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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

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.

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

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

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

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

“I represent Dr. Bob Sears in the California Medical Board’s case against him for writing a medical exemption from vaccination.

We take the board’s accusation seriously. But this case is very clear: this child had two unusual and severe vaccine reactions and his situation warranted a medical exemption. To continue vaccination could have put the child at risk of further harm.

All physicians have an ethical duty to do no harm to a patient. This is no less true when a child suffers serious side effects from any medical intervention.

We anticipate this case will do much to further public education on the importance of recognizing severe vaccine reactions and providing informed consent for medical care. ”

Rick Jaffe

 

FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

Today was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology.

There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted the non-clinical trials clinics shut down. But at least there were representatives from some of these “unproven” clinics and interest groups who made some important points about the rights of patients and how the needs of patients are not being met by the current clinical trials model as it applies to stem cells. I heard a number like 250,000 people are not getting the stem cell treatments they need because of clogged research and regulatory hold-ups. There were numerous calls from very serious, highly credentialed people for the FDA loosen its death grip (my term) restricting access to these therapies, and the thrust of most of these presenters was that these draft guidance documents make thinks much worse.

 

The guidance document are really bad and deny access for many

And that was the big takeaway for me; that the guidelines were much, much worse than even I thought. I understood that the guidelines would make illegal the  21 CFR 1271.15 exempt same surgical procedures provided by many of the 600 plus unregulated stem cell clinics.

But what I didn’t understand until Monday’s hearing is that the FDA intends to radically change the rules so that, for example, the most popular form of breast reconstruction surgery post mastectomy (flap something) would become illegal under the new guidelines. Many other popular and widely successful procedures in other areas like orthopedics would be eliminated (outside of clinical trials). We’re not talking unboarded docs with no relevant experience who take a weekend course and starts shooting people up with stem cells. We’re talking about big-time breast reconstructive surgeons, highly regarded orthopedists and other highly skilled and specialized physicians who have successfully worked with tens of thousands of patients. If the FDA gets its way, according to these folks, Poof! These best practices transplant procedures are gone.

Fortunately, there were some very smart professionals making presentations, including an extremely knowledgeable law professor from Boston College, Mary Ann Chirba. She and several other people with regulatory expertise made the case that this whole guidance exercise was an illegitimate attempt to pass new rules without complying with the rulemaking requirements under federal law.  Works for me!

They and others honed in on the radical revisions to the two key preexisting terms/concepts used by the FDA to work its illegal magic: homologous use and more than minimal manipulation.

 

What’s a “main function?”

It was also pointed out that the guidance documents invented a new concept not existing in the statute or rule, namely the “main function” of a cell or HCT/P which is used as a way of forcing stem cell procedures from just registration under 362 into the IND/NDA drug approval path. It was argued persuasively by several regulatory experts that the creation of this new concept and its resulting transfer of many heretofore legal uses of stem cells into illegal new drug products turns the guidance documents into rulemaking without following federal administrative rulemaking procedures.

 

The FDA doesn’t understand what fat does

Another extremely cogent criticism made by a variety of people including Professor Chirba, other regulators and by both of the two top presenting stem cell researchers, Arnold Caplan and Keith March had to do with the FDA’s view of fat. According to the guidance documents, fat just has a structural function. But these presenters and especially March and Caplan showed that the FDA’s view was biologically unsound.  Fat has definite, known and extremely important non-structural uses, starting with energy storage and continuing to assistance in the healing function. The FDA’s unscientific, unsubstantiated restriction on fat allows it to find most of the important uses of fat and fat stem cells illegal as either non-homologous or as a more than minimally manipulated product. The FDA was absolutely and repeatedly pummeled on this point by my count, at least a half dozen very, smart experts.  I don’t see how even the FDA, which has a very particular agenda, is going to be able to hold on to its limitations/restrictions on fat/adipose tissue.

 

The Big Guys say regulations are holding back progress

The two big-time researchers (Caplan and March) also made the point that the regulatory climate is holding back research. Caplan said that some bone marrow pioneers had observed that if they had the regulatory environment back then as what exists today, bone marrow transplants might never have taken off. Ouch!

Interestingly, Peter Rubin, the plastic surgeon who last Thursday presented the inspiring cases of reconstruction work from fat transfers, presented again. This time he was more critical of the FDA and stated that many of the most successful reconstructive plastic surgery procedures, including breast reconstruction would become illegal under the draft guidance documents. He and many other excoriated the draft homologous document which classifies fat tissue for breast reconstruction as non-homologous because the primary purpose of the breast is lactation. Several of the female presenters had some polite but pointed words to the FDA about that.  Most of the day’s presenters agreed that regulation/regulatory expense was delaying bringing this technology to patients.

 

The 3 Billion Dollar Player Weighs-in

The biggest dollar player was the California Stem Cell Institute which has a 3 billion dollar budget and 12 research centers. Its director spoke, and his message was clear, concise and right on the money (and with 3 billion, it should be). The FDA has to loosen-up its grip and find an intermediate path between unregulated stem cell clinics and full-on clinical trials, because there is a desperate unsatisfied need and that need will be satisfied  – just as water flowing down a hill will find a path –  with or without the FDA’s help. He was very persuasive. Reminds me of an old TV ad: “When EF Hutton talks, people listen.”

Interestingly, no one picked up on what I though was the most egregious over reach in the draft guidelines, namely that the FDA guidelines silently incorporated or read the homologous and more than minimally manipulated requirements from 361 registration facilities (1270.10) into the exemption for same surgical procedure places (1271.15). Under the actual rule (1271.15) same day surgical procedures can do non-homologous and more than minimally manipulation. At least those two terms are not in that rule. Legal Method 101 instructs that if terms are in 1271.10 but not in 1271.15, then the 1271.10 terms and restrictions cannot be read into 1271.15 which is what the FDA is doing based on its interpretation of “‘such’ HCT/P’s.” (Maybe too technical.  I’ll have more to say about that another time.)

 

Maybe there is a viable lawsuit

Something else I realized as a result of a couple of the astute presentations. I said in the last post that you can’t sue on a guidance document because it’s just the agency’s “current thinking.” However, if a guidance document is really disguised rulemaking without meeting the rule changing requirements, then maybe there is a lawsuit. Many presenters were clear about the fact that these guidance documents are disguised rule changes, so I’m now more optimistic about the chances of a legal challenge.

 

People are Mad and are going to do something about it

And speaking of possible legal challenges, while all of the presenters were very professional, very cordial, ostensibly courteous and complimentary to the FDA panel members on the dais, I sensed that quite a few, many in fact, were pretty upset by what the FDA is trying to do with the draft guidance documents.

So here is my prediction/wish/what I hope to make happen.  There won’t be one lawsuit filed if the draft guidelines go into effect. There will many lawsuits. I don’t think these folks are going to go quietly. My sense is that the big players, sophisticated players, like Rubin, the fellow who started a society and has 5800 members, the guy with dozens of clinics, they have seen too many good results to give up their most effective tools. All these guys either run or are closely connected to prestigious professional societies and  I predict that many of them are going to try to stop these guidance documents, in court or in Congress.

I hope for everyone’s sake the FDA really listened today, because people are mad as hell and they’re not going to take it. They want better and quicker access to this new technology, and my hope is they will get it.

Rick Jaffe, Esq.

www.rickjaffe.com

 

 

 

More on The FDA’s Stem Cell Public “Workshop”: Stem Cell Clinical Trials aren’t the Answer for Everyone

More on The FDA’s Stem Cell Public “Workshop”: Stem Cell Clinical Trials aren’t the Answer for Everyone

Not unexpectedly, the organizing theme of the FDA’s Stem Cell workshop  was that patients should only be able to receive their own stem cells for non-homologous use in FDA approved clinical trials until FDA marketing approval (i.e., until a New Drug Application is granted for some non-homologous use).

I’ve been involved in legal/policy issues relating to clinical trials for a long time. I understand that clinical trials is the standard of care for patients when FDA approved treatments (on or off-label) are not available for whatever reason.  Still, I’m here to tell you that from the perspective of patients with life-threatening/incurable diseases, clinical trials aren’t always the best answer for them. Here is why I think so.

  1. The Purpose of Clinical Studies is to Test Drugs, not to cure patients

 

The fundamental and indeed the stated purpose of a clinical trial is to test the safety and efficacy of a therapeutic intervention, not to cure a specific patient of a specific medical condition.

One of the presenters mentioned some empirical data indicating that there is a disconnect between this purpose and the patients’ understanding of the meaning and purpose of clinical studies. My take-away from what he was saying was that many people mistakenly believe that the primary purpose of a clinical trial is to get the patient better. That misunderstanding is consistent with my experience over the course of several decades interacting with patients on clinical trials.

That the purpose of clinical trials is to test interventions, not to cure patients has specific practical consequences for patients which sometimes mean that patients do not get optimal care for the good of the study.

 

  1. Some Phase 1 study patients may not get enough of the drug/intervention

In phase 1 or toxicity studies, patients are specifically told that the purpose of their participation is to study a drug’s toxicity, not to test the efficacy of the drug, and while the investigators hope the patient will obtain some benefit, that is not the goal of the patient’s receiving the drug.

Early patients in some phase 1 studies receive relatively low doses of the drug, based on what the investigators believe to be the therapeutic dose. Doses often get escalated in later subjects in a phase 1 study. I believe this is common in toxicity studies. It’s kind of like you shouldn’t buy a car that was made right before a holiday weekend or on a Monday. Sometimes, it’s not ideal to be one of the first study participants in a phase 1 study, because you may not get what the investigators expect to be an therapeutic dose.

 

  1. How are you helped by a placebo?

Some studies are placebo controlled. Obviously there is no therapeutic intent for those patients. In cancer and other life threatening diseases, placebo controls are no longer employed, and in some placebo controlled studies, placebo recipients are sometimes offered the study drug later or much later.  Still, if a patient is in a placebo controlled study. There’s a 50% chance the patient won’t receive the study drug (at least initially).

 

  1. In Phase 3 studies, you still might not get the study drug

You still might only have a 33-50% chance of obtaining the study drug in a phase 3 trials,

Most phase 3 studies compare the study intervention with FDA approved standard of care therapies. Patients are randomly selected into the different arms of the study, arms being the different groups that receive the study drug or the standard of care therapy. Some studies involve more than one standard of care control arm/option. If there are two different control arms, there is only a 33% chance of receiving the study drug and a 66% chance of receiving a therapeutic option which probably hasn’t worked too well.

 

  1. Most drugs in clinical trial drugs are not ultimately approved

It is true as reported at the Workshop that less than 5% of therapies entering clinical trials obtain NDA approval, but 1. There could be reasons other than efficacy why that happens, 2. Some agents just don’t work on a high enough percentage of patients to justify NDA approval but they do work on some, and if you’re one of those lucky people, you’re a happy camper. So I don’t see the fact that there is a low approval rate of study drugs as strongly supporting the banning of stem cells outside of clinical trials just because of that fact.

 

  1. What happens after the clinical trial is over for you?

Therapeutic interventions in clinical trials are usually given over a relatively short period of time and often there is some surrogate endpoint or target which is less than a complete cure. In cancer it’s called a response.  Let’s say you get a response, or the target improvement in pulmonary function or whatever the parameter the drug is intending to influence. You’re a responder but not cured. Can you still get the Intervention if you need it?

In drug studies, there is a serious issue of continued access to study drugs after the termination of the study. Drug companies are not required to provide study drugs after the conclusion of the participant’s time in the study. There is a movement afoot to change that. I don’t know whether that is an issue in autologous stem cell clinical trials, but it could or would be if the guidance documents become final because it would then be illegal (supposedly) for the person to have access to his/her stem cells after the study.

 

  1. The Biggest Problem with Requiring Clinical Trials for All Autologous Stem Cell Transplants

Here is the big one. The underlying assumption of the FDA’s and the Workshop’s position –that autologous stem cell transplants should only be available in clinical trials – is that any patient who wants an autologous stem cell transplant can enter a clinical study. That seems unlikely, but that’s just my gut feeling. I’m not familiar enough with the stem cell clinical trials to know whether there is a large unmet demand, but in many diseases like cancer, a relatively small percentage of patients enroll or can enroll in clinical trials. In cancer, I think it’s something like 3 or 4%, and I’ve seen numbers like 40% of cancer patients would enter a clinical trial if they could. There are many reasons why some patients aren’t eligible for clinical trials, tied to a variety of factors. Some are too sick for the protocol entry criteria. Some may have had a prior disqualifying treatment (like a previous clinical trial). But my supposition is that there are many more patients out there why would participate in clinical trials involving stem cells,  but can’t for one reason or another.

Assume that to be the case.

What are the policy implications and practical consequences?

On a policy level, there is going to be an arguably significant number of patients who have no therapeutic options. Of course the immediate response to that is what good is an unproven, possibly dangerous option? While it’s a fair question, it’s a better question for foreign interventions than a therapy derived from the person’s own body, because as stated, there are fewer safety concerns.

And, respectfully, I think it’s a too facile response by academics not facing no treatment options for a life-threatening condition. Let these guys who are so quick to cut-off treatment options come back after they have walked in the shoes of these terminal patients and their families.

What about the practical effect of the FDA’s plan to make illegal same day autologous stem cell procedures?

That’s easy and no crystal ball is needed. The cat’s already out of the bag, the cow has left the barn. Patients want the ability to use their own stem cells to treat a wide variety of medical conditions. Former Governor Rick Perry and Bart Starr believe in the therapy, and I dare say tens or hundreds of thousands of others do, and would try it in a heartbeat in there was no other reasonable alternative, whether or not there is an existing clinical trial for which they could qualify. If you’re the Governor of Texas, you can have someone shoot you up, consequences be dammed. Others will have to find other options.

It seems obvious that the effect of the FDA’s intended action will be to drive more people into stem cell tourism and to places which have less substantive and facility regulations than in the U.S. That’s not necessarily a good thing.

I hear one highly-regarded stem cell transplanter might suggest an expansion of the facility registration requirements (contained in 21 CFR 1271.10) to same day transplant facilities (exempt from that requirement under 1271.15). It would certainly enhance the safety profile of these clinics by providing some federal regulatory oversight. It’s a good and creative idea, but it would require a revision to the current regulations.

I have to believe there are far less draconian solutions to the legitimate safety, training and false or unsubstantiated claims concerns which worry the FDA and the institutional players. But maybe it’s time for some creative thinking, rather than a knee-jerk reaction to eliminate what seems to be much needed treatment options for many patients.

To my presenter friends and colleagues, looking forward to hearing what you have to say, (via the web anyway).

Best,

Rick Jaffe, Esq.

www.rickjaffe.com

 

 

 

 

The most important question at the FDA Stem Workshop was the one not asked

The most important question at the FDA Stem Workshop was the one not asked

I didn’t hear the first couple of presentations in the FDA’s Stem Cell workshop. However, I did listen from mid-morning to Dr. Irv Weisman’s closing.  Yesterday’s post was my take on the highlights.  http://rickjaffeesq.com/2016/09/08/really-tough-day-stem-cell-advocates/

Upon reflection, what is disturbing to me is what I didn’t hear, namely a discussion or even a mention of what I think should have been the most important question in the autologous stem cell public policy debate: whether autologous stem cell transplants should be treated differently by the FDA from other types of therapeutic interventions because the material comes from the person’s own body.

This question is both very simple and quite complex. It is complex because it involves not only scientific issues, but also public policy, legal jurisdictional issues, and even federal constitutional issues. And yet, I heard nothing about these issues from the FDA’s blue ribbon panel of thought leaders despite the extremely impressive academic credentials, accomplishments and experience of the workshop participants.

The question is also complicated because it’s only by virtue of the FDA’s as yet untested, convoluted and counterintuitive interpretation of its rules that it has arguable jurisdiction over most of the stem cell clinics it intends to put out of business with its draft guidance documents. (We’ll get into the legal weeds of statutory interpretation of the applicable rules later.)

The entire workshop’s discussion including the ethics presentations was predicated on the tacit premise that autologous stem cell transplants are just like any other therapeutic intervention. As I think about it, that tacit assumption led to a bizarre disconnect in the presentations.

Almost all of the presenters excoriated the use of stem cells therapeutics outside of clinical trials. Yet the most upbeat and heartwarming presentation, to me, was from the plastic surgeon, Peter Rubin who brought forth examples of fat transplants given to wounded warriors and breast cancer survivors. I don’t recall him saying that every one of his transplant patients were treated in clinical trials. I believe that many people receive autologous stem cells or fat HCT/P transplants for homologous use without FDA approval, including for reconstructive work such as he is doing.

Using a person’s body as the transplant material avoids many of the safety issues which occur from a foreign source, whether the source be another person’s stem cells, a chemical or an extract from a plant (like digitalis or vincristine,). Most non-self-interventions likely have L/D (lethal dose) toxicity limits and attendant serious safety concerns in terms of dosage and side effects. Not so with autologous HCT/P transplants.

Sure, in any transplant there are contamination issues, but that applies to any autologous (or allogenic) HCT/P or blood product transplant and thus is not unique to “unproven” stem cell transplanters. So if many of the safety concerns of drug therapies aren’t applicable to autologous stem cell transplants, then it all comes down to efficacy, and whether and how much proof is necessary for a person to be able to use material that comes from that person’s body.

Although none of the luminaries raised the issue yesterday, I think it’s worth asking why aren’t people allowed to use a technology or service which isolates and removes a body part (HCT/P’s)   and reintroduces all or a part of it back into their own body without federal government oversight.  Same day autologous transplants are basically medical procedures.  Normally the FDA is not in the business of regulating medical procedures because it’s the “practice of medicine” which normally is within the jurisdiction of the state medical boards.

I don’t think it’s crazy to ask why should the federal govenrment be involved in medical procedures regulated by state law, and I’m not alone in thinking that autologous HCT/P transplants should have different rules, that the new drug rules do not or should not apply, and that these procedures should be policed by the state medical boards.

In fact, it was the FDA’s position as well, until the proliferation of these “unproven” stem cell clinics. (I discussed this in my first post on the guidance documents http://rickjaffeesq.com/2016/04/21/stemcells/)

I think the presenters yesterday forgot the actual reason the FDA is doing this whole public exercise: to sell its reinterpretation of its own rules. It’s not clear to me that the courts are going to go along with it. Here’s why.

 

It’s always a good idea to start with the law

 

The primary specific source of stem cell regulation is 21 CFR 1271.

In short, stem cells or more generally HCT/P’s (Human Cell and Tissue and Cellular and Tissue Based Products) are categorized or regulated in three ways:

  1. Solely under 1271 (basically tissue facility registration)
  2. As new drugs requiring full IND/NDA approval and registration, or
  3. Not regulated by the FDA

21 CFR 1271.10 sets out the requirement for registration but not new drug approval, and applies if, among other things, the product is not more than minimally manipulated and is for a homologous use.

Here is this rule:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.10

 

What the FDA can’t regulate (at least until now)

 

21 CFR 1271.15 provides that the FDA doesn’t regulate the use of HCT/P’s if the extraction and reinsertion of the material is done in the “same surgical procedure.” Here is the exact language:

“(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.”

Under the plain meaning of this rule, all, most, many or some of what the “unproven” stem cell transplanters are doing is or was perfectly legal.

I have personal knowledge about this because around ten years ago, I contacted the FDA several times and asked them about this precise rule, on behalf of a client who wanted to do same-day autologous transplants and sought a legal opinion from me. I called the FDA several times, because sometimes you get different answers from an agency. Each time, I was told that the FDA doesn’t have jurisdiction over same-day autologous cell transplants. And so I gave my opinion clearing the procedure.

But that was before the 600 plus “unproven” stem cell clinics popped-up with all their purported claims of miracle cures. I’ve talked about this in a previous post. http://rickjaffeesq.com/2016/04/21/stemcells/ .

The point is that implicit in the words of 1271.15 –  the reinterpretation of which is the reason we are going through this FDA public show – is that autologous stem cell transplants are different from medical therapeutics involving a substance not originating in a person’s own body, and are regulated differently.

In fact, same-day, autologous stem cell transplants were not regulated by the FDA, until its regulatory interpretive epiphany precipitated by the wild west stem cell business.  That yesterday’s workshop didn’t even address the FDA’s prior position or the public policy and possibly constitution underpinnings of the actual language of the rule which divests the FDA from the business of regulating same-day autologous transplants, is disappointing, but not necessarily surprising, considering that the purpose of the workshop appears to be providing expert cover and justification for the FDA to make the draft guidelines final.

So how does the FDA get away with asserting jurisdiction over procedures which seem beyond its purview?  The answer is in its Adipose Draft Guidance document.

Here is the draft guidance document:

http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm427795.htm

It’s a nifty trick: It interprets the phase “implants such HCT/P’s” as meaning that anything the unproven stem cell transplanters do beyond rinsing the material turns the HCT/P’s  into something other than the “such HCT/’s.” i.e. the HCT/P removed. Really!?

Here is the exact language where the magic happens:

“Limited handling such as rinsing and cleansing to  remove debris would allow the HCT/P from adipose tissue to retain the structural function, while other processing steps such as cell isolation, cell expansion, or enzymatic digestion generally would not.  Thus, if such other processing steps are performed that prevent the HCT/P from adipose tissue from remaining “such HCT/P,” the establishment manufacturing the HCT/P from adipose tissue would generally not be considered to meet the exception under 21 CFR 1271.15(b).”

It seems to me that the FDA’s interpretation is trying to backdoor the “more than minimal manipulation” idea contained in 1271.10 into the 1271.15 exemption from regulation and jurisdiction.  But the “more than minimal manipulation” language isn’t in 1270.15. It’s an agency add-in, years after the regulation was passed, and as stated, it was not the FDA’s original position.  The FDA’s textual jurisdictional reinterpretation seems far-fetched, inorganic and a somewhat desperate attempt to create jurisdiction over an activity which no one, including the FDA thought it had. Will it work?

In a fair fight; No, of course it wouldn’t work, but the FDA has the home court advantage on several fronts and these advantages might tip the scales.

First, in a court case, an administrative agency’s interpretation of its own regulations is given deference by the courts. I think the FDA’s position is attackable but you never know how far a court will bend over backwards to defer to an agency.

Second, you can’t sue the FDA on a draft or even a final guidance document because of non-intuitive and arcane non-finality rules of administrative law.

Ditto on warning letters. What that means practically is that if an “unproven” stem cell clinic keeps treating patients after receiving a warning letter, (which is basically an FDA cease and desist from engaging in illegal activity), the company can’t sue. It has to wait to see if the agency takes some kind of enforcement action. And here’s where it gets draconian.

Once there’s a warning letter, the doc or company is on notice that their actions are illegal, and specifically that they are violating what I call the FDA trifecta (introducing into interstate commerce an unapproved new drug, misbranding and adulteration).  Before the notice, or actual knowledge of the violation, we’re talking civil liability and/or at most a criminal misdemeanor, which means probation.

After the warning letter, if there are continuing “violations,” that’s an intentional criminal act which means felony and hard time.  So after a warning letter, the only safe play is to stop transplanting. (That’s what the Regenerative Science guys did after they got the warning letter. They sued, got thrown out of court, got sued by the FDA, fought the suit, but stopped doing stem cell transplants during the course of the litigation in case they lost, which they did.)

Bottom line is that docs and companies are disincentivized by the FDA and the system from challenging FDA action even if the action is or maybe outside of the FDA’s regulatory jurisdiction. But I’m hoping that if these guidelines go through and the FDA starts tossing out warning letters, some company is going to take a stand. I hope they do, and I’d like to be the one that smacks them down. Been there, done that, feels good (See chapters 2, 4 and 10 (on the first stem cell criminal investigation) in my book Galileo’s Lawyer).

So let’s get out of the legal weeds of administrative minutiea. It seems to me that the FDA is trying to exercise powers over same-day transplanters that it does not currently have. Maybe it should have that power, or maybe not. But whatever the ultimate policy answer should be, it needs to be discussed and studied. The luminaries yesterday didn’t do it, and I fear their myopic, one-sided view of the world and their ignoring of why autologous transplants are different and heretofore  beyond the purview of the FDA regulators needs to be discussed. Since it hasn’t been done in this workshop, the FDA needs to arrange a do-over with other more open minded, informed thought leaders.

There’s more to be said beyond these legal and policy points, but the hour is late and tomorrow is another day.

Rick Jaffe, Esq.

www.rickjaffe.com