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Author: Richard Jaffe

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

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

vaccineimage
The elimination of the PBE (personal belief exemption) via SB 277 has put a lot of pressure on vaccine concerned California pediatricians to write medical exemptions for the children of vaccine concerned parents. The recently dismissed San Diego federal anti-SB 277 lawsuit showed that at least one school board is collecting information about the docs who write these medical exemptions and will forward the information to the medical board for prosecution.

Based on some non-binding legislative history, and some personal discussions with legislators, the vaccine concerned community was hoping that the medical board could not or would not assert jurisdiction over docs who write these exemptions. That seemed completely unrealistic to me based on my experience dealing with medical boards. These guys just don’t give up jurisdiction on their licensees’ conduct.

In case you had any doubts, the board has made it official in its recent executive summary. Here is its position which couldn’t be clearer:
“The passage of two legislative bills increased the Board’s authority to investigate allegations of misconduct. * * *
In addition, SB 277 (Pan and Allen, Chapter 35) effective January 1, 2016, deleted the personal belief exemption from the existing immunization requirements. The Board will investigate any complaints in which a physician may not be following the standard of care in these two new areas.”
(From page 6: http://www.mbc.ca.gov/Publications/Annual_Reports/annual_report_2015-2016.pdf)

So there you have it. It’s basically open season on docs who write full vaccine exemptions, because according the pediatrician groups and the CDC, there are almost no medically justifiable reasons to excuse a child from all childhood vaccinations.

So what can be done about it? In the very short term, nothing really. Many pediatricians will probably be wary of writing medical exemptions.

Still, here are a couple hints. If your child had some prior vaccinations and had a serious adverse event associated with (not necessarily provably caused by) a prior vaccine, you may be able to obtain an exemption from the right doc, which decision would be literature supported. Make sure you bring documentary proof of the prior adverse event(s). The doc will need it for his records. Prior auto immune problems in the child or family members? That might help as well. Again, bring documentation. Help your pediatrician make the case and help him document the exemption. That’s the best protection for you and your doc. Admittedly, right now there is no medical board authority indicating that this would justify or exculpate a doc who writes an exemption on this basis, but I hope to change that within the next six months, in connection with my work on the current medical board case I’m working on, so stay tuned.

Next, an obvious mid-term solution is to amend SB 277 by making medical exemption decisions unreviewable by the medical board. As stated, there is some legislative history indicating that SB 277 was not intended to have the medical board second-guess the decisions of docs who write these medical exemptions. Realistically, passing such an amendment is a long-shot, but it’s time, energy and money better spent that filing another frivolous SB 277 constitutional challenge. (By the way, whatever happened to the dismissed San Diego federal lawsuit which was supposed to be refiled October 1st?) My suggestion: start working your legislators to get some feedback on whether it’s a possibility. If it is, that’s where the community should put its efforts and money.

Finally, there’s a soon-to-be publicly announced group of vaccine concerned docs, which is open to the public. It’s called Physicians for Informed Consent.

Check out their Facebook page at https://www.facebook.com/search/top/?q=physicians%20for%20informed%20consent.

Here is their web site. www.physiciansforinformedconsent.org

These folks have done more good for the vaccine concerned community even before they’ve officially started than all the lawsuits combined, but I can’t talk about that now. Go to their Facebook page, sign up and support them. They have and will continue to make a difference.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald:
Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA. Both seem to be disruptor/game changers, which is exactly what HHS and FDA need. As a guy who has been battling the FDA for a few years and per your request, here are a couple things which they should do from the get-go, without alot of bureaucratic red tape. Let’s start with getting the FDA bureaucrats off the backs of patients and consumers.

Stem Cells:
You’re not going to believe this, but according to the FDA’s current thinking, patients need the FDA’s permission to use their own stem cells for most medical conditions. Really. That’s crazy isn’t it? There are about 600 clinics here which are giving stem cells to patients, but they will have to shut down if the FDA gets its way. Here are two things which Jim should do immediately:

First: withdraw the FDA’s four pending draft guidance documents which impose some of these crazy restrictions on peoples’ rights. (I’ve talked about this in some of my past blogs in case your people want the details.).

Second: Jim should issue a new policy statement that the use of your own stem cells, tissue or body parts (what the FDA calls “autologous use”) is not regulated by the FDA because it’s the practice of medicine which is governed by state law. That would also include the expansion or culturing of your own stem cells. The one sentence response to hand-wringers about patient safety: the state medical boards are in a better position to oversee doctors who treat patients with their patients’ own body parts.

Dietary Supplements:
My guess is that you’re not into nutritional supplements, but tens of millions of Americans are and they spend upwards of 40 billion dollars a year on them. We have the freedom to purchase supplements with minimal FDA oversight. Basically, manufacturers can’t say supplements can cure diseases or medical conditions. The FDA is trying to change that with another of its “draft guidance documents” on what it calls “new dietary ingredients.” Under the FDA new position, it’s going to be very hard for consumers to buy supplements. So Jim needs to withdraw the pending draft guidance document on “new dietary ingredients.”

I also think manufacturers ought to be able to tell consumers about the research supporting their products, but Jim and I can talk about that later, and he’ll fill you in.

Drugs and Pharma:
Dealing with drugs is more complicated. Because of how busy you are, you might not have picked-up that Congress just passed a law which will streamline the FDA approval process, (supposedly), by allowing the FDA to consider real world results rather than just formal clinical trials, and accepting data from foreign clinical trials (and a bunch of other stuff, but no need to get into the weeds).

This should save Pharma big money in future drug testing, so let’s get something back, since Pharma’s been raping American for years with excessive drug prices (which by the way, it doesn’t do when it sells its drugs in the rest of the world).
You’re 100% right to tell Pharma it has to lower the cost of drugs. For sure, let government agencies negotiate lower drug prices. That will save the government a few hundred billion over time. You’ll have to fight both parties since they’re both in Pharma’s pocket. (It was Congress which gave up the government’s right to negotiate bulk discounts.) But you can fix that. Seems like twitter is the way to go. Just have your followers email the Republican leaders for a bit and that should do it. And no one will complain about your going after congressional leaders on twitter. Your supporters will love it!

Next, a money making idea. I’m going to tell you something which as a businessman you’re not going to believe. The federal government via the NIH actually invents many of the novel drugs which Pharma sells. Guess how much the government receives for the drugs which it discovers?

NADA! Really. The government gives away these drugs, even the ones that eventually becomes blockbuster multibillion dollar revenue producers. Nuts isn’t it. So let’s get our piece from the back end. A couple billion here and there eventually adds up.

Vaccines

I don’t know whether it was real or fake news that you met with Andy Wakefield, but I do hear you have some concerns about vaccines. I do too. I’m working on what may be the most important vaccine case in the country now. It involves a doc who thought a child shouldn’t get any more vaccines after having two very bad adverse reactions. The medical board is going after him. One thing I’ve discovered is that that many physicians are afraid to come forward for fear of professional retailiation from the pro-vaccine scientific Mafia. You might know there are two big scandels involving the CDC, phony safety and non causation data issues. This needs to be looked into.

My Suggestion: Tom needs to get some folks to figure out whether vaccines are causing some diseases like autism, which is what the anti-vaxxers claim. It shouldn’t be a CDC operation since those folks may be part of the problem and may even involved in a cover-up. Nor should the muckimucks at the establishment pediatrician groups be involved (other than as witnesses or targets) since many of them have serious conflicts; they take money from vaccine manufacturers or are vaccine inventors.

Ok, this is just off the top of my head, but doing the above would be a very good start. I’ve got a couple thoughts about replacing Obamacare. I’ll send you something after Saturday Night Live.

And by the way, I’d like to serve, so I’d appreciate it if you could put in a good word about me to Arnold. I hear you’re still involved.

Regards, and best of luck with the new gig.

Rick Jaffe, Esq.

A short, mostly first-hand history on insurance reimbursement for CAM

A short, mostly first-hand history on insurance reimbursement for CAM

In litigating criminal and civil CAM (Complementary and Alternative Medicine) cases for three plus decades, I’ve seen a lot, and I have the medals and battle scars to prove it (meaning good and bad court opinions, jury verdicts and prosecutorial decisions). The decades have also given me a perspective on how things have changed, and haven’t.

For CAM insurance reimbursement (including chiropractic), I see one constant dynamic: Insurance carriers don’t like to pay for CAM services, so (some in) the CAM community come up with workarounds to get insurance companies to open-up their wallets. These workarounds work for a while, then they don’t, then there are new workarounds which work until they don’t, and so the dynamic goes.

Let me flush this out, largely based on my experience working on some of the big CAM insurance civil and criminal cases, investigations and medical board actions. Many of these matters were characterized by the government and/or carriers as “insurance fraud.” Fortunately, more often than not, the judge or fact finders didn’t agree, or at least didn’t think the government or carrier met its burden of proof.

CAM doesn’t get insurance reimbursement

In the 80’s, when CAM really started to take off, the carriers had short and vague exclusions in their policies about not paying for experimental or unconventional treatments/services. Even without specific definitions, those general policy exclusions were usually enough to stop most practitioners from filing claims or receiving reimbursement. Since most CAM treatments do not involve big money, individual patients and clinics did not litigate denials of claims for CAM treatments.

CAM figures out how to open the carriers’ wallets

A couple things happened in mid to late 80’s up until the early to mid-90’s which changed the CAM insurance payment landscape.

First, a few creative billing companies developed coding techniques to create some confusion about the nature of the services provided by CAM practitioners. One highly successful company made tens of millions of dollars for CAM clinics, and even obtained insurance payments for patients treated at Mexican CAM cancer clinics. They did this by creating chemo sounding acronyms for the treatments, and established a California based foundation for billing purposes which disguised the fact that the treatments were given in Mexico.

On the chiropractic front, a few chiropractor-turned consultants popularized the MD/DC business model, whereby chiropractic services were magically transformed into medical care. This regulatory alchemy was based on an obscure Medicare concept called “incident to” billing, the effect of which was to circumvent the severe limitations which most carriers placed of chiropractic care. These rules were also used to bill services of unlicensed people giving advice about “activities of daily living” as incident to services rendered by or under the MD’s provider number. Because of the efforts of these billing companies and consultants, tens of thousands of patients received care paid for by carriers which would have otherwise been denied by the greedy and heartless insurers. (I might not be unbiased.)
From the government’s and carriers’ point of view, it was all insurance fraud. It was relatively hard to prosecute insurance fraud back then, federally at least. Most of the victims were private carriers. There wasn’t much of a federal budget for these prosecutions, except for the most high profile or unlucky cases. (I worked on one of the big cases involving an unlucky and high profile doc.)

In addition, there were some impressive legal victories wherein carriers were forced to pay-out big judgments (including punitive damage awards) for denying expensive investigational or CAM cancer treatments. These judgement caused some shock waves in the health insurance industry and led to some very significant changes in the legal/regulatory/enforcement landscape.

The carriers and feds fight back hard

The carriers figured out that they were not paying for reimbursable conventional care, but rather, excluded CAM care. They were not happy and some started filing lawsuits against the practitioners and even the consultants and billing companies. The carriers also got the feds involved.
Federal prosecutions of insurance fraud became easier and more frequent because of a provision in the 1996 HIPAA law which made health care fraud against a private carrier a federal crime. (18 USC 1347, for those who care). The new law even made medically unnecessary testing and services prosecutable under the federal insurance fraud statute. With the change in the law came some significant federal money to fund federal insurance fraud prosecutions.

I worked on some of the major health insurance civil and criminal health care fraud cases in the 90’s. Mostly the results for my clients were good, but even so, as they say in criminal defense, “You can beat the rap, but you can’t beat the ride.” These cases were brutal and draining for the docs. And when the doc loses, he loses big; his/her medical license and freedom for a time. So the stakes in these cases are huge.

Civil lawsuits against health insurance carriers for non-payment of arguably experimental or unapproved care virtually ended in the 90’s once the carriers figured out that they could use ERISA (employment law) to make these cases unattractive and almost unwinnable by plaintiffs’ attorneys. (In short, ERISA law makes the carriers’ payment decision judicially reviewed under an extremely high abuse of discretion standard. Also, there are no punitive damages in ERISA, thereby removing a big incentive for the plaintiffs’ bar to file these cases.)
On the MD/DC front, the carriers and the feds fought back hard. Aetna went after one of the main MD/DC consultants and the MD/rubber stamp of 50 of the MD/DC clinics in the northeast.

The feds started prosecuting many of the chiropractor owners of the MD/DC clinics and their MD and DC employees. In the early 2000’s, the feds went after the most visible MD/DC consultant and one of his client-clinics in northern West Virginia. The chiro clinic owner got wind of the investigation and fled the country, but the MD, the two employee chiropractors, the office manager and the consultant who set the operation and told them how to bill the carriers were all indicted for insurance fraud.

The MD and office manager plead-out and did some time. The two chiros and the consultant went to trial, but all were convicted. The consultant was also convicted on money laundering charges, which is a very nasty crime because it imposes an unusually harsh sentence, far greater than mere insurance fraud. Despite three appeals, the consultant received a very lengthy prison sentence, and there’s no parole in federal time. This was the worst result I ever received in a case. The government would say that this person was responsible for many millions of dollars of insurance fraud and that he was fairly punished. (The chiro clinic owner who fled the country beat the government’s extradition efforts and continues to live in Ireland.)

This and the other prosecutions reduced the popularity of that MD/DC clinic model. One of the big CAM billing companies was eventually indicted, but the case was ultimately settled and charges dropped. A few docs were eventually indicted and there were some convictions, but nothing like in the MD/DC field.
In the mid 2000’s, there were still some MD/DC clinics but most were operating below the radar screen, and didn’t engaged in the most controversial forms of billing that the prior chiropractic consultants advocated.
Some CAM physicians continued to engage in the obfuscation techniques taught by the CAM billing consultants, but for whatever reason, there wasn’t much activity on the federal criminal front. I worked on an investigation of an autism clinic which used a billing technique to circumvent the carriers’ pathway edits for unconventional autism treatment. Eventually, the carries figured it out and contacted the feds which opened up a grand jury investigation. All I’ll say is that it’s a case you’ve never heard of because there was no indictment. But the clinic did close its doors once the carriers figured out what it was up to.

Also, starting in the mid- 2000’s there began to be a movement in the CAM community to produce specific codes for CAM services. It was called ABC billing (Alternative Billing Concepts). The idea was to create HCPCS type codes which could be used in billing insurance companies for CAM services. My take is that it’s had some success, but not for the primary therapy types of CAM like chelation therapy, environmental therapy treatments, and such.
The problem with the ABC endeavor is that it misunderstands the main reason why CAM practitioners aren’t getting paid for the CAM primary therapy. It’s not because, there is not a specific enough CPT or HCPCS code which is what the ABC codes try to solve. Rather, it’s because most carriers have a policy against paying for treatments not generally accepted by the conventional medical community.

To be fair, carriers do pay for some CAM therapies like acupuncture, chiropractic and even nutrition counseling (given by a properly credentialed provider), but 1. The reimbursement rates for these services are low and 2. That doesn’t help the integrative practitioner who uses a wide variety of primary therapeutic CAM modalities which are not payable under the plans.
So however laudable the ABC coding effort is, it won’t solve the CAM practitioners’ main problem, which is insurance policy exclusion of most or all primary CAM treatment modalities.

What comes around and goes, comes around again

In the last few years, a new billing and coding model has been promoted to the CAM community by various CAM coding companies. It involves use of an arcane Medicare concept, the “incident to” rules, which turn services of NPP (non physician practitioners) and chiropractors into physician services in order to 1. Obtain 100% physician reimbursement rates, rather than the 85% rate of NPP’s, 2. To circumvent the limitations of chiropratic in Medicare and third party pay plans, and 3. To bill people without any health care license or certification under as services of the MD provider. What a novel approach!
In the old days, Medicare had more rigorous and restrictive payment practices than all private carriers, so following Medicare’s rules was in effect, a safe-harbor or guaranty of compliance with the rules of the private pay carriers. However, those days are gone. Some private health insurance have stricter rules than Medicare and/or don’t follow all of Medicare’s rules. So the Medicare safe harbor concept doesn’t necessarily work anymore.
These new CAM billing companies also have some novel interpretations of various other codes, which, it is claimed, obtains insurance reimbursement for primary CAM therapies such as chelation therapy for heart conditions and even detox. You can probably guess some of the ways they achieve these results.

IN SHORT
If you are following the advice of one these billing companies, keep this in mind; just because the carriers’ payment computer programs are spitting-out checks to you for CAM treatments doesn’t mean the carriers actually know what they are paying for, or that they won’t ask for their money back, if and when they ever figure out what’s going on.
And on it goes.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

Unwanted advice for the anti-vaxxer Cali. SB 277 lawsuit reboot

Unwanted advice for the anti-vaxxer Cali. SB 277 lawsuit reboot

Here’s what I’m getting from the Bolen Report’s prediction/foreshadowing of the new SB277 challenge, and so here is some more probably unwanted advice:

500 Plaintiffs:

Really? HELLO: you’re fighting an asymmetrical battle. The government has a lot more financial and personnel power than you guys. Moreover, if what you say is true, namely that big pharma is behind the worldwide vaccine conspiracy, pharma has unlimited resources. You’re going to try to manage 500, or even dozens of plaintiffs? That doesn’t make any sense. What’s the upside? You don’t think the judge will know that there are a lot of you vaccine concerned out there? Get real and keep it manageable. Use just a couple plaintiffs to cover your bases, standing wise (a few affected individuals and a couple groups for associational standing), and that’s it.

Multiple Lawsuits:

Really? Filed by the same lawyers? Same or similar legal theories? You’re just making more unnecessary work for yourselves. The same or overlapping defendants will just file consolidation motions in each of the cases, or xerox the dismissal papers and submit them to all the courts. Filing a bunch of similar lawsuits will do a couple things which you shouldn’t want. It will burn a few months and waste money. Plus, you’ll really ingratiate yourselves with the judiciary, because there’s nothing judges like better than wasteful duplicate litigation which clogs their dockets.

Don’t overstate your case by bad-mouthing all vaccines that were ever given since the beginning of time

I get that the hard core anti-vaxxers think that no vaccine has ever helped a single human being or prevented anyone from getting any disease ever, and that everyone involved in the horrific vaccine genocide should be prosecuted, but for God’s sake don’t put that or any other crazy stuff in the complaint. Those Luddite arguments might play well to the hard core anti-vaxxer element, but you guys who are preparing the papers are professionals. There’s no sense writing stuff which will make the judge and the media think the clients and their lawyers are complete wackos.

Don’t make it personal

There is a tendency in cases like this to identify the boogeyman. The prior lawsuit and the two current pending lawsuits did that, focusing on the pediatrician/legislator and some Santa Barbara government official. It’s already been done and it won’t help your case to personally attack people who advocated or worked for a law passed by the legislature. That is how public health policy is set. Nor will it help your case by attacking government officials who want to make sure that the intent of the law is effectuated. That is the job of such officials. Calling them names and vilifying them will surely make the hard-core anti-vaxxers feel good, but it won’t help you case. If anything, it will hurt it.

Acknowledge the deep legal hole you’re in and move forward from there

All of the extreme anti-vaxxers, and a good percentage of the vaccine-concerned are living in an alternative legal universe. In the universe I and all reasonable and informed people live in, for over one hundred years, starting with the Supreme Court’s decision in Jacobson, every single legal decision has upheld the government’s right to mandate vaccination and has rejected a purported individual’s personal belief based asserted right to avoid vaccination based on an proposed extension of a constitutional right. All of these legal challenges fail because as is is oft-stated, the Constitution isn’t a suicide pact.The personal beliefs of the few will never outweigh the public health of the many.

That means that the only conceivable chance to have a judge think about letting the case proceed –rather than grant the state’s motion to dismiss – is to focus on public safety. Specifically, the public safety of kids, particularly young children, and specifically the vaccine schedule and maybe the dangers of the most popular adjuvants. You guys need to drill down, think small and get into the weeds; pick the most unassailable scientific concerns out there and go with that, rather than big picture things like cover-ups, conspiracies and boogeymen.

Your immediate goal

I would respectfully suggest that the purported goal of having some authoritative judge make some grand declaration about an individual’s rights superceding the right of the public to public health is completely unrealistic and will never ever, ever happen. Even a public health argument is a long shot, because such decisions are usually left to the legislative and executive branches. However, if you present a rational and interesting argument, you might just get a judge to let the case go forward, which should be the primary immediate goal of the new lawsuit, as opposed to filing a facially defective complaint –like the prior dismissed lawsuit, or the wacko papers filed in the two pending lawsuits.

In short, try something different this time; be smart; don’t file papers that the extreme anti-vaxxers will love, but the judges and press will think are crazy. That’s been done and done.

Rick Jaffe, Esq.

www.rickjaffe.com
rickjaffeesquire@gmail.com

Game Changing the Stem Cell Debate

Game Changing the Stem Cell Debate

It’s been almost a month since the FDA’s two day hearing on the draft guidance documents on autologous stem cells. Here is the short version of what happened:

The stem cell research industry, meaning the basic scientists and academic physicians employed at big institutions, and their acronym organizations like the draft guidances. They agree with the FDA that non-homologous, (roughly meaning therapeutic as opposed to replacement) autologous (i.e. my) stem cells (or any kind of autologous tissue or “HCT/P’s”) should only be available in clinical trials until the FDA grants marketing approval for some use. (What happens after approval, in terms of off-label use, is anyone’s guess).

Those institutional players cited four cases of harm to patients. Three were at one clinic where a non-physician injected stem cells into the eyes of the patients which resulted in loss of vision. The other case was someone who took stem cell tourism to the extreme, continent-hopping and injecting every manner of autologous and allogenic stem cells for his degenerative condition.

Testifying on the other side were clinicians providing non-homologous, autologous stem cell treatments to patients. These clinicians have treated or spoke about the tens of thousands of patients who have received various forms of therapeutic HCT/P treatment under the soon-to-be extinct practice of medicine exception (21 CFR 1271.15).

And then there were the HCT/P patients, many with life threatening, incurable or life altering conditions. They all testified in support of Americans having access to their own HCT/P’s in the U.S. It was heart wrenching and uplifting to hear their stories. I couldn’t begin to do justice to their plight and the power of their words, so I won’t try.

But, if there’s one thing I’ve learned about dealing the FDA on access to treatment issues, it’s that the government doesn’t really care about actual patients or even future patients, due to its deep concern about PUBLIC HEALTH and THE SAFETY OF THE PUBLIC, which are sort of like Platonic ideals, and which have only the faintest connection to actual patients and reality.

Powerful as it was, I don’t think the testimony of these patients will change the FDA’s mind on the core issue of a person’s access to his/her own body parts.

There were over six thousand public comments submitted to the FDA after the hearing. However, that’s orders of magnitude too small to make an impact on the FDA.

So after pondering the hearings, I feel like what Roy Scheider felt and expressed when he finally saw JAWS up close: “We’re gonna need a bigger boat.”

Between the media, which has been harpooning all these unregulated stem cell clinics, and the stem cell research industry’s greenlighting the draft guidance documents, we’re gonna need a bigger boat.

The bigger boat has to be a vehicle to reach a lot more people, like many tens of millions. Social media itself can’t do it.

To me, the obvious solution is a documentary. I’ve recently seen Vaxxed. These guys are now on a bus tour all across America. The documentary and the tour is having an impact, and that’s in spite of the fact that Andy Wakefield is a very controversial fellow who has been excoriated in the media.

I was involved in a couple of the documentaries about Dr. Stanislaw Burzynski. He’s also a very controversial fellow and gets a great deal of negative press. Nonetheless, the director/producer made a deal with the cable companies which resulted in the Burzynski documentary being available to something like 40 million cable viewers. Now those are the kind of numbers I’m talking about!

I think the right kind of documentary focusing on the patients and not having a polarizing protagonist could avoid some of the special challenges facing the producers of the two aforementioned documentaries. If done right, it could spark the interest of tens of millions who themselves or their family members are dealing with serious unresolvable medical conditions.

I have to believe that in the stem cell patient community there are media insiders, power players, and even celebs who support access to these treatments and would be willing to help. I also have the feeling that the money to make it happen would show-up.

The stem cell clinical community needs a game changer.

You know what they say: “Go big or go home.”

Rick Jaffe, Esq.
www.rickjaffe.com
rickjaffeesquire@gmail.com

More about the FDA stem cell hearings at:
http://rickjaffeesq.com/category/stemcells/

WHAT’S WRONG WITH THE U.S. HEALTHCARE SYSTEM AND WHAT IT WOULD TAKE TO FIX IT

WHAT’S WRONG WITH THE U.S. HEALTHCARE SYSTEM AND WHAT IT WOULD TAKE TO FIX IT

I spend most of my professional time in the weeds of health care cases, so I thought it might be a nice change of pace to put down some of my observations and general critiques of the system based on my 30 years in the health care arena and as a consumer of health care services.

(I originally posted this back in April, but so much has changed since then, I decided to update the problems, (including the FDA’s recent efforts to take away the most popular form of breast reconstruction surgery from mastectomy patients, add some solutions, and say what it might take to have the solutions implemented.)

Let’s start with a few common macro facts/critiques:

1. The US has the most expensive health care system on the planet, per capita.

2. But by almost all recognized health care benchmarks, American health care has worse health care benchmarks than most other industrialized countries.

3. On the other hand, all types of expensive new technologies are available to Americans with good insurance or who can self-pay, and speaking of new health technologies,

4. Most drug and device innovations in diseases and chronic conditions come from US companies and are tested at least in part in clinical trials in the US, though that is changing somewhat because,

5. The US is the toughest and most expensive place in the world to get drugs approved. But in the last decade or two, access to investigational drugs in the US has opened-up alittle, compared to many western industrialized countries. However, access to investigational drugs is still woefully inadequate (in my opinion). As a frame of reference, each year the FDA allows a thousand or two patients to receive investigational drugs outside of clinical trials. This is a miniscule amount compared to the number of people who want or might benefit from investigational drugs.

The seemingly unavoidable conclusion is that we spend way too much on health care compared to what we get in terms of societal or population level health benefits. But how can that be? We have so much medical innovation coming from the US and we surely have the finest physicians and medical facilities (just ask any US mainstream physician). How can this abundance not translate into the world’s best medical care based on recognized health care benchmarks?

The answer is no doubt complicated, but I suspect that part of our underperforming stems from the nature of statistics and the difference between our health care system and the rest of the industrial world. Almost all other industrialized countries provide health care as a basic benefit to its residents; they have what many here pejoratively call, “socialized medicine.”

In this country, we have two kinds of health care consumers, those with health insurance and those without. Major and moderate medical interventions are far beyond what most people can afford to pay out-of-pocket. Without insurance, people either don’t get all of the health care they need, or get it through ridiculously expensive and inefficient means like ER facilities, and the costs for this inefficient care are ultimately borne by taxpayers or health insureds. That’s no way to run a health care system.

The large number of un or underinsured has to drag down these macro health benchmarks. If so, then a better comparison might be comparing US residents who have good health insurance to the rest of the industrialized world, and ignore the un and underinsureds (which is basically what our Government has done until the advent of Obamacare). I suspect the gap would close significantly but not completely. So beyond the fact that we chose (and continue to choose) to let a portion of our residents live without adequate health care, there are likely other factors which cause us to pay too much for too little.

Maybe another cause of the problem is that we need more health care than people in other countries. Why would that be the case? One answer might be lifestyle and diet. Michael Pollen calls us the “people of corn.” Maybe our diet which is predominately corn based carbs, processed foods and corn fed protein is causing us to need more health care because people in other places just eat better (or less). Being a recent low carb convert/missionary, I suspect this to be the case. But that’s ultimately on us, as consumers. Once the collective mindset recognizes the dangers of the standard American diet, our collective health should improve which would cut our per capita health care costs.

Ok, I’m just fantasizing. It is more likely that we will realize some of the dire predictions about the adverse health effects of excessive carbs and sugar on baby boomers, which will even more dramatically raise health care costs. (See David Perlmutter’s Grain Brain, the books by Gary Taubes, and other books about the dangers of carbs and sugar and what may happen to us baby boomers).
But it’s not completely satisfying just to blame ourselves, let’s look at some of the usual suspects to see if we can lighten the load and stick it to the Man.

Health Insurers

(Full disclosure, I hate health insurance companies. I spent much of my career fighting them, so I am admittedly biased.)
You know what a health insurance company calls a payment to a provider for a critical or necessary health care service to an insured who pays premiums? A “loss.” That says it all.

There is an obvious structural conflict in having any financial intermediary pay for or decide what medical services the insurer should pay for. Insurance companies are in the business of making money (even the so-called “not-for-profits” like the Blues who are as bad as or worse than the “for profits”). The more “losses” they have, the less money they make and the less bonuses for their overpaid, immoral executives. (I told you I was biased) And it’s not significantly different when the carrier is an administrator of a company funded plan. Plan administrators work for the company, and their only allegiance is to the company/client.
Bottom lining it: When you have businesses which have an incentive to pay out as little as possible, so they can make a fair or unfair return on their investment, watch out.

The alternative is a government single-payer system. That is how health care is paid for in all or virtually all other industrialized countries. However we do have government pay heath care in the United States for the old, the poor, veterans and government workers. Results of these programs are complicated and mixed.

I spent a number of years in Israel which has a government single payer plan for all residents. However, they also have a private pay program for supplemental or additional care for anyone who has the funds and desire to retain private physicians or obtain treatments not approved or paid for by the government payer. I think that is the best of all possible worlds. And we already have part of that system here since most unconventional/complementary/integrative care is not insurance reimbursable, and hence is only practically available to the middle and upper-class.

The main criticism of single payer is exemplified by the fact that Canadians wait a long time for non-immediate life threatening operations, and some expensive, cutting edge technologies are not available in government pay England and other such places. But the rich English, Canadians and other foreigners suffering under single pay systems come here for such therapies or to go under the knife quicker, they do medical tourism in other places like South American and Asia. Even if we had single payer here, there is always going to be a demand for new technologies and uncovered services. Where there is a demand, the market will find a way to meet the demand, regardless of how many payers there are for standard, covered care.

Regardless of whether you buy into single-payer, I think all reasonable people acknowledge that the current private pay insurance system we have is a part of the problem. So any comprehensive solution has to involve a fairly radical change from what we now have. And anyone who claims that Health Savings Accounts and/or erasing state lines to promote competition is going to solve the problem is delusional or an ignoramus, or both.

Relatedly, there is one thing I begrudgingly give to those insurance bastards; if the system is going to force carriers to take the preexisting sick and really sick, mandatory enrollment for healthy people is a necessity. The numbers don’t add up any other way. I remember when this was a Republican thing, part of the “personal responsibility” mantra. Somehow, mandatory participation has been transformed into an oppressive government/freedom of choice issue. People supposedly have the God or Constitutional given right to choose not to purchase health insurance. That works fine until the freedom lover shows up at the ER without the money to pay for the needed care, at which point the freedom lover becomes a health care socialist, deadbeat or goes bankrupt. But the result is the same; freedom lovers end up not paying for their care. The rest of us foot the bill. However, reforming health insurance even via single payer will not solve our problems because costs are out-of-control and are not connected to regular market forces.

Hospitals and Providers

After receiving a hospital bill, most people are stunned and realize that the system is broken. The charges for hospital services and testing is staggering, and I would argue unsustainable. One of the biggest problems with Obamacare is that it did not address the cost of services, let alone impose any cost containment measures on facilities, providers or products. It seems to me that any real solution to health care has to involve some kind of price controls/tax/bulk negotiations or some other way to limit the ever escalating cost of medical services for basic necessary medical services.

Many integrative practitioners operate on a cash basis and I don’t see that any such cost containment measures would directly affect them, for the same reason that cosmetic surgeons can charge whatever the market will bear. If you’re cash based, the market, your skill set and your marketing savvy will ultimately determine the true and fair cost and value of your services. However, when the insurance companies rather than the patient pays, the market gets distorted. In that market, without some kind of cost containment mechanism, I think our health care problems are insurmountable.

Apart from lack of cost controls, I think physician mindset and education are major sources of our health care problems. As the CAM (complementary and alternative medicine) mantra goes, we have a disease system, not a health care system, and there is not enough focus on prevention (with some notable exceptions like the anti-smoking and Trans fats campaigns). Money may be behind this as well since medical interventions for diseases and conditions is where the money is, not prevention. While this may be primarily a public health issue, it’s also a physician mindset issue. The best concrete example of this is the lack of medical school training in diet and nutrition. Most CAM practitioners who receive nutrition training at one of the nutrition academies understand how woefully inadequate their medical school training was on the subject.

Finally, I know a lot of CAM practitioners live in the hope/fantasy that all their CAM services will eventually be insurance reimbursable. There are some clever insurance reimbursement ideas which float around from time to time. And every once in a while something good happens, like the American College of Nutrition and its certifying board’s success in getting their nutritionist members qualified for Medicare reimbursement. But on the whole, my opinion is that Medicare and the private pay carriers are never going to knowingly pay for hard-core CAM services like chelation or first-line CAM therapeutics. But there’s no downside to keep hoping and for the community to keep fighting the good fight. By the way, I tell my chiropractor clients and audiences that if they can live without insurance carriers, they’re better off. I feel the same way about CAM physicians. The current and future reality is that the services of CAM practitioners are not for the poor of pocket.

And Let’s Not Forget Big Pharma

In the CAM community, big Pharma is a natural and inevitable target. One issue is of course high drug prices, but it’s complicated because of the length of time and extreme expense it takes to get drugs approved in this country. Still, it was a bad move not allowing the Government to negotiate with Pharma the prices for Medicare drugs. We can thank the Pharma lobbyists and the folks in congress they paid-off. Reversing that enormous Government handout to Pharma is one of the first thing our probable future Dear Leader should do after his coronation, since he’s such a good negotiator (self-described).

Another widespread problem is how Pharma is corrupting scientific research by burying negative research and buying-off physicians. There has been some small corrective action in the last few years. However, savvy physicians shouldn’t accept everything that’s written even in the most prestigious journals, because as some have argued, the mainstream publication system has been corrupted by Pharma money. I also think part of the publication problem is what I referred to in Galileo’s Lawyer as “the church of medical orthodoxy” type thinking, or in Kuhnian terms, the terror of normal science. (http://rickjaffeesq.com/galileos-lawyer/ )

One recent positive is the proliferation of open access, online journals. Their increased popularity among scientists is in part based on the faster turn-around time from draft to publication than mainstream print journals. Open access journals should also lessen the corrupt pharma influence and the anti-CAM stranglehold on the mainstream print journals. There are rumblings and start-ups promising even faster and almost immediate sharing of data, which could change the paradigm in research, the dissemination of results, and expedite access to new technologies.

A final thought: I am hoping there’s a special place in Hell for the Pharma companies and their physician co-conspirators who are getting our kids hooked on ADD drugs so they can be worked up the chain to SSRI’s and be life-long Pharma customer/addicts. I also think some of the teachers may be complicit by too quickly demanding that their high spirited students be drugged. I’d like to see teaches get mandatory training on the dangers of ADD drugs and SSRI’s. May the manufacturers and their pushers get what they deserve.

Provider Shortages for Basic Healthcare

As a consumer, I think there is a shortage of primary care physicians. Witness the uptick in the “concierge” medical model. The idea that you need to pay an annual fee just to have reasonable access to a primary care physician suggests to me that there are not enough of those folks out there.

The other big factor might be that it’s still incredibly hard to get into medical school, and/or there aren’t enough medical schools. It could be that the medical profession likes it that way, to limit competition, and keep the pay higher than it might otherwise be if there were 20% to 30% more medical school graduates each year. So trade protectionism might be a factor.
Interestingly, I’ve seen an increase in the use of physician extenders like NP’s and PA’s in some medical practices and clinic chains. If the model works out, it might help increase access to basic care.

My Brethren, the Lawyers
Of course, let’s not forget the lawyers, and in particular the plaintiff’s malpractice bar. As a result of probably justified complaints from physician groups and others, many legislatures like Texas imposed tort reform. Among other things, these laws limit the pain and suffering component of malpractice awards, which is where the big money is for small and mid-size cases. After the changes took effect in Texas, the plaintiffs’ (and defendants’) malpractice bar was decimated. While there may still be defensive medicine because of feared malpractice cases, tort reform hasn’t slowed down the spiraling costs of health care. So either the lawyers weren’t the problem or tort reform didn’t put enough of them out of business. (I’m guessing most of you subscribe to the latter view.)

And Last But Not Least, the (Over) Regulators

Let me start with a positive. Because of DSHEA, (the 1994 dietary supplement act) we have very good access to anything that can reasonably be called a nutritional supplement.
Now the bad news
The FDA is trying to undo or undermine DSHEA by its new guidance on new dietary ingredients. If the FDA gets it way, any supplement that wasn’t marketed before 1994, in exactly the way or form or formula it was sold pre-1994 will not be able to be marketed without submission of data to the FDA. That will kill the innovative part of dietary supplements.
The other bad news is that because of the regulators and DSHEA there’s not much which companies or even physicians can say about supplements or herbs, in writing at least. The FTC and FDA police the supplement companies, and increasingly, the state medical boards are going after physicians who make “unsubstantiated” or “false and misleading” claims about supplements and their CAM treatments. Parts of the federal law could have been written by Kafka. It is a violation of federal law for the manufacturer/seller and it is a violation of state law for the physician to provide truthful information about the research supporting a supplement, herb or CAM modality unless the research meets the regulators’ threshold of adequate scientific substantiation, a standard which very few supplements or CAM modalities can meet.

I had a case where the FTC went after an herb seller for making the truthful claim that chaparral was used by Native Americans to treat cancer, because of the “implied claim” that it cures cancer. An “implied claim” can be anything the regulators want it to be, and in effect eliminates a supplement manufacturer’s ability to provide any scientific information about virtually all nutritional products.

Physicians must be circumspect and vigilant about what they say about their services and products because the sceptics and quack busters are filing false advertising complaints against CAM physicians based on their web site claims. Nasty stuff; no doctor-patient relationship required. Just a wacko zealot with a computer sitting a thousand miles away with too much time is all it takes to cause grief to a CAM practitioner. Medical boards love these complaints since it’s an easy and cheap way to get practitioners. No medical experts reviewing charts. Just a review of the web site.

The regulators’ position is that they are protecting the public from misinformation. But it seems that much of their efforts are truth inhibiting and are based on an outdated paternalistic view from the days when medical information only came from Marcus Welby, M.D. and Reader’s Digest. So for sure, the regulators are part of the problem, at least for the CAM part of health care.
Of course, the FDA is also in the process of shutting down the hundreds of clinics which offer autologous stem cell transplants to tens of thousands of patients, including post mastectomy patients doing breast reconstruction surgery. This is horrible, and for more details see my previous post, and other posts at www.rickjaffe.com

What’s the solution?

Simple to say, hard to achieve.

Better, more thoughtful and compassionate regulators, congress folk who aren’t controlled by pharma and the insurance carriers and who can focus on people rather than their narrow political agenda.
What’s it going to take to get that? Probably nothing short of a national public outcry. Could be that if enough baby boomers live into their 80’s the system could just break. Between health care and social security, it’s going to be very expensive for our kids when they reach their 50’s and 60’s.
Short to intermediate term prediction: that’s easy, continued stumbling along, with ever increasing costs, decreasing effectiveness, at least at the population and macro level. More people have to spend more money on health care and medical tourism continues to increase.

Or so I see the health care world.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

www.rickjaffe.com