Needle Biopsies Safe?
Dr. Ralph Moss
2004 report from the John Wayne Cancer Institute in California has
rekindled a long-standing debate over whether or not needle biopsies
are safe. The paper set out to examine whether this technique, widely
used to obtain specimens in cases of suspected cancer, might itself
allow malignant cells to spread from an isolated tumor to nearby
lymph nodes. The authors reluctantly conclude that a needle biopsy
may indeed increase the spread of the disease by 50 percent compared
to patients who receive the more traditional excisional biopsies
is a rigorous study, and it comes with an excellent pedigree. The
lead author, Nora M. Hansen, MD, was chief surgical resident at
the University of Chicago (1994-1995) before coming to the John
Wayne Cancer Institute in Santa Monica, Calif., in 1997. She is
currently Assistant Director of the Joyce Eisenberg Keefer Breast
Center, Saint John's Hospital and Health Center, Santa Monica.
Wayne Cancer Institute, a division of Saint John's Hospital, is
the institution that pioneered the procedure known as sentinel node
biopsy. This is a technique for identifying the first lymph node
to which a tumor is likely to spread. By removing that node and
examining it at the time of surgery, it is possible to predict with
great accuracy whether the cancer has indeed spread. This enables
the surgeon to remove only those lymph nodes that have become involved
with cancer, instead of resorting to wholesale lymph node dissection,
a procedure which can leave a patient with long-term pain, edema,
disfigurement and impairment of limb mobility.
report was published in a prestigious journal, the American Medical
Association's Archives of Surgery, which has been published continuously
since 1885. The study was conducted by a team of John Wayne scientists
which, in addition to Dr. Hansen, included Armando G. Giuliano,
MD, chairman of the American College of Surgeons Breast Oncology
Committee and the author of over 200 scientific articles on breast
cancer. I emphasize the credentials of the study's authors in order
to make the point that this is a group of well-respected clinicians
and assuredly not a group of mavericks.
and her colleagues wanted to discover whether the common method
used to obtain specimens from a breast tumor influenced the subsequent
spread of disease to the sentinel node (SN). She and her colleagues
therefore studied 663 women who were known to have breast cancer.
Of these, about half had been biopsied with a needle either
a fine needle aspiration (FNA) or a large-gauge needle core biopsy.
The other half had undergone the physical removal of their tumor
(i.e., an excisional biopsy or lumpectomy). The study found that
women who had had either kind of needle biopsy were fifty percent
more likely to have cancer in their sentinel nodes than women who
underwent the surgical removal of the whole tumor with excisional
report's authors state: "Manipulation of an intact tumor by
FNA or large-gauge needle core biopsy is associated with an increase
in the incidence of SN metastases, perhaps due in part to the mechanical
disruption of the tumor by the needle." This is a discreet
way of saying that needle biopsy, an increasingly common procedure,
was itself responsible for spreading the cancer, although the authors
take pains to qualify this disturbing conclusion by suggesting that
not every cluster of cancer cells found in the regional lymph nodes
will inevitably end up developing into clinically apparent cancer.
implications of this study are vast, since patients who are found
to have cancer in their lymph nodes are automatically classified
at a higher stage and therefore face much more extensive treatment
than those who have small tumors that are limited to the breast.
of being told that they have stage I cancer and that surgery "got
it all," they are now delivered the frightening news that the
cancer has spread outside its capsule and gotten into the lymphatic
system. They then face the possible dissection of the affected chain
of lymph nodes and aggressive chemotherapy, radiation and/or hormonal
therapy to wipe out the stray cancer cells (Chu 1999).
report also potentially throws a monkey wrench into the smooth running
early detection 'machine' that every year identifies and treats
hundreds of thousands of Americans with cancer. Indeed, over the
last few decades the needle biopsy has become an essential element
in the detection not only of breast cancer, but also of many other
kinds of cancer. The advantages of the technique are many: needle
biopsies are nearly painless and bloodless in-office procedures,
and much less expensive and time-consuming than surgical biopsies.
The procedure consists of a hollow needle being inserted into a
suspected tumor in order to retrieve samples for microscopic examination.
In certain cases the tumor may have to be punctured four to six
separate times in the process of obtaining adequate tissue for diagnostic
Get a Band-Aid
and Go Home
it really safe to puncture a tumor in this way, especially when
the tumor is anatomically walled off or encapsulated from the rest
of the body? Isn't this running the risk of spreading the disease,
either into the track formed by the needle, or, worse, by spilling
cells directly into the lymphatic system or bloodstream? Has this
procedure really been carefully thought out and researched before
being implemented on such a massive scale?
read the mainstream media, you would think that the medical profession
is uniformly in favor of this procedure. For example:
1999 report in the Journal of American Medical Association enthusiastically
endorsed the use of needle biopsies.
painful surgical biopsy of breast tissue may no longer be necessary,"
a CNN website enthused, in interpreting the study. Needle biopsies
are "just as reliable, less expensive, and more comfortable"
than the surgical alternative for diagnosing breast cancer"
E. Meyer and colleagues at Boston's Brigham and Women's Hospital
reviewed 1,836 cases of breast cancer diagnosed with the aid of
a needle. They found large-core needle biopsies "accurate,
safe and well accepted by patients and referring physicians."
Instead of an operation, with local or general anesthesia, and
possible deformation of the breast, patients experienced a one-hour
the procedure's over you get a Band-Aid and you go home," said
Meyer (Salvatore 1999).
summarize: in principle the needle biopsy seems like a win-win situation.
It is a simple office procedure, convenient, bloodless and virtually
pain-free for patients. One would certainly not dispense with a
test like this for trivial reasons. Currently, 1.2 million US women
a year undergo breast biopsies. Between 20 and 25 percent of these
tests show cancer, according to Dr. Neil Gorrin, assistant chief
of surgery at Kaiser Permanente Medical Center in South San Francisco
(Viddya 2001). That means that virtually all the women in the US
who were diagnosed with breast cancer (215,990 this year) went through
concerns have been raised about the safety of invasive biopsies
since they were first introduced more than a century ago.
surgical biopsy first came to prominence in the 1870s, through the
work of Carl Ruge and Johan Veit of the University of Berlin, who
showed that only 10 out of 23 women who had undergone surgery for
cervical cancer actually turned out to have the disease. At that
time, surgeons in their arrogance simply assumed that they could
recognize cancer when they saw it: they viewed the suggestion that
tumors should be biopsied before excision as a direct challenge
to their diagnostic and clinical acumen. But the work of Ruge and
Veit effectively changed the prevailing tide of opinion.
fine needle biopsies - described as "a new instrument for the
diagnosis of tumors" - were first reported for head-and-neck
cancer by M. Kun in 1847. They were soon forgotten, but were subsequently
revived by Hayes E. Martin, MD, and Edward B. Ellis, MD, of Memorial
Sloan-Kettering, in the 1920s (Martin 1930). Needle biopsies were
performed on a large scale at Memorial in the 1930s; however, the
technique did not gain many adherents in the US during that time.
Needle biopsies later underwent a resurgence in Scandinavia during
the 1950s and 1960s, and it was from there that the trend spread
to the rest of the world, including back to the United States (Das
the time of World War I biopsy became routine practice in the US,
endorsed by both the American Cancer Society and the American Medical
by no means everyone in the medical establishment was convinced
that biopsy was an unqualified good. James Ewing, the dean of American
cancer pathologists, explicitly condemned puncturing unbroken skin
for the purpose of sampling deeper lesions. He wrote: "It is
especially to be avoided with...tumors of the breast, and all growths
in which incisions of the skin involve also incisions through the
tumor capsule" (Pack 1940: 43).
would of course preclude most of the situations in which needle
biopsies are currently done.
was not alone. The editor of the influential New York Medical
Record had this to say on the subject:
who harpoons or excises a piece of tissue from a tumor with unbroken
cutaneous or mucous surface, especially an encapsulated tumor,
and then waits a day or two while the specimen is being examined,
will almost inevitably destroy his patient's chance of recovery
by operation....To resort to indiscriminate digging into all tumors
on the chance of thereby reaching a diagnosis, which can usually
be made by safer measures, and which moreover is not absolutely
necessary, is positively wicked...." (Pack
words! The author ends on a peculiarly modern note: "[A] physician
acting on this advice would have no defense whatever if the heirs
of his patient should bring a malpractice suit" (cited in Pack
1940, the first American textbook on cancer treatment contained
warnings on the dangers of biopsies. "The medical
literature is full of pleas for and against biopsy of all types
of tumors," wrote Cushman D. Haagensen, MD, of Columbia University,
NY, in 1940. Some doctors are "inquisitive but afraid of doing
harm with biopsy" (Haagensen 1940). Bradley Coley, MD, a bone
surgeon at Memorial Sloan-Kettering Cancer Center (and son of the
famous immunotherapy pioneer, William B. Coley, MD), wrote that
"there is some doubt as to the harmlessness of needling such
tumors. It may not be a wholly innocuous procedure" (Pack 1940).
A survey taken at the time showed that most surgeons agreed that
the excision of suspect tissue was to be condemned and avoided.
so widely and unquestioningly accepted has needle biopsy now become
that anyone who raises a criticism of the technique runs the risk
of incurring the wrath of his or her professional colleagues. For
example, in July 2004 The British Medical Journal
ran an article by a group of Australian surgeons, cautioning against
the use of needle biopsies of the liver explicitly on grounds of
the serious risk of needle track seeding of the tumor (Metcalfe
2004). The researchers stated that there were "certainly...
medicolegal implications for people who perform fine needle aspiration
of any malignant lesion." A radiologist, replied indignantly
to the editor of the August British Medical Journal,
accusing him of practicing "tabloid journalism" by running
this article (Joseph 2004).
needle biopsies become standard practice because they have been
proved safe through a rigorous series of studies, culminating in
the yardstick of scientific measurement, randomized controlled trials
(RCTs)? Or have the safety issues raised long ago by such luminaries
as James Ewing, Cushman D. Haagensen and Bradley Coley simply been
swept under the rug?
may surprise readers, especially those who have undergone this procedure,
to know that controversy over the safety of needle biopsies has
quietly persisted into the modern period. Despite the unshakable
assurance with which a standard textbook states that "the available
evidence indicates that no increased risk of dissemination can be
demonstrated in patients treated by needle biopsy" (Pilch p.
501), doubts remain. Apart from anything else, this statement rests
on two papers, one dating from the 1950s and the other from 1962,
both written by the same Sloan-Kettering doctor, Guy F. Robbins,
MD, neither of which was based on a proper clinical trial (Kaae
1952; Robbins 1954).
David Kinne, a Memorial Sloan-Kettering breast surgeon, supported
needle biopsy and cited as proof of the technique's safety the claim
that there was no difference in survival between patients who received
needle biopsies and those who received excisional biopsies. He then
authoritatively averred, "This establishes that no dispersal
of tumor cells is caused by aspiration biopsy." But that seems
like an awfully big conceptual leap based on limited data, especially
since the data he quoted in support of his assertion was already
three decades old by the time that he cited it.
even Dr. Kinne had to admit that "the extent to which needle
aspiration biopsy may contribute - to a greater or lesser extent
than surgical biopsy - to the hematogenous [blood-borne, ed.] dispersal
of tumor cells has not specifically been determined" (Harris
can follow the fate of needle biopsies through various editions
the American Cancer Society's textbook on cancer.
In the 4th edition (1974), the editor, Philip Rubin, MD, of the
University of Rochester, wrote with refreshing bluntness that surgical
biopsies "may contribute to the spread of cancer in some cases."
elaborated: "Needle biopsy is occasionally used, [but]...a
needle track may harbor nests of cells which may form the basis
for a later recurrent spread....Incisional biopsy of certain highly
malignant tumors through an open operative field may be contraindicated
because of risk of spread of the tumor throughout the operative
by the 7th Edition (1991), this concern was less apparent. The only
caveat in this edition is a whittled down version of the earlier
statement, conceding that one of the disadvantages of the larger
core needle biopsy is "seeding of the needle track with tumor
cells." But now Dr. Rubin and his colleagues were quick to
reassure the reader that "with the advent of FNA [fine needle
aspiration, ed.], this [core needle biopsy] technique is now used
infrequently for palpable lesions..." (p. 43). As if FNA had
been conclusively proven free of the risk of needle track seeding.
the most recent ACS version of the textbook, Clinical Oncology
(2001), no longer offers any cautionary words whatsoever on the
danger of biopsies. In fact, it states flat out, "biopsy of
the breast under local anesthesia has virtually no disadvantages,"
an amazing statement in a field that is filled with complicated
trade-offs of benefit and risk. There is not one word about the
possibility of spreading cancer through biopsy.
sources that at the very least should discuss the possible downside
of needle biopsy act as if there were no controversy whatsoever.
Yet, if you examine the medical literature you do find studies similar
to that of the John Wayne Institute authors, throwing doubt on the
propriety of puncturing tumors in order to recover tissue for sampling.
in 2004, for example, the four Australian surgeons mentioned above
(Metcalfe 2004), published a study in the British Medical
Journal on the risks of fine needle biopsy of metastatic
tumors in the liver. The title of the article succinctly summarizes
their view: "Useless and dangerousfine needle aspiration
of hepatic colorectal metastases" (Metcalfe 2004).
dangerous? Aside from the acknowledged small risk of hemorrhage,
there is the question of seeding the tumor in the track of the needle.
Opinion is divided on how frequently this occurs. Some authors believe
the incidence is small, i.e., between 0.003% to 0.07%. But more
recently, the authors report, much higher rates (0.4% to 5.1%) of
needle track metastases have been reported when FNAC [fine needle
aspiration cytology, ed.] is used in liver lesions, usually for
primary liver tumors (Takamori 2000; Chapoutot 1999; Kim 2000; Durand
2001; Herszenyi 1995). Thus, it is possible that one in twenty needle
biopsies of the liver results in a new tumor.
latest reports on needle biopsies certainly reopen a concern that
has troubled many observers for a long time. I myself raised these
concerns in my first book, The Cancer Industry (1980),
quoting the 1974 ACS textbook cited above. I certainly respect Dr.
Hansen's cautious and scientific approach. It is true that the full
clinical significance of these lymph node metastases is not known
(that is, how many of them would go on to develop into full-blown
metastatic cancers, and how many would remain dormant in the local
is more certain, however, is the devastating effect that the development
of such metastases has on the patients involved. First, instead
of being told that they have a tumor that is almost certain to be
cured by localized treatment (surgery with or without adjuvant radiation),
they learn instead that the cancer has now escaped out of a confined
area and has been seeded into another part of their body. Second,
they will almost certainly now be strongly urged to take highly
toxic combinations of chemotherapy with all its unpleasant and dangerous
side effects, a treatment that would not have been necessary had
the tumor remained confined to its site of origin.
the outrage these patients will feel when they learn that many of
these sentinel node metastases were caused not by the natural progression
of their disease but directly by the actions of well-intentioned
(but ill informed) doctors. Imagine, further, what will happen when
patients find out that questions have been raised about the safety
and advisability of needle biopsies for a number of years by some
of the finest minds in oncology. Imagine the disruption of the smooth
functioning of the "cancer industry" when patients start
demanding less invasive ways of diagnosing tumors. And imagine the
class action lawsuits.
it is because of nightmare scenarios like this that no one in the
medical community has yet come forward to draw the obvious conclusions
from this provocative study for the general public. Doctors are
silent. Politicians are unaware. And journalists, whom we look to
as a "fourth estate" in issues of public policy, are silent
on this, as on most of the really outrageous developments in the
else do we explain the fact that despite the impeccable credentials
of the John Wayne Cancer Institute team, and prominence of the journal
in question, this report has generally been ignored, as has the
equally disturbing report on liver metastases in the British
Medical Journal. Although Reuters did cover the John Wayne
study at the time it was published (June, 2004), a scant three months
later I could find only a handful of websites that still mentioned
it, out of 82,000 that mention needle biopsies in general.
aspiration biopsy continues to be viewed as the gold standard of
diagnostic aids (Crabtree 2004). The whole notion that biopsies
may themselves spread cancer may be too hot to handle for most of
the media and the medical profession. It is one of those medical
secrets that, it seems, is best left unexplored.
Readers will inevitably want to know what options are open to
patients who want to avoid needle biopsies. First of all, one
should fully explore imaging techniques such as CT, MRI, PET scans
and ultrasound. PET scans are particularly sensitive, and can
often detect minute metastases, even before they become clinically
apparent. It should be borne in mind, though, that such scans
do subject the patient to transient doses of radiation. Mammograms
have become increasingly accurate over the years, although there,
too, questions have been raised about the exposure to ionizing
radiation involved, and there are also legitimate concerns about
the compression of the breast that accompanies most such tests,
which itself may on occasion be responsible for dislodging clusters
of cancer cells, thereby facilitating spread.
innovative and non-toxic kind of diagnostic test is thermography,
which detects abnormal patterns of heat emanating from areas of
high metabolic activity. Although thermography has had its ups and
downs, the result of a four year, multi-center clinical trial, led
by the University of Southern California, was unambiguous: "Infrared
imaging offers a safe, noninvasive procedure that would be valuable
as an adjunct to mammography in determining whether a lesion is
benign or malignant." The sensitivity of the test in this study
was an astonishing 99 percent (Perisky 2003).
is directed by Ralph W. Moss, Ph.D. Dr. Moss is the author of eleven
acclaimed books including Antioxidants Against Cancer, Herbs Against
Cancer, Questioning Chemotherapy, and Cancer Therapy. He consults
for thousands of clients through his Moss Reports service. The
Moss Reports specializes in educating cancer patients about
the most promising alternative treatments for their condition.
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