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Hot off the press: The other shoe drops on stem cell clinics

Hot off the press: The other shoe drops on stem cell clinics

The Washington Times reported today that the FDA has filed permanent injunction lawsuits against the two most high profile U.S. stem cell clinics.
Here is the article:
https://www.washingtontimes.com/news/2018/may/9/doj-moves-shut-down-two-stem-cell-clinics/

Both of these clinics received FDA warning letters last year indicating that their operation violated federal law. Today’s action by the FDA in the logical and inevitable conclusion of the FDA’s multi-year effort to eradicate stem cell clinics using autologous stem cell treatments.

See my end of year post, laying out what the FDA did on stem cells and what’s coming:
http://wp.me/p7pwQD-cf

In many of my past posts, I’ve lamented that the initial target of the inevitable FDA action would be the Florida clinic made infamous by causing partial blindness in three patients, and yes, that is one of the two clinic sued by the FDA today. The other was the stem cell network run Mark Berman and his partner. They stand accused of, among other things, using a toxin as part of the stem cell treatments.

I haven’t read the injunction papers yet, but it’s a safe bet that the FDA is arguing that the therapy is 1. an unapproved new drug, 2. misbranded and 3.adulterated. Dollars to donuts the FDA is also going to cite numerous violations/inadequacies with the manufacturing facilities/processes or in FDA speak, cGMP (current good manufacturing practices) and GTP (good tissue practices).

Challenging times are ahead for the two clinics as well as other high profile stem cell clinics who are on the FDA’s radar screen.

More after I’ve looked over the injunction papers.

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

The CME certification powers-that-be go after the other big dog in Integrative Medicine

The CME certification powers-that-be go after the other big dog in Integrative Medicine

The original version of this Post incorrectly stated that IFM’s CME status was revoked by the ACCME. THAT WAS INCORRECT! Sorry about that.

However, the highly respected Institute for Functional Medicine (IFM) has had some issues with its CME course accreditation, via the Family Practice physicians’ group. It’s complicated, so see my post at:
http://wp.me/p7pwQD-d3

Previously, the ACCME had initiated revocation proceedings against other organizations.
See:http://wp.me/p7pwQD-9q

The ACCME has taken on the other big dog in the IM (Integrative Medicine) community: A4M, or more specifically, its subgroup, the Metabolic Medical Institute (“MMI”).
A4M isn’t itself ACCME accredited; it partners with an independent ACCME accredited entity. Recently its accrediting partner, Global Education Group sent a warning letter to practitioners who attended a learning activity entitled Module IV: A Metabolic and Functional Approach to Gastroenterology, that took place September 14-16, 2017 in Chicago, IL.

Here is the warning with the “corrected” information and recommendations:

“As an accredited ACCME Provider, Global Education Group strives to provide cutting-edge, innovative, quality accredited CME content to our learners. This activity you attended did not meet with our high standards of excellence. Of particular note, some of the information presented at Module IV: A Metabolic and Functional Approach to Gastroenterology did not meet the ACCME’s Clinical Content Validation requirements, which requires content include recommendations involving clinical medicine to be based on evidence that is accepted within the profession of medicine with adequate scientific justification. As such, we advise you to proceed with caution regarding the implementation or treatment approaches that were discussed and/or recommended during this activity.

Patient safety is critical. As such, we are providing you with FDA/Government guideline sources regarding treatment and testing concerning gastrointestinal dysfunction and disease. For information regarding appropriate and safe approaches for the problems or symptoms presented during this symposium, please consult the list of scientifically validated sources below:

Appropriate Stool Testing to Establish Effective Intervention:
DPDx – Laboratory Identification of Parasites of Public Health Concern. (2016, May 03). Retrieved April 6, 2018, from https://www.cdc.gov/dpdx/diagnosticprocedures/stool/index.html

Humphries, R. M., & Linscott, A. J. (2015). Laboratory Diagnosis of Bacterial Gastroenteritis. Clinical Microbiology Reviews, 28(1), 3-31. doi:10.1128/cmr.00073-14

Barr, W. & Smith, A. (2014). Acute Diarrhea in Adults. Am Fam Physician, 180-189.

What Is a Stool Culture? (2017). Retrieved April 16, 2018, from https://www.webmd.com/a-to-z-guides/what-is-a-stool-culture#2

Use of Vitamins & Health Supplements:
American College of Medical Toxicology and The American Academy of Clinical Toxicology. (2015). Retrieved April 16, 2018, from http://www.choosingwisely.org/societies/american-college-of-medical-toxicology-and-the-american-academy-of-clinical-toxicology/

Evidence-Based Clinical Practice Guidelines:
AHRQ’s National Guideline Clearinghouse is a public resource for summaries of evidence-based clinical practice guidelines. Retrieved April 8, 2018, from https://guidelines.gov/

Additionally, please utilize this link which includes recommendations from the Choosing Wisely campaign, organized by discipline/body system. This resource provides key clinical recommendations for physicians that promote best practices and help avoid unnecessary medical interventions. The campaign is sponsored by the American Board of Internal Medicine Foundation, including several medical specialty societies.

If you have additional questions or concerns, please contact Global Education Group at 303-395-1782 or cme@globaleducationgroup.com “

More to Come

A4M and the IFM are the two biggest and institutionally most successful IM organizations on Planet Earth. By going after them, it’s pretty obvious that all IM groups are going to be hit with the same DE legitimization tactics, namely CME revocation process for those groups who are direct ACCME accredited, pressure on the accrediting partners like here, plus forcing the seminar providers to publish retractions of IM clinical guidelines based on lack of evidence based support. So if you’re an IM group and haven’t been contacted by the ACCME or your accrediting partner, my guess is that you will be.

What to do about it?

I’ve previously advocated for group consultation and joint action by all the IM groups, but now I’m not so sure. I think there’s going to be some survival-of-the-fittest action that will come into play in the intermediate term. The smarter, more agile groups will figure out how to make their content more resistant to these ACCME challenges.

Having gone to IM conferences for several decades, frankly, I think that some content providers don’t go a good enough job in conveying the importance or context and meaning of the information/studies being talked about. As much as it pains me to say it, there might possibly be some small element of truth supporting the ACCME’s position in some cases. But, I think those kinds of problems are resolvable by creative solutions and more and smarter internal oversight and clearer standards.

So what’s the big takeaway from the all these ACCME’s actions?

The days of any health care professional saying anything they want in a CME accredited seminar are over or coming to an end. Like it or not, those that don’t realize it won’t be providing CME accredited courses. Those who do and can adapt to the new oversight environment will survive and even prosper.

Richard Jaffe, Esq.
www.Rickjaffe.com
rickjaffeesquire@gmail.com

A Bad Decision on IFM’s CME battle

A Bad Decision on IFM’s CME battle

I’ve previously discussed the ongoing efforts by the AACME (the main CME accrediting agency) to revoke the CME granting status of various unnamed integrative medical groups. See post at:

http://wp.me/p7pwQD-9q

But the ACCME isn’t the only organization which grants CAM groups CME course accreditation. The AAFP (American Association of Family Practitioners) does also. The AAFP used to give the Institute for Functional Medicine (IFM) CME status for all its courses. But that changed in 2014 when its CME status was suspended pending a full review. Recently that review has been completed. Although the result could have been alitte worse, it’s not acceptable and underscores why all the CAM groups need to get together and find another solution to this concerted attempt to delegitimize if not eradicate these organizations and the modalities they teach.

Here is the operative language from the decision, as reported by the IFM to its members:

• The COCPD’s topic-specific guidance on functional medicine now says: “Activities and sessions eligible for credit are limited to those that provide clinicians with an overview or scope of Functional Medicine and the techniques that functional medicine practitioners use, so family physicians can educate interested patients about the topic.
• “Activities and sessions for credit that are ineligible include those that teach clinicians how to perform techniques, modalities or applications of functional medicine in their clinical practices.”

Translation: a doc can get CME credit for an introductory course about functional medicine, but not for learning how to use it in a medical practice. Practically speaking, most of the IFM conferences will be non CME, with all the bad for the group and the doctors that entails.

IFM valiantly tried to put the best face on the disspointing decision by noting that:

“While this wasn’t the exact outcome we had hoped for, there are some positives that should not be overlooked:
• In response to the groundswell of support for Functional Medicine both within and outside our community, we are thrilled to see AAFP take a step forward and recognize the merits of Functional Medicine.
• The decision demonstrates that the patient demand for Functional Medicine continues to grow and supports IFM’s efforts to introduce clinicians to the model to help answer patient questions.”

Seems a stretch to me, but I understand the attempt to see the positive in a bad result. Hopefully, this might cause IFM and other groups to start to meaningfully explore other options.

Richard Jaffe, Esq.
Rickjaffeesquire.com
rickjaffeesquire@gmail.com

FDA sends a Happy New Year greeting to another stem cell operation!

FDA sends a Happy New Year greeting to another stem cell operation!

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities.

Here is the warning letter:

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm

Same ol, same ol, but with a twist

The letter is largely the FDA’s standard form warning letters to stem cell operations, but not quite. This entity, based in New Jersey, produces SVF (stromal vascular fractions) from adipose tissue, which is what most of these places do. That product is considered “more than minimally manipulated” under the FDA’s final guidance document. The business also apparently claims that its product may treat a wide variety of diseases, which makes the use “non-homologous,” under the aforesaid guidance document.

The letter also makes noises about a “biologics license.” Places like this New Jersey entity have more of a chance of seeing a unicorn than they do in obtaining a biological license.

And like two prior warning letters, this warning letter finds cGMP noncompliance, including not having a (very expensive) clean room, and well as numerous other facility, hardware, systems and documentation deficiencies involved in commercially producing drugs.

The rub/twist in this case

Based on the warning letter, it appears that this entity doesn’t actually treat patients, but rather just manufactures the product for resale/injection by health care providers.

The other rubs is that there is an IRB (Institutional Review Board) involved and, according to the warning letter, the product is listed “for research use only.” The FDA didn’t think either of these things helped the company’s case and made the product legal.

Just to recap the regulatory process

First, the FDA shows up for an inspections, usually unannounced and with at least three FDA inspectors. They stay for at least a week demanding to see documents. The last day of the inspection, the company is handed a 483 inspection report, which is the agency’s preliminary and non-binding and non-exhaustive findings/”observations.” (In these FDA stem cell inspections, I have to believe the agents have a standard form or template, since all of these entities have the same basic operation and operational deficiencies).

The company is given a short time to respond in writing to the noted 483 deficiencies. The FDA then reviews the response. The FDA is never satisfied with the response (at least in for- profit stem cell entities), so 3-6 months later, a warning letter arrives in the mail, usually after it is posted on the FDA warning letter web page
The company has another short period (15 working days) to respond to the warning letter. Most of the time, and especially if the entities respond without counsel, they just repeat their response to the 483 observations. The FDA then considers the response, and then . . . .?

What’s next?

This is the third warning letter issued against stem cell entities since late summer. (See my earlier post on the prior two warning letters:

http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/

So far, the FDA hasn’t taken the next step which would be a civil injunction action to stop the stem cell providers for administering and manufacturing their products. But dollars to donuts, the civil actions are coming. I suspect they will be (or the two summer warning letter at least) will be filed about the same time, so as to maximize the PR/threat impact.

The FDA’s choice of the three initial targets is interesting and possibly informative

The Florida stem cell clinic involves the most egregious facts. A nurse practitioner injected stem cell products into patients’ eyeballs and caused permanent vision damage, and the operation is run by someone without any actual health care background or training. This should be an easy case for the FDA, on the merits and more importantly, it and won’t cause public outrage even from the pro stem cell clinic field because of the bad facts. As I’ve said before, this is the best initial target, from the FDA and stem cell Mafioso’s point to view.

The California clinic supposedly uses some illegal or non FDA approved toxin either in or in the processing of its HCT/P’s. That’s about as good as you can get from the FDA’s point of view in terms of trying to solidify the FDA’s position on “more than minimal manipulation.” It’s going to be very hard for a federal judge to go for the stem cell advocate’s view if a clinic is using dangerous toxins in its product.

The New Jersey case is interesting and useful to the FDA because it targets an HCT/P manufacturer. This an important part of the FDA strategy because there are many, many docs out there using HCT/P’s who are buying the product from manufacturers like this New Jersey company. With this warning letter, the FDA is telling all these manufacturers that it hasn’t forgotten about them.

We’ll have to see how it all shakes out, but I’m still predicting that multiple injunction actions will be filed by the FDA in 2018, and I’ll bet sooner rather than later.

I still feel that the defense is going to be part legal and part public/legislative, and there’s probably still some arguments to be made which might be more receptive to the courts than to the FDA, but we’ll see.

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

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

As we start the New Year, let’s look back and forward:

CAM’s ACCME problem

The biggest challenge facing the CAM community in the coming years is that CAM organizations are under direct attack by ACCME, the main CME accrediting agency. In the last year or two, the ACCME have initiated a process to revoke several CAM organization’s CME credit provider status.

See my post:

http://rickjaffeesq.com/2017/04/04/bad-day-cam-patients-first-cam-group-caves-accmes-extortionre-education/

If ACCME succeeds, the result would be devastating to these groups because they are financially dependent on their annual conferences. CAM physicians travel to these conferences in no small part to satisfy their annual CME requirements. Removing CME accreditations would likely dramatically reduce attendance, which would put these organizations in deep financial jeopardy. The conferences are where the CAM docs learn about the latest CAM therapies, so it’s all bad, if the CAM groups lose their course accreditation status.

There are now a handful of CAM organization that are in the process of having their CME accreditation status “reviewed.” I think revocation of ACCME CME status is the intended and likely result of ACCME’s review process of these organizations. Most of these groups are keeping this problem quiet, because they understandably fear that disclosure might jeopardize membership and future conference attendance.

What there hasn’t been yet or even seriously discussed is an all-CAM response and mobilization to deal with the problem. And I think that’s a shame and short-sighted.

Reminds me of a joke: A guy jumps off a hundred story building. As he passes the 50th floor, someone asks him “How you doing.” He responds “So far, so good.”

I have to believe there is a smoking gun out there. The ACCME has seven members, one of which is CAM’s biggest institutional adversary/detractor, the Federation of State Medical Boards.

Because there are so many CAM groups that have come under review/attack in such a short period of time, I have to believe that it’s not chance; its a concerted effort, or a conspiracy if you will, to eliminate CAM organizations which will make the dissemination of CAM information much more difficult.

Hey Santa Claus, I know I’m alittle late (or early), but what I want for Christmas is that smoking gun from the Federation to the other ACCME members laying out the illegal conspiracy to revoke the ACCME certification of all CAM groups. That would be a gift that would keep on giving and I think could result in the end of the attack.

Are you listening Santa?

The California vaccine concerned folks

For better and worse, not a lot happened in California vaccine concerned world.
You didn’t need a crystal ball to predict that every lawsuits challenging SB 277 would be dismissed, and that’s exactly what happened. And the same result awaits any new lawsuits which are direct attacks on the law (which removed the personal belief exemption).

The law’s primary legislative sponsor, Dr. Richard Pan, tried some other legislative tricks to eventually force all parents to vaccinate their kids, but nothing has gotten close so far. The vaccine concerned have to remain vigilant because there’s surely more coming from this guy and his vaccine happy posse.

There’s some talk about a SB 277 repeal bill. Obviously that won’t happen next year, but there are benefits to keeping the issue alive in the California legislature. So go for it, I say.

The Biggest surprise

I had thought that 2017 would bring a spate of new board actions against Cali docs who have written medical exemptions, since according to conventional medical authorities, there’s no such thing as a valid exemption from all vaccines throughout childhood. But apart from the Bob Sears case, (and maybe one other), I haven’t seen the California Medical Board go after the many docs who are writing these exemptions. It might because the board requires a complaint from someone to initiate an investigation, and there just aren’t any complaints yet.

What’s going to happen in 2018 for the vaccine concerned?

This year we should get a ruling in Bob Sears’s case and that ruling will tell the community and its docs who are writing the exemptions whether it’s safe to continue to do so. So keep your fingers crossed and stay tuned!

The Green Pharmaceutical homeopathy case

Homeopathy is under attack in California.

See my most recent post on it:

http://rickjaffeesq.com/2017/12/12/update-green-pharmaceuticals-homeopathy-caseyou-can/

The plaintiffs did file a response to Green’s request to the California Supreme Court to review the appellate court’s decision which overturned the bench trial judge’s defense verdict. Green’s lawyers have submitted a reply, and several groups and at least one private attorney (me) filed amicus letters. We should know this month whether the Cali. Supremes will take the case. I hope they do.

Can physicians sell supplements?

Last year, I handled a case in New Mexico involving a physician’s sale of supplements. The AMA considers it unethical for physicians to sell supplements.

Who Cares? The eight or so states that incorporate the AMA ethical precepts into their standard of care laws.

New Mexico went after a physician for selling a therapeutic herbal remedy (Byron White formulas) to a patient, a practice violation based on the AMA precepts. We said it wasn’t.

I didn’t change or clarify the law, but I did get the case against the doc dismissed, (which was my job), and I had some help from star and energy powerhouse Shirley MacLaine.

See my post:

http://rickjaffeesq.com/2017/07/05/new-mexico-integ…danger-work-done/

Thanks again Shirley!

Can a CAM physician sue a medical board for antitrust violation for bringing a board case?

My view is that it’s almost impossible to win such a case.
See my post at:
http://rickjaffeesq.com/2017/04/14/want-sue-medical-board-antitrust-violations-restraining-trade-prosecuting-practicing-kind-medicine/

Nothing has happened since the post to change my mind. Every doc who has tried has had his/her case dismissed. I don’t see anything changing in the next year on that score. Are there possible benefits to bringing this kind of case and getting thrown out of court? It depends on who you ask.

Obamacare

I end with Obamacare because its demise continues to be predicted, but from the CAM business perspective, Obamacare is basically irrelevant. Let’s face it, CAM by definition is unaccepted by the mainstream which in insurance-speak means it is experimental and makes it not insurance reimbursable (at least if the therapies and procedures are properly coded). CAM practice is a cash-based business model. So I don’t see the recent or future efforts to cripple Obamacare as having a direct adverse impact on CAM practitioners. In addition, the large majority of Americans receive their health insurance through their employers or various associations, and those folks will not be directly impacted by whatever the Republicans do to further cripple Obamacare.

Indirectly however, as more people are forced out of insurance, they will either not get the care, or get the care and not pay for it. This will raise the cost of healthcare and health insurance for others. Higher costs for healthcare and healthcare insurance which will result in people having less income for discretionary, non-insurance reimbursable CAM healthcare. So as Obamacare becomes increasingly crippled, in the mid-term, there could be some financial downside experienced by CAM businesses. (I’m not going to go into the morality or efficiency of what’s going on as I’ve already addressed those issues in prior posts dealing with what’s wrong with the American healthcare system.
See my post at:
http://rickjaffeesq.com/2016/09/24/whats-wrong-u-s-healthcare-system-take-fix/

That’s about all for now. Looking forward to the New Year’s challenges.
To paraphrase George C. Scott in Patton as he overlooks the aftermath of a brutal battle: God help me, I love this stuff.

Happy New Year!

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

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’ve just had the distinct but perhaps questionable honor of being quoted extensively by the Grand Inquisitor of all things unconventional (medicine wise). here is his post:

https://respectfulinsolence.com/2017/11/21/fda-cracks-quack-stem-cell-clinics/

Like M.C. Escher so brilliantly explains in his pictures, it all depends on your perspective, whether you think the the FDA final guidance documents are a good or bad thing.

But, one thing I’ve never been able to figure out about the other side is why the obsession with the stem cell clinics with how much money they are making. 580,000 people a year pay a ton of money in cancer treatment and die in spite of what they spent. Where’s the outrage from the other side for all the money which patients spend on approved but unsuccessful treatments? And that’s just cancer. And what about all the approved treatments which have caused or hastened death, disability or morbidity?

To me it all comes down personal freedom. Why should the FDA, Paul Knoeffler or David Gorsky be able to tell me that I can’t pay someone to remove part of my body which may have some healing power and reimplant it, especially if there is no other treatment available, or the options carry lifestyle or serious morbidity risks. We all get that it hasn’t been blessed by the FDA or the stem cell mafiaoso, but it’s my body. That seems to me to be the core issue. We get that people like you think we’re making a foolish decision. But society lets people do many worse things, like smoking. Maybe it’s time for Congress to get involved, if it can pull itself away from the reality show and start doing the people’s business.

rick jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s.

The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well, the final documents are out and the feds didn’t (lossen them up). The final guidance documents are at least as bad as the drafts, and in one important respect, worse.

Here is the main guidance document on minimal manipulation and homologous use.
https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf

The FDA also issued a final guidance document on same day surgical procedures, but practically speaking, that one is irrelevant, based on the main guidance document. And that’s because, per many of my previous posts, the two critical concepts which determine the legality/illegality of the delivery of HCT/P’s to patients outside of clinical trials are: homologous vs. non homologous use, and more than minimally manipulation (“MMM”).

What’s a Non Homologous Use? Answer: It’s what you’re all doing!

If there is one sentence in the FDA guidance document which sums up the FDA’s position on the use of HCT/P’s by the heretofore unregulated clinics, this is it:

“If an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.” (Page 15 of “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, here is the link again: https://pactgroup.net/system/files/GD_HCTs_20171116_UCM585403.pdf )

To remind you, if the use is non-homologous, (meaning not the same function as from where the HCT/P derived), it’s a drug, requiring the IND/NDA path, and the non-homologous use of which is a violation of the regulation, the law which leads to bad things.

Every unregulated stem cell clinic that I am aware of falls within this FDA statement, and I wouldn’t get my hopes up based on the FDA’s “likely” qualification. If you’re using an HCT/P to cure a disease and it’s not something like hematopoietic cells or bone marrow for blood conditions, blood related cancers, or immune system issues, your use is non-homologous according the guidance documents (draft and final).

When is an HCT/P More than Minimally Manipulated? Answer: Every process used on an HCT/P unless there is scientific proof to the contrary

The nastiest thing in the final guidance document is that the FDA has created in effect an irrebuttable presumption that anytime you do anything to an HCT/P, it’s MMM unless there is information that that the process is minimal manipulation, or as the FDA puts it:

“Please note that if information does not exist to show that the processing meets the definition of minimal manipulation, FDA considers the processing of an HCT/P to be “more than minimal manipulation”, (which basically makes the HCT/P a drug)

For structural tissue like fat, MM is defined by the FDA as “processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement.”

For sure, when you separate the mesenchymal stem cell (“MSC”) from the adipose substrate, that’s MMM, let alone when the MSC is further processed into something like SVF or some other derivative product.

Prior to the draft guidance documents and even under the draft guidances, you were more or less free to argue that what you were doing to the HCT/P was not changing its relevant characteristics or MMM (more than minimally manipulating it), and then presumably force the FDA to prove that you were. Under the final guidance document, if there’s no “information” that what you’re doing is MM, then it’s not.

What Kind of Information is Needed Exactly?

Frankly, I’m not sure. Part of my uncertainty is there is some fuzziness, in my mind at least, about what are the relevant characteristics, etc. It’s an FDA created concept or administrative conclusion, rather than a biological fact or physical thing like a stem cell or HCT/P. Or it’s a question of where you draws the line. So is there a new business in creating “information” that some process doesn’t alter relevant characteristics?

How broad is the Guidance Document? Answer: Broad enough to cover basically any human tissue used by the unregulated clinics.

The guidance document covers almost every conceivable human tissue except some specific things like vascularized human organs, blood and blood components as listed in the regs, secretions or extracts like milk or other bodily fluids, bone marrow not MMM and a couple other things which are not of interest to the unregulated stem cell clinics. All other human tissue is subject to the guideline and the resulting restrictions. (See footnote 3 of page 2 of the guidance document for the list of excluded products).

So is there any Good News in the Final Guidance Document? Maybe, if you’re a Super Optimist

Perhaps to lessen the sting to the unregulated stem cell clinics, (or more cynically, to give them a false sense of hope), right in the beginning of the guidance document, the FDA says that in some cases it will use its enforcement discretion, and not enforce its interpretation of the regulations for three years to give stakeholders time to decide whether they are in compliance with the law or need to go the IND/NDA route. Later in the document, the FDA lists some factors which it will use to decide who it will not go after during these three years. (See pages 21-22).

The good of it is that autologous use lowers the risk.

The really bad of it is that high on the FDA hit list is non-homologous uses for serious and life threatening diseases and where the HCT/P’s are delivered by “high risk” methods like IV, infusion and some other methods. (See page 21 paragraph V B). The FDA considers the unapproved use of HCT’s for such life threatening conditions particularly nefarious since it might delay patients receiving “safe and effective medical treatment.” That’s an unfunny joke because the main, if not the only reason people seek out HCT/P treatment is because there are no safe and effective treatment for such conditions.

So basically, if you’re using HCT/P’s for curing or mitigating diseases other than blood or immune conditions, I’d say you’re not going to be the beneficiary of the FDA’s enforcement discretion largess.

Does that mean you should expect to receive a visit or letter from the FDA in the next year or three?

Not necessarily. There are hundreds of you clinics out there. It takes a lot of man-hours (sorry, person-hours) by many line investigators and back office federales to do each investigation. The FDA’s resources are insufficient to open up investigations and engage in the process of finding violations for anywhere near the number of clinics out there.

So what’s going to happen?

The FDA will continue with the administrative process of the high profile clinics which it has recently targeted. I think it will start the investigatory process with a few other high visibility clinics, as time and person-power permits. This will reinforce the message that the FDA is out there and remind the clinics that what they are doing is illegal (according to the FDA).

It will probably take almost a year or two before there is a judicial decision on the validity or enforceability of the guidance document. A safe bet is that the FDA will bring an injunction action against one of these clinics for not, in effect, closing. Injunction cases are tried to the judge, not a jury.

If the first case involves the Florida clinic where a nurse practitioner injected eyeballs with HCT/P’s and caused blindness, well you don’t have to have a crystal ball to know the result. Like I say, bad cases make bad law.

It’s going to interesting times for the unregulated stem cell folks.

More to follow.

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

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

We recently received hearing dates in late May, 2018 for Dr. Bob’s hearing before an administrative law judge. The case is primarily about his writing a note excusing the child from vaccination due to two prior severe vaccine reactions.

But May, 2018 apparently is not soon or severe enough for the LA Times which today published a story complaining that Dr. Bob and many other doctors are still writing medical exemptions that don’t meet the standards of medical exemptions by conventional pediatrics and the CDC (under which standards there are no medical conditions which justify a blanket exemption from all vaccines throughout childhood). The Times seems to want all these docs rounded out or put out of business today.

The title of the article says it all:

“Why hasn’t California cracked down on anti-vaccination doctors? A loophole in state law”

Here is the article:

http://www.latimes.com/local/lanow/la-me-ln-vaccine-doctors-20171106-htmlstory.html

The article has some interesting quotes from Senator Ben Allen, one of SB 277’s authors about the intent of the bill and how he doesn’t support the medical board trying to intimidate doctors who write exemptions. The article also quotes Jay Gordon, another prominent vaccine concerned doc opining that it’s up to the doctor to decide whether to give an exemption or not.

Maybe the board is moving slowly because it’s starting to realize that the issue is more complicated and nuanced than the rabid pro-vaxxers make it out to be.

In working on Bob’s case for the past year, a couple things have come out that surprised me, and having been in the cutting-edge medicine field for more than 30 years, not much surprises me these days.

First, in looking for academic experts for the case, I keep hearing the same thing over and over again. The academic expert is concerned about vaccine safety but can’t go public because of fear of reprisals from the vaccine Mafioso. I find this understandable but disheartening.

Second, I keep hearing about doctors, beyond those in the vaccine concerned movement, who aren’t fully vaccinating their kids, but they are doing it quietly.

Third, there is a black hole out there when it comes to any information other than full-on negative against the vaccine concerned. Scientists not being able to get their work published. Hell, I wrote a simple update on Bob’s case and raised some issues about aluminum, and got banned from Huffington Post for doing so.

This is one of the few areas in medical science and policy where a point of view is considered too dangerous to have openly expressed in the general media apparently. I suppose I understand the reasoning behind it: fear of creating fear which could/would reduce vaccination rates. Seems wrong to me.

If there are any brave academic pediatricians willing to take a stand, get in touch.

Rick Jaffe, Esq.
Rickjaffeesquire.com
www.rickjaffe.com

Big trouble ahead for companies selling homeopathic remedies in California (revised)

Big trouble ahead for companies selling homeopathic remedies in California (revised)

Last month, the California Court of Appeals came out with a decision which should scare the bejesus out of companies selling homeopathic remedies in California. The case is Rosendez vs. Green Pharmaceuticals. Here is the decision:
https://www.leagle.com/decision/incaco20171004089

First horrible thing: It was a class action

You want to get a company’s attention: file a class action. It’s more time consuming and expensive for plaintiff’s counsel to obtain “class certification” as opposed to filing a case for just one or two plaintiffs, but obviously a class action ups the stakes for the defendant. In my view, many class actions are about the lawyers making money, since except in wrongful death or serious injury cases, each class member gets a small amount of money and/or the damage or injury is relatively insignificant. All the real money goes to the attorneys.

This was surely the case here. The plaintiffs’ firm, Newport Trial Group, files a lot of class actions, especially labeling claims against product manufacturers. These guys get a lot of bad press for many reasons, but the legal system allows for these semi extortionistic lawsuits, so these lawyers are just taking advantage of an imperfect system. I’d like to see the class action system changed to make it much more difficult to obtain class certification, but so long as the plaintiffs’ bar continues with its generous and public spirited support of legislators, change is not coming.

So what were the terrible wrongs that this big bad class action lawsuit tried to rectify?

Green Pharmaceuticals makes a homeopathic remedy called “SnoreStop” which claims to eliminate or reduces snoring. It’s a homeopathic product meaning that there are very, very small amounts of the active ingredients or no chemical traces of the active ingredients, (which makes it more potent under the homeopathic principle of infinitesimals/dilution). The company cited one scientific study as support for its claim.

The plaintiffs’ allegation was that the product is just a sugar pill which has no proven benefit, thus making the company’s efficacy claims a violation of California’s false advertising and unfair business practices laws. California like most states, has a false advertising and unfair business practices causes of action. Until recently, these types of statutes were not used a whole lot against CAM health products.

The trial court rules for the defendant, but sometimes winning isn’t enough

The case was tried to a judge. Because of the way the case unfolded, the judge’s decision granting judgment to the defendant was perplexing.

The plaintiffs had a well credentialed expert pharmacologist who testified that 1. None of the ingredients listed on the label have any proven effect on snoring, 2. The homeopathic law of infinitesimals/dilution as well as the other tenant of homeopathy – the law of similars – are unsupported and contradicted by legitimate science, 3. The study supposedly supporting the claims is worthless because of fatal methodological flaws, 4. Whatever benefit the study might have found was due to the placebo effect, or at least the study wasn’t properly placebo controlled.

After the plaintiff rested, the defendant moved for judgment on the grounds that the plaintiff hadn’t made its case (in legal parlance, failure to make a prima facia showing). The judge denied the motion, finding that the plaintiffs expert’s testimony, established a prima facia case for both the false advertising and unfair business practices claims.

By denying the motion for judgment at the end of the plaintiffs’ case, the judge was saying that you Mr. Defendant have to produce evidence to rebut the plaintiffs’ case and if you don’t, you lose.

So the defendant put on its case primarily in the person of Dana Ullman, a very knowledgeable and well-regarded homeopathic practitioner and author. Dana however has no mainstream recognized scientific or health care credentials. Knowledgeable as Dana might be, bringing only a “Mr.” to rebut a “Dr.” on a technical scientific matter is like bringing a knife to a tank battle. Don’t get me wrong, a knife could come in handy in a tank battle, but what you really need is a tank.

The trial court was turned off by the fact that Dana believes in or made some positive comments about radionics, which for those who don’t know, involves healing through mental energy and can use pictures of a person to direct the energy or test the potency of a proposed remedy. Even in the integrative medical community, radionics is way, way out there.

The plaintiffs moved to disqualify Dana as an expert witness. The trial judge granted the motion, finding him biased and unqualified. That should have been a death blow to the defense, but strangely it wasn’t. Despite rejecting the defendant’s expert and plaintiffs’ expert’s withering attack on the one study supporting the snore relief claims, the judge granted judgement for the defense, ruling that the plaintiffs failed to meet their burden of proof. The judge made some noises about the plaintiffs’ expert not having tested the product. But still, the defense had no rebuttal evidence to the Plaintiffs’ case that there was no valid scientific support for the product or its ingredients and the expert’s testimony that the principles of homeopathy were scientific nonsense was unrebutted.

You don’t have to be a legal scholar to realize that the judge’s final decision for the defendant was technically and legally inconsistent with his previous decision requiring the defendant to put on a case to rebut the plaintiffs’ case. Moreover, while judges have some latitude in rejecting expert testimony, in this case, the plaintiffs’ expert testimony was at least allowed into evidence by the judge which meant it met the basic evidentiary test of reliability (the Daubert standard). Because the plaintiffs had some evidence and the defense had no evidence in rebuttal, it’s hard to see what was going through the judge’s mind.

The plaintiffs appealed. Not surprisingly, the appellate court reversed. The decision pointed out the inconsistency of the lower court’s decision, and stated that the plaintiffs produced evidence showing that the product was worthless and hence the claims of benefit or cure were false, and the defendant produced no evidence since its expert testimony was rejected by the lower court and the one study supporting the product was eviscerated by the plaintiffs’ expert.

The appellate court ordered the lower court to enter judgment for the plaintiffs and figure out how much money the company should pay the class members (and their lawyers). Very bad for the defendant obviously.

I hear Green is looking to raise money for a cert petition to the California Supreme Court (There’s no automatic right to appeal to the California Supreme Court).

What the case means, Part 1

Of course the appellate court decision is bad for the company but also bad for all homeopathic manufacturers who sell in California. All homeopathic remedies have some claims that they help some medical or lifestyle problem, and none of these claims are supported by the level of scientific evidence required for drug or even health claims approval. So if it is false advertising and unfair business practices to make a claim which doesn’t have a drug level of proof, then any company that makes such claims could be as liable as the company in this case, and that’s obviously a bad thing.

And of course, Dana Ullman one of the luminaries in the field has taken a professional hit, which hurts the homeopathic community.

The case and its legal context is actually more complicated than it appears, and raises some conundrums and Hobson’s choices for manufacturers of homeopathic remedies, but that requires getting into the weeds of FDA statutes, prior legal cases and some heavy legal analysis, which I’ll save for Part 2.

Stay tuned.

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

Insurance and healthcare for dummies, (and I mean you, members of Congress)

Insurance and healthcare for dummies, (and I mean you, members of Congress)

I just can’t stand it anymore, listening to these idiots in Congress talk about insurance and healthcare costs. The more you listen to these people, the more you realize that most of the people representing us don’t have a clue about what insurance is and what’s required to make health insurance and health care more affordable. Either that or they don’t want to or don’t have the political will to do what is necessary to make sure that everyone has decent medical care.

Every time one of them starts talking about “competition in the marketplace” or that people should have the right not to purchase health insurance, or just get catastrophic insurance and pay dramatically less than people who are bigger users of healthcare, I just want to throw something at the TV, because these guys are missing what is obvious to anyone who has given any thought to the issue.

So in order to make this simple enough so that even a congressperson can understand, let me explain it as a parable (that’s a made-up story to make a point).

Someplace far, far away in a distant time in the past, a bunch of people lived in a town. They noticed that every so often, something bad would happen to a few of them. (It doesn’t matter what happened or whether it happened to their person or property.) This bad thing had a devastating effect on the family and ruined their lives. The problem was there was no way to tell for sure to whom this bad thing was going to happen. The only thing people knew was that periodically something bad would happen and when it happened, the family would lose everything they had.

At one of the town meetings, Joe Aetna suggested that each family put two days of wages each month into a common pot, and that the proceeds would be distributed to the one or two families that this bad thing happened to. All the townsfolk thought that was a pretty nifty idea, and because it was his idea, it was decided that Joe Aetna would collect the money, and when necessary, distribute it to the one or two families to whom this bad thing befell.

The system worked pretty well, and the afflicted families no longer became destitute. Eventually Joe had his daughter do the bookkeeping, and as the town expanded, he brought in his son and son-in-law to help with the collection and the processing of the payments to the unfortunate few. The town agreed that that Joe and his family would be given wages for their service which was deducted from the collections.

No one seemed to mind paying two days of wages per month, even though almost none of the townsfolk received any direct benefit in return. But then two things happened: First, instead of one or two families experiencing this bad thing, for several years in a row, it happened to more than a dozen families. Also, because there were so many more people having this bad thing, the cost of fixing the damage resulting from this bad thing doubled.

The first year Joe Aetna didn’t complain, even though he had to go in his own pocket to pay his family members who were working for him because the money he received from the townspeople (what Joe called “premiums”) didn’t cover the money he had to give over to the dozen families who had this bad thing. (For some reason, Joe called the payouts “losses.”)

Indeed, not only did Joe have to pay his family out of his own pocket, there was a shortfall in what was needed to pay the dozen families. As a result, he was forced to do two things which made him and the recipients of the money very unhappy. First, he had to give a big chunk of the wages he received for operating the fund to the unfortunate (he called them “loss payees”). Second, he only gave the current loss payees half of what the prior loss payee families had received. So while the unfortunate didn’t become destitute, they had to pay a painful amount of their own wages which left them with a lot less wages than the other townsfolk. (Joe called the payments the unfortunate had to make to the tradesmen a “deductible”)

At the next town meeting, Joe said he couldn’t do this anymore and told everyone that based on past recent events, everyone was now going to have to pay eight days of wages a month as a premium to ensure against this bad event, because 1. The bad thing was happening to more people, and 2. The tradesman fixing the bad thing were charging a lot more.

To justify the increase, he pulled out a ledger listing all the events for the past years, and how much he paid out, and he did some magic with numbers which sort of predicted what the future might look like. To give his ledger containing his experience more gravitas, he made up a new official sounding term, an “actuarial table.”

Despite the actuarial table, the townsfolk were outraged by the proposed increase. Another thing they started to realize was that there was a certain pattern or characteristics that were sort of associated with this bad thing. It wasn’t a hundred percent correlation, but if a family had these factors or did these things in the past, the bad event was more likely to happen, and hence they were more likely to need the payouts. Joe admitted this to be the case, and because he really liked making-up new terms, he called these things “risk factors” and “preexisting conditions.”

Some of the townsfolk started making noises that they weren’t going to pay into the fund anymore and they would just take their chances that the bad thing wouldn’t happen to them, especially the ones who realized that they didn’t have the risk factors or the pre-existing conditions.

One townsperson contacted his cousin in a neighboring village. In that village, Sammy Cigna was doing the same thing Joe Aetna was doing. So the townsperson in Joe’s village invited Sammy to offer a fund which would compete with Joe Aetna’s fund, to try to force Joe to lower the premiums.

The problem was that Sammy was having the same kind of problems as Joe. More of his townsfolk were needing payouts, even more than in Joe’s village, and the cost of fixing the problem had tripled!

In fact, because Sammy had recently told his townsfolk that he was going to have to raise the premiums to 10 days of wages a month, some of the townsfolk in Sammy’s town had contacted Joe Aetna about setting up a competing fund in Sammy’s town.

Both Sammy and Joe gave the same response to each other’s townsfolk. “No way am I going to double my losses.”

The situation in the towns was intolerable. The funds were about to collapse between the townsfolk who were threatening to stop paying and the unfortunate who felt they should be made whole, and Joe and Sammy spending their own wages. So it was decided to consult with the regional wise man. Joe and Sammy and a townsperson from both villages took the journey and laid it all out for the wise man.

The wise man pondered the problem a bit, and said he could tell them what needed to be done, and that it was really quite simple, but that it was going to be their job to get the townsfolk to do it, and that might be the hard part.

So Joe says, “Ok Mr. Wise Man, what do we have to do?

The wise man raises his thumb and says: “First, everyone has to pay into the fund.” “This fund which I’ll call “insurance” works by taking money from many people who won’t use the money, and giving it to the few who need it. If only the people who need it buy “insurance,” it doesn’t work. That’s not insurance. That’s paying for it out of your own pocket.

The wise man then raised his pinky finger and says “Second, the people in the land surrounding villages need to pay into the fund. They are less likely to have the loss, so it will lower the number of days of wages people need to pay in, and there’s always a chance the bad thing will happen to them, so they’ll get some comfort. You need the greatest possible number of people in the fund to lower what you’re calling the premiums.

Joe then asks, “Great, anything else?”

The wise man then raised his index finger and says, “Next, you have to talk to the tradesmen fixing the bad thing, and they’re going to have to reduce their cost by 3 days of wages. Since all their work is coming from the townsfolk, they’ll have to do it.

Sammy then asks, “Are we done?”

“No we’re not grasshopper” says the wise man, as he raises his ring finger and says “Joe and Sammy, you’re going to have to cut back one day of wages per month from what you’re charging; the townsfolk are going to have to pay an extra day’s wage, which is a lot better than the six extra days Joe wanted. And, finally, now that we see what some of the risk factors are, it’s going to be in everyone’s interest to cut back or stop some of that behavior, and if that happens, maybe you’ll be able to move back to the two days of wages premium you had before.”

Joe rubs his chin in skeptical contemplation and says: “I see what you’re saying, but some of the townsfolk insist they have the right not to pay into the fund, and a few of the tradesman say they have the right to charge what they want to fix the bad thing. What do I tell them?”

The wise man raises his middle finger and says, “that’s what you tell them.”

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