Showing posts with label MMR. Show all posts
Showing posts with label MMR. Show all posts

July 19, 2011

Revisiting James Murdoch, Brian Deer, The Sunday Times, GlaxoSmithKline and the Attack on Andrew Wakefield

So I started writing a long piece on the James Murdoch/Sunday Times/GSK/Wakefield development, but Dan Olmsted and John Stone did it faster and better than I, so I will just point you there and add my .02.  Which is...

How long does this ridiculous charade have to go on?!

I mean how many of those who have quite obviously be put to task defending an indefensible vaccine program have to be revealed as... well... less than earnest, by main stream sources, before those earnest people in the medical profession, who really care about health outcomes and the public trust, throw up their hands and say... "Well... yes... this has become quite absurd.  Let's stop all the nonsense and sit down at the table with our critics and deal with the real problems."

Let's make a short list of the industry protectionist standard bearers at the various levels and their credibility... well let's call them "weaknesses."

Julie Gerberding:  Claims that she never bothered to read the Poling case, that vaccines can and cannot cause autism, that children with mitochondrial disorders can develop "autism like syndrome" from their vaccines, then upon leaving her post at CDC became the head of vaccines for Merck, who makes the MMR vaccine that damaged Hannah Poling.

Paul Offit: Reprimanded by Congress for his conflicts of interest, successfully sued by the head of Jenny McCarthy's charity for lying about him in a book, had the OC Register retract an article where he made false accusations against CBS News, makes stupid and irresponsible claims that a baby can safely receive 100,000 vaccines at once, gets caught misleading the public and failing to disclose conflicts of interest on a regular basis.

David Gorski: Forgot to mention that he was developing a cancer/autism drug for vaccine maker Sanofi for like five years or something while attacking vaccine safety activists and autism treatment advocates.

Paul Thorsen:  Middle aged club kid under indictment for conspiracy and fraud.

Brian Deer: Lied to families about his name to get them to agree to interviews, feels qualified to diagnose GI disorders on the street despite having no medical background, does not even know the basics of the vaccine causation arguments or who is on what side, routinely says things that are at best, embarrassing, at worst, suggest some ... issues.

Seth Mnookin:  An admitted criminal.

GlaxoSmithKline: Who has the time. Just google "Glaxo Fraud."

And now James Murdoch and the Sunday Times.

Lets take a step into the way back machine and revisit my little chart on the obnoxious level of conflict of interest in those who were... *ahem* protecting the British people's interest by examining the conflicts of interest of Dr. Wakefield and his co-authors in a paper that pointed out that 8 kids started having serious GI problems after MMR and also had developmental disabilities. I have faded out the later comers to the game to focus on the players who started all this bother:


Click to see it full sized

We have of course been pointing out Murdoch's little credibility problem with being placed on the board of GlaxoSmithKline after his Sunday Times began the whole Wakefield attack, but of course, we were just conspiracy theorists for pointing out that little conflict of interest. How dare we impugne the integrity of blah, blah, blah...

So now we learn that Murdoch the Younger is not above doing horrid, and bottom feeder like things to make a buck.  Possibly not even illegally obtaining the private medical information of the child of the leader of his country. If Mr. Brown's son's cystic fibrosis is not something to be handled sacredly, earnestly and above board, what's next, having reporters lie about who they are to autism parents to get info for a hit piece on their doctor?  Oh... never mind.

But no fear for Murdoch that GSK will turn on him... despite his failing morality, he still far exceeds the standards of respectability required to be a board member of GSK, who is standing behind their man for all he has done for their company:

James Murdoch to remain on GSK's board

* Drugmaker says Murdoch has made strong contribution

* Investigations need to run their course

* News Corp executive also sits on Sotheby's board

By Ben Hirschler

LONDON, July 15 (Reuters) - GlaxoSmithKline , Britain's biggest drugmaker, said James Murdoch continued to serve as a non-executive director, and it would watch investigations into the phone-hacking scandal engulfing his family's newspaper business.

The 38-year-old heir apparent to his father Rupert Mordoch's News Corp joined GSK's board in 2009, since when he has made "a strong contribution", a GSK spokesman said on Friday.

In recent days, James Murdoch's reputation has taken a pummelling, with critics saying he was too slow to realise the enormity of the scandal at News International, the British newspaper unit he chairs.

GSK -- a group with plenty of experience of corporate controversy, ranging from rows over executive pay to safety alarms about some of its medicines -- will watch developments closely and is not rushing to any judgments.

"With regard to the activities that are alleged to have taken place at News International, we believe that the full facts must be established and the ongoing investigations be allowed to take place and come to a considered conclusion," the spokesman said.

James Murdoch was paid 98,000 pounds ($158,000) in shares for serving on GSK's board in 2010. He is member of both the drugmaker's corporate responsibility and remuneration committees.

He is also a non-executive director of U.S.-listed auction house Sotheby's .

The News International chairman said on Friday his company would take out adverts in rival British newspapers this weekend to apologise to the nation for wrongdoing at the News of the World, the Sunday paper at the centre of the scandal. ($1 = 0.620 pound) (Editing by Dan Lalor)

(Note that the story is published by Reuters, whose CEO is also on the board of Merck. That other MMR maker. Conspirators Corporate Synergists must stick together, you know)

He has made one hell of a contribution!  He made the salvation of MMR possible.  GSK can't very well abandon their hit man.  If he falls completely, then might more people wake up to the idea that what was done to Wakefield was a scapegoating?  Best to see if you can get away with keeping him on to assure your "corporate responsibility", and hope no one notices that you are trying to keep him propped up to keep your skeletons in the closet.

Can anyone name ONE person who has been out in front in the vaccine defense that actually has a good reputation, is an earnest person and is free of serious conflicts of interest?  I can't think of any at the moment.

So... when the next one pops up, I am going to start the clock running and see how long it takes for their questionable history to start to come to light.

It is just stupid at this point.





January 15, 2011

Deer's MMR Wakefield "Fraud" Story Not Playing in the UK, Deer's Wheels Coming Off His Cart

The Bash Wakefield crew seems to finally have overplayed its hand in the UK. And Deer... well... true colors are showing.

For the last two weeks, the US media has been pounding Deer's fraud allegations. The UK media has ignored them.

In the US, a CNN blogger is calling for Wakefield to be brought up on criminal charges (ironically... even outright mentioning Galileo in his piece). In the UK.... no calls for new investigations, no interviews with prosecutors, no pitchfork wielding mobs calling for Wakefield's head.

Because in the UK, they have been following this story for a decade, they know what is up with it, they know what a weaselly figure Brian Deer is and they are not falling for it. The lapdog media there is not even falling for it. The US media apparently was handed a press release, saw that the British Medical Journal's name was on it, and having no understanding of the case or the players, or what making actual fraud allegations would mean legally, just parroted it.

Child Health Safety reports today that Brian Deer is angry that the only coverage he could get there was the Guardian allowing him to write a blog, which could well have been titled, "Someone Please, Please Pay Attention To Me." And even the blog piece is not being received by the readers it is getting.

In it, Deer recounts his glorious MMR protection and declares that, "13 years passed before I slayed the MMR monster." I get the sense that he is disappointed that he has not been hoisted on the shoulders of a teeming mass of mothers and carried triumphantly through the streets of London.

Shockingly, Deer lashes out against the medical establishment for... get this... PROTECTING Andrew Wakefield! He chastises Ben Goldacre and Paul Offit for not being hard enough on him!

I don't even know what to do with Deer's reference to "a single, severed hand may yet come crawling across the floor."

I am sure this column in the Guardian must have been met with a flurry of text messages betwixt board rooms hither an yon saying, "someone tell Deer to shut up before this whole thing falls apart". (Update: CHS now reporting that Deer has actually shut up.)

And I wonder why his blog was not run in the Sunday Times and if the BMJ is cringing at their endorsement of him.

These charges of fraud are based on the word of Brian Deer alone, as none of us has access to the children's records or interviews with the parents to confirm his claims. And these claims are coming from a man who believes he can be a journalist AND the complainant in the GMC trial, lied to the Lancet 12 parents about his name, calling himself "Brian Lawrence", to get interviews with them and who not only writes very self-aggrandizing pieces (to put it mildly) but posts a page of 36 pictures of himself on his journey from babe to "MMR Monster Slayer" on his journalism blog.



I feel that I am being kind in characterizing Brian Deer as someone whose honesty and judgment one might be wise to question.

Bottom line, it is not being covered in the UK, because there is no fraud. If they cover it, they have to interview prosecutors for interviews and prosecutors know there is no crime here. Worse... the media would have to start asking... "Hey... I know I can't get access to, or publish, private medical records... how 'come Deer can?"

And GSK has to be a little concerned about calls in the UK for criminal proceedings... God Forbid that the parents of these kids are allowed to testify, which they would have to be, and the news carries the fact that the 12 children in the study went in sick and came out better! Then its heads on a platter for the GMC who took away the licenses of doctors who heal very sick children, and a decade and millions in work on the End Wakefield project goes right out the window.

January 7, 2011

Recycling Old Wakfield: Anatomy of a Witch Hunt

Reposing a piece I wrote from a year ago. Or Two Times Ago in the "We Declare Wakefield Debunked" efforts timeline (I think we had three rounds in 2010, but I would have to check). All of it still applies, especially the part where six months from now nothing will have changed in the public skepticism of vaccine safety. What with this paper being such a small part of the vaccine/autism case.

According to Pharma scheduling, I am guessing we will see another media push sometime later this year, but we can probably set our clocks that we will be doing the Wakefield Dance next January as well. Pharma seems to like to start off their year fresh by declaring Andy dead, as they are making a habit of it:

Feb 12, 2010

Anatomy of a Witch Hunt

Much has happened in the last few weeks surrounding Andrew Wakefield, and I have not been available to write about it. It has been truly frustrating to see this story reported as if the GMC hearing was legit and The Lancet as if it was a respectable and unbiased publication, rather than the dog fight between corporate interests and safety advocates that it actually is. Was the fact that 21 autism organizations in the US and UK filed perjury charges against the head of the Lancet for lying about Wakefield's disclosures of his conflicts in the GMC hearing not relevant to the fact that the Lancet retracted Wakefield's article the following week? Apparently the press didn't think so.

Also fascinating that they have tried to portray Wakefield as the guy that invented the autism/vaccine connection, despite the fact that Leo Kanner reported that one of his first 11 cases in the 1940's was a regression following a smallpox vaccine, the VCIP has been paying autism cases for 25 years, and I first heard about the connection in my undergrad psych program in 1988 at George Mason University, so that they can use this GMC hearing to declare the vaccine controversy over. (I have forty or so studies on my "no evidence of any link" page supporting the vaccine/autism connection and I have never even had Wakefield's MMR paper up there.

Fortunately AOA has been all over this.

Today I had an hour and started mapping out the conflicts on interests in all of the forces that are posing as unbiased sources and trashing Wakefield and his work by charging him with conflicts of interest. The irony is lost on too many people.

It is a work in progress. One of my friends in the UK is looking it over to help fill in more of the blanks, so it will be updated.

A few notes not on the chart. Judge Nigel Davis is the judge who ruled that families trying to sue GlaxoSmithKline for the damage done to their children by the MMR would not be given legal aid to do so, ending MMR litigation in the UK. His brother is Sir Crispin Davis, who was the CEO of Elsevier, publisher of The Lancet and was also on the board of GlaxoSmithKline. Additionally... Paul Offit is an industry spokes person for Merck, that was too long to fit into the chart, so I used the more pejorative, "lap dog". And there is word out this afternoon that another Elsevier journal may be trying to bury the Hep B monkey study that Wakefield worked on, although no word from the journal on this yet.

Look at the energy flow in this thing... Props to Dr. Wakefield and his compadres for not backing down under this insane amount of industrial pressure. I mean just look at this billion dollar medical/pharma/media/(arms sales?) unprincipled conglomco machine! Eliot Ness wasn't even up against this big of a beast when he took on the mob. And I have not even included any of the public health infrastructure, or the GMC in this flow chart.

Keep your head up England, and understand that you are under a blitz. They are now officially throwing everything they have at you and they are only exposing their own corruption. Never, never, never, never give up.

Problem for the beast is... they are using all their ammo, and six months from now, nothing will have changed for them. Because the public knows they are full of crap.

click to see it full size.



UPDATE:

A friend in the UK brought something interesting to my attention. It is a flow chart done by a journalist in 1994 on how money and influence flowed around the Burroughs Wellcome pharmaceutical company and all it's satellites (foundations, trusts, doctors, medical institutions, universities, medical journals and even regulatory agencies). One of which is the Wellcome Trust.

I invite to you take a look at the amazingly, unbiased and completely free of conflicts of interesty type research that Wellcome is funding, by reading my piece on Professor Alan Emond's study that shows that kids with autism don't have bowel problems. He claims no conflicts of interest, but fails to mention that he is on the UK's Joint Committee on Vaccination and Immunisation (Britian's version of the CDC's Advisory Committee on Immunization Practices.)

The chart certainly enhances the understanding of how the machine works, but the two facts that make this flow chart so much more interesting is that Burroughs Wellcome of course became Glaxo Wellcome, which became GlaxoSmithKline, who makes the MMR; and that the journalist that created this chart was Brian Deer.



UPDATE: One commenter was looking for a source for my 20 billion dollar figure.

Drugmakers, Doctors Rake in Billions Battling H1N1 Flu
Swine Flu Is Bad for Victims, But Good for Businesses That Cater to Expanding Market
By DALIA FAHMY
Oct. 14, 2009
ABC News/Money

Americans are still debating whether to roll up their sleeves for a swine flu shot, but companies have already figured it out: vaccines are good for business.
h1n1.

Drug companies have sold $1.5 billion worth of swine flu shots, in addition to the $1 billion for seasonal flu they booked earlier this year. These inoculations are part of a much wider and rapidly growing $20 billion global vaccine market.

"The vaccine market is booming," says Bruce Carlson, spokesperson at market research firm Kalorama, which publishes an annual survey of the vaccine industry. "It's an enormous growth area for pharmaceuticals at a time when other areas are not doing so well," he says, noting that the pipeline for more traditional blockbuster drugs such as Lipitor and Nexium has thinned.

As always with pandemic flus, taxpayers are footing the $1.5 billion check for the 250 million swine flu vaccines that the government has ordered so far and will be distributing free to doctors, pharmacies and schools. In addition, Congress has set aside more than $10 billion this year to research flu viruses, monitor H1N1's progress and educate the public about prevention.

Drugmakers pocket most of the revenues from flu sales, with Sanofi-Pasteur, Glaxo Smith Kline and Novartis cornering most of the market.

But some say it's not just drugmakers who stand to benefit. Doctors collect copayments for special office visits to inject shots, and there have been assertions that these doctors actually profit handsomely from these vaccinations.

It is a notion that Dr. Lori Heim, president of the American Academy of Family Practitioners, says is simply not true.

"According to most of the physicians I have talked to, the administration of these vaccines is done for the community's benefit as opposed to anything that helps profit," she says. Heim adds that even though doctors will not have to shell out for the H1N1 vaccine, they will bear the usual costs associated with storage and administering the shots.

"There is an administration fee, for the costs that you can't get reimbursed through Medicare or Medicaid," she says. "This is usually less than, or right at the break-even point."

Still, pharmacies also charge co-payments or full price of about $25 to those without insurance and often make more money if patients end up shopping for other goods.

"Flu shots present a good opportunity to bring new customers into our stores," says Cassie Richardson, spokesperson for SUPERVALU, one of the country's largest supermarket chains. Drawing customers to the back of a store, where pharmacies are often located, offers retailers a chance to pitch products that might otherwise go unnoticed.

Even companies outside of the medical industry are benefiting: the UPS division that delivers vaccines in specially designed containers, for example, has seen a bump in business.

New Entrants in Flu Shot Business

The intensifying competition has irked some doctors.

"Retailers and other non-medical professionals have siphoned off the passive income that once helped to cover medical overhead," says Dr. Caroline Abruzese, an internist in Atlanta. "The larger retail chains can invest up front in large volumes of vaccine at low prices, and market to customers already in their stores."

The promise of profits has attracted new players into the business. Some of the world's largest drugmakers, who in the past avoided the vaccine market because of its limited scope -- its not easy to convince healthy adults to get a shot for measles -- are now jumping into the fray.

Last month alone saw three large vaccine deals. Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm that makes and develops flu vaccines. Merck, which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL.

Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry.

Large and small drugmakers are drawn to the business largely because of scientific advances that promise to radically expand the range of health problems that vaccines can address. In addition to preventing childhood diseases such as measles and polio, vaccines can now also ward off cervical cancer, and researchers are working on vaccines for HIV and tuberculosis.

Scientists believe they can create therapeutic vaccines than treat diseases such as Alzheimers and diabetes after they have set in. (At least one company is betting on a vaccine that helps cigarette smokers quit.)

"These innovations broaden the market potential for vaccine makers and partly explained the renewed interest by drugmakers," says Anthony Cox, a professor at Indiana University's Kelley School of Business who specializes in the marketing of medical products.

But Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents the country's leading pharmaceutical research and biotechnology companies, says that drugmakers are also compelled by the government to join efforts to ensure that there is enough vaccine to go around.

"Because of national security implications, the government felt that they needed to encourage and ask [vaccine manufacturers] to move much quicker," he says. Grayson adds that vaccine manufacturers also face significant costs; aside from the expense of fitting a new vaccine into a tight production schedule, drugmakers GlaxoSmithKline and Sanofi Pasteur were forced to acquire new vaccine production facilities in recent years to keep up with demand.

Alternatives to Vaccines Are Few

While this promise of new treatments for painful diseases brings hope to many, vaccines continue to attract critics. The National Vaccine Information Center, a non-profit advocacy group, is at the forefront of a movement demanding that vaccines be tested more thoroughly before hitting the market. Although there has been little evidence to support their claim, detractors -- including the comedian Jim Carrey -- believe that vaccines are at least partly to blame for the sharp rise in autism in recent decades.

The swine flu vaccine has also attracted its share of critics. Frank Lipman, a New York-based doctor who specializes in a mix of Western and alternative medicine, points out that the swine flu is rarely fatal and that it's too early to tell if it's safe because it hasn't been widely tested.

Others argue that Americans have little choice. The cost of a widespread pandemic, similar to Spanish Flu outbreak in 1918, which killed 675,000 Americans (and 50 million worldwide), would be devastating. The Trust for America's Health, a Washington-based non-profit organization, estimates that a severe pandemic could push down GDP by more than 5 percent and cost Americans $683 billion.

"We're not seeing a pandemic that's this severe," says Jeff Levi, director of Trust for Americas Health. "We've dodged a lot of bullets."

September 9, 2010

Vaccines Don't CAUSE Autism, They Just RESULT in Autism

(looking at my stopwatch) aaaaaaaaand time!

Hannah Poling finally gets paid for her vaccine induced resulted autism.

So if a brilliant Johns Hopkins neurologist and his super smarty nurse/lawyer wife file a vaccine injury claim for their daughter, that is such a slam dunk case that the government does not even bother to fight it but concedes the case, they can expect to wait, let see... add the four, carry the three, divide by pain and suffering and... oh, thats not bad... ONLY ten years, one month and two weeks or so after the child is injured to be paid by the government. Yep! That is one compassionate program alright!

Mind you the Polings have been dragged through the mud, personally and professionally, for daring to file in the VICP and win to get money to help their daughter. Oh... and they also had the bad taste to tell people. In public even. Bastards.

But at least we have finally gotten a straight answer from the government on whether or not vaccines cause autism. Turns out that vaccines don't "cause" autism, they just "result" in autism. From CBS News:

In acknowledging Hannah's injuries, the government said vaccines aggravated an unknown mitochondrial disorder Hannah had which didn't "cause" her autism, but "resulted" in it.

THANK GOD! Parents, you can go back to blindly trusting their government. All your questions and concerns about the safety of the vaccine program have been asked and answered with the utmost integrity and with thorough thoroughness.

Sleep in peace citizens. All is well.

Government heath care is awesome.  More government health care please.

(And I hope Hannah fully recovers and buys a Ferrari with whatever is left of her 1.5 mil)


Update:

I thought I might include this email from David Bowman at HRSA. He sent it to David Kirby last year in response to an inquiry.

From: Bowman, David (HRSA) [mailto:DBowman@hrsa.gov]
Sent: Friday, February 20, 2009 5:22 PM
To: 'dkirby@nyc.rr.com'
Subject: HRSA Statement

David,

In response to your most recent inquiry, HRSA has the following
statement:

The government has never compensated, nor has it ever been ordered to
compensate, any case based on a determination that autism was actually
caused by vaccines. We have compensated cases in which children
exhibited an encephalopathy, or general brain disease. Encephalopathy
may be accompanied by a medical progression of an array of symptoms
including autistic behavior, autism, or seizures.

Some children who have been compensated for vaccine injuries may have
shown signs of autism before the decision to compensate, or may
ultimately end up with autism or autistic symptoms, but we do not track
cases on this basis.

Regards,

David Bowman
Office of Communications
Health Resources and Services Administration
301-443-3376

So again... vaccines cause encephalopathy which progresses into autism, but vaccines don't cause autism. And by the way, HHS does not track whether or not vaccines cause autism, they just pay attention to cases where vaccines cause encephalopathy. Then they stick their fingers in their ears and yell "la la la, I'm not listing", when parents come back a month later and say their child has been diagnosed with autism.

Why does anyone take vaccine advice from these people? Why did I?


Nostalga Update:

Oh alright... one more time just for fun.



And for those of you who would like to reminise more about the absurdity of the governments position on the Poling decision: Spinning the Hannah Poling Case

HOLY CRAP UPDATE: Hannah is not getting 1.5 mil, she is getting around 20 million dollars!

CBS has updated their post to read:

"The first court award in a vaccine-autism claim is a big one. CBS News has learned the family of Hannah Poling will receive more than $1.5 million dollars for her life care; lost earnings; and pain and suffering for the first year alone.

In addition to the first year, the family will receive more than $500,000 per year to pay for Hannah's care. Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime".

The government is paying Hannah Poling 20 million dollars for a vaccine injury that the same government claims does not exist.

I am speechless.

July 15, 2010

We Finally Get a Vaxxed v. Unvaxxed Study, Vaccinated Primates Have Brain Changes Seen In Autism

We finally get a vaccinated v. unvaccinated study. No... no actual children yet, but infant rhesus macaque monkeys.



And no wonder main stream medicine doesn't want vaccine studies with an actual baseline (completely unvaccinated), because the results are dramatic.

The infant primates vaccinated according to the US vaccine schedule (equivalent to their size/development rate, pre 2002 shots WITH full doses of mercury) showed the same brain changes found in children with autism. The amygdala, the fear and anxiety center, did not mature properly in the vaccinated group, and those differences did not appear until AFTER the 12 month vaccines were given.

The abstract:

Influence of pediatric vaccines on amygdala growth and opioid
ligand binding in rhesus macaque infants: A pilot study

Acta Neurobiol Exp 2010, 70: 147–164
©2010 by Polish Neuroscience Society - PTBUN, Nencki Institute of Experimental Biology

Laura Hewitson1,2,*, Brian J. Lopresti3, Carol Stott4, N. Scott Mason3 and Jaime Tomko1

1Department of Obstetrics and Gynecology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA;
2Thoughtful House Center for Children, Austin, TX, USA; 3Department of Radiology, University of Pittsburgh School of
Medicine, Pittsburgh, PA, USA; 4Independent Chartered Scientist, Cambridge, UK;
*Email: lch1@pitt.edu

This longitudinal, case-control pilot study examined amygdala growth in rhesus macaque infants receiving the complete US childhood vaccine schedule (1994-1999). Longitudinal structural and functional neuroimaging was undertaken to examine central effects of the vaccine regimen on the developing brain. Vaccine-exposed and saline-injected control infants underwent MRI and PET imaging at approximately 4 and 6 months of age, representing two specific timeframes within the vaccination schedule. Volumetric analyses showed that exposed animals did not undergo the maturational changes over time in amygdala volume that was observed in unexposed animals. After controlling for left amygdala volume, the binding of the opioid antagonist [11C]diprenorphine (DPN) in exposed animals remained relatively constant over time, compared with unexposed animals, in which a significant decrease in [11C]DPN binding occurred. These results suggest that maturational changes in amygdala volume and the binding capacity of [11C]DPN in the amygdala was significantly altered in infant macaques receiving the vaccine schedule. The macaque infant is a relevant animal model in which to investigate specific environmental exposures and structural/functional neuroimaging during neurodevelopment.

Key Words: rhesus macaques, Macaca mulatta, non-human primates, animal model, neuroimaging, PET, MRI, amygdala, opioids, ethyl mercury, thimerosal, neurotoxicity

The full paper: Hewitson et. al.

The editorial written by the editor of the journal, who says:

An alarming finding is reported by Hewitson and coworkers showing that, in infant monkeys that were immunized, the amygdala does not show the normal pattern of maturation but is hypertrophied. Although these are only preliminary data, given the well-known role of the amygdala in generation of fear and other negative emotions, they support the possibility that there is a link between early immunization and the etiology of autism.

Mark Blaxill and Dan Olmsted's discussion of the paper: New Study Shows Vaccines Cause Brain Changes Found in Autism

It should be noted that in the spring of 2008, The American Academy of Pediatrics was informed of this study. At the conclusion of the DAN conference in Cherry Hill, NJ in April of 2008, Dr. Jerry Kartzinel personally discussed it with Dr. Louis Cooper who was there representing the AAP. Cooper skirted the issue, acting as if he was concerned with the cost of the study, and Kartzinel replied that the study was fully funded and underway. Cooper was clearly not comfortable with the discussion of the study, and changed the subject. In their discussion of what Cooper had seen at the conference and how to proceed with some sort of partnership between ARI and AAP, Cooper had already stated to Kartzinel:
"I’m concerned about immunization policy and how you protect immunization."

To my knowledge, AAP never got back to anyone on their input into, or involvement with, this primate study. Note that the study was not published by Pediatrics, where it belongs, as it is AAP's journal and AAP is Pharma's main vaccine distributor. I am sure they want this buried as deep as is possible.

I am interested to see what AAP's public comment will be on this. If there is one.

AAP's (@ameracadpeds)twitter page can be found here: http://twitter.com/ameracadpeds

Feel free to call this post to their attention.

February 12, 2010

Anatomy of a Witch Hunt

Much has happened in the last few weeks surrounding Andrew Wakefield, and I have not been available to write about it. It has been truly frustrating to see this story reported as if the GMC hearing was legit and The Lancet as if it was a respectable and unbiased publication, rather than the dog fight between corporate interests and safety advocates that it actually is. Was the fact that 21 autism organizations in the US and UK filed perjury charges against the head of the Lancet for lying about Wakefield's disclosures of his conflicts in the GMC hearing not relevant to the fact that the Lancet retracted Wakefield's article the following week? Apparently the press didn't think so.

Also fascinating that they have tried to portray Wakefield as the guy that invented the autism/vaccine connection, despite the fact that Leo Kanner reported that one of his first 11 cases in the 1940's was a regression following a smallpox vaccine, the VCIP has been paying autism cases for 25 years, and I first heard about the connection in my undergrad psych program in 1988 at George Mason University, so that they can use this GMC hearing to declare the vaccine controversy over. (I have forty or so studies on my "no evidence of any link" page supporting the vaccine/autism connection and I have never even had Wakefield's MMR paper up there.

Fortunately AOA has been all over this.

Today I had an hour and started mapping out the conflicts on interests in all of the forces that are posing as unbiased sources and trashing Wakefield and his work by charging him with conflicts of interest. The irony is lost on too many people.

It is a work in progress. One of my friends in the UK is looking it over to help fill in more of the blanks, so it will be updated.

A few notes not on the chart. Judge Nigel Davis is the judge who ruled that families trying to sue GlaxoSmithKline for the damage done to their children by the MMR would not be given legal aid to do so, ending MMR litigation in the UK. His brother is Sir Crispin Davis, who was the CEO of Elsevier, publisher of The Lancet and was also on the board of GlaxoSmithKline. Additionally... Paul Offit is an industry spokes person for Merck, that was too long to fit into the chart, so I used the more pejorative, "lap dog". And there is word out this afternoon that another Elsevier journal may be trying to bury the Hep B monkey study that Wakefield worked on, although no word from the journal on this yet.

Look at the energy flow in this thing... Props to Dr. Wakefield and his compadres for not backing down under this insane amount of industrial pressure. I mean just look at this billion dollar medical/pharma/media/(arms sales?) unprincipled conglomco machine! Eliot Ness wasn't even up against this big of a beast when he took on the mob. And I have not even included any of the public health infrastructure, or the GMC in this flow chart.

Keep your head up England, and understand that you are under a blitz. They are now officially throwing everything they have at you and they are only exposing their own corruption. Never, never, never, never give up.

Problem for the beast is... they are using all their ammo, and six months from now, nothing will have changed for them. Because the public knows they are full of crap.

click to see it full size.




UPDATE:

A friend in the UK brought something interesting to my attention. It is a flow chart done by a journalist in 1994 on how money and influence flowed around the Burroughs Wellcome pharmaceutical company and all it's satellites (foundations, trusts, doctors, medical institutions, universities, medical journals and even regulatory agencies). One of which is the Wellcome Trust.

I invite to you take a look at the amazingly, unbiased and completely free of conflicts of interesty type research that Wellcome is funding, by reading my piece on Professor Alan Emond's study that shows that kids with autism don't have bowel problems. He claims no conflicts of interest, but fails to mention that he is on the UK's Joint Committee on Vaccination and Immunisation (Britian's version of the CDC's Advisory Committee on Immunization Practices.)

The chart certainly enhances the understanding of how the machine works, but the two facts that make this flow chart so much more interesting is that Burroughs Wellcome of course became Glaxo Wellcome, which became GlaxoSmithKline, who makes the MMR; and that the journalist that created this chart was Brian Deer.



UPDATE: One commenter was looking for a source for my 20 billion dollar figure.

Drugmakers, Doctors Rake in Billions Battling H1N1 Flu
Swine Flu Is Bad for Victims, But Good for Businesses That Cater to Expanding Market
By DALIA FAHMY
Oct. 14, 2009
ABC News/Money

Americans are still debating whether to roll up their sleeves for a swine flu shot, but companies have already figured it out: vaccines are good for business.
h1n1.

Drug companies have sold $1.5 billion worth of swine flu shots, in addition to the $1 billion for seasonal flu they booked earlier this year. These inoculations are part of a much wider and rapidly growing $20 billion global vaccine market.

"The vaccine market is booming," says Bruce Carlson, spokesperson at market research firm Kalorama, which publishes an annual survey of the vaccine industry. "It's an enormous growth area for pharmaceuticals at a time when other areas are not doing so well," he says, noting that the pipeline for more traditional blockbuster drugs such as Lipitor and Nexium has thinned.

As always with pandemic flus, taxpayers are footing the $1.5 billion check for the 250 million swine flu vaccines that the government has ordered so far and will be distributing free to doctors, pharmacies and schools. In addition, Congress has set aside more than $10 billion this year to research flu viruses, monitor H1N1's progress and educate the public about prevention.

Drugmakers pocket most of the revenues from flu sales, with Sanofi-Pasteur, Glaxo Smith Kline and Novartis cornering most of the market.

But some say it's not just drugmakers who stand to benefit. Doctors collect copayments for special office visits to inject shots, and there have been assertions that these doctors actually profit handsomely from these vaccinations.

It is a notion that Dr. Lori Heim, president of the American Academy of Family Practitioners, says is simply not true.

"According to most of the physicians I have talked to, the administration of these vaccines is done for the community's benefit as opposed to anything that helps profit," she says. Heim adds that even though doctors will not have to shell out for the H1N1 vaccine, they will bear the usual costs associated with storage and administering the shots.

"There is an administration fee, for the costs that you can't get reimbursed through Medicare or Medicaid," she says. "This is usually less than, or right at the break-even point."

Still, pharmacies also charge co-payments or full price of about $25 to those without insurance and often make more money if patients end up shopping for other goods.

"Flu shots present a good opportunity to bring new customers into our stores," says Cassie Richardson, spokesperson for SUPERVALU, one of the country's largest supermarket chains. Drawing customers to the back of a store, where pharmacies are often located, offers retailers a chance to pitch products that might otherwise go unnoticed.

Even companies outside of the medical industry are benefiting: the UPS division that delivers vaccines in specially designed containers, for example, has seen a bump in business.

New Entrants in Flu Shot Business

The intensifying competition has irked some doctors.

"Retailers and other non-medical professionals have siphoned off the passive income that once helped to cover medical overhead," says Dr. Caroline Abruzese, an internist in Atlanta. "The larger retail chains can invest up front in large volumes of vaccine at low prices, and market to customers already in their stores."

The promise of profits has attracted new players into the business. Some of the world's largest drugmakers, who in the past avoided the vaccine market because of its limited scope -- its not easy to convince healthy adults to get a shot for measles -- are now jumping into the fray.

Last month alone saw three large vaccine deals. Abbott Labs bought a Belgian drug business, along with its flu vaccine facilities, for $6.6 billion. Johnson & Johnson invested $444 million in a Dutch biotech firm that makes and develops flu vaccines. Merck, which already makes vaccines for shingles and other diseases, struck a deal to distribute flu shots made by Australian CSL.

Smaller biotechs are also angling for a slice of the action, making vaccines one of the fastest-growing areas of research in the biotech industry.

Large and small drugmakers are drawn to the business largely because of scientific advances that promise to radically expand the range of health problems that vaccines can address. In addition to preventing childhood diseases such as measles and polio, vaccines can now also ward off cervical cancer, and researchers are working on vaccines for HIV and tuberculosis.

Scientists believe they can create therapeutic vaccines than treat diseases such as Alzheimers and diabetes after they have set in. (At least one company is betting on a vaccine that helps cigarette smokers quit.)

"These innovations broaden the market potential for vaccine makers and partly explained the renewed interest by drugmakers," says Anthony Cox, a professor at Indiana University's Kelley School of Business who specializes in the marketing of medical products.

But Mark Grayson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, which represents the country's leading pharmaceutical research and biotechnology companies, says that drugmakers are also compelled by the government to join efforts to ensure that there is enough vaccine to go around.

"Because of national security implications, the government felt that they needed to encourage and ask [vaccine manufacturers] to move much quicker," he says. Grayson adds that vaccine manufacturers also face significant costs; aside from the expense of fitting a new vaccine into a tight production schedule, drugmakers GlaxoSmithKline and Sanofi Pasteur were forced to acquire new vaccine production facilities in recent years to keep up with demand.

Alternatives to Vaccines Are Few

While this promise of new treatments for painful diseases brings hope to many, vaccines continue to attract critics. The National Vaccine Information Center, a non-profit advocacy group, is at the forefront of a movement demanding that vaccines be tested more thoroughly before hitting the market. Although there has been little evidence to support their claim, detractors -- including the comedian Jim Carrey -- believe that vaccines are at least partly to blame for the sharp rise in autism in recent decades.

The swine flu vaccine has also attracted its share of critics. Frank Lipman, a New York-based doctor who specializes in a mix of Western and alternative medicine, points out that the swine flu is rarely fatal and that it's too early to tell if it's safe because it hasn't been widely tested.

Others argue that Americans have little choice. The cost of a widespread pandemic, similar to Spanish Flu outbreak in 1918, which killed 675,000 Americans (and 50 million worldwide), would be devastating. The Trust for America's Health, a Washington-based non-profit organization, estimates that a severe pandemic could push down GDP by more than 5 percent and cost Americans $683 billion.

"We're not seeing a pandemic that's this severe," says Jeff Levi, director of Trust for Americas Health. "We've dodged a lot of bullets."

August 24, 2009

NBC News Will Take On The Wakfield Contraversy

And it looks like they might even do a real job of investigating it. We shall see.

From Thoughtful House:

Thoughtful House on NBC News
Story Scheduled to be Broadcast this Weekend

August 25, 2009

Dear Friends,

As some of you may have already heard, the NBC television network is producing a special on Thoughtful House and Dr. Andrew Wakefield. We are sending along this note to make you aware of the extent of coverage on various programs and the scheduled broadcast date. First, though, we thought it was important to help everyone understand our decision to cooperate with the reporter, Matt Lauer, and his producer, Ami Schmitz.

In our estimation, there has not yet been any fair coverage in the mainstream media of Dr. Wakefield or the work of Thoughtful House. While we have a large community of supporters that know Dr. Wakefield's credibility and the accomplishments of Thoughtful House and our excellent physicians and clinicians, including Dr. Bryan Jepson, Dr. Arthur Krigsman, and Kelly Barnhill, CN, CCN, many of us in the Autism Advocacy Community spend most of our time communicating with people in similar situations. Our challenge has always been to reach out to a greater population that might not know or understand what is happening with regard to the autism epidemic and the lack of government research into potential causes, which includes looking at vaccine safety. We thought that if we ever were able to communicate with a fair-minded journalist working at a media outlet with both credibility and reach then it was likely to be worth the risk trying to tell our story.

We have taken that chance with NBC. While we initially declined their invitation for a story, we were persuaded to move forward when Matt Lauer was proposed as the correspondent. His reputation for being objective and thorough prompted us to reconsider and ultimately to open our doors. In March, TV crews from The Today Show, Dateline, and NBC Nightly News began gathering material at Thoughtful House in Austin. This involved taping long interviews with Drs. Wakefield, Jepson, and Krigsman, some of our therapists, administrators, and, more importantly, a few of our families. The crews traveled to London to report on the Lancet controversy and interviewed many of the central figures relevant to that part of our story. They also taped interviews, presentations, and families in attendance at the Atlanta DAN conference. Dr. Wakefield was flown to New York by the network and received what he described as a "tough but fair" interview in a one-on-one with Today Show host Matt Lauer. The person we have dealt with throughout the course of this project is Mr. Lauer's producer, Ami Schmitz. Ami has a long resume as a medical journalist and was formerly Dr. Timothy Johnson's producer at ABC News. In our assessment, she has been thorough and diligent in gathering information, documents, and asking the kind of detailed questions that have been glossed over or conflated in previous reporting. We believe, based upon hours and hours of working with Ami, she is writing an even-handed report, which will be narrated and hosted by Mr. Lauer.

Nothing is certain, of course, so we are taking a risk. However, we believe the potential reward is worth that risk; it's entirely possible this will be the first time this subject matter (autism, Wakefield, Thoughtful House, vaccine safety research) has been considered objectively in mainstream media. If that is the case, we have the possibility of communicating with millions of people and that will be nothing but positive for those of us dealing with autism in our own families. We will find out this Friday, August 28. A portion of Mr. Lauer's interview with Dr. Wakefield will be broadcast in an 8-10 minute segment on The Today Show. Either Saturday or Sunday, the NBC Nightly News Weekend will also broadcast a lengthy piece on Thoughtful House and vaccine safety. Coverage will culminate on Sunday night, August 30, at 7 pm EST, with an hour-long broadcast hosted by Mr. Lauer on Dateline NBC. This is scheduled to be adjacent to the Sunday night NFL football game on NBC, which means there is the potential for a large audience. In fact, the cumulative audience for all of these programs means there are likely to be no less than 5 million people who learn about autism and Thoughtful House and, quite possibly, as many as 20 million viewers will see the various broadcasts.

Consequently, you see the reason we decided to cooperate with NBC. The program might just be a game changer in the conversation we are all having in our communities with our governments, health care providers, insurance companies, and overall policies within our culture that marginalize families dealing with autism. We all started off several years ago on what many of us believe is the correct course for treatment and research and it has led us to this moment, and we believe we've made the right decision.

We would like to ask all of you that are active in the autism community to hold all judgment and wait to see the final broadcast. NBC has dedicated substantial time and resources to this story and the producer has made every effort to interview people from all points of view. Our hope is that a fair story will be told and you may submit feedback to the network after the shows have aired. Please do not attempt to contact them prior to the broadcast.

Please share this information with your friends, and if there are any last minutes changes, which we are told is always possible in the news business, you can rely on us to bring them to your attention.

Sincerely,

Anissa Ryland
Director of Operations
Thoughtful House Center for Children

July 3, 2009

Maine CDC Autism Conference: How Do We Know What Autism IS NOT if We Do Not Know What Autism IS? by Jon Poling, MD, PhD

Maine CDC Autism Conference 2009
Looking Forward Beyond Vaccines: How Do We Know What Autism IS NOT if We Do Not Know What Autism IS? Followed by Q&A with other conference speakers.
Jon Poling, MD, PhD
Neurologist, Clinical Assistant Professor
Medical College of Georgia
Father of child with autism


May 27, 2009

Contradictory Rulings in the Vaccine Court

[An alternate version of this piece was written in response to an article in Utah Stories.]

Many have cited three cases in which The Health and Human Service's vaccine court ruled out vaccines as a cause of a child's autism, but don't mention the 10 cases (discovered by CBS News) that were won in that court by children with autism.

Three of those 10 families have gone public, The Polings, The Banks and The Hiatts.

The Poling case is the only one that received mainstream media coverage.

Only ten days after we heard that the court said MMR doesn't cause autism, we heard that the same court said that MMR caused Baily Banks autism.

"In his conclusion, Special Master Abell wrote:

The Court found that Bailey's ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey's ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

And he added this:

Petitioner's theory of PDD caused by vaccine-related ADEM causally connects the vaccination and the ultimate injury, and does so by explaining a logical sequence of cause and effect showing that the vaccination was the ultimate reason for the injury.

Shouldn't we be shouting a collective, "WHAT?!" to The Department of Health and Human Services for their contradictory positions?

Here is the thing, when the Department of Health and Human Services puts the Department of Health and Human Services on trial, and the Department of Health and Human Services wins, that is not news. When they put themselves on trial and loose, as in the Poling, Banks and Hiatt cases THAT IS NEWS!

THOSE are the cases we should be demanding answers from the government on.

The Poling family has requested that their daughters case files can be made public so everyone can know the reasoning behind HHS's decision, but HHS isn't sharing any of their insight into WHY Hanna deserves a million 20 million bucks for her vaccine injury.

So let's not boil this debate down to scientist v. tv stars. There are MANY in the scientific and public health community who believe that vaccines are involved in the autism epidemic.

And apparently HHS itself does too because it keeps paying claims for autistic kids.

Please take a moment and check out the VICP's vaccine injury table for yourself. You will note that "encephalopathy" is listed as a compensated injury for DTaP and MMR.

Then scroll down to the middle of the page and look at the symptoms of encephalopathy for 18 month olds:

1. Loss of eye contact
2. Unresponsive to stimuli except for loud shouts
3. Seems disconnected from the world around him

THAT is a description of a child with "autism".

THAT was a description of MY son after his DTaP shot for which he was diagnosed with "autism".

The government has ruled that vaccines do and do not cause autism. Are You ok with that solid, definitive, case closed argument?

I REALLY hope not.

It is time for HHS to make the Poling documents public, and to answer to the public for their untenable, illogical position.

May 5, 2009

The Next Chapter in the Wakefield Kufuffle

Chapter 2, Return of the Parents:

Media Advisory - News Conference

What:

1) On Wednesday 6th May 2009 a formal complaint will be filed with the General Medical Council of the UK against four senior doctors, all highly regarded members of the UK medical establishment. It is alleged, and supported by documentary evidence, that Dr. Richard Horton, Editor of The Lancet, Dr. David Salisbury of the Dept. of Health, Professor Arie Zuckerman, former Dean of the Medical School, Royal Free Hospital, and Dr. Michael Pegg, Chair of the Ethics Committee of the Royal Free gave false testimony on oath in the GMC hearings involving Dr. Andrew Wakefield, Professor John Walker-Smith, and Professor Simon Murch.

2) At the same time parents of 4 children involved in the original Lancet study, on which the major allegations have been based, will make public statements regarding the GMC hearings.

When: Wednesday May 6, 2009
Time: 11:30am – 12:30pm
Where: The Kingsway Hall Hotel, 66 Great Queen Street, London, WC2B 5BX,
www.kingswayhall.co.uk
Who: U.S. attorney James Moody, director of U.S. charities Safe Minds and the National Autistic Association, acting on behalf of 13 American and British autism organisations, states:

“Dr. Richard Horton, Editor of The Lancet, Dr. David Salisbury of the Dept. of Health, Professor Arie Zuckerman, former Dean of the Medical School at the Royal Free Hospital, and Dr. Michael Pegg, Chair of the Ethics Committee of the Royal Free, should be investigated for supplying false testimony. Furthermore, the current GMC hearing against Drs. Wakefield. Murch and Walker-Smith should be terminated. This unwarranted attack on scientists and doctors who came to the aid of desperately ill children has deterred others from helping similarly affected children, and distracted attention from the public health crisis caused by the substantial rise in autism diagnoses.”

Three families representing four of the 12 children included in the original Lancet publication will speak out publicly for the first time about the GMC hearings to clarify the details of their childrens’ involvement in the case series, and express their families’ support of the doctors they consider to be wrongly under investigation by the GMC. A letter from the families to the GMC expressing support of the doctors being investigated will be read by those who are able to be present.

Contact: James Moody - autismandvax@aol.com; tel: 001 202-298-4766.

April 2, 2009

Peete vs. Peet

Amanda Peet has chosen to mark Autism Awareness Month by telling moms they have to vaccinate their children and that vaccines don't cause autism. She is doing it with her usual lack of subtlety and with out offering any details that might suggest that she actually has done any research and understands the arguments being made.

Holly Robinson Peete has heard enough from Ms. Peet and has made her boldest statement yet about her sons vaccine reaction and regressed into autism:

PEETE VS. PEET ON VACCINES AND AUTISM: Holly Robinson writes open letter to fellow actress Amanda regarding differing opinions.
(April 1, 2009)

Essence.com is featuring an open letter from Holly Robinson Peete to actress Amanda Peet regarding her comments about autism, a disease she believes struck her 11-year-old son after he received vaccinations when he was just 2-and-a-half.

Peete is the first African-American to sit on the board of Autism Speaks, an organization dedicated to increasing awareness and prevention of the disease. She shares her thoughts with the Web site about comments made by Peet, the spokesperson for vaccinateyourkid.org, who recently said that vaccinations don't cause autism.

I'm really disappointed to hear people like Amanda Peet—who have never been affected by autism—make public allegations like vaccinations don't cause autism. It makes me angry because it's so disingenuous to have this kind of public discussion, especially when World Autism Awareness Day is coming up on April 2.

But I know exactly what she is trying to do and that's to instill fear: if your child doesn't get vaccinations, you're going to make every other child sick. Believe me, I understand both sides of the argument because I have four children. Although I have total respect for what any mother feels is best for her child, you can't tell me what is right, because it's not necessarily going to work for my kid. I know because I've experienced it with my eldest son.

When my son was 2-and-a-half, he was just recovering from an ear infection and had been on antibiotics, therefore his immune system was suppressed. He had already missed several appointments for his vaccination so his pediatrician wanted to catch him up on all of them in the same day.

Although I asked if he'd consider waiting or breaking up the cocktail, which contains three viruses, he laughed me out of the office and belittled me. I firmly believe that it took my son to a place of no return and his body could not handle it. He had a violent reaction with convulsions and then he stopped talking and slipped into a silence. He no longer said, "Hi, Mommy," he no longer responded to his name and he no longer made eye contact. And to think that today there are more than 30 vaccines that children are required to receive is scary. I don't know why boys are five times more likely to become autistic, but they are.

I respect Amanda Peet for advocating for her children by trying to keep them safe with vaccines. If I could talk to Amanda Peet, I would say that, I'm glad your child was able to tolerate that level of toxicity, but don't expect me—after witnessing what vaccinations did to my son—to inoculate my other children under the same circumstances.

So who's to blame? Is there some pre-genetic predisposition? Do genetic and environmental factors load the proverbial gun and the vaccines pull the trigger? Since you claim all the studies and conclusions have been drawn, how do you explain the thousands of families that have received millions of dollars from the Vaccine Injury Court? So clearly, the jury is not in and the independent studies on susceptibility and genetic predisposition have not been done.

Knowing all this do you think it's okay to make a judgment about me based on what I know about my son and the rest of my children physiologically? If your mission is to gain the public's trust, then you're not going to get parents to do it by fearmongering. Until you've experienced the physical, emotional and financial toll you simply can't make such public statements.

Despite what happened to my son, I'm not anti-vaccine. However, if the government wants to make me and other parents who have autistic children feel comfortable with vaccinations then there needs to be some independent studies done regarding these treatments. Not only would it make me feel comfortable, but it'd make me feel like I'm being listened to and heard.

Lastly, to Amanda Peet: I would never ever wish what we've gone through in our family on her and her family or anybody. I would just ask her to give the respect she has on her position to mine. It's not about reading so-called studies online; it's about living and learning. My study is my son.

March 28, 2008

Wakefield and Colleagues Should Be Knighted, Not Persecuted

This press released issued by pretty much everyone in the biomedical community.

I say here, here.

U.K. Medical Inquiry Threatens Scientific Inquiry & Progress in Autism

The National Autism Association (NAA), SafeMinds, Unlocking Autism, Generation Rescue, Autism One and Talk About Curing Autism (TACA) wish to express support for Dr. Andrew Wakefield and his colleagues who are unjustly facing a fitness to practice hearing by the General Medical Council (GMC) of the United Kingdom. Dr. Wakefield, a pioneer in autism research and treatment, begins his historic testimony today. The undersigned organizations, along with other U.S. families affected by autism, join in spirit with the U.K. families who are demonstrating today at the GMC offices in London.

The GMC prosecution is a frontal attack on the health and well-being of those around the world who have an autism spectrum disorder. Scientific and medical progress in this field will only be made through open minded thinking on how best to treat and prevent the disabling conditions that accompany this complex diagnosis. The GMC's actions have a chilling effect on the practice of medicine and suppress honest and open scientific inquiry.

Dr. Wakefield and his team of elite researchers at the Royal Free Hospital in London did exactly as they were called to do by their professional curiosity and ethics - find out why so many children have autism and whether gastrointestinal problems play a role in the disorder. Their seminal 1998 paper published in The Lancet reported a series of observations whose common features had coalesced as a new syndrome, autistic enterocolitis. The parents of many patients noted a link between the onset of symptoms and receipt of the measles-mumps-rubella combination vaccine (MMR), but out of an abundance of caution the Lancet paper claimed that the study did not prove an association between MMR and autism. Rather, it prudently called for further research.

The underlying goal of the GMC hearing is to take Dr. Wakefield and colleagues to task for daring to even hint at a vaccine-autism link. The "official" reason is to determine if the scientists profited from their research, but in fact the inquiry is a desperate tactic by vaccination proponents to quiet those who raise questions about the safety of current vaccination practices such as combining three live viruses into the single MMR injection. Recent developments in the U.S. have vindicated Dr. Wakefield's hypotheses. Gastrointestinal problems are now known to be present in many autistic children and gastroenterology has become a standard discipline for autism medical care. The U.S. court for vaccine injury compensation has found that vaccination against multiple diseases on one day led to a case of regression into autism in a child who was developing normally.

Dr. Wakefield should be knighted for his cutting-edge creativity, not persecuted. He made his hypotheses a decade ago, and the rest of science is just now catching up. The public health bureaucrats and their agents - in the U.K. and the U.S. - are more interested in covering up their own misdeeds, poor judgment, or inaction. These include a refusal to make the single monovalent measles, mumps, and rubella vaccines broadly available in response to legitimate concerns over the safety of the triple MMR injection, a refusal to conduct a valid study comparing the rate of autism and other health outcomes in vaccinated and unvaccinated groups, and a refusal to reexamine infant immunization schedules to increase safety. Autism spectrum disorder rates in the U.K. may be as high as 1 in 66 and in the U.S. they are said to be 1 in 150 children, but the public health establishment refuses to declare autism a health emergency, refuses to apply the resources to understanding the disorder, and refuses to conduct the type of unbiased research required.

The U.K. medical establishment has driven Dr. Wakefield from his home, but his loss is America's gain. We are blessed to have Dr. Wakefield as Director of the Thoughtful House Center for Children in Austin, Texas. In a few short years, this has become an international mecca for research, education, and treatment for children with autism. We look forward to a fair GMC hearing and to further ground-breaking research from Dr. Wakefield and his team.

For more information about autism and the undersigned organizations, visit www.autism.org. Details about today's rally in London are available at http://www.cryshame.com/.

National Autism Association
SafeMinds
Unlocking Autism
Generation Rescue
Autism One
Talk About Curing Autism (TACA)

March 21, 2008

The Wakefield Witch-Hunt


The Wakefield witch-hunt
Friday, 21st March 2008
The Spectator

A couple of days ago, yet another story appeared claiming that fresh research had shown that there was no link between the MMR vaccination and autism. This new research was said to have shown that, contrary to the claims made by Dr Andrew Wakefield, the surgeon at the centre of the MMR scare, there was no relationship between gut problems and autism, the core of his concerns. It also claimed that the discovery furthermore damaged the related theory that a gluten-free diet could help children with autism.

Dr Hilary Cass, from Great Ormond Street, said: ‘It is very distressing to have a diagnosis of autism, a lifelong condition.Many families are driven to try out interventions which currently have no scientific basis. For example, advocates of the leaky gut hypothesis offer children a casein and gluten-free diet which as yet lacks an evidence base.’

This particular observation is a telling indication that this study bears little relation to reality. For there are countless families whose autistic children’s suffering from gut problems has only been eased, and their autistic symptoms improved, by the introduction of precisely such a diet. ‘No evidence base’? Tell that to those families. It is their lived experience.

Second, despite the way this was presented in the media this is not a new piece of research at all. It is instead a recycled version of a study by Baird G. et al, published in the Archive of Diseases in Childhood on February 5 and reported in the press around that time. The study drew the following response from Andrew Wakefield:

…The study is severely limited by case definition in the context of the crucial ‘possible enterocolitis’ group. For inclusion in this group they required the presence of two or more of the following five current gastrointestinal symptoms:

* current persistent diarrhea (defined as watery/loose stools three or more times per day >14 days),
* current persistent vomiting (occurring at least once per day, or more than five times per week),
* current weight loss,
* current persistent abdominal pain (3 or more episodes [frequency not specified by authors] severe enough to interfere with activity);
* current blood in stool;


plus:

* past persistent diarrhea >14 days’ duration, and excluding current constipation.


We have over the last 10 years evaluated several thousand children on the autistic spectrum who have significant gastrointestinal symptoms. Upper and lower endoscopy and surgical histology have identified mucosal inflammation in excess of 80% of these children. Almost none of these children with biopsy-proven enterocolitis would fit the criteria set out above. Firstly, these children rarely have vomiting, current weight loss (as opposed to failure to gain weight in an age-appropriate manner), or passage of blood per rectum. The requirement is thus narrowed to a child having two of two relevant symptoms – current persistent diarrhea and current abdominal pain according to their criteria, plus a past history of persistent diarrhea excluding current constipation.

The requirement for the current presence of these symptoms, for 14 or more days continuously, shows a singular lack of understanding of the episodic, fluctuating, and alternating (e.g. diarrhea/constipation) symptom profile experienced by these children. In our experience, ASD children with histologic enterocolitis typically have 1 to 2 unformed stools per day that are very malodorous and usually contain a variety of undigested foodstuffs. This pattern alternates with that of “constipation” in which the unformed stool is passed after many days of no bowel movements at all, and with excessive straining. This group is entirely overlooked by the arbitrary criteria set forth in their paper. With respect to diarrhea and constipation, a detailed discussion of stool pattern in these children is available1 which further highlights the shortcomings of the above criteria. Moreover, the interpretation of pain as a symptom in non-verbal children, as it often manifests as self injury, aggressive outbursts, sleep disturbances, and abnormal posturing, is notoriously difficult. This interpretation requires an insight based upon the correlation of symptoms, histological findings, and response of symptoms to anti-inflammatory treatment. There is no evidence in the Baird et al. paper that these crucial factors were taken into account. This study’s inappropriate symptom criteria would explain the discordance with other reports that have revealed a high prevalence of significant gastrointestinal symptoms in general autism populations2,3.

It is surprising that Dr Peter Sullivan, a co-author on the paper, who presumably provided the above gastroenterological criteria, was not aware of the aforementioned limitations. In his role as a Defendant’s expert in the UK MMR litigation, he will have had access to the clinical records of autistic children with the relevant intestinal symptoms and biopsy-proven intestinal inflammation.

We suggest that the authors might wish to reflect on the ethical implications of setting the bar too high for the investigation of such children by ileo-colonoscopy, with the attendant risk of missing symptomatic, treatable inflammation.

Since the relevant MMR/autism children are considered to be those with regression and significant gastrointestinal symptoms, the appropriate stratification for between-group analyses of measles virus antibody levels has not been conducted; therefore the paper is difficult to interpret, adding little if anything to the issue of causation. Moreover, it is a major error to have presumed that peripheral blood mononuclear cells are a valid ‘proxy’ for gut mucosal lymphoid tissues when searching for persistent viral genetic material.

A further major problem in this study is the number of children who dropped out or who were unable to provide adequate blood samples. We know nothing about either the 735 children who were lost at stage two, or the 100 children for whom blood samples were not available. At the very least, we should be told whether the children who dropped out were likely to be representative of those who stayed in, with regard to the key issues of interest.

For reasons that will emerge in the near future, it would be of interest to know whether siblings of autistic children were included in either of the two control groups. This information is not provided.

As a general observation, this paper contributes nothing to the issue of causation, one way or another. Case definition alone is likely to have obscured the relevant group of autistic children. The study tells us nothing about what actually happened to the children at the time of exposure. We are increasingly persuaded that measuring things in blood many years down the line tells us very little about the initiating events in what is, in effect, a static (non-progressive) encephalopathy unlike, for example, subacute sclerosing panencephalitis, which is a progressive measles encephalopathy. The gut is a different matter, and analysis of mucosal tissues has been very informative, since here, in the relevant children, active ongoing, possibly progressive [AV1]4, inflammation has been identified.

None of Wakefield’s pointers to the irrelevance of or inadequacies in the Baird research was included in the news stories. Nor do these stories refer to other research studies which show a higher rate of gastro-intestinal problems among children with autistic-spectrum symptoms. The recycling of the Baird study was but the latest in a steady drip-feed of such items which appear to be part of a concerted campaign to ensure that the General Medical Council hearing into the conduct of Wakefield’s research, which is shortly due to resume, takes place in as prejudiced an atmosphere as possible. No stone is being left unturned by the medico-political establishment and its creatures in the media to ensure that this doctor is destroyed.

As I have repeatedly said, I have no idea whether Wakefield is correct or not in his concerns about the possible adverse effects of the MMR vaccine on a small sub-set of vaccinated children. Nor do I know whether any of the charges being levelled against him at the GMC has any legs. But I do believe — as I wrote in my series of articles on the subject for the Daily Mail in 2003 here, here and here — that many of the statements made by the Department of Health and medical establishment about the ‘proof’ of the vaccine’s unchallengeable safety are deeply misleading. And I also believe, having spoken to many parents of such children, that their experiences simply cannot be dismissed as they have been by the medical establishment. No-one has ever suggested that the MMR vaccine causes all or most of the incidence of autism. If Wakefield is correct, it is only a small proportion of children whose immune systems may be unable to cope, for whatever reason, which makes them particularly vulnerable to such ill-effects. And contrary to the message being pumped out by the medical establishment that the vaccine has been proved to be safe — by studies which are all either flawed, inadequate or irrelevant — the fairest and most accurate thing to say is that the jury is still out.

One of the most reprehensible weapons being wielded in the witch-hunt against Wakefield is the claim that anyone who gives any credence whatever to his concerns is responsible for the incidence of measles amongst children whose parents are as a result too frightened to give them the MMR vaccination. There are two obvious points to make in response to this piece of moral blackmail: 1) the whole panic could have been avoided by offering single measles, mumps and rubella jabs rather than the triple MMR, and 2) it is surely just as important as avoiding cases of measles mumps and rubella to avoid causing the kind of catastrophic damage to the brain and gut displayed by the children at the heart of this controversy.

And there is a further and quite appalling point to note. This whole saga started because parents of such children found that their family doctors were dismissing out of hand their children’s gut and brain problems, accordingly refusing to alleviate their suffering. Now, as a direct result of the animosity towards Wakefield that has been whipped up — and the fear that any doctor who suggests he might be right will similarly find him or herself at the receiving end of the medical establishment’s fist — children exhibiting this combination of gut and brain damage are finding it difficult to obtain treatment.

Another letter to the Archive of Diseases in Childhood from John Stone, the parent of an autistic child, makes terrifying and distressing reading:

In this regard it is worth noting the recent warning of the National Autistic Society (NAS):

‘The National Autistic Society is keenly aware of the concerns of parents surrounding suggested links between autism and the MMR vaccine. The charity is concerned that the GMC hearing, and surrounding media coverage, will create further confusion and make it even more difficult for parents to access appropriate medical advice for their children. It is particularly important that this case is not allowed to increase the lack of sympathy that some parents of children with autism have encountered from health professionals, particularly on suspected gut and bowel problems. Parents have reported to the NAS that in some cases their concerns have been dismissed as hysteria following previous publicity around the MMR vaccine. It is crucial that health professionals listen to parents' concerns and respect their views as the experts on their individual children…’

The NAS warning relates to the GMC hearing involving doctors Wakefield, Walker-Smith and Murch which is set to resume on 25 March approaching. I do not think it is being unduly cynical to query the publication of this study at the present time as a media event, bearing in mind that it seems to have been carried out five or six years ago. Moreover, the study has once again been promoted as refuting the Wakefield hypothesis when it in fact tests for a possibility that had not been proposed. Meanwhile, the plight of autistic children with gastro- intestinal symptoms is excluded both from the study and public attention, as if they did not exist. The NAS statement warned of ‘creating further confusion’ and this is precisely what this study and its media exposure has done.

As the resumption of the GMC hearing draws nearer, one has to ask whether this will serve the cause of truth and justice and the relief of suffering — or is it instead merely a show trial which will bring about the precise opposite?

March 14, 2008

MMR + Chicken Pox Vaccine = More Seizures

Getting the Merck MMRV (Measles, Mumps, Rubella, Chicken Pox combo vaccine), rather than the MMR and separate Chicken Pox vaccine, results in "slightly more" or more than double the seizures, depending on how you want to spin the story:

"It found a rate of febrile seizure of nine per 10,000 vaccinations among MMRV recipients, and four per 10,000 among children who got separate MMR and chicken pox shots. Of 166 children who had febrile seizures after either type of vaccination, 26 were hospitalized and none died, the CDC said."


So CDC removes its preference for the MMRV vaccine, but does not change it's preference to the MMR and separate chicken pox vaccine. It just does not state a preference. Because half the seizures is not worth stating a preference?!

This does not just call for a preference, it seems to make the MMRV obsolete. What they had before the MMRV was safer.

Is the CDC's priority the health of children or the health of Merck's bottom line?

WASHINGTON (Reuters) - Children who get a combined vaccine against measles, mumps, rubella and chicken pox are slightly more likely to have seizures compared to those getting two separate shots for the same diseases, U.S. officials said on Thursday.

The seizures are not usually life-threatening and the U.S. Centers for Disease Control and Prevention said it was no longer expressing a preference that children get the so-called MMRV combined vaccine rather than two shots -- the MMR vaccine against measles, mumps and rubella (German measles) and a separate one against varicella (chicken pox).

The CDC said it made the change after seeing evidence that children who got the combined MMRV vaccine faced an elevated, but still very small, risk of suffering febrile seizures after vaccination compared to those who got the two shots.

A febrile seizure is a convulsion in young children associated with an increase in body temperature, often from an infection. While frightening, the seizures are not usually dangerous and only a small percentage of children who experience one go on to develop epilepsy.

Dr. John Iskander, the acting director of the CDC's Immunization Safety Office, said it remained very important that parents get their children vaccinated against these diseases.

"These are vaccines that have had enormous public health benefits," Iskander said.

The CDC said the availability of the MMRV vaccine, made by pharmaceutical company Merck, already was limited in the United States because of manufacturing constraints unrelated to vaccine safety, and was not expected to be widely available until 2009.

The CDC said a study examined the risk for febrile seizures seven to 10 days after vaccination among 43,353 children ages 12 months to 23 months who received the MMRV vaccine and 314,599 children of the same age who received the MMR vaccine and chicken pox vaccine administered separately.

It found a rate of febrile seizure of nine per 10,000 vaccinations among MMRV recipients, and four per 10,000 among children who got separate MMR and chicken pox shots. Of 166 children who had febrile seizures after either type of vaccination, 26 were hospitalized and none died, the CDC said.

October 7, 2007

UK: GMC Advises UK Docs To Commit Fraud over MMR

The GMC is Britain's medical ethics council that is currently trying Andrew Wakefield over alleged ethics violations in regards to his research on the MMR.

Apparently they are encouraging doctors to remove children who refuse the MMR from their list of patients to fraudulently raise the MMR uptake statistics.

The docs can then get payments for seeming to have met the governments MMR uptake goals.

So the GMC, whose job it is to maintain ethical medical practices, is apparently giving the nod for docs to commit fraud to prop up vaccine uptake stats and to get cash payments.

I am sure that Wakefield will get a fair hearing.

From UK Lawyer, Clifford Miller:

GMC Advises UK Docs To Commit Fraud over MMR

Is medicine institutionally corrupt? Here you will see the UK's General Medical Council advising UK medical doctors how to commit fraud on the UK's National Health Service for personal financial gain.

The GMC's role is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine by medical doctors. This includes prosecuting UK medical doctors when their behaviour may bring the medical profession into disrepute. Dishonesty, financial impropriety and fraud fall within its purview. This link [1] provides an example of a decided case from its website.

The GMC is a statutory body independent (allegedly) of the NHS and of Government, with responsibility for maintaining the medical register for the United Kingdom. The GMC has statutory powers under the Medical Act 1983 to take action where there are concerns about the fitness to practise of a registered medical practitioner. Where the GMC finds that a doctor is not fit to practise, it has powers to erase that doctor's name from the medical register, to suspend the doctor from the register or to place conditions on the doctor's practice. These restrictions apply to practice in any sector of employment in any part of the UK. [2]

In the UK if doctors meet target levels for numbers of MMR and other vaccinations administered they can claim bonus payments for doing so. If they fail, they cannot claim those payments. One way of claiming the payments is to make a false return.

So how can it be that the GMC advises doctors on how to commit fraud? The GMC pose the question "Can GPs remove some children from their lists, temporarily, for the purpose of calculating the MMR target payment?" Here you will see that its currently available advice is to the effect that "it's OK provided you have patient consent" [3], [4]. It seems it also happens to be OK if it helps to increase the MMR uptake figures. The advice does not appear to be offered for other vaccinations.

And notice how they fail to make any mention of the financial and moral impropriety of doing so when they answer the question they pose like this:-

"This must not be done without the parents' agreement. Parents must be given a full explanation of what was proposed and why, their child's rights as an NHS patient, and the implications for their child's future care. Doctors working within the NHS must treat all patients entitled to NHS services on an equal footing. So temporarily removing a child from a GPs list must not adversely affect their care, for example in accessing secondary care and out-of-hours services, or in providing relevant information to ensure continuity of care and allow effective working with other agencies. Doctors must act honestly in their financial dealings. So GPs must ensure that any arrangement to remove a child from their list and re-register them for ‘immediately necessary treatment', or on some other basis, would be in line with their contractual obligations to the NHS."

Notice that provided the doctor does what the GMC advises and ensures "that any arrangement ... would be in line with their contractual obligations to the NHS" it is fine as "Doctors must act honestly in their financial dealings". Am I missing something or is this starting to look like we need the "men in white coats" to take away the men in white coats?

Not only that but the GMC advice is that if the evidence is available this is not contrary to GMC guidance on good medical practice:-

"Are temporary removals from a GPs list acceptable to the GMC? In the absence of evidence that ‘temporary removals' satisfy the concerns outlined at Q5, we cannot give any reassurance that such arrangements would be seen as consistent with our guidance on good practice."

GMC advice to UK doctors is that doctors "must not ask for or accept any inducement, gift or hospitality which may affect or be seen to affect the way you prescribe for, treat or refer patients." [7] But it seems the GMC do not mind when it comes to MMR, even where the inducement is so strong it encourages fraud on the NHS. But then, the GMC does not seem to mind about that either.

So now you know. If it concerns getting MMR uptake up, fraud is fine. But you had better make sure you implicate the parents and what better way to do that than to pressure them into agreeing their children become temporary patients possibly for emergency treatment only or else be dumped from the patient roster completely. Naturally, I am not saying that is happening nor am I saying the GMC advice is taken to suggest that be done - as it does not, but it could encourage that kind of behaviour. As a lawyer advising pro bono I have direct experience of patients being removed from an NHS doctor's roster after objections to childhood vaccinations.

The GMC has an agreement on cooperating and coordinating with the NHS Counter Fraud service [5]. And "GMC Today" newsletter carried a story ironically titled "Is the NHS immune to fraud?" about reducing and reporting fraud in the National Health Service [6]. The story gives a number to call the confidential NHS Fraud and Corruption Reporting Line and an email address too. It reports:-

"If you have a concern about a fraud taking place within the NHS, please call the confidential NHS Fraud and Corruption Reporting Line on 0800 028 40 60. All calls will be dealt with by trained staff and professionally investigated. Lines are open Monday to Friday 8 am–6 pm. You can also email us at nhsfraud@cfsms.nhs.uk at any time."

I haven't got the heart to tell 'em. Have you?


[1] http://www.gmc-uk.org/concerns/hearings_and_decisions/ftp/ftp_panel_islam_20061013.asp

[2] http://www.gmc-uk.org/about/partners/national_health_service_counter_fraud_service.asp

[3] http://www.gmc-uk.org/guidance/current/library/targeting_preventative_measures.asp

[4] http://www.gmc-uk.org/guidance/archive/Target_payments_for_preventative_health_measures_2003.pdf

[5] Memorandum of Understanding between the General Medical Council (GMC) and the National Health Service Counter Fraud Service (NHS CFS)

[6] Is the NHS immune to fraud? - GMC Today - Oct 2005

[6] Paragraph 74 Good Medical Practice