You can see the first three posts covering Dr. Turkel's book here, here and here.
Because Dr. Turkel had seen such great results with the "U" Series, he decided to try to get the FDA to approve it. Doesn't seem like it is that big of a deal, but it was such a huge deal, that it eventually cost Dr. Turkel the ability to be able to use the "U" Series.
Besides the problems Dr. Turkel received from the FDA, he also received many negative responses from many other national associations.
Back on Page 8 of the book in Dr. Bernard Rimland's Foreword, he wrotes,
Supporting Dr. Turkel's position that the "U" series is effective are the reports of dozens of other physicians around the world who have used the treatment successfully, including some 50 U.S. physicians who were using it until the U.S. Food and Drug Administration (FDA) arbitrarily interposed itself between the doctor and the family of the sick child and forced the doctors to discontinue the treatment.
These are the pro-Turkel arguments. You will agree, I think, that until conclusive contrary evidence is produced, until some evidence turns up showing that the treatment does not work or is harmful, any physician who wishes to use the treatment to try to help his pathetically helpless patients should be permitted to do so. Surely, one would think, it would take substantial and convincing negative evidence to withhold the use of this harmless, promising treatment when there are no alternative methods and the disorder is so devastating.
There is no substantial and convincing negative evidence. There is only one study in the world literature which questions Dr. Turkel's findings, and it is a trivial, improperly conducted, and inadequately reported study.
It is trivial because only twelve children were in the experimental treatment group. So small a sample can lead to findings which are suggestive but not conclusive, even if the study were properly done. It was improperly conducted because, among other shortcomings, it did not follow Dr. Turkel's specifications for the "U" series drugs it was supposed to be evaluating. For example, the investigators included vitamin D in their version of the "U" series drugs and vitamin D counteracts the effects the Turkel treatment is designed to achieve!...Note the authors of the negative report did not report any adverse effects on the children - they said simply that the treatment did not help.This is a small sample of the problems the FDA caused Dr. Turkel. In 1982 Norway accepted the use of the "U" series and the Japanese were able to import the "U" series from Europe, because the FDA refused to let the Japanese import it from the United States. Both Norway and the Japanese had tremendous results!
But, Dr. Turkel still had resistance from the FDA and NIH, which started years prior to this. On page 133, Dr. Turkel writes,
Dr. Richard Masland, Director of the National Institute of Neurological Diseases and Blindness, stated in a letter to the President of the Valley Association for Retarded Children (Connecticut):
'A serious problem related to the evaluation of such a treatment is the fact that it requires the treatment of a rather considerable number of children observed over prolonged periods of time to achieve a valid conclusion'
(January 8, 1962)
The National Institutes of Health (NIH) have not, to date, found a single investigaor willing to conduct a study, even though a considerable number of children have, in fact, been treated and observed over prolonged periods of time. Since the scientific community requires studies, the NIH could be conducting them (page 134). However, the NIH have generally failed to acknowledge the existence of treatment.This is essentially the bottom line to Dr. Turkel's problem with the FDA, NIH and many other organizations: failure to acknowledge the existence of treatment.
Dr. Turkel continues on page 135,
Articles have been published in lay and professional journals about the "U" Series, and the medication has been mentioned in numerous books, in many languages, particularly Japanese and Norwegian, as well as English. However, the NIH published their own bibliography without mentioned The "U" Series or any of the other then-current therapies; evidently, the priorities of the Federal government do not include treatment.
The larger voluntary health organisations (sic) have also not been receptive toward treatment of Down syndrome. The Foundation for Infantile Paralyisis - March of Dimes elected not to close shop when polio was conquered. After entering the field of birth defects, March of Dimes promoted prenatal screening as the answer to the problem of Down syndrome (if the pregnant woman is in a high-risk group). However, after a Down syndrome child is born, help to the family is insufficient. It is expensive to raise a mentally and physically handicapped child. Additional emotional and economic support should be made available.In Dr. Turkel's quest to find someone willing to do research on the "U" series in people with DS, he talked to the National Association for Retarded Citizens.
...NARC headquartered in Texas) announced that "Big Dollars" were needed to find treatment for Down syndrome. None of this research was aimed at perfecting available therapy. NARC is to be commended for bringing retarded citizens into the mainstream. A less dogmatic attitude of its research teams about nutritional therapies would also be helpful to patients.
For reasons that NARC has not clarified, in 1956, when I presented my findings to Dr. Gunnar Dybwad, Executive Director of NARC, intending to give over the "U" Series without cost, Dr. Dybwad told me that NARC was "not interested"Dr Turkel was rejected for trying to get research done on the "U" series and the national associations simply refused. And in doing so, they also accused Dr. Turkel of exploiting families and unethical behavior for presenting medical findings to people who were not physicians. One of those people who he showed his findings to was Dr. Dybwad and also a nurse who attended a meeting.
As he writes on page 138,
The emphasis that larger organizations place on basic research is easy to understand. However, through the years, some of these organizations have been particularly negative about ameliorative therapies.
...There is a remarkable lack of scientific curiosity about medical therapies. Scientists want to find a basic solution, a method of removing the extra #21 chromosome from every cell in the body. But parents of newborn Down syndrome infants are still being told, "Nothing can be done. Institutionalize them." The handicapped infant's right to live has become controversial.He continues on page 139,
The possibility of improving the overall condition of the Down syndrome patient may also alter the pessimistic view of American parents and physicians.That is still a problem today, unfortunately. Even though Dr. Turkel fought long and hard for the help of patients with DS, there is still a "fear of supplemention," if you will. I just wrote about this in the "Afraid of Change?" post a few days ago.
Dr. Turkel compares his treatment with the "U" series as the treatment for PKU. On page 140 he writes,
This situation may appear as hopeless as that encountered in Down syndrome but physicians have not abandoned the possibility of treating the patient. On the contrary, laws have been passed requiring neonatal diagnosis so that the disease can be treated early in life, preventing much of the damage and retardation.So, because of this commonly accepted treatment to ameliorate the problems caused by PKU, why did Dr. Turkel receive such negative responses to his "U" Series?
Even Dr. Jerome Lejeune who discovered that DS was caused by a triplicated 21st chromosome, used supplementation to help people with DS. On page 170 of the book Dr. Turkel says,
I believed then as now that amelioration of Down syndrome was a worthwhile goal. When I met Dr. Lejeune at an international convention in the Netherlands in 1963, I was stunned by Dr. Lejeune's question, "Can your patients do cube roots" (sic) Now that inexpensive calculators can perform that function, this feet possibly seems less impressive: Dr. Lejeune treats Down syndrome patients with some of the same vitamins and other nutrients included in the "U" Series. For 20 years, however, improvement of ameliorative therapy was forestalled by the medical opinion that failure to cure a disease somehow diminished the importance of treatment.Dr. Turkel mentions one of the reasons he received such criticism above, but you can see more of it in these two quotes from pages 172 and 175,
The medical consensus that there were no metabolic imbalances in Down syndrome was so deeply entrenched that as recently as 1977, some medical students were still being taught that the extra genes encode structural defects before birth and then "turn off". It is now recognized that a third copy of one whole or partial extra chromosome disrupts homeostasis and all functions.
...Dr. Frank Menolascino has noted the difficulty of designing studies to test the intelligence-enhancing effects of drugs. He has pointed out that therapy "to enhance the intelligence of a college student would be expected to improve his learning, memory, and general performance. A moderate and gradually accumulating effect would be considered desirable and quite acceptable. However, with a retarded person a drug is often scorned if it produces anything less than a complete and perhaps even a rapid 'cure' -- unless it produces 'normality.'" This point is applicable to the GTC Formula as well as the "U" Series.
This gives insight into the struggle Dr. Turkel dealt with continually. In the next post, I will share the struggle he had with the FDA and the ruin they caused him.