Are Needle Biopsies Safe?

[Guest guest]

There is no meantion of the AMAS test

[ http://www.amascancertest.com/,

http://www.drrons.com/AMAS-test.htm ,

http://www.newmediaexplorer.org/chris/2003/09/27/the_amas_test_for_early_detecti\

on_and_monitoring_of_cancer.htm ]

when discussing alternatives to the needle biopsy - I wonder if the author was

aware of it?

blessings

Shan

Are Needle Biopsies Safe?

http://chetday.com/needlebiopsy.htm

By Dr. Ralph Moss

from CancerDecisions.com Newsletter

 

A June 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 (or " lumpectomies " ).

 

This 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.

 

John 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.

 

The 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.

 

Hansen 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 biopsy.

 

The 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.

 

The 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.

 

Instead 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).

 

The 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 purposes.

 

Get a Band-Aid and Go Home

 

Is 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?

 

To read the mainstream media, you would think that the medical profession is

uniformly in favor of this procedure. For example:

 

A 1999 report in the Journal of American Medical Association enthusiastically

endorsed the use of needle biopsies.

 

" A 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 " (Salvatore 1999).

 

Jack 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

in-office procedure. " When the procedure's over you get a Band-Aid and you go

home, " said Meyer (Salvatore 1999).

 

Win-Win

To 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 this

procedure.

 

Yet concerns have been raised about the safety of invasive biopsies since

they were first introduced more than a century ago.

 

The 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.

 

Remarkably, 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 2003).

 

By the time of World War I biopsy became routine practice in the US, endorsed

by both the American Cancer Society and the American Medical Association.

 

However, 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).

 

That would of course preclude most of the situations in which needle biopsies

are currently done.

 

Ewing was not alone. The editor of the influential New York Medical Record

had this to say on the subject:

 

" [O]ne 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 1940).

 

Strong 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 1940:44).

 

In 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.

 

Yet 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).

 

Have 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?

 

It 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).

 

Dr. 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.

 

But 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 1991:107).

 

ACS Textbook

 

One 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. "

 

He elaborated: " Needle biopsy is occasionally used, [but]...a needle track

may harbor nests of cells which may form the basis for a later recurrent spr

ead....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 field " (ibid.)

 

Yet 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.

 

Finally, 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.

 

Many 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.

 

Earlier 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 dangerous—fine needle

aspiration of hepatic colorectal metastases " (Metcalfe 2004).

 

Why 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.

 

Conclusions

 

The 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 lymph nodes).

 

What 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.

 

Imagine 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.

 

I think 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 cancer field.

 

How 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.

 

Needle 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.

 

NOTE: 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.

 

An 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).