pharmaceutical industry”, wrote Richard Horton, editor of the Lancet, in March 2004 [1]. In the same year, Marcia Angell, former editor of the New England Journal of Medicine, lambasted the industry for becoming “primarily a marketing machine” and co-opting “every institution that might stand in its way” [2]. Medical journals were conspicuously absent from her list of co-opted institutions, but she and Horton are not the only editors who have become increasingly queasy about the power and influence of the industry. Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians [3], and the editors of PLoS Medicine have declared that they will not become “part of the cycle of dependency…between journals and the pharmaceutical industry” [4]. Something is clearly up.

The Problem: Less to Do with Advertising, More to Do with Sponsored Trials

The most conspicuous example of medical journals' dependence on the pharmaceutical industry is the substantial income from advertising, but this is, I suggest, the least corrupting form of dependence. The advertisements may often be misleading [5,6] and the profits worth millions, but the advertisements are there for all to see and criticise. Doctors may not be as uninfluenced by the advertisements as they would like to believe, but in every sphere, the public is used to discounting the claims of advertisers.
The much bigger problem lies with the original studies, particularly the clinical trials, published by journals. Far from discounting these, readers see randomised controlled trials as one of the highest forms of evidence. A large trial published in a major journal has the journal's stamp of approval (unlike the advertising), will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favourable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution. The doctors receiving the reprints may not read them, but they will be impressed by the name of the journal from which they come. The quality of the journal will bless the quality of the drug.
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(Illustration: Margaret Shear, Public Library of Science)
doi:10.1371/journal.pmed.0020138.g001
Fortunately from the point of view of the companies funding these trials—but unfortunately for the credibility of the journals who publish them—these trials rarely produce results that are unfavourable to the companies' products [7,8]. Paula Rochon and others examined in 1994 all the trials funded by manufacturers of nonsteroidal anti-inflammatory drugs for arthritis that they could find [7]. They found 56 trials, and not one of the published trials presented results that were unfavourable to the company that sponsored the trial. Every trial showed the company's drug to be as good as or better than the comparison treatment.
By 2003 it was possible to do a systematic review of 30 studies comparing the outcomes of studies funded by the pharmaceutical industry with those of studies funded from other sources [8]. Some 16 of the studies looked at clinical trials or meta-analyses, and 13 had outcomes favourable to the sponsoring companies. Overall, studies funded by a company were four times more likely to have results favourable to the company than studies funded from other sources. In the case of the five studies that looked at economic evaluations, the results were favourable to the sponsoring company in every case.
The evidence is strong that companies are getting the results they want, and this is especially worrisome because between two-thirds and three-quarters of the trials published in the major journals—Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine—are funded by the industry [9]. For the BMJ, it's only one-third—partly, perhaps, because the journal has less influence than the others in North America, which is responsible for half of all the revenue of drug companies, and partly because the journal publishes more cluster-randomised trials (which are usually not drug trials) [9].

Why Do Pharmaceutical Companies Get the Results They Want?

Why are pharmaceutical companies getting the results they want? Why are the peer-review systems of journals not noticing what seem to be biased results? The systematic review of 2003 looked at the technical quality of the studies funded by the industry and found that it was as good—and often better—than that of studies funded by others [8]. This is not surprising as the companies have huge resources and are very familiar with conducting trials to the highest standards.
The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the “right” questions—and there are many ways to do this [10]. Some of the methods for achieving favourable results are listed in the Sidebar, but there are many ways to hugely increase the chance of producing favourable results, and there are many hired guns who will think up new ways and stay one jump ahead of peer reviewers.
Then, various publishing strategies are available to ensure maximum exposure of positive results. Companies have resorted to trying to suppress negative studies [11,12], but this is a crude strategy—and one that should rarely be necessary if the company is asking the “right” questions. A much better strategy is to publish positive results more than once, often in supplements to journals, which are highly profitable to the publishers and shown to be of dubious quality [13,14]. Companies will usually conduct multicentre trials, and there is huge scope for publishing different results from different centres at different times in different journals. It's also possible to combine the results from different centres in multiple combinations.
These strategies have been exposed in the cases of risperidone [15] and odansetron [16], but it's a huge amount of work to discover how many trials are truly independent and how many are simply the same results being published more than once. And usually it's impossible to tell from the published studies: it's necessary to go back to the authors and get data on individual patients.

Peer Review Doesn't Solve the Problem

Journal editors are becoming increasingly aware of how they are being manipulated and are fighting back [17,18], but I must confess that it took me almost a quarter of a century editing for the BMJ to wake up to what was happening. Editors work by considering the studies submitted to them. They ask the authors to send them any related studies, but editors have no other mechanism to know what other unpublished studies exist. It's hard even to know about related studies that are published, and it may be impossible to tell that studies are describing results from some of the same patients. Editors may thus be peer reviewing one piece of a gigantic and clever marketing jigsaw—and the piece they have is likely to be of high technical quality. It will probably pass peer review, a process that research has anyway shown to be an ineffective lottery prone to bias and abuse [19].
Furthermore, the editors are likely to favour randomised trials. Many journals publish few such trials and would like to publish more: they are, as I've said, a superior form of evidence. The trials are also likely to be clinically interesting. Other reasons for publishing are less worthy. Publishers know that pharmaceutical companies will often purchase thousands of dollars' worth of reprints, and the profit margin on reprints is likely to be 70%. Editors, too, know that publishing such studies is highly profitable, and editors are increasingly responsible for the budgets of their journals and for producing a profit for the owners. Many owners—including academic societies—depend on profits from their journals. An editor may thus face a frighteningly stark conflict of interest: publish a trial that will bring US$100 000 of profit or meet the end-of-year budget by firing an editor.

Journals Should Critique Trials, Not Publish Them

How might we prevent journals from being an extension of the marketing arm of pharmaceutical companies in publishing trials that favour their products? Editors can review protocols, insist on trials being registered, demand that the role of sponsors be made transparent, and decline to publish trials unless researchers control the decision to publish [17,18]. I doubt, however, that these steps will make much difference. Something more fundamental is needed.
Firstly, we need more public funding of trials, particularly of large head-to-head trials of all the treatments available for treating a condition. Secondly, journals should perhaps stop publishing trials. Instead, the protocols and results should be made available on regulated Web sites. Only such a radical step, I think, will stop journals from being beholden to companies. Instead of publishing trials, journals could concentrate on critically describing them.

Examples of Methods for Pharmaceutical Companies to Get the Results They Want from Clinical Trials


  • Conduct a trial of your drug against a treatment known to be inferior.

  • Trial your drugs against too low a dose of a competitor drug.

  • Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic).

  • Conduct trials that are too small to show differences from competitor drugs.

  • Use multiple endpoints in the trial and select for publication those that give favourable results.

  • Do multicentre trials and select for publication results from centres that are favourable.

  • Conduct subgroup analyses and select for publication those that are favourable.

  • Present results that are most likely to impress—for example, reduction in relative rather than absolute risk.

Acknowledgments

This article is based on a talk that Richard Smith gave at the Medical Society of London in October 2004 when receiving the HealthWatch Award for 2004. The speech is reported in the January 2005 HealthWatch newsletter [20]. The article overlaps to a small extent with an article published in the BMJ [21].

References

  1. Horton R (2004) The dawn of McScience. New York Rev Books 51(4): 7–9. Find this article online
  2. Angell M (2005) The truth about drug companies: How they deceive us and what to do about it. New York: Random House. 336 p.
  3. Kassirer JP (2004) On the take: How medicine's complicity with big business can endanger your health. New York: Oxford University Press. 251 p.
  4. Barbour V, Butcher J, Cohen B, Yamey G (2004) Prescription for a healthy journal. PLoS Med 1: e22. doi: 10.1371/journal.pmed.0010022.
  5. Wilkes MS, Doblin BH, Shapiro MF (1992) Pharmaceutical advertisements in leading medical journals: Experts' assessments. Ann Intern Med 116: 912–919. Find this article online
  6. Villanueva P, Peiro S, Librero J, Pereiro I (2003) Accuracy of pharmaceutical advertisements in medical journals. Lancet 361: 27–32. Find this article online
  7. Rochon PA, Gurwitz JH, Simms RW, Fortin PR, Felson DT, et al. (1994) A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 154: 157–163. Find this article online
  8. Lexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality. BMJ 326: 1167–1170. Find this article online
  9. Egger M, Bartlett C, Juni P (2001) Are randomised controlled trials in the BMJ different? BMJ 323: 1253. Find this article online
  10. Sackett DL, Oxman AD (2003) HARLOT plc: An amalgamation of the world's two oldest professions. BMJ 327: 1442–1445. Find this article online
  11. Thompson J, Baird P, Downie J (2001) The complete text of the independent inquiry commissioned by the Canadian Association of University Teachers. The Olivieri report. Toronto: Lorimer. 584 p.
  12. Rennie D (1997) Thyroid storm. JAMA 277: 1238–1243. Find this article online
  13. Rochon PA, Gurwitz JH, Cheung M, Hayes JA, Chalmers TC (1994) Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal. JAMA 272: 108–113. Find this article online
  14. Cho MK, Bero LA (1996) The quality of drug studies published in symposium proceedings. Ann Intern Med 124: 485–489. Find this article online
  15. Huston P, Moher D (1996) Redundancy, disaggregation, and the integrity of medical research. Lancet 347: 1024–1026. Find this article online
  16. Tramèr MR, Reynolds DJM, Moore RA, McQuay HJ (1997) Impact of covert duplicate publication on meta-analysis: A case study. BMJ 315: 635–640. Find this article online
  17. Davidoff F, DeAngelis CD, Drazen JM, Hoey J, Hojgaard L, et al. (2001) Sponsorship, authorship, and accountability. Lancet 358: 854–856. Find this article online
  18. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, et al. (2004) Clinical trial registration: A statement from the International Committee of Medical Journal Editors. Lancet 364: 911–912. Find this article online
  19. Godlee F, Jefferson T (2003) Peer review in health sciences, 2nd ed. London: BMJ Publishing Group. 367 p.
  20. Garrow J (2005 January) HealthWatch Award winner. HealthWatch 56: 4–5. Find this article online
  21. Smith R (2003) Medical journals and pharmaceutical companies: Uneasy bedfellows. BMJ 326: 1202–1205. Find this article online

PLoS Medicine: Ghostwriting at Elite Academic Medical Centers in the United States

Ghostwriting at Elite Academic Medical Centers in the United States
Jeffrey Lacasse and Jonathan Leo assess ghostwriting policies at 50 academic medical centers in the United States and find that only 10 explicitly prohibit ghostwriting.

Jeffrey R. Lacasse1*, Jonathan Leo2
1 School of Social Work, College of Public Programs, Arizona State University, Phoenix, Arizona, United States of America, 2 Lincoln Memorial University - DeBusk College of Osteopathic Medicine, Harrogate, Tennessee, United States of America

Background 

Medical ghostwriting, the practice of pharmaceutical companies secretly authoring journal articles published under the byline of academic researchers, is a troubling phenomenon because it is dangerous to public health [1]. For example, ghostwritten articles on rofecoxib [2] probably contributed to “…lasting injury and even deaths as a result of prescribers and patients being misinformed about risks” [3]. Study 329, a randomized controlled trial of paroxetine in adolescents, was ghostwritten [4][7] to claim that paroxetine is “generally well tolerated and effective for major depression in adolescents” [8], although data made available through legal proceedings show that “Study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm” [9]. Even beyond frank misrepresentation of data, commercially driven ghostwritten articles shape the medical literature in subtler but important ways, affecting how health conditions and treatments are perceived by clinicians. The ability of industry to exercise clandestine influence over the peer-reviewed medical literature is thus a serious threat to public health [1],[10].
In 2009, the Institute of Medicine recommended that US-based academic medical centers enact policies that prohibit ghostwriting by their faculties [11]. However, to date, there has been no systematic assessment of ghostwriting policies at academic medical centers. Since US-based academic medical centers generate biomedical research for a worldwide audience, we chose to conduct the first such investigation on elite US-based academic medical centers. Our methods are shown in Box 1. We sought to describe the current policy situation at US-based academic centers and then to propose an ideal ghostwriting policy.

Box 1. Methods

At the beginning of the 2009–2010 academic year, we evaluated the policies of the top-50 academic medical centers by research ranking according to the 2009 US News and World Report [29]. To avoid response bias, and given that faculty policies are commonly published on the World Wide Web, we searched for publicly available policy documents. We used a standardized search protocol in the Google search engine and key phrases used in policies regulating authorship, ghostwriting, and conflicts of interest. When we were unable to locate a published authorship policy, we contacted a reference librarian at the institution to verify that no policy was available. We also searched each Web site to see if any conflict-of-interest policies or faculty manuals were available on-line. We retrieved only policies that were publicly available and applicable to the entire academic medical center. Our retrieval method removed social desirability bias as a possible confounder but was time-intensive, leading us to examine only the top-50 schools, a trade-off we found reasonable given the influential nature of elite US-based medical schools in the worldwide biomedical research community and the exploratory nature of this research.
One rater (JRL) extracted data from the policies. If an academic medical center explicitly prohibited ghostwriting, this was coded as such, and the policy was transcribed. If ghostwriting was not mentioned, but there was an authorship policy, the policy was coded on whether it mandated (1) a substantive contribution to qualify for authorship and (2) that all individuals who make substantial contributions to the manuscript be listed as authors. Inclusion of both (1) and (2) was coded as prohibiting ghostwriting in practice.
To ensure reliability, two sets of data were blindly recoded by the second author (JL). First, a 50% random sample of those medical centers coded as lacking any authorship policies was recoded. There was disagreement on the existence of an authorship policy at one institution, which was resolved through discussion. Second, a 50% random sample of institutions with authorship policies were recoded on the two primary variables of interest, with perfect agreement between the two raters. All data are available as an Excel spreadsheet file, which includes hyperlinks to each institution's policies (Dataset S1), or as a PDF file (Dataset S2).

Findings of Our Survey 

Of the 50 academic medical centers that we examined (Box 1), ten (20%) explicitly prohibit ghostwriting. Of these ten, seven (14%) include some definition of ghostwriting in their policy, while three (6%) prohibit ghostwriting without defining the term. Many schools have an authorship policy that does not clearly ban all aspects of ghostwriting (n = 13, 26%); the most common reason is a failure to require that all qualified authors be listed. Three academic medical centers (6%) have stringent authorship policies that prohibit it in practice (by requiring both a substantive contribution to qualify for authorship and that all who qualify for authorship be listed) but do not mention ghostwriting by name (Table 1).
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Table 1. Published policies of academic medical centers meeting specific criteria (n = 50).
doi:10.1371/journal.pmed.1000230.t001
By combining the ten schools that explicitly ban ghostwriting with the three schools that have authorship policies banning it in practice, we find that 13 of the top-50 academic medical centers (26%) have policies in place prohibiting medical ghostwriting. Six of the top-ten schools ban ghostwriting in practice, and all top-ten academic medical centers have published authorship policies. Although most schools (n = 45, 90%) had some policy documents posted online, the majority of academic medical centers (n = 26, 52%) had no published policies at all on either ghostwriting or authorship. The Web sites of two schools stated that they did have such policies, but the policies were not currently available online.

Implications of These Findings

A minority of top-50 US-based academic medical centers (n = 13, 26%) publicly prohibit their faculty from participating in ghostwriting. It is ironic that ghostwriting, a major threat to public health, is generally not prohibited within institutions that exist to train physicians and improve the public health. In this way, academic medical centers enable the pharmaceutical industry to covertly shape the medical literature in favor of commercial interests. When a pharmaceutical salesperson hands a clinician an article reprint, the name of the institution on the front page of the reprint serves as a stamp of approval. The article is not viewed as an advertisement, but as scientific research; the reprint is an effective marketing tool because peer-reviewed journal articles generated in academia are perceived to be the result of unbiased scientific inquiry. Deception regarding authorship prevents a discriminating audience from properly assessing the impact of bias in the published article [10]. Importantly, this deception is impossible without the cooperation of faculty employed by academic medical centers.
The practice of ghostwriting explicitly violates the usual norms of academia. We are not aware of any other academic fields where it is acceptable for professors to allow themselves to be listed as authors on research papers they did not write, or to purposefully conceal the contributions of industry coauthors in order to mislead readers. A recent New York Times article characterizes medical ghostwriting as “an academic crime akin to plagiarism” [12]. Anecdotally, we find many of our academic colleagues are stunned to hear about ghostwriting in medical schools, and some of our graduate students express dismay. (They have to write their own papers, and face disciplinary action and even expulsion if they submit term papers they did not write). In contrast, academic medical centers in the US and Europe employ professors who are publicly known to have participated in ghostwriting (e.g., [4][6],[13]). The culture of biomedical research apparently condones or at best takes a neutral position when it comes to ghostwriting. This suggests that ghostwriting will continue to be a problem until policy solutions are implemented. While our survey examined only published policies, the dearth of such policies is cause for concern.
Perhaps ghostwriting policies should be examined in the context of existing policies meant to regulate ethical research behavior. It is possible that some academic medical centers already prohibit ghostwriting under other rules of research integrity. For instance, ghostwriting may be characterized as a form of plagiarism [14], and to our knowledge, all academic institutions consider plagiarism to be a form of academic misconduct. Some academics have listed ghostwritten publications on their curricula vitae, meaning that they were considered for promotion and/or grants on the basis of fraudulent authorship, which would seem to be grounds for disciplinary action. It has been reported that academics receive payments from industry for participation in ghostwriting, and many institutions have rules requiring faculty to report outside income. Failure to report such income truthfully may violate existing policies. In theory, an administrator could penalize a violation of such policies by a faculty member who has participated in ghostwriting. If any of this has ever occurred, it is not publicly known.
A policy is only as useful as it is enforceable. A policy prohibiting ghostwriting that cannot be effectively enforced is unlikely to change practice. It is worth considering, then, whether existing policies of academic medical centers regulating authorship and ghostwriting clearly define “ghostwriting”? Is a policy useful if it forbids ghostwriting but never defines the term? Can we envision an academic being sanctioned for violating a policy that does not define its critical terms? Or does this lack of clarity provide “wiggle room” to evade sanctions? Our review of existing ghostwriting policies (see Datasets S1 and S2) indicates that the clarity of many policies could be improved substantially. For instance, the New York Times reported that Duke University has a policy which bans ghostwriting [15]. On closer examination, what Duke's policy prohibits is courtesy authorship—but it does not require that all contributors who qualify as authors be listed as such. The policy requires that a substantial contribution be made to qualify for authorship, but does not prohibit the concealment of corporate writers in the preparation of the manuscript. A professor could follow this policy to the letter and still participate in something most people would call “ghostwriting” [16] by failing to list a corporate coauthor in the author byline. Other existing ghostwriting policies have similar deficiencies and ambiguities.

An Unambiguous Policy Proposal

Ghostwriting was once the “dirty little secret” of the medical literature [3], but this no longer is the case. Pharmaceutical companies have used ghostwriting to market sertraline [17], olanzapine [18], gabapentin [19], estrogen replacement therapy [20], rofecoxib [2], paroxetine [4],[21], methylphenidate [22], milnaciprin [23], venlafaxine [24], and dexfenfluramine [25]. Ghostwriting is now known to be a major industry [26].
In the near future, we expect administrators of academic medical centers to enact policies that regulate medical ghostwriting. Such policies must be operationalized specifically enough to actually change practice. A problematic policy may be worse than no policy at all, as it may give the misleading impression that the ghostwriting problem has been solved. Therefore, we make the following policy proposal to academic medical centers worldwide.

The Proposal

First, deans of academic medical centers should immediately inform their faculties that a ban on medical ghostwriting will be enacted shortly. Following the suggestion by Barton Moffatt and Carl Elliot [1], the remaining months in the 2009–2010 academic year should be a period of amnesty. Faculty who have participated in ghostwriting will be allowed to come forward and describe their involvement. Known ghostwritten papers should be reevaluated by the academic medical community and considered for retraction.
Next, a policy that clearly defines participation in ghostwriting as a form of academic misconduct should be implemented at the beginning of the 2010–2011 academic year. By modifying several existing authorship policies to close any loopholes and be as specific as possible, we suggest the following wording:
“All listed authors on a publication must meet the authorship criteria set by the International Committee of Medical Journal Editors. Making minor revisions to a manuscript does not qualify as authorship. Participating in the creation of ghost-authored manuscripts is not permitted. A ghost author is defined as someone who makes substantial contributions to writing a publication but is not listed as an author. All individuals who have made a substantial contribution to the manuscript must be listed as authors. Accurately reporting authorship is essential for maintaining research integrity, and violating any of these rules is considered research misconduct akin to plagiarism or falsification of data.”

Implementation and Enforcement

Government funding agencies can play a primary role in encouraging the adoption of this policy. Francis Collins, Director of the US National Institutes of Health (NIH), recently remarked that “I was shocked by that revelation—that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented…if we want to have the integrity of science preserved—that's not the way to do it” [27]. We agree, and suggest that, to encourage the adoption of this policy, NIH and similar funding agencies should refuse to disperse any public research funds to institutions that do not adopt a policy which bans ghostwriting, as we have suggested above. Academic medical centers are funded with public monies because they ostensibly serve the public good. Since ghostwriting harms public health and serves commercial rather than public interests, governments should not support institutions that permit ghostwriting.
At the institutional level, vigorous enforcement efforts should accompany the implementation of such policies. Administrators should carefully monitor the medical literature for clues of ghostwriting, such as an acknowledgment of a medical writer's assistance in a peer-reviewed journal article. When a medical writer is thanked, this will be taken to mean that they do not qualify for authorship, much in the way that a copyeditor does not receive a byline credit. At present, such acknowledgments are suspected to mean that the medical writer actually ghostwrote the paper (Figure 1) [28], but the implementation of a stringent ghostwriting policy will require strict accuracy on this issue. When there is doubt, aggressive investigative action should be taken. The empirical findings of medical literature are unlikely to change, but reports of authorship would thus be honest and transparent.
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Figure 1. Acknowledging ghostwriters does not accurately reflect their authorship role.
Modified from [14]. Used under a Creative Commons license which permits the modification and re-use of intellectual content as long as it is properly acknowledged.
doi:10.1371/journal.pmed.1000230.g001
When it comes to light that an academic has violated this policy, rapid disciplinary action should result. Sanctions should be equivalent to those used in cases of plagiarism or falsification of data. When a behavior poses a significant public health risk, most governments punish such behavior vigorously. For instance, most governments heavily penalize people who drive an automobile while intoxicated; the goal is to protect the public by deterring the behavior. Similarly, it is hard to envision a policy that protects the public from ghostwriting without punishing the behavior.
Ultimately, this policy requires only that academic medical centers follow the norms of science, as exemplified by other departments of the university. Honest and transparent reporting of authorship has always been an essential element of scientific communication. We can think of no ethical or scientific reason why this proposal should not be adopted by every academic medical center.

Conclusion

Medical ghostwriting is a threat to public health which currently takes place only due to the cooperation of researchers employed at academic medical centers. Although there is growing awareness of the danger posed by medical ghostwriting, we find that few academic medical centers have public policies which prohibit this behavior, and many of the existing policies are ambiguous or ill-defined. We have proposed an unambiguous policy which defines participating in medical ghostwriting as academic misconduct akin to plagiarism or falsifying data. By adopting and enforcing this policy, academic medical centers would adhere to the norms of science followed across the rest of the University, and would no longer facilitate clandestine industry influence over the peer-reviewed scientific literature. By prohibiting medical ghostwriting, academic medical centers have a rare opportunity- to significantly reduce a major threat to public health with the stroke of a pen.

Supporting Information


Dataset S1.
Ghostwriting policies by academic medical center - Raw data file in Microsoft Excel format.
(0.07 MB XLS)

Dataset S2.
Ghostwriting policies by academic medical center - Raw data file in PDF format.
(0.09 MB PDF)

Acknowledgments

We thank Tomi Gomory for his helpful comments on a draft of this manuscript. We also acknowledge Michael J. Womack, MSW, and Kathryn Gerber, MSW, for research assistance.

Author Contributions

ICMJE criteria for authorship read and met: JRL JL. Wrote the first draft of the paper: JRL. Contributed to the writing of the paper: JRL JL.

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  28. Gotzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, et al. (2009) What should be done to tackle ghostwriting in the medical literature? PLoS Med 6: e23. doi:10.1371/journal.pmed.1000023.
  29. US News and World Report (2009) Research rankings: Best medical schools. Available: http://tinyurl.com/USNewsPLOS. Accessed 15 December 2009.

The Marvellous Health of Unvaccinated Children

The Marvellous Health of Unvaccinated Children

Françoise Berthoud, MD [medical doctor, paediatrician]

June 25, 2010

Once upon a time, in April 2009 to be exact, I was invited to give a speech at a conference on vaccination. I was to talk after two of the best speakers France has to offer on the subject had their turn, journalist Sylvie Simon and biologist Michel Georget. At hearing them speak in the past, it was absolutely clear to me that the best option is to stay as far away from vaccines as possible. I just did not know what to do instead to best assure staying alive and well. As a paediatrician and homeopath qualified to speak on the subject, I decided to setup a conference called The Marvellous Health of Unvaccinated Children along with my friends, Sylvie and Michel. This work would later evolve into a book that analyses various life choices often made by families that do not vaccinate, including home birth, breastfeeding, simple therapies, good food (often vegetarian), a tranquil living environment and trust in the capacity of the body to heal itself.

In my life as a paediatrician, I had spent lots of time in dialogue with the parents who often needed to voice their fears about both disease and vaccines. We worked out together the best route for their children. Some chose not to vaccinate at all. Others held onto fear of disease, especially tetanus. In those cases, we postponed vaccination as much as possible and used a homeopathic protection and "cleansing" called nosode.

I worked in Switzerland where there is no real legal obligation to vaccinate, only great social pressure. In France, just a few kilometres from my office, there were four compulsory vaccinations at the time (BCG was fortunately removed in 2007, and three remain: Di Te Pol).

Some of the basis of my ability to speak on the marvellous health of unvaccinated children comes from my personal experience as a medical doctor, having collected years of feedback.

  • “My child began coughing immediately after the vaccination.”
  • “He has had constant ear aches since he was vaccinated.”
  • My 16 years old daughter is completely unvaccinated. She is almost never sick. If she does get sick, it’s two days at the most.”
  • The neighbour's kids followed normal vaccination guidelines. They are constantly sick and on antibiotics.”

That was not enough upon which to write a book; however. As it would turn out, I found these observations were paralleled over and over again all over the world. Follow me around the planet.

EUROPE

In England, Michel Odent, MD showed in two studies that children having received no Pertussis vaccine had 5-6 times less asthma than those who were vaccinated for it. The first study was on 450 babies from La Leche League; the second one on 125 children in a Steiner school. (1)

Throughout Europe, a group of mostly paediatricians studied 14,893 children in Steiner schools in Austria, Germany, Holland, Sweden and Switzerland and found that children living in "anthroposophist culture" (where vaccination is largely shunned) were in better health than the controls. (2)

In Germany, one of the European Steiner schools study researchers wrote, “In the eastern part of Berlin before the fall of the wall, we saw less allergies than in the west. This population was poorer, nearer nature and less vaccinated.” Too much hygiene is not always good. As UK researcher and originator of the “hygiene hypothesis” David Strachan might say, "give us this day our daily germs".

In Spain, Xavier Uriarte, MD and J. Manuel Marín, MD published a study in 1999 on 314 children they followed between 1975 to 2000. (3) This group of children is characterized by a majority of homebirth or natural births, prolonged breastfeeding, no vaccinations, holistic health education and no allopathic medicine. There were no serious diseases, few hospitalisations (mostly for traumas), and 3.3% asthma compared to the 20% in the general population. And of course, a lot of money was spared!

USA

The rate of autism in the U.S. is now an unthinkable 1 in 100. Those who are unvaccinated boast numbers that run in shocking contrast to the nation’s statistics. As this article is directed to the American people, I will not go on at length here. Most of you know the work of your very own journalist Dan Olmsted showing the incredible absence of autism in the unvaccinated Amish communities of Pennsylvania and Ohio.

Further impressive is Chicago-based Homefirst Medical Clinic run by a group of doctors including medical director Mayer Eisenstein, MD, JD, MPH. They have no known autism and super-scarce allergies in their children, many of whom were home deliveries, and most of whom have had no vaccinations. In 1985, I translated to French U.S. paediatrician Robert Mendelssohn, MD's How to Raise a Healthy Child in Spite of Your Doctor. Now I find concrete result in the marvellous health of kids whose doctors are his pupils! I like these synchronicities in my life.

AUSTRALIA

In 1942, Leslie Owen Bailey, founder of the Natural Health Society of Australia, accepted guardianship of 85 children whose mothers were unable to care for them. Among these 85 children, no vaccinations were ever given, no drugs were ever taken or used, and no operations were ever performed. The only malady that occurred was when 34 of the children developed chicken pox. They were immediately put to bed and given only pure water or fresh fruit juice. They all recovered quickly without after-effects. Investigations revealed that these children whilst at school had been swapping their healthy lunches for unhealthy conventional foods, so this outbreak was not altogether surprising.

Many of these children inherited poor health due to a history of illness and malnourishment in their mothers. Despite this, and the fact that they were never breastfed nor could enjoy the normal bonding of mother to child, they were able to grow into sturdy, self-reliant children.

NEW ZEALAND

Two studies done in New Zealand in 1992 and 1995 show that the unvaccinated children clearly have less allergies, less otitis (ear aches), less tonsillitis, less running noses, less epilepsies and less ADHD. (4)

JAPAN

An interesting period in Japan was 1975-1980, when a decision was made to begin the first vaccinations at two years of age instead of at two months. The reason was that more and more was discovered linking vaccines and cot-death (SIDS). A study was published in Pediatrics showing that from 1970 to January 1975, there were 57 cases of serious vaccine reactions, including 37 deaths. From February 1975 to August 1981 there were eight cases of serious vaccine reactions, including three deaths. Unfortunately for kids and their parents, the Japanese vaccination plan is now "normalized" again. The study shows well that the immune system is stronger at two years than at two months. How well would these kids have done had they not been vaccinated at all?

We find the same observation in a Journal of Allergy and Clinical Immunology study. Of 11,531 children studied at age seven, here are the results: vaccinated at two months, 13.8% are asthmatic, vaccinated between two and four months, 10.3%, vaccinated after four months, 5.9 %. Again, how well would these kids have done had they not been vaccinated at all?

THE LESSON LEARNED ON VACCINATION

As a concerned, compassionate and considerate paediatrician, I can only arrive at one conclusion. Unvaccinated children have by far the best chance of enjoying marvellous health. Any vaccination at all works to cripple the chances of this end.

www.imcv.info

Sources

___________
1) www.birthworks.org/primalhealth

2) Allergic diseases and atopic sensitization in children related to farming and anthroposophic lifestyle - Persifal study. Allergy 2006, 61 (4) : 414-421.

3) www.vacunacionlibre.org

4) http://www.ias.org.nz

Tuesday, June 29, 2010

Fw: The New Face of Activism

The New Face of Activism

If progressives learn the right lessons from organizing efforts of the past year, they can get back in the game

As activists confront the disappointments of the Obama era, a troubling sense of malaise and despair has crept into the progressive movement. This state of mind is arguably even more of an obstacle than policy challenges or specific failures, because it tends to produce either apathy or unstrategic ranting. While we are no doubt in a tough spot, however, despair is not warranted.

In some ways, the scorecard on the Obama administration's policy agenda is more mixed than critics would like to admit. The economic stimulus package—while smaller and less efficiently targeted than it should have been—represents the greatest investment in antipoverty programs in 40 years. Health care reform represents the largest expansion of the social safety net in decades. The administration also has empowered some agencies with larger budgets, stronger personnel, and greater mandates to enforce critical worker, environmental, and civil rights protections.

But progressive activists do have compelling grounds for disappointment. The administration's coddling of the financial sector, paired with its failure to respond aggressively enough to the wave of suffering brought about by unemployment and foreclosures, has been morally wrong and politically tone-deaf. The failure to respond sufficiently to the needs of communities of color that are experiencing Depression levels of unemployment and hardship—and the reluctance to even acknowledge that targeted responses are required—has set us back in addressing issues of race. And the number of immigrant deportations during the Obama administration's first year was actually higher than during the last year of the Bush administration—an appalling fact considering that the administration can't blame Congress.

The administration's fetishization of deficit reduction also promises to create major obstacles to the preservation or expansion of needed programs for years to come. But the question before us is why we are in this predicament—and what to do to get out of it. And, honestly, the administration is the least of our troubles.

To be sure, the administration's strategic errors have contributed to the situation. Factors beyond the administration's control have played a role, too, such as corporate opposition to any significant reform agenda and the mobilization of the Tea Party, which tapped into populist anger and put progressive forces on the defensive. But it's too easy to get distracted by the proximate causes of our difficulties and lose sight of the big picture.

The main lesson we should draw from the past year and from American history is that it takes social movements that are intense, tenacious, and imaginative to get big things done in our country. Abolition, women's suffrage, and the reforms of the New Deal and the Great Society were not won easily, nor were they brought about by a single election. (The same can be said of the long rise to power of movement conservatism.)

People often complain that President Barack Obama fails to exhibit sufficient passion, and that's true to a point. But no president can generate moral urgency on his own. Most of that passion has to come from below. Lyndon B. Johnson wouldn't have been able to rouse Congress in the famous speech in which he affirmed that "we shall overcome" unless there had been a civil rights movement that for decades had made the moral case and forced the country to look in the mirror.

Weak political leadership, powerful entrenched interests, and a closely divided country are not new challenges. If we learn the right lessons from organizing efforts of the past year, we can recapture momentum for progressive causes.

One place to look for lessons is the immigrant rights movement, which today stands as one of the few parts of the broader progressive movement with the capacity to put hundreds of thousands of people on the streets. Consider the paradox: Some of the most vulnerable segments of our society with the most to lose from engaging in public life have the greatest capacity for mobilization and movement.

The story of the movement goes back decades, but its recent origins lie in the efforts of committed people during the late 1990s to put on the table an issue—the condition of millions of undocumented people living in fear and experiencing extreme exploitation in the workplace—that was, at the time, unspeakable in polite discourse in Washington. Had the issue been left to politicians, no one would have made the demand for a path to citizenship under the conditions prevailing at that time.

Through immigrant service and community organizations, churches, hometown and ethnic associations, and ethnic media, immigrants had built a rich infrastructure that could be tapped for mobilization. This infrastructure gradually has won allies—in evangelical churches, among white progressives, among cops and sheriffs, and among the women's, civil rights, and labor movements—but it began by consolidating power and vision among those with the most at stake.

In 2006 this growing but still disparate movement united in response to punitive legislation sponsored by Representative James Sensenbrenner of Wisconsin that would have criminalized immigrants and anyone who tried to help them—sending not only undocumented immigrants but also priests, teachers, and social workers to jail. Marches involving millions of people—possibly the largest marches in American history—put people on the move not just in Los Angeles and Chicago but also in places like Lexington, Kentucky, and Boise, Idaho. This show of power stopped the legislation and put reform on the national agenda.

Every action begets a reaction, however, and a nativist countermovement rallied to bring down reform legislation in 2007, spawned anti-immigrant policies at all levels of government, and generated a wave of hate in the media. Immigrants mobilized again, resulting in 2 million new Hispanic voters in 2008 and a clear repudiation of those who used prejudice for political gain, with 20 of 22 anti-immigrant congressional candidates in swing districts losing to pro-immigrant candidates.

The movement then prepared for a legislative campaign and built an infrastructure of field operations, communications capacity, and policy development, anticipating that the president would keep his promise to move legislation in his first year. As it became clear that the president and Congress were putting immigration reform on the back burner while the administration pursued policies that still ripped families apart, immigrant leaders prepared to go back into movement mode.

In the early part of 2010, tens of thousands of people rallied in Washington, D.C.; undocumented students walked from Florida to D.C. on a "trail of dreams"; and thousands of new people were brought into the fight through movement-building training. The movement has not disowned legislative tactics or a campaign sensibility, but it's clear that the underlying power to unstick the issue in Congress depends on the ability to unleash people power on a substantial scale.

Persistent, patient, and unafraid, the strategic vision of the immigrant rights movement resembles in ways the vision and advantage of the conservative movement, both today and in the past. The lessons of the immigrant rights movement and of the right—if we understand them correctly—can provide a blueprint for the broader progressive movement. 

First, we know that strategies relying on insider influence are incapable of delivering large-scale change. Dynamics in D.C. reflect the underlying social forces in the country—the extent to which certain ideas and constituencies are seen to be on the move and winning others to their side. Access to powerful people is not power, and it is not a recipe for social change.

Time and again in the immigrant rights movement, mobilizations on the outside have altered the fundamental dynamics in Washington. The pro-immigrant marches in 2006 stopped legislation that at the time seemed inevitable. And the nativist countermobilization in 2007 shattered support for reform in the Republican Party and defeated more legislation. Little of what happened in D.C. in this period can be understood without reference to these movement dynamics.

Second, "call your congressperson" campaigns full of paid ads and Astroturf fail to light up people's imagination or tap their deepest energies. This is a hard lesson to teach. The prevailing orthodoxy in Washington and among progressive organizations is transactional; it's always about the next cosponsor for a piece of legislation or the next issue campaign, all involving organizations being asked to generate calls to Congress.

The Tea Party movement didn't focus on legislative mechanics, nor did it focus on traditional legislative campaign methods—it changed the debate by engaging people around a set of ideas and values and mobilized their intensity in dramatic fashion. The transactional approach needs to be replaced with a movement sensibility that is connected to the heart and the spirit, one that is ongoing and owned by the people involved.

Third, reform movements have to be grounded in and speak to the real experience of the people who are mobilized. Advocates and politicians too often blur issues, couching ideas in poll-tested blather that takes the moral force out of arguments for reform. This mushy rhetoric prevents stories of suffering and struggle—which motivate and compel people in the middle to take a side—from coming through clearly.

The health care debate suffered from the reluctance of some advocates to clearly make the case for what the legislation would accomplish—mainly, providing insurance to roughly 30 million people and offering protections against preda­tory insurance companies. Fearing that forthright emphasis on easily understood moral principles couldn't win in the court of public opinion, we got lost in a morass of arguments about reducing deficits and bending the cost curve.

Fourth, the standard vocabulary of advocacy campaigns has to change. The traditional approach starts by emphasizing support among "swing" voters, fieldwork in swing districts, and advocacy by "unusual voices" such as moderate Republicans or business leaders. This approach is a recipe for trouble without first consolidating broad support from the base. The inten­sity of energy from a base, while usually not sufficient in itself, opens up the possibility for genuine alliances with other social forces and the middle, ultimately leading to majority support.

Consider the way in which the Tea Party was first written off as a fringe phenomenon and now has shaped national dialogue. And how the immigrant rights movement has put on the national table an issue that was literally taboo 10 years ago—and developed a powerful coalition of supporters.

Finally, it's essential to remember that electoral politics are not an end but a means to achieving an agenda. Confusion about the relationship between progressive movements and the Democratic Party is rampant and disabling. Here we could learn a lesson from the Tea Baggers—they are clear that the Republican Party might at times be a vehicle to achieve their ends, but the ends are what matter. And their independent sensibility has resulted in greater influence on the national debate. Electoral outcomes alone do not produce policy gains: Richard Nixon, a Republican, proposed a guaranteed annual income for the poor; Democrat Bill Clinton ended welfare as we knew it.

There are signs that the progressive movement's energy is reemerging. Populist efforts from the left to target the banks are attracting more attention and participants. The Health Care for America Now campaign saved health care reform legislation from death time and time again (by, for example, turning out more people to those infamous town halls than the Tea Partiers did, media mythology notwithstanding). And, of course, patience is wearing thin in the immigrant rights movement, leading to a recommitment to mass action.

Social movements don't always win the change they seek on the schedule they hope for. When they do succeed, however, it's because they clarify what's at stake, force people and politicians to choose sides, develop leaders, make moral arguments with clarity and passion, and generate the kind of mass pressure that is required to break through a sclerotic political system rigged in favor of powerful interests.

The president rode to the White House on the coattails of a set of movements—against Bush, war, and climate change; for youth and immigrants—that developed over the course of a decade in response to the excesses of conservatism. The task at hand for progressives in this decade is to build movements that are courageous, imaginative, and soulful enough to con­tinue the energy. Not only to hold the line against reaction, but to create a more positive, affirmative agenda of our own.