Bio Miracle Life Sciences Pvt. Ltd, based in Pune, India, is aggressively marketing a blood test that they claim can detect "persons at risk of cancers, one year before the currently used diagnostic imaging methods can barely detect the presence of cancer cells in the body." The discoverer is said to be Dr. MB Sahasrabudhe, a former dean of the TATA Cancer Research Institute in Mumbai. The test is claimed to detect, by immunoassay, lymphocytes sensitized against a common cancer antigen‚ or "tumor mimetic antigen," which the promoters claim is shared by all cancers. They claim that the test has a sensitivity of 83.33% and specificity of 96.87%. My colleagues and I believe that this test has no scientific merit whatsoever and is deceptively marketed.
Questionable Scientific Rationale
According to the Biomiracle Web site:
Detecting the presence of lymphocytes specifically sensitized to tumour antigents,in the circulating blood, is immunologically the most reliable and sensitive method of detecting the presence of all types of cancers located anywhere in the body. Since 1 ml of peripheral blood contains about a million and half lymphocyte (sensitize fraction of these are witness for our purpose who can vouch for the presence of cancer cells located somewhere in the body), the sensitivty of detection is increase at least thousand fold if not more. We use Enzyme linked Immuno Sorbent Assay(ELISA) for detecting the presence of sensitizing lymphocytes. It requires only 5ml blood and 2 hours of time.
Realising the total absence of diagnostic and imaging methods for detection of cancer during first 14 months, a method which would detect the presence of assymtomatic cancer was desired. The only method that could pick out person at the risk of cancer would be through periodic health check-ups. Keeping this in view, Dr. M. B. Sahasrabudhe who was formerly Head of Chemotherapy Division and Dean Cancer Reasearch Institute(CRI), Tata Memorial Centre, Bomay has evolved an In-Vitro blood screening technique for detecting presence of cancer cells in the body. . . .
Person above 35 years of age should do the test at least once in a year.
12. What is the uniqueness of High Risk CANCER Indicator (HRCI TEST) marketed by Bio Miracle?
HRCI TEST is a simple blood test, which can detect even if there are only a few CANCER cells in the body.
How to identify a cancerous cell from a normal cell? – Scientist / researchers world over have been working on this. After hundreds of cell surface markers, cell products, metabolic pathways and gene mutations, the answer was found in the Immune system.
In response to the tumor antigen, the B-lymphocytes (WBC) get sensitized. The B-lymphocytes that have encountered the CANCER cells retain the memory. The sensitization is perpetuated in the subsequent generation of the B-lymphocytes through transfer of immunological memory.
Normally the CANCER cells evoke immune response in 5 to 10 days of its coming to being and later it hides itself. Hence the person becomes asymtomatic. These sensitized B-lymphocytes are then maintained and propagated by the tumor cells, which die of apoptosis or hypoxia. The presence of these CANCER-sensitized B-lymphocytes can now be detected by an ultra sensitive ELISA test, which forms the basis of HRCI. The test is positive for most epithelial CANCER
14. What is the credibility of the HRCI TEST?
HRCI TEST is an in - vitro diagnostic test for picking out B-lymphocytes sensitized against tumor markers, common to all types of CANCERS irrespective of the site of the disease or the cell type. After 65 years of research and clinical trials conducted at various institutes and with CRO, the summary shows substantial evidence of the utility of HRCI TEST to detect sensitized B-lymphocytes specific to tumor.
The principle of this test has been published in several International Journals and in Business India (June-july’03). This test has been patented in USA. The test is Rapid, Sensitive, and Accurate. It is immuno assay. The specificity of the test is 96.87% and the sensitivity is 83.33%.
Finding of a single tumor antigen common to all cancers would indeed be a revolutionary discovery, worthy of a Nobel prize, because it would have wide-ranging implications in treatment of cancer by immunologic means and developing anticancer vaccines besides development of reliable diagnostic methods. However, cancer is now understood to be a group of diverse diseases rather than a single disease. The pathogenesis of different cancers varies widely. As more is known about the mechanisms of oncogenesis, the hope that a single common antigen shared by all cancers can be found has receded. Understandably, no such common cancer antigen‚ has been found.
Sahasrabudhe has never published any article in peer-reviewed medical journals regarding such a common cancer antigen. In fact his last publication is more than twenty years ago.
Validation of a marker for cancer screening in asymptomatic people will generally require testing large numbers of subjects, most of whom will never develop cancer, and waiting many years for outcome data to accumulate. Calculation of sensitivity and specificity require comparing the test against a gold standard, which in this case would be diagnosis or nondiagnosis of cancer by a reliable method many years after the test under evaluation is done.
It is clear that no such studies have been done in this case. The test methodology, clinical trials, subject selection etc. have never been published in peer-reviewed literature. In absence of such evidence how can the medical community evaluate such a test? It is further claimed to have been published and acclaimed in the journal, but no citation for such an article is given. From the company website and the brochures being distributed, we are simply provided with newspaper clippings and testimonials.
One Dr. Arvind V Kulkarni has been deputed by the company to defend the test when criticism regarding its scientific validity surfaced in Kerala. Trained as a radiotherapist, he practices and promotes various kinds of alternative medicine and is even a reiki master. In a press conference held at Calicut, he said that only two tests are available to detect early cancer, the Bio-miracle test and AMAS (Anti-Malignin Antibody in Serum). The latter 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 that offers the test. They claim to assay for a substance called "malignin," and for antibodies against it. Even 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. Both tests are promoted in alternative medicine literature as great breakthroughs in the total absence of proper validation studies. But Kulkarni hides these facts even as he is presented to the media as a reputed medical researcher.
Even if all the claims regarding efficacy of the test in detecting very early cancer is accepted, the question of clinical utility remains. Suppose an apparently healthy person tests positive; what are you going to do about it? Especially when even the site of origin of the malignancy remains mysterious. One would have to investigate all organs with the most sophisticated of tests incurring astronomic expenses and if the test proponents were to be believed, the site would still remain elusive. Meanwhile the person diagnosed to have cancer would remain scared to death with no line of management in sight. The most elementary ethical principle of cancer screening is that it is justified only if clear-cut intervention to produce positive impact on survival is possible. That is the reason why compelling evidence and relatively unanimous agreement exist for only three cancer screening recommendations: Papanicolaou (Pap) smears; mammography in women older than 50 years; and fecal occult blood testing (FOBT), flexible sigmoidoscopy or colonoscopy to screen for colon cancer. Unfortunately quacks do not go by elementary ethical principles.
It is no wonder that this unproven diagnostic test of dubious scientific merit has no sanction by the medical community. This is sought to be bypassed by the marketing technique described by the company as direct selling. It is in fact a classical case of Network marketing‚ or Multi-level marketing‚. Each person who undergoes the test at the cost of Rs 4990 can become a distributor by enrolling a minimum of one individual to the Bio Miracle family to be eligible to earn income through company‚s income plan. The distributor gets a cut of Rs 350 from each of the four others he/she enrolls at the first level. At the second, third and fourth levels the distributor earns Rs 25 each from the 16, 64 and 256 persons enrolled in the chain. Rs 100 each from the 1024 people enrolled is granted at the fifth level. According to the company website (http://www.killcancer.biz/businessrule.jsp) "At the end of 5 levels, your matrix commission alone is Rs. 1,12,200/-"
It is the allurement of instant riches rather than the need assessed by a doctor that prompts one to undergo this test. This is in direct contravention to all norms of medical ethics.
Need for Regulation
In the new age of biotechnology, it has become simple to mass manufacture various diagnostic testing kits. This includes various immunoassays and nucleic acid hybridization based tests like the DNA chips. These are instantly patented by the companies. To earn a patent, it is not needed to show scientific rationale or clinical benefit. Indeed most such tests would be marketed before any clinical trial to show efficacy is ever undertaken. More and more of direct selling and mass media campaigns will be resorted to. The marketers would have swindled thousands of unwary consumers before it is realized that the test is entirely useless.
Clearly there is need for Government regulation to check this kind of practice. It has to be insisted that any new diagnostic test should be based on published peer reviewed literature, which includes properly conducted clinical studies. A technical committee should be set up to evaluate the scientific rationality, clinical utility and cost-benefit of new tests based on published evidence submitted by the manufacturer. Laboratories should be warned that they risk losing licence by promoting or conducting non sanctioned tests. Network marketing has no role in ethical practice of medicine. It should be legally discouraged.
Biomiracle test is wake-up call for the medical community and the authorities.
Dr. Aravidan is Professor of Pathology at the Medical College in Calicut, India.
This article was revised on July 16, 2004.