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Author: Richard Jaffe

Board subpoenas , Yes (usually); De facto search warrants, No

Board subpoenas , Yes (usually); De facto search warrants, No

TMB personnel face damage claim for illegally trying to search and seize medical records

 In the late 1980s, my New York law firm did some work for Robert Atkins involving the New York medical board, (aka the Office of Professional Medical Conduct). The board wanted the records of a number of his ozone therapy patients. The patients didn’t want their records released, so Bob Atkins hired our firm to try to quash the subpoena.   We made precedent, but not in a good way. The New York appellate court ruled against us and held that the board has a right to medical records, even over the objection of the patient. In virtually every state, with some variations, a medical board can obtain patient medical records in the absence of patient consent and despite HIPAA. (The one exception is California where if the patient doesn’t want his or her records released, the medical board has to go to court to convince a judge that there is good cause for releasing the records.  I am doing one of those cases right now.)

How this usually shakes out is that a physician receives a letter from the board about a complaint and asks for medical records. The letter will also usually include a subpoena and a business records affidavit form so that the medical records can be admissible in an administrative proceeding. The board’s letter usually gives the physician a few weeks to respond and turn-over the records.

Not too long ago, the Texas Medical Board tried something different for a doctor who they suspected might be operating an unregistered pain management clinic. A medical board investigator along with a DEA agent showed-up at a physician’s office and demanded access to certain medical records on the spot using presenting an instant subpoena (subpoena instantar).

The physician wasn’t in.  The investigators probably falsely represented to the physician’s assistant that if she didn’t comply, the doctor would get in trouble and might lose his license.   The investigators conducted a search of the premises and looked at the records. The doctor wasn’t happy and filed a federal lawsuit against the investigators, the executive director of the medical board and the state, for declaratory relief for a number of things as well as for damages.  Suing medical boards is extremely satisfying emotionally, but very costly and basically never results in a positive, dispositive legal decision. That is because the courts don’t like interfering with ongoing state administrative proceedings, and the federal courts are even more hesitant to get involved in, let alone stop a state administrative action. In fact, practically speaking it is virtually impossible to have a state or federal court stop a board action. The state law concept is called “exhaustion of administrative remedies” and the federal law doesn’t stop board actions under what is called the “Younger abstention” doctrine which says that federal courts shouldn’t interfere with on-going state administrative actions.

The other key concept is “sovereign immunity” which means that you can’t sue the state or the federal government for money damages, unless the sovereign specifically gives an individual the right to do so. No state gives an individual the right to sue it for damages for an illegal search. One rationale is that the state cannot act illegally. On the other hand, individual investigators can act illegally, and as a result, an individual investigator can be sued personally for constitutional violations in some circumstances, the main circumstance being if there was a clearly established constitutional right, and it is assumed that investigators know what those clearly established rights are.

Most of the Texas physician’s lawsuit was dismissed in the defendants’ initial motion to dismiss. But the judge did two wonderful things for the future benefit of Texas doctors. First, he held that the search of the doctor’s office was illegal. Second, he let the case go forward on the damage claim against the individual defendant investigators. For many reasons, it is doubtful that the doctor will ever get any money from the investigators or even recoup his attorneys’ fees. But the judge’s decision, might just stop or slow down this whole subpoena instantar thing which in effect turns a legal subpoena into an illegal search and seizure warrant.

So if you practice medicine in Texas, and board investigators show-up at your office and demand you turn over medical records immediately, you could consider telling the investigator that he/she is violating your clearly established right to be free from an illegal search and seizure and that a violation of that right may result in a suit against the investigator for damages. If you’re not the confrontational type, then just tell them to leave the papers and you’ll have your attorney get back to them. Maybe even have a copy of the judge’s decision handy. (A pdf of it is at the end of this blog).

A caveat: this case applies only to a Texas medical board subpoena/investigator. If you have a DEA registration and dispense controlled substances (even things like testosterone or other scheduled BHRT’s) the DEA has the right to present an inspection notice, enter your office and inspect your DEA paperwork (inventory, dispensing logs, orders, receipts, basically everything piece of paper you are required to maintain under DEA paperwork requirements). So make sure all your paperwork is in order.  If it isn’t, well just make sure it is.

Rick Jaffe

rickjaffeesquire@gmail.com   

 3.29.16_ruling_against_TMB

Are stem cells over?

Are stem cells over?

In 2003, I did my first stem cell case, and it was, as far as I know, the first time the Feds investigated a physician for the clinical use of stem cells. Mitch Ghen had treated a couple of dozen ALS patients with umbilical cord blood. He obtained the material from a Florida cord blood bank. The Feds found out and were not happy. So a half dozen agents raided his clinic in 2003.  After the raid, they threatened to indict the Florida cord blood bank unless it stopped selling Mitch cord blood. It did and that pretty much put Mitch out of the stem cell business. The Feds kept investigating Mitch; calling his patients and former employees all to try to build a case against him. They wanted him to plead to a few minor felonies with probably only a scant few years of actual jail time. I made my arguments and we went round-and-round. In law, sometimes you have to know when to holdem and know when to foldem.  I advised Mitch not to plead guilty to anything. He followed my advice. After more saber rattling, the Feds backed down and moved on to some easier targets. Mitch learned his lesson and his next forays into allogenic (other people’s) stem cell therapy were done abroad. Since that time, it has been clear that allogenic stem cell transplants can only be performed under FDA approved clinical trials. (Galileo’s Lawyer contains a chapter on Mitch Ghen and his run-in with the FDA.  http://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301

However, the allure of stem cells was irresistible to many medical mavericks and they started thinking about autologous stem cell transplants. This had been done legally for decades as part of oncology procedures (bone marrow/stem cell recovery as part of high dose chemotherapy) and other reasons. They focused on the extraction of mesenchymal cells from fat, maybe because it was relatively easy to remove belly fat and liposuction was common and safe. There were various techniques for separating the mesenchymal stem cells from the fat, some chemical and some mechanical via centrifuge.

I believe I wrote the first opinion clearing the use of these cells for transplant in US patients. But there was a rub or a couple rubs. First, the removal and reinjection of the material has to take place during the “same surgical procedure.” But back then, there were no guidelines as to what that meant. There were noises about “homologous,” use, meaning for the same type of thing the cell was made for. But that was also vague (or vague enough for me) and that the material couldn’t be materially altered, or in FDA parlance, the cells couldn’t be “more than minimally manipulated.” Back then, separation either by physical or chemical means was not considered “more than minimally manipulated,” at least by me because there was no specific language so indicating.  (This exemption from full drug regulation for stem cells and tissue (in FDA parlance “HCT/P’s”) is found at 21 CFR 1271.15.  https://www.law.cornell.edu/cfr/text/21/1271.15).

On the other hand, it seemed pretty clear to me (and I assume to others knowledgeable in the field) that the one thing stem cell transplanters couldn’t do was culture stem cells because of two of the above FDA restrictions: First, expanding the original cells over many days or weeks sure seemed like the original cells were being “more than minimally manipulated.”   Second, it would be hard to argue that reinjecting all those expanded cells a week or two after removal was during the same surgical procedure.

By the late mid to late 2000’s stem cells became a big thing.  Of course, there were many clinical studies, but the private clinical practice of stem cells really took off. Organizations like A4M were doing modules and training on clinical stem cell use. All kinds of physicians were offering stem cell treatment for many medical conditions, especially muscle, joint and ligament problems. Even then Texas Governor Rick Perry received stem cell treatment, illegally I might add, as his cells were expanded.

And the clinics kept pushing the envelope.  The folks who (in my view) pushed it too far was the Colorado clinic (Regenerative Sciences) that treated orthopedic patients with cultured stem cells.

That was a bridge too far. The FDA had enough of the Wild West stem cell medicine business. The proponents made too many unsubstantiated claims and were using stem cells as therapeutic drugs without going through the FDA drug testing program (INDs or Investigational New Drug Applications).

In 2008 the FDA sent Regenerative Sciences a warning letter telling the company that what it was doing was illegal. Specifically, it was violating the FDA drug trifecta: the material was an unapproved new drug, it was misbranded and adulterated. The Feds also had problems with the company’s non-compliance with cGMP standards.  http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091991.htm

Yes, the material started out and ended up as the person’s own stem cells (the new ones were daughter cells), and yes the original cells were originally part of the person’s body.  So how could that material be a drug?   Logic is logic, and fair is fair, but FDA law and regulations have a logic unto itself, and as unintuitive as it seemed, under FDA law, something that was literally removed from a person’s body could be converted by regulatory definitional magic into an adulterated, misbranded, unapproved and legally dangerous new drug.

The Company had two arguments. First, the FDA didn’t have jurisdiction over the practice of medicine because only the states can regulate medical practice. Second, the company argued that there was no jurisdiction because the treatment was given in Colorado, so there was no interstate commerce which is a requisite for the FDA to act.

After receiving the warning letter which told the company to stop violating federal law, it followed the usually wise precept that the best defense is offense. The company sued the FDA in Colorado federal court for declaratory and injunctive relief using the two argument.

What did the court say about these arguments?  Nothing. The court only decided that the company didn’t have a right to bring a lawsuit. And herein lies the unfair federal government sleight-of-hand. Even though the FDA told the company that what it were doing was illegal; the feds did it via a “warning letter.” In a move only a regulator would have the temerity to concoct, the feds argued that a warning letter is not “final agency action” and “confers no rights.” It’s just the agency’s current informal thinking on the matter, and that the agency’s thinking could change. The federal courts have accepted this nonsense before, and the Colorado district court did so in this case. So like in other cases, the judge dismissed the company’s lawsuit on jurisdictional grounds.

But the FDA didn’t change its mind, it just wanted to have the case heard in the DC circuit. It didn’t take the FDA long to file an action against the company in DC federal court, seeking basically the opposite of what the company sought, a declaration that what the company was doing was illegal and an injunction stopping the treatment.  But this time the FDA was the plaintiff and the case was in the court which spends much of its time on administrative law cases.

Litigating in court against an administrative agency is sometimes a frustrating exercise. In a regular civil or criminal case, the judge decides the law and how it is interpreted. This gives both parties an equal shot at convincing the judge what a law means. It doesn’t work that way when one of the parties is an administrative agency. Both federal and state courts stack the deck in the agency’s favor in a variety of ways. One way is that when an agency is a party and the case involves the interpretation of a statute or regulation which the agency oversees or enforces, the judge does not have the latitude to make independent and neutral rulings concerning the meaning or interpretation of the statutes or rules. Instead, an administrative agency’s interpretation of its own statute and rules is given deference (The Feds call it the Chevron doctrine). Unless an agency’s interpretation is self-contradictory, makes no sense or is irrational, the agency’s interpretation of its laws and rules will be followed by the court.

This sort of takes the desire out of litigating against an agency, which is probably the point or goal.  Long story short, the district court agreed with the FDA on basically everything and entered an injunction against the clinic barring it from doing the procedure. The judge’s decision was affirmed on appeal by the DC Court of Appeals.https://www.cadc.uscourts.gov/internet/opinions.nsf/947528CDDA0B9A5A85257C7500533DF4/$file/12-5254-1478137.pdf

Enough is enough

The FDA had enough of the autologous clinical stem cell transplanters, so they did what comes naturally to regulators, they (belatedly) asserted jurisdiction and regulated the stem cell clinics, which in all practicality means the Feds are trying to put a stop to the therapeutic use of autologous stem cell transplant outside of clinical trials. They did it (or are in the process of doing it) via two administrative vehicles, warning letters and industry guidance documents.

In 2012, the FDA sent a warning letter to a New York company extracting stem cells (stromal vascular fraction) from fat and promoting their use for a wide variety of medical conditions.http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm297245.htm).

In December 2015, the FDA sent a similar warning letter to a physician doing the same things in California and Florida. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479837.htm

Same basic contention/finding in both instances: the cells were an unapproved new drug because the use was not homologous, the cells were more than manipulated (“your processing alters the original relevant characteristics of the adipose tissue” yada, yada) and of course the obligatory cGMP (current good manufacturing procedures) violations relating to the manufacture of the material.

Apart from lobbing warning letters at the unlucky who hit its radar screen, between late 2014 and 2015, the FDA also circulated specific draft industry guideline documents on the key regulatory points, basically making formal the principles and interpretations of the regulations set forth in the warning letters. Thus, there are draft guidelines on:

What constitutes the same surgical procedure.http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM419926.pdf

What is a homologous use of stem cells. (not much)http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm469751.pdf

And most importantly, what constitutes more than minimal manipulation. This was the biggest blow since the FDA is taking the position (or trying to) that separating the stem cell from its fat structure is more than minimal manipulation, and this pretty much kills the whole therapeutic use of stem cells outside of clinical trials, at least according to the FDA. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm427692.htm

And in case the adipose stem cell transplanters had any doubts that the FDA  were serious about stopping all the fat-based stem cell therapeutics, the FDA even put out a draft guidance specifically on   HCT/P’s from adipose tissue. http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm427795.htm

Note, these are just “draft” guidelines (“guidance documents”). Under the arcane rules of administrative agencies, the agency publishes draft guidances and the public gets to comment on them.  Then there is public hearing where stakeholders can comment to the agency face-to-face. The public hearing on these guidance documents was set for April 2016, but the FDA adjourned the hearing because of the intense public reaction to the guidelines. Supposedly the FDA wanted to give more time for stakeholders to comment. We’ll see, and we’ll also see if the public hearing will be longer than the one day previously scheduled.  The FDA received over seventy written comments about these guidelines so far.  But don’t count on the FDA changing its mind, on any of the big issues anyway. Is it still worth submitting public comments? For sure. You never know. Maybe some congressional muscle might help as well. Ditto for a public ground swell, if such could be managed.

What can stakeholders do if the FDA adopts the draft guidance documents? Not much. But more of that once the guidelines are in final form.  More to come.

 

Rick Jaffe Esq.

 

 

S 2689: Congress to the rescue on stem cells? (Not)

S 2689: Congress to the rescue on stem cells? (Not)

In my last post on stem cells, I painted a pretty bleak picture. Based on warning letters and recent FDA guidance documents, the clinical use of autologous stem cell therapeutics is essentially over. The only way patients are going to be able to receive autologous stem cell transplants for non-homologous use is either in FDA approved clinical trials or outside the United States.

This hasn’t gone unnoticed in Congress. In March, 2016, a bill was introduced, by Senator Mark Kirk and others which purports to help. It doesn’t. It creates an illusion of a solution that changes nothing. The bill does not address the core problem which is that autologous stem cells, even if cultured, should not be regulated as drugs, because under any reasonable analysis, they are not. As I suggested in my previous article, the feds are clamping down on stem cells because of the claims made by transplanters and because of the culturing of stem cells. The FDA’s response is draconian and the Kirk bill doesn’t help in any meaningful way.

Under the proposed bill, ostensibly a new regulatory pathway is created. But before we talk about the new path and why it’s nonsensical window dressing, let’s briefly review the traditional approval path. Under current FDA law, to get a drug approved, a drug sponsor needs to file an IND (investigational new drug application). This is a very big deal in terms of time, expense and volume of paperwork. All available information about the safety and efficacy of a drug must be submitted. Usually this information comes from animal studies.  (However, if there is controlled clinical use or foreign studies, such data is submitted which could bypass phase 1 and go right to phase 2 studies.)

All available pharmacokinetics information (basically mechanism of action and interactions) must also be submitted. A protocol setting out all of the details of the dosage, entry criteria, contraindications, endpoints, and a myriad of other aspects of intended use information must be included in the application. In addition, the proposed informed consent form must be submitted for FDA review, as well as information about the study’s IRB (Institutional Review Board). Also, the sponsor must include information about the principal investigators and sub investigators who will administer the investigational drug to the patients/study subjects. Basically, the IND has to convince the FDA that it is safe to administer the drug to humans, and there is some reason to believe that the drug will work as well in humans as it did in animals, (or in humans if there is prior controlled clinical use). In other words, that there is some reasonable expectation of efficacy.  After the IND is submitted (which usually consist of tens of thousands of pages), the FDA has 30 days to review the filing. If the sponsor doesn’t hear from the FDA in that time, the trials can proceed. Oftentimes, the FDA has questions which have to be answered, which begins the back and forth between the sponsor and FDA. This process can move with the alacrity of the shifting of tectonic plates.

Under the Kirk bill, a supposedly new and streamlined drug approval path is created. It’s called “conditional approval.” The bill gives the FDA one year to come up with some kind of framework to conditionally approve a stem cell application, if the sponsor demonstrates preliminary evidence of safety and a reasonable expectation of efficacy, short of phase 3 levels of proof. See section 351B (a) of the proposed bill. https://www.congress.gov/114/bills/s2689/BILLS-114s2689is.pdf).

On its face, this test seems similar to what is required to obtain an IND, except the Kirk bill seems to assume that the treatment has already been used on humans and there is some legitimate clinical trials data supporting safety and efficacy.

Hmmm. Odd. I thought the bill was supposed to make it easier for a person to get his/her own stem cells? But this seems to require more evidence of efficacy than might otherwise be required of a sponsor to obtain a regular old IND.

These two Kirk bill requirements (preliminary evidence of safety and controlled clinical evidence of a reasonable expectation of efficacy) of course give the FDA complete discretion in determining whether the proposed study meets the criteria. If the sponsor succeeds in this threshold showing, then it has five years to submit the data in an NDA (new drug application).

However, in detailing the additional requirements for obtaining “conditional approval”, Section 351B (b) (8) requires that that the sponsor submit an IND in order to treat any patients under the “conditional approval.”

OK, so everything which has to be submitted in a regular IND has to be submitted for “conditional approval” because you can’t get conditional approval without submitting an IND.

So in substance and paperwork requirements, the bill seems more cumbersome than the requirements for an IND, at least an IND with a couple different protocols.  So what’s the point of the conditional approval thing?  I haven’t figured that out yet.  Seems that the Kirk bill is a waste of time and energy, despite the fact that something like 80 organizations support it. Maybe the devil is in the details. One could always hope that the FDA will actually come-up with a more streamlined process to allow patients to receive stem cells, but I’m just not feeling it from what is in the bill.

My underlying problem is that I don’t think a person’s cells are drugs or should be regulated/prohibited as “unapproved new drugs.”  There seems to be something fundamentally odd and wrong about the federal government regulating a person’s own tissue when the tissue or part of it is reinjected. I get that the separation should be done in a sterile and effective way, (read that the cells aren’t contaminated or destroyed by the separation process) and that the centrifuges should be validated and FDA cleared. But regulating a person’s own biological material which is removed and then reinjected, well that just seems crazy intrusive, or just plain crazy to me, except in the Bizzaro regulatory world.  But actually, the FDA used to agree with my view, in part at least, because up until the first warning letter in 2012, the FDA interpreted 21 USC 1271.15 as stating that separating stem cells from tissue or structure was the practice of medicine and not subject to FDA regulation as long as the product was reinjected in the same surgical procedure. The FDA only changed this reasonable position based on the perceived abuse by stem cell transplanters  (my interpretation).

In that regard, I also get that government agencies might or should be concerned about these exaggerated claims. But the state medical boards can and do police physicians based on their web sites and information conveyed to patients. I think the state medical boards are in a better position to handle enforcement actions against unsupported claims. And of course, this is more in-line with the seeming intuitive notion that a person’s tissue or cells are not drugs just because the material is removed and reintroduced into the body. Both the FDA and the FTC have the statutory jurisdiction to go after the transplanters for false claims if they think the medical boards aren’t doing their job. But prohibiting what is essentially a surgical procedure seems like an unnecessary and complete overreaction to the problem.

So what needs to be done? It’s not complicated. Congress should statutorily overturn the FDA stem cell guidance documents and warning letters by passing a law that autologous stem cell transplantation is the practice of medicine, even for non-homologous use, and even when the cells are cultured/expanded.  Let the state medical boards police the autologous stem cell transplant physicians in terms of their claims and therapeutic use. Texas is already doing just that. Organizations or other sponsors can still do clinical trials. People will still enroll in trials the way they do now, (or did before the warning letters) because of the financial incentives to the patients in enrolling in clinical trials (the “drugs” are free and so are many associated costs). But at least those who decide to have their own stem cells reinjected in their bodies will have the option to do so without government interference, and in my view, that’s a good thing.

Any brave Congress folk willing to take on the FDA?

Richard Jaffe

rickjaffeesquire@gmail.com

Why can’t dying patients have ANY drug they can get their hands on?

Why can’t dying patients have ANY drug they can get their hands on?

For almost 40 years, terminal patients have been trying to obtain access to unapproved new drugs. The latest effort has come from the Goldwater Institute (“GI”) which has made the strategic decision to bypass Congress and the federal courts and go directly to the state legislatures. GI’s legislative efforts have been wildly successful, having passed its “right to try” law in more than half of the states. That’s an almost unbelievable accomplishment and everyone should laud and support it, but it won’t do much practically until Congress is forced to act, and act in a big way.  Before I go into why the state legislative angle won’t do the job, let’s review how we got to where we aren’t, namely open access to pipeline (and other) drugs for very sick people who can’t be helped by FDA approved drugs.   The history is instructive.

It started with laetrile in the 1970’s when terminal cancer patients sued the FDA for access to the apricot pit based cancer remedy. A compassionate and brave Oklahoma federal district court judge held in part that the FDA’s attempt to keep laetrile from terminal patients violated their constitutional privacy rights. https://www.courtlistener.com/opinion/1554980/rutherford-v-united-states/.

The court of appeals affirmed the result, but on a different ground, holding that as a matter of statutory interpretation, the FDA’s safety and efficacy requirements do not apply to terminally ill patients.  The appellate court created this non application of safety and efficacy requirements because it wanted to give the patients laetrile but like most federal appellate courts, it wanted to reach the result without making a constitutional ruling. So the court decided that the statute didn’t apply to terminal patients.

In 1979, the liberal Supreme Court unanimously reversed the court of appeals. Ironically, Thurgood Marshall, – the man who argued Brown v Board of Education (“separate is not equal”) as a lawyer – wrote the opinion that there was no statutory exception to FDA law for terminal patients. Marshall ducked the district court’s right of privacy holding because the court of appeals hadn’t addressed it. The Supreme Court remanded the case to the court of appeals to decide the constitutional privacy issue.   http://caselaw.findlaw.com/us-supreme-court/442/544.html.  The appeals court decided that terminal patients do not have a right of privacy to take medicine of their choosing.

And so ended the right of privacy for terminal patients.  The right has stayed dead or nonexistent until this day, despite efforts by lawyers (including me) to revive it.

Interestingly, even though the federal government denied dying patients’ access to laetrile, many states stepped-up to the plate and passed laetrile access laws. Technically, these laws were in conflict with federal law, in the same way as the state laws legalizing marijuana are in violation of federal law. However, then as now, the feds basically let people have access in the states in which it is legal, or at least the feds didn’t go after the patients.  The state laetrile laws in the 70’s may have been an inspiration to the right to try movement, but ultimately it is a false analogy, as I will explain later.

Access to unapproved drug was raised indirectly in Texas in the Burzynski cases in the 80’s and 90’s. In the early 80’s, a Texas judge held that although Burzynski couldn’t ship his unapproved drugs across state lines, he could provide them to patients in Texas since it appeared to be legal there. In response, the Texas legislature closed the loophole by passing a “mini-FDA act” which made the treatment illegal in Texas.

The issue came up again in Burzynski’s criminal case in the mid 1990’s when a Texas district court held that under Burzynski’s conditions of bail, he was not permitted to give his unapproved new drug to patients. We ended up going to Congress for help.  Congressman Joe Barton and some the Burzynski patients forced the FDA to back down, and the FDA provided a legal way for Burzynski’s patients to get the unapproved drug. (The FDA put all of his patients on a clinical trial protocol. See chapter 2 of my book, Galileo’s Lawyer for a more detailed discussion.  http://www.amazon.com/Galileos-Lawyer-Alternative-Complementary-Experimental/dp/0980118301.  The book’s discussion about how that took place and my characterization of this one clinical trial protocol as a “joke” has become an oft repeated blog and media topic, much to my dismay.  But more about another time.). The Burzynski access issue relating to his bail conditions also prompted congressional hearings on access in general, but nothing came of it.

In the late 1990’s, and early 2000’s, there were other efforts to legislatively open up access to unapproved drugs. One was the Thomas Navarro house bill submitted by former Congressman Dan Burton.  Thomas was a young terminal brain tumor patient who was initially refused access to Burzynski’s treatment. Thomas and his right to get treatment was discussed in a 2000 Republican presidential debate. However the bill went nowhere.

In the 2000’s there was another serious litigation effort in the form of the Abigail Alliance case based on a heart-wrenching story like Thomas Navarro’s. Like the laetrile case, a brave district court judge opened-up access to unapproved drugs on a constitutional basis. However, the DC circuit court overturned the lower court, holding that only the all-knowing FDA has the right to determine what drugs dying patient can take.  https://en.wikipedia.org/wiki/Abigail_Alliance_for_Better_Access_to_Developmental_Drugs_v._von_Eschenbach.

Patient access to investigational drugs hasn’t gone completely unnoticed by the FDA. Because of the AIDS epidemic, since 1987, there has been some form of expanded access, i.e., access to investigational drugs beyond enrollment in clinical trials. Originally called “compassionate use” or “special exception” access. More recently expanded access has, well expanded somewhat, and is now called single patient protocols. There are other larger programs as well (e.g. Treatment INDs for bigger groups). The FDA has even recently streamlined the SPP approval process with the introduction of a two page form instead of a formal IND. (more about that another time) However the FDA’s program is still woefully inadequate. Less than two thousands patients a year are treated under SPP’s, which is a miniscule amount compared to the amount of patients who could benefit from access to investigational drugs.

Which leads us back to the Goldwater Institute’s right to try state legislative efforts.  I think it’s now law in 28 states. Although there are some differences in the laws, the basic state law provides that medical doctors cannot be charged with a medical board violation for providing seriously ill patients with an investigational drug which has completed phase 1 (safety) clinical trials. Many of the laws purport to make it legal for drug manufacturers to provide the investigational drugs to patients. Some states disallow charging for the drugs, others allow it.  Proper informed consent is required.

Of course, the physician and the patient have to obtain the investigational drug from the drug manufacturer, and therein lies the problem. There is and cannot be any way a state can compel a manufacturer of an investigational drug to give or sell it to a patient outside of clinical trials or expanded access. And from there, it just gets worse.

Suppose the drug manufacturer is in a different state from the doc? Can the manufacturer ship an investigations drug across state lines to a physician to administer to a patient in a right to try state? I don’t see how. The right to try law does not and cannot immunize a manufacturer from the federal law violation of shipping an unapproved new drug across state lines. The “law” just doesn’t work that way. While the federal government may not go after Colorado marijuana sellers who sell product to people in Colorado, if any of those sellers start shipping weed out of state, I guaranty the feds would shut them done very quickly.

Similarly, I don’t see how it would be legal for a drug manufacturer to ship an investigational drug across state lines without violating the FDA criminal statutory trifecta (introducing into interstate commerce an unapproved new drug, misbranding and adulteration). What interest would the FDA have in allowing that? None that I can think of. Depending on your perspective, for better or worse, the FDA is intent on controlling the use of investigational drugs and I don’t see it ceding any part of that power to the states.

Furthermore, I don’t see how any competent FDA attorney could advise a drug manufacturer to ship an investigational drug across state lines for use outside of a clinical trial or under formal FDA expanded access.

But even if a manufacturer is in the same state as the administering doctor, based on past precedent (the Regenerative Sciences case discussed in my first stem cell post), dollars-to-donuts the FDA would take the position that if the drug manufacturer buys a test tube or a pencil from an out-of-state source, that’s enough interstate commence for the FDA to assert jurisdiction over the intra state distribution of the investigational drug. But even without the out-of-state purchase of a pencil, the FDA, backed up by federal jurisprudence, has a jurisdictional predicate of “affecting interstate commerce.” Basically, everything affects interstate commence in some way. So lawyers should be telling drug manufacturers that it is not FDA legal to ship unapproved drugs out of state or even within a state, for anything other than an FDA clinical trial or FDA expanded access. And on this I speak from professional experience.

But there is a bigger problem based on the naked realities of self-interest.  There is only one reason a drug manufacturer tests an investigational drug; to get the FDA to approve it for marketing (so the executives can get their bonuses and/or cash-in their stock options after approval).

Why would pharma execs risk the FDA’s wraith to provide their investigational agents outside of FDA sanctioned expanded access programs? To save patients’ lives?  Oh please, you’re listening to too many pharma commercials. Pharma hasn’t even provided wide access to investigational drugs under FDA expanded access, so it’s completely unrealistic to think it will do so in technical violation of federal law.

Going back to laetrile: The state laws legalizing it were effective in allowing access to the drug, but only because the suppliers of laetrile were not pharma beholden to the FDA for drug approval. They were mom-and-pop, cottage industry folks from the herb and supplement field who didn’t give a whit about the FDA or drug approval. Pharma lives and dies in its relationship with the FDA, which is why there is the obscene revolving door between senior FDA regulators and pharma companies.

There is another hard reality. The right to try target group consists of patients who are likely sicker or much sicker than patients who could get the drug in a clinical trial. Why? Because right to try covers terminal patients, and mostly very sick terminal patients who have tried and failed other treatments. These patients usually have many co-morbidities. Drug companies prefer to test their investigational agents on the healthiest people they can find for the drug’s indication. That’s what the entry criteria in the clinical trial protocol are all about.  Why? Healthier people have fewer co-morbidities and will experience fewer side effects which could be attributed to the study drug.  Side effects have to be reported or at least recorded. Although the FDA says that side effects (adverse events “AE’s” or serious adverse events “SAE’s”) for SPP’s and compassionate use do not negatively impact a drug approval decision, drug companies don’t believe it. And they are worried that after approval, evil plaintiffs’ attorneys will use these SAE’s against the company in products liability cases. For these reasons, the drug companies are not and will not buy into the whole bypassing of federal law, state right to try thing.

So what’s the point of right to try? For starters, it is a direct and impressive manifestation of the will of the people. It is very important for federal legislators to hear what people want, to give them the impetus to reign in the FDA. If all or most states pass right to try, I think Congress will have to act.

What kind of new federal law? Maybe there needs to be a new business model for drug approval. I would propose patient funded access to early stage investigational drugs, as a choice for patients. That might entice some smaller drug companies to open up access.

At its core, the issue is who has the right to decide on treatment for dying patients? Is it government bureaucrats, talking heads in the cancer establishment, professional ethicists, mentally disturbed bloggers (more about that another time), or the dying patient and his or her family. Guess where I stand?

This is a bigger issue than right to try, or federal expanded access, both of which require that a drug be in a formal clinical trial before it is available to a patient.  I go the next step, and re-ask the question I asked in the title. Why can’t dying patients have ANY drug they can get their hands on?  I do not think the federal government should be in the business of overseeing or limiting the kinds of drugs or remedies which a terminal patient can take. I think a dying patient should be able to get any drug he/she can get their hands on, and let them weigh the risk and make the decision.

Let’s circle back to the laetrile case. I think the court of appeals got it right when it said that the FDA’s safety and efficacy requirements should not apply to terminal cancer patients. These patients should be able to make their own decisions and take whatever treatment they want. Those terminal patients who want the full and glorious protection of the federal government and the mainstream cancer establishment can limit their treatments to FDA approved drugs and drugs in clinical trials or expanded access. But what right does the federal government or so-called cancer experts have to limit options for people who have no potentially life-saving options?

Each year almost 600,000 people a year die of cancer. I would venture to say that every one of them had some kind of treatment and died on it, as a result of it, or at the very least, the treatment they received obviously did not prevent their death. And the same is true with other diseases.  This is a liberty issue. Either the patient or the government makes these decisions. Right now it’s the government. I think it should be the individual patient.

So the “go big or go home” solution is simple. Remove the FDA’s jurisdiction over terminal patients.  That’s what the Tenth Circuit Court of Appeals did in the laetrile case, and 40 years later, it’s still the best solution I’ve ever heard.  I think many people would agree.

 

Richard Jaffe, Esq.

rickjaffeesquire@gmail.com

 

Federal Right to Try; hopefully not déjà vu all over again

Federal Right to Try; hopefully not déjà vu all over again

 

Recently, a federal right to try bill was introduced in the senate, which is a companion to a bill introduced in the house last summer, HR 3012.  I want so bad to feel hopeful and even excited. I’m trying, I really am, but I was deeply involved in similar past efforts, including the bill championed by the heavy weight senators, “the Toms” (Senate Majority leader Tom Daschle and Tom Harkin) along with Congressman Peter DeFazio. I was also around when Dan Burton tried on the Republican side to pass similar legislation. The prior bills generated a lot of excitement from the health activist community, but little from the rank and file congress folk, and relatedly, little excitement or interest from pharma. My recollection is that none of those bill ever made it out of committee, which is where HR 3012 currently resides. Maybe this time it will be different because of the impressive efforts of the Goldwater Institute’s legislative achievement of passing right to try in 28 states (so far). I hope so.

The federal bill is simple. https://www.congress.gov/bill/114th-congress/house-bill/3012/text   The FDA can’t interfere with a physician or drug company providing a post phase 1 investigational drug to  terminal patients. Sure, there is vagueness in the bill about whether any aspects of current IND law might apply. However, for sure, if passed, the bill would do at least one important thing which is necessary to open up access to pipeline drugs:  Me and my fellow health care attorneys will stop advising drug companies that shipping an investigational drug outside of a clinical trial or expanded access is a violation of federal law.

The other really good news is that presumably under this law, the physician no longer has to fill out a lengthy IND application or even the new streamlined two-page expanded access SPP form. The physician can just administer the drug, right? Does the physician have to report adverse events? What obligations does the manufacturer have once it releases the drug to the physician? The same as in an IND or expanded access? Can the sponsor charge the patient for the drug? If so how much? Cost recovery like under current FDA law? Or a greater amount? How long does the drug manufacturer have to keep on supplying the drug to the patient under right to try?

Apart from these technical questions, there is still the one overarching question/problem in the right to try universe:  why would drug manufacturer agree to provide their investigational drugs outside of clinical trials or FDA expanded access?  Manufacturers haven’t been pushing their drugs into the expanded access program, and there is no reason to think that right to try would change that. The most off-cited reasons for pharma’s past disinterest are: 1. Fear that open access would slow enrollment in clinical trials which would delay drug approval. 2. Fear that negative data from patients who are sicker with more co-morbidities would lessen the chance of, or slow drug approval, and 3. Limited supplies of investigational agents, which could slow approval.  It is already ridiculously slow and costly to have a drug approved in this country, and pharma is worried (and rightly so, I might add) that open access will make the process even slower and more expensive.

Pharma’s past and anticipated future reluctance to embrace expanded access of any kind is for me the big head scratcher, and the reason why I’m just not feeling that federal right to try will have a major impact on the large number of cancer patients who might benefit from pipeline drugs. Under current law, and even under federal right to try, there is no incentive for drug manufacturers to provide investigational drugs outside of clinical trials. Sometimes drug companies can be embarrassed to provide access to their investigational drugs, as has happened in the past with some Facebook shaming campaigns. But that’s not the way to get pipeline drugs to large numbers of desperate patients.

So the obvious answer is to give pharma incentives to provide open access to post phase 1 drugs.  Most of the time when drug manufacturers provide drugs in expanded access, they do not charge for the drugs, even though theoretically they could seek permission to do so. The main reason is probably that manufacturers can only recover the actual costs, and drug companies don’t want the FDA or the public to know how cheap the drugs are to manufacture.

Some drugs are early-stage developed by relatively small drug companies, some of whom are cash-strapped, and such companies answer to investors. Taking these two facts together suggest one possible incentive: let manufacturers charge a reasonable price above cost recovery. This might provide an incentive to some drug companies to offer their investigational products post phase 1.

The talking-head ethicists and professional policy folk might decry the fact that drug companies are charging for unapproved drugs, but again the population is terminal patients. Some of these patients might believe that the lack of efficacy data and the financial risk of using an unproven or ineffective treatment are worth taking. And let’s remember that essentially all of the almost 600,000 people who die each year of cancer had treatment which didn’t cure their disease. So by the actual measure of treatment success, which is cure, all of these people took treatment or many treatments which were unsuccessful.   Someone has to decide when a dying patient should have access to an investigational drug outside of a clinical trial, either a government bureaucrat for the dying patient. Why shouldn’t it be the patient?

Is charging for the investigational drug enough of an incentive to dramatically increase pipeline drug access? Proably not. To get big pharma on board might require big-time additional incentives. Here are a couple possibilities: Give some kind of priority review to companies which provide open access to their drugs.  Give consideration to any positive results achieved under expanded access/right to try, but continue the FDA stated policy of not considering negative data because the population is sicker with more co-morbidities than the patients in clinical trials.

You want to really get pharma’s attention?  Throw in an extra year or two of patent protection if a drug is made widely available by the manufacturer under federal right to try. Orphan drugs already have this kind of incentive, and that program has greatly helped the development of drugs for rare conditions.  The point is that we need to think creatively about incentivizing the drug companies to participate in right to try, both to assist in getting it passed in Congress, and to make it effective in providing pipeline drugs to large numbers of dying patients. The law itself as it is written simply won’t do the job.

Richard Jaffe, Esq.

rickjaffeesquire@gmail.com

www.rickjaffe.com

 

 

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Richard Jaffe, Esq.

www.rickjaffe.com

rickjaffeesquire@gmail.com

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

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

To my Cali. anti-vaxer friends: here’s some probably unwanted but possibly useful advice

So in California come July 1st, there will no vaccine exemptions based on personal belief. However, there still will be a medical exemption, such as it is. My understanding is that pediatrics/public health recognizes some contraindications for specific vaccines, but very, very few (if any) contraindications for not giving a child any vaccine anytime.  I’ve heard that at least one prominent CAM healthcare attorney is advising his California CAM physician clients not to write medical exemption letters for parents who have a fear of or personal belief against vaccination. That might be prudent advice, and certainly no lawyer will get into trouble for giving it.  Obviously, this is all very bad news for anti-vaxers.

I will probably weigh-in on what I think are the medically supported justifications for the exemption another time and another forum.  For now, I’d like to talk to my anti-vaxer friends and colleagues, including those who for tactical/PR reasons characterize their views as in support of “informed consent” about the “dangers of vaccination”. You’re not going to like it, but to paraphrase Ziggy Martin in “Drive,” who’s gonna tell you when you’re too late and aren’t so great   In terms of where we are and the constitutional arguments being tossed around, well, you’re too late, wrong, and less lyrically, the imprecise hyperbolic language is not helping you focus on what may be realistically achievable.

First, the inaccurate hyperbole: California anti-vaxers claim that their kids and child care professionals are being forced by the government to be vaccinated.  Not true.  I’m from Texas, and in Texas we know what forced vaccination looks like. A couple years ago, the Texas legislature tried to force all young girls to get the HPV vaccine. The measure ultimately failed because of the public outcry against forced vaccination. California is not forcing anyone to get vaccinated. Rather, it imposes consequences (albeit draconian) for the unvaccinated; for kids, no public or private school; for adults, you can’t teach kids or be a child caregiver. That’s a big difference constitutionally and legally in general.  But in addition, by mis-framing the issue, you may be missing some realistic partial, medium-term solutions, as I’ll explain in a moment.

A lawsuit has been filed challenging the law eliminating the personal exemption. However, this lawsuit will be dismissed. Vaccination has already been upheld in California, twice before if I’m not mistaken, and the law is well within the government’s police power to protect the general health and welfare, such as it is thought to be (and I’ll get back to that also).

The new argument floating around is that the law violates anti-vaxers’ and their children’s state constitutional right to education. The courts will reject this argument. What most people don’t realize about constitutional rights is that they are not absolute, especially when they have to be weighed against competing rights and interests.  And that would apply to even the most fundamental rights.  Take the rights to life and liberty, which are as core as it gets. These rights don’t prevent the government from incarcerating or even executing criminals, and the rights don’t stop the government from drafting soldiers in times of war.

We all have First Amendment rights, but they don’t extend to shouting fire in a theater (unless of course there is a fire in the theater.) The most recent high visibility case involving weighing competing rights is that idiot Alabama clerk who refused to sign marriage licenses for gay couples because it supposedly interfered with her First Amendment rights of freedom of religion. Apart from the fact her position violated the basic constitutional premise of separation of church and state, whatever individual freedom of religion right she has does not allow her to violate the equal protection rights of gay couples. The court had no difficulty subordinating her individual religious beliefs/rights to the equal protection rights of the many.

(And to anticipate, the courts will hold that the law does not violate the equal protection rights of the anti-vaxers. To make a long story short, because this is a matter of public health and because anti-vaxers are not a federally “protected class” like race, gender, and now sexual preference, the courts will apply what’s called a rational relationship test in adjudging an equal protection claim against the law. This is the kiss-of-death to a constitutional challenge. Under a rational relationship test, the state only has to show or hypothesize that there is some possible, arguable, theoretical, potential rational basis to the law, and the courts bend-over backwards to find that a law has a rational basis.)

But getting back to the weighing of competing rights, it comes-up all the time in criminal cases. First Amendment freedom of press rights and the right of the public to know versus the due process rights of the accused. The privacy of a witness versus the sixth amendment’s confrontation clause right which requires that a defendant be given an opportunity to confront his/her accusers. In short, it is very common for judges to weigh competing rights and interests.

The California right to education is just of one of many rights and interests which the state grants and protects.  Sorry, but the reality is that an overwhelming majority of legislators and California parents believe that the current vaccination program is necessary to protect the health of children, and that allowing parents not to vaccinate their children because of personal beliefs and having unvaccinated kids in public and private schools makes their children less safe.   

There is no doubt in my mind that the new law is a valid exercise of that power, even though it affects the anti- vaxers’ education rights under the California constitution.  In the current and whatever future case there is on this issue, the courts will hold that the education rights of the anti-vaxers are subordinate to the public health and safety of the majority.   

The anti-vaxer comeback is that the majority is wrong and it’s all a conspiracy between government and big pharma; that vaccines have never been proven to be effective, don’t confer any public health benefit, or the benefit is outweighed by the risk and dangers of vaccines, that the diseases they are alleged to prevent are not as deadly as the harm vaccinations cause, and all the rest.

I confess to not knowing who is right; the majority or the anti-vaxers. But in terms of public policy and direct legal challenges, it doesn’t matter. That’s right, it doesn’t matter whether vaccination in the future is determined to be more dangerous than beneficial.  The only thing that matters right now in terms of a direct legal challenge is that there is a consensus of scientific opinion that vaccination programs are safe and highly effective, at least a consensus of conventional medicine, which, by the way, is in practicality, the same thing.

So what to do?

The first and obvious thing to do is try to change the consensus. That’s a hard process and change takes time, but it does happen, if the science supports the change. Thanks to people like Gary Taubes, David Perlmutter, Nina Teicholz, and others, the low fat, high carb diet world view is on the way out.  To that end, the new anti-vax documentary by Wakefield is a very good start. However, someone with mainstream credibility is going to have to take it to the next step. For reasons which I don’t think are justified and ironic to the extreme, Wakefield is viewed as the poster-boy for scientific fraud by the mainstream.   (The irony comes from the fact that the main accusation against him is undisclosed conflict of interest because his research was funded by an interested plaintiffs’ law firm. There is a whole literature on how Pharma has bought and paid for scientific research, and I’d bet that the biggest Wakefield medical detractors do the same thing he did, just on a much bigger scale.)

So more public broadcast and film attention is a must. But there is more, like the substance, technical part. Pretty much everything I’ve read coming from the anti-vaxers is overly emotional and not well-reasoned. It’s a big, complicated, multi-factored, nuanced problem. I think there needs to be sophisticated comprehensive analysis by people who have more than just an MD or PhD after their names. I’d like to see a panel of experts with actual experience in pediatrics, immunology, epidemiology, public health, biostatisticians, methodology, medical epistemology and heuristics get together and figure this out, do a meta-analysis what supports vaccination and put together a product which could stand-up to the mainstream and its talking heads. That kind of endeavor would take some serious funding, and you anti-vaxers are a fragmented community, so there would be financial challenges.  

Now let’s circle back to legal, mindful of why a direct constitutional challenge won’t work, and what to do about it.  As stated, the problem is the competing and superior interests of the majority’s rights. So how do we get around that? Take the majority out of the equation and maybe find a better constitutional vehicle. Right now, your only option is individual home school. I contend that anti-vaxers have a right to associate with other anti-vaxers and so do their kids, and that right to associate extends to education. Right now, the law essentially outlaws group home schooling; i.e., a private schools of similarly minded folks. I believe that law might be subject to a constitutional challenge under the first amendment freedom to associate. This would require a test case of a group, private, home school. Once it hits the radar screen, the state would likely order its closure. That would give the school and the parents standing.

Let’s assume by the time the case goes through discovery, the blue ribbon panel of actual experts with unassailable credentials finds that vaccination…. whatever it finds that’s supportive of the anti vaxer position (assuming that such is the conclusion). I think those opinions and experts have a place in the case. Now we have a trial the likes of which we haven’t seen since the Scopes monkey trial, and wouldn’t that be pretty nifty.

 Of course, that doesn’t get the anti-vaxer kids as a group back in regular schools. Instead, they are segregated.  Some anti-vaxers might think this solution makes them modern day lepers. Maybe it does, but vaccination decisions have consequences, eventually, and in California eventually is now.

Some committed anti-vaxers might find a doc willing to take the chance and write the medical exemption based on some medical pretext, but that’s a temporary, short term solution. Once the schools start seeing the same names show-up on these exemptions, they’ll notify the medical board which will take action and possibly quick action like summary suspension if there is a systematic effort to undermine public health (according to the board’s world view).   So there needs to be realistic and meaningful solutions which accommodate anti-vaxers’ beliefs, but recognize the state of consensus medical knowledge, as hard as that might be for some of my friends to swallow, at least until the world view changes. 

 I’m just saying.   

 

Richard Jaffe, Esq.

rickjaffeesquire@gmail.com

Manly Advice for my Cali. Anti-Vaxer Friends

Manly Advice for my Cali. Anti-Vaxer Friends

Ok, some of you were put-off by the “anti-vaxer” moniker.  Some suggested you’re all health freedom fighters.  I’m not willing to bestow that laudatory title until I see a more cohesive, rational and convincing case made, though I’m sure I am a minority of one on this in the health freedom community.

How about the designator “vaccine-concerned” or “VC” for short? It’s neutral, accurately descriptive, and this is my post.  From now on, I am going to refer to you as “vaccine-concerned” or “VC.” I mean to include both ends of the VC spectrum, and here are the ends of the spectrum as I see it.

At one end are those who want vaccination criminalized because it harms everyone who is vaccinated. It includes people who deny that vaccines have had any benefit to mankind, and that it’s all a pharma scheme to suck money from the masses. It also includes the personal freedom people who think the government has no right to force anyone to get any vaccine or impose any consequences on the unvaccinated, regardless of the perceived consequences that the ignorant majority and conventional scientists think will be caused by the unvaccinated.

At the other end of the spectrum are the folks who are concerned that there might be too many vaccines for kids right now, who accept some preservative-free vaccines for some serious diseases, unless there are sound medical contraindications. It also includes those who will compromise their personal freedom to get inoculations before traveling to some foreign countries where diseases survive which have been long extinct in this country. This end of the spectrum also includes those who understand that the VC, who have strongly-held and metaphysically true beliefs, have to acknowledge and work within the system in which they currently represent a minority view. Indeed, these folks even understand that their views are considered by the mainstream to be anti-science and fringe. (See the just published article in the New Yorker entitled “The Mistrust of Science” by mainstream surgeon, author (and medical establishment tool), Atul Gawande.

http://www.newyorker.com/news/news-desk/the-mistrust-of-science?mbid=nl_TNY%20Template%20-%20With%20Photo%20(51)&CNDID=25050591&spMailingID=9044825&spUserID=MTA5MjQwMzU2NDMzS0&spJobID=941025627&spReportId=OTQxMDI1NjI3S0

(I have to admit that his biography of cancer, The Emperor of All Maladies was breathtaking. Haven’t read his new book The Gene, but I will. I don’t recommend any of his writings to the VC. To borrow a phrase from an email I got about the prior post, it will just make your blood boil.)

Now that we are past the nomenclature, I’d like to address a criticism most colorfully phrased by a chiro who said that I should “grow a pair,” tell the docs how to solve the problem and give the VC parents what they need. Well, I’ve taken that criticism and the metaphor to heart, and I’ve come up with a simple solution which I think satisfies the “grow a pair” admonition.

There is a loosely formed, nascent California group of vaccine-concerned physicians. They approached me to file a direct legal challenge to SB 277. I declined. The July 1st deadline is fast approaching. I’m told that VC parents don’t know what to do, and desperately need a solution.  So you want a simple and manly solution.  Here it is:  Each member of the VC group of physicians should write medical exemptions for any VC parent who comes to them.  If the physician group wants, I’m sure Tim Bolen will post the physicians’ names and contact information to make it easier for the VC parents.

I point out that the California law does not require that the exemption be signed by a board certified pediatrician.

Any California licensed physician can write the exemption, and the decision is not challengeable by the school.

VC California licensed docs have the absolute power to grant the wishes of the VC community.

Of course, it would be best if there was a doctor/patient relationship. All the statute requires is:

“a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt . . . .” (Emphasis added by me)

So what’s the problem?

Many VC physicians have told me that vaccines are dangerous or there are too many of them given over too short a time. These physicians are convinced that the legitimate and best scientific evidence does not support vaccination, or at least the current vaccination schedule. If so, then all you are doing is writing a letter that the child should not receive medically unnecessary or unproven preventive treatment.

In addition, VC advocates, including docs, have informed me that vaccines and/or the California vaccine mandate violates the Helsinki Declaration and the Nuremburg Code. If so, it surely violates the Hippocratic Oath because vaccines harm children, or so I am informed, and you all know the “first do no harm” thing. If forced vaccination violates these universal medical/ethical rules, which are morally superior to US law, and if the science overwhelmingly supports the rejection of vaccination (or even if science just does not support its use), as I am repeatedly told by the passionate VC community, then VC physicians have professional duty and a moral obligation to sign a medical exemption for every child of VC parents.

I would go even further; refusing to write exemption letters makes the VC physician complicit in what I am told is the greatest medical fraud in history, namely the perpetuation of the international vaccination hoax.  

Writing exemption letters for all-comers would be a complete and perfect solution for the California VC community. But what about the physicians writing the letters?

Sure it’s possible that the schools and medical board might not appreciate the courage and principled views of the letter writers in helping the VC exercise their Constitutional rights, but since the real science is on their side, it should all work-out in the end. As long as the medical evidence is on your side and the experts are qualified and authoritative, any competent board attorney should be able to convince the fact finder (initially an administrative law judge) of the correctness and righteousness of the VC position.  So you have nothing to worry about.

Besides, I’m told there are many California VC licensed physicians. So even if a few are lost to board sanction, the VC community could have its needs met for many years, or until the lawsuit(s) directly challenging the constitutionally of SB277 law is/are resolved in the VC’s favor, which I have been assured will happen.

 SO BALLS TO THE WALLS!  It’s time for the VC doctors to step-up and lead the fight.

I’m ready. Who’s with me?

Richard Jaffe, Esq.

(Now with a pair)

rickjaffeesquire@gmail.com

How many cosmeceuticals can fit on the head of a pin?

How many cosmeceuticals can fit on the head of a pin?

    How many cosmeceuticals can fit on the head of a pin?

None, according to the FDA, because there is no such thing.  In FDA-land, there are only regular cosmetics which are essentially un-FDA regulated, and cosmetics which are drugs and regulated as drugs, meaning full-on FDA new drug approval applications.

My guess is that the term “cosmeceuticals” was created from an analogy to nutraceuticals which are dietary supplements which have some structure/function type of medical application or value. Nutraceuticals is a thing because DSHEA allows structure/function claims. Cosmeceuticals don’t exist (from a regulatory point of view) because there are no permissible structure/function claims for cosmetics. (More about this later.) So in a way, a cosmeceutical manufacturer is someone who is manufacturing an illegal product, but hasn’t been stopped by the FDA yet. That is the theory anyway.

In truth, I’ve always had some reluctance to dive into the FDA cosmetic legal arena because of what I thought was a regulatory disconnect between the law and FDA enforcement actions. But that has changed in the last year or two. Now the FDA is more aggressive in going after manufacturers/promoters of cosmetics who make drug/disease/structure function claims. In the last eighteen months or so, it has sent at least a half dozen warning letters to cosmetics companies making drug/disease/prevention/structure function claims. Warning letters are sent to specific companies, but they also are one of the FDA’s main tools for ensuring compliance with the law amongst the industry as a whole.

Two definitions

What are cosmetics?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].

Stuff like skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product would all be considered cosmetics.

The problem area to me is the “altering appearance” thing. I don’t think the FDA gives it a very broad meaning, as some examples from warning letters will show.

What’s a Drug?

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

A product which makes a structure/function claim is a drug, unless it is a dietary supplement (i.e. ingested as a dietary aid) in which case a structure/function claim is permissible because of an exception to the drug definition contained in DSHEA (the 1994 dietary supplement act).

The important take away is that there is no parallel exception for cosmetics (or medical devices). Therefore, based on the functional definition of a drug, if you are a manufacturer of a cosmetic and make a disease/treatment/prevention of disease, or a structure/function claim, under FDA law, you’ve got a cosmetic which is also regulated as a drug. If you don’t have an NDA, you are manufacturing an adulterated, misbranded drug which you are illegally introducing into interstate commerce (or what I call the FDA trifecta, which by the way carries civil and criminal penalties).

What kinds of claims gets cosmetics manufacturers in trouble?

Here are a few claims culled from some warning letters: “removes wrinkles instantly, Ideal for treating, sun spots, age spots, acne scarring, hyperpigmentation, supports the synthesis of new skin fibers, soothes and reduces redness and irritation, strengthen the skin’s ability to repair and protect itself.”

You can’t circumvent the law by attaching the claim to an ingredient rather than the whole product. For example the FDA has put the kybosh on claims that an ingredient “works in a similar way to Botox, increases cell communication and gene activation for the skin healing, thus it plays a fundamental role in the reconstruction of the skin tissue, is very high in lignans that support cell communication.”   So cell communication language seems problematical to the FDA. The FDA even took offense with a claim that an ingredient “helps increase skin hydration by inhibiting hyalurondase.”

Want to increase your odds of getting an FDA warning/cease and desist letter? Use “stem cells” in your product name or advertisements, and then talk about their healing and regenerative powers. The FDA is coming down very hard on stem cell clinics because of false advertising and drug claims, and it has recently issued several stem cell guidance documents, the gist of which is that stem cells are considered drugs.  So to the FDA, using “stem cells” in a name or advertisement for a cosmetic is like putting a sign on your door, web site and forehead that you are manufacturing an unapproved new drug which is misbranded and adulterated.

What about Docs who make disease/prevention/structure/function claims for cosmetics?

The good news: The FDA doesn’t normally involve itself with practicing physicians. So unless a doc is selling cosmetics over the internet, the FDA is unlikely to take issue with the promotion.

The bad news:  In the last few years, the state professional boards have given greater scrutiny to advertising by health care professionals for false or unsubstantiated product claims. Basically, whatever a manufacturer couldn’t or shouldn’t say under federal FDA law, usually can’t or shoudn’t be said by a health care provider under state board law. There might be exceptions and extenuating circumstances, but you shouldn’t get into to trouble by following the federal law.

So a guy jumps off a hundred story building. As he’s passing the 50th floor, he’s asked how he’s doing. “So far so good.”

Be careful!

Rick Jaffe

rickjaffeesquire@gmail.com

 

A glass half empty guy sees it’s really mostly full

A glass half empty guy sees it’s really mostly full

I just gave alittle talk at the Certified Clinical Nutritionist Conference in Jacksonville, Florida. Up until  the last few years, I had been attending their annual conferences for the better part of twenty years, usually giving a talk about what’s going on in the CAM field (complementary and alternative medicine, now called integrative medicine).

As I look back at all those speeches, and others I have given to other CAM groups, it struck me that most of the content of these speeches was about how practitioners and companies can or did get into trouble with the feds or state regulatory authorities, and bringing forth the many examples of the unfortunate victims. In a word, doom and gloom. But in my defense, I spend most of my waking hours dealing with practitioners and companies who are attacked by the government or concerned that they will be, which causes a certain amount of regulatory paranoia. Consistent with my jaded, glass is half empty, view from the trenches perspective, that’s what I talked about in Jacksonville, witness the title of my talk, “(not so) Fun 2016 CAM Facts.”  It was all about who’s being targeted by the regulators and what they’re being targeted for. I may have buried the lead in my talk because it was only as an afterthought that I mentioned that most nutritionists wouldn’t be affected by the recent spate of regulatory action, but that just shows you how perspective influences things.

Because I hadn’t been there for a couple years, and perhaps because the past insane litigation docket has become more manageable, at the conference, I had the space to really listen to some of the lectures and talk to some of the speakers and vendors. Some of what I heard was pretty exciting and probably revolutionary. Of course, the Microbiome was a hot topic (as it’s been for a couple years now) and the therapeutic implications are huge for a wide variety of disease including and especially autism and age related cognitive conditions.

One of the new big things for me was Nitric Oxide. Like many exercise fanatics, I’ve tried L-Arginine pre- work-outs but, I do it mostly on faith because I never really felt any benefit. But after listening to Nathan Bryan’s lecture and reading his book “The Nitric Oxide (NO) Solution,” I have an understanding of why L-Arginine isn’t doing it for me. More importantly, I’ve come away with some dietary and supplement alternative solutions, and a simple test to monitor results. I can’t wait to hit the gym and test it out. I’m thinking that this new NO approach is going be very huge in the near future.

Collagen is something else I’ve tried in the past but I didn’t stick with it. After hearing a lecture about it, I’m going to try again. After walking the exhibit floor with one of my nutrition buddies (thanks Sunny), I’ve made some supplement vendor changes and added a few new things (I’m also a supplement fanatic which I got from my health-nut father and my 30 years in the CAM field.)

In walking the Exhibit Hall, listening and asking questions to try to figure it out, I recalled a snippet of this guy Bryan’s lecture, something about that in his travel in Dubai or some other Arab country the docs were demanding literature support for his NO theory because as he said, supplements were mostly prescribed by medical docs, and there had to be adequate literature support because they were prescriptions.  Then I recalled all the past angst with Codex and what’s going on in the rest of the world.  Despite all the past concern, it’s still not here (and in my view, Codex isn’t coming here anytime soon, perhaps in part due to Scott Tipps who basically lives at Codex and hold their feet to the fire).

I then looked around and saw some of the same non MD nutritionist folks I’ve seeing for a couple decades, and it hit me. Wow. I’m a lucky guy. I can walk around talk to all these knowledgeable people and buy stuff that has or might have a profoundly beneficial effect on my health and wellbeing. And that there’s not too many places in the world where I could do that.  Sure the supplement companies are sort of muzzled, and legally, their free speech is impaired, but the information is out there, on line, at conferences for MD and non-MD practitioners, and to laymen at the big health expos.  More importantly, it’s all available to anyone who wants to try it.  And that freedom and control over one’s body is pretty special, if not unique in this world.

So thank you Keith, Radhia, Sunny, Marty, Theresa, Seth, and Nathan (great lecture and wonderful book), Luke, Lisa and Debra, and the rest of you guys for helping me look beyond the trenches and see how many good and exciting things there are going on in the nutrition and health field, and reminding me of how interesting and fun the ride has been for me.

Best

Rick Jaffe