Andrew Wakefield, Scientific Censorship, and Fourteen Monkeys

A statement from Jenny McCarthy and Jim Carrey
Los Angeles, February 5, 2010

Dr. Andrew Wakefield is being discredited to prevent an historic study from being published that for the first time looks at vaccinated versus unvaccinated primates and compares health outcomes, with potentially devastating consequences for vaccine makers and public health officials.

It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues.

The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury. Dr. Wakefield strenuously denies all the findings of the GMC and plans a vigorous appeal.

Despite rampant misreporting, Dr. Wakefield’s original paper regarding 12 children with severe bowel disease and autism never rendered any judgment whatsoever on whether or not vaccines cause autism, and The Lancet’s retraction gets us no closer to understanding this complex issue.

Dr. Wakefield is one of the world’s most respected and well-published gastroenterologists. He has published dozens of papers since 1998 in well-regarded peer-reviewed journals all over the world. His work documenting the bowel disease of children with autism and his exploration of novel ways to treat bowel disease has helped relieve the pain and suffering of thousands of children with autism.

For the past decade, parents in our community have been clamoring for a relatively simple scientific study that could settle the debate over the possible role of vaccines in the autism epidemic once and for all: compare children who have been vaccinated with children who have never received any vaccines and see if the rate of autism is different or the same.

Few people are aware that this extremely important work has not only begun, but that a study using an animal model has already been completed exploring this topic in great detail.

Dr. Wakefield is the co-author, along with eight other distinguished scientists from institutions like the University of Pittsburgh, the University of Kentucky, and the University of Washington, of a set of studies that explore the topic of vaccinated versus unvaccinated neurological outcomes using monkeys.

The first phase of this monkey study was published three months ago in the prestigious medical journal Neurotoxicology, and focused on the first two weeks of life when the vaccinated monkeys received a single vaccine for Hepatitis B, mimicking the U.S. vaccine schedule. The results, which you can read for yourself here, were disturbing. Vaccinated monkeys, unlike their unvaccinated peers, suffered the loss of many reflexes that are critical for survival.

Dr. Wakefield and his scientific colleagues are on the brink of publishing their entire study, which followed the monkeys through the U.S. childhood vaccine schedule over a multi-year period. It is our understanding that the difference in outcome for the vaccinated monkeys versus the unvaccinated controls is both stark and devastating.

There is no question that the publication of the monkey study will lend substantial credibility to the theory that over-vaccination of young children is leading to neurological damage, including autism. The fallout from the study for vaccine makers and public health officials could be severe. Having denied the possibility of the vaccine-autism connection for so long while profiting immensely from a recent boom in vaccine sales around the world, it’s no surprise that they would seek to repress this important work.

Behind the scenes, the pressure to keep the work of Dr. Wakefield and his colleagues from being published is immense, and growing every day. Medical journals take extreme risk of backlash in publishing any studies that question the safety of the vaccination program, no matter how well-designed and thorough the research might be. Neurotoxicology, a highly-respected medical journal, deserves great credit for courageously publishing the first phase of this vaccinated monkey study.

The press has been deeply misled in the way The Lancet retraction, and Dr. Wakefield’s mock trial, have been characterized. Led by the pharmaceutical companies and their well-compensated spokespeople, Dr. Wakefield is being vilified through a well-orchestrated smear campaign designed to prevent this important new work from seeing the light of day.

What medical journal would want to step in front of this freight train? Moreover, why now, after 12 years of inaction, did The Lancet and GMC suddenly act? Is it coincidence that the monkey study is currently being submitted to medical journals for review and publication?

We urge the media to take a close look at the first phase of the monkey study discussed above and to start asking a very simple question: What was the final outcome of the 14 primates that were vaccinated using the U.S. vaccine schedule and how did that compare to the unvaccinated controls?

The U.S. vaccine schedule has grown from 10 vaccines given to our children in the 1980s to 36 today, perfectly matching the dramatic rise in autism. The work of Dr. Wakefield and his colleagues deserves to be shared with the world to further, rather than censor, scientific progress.

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Senator McCain Files New Bill That Attacks Your Access to Supplements and Repeals Key Sections of the Dietary Supplement Health and Education Act

TAKE ACTION AND TELL YOUR SENATOR NOT TO CO-SPONSOR THIS BILL
Donate to our campaign to STOP this bill!

McCain’s bill is called The Dietary Supplement Safety Act (DSSA). It would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

These protections are far from perfect. They discourage companies from developing new forms of supplements. New supplements may be arbitrarily banned by the FDA or adopted by drug companies in a way that precludes their further sale as supplements.

McCain’s bill would wipe out even the minimal protections contained in DSHEA. It would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others.

Everyone knows that the FDA is friendly to drug companies (which pay its bills and provide good revolving door jobs) and hostile to supplement companies. Under this bill, this same Agency could quite arbitrarily ban any supplement it wished or turn it over to drug companies to be stopdeveloped as a drug and sold for multiples of its price as a supplement.

We must prevent this bill from gaining traction! Protect your access to supplements by contacting your senators today and asking them NOT to co-sponsor the Dietary Supplement Safety Act but rather to oppose it.

TAKE ACTION

McCain’s Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. The recent suspensions of NFL and other professional sports figures is much in the news, and the goal of the sports industry appears to be to shift the spotlight from their players to the supplements industry. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

The problem here of course is one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?

The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power. The Agency simply needs to do it’s job.

TAKE ACTION

Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements? The answer is simple.

There are a lot of vested interests which are threatened by supplements. Drug companies do not like them because they represent a low cost, safer, and often more effective alternative to drugs. The FDA does not like them because supplements do not come through the FDA approval process and therefore do not support the FDA budget.

Why not simply require that supplements be brought through the FDA’s drug approval process? Wouldn’t that create a level playing field?

That is probably the argument that Senator McCain has been sold. But it is a completely false argument. The FDA drug approval process costs as much as a billion dollars. It is not economically feasible to spend such vast sums on substances that are not protected by patent, and natural substances cannot legally be patented.

This is the great “Catch 22” of American medicine. The FDA, which is supposed to guard and promote our health, is hostile to the kind of natural medicine—based on diet, supplements, and exercise—that represents the real future of healthcare. The Agency has either been captured by drug interests or is trapped in a catastrophically expensive, toxic, and ineffective patented-drug model.

Senator McCain has no doubt offered this bill in good faith. But he has been sold a bill of goods by special interests. And he has been naïve enough not to know that he is being used.

TAKE ACTION

This exceptionally bad bill also requires the reporting of all minor adverse events related to supplements. This is in addition to the already existing requirement to report adverse events. This will further stack the deck against small supplement companies by creating new, unnecessary, even more cumbersome, and of course very expensive administrative hurdles. The result: the consolidation of the supplement industry into a few big companies.If passed, this bill will likely result in the disappearance from store shelves of many supplements currently on the market. In addition to fewer supplements, there would likely be much lower doses available. Unbridled authority would be handed to the FDA, an agency that needs a top to bottom overhaul, not ever more power over our lives.

The FDA will like this because it believes that it can more easily control a few industry giants. But isn’t it more likely that the industry giants will eventually gain control over the FDA?

The FDA is already misusing the adverse event reporting process that exists. Drugs rack up thousands of adverse event reports without any action. Just recently, the FDA yanked from the market a supplement product based on just a couple of alleged adverse event reports without even allowing the company (an old and respected firm) to provide any counter-evidence or counter-argument.

The bill also allows the FDA to yank a product (at the company’s expense) if there is a “reasonable probability” that it is “adulterated” or “misbranded”. Let’s remember that “adulterated” could mean there is a minor record keeping error on the producer’s part and “misbranded” can mean that the producer simply tells the truth about the product. An “adulterated” and “misbranded” supplement in Orwellian FDA speak may actually be both completely safe and effective.

If passed, this bill will likely result in the disappearance from store shelves of many supplements currently on the market. In addition to fewer supplements, there would likely be much lower doses available. Unbridled authority would be handed to the FDA, an agency that needs a top to bottom overhaul, not ever more power over our lives.

If McCain’s bill passes, we can look to Europe for a snapshot of what we may be in for: EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot. Europeans already look to the US to obtain their dietary supplements. If this bill passes, where will we obtain ours?

Please take action immediately. TAKE ACTION Tell your senators NOT to co- sponsor this legislation and to do everything in their power to defeat it. Then forward this to your friends and family and ask then to do the same!

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In December, 2009, Bloomberg News published an investigative report by David Evans reported, “Big Pharma’s Crime Spree” documenting major court settlements:

“Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug
companies have paid a total of $7 billion in fines and penalties. Six of the
companies admitted in court that they marketed medicines for unapproved
uses.”

See: http://www.bloomberg.com/apps/news?pid=20601109&sid=a4yV1nYxCGoA&pos=10
and http://www.ahrp.org/cms/content/view/653/109/

Indeed, it is estimated that 15% of drug sales in the U.S. are for unapproved uses “without adequate evidence the medicines work.”

Below, The Wall Street Journal brings the criminal rap sheets of pharmaceutical industry giants up to date: Novartis, Astra Zeneca, Johnson & Johnson.

Several points need to be borne in mind:

1. The prescription drug industry has descended into criminal marketing that includes fraud, evidence falsification, bribery and kickbacks–all to expand the market.

2. The drugs involved in criminal marketing are hazardous toxic drugs whose severe adverse effects–including drug-induced life-shortening chronic disease–far outweigh any trivial short-term clinical benefit. Had the
evidence of the magnitude of harm been fully disclosed, these drugs would not have been approved in the first place.

3. Unless and until company CEO’s and the prominent bought and paid for physicians involved in the criminal promotion of harmful drugs are tried and imprisoned for these crimes, companies will escalate the scope of criminal
drug promotion because the financial incentives are so large and the penalties are a pittance by comparison.

As Shelley Slade, a former Justice Department lawyer who now represents corporate whistleblowers through the firm Vogel, Slade & Goldstein LLP, in Washington, D.C. said: large criminal monetary penalties and civil settlements don’t appear to deter companies sufficiently.

“It’s not going to stop until the government puts some of these executives in jail,” she said.
“Many of these companies view the fines as a small fraction of what they have gained through illegal schemes, and just a cost of doing business.

by Vera Hassner Sharav

ALLIANCE FOR HUMAN RESEARCH PROTECTION
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and
Accountability
http://www.ahrp.org

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FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, January 15, 2010

NLM Censors Nutritional Research

Medline is Biased, and Taxpayers Pay for It

Comment by Andrew W. Saul
Editor-In-Chief, Orthomolecular Medicine News Service

(OMNS, January 15, 2010) Did you know that there are “good” medical journals, and that there are “naughty” medical journals?

No kidding. The good journals are easy to access on the internet through a huge electronic database called Medline This wonderful, free service is brought to you by the US National Library of Medicine and the National Institutes of Health. In other words, by you. By your tax dollars. Generally it is money well spent, until you go searching for megavitamin therapy research papers. Then you will find that you can’t find all of them. That is because of selective indexing.

The National Library of Medicine (NLM) proudly describes itself as “the largest medical library in the world. The goal of the NLM is to collect, organize and make available biomedical literature to advance medical science
and improve public health.”

Hmm. Collect. Organize. Make available. Improve public health.
So, after over 40 continuous years of publication, why is the Journal of Orthomolecular Medicine NOT indexed by Medline? And what are the consequences of such exclusion? In a nutshell, it stops the public from using their computers to learn about all of the scientific research and clinical reports demonstrating the effectiveness of megavitamin (orthomolecular) therapy. It also greatly hampers professionals from seeing pro-vitamin studies.

Have you ever wondered why your doctor simply does not know about vitamin therapy?

Well, wonder no longer. He or she can’t read what isn’t “collected,” electronically indexed, or otherwise “made available” to them.

If the vast majority of journals indexed by Medline are pharmaceutical-friendly, and yet nutritional research is censored, what can you expect?

Your taxes should not be used to fund censorship in a public library,  especially the largest medical library on the planet. It is un-American.

Of course, Medline doesn’t censor everything nutritional. Here is a current example of some research that Medline does in fact choose to index:
PIZZA PREVENTS HEART ATTACKS
Gallus S, Tavani A, La Vecchia C. Pizza and risk of acute myocardial
infarction. Eur J Clin Nutr. 2004 Nov;58(11):1543-6.
“Some of the ingredients of pizza have been shown to have a favourable
influence on the risk of cardiovascular disease. However, there is no single
explanation for the present findings.”

PIZZA PREVENTS CANCER
Gallus S, Bosetti C, Negri E, Talamini R, Montella M, Conti E, Franceschi
S, La Vecchia C. Does pizza protect against cancer? Int J Cancer. 2003 Nov
1;107(2):283-4.
“We analyzed the potential role of pizza on cancer risk, using data from an integrated network of case-control studies. . . Pizza appears therefore to be a favorable indicator of risk for digestive tract neoplasms in this
population.”

But be careful of that olive oil

Wong GA, King CM. Occupational allergic contact dermatitis from olive oil
in pizza making. Contact Dermatitis. 2004 Feb;50(2):102-3.

MORE PIZZA
Here is my all-time favorite: yet another article that Medline actually is indexing. It is not even from a medical journal. I am not making its mile-long title up, either. It is there at Medline, right now, just a few
clicks away from you:

Simon HB.  “My husband subscribes to Harvard Men’s Health Watch, but I read
it even more than he does. I hope you can help us resolve a disagreement. He wants to have pizza two to three times a week for his prostate, but I don’t think it’s a healthy food. Who is right?” (Harvard Men’s Health Watch.
2003 Jun;7(11):8.)

Evidently the very name “Harvard” is enough to get your foot inside the Medline door. That, or “everything but anchovies.”
Oddly enough, the Journal of Orthomolecular Medicine has not published a single article on pizza. At least not so far. Maybe if it did, it would make the cut at Medline.
On the other hand, the Journal of Orthomolecular Medicine has a review board including medical doctors, university faculty, and hospital-based researchers. Since 1967, it has published over 600 papers by renowned authors
including Roger J. Williams, Emanuel Cheraskin, Carl C. Pfeiffer, Bernard Rimland, Abram Hoffer, and Nobel Prize winner Linus Pauling. You should be able to access abstracts (concise summaries) of these papers, instantly and forfree, via Medline. Well, you can’t.

My addition:

Since the National Library of Medicine and the National Institute of Health do not have to take your complaints seriously, I suggest you write to your Members of Congress, you each have one representative and 2
Senators. I am attaching 2 form letters for you to send asking your congressmembers to contact the chairmen of the committees that have jurisdiction over these agencies and those who appropriate funds for their operation and demand that rigorous scientific research on nutritional properties of foods be included in medline. The authoritative medical database that practitioners and consumers use should not be restricted to patented prescription drugs that inflate medical costs.
Select the letter and copy it onto your browser, when you get to your
congressmembers page you can paste it onto area for your comments. Remember to
put in your Representatives name

In order to find your congressional representative go to
(http://www.house.gov)

Click on Write your representative on left side. Select your state and put in your zipcode. The representative contact page will come up. In order to use my form letter.

In order to write your senators using my form letter download
“SenateMedlinefmltr” select the letter and copy it onto your browser. go to (http://www.senate.gov) find your state at the top right. Each state has 2 senators. Write to both.

Click on web form write page.You can go directly to your senators contact page.
When you get to the place for your message paste my form letter into the page.
Remember to put in your senators name.
Eventually we will get this information included in the medline index. If
possible call your legislators and ask who is handling Health Issues for the Congessmember if they trying to contact the legislators in charge of oversight of the National Library of Medicine on this issue.
“The National Library of Medicine refuses to index the Journal of
Orthomolecular Medicine, though it is peer-reviewed and seems to meet their
criteria.” (Psychology Today, Nov-Dec 2006)

NOTE: Four decades of papers from the Journal of Orthomolecular Medicine
are now online for you to read, Medline or no Medline, at
(http://orthomolecular.org/library/jom/)

The JOM Archive is a free service with no advertising.

(Andrew W. Saul taught nutrition, health science and cell biology at the college level. He is the author of Doctor Yourself and Fire Your Doctor! and, with Dr. Abram Hoffer, co-author of Orthomolecular Medicine for Everyone
and The Vitamin Cure for Alcoholism. Saul is featured in the documentary film Food Matters. He is on the Editorial Board of the Journal of Orthomolecular Medicine.) Nutritional Medicine is Orthomolecular Medicine
Orthomolecular medicine uses safe, effective nutritional therapy to fightillness.

For more information: http://www.orthomolecular.org
The peer-reviewed Orthomolecular Medicine News Service is a non-profit and
non-commercial informational resource.
Editorial Review Board:
Carolyn Dean, M.D., N.D.
Damien Downing, M.D.
Michael Gonzalez, D.Sc., Ph.D.
Steve Hickey, Ph.D.
James A. Jackson, PhD
Bo H. Jonsson, MD, Ph.D
Thomas Levy, M.D., J.D.
Jorge R. Miranda-Massari, Pharm.D.
Erik Paterson, M.D.
Gert E. Shuitemaker, Ph.D.
Andrew W. Saul, Ph.D

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