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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

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

To recap and expand on my prior post on the case:

(http://rickjaffeesq.com/2017/11/05/big-trouble-ahead-companies-selling-homeopathic-remedies-california-revised/)

Green Pharmaceuticals which makes SnoreStop was sued by a bottom feeding (IMO) plaintiffs class action law firm for false advertising and unfair business practices in California. The theory of the case was that homeopathy is unscientific nonsense and none of the product’s ingredients have any possible effect on snoring.

What made the case harder for the plaintiffs’ lawyers was that unlike most homeopathic products, the claims supporting SnoreStop were based on a gold standard clinical trial, i.e., a double blind, placebo controlled clinical trial, the results of which were published in a reputable international scientific journal. At the bench trial, the plaintiffs’ expert, a retired pharmacologist, disputed the validity of the study.

The defense called a well-regarded homeopath, but he had no conventional medical or scientific credentials. The judge rejected his testimony in toto as unhelpful and biased. (I’ve talked to both the homeopath and the trial attorney about the reasons for disqualification. It’s complicated and, not having access to the trial transcript, I can’t evaluate the disqualification).

Apparently a company employee (maybe the wife of the owner) also testified and discussed the study. It’s unclear to me (and to the Green Pharma people as well) whether the study was offered and admitted into evidence. I think it should have been if it wasn’t because the study is the scientific justification for the claims, and it was a bench trial so there was no issue of jury confusion.

The trial judge gave judgement to Green, finding that the plaintiffs didn’t prove their case on either count. The decision on its face was odd because after the plaintiffs rested, the defendant moved for judgement arguing that the plaintiffs hadn’t made their case (made a prima facie showing in legalese), but the judge denied the motion, finding that the plaintiffs put on enough evidence such that they could win unless Green rebutted the plaintiffs’ case. But since the judge rejected the defendant’s expert testimony, and he didn’t say he thought that the clinical study rebutted the plaintiffs’ expert testimony, his judgement for the Green was a real head-scratcher in that it seemed inconsistent with his earlier finding.

The plaintiffs took the case up on appeal. The appellate court also had a problem with what the judge did, and not only reversed, but ordered the trial court to enter judgment for the plaintiff class members and figure out how much each should get back from Green. This was an absolutely stunning and shocking result. The appellate court did this by disregarding some pretty important and hard-fought legal precedent protecting homeopathy. The appellate court also, in effect, rewrote the false advertising statute to make it easier to sue any manufacturer. Rewriting statutes is not something the courts are supposed to do.

My friends at the National Heath Freedom Coalition asked me to look at the case and give my opinion. The more I looked at it, the more pissed-off I got. I called some of the people involved to see if I could figure out how this all happened. I haven’t figured it all out yet, but I know enough to know that the appellate court’s decision is dead wrong, sort of outrageous and the result, ordering judgement for the plaintiffs rather than sending the case back for retrial or reconsideration, is either incompressible under clear existing law or idiotic (or both). I also know that the decision will hurt the CAM field and consumers who use products like this.

Green’s lawyers timely filed a petition for review with the California Supreme Court. They did a good job, especially on the technical points about why the appellate court was wrong. Interestingly, the plaintiffs didn’t file any opposition papers. There is no automatic appeal to the Supreme Court in California; it’s discretionary, and it’s very hard to get the Supreme Court to take a case. So the plaintiffs played the odds and didn’t file a response.

I hate legal bullying and I really hate opportunistic class action lawsuits which only benefit lawyers. This case had both. Despite Green’s good papers, I was concerned that more, more concise and focused, and something broader was needed to show the Supreme Court the bad things that would result from this horrible decision.

Well if not me, who?

Here is my amicus letter to California Supreme Court. For some reason, the published clinical study which supported Green’s claim wasn’t made part of the record that the Supreme Court was going to review, so I decided to remedy that problem as well and attached it to my letter.

greenamicusletter1

Hope it helps. Stay tuned!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.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