Wednesday, April 25, 2012

Can We Ever Believe Industry Sponsored Research?


Can we believe industry sponsored research?
- Compiled by Jagannath Chatterjee


Statistical significance is a phrase that every science graduate student learns, but few comprehend. While its origins stretch back at least to the 19th century, the modern notion was pioneered by the mathematician Ronald A. Fisher in the 1920s. His original interest was agriculture. Fisher’s P value eventually became the ultimate arbiter of credibility for science results of all sorts — whether testing the health effects of pollutants, the curative powers of new drugs or the effect of genes on behavior. In various forms, testing for statistical significance pervades most of scientific and medical research to this day.But in fact, there’s no logical basis for using a P value from a single study to draw any conclusion. If the chance of a fluke is less than 5 percent, two possible conclusions remain: There is a real effect, or the result is an improbable fluke. Fisher’s method offers no way to know which is which. On the other hand, if a study finds no statistically significant effect, that doesn’t prove anything, either. Perhaps the effect doesn’t exist, or maybe the statistical test wasn’t powerful enough to detect a small but real effect.http://www.sciencenews.org/view/feature/id/335872/title/Odds_Are,_Its_Wrong


Published research findings are sometimes refuted by subsequent evidence, with ensuing confusion and disappointment. Refutation and controversy is seen across the range of research designs, from clinical trials and traditional epidemiological studies [1–3] to the most modern molecular research [4,5]. There is increasing concern that in modern research, false findings may be the majority or even the vast majority of published research claims [6–8]. However, this should not be surprising. It can be proven that most claimed research findings are false.- John P. A. Ioannidis. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/


In response to the PloS declaration that research studies are false: Firstly I would like to condemn the industry's influence on medical science as the prime factor behind conflict of interest, dishonesty and manipulation in research. The second thing is today's trend to "refute or confirm" things through research. This is inherent bias. Research is for finding out the truth, not to confirm or deny anything. Thus this method is corrupting science. Another fact is corruption in MCI and other institutions which is influencing medical education and also the content of medical texts. Medical education has become so frustrating for the students that they are today buying and reading question-answer books and not the medical text books as they know that passing exams is the only objective. Moreover medical education is today on sale and so we cannot find dedicated doctors who are ready to even talk about reform. Now who gives continuing education to the doctors? The medical representatives and the foreign jaunts by the industry. One knows how accurate these methods are. While doctors should be discussing serious issues among themselves during annual conferences, they instead listen to industry sponsored medical experts because the conferences are totally financed by the industry. As per a recent investigative report corrupt practices in medicine are considered "routine and normal" by the indulging doctors. Doctors serving in private hospitals know that they are mere tools engaged to enhance the profits of the institution. Research bodies employed by the industry know that unless their research shows the industry's products or procedures to be favourable they will not be paid or not get further business, they may also be blacklisted. Doctors fighting corruption in the public sector health are brutally killed, as has happened in UP where three CMOs have been murdered. In foreign countries too medical scientists have mysteriously disappeared or died under mysterious circumstances. Doctors challenging the current paradigm have lost their licences. Doctors have had their reputations tarnished and dubbed as "quacks" for daring to speak the truth. So what PloS has observed regarding published research is not only the truth, but the tip of the iceberg.


Ioannidis is what’s known as a meta-researcher, and he’s become one of the world’s foremost experts on the credibility of medical research. He and his team have shown, again and again, and in many different ways, that much of what biomedical researchers conclude in published studies—conclusions that doctors keep in mind when they prescribe antibiotics or blood-pressure medication, or when they advise us to consume more fiber or less meat, or when they recommend surgery for heart disease or back pain—is misleading, exaggerated, and often flat-out wrong. He charges that as much as 90 percent of the published medical information that doctors rely on is flawed. His work has been widely accepted by the medical community; it has been published in the field’s top journals, where it is heavily cited; and he is a big draw at conferences. Given this exposure, and the fact that his work broadly targets everyone else’s work in medicine, as well as everything that physicians do and all the health advice we get, Ioannidis may be one of the most influential scientists alive. Yet for all his influence, he worries that the field of medical research is so pervasively flawed, and so riddled with conflicts of interest, that it might be chronically resistant to change—or even to publicly admitting that there’s a problem.http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/


The inappropriateness and lack of ethics of studies published in medical journals, as we know, have been questioned in toto by a scientist and a scientific journal. Now we come across a case where the same seems to have happened in a journal devoted to medical ethics! Read for yourself.http://www.insidehighered.com/news/2011/06/13/bioethics_journal_accused_of_ethics_and_managerial_problems


"Vaccines are never meant to be safe. The target is to under report and firmly deny reports of adverse effects and never accept or admit the fact that vaccines can be unsafe in any way. Jagannath, I can tell you one thing if you do not quote my name anywhere while quoting me, the only vaccine that is safe is the one that has not been administered". - A WHO employee who has since retired from active service.


Senior physicians, looking at the current state of things and the way both disease and drugs have changed, are now reflecting about the traditional views of health. What modern medicine has to offer for the future, newer DNA vaccines, plant based pharmaceuticals, and direct tinkering with the human genome, are all terrifying subjects and one is appalled at how such steps can even be considered. Clearly things have gone very very astray, such an outcome was never expected or contemplated, and those who had joined the profession with service of mankind as the aim are today a disillusioned lot. Distinguished physician Prof B M Hegde, is not disillusioned; yet. He offers hope for the future provided we learn from the past and give due thought to what the most modern discoveries in pure sciences are telling us. Holism is the key that he offers as he advises us to move away from reduction-ism. But will those entrenched in power and in league with the major powers in the industry stop to listen? My own experience tells me they will not. Like the Kaurava's they will lead us to terrible times, times from which mankind can never recover, as the processes being recommended are irreversible and also, in case of plant based pharmaceuticals, carry great risks of irreversible contamination of nature.http://www.thehindu.com/opinion/open-page/article2562901.ece


Another gem from Prof B M Hegde, "Whither medical Science?"
http://medind.nic.in/jac/t06/i4/jact06i4p284.pdf


CONFLICT OF INTEREST: New England Journal of Medicine ""Ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers serve as consultants to companies whose products they are studying, join advisory boards and speakers' bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies." Added NEJM: "Many researchers profess that they are outraged by the very notion that their financial ties to industry could affect their work. They insist that, as scientists, they can remain objective, no matter what the blandishments. Can we really believe that clinical researchers are more immune to self-interest than other people? "http://www.alternet.org/story/10009/is_academic_medicine_for_sale/


There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124

  1. ^ "John P. A. Ioannidis". Department of Hygiene and Epidemiology, University of Ioannina School of Medicine. Retrieved 2008-12-31.
  2. ^ Ioannidis, John P.A.. "Curriculum Vitae". Retrieved 4 November 2010.
  3. ^ David H. Freedman (2010). Wrong: Why Experts Keep Failing Us. Little, Brown and Company. ISBN 0316023787. "Born in 1965 in the United States to parents who were both physicians, he was raised in Athens, where he showed unusual aptitude in mathematics and snagged Greece's top student math prize. ..."
  4. ^ Ioannidis, J. P. A. (2005). "Why Most Published Research Findings Are False". PLoS Medicine 2 (8): e124.doi:10.1371/journal.pmed.0020124. PMC 1182327. PMID 16060722. edit
  5. ^ Robert Lee Hotz (2007-09-14). "Most Science Studies Appear to Be Tainted By Sloppy Analysis". Science Journal WSJ.com (Dow Jones & Company).
  6. ^ Goodman, S.; Greenland, S. (2007). "Why Most Published Research Findings Are False: Problems in the Analysis". PLoS Medicine 4 (4): e168. doi:10.1371/journal.pmed.0040168. PMC 1855693. PMID 17456002. edit
  7. ^ Steven Goodman and Sander Greenland (2007). "Assessing the unreliability of the medical literature: A response to "Why most published research findings are false"". Johns Hopkins University, Department of Biostatistics.
  8. ^ Ioannidis, J. P. A. (2007). "Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland". PLoS Medicine4 (6): e215. doi:10.1371/journal.pmed.0040215. PMC 1896210. PMID 17593900. edit
  9. ^ David H. Freedman (Nov 2010) Lies, Damned Lies, and Medical Science, The Atlantic
  10. ^ Ioannidis, J. P. A. (2005). "Contradicted and Initially Stronger Effects in Highly Cited Clinical Research". JAMA: the Journal of the American Medical Association 294 (2): 218–228. doi:10.1001/jama.294.2.218. PMID 16014596. edit
Evidence-Based Medicine—Can You Trust the Evidence?
Yvonne M. Buys, MD
Alasbali T, Smith M, Geffen N, et al. Discrepancy between results and abstract conclusions in industry- vs. nonindustry-funded studies comparing topical prostaglandins. Am J Ophthalmol. 2009;147(1):33-38.

http://virtualmentor.ama-assn.org/2010/12/jdsc1-1012.html
ANALYSIS

Data availability for industry sponsored trials: what should medical journals require?
BMJ  2010; 341 doi: 10.1136/bmj.c5391 (Published 12 October 2010)
Cite this as:  BMJ  2010;341:bmj.c5391
  • Cardiovascular medicine
  • Diabetes
  • Drugs: cardiovascular system
  • Endocrinology
  • Ischaemic heart disease
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  1. Robert Steinbrook, adjunct associate professor12, 
  2. Jerome P Kassirer, professor3
Author Affiliations
  1. rsteinbrook@attglobal.net
Several recent examples illustrate the problems of trusting drug companies to provide the complete picture about the clinical trials they sponsor. Robert Steinbrook and Jerome P Kassirer propose that there is a strong case for journals defining full access to the trial data and requiring that investigators and journal editors have full access.
Concerns about the reliability of the data in the Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes (RECORD) trial1 2 have once again raised an uncomfortable question—what criteria should medical journals use when they consider reports of industry sponsored clinical trials for publication? As published, the open label RECORD trial, which was sponsored by GlaxoSmithKline, showed that the addition of rosiglitazone (Avandia) to metformin or sulfonylurea was not inferior to treatment with a combination of these drugs for a composite endpoint of cardiovascular events and death, and was inconclusive about any possible effect on myocardial infarction.2However, during the course of the review of the study by the United States Food and Drug Administration (FDA), a reviewer who audited the raw data found that potential bias and omissions in the adjudication of cardiovascular endpoints had downplayed the risk of myocardial infarction associated with taking rosiglitazone.3 4 Another FDA official said of the reviewer’s report, “ I think you could sum [the review] up in one word, and the word is truth. Can we trust the sponsor with the results of RECORD?”5 In September 2010, regulatory agencies announced that medicines containing rosiglitazone would be taken off the market in Europe and their use substantially restricted in the United States.6 7

http://www.bmj.com/content/341/bmj.c5391.extract

Home > Health Resource Center > Midlife and Menopause > Our Bodies, Ourselves: Menopause Excerpt
The Politics of Women's Health
Can We Trust the Evidence in Evidence-Based Medicine?
When we and our providers seek solutions to our health problems, we depend on medical research to tell us which treatments work best, how likely it is that a particular treatment will help us, and what kind of risks the treatment entails. We expect this “evidence-based medicine” to bring us the best possible care.
Health professionals’ trusted sources of scientific evidence include research published in respected medical journals, continuing education courses presented by experts, and clinical practice guidelines. Clinical practice guidelines are established by “expert review committees” charged with reviewing the best of medical research to define standards of good care.  
What few of us know is that medical research has undergone a quiet but radical transformation over the past two or three decades.   
Before 1970, the vast majority of clinical research was funded from government sources.1  This has changed dramatically. Three out of four of the clinical trials published in the top medical journals (The Lancet, the New England Journal of Medicine, and the Journal of the American Medical Association) are now funded by pharmaceutical companies.2  In 1991, about 80 percent of drug company-sponsored research was still being done in universities, where academic checks and balances supported the independence of researchers. But by 2000, only 34 percent of this research was still being done in academic medical centers. The rest had been transferred to for-profit research companies.
When drug companies fund research directly through private contracts, they are able to influence the results in many ways. Drug companies are not required to compare their products to other known treatments. They can select the age and gender of the people included in a study to highlight the benefits of the drug and minimize the risks. (For example, they can choose to study their product on healthy younger people who take few other medications and are thereby less likely to have side effects, despite the fact that the drug is more likely to be taken by older people taking multiple medications.) The drug companies can end studies if the results don’t appear favorable and choose not to publish studies that don’t come out they way they had hoped. And many of the authors of the research articles published in even the most respected medical journals don’t have access to all of the data from their own studies—only the data the drug companies choose to let them see. By controlling the design of the research, the criteria by which patients are selected, the analysis of the data, and which results are actually published, drug companies shape medical knowledge.
Research funded by the pharmaceutical and biotech industries is far more likely to produce results that support the sponsors’ interests. Two studies published in 2003, one in the Journal of the American Medical Association (JAMA) and the other in the British Medical Journal showed that commercially funded studies were 3.6 to 4 times more likely than noncommercially funded studies to show positive results for the sponsor’s product.3 Another JAMA study that looked only at highest-quality studies found even stronger bias: The odds that commercially funded research found the sponsor’s product the treatment of choice were 5.3 times greater than for studies funded by nonprofits.4 
The agencies we count on to protect the interests of health consumers are increasingly compromised. More than half of the funding for the Center for Drug Evaluation and Research, the division of the U.S. Food and Drug Administration that approves new drugs and oversees drug safety, comes from user fees paid by drug companies.5  The medical journals we trust to independently evaluate the articles they publish are also being influenced by the biomedical industries, as they depend on money from pharmaceutical advertising and from selling reprints of published articles to corporate sponsors, who then distribute them to physicians. The committees that produce clinical practice guidelines, which inform and direct health care professionals, are now dominated by experts with active financial ties to one or more companies that make the drugs under consideration.6 And about 70 percent of continuing medical education courses for doctors are now paid for by the drug and other medical industries. Since doctors must participate in continuing medical education to maintain their medical licenses, it becomes increasingly difficult for any of them to avoid being exposed to industry-sponsored messages.
As commercial interests gain an increasing role in determining our “medical knowledge,” it is important to understand that the fundamental reason that companies help create and distribute this information is to promote their products and improve their corporate bottom lines. Our health is relegated to, at best, a secondary consideration. We need to question whether doctors should be given financial incentives to follow clinical practice guidelines, as some now are, when those guidelines may be based on incomplete or biased research. Already we have evidence that “pay for performance” incentives can lead to inappropriate care for older people with multiple chronic diseases.7
We need to demand that the public know when medical experts receive research funding or advising fees from drug and biomedical companies. And we need to advocate for stricter standards in the regulatory agencies that evaluate research results and oversee clinical guidelines. As individuals we can ask our health care providers if they practice under “pay for performance” programs and then consider this fact when making decisions about their recommendations for diagnostic tests and prescription medications.
The commercial take-over of our medical knowledge is, at its core, not a scientific problem but a political one. The solution will require an engaged and active citizenry. For more information, see Overdosed America: The Broken Promise of American Medicine.8
End of excerpt.

Excerpted from Chapter 2: Making Health Care Decisions in Our Bodies, Ourselves: Menopause © 2006 Boston Women's Health Book Collective.  
 For more information on how the pharmaceutical industry influences medical knowledge, seeDrug Companies & Doctors: A Story of Corruption and The Truth About the Drug Companies, two articles by Marcia Angell, a physician and former editor of The New England Journal of Medicine
http://www.ourbodiesourselves.org/book/menoexcerpt.asp?id=51&chapterID=31 

Research Ethics and Medical Education
Stephen Leapman, MD, and Sharon M. Moe, MD
Introduction
The question begging to be asked among researchers and educators in Academic Medical Centers is: what do we currently teach medical students and residents about the ethical issues surrounding clinical research activities, from conflict of interest to protection of the patients enrolled in research studies (clinical trials)? The answer unfortunately is "not much, but more than before."
Outside forces have made us look critically at our teaching programs. The Accreditation Council for Graduation Medical Education (ACGME) has adopted requirements for competency in, among other areas, professionalism, practice-based learning and improvement, and systems based practices. Learning outcomes for these competencies require residents to demonstrate a commitment to ethical principles of health care delivery, informed consent, confidentiality, conflict of interest, and ethical business practices [1].
Stephen B. Leapman, MD, is the Frank C. and Ruby L. Moore and George T. Lukemeyer Professor at the Indiana University School of Medicine, where he has been on faculty since 1977. Dr. Leapman has been the clerkship director in the Department of Surgery and a member of the Board of Trustees in the Association of Surgical Education. In 2001, Dr. Leapman became the first executive associate dean for Educational Affairs.
Sharon M. Moe, MD, is the associate dean for Research Support and medical director of the Clinical Trials Program at the Indiana University School of Medicine. She received her medical degree at the University of Illinois, Chicago and completed a subsequent residency at Loyola University and a fellowship in nephrology at the University of Chicago. Her current research interests relate to the pathophysiology and treatment of musculoskeletal disorders in patients with renal failure.

http://virtualmentor.ama-assn.org/2004/11/medu1-0411.html

JOURNAL DISCUSSION
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Financial Conflicts of Interest in Biomedical Research
Jeremy Spevick
In the words of Dennis Thompson, a conflict of interest is "a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influenced by a secondary interest (such as financial gain)" [1]. In the field of medical research a variety of activities can present conflicts of interest, from enrolling patients in clinical trials to industry-sponsored academic research. The latter case brings up questions about the integrity the research: Will industry sponsors begin to set research agendas? Will financial ties to the industry cause researchers to be less objective? Reports that industry-sponsored research is more likely to favor the drug of interest than research not funded by drug companies [2,3] has confirmed that the concerns are valid.

http://virtualmentor.ama-assn.org/2003/07/jdsc1-0307.html


Tobacco industry research
. . . . . . . . . . . . .  . . . . . . . . . . . .  . . . . . . . . . . . . .  . . . . . . . . . . . .  . . . . . . . . . . . . .  . . . . . . . . . . . .  . . . . . . . . . . . .
Research from tobacco industry
affiliated authors: need for particular
vigilance
S Chapman
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Is tobacco industry sponsored science ever likely to be
trustworthy?
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1748072/pdf/v014p00217.pdf 
How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data
Daniele Fanelli*
INNOGEN and ISSTI-Institute for the Study of Science, Technology & Innovation, The University of Edinburgh, Edinburgh, United Kingdom

The frequency with which scientists fabricate and falsify data, or commit other forms of scientific misconduct is a matter of controversy. Many surveys have asked scientists directly whether they have committed or know of a colleague who committed research misconduct, but their results appeared difficult to compare and synthesize. This is the first meta-analysis of these surveys.

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0005738


HOW THE CASE AGAINST WAKEFIELD IS COLLAPSING:
Age of Autism Exclusives
<http:>http://www.ageofautism.com/exclusives.html</http:>

An Elaborate Fraud Series: Brian Deer, BMJ, Murdoch, Dr. Andrew Wakefield
<http:>An </http:>
Elaborate Fraud, Part 1: In Which a Murdoch Reporter Deceives the 
Mother of a Severely Autistic Child
<http:>An </http:>
Elaborate Fraud, Part 2: In Which a Murdoch Newspaper's Deceptive 
Tactics Infect the British Medical Journal
<http:>An </http:>
Elaborate Fraud, Part 3: In Which the Mother of Two Autistic Children 
Demands Accountability From the British Medical Journal
<http:>An </http:>
Elaborate Fraud, Part 4: News Analysis -- The British Medical 
Association Is "Standing Up for Doctors" Even If It Means Attacking Patient


<http:>An </http:>
Elaborate Fraud, Part 5: In Which Brian Deer Defends His Reporting 
and Accuses Autism Parents of a Conspiracy
<http:>An </http:>
Elaborate Fraud, Part 6: In Which "Blagging" is Discredited as a 
Journalistic Tactic, Unless the British Medical Journal Publishes It
<http:>An </http:>
Elaborate Fraud Series Part 7: In Which the BMJ's Prime Example of 
Wakefield's Alleged Misconduct Proves Flagrantly False
<http:>An </http:>
Elaborate Fraud, Part 8: In Which The British Medical Journal Tries 
to Debunk a Clear-Cut Case of Regressive Autism
<http:>An<http:> </http:></http:>

Elaborate Fraud, Part 9: in Which the BMJ's Fraud Claim Collapses -- 
and No One Hears It Fall Blanket Lancet

VACCINATIONS: HOW THE MONEY FLOWS.

Supposedly, Pediatricians developed as child specialists – and, to hear their representatives talk, they are the one-stop shop for all health issues pertaining to children.

Their organization, calling itself the American Academy of Pediatrics (AAP), is totally, and virtually ONLY focused on vaccine promotion. In 2010 the AAP took in $110,079,859.00 in total income. Their thirty-three (33) sub-chapters, together, took in a total of $16,109,174.00. All together they amassed $126,189,033.00 in total 2010 income.

How much money does a Pediatrician make pedaling vaccines?

A lot. Take a look at this chart link for pediatricians, put together by payscale.com. As you can quickly see a salaried Pediatrician, in the US, makes somewhere between $68,654 to $169,517. BUT, add on “Commissions” (vaccine pushing) and that income range changes radically. For, as the chart shows, “Commissions” can range from $293.61 to $352,694.

So, if you look at the broad income range difference – normal salary versus maximum vaccine pushing there is a considerable annual income difference – $68,654 on the low side to a high of $522,211 (for vaccine pushing). Walk out into the parking lot and look at your Pediatrician’s car to help you guess which choices he/she made for income.

If you want a really jaundiced view, ask your Pediatrician about those trips to Paris, Buenos Aries, Hawaii, Fiji, every year while YOU try to make ends meet dealing with neurological issues or Autism in your child. 

- Inputs by Tim Bolen, Investigative Consumer Health Advocate, USA.

THE INDIAN SCENARIO: The fact that doctors and their organisations earn stupendously from vaccines has already been pointed out . In India the fact that the annual conferences of the IAP are hosted by vaccine manufacturers, spending 2 to 4 crores in the process each year, is known to all. It is also known that the doctors earn 30% commission on each vaccine, charge more for administering them, and gain additional amounts on achieving their targets. They also gain by treating the vaccine induced illnesses. Doctors becoming spokespersons of the vaccine industry and lobbying for their interests gain a lot by way of monetary incentives called "fees" as well as frequent foreign trips and career advances. 


Wakefield - What's the Real Story?

http://www.facebook.com/note.php?saved&&note_id=10150344400651510


The Hepatitis B Vaccine - More Politics than Science.

http://www.facebook.com/note.php?note_id=10150347273261510


Vaccines: Analysing the Risk Vs Benefit Arguement.

http://www.facebook.com/note.php?note_id=10150346225991510


A few Facts About the History of Opposition to Vaccines

http://www.facebook.com/note.php?note_id=10150355341091510


Autism: Anguished Citizen of America on the Continuing Wakefield Controversy.
http://www.facebook.com/note.php?note_id=10150384000081510

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