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Author: Richard Jaffe

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

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

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

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

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

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

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

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

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

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

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

Here is their web site. www.physiciansforinformedconsent.org

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

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com

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

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

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

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

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

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

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

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

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

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

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

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

Vaccines

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

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

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

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

Regards, and best of luck with the new gig.

Rick Jaffe, Esq.

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

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

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

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

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

CAM doesn’t get insurance reimbursement

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

CAM figures out how to open the carriers’ wallets

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

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

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

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

The carriers and feds fight back hard

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

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

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

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

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

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

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

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

What comes around and goes, comes around again

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

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

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

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

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

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

500 Plaintiffs:

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

Multiple Lawsuits:

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

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

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

Don’t make it personal

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

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

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

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

Your immediate goal

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

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

Rick Jaffe, Esq.

www.rickjaffe.com
rickjaffeesquire@gmail.com

Game Changing the Stem Cell Debate

Game Changing the Stem Cell Debate

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The stem cell clinical community needs a game changer.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Health Insurers

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

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

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

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

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

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

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

Hospitals and Providers

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

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

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

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

And Let’s Not Forget Big Pharma

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

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

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

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

Provider Shortages for Basic Healthcare

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

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

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

And Last But Not Least, the (Over) Regulators

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

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

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

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

What’s the solution?

Simple to say, hard to achieve.

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

Or so I see the health care world.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

www.rickjaffe.com

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

Using your own stem cells, tissue and body parts without FDA interference should be a no brainer and a slam dunk, but it isn’t. I mean it’s your own body. How can the federal government interfere with your privacy and autonomy right to use parts of your own body as a treatment? The short answer is they can and if the FDA gets its way, future patients are not going to be able to use their own cells and tissue as tens or hundreds of thousands of patients, including breast reconstruction patients, have been doing for years.  Here is how the FDA is going to stop you from using your own stuff (stem cells and tissue like fat, or what the FDA calls “Human Cells, Tissues and Cellular and Tissue-Based Products” or “HCT/P’s as the federales call it.) But first some short regulatory history

How the FDA thinks of your body parts

Until the 1990’s, removing and reinserting body parts wasn’t regulated by the FDA, other than making sure that it was collected and maintained in a safe and sterile way. But then stem cells started to become a popular research field, and all the hype started about the magical therapeutic power or potential of stem cells. So in the late 1990’s the FDA started making noises about regulating stem cells and other human tissue. That would include both your own stems cells (called in medical and regulatory parlance “autologous”, and someone else’s stem cells or tissue (“allogenic”).

In 2005, the FDA published its final rules concerning HCT/P’s.  (Here is the link to 21 CFR 1271, for the legally curious.  (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271)

The regulations created three different regulatory pathways for HCT/P’s; some were considered “new drugs” which required full FDA approval, which is a hideously expensive and unreasonably long endeavor. (This is sometimes referred to as the 351 pathway); some just required that the facility using the stem cells or other tissue register with the FDA (sometimes referred to as the 361 pathway), and if the stem cells or other tissue was removed and reinserted into the person in the “same surgical procedure,” the FDA didn’t regulate it at all because it was the practice of medicine which supposedly the FDA doesn’t regulate.

The FDA’s 2005 regulations introduced two biologic/analytical binary concepts which it uses as criteria for determining which of the three regulatory pathways applied to a particular use of an HCT/P: Homologous vs. non homologous and minimally manipulated vs. more than minimally manipulated.

To oversimply, a use of an HCT/P is homologous if the use of the material in the donor location is the same as in the recipient location. When the FDA regulations were first put out in 2005, there was some vagueness or flexibility in what constituted the same or homologous use.  The regulations stipulated that if the use was homologous, the use might only require registration under the 361 regulatory pathway (and if a number of other requirements were met). But if the HCT/P use was non-homologous (meaning that the use the cell had in the donor location was different from the intended use in the recipient location), then regulatory magic turned your HCT/P into a 351 new drug with the aforementioned hideously expensive and unreasonably long consequences. Seems crazy, but that was the reg.

Now you usually can’t just take stem cells out of your body; they have to be separated from fat, bone marrow, or blood. That means after you take out the material, the stem cells or other material is separated, using either a chemical agent or a mechanical process (like a centrifuge). Usually there is also other processing needed before the material is reimplanted.

The processing of the material gave rise to the second binary concept, minimal manipulation vs. more than minimal manipulation of the HCT/P.  If the cells are not more than minimally manipulated, the procedure could be done with just 361 facility registration (assuming homologous use and several other technical requirements set out in the 1271.1 (Here’s the link to the regulation if you’re turned-on by that kind of thing.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.10 )

But if the cells were more than minimally manipulated, then you are thrown back to the new drug path. Remember, we’re talking about your own stuff. Under the rule, there was some ambiguity as to what was or wasn’t minimal manipulation. Back when the rules first became effective, I had a client who wanted to take out fat, separate the mesenchymal stem cells and reinsert the cells back. To me, it seemed legal under the rules. I called the FDA a couple times to make sure I was right, and everyone at the agency I talked to agreed. But that was then.

Since that time, there has been an explosion of stem cell clinics taking fat from people and reinjecting the stem cells. Worse from the FDA’s point of view, many of these clinics were making all kinds of miraculous cure claims. Problem was there was no proof that the claims were true for most of the diseases or problems claimed to be cured or helped by stem cells. That made the FDA unhappy, which is bad thing. (Trust me, I know how bad it is when the FDA gets unhappy).

Long story short: the FDA decided to clamp down on all of these clinics, and used two of its most effective tactics.

First, it sent cease and desist letters (what the FDA calls a “warning letter”) to a couple of the most visible offenders. (Hit the big guys first to scare-off everyone else). The FDA publishes all warnings letters, and that got the industry’s attention.

Second, in the last year or two, the FDA issued four draft guidance documents “clarifying” the meaning the two key terms homologous/non homologous use and more than minimally manipulated (or not). But the FDA didn’t just clarify these terms; it rewrote the rule to knock-out some of the most popular and effective medical procedures, perhaps most importantly, the most popular post mastectomy breast reconstruction procedure with flap surgery.

No point getting too much in the weeds of how the feds did it (see my last post if the legal weeds is your thing.

http://rickjaffeesq.com/2016/09/13/fda-draft-stem-cell-guidance-documents-exposed-improper-rulemaking-bad-science-heartless-public-policy/

But here is the most egregious example that shows the abject stupidity of what the FDA is trying to do:

Flap reconstructive breast surgery takes fat (usually belly fat) and builds up the breast. Under the guidance documents, the main function of fat is structural. The main function of a breast (in a woman) is lactation.  (Some presenters of the female persuasion who presented at the stem cell public hearing were really annoyed about that characterization).  Lactation is a different function than the function of belly fat (structural). Therefore the use the flap procedure is non-homologous, which means the use has to obtain full FDA approval before it can be used outside of FDA approved clinical trials. Many of the presenters used this as an example of why the draft guidelines are wrong. (more details in my last post: http://rickjaffeesq.com/2016/09/13/fda-draft-stem-c…ss-public-policy/ ‎)

The fact that tens of thousands of women have had this procedure and are walking around feeling better about themselves is irrelevant to the FDA.

I’d like to meet the idiot who came up with this. Better still, I’d like to put him/her/them in a room with a few mastectomy patients who need the flap surgery, and let them explain to the patients why their belly fat and breasts are any of the FDA’s business.

Remember when I said that the FDA told me that docs can take fat out, separate the stem cells and reimplant them without FDA oversight if it was done during the same surgical procedure? Well that’s out the window now. Under the guidance documents, separating the stem cells from the fat constitutes “more than minimal manipulation” of the HCT/P and requires full-on FDA approval because your stem cells are now an unapproved drug and they can’t be reinjected into you without being approved by the FDA.

I get that the FDA is concerned about clinics making unsubstantiated claims. There are also a few well-publicized incidents of harm, most notably some clinic which apparently let a nurse practitioner inject stem cells in the eyeballs of patients. What idiot decided that was a good idea? Still, the remedy to that kind of problem is or could be a combination of civil actions by the patients, criminal prosecution, professional licensure proceedings, or state action to shut the place down. As to claims, The FTC has jurisdiction to deal with false claims issue, as does the state under state consumer deceptive trade practice laws.

The point is that there are a lot of options for dealing with places which do crazy things, harm patients, or make outrageous claims. The solution shouldn’t be that FDA closes down the entire autologous transplant industry because of some exceptional bad examples. Describing this as overkill is an understatement.

So here’s what needs to be done. The FDA has to rescind the draft guidance documents and start over. In the interim, the FDA should get the hell away from my stem cells and other body parts and yours too, at least if we want to take them out and put them back in our own bodies.

What can you do about it? Plenty

The public hearing of the FDA’s stem cell guidance documents ended last Tuesday, September 13, 2016, but the public comment period is open until September 27th.

If you think you might ever need to use your own stem cells or other body parts in the future, or if you know anyone how might need them, or if you think that what the FDA is doing is a bad idea, then write, fax or email the FDA and tell them. Here are some possible points:

  1. Withdraw the four HCT/P guidance documents
  2. Get out of the business of regulating a person’s use of his own body parts
  3. Any opinions  you might have about where they should place their draft guidance documents, or such other opinions you might have on this regulatory exercise, mindful of the rules of polite discourse, based on your discretion and/or temperament.

Maybe if a few hundred thousand people contact these jokers, they might get the message.

 

Where to send your comment?

Here is the information I found about sending comments:

“Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments.”

If you want to go the email route: do one or both:

CBERPublicEvents@fda.hhs.gov

Or go to Federal eRulemaking Portal:  http://www.regulations.gov.

FYI: here is the sub heading from the eRulemaking Portal:

Make a difference. Submit your comments and let your voice be heard.

That’s good advice.

Here is the FDA Federal Register Notice about the Hearings, where you can read the written comments, and more details on submission of comments.

http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM497048.pdf

If you want more details about the issue or love the weeds, here is a link to all my recent posts on this topic. They’re in reverse chronological order, so start with the last one “Are stem cells over?”

http://rickjaffeesq.com/category/stemcells/

 

Tally ho!

 

Rick Jaffe

www.rickjaffe.com

 

(To Clinton Miller, I hope we can do you proud.)

 

 

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

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

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

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

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

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

Rick Jaffe

 

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

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

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

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

 

The guidance document are really bad and deny access for many

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

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

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

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

 

What’s a “main function?”

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

 

The FDA doesn’t understand what fat does

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

 

The Big Guys say regulations are holding back progress

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

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

 

The 3 Billion Dollar Player Weighs-in

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

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

 

Maybe there is a viable lawsuit

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

 

People are Mad and are going to do something about it

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

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

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

Rick Jaffe, Esq.

www.rickjaffe.com

 

 

 

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

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

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

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

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

 

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

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

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

 

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

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

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

 

  1. How are you helped by a placebo?

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

 

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

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

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

 

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

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

 

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

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

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

 

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

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

Assume that to be the case.

What are the policy implications and practical consequences?

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

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

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

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

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

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

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

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

Best,

Rick Jaffe, Esq.

www.rickjaffe.com