A letter to the food and Drug Administration
11 EAST 67TH STREET
Office: Regent 7-4425
Residence: Regent 4-6526
Food and Drug Administration
Bureau of Drugs, Office of
Scientific Evaluation
5600 Fishers' Lane Rockville, Maryland
Gentlemen,
Following the suggestion of Mr. Arnold M. Keller who came to supervise my methods of treatment of obesity on account of the fact that I was a consulting physician for the Anushka Institute, I am writing the present letter.
I am a licensed physician in the State of New York since 1941, But I was originally born in Paris in 1900. I was trained in the University of Paris and had an official position in the Frencll Hospitals of which I am a corresponding member in New York, as an Internist specialized in nutrition. I am a fellow of the New York Academy of Medicine, and of Sciences, have published three books, and over 50 medical publications in scientific periodicals.
This is to tell you that I am very classical in my methods of diagnosis and treatment for the handling of the problem of obesity through mostly correction of nutrition and exercise without the addition of any medicines. But there are some localized forms of abnormal localized fat locked in water tight compartments throughout the connective tissues and poorly named "cellulite" for which the present letter and discussions arise.
To make things clear to you before discussing any variety of superimposed treatment necessary in those cases I herein enclose the summing up of my views on cellulite since its very existence seems controversial, : "Cellulite does exist"!
As you will see following the enclosed paper, some supplementary treatment is almost always necessary to mobilize that unavailable fat which is like isolated in almost cystic formations containing just water and fat. Usually a special variety of massage and mobilization "Bindegewebe"(as the German authors call it), is sufficient with the diet and the exercise to get rid of these deposits.
Sometimes on the contrary, some added measures are needed such as the direct injection in the interstitial tissue of "dissolving enzymes".
I herein enclose for your own investigation the thiomucase pamphlet which constitutes precisely one of these enzymes which is extensively used in Italy, France, Switzerland, Germany, and in this hemisphere in Argentina and Canada.
In a recent interview, the Commissioner of the FDA, Dr. Alexander H. Schmidt emphasized that, "We have the dual responsibility to impede bad Drugs from getting on the market, and not to impede good drugs from getting on the market".
It is under the sponsorship of these principles that I apply for the investigation of this drug old in Europe, but new in this country. In France where the Social Security is as strict as the FDA for the acceptance of drugs, it has been not only extensively accepted, but it is even refunded to the patient when prescribed.
At any rate it is a logical drug since the fundamental substance of the connective tissue is made of mucopolysaccharides which are normally depolyrnerized by the corresponding enzymes mucopolysaccharidase; which liberate water and fat: this represents indeed a physiological basis, and the action of these enzymes can be chemically evaluated by the measure of their hyaluronidasic and chondroitinasic activities.
Contrarily to the Solac Laboratory pamphlet I have not found any definite clinical result of thiomucase either in suppositories or in the intramuscular injections, for the treatment of "cellulite".
I have therefore limited myself to the focal treatment cellulitic infiltrations by direct infiltrations of the thiomucase in the subcutaneous tissues, as per schematic photostat drawing enclosed.
I dissolved the content of one ampule of thiomucase in 8 cc of distilled water, and 2 cc of a xylocaine 0.5% aqueous solution, using a 2 inch needle of 25 gauge specially made for my usage. After these infiltrations the diffusion is increased by electric ionisation.
As all of the foreign authors have noted and published, I have had no accident or incident whatsoever after using those techniques in the last two years, and see no contra-indications.
In short, thiomucase is certainly not a harmful drug and it is certainly in the majority of cases a useful drug. At worst it does nothing when the indications have been misjudged. It is therefore following Dr. Alexander M. Schmidts' principles above mentioned and under these double "aegis" and double directive that I hereby respectively submit this application for the official introduction and utilization of thiomucase in the United States. . .
Furthermore I wrote already directly to the Solac Laboratory- 195 Route D'Espagne, 31023 Toulouse, France to send me a duplicate of all the literature they have to satisfy all possible information you may desire to make this application successful. Having said the above I do not need to add that I am at the total disposal of your administration to participate actively in this research. Since all of my patients are completely checked up clinically, as in a hospital, with a chemical profile and 4 glandular tests performed by the UpJohn Laboratories.
I firmly believe that under such circumstances the best experiment is indeed an accurate clinical observation.
As you can see, I am yours
Very Sincerely,
P.S. - Of course, I told all of my patients who requested the treatment and who brought me these imported drugs, that it was not yet accepted in the United States by the Food and Drug Administration and therefore I had them sign a kind of experimental release, of which I enclose a photocopy.
