Last week I did not really finish in reporting on the DAN Conference, so the newsletter agenda will just have to be pushed back, including my review of the BSC Conference (Biofeedback Society of California) this past weekend.

This year’s Think Tank heard from the advocates of hyperbaric oxygen therapy for the first time. So Dr. Michael Uszler was in attendance, with whom Hershel Toomim has worked with regard to SPECT data, and also Dr. Gunnar Heuser, who was one of the first neurologists to look favorably upon Margaret Ayers’ work for TBI many years ago. The clinical questions around this technique parallel neurofeedback remarkably: How many sessions per week (3)? How long should the sessions be (1 hour)? How many before effects might be expected (20)? How long in total (40, based on TBI work)? What about booster sessions (may be necessary)? The answers largely parallel our own.

Results were presented which showed an average of 20 points in symptom improvement (ATEC score) over a course of treatment (40 sessions). But this number was an average over the age groups, and it turned out that younger children did much better, namely around 30 points, going from an average of 70 to 40. That is a 40% improvement, remarkably similar to the 40% improvement reported by Rob Coben at the last ISNR, also for children, for twenty sessions of NF. Significantly these results were achieved with only 1.3 atmospheres of pressure, which is intrinsically safe (no danger from rapid decompression; no significant flammability risk; etc). This brings the technology nicely to within reach of an individual clinician (both technology-wise and cost-wise). I had originally been put off the scent by Jamie Deckoff-Jones, who committed to the more serious 2.0 atm technology, which is apparently required for certain other medical conditions such as wound healing, and which requires MDs to be in attendance for possible emergencies.

We wondered if there would be any advantage in doing neurofeedback while the person is in the chamber. Also, the question arises whether this technology would be significantly additive over what can be done with straight-forward HEG training. Finally, what would happen if the HEG challenge were to be conducted within the chamber? Would things go more quickly?

Both Drs. Uszler and Heuser declared themselves open to a collaboration, so we’ll see how it goes. Sue has already referred one person to Dr. Heuser in nearby Agoura Hills for complementary hyperbaric treatment.

The report on hyperbaric oxygen therapy (HBOT) presented a puzzle to the Think Tank attendees. After all, one of the principal features of the autistic spectrum is oxidative stress, the difficulty in ridding the body of the unruly unpaired electron carried by certain radicals. How does it improve matters to subject the blood and the brain to elevated oxygen levels? The answer must be looked for in other quarters. Transient enhanced oxygen availability may have the effect of bringing larger neural networks on-line that were not “self-activating” in response to demand. HBOT must be understood by analogy to neurofeedback: an activation procedure that functions at the network level: HBOT from the bottom up (supply-pushing), and neurofeedback from the top down (demand-pulling).

Such activation as may occur nevertheless has fallout less for activation per se than for improved regulation in general. Thus, for example, a hyperactive anterior cingulate was found to normalize with the exposure, as witnessed in SPECT scans. This is just another straw in the wind that we must regard this work from a network rather than a blobology perspective.

The Think Tank meeting also featured a presentation by Dr. Robert Sinaiko, who referred to himself as a “recovering allergist.” Dr. Sinaiko has just successfully emerged from an eight-year siege by the California Medical Board in a proceeding so scandalous that it defies dispassionate description. Briefly, Sinaiko introduced Enzyme Potentiated Desensitization (EPD) into his allergy practice, a technique well known in England and elsewhere in Europe. It has the support of double-blind studies published in Lancet. Sinaiko even went to Europe to receive specific training in the technique, and became one of some 90 docs who adopted it in the US in that timeframe. He employed this technique for over a decade while the research basis for it continued to grow.

I met Dr. Sinaiko early on in our work, probably in the late eighties, and he often referred his patients to our San Francisco office for neurofeedback. “I’ll take care of their physical needs, and you take care of their brains…” He was intensely interested in our work. We also had a major client in common: the Stanbridge Academy, then in Palo Alto, where he consulted along with other forward-looking MDs.

In connection with EPD, Sinaiko often prescribed anti-fungals, and on occasion the less commonly prescribed oral form of amphotericin B. In ring two of the circus, enter the father of a child in treatment with Sinaiko. Sinaiko had repeatedly urged the father to come in for consultation regarding his child, but that never happened. A nasty divorce proceeding was underway. The father claimed disability, and further apparently claimed an increment in his disability pay on the basis that he had custody of his two children. Only he did not have such custody…. He therefore initiated a proceeding to have his wife declared an unfit mother in order to rectify that deficit, and he placed in evidence the fact that his child was undergoing unorthodox treatment under Dr. Sinaiko with the consent of the mother. In support of his case, he inquired with the FDA as to the status of “amphotericin B.” There was no problem here, but as a matter of routine, the FDA sent a copy of their response to the CA Medical Board.

And in ring three of the circus, the CMB put Sinaiko through an eight-week, 26-days trial before an administrative judge, alleging that his practice deviated from the “standard of care” in California. Sinaiko presented a host of nationally recognized experts who testified to the safety and efficacy of his treatments. They also testified that his course of practice was all legal under the FDA operative law. The FDA, incidentally, had never indicated otherwise. In fact, Sinaiko’s work was being done under an operative IRB, even though that was not even necessary. He was, in fact, being scrupulously cautious in his work.

Following the hearing, the Administrative judge ruled all of Sinaiko’s experts were not qualified, and he dismissed their testimony. He ruled against Sinaiko, recommending that his license be revoked, and fining him $100,000 in litigation fees. So the judge even wanted Sinaiko to pay for this kangaroo court. One is reminded of the old custom of paying the executioner for a clean, swift cut, and of Saddam Hussein’s custom of charging the family for the husband’s burial. Even Galileo would have been horrified to be a spectator at this “trial.”

In September 2004 the Court of Appeal ruled unanimously that the Medical Board had violated Dr. Sinaiko’s rights to due process by summarily rejecting the testimony of his many expert witnesses. The Court vacated the ruling against Sinaiko. On February 17, 2005, the CMB reinstated his license in good standing, and with no record of discipline. No fines were ever paid. The condition exacted by the Board in exchange for the reprieve was that Sinaiko would not move against the Board to seek recovery.

Sinaiko’s case at trial had been supported by people such as the following (all MDs):

The former Chancellor of UCSF and Secretary for Health; the Chief of Adolescent and Child Psychiatry at Langley Porter Psychiatric Institute; the Dean of the School of Medicine at UC Berkeley; the Editor-in-Chief of the Ear, Nose, and Throat Journal; plus numerous others. None of them were taken seriously. None of them succeeded in forestalling the railroading of this caring doctor.

Sinaiko reflected on his experience for the benefit of the assembled:

First of all, there was no complaining patient. Not even the father had complained. The Board operated entirely on its own initiative, in violation of its own procedures. The Medical Board newsletter says in black and white: “If there is no patient injury, there is not going to be a prosecution….” At most, there would be a “level 3 intervention” (no discipline; no entry into record). The prosecutor in Sinaiko’s case did not even know what a “level 3 intervention” was!

Said Sinaiko:

“It’s a political process that does not have much to do with truth, or with science.”

“They respond to political realities, not scientific ones.”

Once you are in their crosshairs, “you need to be able to go to your friends.”

“Collective, strategic action is needed in the moment.”

The Board does have literature on how to stay out of regulatory difficulty. None of this would have made any difference in his case.

The Board in particular will not provide rulings on what constitutes accepted practice.

Doctors get entrapped because the rules are unascertainable.

Everyone has the right to petition a public agency, so Sinaiko did. The response:

“We have considered your petition and decided not to consider it…”

The risk lies entirely with the practicing doc. “Compliance is the issue,” it is said, but compliance with what?

Finally, Sinaiko said, “We need to shift the scientific paradigm. All this knowledge and skill mean nothing if we continue living in fear.”

The good news is that mainstream thinking is finally coming around on autism. The “Autism Treatment Network” has been started, a consortium of six major institutions:

1. Harvard U
2. Cleveland Clinic
3. Columbia U
4. Mass General
5. Baylor U
6. U Washington

Said Margaret Baumann, MD: “I frankly feel guilty that it took me so long to realize [that there are real medical issues associated with autism].”

A couple of years ago, the common wisdom was that “…there is nothing going on medically with these kids.”

The medical elite had fulminated: “We have to get these alternative doctors. What they are doing is so dangerous. They are giving the children vitamins and minerals and Acidophilus….”

The change in tone at the organizing meeting was palpable:

Said a director at the NIMH: “The parents have been right. The doctors have been wrong.”

Tom Insull: “The parents have lapped us several times, and we have to catch up.”

Said another: “We should have had Wakefield here.”

In reflection on these hopeful developments, the DAN Think Tankers said: “These people are now where we were in 1995.” And DAN also had Wakefield….

Andrew Wakefield came to give the keynote address at this DAN conference. He is now in professional exile from his native England, operating out of “Thoughtful House” in Texas, having been banished from England for his warnings on the combined MMR vaccine. His presentation was stunning. First of all, he is a very impressive personage on the stage, looking almost too young for all his accomplishments. He showed incredible mastery of a lot of material, and it all just poured out of him. His ruddy British complexion and good looks no doubt charmed his mostly female audience. He recited the various efforts to stop his research in its tracks, reaching all the way even to his activities in the US.

He has lately been pursuing the hypothesis that active measles virus may be surviving in the CNS of some autistic children. Cerebral spinal fluid needed to be drawn for testing. This was not possible in his native land under the circumstances, so he arranged to have the fluid drawn here in the United States. Believe it or not, legal proceedings were initiated to prevent the undertaking of this procedure even in this country. In a continuing cat-and-mouse game, an injunction was obtained to prohibit the procedure. For specificity, the hospital was named in the injunction. In response, the researchers simply made arrangements with another hospital. The CSF was placed in a liquid nitrogen dewar for travel out of the country. Since it could not go into the hold, a first class ticket was purchased and the dewar was dutifully secured with the seatbelt in the seat next to the doc in charge. Alas, the ordeal was not over as the gendarmes had been alerted to the heist of CSF and stormed the plane. Eventually sanity ruled and the plane was allowed to depart with its precious cargo of cerebral spinal fluid aboard.

The larger story of regulatory overreach

Somehow all of this regulatory overreach–with respect to Sinaiko, Wakefield, and Mumper–should at some point trigger some alarms. How can we get things so badly wrong for so long? Let’s see how things have fared in our own field:

At random I picked out the Journal of Neurotherapy, Volume 3, #1, for the summer and fall of 1998. Dan Chartier is listed as the incoming President. He was one of the first to be attacked by his Board of Psychology in North Carolina for doing neurofeedback for ADHD. It cost him more than $17,000 in actual cash to defend himself, not to mention the disruption of his practice, the psychological burden, and the distractions of mounting a defense. Keith Connors was a consultant to the Board on this matter, in hot pursuit of this rogue practitioner.

Daniel Amen is listed as a Consulting Editor. The CA Medical Board tried to put his lights out for quite a while for doing SPECT scans on psychiatric cases. I have no idea what disruptions to his life where caused by this mindless interference. Said Amen: “Psychiatry is the only branch of medicine that does not look at the organ it treats.” Yet he was the one in trouble for doing so.

Another consulting editor listed is Nancy White. We recall that the FDA sent its emissaries to her office to abscond with her Lexicor mapper, making an example of her to intimidate all other Lexicor users and the company. No issue was ever raised by the FDA against Nancy White or against the nature of her practice. The instrument was physically destroyed. The President of the company received a bill for $750,000, matching a bill also received by the company. The FDA in this case served as prosecutor, judge, and jury, and the persons at issue were not even there to defend themselves. Nor did they have their own advocate at these proceedings. Even Ken Lay has it better than that.

Another consulting editor listed is Eric Braverman, MD, whose license to practice medicine was also under threat in New Jersey for some while. His medical practice survived the assault.

Yet another consulting editor was Louise Norris, who was challenged for hiring an MD (among other things), which a psychologist is not supposed to do in New York State. She left the state for other parts.

Finally, Jonathan Walker, MD, is listed as a Member-at-Large for the incoming Board of the SSNR. Some years ago he was challenged by his Texas Medical Board for practicing neurofeedback. He solicited my help at the time in locating other MDs around the country who also practiced neurofeedback and who might therefore support his position.

I called Paul Swingle for advice. He was at McLean Hospital at the time, doing biofeedback in the full light of day, and I supposed that he would have support for doing so among his medical colleagues in Cambridge. Replied Paul Swingle in his acerbic tone: “Not only do I not know of any MDs doing (bio-)neurofeedback competently; I don’t even know any with whom I could have an intelligent conversation about it.” Paul is now in Vancouver, running a huge biofeedback/neurofeedback practice, quite possibly the largest to be found anywhere in the world.

I could list other attacks on MDs and psychologists that have occurred over the years around neurofeedback. There was the challenge to Tanju Surmeli, MD. in Turkey, for example, and the challenge to Jamie Deckoff-Jones, MD, in Massachusetts. All these challenges were turned back successfully, but they hang over the persons involved like swords of Damocles.

Has any of this served the cause of better medicine and better psychology? Not as far as I can see. When will it be recognized that the eunuchs guarding the temple of knowledge will be forever infertile. They cannot create; they can only negate. It would be one thing if the medical vigilantes were even-handed across the board. But consider what happens with a real medical scandal:

I happen to have personal knowledge of a case in which parents of a severely impaired child were found to harbor genes for an enzyme deficiency affecting myelination. A medical colleague at UCSD offered to do an assay on amniotic fluid to test for that enzyme deficiency. Even though this had never been done before, he offered sufficient assurance that the parents were willing to risk another pregnancy. The result was the same as before, only with somewhat moderated severity. The child was majorly autistic.

Years later, a legal proceeding initiated by the parents against the doc resulted in a settlement paid for by the University of California. The terms remain secret. The man’s career was apparently entirely unscathed, and to my knowledge there was never any ethical proceeding on this breach of medical ethics, and no public disclosure of a violation. That’s how things work on the inside.

The scientific product in medical research has become retrospective in orientation. It values nothing but the finished process. It goes in theta function from uninhibited hazing prospectively to fawning obeisance to the frozen literature (“Scripture”) retrospectively.

Psychology can indeed limit its practitioners in any way that it sees fit. But it cannot be allowed to take neurofeedback with it. The “Verkrampte” who are sustaining this scientific apartheid between the “true and virtuous” science and the unwashed scientist/practitioners out in the Bantustans must be resisted at every turn.

With regard to Medicine, it is quite clear that Big PhRMA has its fingerprints all over this, both with regard to the mis-management of autism and with regard to the assault on neurotherapy and neurofeedback. The pharmacological enterprise has hollowed out our regulatory agencies, perverted our science, corrupted the National Institutes of Health and other government agencies, infiltrated the academic sanctum of our universities, and robbed the public of its entitlement to comprehensive medical care. Collectively, its earnings amount to 17% of sales, the highest of all major industries. There may be no larger or more pervasive criminal enterprise in our nation’s history than this. And practically everyone who matters to them up and down the chain has one hand on the goose that lays the golden eggs.

The Halloween effect

Last Wednesday two siblings came in for retesting after twenty sessions. Both had made nice progress. When the TOVA results poured out of the printer, however, the data showed a decline in performance–in both cases. The clinicians were mystified, and the parents were queried at length. The most likely suspect was the candy at Halloween. Indeed the children had overdosed on it. Here was another object lesson on the effects of a sugar challenge to our vulnerable population. Food colorings, etc., could obviously also be involved. In future, we will allow the Halloween effect to subside before retesting.

Nuggets

• “The discovery of ascorbate (Vitamin C) is one of the landmarks of evolution, comparable in importance to light and oxygen…”
  • Albert Szent-Gyorgi
• At DAN I met a mother of four with one autistic child. The father had fled long since. The child became autistic immediately after 8 vaccines at one session, delivered by an HMO. The child had missed a previous appointment, and needed to catch up…
• Steel mills alone shipped 80m pounds of toxic waste to fertilizer companies in 1995.
• A spill of 10lb of phthalates is reportable under Superfund law, but 100,000 lb are delivered to end users in cosmetics every year.
• Average breast milk PbDE approaches the thyroid toxic dose.
• Perchlorate: breast milk levels are in the neighborhood of 10ppb versus 2 in cow’s milk.
• Pesticide mix at average human dietary intake levels produces neurotoxic effects in rats.
• The largest export year for DDT was 1992, decades after the substance could no longer be sold or used in the US.
• The average person today is carrying a thousand times as much lead in their bones as prehistoric man. Pregnant mothers who do not get enough calcium will leach lead out of their bones.
• “The greatest resource we have is angry parents”

Resources for Toxic Loading:

• In Harm’s Way, Boston Physicians for Social Responsibility
• Fateful Harvest, by Duff Wilson
• Our Stolen Future, by Theo Colburn
• Deceit and Denial, by Gerald Markowitz and David Rosner
• Less Toxic Alternatives, by Carol Gorman

Artwork is by the adult son of Bernard Rimland.
The son is in the autism spectrum, and was the reason that Rimland became interested in autism originally.

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