From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 2
In the history of food and drug legislation, a major event or disaster has often served
as the impetus for new legislation. The first statute, the Pure Food and Drugs Act of 1906,
would not have been enacted if not for the shocking impact of Upton Sinclair’s The Jungle.
The novel vividly described the unsanitary conditions and methods in the meat-process-
ing industry. Similarly, the Federal Food, Drug, and Cosmetic Act of 1938 might not have
been passed without the stimulus of the sulfanilamide elixir catastrophe in 1937. At the
time, the US Food and Drug Administration (FDA) calculated that the elixir had brought
death to at least 107 people, most of them children.1 The 1962 Kefauver-Harris Amendments
to the 1938 act were in response to widespread reports of phocomelia (defective fetal
development of the limbs) attributed to thalidomide. First marketed in Germany in 1957,
the drug was never marketed in the US, although a New Drug Application had been filed
by the manufacturer in 1960.
The Medical Device Amendments of 1976 resulted partly from advances in biomedi-
cal technology developed in the 1950s and 1960s. Increased regulation was indicated
to ensure adequate premarket testing. The Cooper Commission specifically cited such
sophisticated devices as pacemakers, intrauterine devices and heart valves in justifying
broader FDA authority. But another reason to more closely regulate medical devices was
the persistent presence of quack devices in the marketplace. Before the enactment of the
Medical Device Amendments, manufacturers did not have the burden of establishing
the safety and efficacy of their products prior to sale. In the case of quack devices, it was
frequently the government that had to engage in research to disprove the manufacturer’s
false claims.
The history of quack medical devices can be illuminating to those of us in the medical
device industry for several reasons. It is important to realize that it was those devices and
the abuses of their manufacturers that aroused Congress to pass additional legislation.
The history of the devices also shaped the attitudes of the device-regulating agencies.
A familiarity with such devices and the baffling and often ridiculous instructions that
accompanied them may facilitate our own review of labeling and advertising. We are
more apt to appreciate today’s full-disclosure labeling after reading about the fantastic
claims made for some medical devices in the past.
The Earliest Years
The first quack device may have been the first medical item patented under the
Constitution. In 1796, the government granted Dr. Elisha Perkins a patent for metal rods
called tractors.2 This invention was a pair of small brass and iron instruments. Each was
about three inches long, flat on one side, rounded on the other and tapered from a hemi-
spheric base to a sharp point. One of the tractors was gold in color, the other silver the
pair sold for five guineas.
On the heels of Benjamin Franklin’s discovery of electricity, Perkins claimed that his
tractors used this mysterious force to unlock the secret door to health. The points of the
tractors were drawn, first one, then the other, across the afflicted surface of the body, from
the center toward the extremities. The tractors allegedly drew disease elements from the
body. Directions for use varied with the illness. Perkins, and later his son, recommended
the tractors for local inflammation pains in the hand, face, teeth, breast, side, stomach and
back and for rheumatism, pleurisy, gout and a multitude of other afflictions. Perkins did
not guarantee the infallibility of his invention he did not think it could relieve headaches
that arose from drinking to excess.3
Considering the time period and the quality of medical practice that prevailed, it was
not surprising that Perkins’ treatment enjoyed amazing popularity. The chief justice of the
US Supreme Court bought a pair of the metallic tractors, and President Washington was
supposed to have been a customer.4 Popularity waned after 1796, when the Connecticut
Medical Society condemned the treatment as “gleaned from the miserable remains of
In the history of food and drug legislation, a major event or disaster has often served
as the impetus for new legislation. The first statute, the Pure Food and Drugs Act of 1906,
would not have been enacted if not for the shocking impact of Upton Sinclair’s The Jungle.
The novel vividly described the unsanitary conditions and methods in the meat-process-
ing industry. Similarly, the Federal Food, Drug, and Cosmetic Act of 1938 might not have
been passed without the stimulus of the sulfanilamide elixir catastrophe in 1937. At the
time, the US Food and Drug Administration (FDA) calculated that the elixir had brought
death to at least 107 people, most of them children.1 The 1962 Kefauver-Harris Amendments
to the 1938 act were in response to widespread reports of phocomelia (defective fetal
development of the limbs) attributed to thalidomide. First marketed in Germany in 1957,
the drug was never marketed in the US, although a New Drug Application had been filed
by the manufacturer in 1960.
The Medical Device Amendments of 1976 resulted partly from advances in biomedi-
cal technology developed in the 1950s and 1960s. Increased regulation was indicated
to ensure adequate premarket testing. The Cooper Commission specifically cited such
sophisticated devices as pacemakers, intrauterine devices and heart valves in justifying
broader FDA authority. But another reason to more closely regulate medical devices was
the persistent presence of quack devices in the marketplace. Before the enactment of the
Medical Device Amendments, manufacturers did not have the burden of establishing
the safety and efficacy of their products prior to sale. In the case of quack devices, it was
frequently the government that had to engage in research to disprove the manufacturer’s
false claims.
The history of quack medical devices can be illuminating to those of us in the medical
device industry for several reasons. It is important to realize that it was those devices and
the abuses of their manufacturers that aroused Congress to pass additional legislation.
The history of the devices also shaped the attitudes of the device-regulating agencies.
A familiarity with such devices and the baffling and often ridiculous instructions that
accompanied them may facilitate our own review of labeling and advertising. We are
more apt to appreciate today’s full-disclosure labeling after reading about the fantastic
claims made for some medical devices in the past.
The Earliest Years
The first quack device may have been the first medical item patented under the
Constitution. In 1796, the government granted Dr. Elisha Perkins a patent for metal rods
called tractors.2 This invention was a pair of small brass and iron instruments. Each was
about three inches long, flat on one side, rounded on the other and tapered from a hemi-
spheric base to a sharp point. One of the tractors was gold in color, the other silver the
pair sold for five guineas.
On the heels of Benjamin Franklin’s discovery of electricity, Perkins claimed that his
tractors used this mysterious force to unlock the secret door to health. The points of the
tractors were drawn, first one, then the other, across the afflicted surface of the body, from
the center toward the extremities. The tractors allegedly drew disease elements from the
body. Directions for use varied with the illness. Perkins, and later his son, recommended
the tractors for local inflammation pains in the hand, face, teeth, breast, side, stomach and
back and for rheumatism, pleurisy, gout and a multitude of other afflictions. Perkins did
not guarantee the infallibility of his invention he did not think it could relieve headaches
that arose from drinking to excess.3
Considering the time period and the quality of medical practice that prevailed, it was
not surprising that Perkins’ treatment enjoyed amazing popularity. The chief justice of the
US Supreme Court bought a pair of the metallic tractors, and President Washington was
supposed to have been a customer.4 Popularity waned after 1796, when the Connecticut
Medical Society condemned the treatment as “gleaned from the miserable remains of