Monday, May 2, 2016

Medical exemptions to vaccine mandates for sale after SB277! Get ’em before they’re gone!

NOTE: Anyone who has seen several derogatory articles about me on the web and is curious about what the real story is, please read this and this.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it's not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

SB277, which eliminates nonmedical exemptions to school vaccine mandates in California, is a very good law, but it’s not perfect. Unfortunately, one provision allows the issuance of medical exemptions based on the say-so of doctors using antivaccine misinformation and pseudoscience.

 
I realize that it’s a cliché to say so, but some clichés are true. Time really does fly. It’s hard to believe that a year ago California—and, by proxy, the rest of the country—was in the throes of a major political war over the bill SB277. SB277, you will recall, was a bill introduced into the California Assembly in the wake of the Disneyland Measles outbreak in early 2015 that eliminated non-medical exemptions to school vaccine mandates beginning with the 2016-2017 school year. Ultimately, SB277 passed and was signed into law by Governor Jerry Brown last July. It was an uncommon victory for science and public health, and already appears to be having a positive effect on vaccine uptake in kindergarten children..

Unfortunately but not unexpectedly, to say that the proposal and passage of SB277 into law drove the antivaccine movement into even greater fits of crazy in response is to put it mildly. It became a common trope on antivaccine websites and blogs to see SB277 compared to fascism, in particular the Holocaust. Robert F. Kennedy, Jr. and “Dr. Bob” Sears explicitly compared SB277 to the Holocaust. Truly, the Godwin was strong in the antivaccine movement. One particularly offensive meme that went around at the time consisted of antivaccinationists suggesting that SB277 was a major step in the direction of requiring children to wear a badge or armband to identify themselves, the way that the Nazis required Jews to wear badges or armbands with a yellow Star of David on them. One, Heather Barajas, even went so far as to be photographed with her children wearing such an “unvaccinated” badge and juxtapose that photo with photos of Jews from the Third Reich wearing yellow Stars of David.

The flaw in SB277

SB277 is generally a good law, but it’s definitely not perfect. Perhaps its most glaring weakness is that all that it requires for a child to obtain a medical exemption is a letter from the child’s doctor. In other words, any physician can provide a letter for parents to use to get a vaccine mandate. It’s useful to look at the other two states that do not allow nonmedical exemptions to school vaccine mandates, Mississippi and West Virginia. Basically, in its acceptance of the word of basically any physician, SB277 is similar to Mississippi law. In contrast, in West Virginia, it isn’t just the word of the child’s physician that matters; all requests for medical exemptions are reviewed by an Immunization Officer, who determines if they are appropriate “based upon the most recent guidance from the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) with respect to medical contraindications or precautions for each vaccine.”

On the surface, SB277 would indeed seem to be a godsend to antivaccine pediatricians, who will likely see their business boom in the wake of SB 277, as parents, no longer able to get nonmedical exemptions, start looking for medical exemptions, much the way parents in states that allow religious exemptions but not personal belief exemptions, suddenly found religion and used it as a justification for not vaccinating. Resistance will flow wherever it can. I’m just happy that, in this case at least, only letters from a physician will be valid for obtaining a medical exemption; one could only imagine what would happen if letters from naturopaths and chiropractors, who, unfortunately, are licensed “health care professionals” in the state of California, were permitted. Over at my not-so-secret other blog, I predicted this would happen based on statements of antivaccine-friendly pediatricians such as Dr. Jay Gordon and Dr. Bob Sears last summer.

Now, as the 2015-2016 school year winds to a close and parents are thinking about the 2016-2017 school year, I have discovered that my predictions were correct.

A gold rush among antivaccine-sympathetic pediatricians

Over the weekend, I saw this story by Kaleigh Rogers, California Doctors Are Advertising Ludicrous Medical Exemptions to Anti-Vaxxers, that appeared to confirm my predictions:

Dr. Tara Zandvliet, a pediatrician based in San Diego, has a pretty typical doctor’s website. The design is reminiscent of a late-90s Dreamweaver template; the color palette is beige, yellow, and brown. There’s an online system where you can book an appointment, a list of the services she offers and the prices, and a short bio listing her credentials.

But there’s one part of the site that stands out: a page that lists qualifying conditions to obtain a medical exemption from having your child vaccinated. These conditions include things like asthma, eczema, and psoriasis, and for $120 per child, Zandvliet will offer a 40-minute consultation to decide whether or not you qualify.

Last year, California changed its laws to eliminate personal belief and religious exemptions for vaccines. These exemptions were what anti-vaxxer parents had been using to continue sending their kids to school unvaccinated. Now, in order for children to attend school (private or public) in California, they must be up to date on the required shots. No special treatment for personal beliefs. So some parents are now turning to medical exemptions to take the place of their personal belief coverage.

Unsurprised but curious, I wandered over to Dr. Zandvliet’s website, screen captured her page and saved it as a web archive (in case it disappears down the old memory hole). The list of qualifying conditions for medical exemptions is long and—shall we say?—not what I would call evidence-based. Sure, there are accepted indications there, such as immunodeficienciies, malignancies whose treatment causes immune suppression, and a history of severe reactions to vaccines and vaccine components. Then, however, there’s a cornucopia of non-evidence-based reasons, including:

Hyper immune conditions
Including, but not limited to:
Asthma
Allergies to food, bee stings, medicines that include hives/swelling/wheezing (hay fever does not count)
Eczema
Hives

Autoimmune Conditions
Including, but not limited to:
Celiac
Crohn’s
Ulcerative Colitis
Lupus
Sjogrens
Scleroderma
Mixed connective tissue
Hashimoto or Graves thyroid (not regular low thyroid)
Psoriasis
Vitiligo
Vasculitis
Antiphospholipid antibody
Multiple Sclerosis
Rheumatoid arthritis (not old age or overuse arthritis)
Wegeners
Type 1 diabetes (child type)
Eosinophilic esophagitis

Let’s just put it this way. None of the above conditions is a contraindication to vaccination. Indeed, the list of true contraindications to vaccination is brief, and very little of what’s on Dr. Zandvliet’s list is on that list. I suppose I should give Dr. Zandvliet credit for one thing. At the end of the list, it does say that autism, autism spectrum disorder, and behavioral issues are not “not sufficient to meet medical exemption requirements.” Goody for her. I was kind of depressed to note that Dr. Zandvliet is double boarded in internal medicine and pediatrics, which is very difficult to accomplish. She’s also board certified in integrative medicine; of course, as I pointed out before when that board certification was first announced, it’s a highly dubious board certification, to say the least.

In other words, Dr. Zandvliet’s practice consists of “integrating” quackery with science- and evidence-based medicine, because that’s what integrative medicine is, by definition. If you don’t believe me, just check out Dr. Zandvliet’s FAQ, where she does the antivaccine shuffle in which she concedes that vaccines “can save lives” but she believes in “talking to parents about the necessity of some of the less essential vaccines” and often suggests “alternative” vaccine schedules. Elsewhere, she points out how she prefers “lifestyle changes to medication,” believes that “acupuncture and Chinese herbal medicine are based in science that has yet to be understood fully,” and supports the “use of nutritional supplements.”

Not surprisingly, Dr Zandvliet testified last year against SB 277, invoking the same sorts of overblown claims of vaccine “injury” and “health freedom” that we’re used to seeing from SB 277 opponents:

She could be “Dr. Bob” or “Dr. Jay.” Speaking of Dr. Bob (Dr. Bob Sears, that is), not surprisingly, he makes an appearance in the article.

Dr. Bob: A trailblazer in selling nonmedical exemptions

Shortly after the passage of SB277, I and others were already speculating that some antivaccine doctors would see the law as an excellent chance to profit. For example, on Twitter:

Meanwhile, our old friend Dr. Jay Gordon wrote:

Governor Brown signed this law because of the strong medical exemption provisions. He recognized that parents with reasonable medical objections—as opposed to personal or religious objections—must still have access to exemptions for their children.

Consult with a physician who knows your child and your family.

No one should scare you into or out of vaccinating.

Dr. Jay often plays the “false balance” card, making it seem as though pro-science vaccine advocates are desperately trying to “scare” parents into vaccinating, when it’s really antivaccine activists who are trying to scare parents out of vaccinating with false claims that vaccines cause autism, diabetes, sudden infant death syndrome, asthma, and a plethora of other diseases and conditions. Be that as it may, Dr. Jay isn’t really the culprit here. He’s just pointing out a loophole in the law that’s big enough for Dr. Bob to drive a Lamborghini through, something we discover later in Rogers’ article, when she cites a Facebook post from last July by everybody’s favorite antivaccine-sympathetic (if not outright antivaccine) pediatrician, Dr. Bob Sears:

The key passage reads:

The guidelines for providing medical exemptions are extremely broad in the new California law. Parents, physicians, legal experts, and some legislators fought to have the term “contraindication” removed from the guidelines, and succeeded. This means that is it up to the personal judgement of each physician and patient to work together to determine if a child qualifies for a medical exemption. The California bill declares that an exemption can be granted if “the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances including, but not limited to, family history, for which the physician does not recommend immunization . . .”

While it’s true that Dr. Sears recommended against seeking medical exemptions “now,” remember that this Facebook post was written 10 months ago, over a year before the 2016-2017 school year is to begin. His reasons for recommending against seeking medical exemptions then was purely strategic, because there is a provision in SB277 that grandfathers in children who already had exemptions. They can continue to use those exemptions until they hit a new grade span (starting preschool, entering kindergarten, or beginning the seventh grade), at which point they’ll need to be up to date on their vaccines.

In any case, Sears blazed the trail in defining the conditions that physicians should consider in writing up letters of support for exemptions to school vaccine mandates. Indeed, last July, he held a “vaccine open house” in Culver City that he advertised on his Facebook page:

Alarmed at what Dr. Bob was doing, a pro-science advocate attended and took careful notes. His town hall tarted with an hour-long PowerPoint presentation full of antivaccine misinformation and errors by someone else. Dr. Bob, however, was clearly the star of the show and spoke next. After stating how much he hates SB277 and acknowledging how much all the attendees hate the law, he got into his main topic, namely how to comply with the law without vaccinating. His talk was chock full of misinformation and disingenuousness. Basically, his talk was summarized in the Facebook post above.

Advice from an antivaccine doctor to antivaccine parents and the vaccine-averse

If you don’t think Dr. Bob is antivaccine, consider this. He started out his part of the town hall by referring to autism as a “known side effect” of vaccines. It is not, and he knows it. If he doesn’t know it, he is utterly incompetent in evaluating evidence or was cynically pandering to his audience. Take your pick.

Among the tidbits of information Dr. Bob dropped on his audience were:

  • A description of an effort to amend the law to allow chiropractors and naturopaths to issue medical exemptions. I know antivaccinationists tried to get that slipped into SB277 and failed. One can only hope the legislature doesn’t fall for that one. If you think Dr. Bob will give an exemption to virtually anyone who wants one, just let chiropractors and naturopaths write exemptions based on “aggregate toxicity” or something like that.
  • A suggestion that parents seek out a DO because, or so Dr. Bob thinks, they tend to be more “open minded” than MDs. Personally, this hasn’t been my experience, at least not in the US, but I don’t know many DO pediatricians or primary care docs. One of the best surgical intensivists I ever knew was a DO, as is one of the premier phase I cancer clinical trialists in the country, Dr. Pat LoRusso.
  • Another suggestion that parents seek out physicians in solo or small private practices rather than larger groups. The reason for this one to me is obvious. Larger groups tend to have more explicitly codified practice guidelines.

Dr. Bob then got into the nitty-gritty of telling parents just how they can avoid the requirement of SB277. According to Dr. Bob, here are the ways to get around the law other than home schooling. The first method is to get an Individualized Education Program (IEP) that specifies regular classroom time. For those who have no experience with them, let me briefly explain. IEPs are mandated by the Individuals with Disabilities Education Act (IDEA) for children with special needs. If a child receives special educations services, he must have an IEP that includes a description of how the child is doing, the child’s specific annual education goals, specific special education supports and services that the school will provide to help the child reach those goals, modifications and accommodations the school will provide to help the child make progress, and other information. To comply with federal law, SB 277 specifically stipulates that the law “does not prohibit a pupil who qualifies for an individualized education program, pursuant to federal law and Section 56026 of the Education Code, from accessing any special education and related services required by his or her individualized education program.” So you can see where Dr. Bob was dishonestly going. In fact, he was quite explicit. He recommended that parents seek an IEP, even for “minimal speech delay or learning issue” when the child is 2 or 3 years old so that they have it later and will be “protected” from SB 277 for the entire child’s school career. This is gaming the system at its most blatant.

Naturally, the other option is a medical exemption. Dr. Bob, as did Dr. Jay before him, characterized whether or not a medical exemption is granted as being “completely up to the opinion of the doctor,” which unfortunately is basically true, as Rogers’ article points out. This led him to recommend “seeking out open-minded doctors,” doctors (apparently like Dr. Zandvliet) who apparently agree with his non-evidence-based reasons for not vaccinating, including:

  • Prior vaccine reaction in child, sibling, parent, or more distant relative (protected by mention of “family history” in SB277)
  • Family history of autoimmune disease. He added: “And everyone has autoimmune disease in their family.” (Nudge, nudge, wink, wink, know what I mean, say no more!) The audience laughed appreciatively. He went on: “So an openminded doctor could use a family history of vitiligo, celiac disease, autoimmune thyroid disease, or other disease on to support a medical exemption.”
  • Autism, learning disorders, and ADHD
  • Allergies, esp if more severe
  • Other chronic conditions

Of course, as is the case with Dr. Zandvliet’s list of reasons for medical exemptioins, none of these are evidence-based reasons, except for a personal prior severe reaction to a previous vaccine, a severe allergy to a vaccine component (which would only be valid as a reason not to use that vaccine), and, of course, immune compromise. Such reactions or allergies in family members don’t count, although unfortunately “family history” was placed into the law as a potential reason to grant a medical exemption. During his town hall, Dr. bob also mentioned the state medical board; it’s also one part of his message that’s not in his Facebook post on the subject. In brief, he told the audience that he had spoken to someone at the California Board of Medicine and been told that to date “they have not investigated any doctor for writing medical exemptions.” He stated they could, but to get involved they would need someone to file a complaint about a specific case. Yes, clearly Dr. Bob had thought about this issue and made preparations to cover his posterior, to the point where he apparently believes that if the board investigates, “nobody would get into trouble, they would just void the exemption.” Personally, I wouldn’t be so sure of that, but apparently Dr. Bob is sure enough to be telling parents this, even adding, “There might be people out to get me, but not the Medical Board.”

Finally, Dr. Bob talked strategy. Remember how I said that his suggestion that parents not seek medical exemptions last summer was strategic, rather than based on honest? He even asked them to “save those [exemptions] for the people who are not grandfathered in; wait until your 3rd grader is about to be a 7th grader before seeking an exemption.” What he meant by this is as follows. He also discussed taking advantage of “conditional entry” in order to spread vaccines out over years. “Conditional entry” means that a child who hasn’t met all the vaccine requirements can still be enrolled as long as there is a plan to eventually complete required vaccinations, which usually requires a note from a doctor outlining the plan. Dr. Bob actually advised dragging this process out over months or even years, only getting vaccines when the school absolutely insists on it, and hoping the school is too busy to call, saying, “You might not get by with this in a regular public school, so try charters and small private schools—seek those schools out.”

After the main meeting broke up, there was a smaller group of parents still asking Dr. Bob questions, his answers to some of which were overheard. For instance, he was asked how much an office visit costs (his answer: $180) and whether he took insurance (his answer: no, other than TriCare). At one point, a woman approached and told Dr. Bob that her pediatrician whom she otherwise liked would not issue an exemption, asking if he would see her for a one-time visit. His response? “I would be happy to provide that service.” He also confirmed that a one-time medical exemption visit is $180 and that he’d be willing to issue such an exemption and send the child back to his primary pediatrician. When asked whether that was a conflict of interest, Dr. Bob was taken aback, reacting with genuine surprise and answering, “Do you expect me to see them for free?” According to my reader, Dr. Bob seemed genuinely not to understand the point of the question.

Of course he didn’t.

The antivaccine quackery continues

If you want to see just how much Dr. Bob has aligned himself with the antivaccine, pro-quackery movement, consider this: He’s still giving seminars on how to obtain medical exemptions; only now he’s charging $20-$50 a pop for them. For example, on May 11, if you live near Irvine, CA, you can attend a seminar in which Dr. Bob will appear with a homeopath, Dr. Bob Sears – Mandatory vaccine laws: Are they necessary? Will they even work? What are your options? Homeopath Tania – Homeoprophylaxis for immune boosting. That’s right. Dr. Bob is appearing side-by-side on stage with a practitioner of The One Quackery To Rule Them All, homeopathy. This practitioner, Tania Dilmani, offers just as much quackery on her website as you would expect from a homeopath, plus an amazing helping of self-promotion as well.

Dr. Kelly Sutton: Selling webinars telling parents how to obtain a medical exemption to school vaccine mandates, whether the exemption is appropriate or not.

Dr. Kelly Sutton: Selling webinars telling parents how to obtain a medical exemption to school vaccine mandates, whether the exemption is appropriate or not.

Unfortunately, Dr. Bob is not alone on the medical exemption seminar circuit in California—webinar circuit, actually. Rogers cites another med-peds doc, Dr. Kelly Sutton, who is offering webinars on how to avoid the requirements of SB277 by seeking medical exemptions to school vaccine mandates. Shockingly (that’s sarcasm, obviously), Dr. Sutton practices anthroposophic medicine, one of the quackiest of quack medicines. Her website describes her approach thusly:

Dr. Sutton bases her diagnosis in part on conventional medicine: history, physical, laboratory and imaging, and subspecialist consultation when needed. Significant understanding arises from listening to aspects of an individual’s biography, life purpose, the emotional context of illness and health, and understanding the level of vitality and strength of the life forces. She treats acute and chronic illness using the least toxic effective treatment for the condition. Anthroposophic remedies (low potency homeopathic preparations and herbs), diet, nutritional supplements, healthy rhythm, warmth are some of the foundational principles she employs. Anthroposophic therapies play a key role in treatment.

Yep. More homeopathy.

She bills her seminars as the “Step-by-step Program to Help Protect Your Child
from the ‘One Size Fits All’ California Vaccine Mandate!
,” promising to provide the “tools and knowledge you need to protect your rights as a parent to choose the healthcare of your child” and take attendees “from cornered to confident.” She offers this all for $27—but only if you take advantage of the early bird special. You can get a taste of what she’s offering here. I must admit that I laughed out loud when Sutton started her webinar out by claiming that her presentation is neither antivaccine nor pro-vaccine, but rather pro-parent. This, of course, led me to ask” What about pro-child?” That’s because antivaccine views seem to be always far more about the parent than the good of the child. Indeed, as I’ve pointed out many times before, the attitude of many antivaccine parents is that their rights matter more than that of the child and that the child is essentially their property.

Even more hilariously, Sutton tells parents to trust themselves and that no one cares more or knows more. Really? I’d say scientists and pediatricians know more than the vast majority of parents about vaccines, their indications, their benefits, and their risks. Sutton is basically massaging her marks to assure them that they’re the smartest ever and no one knows more about the topic at hand than they do. The rest of the video is chock full of antivaccine misinformation and tropes, such as the “vaccines didn’t save us” gambit, the claim that Pasteur was wrong. I was also shocked at how amateurish the graphics in the webinar were, as well.

Finally, I’ve discussed how genetic profiling is still in its infancy, even for cancer. Even so, quacks do so love to get ahead of the science and claim to be able to use it to diagnose and treat conditions. Rogers called a number of clinics listed on Bob Sears’ website posing as a patient asking about a medical exemption for her children and noted:

I also cold-called a random selection of California clinics listed on Sears’s website as “vaccine friendly,” and posed as a patient inquiring about medical exemptions. Most of the clinics told me it was highly unlikely my child would qualify for a medical exemption and that they would not consider it for anyone who wasn’t already an established patient.

But a few offered other responses. One clinic told me new patients hoping for a medical exemption must first get DNA testing done by 23andme, “so that we have proof of a genetic predisposition.” Another suggested I use the form on Zandvliet’s site as a guideline before coming in for a consultation. One other suggested I attend an upcoming seminar hosted by Sears.

There is, of course, no convincing (or even suggestive) evidence that 23andme testing can reliably identify genetic predispositions to adverse vaccine reactions. Any clinic making this claim is just making it up as it goes along. I expect, however, to see a lot more of this.

The quack gold rush looking to cash in on issuing medical exemptions to school vaccine mandates is starting to look like an old Betty Boop cartoon.

The quack gold rush looking to cash in on issuing medical exemptions to school vaccine mandates is starting to look like an old Betty Boop cartoon.

What can be done?

Clearly, the great leeway granted physicians in identifying diseases and conditions upon which to base a letter supporting a medical exemption to school vaccine mandates for an individual patient is a feature, not a bug, in SB277. It was a compromise without which the bill likely would never have become law. So the question will be: Can anything be done to prevent antivaccine-sympathetic doctors from issuing vaccine mandates to just about anyone. Ten months ago, I sarcastically predicted:

Clearly, doctors like Bob Sears, Tara Zandvliet, and Kelly Sutton are doing their best to make my prediction come true. What kind of push-back can they expect?

Unfortunately, there’s not much that can be done. Rogers points out that the percentage of children with medical exemptions in California is below 1% and has been stable for decades. If that rate starts to rise, it could be an indicator that more doctors are offering more dubious medical exemptions. However, it could take years for such an increase to manifest itself, because many California children are still grandfathered in with their nonmedical exemptions and won’t be facing a school year where they have to catch up on their shots for years. Rogers notes:

It’s also not totally clear that, if a doctor did offer a medical exemption for a child because his or her grandmother has psoriasis, it would be illegal. There are no official “rules” for what qualifies a patient for a medical exemption, outside of the CDC’s recommendations, and the law leaves it up to the discretion of the doctor. In general, that’s a good thing, because it would be difficult to very precisely account for every possible situation when a medical exemption would make sense.

I disagree. the vast majority of these “possible situations” are not indications for medical exemptions, as the number of such indications is few and the indications are clear. West Virginia, as I pointed out above, doesn’t leave it just to the physician’s discretion. It double checks the reason given for a requested exemption before permitting that exemption.

Really, the only option, barring a change in the law, is the state medical board, as Rogers quotes law professor and pro-vaccine advocate Dorit Reiss discussing:

But it also opens up the possibility of medical exemptions being used to fill the role of personal belief exemptions. The only way a doctor might be subject to discipline for handing out questionable medical exemptions would be through the Medical Board of California.

“You could complain to the board and say it’s a violation of the standard of care, but it’s not formalized,” Reiss said. “Doctors that advertise online saying they’ll give medical exemptions are kind of natural targets. They kind of deserve to be closely monitored.”

A spokesperson for the Medical Board told me it’s not specifically monitoring who gives out medical exemptions or how many, but that just like anything else a doctor does, this decision would need to meet the board’s standard of care.

Given how toothless most state medical boards are, I wouldn’t hold my breath waiting for California’s board to go after the Dr. Bobs of its state. Contrary to Rogers’ assertion, this aspect of SB277 is toothless and California will have to depend on the essential honesty and science-based practice of the vast majority of its pediatricians and family practice doctors. That appears to have been enough in Mississippi, but whether it will be enough in the woo-friendly, antivacine-riddled state of California remains to be seen. I’m cautiously hopeful that it will be, but I wouldn’t be surprised to be wrong.

Don’t get me wrong. The passage of SB 277 is a major victory in the struggle to protect children from the ravages of infectious disease and a major defeat for the antivaccine movement, which marshaled pretty much everything it had to defeat it and still came up short. But it is not perfect. It’s politics. Compromises had to be made. SB277 makes the situation in California much better than it was before with respect to child health and should serve as a model for the remaining 47 states that allow religious and personal belief exemptions. It is a beginning, not an end, and part of what needs to be done now is to keep an eye on its implementation.



from Science-Based Medicine http://ift.tt/1W1sIiB

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