negative article from the WSJ
Reprinted from "The Wall Street Journal", January 5, 1999.
Screen Play:
Breast -Scan Device Gets Nowhere in U.S.,
Sells in Latin America
---
Pad to Detect Tumor's Heat Targets Women Unable To
Afford Mammograms
---
Plenty of False Negatives
By Pamela Druckerman
01/05/99
The Wall Street Journal Page A1 (Copyright (c) 1999, Dow Jones &
Company, Inc.)
CASCAVEL, Brazil -- Dorilde Folador, the wife of a farmer, is in the
city for a medical procedure she has rarely had in her 53 years: a
screening for breast cancer. When the doctor announces that it is
negative, she breaks into a smile. "I'm going to tell my friends about
BreastCare," she says.
BreastCare is a test that checks women by detecting hot spots on the
skin. It is designed to pick up the slightly higher temperature that a
growing tumor's blood supply can create. It's a simple device,
basically two foam pads with rows of blue dots that turn pink at
certain temperatures.
A local distributor brought BreastCare to this isolated agricultural
city two months ago, approaching gynecologists with a brochure
highlighting the fact that the U.S. Food and Drug Administration had
cleared the product.
That's true. But it doesn't mean any doctor in the U.S. is likely to
perform a BreastCare screening. The FDA has never endorsed the
product's effectiveness. And the position of American cancer
specialists is that, plausible or not, this method of screening has never
been shown to work.
Their stance is a source of great frustration to Zsigmond Sagi, a
Hungarian-born physicist who devised the product and defends it with
a fervor that leaves little doubt of his sincerity. The 66-year-old Dr.
Sagi has been seeking a market for his invention for the past 20
years, ruining his marriage with the long hours he put in and piling up
debt at the small company he formed to produce it.
Dr. Sagi says detractors in the U.S. medical establishment are
dogmatically devoted to mammography and refuse to see the good in
his product. Even though few specialists doubt that a growing tumor
can produce heat -- the basis for his test -- "all radiologists think that
nothing else on the earth is good except mammograms," Dr. Sagi
complains.
This robs women in the developing world of a shot at beating the
disease, he argues. Breast tumors there are found at a much later
stage, on average, than in the U.S. The cost of mammography is
prohibitively high, and there aren't enough machines to go around. So,
Dr. Sagi says, less-expensive BreastCare screening, while not
perfect, is better than the alternative: no screening at all.
"I believe that we have a product which is very, very important in the
early recognition of abnormalities in the breast ," he says. "If they
can tell me that mammograms are better than anything on the earth, I
don't care. We're not competing. We're trying to help the woman."
He is also, of course, trying to help his business, known as Scantek
Medical Inc. and based in Denville, N.J. Scantek, which is publicly
held but of which Dr. Sagi owns 31.8%, makes the thin, 6-inch-wide
foam pads at its New Jersey warehouse.
The evidence Dr. Sagi cites for BreastCare goes back to the early
1980s. At New York's Memorial Sloan-Kettering Cancer Center and
other hospitals, the product, then called the Breast Cancer Screening
Indicator, was tried on 179 women who were scheduled for biopsies. It
registered positive for 83% of women whose subsequent biopsies
showed they had cancer. For women who had tiny cancers less than 1
centimeter across, it registered positive nearly 90% of the time.
But the test also came out positive for many women who didn't have
cancer, nearly half of such patients. And it gave negative readings to
55 women -- one-third of whom in fact did have cancer, as shown by
later biopsies. Says David Dershaw, director of Sloan-Kettering's
breast -imaging department:
"It's bad to tell women that don't have cancer that they do have
cancer. It's worse to tell women that do have cancer that they don't.
This does both."
In another early-1980s study, involving women who weren't scheduled
for biopsies but simply came to a hospital for screening, BreastCare
was used on 2,805 women and the results compared with mammogram
and physical-exam results. BreastCare registered positive in 87% of
women who also had suspicious mammograms or physical exams,
though once again there were many false positives. It registered
negative in 99% of women who screened negative using the other
methods.
But neither study was ever published in a peer-reviewed medical
journal, a step essential to credibility in the medical world. Dr. Sagi
says he planned to submit the data for publication but ran out of
money.
Another publication effort was made many years later, in 1996. His
U.S.-Canadian licensee, a company in Cranford, N.J., called
HumaScan Inc., hired a University of Virginia institute to prepare the
trial results for publication. But the physician who headed the project,
David Martin, says researchers found "internal inconsistencies"
between summaries of the findings and an audit of the raw data, and
halted publication efforts. A HumaScan official, Ken Hollander,
denies there were inconsistencies but says that "over the years, I
guess things were lost."
Dr. Sagi says that BreastCare is currently being tested in Italy at the
Instituto Europeo di Oncologia and that results will be submitted for
publication in about two months. Scantek has signed a distribution
agreement with an Irish company and is close to signing one in Spain,
he adds. Additional trials are under way in Latin America.
Although marketers there repeatedly describe BreastCare as
FDA-approved, they leave a few things out. For one, the FDA said
the product could be sold only as an adjunct to other testing.
More important, it wasn't really "approved," as that term is now
understood, says Susan Alpert, director of the FDA's office of device
evaluation. She says approval means the agency has evaluated a
product's clinical data for both safety and effectiveness and found it
passes muster on both counts. With BreastCare, all the FDA did was
decide -- in 1984 -- that the product could be sold because it was
"substantially similar" to a product already on the market. And that
was one that had come to market before the FDA started regulating
medical devices at all, in 1976.
"These very early devices, if they could detect differences in heat,
they went to market," Ms. Alpert says. "There is some indication
that tumors cause heat, but that doesn't mean these things are
detecting any abnormality underneath."
Daniel Kopans, a Harvard radiology professor and author of a widely
used textbook on breast imaging, agrees. He says heat from a tumor
that is even a few millimeters below the surface often doesn't reach
the skin, because it is insulated by breast tissue. To him, a big
problem with BreastCare is false negatives. "It's not just that these
are not useful, but they could be harmful in that way, by giving
someone a false reassurance," he says.
The American Medical Association says thermography has no
demonstrated value as a diagnostic tool. Medicare quit covering
thermography for breast -cancer detection in 1984, and ceased paying
for the procedure for any medical use in 1992.
These distinctions haven't reached Juan Carlos Mino, Paraguay's top
BreastCare marketer, who was given a stack of literature on the
product by his headquarters in Asuncion and sent out to sell it.
Wearing a crisp white shirt and carrying a black bag filled with
brochures and drug samples, the smiling salesman spends his days
visiting doctors to sell BreastCare along with treatments for epilepsy,
hypertension and Parkinson's disease.
"I say that in the U.S., it's the best," he says. "When someone goes
to a public health clinic, the first thing they do is a test. And what do
they use? BreastCare."
Mr. Mino doesn't raise the possibility that the test could come out
wrong. He tells doctors the FDA wouldn't approve a device without
ensuring that it works. "If you use the BreastCare very well, like it
says in the manual, there aren't false positives or negatives," he
explains cheerily.
And he makes sure to mention to doctors that while they don't get
paid for a mammogram, since that involves a referral elsewhere, they
can use BreastCare right in the office, marking up the price.
Scantek makes the devices at a cost of about $1.50 a set, selling them
to the Latin American licensee, Sandell Corp. in Montevideo,
Uruguay, for $8.30 each. Offered through distributors in Uruguay,
Paraguay, Brazil, Bolivia and Peru, the devices can end up costing the
patient as much as $42. Doctors use each kit just once.
Sales so far are minimal, but Sandell has agreed to make purchases
that will reach at least 90,000 units a month in the fourth year. And
Scantek has already received about $500,000 in license fees from
Sandell, resulting in a profitable Sept. 30 quarter. Scantek is in the
process of acquiring Sandell outright, Dr. Sagi says.
Efforts to market BreastCare in the U.S. and Canada are going
poorly. The licensee, HumaScan, recently said it faced "severe
liquidity problems" and would suspend relations with its outside sales
force and slash its payroll to four.
Dr. Sagi says the cost of BreastCare will come down as Scantek
begins making the kits in Latin America. He also says he will review
all marketing materials used there. The kits' Latin licensee says it
can't control what every salesman says.
In Paraguay, Mr. Mino drives down a dirt road in Ciudad del Este,
pulling up in front of a scruffy one-story building with a hand-painted
sign that says Hospital Maria. In the waiting room, a candle burns in
front of a religious shrine, while a television set on a plastic chair
blares music.
The doctor, Paul Zenteno Reyes, folds his arms over his chest as Mr.
Mino makes a case for BreastCare. It doesn't require any investment
in equipment, and it finds small tumors "like a mammogram," the
salesman says. As he listens, the doctor slowly warms to the product
and leans over to finger the brochure.
Mr. Mino's pitch impresses the doctor, who says he is a
gastroenterologist but also specializes in breast health. Like most
doctors here, Dr. Zenteno doesn't send his patients for mammograms
unless they have a family history of breast disease or he suspects a
tumor. Anyway, there is only one mammography machine in the city.
"This can work well for me," he finally says. "I think this could be
just like the Pap smear. This is the same thing." He promises to read
a photocopied manual left by the salesman.
There is clearly a need for better breast -cancer screening in the
region. Of 40,000 Brazilian women diagnosed with breast cancer each
year, say doctors here, about 60% have tumors that are already at
least 5 centimeters in diameter and can be easily felt or even seen. At
that stage, the survival rate is often as low as 20%.
Typical is the care for residents of the ramshackle Santo Amaro
neighborhood outside Sao Paulo, where clotheslines connect a mash
of aluminum-roofed cinder-block houses. At the Centro Medico Unisa
public clinic, a doctor, Alfredo Barros, says mammogram screening
isn't even a possibility for the hundreds of women who visit the clinic
each day. The $125 cost would support a family from this
neighborhood for a month. The state health system, the medical plan
for about 70% of Brazilians, generally covers mammograms only for
those who have a family history of breast cancer or in whom a lump
has been found.
"They come here showing signs of advanced breast cancer," says the
bearded doctor, who heads the gynecology unit and is participating in
Brazilian trials of BreastCare arranged by Sandell, the distributor.
"There isn't any breast -cancer screening program here."
BreastCare is a big deal for Carmen Zaro, a 30-year-old Brazilian
bank manager in Cascavel who has sneaked out of work early to do
the test at her gynecologist's office. The lanky redhead sits in a hot
examination room as a receptionist slips the foam pads inside her bra
and adjusts the straps for a closer fit. Ms. Zaro's father died of
cancer, and she is anxious to know the test results.
Fifteen minutes later, Ms. Zaro pulls out the pads and hands them to
her doctor, bending over to get a better view as he analyzes the foil
strips. She watches as he carefully counts out the rows of dots that
have changed from blue to pink.
"You are fine!" the doctor finally says. He hands her the pads as a
memento and tells her to come back in six months to repeat the test.
Relieved, she leans back and throws up her hands.
A few doctors have found another use for BreastCare. Some plastic
surgeons say they are using it instead of mammograms for patients
having breast augmentation or reduction.
One such patient is Tais da Gama, and her experience is rather
different from Ms. Zaro's. Ms. da Gama, an affluent lawyer in
Brasilia, went to her doctor for reduction surgery. She had had a
mammogram six months earlier, and it was negative. But her surgeon
screened her with BreastCare, and it registered positive in one breast
. The doctor ordered another mammogram, which picked up
calcifications later found to be pre-cancerous. They were removed
during the reduction surgery.
"I thought I had something when it was positive," Ms. da Gama says
of the thermography test. "It was one more reason to find out what
was going on." Bottom line: U.S. doctors say the BreastCare doesn't
work, but Ms. da Gama credits it for finding a lump. "I'm very
religious," she says, "and I always pray for the person who invented
BreastCare."
Copyright (c) 1999 Dow Jones & Company, Inc. All Rights Reserved
================================
DDG Comments On Wall Street Journal
Article
Glen Rock, New Jersey January 12, 1999 9AM EST
D-Lanz Development Group, Inc., ("DDG") (DLNZ-OTC Bulleting
Board) commented today on the front page Wall Street Journal
article on Scantek Medical, Inc., licensor of DDG's BreastCare
product. Roger L. Fidler, President of DDG, remarked "The story
raised several questions which I wish the writer would have answered.
The characterization of the South American "side" of the story was
more sensationalist than enlightening, although the point was made
that BreastCare is a major benefit to women in the developing world,
at least according to the women using BreastCare. The implication
that American physicians aren't likely to use the product misses the
point. Few American physicians, and almost all women in this country,
even know the product exists or can be made available to them. In
fact, I believe that within a relatively short period of time the product
will come in to common use in the United States. The Humascan
failure probably reflects more on Humascan management than any
other factor. Since Scantek developed its manufacturing capability in
July, 1998, only progress has occurred with respect to market
response and acceptance on a global basis. This state of affairs will
systematically improve with time. With clarification of the United
States marketing program in the coming months, I believe that use of
the product will rapidly increase in the United States. The Journal
may also be surprised by the strength of the response in the coming
months from women's health groups. BreatCare has already
demonstrated that it is as accurate as a mammography in many
situations and is the only method which provides a digital output that
can be interpreted by a lay person capable of understanding relatively
simple instructions," Mr. Fidler continued "The denigration of this
technology is premature and ill-advised. A careful review of even the
existing test data demonstrates efficacy. Certainly in the international
health care arena the product can be made widely available, and one
would have thought that the premier daily financial publication would
have noted the incredible potential user base for this product and the
financial implications if such a base can be accessed as both Scantek
and DDG are presently in the earliest stages of so doing.
For further information
Contact Roger Fidller, CEO
(201) 457-1221
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