Monday, May 24, 2010

THE CHICAGO PRINCIPLES

The American Rally for Personal Rights, to be held in Chicago’s Grant Park this coming Wednesday, May 26, is not intended to be a one-day effort. It marks the birth of the Center for Personal Rights, dedicated to the same principles as the rally itself. Those principles have been reduced to a statement that has been dubbed “The Chicago Principles on Vaccination Choice:”

We, the people who affirm our belief in personal rights, in order to promote the general health and welfare for ourselves and our children and to establish justice, advocate the following principles:



1. Vaccination choice based on complete and accurate information is a fundamental human right. 



2. The right to conscientious objection from vaccination mandates, namely the right to a philosophical exemption, is a fundamental human right. 



3. Laws that make education, employment, daycare and public benefits contingent on vaccination status, except in the most extreme of public health emergencies, violate the fundamental human right to vaccination choice.



4. When vaccination is used as a preventive medical intervention for healthy individuals, the precautionary principle must apply. If there is no public consensus about the need for or safety of certain vaccines, they should neither be recommended nor mandated for universal use. 



5. Individuals who are in a position to evaluate, recommend and mandate vaccines must be free of all actual and perceived conflicts of interest.

CALLS FOR IMMEDIATE ACTION IN THE UNITED STATES



1. Congress should conduct oversight hearings on the national vaccine program, including mandates for the military and immigrants, examining vaccine safety, conflicts of interest, suppression of science, evidence of vaccine injury, and comparative empirical data from countries with differing vaccine schedules.



2. Congress should immediately initiate a study of vaccinated versus unvaccinated populations for long-term heath outcomes. Such a baseline study has never been done, suggesting that the vaccine schedule as a whole is an experiment on human subjects. This bill is called the “Comprehensive Comparative Study of Vaccinated and Unvaccinated Populations Act” and was originally co-sponsored by Rep. Maloney (D.- N.Y.) and Rep. Osborne (R. – Ne.).



3. Congress should create an independent Agency for Vaccine Safety Research. This agency must be completely separate from the Centers for Disease Control, which promotes federal vaccination recommendations for state mandates. This bill is called the “Vaccine Safety and Public Confidence Assurance Act” and was originally co-sponsored by Rep. Weldon (R.-Fl.) and Rep. Maloney (D.- N.Y.) 



4. Congress should abolish the Vaccine Injury Compensation Program or make it optional. The Program has failed in its purpose to quickly, generously and administratively compensate families for vaccine injury and to improve vaccine safety. 


5. Vaccine manufacturers should be subject to ordinary tort liability and civil trials for vaccines. All statutes that shield vaccine manufacturers from ordinary tort liability for vaccine products, such as the National Vaccine Injury Compensation Act (1986) and the Public Readiness and Emergency Preparedness Act (2005), violate the U.S. Constitution’s Seventh Amendment right to a trial by jury in civil cases.


If you support this statement, please go here to sign the on-line petition. And join us Wednesday in Chicago (or on-line if you can’t be there in person).

Friday, May 21, 2010

HE PROBABLY THINKS THIS POST IS ABOUT HIM

The President’s Cancer Panel (pdf here) recently issued a report detailing specific recommendations about potential environmental factors contributing to skyrocketing cancer rates and what we can do to minimize those risks. It’s all sounds pretty familiar to those of us whose experience living in the autism epidemic has caused us to look at the role environmental insults play in the spread and exacerbation of autoimmune disorders, including ASD. Gee, it turns out that organic produce, grass-fed beef and avoiding environmental toxins might actually be good for us. Who’d a thunk it?

The report is a remarkable ⎯ especially as it comes courtesy of the federal government ⎯ 240-page document that’s well worth a read. And it’s gotten praise from a couple of interesting sources.

First, we heard from the New York Times, in an excellent op-ed piece. It is beyond encouraging that the most mainstream of media outlets is willing to say that we just might need to rethink the way we live our lives, even if it means that corporate America might need to live with less profits.

Then I came upon a very surprising commentary on the report. I was not so surprised that the mighty Orac would want to discuss a report about cancer; after all, that is supposedly how he makes a living (as an oncological surgeon and researcher). But much of what he had to say brought a smile to my face.

I have to confess that I’ve always had a bit of an odd fondness for Orac. Not long after the Little Rankster was diagnosed as being on the spectrum, my wife began to attack the problem from a medical standpoint. She eventually became convinced of something that initially struck her as being counter-intuitive to everything she had learned ⎯ that ASD might be triggered by damage from vaccines (or something in them), and that it can be treated biomedically to undo that damage. My wife is one of the smartest people I’ve ever known, so when she became convinced, I knew I had to take a look at the hypothesis. My research led me to the oh-so-dangerous internet, where I became fascinated by the scientific and political debate. And that led me to Orac.

I don’t even recall what post it was at the Huffington Post, but there was a real lively discussion going on in the comments. The two most interesting people commenting, on opposite sides of the question, were both doctors: Alan Clark and Orac. Dr. Clark inspired me with his intelligence, his passion, and his integrity. (It is one of the great regrets of my life that did not get a chance to meet Alan before his untimely death, but I have been lucky enough to have a treasured friendship with his wife, Lujene.) Orac inspired me in a somewhat different way. After a little friendly sparring at HuffPo, I went to Orac’s blog and checked it out. My first thought was, “oh hell, I can do that.”

Despite sharp disagreement on the issues of autism causation and treatment (a dilemma Orac never had to face on a personal level), and the broader issue of vaccine safety, Orac and I stayed on fairly good terms for a couple of years, exchanging thoughts and greetings both on- and off-line. That ended after I declined his suggestion to “disassociate” myself from the instigator of a famous internet prank (in retrospect, it seems even funnier than it did at the time) which targeted Orac (see here and here).

It was probably about time anyway that we dispensed with the trappings of cordiality. By that time, Orac, despite the tongue-in-cheek tone of his blog, had started to take himself way too seriously. His pronouncements of what is and is not science began to take on the clothing (albeit the same cloth used to tailor the emperor’s new clothes) of purported infallibility.

But then again, he always had that white-coat arrogance wherein he refused to recognize any science that did not meet his expectations. Once he had determined for himself what the science of vaccine safety and autism was, no additional data would make him change his mind. And if those who thought differently might expand a hypothesis based on additional observation ⎯ a very reasonable exercise of the scientific method ⎯ such expansions would be laughed away as “moving the goal posts.”

Arrogance like that, though, borders on hubris, and often leads to amazing inconsistencies. And that leads me to Orac’s recent review of the President’s Cancer Panel report (or as Arlo Guthrie once said: “I told you that story so I could tell you this one”).

Orac has always been one to speak of the vaccine-autism controversy as a closed subject. He believes that science has spoken and clearly rejected any connection based on the epidemiological studies that vaccine defenders point to time and again. Like most such defenders, Orac ignores the fundamental flaws in the methodology of those studies as well as the obvious conflicts of interest that weigh against credibility. That’s why I found myself smiling to see the following passage in Orac’s discussion of the President’s Cancer Panel Report:
As tough as biomedical research is in cancer, to my mind far tougher is research trying to tease out the relationship between environmental exposures and cancer risk. If you want complicated, that’s complicated. For one thing, obtaining epidemiological data is incredibly labor- and cost-intensive, and rarely are the data clear cut. There’s always ambiguity, not to mention numerous confounding factors that conspire to exaggerate on the one hand or hide on the other hand correlations between environmental exposures and cancer. As a result, studies are often conflicting, and making sense of the morass of often contradictory studies can tax even the most skillful scientists and epidemiologists.

So let me get this straight. When one is trying to determine the relationship between environmental insults (including vaccines) and the triggering of autism spectrum disorders, even badly designed epidemiological studies can prove conclusive, no matter how provocative findings in clinical and laboratory settings may be. But in the case of cancer, it’s “complicated.”

That very same paragraph compounds the intellectual inconsistency:
Communicating the science and epidemiology linking environment and cancer to the public is even harder. What the lay person often sees is that one day a study is in the news telling him that X causes cancer and then a month later another study says that X doesn’t cause cancer. Is it any wonder that people are often confused over what is and is not dangerous? Add to this a distinct inability on the part of most people, even highly educated people, to weigh small risks against one another (an inability that has led to phenomena such as the anti-vaccine movement), and the task of trying to decide what is dangerous, what is not, how policy is formulated based on this science, and how to communicate the science and the policy derived from it to the public is truly Herculean.

Somehow you just knew, didn’t you, that Orac would get in a dig at what he labels the “anti-vaccine movement.” We differ, of course, on the semantics. I would call it the “safe vaccine” movement, but in Orac’s mind, if you ain’t 100% for the current schedule, you’re an “anti.” Besides, labeling those who disagree with you as “anti-” something makes for a nice, short-hand ad hominem (oh God, I don’t believe I said that).

Beyond the use of an inaccurate label, though, Orac displays arrogance of a truly Offittian magnitude. In his mind, anyone who does not wear a white coat to work is utterly incapable of understanding the subtleties of the scientific method. We are incapable of being able to exercise appropriate judgment in weighing “small risks.” Of course, he simply takes it on face value that the risk of adverse effects from vaccines is small, and any evidence to the contrary is discarded as unreliable.

Orac’s post is rich in irony. One of the recommendations of the panel, seemingly finding favor in Orac’s mind is the following:
The adoption of a new “precautionary, prevention-oriented approach” to replace our “current reactionary approaches in which human harm must be proven before action is taken to reduce or eliminate exposure.” As a part of this approach, it is recommended that the burden of proof of safety should be shifted to the manufacturer, rather than the current burden of proof being upon the government to prove harm.

Really. Would Orac agree that it might be a good idea to apply that same principle to studying the long-term impact of not just individual vaccines and components, but also of the synergistic effect of all of the vaccines on the current schedule? Up to now, he seems to have felt that members of the public, rather than manufacturers or the government, should bear the burden of funding any such research.

I almost shot my morning coffee through my nose when I read Orac’s whole-hearted approval of the Panel’s discussion of environmental factors in childhood cancers:
The report emphasizes quite strongly that what we know about the environmental contribution to cancer has lagged far behind our knowledge of other aspects of cancer. More importantly, one aspect of the environmental contribution to cancer that we often don’t consider strongly enough is that children tend to be more susceptible to environmental insults of many kinds, particularly carcinogenic insults:
An analysis by the National Academy of Sciences found that children are particularly vulnerable to environmental contaminants for several reasons. Due to their smaller size, children’s exposures to toxics are disproportionately large compared with adults. Because their metabolic pathways are immature (particularly during fetal development and in the first months after birth), they are slower to metabolize, detoxify, and excrete many environmental chemicals. As a result, toxins remain active in their bodies for a longer period of time than would be the case in adults. In addition, children have lower levels of some chemical-binding proteins, allowing more of a toxic agent to reach various organs, and their blood-brain barrier is more porous than that of adults, allowing greater chemical exposures to the developing brain. Children’s bodies also are less able to repair damage due to toxic exposures, and the complex processes that take place during the rapid growth and development of children's nervous, respiratory, immune, reproductive, and other organ systems are easily disrupted.

Replace the word “cancer” with your choice of “autism,” “autism Spectrum disorders,” or “developmental delays,” and he sounds like one of us. And wait until you see what Orac had to say about the dramatic rise in childhood cancers, even while the mortality rate dropped:
The reason for this increase is not known, but genetics is an unlikely cause for such a rapid increase. In addition, it is unlikely that better diagnosis due to the introduction of MRI and better CT scanning is likely to be the cause, because the increase is too steady. That leaves environmental factors as one suspect for a major cause.

Gee, Orac, are you sure that the rise in diagnoses was not just due to increased awareness? Or maybe it’s just a lot of parents that want all the services available to sick kids.

It seems that Orac is the perfect example of selective belief in the intractability of scientific “fact.” Because the science suggesting a link between vaccines and ASD is still emerging, the hypotheses are constantly being refined. Orac, and others of his ilk, scoff at that evolution and say that we are “moving the goal posts.” But when it comes to cancer science, his song has a different lyric:
One recommendation of the report that intrigued me was its assessment of how science has generally focused on one compound at a time without considering how they may interact. This reminds me of how in the past we concentrated on one gene at a time as a causative agent for cancer (such as oncogenes); yet over the past ten years it has become increasingly clear that cancer is often driven by many genes, each of which individually plays a relatively small role.

It’s easy to understand how Orac came to the arrogance that shines through his prose. First, it’s not an uncommon characteristic among his profession. Beyond that, however, it cannot be denied that he has become famous through his blog. He writes in a lively style, and his sophomoric humor plays well with jaded grad students. He purportedly gets site visits in numbers that any blogger would envy. That’s enough to give anyone a swelled head.

On a personal level, he’s probably not a bad guy. David Gorski is likely a faithful husband, I certainly doubt that he would kick his dog, and he might even take his turn at buying rounds when he’s at the local tavern. But as Orac, he’s so arrogant as to be completely blind to the inconvenient truth that is hitting him in the face. And he’s not alone.

Orac, and far too many of his ilk, look at things like the report of the President’s Cancer Panel, and they fail to see ⎯ or at least fail to acknowledge ⎯ that what they’re seeing is just one part of a multifaceted picture, showing what we’re doing to the immune systems of the latest generations. I pray that they start hoping their eyes and minds in time to start saving the generations to come.

Monday, May 17, 2010

BE THERE

Wednesday, May 26, 2010. Chicago's Grant Park. For more information go here.

Thursday, May 13, 2010

ALL IS NOT WELL

Early in his movie career, Kevin Bacon played a character named Chip Diller, in the seventies classic, Animal House. His role was small, but he contributed two scenes that were oh-so-memorable.

During a pledging ceremony at the evil and exclusive Omega house, young Chip is repeatedly paddled on his posterior. With each new helping of pain and potential harm, the new pledge is made to exclaim, “Thank you sir, may I have another.” Later in the movie, we see Chip, dressed in his ROTC uniform, acting as a parade marshal for the homecoming festivities. In response to the mayhem created by those bad boys from Delta house, Chip screams out that everyone should “remain calm; all is well.” Of course, all is not well.

I’ve been thinking of Chip lately while observing the coverage ⎯ or to be more precise, the lack of coverage ⎯ of the disclosures that extraneous DNA from pig viruses (and other foreign bodies) was found in both of the Rotavirus vaccines.

For a good discussion of the problem, see these posts (here, here, here, here, here, and especially here) in Age of Autism.

Here’s the basic background. First, in March GSK’s Rotarix vaccine was found to contain DNA from PCV-1, a pig virus. The FDA suspended its use, pending review. Of course, in the meantime, that left the market clear for the sole competitor, Merck’s RotaTeq (developed by our old pal, Paul Offitt).

Then shortly before the FDA hearings on the Rotarix tainting, it was discovered that the RotaTeq vaccine, in fact, contained DNA from two pig viruses, PCV-1 and PCV-2.

The FDA meeting on the Rotarix fiasco occurred, predictably on a Friday. Traditionally, Friday afternoon tends to be when one releases news that one hopes will never be heard. The FDA’s (in)action was all too predictable. No vote on further suspension of the vaccines was taken. Although the panel did say that further long-range studies were advisable, and that parents should be informed that the errant viruses were found in the vaccines (and, of course, Friday afternoon is the ideal time to disseminate that thought, isn’t it?), the overall impression is that nobody on the panel thought there was any immediate concern.

One of the FDA panel members, Dr. Harry Greenburg, was quoted as saying: “The benefits (of the vaccine) far outweighs the risk.” Apparently there was a script floating around the meeting room, because another panelist, Dr. Melinda Wharton, was quoted as saying, “Based on where we are with current knowledge, to me the known benefits clearly outweigh the risks.”

And that was the theme of the scant attention paid by the media. The benefits outweigh the risks. Remain calm; all is well. That theme was based on two elements: the vaccines are effective, and there is a low risk of infection.

Despite lots of chatter in the media that the Rotavirus vaccines have been proven effective in preventing the disease, some studies presented to a recent WHO meeting, suggest that the reported efficacy rates in specific countries vary and depend in large extent to the overall development of the respective areas. In other words, it is difficult to determine whether it’s the vaccines that are preventing Rotavirus, or whether it’s improvements in sanitation, water supplies, and health care.

As to the risk of infection by humans, the FDA panel seems to take as gospel that there is little or no risk because there are no reported incidents of humans contracting PCV-1 or PCV-2 by ordinary contact with infected swine.

Apparently pigs are quite choosy about what infections they will transmit to humans.

Do the FDA panel members not appreciate that there might be a very real difference in transmission by external contact and by internal exposure to DNA? And even if the panel members base their lack of concern on the fact that no vaccinated children have been reported as having the same symptoms as pigs display, the assumption seems to be that clinical manifestations by one species, with no real means of communicating “where it hurts,” would be identical to the clinical picture in a very different species.

Autistic kids ⎯ at least those from families practicing biomedical interventions ⎯ tend to be exhaustively tested. Anecdotally, I am aware of numerous children on the spectrum who have been found to be carrying exotic diseases normally found only in primates, swine, and other non-human critters. I am certainly not proclaiming that those diseases, which are likely contracted through routine vaccines, contribute to the triggering of autistic symptoms. Nor do I know whether there is any harm at all. And that’s the point. We really don’t know. Nobody has been concerned enough to fund appropriate studies.

Maintaining a presumption of safety in the face of legitimate concerns does not serve our children’s interest. It serves only the profits of vaccine manufacturers and the eroding confidence in the sacred cow of public health: the vaccine schedule.

No, all is not well. But the response by the CDC, AAP, FDA, and the rest of the alphabet soup that delivers our health care, is that we should grit our teeth and say: “Thank you sir, may my child have another.”

Friday, May 07, 2010

WHY RALLY?

Last week I blogged about the American Rally for Personal Rights, to be held in Chicago’s Grant Park on May 26, 2010. I thought I might say a little more about our personal commitment to this event and this cause.

Questioning our country’s regulation of vaccine safety could not be more timely. Every day we hear about more and more extraneous viruses being found in vaccines. A May 7th hearing by a FDA committee looked at such problems in the RotaRix vaccine, and it was acknowledged that there may be far more such viruses than have been identified. That meeting came just one day after the announcement that the competing RotaTeq vaccine developed by Paul “10,000 in a day” Offitt contained PCV1 and PCV2 virus DNA fragments. That’s right; kindly Doc O has been injecting our kids with a pig virus, with unknown effects on humans.

Just seven weeks before that news came out, the FDA announced that there was no such contamination in the RotaTeq. I wonder who at the FDA will get the same treatment afforded to Julie Gerberding, the former head of the CDC who is now the president of Merck’s vaccine division, the same company that manufactures and sells ⎯ you guessed it ⎯ RotaTeq.

Safety concerns are routinely swept under the rug, which should surprise no one considering the cozy relationship and revolving door between the industry and the agencies that are supposed to regulate it.

It makes us mad that science has been perverted into a vehicle to make huge profits with no concern for the safety of the consumer. And it makes us mad that our government aids and abets that process.

My wife has spent her professional life working in hospitals, and has seen an explosion of chronic disease and autoimmune disorders in recent years. All of this is happening in younger patients than ever before. That’s on top of the breath-taking rise in developmental disabilities in children. And nobody is asking why.

The causes of all these problems are no doubt complex, and include various environmental exposures and a tainted food supply, but one can’t help but observe that the rise in these problems has occurred at the same time our vaccine schedule has increased. Unfortunately, it took something happening to our family to open our eyes.

A few hours after he was born, our son’s pediatrician injected him with a vaccine for Hepatitis B, which contained thimerosal. Our son’s speech developed slower than normal, but he was otherwise a bright and engaging child. Like all good parents, we continued to let our child receive more vaccinations whenever our pediatrician said he was supposed to get them. What else were we supposed to do?

When he was a little over four-years-old, the Little Rankster received seven vaccines in one day. Overnight, he stopped making eye contact, all of his developing speech disappeared, and he lost control over his emotions.

Our son was diagnosed as being on the autism spectrum. We were told to put him on Ritalin, get him into a special school, and to start searching for an institution that would almost certainly be needed. Instead, we looked for the reasons our son regressed. It was then that we learned of the growing controversy and the possibility that vaccines or their components might play a role in triggering ASD. Our response to all of this was to try undoing some of the damage vaccinations did.

Almost immediately after commencing biomedical interventions, we started seeing remarkable improvements, and we continue to see that. The Little Rankster has progressed far more than multiple “experts” told us he would. He functions quite well in a mainstream academic environment, sings in the school chorus, and this past year was elected by his classmates to serve on the student council. We can’t say he’s completely “cured,” but he’s a lot closer than we were told he could ever be.

Yet the whole time we have followed this path, the mainstream doctors who saw our son told us that everything we were doing was quackery and unproven, because there were no double-blind placebo studies. The fact that our son has progressed remarkably, and is well on the road to a meaningful recovery, has impressed few of those mainstream physicians. Truly, there are none so double blind as those who will not see.

Those same doctors who told us we were following a false path, also told us that vaccines could not have played any role in triggering our son’s ASD. How could they be so sure? Did they make detailed studies of the science themselves? Well no, but they could assure us that public-health officials have studies the problem extensively, and have proved there is no connection. Ah yes, let’s just trust the public-health establishment ⎯ an unholy alliance between government regulators and the institutions they’re supposed to be regulating, and the 14 studies they keep citing to reassure us that our concerns are unfounded.

The problem is that nobody has yet asked the really hard questions. The science is far from settled, and the more the public-health establishment keeps protesting that it is settled, the more we all have to wonder why they aren’t interested in asking those hard questions.

Dr. Bernadine Healy, the former head of the National Institutes of Health, is one of the rare administrators who found a life outside of the industry. She is a vaccine advocate, who nevertheless believes that the issue is far from resolved. Why did she have to wait until after she left the NIH before acknowledging doubt in the safety of vaccines for particular individuals, as opposed to the general population?

The vaccine schedule is the sacred cow of public health. The protectiveness shown by so many comes from two different sources. For one group, it is purely a matter of profit; there’s too much money to be made on vaccines. The profit margin per dose may not be as high as some pharmaceutical products, but then again, there is no other product that is virtually mandatory for every child who will attend public school. The other group of protectors are those who might realize there is some danger, but act on the misguided belief that collateral damage is acceptable for the protection of a larger number of the population.

One-size-fits-all approaches to health care, though, are more than just bad medicine for individual patients; they represent a morally bankrupt policy. No child should be sacrificed for a hypothetical “greater good.”

It is past time for our public health establishment to ask difficult questions about the official vaccination schedule and the harm that might be resulting. Until those questions are asked, the regulators and regulated are not deserving of any credibility. In the meantime, all parents should have the right to make informed medical choices that are right for their particular situations.

The idea of a religious exemption recognized by some states is wrong not just because it encourages even atheist parents to claim religious views. It is wrong because it robs parents of the right to weigh the potential benefits against known risks with regard to each vaccine on the schedule.

As Americans, we deserve the right to make informed decisions regarding each medical procedure our children may undergo. That includes vaccinations. And that’s why we’ll be at the American Rally for Personal Rights. We owe it to our son, and we owe it to the grandchildren we will someday have.