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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First: withdraw the FDA’s four pending draft guidance documents which impose some of these crazy restrictions on peoples’ rights.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 The FDA is trying to change that with another of its “draft guidance documents” on what it calls “new dietary ingredients.”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 So Jim needs to withdraw the pending draft guidance document on “new dietary ingredients.”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.


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.

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

So in California come July 1st, there will no vaccine exemptions based on personal belief. However, there still will be a medical exemption, such as it is. My understanding is that pediatrics/public health recognizes some contraindications for specific vaccines, but very, very few (if any) contraindications for not giving a child any vaccine anytime.  I’ve heard that at least one prominent CAM healthcare attorney is advising his California CAM physician clients not to write medical exemption letters for parents who have a fear of or personal belief against vaccination. That might be prudent advice, and certainly no lawyer will get into trouble for giving it.  Obviously, this is all very bad news for anti-vaxers.

I will probably weigh-in on what I think are the medically supported justifications for the exemption another time and another forum.  For now, I’d like to talk to my anti-vaxer friends and colleagues, including those who for tactical/PR reasons characterize their views as in support of “informed consent” about the “dangers of vaccination”. You’re not going to like it, but to paraphrase Ziggy Martin in “Drive,” who’s gonna tell you when you’re too late and aren’t so great   In terms of where we are and the constitutional arguments being tossed around, well, you’re too late, wrong, and less lyrically, the imprecise hyperbolic language is not helping you focus on what may be realistically achievable.

First, the inaccurate hyperbole: California anti-vaxers claim that their kids and child care professionals are being forced by the government to be vaccinated.  Not true.  I’m from Texas, and in Texas we know what forced vaccination looks like. A couple years ago, the Texas legislature tried to force all young girls to get the HPV vaccine. The measure ultimately failed because of the public outcry against forced vaccination. California is not forcing anyone to get vaccinated. Rather, it imposes consequences (albeit draconian) for the unvaccinated; for kids, no public or private school; for adults, you can’t teach kids or be a child caregiver. That’s a big difference constitutionally and legally in general.  But in addition, by mis-framing the issue, you may be missing some realistic partial, medium-term solutions, as I’ll explain in a moment.

A lawsuit has been filed challenging the law eliminating the personal exemption. However, this lawsuit will be dismissed. Vaccination has already been upheld in California, twice before if I’m not mistaken, and the law is well within the government’s police power to protect the general health and welfare, such as it is thought to be (and I’ll get back to that also).

The new argument floating around is that the law violates anti-vaxers’ and their children’s state constitutional right to education. The courts will reject this argument. What most people don’t realize about constitutional rights is that they are not absolute, especially when they have to be weighed against competing rights and interests.  And that would apply to even the most fundamental rights.  Take the rights to life and liberty, which are as core as it gets. These rights don’t prevent the government from incarcerating or even executing criminals, and the rights don’t stop the government from drafting soldiers in times of war.

We all have First Amendment rights, but they don’t extend to shouting fire in a theater (unless of course there is a fire in the theater.) The most recent high visibility case involving weighing competing rights is that idiot Alabama clerk who refused to sign marriage licenses for gay couples because it supposedly interfered with her First Amendment rights of freedom of religion. Apart from the fact her position violated the basic constitutional premise of separation of church and state, whatever individual freedom of religion right she has does not allow her to violate the equal protection rights of gay couples. The court had no difficulty subordinating her individual religious beliefs/rights to the equal protection rights of the many.

(And to anticipate, the courts will hold that the law does not violate the equal protection rights of the anti-vaxers. To make a long story short, because this is a matter of public health and because anti-vaxers are not a federally “protected class” like race, gender, and now sexual preference, the courts will apply what’s called a rational relationship test in adjudging an equal protection claim against the law. This is the kiss-of-death to a constitutional challenge. Under a rational relationship test, the state only has to show or hypothesize that there is some possible, arguable, theoretical, potential rational basis to the law, and the courts bend-over backwards to find that a law has a rational basis.)

But getting back to the weighing of competing rights, it comes-up all the time in criminal cases. First Amendment freedom of press rights and the right of the public to know versus the due process rights of the accused. The privacy of a witness versus the sixth amendment’s confrontation clause right which requires that a defendant be given an opportunity to confront his/her accusers. In short, it is very common for judges to weigh competing rights and interests.

The California right to education is just of one of many rights and interests which the state grants and protects.  Sorry, but the reality is that an overwhelming majority of legislators and California parents believe that the current vaccination program is necessary to protect the health of children, and that allowing parents not to vaccinate their children because of personal beliefs and having unvaccinated kids in public and private schools makes their children less safe.   

There is no doubt in my mind that the new law is a valid exercise of that power, even though it affects the anti- vaxers’ education rights under the California constitution.  In the current and whatever future case there is on this issue, the courts will hold that the education rights of the anti-vaxers are subordinate to the public health and safety of the majority.   

The anti-vaxer comeback is that the majority is wrong and it’s all a conspiracy between government and big pharma; that vaccines have never been proven to be effective, don’t confer any public health benefit, or the benefit is outweighed by the risk and dangers of vaccines, that the diseases they are alleged to prevent are not as deadly as the harm vaccinations cause, and all the rest.

I confess to not knowing who is right; the majority or the anti-vaxers. But in terms of public policy and direct legal challenges, it doesn’t matter. That’s right, it doesn’t matter whether vaccination in the future is determined to be more dangerous than beneficial.  The only thing that matters right now in terms of a direct legal challenge is that there is a consensus of scientific opinion that vaccination programs are safe and highly effective, at least a consensus of conventional medicine, which, by the way, is in practicality, the same thing.

So what to do?

The first and obvious thing to do is try to change the consensus. That’s a hard process and change takes time, but it does happen, if the science supports the change. Thanks to people like Gary Taubes, David Perlmutter, Nina Teicholz, and others, the low fat, high carb diet world view is on the way out.  To that end, the new anti-vax documentary by Wakefield is a very good start. However, someone with mainstream credibility is going to have to take it to the next step. For reasons which I don’t think are justified and ironic to the extreme, Wakefield is viewed as the poster-boy for scientific fraud by the mainstream.   (The irony comes from the fact that the main accusation against him is undisclosed conflict of interest because his research was funded by an interested plaintiffs’ law firm. There is a whole literature on how Pharma has bought and paid for scientific research, and I’d bet that the biggest Wakefield medical detractors do the same thing he did, just on a much bigger scale.)

So more public broadcast and film attention is a must. But there is more, like the substance, technical part. Pretty much everything I’ve read coming from the anti-vaxers is overly emotional and not well-reasoned. It’s a big, complicated, multi-factored, nuanced problem. I think there needs to be sophisticated comprehensive analysis by people who have more than just an MD or PhD after their names. I’d like to see a panel of experts with actual experience in pediatrics, immunology, epidemiology, public health, biostatisticians, methodology, medical epistemology and heuristics get together and figure this out, do a meta-analysis what supports vaccination and put together a product which could stand-up to the mainstream and its talking heads. That kind of endeavor would take some serious funding, and you anti-vaxers are a fragmented community, so there would be financial challenges.  

Now let’s circle back to legal, mindful of why a direct constitutional challenge won’t work, and what to do about it.  As stated, the problem is the competing and superior interests of the majority’s rights. So how do we get around that? Take the majority out of the equation and maybe find a better constitutional vehicle. Right now, your only option is individual home school. I contend that anti-vaxers have a right to associate with other anti-vaxers and so do their kids, and that right to associate extends to education. Right now, the law essentially outlaws group home schooling; i.e., a private schools of similarly minded folks. I believe that law might be subject to a constitutional challenge under the first amendment freedom to associate. This would require a test case of a group, private, home school. Once it hits the radar screen, the state would likely order its closure. That would give the school and the parents standing.

Let’s assume by the time the case goes through discovery, the blue ribbon panel of actual experts with unassailable credentials finds that vaccination…. whatever it finds that’s supportive of the anti vaxer position (assuming that such is the conclusion). I think those opinions and experts have a place in the case. Now we have a trial the likes of which we haven’t seen since the Scopes monkey trial, and wouldn’t that be pretty nifty.

 Of course, that doesn’t get the anti-vaxer kids as a group back in regular schools. Instead, they are segregated.  Some anti-vaxers might think this solution makes them modern day lepers. Maybe it does, but vaccination decisions have consequences, eventually, and in California eventually is now.

Some committed anti-vaxers might find a doc willing to take the chance and write the medical exemption based on some medical pretext, but that’s a temporary, short term solution. Once the schools start seeing the same names show-up on these exemptions, they’ll notify the medical board which will take action and possibly quick action like summary suspension if there is a systematic effort to undermine public health (according to the board’s world view).   So there needs to be realistic and meaningful solutions which accommodate anti-vaxers’ beliefs, but recognize the state of consensus medical knowledge, as hard as that might be for some of my friends to swallow, at least until the world view changes. 

 I’m just saying.   


Richard Jaffe, Esq.