what internet

ONENESS, On truth connecting us all: https://patents.google.com/patent/US7421476B2

Wednesday, June 30, 2010

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).
thumbnail
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.
thumbnail
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.

References

  1. Moffatt B, Elliott C (2007) Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspect Biol Med 50: 18–31. Find this article online
  2. Ross JS, Hill KP, Egilman DS, Krumholz HM (2008) Guest authorship and ghostwriting in publications related to rofecoxib: A case study of industry documents from rofecoxib litigation. JAMA 299: 1800–1812. Find this article online
  3. PLoS Medicine Editors (2009) Ghostwriting: The dirty little secret of medical publishing that just got bigger. PLoS Med 6: e1000156. doi:10.1371/journal.pmed.1000156.
  4. McHenry L, Jureidini J (2008) Industry-sponsored ghostwriting in clinical trial reporting: A case study. Account Res 15: 152–167. Find this article online
  5. SmithKline Beecham (1998) Adolescent depression. Study 329. Proposal for a journal article. Available: http://www.webcitation.org/5mOJ8CJuz. Accessed 29 December 2009.
  6. SmithKline Beecham (1998) Keller et al. Draft I dated 12/18/1998, prepared by Sally Laden of Scientific Therapeutics Information. Available: http://www.webcitation.org/5mOJGmrM0. Accessed 29 December 2009.
  7. Jureidini JN (2007) Comparison of first to final draft [Study 329]. Available: http://www.webcitation.org/5mOJMHUhX. Accessed 29 December 2009.
  8. Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, et al. (2001) Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 40: 762–772. Find this article online
  9. Jureidini J, McHenry L, Mansfield P (2008) Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Saf Med 20: 73–81. Find this article online
  10. Sismondo S, Doucet M (2009) Publication ethics and the ghost management of medical publication. Bioethics. E-pub ahead of print (2009 Feb 10). Find this article online
  11. Institute of Medicine (2009) Conflict of interest in medical research, education, and practice. Available: http://books.nap.edu/openbook.php?record ​_id=12598 . Accessed 15 December 2009.
  12. Wilson D, Singer N (2009 September 11) Ghostwriting is called rife in medical journals. New York Times B5: Find this article online
  13. Berenson A (2005) Evidence in Vioxx Suits Shows Intervention by Merck Officials. The New York Times Available at: http://tinyurl.com/VioxxPLOS. Accessed 24 December 2009.
  14. Fugh-Berman A, Dodgson S (2008) Ethical considerations of publication planning in the pharmaceutical industry. Open Medicine 2. Available: http://www.openmedicine.ca/article/view/ ​118/215 . Accessed 15 December 2009.
  15. Singer N (2009 August 19) Senator moves to block medical ghostwriting. New York Times B1: Find this article online
  16. Langdon-Neuner E (2008) Medical ghostwriting. In: Singh AR, Sinh SA, editors. Medicine, mental health, science, religion, and well-being (MSM 6, Jan–Dec 2008). pp. 257–273.
  17. Healy D, Cattell D (2003) Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry 183: 22–27. Find this article online
  18. Lopatto E, Feeley J, Fisk M (2009 June 12) Eli Lilly “Ghostwrote” articles to market Zyprexa, files show. Available: http://tinyurl.com/BloombergPLOS. Accessed 15 December 2009.
  19. Steinman MA, Bero LA, Chren M-M, Landefeld CS (2006) Narrative review: The promotion of gabapentin: An analysis of internal industry documents. Ann Intern Med 145: 284–293. Find this article online
  20. Singer N (2009 August 5) Medical papers by ghostwriters pushed therapy. New York Times A1: Find this article online
  21. McHenry L (2005) On the origin of great ideas: Science in the age of big pharma. Hastings Cent Rep 35: 17–19. Find this article online
  22. Petersen M (2002 November 22) Madison Ave. has growing role in the business of drug research. New York Times A1: Find this article online
  23. Healy D (2004) Let them eat Prozac. New York: New York University.
  24. Brody H (2007) Hooked. Rowman & Littlefield.
  25. Elliott C (2004) Pharma goes to the laundry: Public relations and the business of medical education. Hastings Cent Rep 34: 18–23. Find this article online
  26. Sismondo S (2009) Ghosts in the machine: Publication planning in the medical sciences. Soc Stud Sci 39: 171–198. Find this article online
  27. C-SPAN (2009) Newsmakers with Dr. Francis Collins. Available at: http://www.c-spanarchives.org/program/29 ​0855-1 . Accessed 29 December 2009.
  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.

Monday, June 28, 2010

Fw: Tropical Update 6/28

here it comes....  oil oil everywhere
Disaster Zone 1
 
----- Original Message -----
Sent: Monday, June 28, 2010 2:33 PM
Subject: Tropical Update 6/28

Alex has entered the Gulf of Mexico...


Since my update on Friday afternoon, TD1 was upgraded to TS Alex early the following day.  It made first landfall on Belize City, Belize as a 50kt tropical storm, tracked northwest across the Yucatan Peninsula, and entered the southern Gulf of Mexico late Sunday night.  Toward the end of the trip across the peninsula, it weakened slightly to a Depression, but almost immediately regained TS strength upon entering the warm Gulf waters.  At 15Z today, the intensity was 50kts and 989mb.

As of this writing, the bulk of the deep convection is located to the east of the low-level center, and it looks fairly ragged and disorganized, as one would expect after spending nearly a full day over land.  However, Alex is forecast to become a minimal CAT2 hurricane as it approaches the western Gulf, making landfall early Thursday morning near the US/Mexico border.  One thing I'll point out is that model guidance has been gradually shifting the landfall point further and further north with each new run.  I'd suspect that the official forecast track will follow that trend and nudge slightly northward with each advisory.

In the US, coastal areas can expect a storm surge up to 6' near Brownsville and Corpus Christi, and minimal up to at least the TX/LA border.  In the coming days, larger and larger swells and waves will make their debut in the north-central Gulf; certainly a negative impact on the oil leak situation.  Instead of the typical 3-4' swells offshore of LA, MS, AL, and northwest FL, swells of 8-10' will make their way up there by Wednesday.

For the latest on Alex, please visit
http://einstein.atmos.colostate.edu/~mcnoldy/tropics/atlantic/

Brian
--  *===========================================*    Brian McNoldy, Research Associate III        Dept. of Atmospheric Science          Colorado State University            Fort Collins, CO 80523                 970.491.8558 http://einstein.atmos.colostate.edu/~mcnoldy/ *===========================================* 

Gulf of Mexico Presents Unprecedented Toxicity Problems

Gulf of Mexico Presents Unprecedented Toxicity Problems

If you`re living in the U.S., particularly within a thousand miles of the Gulf, you need to detoxify your body now. Here`s why: Crude oil is packed with a toxic chemical called benzene. Even in small amounts, benzene is associated with leukemia, Hodgkin`s Lymphoma and other serious blood and immune system diseases. The EPA`s "safe level" for benzene is 4 ppb (parts per billion) and benzene is being found in Gulf air at levels of 3,000 ppb. Crude oil is being smelled hundreds of miles away, and make no mistake, if you can smell oil, you`re breathing highly toxic benzene.

With the oil, numerous toxic gases are also gushing from earth and gases that everyone near the Gulf is being exposed to include hydrogen sulfide and methylene chloride. The EPA`s allowable limit for hydrogen sulfide is 5-10 ppb (parts per billion), but on May 3rd air levels of 1,192 ppb were recorded. A former oil company CEO says these levels pose serious, even fatal, risks to adults and unborn children. Hydrogen sulfide acts like carbon monoxide and cyanide gases - it inhibits cellular respiration and oxygen uptake, and causes cellular suffocation. As for methylene chloride, the body changes it to carbon monoxide - and it`s known to cause liver damage, skin damage and cancer. The EPA`s safe level for methylene chloride is 61 ppb - and it`s being found in the air at levels of 3,000 ppb.

Most people know that the chemical dispersant BP is using is highly toxic. It`s so toxic that the EPA ordered BP to use a different and less toxic dispersant - an order which BP ignored. Currently, over a million gallons of these toxic chemicals have been dumped into our oceans. With the Exxon Valdez oil spill, the same dispersant caused serious respiratory, liver, nervous system, kidney and blood damage in people - and reports that clean up crews in the Gulf are falling ill are plenty. On the manufacturer`s label, it says that no toxicity testing has been done, but these chemicals being used in enormous and uncontained quantities are obviously very toxic.

All of this sounds bad, and it is, but here`s the kicker: as part of the earth`s interconnected ecosystem, rain water comes from the oceans. So, it shouldn`t be a surprise that scientists are predicting severe destruction across the U.S. from toxic rains - and it appears the first cases are being reported about 400 miles from the Gulf. In fact, hundreds of acres of Tennessee farm land are at risk.

The crops have small, raindrop-sized burn marks on them and while the mainstream media is reporting crop damage, they haven`t yet made the connection between the toxic, chemical-ridden rains and the potential crop failure. It`s being reported that these raindrop-sized burn marks are affecting everything in sight, and no plant is immune. Dead birds are also being found nearby. These crops may fail and if they do survive, it`s likely they`ll be toxic to consume because plants being watered with toxic chemicals will absorb those chemicals into their cells.

So, what can you do? Detoxify your body now and continue to do so regularly in the months and years to come. These chemicals in the air - and likely soon in the drinking water and in crops that do survive - present a very real danger inside our bodies. Thankfully, there are methods to remove these chemicals - but it`s up to you to take the steps to do so.

More:
http://docs.google.com/viewer?a=v&q...
http://www3.interscience.wiley.com/...
http://www.prisonplanet.com/may-lev...
http://www.youtube.com/watch?v=eGxG...
http://www.eutimes.net/2010/05/toxi...
http://www.wreg.com/news/wreg-myste...
http://en.wikipedia.org/wiki/Corexit

Sunday, June 27, 2010

The Coming Gulf Coast Firestorm: How the BP oil catastrophe could destroy a major U.S. city

The Coming Gulf Coast Firestorm: How the BP oil catastrophe could destroy a major U.S. city

It's hurricane season in the Atlantic, and that means Mother Nature could be whipping up fierce storms and sending them charging into the Gulf Coast any day now. In a normal hurricane season, that's bad enough all by itself... remember Katrina? But now there's something even more worrisome in the recipe: There's oil in the water.

So what happens when a Katrina-class hurricane comes along and picks up a few million gallons of oil, then drops that volatile liquid on a major U.S. city like Galveston or New Orleans?

Now, before we pursue this line of thinking any further, let's dismiss the skeptics out there who think oil can't drop from the sky because oil doesn't evaporate. Actually, if you look at the history of hurricanes and storms, you'll find thousands of accounts of lots of things that don't evaporate nonetheless falling out of the sky. The phrase "raining cats and dogs" it's entirely metaphor, you know: There are documented accounts of all sorts of things raining down from the sky: Fish, frogs, large balls of ice, and so on.

If rain storms can pick up fish out of the ocean, then drop them on land, then they certainly have the capacity to pick up oil, too.

Besides, as any chemist will tell you, the various petrochemicals found in crude oil evaporate even without a storm picking them up! Oil, in other words, does evaporate into the air. Or, more accurately, some of the lighter chemicals in crude oil evaporate even at temperatures of around 100 degrees (F). Those are Gulf Coast temperatures.

These chemicals burn

Now, these lighter chemicals that more easily evaporate also happen to have lower flash points, meaning they catch on fire more easily and at lower temperatures than other elements in the oil. The flash point for gasoline, for example, is much lower than diesel fuel. That's because gasoline is "more flammable" and is a lighter fuel than diesel.

The EPA classifies oils into Classes A - D. Class A is the lightest kind of oil, which the EPA describes as follows (http://www.epa.gov/oem/content/lear...)

"These oils are highly fluid, often clear, spread rapidly on solid or water surfaces, have a strong odor, a high evaporation rate, and are usually flammable. They penetrate porous surfaces such as dirt and sand, and may be persistent in such a matrix."

That same EPA document makes it quite clear that the more volatile oils can evaporate from crude oil, rendering the remaining oil heavier and more "tar-like."

And we already know these oils can catch on fire. That's the whole point of tapping crude oil, of course: To pump it into engines then catch it on fire in order to turn the energy of that mini-explosion into force (to drive the eight pistons in your gas-guzzling SUV, for example).

How the fire happens

So let's say the oil blowout continues, and the Gulf of Mexico is carrying millions of gallons of crude oil as a massive hurricane approaches. It's a hot July day in the Gulf of Mexico, with temperatures soaring towards 110 degrees, accelerating the evaporation of volatile oils which get mixed in with hurricane-force winds.

The hurricane makes landfall in New Orleans, let's say, dumping potentially hundreds of thousands of gallons of what is essentially "volatile fuel" on the city of New Orleans. Now, at first it's just a wet, slippery toxic mess that kills trees and grass. But what happens after the storm when the sun dries out the city?

All the dead trees killed by the oil turn into kindling. The sun evaporates off the rain water, leaving behind fuel. A few days of sun baking and you have a city doused in fuel, ready to burst into flames. It's every fireman's worst nightmare. The whole city is essentially turned into a giant match.

Now, sure, the more volatile fuels might evaporate, but as they do, they'd fill the city with explosive fumes. One spark, one fire, one lightning strike and your whole city literally goes up in flames. The BP oil spill, in other words, provides the fuel that could turn an ordinary hurricane into Mother Nature's arson attack on an entire city.

Like a nuclear bomb

This would not be an ordinary city on fire, either: It would be a city doused with volatile fuels that soaked it to the core. The sewers would explode like massive terrorist bombs, ripping to shred any underground infrastructure (fiber optics, water delivery, electrical infrastructure, etc.). The pavement itself would be on fire, as would parks, grasslands and forests. The city would burn from top to bottom, and there would be no point even trying to put out the flames. All we could do is evacuate and watch it all burn to the ground.

And in the aftermath, you'd still have oil covering the beaches, oil in the ocean, and the threat of more firestorms yet to come. It could be just the first of many such incidents striking the Gulf Coast.

Think this couldn't happen? Sure, and BP said the oil was a "tiny" little leak that didn't matter, either. They said the oil rigs would never explode. They said they would cap the blowout. They said they would protect the shores. And all along the problem just got worse and worse until even the press noticed that these corporate criminals just couldn't stop lying.

Now, BP is at least $20 billion in the hole in an effort to compensate some of the Gulf Coast businesses for the damage they've caused. But how will they compensate people if an entire city burns to the ground?

The answer? They won't. That would be the end of BP. Immediately bankruptcy. B.P. = "Bankruptcy Protection," after all.

No more payments go out to anyone. BP goes belly up just like all the fish being murdered by CorExit dispersant chemicals in the Gulf right now. The company goes down in flames just like New Orleans (or some other major city on the coast).

Of course, the scenario I'm describing here is theoretical, and I hope it's a worst-case scenario, too. But it is possible. Catastrophe is what happens at the intersection of poor planning and bad luck. BP has given us poor planning, and now Mother Nature may be about to deliver a heavy-handed dose of bad luck in the form of a seasonal hurricane that takes oil from the Gulf and dumps it on land.

We can only hope that these two elements do not collide on our shores. For if they do, we may witness loss on a scale our world hasn't seen since the dropping of atomic weapons on civilian populations in World War II. If a hurricane drops oil on New Orleans (or any other Gulf Coast city) and it goes up in flames a few days later, the aftermath will, indeed, resemble the effects of a nuclear bomb explosion.

You probably don't want to be anywhere near that. Needless to say, if it starts raining oil in your neighborhood, that might be a good time to grab whatever you value and get outta Dodge.

Wednesday, June 16, 2010

THE PRESIDENT'S OIL SPILL SPEECH

THE PRESIDENT'S OIL SPILL SPEECH

THE PRESIDENT'S OIL SPILL SPEECH

President Obama delivered his first Oval Office speech on the heels of his latest visit to the Gulf region - the fourth since the Deepwater Horizon rig explosion in April. With such an environmental and economic crisis present, the president needs to exert leadership to protect our precious coastal resources and clean up the spill, says Nicolas Loris, a research assistant at the Heritage Foundation's Roe Institute for Economic Policy Studies.
His message was the wrong one, says Loris. Instead, he continued to politicize the crisis by pushing for cap and trade legislation and to establish a separate claims fund -- financed by BP -- that will do very little to address the issue at hand. President Obama is right in saying that the Gulf region will bounce back, but not with the policies of cap and trade and banning offshore drilling that he's suggesting.
The President has been using the oil spill to push cap and trade and "clean" energy investments forward:
  • But global warming legislation -- placing caps on carbon dioxide emissions -- would do nothing to improve clean-up or to prevent future spills.
  • It would distract from the very efforts to clean up and stop the oil that must be the top priority now.
  • Nor would emissions caps magically create new problem-free sources of alternative energy.
  • Instead, global warming legislation would raise energy costs for all Americans and kill much needed jobs.
Under a regime like the President proposed, higher energy costs would spread throughout the economy as producers everywhere try to cover their higher production costs by raising their product prices, further impacting Americans. The result will be a much slower economy and lost jobs at a time when the top priority for Americans is economic growth. This is hardly the bounce back for the Gulf's economy, says Loris:
  • Implementing the House-passed Waxman-Markey cap and trade bill would put a chokehold on Louisiana's economic potential, reducing the state's economy by $8.33 billion in 2035.
  • Beginning in 2012, job losses will be 21,832 higher than without a cap-and-trade bill in place.
  • And the number of jobs lost will only go up, increasing to 31,468 by 2035.
Source: Nicolas Loris, "The President's Oil Spill Speech," Heritage Foundation, June 15, 2010.
For text:
http://blog.heritage.org/2010/06/15/the-presidents-oil-spill-speech/
For more on Energy Issues:
http://www.ncpa.org/sub/dpd/index.php?Article_Category=22




Here we go again:
Cap-and-trade is going to happen. Or, if it doesn't, something like it will. The moral is the same as for all the other bubbles that Goldman helped create, from 1929 to 2009. In almost every case, the very same bank that behaved recklessly for years, weighing down the system with toxic loans and predatory debt, and accomplishing nothing but massive bonuses for a few bosses, has been rewarded with mountains of virtually free money and government guarantees — while the actual victims in this mess, ordinary taxpayers, are the ones paying for it.

Monday, June 14, 2010

Ocean Circulation Group Models

Ocean Circulation Group Models
The College of Marine Science - USF, Ocean Circulation Group maintains a coordinated program of coastal ocean observing and modeling for the West Florida Continental Shelf (WFS). Modeling includes a West Florida Shelf version of ROMS nested in the Navy's operational HYCOM. We are also diagnosing model output from the Navy's HYCOM, from NCSU's SABGOM ROMS, and also from the NOAA RTOFS. All of these model-based, oil spill trajectory forecasts, each updated daily with new wind forecasts and new satellite derived oil location reinitializations are provided below.
· WFS Model Forecasts
· WFS Model Oil Spill Trajectory Hindcast/Forecast (superimposed with winds) New!
· WFS ROMS Oil Spill Trajectory Hindcast/Forecast (with surface currents and SST) New!
· WFS ROMS model Oil Spill Subsurface Trajectory Hindcast New!
· Global HYCOM based Oil Spill Trajectory Hindcast/Forecast New!
· Navy GOM HYCOM based Oil Spill Trajectory Hindcast/Forecast New!
· SABGOM based Oil Spill Trajectory Hindcast/Forecast New!
· RTOFS based Oil Spill Trajectory Hindcast/Forecast New!
· Four-panel view of four oil spill trajectory models New!

Saturday, June 12, 2010

Big Pharma's Bald-Faced Lies on Medical Science

Big Pharma's Bald-Faced Lies on Medical Science

Here, Dr. Beatrice Golomb, MD, PhD, shares shocking information about the underbelly of medical science to help you understand how, and why, the "scientific method" has become so manipulated and willfully distorted by the drug industry.

Sources:


Dr. Golomb is one of those rare commodities. She has earned an MD and a PhD and, is an associate professor of medicine, and associate professor of family and preventive medicine at the University of California at San Diego. But she is a rare commodity because she has integrity, and has not sold out to the drug companies while most other researchers have.

"I was initially perplexed by the disparities I saw between the published evidence, review papers, guidelines, and follow-up papers after trials were published," she explains, when asked how she became interested in the topic of Big Pharma distorting scientific evidence.

She had been researching statins (cholesterol lowering drugs), and she was perplexed by how people could come to the conclusions they were coming to, based on the data. "I would ask my colleagues, how could they have read this paper and come to this conclusion?"

Over time, as she began examining the evidence relating to conflict of interest and published results, she discovered there were forces at play that lead to disparities between:

  • the evidence that was published, relative to the "truth" of that evidence, and
  • the secondary representations of that evidence and the evidence that was published originally

"There is actually widespread evidence, even within the medical literature, showing that these forces can lead to qualitative differences in the conclusions relative to the fact," Golomb says.

A Perfect Example of Drawing the Wrong Conclusion from Published "Scientific Evidence"

Early in the interview Dr. Golomb cites a perfect example of the qualitative difference between the scientific facts amassed and the conclusions drawn.

"FDA analysts now have access to clinical trials whether or not they are published because of the clinical trial registries that some journals now require. (That doesn't actually require that those results then be published, but at least now there is opportunity for the FDA to get access to those studies, and sometimes to the evidence from the studies.)

So the FDA conducted an analysis of antidepressant drug trials and found that of 38 trials for which the evidence appeared favorable, 37 had been published. Whereas of 36 trials for which the evidence did not appear favorable toward antidepressant drugs, 22 were not published at all, and 11 were published in a way that misleadingly conveyed the outcome as though it was favorable.

So that research, the "published evidence," would be that over 90 percent of publications were favorable, relative to "truth" (at least as determined by the FDA analysts), which was about 50 percent.

… So that's an example of how the evidence we see can be dramatically different from the evidence that was procured, and there are actually a number of mechanisms that lead the evidence that was procured to already have disparities, generally favoring treatment benefits, relative to truth."

Many of the critics against natural or alternative health claim that we have abandoned the scientific method, and I think nothing can be further from the truth.

I have enormous respect for the scientific method, and I think when it is done properly it can clearly provide us with profound and valid truths that can guide and direct our treatment protocols.

But what many people fail to appreciate is that much of the research published has been deeply influenced and severely tainted by tremendous conflicts of interest and profit-driven motives.

Dr. Paul Offit, for example, an infectious disease specialist at the Children's Hospital of Philadelphia, has been quoted as saying:

"Science is not a democracy where people's votes decide what is right. Look at the data, look at science and make a decision based on science that has been published."

But what he is really advocating with this statement is blind faith in "facts" that may have been produced in the midst of, and sorely skewed by, massive conflicts of interest.

You Won't Find What You Purposefully Avoid Looking for

Dr. Golomb was previously the scientific director for the Department of Veteran Affairs and on the Research and Advisory Committee on Gulf War Veterans' illnesses. This experience also predisposed her to being more sensitive to issues that many other physicians are not attuned to.

"Part of the reason I got interested in the Gulf War area was because I was already concerned about the way inferences were drawn about that condition… I had seen the conclusions of the Institute of Medicine and the Presidential Advisory committee reports relevant to Gulf War illness at that time, and… inferences were basically absence of proof of a connection between organic factors and illness, which is interpreted as "proof of absence" of a connection…

But no one had looked, and therefore no one had "proved" that the exposures they had received were related to their illness. They then concluded that there couldn't be a relationship.

But you couldn't conclude there was "no relationship because there was no evidence" because nobody had looked, or even asked if it was biologically possible and therefore merited more inquiry."

This seems to happen more frequently than you might think. Absence of proof of a connection between a toxic exposure and disease tends to morph into "proof of absence of a connection."

But in reality, the absence of proof is oftentimes little more than a refusal to investigate the matter in any serious way.

"It was clear that some of the exposures Gulf War veterans had, had strong biological plausibility as precipitants for their illness, and I outlined… a research plan that would help to evaluate whether in fact there was a cause of relationship.

…I suggested that we look at the genetic variants of the enzymes that detoxify some of the chemicals they were exposed to, on grounds that if these chemicals were causally linked to illness, [then] people who have sluggish variants of these detoxifying chemicals should be more likely to be ill, and sure enough, they are. And people who had higher levels of exposure to these chemicals would be more likely to be ill, and sure enough, they are."

Why is There so Little Independent Research When We Know Profit Motives Drive Conclusions?

Not surprisingly, based on Dr. Golomb's investigations into statin drug studies, ALL of the large randomized control trials of statin drugs have been funded by drug companies. And when you consider that the pharmaceutical industry makes about half a trillion dollars annually, it's easy to see how statin drug research may have been clouded by conflict of interest.

So why is there not more independent research being done?

"It's very expensive to do those studies," Golomb explains. "The only other source of funding for reasonable sized studies is the National Institutes of Health (NIH).

We approached the NIH to conduct a study to see whether coenzyme Q10 might mitigate muscle side effects of statins, and we were told by NIH officers that they wouldn't even consider to do the study unless we ask the drug company to supply the statin…

So I contacted the NIH and I said, "I'm really trying to have a career free of drug company conflict of interest, would it be such a problem to have one study that doesn't have a drug company involved in it?"

And they said, somewhat reasonably, that their interest is in leveraging their funding and therefore, no, they would not consider an application unless we asked the drug company to supply the drug, which of course already set some level of conflict of interest."

So, unfortunately, the need of the government to leverage their investment has the unfortunate side effect of also producing ties to industry. Clearly, a pharmaceutical company is not going to jump at the chance to give their drug to an independent researcher who may find that the drug has significant problems.

If they voluntarily supply the drug, they're naturally going to want to have a say in what results are published at the end.

How the Publication Process Can Easily Add to the Problem

But looking at the funding, and hence the potential for direct conflict of interest, of the research in question is not the only problem we face when trying to decipher the truth of any given study.

Once the data has been collected, there's a whole other set of variables that come into play, with respect to submitting them to peer-reviewed journals.

"We've already alluded that there are funding disparities, and that less favorable studies – if they are drug company funded – are less likely to be submitted for publication. And then there are issues at the level of the journal.

It would be nice to think of medical journals as these bastions of truth and light that have no bias, but in fact, they're businesses, and they make their money, in many cases, from drug company advertisement, and also from sales of the glossy reprints of the drug favorable articles to industry.

And interestingly, several former editors and chiefs of major medical journals, Richard Smith of the BMJ (British Medical Journal), Richard Horton of the Lancet, and also a couple of former editors-in-chief of the New England Journal of Medicine have written books and opined heavily on the favorable impact of drug company influence on medical publishing.

There are strong conflicts by the journal to publish drug company favorable articles in order to reap those hundred thousand dollars or so in reprint sales for the favorable articles, and also to keep the drug companies happy so that they continue to get drug company advertising."

This is an important point that I don't want you to miss: There are drug reps whose sole responsibility is to "educate" physicians about new drugs, and one of their primary tools is to provide reprints of favorable studies.

This is not something that they can simply photocopy in their office, because that would be copyright infringement. So they actually have to pay for that reprint from the journal, and that's exactly what Dr. Golomb refers to here as "reprints."

In many cases, these reprints can amount to income in the six figures, over and above the income the journal generates from the drug company's advertisements in the journal.

This profit-driven motive to publish shoddy studies of dangerous drugs creates a major conflict of interest within the journal itself.

"The evidence that this has an impact comes from several sources," says Golomb. "One was the Annals of Internal Medicine that, some years ago, published an article on the impact of drug company advertising on physician behavior... and the article was not flattering to drug company advertising.

Somebody tracked the impact on the Annals revenues… before the article, and after the article, and... they estimated that they lost $1-1.5 million in advertising revenue over the ensuing several years as an apparent consequence of having published that unflattering article.

… And there is direct evidence now as well, of drug companies rejecting unfavorable articles -- articles unfavorable to industry, based on factors other than article quality."E

Two additional problems that have flourished within scientific publishing are the issues of ghostwriting, and duplicate publications. I expounded on both of these issues in this previous article.

Although it is considered a serious ethical breach to publish the same clinical trial more than once, this is in fact what has happened with some drug trials, which Golomb discusses in this interview.

Why is this problematic?

Because, for example, if you were to do a meta-analysis, where you review all available studies on a particular drug, you'd be mislead to believe that there are far more favorable studies than there really are. And if that republished study was flawed or the results manipulated through conflicts of interest to begin with, then what you end up with is essentially scientific fraud.

Then there's the process of gaining favorable reviews by other experts – another area fraught with potential conflicts of interest. To learn more about the ins and outs of the peer review process, I urge you to listen to the interview in its entirety, or read through the transcript.

In it, Dr. Golomb discusses the policies in place regarding conflict of interest; why these policies so often fall short; and how pharmaceutical companies manage to circumvent these policies to still publish their sometimes downright imaginary findings.

Some of her stories detail the devastating collapse of the entire system that occurs far more often than anyone could possibly imagine.

But she also discusses the potential for reforming the system. Part of rescuing the honor and validity of the scientific method is to put an end to the indoctrination by pharmaceutical companies that occur from day one in every medical school.

"… Most of the physicians who are doing the training are conditioned by the existing literature and the existing "expertise," which is influenced by all the factors that we've just mentioned.

So they legitimately believe the benefits of these drugs -- often to a degree that's not even supported by the published randomized trial evidence, because it will also be supported by the follow-on review papers, commentary expertise, and guidelines.

But medical students have actually been on the vanguard of trying to make change and the American Medical Student Association actually developed a policy of trying to rate the impact of conflict of interest in the classroom.

My understanding is that this was motivated initially by a medical student at Harvard who had listened to their lecture on statins, and somebody in the classroom had raised their hand and asked the question about statin adverse effects and it was answered in such a derisive and dismissive way that this other student looked up the lecturer online and discovered that he had all these conflicts of interest with statin industry.

That ended up prompting the student group to try to take action."

Isn't that always how real change starts? With just one person, asking the right questions, expecting answers, and being willing to look deeper rather than accept something as "truth" at face value.

It's unfortunate, but the science based system we currently have has some fatal flaws.

It's virtually impossible to expect a publicly traded pharmaceutical company, which has a major obligation to its stockholders, to simultaneously have the patient's best interest at heart. As Golomb says, the two are fundamentally incompatible. And yet this is THE source of the vast majority of the funding for all our science-based evidence.

Remember, the end consumer here is you – if you take any type of drug.

So although these issues may seem far removed from your life, they absolutely affect a vast majority of you, every single day. The decisions about what drugs to prescribe are being made based on the research published. Oftentimes individuals will decide they want to take a specific drug based on a TV advertisement they just saw, which also spouts claims derived from this scientific process.

Knowing what you know now, after listening to this interview, how comfortable do you feel about taking Paul Offit's advice to just "make a decision based on science that has been published"?

Hopefully, this interview will cause you to think a little deeper about the process of the scientific model in general, and how to evaluate scientific evidence in particular.

Related Links:

Is YOUR Doctor Saying No to Drug Company’s ‘Free Lunch’ Deception Campaign?