DBT guidelines questioned on toxicity studies for Bt brinjal

Even as the Genetic Engineering Appraisal Committee (GEAC) decided to constitute a sub-committee to review the toxicology data generated by two applicants for genetically modified brinjal, biologist Dr. Pushpa M. Bhargava has questioned the guidelines of the Department of Biotechnology (DBT) on transgenic crops.

Dr. Bhargava and others had asked for the raw data on toxicity studies on rats using transgenic brinjal, which were carried out by Dr. Sesikeran, former director of National Institute of Nutrition at Hyderabad.

He found statistically quite significant differences between rats fed on Bt Brinjal and those fed on a normal meal in respect of several important parameters, said Dr. Bhargava.

However, Dr. Sesikeran had said that as all the values (both of the control and of the experimental animals) fell within the normal range of variation, the differences were not significant, and that there was no need to repeat the experiment.

Our point was that if on repetition the same differences are found again, they are bound to be significant, Dr. Bhargava pointed out. Further, he used only 20 animals (10 female and 10 male) in both experimental and the control groups, which is the minimum number for such tests. Dr. Sesikeran must explain why only a minimum number was used, he said.

In a letter to Dr. Ranjini Warrier, member-secretary, GEAC, on July 23, Dr. Bhargava, who was responding to the two emails of July 20 from Dr. Sesikaran to all the members of GEAC, said, According to Dr. Sesikeran, DBT guidelines of 2008 say the following in regard to Interpretation of results of safety studies: The design and analysis of the study should be kept as simple as possible, avoiding unnecessarily complex, sophisticated statistical techniques. If the design is simple, the statistics are likely to give straightforward results. Non-statistical knowledge must be applied in study design and proper interpretation of the biological significance of the results. Just because two treatments are statistically significantly different does not mean that the difference is large enough to have any biological importance or any practical significance.

Dr. Bhargava said he would like to know which international body endorsed this as scientifically; it does not make any sense. In fact, every sentence in this statement is flawed. For example, what is meant by the statement, If the design is simple, the statistics are likely to give straight forward results. Then, what is Non-statistical knowledge that must be applied in study design and proper interpretation of the biological significance of the results.

Further, the last sentence is biased and misleading, he said.

Surely, if the same statistically significant difference between the control and the experimental group in regard to a particular parameter is observed in repeated experiments, it is bound to have biological importance irrespective of the values falling or not falling between the normal range of variation. This can be verified by referring to any independent biology-oriented statistician of stature in India or abroad, Dr. Bhargava pointed out.

He asked the GEAC to respond to some questions he has raised in the next meeting.

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DBT guidelines questioned on toxicity studies for Bt brinjal

Skinspirations Study Supports Medical Findings: Stem Cell Treatment Triggers Tissue Regeneration

Tampa Bay, FL (PRWEB) July 28, 2014

Nearly 53 million Americans today are suffering with arthritis, with the majority of them diagnosed with osteoarthritis. (1) Osteoarthritis is a degeneration of joint cartilage and its underlying bone, causing significant pain and stiffness. While osteoarthritis has no cure, stem cell therapy has been demonstrated to induce profound healing in many forms of arthritis, according to the Stem Cell Institute. (2) Dr. Cynthia Elliott of Skinspirations, a center for cosmetic enhancement devoted to non-surgical aesthetics and now also specializing in administering regenerative medicine by stem cell, has made use of these services in a recent case study, which resulted in improved health in one of their clients.

Stem cells are unique from other cells for the following reasons:

(a)They can renew themselves through cell division; and (b)Under certain conditions, they can become tissue or organ-specific cells.

Stem cells are revered for their ability to make replacement tissues, as it relates to regenerative therapy. (3) Medical scientists and researchers are discovering the seemingly endless possibilities of what stem cells can treat, including brain damage, bone repair, kidney disease, etc. (4) This treatment is starting to boom in the medical world as a viable procedure, but Skinspirations has already had these practices in place, establishing them as progressive practitioners in the field.

Skinspirations is specifically studying the Stromal Vascular Fraction (SVF)another term for stem cell treatmentand how it affects knees with severe arthritis. According to Dr. Elliott, Stromal Vascular Fraction can help to repair, replace and restore any damaged cells within the bodyDr. Elliott performed the stem cell procedure on her uncle after first treating other patients during her training, and he experienced the following results:

Case in Point:

Joe Elliott, a 63-year-old male, had severe arthritis in one knee. Doctors advised him to get a knee replacement, but Joe was hoping to avoid surgery for as long as possible. After talking to Dr. Elliott about the treatment, he drove to Skinspirations from Missouri to go forward with the stem cell procedure.

Dr. Elliott performed the treatment with the following steps:

(1)Numbed his abdomen with anesthesia; (2)Removed about 100 cc of fat; (3)Processed the fat to isolate the SVF; (4)Numbed the arthritic knee; and (5)Injected the pellet of SVF into the joint of his arthritic knee.

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Skinspirations Study Supports Medical Findings: Stem Cell Treatment Triggers Tissue Regeneration

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