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NCRHI News, September/October 1999

Volume 22, Issue #5

PRODUCT GLUT MAY SPELL TROUBLE
FOR SUPPLEMENT HUCKSTERS

New Rochelle, NY 8/23/99, PRNewswire. The acquisition of General Nutrition Companies (GNCI) by Royal Numico, N.V. this month could be the start of a far-reaching consolidation in the troubled nutritional and natural products industry, according to the inaugural issue of NutriBiz, published by Corporate Research Group. Midsized firms with revenues of $100 million to $750 million, such as Rexall Sundown, Twinlab, Nutraceutical International, NBTY/Nature's Bounty and Weider Nutrition, are possible acquisition candidates, given the generally low valuations accorded to nutrition and natural products companies, say analysts quoted in NutriBiz. NutriBiz reports that a product glut at retail has led to disappointing sales and earnings for a number of industry leaders, with nutrition stocks badly lagging the overall market. Second quarter earnings for 30 companies fell 16%, NutriBiz says. Market valuations for 30 leading companies were down 11% through June to $10.9 billion, and valuations fell another 4.3% in July, the newsletter says.

The August issue of NutriBiz also covers:

MANNATECH SAYS IT WAS MISLED BY DOCTOR

©1999 LP Bloomberg with permission.

On August 20, 1999 Mannatech Inc. said it has cut all ties to the California physician who wrote a now discredited medical journal article used by the nutritional supplements company to sell its pills. It now says Dr. Darryl See, the article's author, backed his claims with false documents, and that it's considering a lawsuit against him. See's study ranked Mannatech's pills, including its flagship Ambrotose, in the top five of 196 nutritional supplements tested. A company investigation confirmed a Bloomberg News report that See's study was neither funded by the National Institutes of Health nor conducted under the auspices of the University of California at Irvine medical school, as it claimed. "We have disassociated ourselves completely and unequivocally from Dr. See," said Samuel Caster, Mannatech's president. "Unfortunately, Dr. See misrepresented himself and his work."

Mannatech also quoted from a Bloomberg News report in which Marikel Chatard, the technician who See said did most of the lab tests for the study, denied participating in it. The company said it verified Dr. See's claims before using the his study. "We did everything we possibly could to ensure the material was authentic," Caster added. That included paying $30,000 for an audit of See's study, which it previously used to defend it. Bloomberg News reported that See never provided the laboratory notebooks requested by the auditor to authenticate his data.

Mannatech still hasn't disclosed that it paid See more than $100,000 to speak at sale rallies and conduct research, and that his wife has been a Mannatech distributor since 1997, as See told Bloomberg in an interview. Mannatech sells its pills through an army of more than 400,000 distributors. Company executives weren't available for comment. See resigned from the university's faculty after an investigation censured him for violating research rules, including falsifying documents and conducting laboratory experiments on a rabbit without sufficient anesthesia. The Journal of the American Nutraceutical Association, which published See's article, has stopped selling reprints of See's articles, books and videotapes. See recommends Mannatech's supplements for treatment of diseases such as AIDS and cancer in an audio cassette distributed by Mannatech.

On Friday, Bloomberg News reported the NIH is investigating Mannatech's relationship with Dr. Robert Ortmann, one of its scientists who is also a part-time Mannatech salesman. The agency ordered him not to appear at a company sales rally tomorrow in Olympia, Washington. Coppell, Texas-based Mannatech shares today fell 1/16 to 7 7/8. They've lost one-third of their value this month.

BENEFIT/RISK OF NECK MANIPULATION

An assessment of the benefits and risks of manipulation of the cervical spine (MCS) was done based upon a review of the literature (1925-1997); 177 injuries were reported in 116 articles. The majority of injuries were attributed to manipulation by chiropractors. Physical Therapists (PTs) were involved in less than 2% of reports. The author determined that the best estimate of benefit from MCS was 13-16% decrease in pain; a range of risk estimates for severe neurovascular compromise of from 1-in-50,000 to 1-in- 5 million; the risk of minor exacerbation of neck pain per physical therapist manipulation in New Zealand was 0.21%. There is no evidence that MCS achieved better clinical outcomes than mobilization.

[Di Fabio RP. "Manipulation of the cervical spine: risks and benefits," Physical Therapy, 1999;79(1):50-65]

HISTORICAL OBSERVATION ABOUT ASTROLOGY

Boston Globe, 7/26/99 p.C2 -- Recently, an astronomer at the Lick Observatory in California found in the institution's library a horoscope cast by the 17th-century astronomer Johannes Kepler for an Austrian nobleman, Hans Hannibal Huetter von Huetterhofen. The document had been purchased in Russia in 1886 by the first director of the Lick Observatory and had lain forgotten for a century. Present-day astrologers always drag out poor Kepler in support of their bogus craft. See, they say, even such an eminent scientist as Kepler was a believer. Kepler practiced astrology only as a matter of financial necessity. His heart certainly wasn't in it. He wrote: "A mind accustomed to mathematical deduction, when confronted with the faulty foundations [of astrology], resists a long, long time, like an obstinate mule, until compelled by beating and curses to put its foot into that dirty puddle." Kepler's distrust of the "dirty puddle" hasn't rubbed off on Americans. Polls show that half of Americans are open to astrological influences in their lives. Most newspapers and magazines offer horoscopes. Even those people who say "Oh, I just do it for fun" will sometimes admit that "Well, maybe there's something to it." "After all," they say, "science doesn't know everything. Maybe, just maybe, the positions of the planets and stars do affect out lives. Haven't people believed it for thousands of years? Didn't Kepler believe it? I may not be able to prove it is true, but neither can science prove it is wrong." And, of course, they are right. Science can't prove that astrology is wrong because the whole system is so slippery and vague that it's impossible to get a grip on it. That's what Kepler meant by "dirty puddle." A typical horoscope is loose enough to let almost anyone see themselves in it. Whatever Kepler gave Hans Hannibal Huetter von Huetterhofen, we can be confident that his customer went away thinking he got his money's worth. It was the genius of the British philosopher Karl Popper to realize that nothing in science can ever be proved absolutely true. Just because something "works," doesn't mean it's right. But what we can sometimes do with confidence is show that a scientific idea is wrong. As Popper said, good science is "falsifiable." An idea that offers ample opportunities for falsification, yet resists refutation, is to be valued highly. An idea that can't be proved wrong is simply not science. When Kepler discovered what we now call Kepler's Laws of Planetary Motion, he found precise mathematical formulae that describe the motions of the planets and their moons to a high degree of precision. A single unambiguous exception to the laws would show that something is amiss. Four hundred years later we have not found an exception. But when Kepler cast horoscopes, it was a "well, maybe" sort of thing. Since the 1950s, many scientific studies have attempted to assess the accuracy of astrological predictions, usually by asking astrologers to match horoscopes to people in blind tests. The results have been overwhelmingly negative. In spite of hundreds of person-years of research, not one shred of reliable evidence has emerged to show that astrology is anything but bunk. Do astrologers therefore concede that their horoscopes are a swindle? Not on your life. The system is much too elastic for that. Psychologist Ivan Kelly of the University of Saskatchewan lists a number of ways astrologers get around the scientific critique of their craft:

[From an article by Chet Raymo used with permission -- Raymo is a professor of physics at Stonehill College and the author of several books on science.]

EMF RESEARCHER'S MISCONDUCT

In a blow to a research area hungry for credible findings, the federal Office of Research Integrity (ORI) reported last month that a biochemist "engaged in scientific misconduct ...by intentionally falsifying and fabricating data and claims" in two studies on how electromagnetic fields (EMFs) --the kind shed by power lines and home appliances affect living cells. The researcher, Robert P. Liburdy, formerly of the Lawrence Berkeley National Laboratory (LBNL) in California, has agreed to ask the journals to retract the results. "There's a lot of acrimony in the EMF debate, and this won't calm things dawn," says Richard G. Stevens, a cancer epidemiologist at the Pacific Northwest National Laboratory in Hanford' Washington. Liburdy's findings were among the first to offer a plausible mechanism for a possible link between EMF exposure and cancer or other diseases. In a pair of 1992 papers of which he is the sole author, Liburdy offered evidence that EMFs increase the flow of calcium into Lymphocytes, a kind of immune cell produced in the thymus. The papers created a stir, as calcium ions signal cells to turn genes on and off, and play a role in cell division. Because tumor growth is tied to cell proliferation, an alteration in calcium signaling could conceivably lead to cancer. But in an analysis obtained by Science, ORI states that "Liburdy's claims that EMF causes cellular effects related to calcium signaling [in three figures in the two journal articles] are not supported by the primary data." Responding to an unknown whistle blower's allegations of scientific misconduct bv Liburdy, LBNL in January 1995 appointed a panel of four lab scientists to investigate. After scientists, the panel concluded in a July 1995 report that Liburdy "deliberately created 'artificial' data where no such data existed" in a figure in FEBS Letters. In addition, it found, he fabricated data noise for a figure in the Annals of the New York Academy of Sciences "in order to mislead the reader." These actions, the panel stated "fall within the definition of scientific misconduct " When contacted by Science, LBNL officials declined to comment, other than to confirm that Liburdy no longer works at the lab. Because Liburdy had been awarded more than $3.3 million in federal grants for his EMF research, ORI launched a formal review of LBML's report in fall 1997. ORI approved a request by Liburdy for an interview with ORI staff and two outside experts, which took place in March 1998. At the meeting, Liburdy produced original data he had not shared with LBNL investigators, according to the ORI report. But the data failed to exculpate him In its analysis, ORI accuses Liburdy of having lied to LBNL and ORI investigators, and it "concurs with [LBNL's] findings of scientific misconduct." "Some of the numbers, essentially, he made up," says John

Krueger, an ORI investigator involved in the case. In a May 1999 agreement signed by Liburdy and OR] acting director Chris Pascal, Liburdy agreed to retract the tainted figures in the two papers and not to receive federal funds for 3 years. He "neither admits nor denies ORl's findings of scientific misconduct," the document states. Liburdy did not respond to requests for an interview. The misconduct findings are unlikely to shift the playing field in EMF research. Since 1992, 20 to 30 scientific papers have looked at EMF exposures and calcium signaling, without settling the issue, says Christopher Portier, associate director of the environmental toxicology program at the National Institute of Environmental Health Sciences NIEHS). In a report to Congress released on 1: June, NIEHS director Kenneth Olden states the scientific evidence that EMF exposures "pose any health risk is weak" and that mechanistic and toxicology studies "fail to demonstrate any consistent pattem." The day before the report came out, National Institutes of Health officials had asked NIEHS to determine quickly whether any of Liburdy's research had influenced the report's conclusions, Portier says. The truth was simple, he says: "It had no impact whatsoever."

[Vergano D. "EMF Researcher Made Up Data," Science, 1999;285 (Jul 2):23-4]

ANTI-MALIGNIN ANTIBODY--A SCREENING TEST FOR CANCER?

Edward Friedlander, M.D., erf@alum.uhs.edu

I am a pathologist, board-certified in both anatomic and clinical pathology. I operate the world's largest public pathology site, which includes a free personalized help line. I have received about ten inquiries in the past few years about the "anti-malignin antibody in serum" blood test (AMAS). This is said to be an extremely accurate way of determining whether cancer is present somewhere in the body. This is every pathologist's dream. As its proponents point out, such an assay could replace the current methods of cancer screening, and would render most biopsies and other invasive studies unnecessary. "Anti-malignin antibody" has been promoted as such for over twenty years by a single husband-wife team, with occasional brief reports in the medical literature. The team operates the only lab which offers the test. They claim to assay for a substance called "malignin", and for antibodies against it.

Unlike other independent medical thinkers, the team is not presenting a mysterious, arcane, or secret substance. They claim instead that it's a tumor antigen, like many others that are known -- except that it is ubiquitous among malignant cells and distinguishes them from their benign counterparts. They have conducted themselves decently, and obviously believe in their test. The team is the only group offering the assay. There is an Italian report, not from the main group, but in the obscure International Journal of Biological Markers from 1997 which I presently have on order. The promoter's website states that Smith-Kline labs also did the test and published results in symposium proceedings in 1983, though nothing in the refereed scientific literature. That's all.

The wording of the claims for "anti-malignin antibody" never actually say that a person can forego pap smears, mammography, or biopsy of suspicious lesions. But some of the test's proponents suggest that this is possible, and this makes me worry about a public health hazard.

I have no first-hand knowledge of the team that offers the test, and am relying (as is the norm in real science) on publications. According to the 1999 AMA directory, he is boarded in neurology-psychiatry, but practicing immunology and oncology. She is listed as practicing psychiatry and "other", and as unboarded. He also made some contributions in mainstream neurochemistry before 1980, and has a recent publication on virus receptors and dementia in a theme issue of Annals of the New York Academy of Sciences.

Except as noted, after over 20 years, no other group has published in the refereed literature on "malignin" or given any independent evidence that the substance actually exists. (Nor has anybody reported being able to confirm the existence of "astrocytin," another substance which the same team claimed to have discovered at the same time as "malignin".) Again, I have no personal experience either with this supposed substance or with the people who describe it. But I am familiar with assays and procedures of the kinds described in their publications.

The account of the origin of "malignin" is itself curious. According to one source linked below, the principal proponent of the test "discovered that the outer coating on cancer cells contain [sic] sugar molecules over an inner layer of protein (glycoproteins). Cancer cells bump into each other and the outer layer is ground off -- exposing the inner protein layer and the malignin antigen."

I've spend a good amount of my life looking at cancer cells. This business about them bumping into each other just isn't true, especially in the early stages. In fact, they're no more mobile than the surrounding cells, and much less mobile than the benign cells of the bloodstream, bone marrow, or lymphoid organs, where collisions among cells happen constantly.

At another site, there is a more sophisticated-sounding account. "Early in the process of malignant transformation, there is a 50% loss in the amount and heterogeneity of the carbohydrate constituents of the cell membrane glycoprotein GlycolOB which results in the appearance of peptide epitopes (malignin) in AglycolOB." Visitors should know that the claim that there is a 50% loss of carbohydrate content and heterogeneity in the cell membrane when a cells turns cancerous is unsubstantiated at best, and... a "Medline" search over the refereed literature shows no other mention of either GlycolOB or AglycolOB. If the author is referring to OB, the leptin receptor (an appetite regulator), the above account makes no sense. I am presently tracking down all of the team's publications. Except for three letters to Lancet, they are in obscure medical journals.

I was startled, though, by the Lancet letter from July 18, 1981. Pathologists routinely use antibodies as stains to identify particular types of cells. In fact, anti-malignin antibody is promoted to the public as a way for pathologists to distinguish benign from malignant cells under the microscope. The "Lancet" letter announces the use of anti-malignin antibody as a stain, and the fact that it successfully stained three different types of cancer cells in wet preparations.

But what is most curious is that the writer does NOT mention trying out the antibody on any non-cancerous cells. This would be extremely easy to do. If the antibody is really specific for cancer cells, it would leave benign (non-canceous) cells unstained. If the author really believed his own fundamental claim, he would stain sections of tissue containing both benign and malignant cells (i.e., the edges of cancer masses). If he is right, he would see stain only on the cancer cells. After eighteen years, we still have no photos or reports of any such investigations.

Even without a blood assay, if the antibody had demonstrated the predicted ability to distinguish benign and malignant cells, the photographs would have been published within the lead article of the prestigious medical journal of the author's choice. And any second-year medical student knows this. On this evidence alone... at least for now, I will draw the obvious conclusion.

To the team's credit, they engage in no dark talk of conspiracies to suppress a breakthrough. But the truth is that the screens that actually work (i.e., that work in more than one person's lab) are quickly taken by big-money corporations and used to earn huge profits. It is inconceivable that no biotechnology corporation has tried to reproduce the work on "malignin". And no major lab has told an audience of fellow-scientists that "malignin" even exists.

Real science is the serious business of trying to make sense of the world, constantly testing and taking elaborate precautions against self-deception. No one can say with real confidence exactly what's going on here. I believe in the sincerity and good intentions of the persons offering the test, and those promoting it. For now, I must simply caution physicians and patients alike against basing clinical decisions on the "anti-malignin antibody serum test." The principal website promoting anti-malignin antibody is: amascancertest.com

Follow Up

I have now (July 27, 1999) obtained and reviewed the other major publications on "malignin". I found the following to be the most revealing. J Med. 13:49, 1982. The team presents data on staining of cells from patients known to have cancer, and those known not to have cancer. What's astounding is that the team did not focus on whether the actual cells they were staining were cancerous, but only whether the patients had cancer. On the evidence, the team took any cells that were handy. There were 22 specimens, evidently all liquid (effusions, brushings, or aspirations), since duplicates were sent to pathologists for papanicolaou examination. The authors report "Standard Papanicolaou stain examinations performed blind on duplicates of these specimens by other pathologists were correct in 17/22 specimens (77%)." It is commonplace for a person with cancer to produce specimens that do not contain cancer cells, and visual examination by a pathologist remains the gold standard for diagnosis. If I understand English, this means that the group is reporting that its antibody stains cells from cancer patients even if there are no cancer cells in the specimen. This is weird, since the team also claims that only cancer cells express malignin. The photos that accompany the article are also curious. The pattern of staining on the supposed squamous lung cancer cells looks coarse and very irregular. (I can't tell that this isn't just nonspecific dye binding to a bit of lung debris.) The "lymphocytic leukemia cell from blood" (somebody did a papanicolaou stain on blood?) looks like a normal lymphocyte though I can't exclude a very low-grade leukemia. The "ovarian carcinoma cells at surgery" appear not to be stained at all, and the "anaplastic astrocytoma at surgery" photo is probably not really stained either, since there is no nuclear-cytoplasmic differentiation. The remaining photo isn't even from one of the 22 patients, but from a cell culture of a squamous cancer from a group in Florida, which I found despite the article's reference to the mainstream journal Cancer Research being incorrect. Something is not right here.

Neurochem Res 4:465, 1979. The team described two more proteins, which they named "recognins". Nobody else has ever reported that either of these even exists.

Cancer Det Prev 6: 317, 1983. An author in Germany reviewed tumor markers in the CNS, mentioning astrocytin and malignin and the team's claims. He adds that "These findings remain to be confirmed by others" -- as true today as it was 16 years ago. Int J Biol Mark 12:141, 1997. The Italian NCI team reviews the original team's work uncritically. There is no "Materials and Methods" section, and no new data. In other words, even these people do not have an independent assay for "malignin", and has not even described the substance independently. My local biochemist reviewed the articles and pointed out:

The team writes about supposed phylogenetic relationships without even reporting a sequence; The team writes about carbohydrates components of the molecules they have supposedly discovered, without ever describing what the carbohydrates are; The team gives molecular weight by chromatography rather than by ultracentrifugation, which was the norm even 20 years ago.


Newsletter contents copyright 1999, National Council Against Health Fraud, Inc.
Items may be be reprinted without permission if suitable credit is given.

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