Browsed by
Category: Uncategorized

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Under current law, it is illegal for patients to have their own stems cells removed, cultured/expanded and reinjected. That’s too bad because there are plenty of instances where this treatment seems to be helping patients with incurable chronic diseases such as MS. Patients who want this type of treatment have to go abroad, usually either Mexico or Panama. That’s quite burdensome for some, given their medical problems.

Texas MS Patients to the Rescue, (maybe)

During the current Texas legislative session, a group of deeply committed Texas stem cell patients have been leading the charge to change the law in Texas, to allow patients access to their own cultured/expanded cells and even allogeneic stem cells.

The bill they have championed, HB 810, passed the Texas House easily and just a few days ago passed the Senate, and Governor Abbott has promised to sign it. So all good right? Well, actually no.

There’s a hitch and it’s a big one.

In Texas it’s easy to kill a bill, and very hard to pass a bill if there is any opposition whatsoever. And there is a lot of opposition to this bill, some visible and some, I believe, behind the scenes.

How to cut the heart out of a bill

One of the nastiest ways to kill a bill is to gut it with an amendment; by making it meaningless via a seemingly innocuous and reasonable addition. That’s exactly what the Senate did to HB 810. My guess is that there were one or two Senators who were told by the powers-that-be,(and that would probably be the Texas Medical Association and the Texas Medical Board) to kill the bill, and this Senator or two, convinced the other Senators to go along with the changes, with the other Senators not realizing that they were actually killing the bill.

HB 810

HB 810 gives people the right to use their own cultured stem cells and even other adult stem cells (meaning from umbilical cords and from humans, but not fetal stem cells) as long as the use was part of a “clinical trial.” However, HB 810 did not say that it had to be an FDA approved clinical trial, and that is important. So HB 810 would allow doctors to do their own non-FDA approved clinical trials. That’s critical because getting the FDA to approve a clinical trial, via filing an IND (Investigational New Drug application) is a very, very expensive and time consuming process and well beyond the abilities and financial wherewithal of doctors and clinics.

Under the bill, a physician had to agree and certify that the treatment was necessary, and of course there had to be informed consent. But that’s basically it. HB 810 would have dramatically opened the doors for patients with all kinds of diseases to receive their own expanded cells and someone else’s stem cells in Texas.

HB 810 is good news for patients, but bad news for the establishment types

That would be very good news for patients with chronic, incurable diseases who are willing to accept the risk of undergoing treatments which haven’t been approved by the FDA. But it would be very bad news for the stem cell research Mafioso, the guardians of the Holy Grail who are trying to corral everyone they can into FDA approved clinical trials. It would be worse news for the medical establishment types who have the heartfelt belief that patients need to be protected from their own foolishness, and the false hope that their own stem cells might be able to help cure or mitigate their condition, or that these foolish people have the right to try this kind of treatment in the U.S. These folks have decided that they decide when patients can use their own body parts.

I surmise that some of these establishment types had some quiet conversations with one or two state senators and were told to kill HB 810.

Here’s what they did, and regrettably, it’s good.

The HB 810 Bill-Killer’s Amendments

1. The Senate bill added a provision that the use of stem cells sanctioned by HB 810 has to be in accordance with 21 CFR 1271, which is the section of the federal code of regulation which states that autologous, expanded stem cells (your own stem cells which are cultured) and someone else’s stem cells are drugs and cannot be used until they are approved for marketing by the FDA (or under an FDA approved clinical trial). This completely eviscerates HB 810. The whole point of the bill was to allow patients to get stem cell treatment which did not comply with 21 CFR 1271. It’s already legal to use stem cells which are 1271 compliant, so… well you get the idea.

2. Another Senate amendment requires that the stem cells can only be administered in a hospital or ambulatory surgical center. That’s a very expensive proposition and basically puts stem cell treatment beyond the reach of most physicians. By the way, this was the same tactic used in the Texas abortion law to effectively outlaw abortion clinics, (which provision was, I believe, struck down.)

3. Finally, the Senate amendment proposed that stem cells can only be given if their use is approved by a university or big hospital IRB (Institutional Review Board). I can tell you that no university is going to approve non-FDA approved stem cell treatment unless the clinical trial is approved by the FDA, via the full IND process. Further, stand-alone big hospitals don’t have a full IRB, and those which do research and have IRB’s are not going to jeopardize their on-going research by using or allowing their IRB’s to sanction non-FDA approved drugs to be administered outside of FDA approved clinical trials. For these folks, there is no such thing as a non-FDA approved clinical trial of a non-FDA approved drug. Practically speaking, this makes it very difficult to impossible for a physician to deliver these unapproved stem cell treatments under this Seanate amendment.

There are only a couple days left in the current legislative session. While there is still time to negotiate, my guess is that the Senator(s) who introduced these amendments, who did so to kill HB 810 is (are) not going to back down, barring some almost miraculous level of public pressure put on him (them).

Here’s hoping……

Rick Jaffe, Esq.

rickjaffeesquire@gmail.com

ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

ALL’S MOSTLY QUIET ON THE FDA FRONT, but don’t expect that to last now that there’s a New FDA Commissioner

It seems like forever ago since the FDA’s 2015-2016 attempt to increase its regulatory powers, or more pointedly, since the FDA regulatory thugs have tried to dramatically restrict the personal freedom of US citizens.

The good news is that most of the major proposed changes are still up in the air. The not-so-good news is that now that the FDA has a new commissioner (Scott Gottleib was confirmed by the Senate on April, 27, 2017), I’m expecting things to happen, not all of them good.

Let’s review what’s up in the air/awaiting decision/finalization, but first let me remind you about the FDA’s two main mechanisms by which it increases its power over consumers and companies that provide health care goods:FDA guidance documents and warning letters.

Guidance documents are industry-wide statements of the FDA “current thinking” on a subject. They have a one way force-of-law. The FDA can sue you for doing something in violation of a guidance document, but you can’t sue the FDA about the guidance document because it’s just the “agency’s current thinking on a subject” and so there’s nothing you the consumer or the business person can do about it, at least until you get sued.

A “warning letters” tell a specific company that they’re violating the law and should stop or else. But you can’t sue the FDA to challenge the warning letter because it takes the position that it’s not sure, they might change their mind, it’s not a “final determination” or maybe they’re just kidding. You have to wait until the FDA goes after you.

The first takeaway is that so far, things are still mostly quiet on the FDA front, but as stated, I’d expect that to change with a new FDA commissioner on board.

The Big things up in the air in FDA Land

To recap the FDA’s broad efforts to expand its powers and jurisdiction and where the draft guidelines are awaiting final approval:

1. Stem Cells: The FDA proposed four guidance documents back in the 2015-2016 which would have basically destroyed the U.S. autologous stem cell business for everything from diseases to breast reconstruction after mastectomies. See my post on these guidance documents at: http://rickjaffeesq.com/category/stemcells/

2. Dietary Supplements: The FDA proposed changed via a revised definition of a new dietary ingredient which would have turned many dietary supplements into drugs or would require drug like testing. See my post at: http://rickjaffeesq.com/category/supplements/

3. Compounding pharmacies: new regulations would severely hamper the ability of compounding pharmacists to continue to operate.

If you’re an anti or concerned vaxxer, you already know, Scott’s public comments have been in line with Pharma’s and the rest of the vaccine establishment’s position. Better luck with the CDC.

Now might be an excellent time for the supplement industry and the autologous stem cell industry and its patient supporters to reengage in a federal campaign.

Still it’s not like the FDA has been asleep

So what has the FDA been up to since this year so far?

Probably the best way to get a beat on what the FDA is up to is to review the warning letters it has issued. I’ve done that and here’s what I’ve come up with:
(If you want to look over the FDA recent warning letters yourself, here’s the place:
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/default.htm?Page=1)

Supplements have been given scrutiny in the following areas:

Supplements converted into unapproved cancer treatments:

Sometimes the FDA focuses on an issue or problem after receiving a complaint about a violation, then it goes after a bunch of folks violating the law usually on the same day. That happened in on April, 17th when the FDA sent almost a dozen warning letters to supplement makers who were marketing their products as cures or treatments of cancer. That’s a definite no-no in FDA controlled land.

Putting drugs into supplements

Some supplement manufactures have decided that the best way to increase the potency of their products to remedy some condition is by putting in a touch of a drug, or what the FDA calls an “active pharmaceutical ingredient” or “API”). It really kicks-up the product a notch, but of course, it’s illegal. I’ve worked on the issue, and the FDA’s remedies are quite draconian; for starters they make you write to all the customers and refund the money they paid, and do a product recall. And that’s it if you’re lucky. If you’re not or the feds think you did it intentionally, think an indictment on multiple FDA felony counts.

Are you a Good Manufacturer? (And that includes you distributors and resellers)

Supplement manufacturers have to manufacture their products in accordance with current good manufacturing practices (CGMP). It’s onerous but it’s the cost of doing business. Lately the FDA has sent a bunch of warning letters to supplement manufacturers complaining of lack of compliance with a lot of the technical and paperwork requirements. The surprising part of this area of regulatory law is that the downstream distributors and resellers also have quite significant regulatory obligations to ensure CGMP compliance and/or quality control. I’ve seen supplement distributors hung out to dry for very specific and somewhat onerous regulations.

Compounders Get unwanted attention

Even though the draft compounding guidelines are still pending, that hasn’t stopped the FDA from issuing warning letters to a few compounders. Things should really pick up for the FDA once the guidance documents are finalized.

So in short,
the FDA has been continuing to do what it is always does, which is some combination of protecting the public and interfering with the rights of consumers. How much of one versus the other depends on what your core beliefs or main issues are. But still, with these three big areas with pending draft guidelines (stem cells, dietary supplements and compounding), now that there is a new FDA commissioner, I’d look for some resolution of these big open issues in the next few months.

From all accounts, the new Commissioner is very friendly with Pharma and wants to see the drug approval process streamlined and shortened which will be good for Pharma. Don’t look for any help from him on the vaccine safety issue. The jury is still out on him on stem cells and supplements, but I don’t see much reason for optimism, unless there is a continued public outcry for access to more information about supplements and more access to our own body parts.

Here’s to hoping, (and maybe some doing).

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

I want to sue the Medical Board for Antitrust violations, because it’s restraining trade by prosecuting me for practicing my kind of medicine.

I want to sue the Medical Board for Antitrust violations, because it’s restraining trade by prosecuting me for practicing my kind of medicine.

I hear that a lot from CAM docs. There is nothing more emotionally satisfying for a doc being prosecuted/persecuted by a medical board than to turn the tables and sue the board, its ignorant and venal board members and its executive director. Aside from the pure joy for the doc, isn’t the best defense a good offense?

Good sentiment for sure, but regrettably, two problems

First, board members are typically immune from damage awards regarding their decisions. That brings up a related but often forgotten point. Usually, docs want to sue the board after the informal settlement conference has failed to dismiss the investigation, or right after the board staff files the administrative case. But at this juncture, most of the board members haven’t even heard of the doc and only will learn about the case after an administrative judge issues a proposed decision.

But we’re suing in part to stop the bastards from ruling against me in the future and interfering with my right to practice, right?

That leads to the second problem, and here’s the short of it: No court has ever or will ever stop an on-going medical board proceeding.

But what if the board hasn’t followed its own rules in filing the administrative complaint against me?

Doesn’t matter. The reason, in legal parlance is ripeness (maybe also failure to exhaust administrative remedies).

Until the board makes an actual and enforceable decision on your case, there is nothing for the Court to do, because the board hasn’t taken final action, and courts only review final actions of administrative agencies, (unless specifically granted the authority to do so, and that’s almost never the case). Maybe the administrative judge and the board will agree with you after a hearing. That’s the way the courts look at it, so they wait until the board makes its decision.

But filing the case against me is public and hurts my reputation and I’m being injured now even without a final board decision.

Sorry, but that doesn’t matter. Having an administrative case or even a criminal case filed against you is not something which can be stopped by another court just because you think the board or prosecutor is wrong, out to get you, or even if you think you will suffer harm because there is a pending case against you. Very sorry, but the law just doesn’t stop cases against people because the case might injure a person’s reputation or business.

So whatever tactical reasons there might be for suing the board which has or is about to file a case against a doc, expecting that a court will actually stop the board from proceeding with its case is not realistic; it’s just not going to happen.

There might be other reasons to sue the board: Maybe you think you can wear a government agency down. Maybe you want to show that you’re a tough guy. Or maybe (and this is my personal favorite) you have such a deep respect for the legal profession, and such gratitude for the noble attorneys who defend CAM docs that you want to make a substantial contribution to their well-being.

Well, if that’s your motivation, then I say go for it!

But know that the trial court is going to deny your request to stop the board from proceeding against you, the appellate court will affirm the dismissal, and neither the state supreme court nor the U.S. Supreme court will hear your case (in case you want to make a really, really big contribution to your attorney’s financial well-being).

>Antitrust to the Rescue?

Well what about this new antitrust deal?

A new or developing thing is trying to sue boards for antitrust violations. Every CAM doc has heard that a couple years back the Supreme Court upheld the FTC’s suit against the North Carolina Dental Board’s because it tried to stop non dentists from offering teeth whitening at shopping malls. Here is the Supreme Court’s decision:

http://www.scotusblog.com/case-files/cases/north-carolina-board-of-dental-examiners-v-federal-trade-commission/

So why can’t I sue the board for antitrust restraint of trade for trying to put me out business; the board is restraining my trade?

It’s a fair question. I could tell you the answer in a one word sentence, but better to give some background and analytical tools, so you can understand what’s required to present a viable antitrust claim.

You can’t sue the state government for antitrust (and neither can the federal government)

States cannot be sued for antitrust violations. Congress understood that it couldn’t prohibit all state regulation which displaced or affected competition. This limitation of federal antitrust law was laid out by the Supreme Court in Parker v. Brown in 1943.

But what about state agencies like the medical boards which are usually controlled by professionals who are competing with the people the board is targeting?

Very good grasshopper! That was exactly the question raised and answered in the North Carolina Dental Board case.

The Federal Trade Commission sued the North Carolina Dental Board for restraint of trade because it had sent warning letters to shopping mall dental whitening stores which services were not performed by dentists. North Carolina law didn’t specifically say that teeth whitening was the practice of dentistry.

The Board tried to wrap itself in the Parker v Brown state immunity from antitrust liability mantle. But the Supreme Court said no. It held that because the dental board was controlled by “active participants” (meaning competitors of the mall dental whitening places) and because the board’s decisions were not “actively supervised” by some higher authority, the dental board was not entitled to state immunity from antitrust liability.

Not only did the Supreme Court hold that the dental board could be sued for antitrust, the FTC found that the dental board did illegally interfere with competition and ordered it to stop. So it was a complete loss for the North Carolina Dental Board.

Two questions: First, what does it mean for a board to be actively supervised? The FTC has published some guidelines. Here they are.

https://www.ftc.gov/system/files/attachments/competition-policy-guidance/active_supervision_of_state_boards.pdf

But I can tell you that in a state like California, where the Medical Board’s decisions are final, and can only be reversed by a superior court judge, that’s not active supervision.

The second and big point is just because a board is not immune from antitrust liability doesn’t mean that any tom, dick or doc can assert a viable antitrust claim; you still have to plausibly assert all the requisite elements of an antitrust violation. And that my friends is where an antitrust case filed in response to an administrative complaint against a doc runs into trouble.

Restraints of trade as would be asserted by a doc against a medical board would be evaluated under a “rule of reason” analysis, meaning the court considers the net effect of the restraint on “competition.” The oft-repeated mantra in antitrust jurisprudence is that “the antitrust laws protect competition, not competitors.”

An antitrust plaintiff cannot assert a valid antitrust claim, let alone win, by alleging that the restrictive action by the board harmed the doc. The doc would have to show how the board’s action harmed competition or the type of services generally.

In a board administrative case, especially one that hasn’t yet resulted in an adverse order, it’s going to be hard-to-impossible to show injury to anyone but the suing doc, (and that assumes a court would find injury to the doc, which is doubtful since the board hasn’t done anything, if the antitrust action is filed before the board makes a final decision).

To see if your case involves harm to competition, do a thought experiment: Forget about your case. What’s left? If your case is the main part of the claim, and there aren’t many other practitioners who are being subjected to the same thing, then the case doesn’t impact competition.

Well what about the chilling effect the case will have on other CAM docs, or the fact that this case will be a “springboard” to other cases?

Sorry, the courts have rejected that argument, because it’s too speculative. Here are two cases where the doc sued the board for antitrust, and got thrown out of court for lack of antitrust injury, despite their springboard or chilling effect argument.

http://www.leagle.com/decision/In%20FCO%2020160516084/PETRIE%20v.%20VIRGINIA%20BOARD%20OF%20MEDICINE
http://www.leagle.com/decision/In%20FDCO%2020170222F17/JEMSEK%20v.%20NORTH%20CAROLINA%20MEDICAL%20BOARD

There has to be hard and specific evidence of that the board’s actions will have a negative effect on competition, like there was in the North Carolina Dental Board case where the stated purpose of the warning letters was to put the non-dentist teeth whitening clinics out of business.

North Carolina provides another example of what it takes to successfully allege an antitrust case against a professional board. The North Carolina Acupuncture Board, at the behest of the acupuncture trade association sent out letters to physical therapists to cease and desist doing “dry needling” because the acupuncturists thought that the technique belonged to them exclusively. The PTs sued for antitrust violations. The acupuncture board tried to dismiss the case, but the judge allowed the antitrust part of the case to go forward, because the PTs alleged antitrust injury, i.e. the board’s action alleged a specific negative effect on competition, not just an individual PT. Here is the case:

http://www.leagle.com/decision/In%20FDCO%2020170131D06/HENRY%20v.%20NORTH%20CAROLINA%20ACUPUNCTURE%20LICENSING%20BOARD

The lessons I take from these cases are:

1. If a board tries to stop a group of providers not licensed by the board but which offers the same services of the board’s active participants, that states antitrust injury and a viable antitrust claim (assuming the other requirements are met, but

2. It is impossible, or close to it, for a doc to successfully sue a medical board for antitrust violations if the basis of the antitrust suit is that the board has started or is about to start a disciplinary action against him/her.

So if you’re going to sue a board for antitrust because the board has started a disciplinary action against you, have a realistic idea of what you can get out of it, and what you won’t.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Maybe it’s time for the health concerned multitudes to come together, throw their weight around and change things up

Maybe it’s time for the health concerned multitudes to come together, throw their weight around and change things up


Per my two last posts, the CAM (Complementary and Alternative Medicine) community is under attack on at least two fronts. First, several CAM professional or issue related organizations have recently been subjected to corrective action regarding their CME accreditation for their annual conferences. Some of their last year’s conference CME’s have been retroactively rescinded, they have had their future conference CME accreditation withdrawn, and/or the groups have been warned to conform to “evidence based medicine,” code for conventional medical practice. See my post:
http://rickjaffeesq.com/2017/03/16/the-next-big-cam-battle-is-here-and-its-ugly/

This is significant because these organizations depend on physician seminar income to sustain them, and practitioners depend on these seminars to learn the latest research and best practices involving CAM therapies. My prediction is that more CAM related organizations will be subjected to the same kind of scrutiny and corrective action by the ACCME. My hunch is that some entity other than the ACCME is calling the shots on this.

The second shot across-the-bow comes from a medical board in a state law that has incorporated the AMA’s “ethical standards.” These standards render unethical the sale of health related products. This board has initially determined that this ethical prohibition applies to a physician prescribing and selling active CAM therapy, which can only be obtained from the physician, after the physician receives training. See my post:
http://rickjaffeesq.com/2017/03/22/can-cam-docs-legally-prescribe-and-sell-herbals-and-nutritional-supplements-as-therapy-without-bad-things-happening-prescribe-yes-sell-well-see/

This has been a mostly dormant issue despite the AMA ethical rule, since countless CAM physicians sell supplements or prescribe food, herbals or dietary supplements as primary or secondary therapy without incident. I’m thinking this new case may be a foreshadowing of more to come.

These two fronts are interrelated because a part of the ACCME’s stated concerns is the financial connection between the lecturers and their sponsoring companies. However, I think the ACCME’s concerns are pretextual because this issue has been successfully dealt with for decades by CAM and mainstream groups, through disclosure of conflicts and prohibitions from mentioning specific products. Do you think Paul Offit and folks like him never lecture about their vaccine research and products which they’ve patented or in which they have a financial stake?

But there are other assaults on people who hold beliefs skeptical of some mainstream medical or public health modalities and who have a preference for more natural or less invasive modalities. For example, if you are concerned about the safety or number of vaccines which your children are getting, well you’ve had some tough times lately.

More states are eliminating the personal belief exemption (PBE), and in California, which is perhaps the epicenter of the vaccine concerned movement, the last year was really bad: SB 277 which eliminated the PBE kicked-in. The people who brought you SB 277 are upping their game with SB 18, which over time will likely force home-schoolers and other exempt children to be fully vaccinated, on pain of having the state sue their parents for violating their constitutional rights to “proper medical care.” See my post on SB 18:
http://rickjaffeesq.com/2016/12/21/no-cali-mandatory-childhood-vaccination-yet-may-coming/

Plus, the California Medical Board has brought a case against one of the most high profile vaccine concerned docs, Bob Sears. See my post:
http://rickjaffeesq.com/2016/09/13/press-release-re-dr-bob-sears-case-ca-medical-board/

Tough times indeed

So a couple weeks ago I participated in PIC’s (Physicians for Informed Consent) initial meeting for vaccine concerned docs and interested laymen. For me, the most emotionally moving and enlightening speaker was Candace Lightner, the founder of MADD (Mothers Against Drunk Drivers). Like many movement founders, a horrendous personal tragedy transformed an apolitical stay-at-home mom named Candy into the political and organizational super human, Candace Lightner. In the 30 plus years since she founded MADD, her group has passed something like 1500 laws against drunk drivers. It has been estimated that her organization has saved over 400,000 lives. Now that my friends is a huge positive societal impact.

Meeting and listening to Candace got me thinking about other people and groups who have had a transformational political or societal/health impact with whom I have worked with over the years.

Remember Act-Up, the 1980’s and 90’s AIDs activist group? This group had major impact in forcing the federal government to focus on AIDS research. I recall one of its early techniques. There was this new high-tech communications tool which had taken the business world and the government by storm. You could actually send documents over the telephone lines. It was like magic and was called a facsimile machine, later shortened to fax. Act-Up was the first group to make an effective use of the fax blast. It inundated the FDA with something like 300,000 faxes in support of faster drug approval and allowing the personal use exemption for imported foreign drugs. These folks tied up the FDA’s fax lines for days. And it worked!

In the 90’s I did a lot of work for chiropractor groups. The Chiros don’t take any crap from anyone, not even the AMA, as proven by their successful antitrust lawsuit against the AMA in the 1970’s. I got into the mix with my federal racketeering lawsuit against the New Jersey Department of Insurance Fraud for trying to illegally extort fines from New Jersey Chiropractors. See chapter 6 in Galileo’s Lawyer
https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/

In the ensuring years, I’ve had some interesting battles for other groups fighting the mainstream and specialty practitioners in fields like environmental medicine, cancer, chelation, bioidentical hormone therapy, herbal treatments, homeopathy and many, many other CAM treatments.

I’ve also encountered some of the high profile medical gurus and thought-leaders. Back in the late 1980’s, my New York law firm represented Bob Atkins, who started or foreshadowed the entire paleo and low carb movement. He was a character and a strong voice in the nascent CAM community. He would have really enjoyed seeing how much his ideas have been embraced of late.

More recently, I’ve encountered best-selling doctor-authors like David Permutter and Steve Sinatra. I even helped edit Suzanne Somer’s cancer book, Knockout. Her books about bioidentical hormones have been transformational for women around the world (and their husbands or partners are pretty happy about that too, I suspect). I think she’s sold over 25 million books, (and many thigh masters too). She is surely one of the most influential voices in the CAM health field in the modern era.

I have also encountered some of the important health media types like Jonathan Colin of the Townsend Letter and Don Peterson, the Publisher of Dynamic Chiropractor, and more recently Del Big Tree, a Vaxxed producer (whom I’ve joked about in public that when I come back, I want to come back as him).

And then there are the health freedom fighters and groups who fight against all manner of attacks on health freedom; people like Diane Miller who runs the National Health Freedom Coalition which is connected to dozens of groups on all kinds of issues from organic farming, to GMO labeling, to access to unlicensed health practitioners.
And then there are all the schools which teach all this stuff. Places like University of Bridgeport and Bastyr.

After meeting Candace at the PIC conference, I started thinking about how many people around the country these medical media gurus, the CAM medical groups, disease groups, and the activists have influenced. It strikes me that it’s a very, very big number, surely in the millions, if not in the tens of millions.

Think not? Consider the size of just the nutritional supplement industry. I’ve heard estimates of almost 20 billion dollars a year. Add to that other products and visits to CAM practitioners, the millions of books sold by the health media gurus, the zillions of clicks on the mega popular health web sites. I’m telling you, it’s a really big number.

So I got to thinking …

There are all kinds of established groups representing specific constituencies, like AARP. Many are not tied to one political party, but exercise influence on the political process. There are many, many disease groups which organize and lobby, some CAM oriented, most not and some are just shills for Pharma’s interest.

What there doesn’t seem to be is a highly visible and effective group/coalition that looks after the interests of all the health concerned, CAM oriented, CAM practitioners, CAM oriented chronic disease patient groups, and the health freedom groups. And yes, I know that there are some groups which are trying to do this, but I don’t think any of them has been effective. As far as I’ve seen, none has been able to bring together all the CAM professional, disease and grass roots organizations.

What could a congress/coalition of such groups expect to achieve? For starters, information exchange amongst the groups would be a good thing and would be easy to accomplish. A resulting coalition might even have some influence in the current national debate about health care.

Apart from the ACCME accreditation problem and the AMA ethics prohibition on the sale of supplements, there are many other big and little things which a congress and coalition could address. Making real progress on these issues would take the action of the entire CAM community. Here are a couple of my biggies, which I think are the key to changing the health world view:

1. Pharma advertising

Did you know that the US and New Zealand are the only two industrialized countries which allow direct-to-consumer TV advertising about drugs? Pharma’s advertising money buys too much influence on the media, most of it unhelpful from a societal point of view. I think we could make some real progress in public health if Pharma was banned from the TV media, the way cigarettes were banned a few decades ago. It might also help with the black hole and extreme negative outlook the media has towards all things CAM. I think the entire CAM community/industry needs to take this on as one of the top two action items.

2. Helping to Bury The Evidence Based Medicine Medico/Religious Paradigm

I think we are at the very beginning of the end of the dominance of the “evidence based medicine” thing. (I’ve discussed how that paradigm arose in Chapter 7 of my book.)

In cancer, because of tumor testing and targeted agents, the whole protocol/cookbook/prior clinical trials/regional clinical study group approach is starting to die out, at least for tough multiple gene cancers. Although I had been involved in this battle for a dozen years, mostly via Dr. Burzynski, my realization that we’re at the beginning of the end of the evidence-based medicine era hit me after reading Siddhartha Mukherjee (the author of the stunning book on cancer called The Emperor of All Maladies), New York Times article last year. The title says it all (or a lot of it anyway): “The Improvisational Oncologist: In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.”
https://www.nytimes.com/2016/05/15/magazine/oncologist-improvisation.html?_r=0

In the article, he says that all oncologists are or will become empiricists, meaning they will create individualized treatment plans based on the specific markers and tumor testing results, and that the days of cookbook/protocol driven cancer treatments are numbered. I suspect that the same thing is going to happen in various other medical specialties involving heretofore incurable chronic conditions. (An aside, the medical establishment came down hard on this guy for his article, big surprise.)

The above two issues seem core, and a solution to both would go a long way to undoing the stranglehold which conventional medicine has over policy makers and the body politic.

Here are a couple more issues:

3. Limiting the Government’s role in medical decision-making by eliminating the federal government’s jurisdiction over a person’s own body parts

It drives me nuts that the federal government interferes with my ability to use my own stem cells and other body parts. I mean it’s my body. If I want to hire a doctor to remove, my body parts, grow them and put them back inside me, why the hell should the federal government be involved? If the doc is screwing up, or has an unsanitary facility, let the state medical board or the state department health go after the doc. But the notion that the federal government gets involved in this kind of treatment just galls me. I’m hoping that the new FDA commission might help out on this one, and he’s more apt to do so if a few million people give him a piece of their mind. This will be necessary to counter the stem cell institutional-based Mafiosi who want to control my body parts until they are satisfied that my body parts are safe and effective for me to use for an intractable and incurable disease. Just stating the problem shows how overreaching the FDA’s current position is.

Of course, every disease and interest group thinks that their issue is the most important, and it absolutely is to them and those affected by their issue or disease.

But in the end, I’m thinking we have to go big and broad, at first, at least, and let the powers-that-be know that we’re here and a force to be reckoned with. But there is one more issue which should be addressed.

4. Vaccination

Vaccine issues have an element of complexity different from other health issues for the simple reason that the so-called “established science” has concluded that the lack of community vaccination adversely affects other people and public health. (Yes, the vaccine-concerned vehemently disagree with the established view). This is unlike other CAM or health freedom issues which only affect the individual, like the right to take an unproven treatment, the right to be informed if a product is GMO, or the ability of a physician to receive CMEs for learning new CAM methods.

One result of this difference is that many reasonable people, and even some CAM inclined people think the vaccine-concerned, (or at least the hard-core anti-vaxers) are unreasonable and dangerous. I’m sorry, but that’s just a fact. So care is needed, at least on an all-CAM level. As a litigator, I focus on the weakest part of an adversary’s position. Here are two of the weakest pasts of the mainstream’s vaccination argument:

a. Vaccine testing, (or the lack thereof) especially in pregnant women

Pregnant women appear to be Pharma’s next big vaccine marketing push. I think that is going to scare the bejesus out of many reasonable people, and open up the issue of the lack of adequate testing in general. I’d like to see some serious national public advocacy on this issue.

b. Finally, Get William Thompson on the Record!

This might be the most immediately impactful and most feasible action item. If reports are true, that a key CDC study which supposedly proved no connection between vaccines and autism was intentionally manipulated by the authors, that would be huge, and impactful well beyond vaccination and autism.
The most important thing I’ve learned in all the years doing what I do is that science isn’t nearly as neat, clean and objective as the high priests of the church of medical orthodoxy would have us believe. Showing that the government manipulated data and findings to achieve a predetermined result, if that’s in fact what Thompson’s testimony would show, would be… Well let’s just try to get him on the record and see what develops.

The bottom line (finally!)

I’m no Candace Lightner, but I do know how to raise a call-to-arms, and start the ball rolling. I’d like to see as many CAM professional groups, disease groups, issue groups, freedom groups, and even a few media and thought leaders sitting down in one place at a congress of groups. The purpose would be to establish some core common principles, concerns and action items, and identify resources and funding sources for continued efforts on areas of mutual concern.
I’m thinking end of May might be the time for the first congressional pan CAM conference.
Any thought leaders, media luminaries or future Candace Lightners interested?

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

Can CAM Docs Legally Prescribe and Sell Herbals and Nutritional Supplements as Therapy without Bad Things Happening? Prescribe, YES. Sell? WE’LL SEE

Can CAM Docs Legally Prescribe and Sell Herbals and Nutritional Supplements as Therapy without Bad Things Happening? Prescribe, YES. Sell? WE’LL SEE


Many CAM and integrative doctors recommend and/or sell all kinds of nutritional and herbal products to their patients. There is a supplement manufacturer sub-industry which only sells to physicians and other health care professionals, for resale to patients. And most of the top tier, high profile docs have their own private label supplement brands. That’s a fact. But is it legal and ethical to do so?

Legal is a matter of state law. But for better, (but mostly) for worse, ethical is largely determined by those noble, public-spirited and never ethically-challenged folks at the AMA (American Medical Association for those living under a rock). They’re not completely controlled by Pharma; just ask them and they will tell you. And they’re not trying to stop cheaper non-patentable interventions like nutritional supplements and herbs, all at Pharma’s behest. Their thought leaders do not receive tens, hundreds of thousands, or millions of dollars from Pharma for research, public relations and advocacy. Just ask them and they will tell you.

And their “ethical guidelines” reflect an open-minded attitude serving the best interests of the patients. Ok, you get the point.

So is it AMA “ethical” for physicians to sell nutritional and herbal products? Technically yes, but practically, not so much:

Here’s the latest iteration of the AMA “ethical” rule on the sale of health related products. (Sorry, it’s longish)

9.6.4 Sale of Health-Related Products The sale of health-related products by physicians can offer convenience for patients, but can also pose ethical challenges. “Health-related products” are any products other than prescription items that, according to the manufacturer or distributor, benefit health. “Selling” refers to dispensing items from the physician’s office or website in exchange for money or endorsing a product that the patient may order or purchase elsewhere that results in remuneration for the physician. Physician sale of health-related products raises ethical concerns about financial conflict of interest, risks placing undue pressure on the patient, threatens to erode patient trust, undermine the primary obligation of physicians to serve the interests of their patients before their own, and demean the profession of medicine. Physicians who choose to sell health-related products from their offices or through their office website or other online venues have ethical obligations to:
(a) Offer only products whose claims of benefit are based on peer-reviewed literature or other sources of scientific review of efficacy that are unbiased, sound, systematic, and reliable. Physicians should not offer products whose claims to benefit lack scientific validity.
(b) Address conflict of interest and possible exploitation of patients by: (i) fully disclosing the nature of their financial interest in the sale of the product(s), either in person or through written notification, and informing patients of the availability of the product or other equivalent products elsewhere; (ii) limiting sales to products that serve immediate and pressing needs of their patients (e.g., to avoid requiring a patient on crutches to travel to a local pharmacy to purchase the product). Distributing products free of charge or at cost makes products readily available and helps to eliminate the elements of personal gain and financial conflict of interest that may interfere, or appear to interfere with the physician’s independent medical judgment.
(c) Provide information about the risks, benefits, and limits of scientific knowledge regarding the products in language that is understandable to patients.
(d) Avoid exclusive distributorship arrangements that make the products available only through physician offices. Physicians should encourage manufacturers to make products widely accessible to patients.

So what does this gobbledygook mean? Well, it means that you CAM docs have a problem.

First, virtually no supplements or herbal remedies have the kind of scientific support set out in subparagraph (a). There are only a few supplements for which the FDA have approved health claims, like folic acid for pregnant mothers, and such. I also suspect that the peer-reviewed literature the rule refers to means mainstream journals to the AMA. My guess is that this AMA subsection could be used to render “unethical” the recommendation of the products routinely recommended and sold by physicians.

But there are bigger problems.

Subsection (b) seems to suggest you have to either give away the products, or sell them at cost in order to avoid the conflict of interest or appearance of the conflict. Moreover, you’re only supposed to give away or sell at cost enough product to meet the patient’s immediate needs, or until they can get the product from a less conflict-ridden source.

This is idiotic. By the logic of this provision, if you go to a surgeon for a surgical consult, it would be unethical for the surgeon to actually perform the surgery rather than just recommend it, because he has a financial interest in performing the operation.

But not to worry, under the rule, the surgeon can lessen the conflict by either 1. Operating for free, or 2. Charging his actual cost, rather than the high fees the surgeon normally charges. To further lessen the conflict, he should only do a temporary surgery, just fix the problem enough to allow the patient to go to another surgeon who has no financial conflict of interest arising from the first surgeon’s surgery recommendation. The same would apply to an interventional cardiologist recommending a stent, angiogram/angioplasty or to any other physician who both makes recommendations and provides a procedure or therapy to effectuate or implement the recommendation.

To generalize, there is the same conflict of interest for any professional who both consults and does something. By the logic of the AMA rule, a lawyer cannot both recommend suing and actually suing (unless he sues for free or at cost). Nor could a lawyer prepare a trust, or do anything the lawyer recommends, because implementing the recommendation means that the lawyer makes extra money for the doing, which under the logic of the AMA rule irreparably taints the lawyer’s judgement (unless the service is done for free or at cost, and is only a temporary fix until a conflict-free professional is retained).

The AMA world view embodied in this rule reminds me of the commercial for a personal identity protection company. You know these commercials: There’s a patient with his mouth open in a dentist’s chair, and a guy with a white coat looking in the patient’s mouth who says “you have one of the worst cavities I’ve ever seen.” The patient says. “OK doc, fix it.” And the guy in the white coat says “Oh, I’m not a dentist; I don’t fix teeth, I’m just a dental monitor.”

In the AMA la-la ethical world, the guy tells the patient “Yes I am a dentist and I’d like to fix your tooth, but I have a conflict because I’m going to make extra money doing what I said should be done. So, we’re done here and you have to see another dentist who will actually fix your cavity”

Is this really how we want physicians who have a service or product to act? Have them become health care monitors, and have another class who are health care problem fixers?

Let’s not leave AMA ethical la la land yet: At the new dentist’s office, the dentist looks over the films, examines the patient, and concurs with the recommendation, thereby creating a chargeable evaluation and management fee. Doesn’t the new dentist also have a conflict? He’s got his examination fee, and he’ll get extra money for fixing the cavity. This can get ridiculous!

Let’s face it, we rely on professional to give their opinions and implement a solution within the professional’s expertise. This happens zillions of times a day, all over the world. To single out physicians who use and sell the kind of products used by millions of people is just nuts.

This rule obviously hasn’t been used to stop surgeons, cardiologists or dentists from doing the thing they were trained to do. But what about a CAM physician who uses herbals or nutraceuticals as primary therapy? Can they do that, or are they caught in the same AMA ethical net?

But before we get to that, here is another question:

Does this AMA ethical rule matter?

Short answer: yes

Alittle longer answer: it matters because some state medical board laws have specifically incorporated the AMA ethical rules into their standards of professional conduct, such that a violation of an AMA ethical rule is a violation of the state’s medical board law. Even in the absence of express incorporation, states can and do go after physicians for ethical violations of all sorts (just ask docs like Burzynski about that).

Why is any of this relevant or important to CAM docs?

There’s a new case against a doc (it’s my case, and not in California or Texas where I maintain offices, but I don’t want to give the details just yet) which raises the very issue of whether it is unethical and a state board law violation to use and sell herbal and nutritional interventions as primary therapy. What makes the case more interesting is that the therapy is only available from physicians, and only physicians who have gone through the company’s training about how to use the products. (Many of you CAM docs probably know the product line I’m referring to.)
How can the AMA possibly view this kind of thing as the “sale of health a related product?” Well maybe it doesn’t, but initially at least, the state medical board seems to think it is the sale of a “health related product” and is going after the doctor for do so.

Here’s where it gets interesting with the AMA ethical rules: The second opinion after the sale of health related products is the following ethical precept:

9.6.6 Prescribing & Dispensing Drugs & Devices In keeping with physicians’ ethical responsibility to hold the patient’s interests as paramount, in their role as prescribers and dispensers of drugs and devices, physicians should:
(a) Prescribe drugs, devices, and other treatments based solely on medical considerations, patient need, and reasonable expectations of effectiveness for the particular patient.
(b) Dispense drugs in their office practices only if such dispensing primarily benefits the patient. (c) Avoid direct or indirect influence of financial interests on prescribing decisions by: (i) declining any kind of payment or compensation from a drug company or device manufacturer for prescribing its products, including offers of indemnification; (ii) respecting the patient’s freedom to choose where to fill prescriptions. In general, physicians should not refer patients to a pharmacy the physician owns or operates. AMA Principles of Medical Ethics: II,III,IV,V.

Does this section apply to a doctor prescribing and selling a product used as primary therapy if the product is only available from the health care provider and only from one who is trained by the manufacturer? It seems to.

Although the heading only refers to “drugs” and “devices”, the actual rule specifically mentions “drugs, devices, and other treatments.”

A prescription is just a written order issued by a healthcare provider containing the provider’s recommendation for a product, such as a drug, device, or other treatment, or in some cases a recommendation of behavior (like bedrest). So a written order by a physician to take an herb or nutritional supplement in order to cure or mitigate a disease is a prescription and such products are prescribed. (And in case you are concerned, the fact that a physician prescribes an herb or supplement for the treatment of a disease doesn’t turn the product into a drug, because it’s the manufacturer’s intent that governs not the prescribing practices of healthcare providers, under FDA law.)

Admittedly, the language in (b) mentions a pharmacy, but not all prescribed things are found in pharmacies. Take the aforementioned bedrest for example. And we’re stipulating that the prescribed products can only be obtained through the doctor, and is not available directly to the consumer.

So does this AMA rule 9.6.6 sanction a physician prescribing an herbal remedy or supplement for the treatment or mitigation of the disease or medical condition?

I looked at the literature and haven’t seen any cases on this yet. I think it does, and the case I’m working on will provide what may be the first legal ruling on the issue.

As a backup, it seems to me that even if both AMA ethical rules could apply, I don’t see how a medical board can sanction a physician for a violation of an ethical rule where the physician’s actions are ethical under another ethical rule, or arguably so. It seems to me that a board must first make this determination, publish it and put the licensees on notice, which my research indicates has not yet been done in this state at least.

So although I think I am right, as of right now, there doesn’t appear to be a definitive answer to the question as to whether a CAM physician can prescribe and sell an herbal remedy or nutritional supplement or supplement regime as primary therapy for the treatment or mitigation of a disease, at least in a state which has specifically incorporated the AMA ethical rules.

But give me six months or so and I’ll give you the answer; hopefully the one you’re looking for.

In the meantime, and to make that happen, any academics out there with some ethics background care to opine and help make it happen? I’ll be waiting to hear from you.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Finally, Some Intelligent Action by the Cali Anti SB 277 Community!

Finally, Some Intelligent Action by the Cali Anti SB 277 Community!

I’ve been a vocal opponent of all of the anti-SB 277 constitutional lawsuits. The most recent one was a federal lawsuit filed in mid-November, 2016, in Los Angeles, and dismissed by the federal district court in January 2017. I think all of these lawsuit were (and will be if more are filed) a terrific waste of time and money. As I have repeatedly said, as long as the medical consensus is that 1. Vaccines are safe and 2. Herd immunity (from vaccines) is a thing, no court will ever overturn a mandatory vaccination law or a law eliminating a PBE (personal belief exemption) or a religious exemption.

(For my reasoning, see my posts in the SB 277 section of my web site. Here is the link.
http://rickjaffeesq.com/category/sb-277/ )

Whatever satisfactory resolution the VC (vaccine concerned) community is going to achieve, I am certain it won’t come from the judiciary, at least so long as 1. and 2 above are the “accepted” scientific facts. The constitution isn’t a suicide pact, and the few do not have the right to infect the many, and that’s what judges are thinking when you file these lawsuits because of the “accepted” science. The vaccine concerned have to figure out a more productive use of their limited time and resources.

(Hint: change the accepted science or change-out the folks who decide what’s accepted, and that’s not as far-fetched as it would have seemed prior to November 8, 2016.)

While I doubt my message got through to anyone of authority in the movement, I am happy to report that I’ve seen some signs of intelligence in the VC community, post SB 277. No answers yet, but at least there is a promising gathering of some of the folks who could possibly come-up with solutions, both on the medical/research level and on the political action level.

I’m talking about the upcoming vaccine safety conference organized by a new group called Physicians for Informed Consent (PIC). As suggested by the name, this is a group of physicians who at the very least are skeptical of the current vaccine schedule and have some safety concerns. Many of the group’s members are pediatricians who have to deal with vaccine issues every day. The conference is this Sunday, May 12, 2017 at the Costa Mesa Hilton.

Here is the Facebook link to the event. Registration technically closes Friday.
https://www.facebook.com/events/1834537363451194/

The conference has two parts. The morning session is only open to physicians and will consist of a panel discussion with some of the leading vaccine concerned physicians explaining their views on when medical exemptions are appropriately given. That will be followed by a legal panel discussing the legal issues in giving medical exemptions in California. I will be speaking at that panel, and I can tell you that some discussions might be controversial, because at least one of the speakers is blunt and has been highly critical of past VC actions, (but he shall remain nameless).

If you are a California physician and write exemptions or thinking about doing so, you should be at the meeting, period.

Starting at 11:00, the meeting is open to the public. There will be various topics about vaccine safety from some well-known vaccine researchers. A couple of the docs from the morning panel will give their insights to the public about the general requirements California physicians will or should employ in evaluating when a school vaccine exemption should be given. The group’s general counsel will also give his insights about the legal challenges facing the docs and the VC community.

My guess is that this information will help the vaccine concerned public understand what’s required of them to obtain an exemption.

One of the most interesting presentations is likely to be from the founder of MADD (mothers against Drunk Drivers). That’s a pretty impressive grass-roots movement which has had a tremendous positive influence in the country and legislation. My view is that it’s going to take a MADD-like movement to effectuate any real change in the medical, public policy and legislative landscape regarding the safety of vaccines, and to take on Pharma and the medical/public health establishment. So I hope the thought and movement leaders listen carefully to what she has to say. It was a pretty nifty, out-of-the-box idea to invite her. Kudos to Shira Miller and her crew for bringing her to the VC community.

On the merits, I have a strong feeling that there’s going to be presented some new information, at least to the docs, about a powerful new explanation of the connection between vaccines and neurological related conditions, including autism, based on some doctors’ (Diane Powell) and thought leaders (JD Handley) connecting the international research dots. Think microglia/pruning and the brain’s immune system. Who knows, maybe even an attorney might talk about the implication of these concepts as a game changer which cuts across the scientific/policy/legislative and even the medical administrative landscape.

Stay tuned and more after the conference!

Rick Jaffe, Esq.
www.rickjaffe.com

Burzynski and the Texas Medical Board’s Upcoming Face Off: It’s Time for the Texas Legislature to Complete the Medical Board Fix

Burzynski and the Texas Medical Board’s Upcoming Face Off: It’s Time for the Texas Legislature to Complete the Medical Board Fix

On March 3, 2017, the Texas Medical Board (TMB) will decide on a sanction for Stanislaw Burzynski, M.D. Ph.D. in the current case against him. Because I am his long-time former attorney who handled both of his prior medical board cases and was the attorney on this case until a few months before the hearing, I have a unique perspective. But there’s a caveat: I am still bound by the attorney/client privilege. However, it’s a free country, and I can give my opinion based on public documents, what was told to me by people on the other side, and my perspective.

Some Background about Medical Board Cases

Over the last three plus decades I have defended medical mavericks in board cases in maybe thirty states. In most states, medical board investigators investigate the complaints and a panel of the medical board members decides whether a complaint will be prosecuted. Medical board cases are prosecuted by the medical board’s litigation department (like in Texas) or the state attorney general’s office (e.g., California). Ultimately, the members of the medical board decide the case, usually advised by the medical board’s general counsel (like in Texas) who is the boss of the litigation department, which prosecutes the case. Very cozy and efficient isn’t it?

The above cartoon is how it looks from the defense table in these cases.

In fairness, most states now have an administrative law judge (ALJ) who is independent of the board, and who either hears the case, or advises the board members about the legal issues (Washington is an example of the later). But even in states where the ALJ hears the case and issues a decision, the ALJ is just issuing a “proposal for decision” (PFD) which is sent to the board for review. In most states, the boards have almost complete discretion to accept or reject all or any part of the ALJ’s PFD, and can simply write its own decision based on the record in the case (like in California).

The frustration for defense counsel in these administrative cases is that you could get a perfectly reasonable decision from a neutral, professional judge, only to have it completely rejected by the medical board, just because….

The First Burzynski Medical Board Case

That happens all the time with medical mavericks and that’s exactly what happened to me in Burzynski’s first medical board case in the 1990’s. After six years of litigation, the ALJ cleared him of the most serious charges, only to have the charges reinstated by the medical board. (If you want the details, see chapter 2 in Galileo’s Lawyer. https://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301/.

However, the board’s reinstatement lasted less than two hours. We got an immediate TRO freezing the board’s decision, then a preliminary injunction pending the protracted appeals process. By the time the Court of Appeals affirmed the board’s order two years later, it was moot and no longer had any practical effect. (Described in detail in my book). I don’t think the board was happy with Burzynski or his lawyer.

Many years later, in its 2011 legislative session, the Texas Legislature recognized the general problem of the medical board making arbitrary changes to ALJ’s decisions and passed a compromise, partial fix. Before I tell you the fix, here’s what you need to know about administrative law decisions, regardless of whether they are made by a judge or a board. Each decision has three parts: findings of fact, conclusions of law, and a sanction (if a violation is found).

Prior to the 2011 change in the law, the TMB like most administrative agencies, could accept, reject or change any of the three components of an ALJ’s PFD. However, after the 2011 change, the TMB lost its ability to alter or reject a finding of fact or a conclusion of law. The compromise was that Texas ALJs could no longer issue proposed sanctions. The upshot was that if the ALJ found no violations, the TMB’s only remedy was to appeal the ALJ’s decision to the Texas district court, and good luck with that.

On the other hand, if an ALJ sustains some allegations of misconduct, meaning the judge issues findings of fact and conclusions of law against the doc, the Board decides the sanction.

Burzynski/Medical Board: Round 2

The TMB went after Dr. Burzynski again between 2010 and 2012, and that case was governed by the new law. Right before the hearing in April 2012, I received a favorable legal ruling which effectively cut the heart out of the board’s case. Because the ruling was unchangeable by the board based on the 2011 law, the board was forced to withdraw its case against Burzynski. That was very good for us, because it’s always better not try a board case. It was even better because the medical board was forced to dismiss its own case.

It was probably sort of humiliating for the TMB since many in the medical establishment and the quack busters/sceptics were adamant that that Dr. Burzynski’s license be revoked and that his clinic be shut down. The board didn’t get it done.

Round 3

After losing that case, the TMB almost immediately went after Burzynski again. This was a continuation of what the various branches of government had done to him in the 80’s and 90’s. I called it “whack-a-mole” in my aforementioned book.

So starting in 2013-2014 the board began anew. It started with a simple complaint piggybacking on some warning letter the FDA wrote about Burzynski’s web site promoting the clinical trials. The board claimed that the FDA letter was proof of false advertising under state law or the letters themselves were actionable.

Then the case metastasized into a 204 page complaint, alleging hundreds of violations for dozens of patients both in and out of clinical trials, ethical clinical trials violations, advertising violations, and billing insurance violations. It was a cacophonous symphony of crazy medical propositions (like that after a patient had brain surgery which successfully, but temporarily removed a malignant brain tumor, it was wrong for Burzynski to treat him without another brain biopsy, even though those brain tumors inevitably grow back and he already had radiological evidence of recurrence), and inane medical theories, (like all of his cancer patients in his private medical practice had to be on clinical trials). It was probably the longest and most over-the-top complaint ever filed by the board, but our answer was also probably the longest and most detailed.

It was evident from the tone of the complaint and confirmed by conversations with staff that the TMB was out to ruin Burzynski and show the entire country that his treatment didn’t work, that he knew it, and that he was a fraud and charlatan, preying on the most vulnerable, the terminally ill. The stated goal was to thoroughly discredit him, his treatment and his clinic in such a forceful manner that the revocation of his license, which was the goal, could not be questioned by any reasonable person. It seemed to me these guys were also looking for payback for their previous legal failures and the prior failures of the Department of Health and various other state and federal agencies to put him out of business. (And I take part of the blame/credit for helping that not happening).

When you’ve got lemons, make lemonade, so this case was an opportunity to show that Dr. Burzynski was a medical pioneer, that he was helping some, and in fact saving the lives of patients who would have died without him.

I worked on and prepared the case for the better part of two years. I left the case a few months before the hearing and was replaced by a team of lawyers from two highly regarded boutique law firms. The head of the team was Dan Cogdell, a luminary in the Texas criminal defense bar. We had worked together on Burzynski’s two federal criminal trials in the mid 1990’s. Over the decades, I have met a few lawyers as good as Cogdell, but never anyone better.

I lost touch with the case, but was pleased to learn that in October 2016, ALJs threw out all of the serious accusations and especially the alleged standard of violations which allegations I thought were idiotic, and most of the dozens if not hundreds of specific misconduct alleged against Burzynski. But the judges did sustain eight or so relatively minor offenses, like failure to supervise unlicensed physicians, aiding and abetting the unlicensed practice of medicine, some specific informed consent charges, and some inadequate documentation. Here is the decision. https://cis.soah.texas.gov/dmwebbasic/tokweb27.ASP?WCI=opendocument&SKEY=407545_0_9_63&localtimezone=480

The press considered the decision a victory for Burzynski and major defeat and embarrassment for the board. Despite all the bluster in the board’s complaint about what a quack and charlatan Burzynski was and how he was hurting patients and conducting illegal and unethical human experimentation, the ALJs rejected all of those charges. The ever colorful and entertaining Cogdell was quoted as saying that the decision was a pimple not cancer.

Perhaps most rewarding as the former attorney were the ALJs findings that Burzynski was a medical pioneer and had helped some of his patients, which is exactly what we told the judges we’d prove from the get-go. Based on the ALJs’ decision, Cogdell and his diligent, highly skilled trial team did excellent work, and Burzynski and his patients have much to be thankful for.

So this is now the third time in twenty plus years that the TMB has tried and failed to prove that Burzynski is providing a worthless treatment and/or is hurting people, and the second time a judge found that he was helping people (the first being the original board case).

But per the Texas administrative rules discussed above, because the ALJs did sustain some charges, the Board gets to decide on the sanction.

Like many medical boards around the country, the TMB publishes disciplinary guidelines.
http://texreg.sos.state.tx.us/fids/201505185-1.html.
The guidelines have a have a low and a high range of sanctions. Many sanction even on the low range seem onerous to me. Some of the sanctions on the high range seem crazy oppressive for some relatively minor violations.

Not surprisingly, board staff prosecutors are asking for severe sanctions; stayed license revocation, pending completion of a lengthy probation period, $360,000 in fines, restitution of almost 20k, oppressive monitoring, informed consent approval, plus the standard CME course work and passing the jurisprudence exam. (The board staff’s proposed sanction awaiting the board’s signature on March 3rd is attached as a pdf at the end). My view is that the way the proposed order is written, he’ll never get out from under it, which is exactly what the board intends.

My problem with board staff’s proposal is threefold. First, structurally, the board is wearing too many hats. The board decided to prosecute to case, prosecuted the case and now gets to decide the sanction. Legal though it is technically, I have a general problem with that. I think most reasonable people would think that the same entity which investigates, decides to prosecutes, and prosecutes shouldn’t decide on the sanction. The fact that there are nominally separate departments doesn’t change the inherent lack of fairness in the process. It’s only in administrative law, which has fewer constitutional protections than regular legal proceedings, that the government can get away with this kind of thing.

My specific problem is that people are only human. I don’t see how the board can be fair, given its prior – let’s say, unsatisfying previous experience with Dr. Burzynski. The proposed sanction order was drafted by or under the supervision of the Board’s head of litigation, who works under the board’s general counsel, who by the way, was the head of litigation who worked out the dismissal of its 2012 case against Burzynski.

I know and like these guys, and most of the board’s attorneys are competent and diligent (though they are overworked and underpaid, if anyone in the Legislature is listening). I also respect the many members of the TMB whom I’ve appeared before, but still…. I don’t see how they can be objective in this case. Despite their politeness and overt professionalism, I’ve sensed a great deal of ill will towards Dr. Burzynski, probably in part because, heretofore, things haven’t gone as they and Burzynski haters have hoped. Based on media reports, many in the mainstream fault the board for the fact that Burzynski is still out there. I think that will color the board’s judgment in deciding on the sanction.

My other problem is that I think, generally speaking, conventional medical professionals do a poor job properly evaluating and valuing medical mavericks. Board members in all or most states are picked by the governor. They aren’t necessarily the best or smartest physicians. Generally, the governors pick politically connected docs and/or those who package the most money for the Governor’s election campaign. They are typically medical insiders who know how to get along, and who are in the high priesthood of what I call the church of medical orthodoxy. Their orientation is not forward thinking, and in the case of Texas, I think the medical board unnecessarily stifles medical innovation.

But it’s not just me saying so. In both the current Burzynski case and the case in the 90’s, the ALJs questioned how medical progress would occur if the board could sanction a doctor like Burzynski for being an innovator. It’s a point which the Texas Legislature should take to heart.

So what’s the solution?

The Texas legislature should finish the job it started back in 2011. Change the law and let the ALJs decide the whole medical disciplinary case. If the board doesn’t like the result, let it appeal to the courts (with the aforementioned “good luck”). Texas ALJs are very, very good, (even if they occasionally don’t see the brilliance of my arguments or the righteousness of my clients). Plus, as discussed, there are written guidelines with high and low sanction levels and exacerbating and mitigating factors. Public health will be well-protected by allowing Texas ALJs to decide the entirety of medical disciplinary cases.

Ironically, this legislative session the TMB is currently in Sunset Review, which means that technically the Legislature is deciding whether to continue the board for another 10 years, and if so, under what conditions. The legislative review committee has issued its report and big surprise, it decided that the state needs the medical board to protect the public. Here is the sunset commission’s report.
https://www.sunset.texas.gov/public/uploads/files/reports/Texas%20Medical%20Board%20Staff%20Report%20with%20Commission%20Decisions.pdf

Sunset review won’t help Burzynski next week, but I think if some of the TMB savvy legislators like Bill Zedler or Lois Kolkhorst, or even a formidable guy like Lt. Governor Dan Patrick (whose show I recall doing a long time ago) take an interest in this case and let the board know they’re watching, and that this could be the last case the board ever decides, maybe just maybe……

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Board Staff’s proposed sanction order:

sanctionproposal

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Mr. President: looks like you’ve kept your word so far on Obamacare by signing a vague executive order allowing federal government agencies to do what they can to lower the costs or make more efficient whatever the agencies can figure out they can do without congressional approval. Hopefully that will work out.

I have a couple of ideas for some quickie executive orders, consistent with your campaign speeches or your thinking. As always, I’ll keep it short:

1. Consumers importing cheaper prescription drugs

Congress took up the issue, and since both parties are in the Pharma’s pocket, it once again declined the chance to help people by allowing them to import prescription drugs from Canada and other places where Pharma sells its products for a lot less money. You recently took Pharma to the woodshed in a recent tweet. On behalf of the people, thanks. In your inauguration speech, you railed against Congress for not watching out for us. Here’s my suggestions:

First: we need a standard Trumpian tweet excoriating Congress for protecting Pharma by its recent action in continuing the prohibition of patients from importing drugs manufactured by major drug companies which are sold for a lot less money abroad.

Second: how about an executive order ordering the FDA, DOJ and Customs not to enforce the existing drug importation restrictions. That would send a message to Pharma and Congress, as well as immediately save patients money.

Yes, you and the rest of the Republicans hassled Obama for using executive orders to circumvent enforcement of existing federal laws like immigration.

But let’s get real. That’s just an argument used by the party that doesn’t control the presidency. Further, I don’t think we should worry about little things like consistency. I’m guessing you’re okay with that, especially if some minor inconsistency can benefit the people who supported you, and trust me, your working class supporters will really appreciate having the option of cutting their out-of-pocket drug costs by half or more. You do this, and I guaranty your approval rating will jump-up a few points.

2. Stem Cells

Don, first thing I’d like you to do is call Rick Perry, and ask him about his experience in getting a stem cell transplant for his back problems. FYI, his stem cell procedure was flat-out illegal under federal law. But he was the Governor, so who was going to stop him? I’ve heard it helped him alot. If so, why shouldn’t the tens of thousands of patients who could similarly benefit from stem cell treatments get them? Do you really have to be a Governor to get the state-of-the-art treatment?

I’ve covered the FDA’s regulations and the technicalities in numerous prior posts,
http://rickjaffeesq.com/category/stemcells/

But the bottom line is that your FDA severely limits access to stem cell treatments, and you should do something about it immediately, even before the FDA Commissioner is identified or sworn-in. So here’s what I suggest:

First: A quickie executive order that whatever draft guidance documents concerning stem cells (and there are currently four, explained in prior posts, see above) are on hold, and no final guidance documents will be issued except on the approval of your FDA Commissioner.

Second: Another executive order that as matter of enforcement policy, neither the FDA nor the Department of Justice will take any action against a clinic which removes stem cells or any other human tissue from a person, and reinjects or reimplants that tissue into that person. And the enforcement policy should make clear that it applies even when the stem cells are other materials are expanded or cultured, which is the procedure which was so successful on Rick Perry. If Rick Perry could do it, let the rest of us have access to this stuff. (And BTW, there is less of or no consistency problem here since the regulations actually allow many stem cell treatments; it’s just the FDA has decided in its infinite unwisdom to try to stop almost all of these procedures.). The institutional stem cell players and the aforedescribed media cheerleaders won’t like it, but your supporters and many, many others will love you for it.

3. Vaccination

First: Let’s get moving on the Bobby Kennedy Jr. Vaccine/Autism thing. Maybe this could be done by executive order as well. Hell, it’s just a commission. I know you received some pushback from the institutional vaccine pushers and their cheerleaders in the media, but there is a groundswell of support for Bobby and the Commission from the people, and per your speech yesterday, that’s what important to you.

Second: as you probably know, federal agencies have some kind of internal oversight, referred to as the “OIG” (Office of Inspector General). In light of some of the recent stories about cover-ups and scientific fraud at the CDC concerning the autism issue, you need to give some serious consideration to the CDC OIG position. Your pick needs to be willing to take on the powers that be in the agency. So choose wisely.

Enjoy the job, and hope you really shake things up in the health care field. It’s long overdue!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Hey Robert Kennedy Jr: Congrats and here’s a suggested first topic for the vaccine commission: Are aluminum adjuvants in childhood vaccines harming kids?

Hey Robert Kennedy Jr: Congrats and here’s a suggested first topic for the vaccine commission: Are aluminum adjuvants in childhood vaccines harming kids?

Robert: congrats on your appointment as head of Trump’s vaccine study commission. I think the commission is a terrific idea, and there couldn’t be a better choice than you. I’m sure you’re getting a good laugh about how concerned and “alarmed” the pro-vaxxers are at your appointment. They’re trying to calm the true believers by pointing out all that Trump can’t do in terms of changing vaccine policy.

But Robert, there’s one thing you can do, and it will scare the bejesus out of them: shine a light on the growing body of scientific evidence on the dangers of vaccination which is being ignored, suppressed or altered. The thing they fear most is an open and public debate on these issues.And with your new gig, you can definitely shine a lot of light.

Assuming you commission has subpoena power, you’re sure going to enjoy subpoenaing the CDC whistleblower, William Thompson to testify. And for grins, maybe subpoena his boss who decided not to honor your prior subpoena to have Thompson testify in that civil case you filed. Let him put on the record how that decision was made and why.

After the Thompson related scientific fraud and cover-up mess is cleared up, may I respectfully recommend for your consideration a first scientific topic for the Commission: You know that alot of childhood vaccines contain aluminum as an adjuvant, to make the vaccine more potent or reactive. But are they really as safe as the vaccine manufacturers and the FDA say they are? I’m pretty sure you already know the answer to the question, and that your answer is much different from the U.S. Government’s current answer.

To recap the FDA’s public reassurances: “the risk to infants posed by the total aluminum exposure received from the entire recommended series of childhood vaccines over the first year of life is extremely low, according to a study by the U.S. Food and Drug Administration (FDA).” http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm284520.htm.

If that were true, it would be very reassuring.

I think you guys should verify the government’s position, because as you know, there is a growing body of evidence that aluminum is very dangerous to children and adults. Many forward thinking researchers suspect it’s most likely (but certainly not proven) to be a result of defects in the genes and pathways which process heavy metals like aluminum. (Actually, in a criminal case a few years back, I commissioned a white paper which summarized data from two thousand autistic kids and their parents. Lo and behold, the conclusion was just that; some kind of genetic SNP defect/pathway which processes heavy metals was evident in the autistic kids and their tested parent).

Aluminum toxicity is also an issue I’m looking deeply at in the Bob Sears medical board case. I suspect it’s a significant reason why vaccine savvy docs are so concerned about giving so many vaccines to infants and small children over such a short period of time.

You know what’s funny, (or not) or strange, (or not): most of the research on the toxicity of aluminum in vaccines is done outside of the U.S. That’s probably because of the pro-vaxxer’s stranglehold on research, and what some actually think is the manipulation of U.S. research data to hide negative vaccine data. But then you’re about to give the public answers to these questions, big time, especially if you can get the aforedescribed subpoena power.

Just to remind you, the world’s leading authority on the biochemistry of aluminum is Chris Exley in England. He has just co-authored a soon-to-be published article on the Alzheimer’s and aluminum. http://www.sciencedirect.com/science/article/pii/S0946672X16303777.

He’s also pretty familiar with the aluminum toxicity issue in childhood vaccines and has published his work in another recent article in some journal called Nature, which I think the pro-vaxxers have heard of. http://www.nature.com/articles/srep31578.

Despite the suspicion that there are genetic defects which impair heavy metal processing and excretion in some people, according to Exley, “we have not yet identified and confirmed any specific genetic predisposition which definitely alters the metabolism of aluminum. Perhaps the closest to this that we have is a condition called MMF (macrophagic myofasciitis) which is a condition linked to both aluminum adjuvants and a known genetic mutation.” According to Exley, the guy you have to talk to about MMF is Professor Romain Gherardi, who was the first to recognize the condition. He’s also not in the U.S., but in France.

And for an overview of the research on Vaccines and Autoimmunity of course consult with and bring in Professor Yehuda Shoenfeld from Israel, who as you know recently co-edited the definitive book on the subject called, not surprisingly, Vaccines and Autoimmunity. https://www.amazon.com/Vaccines-Autoimmunity-Yehuda-Shoenfeld/dp/1118663438. But you’ve probably got Yehuda’s number on speed-dial. He’s connected to everyone in the vaccine and autoimmune research field.

Since it’s a government commission, it should be fair and give all sides an opportunity to express their viewpoint. Especially those who believe that every child should receive every single vaccine on the current schedule unless the child meets the specific labeled contraindication, which is basically the pro-vaxxer’s view.

I for one would love to hear Paul Offit testify before your commission and explain his view that all kids could theoretically get 10,000 vaccines without any problems.

I’d also like to hear more about the vaccine makers’ brilliant new marketing idea to create a full vaccination schedule for pregnant women, because sometimes you just can’t get enough of a good thing.

So good luck and Godspeed with this Robert. Time to stir things up in this field, and you be the man to do it.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

There is no Cali. mandatory childhood vaccination YET, but it may be coming

There is no Cali. mandatory childhood vaccination YET, but it may be coming

Vaccine concerned (VC) folks decry the recent loss of the personal belief exemption via SB 277, and feel like they’ve been abducted to some kind of communist state. (But hey, ever been to Berkeley!) The present legal reality is that we don’t have mandatory or forced vaccinations here. Rather, vaccines are required for people to engage in certain institutional activities; e.g., kids who want to go to school, or adults who want to work with kids or in health care.

Neither California, nor any other state (that I am aware of) forces a person to be vaccinated. Texas tried to force the HPV/Gardisal vaccination on young girls, but that was shot down.

But alas, we just might get forced childhood vaccination here in California, if I’m reading the tea leaves right. But that would be unconstitutional right? Not necessarily. In fact, the oft-cited original constitutional case on mandatory vaccination, Jacobson v Commonwealth of Mass. http://caselaw.findlaw.com/us-supreme-court/197/11.html held that the state can force people to get vaccinated. True, the opinion said so in the context of a public epidemic, but that’s just a detail, and wouldn’t necessarily stop the state from compelling a vaccine program not tied to an actual outbreak, especially given all of the decisions in the last one hundred years which have limited a person’s ability to challenge a state’s pro-vaccination policies.

So let’s say some self-proclaimed well-meaning folks and some big business interests wanted to force every child in a state, say California for example,to get every conceivable vaccine the vaccine manufacturers now or in the future push? How should they do it, hypothetically?

HOW TO FORCE ALL KIDS TO BE VACCINATED IN A FEW (RELATIVELY) EASY STEPS
Step 1
First, if the state has a personal belief exemption, get rid of it.
SB 277: CHECK

Step 2
Even the most rabid pro-vaxxers acknowledge that there have to be some temporary medical exemptions for kids with very serious diseases who are undergoing immunocompromising treatment.

The second step is to limit medical exemptions to the very few contraindications listed on each vaccine’s label and for only the short duration of the labeled contraindication.

Limiting exemptions to labeled contraindications essentially eliminates all blanket medical exemptions from vaccination, because most pro-vaxxers believe there are no medical conditions which justify an exemption from all vaccinations throughout childhood (maybe one, death, but Phama is probably thinking about a workaround for that too).

But the ugly reality for the hypothetical folks who want every child vaccinated is that there are a fair number of VC docs who will probably continue to write medical exemptions. Why? Because under SB 277, a medical exemption which complies with the law is not reversible or reviewable by a school.

So it’s absolutely vital to dissuade the VC docs from writing exemptions.

How? Simple: scare them. How? Two obvious tactics:

First, file charges against a highly visible VC doc CHECK

See my press release on Bob Sears’ cases:

Press Release re Dr. Bob Sears case with Ca. Medical Board

here is my original post on Bob’s case: http://rickjaffeesq.com/2016/09/09/begins-first-accusation-filed-vaccine-exemption-writing-doc/


Second, make a public announcement that docs who issue medical exemptions which don’t meet the “standard of care” (i.e., are not forever contraindicated by the package label of each and every vaccine for which the exemption is sought, will be prosecuted by the board. (And by the way there are no such recognized complete exemptions according to the CDC and AAP).

The Medical Board’s recent announcement. CHECK
(See my last post)

How to force vaccination on the rest?

What about the home schoolers and parents who manage to get a non-standard of care full and indefinite medical exemption from the few and brave VC docs who still write exemptions? So what should the pro-vaxers who want to mandate vaccination for all children do?

Before I tell you, let me give you some legal background on parental rights. I’ve had extensive involvement with one very discrete aspect of parental rights, based on my work with CAM cancer clinics and in particular, a well know Texas clinic that has treated thousands of children with advanced cancer. (See chapters two and three in Galileo’s Lawyer. http://rickjaffeesq.com/

Not to digress, but there are no Christian Scientist children with serious medical conditions

Here’s the short of it: a person can refuse necessary medical treatment for him or herself, but a parent cannot decide to withhold needed medical treatment for a child. Not only is there no parental constitutional right to withhold necessary medical treatment from your own child, if a parent does not allow a child to receive necessary medical treatment for a serious medical condition, the parent’s legal custody will be temporarily terminated, and a guardian will be appointed to make medical decisions on the child’s behalf.

This has happened dozens of times across the country in cancer cases. Most are familiar with the common scenario. A child is diagnosed with advanced cancer, for which there is a supposedly curative or beneficial treatment. The parents refuse because of religious/philosophical reasons or because the parents don’t like the side effects of the recommended treatment and want to go the “natural way.”

After failing to convince the parents, the doctor (most often a chemotherapist) contacts the state child protective services. Eventually the case lands in family court. After a hearing, the parents are ordered to produce their child for treatment, or the parents lose legal custody of their child and a guardian is appointed who makes the decision for the child to undergo the treatment. For young children, under 10 or 12, the courts always order the conventional treatment. My rule of thumb is that if the kid can drive to the hearing, he/she may get to decide. But still, for young children, judges always force the child to receive necessary or potentially life-saving treatment, regardless of the philosophical beliefs or wishes of the parents.

It gets more complicated when the parents want to go with an alternative to conventional treatment and the alternative treatment has some rational basis and/or where there is a semi reputable doctor who can vouch for the alternative treatment. But the point is that not giving treatment to a child who has a serious medical condition where there are treatment options, is not an option a judge will consider.

In short, parental rights, and their opinions and beliefs are largely irrelevant in these kind of family court cases. In other words, parents do not have the right to withhold medical treatment/interventions deemed medically necessary for the health of the child. And there will never be such a right.

Yes, there are cases which talk about constitutionally protected parental rights, especially in the context of visitation rights, meaning a parent’s right to limit a grandparent’s visitation rights. But no case has ever applied a parental right to allow a parent to deny necessary medical care to his/her child.

Notwithstanding all of the above, obviously parents make medical decisions for their children all the time, and obviously their judgment is usually never questioned, except in the rare case of a principled basis refusal to allow conventional or any other needed treatment.

So let’s now go back to a hypothetical plan to mandate vaccinations for all children.

I suppose, you could try a frontal assault, by simply proposing a law requiring all children to be vaccinated according to the AAP and CDC guidelines. But that’s an emotional, hot button issue as the SB 277 battle showed, and it would be very messy. And remember, parents do have some rights and do initially make all medical decisions for their children.

Parental rights, hmmm. But there are a lot of stupid and ignorant people out there, (more than you would think based on recent events) and sometimes parents don’t act in their child’s best interest. Hmmm. What about the rights of the child? And can the rights of the child be in conflict with the decision and rights of the parents? Clearly so, as the cancer chemotherapy cases show.

Step 3: Children have rights too!

So the next step is to obtain legislative acknowledgement that children have rights independent of the rights and responsibilities of their parents. The beauty of this is how do you argue against the rights of children? The key is to create a bunch of general, obvious and innocuous sounding rights that won’t raise a heated fight like SB 277. The bill should create the obvious sounding right that kids are entitled to parents who make decisions in their child’s best interest. Go argue with that.

Equally obvious and seemingly innocuous is a child’s right to have “appropriate” health care. (who decides what is appropriate is the question of course). These are the two sleeper rights needed to effectuate the plan. The play would be to hide these sleeper rights in other even more obvious rights using unassailable buzz words like a “safe environment”, “emotional well-being” “social development.” What kind of jerk would oppose a bill ensuring that children have the tools to optimally develop?

How many rights? More than a few and less than ten. I’m spit-balling here, but seven sounds about right.

A tactical decision: Who should carry the bill? You don’t want to raise unnecessary concerns. It could be anyone, but it shouldn’t be the guy who spearhearded SB 277, Peter Pan or whatever his name was. Anyone but him, if what you want to hide what you’re really doing. But then, maybe a guy like that sees himself as the medical savior of all these poor unvaccinated kids. Anyway, Peter wouldn’t be my pick to lead the fight, if the goal is to pass this bill quietly.

So where are we hypothetically? SB 18 has been recently introduced by none other than Peter Pan aka Dr. Richard Pan, and the bill does it all. http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB18

SB 18: CHECK

Step 4
But how to put some meat on the bare bones of these general, highly laudatory rights, including the right to have parents make correct medical decisions and a child’s rights to have “appropriate medical care”?

The best way would be to have the bill call for research based policy recommendations on these rights to ensure that all children are benefited equally by these rights. Also, say further legislation effectuating these policy recommendations will be forthcoming. These things take time, so give it a relatively long target date, maybe five or half dozen years.

After the bill is passed, create some special blue ribbon committee of recognized experts of the relevant medical specialties and overseeing organizations. Hey, how about the American Association of Pediatrics, the federal Center for Disease Control and the State Department of Health. Completely beyond reproach right?

The panel will have a bunch of meetings, commission reports to make it look as if it is actually investigating the issue. But it’s just windowdressing. The actual results of the panel are already known by the supporters of the bill and the panel members.

I’m going to pull out my crystal ball, go out on a limb and tell you the results of this hypothetical blue ribbon panel, years before the panel is formed or releases its findings: Here they are:
1. Childhood vaccines are thoroughly tested before they are released to the public.
2. Serious side effects from vaccines are extremely rare.
3. Despite the all the hysterical allegations, there is no proven causal connection between any childhood vaccine and any physical or mental disease, or any abnormal childhood developmental condition.
4. The vaccines administered to children per the most recent fully proven vaccine schedule dramatically reduce a child’s likelihood of contracting the disease which is the target of the vaccine.
5. The greater the percentage of children vaccinated, the greater the “herd immulogical” response which protects all vaccinated and unvaccinated children.
6. Based on the foregoing, there is no rational basis for any parent to withhold any childhood vaccine, except for a medically justifiable reason.
7. Medical exemptions from vaccinations should be based solely on a specific vaccine’s contraindications stated on the vaccine’s label or package insert and only for the duration of the medical condition justifying the temporary exemption.
8. Because of the uncontroverted scientific evidence in support of childhood vaccination, all children have the state constitutional right to obtain all vaccines recommended by the AAP and CDC.
9. To effectuate that right and promote the well-being of children, all parents have an obligation to fully vaccinate their children, unless there is a specifically recognized temporary contraindication.
10. The state should use all means at its disposal to enforced the child’s constitutional rights.

The panel members will receive the thanks of a grateful state (and whatever other hypothetical benefits they and their friends may obtain).

So what would happen next?

Here’s what I would do if I was charged with implementing these newly flushed-out rights:

Have local schools pick the heathiest looking vaccine medically exempt students. (An easy task since it’s rumored that unvaccinated kids are actually much healthier than their vaccinated co-students.)

File complaints against the vaccine exemption issuing docs, because there’s never enough pressure than can be put on docs who put their patients at risk of preventable disease and endanger “herd immunity.”

Contact California Child Protective Services and complain about the parents’ medical abuse based on their failure to protect the child’s constitutionally protected health rights. CPS will do a visit, and if that doesn’t work, a proceeding against the parents for violating their child’s state constitution rights to “appropriate medical care,” and forcing them to act in the best interests of their child would be initiated.

Eventually the case will land in the California Supreme Court, but if the issue is framed as a child’s right to necessary medical treatment vs. the parents’ right to withhold such treatment, the VC community won’t like the result.

But that decision won’t be for years, In the interim, there will be some high-profile CPS cases filed, and that surely will have a chilling effect and impact the decisionmaking of parents.

This is all hypothetical, except it isn’t. It’s obviously happening right now. Opposing SB 18 is a good place to begin. Better still, use this bill as a vehicle to reopen the public debate about vaccine safety, efficacy and herd immunity.

My view is that the VC community will never achieve anything by asserting what is viewed as a constitutional right of the few to infect or put at risk the many. Instead, focus on the science, or lack thereof.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com