[Congressional Record Volume 140, Number 40 (Thursday, April 14, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: April 14, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
THE FDA IS HARMFUL TO THE HEALTH AND POCKETBOOKS OF OUR PEOPLE
The SPEAKER pro tempore. Under a previous order of the House, the
gentleman from Tennessee [Mr. Duncan] is recognized for 5 minutes.
Mr. DUNCAN. Mr. Speaker, almost no agency is more harmful to the
health and pocketbooks of our people than the Food and Drug
Administration.
Already the FDA has driven the cost of medicine out of sight by
making it unbelievably expensive and bureaucratic to get a drug
approved.
Now the Wall Street Journal, on its front page 2 days ago, reported
on a 9-year battle the FDA has had with a small company in Illinois:
Let me read a portion of this story:
It is as simple as a medical device can get: two sealed
plastic sheets with lubricant in between. It is laid over a
woman's breast like a clot during an examination, to reduce
friction.
Glenda Richardson thinks it probably spared her death from
breast cancer. John Withers, a surgeon at the Maui Clinic in
Hawaii, says it is one of the most effective weapons against
breast cancer in years. And Patricia Redmond, a New York
radiologist, says it ``can absolutely save lives.''
But don't try buying it in the U.S. Though many doctors and
cancer specialists hail the Sensor Pad as a useful tool in
detecting the disease that many women fear most, and though
it years ago sailed through approval processes in countries
in Europe and Asia, the Food and Drug Administration won't
let Inventive Products Inc. sell it in this country.
Grant Wright, the president of Inventive Products, and his
father, Earl, the pad's co-inventor, have been fighting for
nine years to get clearance for the product. What began as an
FDA request for more information has degenerated into a long,
debilitating struggle and allegations that the Wrights
violated federal law. So frustrated did the Wrights become
about the bureaucratic maze that six years ago they started
selling the pad to U.S. hospitals without FDA clearance. That
triggered a court battle that they lost in 1992. Now they are
back to trying to win FDA blessing for the pad.
Stifling innovation?
But if the dispute is not resolved soon, Grant Wright says,
he will close his Decatur, Ill., company, which costs about
$4,000 a month to operate and has already burned through
$356,000 in legal fees. `I'm 33, with a wife and three kids,'
he says `I've got to do something with my life.'
Mr. Wrights's struggle, in the eyes of some, is more than
just the tale of a small-town entrepreneur's tangle with far-
away bureaucrats; it is more, too, than a study of how the
medical-devices industry in the U.S. copes with the world's
most stringent regulatory system. To some advocates of his
simple device, it is a manifestation of the way the nation's
litigation-driven aversion to risk can stifle innovation in
the medical marketplace. `We as a society refuse to take
risks and want 100% guarantees that our lives are going to be
perfect,' says Mary Palmore, a Chicago gynecologist.''
Breast cancer killed an estimated 46,000 women in the United States
last year and was the second-biggest cancer killer of women.
This is a device that has saved the lives of women all over the world
because early detection is essential.
This product was approved after 30 days in Canada. It has been
approved easily in Japan, Singapore, Korea, Thailand, and most of
Western Europe.
The only place where the company has had trouble is in the United
States.
Why? because Washington bureaucrats are so arrogant that they think
they can run our lives better than we can ourselves.
They think they can spend our money for us better than we can
ourselves.
They justify everything in the holy name of safety.
I have no objection to some testing for safety. But you can go
overboard on anything.
But there is no such thing as a perfectly 100 percent safe drug or
anything else.
I have had a bleeding ulcer three times. For me aspirin is an unsafe
drug. But for most people it is a good thing and I am glad it is on the
market?
How in the world can they justify taking 9 years for something that
took 30 days in Canada?
All it really is, is a power play on the part of the FDA. A
bureaucratic temper tantrum. They want to show who is boss.
Apparently this small company in Illinois did not bow down to them
far enough. It did not show the proper respect.
The company sold the product for awhile on the legal theory that it
was not strictly a medical device and thus was outside the FDA's
jurisdiction.
In 15 months' time, they sold 250,000 pads to 200 hospitals.
Do people want to buy this product? You bet they do.
But because of the FDA, they are not going to be allowed to buy
something that could potentially save their lives.
Another sad thing, in addition to lives that will not be saved, is
that if this product had been produced by some extremely big business,
it probably would have been easily approved years ago.
I have said many times that big government really helps only the
bureaucrats who work for it and extremely big businesses.
Only big business can comply with all the rules and red tape and get
the favorable rulings from the bureaucrats and the tax breaks,
government contracts, and so forth.
Small businesses simply cannot sit on a product for years or come up
with the often times many millions that it takes to gain bureaucratic
approval.
The American Medical Association has estimated that it now takes
almost $300 million and several years to get a drug to market.
Only one out of every 4,000 drugs gains final approval.
No wonder the drug industry has become concentrated in the hands of a
few giants.
Almost no small companies could afford to go through this
bureaucratic maze.
If somebody comes up with a cure for cancer, we probably won't hear
about it for years because the FDA will bog it down.
And if somebody does discover a cure, they will be forced to sell out
to one of the pharmaceutical giant unless they have many millions to
play the FDA game.
All of this is really driving up the cost of medicine in this country
and is really hurting the poor and working people of this Nation.
I call on the FDA to get off its bureaucratic duff and approve this
product that hospitals, doctors, and patients all over this country
want to use.
To not do so would be one of the worst abuses of power that has ever
occurred in the city.
This is supposed to be a free country. This is supposed to be a
Government of, by, and for the people--not of, by, and for the
bureaucrats.
I ask to include the story about this bureaucratic horror story in
today's Record.
How A Device to Aid in Breast Self-Exams is Kept Off the Market
(By Brent Bowers)
It is about as simple as a medical device can get: two
sealed plastic sheets with lubricant in between. It is laid
over a woman's breast like a cloth during an examination, to
reduce friction.
Glenda Richardson thinks it probably spared her death from
breast cancer. John Withers, a surgeon at the Maui Clinic in
Hawaii, says it is one of the most effective weapons against
breast cancer in years. And Patricia Redmond, a New York
radiologist, says it ``can absolutely save lives.''
But don't try buying it in the U.S. Though many doctors and
cancer specialists hail the Sensor Pad as a useful tool in
detecting the disease that many women fear most, and though
it years ago sailed through approval processes in countries
in Europe and Asia, the Food and Drug Administration won't
let Inventive Products Inc. sell it in this country.
Grant Wright, the president of Inventive Products, and his
father, Earl, the pad's co-inventor, have been fighting for
nine years to get clearance for the product. What began as an
FDA request for more information has degenerated into a long,
debilitating struggle and allegations that the Wrights
violated federal law. So frustrated did the Wrights become
about the bureaucratic maze that six years ago they started
selling the pad to U.S. hospitals without FDA clearance. That
triggered a court battle that they lost in 1992. Now they are
back to trying to win FDA blessing for the pad.
stifling innovation?
But if the dispute isn't resolved soon, Grant Wright says,
he will close his Decatur, Ill., company, which costs about
$4,000 a month to operate and has already burned through
$356,000 in legal fees. ``I'm 33, with a wife and three
kids,'' he says. ``I've got to do something with my life.''
Mr. Wright's struggle, in the eyes of some, is more than
just the tale of a small-town entrepreneur's tangle with
faraway bureaucrats; it is more, too, than a study of how the
medical-devices industry in the U.S. copes with the world's
most stringent regulatory system. To some advocates of his
simple device, it is a manifestation of the way the nation's
litigation-driven aversion to risk can stifle innovation in
the medical marketplace. ``We as a society refuse to take
risks and want 100% guarantees that our lives are going to be
perfect,'' says Mary Palmore, a Chicago gynecologist.
Dr. Palmore acknowledges that the FDA has a legal duty to
ensure that the pad isn't falsely promoted as a diagnostic
tool, but suggests that the agency itself may be caught up in
what she sees as a national obsession with safety. ``The FDA
is concerned that in our litigious society, a woman will say:
`I used it, and I got cancer anyway,''' Dr. Palmore says.
The agency says that safety, not litigation, is its main
concern. And it strongly defends its refusal to authorize the
Sensor Pad. ``Their intention is very worthy,'' Susan Alpert,
director of the FDA's Office of Device Evaluation, says of
the Wrights. ``But the issue for the agency is of ensuring
that we don't allow to market any device that poses
significant risk without an attendant benefit.''
Indeed, many consumer advocates and health-care specialists
applaud the FDA's rigor in screening devices, and some
complain that it doesn't act forcefully enough. The FDA,
meanwhile, faces a huge backlog of applications for new
medical devices, which has stretched the average review time
to 196 days. The agency says it is working hard to whittle
the backlog of more than 5,000 applications.
Breast cancer took an estimated 46,000 lives in the U.S.
last year and was the second-biggest cancer killer of women.
Early detection is essential in defeating it, and frequent
self-examination is essential to that effort. But many women
don't find this easy, and that is where the pad comes in. Its
lower sheet clings to the skin while the top sheet ``floats''
on a thin layer of liquid silicon, eliminating friction so a
finger can explore the contours of an object as small as a
grain of salt.
``The thing that amazes me,'' says the younger Mr. Wright,
``is that the research spending [on breast cancer] keeps
going up and I can't get this simple $7 product into the
hands of women who want it.''
His father, Earl, once thought the Sensor Pad would be a
big success. Mr. Wright, 63, is an established inventor whose
products range from a blood-serum filter used in laboratories
to nonaerosol foaming pumps used by hospital surgeons. Mr.
Wright in 1986 set up Inventive Products as a subsidiary of
his Earl Wright Co. solely to make and market the Sensor Pad.
He put his son in charge.
Gaining approval to sell it in other countries wasn't a
problem. Inventive Products applied for marketing
authorization in Canada in 1985 and got it within 30 days,
Grant Wright says. He also says the pad has been approved in
Japan, Singapore, Korea, Thailand and most West European
countries, although Inventive Products hasn't actively
promoted it abroad. ``We've had no problems anywhere in the
world,'' he says.
Except at home. When the Wrights sought FDA clearance for
the device in 1985, the agency's initial response was
positive. Still, the government wanted more information.
``Every time we submitted information, they asked for more,''
the son recalls. After several months, the agency denied
approval for the pad--but indicated its concerns might be met
by extensive labeling changes.
The FDA wanted the labeling to state that the Sensor Pad
could be sold by prescription only. And it wanted all
references to breast cancer deleted. The label was to include
the chemical composition of the device. It also was to
describe the 10-inch-diameter pad's ``susceptibility to heat,
sunlight, soap, Formalin, alcohol and other mechanical
agents.''
Mr. Wright says he immediately set about complying with the
requests. But about three months later, he says, the FDA
inexplicably notified him that it wouldn't reconsider
approving the product. Instead, he was told, Inventive
Products would have to go through a laborious ``premarket
approval'' process for new medical devices.
This process is meant to keep new, mostly high-technology
instruments off the market until they can be adequately
tested for safety. Few people would disagree that the FDA
should get convincing evidence that invasive devices are
safe. More than 200 people died in the 1980s when their
Bjork-Shiley heart valves fractured, for instance. But Mr.
Wright argues that the Sensor Pad poses no direct risk to
users.
The FDA responds that the indirect risk--that a cancerous
lump would go undetected--is potentially lethal.
The agency's Dr. Alpert says the fact that a device is
simple doesn't necessarily mean it is benign; everything
depends on its ``intended use.'' She dismisses endorsements
from doctors and patients--which, she says, many device
makers trot out--as anecdotal evidence that is insufficient
to make a scientific case. ``Reporting doesn't do it--data
does,'' she says.
In 1992, only 12 medical devices were given FDA premarket
approval, including heart pacemakers, lenses that are
implanted into the eye after cataract surgery and devices for
smashing kidney stones. Of the simple, noninvasive pad,
``I've never seen a product like this held off the market,''
says John Isaacs, a gynecologist in Evanston, Ill., who is
the author of a textbook on breast disease.
But the FDA says the Sensor Pad needs to be scrutinized
because it isn't ``substantially equivalent'' to a product
already on the market, a legal requirement for quick approval
of simple devices. The Wrights argue that the pad is
substantially equivalent to soap and water, a mixture the
medical community has long recommended to reduce friction in
breast self-examination.
To obtain premarket approval, the FDA said, Inventive
Products would have to conduct exhaustive clinical tests on
women, comparing the number of breast-cancer cases detected
through self-examination with and without the Sensor Pad.
Such tests, Mr. Wright says, would require a huge sample--a
minimum of 82,000 women--to produce statistically meaningful
results. An FDA spokeswoman disputes that figure. ``We want
to be as reasonable as we can,'' she says. ``The number will
be much less than that.''
Mr. Wright says he has already done two trials with
simulated breast models, which he claims yield more accurate
results. In the first, women examined the artificial breasts
for lumps using both the pad and their bare hands. In the
second, they used both those methods and also a third
method--soap and water on their hands. The tests showed that
the pad enhanced sensitivity and resulted in increased lump
detection, Mr. Wright says.
The FDA rejected his trials as insufficient. The prospect
of starting over with the lengthy, expensive tests the FDA
demanded pushed the Wrights to change their course. Because
they never considered the pad to be a medical device as
defined by federal law, they decided in 1988 to market the
product directly to hospitals. The Wrights say they--and
their attorney--figured the FDA either would recognize its
lack of jurisdiction or take Inventive Products to court and
force the issue.
Over 15 months, the Wrights sold 250,000 pads to some 200
hospitals. But in April 1989, federal agents raided the
company's Decatur plant and a number of hospitals and
confiscated the pads.
The action came one day after Earl Wright was named a
finalist in the Intellectual Property Owners Foundation's
inventor-of-the-year contest for his ``touch-enhancing
device.''
Grant Wright challenged the FDA's claim to jurisdiction
over the pad. But in 1990, a U.S. district court in Danville,
Ill., ruled for the FDA. Mr. Wright appealed, and two years
later an appellate court in Chicago upheld the ruling. At
that point, Inventive Products told the FDA it had ceased
marketing the pad.
But Mr. Wright didn't give up. In March 1992, he filed an
ethics complaint with the FDA's integrity office against some
agency officials after learning that they had met with a
minority shareholder of the company without his knowledge.
After he filed the complaint, he says, the FDA turned
hostile. At a meeting in Washington in August 1992 to discuss
requirements for premarket approval, he says, an FDA lawyer--
flanked by 10 other agency officials and a Justice Department
lawyer--``told us we'd never get our product to market.''
An agency spokeswoman says it is doubtful such a remark was
made. ``We have gone out of our way to show the Wrights how
to get their product marketed. Such a comment doesn't make
sense,'' she says.
Mr. Wright promptly fired off letters of complaint about
the meeting to the FDA and to Rep. John Dingell of Michigan,
who is known for flailing the FDA for its missteps. More
letters flew back and forth. An FDA integrity officer wrote
that the FDA was acting in good faith. Mr. Wright responded
by demanding an investigation of the FDA lawyer who attended
the August meeting. A couple of days later, his Washington
lawyer sent a seven-page letter to a Dingell staffer,
accusing the FDA of ``hounding'' Inventive Products.
Four months later, the Wrights received notice from an FDA
compliance officer that the agency was investigating them for
possible violations of federal law for selling the pad in
1990-91. Mr. Grant says he has received no word about the
investigation since an FDA administrative hearing in Chicago
last June. But, he says, he has gotten the message: ``If you
squawk, they will slap you around.'' The FDA denies taking
any retaliatory actions.
Meanwhile, members of the medical community continue to
support the Sensor Pad. Dr. Withers, the surgeon at Maui
Clinic, says the pad has twice enabled him to feel otherwise
undetectable lumps. He scoffs at the idea that using it might
give women a false sense of security, one of the FDA's main
concerns. ``There is no question that the Sensor Pad
increases my tactile ability,'' he says. ``It makes it 100%
easier.''
Gale Katterhagen, medical director of the cancer center at
St. Joseph Medical Center in Burbank, Calif., says tests he
conducted for Inventive Products several years ago indicated
that women who used the pad were 22% more likely to perform
monthly breast exams. ``This device is harmless,'' Dr.
Katterhagen says.
Women who use the pad swear by it. Ms. Richardson, a 43-
year-old Decatur resident, doubts that she would have found
two small lumps without the pad. She had a double mastectomy.
``It probably saved my life,'' she says, adding that she gave
one to her 19-year-old daughter.
Mary Gorman, a 55-year-old writer in Washington, is certain
the pad saved her breast. ``I found my cancer before it was
detectable on a mammogram,'' she says. Her surgeon, Katherine
Alley, says the device may have saved Ms. Gorman's life.
Considering the lethality of breast cancer, Dr. Alley says,
``it is just ridiculous'' to keep the pad off the market.
Potential demand appears to be huge. When a Pittsburgh
hospital offered on local TV in 1990 to send out free
samples, it was flooded with 36,000 calls and letters.
For all that, the FDA's Dr. Alpert believes that Inventive
Products is largely responsible for the delays it has
encountered. ``There are lots of different kinds of trials
they could do to show this is effective.'' she says. ``It
doesn't have to be years and years.''
The elder Mr. Wright has managed to commercialize the
Sensor Pad's antifriction technology for a much smaller
market. He has built the Slipp, a nylon and plastic sheet
used in hospitals to transfer patients from a gurney to a
bed. About 500 have been sold.
But his son spends much of his time in his nearly empty
headquarters explaining to doctors why he can't send them
samples of the Sensor Pad. Last year, he laid off his own
brother, reducing his work force to himself and his secretary
from a peak of 28 six years ago. ``We're at the point of
surrender,'' he says.
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