Quackery in the Medical Device Field
Kenneth L. Milstead
I am honored to be selected to appear on this program to present a special report from the Food and Drug Administration on Quackery in the Medical Device Field. I share this honor with several of my associates who have participated in our program against devices—Dr. Joseph B. Davis, Dr. Martin Dobelle, and Mr. Robert J. Kennedy of the Bureau of Medicine, Mr. John T. Cain of the Bureau of Enforcement, and Mr. Gifford Hampshire of the Division of Public Information. So, while I will make the presentation, it should be understood that this is an institutional report which has the approval of the Commissioner of Food and Drugs.
October 25, 1963
I should also like to call your attention to the report on Fake Medical Devices prepared by our Division of Public Information. This report is a catalogue of regulatory actions covering devices since the first Congress and a supplement to this paper. We are sure that a casual review of this report will impress you with not only the magnitude of the problem of quackery in devices, but will elicit from many of you that shopworn expression: "Why don't they do something about it?"
We do. Since the passage of the Federal Food, Drug, and Cosmetic Act in 1938, which brought medical devices under Federal control, interstate traffic of hundreds of such articles has been stopped. Some of the most notorious swindles of all times were exposed in these court actions. I need only mention Dinshah Ghadiali and his Spectro-Chrome device, Wilhelm Reich and his Orgone Accumulator, Ferguson and his Zerret Applicator, uranium pads and pillows, the Cosmic Ray Radiator, the "Magic Spike," Farmer Brown's Master Cell, etc., etc. In addition, hundreds of misbranded "do-it-yourself" devices have been removed from the market or have had their labeling changed to eliminate false claims. These include vibrators, massagers, air purifiers, negative ion generators, bust developers, sandals, whirlpool baths, muscle stimulators and many others.
During the past 24 months FDA has seized 111 different types of misbranded or worthless devices. This involved 15,070 individual units.
During the 12-month period alone ending June 30, 1963, 54 different types of bizarre diagnostic and treatment devices were seized in 358 seizure actions. This involved a total of 7,986 devices. In addition, 832 devices were voluntarily destroyed, making seizure unnecessary.
While this is significant progress in dealing with fake medical devices, there is much more that needs to be done, and we need your help. We hope that this paper will stimulate all of you to reexamine your efforts and to get in this device fracas with us, for with determined effort and enlarged courage on the part of all enforcement officials, we are confident that this is a health fraud that can be greatly minimized.
In March of 1962 the United States Court of Appeals for the Seventh Circuit in Chicago, in affirming the decision of the lower court enjoining the interstate distribution of the Ellis Micro-Dynameter device, stated:
The Micro-Dynameter is not safe for use even in the hands of a licensed practitioner. A device whose labeling claims it to be an aid in diagnosing as many diseases as this one, when in fact it is not, is unsafe for use no matter who uses it."
The decision continued. . .
In finding the labeling false and misleading, the District Court set out a list of some 55 diseases and conditions which defendants claimed their device would be “adequate and effective for diagnosing.” These run the gamut of most of the ills affecting “the health status of man.” The Court further found that the labeling made false and misleading representations that the device “shows what is actually going on down deep in the tissues of the body”; that it "provides the practitioner with the ability to restore at least 80 percent of previously unhelped cases to health by following its indications."
The Court concluded. . .
With apparent good cause the government argues that the defendants' device is of the "quack" variety. There is sound reason in fact and in law for the issuance of the injunction in the form and manner determined by the District Court for the protection of the public.
This landmark decision based on scientific evidence brought an end to the distribution of the Micro-Dynameter, a simple device surrounded by an aura of legitimacy that has caused incalcuable harm.
Perhaps even more important, the decision marked the beginning of the end of an era of quackery which has thrived in this country for more than a century. This era might be referred to as the Electro-magnetic Era of Medical Quackery which had its beginning in the theories of Dr. Elisha Perkins.
In this paper we will trace the development of this era of quackery and identify those who have played a prominent role in it in the past and who seek to perpetuate this form of quackery now.
From this review, we hope will come a better understanding and appreciation of the problem of quackery in the medical device field and improved laws and procedures for dealing with this evil. For the tentacles of quackery are long and devious and penetrate deep into our society. From an enforcement standpoint, our objective is to cut off the tentacles one by one through the application of science and law and ultimately to destroy this Octopus of Fraud called quackery that feeds on ignorance, fear, and the suffering of man.
Dr. Elisha Perkins was one of the first to exploit the mysteries of magnetism and electricity to treat the sick. In 1796 he patented his metallic "tractors" consisting of two pointed rods about three inches long, made from different kinds of metal. By pulling them downward over the affected part, the disease was supposed to be yanked out. President Washington was one of his customers. Hundreds of educated people believed in the Perkins theory, including doctors, ministers, and members of Congress.
Dr. Perkins' theories were widely disseminated both in this country and abroad. They still persist today. We see them in the magnetic belts, magnetic bracelets, and many types of complicated-looking but scientifically simple contraptions which continue to be promoted by misguided or dishonest persons for the treatment of diseases.
There is no scientific evidence to support the theories of Dr. Perkins, and all devices based on his theories are considered worthless for any medical purpose. We are removing them from the market whenever and wherever they are encountered.
In the decades following Dr. Perkins there were others who endeavored to capitalize on the magic of electricity and magnetism. But the 19th century was very much the era of the patent medicine and it was this form of quackery which developed to its maximum of popularity. The advent of the telephone and the electric light provided a background for the promotion of gadgets like the "Electropathic Corset for the Ladies"—a boon to delicate women and all who sutTer from organic diseases, rheumatic affections and weak back. Addison's Galvanic Electro Belt was promoted to the men—"for lost manhood there is nothing like electricity." At the end of the century Dr. Hercules Sanche developed his Electropoise and Polizer to aid the "spontaneous cure of disease." His Oxydonor was a Polizer containing an added stick of carbon. For this improvement the price went up from $10 to $30.
In the early part of this century Dr. Albert Abrams of San Francisco, who has been described as the "Dean of All Twentieth Century Charlatans," originated his system of "Radionics" which was based on the pseudo-medical theory that electrons are the basic biological unit and all disease is a "disharmony of electronic oscillation." Dr. Abrams developed both diagnostic and treatment devices to adjust these oscillations. He operated his phony business under the sophisticated name of the "College of Electronic Medicine" before there was a federal law controlling devices. Through the "College," Abrams was able to expand his profitable operations on a nationwide basis. And, just as Perkins had cashed in on popular interest in the new science of electricity, so Abrams cashed in on the popular interest in the new field of radio communications. He died in 1924, leaving an estate estimated at $2 million.
Following Abrams' death, his clinic and other operations were taken over by Fred Hart and operated as the Electronic Medical Foundation. Mr. Hart, who has no scientific training, carried on Abrams' thriving business and placed hundreds of expensive diagnostic and treating machines in the offices of practitioners throughout the country, where they are still being used. Here is how the business was conducted: The practitioner would mail a sample of blood on a piece of blotting paper to the clinic in San Francisco, where it would be placed in a device called the "Radioscope" which was supposed to measure the "emanations" associ—ated with different diseases given off by the dried blood. This device is a box containing dials, lights, and wires, and a slot in which may be placed a specimen carrier of filter paper bearing dried blood of the patient. Metal plates connected with the box were held by a person who was designated the "reagent" and who was supposed to serve as a "detector" for the radiations allegedly emanating from the blood spot. The operator of the machine would stroke the abdomen of the "reagent" with a plastic wand. If the wand "stuck" to a particular location, that was supposed to be a manifestation of an "electronic reaction," and the operator allegedly could determine from this the identity, kind, location and significance of any disease present. Readings from this machine were sent back to the practitioner on a postcard, telling him the disease his patient was supposed to have and the type of treatment to be given by one of 13 different "treatment" machines the practitioner had previously purchased. These treatment machines were basically of two kinds:
(1) devices producing a weak magnetic field, and
(2) devices emitting short-wave radio frequencies.
Neither type of device has any value in the treatment of disease.
Just five years ago, in 1958, the District Court in San Francisco entered an injunction which prohibited further distribution of 13 types of medical devices by Fred Hart and his Electronic Medical Foundation. A comprehensive investigation of the machines by the Food and Drug Administration showed them to be complete fakes; they could not distinguish between colored water and blood, or the blood of a living man from that of a dead man. Blood submitted from an amputee resulted in a report of arthritic involvement in the right foot and ankle which the man had lost several years before. Blood from a rooster resulted in a diagnosis of sinus infection and dental caries. Fred Hart stipulated to the injunction, but later violated it, for which he pleaded no contest and was fined S500. The Electronic Medical Foundation has been dissolved and Mr. Hart has moved his operations to Monrovia, California, where he now directs the operation of the National Health Federation.
Although we have stopped the distribution of devices by the Electronic Medical Foundation, our job is not complete, because there are hundreds of these worthless devices still being used. They are illegal. The practitioners who are using them should promptly discontinue their use and either destroy them or dispose of them for non-medical purposes. We cannot overlook the continued swindling of people who are led to believe that they are receiving competent medical care when they are treated with one of these devices. Their names are:
Regular Push Button Shortwave Oscillocast Sweep Oscillotron
Sinusoidal Four-in-One Shortwave Oscillotron Galvanic Five-in-One Shortwave Oscillotron Depolaray
New Depolaray Junior
The devices distributed by Perkins, Abrams, and Hart spawned many others which are equally inimical to the public health. The most direct descendant of the Perkins "tractors" today is the Micro-Dynameter. This device is a galvanometer mounted in an impressive cabinet. On its face is a scale or meter to measure in milliamperes the flow of current, together with a number of dials which can be set at numbered or lettered positions. The current which flows, and is measured by the scale or meter, is generated by closing the circuit between two dissimilar metal "probes." The circuit is closed by placing the "probes" at different points on the human body.
In actual operation, the patient holds in his hand a combination electrode (or "probe") consisting of a silver pole and a zinc pole. A lighted needle then moves across the scale on the face of the device. The reading obtained is the "Potential Energy" or "Vital Reserve" of the body. A second reading, obtained by adjusting the knobs on the face of the cabinet, is the "Metabolic Index," and supposedly measures the "exchange rate of cellular waste and nutriment" in the body. The final reading, obtained with the same knob settings as the “Metabolic Index," but after the patient takes a deep breath, is the "Oxygenation Index."
These readings are recorded on a card, and by drawing lines between the points indicated two other values are obtained-the "Dynamic Energy" and the "Health Index." These are claimed to show the general state of the health of the body.
With an electrode of antimony alloy placed on the tongue and an iron electrode on the arm, the patient's "Acid/Alkaline Balance" is determined. In other tests, one electrode is held in the patient's hand and the other moved to various areas of the body. High readings are claimed to indicate areas of pathology.
In general, the claims for the machine are that it can discover changes in living tissue by measuring electrical current produced by such tissue changes.
Carefully controlled tests showed that the amount of current flowing between the electrodes of the device was due to the amount of perspiration on the skin and was not dependent on the health or diseased condition of the body.
Commissioner Larrick has reviewed our action against this device which resulted in the historic decision referred to previously. While more than 1,000 of these devices have been taken out of medical use, we know that a considerable number are still in use and we are continuing our investigation to locate them and place them under seizure. We again call on persons now using this worthless and illegal device to cease using it and to dispose of it for non-medical purposes.
The Toftness Clinic at Cumberland, Wisconsin, has been distributing several models of an electrical device manufactured by Electronic Instrument, Inc., of Tiffin, Ohio. It too is based on Abrams' theories of the diagnosis or "analysis" of disease. The Neurolinometer, or "blackbox" as it is frequently referred to, consists of a monopolar electrode, a power supply and a single stage amplifier connected to a wire mesh below a Bakelite plate. In use, a metal disk attached to a handle is passed up and down over the spine. It is claimed that this disk is capable of detecting nerve impingements along the spine, indicative of disease conditions elsewhere in the body. Minute nerve impulses are claimed to be transmitted through the disk to the Bakelite detecting plate. The operator of the device rubs his fingers over the plate and is supposed to detect a "stickiness" when the disk passes over any bad spot along the spine. The trouble spots are then treated by various methods. Electronic Instrument, Inc. distributed several other devices which varied in size and shape but in general had an impressive appearance with panels of lights, rows ot switches, control knobs, and electrodes. Some are supposed to measure elec—trical frequencies emanating from diseased areas of the body although there is no scientific evidence of the existence of such electrical frequencies. Treatment is often given through a high frequency electric current in harmony with the allegedly measured frequency. The patient may feel a tingling sensation from the current with some of the machines.
In April 1962, a federal court order was entered in the District Court in Toledo prohibiting further distribution of seven devices by Electronic Instrument, Inc., Tiffin, Ohio, Dale C. Mowery, its president, and Helen R. Mowery, its secretary and treasurer. The devices are:
Electron-O-Ray Model 51
Radioclast Model 40
Radioclast Model P
Radioclast Treating Unit
Electron-O-Ray Model 46.
Again one of the tentacles of quackery was severed by the court order, but sick patients continue to be treated with Toftness devices in the possession of health practitioners throughout the country. We are in the process of rounding up these devices. Fifty-four Neurolinometers have been seized and 21 voluntarily destroyed.
All practitioners who are using any of these devices for the diagnosis and treatment of disease should discontinue such use and dispose of the devices for non-medical use. They are worthless for the diagnosis or treatment of any disease and are illegal if used for this purpose.
Perkins, Abrams, Hart, Electronic Medical Foundation, National Health Federation, Ellis Research Laboratories, Inc., Electronic Instrument, Inc., the Toftness Clinic, but this is not all.
Lester L. Roby, Sr. of Tiffin, Ohio, has been in the health-device business for over 25 years. He has been distributing several Abrams-type devices to practitioners charging as much as $1,200 each. In general, they consist of bulky cabinets containing electrical parts that produce low voltage, low frequency currents. They have no therapeutic value.
In June of this year the Federal Court in Toledo barred by injunction order the further distribution of four Roby devices. Defendants in the action were L. L. Roby Manufacturing Corporation, the International Electronic Research Society, Inc., Lester L. Roby, Sr., and his son, Lester L. Roby, Jr. The International Electronic Research Society, Inc., was the distributor for the "scientific" reports explaining in pseudomedical terminology how to use the devices. The impressive-looking machines were known as:
Electronic Magnetic Model G
Radioclast Model 40
Auto-Electronic Radioclast Model 20, Series 800 Electronic Analysis Instrument Model F
We do not have accurate information on the number of these worthless devices that are now being used, but it is large. Until their use is discontinued they represent a threat to the health and life of every patient on whom they are used. We call on all users of these worthless and illegal devices to discontinue using them for any medical purpose and dispose of them for non-medical use. This will not only protect innocent sick people, but will save the government the expense of locating and seizing these devices.
So the list grows, and it becomes clearer and clearer that here is a malignancy in the field of medicine. The number of devices, organizations and practitioners participating in this hoax in the name of science is too big to ignore and their threat to the public health too great to tolerate.
Although we will not be able to cover all the devices that claim to wear the mantle of science, we do want to add three more:
The Hubbard E-Meter
The Drown Radio Therapeutic Instrument.
The Endocardiograph is distributed by the Endocardiograph Company, Inc., Milwaukee, Wisconsin, which is one the enterprises of Royal Lee. Lee is the non-practicing dentist who distributes dietary products to health practitioners for the treatment of all diseases, a director of the National Health Federation, and probably the largest publisher of unreliable and false nutritional information in the world. He is also the inventor and distributor of the Endocardiograph device, an electrical amplifying recording stethoscope used by practitioners to diagnose diseases, following which one of Lee's vitamin preparations is used for treatment. According to the literature describing the use of the device, the practitioner is able to "detect and analyze" hypertrophy of the heart, muscular fatigue of heart muscles, and diseases due to vitamin and other diet deficiencies which are alleged to include practically all diseases. In January of 1962, Royal Lee, Vitamin Products Company, Lee Foundation for Nutritional Research, Endocardiograph Company, Inc., and Leeland, Inc., all enterprises of Royal Lee, were enjoined from shipping misbranded drug products in interstate commerce. But this action did not cover the Endocardiographs that are now being used. On October 24, 1963, only yesterday, three of these devices were seized in Baltimore in possession of Vitamin Products Co. of Maryland, one of Royal Lee's distributors. The devices were being used to diagnose serious diseases for which the distributor was selling Lee's preparations for treatment. The government charged that the labeling of the device contains statements which falsely represent the article to be effective to detect and diagnose vitamin and other diet deficiencies, hypertension caused by excessive amounts of cholesterol, hypertrophy, and numerous other disease conditions.
The Hubbard E-Meter, which is another skin galvanometer-type device similar in principle to the Micro-Dynameter, is now under seizure here in the District of Columbia. In January of this year the United States marshal seized in possession of the Academy of Scientology and related organizations 117 devices referred to as the Hubbard E-Meter. Scientology is an organization founded a number of years ago by a science writer, L. Ron Hubbard. Branches are found throughout the United States.
Also seized were about three tons of labeling containing therapeutic claims. The government charged that the labeling falsely represented that the devices are effective for the diagnosis, prevention, treatment, detection and elimination of the causes of all mental and nervous disorders such as neuroses, psychoses, schizophrenia, and all psychosomatic ailments. Psychosomatic ailments were represented to include most of the physical ailments of man such as arthritis, cancer, stomach ulcers, radiation burns from atomic bombs, polio, etc., etc. It was further claimed that the device is effective in improving the intelligence quotient, to measure the basal metabolism, and "change of state of man." The seizure action is awaiting adjudication in the Federal District Court.
The Drown Radio Therapeutic Instrument is a "radionic" type device developed upon the Abrams Electronic Reactions theory by Ruth B. Drown of Los Angeles, who also operated as Drown Laboratories. It consists of an impressive arrangement of dials, terminal posts and an ammeter or voltmeter. It was represented to be effective in forming "health cells," making blood counts and urinalysis, and for both diagnosing and treating practically all diseases, including cancer, as well as for loss of speech and loss of memory.
Dr. Drown contended that a drop of the patient's blood placed on a blotter forms crystals and these, like the crystals in early radio receiving sets, activate the device to the proper wave length whereby an absolute diagnosis could be made. Once the diagnosis was secured, even though the patient was thousands of miles away, she claimed the device would broadcast the necessary "healing waves" back to the patient and effect a cure.
One of the devices was seized in 1949 because of claims for its use in diagnosing and treating a large number of diseases. Dr. Drown was prosecuted and following trial was found guilty and fined $1,000. Since that time, as far as we have been able to determine, she has not engaged in interstate commerce and consequently has not been subject to jurisdiction of the Federal law. But she did continue to operate a treatment center in Hollywood which has been under intensive investigation by the California State Bureau of Food and Drug Inspection under the direction of Mr. Milton Duffy. On October 9, 1963, the Los Angeles County Grand Jury returned an indictment against Dr. Drown, her daughter, and four others, charging them with grand theft and attempted grand theft in diagnosing and treating patients for non-existent diseases with worthless electric devices. At the same time 50 Drown devices being used at the Drown Laboratories were seized.
This action by the State of California is only one of many that this State has taken over the years against fake medical devices. We are most encouraged by this vigorous enforcement at the local level.
While we have not exhausted the list of devices that are based on the electromagnetic theories of Perkins, Abrams, Hart, et al, we have covered the principal ones that are used by health practitioners.
Some may want to argue that worthless devices have a place in the diagnosis and treatment of disease. The United States Court of Appeals settled this argument in the Micro-Dynameter case when it held that worthless devices are not safe for use even in the hands of a licensed practitioner. If this were not true, then all medical science would be a mockery and we would return to the dark ages of superstition, the witch doctor, and snake oil remedies.
But we know, and most consumers know, that medical science is not a mockery. In this scientific age it is possible to determine whether a drug or a machine or a method will do what it is supposed to do. The time is past when the promoter and user of a worthless device can hide behind a cloak of secrecy and mystery, for secrecy and mystery are incompatible with science.
Science has stripped away the mystery of quack devices and left bare the truth, which is that there are no secret cure-all machines that are capable of diagnosing or treating different kinds of disease simply by turning dials, and applying electrical contacts to the body. Such devices are fakes! Their promoters are eccentric individuals and pitchmen who would turn medical science into a side-show.
This Congress is a demonstration that scientific medicine and law enforcement stand together against quackery in all of its forms and all of its disguises.
The Federal Food, Drug, and Cosmetic Act does not empower the government to regulate the practice of medicine. This is left to the states through their medical practice laws and regulations. But the law does empower the government to regulate the distribution of devices used for medical purposes and we know of no state that licenses anybody to diagnose and treat disease with a worthless device.
Device quackery has no legitimate claim to immunity. It is the most despicable of all quackery, for it uses science to advance its cause. It takes advantage of the people's confidence in the great discoveries in science and their belief in the incredible.
The progress of science is irreversible. We have made clear our determination to deal with device quackery. We invite all of you to join with us in a relentless battle of science and law against superstition and fraud.
Dr. Milstead was Deputy Director of the FDA Bureau of Enforcement. This paper was presented on October 25, 1963 at the Second National Congress on Quackery in Washington, D.C. The meeting was cosponsored by the Amricam Medical Association and the FDA.
This article was posted on April 21, 2006.