[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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