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HOW TO EVALUATE
NEW MEDICAL DISCOVERIES
By Harry K. Ziel, M.D.
Of late, the internet represents
a great potential for transmission of medical misinformation to an unwary public. As the use of the internet geometrically
increases, web surfers intent on learning the most up to date information on disease treatment are exposed to a vast array
of unproved therapies. All the traditional safeguards are lost when usually well intentioned authors, enthusiastic to announce
their discoveries, pass along their latest findings over the convenient computer network.
CAM "SCIENTIFIC' REPORTING
A patient with an unusual medical
condition like pulmonary interstitial fibrosis or dermatomyositis may surf the web to find any number of sites which discuss
his condition. That unsophisticated patient may download, read, and believe that medical researchers have found that a particular
diet or herbal medicine is effective in treating his disorder. Desperate with an uncommon disease that is showing no or slow
response to traditional allopathic medicine (TAM), the patient is prone to look for and to utilize a number of complementary
alternative medical (CAM) nostrums of no value or even a substance that causes harm. These computer web sites are the equivalent
of Tijuana locations touting falsely advertised miracle cures that are falsely advertised, like laetrile.*
TAM SCIENTIFIC REPORTING
Excluding internet reporting,
transmission of responsible scientific information today falls into the venue of a huge number of scientific journals. A hierarchy
of scientific journals exists in each specialty area. Specialty organizations support the publication of most journals in
their fields. For instance, the American Chemical Society's publication division supports publication of 27 different journals.
In all, publication companies in United States print approximately 16,000 various peer-reviewed journals.
In each specialty area of medicine,
a hierarchy of journals has developed over time. The most prestigious and selective medical journal is The New England Journal
of Medicine (NEJM), published since 1812 by the Massachusetts Medical Society. Only one out of 10 articles submitted survives
the NEJM peer review process. NEJM editors send articles submitted to anonymous reviewers, experts in the fields covered by
the articles to be considered for publication. These highly responsible referees must reject, accept with recommended revision,
or rarely accept without revision all articles that clear the editors' primary review.
A close second to the NEJM is
the Journal of the American Medical Association (JAMA). The American Medical Association has published the JAMA since 1883.
The JAMA also accepts about one in 10 articles submitted. For the fields of general medicine, these two journals have attained
the first tier status in the hierarchy of medical journal reporting.
Journal editors today virtually
require that all the authors have subjected their data to sophisticated statistical evaluation. One of the referees evaluating
the article is a statistician who must peruse and agree with the testing of the data. First tiered medical journals require
that authors follow set formats. Editors insist on pertinent references supporting views the authors present. Authors must
disclose their sources of financial support. Purposals to perform research must first clear investigational review boards
(IRBs). Before the research protocol starts, IRBs insist on meaningful studies, check on adequate size of patient cohorts
to attain statistically significant conclusions, require patient consents which enumerate all patient risks as well as provision
for study termination should patient injury become manifest.
Lower tiered journals tend to
accept articles which meet with ever lower standards of quality review. The lowest tiered journals may accept and publish
nearly all articles submitted. Obviously, one needs to scrutinize and be more wary of conclusions tabulated in the lower tiered
journals. Unpublished internet findings have the least degree of peer review and accordingly should bear the greatest skepticism.
Without any ability to review the material and methods, the statistical evaluation of the data, the quality of internet study
conclusions are highly problematic.
HIGH FIBER DIET AND COLON CANCER
High quality peer reviewed reports
can not be accepted fully, even if data appear to be statistically valid. Unrecognized biases often contaminate data. Statistical
validation simply suggests truth. Only multiple studies, all statistically valid, each concluding similar findings, biologically
plausible, with increasing exposure correlating with increasing effect will point to a causal rather than a casual association
between cause and effect. The best studies are prospective in which patients are randomly assigned to a study group or a control
group. Both the researchers and the patients are unaware (blinded) into which study or control group patients are enlisted.
Study medications and placebos look alike. Researchers check compliance in taking medication by inspecting patient logs and
remaining medication during each visit. Prospective studies are long and expensive.
As an alternative to prospective
studies, researchers often choose to perform retrospective case control studies which are far faster and less expensive to
conduct than prospective studies. Selection of control patients randomly chosen and matched by age, ethnicity, parity, Ponderal
index, socioeconomic status etc. are paramount to avoid bias in retrospective case control studies. Simple observational studies,
sometimes matched with historical controls, provide information of a far lessor quality on which physicians must sometime
decide therapy when no better information is available.
To illustrate why multiple studies,
each coming to the similar conclusions, must be the gold standard for scientific decision making, one needs only to point
to the recent NEJM article which refutes the long held belief that a high fiber diet was protective against colon cancer.
In 1971, Denis Burkitt first reported that Africans who ate a high fiber diet had a low incidence of colon cancer. A 1992
meta-analysis done by Howe et al of 13 case control studies documented both a protective effect of fiber against colon cancer
as well as a dose-response relationship (greater fiber use resulted in less colon cancer incidence). Thun et al in 1992 and
Steinmetz et al in 1994 both showed an inverse relationship between high fiber intake and colon cancer occurrence indicating
protection from colon cancer from fiber intake. Because of other associated benefits of high fiber intake, i.e., reduced incidence
of diverticulosis, less coronary artery atherosclerosis, lower incidence of hypertension, and less frequent type 2 - non insulin
dependent diabetes, high fiber became a highly encouraged prophylactic disease intervention. The fiber bandwagon was rolling
along!
Hints that fiber was ineffective
in colon cancer prevention however arose from four publications. Responsible were DeCosse et al in 1989, McKeown-Eyssen et
al in 1994, MacLennan et al in 1995, and Platz et al in 1997.
Fuchs et al in the January 21,
1999 issue of the NEJM reported from the Nurses' Health Study begun in 1976 that no protective association existed secondary
to the use of high fiber diets from colon cancer or from premalignant adenomas known to precede colon cancer development.
Their meticulous study refuted a belief held for the past 28 years. The Nurses' Health Study is an ongoing prospective study
of 88,757 women conducted by a highly regarded research team at Harvard, one member of which team, Walter Willett, has made
dietary influence on disease development his life's work.
Shari Roan, writing in the January
25, 1999 Los Angeles Times, was quick to jump both on and off the Nurse's Health Band Wagon saying that the report shows that
one can not trust a "lone study". Her assessment of where we stand in understanding the causes and prevention of colon adenomas
and cancer is just what the public needs to hear.
A true skeptic must say, "I
still see no gold standard met. The story of colon cancer prevention is complicated by too many other factors than fiber ingestion.
The skeptic requires many more studies involving complex carbohydrates and sugars, carcinogens derived from high temperature
cooking , ingestion of smoked fish and meats, camplobacter and other enteric pathogens, genetic predilection, as well as pesticides
and other contaminants from foodstuffs and water to begin to find the solution to the colon cancer causes and prevention's.
It's not a crime to admit one does not know.
SKEPTICISM MUST REIGN SUPREME
!!!
The skeptic who steps outside
the parade to await the final float before he steps back into line will experience the fewest upsets. The cocky drum major
who heads a parade is most conspicuous if he leads followers who are all out of step. Scientific proof may take generations
before discovery.
*Laetrile is a good point of example for
there is nothing peculiar about the chemical contents of peach kernels that support strongly a medicinal claim. The traces of cyanide are not medicinal and the other substances are found in the common almondto which
the peach is a member of the family. Speculation as to some natural curative
effect of a chemical without a demonstration of its biochemical mechanism is mere product hype. When a credentials is added to a name, this does not entail that the experts knowledge is in fact scientifically
sound. There are a few who have earned such initials attached to a name how have
a religious belief in quackery, and there are many more who have obtained such letters from institutions that do not qualify
them to practice medicine or be employed at a university as a research scientist. Their
articles have an odor like that of laetrile, rotten almonds, and the results can be as deadly as cyanide. For the failure to obtain proper treatment of a medical condition has accounted for many early deaths.
References:
1.Burkitt D P. Epidemiology of cancer of the colon and rectum.
Cancer 1971; 28:3-13.
2. DeCosse J J, Miller H H, Lesser M L. Effect of wheat fiber and vitamins C and E on rectal polyps
in patients with familial adenomatous polyposis. J Natl Cancer Inst 1989; 81, 1290-1297.
3. Fuchs C S, Gioannucci E L,
Colditz B A, Hunter J H, Stampfer M J, Rosner B, Speizer F E, Willett W C. Dietary Fiber and the Risk of Colorectal Cancer
and Adenoma in Women. N Engl. J Med 1999; 340: 169-176.
4. Howe G R, Benito E, Castelleto R, et al. Dietary intake of fiber
and decreased risk of cancers of the colon and rectum: evidence from the combined analysis if 13 case-control studies, J Natl
Cancer Inst 1992;84:1887-1896.
5. MacLennan R, Macrae F, Bain C, et al. Randomized trial of intake of fat, fiber, and beta
carotene to prevent colorectal adenomas: the Australian Polyp Prevention Project. J Natl Cancer Inst 1995, 87:1760-1766.
6.
McKeown-Eyssen G E, Bright-See E, Bruce W R, Jazmaji V. A randomized trial of a low fat high fibre diet in the recurrence
of colorectal polyps: Toronto Polyp Prevention Group. J Clin Epidemol. 1994; 47:525-536.
7. Platz E A, Giovannucci E, Rimm
E B, et al. Dietary fiber and distal colorectal adenoma in men. Cancer Epidemiol Biomarkers Prev 1997; 6: 661-670.
8. Steinmetz
K A, Kushi L H, Bostick R M, Folsom A R, Potter J D. Vegetables, fruit, and colon cancer in the Iowa Woman's Health Study.
Am J Epidemiol 1994; 139: 1-15.
9. Thun M J, Calle E E, Namboodiri M M, et al. Risk factors for fatal colon cancer in a
large prospective study. J Natl Cancer Inst !992; 84: 1491-1500
Quackery: How Should It Be Defined?
Stephen Barrett, M.D.
"Quackery" derives from the
word quacksalver (someone who boasts about his salves). Dictionaries define quack as "a pretender to medical
skill; a charlatan" and "one who talks pretentiously without sound knowledge of the subject discussed." These definitions
suggest that the promotion of quackery involves deliberate deception, but many promoters sincerely believe in what they are
doing. The FDA defines health fraud as "the promotion, for profit, of a medical remedy known to be false or unproven." This
also can cause confusion because in ordinary usage -- and in the courts -- the word "fraud" connotes deliberate deception.
Quackery's paramount characteristic is promotion ("Quacks quack!") rather than fraud, greed, or misinformation.
Most people think of quackery
as promoted by charlatans who deliberately exploit their victims. Actually, most promoters are unwitting victims who share
misinformation and personal experiences with others. Customers of multilevel companies that sell health-related products typically
have been persuaded by friends, relatives, and neighbors who use the products because they believe them effective. Pharmacists
also profit from the sale of nutrition supplements that few customers need. In most cases pharmacists do not champion the
products but simply profit from the misleading promotions of others. Much quackery is involved in telling people something
is bad for them (such as food additives) and selling a substitute (such as "organic" or "natural" food). Quackery is also
involved in misleading advertising of dietary supplements, homeopathic products, and some nonprescription drugs. In many such
instances no individual "quack" is involved -- just deception by manufacturers and their advertising agencies.
Quackery is not an all-or-nothing
phenomenon. A practitioner may be scientific in many respects and only minimally involved in unscientific practices. Also,
products can be useful for some purposes but worthless for others. For example, vitamin B12 shots are lifesaving in cases
of pernicious anemia, but giving them frequently to "pep you up" is a form of medical fraud.
Quackery and poor medical
care overlap but are not identical. Quackery entails the use of methods that are not scientifically accepted. Malpractice
involves failure by a health professional to meet accepted standards of diagnosis and treatment. It includes situations in
which the practitioner was negligent while using standard methods of care. Leaving a surgical instrument in a patient's abdomen
or operating on the wrong part of the body are examples of malpractice unrelated to quackery.
To avoid semantic problems,
quackery could be broadly defined as "anything involving overpromotion in the field of health." This definition would include
questionable ideas as well as questionable products and services, regardless of the sincerity of their promoters. In line
with this definition, the word "fraud" would be reserved only for situations in which deliberate deception is involved.
Unproven methods are not
necessarily quackery. Those consistent with established scientific concepts may be considered experimental. Legitimate researchers
and practitioners do not promote unproven procedures in the marketplace but engage in responsible, properly-designed studies.
Methods not compatible with established scientific concepts should be classified as nonsensical or disproven rather than experimental
quack issues easily exposed--jk
1. There is no reasonable health science modus operandi.
2. Failure to find widespread
application by physicians. Market place forces assure that a wonder treatment
will find acceptance.
3. Failure to be published
in a major peer-review medical journal. The lack of funding for rigorous scientific
study of an alternative medical treatment reflects the reasoned conclusion that the treatment will at best be only marginally
better, and most like perform no better than the placebo control.
4. Reliance upon testimonials. .
5. The results are contrary
to a large body of experimental, published results.
6. The source is from
the alternative health group.
1. Reasonable entails
a method of operation that is supported by known and documented biological pathways.
There is no known mechanism in the cells of the body designed to be influenced by a magnet—that strong magnetism
might well over prolonged periods of time prove disruptive of biochemical reactions.
(People are routinely subjected to a strong field for nearly an hour when having an MRI). Since magnets are not used to influence in the laboratory chemical reactions, a reasonable conclusion is
that they don’t in the body as well. Secondly the effects are much more
likely to be disruptive rather than therapeutic. For vitamin C, for example,
has special receptors in the body, but for magnetic fields there aren’t.
2. This is very telling
for other the centuries there are tens of thousands of purported wonder treatments that either fail to be demonstrated as
effective or have vanish. A clearly superior medical treatments will have a body
of published results supporting their use, and thus gain wide-spread acceptance. Controversies
are generally over which alternative is best. Unfortunately treatments that are only marginally better often languish for
want of aggressive marketing (see, e.g., my articles on aspirin).
3. Any treatment worth
its salt will be tested and the results submitted to a medical journal. If magnet
on the wrist cured liver dysfunction, then the manufacturer of that product ought to advance its marketing by having a study
done and then published in an important medical journal. Being published does
not prove the case: there are trade publications for alternative treatments and
their review of the submitted work is scant at best.
4. True believers are
as much a proof of angels dancing on the head of pins as they are of the curative property of the magnet. And just as there are scientists who profess to believe in a young world, so too are there physicians and
researchers whose beliefs are equally absurd. The issue isn’t proven because
some person with a MD or PhD believes in a treatment, but rather the consensus of his peers.
5. Reproducibility is
part of the gold standard. A result that stands in conflict to a large body of
evidence is much more like to be in error.
6. The overall track
record of alternative health is dismal. There isn’t one wonder cure. Sure a few herbal sources have yielded useful medications, such as willow back and
fox glove; however, in each case both I have been greatly improved by medical science.
The failure of ginkgo extract, wheat-grass juice or golden seal to pass the tests of medical science is because upon
scientific examination they don’t work
The
overall track record is the best marker, for often in the market place forces are less than honest about the evidence—as
Dr. Barrett illustrates below
http://quackwatch.org/04ConsumerEducation/QA/magnet.html)by Stephen Barrett, MD.
The main basis for the claims is a double-blind test study, conducted at
Baylor College of Medicine in Houston, which compared the effects of magnets and sham magnets
on knee pain. The study involved 50 adult patients with pain related to having been infected with the polio virus when they
were children. A static magnetic device or a placebo device was applied to the patient's skin for 45 minutes. The patients
were asked to rate how much pain they experienced when a "trigger point was touched." The researchers reported that the 29
patients exposed to the magnetic device achieved lower pain scores than did the 21 who were exposed to the placebo device
[3} Although this study is cited by nearly everyone selling magnets, it provides no legitimate basis for concluding that magnets
offer any health-related benefit:
- Although the groups were said to be selected randomly,
the ratio of women to men in the experimental group was twice that of the control group. If women happen to be more responsive
to placebos than men, a surplus of women in the "treatment" group would tend to improve that group's score.
- The age of the placebo group was four years higher than
that of the control group. If advanced age makes a person more difficult to treat, the "treatment" group would again have
a scoring advantage.
- The investigators did not measure the exact pressure
exerted by the blunt object at the trigger point before and after the study.
- Even if the above considerations have no significance,
the study should not be extrapolated to suggest that other types of pain can be relieved by magnets.
- There was just one brief exposure and no systematic follow-up
of patients. Thus there was no way to tell whether any improvement would be more than temporary.
- The authors themselves acknowledge that the study was
a "pilot study." Pilot studies are done to determine whether it makes sense to invest in a larger more definitive study. They
never provide a legitimate basis for marketing any product as effective against any symptom or health problem.
Two better-designed, longer-lasting pain studies have been negative:
- Researchers at the New York College of Podiatric Medicine
have reported negative results in a study of patients with heel pain. Over a 4-week period, 19 patients wore a molded insole
containing a magnetic foil, while 15 patients wore the same type of insole with no magnetic foil. In both groups, 60% reported
improvement, which suggests that the magnetic foil conveyed no benefit [4].
- More recently, researchers at the VA Medical Center in
Prescott, Arizona conducted a randomized, double-blind, placebo-controlled,
crossover study involving 20 patients with chronic back pain. Each patient was exposed to real and sham bipolar permanent
magnets during alternate weeks, for 6 hours per day, 3 days per week for a week, with a 1-week period between the treatment
weeks. No difference in pain or mobility was found between the treatment and sham-treatment periods [5].
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