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My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

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Although many, many of my posts lately have been about the vaccine issue, I view myself as a health care attorney who focuses on novel and unconventional treatments and technologies. The legal contexts may be different, i.e., medical board work, civil litigation, or federal criminal cases (FDA and health care insurance issues) but the overarching commonality is constant, unconventional health care and ensuring the broadest possible access to it.

In my FDA-related work, that basically pits me against the government and I advocate and litigate for greater access to unapproved treatments. (And that puts me at odds with many in vaccine concerned community on an issue like access to EUA vaccines, which I support one hundred percent, so long as it is not compulsory.) I think people should be allowed to get any treatment or medical intervention they can get their hands on regardless of the status, as long as there is proper informed consent (which raises issues as well, but I’ll leave that for another time).

One of the areas I work in is the stem cell field. I am following a bench trial on the FDA’s attempt to obtain an injunction against a clinic’s use of autologous (the person’s own) stem cells. I am listening to it on my iPad kind of like background music, and as I was writing this post on VAER’s I heard in the distance an FDA MD regulator being cross-examined on the fact that there were very few reported side effects from stem cell treatments.

Guess what the FDA regulator said in response? She said that everyone knows side effects of drugs are vastly underreported and thus side effects rates can’t be relied upon. It caused a momentary confusion in me and I thought I was having an auditory hallucination since I had spent so much time thinking about the underreporting of vaccine side effects. It reminded me of a cross-over episode in TV world (where the characters in one show appear in character in another show). Nothing more than life’s little strange ironies.

But on to the main topic. There is a great deal of media and social media attention about VAERS (Vaccine Adverse Event Reporting System), and my prior post on the Harvard Pilgrim study has engendered some interesting comments. I think it might be helpful to actually relate the basics about VAERS which might help avoid some confusion, for those who have not actually looked at the issue directly.

VAERS has its own website and it contains more than just the numbers of deaths and injuries from the COVID vaccines. It explains what it is and does, and at least by implication, what it does not do.

You can look it over yourself. Here is the link. https://vaers.hhs.gov/about.html

VAERS was created in 1990 to monitor adverse events from vaccines. (I am pretty sure as part of the vaccine compensation act).

You all know that it created a reporting system for vaccine adverse events/effects

So what’s an adverse event?

Here is as good a definition as any (not taken from the VAERS web site).

“Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.” [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.]

As everyone knows, (but few acknowledge when discussing the dangers of vaccines) an adverse event report filed with VAERS is a just report of an adverse event occurring after a vaccine injection. No single or group of VAERS report about a vaccine establishes a causal connection. It is not the purpose of VAERS to make, investigate or establish the scientific connection/causation or lack thereof between the administration of the vaccine and an adverse event. The VAERS database is just the database of all adverse events which meet the VAERS criteria, where each filing was by some person or entity, presumably with knowledge about something bad that happened to a person within some specified time period after receiving a vaccine.

More specific on the purpose of VAERS (from the website):

“(VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.”

What are the objectives of VAERS?

Here they are from the website:

“The primary objectives of VAERS are to:

Detect new, unusual, or rare vaccine adverse events;
Monitor increases in known adverse events;
Identify potential patient risk factors for particular types of adverse events;
Assess the safety of newly licensed vaccines;
Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
Recognize persistent safe-use problems and administration errors;
Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.”

And of course, it is a self-reporting and uncurated system, meaning anyone can report an AE temporally associated with the vaccine, but presumably, only people with direct knowledge of the untoward event should do the reporting (unless it is the person’s job to make that report, I presume).

So what is considered the temporal relationship and what kind of things can be reported?

Well, that’s easy, the website has a downloadable pdf of the reportable events and how long after the vaccine shot, an AE should be reported (i.e. the maximum time limit after the shot and the time limit is shorter than you would think).
Here is the PDF: VAERS_Table_of_Reportable_Events_Following_Vaccination(2)

As you can see, the event has to have occurred anywhere between 7 and 42 days after the shot, depending on the vaccine and the event. e.g., 7 days max for the DTaP and others, up to 42 days after the shot for arthritis associated with the rubella shot.
In reviewing the chart, it seems to me that the only localized event reportable is shoulder injury from the shots.

For grins, I looked over the screen for reporting an AE because I wanted to see if anyone could file an AE about anyone. I wanted to see if I could file one for say Hank Aaron. FYI: here is the screen. https://vaers.hhs.gov/esub/index.jsp. I suppose you could, but you’d have to make up a lot of his information. And at the bottom, there is a notice that providing false information is a crime.
But basically, you have to give the date and type of vaccine and when the event started and other such information, and presumably, there is some kind of internal edit that wouldn’t process an entry if it is outside of the temporal association limits.

So the bottom line is that a VAERS report is just a description of some bad thing (including death) that happened to a person after receiving a vaccine within a certain period of time after receiving the shot, and that time or window depends on which shot and the kind of every, but the outside window or temporal connection is anywhere between 7 and 42 days.

That much you can glean from the VAERS website. What happens with the information once it gets posted?

And there we have the limits of my knowledge and investigations. Presumably, the CDC and perhaps the FDA look at all these reports. There were only six reported blood clotting problems with the J&J vaccine but that was enough for the FDA to put the vaccine on clinical hold for a week or so. Some criticized the action as being unnecessarily cautious. I assume they quickly picked up on the blood clot issue because of a similar issue with the Asta Zenaca vaccine in Europe and the common ingredient/method used both.

Are the several thousand reported deaths reported to VAERS being investigated? I don’t know, but I hope so.

Another Key Term: Background rate

Another important term in all this is background rate, meaning the rate that a percentage of the population will experience that particular event, say a blood clotting problem. There is a known number for that, and from what I read, the authorities determined that the 6 cases were within the background rate. A background rate above the reported adverse event rate doesn’t necessarily disprove that the AE was caused by the vaccine, but I think it is fair to say that public health authorities are looking for AE’s significantly greater than the background rate, in part because resources are limited. It seems to me that death in terms of the background rate is particularly tricky, obviously because it is an event that everyone eventually experiences and you would expect the background rate of death to have a straight relationship to age.

That brings up another point; early on, a disproportionate number of older people were dying of COVID than younger people. There was a lot of speculation as to why, and many in the vaccine community rejected these statistics basically claiming that the old were dying of co-morbidities (or had co-morbidities) so they don’t count as COVID deaths. (I think that is an erroneous argument). In terms of background rate, I guess the argument is that old people die a lot more than younger people; ie the background rate is higher because of age and more of them have co-morbidities. But I also hear that the old are dying at a much lower rate now, and the big difference is that the older got the vaccine first, and the purpose of the vaccine/the only benefit found/ was to stop people from dying of COVID, (and not necessarily prevent infection or transmission). I guess my saying that again puts me at odds with most of the vaccine concerned.

Now some hard truths and maybe a practical strategic suggestion that could help

The core mantra of the public health establishment is that vaccines are safe and effective and side effects are rare and of course, this is being repeated in the COVID vaccination world. But it is now a lot harder to sell that message during a pandemic where the world’s attention is on the disease and the focus has shifted to vaccines. AE’s and deaths are being reported in social media which is impacting decision-making both in individuals and in the public health policy context. The hard truth is that even if all or a significant percentage of the 3-5k VAERS reported deaths were caused by the vaccines, that would be one hundred times less than the reported number of deaths and orders of magnitude less than the death rate from the disease. I know that many of you don’t accept the COVID death numbers or the death rate, but that really doesn’t matter because those are the numbers upon which public health decisions will be made, and specifically, the decision about full approval/biological licensure of the COVID vaccine.

All medical interventions have risk, and some have a risk of death (I recall when bone marrow and stem cell transplants were done for advanced cancer, it carried something like a 2-4 percent fatality rate from the procedure). The COVID vaccines are going to be approved/biologically licensed despite the relatively small percentage of serious adverse events and even deaths, and I have no problem with that, given my background and many many years of fighting for access to treatment and allowing people to make up their own minds about their health care options. Of course, that makes the key issue mandates upon full biological licensure. And as you all know or fear, mandates are coming. Institutions have already told you all that. And of course, there will be many challenges to these mandates, but odds are they will fail under the expected process. The solution may be to change the expected process.

While drugs and vaccines are approved even if there is a measurable risk of mortality, the FDA has special conditions and warnings, the most severe of which is a black box warning on the labeling. If a very small but measurable adverse event is the possibility of death, that might warrant a black box or other lesser warning. I would propose as a strategic goal a nationwide effort to raise the issue of a black box warning on all COVID vaccines, after a public and thorough review of the VAERS report of deaths.

In order to convince the public of the safety of vaccines, each step of this process would have to be transparent and subject to public comment. You know what they say about light being the best disinfectant, and let the chips fall where they may.

This is something that many groups could adopt. It could become a national thing. It is likely to be something that could enlarge the base. It involves tactics that are relatively known and simple, i.e., contacting your federal legislators and maybe some direct campaigning of the FDA. If you think this has any merit, share this post or at least this last part, and let’s see if it gets any traction.

Having a black box or another type of labeled warning of death from the COVID vaccines could do all kinds of interesting things to the COVID mandatory vaccine debate, and even the public discussion of this technical regulatory issue would be enlightening and worthwhile (and hint, that would be an understatement).

#covidvaccineblackboxwarning

Rick Jaffe, Esq.

Can My Employer Make Me Wear a Mask at Work, and What if I have a Medical Condition Which Makes Wearing a Mask Dangerous to Me?

Can My Employer Make Me Wear a Mask at Work, and What if I have a Medical Condition Which Makes Wearing a Mask Dangerous to Me?

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This is a popular question these days, so let me lay out the law as I understand it.

Actually, the basic law is pretty straightforward. Mostly what I will do is quote from the federal government’s EEOC (Equal Employment Opportunity Commission) web site which deals with employment discrimination issues. And yes, the ADA (Americans with Disabilities Act) does come into play in the analysis.

Here is the URL for the EEOC document I am quoting from:
https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act. It contains much useful information about employment issues and has been updated to reflect the present pandemic.

Here is the answer in short:

“• 12. During a pandemic, may an employer require its employees to wear personal protective equipment (e.g., face masks, gloves, or gowns) designed to reduce the transmission of pandemic infection?
Yes. An employer may require employees to wear personal protective equipment during a pandemic. However, where an employee with a disability needs a related reasonable accommodation under the ADA (e.g., non-latex gloves, or gowns designed for individuals who use wheelchairs), the employer should provide these, absent undue hardship.

• C. REASONABLE ACCOMMODATION
A “reasonable accommodation” is a change in the work environment that allows an individual with a disability to have an equal opportunity to apply for a job, perform a job’s essential functions, or enjoy equal benefits and privileges of employment.(23)(footnotes ommitted)

An accommodation poses an “undue hardship” if it results in significant difficulty or expense for the employer, taking into account the nature and cost of the accommodation, the resources available to the employer, and the operation of the employer’s business.(24) If a particular accommodation would result in an undue hardship, an employer is not required to provide it but still must consider other accommodations that do not pose an undue hardship.(25)
Generally, the ADA requires employers to provide reasonable accommodations for known limitations of applicants and employees with disabilities.(26)”

Does that mean I don’t have to wear a mask if I can show it could/would be harmful to my health?

Not really, because a “reasonable accommodation” would more likely be an unpaid leave or working from home. Perhaps in the right setting, working in complete isolation in an office might be a public health safe reasonable accommodation, but even if so, I think it would likely create an “undue hardship” for the employer, for a variety of reasons, including the morale/fear/resentment of the other workers. But still, I suppose it might still be possible depending on the kind of work you do and the specifics of the work environment.

Be advised that if you seek to obtain a “reasonable accommodation,” it will involve a back and forth process with your employer in which among other things, you will have to prove your disability under the ADA, as well as provide other pertinent information. (And no, you can’t both claim a medical disability/request a reasonable accommodation and assert HIPAA protection for the health information which is the basis of the accommodation.)

But why couldn’t I just not wear a mask in the office?

In a pandemic, not wearing the required PPE would be (and is) considered a “direct threat” which is defined as “a significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”(20) If an individual with a disability poses a direct threat despite reasonable accommodation, he or she is not protected by the nondiscrimination provisions of the ADA.”
Meaning they don’t have to let you work without a mask despite your medical inability to wear one.

So, while I suppose some employers might go for it, in these time of the politicalization of mask wearing, I think that if an employer has an employee mask requirement, most likely it will not make an exception to allow a person (or a small group of the medically unable) not to wear one and work in an office where everyone else is masked.

What About my Constitutional right not to wear a mask?

Sorry, there is no such animal, not now, nor will there ever be IMO. Your constitutional rights stop when you endanger others. Governments have to right to take measure to protect the public under its police powers.

Events of yesterday and today (July 29 and 30) back this up. That idiot Texas Congressman who was flaunting his refusal to wear a mask in Congress and in recent televised committee hearings tested positive. Fellow congressfolk are outraged, which has prompted the Speaker to impose a mask order. We will see if the Texas Congressman or any other challenges it in Court, but I sort of doubt it will be challenged. If Congress can order its members to wear a mask, what chance do you think you would have in convincing a court that the Constitution gives you a right not to wear one? And the irony of course is that I think most court houses have mask requirements, so you would probably be making the argument to a judge and her staff who are all wearing a mask (or hearing the case via zoom). Good luck with that!

But I don’t think masks stop the spread of the virus and I have read on the internet that there are other doctors who agree with me, and isn’t that what those doctors who stood in front of the Supreme Court said?

Yes, they did say it, and other physicians have also challenged whether mask wearing really helps, but the majority and accepted opinion is that masks helps. In this game, the majority opinion prevails, and so the courts will find.

But still, why can’t I go to court and ask it allow me to not to wear a mask at my job because of my medical condition?

Well, you can file a lawsuit about just about anything, but the law is pretty clear under the ADA, and you’d lose (even assuming you had a ADA recognized disability. In fairness, I don’t think there are any appellate court decisions yet on mask wearing and the ADA. I am sure there will be (or maybe ever are already) some cases, but I feel confident that no court will find that an employee has a constitutional right not to wear a mask if an employer requires marks during this pandemic.

So, to ask the basic question in another way:

If I have a doctor’s letter saying that wearing a mask is dangerous for me, would that force my employer to allow me to work without a mask?

I think the answer is no.

Rick Jaffe, Esq.

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

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

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

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

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

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

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

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

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

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

Tough times indeed

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

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

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

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

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

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

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

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

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

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

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

So I got to thinking …

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

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

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

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

1. Pharma advertising

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

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

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

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

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

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

Here are a couple more issues:

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

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

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

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

4. Vaccination

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

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

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

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

b. Finally, Get William Thompson on the Record!

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

The bottom line (finally!)

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

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

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

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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

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

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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.

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

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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

Are all these anti-patients’ rights laws necessary for autologous stem cell transplants?

Are all these anti-patients’ rights laws necessary for autologous stem cell transplants?

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A long time ago as a first semester law student, I took the “Legal Method” course on how to read cases, the rules of statutory construction, and generally the analytic tools which lawyers use to analyze the law.

I still remember the professor explaining how sometimes a law is created which makes sense when created, but the reason for the law is later eliminated, but the law continues.  He gave the example of the old English common law rule barring civil wrongful death causes of action. Meaning, if one person negligently killed another, the family of the decedent could not sue the wrongdoer/tortfeasor in civil court for damages. The rule made sense when created because in England back then, the property of the wrongdoer would escheat to the state. (Lawyer or neutral phrase for the government taking your property for no good reason).  Since the state confiscated the person’s property, there was no point of a civil damage remedy for the surviving spouse or family.  Eventually, the escheat law was eliminated for wrongful death tortfeasors, but the wrongful death civil action prohibition continued for a very long time.

Eventually, some  anti-authoritarian oddball realized that the wrongful death prohibition no longer made any sense. I have to assume that the-powers-that-be back then had a knee-jerk reaction against the oddball, perhaps trying to invent new rationales for keeping the law, probably something about protecting the general public.  But eventually a wrongful death right of action was created.

I think there’s a lot of that going on nowadays in the freedom-inhibiting health care regulatory framework. Meaning and specifically, there are some laws which over-protect us based on an outdated model of the relative access to information by the parties to a health care transaction. If you’re scratching your head about what I mean, here is a more recent and closer example.

But first, a micro course on medical malpractice: There are three elements to a medical malpractice claim; a departure from the standard of care, causation and damages. Unconventional care (alternative medical treatments/integrative medicine. or however you want to call it) is by definition a departure from the standard of care. So even if the patient sought out and consented to unconventional care, the patient can still sue the unconventional care provider for malpractice if the treatment caused injury or harm (including the harm of not undergoing a conventional “effective treatment.”) Although there is a common law defense called “assumption of risk,” it didn’t apply to the doctor/patient transaction because of the perceived imbalance of knowledge between the parties.

This was the law up until the early 1980’s.  Let’s try to image what it was like back then where there was no internet, there were just three networks and we listened to disc jockeys who didn’t curse or rant about politics; they just played music.  The only medical news we got was from newspapers and the medical sections of the weekly news magazines. (For those of you too young to remember, and as hard as it is for you gen xers to believe, tens of millions of people used to purchase little booklets each week to read about the news, entertainment, science and other public interest matters, all in one glossy booklet/magazine. Quaint stuff for sure).

People who didn’t read the specialized medical literature or go to the medical conferences experienced a relative imbalance of information. And that imbalance was the rationale for not allowing assumption of risk as a defense to a medical malpractice claim.  But even in the dark pre-internet era, things changed in terms of our assessment of the imbalance of information between the doctor and patient and assumption of risk. Here’s how it happened.

A woman was diagnosed with early stage breast cancer. Let’s call her Eidth.  Her Oby-Gyn and three other doctors told her to have a mastectomy and if she did, she was told she would mostly likely live a normal life. She refused and wanted to go the “natural way.”  So she found an alternative cancer doctor in New York. Maybe he told her to get a lumpectomy, which she refused, but he still treated her with some trace mineral elements including selenium which he had been using on cancer patients for decades.

She got much worse despite the treatment and eventually was forced to have a bi-lateral mastectomy. She lived, but she sued the unconventional doctor for malpractice. It was my firm’s first case in the health care field. Because of our lack of experience, we couldn’t understand why assumption of risk wasn’t a viable defense, but all the experienced malpractice attorneys kept talking about the imbalance of information.

As luck would have it, before the trial, the New York Court of Appeals had issued a ruling that a teacher who voluntarily participated in a donkey race in a school gym might not be able to recover for his injuries from falling off the donkey, if he “expressly assumed the risk” of racing on a jack-ass in a gym.  Well, our doctor/client wasn’t a jack-ass, but why couldn’t the patient assume the same risk as the teacher. Wasn’t it just an issue of fact whether the patient had all the material information, just like the teacher, and expressly agreed to assume the risk? We thought this whole imbalance metaphor had gone on too long, given the new world of color TV, and high tech glossy magazines. Hell, people had recently begun sending each other pieces of paper and even complete documents over the phone lines with something called a facsimile machine. It was a new world of information and we thought it was time for a change.

We tried to get the federal judge to give an assumption of risk jury instruction, citing the donkey case, but she refused, citing the fact that no New York state case had ever applied the assumption of risk affirmative defense in a medical malpractice case. She was right about that, but someone has to change the law.

The trial resulted in our first million dollar verdict, but of course, since we were defense counsel, it wasn’t such a noteworthy accomplishment. We took the case up on appeal, and in what might be considered a landmark decision, the Second Circuit Court of Appeals created an assumption of risk affirmative defense to a medical malpractice case. The judges felt that if the patient was provided with enough information about the potential risks and benefits, and expressly assumed the risk of the treatment which she knew was technically a departure from the standard of care, then she couldn’t recover against the doctor. Then and now, it seemed like the right result. So my first million dollar verdict was reversed (a good thing for defense counsel).

Because it was clear that the patient really did expressly assume the risk, and maybe because of some good lawyering on our part after the case was sent back for retrial on the sole issue of assumption of risk, the plaintiff’s counsel walked away from the verdict and dismissed the case.  (More details about the case in Chapter 1 of Galileo’s Lawyer which will be released in about a week on Kindle, Nook and other eBook places)

So even in the dark ages of the pre-internet, glossy magazines and new-fangled inventions like the fax machine, patients could assume the risk of non-standard treatment. Thirty years later, there is an abundance of medical information available to every human being with a mobile device and access to the internet.  You can join web sites where members will diagnose you. Many medical journal articles are available on-line for free and there are hundreds if not thousands of web sites offering advice and medical information. You can go on-line and find every single clinical trial for every single disease. Despite all of the information at the consumer/patient’s fingertips, the government still feels the need to protect a patient from treatment which is literally taken from the patient’s body and put back the very same day. How can that be?

The point is that times have changed. We live in the era of information abundance and google doctoring. Patients have a quantum level more information than was available to previous generations. As a result, patients can and should be given more responsibility for their treatment decisions, or at least for those patients who are willing to assume the risk of less than fully “proven” treatment (which always works). That applies with ever greater force to terminal patients or patients with incurable progressive diseases like MS and ALS. And it applies with even greater force when the so called treatment is just removing some fat from the person’s body, separating the fat from the stem cells and reinjecting the stem cells during the same procedure. These overprotective laws and guidelines seem like the continued prohibition of wrongful death actions after the escheat law was changed.

Because the Kirk/Alexander/Collins/regrow/ replant/explant/exlax, bill reaffirms the FDA’s jurisdiction over some same day autologous stem cell procedures, and particularly adipose to mesychemal transplants, this bill is just as backward as any other effort to come-up with new justifications for laws which don’t make sense anymore.

It is ironic that the FDA’s original interpretation of the key phases –more than minimal manipulation, same surgical procedure and homologous – which led the FDA to decline jurisdiction over basically any same day autologous transplant, gave physicians and patients the ability to make these decisions rather than the FDA. Those were the good old days (pre-2012). Hmmm, so maybe my Legal Method recitation isn’t precisely on point since the FDA’s original interpretation was correct. Oh well, I have always found it to be a lesson worth remembering, and so might you.

Richard Jaffe, Esq.

www.rickjaffe.com

rickjaffeesquire@gmail.com

Galileo’s Lawyer is coming out in EBook next week, Kindle, Nook and apple iBook. Chapter 9 is about the first FDA criminal investigation of a cord blood stem cell transplant clinic.

What’s Wrong with American Health Care

What’s Wrong with American Health Care

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Recently, the esteemed publisher/editor/writer of the Bolin Report asked me what I thought was wrong with the US health care system. I was taken aback. Even though I have been involved in health care cases, organizations, and legislative initiatives for a long time, I don’t often get asked big picture questions. 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. So here goes.
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 heath 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 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.

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?

And yes, that special place will also house some of the vaccine manufacturers, especially those who still use thimerosal.

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, we have very good access to anything that can reasonably be called a nutritional supplement. The bad news is that because of the regulators and the same law, 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.

Anyway, that’s my take on at least some of the problems with our health care system.
Thanks Tim, this was fun and got my juices flowing. I think I’ll keep on doing this and start a blog and rant some more. At www.rickjaffe.com. Stay tuned!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com