Biotechwiz

DIABETES

On the third of March 2010, UK based leading stem cell Therapy Company ReNeuron announced positive pre-clinical data for the treatment of Peripheral Arterial Disease (PAD) in Diabetic Patients using its indigenously developed Stem cell line ReN009. PAD occurs when there is a build-up of plaque in the arteries. This plaque generally is made up of fats and cholesterol, calcium and fibrous components of the body. Periodic build-up of such fats in the arteries can cause them to harden and narrow the lumen (Hollow space) of the artery. This narrowing prevents proper blood flow within the body. Known as Atherosclerosis, this generally affects blood flow to the legs but can also affect flow to kidneys hands and other parts of the body. PAD is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, amputation.  PAD is commonly associated with other conditions, including diabetes, obesity and stroke.  At least 1 in 20 people over the age of 55 have some degree of PAD and it becomes more common with increasing age. For more on this disease please click here

The current research was conducted in collaboration with Professor Paolo Madeddu, Dr Rajesh Katare and colleagues at the Bristol Heart Institute, University of Bristol, UK, and is based on earlier successful pre-clinical efficacy studies with ReN009 conducted by that group.  In this latest study, researchers tested the newly-developed freeze-thaw formulation of ReNeuron’s CTX stem cell line, via intramuscular injection, in a recognized diabetic mouse model of hind limb ischaemia.  The CTX cell line forms the basis of ReNeuron’s ReN009 therapy for PAD as well as its ReN001 therapy for stroke.  Initial clinical trials with ReN001 are due to commence in the UK shortly, following following final regulatory approval last month.¹

The results of the new ReN009 study initially showed that the diabetic mice had reduced blood flow capacity compared to the non-diabetic control mice. When treated with the ReN009 cells, the diabetic mice exhibited a significant and dose-dependent recovery of blood flow to the ischaemic limb, with significantly increased re-vascularisation of the damaged tissue as measured by increased capillary and arteriole density.  These results were presented by poster at the Diabetes UK Annual Professional Conference in Liverpool, UK, running from 3-5 March.¹

This therapy is being developed as an allogenic (non-patient specific) stem cell treatment for late-stage PAD, or critical limb ischaemia, in diabetic patients for whom PAD is a side-effect of their diabetes.  In diabetic patients, PAD progresses rapidly with vascular surgery showing a poor prognosis and many a times leaving doctors with only amputation as the option for treatment.  A stem cell- based therapy like the ReN009, offers hope to be able to enable the rebuilding of the vascular system in the limb and hence restoring blood flow to that limb and probably preventing amputation.

This is one technology to look out for! !

RETINITIS PIGMENTOSA

On February eighteenth, 2010, ReNeuron announced that its collaborative research in the US with the Schepens Eye Research Institute at Harvard Medical School would receive a boost in terms of funding from a private company in the US. The aim this time is to take research to the clinics in the US for the treatment of the disease known as Retinitis Pigmentosa. Retinitis Pigmentosa is a group of inherited disorders characterized by progressive peripheral vision loss and night vision difficulties (nyctalopia) that can lead to central vision loss. For more on this disease, click here.

This will be the first phase of a two year translational programme to take human retinal progenitor cells (hRPCs), a cell line that has been designated as ReN003 and extrapolate results to human patients in the US. This phase will aim to demonstrate an improvement in vision after grafting of hRPCs in ophthalmic disease models.

Following transplantation in a rodent model of damaged retina, the hRPCs were seen to integrate with the host retinal tissue and differentiate to express the protein rhodopsin, a marker for the light- sensitive rod cells found in healthy retina. This research has tremendous implications not only for Retinitis Pigmentosa, though this is the initial target, but also for other degenerative and age-related disorders affecting sight, such as age-related macular degeneration and diabetic retinopathy. The lead investigator of these studies at the Harvard medical School is Dr. Michael Young.

I hope that both the experimental treatments outlined above will be reality soon and we will be able to bid goodbye to debilitating and even life-threatening disorders such as the ones outlined here very soon.

References:

1. http://www.reneuron.com/news__events/news/document_239_237.php
2. http://www.reneuron.com/news__events/news/document_237_237.php

Stem cell therapy has drawn a lot of interest lately. This therapy has shown promise in treatments of a large number of life- threatening and/or debilitating disorders that are genetic in nature. Stem cells are like base cells. They are like clay that can be molded into any desired shape. These master cells are multi potent and if given optimum conditions, they can be induced to grow into any one of the various  types of differentiated cells in our body; for example Brain or liver cells. Thus these special cells have two important attributes: 1. They can renew themselves by cell division even after relatively long periods of inaction. 2. Once they have divided, each daughter cell can either remain as a stem cell, retaining all its pluripotency or it can differentiate into any one of the different organ types in the body. Stem cells also exist in various tissue systems to serve repair functions.

Typically stem cells are divided into adult stem cells and embryonic stem cells. Embryonic stem cells are derived from the Blastocyst stage of Embryos. Embryonic stem cells can generally give rise to almost all the different cell types in the human body. Adult stem cells on the other hand, generally give rise only to all the different cells of the particular tissue from which they are derived. What does this mean? In simple terms, Hematopoetic Stem cells derived from bone marrow can give rise to all the different types of blood cells but not to cells of a very different organ system such as neurons of the brain. So in a sense they are of limited capacity. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be “reprogrammed” genetically to assume a stem cell-like state. This new type of stem cell is called induced pluripotent stem cells (iPSCs).

The unique properties of these cells have given rise to a new field of research known as Regenerative or Reparative medicine. This field is defined as the field of medicine dedicated to the use of stem cells for treatment of diseases by inducing them to differentiate into the tissue type that has been destroyed. A large number of Genetic diseases are now currently being treated by the use of Regenerative therapy. Acute Lymphoblastic Leukemia, Common Variable Immune Deficiency, Hunter’s Syndrome, Thalassemia, and Tay Sach Disease to name just a few are being treated using these therapies.

So What Is Cord Blood?

Cord Blood

After the birth of a baby the umbilical cord that forms the connection between the mother and child when still in the womb is cut. Even so, some blood remains in the blood vessels of the placenta and the attached umbilical cord. The baby now no longer has need for this blood which is called placental blood or umbilical cord blood: “cord blood” for short.

Cord blood contains all the normal elements of blood – red blood cells, white blood cells, platelets and plasma. But it is also rich in hematopoietic (blood-forming) stem cells, similar to those found in bone marrow. Cord blood, therefore, is being used increasingly on an experimental basis as a source of stem cells, as an alternative to bone marrow. Most cord blood transplants have been done to treat diseases of the blood and immune system. It has also been used to restore the functional deficiencies of several genetic metabolic diseases. Scientists are investigating the possibility that stem cells in cord blood may be able to replace cells of other tissues such as nerve or heart cells. Whether cord blood can be used to treat other kinds of diseases will be learned from this research.

In this context, I would like to quote from a 2007 document released by the American Diabetes Association with respect to a clinical trial carried out using Cord Blood cells. “In a small pilot study, transfusion of stored, autologous (i.e. the person’s own), umbilical cord blood into a group of children newly diagnosed with type 1 diabetes appears to have reduced their disease severity, possibly re-setting the immune system and slowing the destruction of their insulin-producing cells, according to a report presented at the American Diabetes Association’s 67th Annual Scientific Sessions.” “After only six months, it is too early to tell how long the children will benefit from this therapy, but early signs indicate that it may have helped enhance blood glucose control and management,” said Michael J. Haller, MD, Assistant Professor of Pediatric Endocrinology at the University of Florida College of Medicine and lead author of the study, “but more important than the potential benefit in these children, this first use of cord blood in diabetes will help us focus on what it is in the cord blood that yielded the benefit,” he said. “We then hope to isolate and grow that cell type to develop therapies for a larger pool of people, not just those who have stored cord blood.” He discussed how such a cellular therapy might be one component of a future immune-modulating “cocktail.” This I think underlines the basis of all stem cell related therapy.

In a study in rats, it was shown that, Intravenous injections of cells from human umbilical cord blood improved the neurological and motor function of the rats that were recovering from severe traumatic brain injury. This was demonstrated by researchers at Henry Ford Health Sciences Center (HFHSC), Detroit, and the University of South Florida (USF), Tampa. If this is indeed true, then we will have hit upon a relatively easily obtained source of stem cells that can be safely collected and screened and stored for future use.

What is even better is that unlike bone marrow or organ transplants an exact match of cord blood antigens is not necessary.

What Is Cord Blood Matching?

HLA matching

Whenever any type of transplantation is carried out, organ transplants or blood transfusions, it is necessary to “match” markers that are known as antigens of the donor and the recipients. What are these antigens? They are proteinaceous ‘tags’ or molecules that are present on surfaces of cells and tissue of our body. These tags define our uniqueness. The moment a foreign ‘tag’ enters our system; our body senses it and we mount an immunological response to the same. This is known as rejection. So if a person undergoing a kidney transplant for example, receives a kidney whose tissue has antigenic tags that are very different from those of his own kidney, his body will attack the transplanted kidney and he will have what is known as a Graft Rejection. Similar is the case with blood transfusion and hence only after determining the relevant blood group can the transfusion be successfully accomplished. Rejection reactions are extremely strong reactions and can be fatal. Thus, the advantages of not requiring a complete antigenic match while using cord blood for cure become evident. In a cord blood transfer, the antigens that are matched are known as HLA (Human Lymphocyte Antigens); the same ones that are matched during organ transplants. Now there are a large number of different HLAs found in our tissues so not all of them are matched for reasons of practicality. Out of all of these, 6 important antigenic clusters that are found to be of prime importance in rejection processes have been identified. These major groups are, HLA A, B and DRB1. Complete matches between the donor and the recipient would mean 2 pairs each Of HLA A,B and DRB1; a total of six. This complete match is known as a 6/6 match or a 6/6 HLA match. Sometimes an additional set of antigens are used for better matching. These are, HLA C and DQ. Thus, complete matching of these additional markers yield a total of 10 points. So, one may have a 6/10 match or a 10/10 match or a 5/10 match. Generally, the first 3 antigens are used and a 6/6 match is considered perfect. While a 5/6 match works best, a large number of successful procedures have been carried out using just a 3/6 match that is only 3 out of the stipulated 6 markers match! That is incredible and it exponentially increases chances of success in finding a donor.  Today almost 70 different genetic disorders can be treated using Cord Blood.

Cord Blood Banking In India

The awareness about cord blood banking has seen a spurt in India, with a large number of companies entering the fray in order to set up such blood banks. Cord stem cell banks process leftover umbilical cord blood from the placenta and umbilical cord after the baby is delivered, and preserves by freezing them in liquid nitrogen at a temperature of -195 degrees celsius. Umbilical cord blood banks can be divided into two categories: private and public. In private banks, one can keep the umbilical cord for two decades, which can be claimed by the family or the patient. For example, At Lifecell, one such private bank, each client has to incur Rs 27,000 ($621 USD) as enrollment and processing fees and will be charged Rs 2,900 ($66 USD) every year as storage cost. For one-time payment, the cost comes to Rs 59,900 ($1,377 USD). The donor cannot stake claim from public banks. Similarly, The Apollo Group of Hospitals has also recently signed a memorandum of understanding with the American blood bank Histostem Inc to offer stem cell therapy to patients from South Asia. As part of the deal, Histostem India will train doctors and nurses at Apollo for stem cell treatment protocols and develop new treatment protocols with relevant regulatory approval. (Source). For a list of cord blood banks in India, please refer to this link.

The costs are still prohibitively high and out of reach of most middle class families in India. There are some incentives available through the banking sector in the form of loans, for example, StemOne Biologicals Private Limited formerly Cord Life Biotech had a strategic alliance with the bank ICICI.  Cord blood clients could obtain personal loans from ICICI to cover the cost of cord blood banking.  According to Stem Cells Research Forum of India (SCRFI), India’s stem cell market is growing at a rate of 15% per annum and is estimated to hit US $ 40 Million by the year 2010. As of 2008, StemOne Biologicals Pvt Ltd. is the only company in India offering the entire spectrum of stem cell related services: In addition to cord blood banking, they offer other forms of autologous stem cell cryopreservation.  StemOne is expanding to offer cord blood banking through more marketing associates and to support stem cell based therapies at medical centres. (Source).

The cost remains a major concern in India as also the putative benefits of the technology. However, If one has a history of genetic disorders in the family, onemight want to consider this technology that has changed millions of lives across the globe. Maybe, in time, we might be able to come up with schemes to subsidise the cost for poor and needy families and then Cord Blood Therapy will really have achieved a miracle ! !

REFERENCES:

Image Credit: 1.  Cord Blood: www.afroromance.com/blog/cord-blood-banking.htm

2. HLA match Diagram: www.marrow.org.

Well, while we are on the subject of transgenics, the current news byte seems to be right on target. The latest in transgenic technology also represents a break-through in the development of animal models for testing of viral diseases. Scientists at the Salk institute in La Jola have managed to develop a mouse that has a human liver. This research was carried out principally by Dr. Inder Verma.What this means is, that the animal now sports a liver that is made up almost entirely of human hepatocytes. This will make it easier to use this mouse as a model to study human viruses affecting the liver such as Hepatitis B and C.

THe Humanised Mouse !

The problem with viruses is their host specificity. What this simply means is, viruses attacking a human being will generally have no effect on a mouse and vice versa. While this is good as the non- human viruses will not spread rapidly and infect humans, it does present substantial problems to scientists trying to study the pathology of human viruses and developing vaccines and drugs for the same. Since one cannot test therapies directly on human beings, a viable alternative needs to be provided. In the past, we have experimented with using in vitro cell cultures; liver cells grown in a Petri dish. However, this model has severe limitations due to the lack of proper organ structure and complete absence of the kind of interactions between cells and organs seen in a complete organism. Alternatives to this were to use animals such as mice that completely lacked a viable immune system (nude mice) for studying tumors of human origin. The tumors would be transplanted into these mice and their effects and probable curative measure would be studied.

However, this model has its side effects too. As Dr. Inder says, clinically speaking, a tumor does not start by acquiring millions of tumor cells from outside the system. It starts with one or two or ten cells that have lost control of their cell division cycle and hence keep on multiplying uncontrollably to give rise to a tumor. So, to that extent, transplanting a tumor into a mouse is really a fundamentally different process and may not yield real-time data as needed. However, with this new model where the mouse liver cells are literally taken over by human liver cells (Hepatocytes) so that they overgrow to give a liver that is almost entirely human, we will be able to study the actual process of tumorigenesis or viral infections along with the possible cures and vaccination methods.

This physiological change was confirmed when these ‘humanised’ mice were subjected to challenge with the Hepatitis B and C viruses. The normally resistant mice developed the infection clinically. As we have already discussed, the initial resistance to these viruses was due to the host specificity of the viruses. The receptors required by the HBV or HCV were not to be found in the mouse liver and hence the immunity. Now, however, with a human liver, these mice became susceptible to the infection just like their human counterparts.

Dr. Inder Verma: Salk Institute

What was even better, the current first line of treatment for Hepatitis C worked just as well as it does with the human liver. This treatment consists of using Pegylated Interferon. What is Pegylated interferon? Well, interferon is a natural protein produced by our bodies in response to a viral infection. It works by inducing resistance to the infecting virus in the cells surrounding a virally infected cell in the body. It is therefore like a chemical signal sent out by a cell that has already been infected to the other healthy cells to raise their defences. Now, this natural interferon molecule was coupled with the chemical Polyethylene Glycol via a process called Pegylation (Technical definition of the process¹: PEGylation is the technique that involves the modification of a protein, peptide or nonpeptide molecule (drug) by covalent attachment of one or more PEG molecules for the purpose of enhancing therapeutic value. Advanced PEGylation10 involves attaching specific, modified polyethylene glycol (PEG) polymers to biomolecules) to yield what is known as Pegylated Interferon. The commercially available molecule is Pegasys (Pegylated Interferon Alpha 2a). The mode of action of this drug is as yet unclear. It is thought to bind to specific cell-surface receptors, suppressing cell proliferation and viral replication. It has also been observed to increase the effector protein levels and to reduce white blood cell (WBC) and platelet counts.

PEGylation is necessary for the reasons such as increasing the solubility, stability, circulation half-life, for minimizing the rapid kidney clearance, for achieving the controlled release, etc. Advanced PEGylation overcomes the drawbacks of the earlier technology. Four types of bioconjugates of PEG comprise conjugation with peptides and proteins, with lipids, with low molecular weight drugs and with biological macromolecules. PEGylation is widely applied in various fields viz. medical, diagnostic, synthesis of peptides and carrying out some organic synthetic reactions.¹

The applications of this chimeric mouse are tremendous and it will boost research and investigations into viral disease, vaccination and cure. This study has been published on February 22 in the Journal of Clinical Investigation. Dr Inder M. Verma is a Professor, Irwin and Joan Jacobs Chair in Exemplary Life Science,  Laboratory of Genetics, at the Salk Intstitute. For a detailed profile please click here.

REFERNCES:

1. www.kppub.com

The debate on the modified Brinjal seemed to have ended when Indian Union Minister for Environment and Forests, Jairam Ramesh abruptly calling off the battle and settling for a 2 year moratorium on the commercial release of the Bt-Brinjal in India. However, he made it clear that this decision was for Brinjal alone and as of now did not apply to all the other modified foods in the pipeline. So, we must prepare ourselves for the inevitable controversies that might arise once these other modified veggies are forced into the limelight. Of course the Government is now seriously looking at a National Biotechnology Regulatory Authority (not approval, mind you, but regulatory) for assessing the safety and putative efficacy of these crops. The idea, while supported in principle by most sections, nevertheless has incurred some negative comments. Many scientists and activists regard the move with suspicion as it has been mooted by the Department of Biotechnology, which has a vested interest in promoting transgenic Crops in India.

The war is not over even as far as the various Ministers and Departments of the Government of India (GOI) are concerned. Agriculture Minister, Sharad Pawar wants the moratorium reversed as he feels the current data provided by the Company (Monsanto –Mahyco) and the tests carried out by them are sufficient to warrant commercialization of the crop. Similarly, though not directly opposing the Moratorium, Minister Prithviraj Chauhan says that he is “satisfied with the tests carried out by the scientists but not opposed to further tests for evaluating safety.” With all this strong posturing and severely divided scientific opinion, the Prime Minister Manmohan Singh has been forced to step in and prevent a full-blown face-off between his ministers. He will meet with the ministers today and try to sort out the differences in opinion that have arisen. He will also try and clear the scene as far as the approval authority is concerned. Considering that the GEAC has come under flack for its controversial decision, the big question is if not the GEAC, who will be the next body that will decide the fate of the crops.

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Drew Endy

Drew Endy is a forty- something Engineer. He has earned degrees in Civil, Environmental and Biochemical Engineering and today he is a faculty of the prestigious Stanford University. So, what else is new?  one might ask. Well, what is new is that his passion for building things is not limited to the sterile world of machines and electronic parts alone. Drew Andy wants to get down and dirty with Biology! “I build things, that’s what I do”, says this self- effacing man who has become the face of one of the newest kids on the technology block; Synthetic Biology. And what is this Synthetic Biology?

Wikipedia defines Synthetic Biology as follows: Synthetic biology is a new area of biological research that combines science and engineering in order to design and build (”synthesize”) novel biological functions and systems. A more technical definition states, “Synthetic biology refers to both:

• The design and fabrication of biological components and systems that do not already exist in the natural world  &,
• The re-design and fabrication of existing biological systems”.¹

To make matters simple, Synthetic Biology aims to use the components of nature as building blocks to build hitherto non-existent systems. So, how is this approach supposed to be different from the current field of Genetic Engineering? Well, in the latter, scientists cut and chop pieces of DNA, the fundamental molecule of information in living systems, from different organisms and paste them together. The aim of this is to improve the existing system by augmentation with a desirable trait from another DNA molecule. So, we have the easily cultivable E. coli cell spliced with genes producing Human Insulin yielding virtual factories of this much-needed molecule. Or we have crop plants spliced with genes to increase their tolerance to salt or to improve their yield or size of the grain, all efforts to improve the existing quality of the plant.

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Well, the world celebrated the Birthday of Charles Darwin on the twelfth of February, a few days back. International Darwin’s Day was observed in many Universities and Colleges of the World where special events and conferences marked our tribute to one of the greatest naturalists and Scientists of our time. This unassuming man defied his fate so to speak and became a scientist instead of a clergyman, much against his father’s wishes.

Battling his intense fear of the sea, he undertook the now legendary voyage aboard the HMS Beagle, and collected and classified a colossal number of specimens, both plant and animal. In fact, he even collected mineral rocks and skeletal remains. So great was his passion for collection and identification, that he began observing details that had earlier been overlooked. From these details emerged a theory and he wrote his seminal work, “On The Origin of Species”.

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We have all heard of stem cells. These are the magical ‘starter cells’ that have the capacity to grow into any type of differentiated cell of the adult body. If given optimal growth conditions and with some amount of external hormonal supplementation, theoretically one can induce these multi-potent cells to grow into say liver cells, or brain cells for that matter.

The discovery of this unique potential of these cells led to the probability of using them for therapy. What If these stem cells could be harvested and grown externally in a medium and then transplanted into patients having a chronic dysfunction of cells or organs systems? This would indeed be a much-needed breakthrough in the field of therapeutics. Thus was born the idea of Stem Cell Therapy. The process of injecting stem cells into a person or organism to repair specific tissues or to grow organs is known as Stem Cell Therapy.

Over the years Stem cell research has progressed significantly and the latest news in this field stands testimony to the hard work and relentless research of scientists working in this field. The ReNeuron Group on the second of February, 2010, announced that the UK Gene Therapy Advisory Committee (GTAC) has given a “full and final Favorable Opinion to ReNeuron’s proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke.”  The GTAC is the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK. The ReNeuron Company is a Guildford (UK) based stem cell research company. This approval represents the final stage in a long process the company has been going to through to gain approval to test its expanded neural stem cell line on patients suffering from Ischemic stroke. In the official website, the company makes the following declaration:  ‘We have received regulatory and conditional ethical approvals to commence a ground-breaking Phase I clinical trial in the UK with our lead ReN001 stem cell therapy for disabled stroke patients. We are developing stem cell therapies for a number of other conditions, including peripheral arterial disease and diseases of the retina.’ continue reading…

In a move that took the nation by surprise, Indian Minister for Environment and Forests, Jairam Ramesh, announced a moratorium on the commercialization of Bt-Brinjal. He did this almost a day ahead of schedule and managed to leave everyone amazed at the speed with which the decision was made. Coming in the wake of heated and emotional debates with farmers, scientists, environmental groups and various other stake-holders, held across India, the decision has come as a huge relief for marginal farmers who would have borne the brunt of this technology to the hilt. Also, I personally consider this to be a victory of activists like Dr.Vandana Shiva, who have been battling the skewed policies of Monsanto for years now. The furore created by the current food-crop has been instrumental in making the government listen to sane voices instead of simply pushing an invalidated and potentially dangerous technology down our throats. So I guess it is a victory for democracy as well. This debate has taught us many important lessons, and I think this is a good opportunity to learn from them and to enable ourselves to build a strong, unbiased and scientifically irrefutable system for regulating the entry of new technology in this country.

Jairam Ramesh

In a hurried press conference on Tuesday night, Mr. Ramesh, announced the moratorium on Bt-Brinjal, which has been marketed in India by Mahyco-Monsanto. The moratorium will last “till such time independent scientific studies establish, to the satisfaction of both the public and professionals, the safety of the product from the point of view of its long-term impact on human health and environment, including the rich genetic wealth existing in brinjal in our country,” said Ramesh. He further went on to say, “If you need long term toxicity tests, then you must do it, no matter how long it takes… There is no hurry. There is no overriding urgency or food security argument for [release of] Bt brinjal. Our objective is to restore public confidence and trust in the Bt brinjal product. If it cannot be done, so be it.” He made an important point as far as seed security and biodiversity are concerned, saying, “I don’t believe India should be dependent on the private sector seed industry, I believe seeds are as strategic to India as space and nuclear issues.”

Dr M S Swaminathan

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In what is turning into the most awaited event of the year, the countdown to the decision on the fate of our beloved Brinjal has begun. I am sure there are millions like me waiting with bated breath for Union Minister for Environment of the Government of India to pronounce judgment on the commercialization of the controversial Bt-Brinjal crop, the very first food crop to be approved for direct human consumption in the world. The decision is to be made tomorrow, after tumultuous public debates organized by the minister across India with the major stake-holders in the current situation, namely, Farmers, Social activists, Consumers and Scientists. Seldom has any debate been so heated or has any Minister lost his head so many times even going so far as to tell opposing activists “to get your heads examined”. He further went on record last night on national television saying that he did not want to make anyone happy. But, I humbly submit Mr. Ramesh that you seem to be missing the point by a long shot. You are not voted to power to make people happy but to see to it that the constitution of the country is safeguarded and that justice is done to all sections of society in any matter that comes before you.

As we wait for the announcement to be made, the debate has far from ended. Hot discussions in scientific and social circles still abound and opinion is sharply divided. In this situation, I thought I must make an effort to summarize the implications of the impending decision one way or the other. This is by no means a complete argument or statement of facts however, as the sheer volume of data and papers available on the matter of GM available nationally and internationally is overwhelming. I have just tried to pin down some of the aspects that have repeatedly come up during this fantastic debate.

Brinjal-In the Eye of the Storm

If We Say Yes To The Commercialization Of Bt-Brinjal

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Some interesting facts: ³

GM tomatoes: The first and only safety evaluation of a GM crop, the FLAVR SAVR^TM tomato, was commissioned by Calgene, as required by the FDA. This GM tomato was produced by inserting kanr genes into a tomato by an ‘antisense’ GM method. The test has not been peer-reviewed or published but is on the internet. The results claim there were no significant alterations in total protein, vitamins and mineral contents and in toxic glycoalkaloids. Therefore, the GM and parent tomatoes were deemed to be “substantially equivalent.”

In acute toxicity studies with male/female rats, which were tube-fed homogenized GM tomatoes, toxic effects were claimed to be absent. However: Some rats died within a few weeks after eating GM tomatoes.

• The unacceptably wide range of rat starting weights (±18% to ±23%) invalidated these findings.
• No histology on the intestines was done even though stomach sections showed mild/moderate erosive/necrotic lesions in up to seven out of twenty female rats but none in the controls. However, these were considered to be of no importance, although in humans they could lead to life-endangering hemorrhage, particularly in the elderly who use aspirin to prevent thrombosis.
• Seven out of forty rats on GM tomatoes died within two weeks for unstated reasons.
• These studies were poorly designed and therefore the conclusion that FLAVR SAVR^TM tomatoes were safe does not rest on good science, questioning the validity of the FDA’s decision that no toxicological testing of other GM foods will in future be required.

GM maize: Two lines of Chardon LL herbicide-resistant GM maize expressing the gene of Phosphinothricin Acetyltransferase Enzyme (PAT-PROTEIN) before and after ensiling showed significant differences in fat and carbohydrate contents compared with non-GM maize and were therefore substantially different. Toxicity tests were only performed with the PAT-PROTEIN even though with this the unpredictable effects of the gene transfer or the vector or gene insertion could not be demonstrated or excluded. The design of these experiments was also flawed because:

Rats’ ability to digest was decreased after eating GM corn.

• The starting weight of the rats varied by more than ±20% and individual feed intakes were not monitored.
• Feed conversion efficiency on PAT-PROTEIN was significantly reduced.
• Urine output increased and several clinical parameters were also different.
• The weight and histology of the digestive tract (and pancreas) was not measured.

Thus, GM maize expressing PAT-PROTEIN may present unacceptable health risks.

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