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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

 

 

 

 

 

 

 

 

 

 

And So it Begins: First Accusation filed against a Vaccine Exemption Writing Doc

And So it Begins: First Accusation filed against a Vaccine Exemption Writing Doc

 

As I’ve told the mostly unwilling-to-listen Vaccine Concerned Community, the real battle, and the one which will have the most direct positive or negative impact on this community is the future actions by the California Medical and Osteopathic Boards against the docs who write unlimited medical exemptions for the kids of the vaccine concerned. Well the future is now.

A few days ago, the Medical Board filed an accusation accusing a well known and highly regarded CAM doctor of gross negligence and inadequate record keeping for writing blanket exemptions. The only good news is that the exemption was written a couple years ago, so it’s not a result of any “conspiracy” between public health officials and the boards stemming from SB 277, but not to worry (or to worry), those accusation are coming too, though probably not for several months at least, and following the administration investigative process.

here is a link to the accusation. It’s a template as to what will likely follow in other cases.

searsaccusation

 

More as things develop.

 

Rick Jaffe, Esq.

 

 

 

A Really Tough Day for Stem Cell Advocates

A Really Tough Day for Stem Cell Advocates

The FDA’s Stem Cell “Workshop” just ended, and if you’re a person who wants continued access to stem cell therapies outside of clinical trials (or a transplanter of “unproven stem cell therapy”), it was a very depressing day. It was way worse than I had feared in my post yesterday.  http://rickjaffeesq.com/2016/09/07/fda-stem-cell-meetings-close-hand-stakeholders-sides-worried-one-side-really-worried/

Sure the two ethicists said that it was wrong and unethical to provide unproven stem cell therapy except in FDA sanctioned clinical trials. But the real punch came from two of the last speakers who discussed some horror stories of the severe harm caused by “unregulated” and “unproven” stem cell transplanters.

Stem Cell Horror Stories

Unregulated Stem Cell Therapy Causes Cancer

A Harvard fellow who co-wrote the recent oft-quoted case study of the stroke patient who traveled the world doing stem cells only to develop a stem cell treatment induced CNS tumor throughout most of his spinal column gave the gory details of the case, including a painstakingly detailed complete histology of the tumor. The only good news (if it can even be called such) is that, if I understood correctly, he concluded that the stem cells causing the tumor were not the patient’s but were the result of an allogenic transplant the patient received.

Unregulated Stem Cell Therapy Causes Blindness

The other presenter, an eye doctor, talked about three patients who received stem cells for macular degenerative disease. The procedures were performed in a South Florida stem clinic by a nurse practitioner, not under the supervision of a licensed physician. In each of the three cases, there was severe harm, requiring emergency surgery with catastrophic negative results to the eye sight of the patients. Of course these might be unusual and exceptional cases, but they will no doubt be used by the FDA to demonstrate the need for exactly the draft guidance documents which it is proposing to stop these medical horror stories from reoccurring.

FDA Implored to Stop the Maiming by Snake Oil Stem Cell Transplanters

Other members of the panel including leaders of disease advocacy/research entities all decried “unproven stem cell therapy” and implored the FDA to put these unethical stem cell purveyors of false hope out of business.

One panel member pointed out that the problem was just not in the U.S. and that there were these kinds of clinics in many parts of the world and because of the internet, it was easy to find out about them. One clinician lamented that when prospective patients call him and he has to tell them that he has no treatment options for them, the patients get mad and argue with him.

 They should all be delicensed!

The day’s moderator was Irv Weisman, who is one of the biggest names in academic stem cell research. In his summary, he suggested that U.S. physicians who perform unregulated stem cell transplants abroad to skirt U.S. regulations be delicensed.

To listen to these guys, it would appear that stem cells given outside of clinical trials have never helped anyone. In one sense that might be true. If all you care about is scientific data from well-designed FDA clinical trials, then they are right.  Anecdotal evidence is not science, and all seemed to agree that all the non FDA trial data which is published is not worthy of consideration because of design flaws.

There is a Consensus

The absolute, universal consensus of today’s workshop was that stem cells should only be available in the U.S. in FDA approved clinical trials, until such trials prove that there is a safe and effective non homologous use for them. And anyone who provides “unproven stem cell therapy” to patients outside of clinical trials is a greedy, unethical charlatan who should lose their medical license…That’s a tough message, but no doubt a welcome one for the FDA since the elimination of non-homologous autologous stem cell therapy outside of clinical trials is the purpose and end result of the four draft guidance documents.

One thing I am clear on: the positions taken today by the people the FDA considers the thought leaders in the field really, really need to be addressed by the stakeholders on the other side next week, head on.

I’m going to give this a good think over the next day or two and maybe make some suggestions to my presenter friends.

Stay tuned.

Rick Jaffe, Esq.

 

FDA Stem Cell Meetings Close at Hand: Stakeholders on Both Sides are Worried, but One Side Should be Really Worried.

FDA Stem Cell Meetings Close at Hand: Stakeholders on Both Sides are Worried, but One Side Should be Really Worried.

Next Monday and Tuesday, September 12 and 13th is a widely acknowledged big day in the stem cell world; it’s the two day public hearing on the FDA’s four draft guidance documents.  (Here is a link to the FDA’s announcement. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm.  The entire event will be live broadcast via a link on this FDA page.

The draft guidances are a big deal because, as I’ve said before,  http://rickjaffeesq.com/2016/04/21/stemcells/,  they will make illegal almost all autologous cell transplants outside of FDA approved clinical trials, including the ever popular stem cell transplants from adipose tissue.   It’s been reported that there might be over 500 U.S. clinics physicians/clinics doing some form of autologous stem cell transplants for a wide variety of conditions, so you can bet that this new industry is watching closing and worrying. They have plenty to worry. Let’s start with what’s out there.

 

The lines are drawn 

For at least the past year, there has been what I would call an institutional attack on the clinical use of autologous stem cells, and by that I mean the use of autologous stem cells outside of FDA approved clinical trials. Thought leading papers, especially the New York Times have run articles against the stem cell clinics both here and abroad. The most recent article, in July, 2016, http://www.nytimes.com/2016/07/28/upshot/stem-cell-therapies-are-still-mostly-theory-yet-clinics-are-flourishing.html?_r=0  seemed more like a retweet or bump of an article by one of the main anti-stem cell talking heads, Paul Knoepfler, a PhD who works at U C Davis.  Just google “stem cells and false hope” and see what comes up. Knoepfler published an article which is the source of the now widely reported 500 or 600 plus clinics in the United States performing autologous stem cell transplants outside of clinical trials.  But other news media outlets have also taken up the call to ban the clinical use of stem cells until they go through the complete drug approval process. http://www.webmd.com/a-to-z-guides/features/stem-cell-treatments-false-hope-warning-signs

Apart and together with the media outcry are ethicists and public policy position papers decrying the unregulated stem cell business.  (Here is one from the Texas Baker Institute http://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-015-0069-x ).

The knock on the clinical stem cell business is that it is unproven and untested and hence might be dangerous or ineffective and shouldn’t be given outside of clinical trials until proven safe and effective. This is same criticism leveled against the “right to try” state and federal legislative initiatives. (See my post on the federal right to try:: http://rickjaffeesq.com/2016/05/24/federal-right-try-hopefully-not/ ‎

 

Maybe the Really Important Meeting Is Not What We Think It Is

What hasn’t received as much attention from the stakeholders is the stem cell workshop which will take place tomorrow. Thursday September 8th which I think will be as or more important.  http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm518541.htm.

This workshop will be presentations from the scientific/policy/ethics luminaries and thought leaders. From what I can tell, none of them are directly involved in the clinical use of stem cells beyond what is in accordance with FDA approved use. My guess is that all of the speakers are against the clinical use of stem cells except in clinical trials, and until they pass through the full approval process.

The two lectures  I’m most interested in hearing about are : Jonathan Kimmelman, PhD, Ethics, Evidence, and Regulatory Approval for Cell-Based Interventions and  Massimo Dominici, MD, Dissecting Unproven Cellular Therapies: The International Society for Cellular Therapy (ISCT) Position.

 

My guess is that, consistent with the talking heads in the past media articles, their conclusion will be that it’s unethical and dangerous to allow the unregulated use of autologous stem cell transplants outside of clinical trials and before FDA approval.

 

Why this is important is because I think the FDA is going to cite the workshop position papers as a reason to make the draft guidance documents final without substantial changes. And these speeches will justify the FDA’s position to make adipose stem cell transplants illegal outside of clinical trials.

 

Why do I think that’s going to happen? Well first the obvious. That’s the import of the draft guidelines and the FDA has had a few years to think about the problem. The problem is that the originally thought-to-be tiny regulatory loophole in 21 CFR 1271.15 (which says that autologous same day procedure transplants aren’t regulated by the FDA) has mushroomed into an entire industry with all kinds of wild west claims and with virtually no barriers to entry stopping any doc from cashing in. That has the FDA very, very nervous.

 

But beyond the obvious and the din of media and institutional based criticism of the field, there is a broader FDA context, which I am aware of because I do a lot of stuff beyond stem cells.

Let’s look at two other big things the FDA is working on right now.

 

FDA tries to tame the Wild West of Dietary Supplements

 

A month ago, the FDA released its long awaited revised draft guidance on dietary supplement NDIs (New Drug Ingredients).  The guidance document is highly restrictive and, if enacted, will severely limit access to dietary supplements.  (See my recent blog on this http://rickjaffeesq.com/2016/08/16/maybe-glass-still-less-half-full-water-might-start-leaking/

The FDA’s concerns about supplements is basically the same as its concerns with stem cells, namely unsubstantiated claims for products which haven’t been adequately tested for safety and efficacy.  The proposed solution: make supplements with “new dietary ingredients” (broadly defined) subject to rigorous testing. Sound familiar?

 

Pharmacy Compounders Get Unwanted Federal Attention

 

Second, in 2012, a compounding pharmacy literally killed over 60 people from a contaminated batch of a compounded product. Up until that time, compounders were largely unregulated by the FDA and were overseen by the state pharmacy boards. But many compounders were blurring the lines between a compounded drug for patients and drug manufacturing.

 

As a result of the outcry over these deaths, there were congressional hearing, new legislation, new regulations, and proposed draft guidances. Bottom line. Increased regulation and scrutiny of these pharmacies by the FDA. This example is different from the NDI supplement and stem cell guidance documents in that there was actual severe harm, but it still shows that if the FDA believes there is an abuse and a regulatory vacuum, they will regulate.

 

Of course, autologous stem cells are different from supplements or compounded drugs for the obvious reason that the source is the person’s own body, which presumably eliminates contamination from the source issues. But it doesn’t address the claims issue which I think is at the heart of the FDA’s and institutional opposition to the clinical use of stem cells. And admittedly, there are probably still some safety issues, and most likely some training issues, because anyone with a valid medical license can become a stem cell transplanter, and it’s a lot easier logistically than doing brain surgery which requires a real surgical center. In fact, stem cell transplants are commonly done in regular medical offices. Some might view that as not a good thing.

 

Perhaps interestingly, in the 1997 FDA modernization act, there were advertising restrictions placed on compounders as a compromise solution, but those restrictions were ruled unconstitutional by the U.S. Supreme Court.  (Western Stateshttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM155167.pdf.  Because of Western States, my guess is that the FDA is not going to offer a compromise by limiting stem cell advertising because of its past negative experience.

 

For all these reasons, I think the FDA’s mind in pretty much made up. Tomorrow’s stem cell workshop will provide a nice piece of cover, and I expect it to be relied upon by the FDA when the final guidance documents come out.

 

The FDA has to give stakeholders the right to comment, but there’s no law that says the FDA has to really listen.

 

Circling back to the dietary supplement NDI draft guidance document, the original one came out many years ago, but due to the enormous public outcry complaining about them, the original draft guidance was rescinded. That bought the field many years of a guidance free existence. Sometimes that’s about as good as you can get, and I think with the stem cell draft guidance documents, that’s as good a strategy as any I’ve heard.

 

 

Rick Jaffe, Esq.

 

Shocker! SB 277 Preliminary Injunction Motion Denied

Shocker! SB 277 Preliminary Injunction Motion Denied

In an 18 page decision, Judge Sabraw denied the vaccine concerned plaintiffs’ motion for a preliminary injunction. Big surprise! He also set out the grounds why he will dismiss the case, after the defendants file their motion to dismiss, which I would guess would be in the next week or two.

Unfortunately, the law has been clear for a hundred years, up to an including last year’s New York case. States are not required to have a personal belief exemption or a religious exemption to vaccines because the rights of the few are subservient to the the health of the many. That’s just established law. Until the vaccine concerned present a case to a court that 1. herd immunity is wrong and 2. vaccination damage to kids is horrible, understated or underreported and that the programs are massively unsafe and do not prevent disease, no judge is going to overturn a state’s decision to remove PBE’s or religious exemptions.  The injunction motion did not have any real record or evidence to support such a finding, so it was doomed or dead on arrival

Maybe the vaccine concerned will never accept the decision, the appeal decision or the law, but it doesn’t matter. This lawsuit is going to be dismissed, before the end of the year, the appeal will be denied, just like in Phillips v. New York (which is pretty similiar to this case and suffers from the same legal and record defects) and the  Supreme Court will not grant certiorari, just like in Phillips.

Deal with it,  and maybe it’s time for a Plan B.

Here is the Judge’s decision. He’s right on the money, based on the law, and the record before him.

denialinjunction

 

Rick jaffe

 

THE “RIGHT TO ASSOCIATE” STOPS ALL INVESTIGATIONS AND PROSECUTIONS!

THE “RIGHT TO ASSOCIATE” STOPS ALL INVESTIGATIONS AND PROSECUTIONS!

(I’m just kidding, but the proponents selling this stuff aren’t)

In the last 30 years, I have heard all manner of crazy legal ideas propounded by nonlawyer “legal experts” which supposedly immunize or protect licensed and/or unlicensed health care practitioners from government oversight, investigations and prosecutions. Most of the ideas are based on the one of the first 10 constitutional amendments (12, if you’re Donald Trump).

For example, take the Ninth Amendment, which provides that “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.”

This is the so-called unenumerated rights amendment. Some lay legal experts took the position that doctors and others had an un-enumerated right to give or receive any treatment they want regardless of the wishes/laws of the federal or state government. It supposedly gave people all kinds of other rights and abilities not to comply with federal or state law. I recall one of the leading “legal experts” on this was a guy named Conrad LeBeau. If I’m not mistaken, he was prosecuted for some kind of criminal offense, raised the argument in his defense, and to no surprise to anyone other than him and his co-believers, he was convicted and went to prison.

I recall that people also tried to get to the same place with the 10th Amendment, which provides that “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.”

That hasn’t worked out either, in the sense that there are no published cases which have disallowed a federal or state agency from investigating, suing or prosecuting a physician because the physician’s 10th Amendment rights.

But by far, the most popular constitutional panacea which supposedly completely immunizes licensed practitioners from federal and state oversight is based on the First Amendment’s so-called right to associate.

First things first, and a news flash for many:  The text of the First Amendment does not include any language concerning the right to “associate” or to form an “association.” Rather, the right to associate was created by the Supreme Court. For the legally interested, in NAACP v. Alabama, 357 U.S.449 (1958), the Supreme Court held that freedom of association is an essential part of the First Amendment’s freedom of speech provision because effective speech often requires that people join or associate with others. The free speech written right, in conjunction with the written right to “assemble” and petition the government, (also part of the First Amendment), constitute the basis of the Supreme Court’s creation of the implicit judge created constitutional right to associate.

There is a body of case law defining and explaining the right to associate, but it deals with the circumstances under which organizations can exclude people who want to join a group, or whether organizations or businesses can decline to provide services to specific groups of people. For example, the Jaycees was a business related group for men. The Supreme Court held that their members’ right to associate did not allow them to exclude women, because the exclusion was not based on the expressive aspect of the excluded group. On the other hand, a private organization, say an LGBT group, can exclude homophobes from membership because they might adversely effect the group’s ability to express its LGBT point of view.

The other big issue in the right to associate jurisprudence is whether private groups can discriminate against certain people by not provide services to them (i.e. racial minorities or gays). Short answer: They can’t.

I’ve told you the two big jurisprudential/litigation areas involving the right to associate. What doesn’t exist are cases which hold that the right to associate allows health care professionals to engage in illegal or unprofessional activity, and more importantly, that the right to associate somehow divests the federal or state government from asserting jurisdiction over people who may be engaged in illegal activity, or actions which violate some state law or professional standards (like the standard of care).

In short, I have yet to see a reported case or decision on an online case service such as Lexis, West Law or Pacer which held – meaning that the controlling principle of the case – was that a state or federal government did not have the right to investigate or prosecute a person for health care services because the service offerer and recipient were members of an association.

Every time I talk about this non-existent panacea right to associate in public, I ask the audience that if they know of a reported case, to send me the case citation. I have yet to receive a single case citation. The only time I’ve ever seen the issue addressed in a court case was in a Washington state FDA prosecution where the defendant himself raised the issue in a motion to dismiss. His lawyer apparently wouldn’t file the motion, so the defendant filed the motion himself. The judge refused to address the motion because the defendant was represented by counsel.

Circling back to the right to associate, as I said, it’s not in the text of the First Amendment, it’s a judicial creation found to be a necessary component of free speech (and possibly the right to assemble and petition the government). Since the judges created it, the parameters, boundaries or limits of the right are only what the judges say they are.  And the judges (and in particular the Supreme Court) haven’t created any kind of generalized right to associate, let alone a generalized right which divests the government from exercising its police powers. I am certain that the Supreme Court never will create such a right because it would interfere with the government’s police powers. It’s a fool’s bet to bet against the government’s ability to address, rectify or punish conduct which it deems illegal or against public health. (My message to the vaccine concerned as well, per previous posts).

So what about the “legal experts” who are advocating (read, selling) right to associate kits and $2,000 seminars? From what I can tell, when they do cite cases, they cite the non-binding language (called “dicta”) from unrelated cases. One of the first things lawyers learn in law school is to separate the holding of the case, which is the principle of law the case stands for, from the dicta which is the personal opinions or other non-essential parts of the opinion which are not considered binding or precedential. Another thing these folks talk about is the letters they’ve written on behalf of practitioners which supposedly stopped an investigation. Recently, I’ve heard about confidential settlements which they can’t talk about.

Hint: for licensed practitioners, I’ve never heard of a confidential settlement with a medical board. I don’t think it exists because it’s against public policy. A board’s job is to protect the public, and between that and open records, I don’t think a confidential settlement with a state medical board is a thing.

This is all nice and possibly even interesting, but does any of it have any practical impact on practitioners? I think so. Some of you folks have bought into the right to associate (non) thing (literally and figuratively), and make your patients join your “medical association.” That’s fine and harmless.

But suppose you get a board subpoena for medical records of one of your patient/members. You have two choices. Give over the records or use the “right to associate” argument and decline to produce the records. That’s a decision with big consequences.

Failure to provide medical records pursuant to a lawful, self-executing subpoena is a prosecutable violation of the medical practice act. The result of your refusal will probably be a court order to compel you to turn over the records. (And the judge will issue the court order notwithstanding your right to associate argument for the reasons stated above).

What do you do then? If you don’t comply with the court order, next thing is a motion for contempt. Judges don’t like putting Docs in jail, so you’ll get a short reprieve, probably, but in the end, there’s a good chance that if you don’t comply, you could get a few free meals courtesy of the state.

Think I’m kidding or exaggerating? I haven’t personally seen this happen to  a Doc, but a long time ago, in a faraway place (Manhattan), a lawyer refused to turn over to me a client’s case files. I got a court order compelling him to do so. He still refused, so I filed a motion for contempt. The judge gave him another chance and he still refused, so the judge signed the contempt order.

I found out when the lawyer had a late in-the-day court appearance and had him arrested on the steps of the Manhattan federal courthouse. Because of the late hour, the judges were already gone, so the lawyer spent the night in jail (the Tombs, as I recall). They brought him to the judge the next afternoon (it took some extra time because I apparently misfiled the paperwork).  He didn’t look or smell too good. I got the files the next day.  Eventually, in large part because of what he did in that case and another case where he pulled the same trick, he was disbarred. Maybe I caused that too, but it was a long time ago and who remembers.

I tell you this for a couple reasons; to show that bad things can happen and escalate if you don’t follow lawful orders. The lawyer I went after wasn’t a bad lawyer; he just made some poor choices (and his actions pissed me off). Why is that relevant?

Flash to CAM Docs: the members of the state medical boards are politically connected conventional doctors. By and large, these folks think that CAM is worthless if not harmful to patients, and all you CAM Docs are just in it for the money or stupid, or both. (Maybe a slight exaggeration, but that’s my perspective as a result of appearing at most of the state medical boards over a few decades).  The idea that a CAM practitioner would do something which is a slam dunk violation of the medical practice act, and confirms board members’ view of your evilness or stupidity (or both) seems like a poor choice.

Two final things:

We had a hearing in the other case in which the lawyer refused to turn over records. The federal judge was a white haired southern gentleman. The first words out of his mouth were: “Mr. Sheridan, you remind me of a slab of meat rolling towards the buzz saw, and for the life of me, I can’t understand why you’re running towards that saw.”

And finally this: A Texas fellow who is one of the main “legal experts” selling the right to associate and other do-illegal-stuff-and-get-away-with-it miracle kits hit the fed’s radar screen. He was arrested for securities violations. I guess he argued that because his customers were members of his association and maybe some of the other stuff he peddled, the feds couldn’t touch him. The judge apparently disagreed. The jury convicted him and he went to prison.  The good news is that he’s out now and back selling these kits, insisting that they work just fine.

 

Rick Jaffe