Against the Double Standard: A Reply to the ACS (Part 1)

How does one judge the relative merits of cancer treatments? What are the standards by which a treatment is declared effective or ineffective? The American Cancer Society has an answer to this thorny question. At the ACS website (www.cancer.org) they categorize all cancer treatments as follows:

1.  Proven or mainstream
   
   
2.  Experimental (in clinical trials)
   
   
3.  Complementary
   
   
4.  Alternative
   
   
5.  Quackery

"Proven" is equated with "mainstream." In ACS's view, such treatments are primarily surgery, radiation and chemotherapy. However, I think the equation of proven with mainstream is erroneous. The dictionary defines mainstream as "ideas, actions, and values that are most widely accepted by a group or society." They are widely accepted but are they necessarily true? The answer is, Not always. The mainstream often lags behind advanced scientific thinking.

Biophysicist Beverly Rubik, PhD, has made a lifework of studying innovative science. She notes: "Whereas the scientific community believes that it deals with novel controversial discoveries in a rational manner, this is rarely the case. The history of science, medicine, and technology is full of rejections of novel discoveries that seemed anomalous in their time. Long after their time," she concludes, "many of these scientists whose ideas were rejected were regarded as formative thinkers who made significant contributions or even launched new scientific paradigms."Ê

There are numerous examples of this. For example, until 1975, the ACS itself condemned the methods of pioneer immunologist William B. Coley, MD on their list of "unproven methods of cancer management." Today, however, Dr. Coley is universally revered as the godfather of immunotherapy.

Or consider the Halsted radical mastectomy. Twenty-five years ago, the ACS (like almost everyone else) upheld this mutilating operation as obligatory for nearly all women with breast cancer. Dr. George Crile, Jr., of the Cleveland Clinic, was attacked for his view that simple lumpectomy (with or without adjuvant radiation) was adequate treatment for many cases. Today, Crile's heretical view is mainstream.

Treatments vary from country to country, as Lynn Payer showed in her masterful work, Medicine and Culture. In Germany, between 40 and 60 percent of cancer patients use mistletoe as part of their cancer treatment and many forms of "alternative medicine" are accepted as "mainstream." In France, homeopathy is almost universally accepted as "mainstream." What is "mainstream" depends on where in the stream you find yourself.

I once spoke to an audience that included prostate cancer patients in England. When I mentioned the Prostate Specific Antigen (PSA) test I was greeted by a sea of blank stares. The PSA test, Êquite "mainstream" in America, is relatively unknown in Great Britain

The World Health Organization states that "most of the populations in various developing countries around the world depends on traditional medicine for primary health care"Ê In China, traditional medicines account for 30 to 50 percent of the total consumption of medicines. In Japan, from 1974 to 1989, there was a 15-fold increase in Kampo medicinal preparations in comparison with only 2.6-fold increase in the sales of mainstream pharmaceutical products.

"The Japanese per capita consumption of herbal medicine," says WHO, "appears to be the highest in the world" (WHO 1996). In these countries, herbal medicine is "mainstream," accepted by almost all lay people and most physicians.

In fact, sometimes what is mainstream in one part of the United States is not so in another region or state. There are large differences in how cancer is diagnosed and treated across the nine geographic regions of the Surveillance, Epidemiology, and End Results (SEER) Program. Here are examples from four of the most common cancers:

What Makes a Treatment "Proven" ?

Is there really such a thing as "proven" cancer therapies? How does one attain the status of a "proven" therapy? The ACS says that to be proven a treatment must be:

1.  Tested following a strict set of guidelines;
   
   
2.  Shown to be safe in such tests;
   
   
3.  Shown to be effective in such tests;
   
   
4.  Published in peer-reviewed journals; and
   
   
5.  Approved by the Food and Drug Administration (FDA).

This is, in fact, the way that new chemotherapeutic agents are readied for market. So if the ACS discussion were limited to chemotherapy, it would bear some relation to reality. New allopathic drugs are routinely developed through an evaluative process that ideally progresses from laboratory (in vitro) studies, to animal (in vivo) tests and, if they have shown promise in those preliminary tests, to three phases of clinical trials, ending in randomized controlled trials. (There is also a fourth phase, which we needn't deal with.)

Only when a treatment has completed this rigorous course of treatment, says ACS, does it "become part of the standard, mainstream collection of proven therapies used to treat disease in human beings."

(Next month I will deal with why radiation therapy is not a "proven" cancer treatment.)

The Chemotherapy Concession

The January 1, 2001 issue of the Journal of Clinical Oncology revealed that in 1999 the average annual income of oncologists in private practice was $253,000. By comparison, oncologists in academic medicine earned "only" $142,000. Where does the bulk of a private oncologist's income come from? The Journal of the National Cancer Institute (JNCI) commented that "private-practice oncologists typically derive two-thirds of their income from selling chemotherapy" (JNCI 2001;93:491).

However, in academic hospitals, this "chemotherapy concession" (again to quote the JNCI) "is not held by the individual physician; revenues go instead to the institution." These phrases in mainstream journals lay bare the economic motivation behind the excessive use of chemotherapy. One proposed solution to this income gap, say Thomas J. Smith, MD and colleagues at the Medical College of Virginia, is to make "academic oncology practices more profitable and salaries more generous."

In other words, academic oncologists should become more efficient billers, prescribing even more drugs and squeezing more revenue out of every therapeutic opportunity. Perhaps they would then be compensated by their universities for the larger bills. I'm sure anyone who has been billed for cancer treatment will recoil at the suggestion. That route might be good for the drug industry, but would it benefit patients? Here's a modest proposal: how about lowering the cost of cancer care through the introduction of less toxic and less costly CAM treatments?Ê

Harvard Professors Question Biopsies

The conventional approach to breast cancer consists of mammography, followed by biopsy, and surgery, with or without adjuvant radiation. This has been the approach for many years; new philosophical views are rarely found in the scientific literature. Recently, however, several Harvard professors have questioned the safety and effectiveness of this conventional approach. They raise the possibility that "surgical wounding" as they call it, might actually lead to the spread of cancer and increased deaths from breast cancer in younger women (Lancet 2001;357:1048).

Prof. Michael Retsky, Romano Demicheli, and William Hrushesky of Children's Hospital and Harvard Medical School point out that removal of experimental cancers can trigger the growth of new blood vessels in previously dormant cancers (micrometastases). In experimental animals, it was long ago shown that this could lead to early relapse and death (Science 1959;130:918-19).

In the 1990s, a substance called "angiostatin" was isolated in Prof. Judah Folkman's laboratory. It was produced by tumors but instead of promoting cancer, as you might expect, it controlled the growth of small lung tumors. When one surgically removes aÊ tumor one also removes the source of antigostatin; small tumors may flare up, killing the host.

One of the curiosities of breast cancer studies is that although screening mammography finds tumors earlier, in randomized controlled trials, it generally fails to convey a survival advantage for women in their forties. How can this be? The Harvard researchers suggest that any advantage derived from early detection in this age group is offset by an increase in metastases caused by the stimulation of tumors by surgical wounding.

"Data suggest," they write, "such acceleration of disease occurs in 27 percent of premenopausal women with node-positive breast cancer." "Stage progression" of these women's cancers offsets any benefit from the screening.

The authors suggest no way out of this dilemma. Perhaps the answer lies in the non-invasive techniques (such as hyperthermia or galvanotherapy) that are practiced at some non-conventional clinics. Whatever the solution, it's refreshing to find such daring thinking coming from such a conservative institution.

The Tightening Grip of Big Pharma

"The tightening grip of big pharma" -- no, it's not a new pamphlet from the National Health Federation, but the April 14 editorial in the Lancet (2001;357:1141). The editorial cites many cases in which big pharmaceutical companies have demanded the "right" to censor results that are not to their liking. For example, a Lancet author recently came under drug company pressure to remove data from a paper that questioned the safety of a drug. In return, the journal threatened to expose the name of the company and describe its tactics. In this instance, the company backed down.

This is nothing new. "Efforts by drug companies to suppress, spin, and obfuscate findings that do not suit their commercial purposes were first revealed to their full, lethal extent during the thalidomide tragedy," in the 1960s, writes the Lancet. But as the Lancet remarks, "the insidious tactics of big pharma have changed little."

We would add that Big Pharma's "insidious tactics" also extend to alternative medicine. The most striking example of this was a recent paper on St. John's Wort. This negative clinical trial made headlines all over the world. It purported to show than this popular herb does not have a beneficial effect on severe mental depression. But no reputable source ever claimed that it did! St. John's Wort is usually prescribed for mild to moderate depression, which was not tested. What was particularly alarming was that the study I question was funded by Pfizer, Inc., one of the biggest manufacturers of antidepressant drugs. So now the testing of herbal treatments is brought to us by "Big Pharma" as well, which then ostentatiously washes its hands of the interpretation of the data. This is a scandal worthy of a Congressional investigation.

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